Pfizer

Eyes, mouth & ears symptom reports

Female, 40 - 59 years

Age Reported Symptoms Notes
40 2020-12-31 eye twitching CAREGIVER RECEIVED FIRST VACCINE DOSE AND SOON AFTER BEGAN TO FEEL DIZZY AND HER EYES BEGAN TO TWITC... Read more
CAREGIVER RECEIVED FIRST VACCINE DOSE AND SOON AFTER BEGAN TO FEEL DIZZY AND HER EYES BEGAN TO TWITCH, FOLLOWED BY UNCONTROLLED SHAKING, WITH HIGH FEVER FOLLOWED BY SEVERE SHORTNESS OF BREATH AND GASPING, WITH TIGHTNESS AROUND THE CHEST. TRANSPORTED TO EMERGENCY DEPARTMENT. HAD MULTIPLE EPISODES OF ITEMS LISTED ABOVE WHILE IN ED, INCLUDING HEAVINESS IN HER LEGS AND TINGLING IN ARMS. SHE WAS DISCHARGED FROM ED AT 10:30PM BUT WAS READMITTED ON 12/24 TO ED FOLLOWING SIMILAR ISSUES. TO DATE SHE HAS HAD 5 RAPID RESPONSES IN HOSPITAL DUE TO REPEAT OF SIGNS/SYMPTOMS. CT AND PULMONOLOGY CONSULT SCHEDULED FOR 12/28/2020.
40 2021-01-01 ear itchiness Rash throughout scalp, face, neck, ears,torso,thighs,legs, arms, back, itchy throat and ears. Benad... Read more
Rash throughout scalp, face, neck, ears,torso,thighs,legs, arms, back, itchy throat and ears. Benadryl 50 mg Pepcid 40 mg Prednisone 60 mg The rash started after 1 hour. Took 25 mg benadryl then by 9 pm it got worse, took another 25 mg benadryl without improvement. Continue taking benadryl next day and took pepcid by 12 noon the next day. Following day 22nd December the patient went to hospital ER at 1200 noon. There got prescribed 60 mg prednisone PO with benadryl 50 mg and pepcid 20 mg. Received instructions to continue taking same dose for another 4 days.
40 2021-01-03 eyelid function disorder Chest started tightening then started having a hard time swallowing. Felt dizzy, faint, and as thoug... Read more
Chest started tightening then started having a hard time swallowing. Felt dizzy, faint, and as though I was going to pass out. Epi pen was administered when I wasn't able to swallow. Was taken to ER on a stretcher, however they said on the way, I wasn't responding and couldn't open my eyes. Muscles began cramping and loss sensation in limbs. Hands wouldn't open up as they cramped. Blood pressure kept going up and down.
40 2021-01-03 vision blurred Approx. 3 hours after being vaccinated. Developed confusion, dizziness, and blurred vision. Went to ... Read more
Approx. 3 hours after being vaccinated. Developed confusion, dizziness, and blurred vision. Went to ER. BP noted to be 163/100. After one hour and a half, BP in the 120's systolic and 90's diastolic. Continued to have blurred vision. Blood pressure became labile and continued to be in the range of 160's over 100's to 130/90's. After 48 hours, vision no longer blurred, Blood pressure returned to normal baseline and maintained. Took BP for over one week after, morning, noon, and night on the Left arm and Right arm. My BP stayed in the 117/70-120/80 range. Wanted to make sure I had no underlying hypertension. No other adverse issues.
40 2021-01-04 loss of smell, loss of taste Headache congestion clear nasal discharge throat pain and inflamation no smell no taste
40 2021-01-04 taste impairment Headache, nausea, metalic taste, general malaise, low back pain
40 2021-01-04 ear discomfort Severe headache, bilateral ear pressure, intense vomiting, chills, dizziness, fatigue, nausea
40 2021-01-04 mouth numbness, mouth tingling Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left h... Read more
Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; This is a spontaneous report from a contactable Nurse (patient). A 40-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: EK9231) on 23Dec2020 07:15 PM via unknown route of administration (vaccine location: Left arm), at single dose (first dose) for COVID-19 immunization. Medical history was reported none. Concomitant medications included ibuprofen. There were no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not use other vaccine in four weeks. Patient experienced Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in her left hand/fingers and the left side on her lip on 25Dec2020. Patient did not receive any treatment. The outcome of the events was not recovered. This case was assessed non-serious by reporter. The events did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.
40 2021-01-04 mouth numbness Intially started as lip numbness, then tongue, lasting for about 10-15 minutes. It went away, then ... Read more
Intially started as lip numbness, then tongue, lasting for about 10-15 minutes. It went away, then about 10 minutes later her Right arm became numb, then it returned to her lips on the Right side of her mouth, and then feeling wobbly, weakness on the Right leg. Elevated blood pressure, 182/112. Got medication prescribed and is lowerin blood pressure now, within an hour of taking medication, but numbness remains.
40 2021-01-04 lip swelling, tongue itchiness Patient with very mild swelling lip and itchy feeling of tongue. Given 37.5 mg Benadryl, all sympt... Read more
Patient with very mild swelling lip and itchy feeling of tongue. Given 37.5 mg Benadryl, all symptoms resolved.
40 2021-01-04 mouth tingling Hives, wheezing,SOB,itching, Tingling in tongue initially. 01/05/2021 Fever 100.8, headache and join... Read more
Hives, wheezing,SOB,itching, Tingling in tongue initially. 01/05/2021 Fever 100.8, headache and joint pain Treated with Albuterol inhaler and Benadryl 25mg x2
40 2021-01-04 swelling around the eyes Angioedema; This is a spontaneous report from a contactable Other Health Professional (patient). A 4... Read more
Angioedema; This is a spontaneous report from a contactable Other Health Professional (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL1284, intramuscular in the right arm (also reported as right shoulder), first dose on 22Dec2020 00:30 at a single dose for Covid-19 immunization. The patient's relevant medical history included severe reaction to some animal dander and pollen, severe reactions to poison oak, possible drug induced reactions (unspecified) post C-section, mild rash with influenza vaccine this year (2020) (with no other hx of adverse reaction to a vaccine); had allergies to pollen, mold, some animals. The patient previously took influenza vaccine (split virion, inactivated) and experienced rash. The patient had no covid prior vaccination nor was she tested post vaccination. Adverse event reported was angioedema on 24Dec2020 with outcome of recovering. Systems started appearing on 23Dec2020 evening with slight rash and fluid collection under right eye. Developed more rash on 24Dec2020. In the evening to early morning of 25Dec2020, symptoms worsened significantly. Rapid swelling to face occurred. Swelling was concentrated around eyes and cheeks the most. Both right and left side of the face and neck were affected. However, the right side face had a more pronounced reaction. MD ordered oral prednisone and Benadryl as treatment plan. Also, ordered episode-pen for a worst case scenario. Symptoms have been improving under treatment but still persist some. The events were reported as non-serious. The adverse event start date was 24Dec2020 (as reported). The event resulted in doctor or other healthcare professional office/clinic visit.; Sender's Comments: There is a reasonable possibility that the event angioedema was related to BNT162b2 based on known drug safety profile and temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
40 2021-01-04 sensitivity to light, eye pain eye pain; sensitivity to light; headache/Headache worsened/migraine; This is a spontaneous report fr... Read more
eye pain; sensitivity to light; headache/Headache worsened/migraine; This is a spontaneous report from a non-contactable healthcare professional. A 40-year-old female patient received BNT162B2 on 29Dec2020 12:30 at left arm at single dose for COVID-19 immunization. Medical history included chronic kidney disease. Concomitant medications included labetalol, lisinopril, tolvaptan (JYNARQUE), calcium, and ascorbic acid/ferrous fumarate (VITRON C). Patient experienced headache the night on 29Dec2020 21:00 after took the vaccine. Slept the night without much trouble. Headache worsened in the morning, almost felt like a migraine attack with sensitivity to light and eye pain etc. on 30Dec2020. Treatment was not received for these events. Outcome of the events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
40 2021-01-04 ringing in ears bilateral tinnitus; This is a spontaneous report from a contactable physician (patient). A 40-year-o... Read more
bilateral tinnitus; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiration date were not reported, intramuscular in the arm left, first dose on 19Dec2020 09:30 at a single dose for Covid-19 immunization. Medical history included hypothyroidism. The patient previously took penicillin and had allergy with hives. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with Covid 19 nor was she tested for Covid 19. Concomitant medication included levothyroxine. The patient noticed onset of bilateral tinnitus that was constant and new since the injection. She doesn't know that it was related but it was very new in onset about 24 hrs after the vaccine and quite an obvious change. She mentioned that she is only 40 and has no known hearing loss and an ENT physician so can pinpoint no other triggers. The event resulted to a doctor or other healthcare professional office/clinic visit. No treatment received for the event. The outcome of the event bilateral tinnitus was not recovered. Information on the lot/batch number has been requested.
40 2021-01-05 inability to speak Weak, nausea, hives, high fever 102.9 for 16 hours, chills, joint pain (arms, hips, legs and back), ... Read more
Weak, nausea, hives, high fever 102.9 for 16 hours, chills, joint pain (arms, hips, legs and back), symptoms improved after 32 hours. Loss of voice at 42 hours but has since came back.
40 2021-01-05 mouth tingling Started with tingling in arms and hands within 5 minutes, then tingling in tongue, and heart racing,... Read more
Started with tingling in arms and hands within 5 minutes, then tingling in tongue, and heart racing, lead to difficulty breathing and turning pale. Staff stuck me with an EpiPen in my right thigh and EMT was called and Benadryl was administered.
40 2021-01-05 mouth tingling Warmth at injection site Warm all over body Itchy tingling on my lips. Same feeling I have when I ea... Read more
Warmth at injection site Warm all over body Itchy tingling on my lips. Same feeling I have when I eat shrimp.
40 2021-01-05 taste disorder Chest heaviness and pressure about 10 minutes afterwards, got better then came back multiple times t... Read more
Chest heaviness and pressure about 10 minutes afterwards, got better then came back multiple times that same day. I also had sore throat and funny taste in my mouth. That night is when I mainly definite effects, chills, fatigue, body aches, low grade fever and head ache. Wednesday and Thursday I was in bed with fever, nasal congestion, body aches. Friday I started to feel better and function. By Saturday I was fine. Was in communication with my PCP. My daughter, 3 years old tested positive for Covid on 1/4/2021 and now I'm starting to feel bad.
40 2021-01-05 visual impairment I started seeing a squiggly bright circle. It started as a spot then grew to a bright outlined circl... Read more
I started seeing a squiggly bright circle. It started as a spot then grew to a bright outlined circle. I also started to get a headache. I took 3- 200mg ibprofen. About 10 minutes later, the vision problem went away.
40 2021-01-06 mouth numbness, lip swelling Swollen and numb upper lip; Swollen and numb upper lip; This is a spontaneous report from a contacta... Read more
Swollen and numb upper lip; Swollen and numb upper lip; This is a spontaneous report from a contactable healthcare professional, the patient. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1685), via an unspecified route of administration in the left arm on 31Dec2020 at 12:30 PM (at the age of 40-year-old) as a single dose for COVID-19 immunization. Medical history included diabetes mellitus, high cholesterol, and hypothyroidism. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included atorvastatin (LIPITOR), metformin, sitagliptin (JANUVIA), empagliflozin (JARDIANCE), and dulaglutide (TRULICITY). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jan2021 at 07:00 AM, the patient experienced swollen and numb upper lip. The events were reported as non-serious. The patient did not receive any treatment for the swollen and numb upper lip. The clinical outcome of the swollen and numb upper lip was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
40 2021-01-07 ear pain Employee woke with sensory disturbance on left side of face itchy sensation, left eyelid and bottom ... Read more
Employee woke with sensory disturbance on left side of face itchy sensation, left eyelid and bottom lip droop, left ear pain. She was ordered steroids by her PCP.
40 2021-01-07 mouth numbness, ear pain, pain in jaw Tingling and numb face and lips mostly on right side of face, right ear pain, right jaw pain, right ... Read more
Tingling and numb face and lips mostly on right side of face, right ear pain, right jaw pain, right side headache, sore arm at site, nausea, dizziness, lethargic
40 2021-01-07 mouth tingling Pfizer-BioNTech COVID-19 Vaccine EUA Patient experienced tingling tongue, odd taste on her tongue a... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Patient experienced tingling tongue, odd taste on her tongue and neck swelling. Actions taken: Patient stated she had her own 50 mg of Benadryl with her and had taken it at 1305. She states she has other reactions to medications in the past and it feels the same way. Patient monitored, EMS called and care transferred. Patient was alert and oriented.
40 2021-01-07 light flashes or floaters in the eye After receiving injection, patient reported SOB, chest tightness, hand tremor, and seeing stars. Ra... Read more
After receiving injection, patient reported SOB, chest tightness, hand tremor, and seeing stars. Rapid response called , patient observed for 30 minutes and walked to car. Patient then presented to emergency department at 12:06pm with concern for reaction and h/o heart mumur as a child. Patient referred to Urgent Care Clinic and presented at 12:30, endorsed headache and anxiety. Patient received acetaminophen 1,000mg PO x 1 dose, diphenhydramine 25mg PO x 1 dose, and ibuprofen 600mg PO x 1 dose in Urgent Care. Crackers and water given. Patient provided education on managing anxiety and discharged.
40 2021-01-07 swollen tongue, mouth tingling Patient report tingling of the tongue and pain with swallowing. Right side tongue swelling and righ... Read more
Patient report tingling of the tongue and pain with swallowing. Right side tongue swelling and right side facial tingling with difficulty to swallow occurred 45 minutes after receiving the vaccine. Patient took 50 mg of Benadryl after 10 minutes there was improvement and after 30 minutes it completely resolved. She woke up the next morning with HA and diarrhea she took Tylenol and will monitor.
40 2021-01-07 swollen tongue Acute allergic reaction Tongue swelling Facial swelling Throat swelling Rash on throat and chest Re... Read more
Acute allergic reaction Tongue swelling Facial swelling Throat swelling Rash on throat and chest Redness in throat Diaphoresis Momentary loss of consciousness
40 2021-01-07 ringing in ears Around at 7AM when I arrived at work I started feeling chills, took temperature 99.5F that is alread... Read more
Around at 7AM when I arrived at work I started feeling chills, took temperature 99.5F that is already elevated for me. About 9:30 my temp was 101.8F and they sent me home. I just had the chills and fever. I got home and developed a headache and around 1PM I started feeling really dizzy. The temperature did not subside and the next day I woke up and I couldn't function, I felt really dizzy I kept laying down and drinking water, I could not keep anything down my stomach did not feel well. I felt like I had to vomit. When I sat down in the toilet then my ears started ringing pretty bad all of a sudden I could not hear anything and I passed out in the toilet. My husband found me and tried to wake me up. After that I still feel dizzy. I did not have any appetite either. I could barely hold water. The next day I was not as dizzy but my stomach was still upset but I could hold some soup down but then started with diarrhea. Employee health kept calling me everyday and I did the the telehealth appt and I also had a little bit of a rash in my chest that appeared all of a sudden red like a streak. The dizziness I had for the first 4 days, diarrhea did not come until the 3rd day and I had it for 2 days and my temperature was back to normal on the 4th day. Everything started to get better (my stomach stopped feeling queezy) around the 4th day but still felt fatigued until about 12/29/2020.
40 2021-01-07 tongue discomfort bloody tongue; throwing up/puking; tongue burning two days later bloody tongue; chills; legs shaky; ... Read more
bloody tongue; throwing up/puking; tongue burning two days later bloody tongue; chills; legs shaky; intense migraine; nauseous stomach; I have not been this sick; This is a spontaneous report from a contactable other HCP (patient). A 40-year-old female patient received the first dose of BNT162B2, Lot number: Ek5730, intramuscular on an unspecified date at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 24Dec2020 03:00, the patient experienced intense migraine and nauseous stomach. On 24Dec2020 07:00, she started throwing up, chills, legs shaky and her symptoms had lasted from Christmas Eve until 29Dec2020. On 27Dec2020, patient's tongue was burning and two days later she had a bloody tongue. She stated, "I have not been this sick as far as I can remember it was awful. I am a healthy person I get the flu shot and any vaccine/shot necessary and have never been sick like this". Since the vaccination, the patient had been tested for COVID-19. She had a nasal swab and SARS cov 2 RNA for which she had a negative result on 29Dec2020. Stated that the test came back negative so these reactions had to be her body fighting off the vaccine. She stated she is no longer puking, no longer shaky or chills but faithfully at 3 am she woke up and had an intense migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any treatment for the events. The outcome of the events "chills", "legs shaky" and "throwing up/puking" was recovered on 29Dec2020. The outcome of the other events was recovering.
40 2021-01-08 pain in jaw 1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pa... Read more
1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pain, skin sensitivity (feeling like a sunburn when touched) chills and fever (100.4) around 8pm. 1/7/21: fever (101.1), headache, dental/jaw pain around 2am. Nausea started around 6am. Fever lasted all night till around 10am. Blood pressure 138/85 and resting HR 125 and fever started again around 12pm. Chest tightness during exhalation around 2pm. Went to the Emergency Room around 2:30pm. Fever and headache returned around 8pm and gone by 10pm.
40 2021-01-08 feeling of choking, mouth tingling, hearing loss 11:30 SHOT GIVEN, BY 11:40 FELT TINGLING IN LIPS AND THROAT AND HEART RATE 125 (MY RESTING HEARTRATE... Read more
11:30 SHOT GIVEN, BY 11:40 FELT TINGLING IN LIPS AND THROAT AND HEART RATE 125 (MY RESTING HEARTRATE IS 68), BY 11:45 TIGHTNESS IN CHEST AND NECK, HEARTRATE STILL 125 RANGE, NOON: BP 154/75 (MY NORMAL IS 96/58) AND HIVES 12:10 BENADRYL (25MG) GIVEN 12:25: BP 163/78 AND ALL OTHER SYMPTOMS STILL PRESENT 1:00 SECOND BENADRYL (25MG) GIVEN 1:11: BP 158/78 1:45 HEARING TURNED MUFFLED MOVED DOWNSTAIRS TO ER SECTION AT HOSPITAL GIVEN STEROIDS, PEPCID AND WATCHED FOR ADDITIONAL TIME ON 1/9/21: STILL ON BENADRYL AND STEROIDS: WOKE UP AT 8:00 AM SORE ARM AND SLIGHT HEADACHE, 9:00 RED SPLOTCHES ON FACE, NECK AND CHEST, 11:30AM ON 1/9/21: TIGHTNESS IN CHEST AND NECK CONTINUING STEROIDS AND BENADRYL
40 2021-01-09 eye swelling, lip swelling I received my 2nd dose around 11:15am on Wednesday. Approximately 6 hours after getting the shot I ... Read more
I received my 2nd dose around 11:15am on Wednesday. Approximately 6 hours after getting the shot I started feeling tired and a couple hours after that I felt crummy and the chills started. Mine weren't nearly as bad as some others have experienced. I didn't sleep well that night and woke up with a mild headache and body aches. Approximately 10AM on Thursday I noticed I had swelling in my upper lip and later my jawline with slight numbness. My eyes started feeling puffy that evening, approximately 6:30pm, and the symptoms began to improve after taking a Benadryl around 7:15pm. The swelling and numbness didn't seem to move down towards my throat nor did I experience any difficulty breathing or swallowing. I sl
40 2021-01-09 tongue itchiness Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice ... Read more
Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice with persistent wheezy cough after 5 min Progressed to itchy/burning/red face/chest/ears after 10 min. Wheeled to the emergency department 20-25 minutes after injection. Had to have benadryl, solumedrol, pepcid, zofran, and an epinephrine injection to stop the anaphylaxic reaction.
40 2021-01-09 toothache, pain in jaw headache and jaw/tooth pain on left side only evaluated by EMTs Vital signs stable , neuros intact, ... Read more
headache and jaw/tooth pain on left side only evaluated by EMTs Vital signs stable , neuros intact, lungs CTA
40 2021-01-10 taste impairment This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient r... Read more
This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient reports nausea, feels like throat is closing, change in her voice (hoarse), patient reports a metal taste in her mouth. Flushed cheeks, facial swelling and whole body was red and flushed, reddish spotting. Also reporting headache. She is still reporting the abnormal taste and headache.
40 2021-01-10 swollen tongue Tongue swelling, headache, tachycardia, elevated BP
40 2021-01-11 eye irritation, eye swelling Left eye feels full, swollen, chills.
40 2021-01-11 eye pain PAIN BEHIND EYES, HEAD TO EXPLODE DOWN BAck OF HEAD
40 2021-01-12 burning mouth syndrome, ear pain heaviness on the one/left side of her body; left ear pain; left side of tongue is sore; pain that we... Read more
heaviness on the one/left side of her body; left ear pain; left side of tongue is sore; pain that went down from her neck to her abdomen; pain that went down from her neck to her abdomen; injection pain on left arm.; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EJ1686, expiration date not reported), intramuscular on the left arm on 05Jan2021 at 15:00 to 05Jan2021 15:00 at SINGLE DOSE for Covid-19 vaccine. Medical history included allergies, gallbladder problems, and had a little diarrhea. Concomitant medications included famotidine (PEPCID) for any potential allergic reaction, and diphenhydramine hydrochloride (BENADRYL) for allergies, all are ongoing. On 05Jan2021, the patient experienced left ear pain, left side of tongue is sore, pain that went down from her neck to her abdomen, injection pain on left arm, and on 06Jan2021, heaviness in one/left side of the body. The patient is most concerned with the pain she is experiencing. The patient was calling about Covid vaccine and got her first shot yesterday, on 05Jan2021, around 3pm. The patient stated that they had her stay about 30 minutes to make sure no major side effects. She had gone home and noticed that her tongue on left side was swollen and persisted into the evening and had a little diarrhea. She was experiencing left ear pain and decided to lay down. She stated that when she laid down noticed that she had pain that went down from her neck to abdomen, that when she woke up this morning that she had pressure on left side of her body and everything else had gotten better. She clarified that it was not swollen but sore. She stated that the diarrhea is not related to the Covid vaccine but is because she had gallbladder problems, her gallbladder was taken out before the vaccine. She stated not pressure just heavy and that the arm was regular injection pain. She stated that the shooting pain in ears is continuous like she was getting an ear infection. She stated that the symptoms are all on her left side, she clarified pressure on left side as heaviness. Stated that the allergies were diagnosed way before Covid vaccine. The patient wanted to know if other people have experienced these side effects. She stated that left side of tongue swollen resolved overnight because she did not wake up with it. Later she clarified that her left tongue was sore. Resolved completely. She stated left ear pain started last evening, that it comes and goes. Stated that the pain that went from neck to her abdomen started yesterday evening and stopped yesterday evening. Stated her left arm is sore. Stated it is sore if she touches it and is okay if she is just sitting there. She stated that she took diphenhydramine hydrochloride 25mg in case her tongue was swollen and she was having a reaction. Stated that she took two acetaminophen (TYLENOL) before she went to bed. The outcome of the events of left ear pain and injection pain in left arm was not recovered, while pain that went down from her neck to abdomen recovered on 05Jan2021, heaviness in one side of the body recovered on 06Jan2021, the rest of the events recovered on an unspecified date. The seriousness of left arm injection pain was not provided, reporter assessed other events as non-serious. The causality for the event of injection pain to left arm was related to the suspect drug, causality for other events was unknown.
40 2021-01-12 lip swelling drowsiness within 1 hour swelling on upper lip (lasted about 15 minutes) occurred 4 hours after vacc... Read more
drowsiness within 1 hour swelling on upper lip (lasted about 15 minutes) occurred 4 hours after vaccine administered increased temp and bodyaches occurred approx. 6 hours after vaccination
40 2021-01-13 taste impairment Systemic: Chills, Systemic: Headache, Systemic: dizziness, bitterness in taste in mouth, shaky, hand... Read more
Systemic: Chills, Systemic: Headache, Systemic: dizziness, bitterness in taste in mouth, shaky, hands cold to touch, high heart rate - 120, BP 154/89
40 2021-01-13 eye swelling, mouth swelling, mouth numbness In the early morning around 3:00 a.m. presented swelling in the eyes, numbness of the tongue, swolle... Read more
In the early morning around 3:00 a.m. presented swelling in the eyes, numbness of the tongue, swollen mouth and tingling in the face. where it took a Benadryl at the time.
40 2021-01-13 mouth tingling developed severe headache and tongue tingling 10' after injection: transferred to ED. sx resolved up... Read more
developed severe headache and tongue tingling 10' after injection: transferred to ED. sx resolved upon arrival to ED. no further intervention. - observed for 4 hrs, d/c to home
40 2021-01-13 vision blurred Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Systemic: blurred/visio... Read more
Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Systemic: blurred/vision changes, tachycardia-Medium
40 2021-01-14 dry mouth 1330-Patient relates her mouth went dry and she became dizzy. Also c/o nausea and HA .HR 72 BP 151/... Read more
1330-Patient relates her mouth went dry and she became dizzy. Also c/o nausea and HA .HR 72 BP 151/104 O2-84-94%RA. Patient c/o tingling in fingers and toes 1340-Patient to ED room 18. 1545-Patient discharged from ED with dx of Vasovagal response
40 2021-01-14 ear discomfort, oropharyngeal discomfort I received my shot at 12:15 at around 12:30 I started feeling more aware of my throat. My swallowing... Read more
I received my shot at 12:15 at around 12:30 I started feeling more aware of my throat. My swallowing felt slightly off however, I was not aspirated secretions. My throat felt slightly thick and I had the sensation of wanting to clear my throat. I took a deep breath and I could breath. It started to feel like my throat was getting sore or irritated. I felt slightly warmer. I decided to wait the full 30 minutes. When I went to stand had a moment of dizziness that passed but then I felt lightheadedness for about 2 hours after the injection. My ear felt like it was warm and there was slight pressure there. My throat continued to feel irritated and still feels lightly irritated after 4 days. After about 3 hours it felt like something lifted and I felt better. That night I was really fatigued and tired. Maybe slightly cold. The next day felt fine except for the throat irritation that still persists today. The side where I received the injection my arm, shoulder, and chest area felt affected for two days after receiving injection.
40 2021-01-14 feeling of choking Chest tightness, Difficulty in breathing, Tachycardia, Throat tingling and burning.
40 2021-01-14 sensitivity to light within 1 hour of the injection I started to get a migraine headache with photo sensitivity and nause... Read more
within 1 hour of the injection I started to get a migraine headache with photo sensitivity and nausea. within 12 hours i had body aches and chills which resolved. after five days i have still been experiencing migraine headaches
40 2021-01-14 visual impairment Anxiety; Headache; Seeing stars; Chest tightness; Hand tremor; SOB; This is a spontaneous report fro... Read more
Anxiety; Headache; Seeing stars; Chest tightness; Hand tremor; SOB; This is a spontaneous report from a contactable pharmacist. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284; Expiration date was not reported), intramuscularly on the left arm on 06Jan2021 (10:15) at a single dose for COVID-19 immunization at the hospital. Medical history included migraines; heart murmur with surgery; grand mal seizure that has resolved; and contrast dye allergy. Concomitant medications included sumatriptan and norethindrone [norethisterone]. The patient previously took phenytoin, iodine, terconazole, tramadol and cetirizine; and had allergies with these medications. On 06Jan2021 (10:15), the patient was seeing stars; had chest tightness; hand tremor; and shortness of breath (SOB). The patient was referred to the Urgent Care Clinic due to these events. On 06Jan2021 (12:30), at the Urgent Clare Clinic, the patient had anxiety and headache. The patient had received acetaminophen, diphenhydramine, ibuprofen and water as treatment for the events, 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was provided with education on managing anxiety. The outcome of the events was recovered in Jan2021 for 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was unknown for 'headache' and 'anxiety'. The patient did not have COVID-19 prior to vaccination, and was not tested post-vaccination.
40 2021-01-15 mouth numbness, lacrimation increased, taste impairment Received the COVID-19 Pfizer-BioNTech vaccination at 8:40pm at a stadium location. Around 8:57, I ... Read more
Received the COVID-19 Pfizer-BioNTech vaccination at 8:40pm at a stadium location. Around 8:57, I had a metallic taste in my mouth and the left side of my tongue went numb. A little later the left side of my face felt weird and the inside of my ear felt numb. It wasn't tingling, but it felt like I had a Novacaine shot (like when you get a filling at the dentist). My neck got stiff and I was really tired. The symptoms lasted about 4 hours. When I woke up this morning the left side of my face and jaw still do not feel 100%. My left eye is watery. I'm very tired.
40 2021-01-17 drooling, eye movement disorder employee reports LOC for approx. 10-15seconds witnessed by family member who states her eyes rolled ... Read more
employee reports LOC for approx. 10-15seconds witnessed by family member who states her eyes rolled back and she began to drool. she has a history of passing out when not feeling well or vaccine. Eval in ED, treated with benadryl IV and fluids. D/c home.
40 2021-01-18 eye pain, eye discomfort after first dose developed fever 101, shaking chills, anorexia, malaise, and myalgias. Lasted 2.5 da... Read more
after first dose developed fever 101, shaking chills, anorexia, malaise, and myalgias. Lasted 2.5 days. Eye pain and pressure
40 2021-01-18 mouth swelling, loss of taste, taste impairment, mouth numbness, swollen tongue Within 6 minutes I had a metalic taste in my mouth, the roof of my mouth went numb, my tongue starte... Read more
Within 6 minutes I had a metalic taste in my mouth, the roof of my mouth went numb, my tongue started to swell up, the inside of my mouth started to swell up. I lost sense of taste to even water. I was allowed to take my 50 mg of benedryl. My BP was 171/100. I was taken to the ED and that is where I received the vaccine as well.
40 2021-01-19 loss of smell, loss of taste 1day after my vaccine I had fever, body aches, headache. 13 days after this vaccine my sense of smel... Read more
1day after my vaccine I had fever, body aches, headache. 13 days after this vaccine my sense of smell and taste are almost gone. I also had this happen also 12 days after my 1st vaccine and both my COVID swabs were negative then.
40 2021-01-19 pain in jaw Hypertensive Emergency (BP 219/114) with no previous blood pressure issues; Radiating chest pain, le... Read more
Hypertensive Emergency (BP 219/114) with no previous blood pressure issues; Radiating chest pain, left arm pain; jaw pain; This is a spontaneous report from a contactable other Health Professional (patient). A 40-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EX5170), via an unspecified route of administration on 16Dec2020 15:00 at single dose in left arm for covid-19 immunization. Medical history included symptomatic PVC's (Premature ventricular contractions), tachycardia, bradycardia, CVA (cerebrovascular accident) from 2018 to an unknown date, asthma and rhythm. Concomitant medication included flecainide, spironolactone, metoprolol for rhythm. The patient had known allergies included hydrocodone bitartrate, paracetamol (VICODIN), eletriptan and adhesive. Prior vaccination, the patient had no covid. On 22Dec2020 18:00, the patient experienced hypertensive Emergency (BP 219/114) with no previous blood pressure issues. Radiating chest pain, left arm pain, and jaw pain. Admitted to the hospital where an echocardiogram and angiogram was performed showing clear coronary arteries and no hypertensive remodeling of the heart. Issue has been ongoing since, despite interventions. The events result in emergency room/department or urgent care and hospitalization from an unspecified date for 1 day. The patient received the treatment for the events included frequent nitroglycerin, hydralazine and metoprolol. The patient underwent curative-SARS-Cov-2 Assay RT-PCR on 01Jan2021 with negative result. The outcome of the events was not recovered.; Sender's Comments: Based on the information available, contributory role of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE,) to event "hypertensive emergency (BP 219/114) with no previous blood pressure issues" cannot be excluded. The events chest pain and pain in jaw are attributed to underlying medical conditions and assessed unrelated. BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE,). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
40 2021-01-19 swelling of eyelid, lip swelling swelling to left armpit, left eye, left cheeck and lips.
40 2021-01-20 inability to speak Fever, chills, headache, body aches, tired and loss of voice
40 2021-01-20 eye pain, bloodshot eyes Shingles: Redness and tenderness in right eye area at 7:00 PM on 1/14/21, later that nigh (approxima... Read more
Shingles: Redness and tenderness in right eye area at 7:00 PM on 1/14/21, later that nigh (approximately 11:00 PM) experienced sharp pain behind right eye. On 1/15/21 bumps in right eyebrow and itchiness on right side of scalp. on 1/16/21 developed redness in right eye. Pain behind right eye and itchiness persisted for >5 days. Went to Urgent Care on 1/20/21 and shingles suspected. Referred to confirm diagnosis. Antiviral pills and drops prescribed, as well as steroid drops.
40 2021-01-20 mouth numbness I received the first dose in the morning and by the evening my mouth (lips, area around lips, roof o... Read more
I received the first dose in the morning and by the evening my mouth (lips, area around lips, roof of mouth, tongue) feel numb. It is a little better, however, I still have numbness around my mouth and tongue. I don?t know if I should receive the second dose.
40 2021-01-21 mouth numbness I begin to lose consciousness; I felt lightheaded; My face and ears got red and I begin to feel warm... Read more
I begin to lose consciousness; I felt lightheaded; My face and ears got red and I begin to feel warm; My face and ears got red and I begin to feel warm; Then My whole body felt really weird; my lips went numb; Afterwards for approximately 4 hours I could barely talk or open my eyes; Afterwards for approximately 4 hours I could barely talk or open my eyes; I got red rash on my neck and chest; I felt so weak, I could not move my body!; This is a spontaneous report from a contactable Other HCP reporting for herself. A 40-years-old female patient received the second dose bnt162b2 (BNT162B2) vaccine , intramuscular in the left arm on 18Dec2020 12:15 at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. On an unknown date the patient received the first dose of the vaccine. The patient experienced got red rash on my neck and chest on 18Dec2020 12:15 with outcome of recovering , felt lightheaded on 18Dec2020 12:15 with outcome of recovering , face and ears got red and begin to feel warm on 18Dec2020 12:15 with outcome of recovering , then whole body felt really weird on 18Dec2020 12:15 with outcome of recovering , lips went numb on 18Dec2020 12:15 with outcome of recovering , begin to lose consciousness on 18Dec2020 12:15 with outcome of recovering , afterwards for approximately 4 hours could barely talk or open my eyes on 18Dec2020 12:15 with outcome of recovering , felt so weak, could not move my body on 18Dec2020 12:15 with outcome of recovering. The patient was hospitalized for one day for all the reported events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Dec2020 . The patient received Epipen injection, steroids, saline & Benadryl as treatment for the reported events. Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on the compatible time association, the reported events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
40 2021-01-22 mouth tingling Heart palpitations Chills Freezing hands Chills Stomach pain Body aches Headaches Loss of focus Weak... Read more
Heart palpitations Chills Freezing hands Chills Stomach pain Body aches Headaches Loss of focus Weak Lightheadedness Dizzy Loss of balance Tingling in lips Swollen throat
40 2021-01-23 eye swelling Got vaccine around 12pm on 1/23/21 Woke up on 1/24/21 around 9am with very swollen eyes
40 2021-01-24 mouth numbness, mouth tingling, feeling of choking Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nyst... Read more
Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nystagmus in her eyes; passing out; vomiting/puke when vertical; Dizziness; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; heart rate 125; BP of 170/100; throat tightness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=El1283) via an unspecified route of administration at left arm on 08Jan2021 11:30 at single dose for covid-19 immunization. Vaccine was administered at hospital. Medical history included ongoing autoimmune disorder. The patient had known allergies to Amoxicillin and wasps. No family medical history relevant to events. Ongoing concomitant medication included hydroxychloroquine sulfate (HYDROXYCHLOROQUINE) for autoimmune disorder, celecoxib (CELEBREX) for autoimmune disorder, oral dimenhydrinate (DRAMAMINE), oral fexofenadine hydrochloride (ALLEGRA) and oral famotidine (PEPCID). No other vaccine in four weeks. The patient previously took flu vaccine (Expiry Date: Nov2020), tetanus vaccines for immunization. At 11:40 on 08Jan2021, the patient had tingling and numbness in throat and lips, heart rate was 125. By noon had hives and blood pressure (BP) of 170/100 (normal BP was 96/58 and heart rate was 65), chest tightness and throat tightness, the patient was given Benadryl (50mg) and monitored. No change so walked to emergency room. Given intravenous Benadryl and steroids then released the same day on 08Jan2021. The patient woke up on Saturday and shortly after hives came back, itching, chest tightness, headache and body aches. Saturday night on 09Jan2021 she went back to hospital due to continued reaction from 09Jan2021 06:00 pm until 10Jan2021 04:30 PM. The patient was admitted for heart testing then released on Sunday afternoon simply due because each doctor said they didn't know what to do. The patient slept from late Saturday night to Monday (except testing and eating at hospital), on 11Jan2021 around noon the patient took a shower and hives, itching and tingling all came back. Completely started over with reaction and started dizziness. On Tuesday 12Jan2021, primary care physician (PCP) for tests. Chest tightness started subsiding but very dizzy, puke when vertical. Wednesday: rheumatoid doctor. The patient had extreme vertigo. Other reported events: passing out, vomiting. Nystagmus in her eyes was very strong so that she got very dizzy. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care or Hospitalization. Adverse event start time also reported as 11:45 am. The patient underwent lab tests and procedures which included blood pressure 170/100 on 08Jan2021, blood test and electrocardiogram (EKG) with unknown results, heart rate: 125 on 08Jan2021. Normal BP was 96/58 and heart rate was 65. Heart and lungs examination with clear result. The patient had no Covid prior vaccination. Nasal Swab of Covid tested post vaccination on 05Jan2021 with a result of negative. Heart rate 125 recovered on 12Jan2021. BP of 170/100 recovered on 12Jan2021. Chest tightness sometimes she has episodes. She cannot walk without assistance. She stated she currently was 100% dependent on someone else. Throat tightness recovered on 11Jan2021. Outcome of other events was not recovered. She was treated at hospital with Oral and IV Benadryl and IV Steroids on 08Jan2021. On 09Jan2021 she was administered Oral Prednisone, Oral Diphenhydramine HCl (BENADRYL) and Oral Acetaminophen(Tylenol). Steroids switched from prednisone Oral to dexamethasone Oral twice daily. On 13Jan2021 she started on ondansetron (ZOFRAN) 4mg 3xday Promethazine (Fenagrin) 25 mg once at night. Information on Lot/Batch has been requested.
40 2021-01-25 mouth tingling 1:42 injection 1:58 reported tingly lip and feels funny, Benadryl 50mg given, no injection site reac... Read more
1:42 injection 1:58 reported tingly lip and feels funny, Benadryl 50mg given, no injection site reaction, lip and tongue unremarkable POX 99, P 78, bp 128/66 2:05 feels "funny, " dropping papers, appears nervous 2:20 DNS reported improved tingle 2:30 Dr. evaluated cleared resident to go home before Benadryl kicks in, tired. She stated "I feel fine"
40 2021-01-25 photosensitivity reaction nuchal rigidity; migraine; photosensitivity; auditory sensitivity; arthralgia; lethargy chills/ rigo... Read more
nuchal rigidity; migraine; photosensitivity; auditory sensitivity; arthralgia; lethargy chills/ rigors; nasal stuffiness; chest congestion; wet cough; This is a spontaneous report from a contactable physician. A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL1283), intramuscular on 08Jan2021 17:00 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient had the first dose last 18Dec2020 (lot number=EJ1685). The patient experienced nuchal rigidity, migraine, photosensitivity, auditory sensitivity, arthralgia, lethargy chills, rigors, nasal stuffiness, chest congestion, wet cough on 09Jan2021 05:00. The outcome of the event nuchal rigidity was not recovered while other events were recovered with sequelae.
40 2021-01-25 swollen tongue On same day of vaccination of 2nd dose, patient developed tongue swelling and neck; joint aches
40 2021-01-26 ear pain Starting 6-7 hours after the vaccine I began to have the most severe ear pain that would not go away... Read more
Starting 6-7 hours after the vaccine I began to have the most severe ear pain that would not go away with Tylenol/ibuprofen. I was unable to get up/sit up on my own. My lumbar spine seized up and spasmed feeling like I had an acute injury. I had chills but no fever.
40 2021-01-26 mouth tingling About 20 minutes after receiving her 2nd dose of vaccine, the patient developed tingling lips (no ap... Read more
About 20 minutes after receiving her 2nd dose of vaccine, the patient developed tingling lips (no apparent angioedema), itching and warmth of the face and chest. Her face and upper chest did appear flushed. She was administered Benadryl, and her symptoms resolved after half an hour.
40 2021-01-26 sensitivity to light, bloodshot eyes, eye pain I developed R eye redness, pain and photophobia on 1/21 and was diagnosed with anterior uveitis. I a... Read more
I developed R eye redness, pain and photophobia on 1/21 and was diagnosed with anterior uveitis. I am being treated with prednisolone drops and a dilating eye drop. My symptoms have improved significantly with the eye drops. I do not know if this is at all related to the vaccine - I have a h/o one other episode of anterior uveitis in my L eye in 2004, felt to be HLA-B27 associated - however I figure it is worth reporting just in case.
40 2021-01-26 swollen tongue heart palpitations; Stated that it felt like nerves on inside of her body were reacting like bugs cr... Read more
heart palpitations; Stated that it felt like nerves on inside of her body were reacting like bugs crawling on the inside of her skin; bad headache; Sore throat; tongue swollen; tired; weak; This is a spontaneous report from a contactable consumer reported for self. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 12Jan2021 on Arm Left at single dose (lot: EK9231) for covid-19 immunisation. Med history and concomitant medications were none. The patient had injection done yesterday (12Jan2021) and wanted to report symptoms. Stated that it felt like nerves on inside of her body were reacting like bugs crawling on inside of her skin 12Jan2021 at 6:30pm which calmed down at 10:00pm, bad headache 12Jan2021 at 6:30pm, sore throat, tongue felt swollen happened on 12Jan2021 after the injection, both resolved at 10:30pm. Stated that she did do Benadryl. Stated that she took another Benadryl this morning and it feels like it is wearing off and the sensation is coming back. Stated felt tired and weak on 12Jan2021. Stated felt like having palpitations and heart going too fast on 13Jan2021. Stated that she called her primary healthcare provider and was told to call Pfizer. Wanted to know if she needed to go to her doctor. Outcome of the events sore throat, tongue felt swollen was recovered 12Jan2021 10:30pm. Outcome of other events was not recovered.
40 2021-01-27 eye movement disorder, drooling Patient is a healthcare worker who received the first dose of the COVID-19 vaccine. Later that day,... Read more
Patient is a healthcare worker who received the first dose of the COVID-19 vaccine. Later that day, patient had excessive fatigue and some site injection pain. The next morning patient has loss of consciousness witnessed by husband. At the same time patient was drooling, not speaking clearly, and then eyes rolled back in her head, and passed out for a few minutes.
40 2021-01-27 extreme sound sensitivity, ear pain Both arms hurt; Fatigue; Headache that moves; Ear aches; Noises are louder; Mind goes blank while re... Read more
Both arms hurt; Fatigue; Headache that moves; Ear aches; Noises are louder; Mind goes blank while recalling information in a conversation; Feverish feeling but no fever; Heaviness of the body like moving in honey; Achiness; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3248, expiration date not reported) via an unspecified route of administration on the right arm on 12Jan2021 18:45 at a single dose for COVID-19 immunization. Medical history included PCOS, Raynauds, PTSD; and known allergies: Sulpha, sulfites, pseudafed, penicillin, cephalosporins, bromfed, IV contrast, pineapple. Concomitant medication in two weeks included levocetirizine dihydrochloride (XYZAL), omeprazole, escitalopram oxalate (LEXAPRO), lamotrigine (LAMICTAL) and levothyroxine sodium (LEVOTHYROXIN). On 12Jan2021 08:45 PM, the patient experienced both arms hurt, fatigue, achiness, headache that moves, ear aches, noises are louder, mind goes blank while recalling information in a conversation, feverish feeling but no fever, heaviness of the body like moving in honey. Therapeutic measures were taken as a result of the events which included Ibuprofen (ADVIL) and acetaminophen (TYLENOL). The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.
40 2021-01-27 mouth tingling Complaint of tingling tongue that was unfounded on exam.
40 2021-01-27 sensitivity to light weakness; confusion; dizziness; headache; hypotension; diarrhea; fatigue/lethargy; fatigue/lethargy;... Read more
weakness; confusion; dizziness; headache; hypotension; diarrhea; fatigue/lethargy; fatigue/lethargy; nausea; unilateral pain; photophobia x 3 days; Vomiting; This is a spontaneous report from a non-contactable Other HCP (patient). This 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 14Jan2021 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 40-years-old. No other vaccine was received in four weeks. Medical history included migraines, IgM, and MGUS. Historical vaccine included first dose of BNT162B2 in left arm for COVID-19 immunisation. Concomitant medications included fremanezumab (AJOVY), escitalopram oxalate (LEXAPRO), and NURTEC (as reported). On 14Jan2021, the patient experienced vomiting, nausea, hypotension, weakness, unilateral pain and weakness, dizziness, confusion, headache, fatigue/lethargy, diarrhea, photophobia x 3 days. Events were recovering. No treatment was received for the event. No follow up attempts are possible; information about lot/batch number cannot be obtained.
40 2021-01-28 bloodshot eyes Arm and face swelling, fever, bloodshot eyes, rapid heart rate, body pain, nausea, and headache. Too... Read more
Arm and face swelling, fever, bloodshot eyes, rapid heart rate, body pain, nausea, and headache. Took Tylenol, fluids, Benadryl, and rest.
40 2021-01-28 feeling of choking Tingling sensation in throat 5 minutes after vaccine to 45 minutes after. Sensation didn't decrease.... Read more
Tingling sensation in throat 5 minutes after vaccine to 45 minutes after. Sensation didn't decrease. Went back to work at unit. Has history of anaphylaxis to certain medications and ADR to TDaP
40 2021-01-30 mouth tingling, mouth discomfort patient reported mild tingling/burning in lower lip; symptoms did not worsen during 30 minute observ... Read more
patient reported mild tingling/burning in lower lip; symptoms did not worsen during 30 minute observation period; patient denies any additional symptoms; states that she had this same symptom after her first vaccination and that it lasted for about 1 hour
40 2021-01-31 eye pain, eye swelling, swelling of eyelid left auxiliary Lymphadenopathy and lymphadenitis; left auxiliary Lymphadenopathy and lymphadenitis; ... Read more
left auxiliary Lymphadenopathy and lymphadenitis; left auxiliary Lymphadenopathy and lymphadenitis; eyelid swelling; left eye swelling; left eye swelling and tenderness; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 14Jan2021 07:30 at a single dose for COVID-19 immunization. Medical history included seizure, COVID prior to vaccination and penicillin allergy. Patient was not pregnant at the time of vaccination. Concomitant medication included levetiracetam (KEPPRA) and lacosamide (VIMPAT). No additional vaccines administered within 4 weeks before the vaccination. The patient previously took LAMICTAL and experienced allergy. The patient experienced Left auxiliary lympadenopathy and lymphadenitis, eyelid swelling, and left eye swelling and tenderness on 15Jan2021 15:00. Patient took BENADRYL as treatment for the events and was recovering. Patient had not been tested since the vaccination. Information on the lot/batch number has been requested.
40 2021-01-31 eye pain I experienced red, irritated eyes following the vaccine. Also experienced a blister likely chemosis ... Read more
I experienced red, irritated eyes following the vaccine. Also experienced a blister likely chemosis which lasted approx 1 day.
40 2021-01-31 mouth tingling, mouth numbness She pretreated with Claritin and tums. About 20 minutes after the injection she began having tinglin... Read more
She pretreated with Claritin and tums. About 20 minutes after the injection she began having tingling and numbness in her mouth that persisted all day. The following day the tingling had improved but there was residual numbness. She also noted fatigue and body aches.
40 2021-01-31 mouth tingling Pt received first dose and stated feeling throat swelling. Monitors with vitals and called Allergy. ... Read more
Pt received first dose and stated feeling throat swelling. Monitors with vitals and called Allergy. BP WNL, Tachycardic to 106. No signs of facial edema, no difficulty breathing or swallowing, Allergy recommended to give 10mg of Zyrtec. Afterward developed tingling in mouth. Observed total of 1hr. No progression of symptoms and allowed to go home.
40 2021-01-31 toothache, pain in jaw, mouth pain Severe headache - mostly top front of head radiating to mouth (teeth/jaw).
40 2021-02-01 eye irritation I got chills; mild headache and just tired. It lasted and then I got sick on the 1st; Got tested for... Read more
I got chills; mild headache and just tired. It lasted and then I got sick on the 1st; Got tested for COVID January 3rd, 2021; On January 1 mild headache; tired and very congested but then real runny nose (went back and forth). On January 2, I got a fever - 101. Took Tylenol. On January 3, I got a fever. I was taking zinc; vitamins. My doctor prescribed medicine but I only took it twice as I didn't like how it made me feel - made it feel like I had something in back of my throat. I still have headaches - they aren't going away and neither is the tiredness. Yesterday, I woke up fine - but when I was at work started feeling very tired; and headache was so bad it felt like eyes were burning. Today I had a mild headache. I was staying at a hotel until the tests for COVID came back negative. I normally don't have headaches and fatigue.
40 2021-02-01 painful gums after the vaccine, I started to feel Body aches, chills, nausea, gum pain, I felt fine prior to the ... Read more
after the vaccine, I started to feel Body aches, chills, nausea, gum pain, I felt fine prior to the vaccine, I went to an Express Care they did a Covid 19 test, result was negative, I had a video visit with my doctor because I developed cough, chest tightness and shortness of breath, they did a 2nd Covid 19 test result was negative, The cough become persistent and the cough caused pain in my chest and back, The Doctor prescribed guaifenesin with codeine, albuterol and something for my gums. the cough and pain in chest was worsen and the Doctor gave me the zpack, I was out of work for 10 days. they said I had an acute URI
40 2021-02-01 mouth numbness Guillain Barre Syndrome; the patient's tongue started to go numb; The initial case was missing the f... Read more
Guillain Barre Syndrome; the patient's tongue started to go numb; The initial case was missing the following minimum criteria: Unspecified adverse event. Upon receipt of follow-up information on 18Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from contactable consumers, sibling of the patient and his wife. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. There was no medical history, Family Medical History Relevant to adverse events or concomitant medications. There were no Prior Vaccinations within 4 weeks and no additional vaccines administered on same date of the Pfizer suspect. The sibling of the patient reported the patient had an adverse event after the vaccine that he later described as Guillain Barre. The patient was hospitalized after receiving the COVID vaccine on 08Jan2021. She was admitted to the hospital, the consumer (the sibling's wife) thought, on either 14-15Jan2021. She was not sure of the admitting diagnosis but patient was being treated for Guillain Barre Syndrome. Patient has had a spinal tap on an unspecified date, no results were known. The patient was very healthy, in general the consumer knew she had no typical comorbidities. The reason it was thought to be related was she was perfectly healthy prior and right after she got the vaccine, the patient's tongue started to go numb, that day or the day after (in Jan2021). The events required a visit to Emergency Room, but not to Physician Office. Weight was unknown but the patient was very fit, and BMI (Body mass index) had to be in the normal range. The outcome of the events was unknown.
40 2021-02-01 vision blurred, mouth numbness Left side facial numbness and tingling. tongue numbness. left eye blurred vision. Symptoms stayed... Read more
Left side facial numbness and tingling. tongue numbness. left eye blurred vision. Symptoms stayed active for 24-48 hours
40 2021-02-02 eye swelling angioedema of face, feet and hands. severe headache started 30 mins after injection, noticed swelli... Read more
angioedema of face, feet and hands. severe headache started 30 mins after injection, noticed swelling of eyes 1 hour after injection. less than 12 hours later, full facial swelling, hands and feet. continued to worsen for the next 5 days. swelling started to slightly subside day 5. fever until day 4. vomit day 3. chills until day 4. severe headache until day 18.
40 2021-02-03 loss of taste, ringing in ears, ear infection, loss of smell December 28,(before the vaccine) I was exposed to COVID at work. I started feeling feverish on Mond... Read more
December 28,(before the vaccine) I was exposed to COVID at work. I started feeling feverish on Monday at work. I needed to use my inhaler twice that day. I couldn't stop coughing at work. At home that night - used inhaler again and I had an elevated temperature - 99. something is high for me. I missed work on Tuesday. Couldn't breathe and it hurt my chest to breathe. My temp was over 100. Dr appt - went to it late afternoon he wanted me test for COVID. Took vitals - mostly normal - temp.; checked OXYGEN - normal. COVID test - was positive. Temperature went to 101 that night - couldn't breathe good - couldn't stop shaking; I was aching and I was in pain; I couldn't feel warm enough. Tried to sleep and drink fluids. Still didn't have test results from COVID test on Thursday - temp was up to 102 now. The doctor said they couldn't do anything until they had results back of test. Friday - 101 and 102.8 - temperature that day. After hours clinic - I called them - Dr - I had to gasp for every breath and I was coughing a lot. He prescribed Benzymidate - cough pearls and Azithromycin - started taking those that night. By Sunday afternoon, my fever continued and I still didn't have COVID results yet. My mom took me to Urgent Care on Sunday - still running fever; he looked at my lungs and listened - he could hear wheezing and crackling in my lungs - he determined pneumonia - he didn't know what kind - he gave me Augmentin - he told me to use both my Albuterol inhaler and steriod haler; Mucinex expectorant twice a day; Vit C and Vit D and Elderberry and Tylenol and two antibiotics. Saturday - before I went to Urgent Care on Sunday - I noticed I couldn't smell. Monday is when I got the positive test for COVID. Provided info to work and I tried to figure out how to work. Even though I was still very sick, I worked again online on Monday. But I couldn't keep working - got really whoozy; coughing and gasping felt like I was going to pass out and felt like I could hardly breathe. My mom called 911 for me. I managed to get to the bathroom - but having trouble breathing and I almost threw up - heard ringing in my ears and room was spinning. There is a lot of things after that I don't remember - when they moved me to ambulance to hospital bed I realized I had an IV in me. They stabilized me. They let me go home. I took the rest of the week off from work. Took a lot of medication and was keeping up with my vital during that week - 99.8 - 102.8 - for ten days I ran that fever. Broke Jan 20th. I went back to work on Jan 25. Still had to use an inhaler a lot. I'm slowly getting taste back; I can't taste flavor but can taste salt . I'm slowly getting smell back. I still have a lot of congestion but not as bad. Ears were bothering me this weekend so I did go to urgent care on they put me on a third antibiotic for an ear infection. Gave COVID to my son and my mother. Still have trouble catching me breath. January 23 - my isolation was extended to . the county extended my isolation period because of my family getting COVID. I'm about 75% recovered, I'd say.
40 2021-02-03 lip swelling, swelling of eyelid Swollen face, eyes lids, nose and lips. Received the vaccine on 1-11-21. Experienced left arm numbne... Read more
Swollen face, eyes lids, nose and lips. Received the vaccine on 1-11-21. Experienced left arm numbness and pain on site. Numbness subsided and pain was minimal. Went to bed and work up around 6am to face, eyes, nose and lips swollen. Barely unable to open eyes. Immediately contacted employer employee health and contacted PCP. Appointment scheduled with PCP. PCP assessment completed. Recommended prednisone for swelling. Unable to take because of previous reaction. Recommended for Benadryl to be taken every 4-6 hrs and also Ibuprophen
40 2021-02-03 swollen tongue, tongue blistering Tongue had blisters on edges and tip and swollen. Reports of it feeling scalded.
40 2021-02-04 eye pain Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under ey... Read more
Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye.; Tenderness under eyebrow of right eye/pain behind right eye that did not go away for more than 5 days; Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye.; This is a spontaneous report from a contactable healthcare professional (HCP). A 40-year-old female patient received first single dose of BNT162B2 (Pfizer- BioNTech, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 14Jan2021 16:00 for COVID-19 immunization. Vaccination facility: Hospital. The patient had no relevant history. The patient was not pregnant at time of vaccination and at the time of reporting. The patient had no known allergies. The patient did not have Covid prior vaccination. Concomitant medication (other medications in two weeks) included multivitamin (unspecified). There was no other vaccine in four weeks. On 14Jan2021 19:00, the patient experienced shingles: approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye. Experienced pain behind right eye that did not go away for more than 5 days. Sought medical attention and ophthalmologist diagnosed shingles on 20Jan2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. Treatment for the adverse events included antiviral medication and steroid drops. Patient was not Covid tested post vaccination. The patient had not recovered from the events at the time of reporting. Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events herpes zoster, eyelid pain and erythema of eyelid cannot be excluded. The information available in this report is limited; information on previous occurrences of shingles, if any, would aid in case assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
40 2021-02-06 visual impairment 15 minutes after injection, I saw white spots and felt dizzy. The white spots in vision occurred o... Read more
15 minutes after injection, I saw white spots and felt dizzy. The white spots in vision occurred on and off for the following 24 hours. Injection site warm to touch (compared to other arm) but without redness.
40 2021-02-07 taste impairment Pfizer-BioNTech COVID-19 Vaccine Patient got first dose of vaccine on 2/3/2021. After getting dose,... Read more
Pfizer-BioNTech COVID-19 Vaccine Patient got first dose of vaccine on 2/3/2021. After getting dose, she felt anxious, increased heart rate and had a metallic taste in back of her throat. Patient was sent to ER for evaluation at 10:27am. Patient felt better and discharged at 12:11pm
40 2021-02-07 mouth tingling 25 minutes after her vaccine, patient's tongue and lips started tingling. She said they were not swo... Read more
25 minutes after her vaccine, patient's tongue and lips started tingling. She said they were not swollen but she definitely had a tingling feeling. She felt as if she had difficulty swallowing and had some hives on her back. These symptoms all resolved after 3 hours. She never had trouble breathing and was able to eat her dinner.
40 2021-02-08 ear discomfort Received second vaccine on 2/4/21 and on 2/8/21 went to urgent care for bilateral ear pressure and s... Read more
Received second vaccine on 2/4/21 and on 2/8/21 went to urgent care for bilateral ear pressure and sinus congestion that was present since 2/7/21.
40 2021-02-09 dry mouth, mouth tingling, thirst, photosensitivity reaction uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils; t... Read more
uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils; top back roof of the mouth, uvula and tonsils felt tingly; migraine; light sensitivity; dry mouth; thirst; racing heart; felt very hot; felt dizzy, like how it felt when standing up too quickly, but she was already standing; sharp pain in her shoulder; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), via an unspecified route of administration (left arm), on 31Dec2020 13:30, at single dose, for covid-19 immunization. Medical history included chronic migraines and depression. The patient has no known allergies. Concomitant medication included erenumab aooe (AIMOVIG), clarithromycin (CLARITIN), ibuprofen (IBU), mirtazapine (REMERON), paracetamol (TYLENOL), ascorbic acid (VIT C), and ergocalciferol (VIT D). The patient reported that "about 20 min" after receiving the vaccine, the patient's top back roof of the mouth, uvula and tonsils felt tingly. Then she started having a migraine, with light sensitivity, dry mouth, thirst, racing heart, and felt very hot. For a few seconds she felt dizzy, like how it felt when standing up too quickly, but she was already standing. Simultaneously, she had a sharp pain in her shoulder while she was dizzy. These reactions did not begin to subside until about 4 hours later. All these aforementioned adverse events happened on 31Dec2020 14:00 and the patient recovered from them on an unspecified date with lasting effects (recovered with sequel). After the tingly feeling in her mouth went away, she noticed that her uvula was dropped very low on an unspecified date. It did not look red and it was not sore, but it was so long that it touches her tongue and/or sticks to her tonsils. It has been 3 weeks later and her dropped uvula has not improved or changed. The patient did not recover from the event "uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils". She added that she tried to get her 2nd dose on 22Jan2021, but the clinic and the physician did not feel comfortable with giving her the 2nd dose because they have not heard of any cases of side effects of the tingly mouth/uvula/tonsils and continued dropped uvula. No treatment was received for all the adverse events reported. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had the following Covid tests post-vaccination: via nasal swab on 22Jan2021 with result of negative; via nasal swab with Color on 19Jan2021 with result of negative; via nasal swab on 15Jan2021 with result of negative; via nasal swab with Color on 12Jan2021 with result of negative; via nasal swab with Color on 08Jan2021 with result of negative and; via nasal swab with Color on 06Jan2021 with result of negative.
40 2021-02-09 mouth tingling Shortly after receiving the vaccine, I felt a very slight tingle in my lips- so slight that I though... Read more
Shortly after receiving the vaccine, I felt a very slight tingle in my lips- so slight that I thought I was imagining it and so I didn't say anything. As I was driving home, I started to feel it more and also felt it in my tongue. When I got home, the only antihistimine I had was claritin, so I took that. Then, I got nervous, felt tightness in my chest and went to the ER. They gave me benadryl and that helped. I stayed in the ER for an hour to be monitored and they said everything was fine.
40 2021-02-09 swollen tongue, dry mouth 5 Mins into the vaccine I started to feel a sensation to my tongue. 40Mins into the vaccine my heart... Read more
5 Mins into the vaccine I started to feel a sensation to my tongue. 40Mins into the vaccine my heartrate as high 120-150 I started to get really dizzy, I had shortness of breath I felt like I was getting ready to faint . I started having getting cotton mouth(Dry mouth). 8 hours post vaccine I started the heart rate went down but I started feeling like I had something in my throat . the bumps on the back on my tongue was swollen. I took Zyrtec and Pepcid Blood pressure was high Glucose was high
40 2021-02-09 swollen tongue, burning mouth syndrome, painful gums administration_date=22Jan2021, dose_number=2/administration_date=30Dec2020, dose_number=1; Swollen a... Read more
administration_date=22Jan2021, dose_number=2/administration_date=30Dec2020, dose_number=1; Swollen and tenderness in tongue; Swollen and tenderness in tongue; Tender gums; soreness on right side of neck under ear; This is a spontaneous report from a contactable other hcp (patient). A 40-year-old female patient received second dose of bnt162b2 (lot number: EL3246), intramuscularly at arm left on 22Jan2021 15:00 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (lot number: EH9899) intramuscularly at left arm on 30Dec2020 15:00 for covid-19 immunisation. Not Pregnant at the time of vaccination. The patient receive no other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced swollen and tenderness in tongue. Tender gums and soreness on right side of neck under ear, from 24Jan2021 08:00 AM. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included Prednisone and Pepcid. The outcome of the events was recovering.
40 2021-02-09 vision blurred, visual impairment blurry vision, kaleidoscope vision accompanied by a headache - entire body soreness, soreness at inj... Read more
blurry vision, kaleidoscope vision accompanied by a headache - entire body soreness, soreness at injection site
40 2021-02-11 tongue disorder, mouth numbness About 5 min after receiving the injection, throat and tongue began feeling numb and tongue felt thic... Read more
About 5 min after receiving the injection, throat and tongue began feeling numb and tongue felt thick. 30 minutes after injection, sudden need for BM. Oral, liquid Benadryl taken. BP 120/96, HR 93, SpO2 96%.
40 2021-02-14 taste disorder red rash came up on her chest; upper chest muscles just below her collar bone. the pressure of the w... Read more
red rash came up on her chest; upper chest muscles just below her collar bone. the pressure of the water hitting her was painful; Diarrhea; pain and stiffness in her chest that extended across her shoulders; can't seem to regulate her body temperature; laboring to breathe; joint pain; pulse and it had dropped down to 40; She has a history of tachycardia, but her pulse kept reading normal; muscle pain; inflammation; she woke up and she was itchy around her left forearm. She was really itching; couldn't really taste, things didn't really taste right to her; immediate soreness in arm; she has pain that extends up into her neck; Nausea; hasn't had much of an appetite; sweating; left hand swelling; hives on forearm; gastrointestinal issues; Fever; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982), intramuscular at left arm on 21Jan2021 15:38 at a single dose for COVID-19 immunization. Medical history included Tachycardia (started about 4 years ago), Hypertension (started about 4 years ago) and Essential tremor from 2020 (she has been having symptoms for a while; finally, during the summer of 2020, she was diagnosed through a neurologist) and anxiety, all ongoing; pain, back problems and sleep disorder.Concomitant medications included ongoing Tizanidine as muscle relaxant for back problems, ongoing Metoprolol tartrate for hypertension and tachycardia, Primidone for Essential tremor and ongoing Clonazepam for essential tremors, to help her sleep, and also for anxiety. No prior vaccinations (within 4 weeks). The patient got the first COVID vaccine dose. Afterwards, she went to school and it "was downhill from there". 5 days of persistent symptoms including sweating, muscle pain, joint pain and left hand swelling. It was further reported that she had to wait 15 minutes and then she drove home which is about a 35-minute drive. So about 45 mins after receiving the vaccine, she noticed her tongue, it was more on the right side of her tongue, she can't explain the sensation. She couldn't really taste. Things didn't taste right to her. This lasted 24 hours. She woke up the next day, 22Jan2021, feeling not quite right. She took some Tylenol that morning and went on into school. She took some ibuprofen in the middle of day, it wasn't a big deal. She has a history of tachycardia, but her pulse kept reading normal. She had a drink she was drinking from lunch and she ended up having the remainder of it the last few hours of that day. At about the end of her workday, around 15:30 she was finishing the Cdrink off and she said to herself "oh that taste like a regular drink again". This tongue sensation/lack of taste resolved. At that point, she got really excited because she thought this was all that she would experience with the vaccine. She was grateful she had the chance to have the vaccine. She mentions her arm was very sore right off the bat. She experienced immediate soreness in her arm right after receiving the COVID-19. She thought when they were injecting her, it hit her bone. In fact, she joked about this with the person administering the vaccine. The person at the facility told her to rub it, it actually helps with that. This kind of soreness didn't seem like a major problem. She was still experiencing this soreness. If she is sitting on the couch sideways, with her side of her arm against the couch, she has pain that extends up into her neck. It was pretty painful. Friday, 22Jan2021 (24 hours later after receiving the vaccine), by the time she got home from work, she was really sore. She had some real muscle pain around her hips and upper thighs, both of them. The soreness extended across. It was like she had inflammation that started flaring up. She felt pretty sore that evening. It wasn't like a normal muscle soreness. She went to bed because she was pretty tired. The next morning (Saturday, 23 Jan 2021), she couldn't get off the couch. She had such bad muscle and joint pain. She slept off and on, the pain was pretty bad. Her whole body had so much stiffness and inflammation. Every muscle and every joint just hurt. She confirmed that she hasn't been able to regulate her body temperature. This has been going on since Saturday evening (23Jan2021). She stated that this wasn't normal for her. She does take medications to lower heart rate but she hadn't taken it. She was talking to her best friend about how she had been sore and slept all evening. She checked her pulse and it had dropped down to 40. Her O2 level was at 92. She didn't think it was that big of a deal. Her best friend was kind of freaking out about it. She had such pain and stiffness in her chest that extended across her shoulders, it made it difficult to breathe. She was laboring to breathe. She checked her pulse thinking maybe she was feeling anxious about it and her HR was up, but it wasn't. She states happened so bad yesterday, yesterday was worse than before. She got up on Sunday morning, 24Jan2021, and took a hot shower. When the water from the shower head hit her chest, clarified as her upper chest muscles just below her collar bone, the pressure of the water hitting her was painful. However, she was able to get up, she was moving around. Still the whole time. she had this fever-ish feeling. Her kids were telling her that they were sweating because she had the house at 76 degrees. Monday morning, 25Jan2021, she woke up and she was itchy around her left forearm. She was really itching on Friday night, but she didn't think anything about it. When she took a hot shower yesterday (25Jan2021), a red rash came up on her chest and it looked like she had hives on her forearm. She didn't know if the hot water flared that up, but she doesn't have any allergies. She also had gastrointestinal issues. She has had some nausea that has lasted the entire time since she received the vaccine. She clarifies the nausea has came and gone. She hasn't had much of an appetite. They thought she had a fever yesterday at school. It was 99. something but she had already taken Tylenol a couple hours before and she was sweating so much. She states she has also had diarrhea the last few days, clarified as the last 2 days (24Jan2021). She has already spoken to someone to report her symptoms but wasn't sure about and had question about getting the second vaccine dose. She reported having gone to Urgent care where she was told she had Post covid vaccine syndrome and that she shouldn't have a problem with the second dose. She explained she went to the urgent care yesterday, 25Jan2021. She called her doctor that morning and was told to continue to treat her symptoms and take ibuprofen and Tylenol but if she got worse, to go to urgent care. So, she went to the urgent care (Product information for the Tylenol and Ibuprofen she has been taking (Ibuprofen: UPC/NDC: not provided when probed. Lot: P142385 Expiry date: Apr2023 and Tylenol: UPC/NDC: not provided when probed. Lot: P121664 Expiry date: Sep2023). The nurse just explained (Name Withheld) was having the same exact symptoms as the patient, except it was (Name Withheld) second dose. Her symptoms were identical to the patient. The patient wasn't initially sure if it was from the vaccine or if it was her anxiety. The patient didn't feel anxious and her heart rate wasn't up. The patient told she didn't think anxiety caused her to feel like she had a fever. The school nurse looked it up and found out more symptoms kind of wax and wane. Her symptoms got much worse. On 25Jan2021, Test: Rapid COVID-19 test Result: Negative. The event immediate soreness in arm was not recovered; event couldn't really taste, things didn't really taste right to her recovered on 22Jan2021 and nausea recovered in Jan2021; and unknown outcome for the other events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021101606 same reporter/drug, similar events, different patient
40 2021-02-15 thirst Extreme thirst for 3 days; Extreme energy/hyperactivity for 2 days; Insomnia for 3 nights
40 2021-02-16 lip swelling, mouth tingling In monitoring area shortly after vaccination, patient reported to EMS observation staff she was expe... Read more
In monitoring area shortly after vaccination, patient reported to EMS observation staff she was experiencing "lip tingling." In speaking with staff during assessment, patient's symptoms progressed to c/o lower lip swelling and trouble swallowing. Redness and swelling noted around mouth and nose. IM epinephrine administered at 18:08 and 911 called for transport to hospital.
40 2021-02-17 toothache, pain in jaw 1st dose Vaccine 1/9/21; 2nd dose vaccine 2/14/21; developed hives/rash 2/15/21, resolved with Benad... Read more
1st dose Vaccine 1/9/21; 2nd dose vaccine 2/14/21; developed hives/rash 2/15/21, resolved with Benadryl; developed chest pain, SOA, HA, jaw/teeth pain , and nausea 2/17/21; seen at Clinic 2/17/21 and sent to ED same day for eval; was d/c'd home from ED 2/17/21.
40 2021-02-18 eye swelling, eye pain 24 hours post vaccine, developed bilateral eye swelling, itchy ness full body and right orbital pain... Read more
24 hours post vaccine, developed bilateral eye swelling, itchy ness full body and right orbital pain along with the feeling of my heart racing. Swelling lasted 9 hrs, self medicated with Zyrtec (Benadryl makes my heart race) . Tylenol 1000mg every 4 hrs for headache pain. Headache is still present daily. Switched to 800 Motrin every 6 hrs. Headache and lower extremity muscle pain, as well as nerve twitches and cramping still occurring 8 days post vaccine.
40 2021-02-19 vision blurred, double vision Symptoms started with blurred vision within 30 minutes had full double vision , dysarthria and aph... Read more
Symptoms started with blurred vision within 30 minutes had full double vision , dysarthria and aphasia . Went to sleep, woke up 1 hour later bc I felt like I couldn?t breath. My arms and legs were very heavy felt close to paralyzed. I was able to move but movement was very ataxic and labored. Next morning the limb heaviness was gone, double vision was gone but had blurry vision for approx three days. Still having word finding difficulty, but mild.
40 2021-02-21 ear infection, mouth numbness After first dose on 1/11/2021 employee mentioned she had sinus congestion and a head ache for 2-3 da... Read more
After first dose on 1/11/2021 employee mentioned she had sinus congestion and a head ache for 2-3 days. She also experienced numbness of her left hip and swelling of her wrist. She was seen by her PCP and they did not associate the condition with the vaccine. After her 2nd dose on 1/28 she had a slight cough for 3 day and swelling of the arm and leg. She went to urgent care on 2/19 due to swelling and pain of her arms and legs. She was prescribed gabapentin, and pain medications. Employee developed left sided facial pain paralyses and went to the ED on 2/21 diagnosed with Bells Palsy and given acyclovir, norco and she is taking antibiotics for an ear infection. Currently still symptomatic.
40 2021-02-21 mouth tingling A fast heartbeat- Dizziness, and weakness; Numbness and tingling; The muscles of my fingers went sti... Read more
A fast heartbeat- Dizziness, and weakness; Numbness and tingling; The muscles of my fingers went stiff, where my thumbs couldn?t move away from my inner palms and my other fingers would not bend. I also had difficulty speaking, as if my tongue was numb or hard to move.  This lasted about an hour (15 hrs post-vaccine).
40 2021-02-22 taste disorder Chest tightness, after taste in mouth, palpitations, temp 98.4 degrees, BP - 122/82, Pulse - 80 (pat... Read more
Chest tightness, after taste in mouth, palpitations, temp 98.4 degrees, BP - 122/82, Pulse - 80 (patient states vitals elevated from normal); shaking, dizzy, nausea
40 2021-02-22 vision blurred Headache, muscle pain, sore throat, fever, sinus pressure, difficulty focusing eyes, fatigue. Memor... Read more
Headache, muscle pain, sore throat, fever, sinus pressure, difficulty focusing eyes, fatigue. Memorable symptoms began on Feb. 19th, the worst day was Feb. 20th, when I was unable to complete my usual daily activities. My symptoms have begun to improve today, Feb 23rd. On Dec. 17th, 2020 I was diagnosed with COVID19.
40 2021-02-23 ear pain Insomnia, nerve pain in ears and legs, headache, fatigue after the insomnia, chills.
40 2021-02-23 mouth numbness Tingly face, minor numbness in left arm (injection side) maybe mouth and tongue numbness too
40 2021-02-23 lip swelling, lip itchiness, swollen tongue, tongue itchiness Swelling and itchiness of the upper lip and tongue about 10 minutes after the vaccination.
40 2021-02-23 mouth tingling Following the injection, after approximately four hours later I began to feel some slight disorienta... Read more
Following the injection, after approximately four hours later I began to feel some slight disorientation and tiredness. Later the same evening I experienced brain fog and confusion for the next several days as well as a terrible headache. Additionally my tongue felt tingly. All of these symptoms passed within several 3- 4 days following the vaccination. injection site discomfort was also a symptom.
40 2021-02-24 mouth numbness 40 y/o female who developed anaphylaxis to Pfizer vaccine. Pt first developed itchiness of throat ,... Read more
40 y/o female who developed anaphylaxis to Pfizer vaccine. Pt first developed itchiness of throat , followed by generalized pruritus and the sensation of "throat tightening." Received epi from medical team but initially refused ER visit. Symptoms resolved but returned 15 mins later with numbness of the lips and throat, sensation of throat closing being additonal symptoms. She was agreeable to transport after the second episode.
40 2021-02-26 ear itchiness My face began to itch around 9 pm last night. I woke this morning with a slightly swollen face and e... Read more
My face began to itch around 9 pm last night. I woke this morning with a slightly swollen face and extremely itchy face even my ears. I took a antihistamine which has helped but it still itchy. It?s currently 1 pm the following day after the first dose
40 2021-02-28 eye irritation Started feeling lethargic and weak at 6:30pm 2/28/21. Stomach bloating, eyes burning, no appetite, ... Read more
Started feeling lethargic and weak at 6:30pm 2/28/21. Stomach bloating, eyes burning, no appetite, then burping that tasted and smelled sulfur-like. Around 4am 3/1/21 woke up to nausea and diarrhea. Did not go to work. Slept on and off . Drank water and ate crackers. Took Immodium and it helped for a few hours. As on 7:30pm 3/1/21, I am still nauseated and have diarrhea . No energy to do any daily activities. Been laying down the entire day. Exhausted and out of breath going up the stairs to bedroom.
40 2021-02-28 gaze palsy Sore arm, prolonged headache (possibly from the migraine I had the day I got the vaccine) Pregnant;... Read more
Sore arm, prolonged headache (possibly from the migraine I had the day I got the vaccine) Pregnant; due date June 16 2021. First pregnancy at the age of 40.
40 2021-02-28 feeling of choking, mouth numbness About an hour after vaccination, my throat was tingling and my heart rate went up. It came down afte... Read more
About an hour after vaccination, my throat was tingling and my heart rate went up. It came down after a bit and my throat/tongue felt slightly numb until I took a Benadryl.
40 2021-02-28 taste disorder taste was altered (sweet foods, not as sweet; savory food, taste bland and bitter); This is a sponta... Read more
taste was altered (sweet foods, not as sweet; savory food, taste bland and bitter); This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264: expiry date: unknown) via an unspecified route of administration in the right arm, on 27Jan2021 at 14:45, at a single dose, for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. Concomitant medications included metoprolol and duloxetine hydrochloride (CYMBALTA). The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. Place where vaccine was administered was reported as "other". On 27Jan2021, about 7 hours post injection, the patient's taste was altered (sweet foods, not as sweet; savory food, taste bland and bitter). A full 24 hours after first injection, taste was still altered. The event was considered non-serious. The patient did not receive therapy for the event. Outcome of the event was not recovered. The patient has not been tested for COVID-19 since vaccination.
40 2021-03-02 taste impairment, mouth tingling Patient had 2 minutes left on her 20 minute post-vaccination observation and began to complain of me... Read more
Patient had 2 minutes left on her 20 minute post-vaccination observation and began to complain of metallic taste, tongue feeling wierd and facial itching; no SOB, no rash or redness noted; Vitals were WNL, given Benedryl 50 mg chewable and drink of water; at no time did client c/o or appear SOB, pO2 remained at 99% and vitals remained WNL; continued observation for an additional half hour and c/o subsided; client released to home.
40 2021-03-02 eye irritation, ear pain Dizzy Friday when given shot, Chills and fever Friday night, upset stomach, headache, low grade feve... Read more
Dizzy Friday when given shot, Chills and fever Friday night, upset stomach, headache, low grade fever on Saturday, upset stomach, headache, lowgrade fever on Sunday, Swollen lymph nodes, rash on chest/shoulders/upper back and chills Monday, Rash spread to torso, arms, legs and neck, eyes burned and left ear hurt, chills, fever was 104, resting hear rate was 120 bpm
40 2021-03-03 mouth numbness Pt was vaccinated in facility with a 15 min observation done. Pt ambulated to car with mother at sid... Read more
Pt was vaccinated in facility with a 15 min observation done. Pt ambulated to car with mother at side. Pt and mother left site to go home when pt told mother "my lips feel numb". Mother drove pt back to facility and came in to tell us that her daughter was in the car and c/o mouth feeling numb. Myself, Site Leader and charge nurse went outside to car. Pt was sitting on passenger side of car A/Ox3. Denies feeling sob, headache and chest pain. V/s obtained with inital v/s b/p 118/84, HR 83 O2 98% on RA. Advice pt that we could call EMS for further evaluation. Pt refused. Wanted to go home and take benadryl if numbness presist. Verbalized understanding of risk and outcomes of monitoring any other adverse symptoms.
40 2021-03-03 lip itchiness Histamine reaction: red, hot sweaty cheeks that became a little puffy; slightly itchy lips; red splo... Read more
Histamine reaction: red, hot sweaty cheeks that became a little puffy; slightly itchy lips; red splotchy patches on parts of my legs, chest, feet (mostly toes), and hands (mostly fingers). Started with my cheeks within minutes of the shot, got worse over the next hour. It took about 4-5 hours to dissipate. But even the next day, I have been a little itchy.
40 2021-03-03 swollen tongue, lip swelling lip and tongue swelling, subjective throat swelling, pruritis epi 0.5 mg IM, benadryl 50 mg IV, sol... Read more
lip and tongue swelling, subjective throat swelling, pruritis epi 0.5 mg IM, benadryl 50 mg IV, solu-medrol 60 mg IV, pepcid 20 mg IV
40 2021-03-03 swollen tongue Patient received the COVID-19 Pfizer vaccine at 08:41 am on 2/28/2021. Patient began to experience t... Read more
Patient received the COVID-19 Pfizer vaccine at 08:41 am on 2/28/2021. Patient began to experience tongue swelling and her throat tightening. At 9:35 AM, Diphenhydramine 50mg IM Injection was given in the Right deltoid. Diphenhydramine lot number 6124005, EXP 04/22. At 9:48 AM, Patient continued to sound and feel throat raspy and coughing, patient was given an Epi pen into her right thigh. Epi pen lot number 0FM501, EXP 05/22. Patient was also given Solu-Medrol 40mg injection into the right glute at 10:30AM. Solu-Medrol lot number DP2618, EXP 01/22.
40 2021-03-04 oropharyngeal discomfort shortness of breath, chest tightness, throat fullness within 5 minutes of administration. With CPAP ... Read more
shortness of breath, chest tightness, throat fullness within 5 minutes of administration. With CPAP support (I use this at night for my autoimmune disease), I did not require intervention. Lasted 24 hours.
40 2021-03-04 vision blurred, sensitivity to light After getting the shot, I walked over to the observation area a few yards away. I sat down and my vi... Read more
After getting the shot, I walked over to the observation area a few yards away. I sat down and my vision went blurry and the room lights were too bright. I spoke with a dr about taking ibuprofen for my ankle, as I was told to only take Tylenol. The dr said that I was fine to take it. I didn?t want to ask about my vision because I was embarrassed and didn?t want to be stressing or panicking and that be the cause of my vision issues. But it didn?t subside so I checked with a nurse before leaving, about 15 mins after the vaccination and asked if I was ok and she said yes, that she only had 1 other person tell her about blurred vision. I walked to my car and the sun was so bright I had to shield my eyes. I got in the car and took my mask off. I looked in the mirror and my cheeks and chin were flushed but my skin was pale. My husband sat with me for 10 mins and then went in for his shot. At this point it had been a little over 30 mins since getting vaccinated. I FaceTimed my mom so I wouldn?t be alone. As we were talking she said my face was getting puffy and I was getting darker circles under my eyes. I got off of the phone with my mom and called my husband on FaceTime. I asked him to talk to the dr for me and let her see my face. She said my face was swollen and red and asked if I could breathe or felt like my throat was closing over or tongue was swollen. I told her no. Once again I was told I was ok and to take Benadryl. An hr or so after the 1st dose vaccination I was able to get Benadryl and Tylenol. In a 12hr period I took 2 doses of Benadryl and 2 doses of Tylenol. My face got better in 12-24hr but I still have blurred vision and light sensitivity.
40 2021-03-05 eye itchiness Pt. c/o itching of eyes, abdomen, behind ears and sore throat. Denied SOB or chest pain. Hx of ana... Read more
Pt. c/o itching of eyes, abdomen, behind ears and sore throat. Denied SOB or chest pain. Hx of anaphylaxis to TDap and NSAIDs. Pt stated felt similar to other reactions in past. 0917 BP 175/112 and 0927 170/105. Pt. states forgot to take BP meds. 0921 Benedryl 50 mg IM given per Dr. orders. Pt. observed for 20 min and reported all symptoms subsided. Pt. released to home driven by spouse.
40 2021-03-05 ringing in ears, eye strain 8 minutes after the administration of the vaccine (while in the observation area) I started to feel ... Read more
8 minutes after the administration of the vaccine (while in the observation area) I started to feel really off (dizzy, anxious, ringing in right ear). I ended up becoming unconscious with seizure like activity. They rushed me to the ER and kept me for 6 hours with lots of testing. XRay, blood test, CT of head, EKG, Urine test...all came back normal. Doctor said it was likely a reaction to the vaccine. I am 40 years old with no history of seizures or allergic reactions to vaccines. The week following I experienced confusion, migraines, dizziness, slow cognitive processing, eye strain, word finding difficulties, and exhaustion. I had to take a week off of work to recover. This is the second week and I am still experiencing headaches and occasional dizziness/eye strain.
40 2021-03-07 loss of smell chest pain; loss of smell; fever; headaches; vomiting/nausea; vomiting/nausea; This is a spontaneous... Read more
chest pain; loss of smell; fever; headaches; vomiting/nausea; vomiting/nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot number: EL9264), via an unspecified route of administration in the left arm on 30Jan2021 15:45 at a single dose for covid-19 immunization. Medical history included heart problems, migraine, anemia, asthma and unspecified allergies. The patient is not pregnant. The patient's concomitant medications were not reported. On 30Jan2021 19:00, the patient experienced chest pain, loss of smell, fever, headaches, vomiting and nausea. The patient did not receive treatment for the events. The outcome of the events was not recovered.
40 2021-03-07 vision blurred Dizziness, blurry vision, took oral Tylenol. BPs 98/68 (pulse 58), 97/66 (pulse 59).
40 2021-03-08 ear pain Pain in back started then spread to right side and chest in about a week, called doctor's office and... Read more
Pain in back started then spread to right side and chest in about a week, called doctor's office and they said to report as a side effect of COVID vaccine. That pain has lessened but not completely gone. Ear pain started on 3/7/21, ear pain lessened after 24 hours but not completely gone.
40 2021-03-09 mouth numbness tongue numbness, headache and shortness of breath
40 2021-03-09 bloodshot eyes this morning she noted a red blotch on her left eye sclera. her right eye is fine. she denies rubbin... Read more
this morning she noted a red blotch on her left eye sclera. her right eye is fine. she denies rubbing her eye, foreign body, or coughing or sneezing or force. instructed not likely related but asked to call back if worsening, vision loss, or blurred vision. wash hands well after touching face. call back prn.Followed up with patient today. She said that the red blotch in her eye is still there but not as red and can tell that it is going away. It doesn't bother her. She did contact her PCP and they told her that it is likely not related. She thanked me for my call. Will close case.
40 2021-03-09 sensitivity to light, tongue disorder A few hours after receiving my 2nd dose vaccine I got sores on my tongue. The following day I felt v... Read more
A few hours after receiving my 2nd dose vaccine I got sores on my tongue. The following day I felt very fatigued, had a low fever for a couple hours, sore neck and shoulder to the injection site, sore throat, headache, light sensitivity and hazy/foggy feeling. I also had a finger feel sore and inflamed for about 5 days. It has been 1 week now and I still have major fatigue, headaches, brain fog, morning sore throat and just a feeling of ?not well?. I try to workout, but after I get so fatigued I can?t perform regular daily tasks. I have been so foggy, I can?t help my kids with their school work.
40 2021-03-09 vision blurred blurred vision, diaphoresis, hypotension, placed in trendelburg position
40 2021-03-10 dry throat About 10 minutes after receiving the vaccine, the back of my neck started tightening badly and start... Read more
About 10 minutes after receiving the vaccine, the back of my neck started tightening badly and started getting uncomfortable. My throat then started to get dry and began breaking out with a rash on my neck and chest. This lasted about 30 minutes before the symptoms started to cease (in total 45 minutes after receiving the vaccine). Within 2 hours after receiving the vaccine, all symptoms had subsided. Treatment - at the vaccine clinic, EMTs observed me and took my vital signs. My blood pressure was slightly elevated, but did not require medical treatment. They continued to monitor me with the recommendation that I use my EPI-pen if symptoms got worse and instructed me to seek emergency medical treatment if symptoms got worse. No further treatment was sought out as symptoms all started to improve.
40 2021-03-10 mouth numbness 20 minutes post injection developed numbness of the mouth and tongue that lasted for 48 hours then r... Read more
20 minutes post injection developed numbness of the mouth and tongue that lasted for 48 hours then resolved. Myalgias, fatigue and athralgias lasted a week and improved in 1 week in severity but intermittent athrlagias continue to occur. Over 1 month post 2 nd injection developed numbness of bilateral hands and feet and numbness of the mouth had recurred and is persistent for 6 days now.
40 2021-03-10 mouth numbness Swelling of the right side of the pharynx and numbness of the tongue almost immediately
40 2021-03-12 taste impairment Immediately after administer, I felt ?weird?. Almost a little light headed. As the minutes passed, I... Read more
Immediately after administer, I felt ?weird?. Almost a little light headed. As the minutes passed, I began feeling dissociated. Almost out of body, like I was under the influence. I began to struggle to answer questions and stay awake. I willed myself to stay calm and stay awake. I was given water and observed for an hour. My face began to feel numb and the roof of my mouth itchy. The ?high? feeling was eventually replaced by the feeling of being extremely tired. After and hour I was good to drive but extremely tired when I got home. About an hour after the shot I can taste a blood or metallic taste in my mouth. I still feel ?drugged? or tried.
40 2021-03-12 vision blurred Left arm pain between elbow and wrist, extreme nausea, pounding headache, dizziness, blurry vision, ... Read more
Left arm pain between elbow and wrist, extreme nausea, pounding headache, dizziness, blurry vision, rash on face, extreme fatigue
40 2021-03-13 tongue discomfort Felt fine after the shot. Woke up feeling fine the next day and then about 2 pm my tongue felt like ... Read more
Felt fine after the shot. Woke up feeling fine the next day and then about 2 pm my tongue felt like it was on fire and so did the fingers on my right arm. Now my whole body hurts and I feel like I?m going to throw up.
40 2021-03-14 mouth tingling Tingling in mouth and tongue.
40 2021-03-16 drooling, mouth tingling Caller states that she got her Vaccine at 2pm today. Now with a tingling sensation on her lips and ... Read more
Caller states that she got her Vaccine at 2pm today. Now with a tingling sensation on her lips and an increase in salivation. Able to speak in long sentences. Instructed to increase her fluid intake, use mints to her secretions and if it worsens or she notice any lip swelling or resp distress, to report to the nearest ER. RN
40 2021-03-16 vision blurred Fever/chills, intense body aches, headache, occular blurring, muscle weakness, loss of appetite
40 2021-03-17 swollen tongue Patient was advised to receive the vaccine regardless of an itchy throat with the first Pfizer Covid... Read more
Patient was advised to receive the vaccine regardless of an itchy throat with the first Pfizer Covid vaccine with some feeling like throat and tongue were swelling but EMTs on the scene administered IV benadryl with the first dose. With doctor recommendation to receive the second dose about 20 minutes after she received the second dose she started feeling her tongue have a fuzzy swelling sensation and began coughing frequently around 11 a.m.. Patient took 50 mg of Benadryl of her own immediately before the vaccine in order to counteract the same reaction from the first one. Due to increasing symptoms she received Epinephrine 0.3 mg/0.3 ml one shot at 11:09 a.m. and a second shot at 11:17 a.m. Patient began to show signs of improvement from the Epipen but not enough with one shot so she proceeded with the second one. She was able to leave the vaccine clinic to see her general practitioner that afternoon. She expressed that she felt jittery after the shots and we determined that the Benadryl liquid she had with her and took had Phenylephrine in it as well which combined with the Epinephrine was causing the shakiness. She felt stabilized but weak. Her blood pressure was 140/100 at 11:50 a.m. and 137/88 at 11:55 a.m. Her allergist and general practitioner were contacted and notified of the incident and they instructed her further to use Benadryl tonight and to contact them tomorrow about any further concerns. She reported this evening at 5:27 p.m. that she was okay and did not have any further issues or the feelings of the allergic reaction.
40 2021-03-17 vision blurred BlurredVision, Dizziness, Myalgia, Arthralgia, Fever, Angioedema, INJECTION SITE PAIN, SWOLLEN GLA... Read more
BlurredVision, Dizziness, Myalgia, Arthralgia, Fever, Angioedema, INJECTION SITE PAIN, SWOLLEN GLANDS Narrative: Other Relevant History:
40 2021-03-18 mouth tingling, feeling of choking My face (cheeks) went numb. My tongue and throat started to tingle, like I was having an allergic ... Read more
My face (cheeks) went numb. My tongue and throat started to tingle, like I was having an allergic reaction. I had taken a Claritin for allergies before I received the injection. The numbness started approximately 30 minutes after receiving the injection. It last until I took additional allergy medicine three hours after the injection.
40 2021-03-18 swollen tongue, lip swelling Within 2 to 3 minutes after the shot, I experienced swelling in my throat. My glands were sore. I wa... Read more
Within 2 to 3 minutes after the shot, I experienced swelling in my throat. My glands were sore. I was monitored for 30 minutes by the nurse and as the symptoms were not getting worse she suggested I drive home and take Benadryl. It was a 45 minute drive. Halfway home (about one hour after my shot) I started experiencing itching, swollen tongue, swollen lips. I took 62.5 mg of Children?s Benadryl and met up with my husband and he drove me to the ER, arriving at about 10;15. After being there about 15 minutes some of my symptoms started going away. At about 11 a rash appeared on my chest. The ER doctors gave me Pepcid 10 mg around 1130 or so. They just charge me and recommended I follow up with my allergy doctor.
40 2021-03-18 swollen tongue, mouth itchiness I began to feel very itchy all over my body within 30-60 minutes, I felt swollen in my hand, feet, t... Read more
I began to feel very itchy all over my body within 30-60 minutes, I felt swollen in my hand, feet, tongue, my mouth and throat felt itchy, the itching got so bad that i had hives in some places such as my forearm and legs and skin just felt like it was on fire, I had issues breathing and felt as though someone was sitting on my chest, i have been shortness of breath since and have trouble catching my breath.. This was all that same night. The next day I had the same issues adding the sore arm of the injection site and feeling very tired all day. the next day from there am I am feeling better but am still experiencing shortness of breath, I am using my inhaler, I am still itchy but not as severe as the first night or next day. The arm tenderness has gone unless you touch the injection site and am no longer feeling over tired.
40 2021-03-18 ringing in ears Tinnitus
40 2021-03-18 ringing in ears Ringing in ears. The first time it happened I woke up and thought the sound was external, and I wok... Read more
Ringing in ears. The first time it happened I woke up and thought the sound was external, and I woke up my husband who said he didn?t hear anything. I realized at that point it?s the ringing in my ears. I hear it more at night time.
40 2021-03-18 ringing in ears Severe headaches which resided after 2 days. On the third day, I began to experience ringing in my e... Read more
Severe headaches which resided after 2 days. On the third day, I began to experience ringing in my ears which has not resolved.
40 2021-03-19 taste impairment Immediate but for 24 hrs only: bad taste in mouth elevated blood pressure/heart rate dizziness la... Read more
Immediate but for 24 hrs only: bad taste in mouth elevated blood pressure/heart rate dizziness lasted two days: fever muscle/joint pain still continues: insomnia
40 2021-03-19 taste impairment Systemic: metallic taste in mouth -Mild, Systemic: Flushed / Sweating-Mild, Additional Details: pati... Read more
Systemic: metallic taste in mouth -Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient states that she has metallic taste in her mouth post observation of 30 minutes -- patient states she still has it upon leaving
40 2021-03-19 swelling of eyelid Received vaccine around 11:40am. Around 7pm same night on 3/19/21 noticed rash to tops of both feet,... Read more
Received vaccine around 11:40am. Around 7pm same night on 3/19/21 noticed rash to tops of both feet, with mild swelling and itching to feet and lower legs. Took 2 benadryl and went to sleep. Woke up this morning with facial swelling, eyes swollen shut. Took Claritin and states improved greatly. Reports itchiness in throat but denies difficulty breathing, throat swelling, chest pain or shortness of breath. Rash on feet/legs was gone when she woke up, still has itchy sensation to body but no rash. Patient reports improving symptoms at time of evaluation in Urgent Care, but would like to report side effect/reaction.
40 2021-03-19 ringing in ears I developed heart palpitations, visited an urgent care, my primary care physician, the ER, and a car... Read more
I developed heart palpitations, visited an urgent care, my primary care physician, the ER, and a cardiologist and have subsequently developed tachycardia with changed in position/posture. I recently developed tinninutus on 3/13 that has not resided.
40 2021-03-20 loss of taste The day after the shot I had numbness in my right leg and foot. Three days after the shot I woke up ... Read more
The day after the shot I had numbness in my right leg and foot. Three days after the shot I woke up with the inability to taste. I can smell but no taste. ?Pfizer-BioNTech COVID-19 Vaccine EUA?
40 2021-03-20 ringing in ears, hearing loss This report is in relation to acute sudden onset tinnitus in left year one day following first shot ... Read more
This report is in relation to acute sudden onset tinnitus in left year one day following first shot of COVID vaccination. Received first COVID vaccine shot in my left arm. I felt a bit tired and foggy but nothing too bad or out of the ordinary. Exactly 31 hours later, I was talking with my daughter when a very loud ringing noise entered my ears. It subsided slightly but then a persistent ringing -- tinnitus -- remains in my left ear. I saw an audiologist who indicated a slight dip in hearing acuity in the left ear at a higher pitch. I am currently on prednisone (20mg 1x per day) and doxycycline but it has been 4 days with no dissipation or relief. I have not suffered from tinnitus before.
40 2021-03-21 ear pain, ear discomfort Within hours of the vaccination, my ears started ringing (tinnitus) and worsened throughout the week... Read more
Within hours of the vaccination, my ears started ringing (tinnitus) and worsened throughout the week. There has been no change, no easing of symptoms. It persists, disrupts my daily life, including increased anxiety and lack of sleep. In addition to the ringing, my ears feel full and hurt. I've been to 3 doctors (PCP, Allergist, ENT) since Thursday March 18, and no one has been able to help me or offer much advice. In addition to ear issues, I have loss of appetite, nausea, and diarrhea that also persist. Odd sensations in my head, like shooting pains or soreness, also occur.
40 2021-03-21 eye pain, vision blurred, sensitivity to light About ten days after the vaccine, I got Iritis in my left eye. I noticed some blurriness and my eye ... Read more
About ten days after the vaccine, I got Iritis in my left eye. I noticed some blurriness and my eye was painful and got worse over the course of three days. I went to the eye doctor and they diagnosed Iritis in my left eye. Sensitive to light and darkness and it was very painful. I was prescribed Steroids and it took two weeks before my vision improved and the pain was lessened. It took six weeks of Steroids before the condition was resolved. No symptoms after the second dose.
40 2021-03-21 mouth numbness, mouth tingling Felt numbing/tingling on and around lips. Lasted about 30 minutes then went away
40 2021-03-22 mouth numbness Numbness in left cheek, occasionally to left eye lid to upper left lip. Numbness comes and goes. C... Read more
Numbness in left cheek, occasionally to left eye lid to upper left lip. Numbness comes and goes. Currently still feel numbin face.
40 2021-03-22 pain in jaw High fever, 102.5. Headache, joint pain (specifically jaw and knees), lethargy, chills
40 2021-03-22 mouth tingling Pt presented to the medical tent with complaints of tingling in her tongue. States has long history ... Read more
Pt presented to the medical tent with complaints of tingling in her tongue. States has long history of allergies, has 2 epi pens with her and premedicated herself prior to coming to the vaccination site with 50 mg of PO benadryl at 1100. As pt was monitored she developed a rash on neck that was splotchy, flat, red. Tongue tingling stopped and moved to her fingers. BP was 152/90, other VS were WNL. Seen by MD on site. 1252 pt was feeling better, rash gone, all tingling gone. Pt left on own from vaccine site.
40 2021-03-22 ringing in ears Constant Tinnitus with spiking attacks, non-stop
40 2021-03-23 dry mouth Throat stated to felt tight, lightheaded. Pt had COVID November 2020. More swollen under chin area a... Read more
Throat stated to felt tight, lightheaded. Pt had COVID November 2020. More swollen under chin area and lymph nodes. Patient states her mouth feels dry.
40 2021-03-24 gaze palsy, vision blurred 2.5 hours after vaccination, I was sitting watching tv when I had a sudden neurological event. It wa... Read more
2.5 hours after vaccination, I was sitting watching tv when I had a sudden neurological event. It was like a seizure. I was unable to talk, my eyes rolled back, and my right shoulder and arm seized up. I was sputtering and unable to make it stop. Lasted for a minute or two then stopped for a minute and happened again. I felt disoriented, confused, scared. I was unable to walk straight or visually focus on anything. I contacted my primary care doctor and she recommended I be seen immediately but advised I call Providence and speak with a nurse. I did that and the nurse said to come in to the ER immediately. I did.
40 2021-03-24 mouth tingling, lip swelling 03.15.2021 1:40 vaccinated 1:55 left site, returned home ~3:00 began itch around waistband. Aleve fo... Read more
03.15.2021 1:40 vaccinated 1:55 left site, returned home ~3:00 began itch around waistband. Aleve for back. 3:30-4:00 symptoms undeniable: itch on neck, face, trunk, lips tingle/swell, lump in throat. Hoarse. No hives. 4:00 Claritin 4:30 talk to Dr take vitals (Sp02 100%, heartbeat normal, BP 131/79, pulse 67, temp normal) 5:15 Benadryl 5:30 itch spreads to whole body, including legs 6:30 talk to Dr Symptoms steady now. 7:30 fall asleep from Benadryl 8:30 wake up for dinner 9:30 laying in bed, breathing becomes shallow. O2 and bpm still normal. 10:00 Talk to Dr. Advises ER if vitals outside of norm. Report to PCP in am. 11:00 breathing normalizes. Sp02 and bpm normal, BP 122/82, pulse 70. Aleve before bed. midnight-1:00 fall asleep 03.16.2021 7:20 Wake up. Water, Wellbutrin, Aleve. Read in bed about an hour until fall back asleep. 11:15 Wake up. Headache. Sp02, bpm, temp, normal. Stay in bed. 12:25 Send report to Dr. 12:30 Get out of bed for first time; coffee, bathroom. Back to bed. 1:10 Spoke with triage nurse. Concern is that lips are still swollen at almost 24 hours. Recommends urgent care for steroids if increased lip/face or respiratory symptoms. Can take Claritin an hour early. 2:30 Get out of bed and shower. Warm to wash, cool to rinse. Got dressed, moved around. Increased itching, skin mottled; still no hives. Aleve. 3:00 Claritin, call from Dr nurse. 3:30 Heat up late lunch, continue to move around the house, answer work questions. 4:30 Upticked symptoms not abating, still mottled skin, lips more swollen. Harder to swallow and dry cough starts, worse when talking. Take vitals: Sp02 and bpm normal, BP 107/83, pulse 73 5:00 Leave for urgent care; BP there 159/71, pulse 79, temp normal. No steroids. Referral to allergy/immunology. Prescription H2 inhibitor, switch to Zyrtec in am. 6:40 Pepcid. Back in bed. 11:30 Benadryl, Aleve. 12:40 Sp02, bpm normal 1:15 Fall asleep 03.17.2021 8:55 Wake up. Water, Wellbutrin, Aleve. 9:30 Sp02, bpm normal. Get up for Pepcid, Zyrtec, bathroom then back in bed. 11:20-11:40 Dozed off, woken up by heart symptoms. Palpitations, panic feeling. Sp02, bpm normal 12:45 Dr called. Allowed to switch back to Claritin tomorrow. Recommends Benadryl more often. Allergy: 504.842.6742 Dr 3:00 Aleve. BP 117/80 pulse 75 4:15 Benadryl 8:20 Hoarse again 9:20 Pepcid. Itching increasing as Benadryl wears off. 10:20 Benadryl 10:30 BP 103/77, pulse 73. Sp02, bpm normal, PI 2.5% 11:45 Aleve 12:00 itching increasing as move around/get ready for bed 1:15 Fall asleep 12.18.2021 6:30 Benadryl. Tired, itch still present (improving), headache. Fell back asleep 7:30. 8:55 Water, Wellbutrin, Aleve, Claritin, Pepcid. Fell back asleep until 11:30 11:45 Sp02, bpm normal, PI 8.0 2:00 Finished shower, didn't worsen itch. 2:45 Aleve 6:00 Been "on" for work about 4 hours. Exhausted. Nauseated. Verge of collapse. Most itching is face/scalp and clothing seams. Lips almost normal though. 8:00 Meds definitely wearing off; face/lips symptoms increasing again. 8:30 Benadryl. Throat symptoms. Swollen lymph nodes. 9:15 Pepcid. Slight cough returned. 10:30 BP 120/85, pulse 80 (was just moving around quickly), Aleve. Itching better, throat/lymph nodes painful 12:45 Benadryl. Ibuprofen. Neck muscles hurt too. 1:15-1:30 fall asleep 03.19.2021 9:00 Water, Wellbutrin, Aleve. Throat still swollen. Itch primarily face/head, back of thighs. 9:15 Pepcid, Claritin. Sp02 normal, bpm low (51-53 back in bed), PI 4.1 3:15 Aleve. Lump in throat still impacts swallowing. Eating makes me hoarse. Neck muscles hurt. 11:00 Pepcid 12:15:Benadryl, Aleve. BP 109/76, pulse 69 2:30 fall asleep 03.20.2021 10:00 Water, Wellbutrin, Aleve. Lips swollen again. 10:15 Pepcid, Claritin 11:25 Symptoms: itching better, mostly gone from body (remains on head). Headache. Throat/neck improved. Lips still swollen. Sp02, bpm normal. PI 10.2% 6:00 Aleve. Itching only head/face. Throat/neck still symptomatic. 11:30 Aleve, Pepcid. Sp02 normal, bpm 70s. 12:15 Benadryl 1:20 Throat sore but no lump. Lymph nodes returning to normal. Still some itch head/face/neck. 1:45-2:00 fall asleep 03.21.2021 7:00 Claritin, back to sleep 11:00 Aleve, Pepcid, Wellbutrin. 5:00 Aleve 11:10 Pepcid, Benadryl. Mild itching. No lump. Throat still slightly sore. BP 113/77, pulse 69 12:20 Aleve 1:15-1:30 fall asleep 03.22.2021 9:45 Water, Wellbutrin, Aleve, Claritin, Pepcid 5:50 Aleve 10:00 Pepcid 12:15 Aleve. Minimal, occasional itching. Lips almost normal. Sp02 normal, bpm 70s 03.23.2021 9:45 Water, Wellbutrin, Aleve, Claritin, last Pepcid
40 2021-03-24 swollen tongue, mouth itchiness 11:26am mild dizziness and confusion. Roof of mouth itching 11:35am moderate to severe dizziness a... Read more
11:26am mild dizziness and confusion. Roof of mouth itching 11:35am moderate to severe dizziness and confusion. Roof of mouth itching and mild tongue swelling. Saw nurse at observation site and was taken to paramedics. They took vitals and blood glucose which were normal. They gave me two shots of 25 mg of Benadryl, which helped tongue swelling but nothing helped dizziness and confusion. Agreed to go to the hospital by ambulance. By the time I was seen in the ER, symptoms resolved other than fatigue from benadryl. Discharged around 2:30pm
40 2021-03-24 tunnel vision Classic vasovagal reaction without syncope Warmth, clamminess, dizziness, partial tunnel vision Self... Read more
Classic vasovagal reaction without syncope Warmth, clamminess, dizziness, partial tunnel vision Self resolving symptoms with BP, pulse, O2 sat all within acceptable ranges with 60 minute observation No orthostasis and comfortable ambulation at discharge from observation unit
40 2021-03-25 eye twitching Day 2 tired, Day 3 and 4 headache, Day 5 and 6 - intermittent eye twitch with ocular migraine sympto... Read more
Day 2 tired, Day 3 and 4 headache, Day 5 and 6 - intermittent eye twitch with ocular migraine symptoms in right eye.
40 2021-03-25 dry throat Dry throat, cough. BP 133/88 (pulse 61).
40 2021-03-25 swollen tongue Swollen tongue, tight throat and chest, dizziness, light headedness, and nausea. Given epinephrine,... Read more
Swollen tongue, tight throat and chest, dizziness, light headedness, and nausea. Given epinephrine, Benadryl and Zofram
40 2021-03-25 tongue discomfort Burning at tip of tongue without swelling and whole body feeling hot
40 2021-03-26 swelling of eyelid 4 hours after the shot, I noticed that my left eyelid was a bit swollen. No pain or itchiness. Not s... Read more
4 hours after the shot, I noticed that my left eyelid was a bit swollen. No pain or itchiness. Not sure when it began to swell. I didn't think much of it, until about 2 hours as I could feel that it was more swollen. I was with friends, they recommended benedryl. So, went and talked to a pharmacist. On the way there, back began to feel itchy (similar to when I have broken out in hives in the past when an allergic reaction starts). Pharmacist recommended 25 ml of liquid benedryl every 4-6 hours and increase to 30 ml if swelling remains. After 1-2 days, if still present to go to doctor. I already have a doc office visit early Monday morning.
40 2021-03-26 enlarged tonsils First 24 hours: Large red raised hot-to-touch bump at injection site (applied ice pack) Severe pain ... Read more
First 24 hours: Large red raised hot-to-touch bump at injection site (applied ice pack) Severe pain from site up back of neck and down to fingers Low grade temperature 99.9° Next 24 hours: Still have large raised red hot-to-touch bump at injection site but now site is very itchy (applied ice pack) Pain has dulled but still present Fever gone Sore throat and slightly swollen tonsils
40 2021-03-26 toothache After 2nd Dose: 1st Day- 5pm onset: Markedly increased heart rate while sitting at rest. Fever, fati... Read more
After 2nd Dose: 1st Day- 5pm onset: Markedly increased heart rate while sitting at rest. Fever, fatigue, intense muscle weakness & achiness, felt like weights in my veins. Sleep overnight was disrupted often. Intense strange dreams, perhaps lucid. 2nd Day- 9am: Fever & weakness subsided, muscles remained achy particularly with increased activity. Tiredness. 3pm: Fever returned. 5pm: Strong heart palpatations. Achy muscles. 8pm: Tiredness. Strange dreams, still lucid. 3rd Day- Still slight achiness. 3pm: Intense heart palpatations, pre-menstrual cramping (11 days early, my cycle is extremely regular). 5pm: Heart palpatations, muscles felt almost an electric pulsivity. 6pm: Tooth pain for about two hours. 8pm: Vaginal discharge (clear lubricant), lasted till 3am. 4am: Urine had extremely sour smell. *3rd day indicated to me that my hormones/hypothalamus may have been affected? Very strange, out-of-cycle behaviors. I have been sexually inactive for over 6 months.
40 2021-03-27 loss of taste Facial numbness, loss of taste. Also note- my VARS account is not accurate & you cannot adjust you a... Read more
Facial numbness, loss of taste. Also note- my VARS account is not accurate & you cannot adjust you answers- it has not been doing daily checks on me - it says I?m good when still having symptoms- there is not way to contact or correct info on that system.
40 2021-03-28 ringing in ears, hearing loss, deafness On 3/10/2021 Migraine headache started at 6:15pm Ear ringing (tinnitus) started at 7:00 pm 3/11/202... Read more
On 3/10/2021 Migraine headache started at 6:15pm Ear ringing (tinnitus) started at 7:00 pm 3/11/2021 Additional hearing muffled was was noticeable 3/16/2021: severe migraine, throwing up, nauseous 3/17/2021: facial rash prominent **hearing loss deemed permanent, ringing continuous
40 2021-03-28 vision blurred, eye swelling, bloodshot eyes starting nearly exactly 48 hours after vaccination: - fever: 99.5 - 101 (~48 hours) - chills (~48 ho... Read more
starting nearly exactly 48 hours after vaccination: - fever: 99.5 - 101 (~48 hours) - chills (~48 hours) - night sweats (~96 hours) - fatigue (~ 7 days) - muscle aches (~7 days) - headache (~7 days) - bloodshot & swollen eyes & blurred vision (started 5 days after vaccine, got Rx for bacterial eye infection 9 days after vaccine)
40 2021-03-29 eye swelling Left Eye swelling; Severe Itching all over; Severe Headache; Stiff neck; This is a spontaneous repor... Read more
Left Eye swelling; Severe Itching all over; Severe Headache; Stiff neck; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient she received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6198) via an unspecified route of administration in the left arm on 26Feb2021 at 16:30 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Medical history included variable immune deficiency, asthma, and eosinophilic esophagitis (EOE). Allergies to medications included amoxicillin, erythromycin, clindamycin, ciprofloxacin (CIPRO), sulfamethoxazole/ trimethoprim (BACTRIM), and oxycodone/ paracetamol (PERCOCET). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 26Feb2021 at 17:15, the patient experienced left eye swelling, severe itching all over, severe headache, and stiff neck. The patient was not treated for left eye swelling, severe itching all over, severe headache, and stiff neck. The clinical outcome of left eye swelling, severe itching all over, severe headache, and stiff neck was not recovered.
40 2021-03-29 mouth tingling, mouth numbness lip tingling and numbness
40 2021-03-29 ringing in ears I received my second dose of the Pfizer vaccine on a Tuesday evening and had no adverse symptoms tha... Read more
I received my second dose of the Pfizer vaccine on a Tuesday evening and had no adverse symptoms that night. When I woke up the next morning, I had a very, very bad headache and ringing in my ears. The headache began to subside by that night, but the tinnitus continued. By the following day (Thursday), the headache was gone but I was still tired and the tinnitus continued. By Friday, I felt basically back to normal, except for the tinnitus. It is now Tuesday, one week from the shot, and the tinnitus continues.
40 2021-03-30 ear pain Fever for over 3 days, going up to 103F; severe migraines; dizziness; brain fog; loss of appetite; t... Read more
Fever for over 3 days, going up to 103F; severe migraines; dizziness; brain fog; loss of appetite; throat ache; ear ache; unable to get out of bed for 3 days; extremely swollen lymph nodes; This is a spontaneous report from a contactable Other Health Professional, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EL9262), via an unspecified route of administration, in the left arm on 30Jan2021 at 10:15 AM as a single dose for covid-19 immunisation. Medical history included allergies to sulfa antibiotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included ibuprofen (IBUPROFEN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EJ1686) via an unspecified route of administration, in the left arm on 08Jan2021 at 10:00 AM as a single dose for covid-19 immunisation. On 30Jan2021 at 12:00 PM the patient exepereinced fever for over 3 days, going up to 103F, extremely swollen lymph nodes, severe migraines, dizziness, brain fog, loss of apetite, ear and throat ache, unable to get out of bed for 3 days. No treatment was given to the events. The events were assessed as non-serious by the reporter. Outcome of the events were not recovered.
40 2021-03-30 eye irritation, mouth tingling, taste impairment sore arm where shot was given; nauseous; shortness of breath; tongue tingly; right Eye bothersome; m... Read more
sore arm where shot was given; nauseous; shortness of breath; tongue tingly; right Eye bothersome; metallic taste; elevated heart rate; headache; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: EL 3257, Expiration date: unknown) via unspecified route on 30Jan2021 01:30 PM, in the left arm, deltoid at a single dose for COVID-19 immunization. The patient's relevant medical history included asthma and seasonal allergies. Concomitant medications included Nortriptyline, oxcarbazepin, montelukost. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient did not have COVID-19 prior to vaccination or tested since the vaccination. On 30Jan2021 at 02:00 PM the patient experienced very sore arm where shot was given, nauseous, shortness of breath, tongue tingly, right eye bothersome, metallic taste, elevated heart rate and headache. It was unknown if the patient had received any treatment for the events. Outcome of events was not resolved.
40 2021-03-30 mouth itchiness, swollen tongue Anaphylactic shock. Tongue, Hands and feet swelling. Hives all over body, skin felt like it was burn... Read more
Anaphylactic shock. Tongue, Hands and feet swelling. Hives all over body, skin felt like it was burning from itching so bad. Inside of mouth and throat itching. Chest felt like someone was sitting on it.
40 2021-03-30 oropharyngeal discomfort Patient got her covid 19 vaccine. 5 minutes after her shot she said her throat was hot. BP was 135/9... Read more
Patient got her covid 19 vaccine. 5 minutes after her shot she said her throat was hot. BP was 135/90. Pulse 75. No signs of distress. I gave her 50mg of benadryl. Patient stayed for 30 minutes. All symptoms were resolved by when she left.
40 2021-03-30 toothache Nerve pain in all of my skin (including hair follicles and teeth); extreme headache; 101 degree feve... Read more
Nerve pain in all of my skin (including hair follicles and teeth); extreme headache; 101 degree fever; lethargy; shivers; slept for 17 hours on and off; numbness in my face and fingers; numbness in my face and fingers; zinging pain in my teeth; This is a spontaneous report from a contactable Other HCP. This 40-year-old female Other HCP (patient) reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL9267) via an unspecified route of administration from 11Feb2021 at 03:00 pm to 11Feb2021 at 03:00 pm at single dose (dose number; 2) on left arm for covid-19 immunisation. Vaccine facility type was reported other. Patient was 40 years old and not pregnant at the time of vaccination. Patient's medical history included Known allergies: Sulfa (unspecified dates). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL9262) via an unspecified route of administration from 21Jan2021 at 3:30 pm to 21Jan2021 at 03:30 pm on left arm at single dose (dose number; 1) on left arm for covid-19 immunisation. Concomitant medications included (other medications in two weeks) Ibuprofen and ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN-C) and birth control from an unspecified date to an unspecified date at unknown dose and frequency for an unspecified indication. If other vaccine in four weeks; no. On 12Feb2021 at 02:00 pm, patient experienced nerve pain in all of her skin (including hair follicles and teeth), extreme headache, 101 degree fever, lethargy, and shivers. This hit her at almost 24 hours after injection. She slept for 17 hours on and off. She awoke this morning with numbness in her face and fingers, but also zinging pain in my teeth. The reported adverse events did not result in emergency room or physician's office visit. Treatment received was reported as no for the adverse events. Patient did not have covid prior vaccination and was not tested for covid post vaccination. The outcome of events was recovering.
40 2021-03-30 vision blurred Tightness in the chest, warmth in the chest, blurred vision and sudden drop in blood pressure to the... Read more
Tightness in the chest, warmth in the chest, blurred vision and sudden drop in blood pressure to the point of almost losing the consciousness, sweat, weak pulse. The symptoms appeared at about 4 mins after the injection in the resting area. The patient was taken on the wheelchair to lay down. The pressure was taken, the EkG. The ambulance cam after 20-30 mins. The patient started recovering but still felt tightness in the chest. The patient was taken to the Medical Center. The patient was given a blood test and urine test. The patient started feeling better and was sent home after about 3-4 hours.
40 2021-03-31 eye irritation burning eyes within a few minutes of vaccination, no swelling, no SOB, no tingling
40 2021-03-31 eye swelling Body aches, chills, mild swelling of eyes
40 2021-03-31 mouth tingling Dizziness, 1:30 pm, lasted 12hrs. Headache, 1:30 pm, lasted 12hrs. Tingling tongue, 1:30 pm, ongoing... Read more
Dizziness, 1:30 pm, lasted 12hrs. Headache, 1:30 pm, lasted 12hrs. Tingling tongue, 1:30 pm, ongoing. Tingling roof of mouth, 1:30 pm, ongoing. Tingling lips, 1:30 pm, ongoing.
40 2021-04-01 dry eye 15:21-REceived vaccine injection L deltoid. 15:30-Arrived in observation area, reported onset of H/A... Read more
15:21-REceived vaccine injection L deltoid. 15:30-Arrived in observation area, reported onset of H/A, LUE pain and warmness, numbness of left UE and LE and dry eyes.Dr. present. 16:09-VS: 175/69; HR 80; SpO2 98%. 16:14-Epinephrine 0.3mg L lat thigh per Dr. 16:19-VS: 184/91; HR 74; SpO2 98% 16:40-VS stable, pt W/O discomfort. Released home per Dr.
40 2021-04-01 taste impairment, mouth numbness Patient received Pfizer EW0150 by Nurse. Patient in observation area notified Nurse stated feeling o... Read more
Patient received Pfizer EW0150 by Nurse. Patient in observation area notified Nurse stated feeling of dizziness, flushness, numbness in tongue, throat itching and metallic taste. No audible wheezing, no shortness of breath, and no difficulty swallowing. (BP 153/99, HR, 77, Spo2: 98%) Patient with history of Asthma/Anaphylactic reactions. Allergies to Penicillin. Under observation, patient reports of improvement in condition, although still persistent throat itching and tongue numbness. 25mg Benadryl PO administered. HR: 83, BP:118/80, Spo2: 99%, patient further monitored and states feeling well with all symptoms completely resolve. Pt dc/ed educated on s/s to look out for. (HR 77, BP:112/70 O2:99%)
40 2021-04-01 lip swelling, mouth tingling Patient complained lips tingling & tongue was swelling. Onsite EMS was called vitals HR 82 BP 132/8... Read more
Patient complained lips tingling & tongue was swelling. Onsite EMS was called vitals HR 82 BP 132/87. 25 diphenhydramine was given She felt better and went home.
40 2021-04-01 oropharyngeal discomfort, tongue disorder She got her vaccine, and within the first 15 minutes felt like her tongue was fat. The reaction sta... Read more
She got her vaccine, and within the first 15 minutes felt like her tongue was fat. The reaction started at 1:15 and her headache was getting bad and turning into a migraine, and took her migraine medicine. She was getting a stretching and painful sensation in her skin over her head. She lost her ability to swallow, and everything around her face and neck were numb. She called the hotline and called her doctor, and was able to focus very hard and able to swallow but felt very narrow passageway. She then felt like she had a bubble in her throat, and then decided to call 9-1-1. The first responders came to her house and said that they could not see anything in her throat, they gave her Benadryl and within the hour everything seemed to dissipate and they stayed with her until she stabilized. Her BP was high and her heart rate was high as well, 98-100. Her temperature was 98.5. She felt really awful and nothing was going on with her throat or breathing after the Benadryl and felt foggy and tired and by the third day she was completely fine.
40 2021-04-02 deafness unilateral, ringing in ears 9:40am injection. 10:30am migraine started. 10:40am strong ringing in my left ear, and feel dizzy. 1... Read more
9:40am injection. 10:30am migraine started. 10:40am strong ringing in my left ear, and feel dizzy. 11am spine, back, and joints hurt. Ringing in both ears, but I have lost partial hearing in my left ear. 10:22pm, still ringing in left ear, partial hearing, small headache, deep aches.
40 2021-04-02 sensitivity to light Generally occurring and resolving within 36 hours: Generalized neuropathic pain that turned graduall... Read more
Generally occurring and resolving within 36 hours: Generalized neuropathic pain that turned gradually into generalized nociceptive pain / soreness; Pounding headache at the base of the brain; Tachycardia; Sensation of pounding heartbeats; Nausea; Sensitivity to light; Loss of appetite and thirst; Low-grade fever Still occurring at 48-53 hours: Nausea Light headache; Sensitivity to light; Some sensation of heart racing; Localized pain in different areas of the body
40 2021-04-03 feeling of choking, mouth tingling Patient reported throat/lip tingling and headache within 10 minutes of receiving vaccine. Patient wa... Read more
Patient reported throat/lip tingling and headache within 10 minutes of receiving vaccine. Patient was given benadryl and observed. Condition improved.
40 2021-04-03 taste disorder This was my second shot, I had no adverse reactions to the first. For 8 days after my second shot, I... Read more
This was my second shot, I had no adverse reactions to the first. For 8 days after my second shot, I had a continuous headache stemming from the base of my skull. I had read this as a possible side effect so I was not concerned. On the 9th day, I woke up without a headache and thought my symptoms were over. However on that day, my sense of taste started changing. I started putting a lot more salt on things. In the following 3 days, it's progressed that anything sweet has a rancid taste. Bitter and salty items taste just fine but even plain water now tastes foul and it seems to be getting worse each day. I've never experienced this before so I am assuming it's the vaccine. At a guess, this isn't a big deal. I wouldn't be concerned except it started a week after vaccination instead of immediately. I thought it best to at least document it by informing someone.
40 2021-04-03 ringing in ears Ringing in ears - still hasn't gone away 24 hours later.
40 2021-04-03 ringing in ears Constant Bilateral Tinnitus, with attacking episodes multiple times a day; This is a spontaneous rep... Read more
Constant Bilateral Tinnitus, with attacking episodes multiple times a day; This is a spontaneous report from a contactable physician (patient). A 40-year-old non-pregnant female patient received BNT162B2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EL1283) first dose via an unspecified route of administration on 29Jan2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications included iron supplement (SPATONE IRON supplement) for unspecified indication. On 14Feb2021 the patient experienced constant bilateral tinnitus, with attacking episodes multiple times a day (tinnitus) (disability). Therapeutic measures were taken as a result of constant bilateral tinnitus included prednisone taper. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not underwent diagnosed with COVID-19. After the vaccination patient did not tested for COVID-19. The outcome of the events was not recovered.
40 2021-04-04 bloodshot eyes, eye itchiness, eye pain, eye swelling 4am the day after my first shot I woke up to swollen, blood shot eyes which were irritated and itchy... Read more
4am the day after my first shot I woke up to swollen, blood shot eyes which were irritated and itchy. After an hour and a half the symptoms were not getting better so I decided to take claritin since it was similar to the allergic reaction I have to mold. An hour later my eyes were better but still sore around them. The next day they were completely better. Also, since taking the vaccine I seem to forget things easily, things that I put in the microwave are sitting there the next morning which is very unusual for me to be so forgetful so many times and even at work my focus was scattered and things that were routine were becoming challenging to remember to complete. After 2 weeks it seems to have faded, although once I became aware of what was happening I have made a conscious effort to remember things. I realize that these may seem like small events, but I feel that it is something that should be looked into as it was/is rather concerning since this was only my first shot and the second is supposed to react worse. I am still contemplating whether getting a second shot is wise for me.
40 2021-04-04 mouth tingling, lip swelling, swollen tongue Dizziness, tingling and itchy skin, swelling and tingling of lips and tongue, slight throat swelling... Read more
Dizziness, tingling and itchy skin, swelling and tingling of lips and tongue, slight throat swelling. Treated at home with 50 mg Benadryl every 6 hours, Pepcid, and Predinsonl (steroid pack).
40 2021-04-04 vision blurred, ringing in ears, swelling around the eyes Pt received shot at 1145. At 1220, pt reported sx fo puffy eye lids (no puffiness visible outwardly)... Read more
Pt received shot at 1145. At 1220, pt reported sx fo puffy eye lids (no puffiness visible outwardly), ears ringing, blurry vision, feeling hot, weakness in muscles. VS: BP 126/68, P85, RR18, O2 99% RA, T98.6F. Pt takes benadryl 25mg po bid. Last dose 0400 today. Pt reports multiple previous hospitalizations for congestive heart failure, tachycardia, and bradycardia. She takes ?1500 of Levothyronine? and ?Mididrine four times a day to raise my blood pressure.? She does not want more benadryl at this time. She is calm outwardly. No signs of distress noted outwardly. Diminished lung sounds in bilat lower lobes. Pt smokes cigarettes. Dr consulted. Pt advised to wait in high risk obs for another 30 min to see if symptoms resolve. After about 5 minutes, pt requested EMS. No worsening conditions noted or reported. EMS called and came to assess pt. Pt left via EMS to go to hospital at approximately 12:15pm. Pt notified to follow up with her PCP prior to second dose of vaccine.
40 2021-04-05 loss of taste Lost sense of taste, reduced sense of smell
40 2021-04-05 eye swelling About 90 minutes after the shot, my face swelled up and had hives. My left eye would not open all th... Read more
About 90 minutes after the shot, my face swelled up and had hives. My left eye would not open all the way. I had hives on my back, chest and both arms. I got the symptoms under control after 9 Benadryl pills. 2 days after the shot - my lymph nodes swelled up in my neck and on my left clavicle. I did not treat these. 3 days after the shot, out of nowhere, my left cheek swelled up and there were hives and my eye was half swollen shut. Symptoms were under control after 2 Benadryl pills. My lymph nodes remain slightly swollen, but not as severe as on Day 2.
40 2021-04-06 ear discomfort I woke up with acute vertigo on Thursday. The room was spinning. I could not function from about 8:0... Read more
I woke up with acute vertigo on Thursday. The room was spinning. I could not function from about 8:00 a.m. until about 6:00 p.m. I went to the doctor the next day, Friday, and was diagnosed with labyrinthitis due to allergies. I had no allergy symptoms. By Saturday, I was no longer dizzy but my ears felt full and continue to feel clogged 6 days after the onset of the vertigo.
40 2021-04-06 swollen tongue, mouth tingling, mouth swelling Numb, swollen and tingling tongue and mouth (lasted for about a week) Headache, severe dizziness
40 2021-04-07 lip swelling Lip swollen
40 2021-04-07 light flashes or floaters in the eye dizziness "flashes of light". Evaluated by EMS-Cleared
40 2021-04-08 lip swelling Patient received Pfizer COVID-19 vaccine on 4/6/2021. Patient reports the following adverse reactio... Read more
Patient received Pfizer COVID-19 vaccine on 4/6/2021. Patient reports the following adverse reactions: facial swelling, lips swelling, reddness, small hives. Patient was given 25mg Benadryl PO per protocol. Dr was made aware. Monitored patient. Patient started to experience some throat tightness but no shortness of breath or difficulty breathing. Spoke with Dr again and gave patient 0.3mg Epinephrine in right deltoid. Dr came down to clinic as patient was going to ED per car with her sister driving. In the ED , patient was treated for anaphylaxis at hospital and stayed overnight (epinephrine, solumedrol, pepcid x2). After discharge on prednisone 40mg daily x5 days, patient came back with hives and was readmitted and treated overnight with pepcid/benadryl expect to be discharged again today.
40 2021-04-08 mouth tingling 10 mins after injection, developed tingling in mouth and lips, tightening in throat, blotchy chest a... Read more
10 mins after injection, developed tingling in mouth and lips, tightening in throat, blotchy chest and neck. arrived to obs, 1830 bp 140/69 hr 95 rr 18 sats 96%, feeling hot. water and apple juice given, started feeling relief and blotchy neck and chest improving. 1838 bp 112/66 hr 97 rr 18 sats 95% on ra. 1847 bp 118/67 hr 67 rr 20 sats 99% on ra, blotchty areas resolved, and facial/mouth tingling resolved as well as throat tightness. escorted to exit with no further issues. instructed on benadryl once home.
40 2021-04-08 swollen tongue 4/7/21 8pm-Itchy skin, rash on injection site. 4/8/21 7am-swollen throat and tongue, itchy skin.
40 2021-04-08 swollen tongue Patient described a swollen tongue and senation in back of throat sensation. Onsite EMS was called v... Read more
Patient described a swollen tongue and senation in back of throat sensation. Onsite EMS was called vitals BP 128/60. Patient recovered and went home.
40 2021-04-08 ringing in ears Tinnitus in both ears
40 2021-04-09 ear discomfort both ears have a red flaky rash with small white bumps. Skin in dry to the touch and very itchy. ras... Read more
both ears have a red flaky rash with small white bumps. Skin in dry to the touch and very itchy. rash has lasted 6 days at time of reporting
40 2021-04-09 eye movement disorder Seizure like events; Began sputtering; My shoulder and neck seized up; Eyes rolled back in her head ... Read more
Seizure like events; Began sputtering; My shoulder and neck seized up; Eyes rolled back in her head and she had no control over it; Did not remember some of it; Confused; Unable to focus with her eyes; Extreme fatigue; Walking is unsteady; This is a spontaneous report from a contactable consumer (the patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: 59267-1000-03), via an unspecified route of administration, administered in left arm on 24Mar2021 16:45 as single dose for COVID-19 immunization. Medical history included asthma, bronchitis, anxiety, allergy to Aspirin, NSAIDs, agave, soy, and dairy. The patient has no history of COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not COVID tested post vaccination. Concomitant medications included venlafaxine and progesterone taken for an unspecified indication. On 24Mar2021, 19:30, the patient experienced seizure like events. She began sputtering, her shoulder and neck seized up, eyes rolled back in her head and she had no control over it and did not remember some of it. It happened twice in a row. She had been confused, unable to focus with her eyes, extreme fatigue, and her walking was unsteady. The adverse event resulted in Emergency room/department or urgent care. The patient received treatment for the events. The patient was requested for testing and referral for neurologist for MRI. The patient has not recovered from the events. Follow up attempts are possible. Further information is expected.
40 2021-04-09 eye itchiness slept over 20 hours day 4, plus 12 day 5; Joint and muscle pain; Joint and muscle pain; extreme fati... Read more
slept over 20 hours day 4, plus 12 day 5; Joint and muscle pain; Joint and muscle pain; extreme fatigue/exhausted; Congested with runny nose; Congested with runny nose; itchy eyes; generally feeling ill; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 40-year-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247, Expiry date: unknown) intramuscular, administered in Arm Left on 29Jan2021 09:45 am (at the age of 40-years-old) at a single dose for covid-19 immunisation. Medical history included sinus tachycardia, panic disorder, depression, chronic fatigue syndrome, PCOS. Allergies to medications, food, or other products was Penicillin. Concomitant medication patient received within 2 weeks of vaccination included Metformin 500mg, Metoprolol 50 mg, Paroxetine 50 mg and vitamin D. The patient previously took first dose of BNT162B2 (lot number: EL0140) on 08Jan2021 on right arm at a single dose for covid-19 immunisation and 2 weeks or so after first shot, noticed severe itching on my left upper thigh with bumps and after this shot, itching has spread to face and arms. The patient experienced joint and muscle pain, extreme fatigue/exhausted on 31Jan2021, slept over 20 hours day 4, plus 12 day 5 on 01Feb2021 and congested with runny nose, itchy eyes, generally feeling ill in 2021. The event was considered as non-serious. Facility where the most recent COVID-19 vaccine was administered was Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. No treatment was received for the adverse event. The patient underwent lab tests and procedures which included Oropharyngeal: negative on 01Feb2021. The outcome of all the events was not recovered.
40 2021-04-09 light flashes or floaters in the eye, vision blurred Fatigue on-going. Retinal/occular migraine - left eye sight blurry, flashing, spinning zig zag light... Read more
Fatigue on-going. Retinal/occular migraine - left eye sight blurry, flashing, spinning zig zag lights without bad headache. Never experienced the vision issue before.
40 2021-04-10 loss of taste, thirst Adverse effects were Covid-19 like symptoms that consisted of; foggy brain, extreme thirst, chills, ... Read more
Adverse effects were Covid-19 like symptoms that consisted of; foggy brain, extreme thirst, chills, shakes, cold, fever, body aches, loss of taste and extreme exhaustion.
40 2021-04-10 eye discomfort Red raised areas that start at left eyebrow and go into hairline. Red raised bumps throughout scalp ... Read more
Red raised areas that start at left eyebrow and go into hairline. Red raised bumps throughout scalp on the left side. Left swollen lymph node behind ear that is continuing to swell. Pressure from lymph node swelling now felt near left eye. All bumps can be itchy at times.
40 2021-04-11 loss of taste Lethargy High fever Migraine Loss of taste Body aches
40 2021-04-12 dry mouth Within minutes of receiving the injection I experienced waves of dizziness to the point of almost pa... Read more
Within minutes of receiving the injection I experienced waves of dizziness to the point of almost passing out, rapid heartbeat, full body hot flashes, sweating, hand tremors,, dry mouth Observed for 30 min and released with no intervention. Waves of vertigo continued throughout the day, but are decreasing in frequency but not intensity as days go on. Within an hour of injection psoriasis on left leg flared and was raised, red and extremely itchy through Sunday, 4.11.21. Severe headache through end of day on 4.9.21. Treated allergic symptoms with 10ml Benadryl every 5 hours for 2 days, Ibuprofen PRN for pain. All symptoms subsided except for headache and dizziness/vertigo but appears to be decreasing in frequency but not intensity.
40 2021-04-12 lip swelling had swelling of cheeks, lips, cough , trouble swallowing about 30 minutes after vaccine administrati... Read more
had swelling of cheeks, lips, cough , trouble swallowing about 30 minutes after vaccine administration
40 2021-04-12 swollen tongue Flushed face and chest pressure at 09:34. Patient brought her own childrens oral Benadryl and took 4... Read more
Flushed face and chest pressure at 09:34. Patient brought her own childrens oral Benadryl and took 40 mL as instructed by her doctor . At )9:53, patient stated her throat was getting tight and her tongue swelling so she received a epipen.
40 2021-04-12 ringing in ears Tinnitus
40 2021-04-12 ringing in ears Tinnitus in both ears
40 2021-04-13 dry mouth Patient developed temporal headache 5 minutes post vaccination, along with slight dizziness, dry mou... Read more
Patient developed temporal headache 5 minutes post vaccination, along with slight dizziness, dry mouth, and inability to catch a deep breath. Patient laid down to rest, had vitals checked. Patient was moved to a sitting position after 10 minutes, and stated that she felt better. She was given some water and monitored for another 10 minutes. Vital signs were rechecked and she was released.
40 2021-04-13 ear pain, ear swelling Have developed large red welt at injection that has been spreading slowly and continuously over past... Read more
Have developed large red welt at injection that has been spreading slowly and continuously over past 30 hours. Started approximately size of dime, is larger than a quarter after 30 hours. Red in color, hot, swollen. Left ear is starting to get swollen and painful on inside - due to swollen lymph node under ear.
40 2021-04-13 painful gums, bleeding gums, swollen lips Rash on entire body mainly torso. Extra sensitive gums that bled when teeth were brushed. Rash on in... Read more
Rash on entire body mainly torso. Extra sensitive gums that bled when teeth were brushed. Rash on inside of both lips and in the back of my throat. Diarrhea, body aches, vomiting, mild fever, splotchy skin,
40 2021-04-13 mouth numbness Headache & Numbness in lips/nose within the 1st hour. I called to report symptoms and was advised t... Read more
Headache & Numbness in lips/nose within the 1st hour. I called to report symptoms and was advised to monitor and if gets worse to call back and go to ER. At this time I am ok and no need to go to ER as I am not having trouble breathing and no swelling.
40 2021-04-13 mouth tingling I started to feel a tingling sensation on my tongue about 2 hours after the injection. It did not ge... Read more
I started to feel a tingling sensation on my tongue about 2 hours after the injection. It did not get worse and has remained constant. I fell asleep and woke up with the sensation of my tongue tingling. It has been almost 24 hours since the injection and it still tingles.
40 2021-04-14 loss of taste Severe leg pain (inability to stand for longer than a minute). Extreme fatigue. Facial numbness. Los... Read more
Severe leg pain (inability to stand for longer than a minute). Extreme fatigue. Facial numbness. Loss of taste.
40 2021-04-14 ear discomfort, ringing in ears Less than 24hrs after first shot on 03/24/2021 right ear is muffled. Feels like it clogged. Never we... Read more
Less than 24hrs after first shot on 03/24/2021 right ear is muffled. Feels like it clogged. Never went away Less than 24hrs after second shot on 04/14/2021 right ear is still muffled and now I have a buzzing sound in my ear.
40 2021-04-14 mouth tingling I have been experiencing these symptoms for three days now. -moderate dizzy spells/vertigo -severe... Read more
I have been experiencing these symptoms for three days now. -moderate dizzy spells/vertigo -severe headache -severe fatigue -sore arm in injection site -swollen lymph nodes -tingling in tongue -achy muscles/joints
40 2021-04-14 tunnel vision Tunnel vision, near syncope, rapid heartbeat, rapid increase in blood pressure. Lasted at least 30 ... Read more
Tunnel vision, near syncope, rapid heartbeat, rapid increase in blood pressure. Lasted at least 30 minutes while I waited at the clinic. Was given one Benadryl. Symptoms cleared but was still not symptom free when I drove home.
40 2021-04-15 eye twitching My left eye started twitching within two days of getting the first dose. This persisted and accelera... Read more
My left eye started twitching within two days of getting the first dose. This persisted and accelerated after the second dose. While it has mostly subsided, the twitching does occasionally return.
40 2021-04-15 taste impairment Seconds after injection my left arm had an icy numb sensation from injection site to my fingers. Tod... Read more
Seconds after injection my left arm had an icy numb sensation from injection site to my fingers. Today Three weeks later I experienced same icy sensation plus numbness/weakness, decreased sensation in fingertips. 2. Still have bad Headaches still after 3 weeks 3. Extreme Fatigue still after 3 weeks 4. Last few days, three weeks after shot, I have worsening/ Increased joint pain, spiky pain in joints, chills and entire body aches like I have the flu. No fever, no runny nose, etc. Just the body aches, joint pain like people experience with the flu. 5. Decreased mental sharpest last 2 weeks since shot. 6. Light headedness, dizziness. 7. Immediately after shot I experienced metal taste in my mouth. Since the shot, I still experience occurrences of metal taste every day. 8. Today experiencing slight numbness in right foot. 9. Swelling in fingers
40 2021-04-15 taste impairment Burning in chest and throat. And weird taste along with it. As if after getting and iodine shot for ... Read more
Burning in chest and throat. And weird taste along with it. As if after getting and iodine shot for a cat scan.. the same metallic taste.
40 2021-04-15 eye pain Body aches, chills, fatigue, headache, and eye pain for 24 hours. Arm soreness at the site for 3 day... Read more
Body aches, chills, fatigue, headache, and eye pain for 24 hours. Arm soreness at the site for 3 days, followed by swelling and itch on entire upper arm where vaccinated. Swelling and itch lasted for 10 days.
40 2021-04-15 mouth swelling, lip swelling, mouth pain, lip itchiness I woke up with a swollen and itchy upper and lower lip. Also, the area under the tongue is swollen a... Read more
I woke up with a swollen and itchy upper and lower lip. Also, the area under the tongue is swollen and sore. I have not used a different product or eaten any different foods. I am taken Benadryl and it seems to be helping.
40 2021-04-15 visual impairment, eye irritation Site: Pain at Injection Site-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Detail... Read more
Site: Pain at Injection Site-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Pt said her arm was sore for two days and also her Left Eye Burned and felt like acid was in her eye for about 90 second time periods about 3 episodes a day for 2 days.
40 2021-04-16 eye pain Asymptomatic until bedtime, 101.9 fever for 6 hours and currently 100.3, but it's fluctuating. Sever... Read more
Asymptomatic until bedtime, 101.9 fever for 6 hours and currently 100.3, but it's fluctuating. Severe shaking chills, and throbbing bone and joint pain. My perineum also oddly feels as though I've been kicked rather hard. Sleepless night until chills subsided. Then experienced mild nausea, and pain in both palms while hand washing. No congestion, but dry inflamed sinuses and eye pain. I developed a headache this morning, but only while standing.
40 2021-04-17 eye strain Children said I would sit up say weird things then faint; dizzy; heavy eyes; heavy head; laid down d... Read more
Children said I would sit up say weird things then faint; dizzy; heavy eyes; heavy head; laid down do not remember anything from the evening; Children said I would sit up say weird things then faint; severe vertigo; confusion; shook uncontrollably for 30 minutes; This is a spontaneous report from a contactable consumer(patient). A 40-year-old non-pregnant female patient received first dose of BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at 10 am (Batch/Lot Number: EN 6199) as single dose (at 40-year-old) in arm left for COVID-19 immunization. The patient wasn't pregnant at the time of vaccination. The patient had ongoing allergy to intravenous pethidine hydrochloride (DEMEROL). No other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL). Prior to vaccination, it's unknown if the patient was diagnosed with COVID 19. Since the vaccination, the patient hasn't been tested for COVID19. At 7pm the patient became incredibly dizzy, heavy eyes, heavy head, laid down did not remember anything from the evening. Children said she would sit up said weird things then faint. Laughed and shook uncontrollably for 30 minutes. Next morning severe vertigo, confusion. Went away the third day. No seriousness criteria reported. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the events. The outcomes of the events were resolving.
40 2021-04-17 dry mouth, tongue discomfort Extreme head ache, irritability, dry mouth, numbness and tingling of my left arm, my tongue feels ti... Read more
Extreme head ache, irritability, dry mouth, numbness and tingling of my left arm, my tongue feels tingly. I feel like I drank about ten red bulls my heart feels like its racing!
40 2021-04-17 taste impairment Metallic Taste in Mouth; Sweating; Vertigo; This is a spontaneous report from a contactable consumer... Read more
Metallic Taste in Mouth; Sweating; Vertigo; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 40-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Brand: Pfizer), dose 1 via an unspecified route of administration in Arm Left on 29Mar2021 16:30 (Lot number and expiry date was not reported) as single dose for covid-19 immunisation. Medical history included hypersensitivity from an unknown date and unknown if ongoing Allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, was the patient diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 29Mar2021 16:45, the patient experienced metallic taste in mouth, sweating and vertigo. Therapeutic measures were not taken as a result of adverse event. The outcome of the event was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained
40 2021-04-17 mouth itchiness 10 MINS AFTER VACCINE, FELT ITCHY THROAT AND TOP OF MOUTH. WATER GIVEN IN OBS, IMPROVED AFTER A FEW ... Read more
10 MINS AFTER VACCINE, FELT ITCHY THROAT AND TOP OF MOUTH. WATER GIVEN IN OBS, IMPROVED AFTER A FEW MINUTES, STATES JUST FEELS LIKE MILD ALLERGY TICKLE/IRRITATION IS ALL THAT REMAINS. INSTRUCTED ON BENADRYL IF NEEDED AT HOME AND TO MONITOR AND SEEK FURTHER EVAL IF WORSENS. ESCORTED TO EXIT TO MEET SPOUSE WITHOUT ISSUES AT 1545. 1530 INITIAL BP 172/97 HR 98 RR 20 SATS 98% ON RA (REPORTS SITUATIONAL ANXIETY) 1540 BP 131/88 HR 73 RR 18 SATS 100% ON RA
40 2021-04-18 deafness - Sudden loss of hearing in left ear on April 10 (5 days after second COVID shot) upon waking up in ... Read more
- Sudden loss of hearing in left ear on April 10 (5 days after second COVID shot) upon waking up in the morning around 8:00 am. - Loss of hearing was becoming more pronounced, so I went to the doctor for an exam on 4/14. Dr. could not determine cause of hearing loss. Scheduled an audiology exam and appointment with ENT for 4/15. Doctor prescribed oral steriods to try and save hearing. While I was at the pharmacy waiting for my Rx, I suddenly developed vertigo around 5:30 pm, which resulted in being sent to the ER. I could not stand, felt faint, and was vomiting excessively. - At the ER, was given lots of anti-nausea medication. Eventually, the tests determined that there was nothing obviously wrong in my brain (aneurysm, stroke, tumor, etc.), and the medication stopped the vomiting such that I was able to be discharged around midnight.
40 2021-04-18 eye swelling, eye pain My left eye is swollen and darker in color. It?s painful to blink.
40 2021-04-18 mouth numbness Approximately 3 to 4 minutes after receiving my first vaccine, I had a hot feeling travel from my to... Read more
Approximately 3 to 4 minutes after receiving my first vaccine, I had a hot feeling travel from my toes up to my head. I then became dizzy and felt very faint. The tip of my tongue also became numb. I was too embarrassed to alert the hospital worker. The sensation lasted about a minute. However, the last 2 1/2 days I have been having a fast heart rate after doing minimal activities. I feel very winded by the slightest task. I did go to a clinic today to get my vitals checked. They were fine- but I still continue to feel like my heart rate spikes when I do something as minimal as emptying the dishwasher. It?s very scary and uncomfortable and makes me fearful of taking the second shot.
40 2021-04-18 mouth tingling Approximately 50 minutes after injection, having waited the 30 minutes for observation, while drivin... Read more
Approximately 50 minutes after injection, having waited the 30 minutes for observation, while driving home my tongue started to feel wrong and the top started to tingle. Uncertain which direction this was going to go, I drove to the ER (which was near home, close to where I was at the time). I felt light-headed for a little bit just after getting a room and talking with the insurance & copay person. The doctor noticed I was flushed/red, which extended from my face down my chest and shoulders. The reaction didn't seem to progress further than that, thankfully. I was treated with Solumedrol, Famotidine, Benadryl.
40 2021-04-19 mouth swelling, lip swelling I don?t like her lips and mouth is swollen
40 2021-04-19 sensitivity to light, bloodshot eyes I received my first dose of the Pfizer vaccine on April 7th. The same day that I received it my eyes... Read more
I received my first dose of the Pfizer vaccine on April 7th. The same day that I received it my eyes turned red, blood shot. Specifically the left eye, and I had my shot in the left arm. I thought it was odd but after a day or so it went away. On 4/17 I went to the beach, and my eyes got almost sun burnt even while wearing sun glasses with a hat, under an umbrella. I go to the beach all the time and this has never happened before. I do not know if any of this is related to the vaccine and my symptoms are not drastic enough to warrant a trip to the doctor yet, however I felt that I should report this.
40 2021-04-20 loss of taste, smell distorsion Loss of taste, hard of smelling, sore arm
40 2021-04-20 mouth swelling Oral swelling, hot flashes. Patient did not seek medical attention during event, states she self me... Read more
Oral swelling, hot flashes. Patient did not seek medical attention during event, states she self medicated with diphenhydramine within an hour of vaccination. Symptoms completely resolved by next morning. Patient endorsed symptoms during screening for second dose of vaccine 21-days later.
40 2021-04-21 inability to speak Patient received first dose of COVID vaccine today, appointment time 1430, received first dose vacci... Read more
Patient received first dose of COVID vaccine today, appointment time 1430, received first dose vaccine at 1433. After receiving vaccine, patient sat in observation area and reported her voice "going away" sharing that with other allergies her voice often softens and she has a hard time communicating. No signs of shortness of breath, respirations even and not labored, oxygen sat at 100%, pulse 102, BP 112/66. Face flushed. Administered 1ml of benadryl IM, 50 mg total. Patient still expressing difficulties verbalizing and now stating a small feeling of tightness in her throat, face continued to be flushed. Administered epi pen to left thigh. Called 911. BP 110/60, 109, 100%. Gave report to ED RN and to paramedic responding. Patient then transferred to ED with paramedic assist. At time of transfer, patient reporting improvement with ability to communicate via voice, face less flushed and improved tightness in her throat.
40 2021-04-21 ear pain, taste disorder -LIMP ARM WITHIN 30 MINUTES OF VACCINATION -LEFT ARM, NECK, AND FACE SWELLING WITHING AN HOUR OF REC... Read more
-LIMP ARM WITHIN 30 MINUTES OF VACCINATION -LEFT ARM, NECK, AND FACE SWELLING WITHING AN HOUR OF RECEIVING VACCINE - LASTED FOR 6 DAYS -UNABLE TO MOVE LEFT ARM, RAISE IT, OR LIFT ANYTHING FOR THE PAST 18 DAYS -UNABLE TO GRASP OBJECTS WITH LEFT ARM FOR THE PAST 18 DAYS -UNABLE TO SLEEP ON LEFT SIDE - CAUSES EXTREME PAIN -TINGLING AND NERVE SHOOTING PAIN ON LEFT ARM FROM FINGERS TO NECK, FRONT AND BACK CHEST LEFT SIDE -MUSCULAR NODULE DEVELOPED ON LEFT SHOULDER UP TO MY KNECK - CAUSING SEVERE EAR PAIN -EXTREME FATIGUE - LETHARGIC FOR THE PAST 18 DAYS -SEVERE JOINT/PAINT THROUGH OUT ENTIRE BODY -LOST OF TASTE -NIGHTSWEATS FOR PAST 18 DAYS -FEVERS RANGING BETWEEN 99.0 - 103 F FOR PAST 18 DAYS -NAUSE FOR PAST 18 DAYS -LOST OF APPETITE -DIARRHEA AND LOOSE STOOLS FOR THE PAST 8 DAYS (NO BLOOD) -BRAIN FEELS FOGGY ALL THE TIME - FEELING AS IN A DAZE FOR PAST 18 DAYS -SHORTNESS OF BREATH - JUST FROM WALKING OR MOVING AROUND -SKIN IS SUPER SENSITIVE AND ITCHY -UNABLE TO DRIVE BECAUSE OF THE FATIGUE AND UNABLE TO USE LEFT ARM. -UNABLE TO WORK - RELYING ON OTHERS TO TAKE CARE OF ME.
40 2021-04-21 eye swelling, dry throat throat constriction, dryness, scratcy/itchy. facial itiching, head, arm, back itching, eye swelling,... Read more
throat constriction, dryness, scratcy/itchy. facial itiching, head, arm, back itching, eye swelling, overheating, tachycardic. epinephrine administered, 911 called, ambulance taken across the street to ER for observation. steroids given. further benadryl taken at home. symptoms started 10-15 minutes post injection. I am allergic to PEG, my allergist put me on a pre dose of anthystamines & steroids to lessen or prevent reaction so overall reaction was fairly mild but epi was the only thing left to give as I had already had 400mg hydroxyzine, 40 mg pepcid x3, 28mg medrol x5 during the 24 hours prior to my vaccination.
40 2021-04-21 mouth numbness Numbness of tongue on 4/15/21 Right facial droop on 4/16/21 Went to ER on 4/16/21
40 2021-04-21 pain in jaw Several days after 2nd dose of Pfizer I started experience increased pain in my jaw as well as my ri... Read more
Several days after 2nd dose of Pfizer I started experience increased pain in my jaw as well as my right thumb. I do have TMJ though it is controlled/mild and haven?t had issues with it in a few years. After 2nd dose experience pain and discomfort throughout the day. I have also been experiencing increased pain and discomfort in my right thumb where I believe I have some signs of arthritis since receiving the 2nd dose.
40 2021-04-21 ringing in ears Tinnitus. I had a very mild case prior to last week due to side effects of migraine medications in ... Read more
Tinnitus. I had a very mild case prior to last week due to side effects of migraine medications in the past; unless in absolute silence, I usually forgot I had it. The volume has increased by at least 3 or 4 times; it is now shrill and ever-present.
40 2021-04-21 vision blurred Patient (DOB 6/11/1980) received dose 1 of the Pfizer COVID vaccine (lot EW0162, expiration 7/2021) ... Read more
Patient (DOB 6/11/1980) received dose 1 of the Pfizer COVID vaccine (lot EW0162, expiration 7/2021) at 1050. At 1052, patient laid down on the ground with her feet propped up on her chair in the observation area. PHN and RN approached the patient to assess. Patient reported blurry vision and feeling as though she was going to faint before she laid down. Patient reported a fear of needles and fainting with previous injections. Vital signs: O2 98%, pulse 72, blood pressure 120/90, respirations 14. Patient reported eating breakfast then going on a run before coming to the vaccine POD. Patient denied allergies, medications, or medical conditions. At 1058, patient reported symptoms were improving. Vital signs: O2 97%, pulse 70, blood pressure 120/95, respirations 14. At 1102, the patient sat up, drank some water, stated she felt wobbly and laid back down. Vital signs at 1104: O2 98%, pulse 66, blood pressure 120/90, respirations 14. Patient sat up reporting decreased dizziness. At 1114, vital signs: respirations 16, O2 99%, pulse 72, blood pressure 120/98. At 1116, patient stood up momentarily while monitored closely by PHN and RN, then laid down again reporting feeling dizzy. Vital signs at 1118, O2 96%, pulse 69, respirations 16, blood pressure 120/90. Patient sat up, then laid down again reporting dizziness. PHN asked patient to contact a family member to drive her home. Patient reported she wanted to leave and wait for her husband in her car instead of the vaccination room. PHN encouraged patient to wait in the observation room so medical staff could monitor until symptoms resolved or called 911 per emergency protocol. At 1130 patient sat up. At 1138, patient stood up, denied dizziness. RN walked patient out to the parking lot. Patient left at 1140, walking with steady gait.
40 2021-04-22 loss of smell, loss of taste Received 2nd COVID vaccine on 1/9/2021. On 4/11/2021 developed headache, loss of taste/smell, and n... Read more
Received 2nd COVID vaccine on 1/9/2021. On 4/11/2021 developed headache, loss of taste/smell, and nasal congestion. Tested positive for COVID.
40 2021-04-22 lip swelling The day of and day after my arm was sore at the injection site and hard to lift. I also had a heada... Read more
The day of and day after my arm was sore at the injection site and hard to lift. I also had a headache. Both went away after 2 days. However, 9, days later I noticed red spots on my thighs that were itchy. As the day progressed they got worse and bigger and itchy. They were red raised lesions. I woke up in pain and noticed the spots all over my thighs; buttox and my lower lip became very swollen. I went to the hospital they said it was an allergic reaction to something. I had not done anything out of the ordinary in the last couple weeks other than the 2nd dose of the vaccine and a spray tan. They gave me Benadryl and steroids
40 2021-04-22 eye discomfort Upper respiratory congestion, mild nonproductive cough. Dizziness. Headache. Eye pressure. Diffus... Read more
Upper respiratory congestion, mild nonproductive cough. Dizziness. Headache. Eye pressure. Diffuse body aches: "Heaviness" in legs; not weakness. Mild nausea associated with coughing, however no emesis. Denies chest pain/abdominal pain. albuterol 90 mcg/actuation inhaler 6 puff 6 puff, Inhalation, Once, Fri 2/5/21 at 1610, For 1 dose guaiFENesin ER 12 hr tablet 600 mg azithromycin tablet 500 mg D/c with new Rx for: Azithromycin 250mg: 2tabs PO on day 1, then 1tab on days 2-5 Mucinex 600mg 12 HR tablet: 1 tablet PO BID x7 days Encounter Diagnoses 1. Suspected COVID-19 virus infection 2. Upper respiratory tract infection, unspecified type
40 2021-04-23 lip swelling swelling of lip; This is a spontaneous report from a contactable physician (patient). A 40-years-old... Read more
swelling of lip; This is a spontaneous report from a contactable physician (patient). A 40-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm right on 26Jan2021 10:00 (Batch: EJ1685; Lot Number: EL3248; expiry: not reported) as single dose for covid-19 immunisation at hospital (at the age of 40 years). Medical history was none. The patient concomitant medications were not reported. No predisposing factor and no culture performed and no antipyretic use (around the date of Vaccination). On 26Jan2021 10:00, the patient experienced swelling of lip occurred after second dose. The patient also stated that the no action was taken for adverse event (no therapeutic measures were done) and reaction recurred on re-administration of product. The outcome of event was unknown. Pfizer product had a causal effect to the adverse event (Causal Relationship): Yes
40 2021-04-23 swollen tongue Pt endorsed a swollen tongue several minutes after receiving the vaccine. Pt was given Benadryl IM a... Read more
Pt endorsed a swollen tongue several minutes after receiving the vaccine. Pt was given Benadryl IM and released.
40 2021-04-23 ringing in ears Vertigo, presyncope, migraine, menstruation, back ache, nausea, tingling In the fingers, tinnitus
40 2021-04-23 vision blurred blurred vision in both eyes which lasted for 30 minutes. at 30 minutes the vision was back to 90% an... Read more
blurred vision in both eyes which lasted for 30 minutes. at 30 minutes the vision was back to 90% and returned to 100% soon after.
40 2021-04-23 visual impairment, vision blurred, eye swelling, light flashes or floaters in the eye Symptoms started approximately 23 hours after my first Pfizer dose. I had a visual disturbance that... Read more
Symptoms started approximately 23 hours after my first Pfizer dose. I had a visual disturbance that lasted ten minutes. First my vision went blurry at the edges, then I saw flashes of light and eventually I saw a zigzag pattern across my vision. Since this happened the left side of my face primarily above and below my eye has been tingly and numb feeling, as well as slightly swollen. I have also had vertigo for 11 days now that is getting worse instead of better.
40 2021-04-24 taste impairment Within 15 minutes after receiving the first vaccine shot I was I was lightheaded and had a metallic ... Read more
Within 15 minutes after receiving the first vaccine shot I was I was lightheaded and had a metallic taste in my mouth. The metallic taste went away but I felt light headed until I fell asleep. At 2:00am woke up with severe muscle aches all over my body. The next morning I woke up sweating, muscle aches, lightheaded, fatigue, and nauseated. I also had a headache but it was a different type of headache than I?ve ever had before, it felt like my eyes were going to pop so I decided to check my heart rate and blood pressure and both were high. My blood pressure was 132/89, it is typically low (around 104/55). My heart rate was 109 and it?s typically in the 60?s or 70?s. I stayed with these symptoms until 04/17/2021. On 04/18/2021 I woke up for the first time since receiving the Covid-19 vaccine not sweating, hurting, and with a normal heart rate and blood pressure. As of today 04/25/2021 I am still dealing with fatigue.
40 2021-04-24 ear pain From 10pm on Monday 5 April until the morning of Wednesday 7 April (approximately 33 hours) I had a ... Read more
From 10pm on Monday 5 April until the morning of Wednesday 7 April (approximately 33 hours) I had a severe reaction to the second dose of the vaccine. The night of 5 April I had extreme chills, uncontrollable teeth chattering, and freezing sweats. I had sharp shooting pains in my feet, legs, hands, and arms that lasted 24 hours. I also had sharp shooting pains in the back of my head and then it began in my ears. When moving my head for the next full day I experienced extremely sharp pain in one or the other ear. Sometimes the pain returned in my arms. I had tightness in my chest, shallow breathing, and extreme fatigue but also could not sleep due to the pains and the sharp ear pains when turning my head. I had a fever from 100-101 degrees from the first night and still had 101 at 10pm on 6 April (24 hours later). That night I took a Motrin due to the sharp ear pains. (The first night I had only taken Tylenol.) Throughout the second night, I woke up many times drenched in sweat and upon waking up on the following morning, my fever had broken. Throughout day 3 (Wednesday 6 April), I still had tightness in my chest, shallow breathing, and periodic sharp ear pain when moving my head but my fatigue, chills, and fever had subsided.
40 2021-04-24 swollen tongue, lip swelling anaphylaxis; rash/hives on face; rash/hives on face; progressed to swollen lips, tongue; progressed ... Read more
anaphylaxis; rash/hives on face; rash/hives on face; progressed to swollen lips, tongue; progressed to swollen lips, tongue; cough; throat irritation; wheezing; This is a spontaneous report from a contactable consumer (patient). The 40-year-old non pregnant female patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine, lot number: EW0150 expiry date unknown) via an unspecified route of administration on Left arm as a single dose on 06Apr2021 09:30 AM. Medical history included asthma, known allergies: Biaxin, albuterol, xopenex, apples, pears, stone fruit (peaches, plums, apricot, etc), almond, hazel-nut. Concomitant medications included Zyrtec, Nasonex, Flovent, Singulair and Zoloft. On 06Apr2021 10:00 AM, started with rash/hives on face, then progressed to swollen lips, tongue, cough, throat irritation/swelling and wheezing. Initially treated in emergency room (ER) for anaphylaxis then released. Within 30 minutes, symptoms returned and was treated ER for anaphylaxis and was admitted for observation. She was discharged in the morning of 07Apr2021, but had to return to ER that evening, and was discharged in the morning of 09Apr2021. She was treated with Epinephrine, Benadryl, steroids and Pepcid. She did not receive any other vaccine in four weeks prior to the suspect. The patient was not suffering from covid prior vaccination. On 06Apr2021, she was tested through Nasal Swab for Covid and results were found to be negative. The outcome of events was recovering. No further information was available.
40 2021-04-25 loss of taste, loss of smell Loss of smell and loss of taste greatly diminished.
40 2021-04-26 loss of taste Patient stated she took the vaccine on Monday 4/5/21 @1600 and within 10 minutes she felt her arm st... Read more
Patient stated she took the vaccine on Monday 4/5/21 @1600 and within 10 minutes she felt her arm started to go numb and it was swollen (face and neck), radiating back pain and a nodule in neck and pain shooting all throughout the arm, loss of appetite, n/v, sob (no chest pain), lethargic, fever (ranging from 99-103), diarrhea developed within the last week, lost a sense of taste, headache, she can move arm but she's in a lot of pain.As of 4/22/21 patient is just experiencing shooting arm pain, nausea, fever, lethargic, SOB (patient feels exhausted when moving around the house), and started to experience some itchyness as of this morning. Patient took tylenol at least 6 times since she took the vaccine, she stated it helps with the pain but once it wears off the pain comes back. Advised patient to continue with the tylenol/ibuprofen for the fever and pain, and benadryl to help with itchiness or she can apply benadryl cream/hydrocortisone to help. Also advised her that if her sob continues and it gets worse to seek medical attention (ER or urgent care). 4/25-Patient continues with fever, negative for Covid test, continues with loss of taste, recommended for her to see primary provider.
40 2021-04-26 mouth numbness Numbness in face, tongue and arm
40 2021-04-26 swollen tongue weird feeling, itchy all over mostly arms. increased phelgm with throat / tongue/ swelling; anxiou... Read more
weird feeling, itchy all over mostly arms. increased phelgm with throat / tongue/ swelling; anxious.
40 2021-04-26 ringing in ears Numbness on both sides of my face, fluttering feeling in brain and tinnitus in both ears
40 2021-04-26 ringing in ears Received the vaccine at 9:30 am. Originally felt fine with mild soreness in the arm. Woke up around... Read more
Received the vaccine at 9:30 am. Originally felt fine with mild soreness in the arm. Woke up around 2:15 am to use the restroom, and got extremely dizzy... started to feel weird, and felt like there was a rush all over. My head started to feel like it was closing in and there was a static, crackling, speaker-like sound along with tinnitus in my ears making it feel like I was in a tunnel. I sat on the floor and waited several minutes until the feeling passed and was able to get back into bed. I waited several more minutes until I felt "normal" again. Was able to get back to sleep, and feel better this morning, with no dizziness, but will continue to monitor any additional symptoms closely.
40 2021-04-26 vision blurred, visual impairment Wed, April 14: headache, light headed, feeling of going to pass out, blurred vision, very tired, we... Read more
Wed, April 14: headache, light headed, feeling of going to pass out, blurred vision, very tired, weak, diarrhea. Thur April 15 ? very light headed, feeling of going to pass out, numb pinky, very weak, very shaky, very tired. Went to ER after almost passing out they gave me fluids, did a chest xray and ekg, covid test, pregnancy test. They sent me home saying I was dehydrated. ? slept for 4 hours after ER, felt tired, hard to focus, diarrhea then that night slept all night. Fri April 16 ? a bit better in morning but vision still not right, at dinner table felt drunk (did not have any alcohol), very tired, face felt flushed (no fever), hard to focus, headache came on before bed (took 2 Aleve) Sat April 17 ? tired, went to doctor for additional blood work, slept after appointment, face flush (no fever), vision still not right. Doctor said this is likely vaccine related. Sun April 18 ? felt same as Saturday Mon April 19 ? very tired, vision still not right, hard to focus at work, want to sleep, face felt hot and tingly (no fever) Tue April 20 ? allergy type symptoms in morning. Sneezing, runny nose, slight headache. These symptoms went away. From April 21-28 - other symptoms mostly going away except vision issues. April 28th most symptoms went away but vision is still blurry, see floaters, feels like I have Vaseline over my eyes. Going to see an eye doctor ASAP.
40 2021-04-26 vision blurred Possible TIA (diagnosed in Urgent Care); loss of balance; dizziness; headaches; neck pain; blurred v... Read more
Possible TIA (diagnosed in Urgent Care); loss of balance; dizziness; headaches; neck pain; blurred vision/blurry eye (right); right arm/leg weakness; This is a spontaneous report from a contactable consumer (the patient). A 40-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown due to it was never shown vial, just administered injection by nurse) via an unspecified route of administration in left arm on 16Apr2021 18:00 at age of 40-year-old at single dose for COVID-19 immunisation. Relevant medical history was "none". No known allergies. Concomitant medications included levocabastine hydrochloride (ZYRTEC) taken for an unspecified indication from an unspecified date, and multivitamin. The patient did not take other vaccine in four weeks. No COVID prior vaccination. COVID not tested post vaccination. The patient experienced Possible TIA (diagnosed in Urgent Care), loss of balance, dizziness, headaches, neck pain, blurred vision, right arm/leg weakness, blurry eye (right). The events onset date was provided as "18Apr2021 10:00 a.m.". The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). No treatment received for the events. The outcome of the events was not recovered. Information about lot/batch number has been requested.
40 2021-04-28 ear swelling Ear and face swelling. Headache nausea body aches chills. I tool benadryl and ibprophin
40 2021-04-28 taste disorder, eye discomfort 1/28 1st Pfizer > 1/29 Onset, dizziness, nausea, h/a, eye pressure, "heaviness" in legs, altered tas... Read more
1/28 1st Pfizer > 1/29 Onset, dizziness, nausea, h/a, eye pressure, "heaviness" in legs, altered taste 2/3 Cough, mild congestion Seen in ER on 2/5 for evaluation of cough. Reports 3 days of upper respiratory congestion, mild nonproductive cough. Diffuse body aches. Mild nausea associated with coughing, however no emesis. Denies chest pain/abdominal pain. ROS positive for: fatigue, congestion, cough, myalgias.
40 2021-04-28 ringing in ears, ear pain, ear discomfort Exhaustion and nausea for 2 days. The same time jaw tightness ear pain, ringing and fullness started... Read more
Exhaustion and nausea for 2 days. The same time jaw tightness ear pain, ringing and fullness started. These other symptoms are still present after almost 3 weeks.
40 2021-04-28 ringing in ears Tinnitus in left ear
40 2021-04-29 ringing in ears The evening of the vaccine I started getting sore ovaries, which continued for about 3 days, waking ... Read more
The evening of the vaccine I started getting sore ovaries, which continued for about 3 days, waking me up that first night with the pain. It felt like they were hot and aching, like they were working very hard, something I haven't experienced before. This was 5 days after my last period finished. I had spotting the next day, which I never have, and then my breasts became very sore, lumpy and tender for the next week or more - very concerning as I have had a fibroadenoma before. Symptoms were similar to being pregnant, but I have just started my next period, and did a pregnancy test which came back negative. I have also had ongoing light tinnitus, which started a few days after the vaccine. Again, I haven't had this before, and it has been almost 3 weeks now and it is still at the same intensity. I am very worried about getting the second vaccine next week.
40 2021-05-01 thirst Symptoms: Fatigue, Severe Headache, Extreme Thirst Treatment: Extra Strength Tylenol, Rest, Plenty o... Read more
Symptoms: Fatigue, Severe Headache, Extreme Thirst Treatment: Extra Strength Tylenol, Rest, Plenty of fluids Time Course: 2 days
40 2021-05-02 loss of smell, loss of taste Headaches and New loss of taste or smell
40 2021-05-02 vision blurred, ringing in ears Headache with blurred vision, nerve burning pain throughout my body, muscles cramping and pain in bo... Read more
Headache with blurred vision, nerve burning pain throughout my body, muscles cramping and pain in both legs and ringing in both ears. Tinnitus. And I've did not have this before my vaccination.
40 2021-05-04 taste impairment Chills, headache, muscle soreness (back & armpits), mild fever, soreness at injection site, metallic... Read more
Chills, headache, muscle soreness (back & armpits), mild fever, soreness at injection site, metallic taste at back of throat, slight cough, itchiness in nasal cavity, occasional sneezing
40 2021-05-04 swollen tongue the patient complained of face tingling and sensation of tongue swelling a few minutes after receivi... Read more
the patient complained of face tingling and sensation of tongue swelling a few minutes after receiving vaccine. Her tongue did not appear swollen, she had no shortness of breath. Her symptoms resolved after an additional 30 minutes of observation and she was discharged to home. She did not require medical intervention.
40 2021-05-05 feeling of choking Tingling throat Swollen Uvula Very stiff/swollen neck feeling
40 2021-05-05 tongue itchiness, lip swelling, mouth tingling, lip redness, swollen tongue Experienced lip swelling, redness, and tingling; tingling, itchy, and slightly swollen tongue; itchy... Read more
Experienced lip swelling, redness, and tingling; tingling, itchy, and slightly swollen tongue; itchy throat; and fast heart beat. Symptoms began approximately 15 minutes after I received the vaccine. I was 4.5 months pregnant at the time, due date September 5, 2021.
40 2021-05-05 vision blurred A couple of hours after the second Covid Vaccine I developed a headache, then body chills and low gr... Read more
A couple of hours after the second Covid Vaccine I developed a headache, then body chills and low grade fever lasting 1 day. The headache lasted for about 3 days, then when it went away I became dizzy and light headed and had trouble concentrating. This dizziness lasted for over a month. It got a little better, but then I had some short term memory loss. After the MRI I had blurry vision for about an hour, then turned into dizziness and trouble concentrating.
40 2021-05-06 dry mouth The patient began to feel like there were ants crawling on their skin. It begain in the arm that re... Read more
The patient began to feel like there were ants crawling on their skin. It begain in the arm that received the injection. She then began to feel very hot and a lot of nausea. She then felt like she was going to throw up. Pt did not throw up. Pt sat down longer and the tingling began to subside. She was still feeling nausea and was hot. She got a dry mouth and her mouth felt very hot. We provided her with some water to help with her dry mouth. We also asked the patient if she wanted some benadryl and she said yes. Patient refused an ambulance and was going to have someone at home with her.
40 2021-05-06 hearing loss Exhaustion began 12 hours after vaccination and progressed to lightheadedness, muffled hearing and ... Read more
Exhaustion began 12 hours after vaccination and progressed to lightheadedness, muffled hearing and the inability to stand without feeling faint. Chills, fever of 100-101 began at 18 hours after vaccine. At 26 hours post vaccine fever has reduced to 99 and ability to stand without feeling faint has increased
40 2021-05-06 toothache At 2am 4/30/21 woke up with a terrible headache that hurt so bad my molars hurt, chills, full body m... Read more
At 2am 4/30/21 woke up with a terrible headache that hurt so bad my molars hurt, chills, full body muscle aches, fatigue. This lasted the entire day and through the next night and morning on 5/2/21 around 10am chills subsided, aches subsided and I was able to finally get out of bed. headache gradually went away throughout the day. On 5/3/21, just felt fatigued all day. Then have been feeling back to normal since 5/4/21.
40 2021-05-07 taste impairment Metallic taste in mouth Severe back muscle pain Swollen groin lymph nodes Headache Chills Gener... Read more
Metallic taste in mouth Severe back muscle pain Swollen groin lymph nodes Headache Chills Generalized severe pain throughout body Pain to move
40 2021-05-07 ringing in ears, ear infection Ear infection and tinnitus lasted longer than 2 weeks. Utilizes drops for 6 days then was moved to ... Read more
Ear infection and tinnitus lasted longer than 2 weeks. Utilizes drops for 6 days then was moved to amoxicillin 500 mg with Sudafed. Still no relief after 4 days. Switched Zyrtek to Zyzal
40 2021-05-09 loss of smell Chills, tired, body aches, loss of smell, fever, rash on hands and thighs, stomach aches, no appeti... Read more
Chills, tired, body aches, loss of smell, fever, rash on hands and thighs, stomach aches, no appetite, on day 10 and still not feeling 100%.
40 2021-05-09 loss of smell Fatigue, body aches, swelling injection site, chills, cough, runny nose, loss of smell,headache
40 2021-05-09 ear discomfort, ringing in ears Severe non stop ringing in my right ear. It sounds like I have an earphone in that is playing non-st... Read more
Severe non stop ringing in my right ear. It sounds like I have an earphone in that is playing non-stop static or high pitched ringing in my ear, and it feels like there is pressure.
40 2021-05-09 lip swelling Lip swelled slightly and felt tingly a few hours after the shot (5ish hours). Took benadryl and seem... Read more
Lip swelled slightly and felt tingly a few hours after the shot (5ish hours). Took benadryl and seems to have improved mostly but not 100% (still same day as shot)
40 2021-05-09 ringing in ears light-headed (3+ hours); tightening in neck and throat, and ringing in ears (30 mins)
40 2021-05-09 vision blurred Severe flu like symptoms. Body hurts to even touch from head to toes, uncontrollable shaking/shiveri... Read more
Severe flu like symptoms. Body hurts to even touch from head to toes, uncontrollable shaking/shivering, freezing hold or suffocating hot, eyeballs keep loosing focus, feeling like I'm having a anxiety or panic attack, short of breath. First day I felt fine, next day I woke up feeling like I was hit by a car and second day after I'm feeling all the symptoms listed above on a scale of 1-10 I'm at a 10 for discomfort
40 2021-05-10 ringing in ears Loud ringing in ears developed about two weeks after the first Pfizer Covid vaccine shot and has not... Read more
Loud ringing in ears developed about two weeks after the first Pfizer Covid vaccine shot and has not gone away since.
40 2021-05-11 lip swelling Pt received 2nd dose of Pfizer CIOVID-19 vaccine today, 5/12/2021 and within 5 minutes reports lip a... Read more
Pt received 2nd dose of Pfizer CIOVID-19 vaccine today, 5/12/2021 and within 5 minutes reports lip and face swelling and throat tightness. Pt denied any reactions from 1st dose of Pfizer COVID-19 vaccine, but report she has idiopathic anaphylaxis, an autoimmune disorder, chronic hives, asthma and she has anaphylactic episodes about once a month. Pt given 2 epi pen autoinjections in thigh in office prior to EMS arrival. Pt was transported in stable condition to Hospital ER via EMS for further evaluation and monitoring.
40 2021-05-11 vision blurred I had the usual symptoms the first day after, fever/chills etc. It?s now a week later and I have had... Read more
I had the usual symptoms the first day after, fever/chills etc. It?s now a week later and I have had heart palpitations for 4-5 days, blurred vision and an urgency to urinate. I have felt faintish as well. I am hoping this passes soon.
40 2021-05-12 ringing in ears Buzzing in left ear started 2 days after the second covid 19 vaccination.
40 2021-05-13 thirst I walked down a very short flight of stairs to take laundry out of the dryer. My heart started racin... Read more
I walked down a very short flight of stairs to take laundry out of the dryer. My heart started racing and I began to sweat uncontrollably. My hands and feet became clammy. I became very hot and thirsty and distressed. My hands and feet were very clammy and I had to sit down and take deep breaths. I drank two water bottles of water and poured some on me to cool off. My breathing was compromised and I was taking gulps of air. I became slower in movement and responses and too disoriented to drive. I asked my boyfriend to give me a ride to the ER. I went through intake and was later given an EKG, IV for bloodwork and Chest X-ray. Symptoms: Nausea, palpitations, heart racing, muscle aches, chills, sudden sweating, clammy hands and feet, extreme thirst, difficulty breathing, slowed responses, slowed speech, burning tingling from top of neck down to left arm.
40 2021-05-13 ringing in ears Ringing in left side ear
40 2021-05-14 taste impairment Severe Diarrhea, anything I ingest, water, food, is expelled within 25 mins. Severe abdominal crampi... Read more
Severe Diarrhea, anything I ingest, water, food, is expelled within 25 mins. Severe abdominal cramping as well. Hot and cold sweats, extreme lethargy, metalic taste in mouth, cognitive delay, trouble focusing, short term memory recall
40 2021-05-14 eye itchiness then itch was mild for 1 hour/Started itching all over the worst was behind; itching all over the wo... Read more
then itch was mild for 1 hour/Started itching all over the worst was behind; itching all over the worst was behind my eyes deep in sockets; Sharp pain both arms 1 min.; left arm was swollen; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 30Apr2021 at 11:15 (at the age of 40-years-old) as 1st dose, single for COVID-19 immunisation. Medical history was reported as yes but not specified. The patient's concomitant medications were not reported. On 30Apr2021 at 11:15, the patient experienced sharp pain both arms for 1 minute then itch was mild for 1 hour. Started itching all over the worst was behind her eyes deep in sockets that lasted 2 days, had to take diphenhydramine (BENADRYL). Left arm was swollen that night and lasted 2 days. On day 3, she was still itching but not as bad. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
40 2021-05-14 mouth numbness 101.2 fever, rigors, body aches, exhaustion, enlarged lymph nodes under right arm, partially numb up... Read more
101.2 fever, rigors, body aches, exhaustion, enlarged lymph nodes under right arm, partially numb upper lip
40 2021-05-14 sensitivity to light Dose 1 - soreness at injection site; mild fatigue for a 3-4 days, swollen lymph nodes under left arm... Read more
Dose 1 - soreness at injection site; mild fatigue for a 3-4 days, swollen lymph nodes under left armpit about 5-7 days after the dose was given that lasted for 4-5 days. Dose 2 - mild swelling and soreness at injection site beginning in first 24 hours after dose given; active chills for about 30 min beginning just shy of 12 hours after dose was given; nausea and vomiting that last 24 hours after symptoms began; intermittent neck and head pain (sometimes sharp/severe head pain) over first 24 hours after symptoms began; dull headache with light and noise sensitivity between 24-48 hours; backache for 2-3 days; fatigue for first 24-48 hours. Dose given on Tuesday afternoon and worst symptoms experienced Wednesday, feeling slightly better by Thursday morning but milder symptoms described above returned midday. Friday, I was cautiously returning to very light activity around the home and without previous symptoms, but refrained from being up and about too much, as I would feel off and slightly light headed. As of this morning (Saturday), only soreness/light swelling at injection site and slight lymph node pain remain.
40 2021-05-14 ringing in ears Immediately after first dose, maybe within 1-2 minutes, my lips became numb and tingly. Similar to ... Read more
Immediately after first dose, maybe within 1-2 minutes, my lips became numb and tingly. Similar to when oral anesthesia at dentist wears off. After second dose, about 7 days later I started hearing a loud ringing in my ears, tinitus. It was very disturbing for the first 2-3 weeks, but continues to improve luckily.
40 2021-05-14 vision blurred high blood pressure; chest pains; cold sore; dizzy / lightheaded; vision is blurry; tingling in hand... Read more
high blood pressure; chest pains; cold sore; dizzy / lightheaded; vision is blurry; tingling in hands and feet; Memory loss; experienced early period with clotting which stopped in 2-3 days then started faint spotting; Throat closure sensations; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm right on 03Apr2021 (Batch/Lot Number: Er8734) as single dose at the age of 40-year-old for covid-19 immunisation. Medical history included allergy to amoxicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. No other medications the patient received within 2 weeks of vaccination. The patient had not received other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date the patient experienced early period with clotting which stopped in 2-3 days then started faint spotting again a day later, high blood pressure, cold sore, dizzy / lightheaded, vision is blurry, chest pains, tingling in hands and feet, memory loss. On 03Apr2021 18:00 the patient experienced throat closure sensations. The course of events was as follows: Throat closure sensations, high blood pressure, chest pains, cold sore, dizzy / lightheaded, early period with clotting which stopped in 2-3 days then started faint spotting again a day later. After 25 days, I am still dizzy and have tingling in hands and feet. Memory loss, and vision is blurry. The adverse events resulted in Doctor visit, Emergency room/department or urgent care. The events early period with clotting and started faint spotting again a day later, throat closure sensations were considered medically significant. No treatment received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.
40 2021-05-15 ear discomfort Pressure in ears ever since vaccine, increasing in frequency over time. Mostly when seated but in mo... Read more
Pressure in ears ever since vaccine, increasing in frequency over time. Mostly when seated but in motion (when driving in a car, on an exercise bike). Feels like I am in an airplane rising in height with pressure building in ears. Not debilitating in any way but the increasing frequency led me to want to report this.
40 2021-05-16 taste impairment Metallic taste in mouth about 20 minutes after receiving the vaccine Sore at injection spot in left ... Read more
Metallic taste in mouth about 20 minutes after receiving the vaccine Sore at injection spot in left arm and almost a numbness in left arm. My left arm feels fuzzy. The rest of me is fine right now.
40 2021-05-16 extreme sound sensitivity, ringing in ears I began noticing tinnitus in both ears (high pitched sound) when falling asleep or waking up. I can'... Read more
I began noticing tinnitus in both ears (high pitched sound) when falling asleep or waking up. I can't point to anything else in my life which could have changed to account for it. I haven't been exposed to more noise than usual. I do feel like my hearing is sensitive currently. Like normal volume on my headphones which hasn't bothered me for the past year now feels like too much sound.
40 2021-05-16 ringing in ears, mouth itchiness, ear itchiness Hot, itching ears outside and inside starting at 4:00pm. Followed by itchy mouth, racing heart, and ... Read more
Hot, itching ears outside and inside starting at 4:00pm. Followed by itchy mouth, racing heart, and all over skin itching. I took an extra Claritin at about 4:15. Then around 5pm I had a sudden feeling of an allover body sensation like a surge of electricity or drop in blood pressure, and had ringing in my ears and slowing of thoughts and movement and awareness. Went to the ER. Still itchy and ears were red. About 2 hours later all itching was gone and ears were no longer red. Stayed at the ER until 7:40pm.
40 2021-05-17 ear discomfort, ringing in ears 5 days after my first Pfizer injection, I had aural fullness & pressure, left ear greater than right... Read more
5 days after my first Pfizer injection, I had aural fullness & pressure, left ear greater than right and tinnitus much higher than baseline, more so on left side (same side as injection). This has slightly gotten better ~ 6 weeks after first dose, but is not fully back to baseline. I have taken Flonase every day in an effort to gain some relief and occasional Ibuprofen. After much hesitancy, I received the 2nd dose on 4/28/21 and two days later felt nauseous, dizzy, headache and feel like I am off balance (rocking on a boat) and motion sickness. Sometimes I get episodes where I get shaky, very dizzy and as if I might faint. I have never felt like this prior to the vaccine. My PCP put an order in to check my A1C to check blood sugar levels and everything was normal. I have had no change in my diet. I do eat a balanced healthy diet. Prior to the vaccine I would exercise regularly and lead a healthy lifestyle.
40 2021-05-17 lip swelling 24 hours post vaccination, I developed significant and noticeable swelling of my lips and areas of m... Read more
24 hours post vaccination, I developed significant and noticeable swelling of my lips and areas of my face where hyaluronic filler was placed six months ago. Swelling began 24 hours after vaccination and increased up to 36 hours post vaccination before symptoms began to subside. I did not have any reaction like this after the first injection.
40 2021-05-17 ringing in ears tinnitus, noticed first about 3 weeks after first shot, worse the week after second shot. still not... Read more
tinnitus, noticed first about 3 weeks after first shot, worse the week after second shot. still noticeable at night but less bothersome.
40 2021-05-18 lip swelling Rapid response called to Internal Medicine waiting room at 1010. Pt found sitting upright in the ... Read more
Rapid response called to Internal Medicine waiting room at 1010. Pt found sitting upright in the waiting room chair alert with a patent airway and unlabored and adequate respirations. Pt is crying stating she is embarrassed. MD present along with MA and RN. Pt is assisted to the wheelchair and brought in to the infusion room for further monitoring assessment. Pt received first covid vaccine today and states she was monitored for 15 minutes without side effects. She got in her car and started to drive away when she began to feel dizzy and experience slight lip swelling. Pt drove back to Medical Center and walked inside to IM waiting room. Vitals obtained. BP slightly elevated and all other vitals WNL. Assessment performed by MD and 25 mg IM Benadryl is ordered at this time d/t slight lip swelling. 25 mg Benadryl given IM in right deltoid at 1020. Pt monitored for 15 minutes with signs of improvement. Lip swelling decreased and BP returned to normal range. MD reassess pt at 1035 and advises pt she can return home at this time.
40 2021-05-20 ear discomfort dizziness, ear fullness in both ears, headaches. Still experiencing these same symptoms at 6 weeks p... Read more
dizziness, ear fullness in both ears, headaches. Still experiencing these same symptoms at 6 weeks post shot
40 2021-05-20 lip blister Shingles on left-side of face, on V2 dermatome. blisters appeared on eye lid, lips, upper lip, tem... Read more
Shingles on left-side of face, on V2 dermatome. blisters appeared on eye lid, lips, upper lip, temple area, nose
40 2021-05-21 loss of taste Client reported loss of taste starting 2 hours after 1st dose and resolved without intervention the ... Read more
Client reported loss of taste starting 2 hours after 1st dose and resolved without intervention the evening of the next day.
40 2021-05-21 canker sore, ear discomfort broke out in canker sores all over mouth again; Slept 17 hours q day; severe fatigue; Sinus and ear ... Read more
broke out in canker sores all over mouth again; Slept 17 hours q day; severe fatigue; Sinus and ear pressure; Sinus and ear pressure; Generalized aching; break out in canker sores all over my mouth; sore muscles all over; joint pain; mild itching to upper torso, breasts and under arms; low grade fever; chills; face became pink and warm; felt burning sensation throughout my body; This is a spontaneous report from a contactable nurse (patient). A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in deltoid left on 03Feb2021 12:00 (Batch/Lot number was not reported) as 1st dose, single at age of 40-years-old for covid-19 immunization. Medical history included Asthma, 3 herniated discs in neck, hx of pneumonia, hypertension (HTN). Known allergies included: Ceclor, PCN, Doxycycline, Bactrim DS, Codiene, berries and anaphylaxis to Latex. Concomitant medications the patient received within 2 weeks of vaccination included: lisinopril; hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse event started on 03Feb2021 14:00 PM, within first 24 hours the patient experienced mild itching to upper torso, breasts and under arms, also had low grade fever and chills in this time. Within first 24 hours, face became pink and warm, and felt burning sensation throughout her body. At this point the patient took Pepcid and Benedryl and it seemed to control symptoms. On 09Feb2021, the patient begun to break out in canker sores all over her mouth, total of 5 (the patient did not have a canker sore since high school), began to develop sore muscles all over and joint pain that progressed to severe by 12Feb2021. Worse in mornings. Got a flu and covid test (Nasal Swab). They were negative. 17Feb-20Feb2021 severe fatigue and cont. Joint pain. Slept 17 hours q day. Sinus and ear pressure. Generalized aching. The patient did not get 2nd vaccine. 01Mar2021 broke out in canker sores all over mouth again. Took 4 days to resolve. The patient was still having significant joint pain throughout her body, worse in mornings. The patient never had this before vaccine. Events resulted in disability or permanent damage. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event canker sores was recovered, of other events was not recovered. Follow up needed, further information has been requested.; Sender's Comments: "Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded" The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
40 2021-05-22 taste impairment Beginning after the observation period, had a metallic taste in mouth for several hours. Wasn't seve... Read more
Beginning after the observation period, had a metallic taste in mouth for several hours. Wasn't severe, but nothing tasted right for awhile (even water tasted odd).
40 2021-05-24 mouth numbness About 20 minute after vaccine was administered I felt a subtle numbness feeling to the right of my m... Read more
About 20 minute after vaccine was administered I felt a subtle numbness feeling to the right of my mouth. Then it was felt on most of my right cheek. It lasted the whole day and the next morning it was mostly gone. Since then my right eyelid and under eye have been a little red which isn't normal for me. Some tingling in right leg felt as well. Mainly concerned about the face sensation and not sure if I should proceed with second shot.
40 2021-05-25 deafness unilateral, ear discomfort, ringing in ears Slight tinnitus that comes and goes in both ears. More concerning is intermittent hearing loss in r... Read more
Slight tinnitus that comes and goes in both ears. More concerning is intermittent hearing loss in right ear. Feels like hearing volume turns up and down, as though there is a blockage. There is also pressure that won?t go away (pop). I have not sought treatment and am waiting to see if issue resolves on its own. I don?t want to take steroids.
40 2021-05-25 lip swelling left side of lower lip swelled up.; This is a spontaneous report from a contactable consumer, the pa... Read more
left side of lower lip swelled up.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm on 23Feb2021 at 09:30 and received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm at 09:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Mar2021, the patient's left side of lower lip swelled up, about 18 hours after the second dose. The patient had no trouble in breathing. The patient did not receive any treatment for the event. The clinical outcome of the event left side of lower lip swelled up was recovered on an unspecified date. Information about lot/batch number cannot be obtained. No further information is expected.
40 2021-05-25 pain in jaw Left arm numbness; hand tingling; left jaw pain; Left side of face and scalp began to burn; Internal... Read more
Left arm numbness; hand tingling; left jaw pain; Left side of face and scalp began to burn; Internal tremor of the brain; dizziness; This is a spontaneous report from a contactable consumer reported for herself. A 40-years-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,: solution for injection, Batch/Lot Number: Er8730 and Expiration date was not reported), via an unspecified route of administration, in right arm (age at vaccination 40-year-old) as 2nd dose, single for covid-19 immunisation and patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,: solution for injection, Batch/Lot Number: En6208 and Expiration date was not reported), via an unspecified route of administration, administered in right arm on 19Mar2021 09:45 AM for covid-19 immunisation. Medical history included hypervitaminosis, migraines, and prior to vaccination, patient was diagnosed with COVID-19. The patient was allergic to Levaquin. Concomitant medications that patient received within 2 weeks of vaccination included ferrous citrate (IRON [FERROUS CITRATE]). Facility where the most recent COVID-19 vaccine was administered in hospital. Patient did not receive any other vaccines within 4 weeks previous to the COVID vaccine. Prior to vaccination, patient became now not diagnosed with COVID-19. Patient underwent laboratory test which includes nasal Swab Pcr, covid test on 11May2021 and the result was pending. On 09Apr2021 10:00 the patient experienced left arm numbness 5 minutes after injection, hand tingling, left jaw pain. Left side of face and scalp began to burn one day after injection. Internal tremor of the brain and dizziness. Treatment was received for all event as medical supervision from hospital staff. Since the vaccination, the patient was not tested for COVID-19. The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.
40 2021-05-25 swollen tongue, tongue disorder, dry mouth My tongue became swollen and my mouth became dry. I began chewing on the inside of my cheeks and my ... Read more
My tongue became swollen and my mouth became dry. I began chewing on the inside of my cheeks and my teeth left groves on the perimeter of my tongue. The swelling lasted around 2 months and I am still experiencing extremely dry mouth and issues swallowing, especially at night. Initially my Dr prescribed an oral rinse for non-typical thrush, but it didn't really help. I saw an ETN who told me to take a multi vitamin. Both Dr's ran blood work.
40 2021-05-25 ringing in ears TINNITUS bilateral, loud, persistent Joint soreness Foggy thinking Pain at injection site Headache W... Read more
TINNITUS bilateral, loud, persistent Joint soreness Foggy thinking Pain at injection site Headache Weird twinges all over body randomly
40 2021-05-26 deafness, ringing in ears I became very light headed and passed completely out. I do not remember anything leading up to this ... Read more
I became very light headed and passed completely out. I do not remember anything leading up to this or while it was happening. When I came too, I couldn't hear, had ringing in my ears, couldn't walk on my own, and my husband said I was very cold. Two days later and i still have dizzy spells and extreme fatigue.
40 2021-05-26 lip redness Left side face numb, droopy; Huge cluster of cold sores left side face. Mouth and eye; Lips cherry r... Read more
Left side face numb, droopy; Huge cluster of cold sores left side face. Mouth and eye; Lips cherry red; Huge cluster of cold sores left side face. Mouth and eye; Left side face numb, droopy; Loss appetite; Kidney pain; mild body aches; tired and not wanting to do anything; simply not feeling well,; This is a spontaneous report from a contactable other hcp (patient). A 40-year-old female non-pregnant patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at age of 40 years old as single dose for covid-19 immunization. Medical history included Asthma, allergies, Herpes Virus and Penicillin allergies. Concomitant medications included montelukast sodium (SINGULAIR); fluticasone propionate, salmeterol (WIXELA INHUB); salbutamol sulfate (PROVENTIL HFA); cetirizine hydrochloride (ZYRTEC ALLERGY); budesonide (RHINOCORT ALLERGY). No other vaccines received within 4 weeks prior to the COVID vaccine. No covid prior vaccination. Covid tested not done post vaccination. The patient previously took Amoxicillin and experienced allergies, first dose of bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) (Lot number: EW0185) on 08May2021 10:13 AM at Right arm as single dose for covid-19 immunization. Adverse events occurred after 1st dose from 09May2021 07:00 AM included mild body aches, no arm pain, tired and not wanting to do anything after few days, simply not feeling well, loss appetite and kidney pain. Acyclovir was received as treatment and not recovered. After 2nd dose, lips were cherry red next day. By end of day, huge cluster of cold sores left side face, mouth and eye. Left side face was numb, droopy. The patient still had no will do anything but didn't feel sick. Loss appetite and kidney pain progressed from time 1st dose to 2nd. The outcome of the events was unknown. Information on lot number/batch number was requested.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the event so facial droopy, huge cluster of cold sores left side face, mouth and eye cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : 2021530924 same patient/reporter/drug, different AE/dose
40 2021-05-26 mouth tingling Patient stated prior to vaccine that she had itching and throat tightness after her first Pfizer vac... Read more
Patient stated prior to vaccine that she had itching and throat tightness after her first Pfizer vaccine from Pharmacy. It was resolved by PO Benadryl. Patient took 25 mg Benadryl PO prior to receiving 2nd Pfizer vaccine. After vaccine, patient reported throat tightness, mouth tingling, and shortness of breath. Epipen 0.3mg SubQ was administered. Patient taken to ER. Given methylprednisolone 125mg x 1 before discharge from ED with prednisone prescription.
40 2021-05-27 eye pain Heart pounding and fluttering; Migraine headache; neck pain; dizziness; head and neck hot to the tou... Read more
Heart pounding and fluttering; Migraine headache; neck pain; dizziness; head and neck hot to the touch (no fever); eye pain; exhaustion; vertigo; mild nausea; Left temple throbbing and pulsating/headache; Heart pounding; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Apr2021 16:30 (Batch/Lot Number: ER8736), age at vaccination of 40-years-old, as single dose, for covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant and was not pregnant at the time of vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced migraine headache everyday, neck pain, dizziness, head and neck hot to the touch (no fever), eye pain, exhaustion, some vertigo and mild nausea, left temple throbbing and pulsating, heart pounding an fluttering occasionally, all on 30Apr2021 at 1730. No treatments were give for the events. Facility where the most recent COVID-19 vaccine was administered: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 10May2021. The patient had not recovered from the events. Information on the lot/batch number has been requested.
40 2021-05-28 taste impairment Metallic taste in mouth; Chills/hot spells; nausea; vomiting; body aches; hip and back pain; sharp p... Read more
Metallic taste in mouth; Chills/hot spells; nausea; vomiting; body aches; hip and back pain; sharp pain in left upper chest; Chills/hot spells; This is a spontaneous report received from a non-contactable Other-HCP. A 40-Year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EN9581 and Expiration date not reported) via an unspecified route of administration, in Arm right, on 13Feb2021 at 02:30 PM (at the age of 40 years) as 2nd dose, single for COVID-19 immunisation. The patient medical history included Known allergies was reported as pseudoephedrine, Cephalexin, eggs, melon and concomitant medications included Multivitamin, St Johns Wort (medications in two weeks). Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3246 and Expiration date not reported) via an unspecified route of administration, in Right arm, on 23Jan2021 at 02:30 PM as 1st dose, single for covid-19 immunisation. The patient didn't receive any other vaccine in four weeks. There was no covid prior vaccination. The patient was covid tested post vaccination. On 13Feb2021, at 02:45 PM, the patient had experienced Metallic taste in mouth and feeling hot initially, Chills/hot spells, nausea, vomiting, body aches, hip and back pain, sharp pain in left upper chest. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests which includes Rapid Antigen Nasal Swab test post vaccination on 15Feb2021 with the result of negative, on 17Feb2021 with the result of negative, on 19Feb2021 with the result of negative, on 22Feb2021 with the result of negative, PCR Nasal Swab test on 24Feb2021 with the result of pending. There was no treatment received for AE. Outcome of the events was reported as Recovered with lasting effects. No follow up attempts are possible. No further information is expected.
40 2021-05-28 mouth tingling Onset of severe nausea followed by difficulty breathing, uncontrollable incessant dry heaving and co... Read more
Onset of severe nausea followed by difficulty breathing, uncontrollable incessant dry heaving and coughing, spasms, full body shaking, full body tremors, inability to speak, seizure like reaction, dizziness, tingling in tongue,
40 2021-05-28 toothache Large Swelling of the supraclavicular on the left hand side of the body with pain. Fever, chills, jo... Read more
Large Swelling of the supraclavicular on the left hand side of the body with pain. Fever, chills, joint pain, bone pane, teeth pain, inability to sleep.
40 2021-05-31 loss of smell I sat down after vaccination and I felt sore right away up arm and up shoulder, went home, as drivin... Read more
I sat down after vaccination and I felt sore right away up arm and up shoulder, went home, as driving, migraine began, vomiting, couldn't smell. Had to go to Dr and get shot for headache and nausea, vomited for 2 days, loss of appetite, bad body aches. After that I was able to eat and drink bland and it subsided.
40 2021-05-31 ringing in ears, deafness, ear discomfort April 15- second Covid shot April 22 - first big vertigo spell. Deafness then ringing in right ear A... Read more
April 15- second Covid shot April 22 - first big vertigo spell. Deafness then ringing in right ear April 23 - mild ringing in both ears and thumping, pressure in head May 4th - very noticeable ticking in right ear May 9th - felt sick, off, hard to take a deep breath, pounding head, fullness in ears, ringing, emotional May 11th - ENT visit. Ears clear, hearing fine May 18th - May 23- off and on headaches, difficulty breathing May 24th - Headache that didn?t go away with medicine. Fullness in ear. Nausea May 25th - Sleepless night, stiff neck, very full head. Medicine providing no relief(Excedrin, Sudafed, Flexeril) can feel fast heartbeat, ringing, and pulsation in ears, stiff jaw May 26-28 - light head congestion May 29- headache returns May 30- head congested even after Sudafed. Ears feel ?wet? hard to take a deep breath, lots of yawning. Flushed face and blotchiness on neck. May 31 - Difficulty breathing, ringing in both ears
40 2021-06-01 eye pain, visual impairment I woke up to the worst migraine in my right eye the day after my 2nd COVID shot. The next day, I had... Read more
I woke up to the worst migraine in my right eye the day after my 2nd COVID shot. The next day, I had what looked like blinds (white/black) lines in my vision, then half moon shape in my vision in my right eye for days. Dizziness (I felt like I was on a boat dock), confusion, tiredness and pain the back of the eye for two weeks, numbness of the eyes. I went to the Opthalmologist who stated that I was having an ocular migraine. My Neurologist also said I was having an Ocular Migraine, but I?m stuck in the Postdrome Stage. Gave me Topiramate daily and told me stay away from screens and reading (that means no working and no TV). With the meds, I?m 70% back to my old self, I can drive again, run errands, do yard work, but I can?t work. We increased the dose, still can?t use screens and side effects pushed us to find another drug. Started new drug Amitriptyline on May 30, and symptoms are not disappearing. I have had symptoms (mostly eye numbness, vision issues, dizziness) continuously all day, everyday for 3 39 days and counting
40 2021-06-01 lip swelling Rash over entire body -3weeks and counting, swelling of lips in the morning 2 days, swelling of left... Read more
Rash over entire body -3weeks and counting, swelling of lips in the morning 2 days, swelling of left ankle every night -3 weeks and counting
40 2021-06-01 mouth tingling Patient started with tongue tingling, felt her jaw getting tight and redness to her chest. Patient g... Read more
Patient started with tongue tingling, felt her jaw getting tight and redness to her chest. Patient given Benadryl in COVID pod as well as an Epi Pen. Patient transported to ED and given IV solumedrol and Pepcid. Racemic epi and neb given as well. patient symptoms have since improved.
40 2021-06-01 vision blurred blurred vision/After my 2nd dose my vision is substantially worse, to where I cannot drive even 3 da... Read more
blurred vision/After my 2nd dose my vision is substantially worse, to where I cannot drive even 3 days later; huge lump under where she received the vaccine; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), 1ST DOSE, single on 23Apr2021 (Batch/Lot Number: EW0170) and 2ND DOSE, single on 14May2021 (Batch/Lot number was not reported), both via unspecified route at 9:50 am, arm left for covid-19 immunisation. Medical history included does wear glasses and mild psoriasis (just uses something topical if she has a flare up) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient historical vaccine includes: flu vaccine from unspecified date for immunization. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient is calling about the Covid 19 vaccine. After she received her first Covid 19 vaccine on 23Apr2021, she had blurred vision starting on Sunday, 25Apr2021. She called the pharmacy and was told that blurred vision was a rare side effect and her vision should clear. She received the second Covid 19 vaccine on Friday, 14May2021 and she experienced the blurred vision again except this time she can't see anything unless it's about 2 inches from her eyes. She doesn't have a job she has to go to but she is a stay at home mom and she home schools her children. She can't even see the text in books. She can't drive, not even to the grocery store. She is asking how long is this going to last. Her arm has a huge lump under where she received the vaccine. The lump is still there from the first vaccine and she has another lump from the second vaccine. Her left arm now has 2 lumps. She thought that might be an allergic reaction but the same lady gave her both injections and stabbed her pretty hard when she gave the Covid 19 vaccine. The pharmacist did tell her she can get blurred vision with any vaccine but she always gets her flu vaccine and she's never had blurred vision before. She received her second Covid 19 vaccine on Friday, 14May2021 in the left arm. She can't find the vaccine record card, she had two vaccine records card because she forgot to bring the first vaccine record card to her second appointment. The NDC for the second vaccine is on her receipt. NDC 59267-1000-01, Lot/Expiry not known for second dose. First Covid 19 vaccine information is in the suspect product field. She received her first Covid 19 vaccine on Friday, 23Apr2021 and she had blurred vision on Sunday, 25Apr2021. She thought at first it was pink eye or conjunctivitis because her vision was blurry and she thought, what did her children bring home to her. Her eyes weren't pink though. She called the pharmacist and he told her it was a side effect. Her vision did get better about a week before the second Covid 19 vaccine but it wasn't completely back to normal. She received the second Covid 19 vaccine on 14May2021 and she experienced more blurred vision on Sunday, 16May2021 but it's much worse and it's not gotten better. She's trying to read from her coffee machine and she can't even see what it says. This can't be normal. Does she need to see an optometrist? She reports she could still drive after her first Covid 19 vaccine because the blurry vision wasn't that bad but this time it's scaring her a little bit. She reports she does wear glasses but only for night time. Her pupils don't dilate well so she tries not to drive at night.The reporter added that around 48 hours after my first dose I began having blurred vision, it got slightly better before my 2nd dose, however, it did not get completely better. After my 2nd dose my vision is substantially worse, to where I cannot drive even 3 days later. The outcome of the event was recovering for blurred vision and not recovered for the other event. The patient was did not required emergency room and physician office visit. Follow up attempts are needed. Further information has been requested.
40 2021-06-02 ear pain affected her immunity; Hashimoto thyroiditis; test showed higher level of TSH; feeling pain on left ... Read more
affected her immunity; Hashimoto thyroiditis; test showed higher level of TSH; feeling pain on left side a lymphatic thyroid pain and ear pain.; feeling pain on left side a lymphatic thyroid pain and ear pain.; This is a spontaneous report from a contactable pharmacist (patient). A 40-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EL8982, expiration date unknown) via an unspecified route of administration at arm right on 04Feb2021 at 10:00 AM at age of 40-year-old at single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination. Medical history included in vitro fertilization (IVF). Patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EL0142, expiration date unknown) via unspecified route of administration at right arm on 13Jan2021 at 10:00 AM at age of 40-year-old for COVID-19 immunization. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included desogestrel, ethinylestradiol (ENSKYCE) within 2 weeks of vaccination. Patient reported that she never had thyroiditis in her life before. On 20Feb2021 at 06:00 AM (about two weeks after 2nd dose), patient started feeling pain on left side a lymphatic thyroid pain and ear pain. Doctor prescribed antibiotics. She was in the middle of IVF process and had all record no thyroid issues before this date. Blood test on 29Apr2021 showed higher level of TSH, on 08May2021 showed higher level and on 14May2021 showed that level become 6.05. Patient made appointment with endocrinologist. And today on 19May2021, she was diagnosed with acute Hashimoto thyroiditis. She had all her thyroid records never had any issues. Patient stated that she was not too sure if this was caused by vaccine but certainly affected her immunity. Patient was prescribed levothyroxine to start from tomorrow (20May2021). Her IVF was cancelled till her TSH level get fixed. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient received Ultrasound of thyroid, antibiotics, levothyroxine as treatment for the events. Outcome of event "affected her immunity" was unknown, of the other events was not recovered. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Patient had COVID test post vaccination included nasal swab on 30Mar2021 which was negative. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on autoimmune etiology of reported autoimmune thyroiditis and event occurrence post two doses of vaccination and elevated TSH levels, the causal role of BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
40 2021-06-02 ringing in ears About 12 days after my vaccination, I began to experience ringing in my ears and lightheadedness. On... Read more
About 12 days after my vaccination, I began to experience ringing in my ears and lightheadedness. On May 9, it began, and it was very loud (more so on my right ear). Then it subsided and became more high pitched but less loud and noticeable, but more noticeable in my left ear. It continued for me as a new background noise for weeks. After some time, I went to an ENT, they did a hearing test, which came back normal. The ringing continued. I saw my primary doctor. He suggested it might be seasonal allergies, despite this never happening to me before during allergy season. He prescribed an OTC nasal spray. The ringing continued and finally subsided during the 1st week of June. Every now and then my ear will feel full and ringing will return, but it?s sporadic now (really only happened twice from 5/30 - 6/3 and not constant anymore. Sometimes noticeable at night now.
40 2021-06-03 mouth numbness, oropharyngeal discomfort doesn't have much of appetite; 148/70 on the blood pressure; allergic response; tongue was a little ... Read more
doesn't have much of appetite; 148/70 on the blood pressure; allergic response; tongue was a little numb; hard to swallow; Throat was closing up; mouth feeling numb; couldn't really speak; Coughing; super shaky; feet was also feeling numb; face looked swollen; Chest tightness; chest pain; abnormal EKG; Her throat was a little sore; tired; This is a spontaneous report received from a contactable consumer (patient). A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in the left Arm on 17May2021 12:30 (Batch/Lot Number: EW0167) as single dose (at the age of 40-year-old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (lot number EW0158) on 15Apr2021 at 12: 50PM (at the age of 40-year-old) in the left arm for covid-19 immunisation and on 15Apr2021 her arm was numb on the side where she received the injection for more than 24 hours, it went numb pretty quickly after the first dose - then it was numb for about 24 hours. It went away completely in two days, but the patient was unsure if that is an adverse reaction. The patient experienced tongue was a little numb on 17May2021 with outcome of recovering , hard to swallow on 17May2021 with outcome of recovering , mouth feeling numb on 17May2021 with outcome of recovering , throat was closing up on 17May2021 with outcome of recovering , couldn't really speak on 17May2021 with outcome of recovering, coughing on 17May2021 with outcome of recovering, super shaky on 17May2021 with outcome of recovering, feet was also feeling numb on 17May2021 with outcome of recovering, face looked swollen on 17May2021 with outcome of recovering, chest tightness on 17May2021 with outcome of unknown, chest pain on 17May2021 with outcome of unknown, abnormal EKG on 17May2021 with outcome of unknown, her throat was a little sore on 17May2021 with outcome of unknown, tired on 17May2021 with outcome of unknown, doesn't have much of appetite on 20May2021 with outcome of unknown. Details as described as follows: Reports she went to sit in the waiting area, after 5 minutes she noticed her tongue was a little numb. She took her card out of her purse, and noticed it was a little hard to swallow, this was within about 8 to 10 minutes. She sat for another 5 minutes and then decided to ask about her tongue feeling numb and was taken to the nurses station. She told them about her tongue, and as she was talking her mouth was feeling more numb and it was getting harder to swallow. As the nurse was talking to her it was like she couldn't really speak. The nurse said this is way past Benadryl and called to another nurse for an Epipen. Caller states she started to cough as her throat felt like it was closing up. They jabbed her with the Epipen within 15 minutes of receiving the vaccine. She got some relief for a couple of minutes and then her body went back into the allergic response. They put her on the oxygen finger machine and then her throat started to close again. They gave another Epipen and then the ambulance arrived. She is unsure how long after she got the second Epipen that the ambulance arrived but it was no more than 5 minutes. They told her they had to call 911 right after giving the first Epipen. When the ambulance team came, she felt like she had novocaine in her mouth, her mouth was super numb and she was super shaky. They said the shaking was normal from an Epipen. Adds her feet were also feeling numb. She didn't know before that the shaking was from the Epipen. She was able to walk to the ambulance and her husband came and the med team was asking him if her face looked swollen and he said her face looked swollen. States her mouth felt like it was moving funny and she was exaggerating her speech trying to make her mouth move right. Adds she was still unaware that this could be an allergic reaction and was just trying to remain calm. At the site, she noticed her vitals on the machine and she saw 148/70 on the blood pressure. Adds it was about the same in the ambulance, it was 148/64. She was not able to collect any information about the Epipen other than they were yellow with a blue cap and they held it in her leg for three seconds. No lot or expiration date known for the Epipens. In the ambulance she was treated with Intravenous (IV) steroids and dose of Benadryl 50mg. As she was being transported to the hospital, she started to have chest pain. They did an EKG in the ambulance with no remarkable findings. Adds she has a follow up with her Primary Care Provider (PCP) today. When she arrived at the Emergency Room (ER) they monitored her for a couple of hours. She had another EKG at the ER and was told that it was normal so they released her. She has no product information for the steroids or the Benadryl that she received. No lot or expiration date known. When she got home everything was calming down. Her throat was a little sore and she was tired. The next morning her chest was still tight. She called the doctor who told her to just relax and come back to the ER if she has palpitations or difficulty breathing. Mentions she got the results of the EKG in ER now, and it said it was abnormal as compared to a previous EKG she had, and something about the T axis. Adds now she doesn't have much of appetite and her tongue still feels a little off. Caller interrupts the call to say her doctor just called and she needs to go. Unable to complete the report at this time. The outcome of other events was unknown. No follow-up attempts are needed. No further information is expected.
40 2021-06-03 mouth tingling Neuropathy initially in right arm, then subsided after two days. Neuropathy/tingling of fingers and ... Read more
Neuropathy initially in right arm, then subsided after two days. Neuropathy/tingling of fingers and toes returned with increasing sensation on May 21, 2021. On friday May 28, 2021 lips are now tingling and more feeling of full body tingling and weakness followed by close to fainting spells. Sunday night worst headache of life, followed by chills, almost fainted, went to ER and all tests normal. Neuropathy has not left. Sent home with no answers. Wednesday June 2, 2021 tingling of hands, feet and lips more extreme followed by moments of shortness of breath and fainting. Went back to ER all vitals normal. Two days later I have missed two days of work because my body is so weak and the nreopathy remains. Please help. I cannot continue to live with these symptoms. I had zero health issues leading up to this and all of the dr's are stumped.
40 2021-06-03 swelling of eyelid Angioedema ? large hives, swelling of face and eyes, itching and fatigue
40 2021-06-03 ringing in ears Slightly lightheaded; Slight ringing in my ears; Resting heart rate began to increase; Facial/neck f... Read more
Slightly lightheaded; Slight ringing in my ears; Resting heart rate began to increase; Facial/neck flushing; Became hot; This is a spontaneous report from a contactable nurse, the patient. A 40-year-old non-pregnant female patient received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6200), via an unspecified route of administration on the left arm on 17Mar2021 at 14:15 (at the age of 40-year-old) for COVID-19 immunisation. Concomitant medications (within 2 weeks of vaccination) included vitamin E, hydrolyzed collagen, vitamin C, biotin. She has no known allergies to any medications, food, or other products. She did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine and was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, she had not tested positive for COVID-19. On 17Mar2021 (within 2-3 minutes after the vaccination), she became slightly lightheaded with a slight ringing in her ears; Her resting heart rate began to increase from 70 beats per minute up to 131 beats per minute with facial/neck flushing and she also became hot. The symptoms resolved within the next 2-3 minutes. It was also confirmed that she was 5 hours out from receiving the vaccine without further issue. No therapeutic measures were taken to treat these events. The clinical outcome for the events became hot, facial/neck flushing, resting heart rate began to increase, slightly lightheaded, slight ringing in her ears was recovered on the same day (17Mar2021). No follow-up attempts are needed. No further information is expected.
40 2021-06-04 taste impairment Mild metal taste in mouth approx. 1 minute after shot was administered; Soreness in left arm, around... Read more
Mild metal taste in mouth approx. 1 minute after shot was administered; Soreness in left arm, around site injection started approximately 6 hours after administration; spread to about 3 inches outward around from site of injection; Migraine started around 24 hours after shot was administered, with pain concentrated behind right eye; Fatigue; ended up sleeping nearly 12 hours; This is a spontaneous report received from a non-contactable consumer or other non hcp. A 40-years-old non pregnancy female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0186), via an unspecified route of administration in Arm Left on 28May2021 15:00 (age at vaccination 40years old, No pregnancy at time of Vaccination) as single dose for covid-19 immunization. Medical history included lactose intolerance from an unknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed with covid-19. Concomitant medication(s) included Vitamin C, Vitamin D, Calcium Citrate, Iron taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination the patient was not diagnosed with covid-19. The patient received other medications in two weeks. On 28May2021 21:00 the patient experienced mild metal taste in mouth approx. 1 minute after shot was administered; dissipated a few minutes afterward. Soreness in left arm, around site injection started approximately 6 hours after administration; spread to about 3 inches outward around from site of injection; no swelling. Migraine started around 24 hours after shot was administered, with pain concentrated behind right eye. Fatigue; ended up sleeping nearly 12 hours. After 42 hours, migraine has gone away; remaining symptom is soreness - now reduced to half the area and still concentrated around site injection area. Patient was not received treatment for the events. Since the vaccination, the patient has not been tested for covid-19. The clinical outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
40 2021-06-06 lacrimation increased I had an allergic response that included itchiness, watery eyes, congestion... then settled into bro... Read more
I had an allergic response that included itchiness, watery eyes, congestion... then settled into bronchitis. I still have the bronchitis.
40 2021-06-07 mouth pain, oral mucosal blistering, painful gums 3:30 am that night I got shaking fever/chills. I expected that but about 5 days after the shot the i... Read more
3:30 am that night I got shaking fever/chills. I expected that but about 5 days after the shot the inside of my mouth was in a lot of pain. A fever blister formed on my lower lip (left) and the inside of my mouth felt raw. It has been going on 2 days now- it?s hard to eat and hurts to talk. My gums are sore and I can feel raw spots on the roof of my mouth-like blisters.
40 2021-06-07 mouth tingling, feeling of choking Patient complained of tingling of the mouth and throat "like when I have peanut allergy". Patient re... Read more
Patient complained of tingling of the mouth and throat "like when I have peanut allergy". Patient reported that she took a Zyrtec and denied difficulty swallowing or breathing. Vital signs stable. Complained of nausea and that her chest felt heavy. EMS called and was taken to the hospital.
40 2021-06-07 swelling of eyelid Facial hives Eye lid swelling Symptoms began at 630pm 2 25 mg tablets (50mg total) taken orally at 7... Read more
Facial hives Eye lid swelling Symptoms began at 630pm 2 25 mg tablets (50mg total) taken orally at 7pm Symptoms resolved within 4 hours
40 2021-06-07 vision blurred speech difficulties (couldn't think of words, slurred words); Blurry eyesight; fever; clammy skin; h... Read more
speech difficulties (couldn't think of words, slurred words); Blurry eyesight; fever; clammy skin; headache; fatigue; itching skin; loss the ability to focus eyesight on phone, computer screen or books.; This is a spontaneous report from a Non-Contactable consumer (patient). A 40-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3302), via unspecified route of administration in the Left arm, on 25May2021 at 10:30 AM, as a single for COVID-19 immunisation. Medical history included Hypothyroid. Concomitant medications included armour, liothyronine and spironolactone. The patient had no known allergies. On 25May2021 at 02:30 AM, the patient experienced Blurry eyesight, fever, clammy skin, headache, fatigue, itching skin, speech difficulties (could not think of words, slurred words), loss the ability to focus eyesight on phone, computer screen or books. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not been tested for COVID-19. The patient was not tested for COVID-19 post vaccination. The patient did not received treatment for the events. The outcome of the events was recovered with lasting effects. No follow-up attempts are possible. No further information is expected.
40 2021-06-08 ear discomfort, fluid in middle ear The evening following the 2nd dose of covid 19 vaccine my arm was sore and I was tired. That night i... Read more
The evening following the 2nd dose of covid 19 vaccine my arm was sore and I was tired. That night it progressed into a fever of 104, severe body aches in almost all my joints, headaches, bradycardia and body chills. The fever was minimal reduced by switching Tylenol and Ibuprofen every few hours to about 102. Fever, chill and body aches started to subside in about 24 hours. Today I have sore throat, pressure/fluids in ears, slight chest pains and bradycardia, light headache and swollen lymph nodes in throat , inject site is still sore but most bothering is dizziness that is setting in.
40 2021-06-08 oral mucosal blistering AFTER THE FIRST VACCINE: HERPES BASED BLISTERS IN MOUTH TO THE POINT THAT TAKING OR EATING WAS VERY ... Read more
AFTER THE FIRST VACCINE: HERPES BASED BLISTERS IN MOUTH TO THE POINT THAT TAKING OR EATING WAS VERY PAINFUL. SAW MY PA ON 03/25/21. VALTREX PRESCRIBED. BLISTERS WERE MUCH BETTER WITHIN 48HOURS. 03/27/21 UNEXPECTEDLY HAD MY PERIOD. I HAD JUST FINISHED UP MY PERIOD WHEN I HAD THE VACCINE ON 03/18/21. THIS PERIOD WAS UNLIKE ANY OTHER. THE BLEEDING WAS INCREDIBLY HEAVY, FULL OF CLOTS AND LASTED 9 DAYS. MY USUAL CYCLE IS 5. AFTER SECOND DOSE: ANOTHER UNEXPECTED PERIOD. THIS TIME NOT AS HEAVY, NOT AS MANY CLOTS AND DID NOT LAST AS LONG. SORE UNDERNEATH ARM AND LYMPH NODE UNDER ARM SWELLED.
40 2021-06-09 lip redness, lip dry, lip itchiness, lip swelling Lips swelling, itchiness, dryness, peeling and redness 2 weeks after vaccine, went to the doctor and... Read more
Lips swelling, itchiness, dryness, peeling and redness 2 weeks after vaccine, went to the doctor and was told to take a histamine for a few days and if it doesn?t improve to take a steroid.
40 2021-06-09 sensitivity to light Fever over 103°, chills, severe headache with light sensitivity, rash halfway down my arm on the ar... Read more
Fever over 103°, chills, severe headache with light sensitivity, rash halfway down my arm on the arm where injection was given
40 2021-06-11 vision blurred Dizziness, blurriness, weakness to the point of blacking out and falling. I woke up in the bathtub w... Read more
Dizziness, blurriness, weakness to the point of blacking out and falling. I woke up in the bathtub with a huge lump on my head bleeding.
40 2021-06-15 eye disorder, vision blurred Systemic: Dizziness / Lightheadness-Mild, Systemic: Blurry vision, severe-Severe, Systemic: Headache... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Blurry vision, severe-Severe, Systemic: Headache-Mild, Additional Details: Patient received her second vaccine dose at 10:34am on 6/15/21. She returned to the pharmacy at 4:08pm alert and oriented to complain of blurry vision. She was unable to open her eyes completely and stated that she started having blurry vision at around 1pm that day. In addition to the blurry vision, patient stated having a headache and feeling light headed. She denied any difficulty breathing or swelling of the mouth/throat. Immediate medical attention was recommended but denied by patient.
40 2021-06-15 eye swelling Symptoms - Right eye swelling on June 10, rash on right side of face on June 11, swollen lymph nodes... Read more
Symptoms - Right eye swelling on June 10, rash on right side of face on June 11, swollen lymph nodes on June 12, face tingling on June 15. Initial Diagnosis - Stye on June 13 Later Diagnosis - Shingles on June 16 Initial Treatment - Prednisone and Clindamycin Later Treatment - Valacyclovir
40 2021-06-15 swollen tongue, tunnel vision After 5 min experienced tunnel vision, felt was going to pass out & tongue swelled Seen @ ER + given... Read more
After 5 min experienced tunnel vision, felt was going to pass out & tongue swelled Seen @ ER + given benadryl + steroids
40 2021-06-15 ringing in ears I've developed 24/7 tinnitus since 5/12 afternoon.
40 2021-06-15 toothache, eye strain On the third day after receiving my 2nd Pfizer vaccine I broke out in a vesicular type rash in the V... Read more
On the third day after receiving my 2nd Pfizer vaccine I broke out in a vesicular type rash in the V2 dermatome. I was prescribed Valcyvlovir 1gm TID after being diagnosed in the ER the same day. The next day some more blisters broke out in the same dermatome above my left eye off to the corner, my left nostril, left lip, and left side of bridge of nose. I also have increased pain in my left tooth in the incisor section. I followed up with the eye doctor.
40 2021-06-16 mouth numbness Rash on face and chest; periodic numbness and tingling in left side of face/cheek is ongoing still/N... Read more
Rash on face and chest; periodic numbness and tingling in left side of face/cheek is ongoing still/Numbness and pins and needles feeling in left side of face and cheek; Numbness in left side of face, tongue and throat; Numbness in left side of face, tongue and throat; Numbness in left side of face, tongue and throat; This is a spontaneous report from a non-contactable consumer (patient) reported for herself. A 40-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0172, Expiration date: unknown) via unspecified route of administration, administered in left arm on 05May2021 at 16:30 pm (age at vaccination was 40 years) as first dose, single dose for COVID-19 immunization. The patient did not have any medical history. The patient had known allergies to penicillin and carmel color, eggs, pistachios. Concomitant medications the patient received within 2 weeks of vaccination included ergocalciferol (VIT D), ascorbic acid, beta vulgaris root, iron amino acid chelate, rosa canina fruit, rubus idaeus leaf (IRON SUPPLEMENT WITH VIT C & HERBS) and Multi Vitamin. The patient previously took amoxicillin, erythromycin, z-pac, codeine and experienced drug allergy. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 05May2021 at 16:45 pm, the patient experienced numbness in left side of face, tongue and throat, starting 15 minutes after the shot. Throat and tongue were back to normal after 24 hours. Numbness and pins and needles feeling in left side of face and cheek continually for 3 weeks, periodic numbness and tingling in left side of face/cheek was ongoing still. Rash on face and chest began 48 hours after shot and lasted 3 days. The device timestamp and device date was reported as 07Jun2021. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. The events were reported as non-serious. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
40 2021-06-16 smell distorsion Within a few days of the second shot, patient's sense of smell started to become distorted and is co... Read more
Within a few days of the second shot, patient's sense of smell started to become distorted and is continuing to change and get slightly worse. Favorite foods smell so bad that she cannot eat them.
40 2021-06-17 visual impairment Numbness of my right hand, and blotchy vision -- white spots on vision
40 2021-06-18 ringing in ears, vision blurred April 21st: 10:30am: got 1st vaccine shot of Pfizer 11:15am: started getting blurry vision in le... Read more
April 21st: 10:30am: got 1st vaccine shot of Pfizer 11:15am: started getting blurry vision in left eye 2:00pm: started getting dizziness, tightness in chest, slight difficulty breathing, pressure in chest and lightheadness April 29th: started getting ringing in the ears (tinnitus) May 3rd: started getting rapid, fast heartbeat that wouldn't slow down. Continued all night so had to go to the ER at midnight Feelings of lightheadness lasted 1 week. Now almost 2 months later, I am still having dizziness and tinnitus. These two issues have interfered with day to day activities
40 2021-06-21 mouth discomfort, eye twitching Right eye twitched non stop and corner right side mouth would not meet lt side when smiling (slightl... Read more
Right eye twitched non stop and corner right side mouth would not meet lt side when smiling (slightly drooping) from 730pm to 130am day of injection.
40 2021-06-22 taste impairment Metallic taste in mouth within hours of injection, lasted several days.
40 2021-06-22 smell distorsion Starting 2 days after my second Pfizer vaccine and continuing to present (one month later) I'm expe... Read more
Starting 2 days after my second Pfizer vaccine and continuing to present (one month later) I'm experiencing an unpleasant smell that I an best describe as 'metallic sweet burnt corn' when I smell raw onions, basil, or organic matter like feces (I have a baby so I smell this when I change her diaper, or when I go to the bathroom), compost, or my own arm pits when sweaty. I believe this to be "parosmia" as no one else can smell it and it just started after my second vaccine.
40 2021-06-23 loss of smell, loss of taste Patient ended up getting COVID-19 even after she got vaccinated 5 months beforehand. Symptoms were c... Read more
Patient ended up getting COVID-19 even after she got vaccinated 5 months beforehand. Symptoms were cough, headache, loss of taste and smell, congestion.
40 2021-06-24 ear pain, ear discomfort Lymph nodes enlarged in left armpit, painful armpit, and the pain radiates to my left breast/Lymph n... Read more
Lymph nodes enlarged in left armpit, painful armpit, and the pain radiates to my left breast/Lymph nodes enlarged on right neck \extremely painful even without touching; Right leg: joint pain, shooting pain here and there along the leg, hip pain, leg muscle weakness; Right leg: joint pain, shooting pain here and there along the leg, hip pain, leg muscle weakness; Lymph nodes enlarged in left armpit, painful armpit, and the pain radiates to my left breast; Lymph nodes enlarged in left armpit, painful armpit, and the pain radiates to my left breast; difficult swallowing due to the pain; Right ear painful, feeling like too much pressure on it; Right ear painful, feeling like too much pressure on it; Right head painful, excruciating pain; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Ew0185 and Expiry date: Unknown), via dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took penicillin [penicillin nos] for drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient was not diagnosed with covid 19 and has not been tested for COVID-19 Since the vaccination. On 21May2021, the patient experienced right leg: joint pain, shooting pain here and there along the leg, hip pain, leg muscle weakness; lymph nodes enlarged in left armpit, painful armpit, and the pain radiates to my left breast; lymph nodes enlarged on right neck (multiple places: under chin, above collar bone, beside right ear), extremely painful even without touching, difficult swallowing due to the pain; right ear painful, feeling like too much pressure on it and right head painful, excruciating pain. The patient was not received any treatment for the events. The outcome of events was not resolved.
40 2021-06-24 eye itchiness 30 minutes after receiving vaccine my arms abdominal and legs began itching and had red patches like... Read more
30 minutes after receiving vaccine my arms abdominal and legs began itching and had red patches like hives. I ignored this and continued working. Then insides of my ears began itching. I told the pharmacy techs that were qt my place of work administering the vaccine. They gave me 50mg of benadryl, at that time my eyes had begun to itch and started coughing. Pulse rate was 160. No shortness of breath and no tongue swelling. They offered an epipen but as a nurse myself I declined and wanted to wait to see if benadryl would be effective. I was monitored for an hour. By the end of the hour I was not coughing, my eyes and inner ears had stopped itching and my pulse was back below 100. I still had hives and moderate itching to my body which resolved about 2 hours after taking benadryl.
40 2021-06-25 mouth tingling Tired; Feeling ill/Not feeling well; My lips became tingly; Throat got swollen; Nausea; Tightness; T... Read more
Tired; Feeling ill/Not feeling well; My lips became tingly; Throat got swollen; Nausea; Tightness; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 40-year-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6198 and Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 05Mar2021 at 09:40 as dose 1, single for covid-19 immunisation. Medical history included eczema (I had little bit of eczema but it is not bad.) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced throat got swollen, nausea on 05Mar2021 and tired, not feeling well and feeling ill on an unspecified date, tightness and my lips became tingly on 05Mar2021 at 09:45. The reporter stated, she had the first Pfizer shot on 05Mar2021 and within 5 minutes his throat got a bit swollen, her breathing was fine able to eat and drink with no problem and then at 9:45am within an hour her lips became tingly about 12:30PM she took some Motrin, and symptoms went away. Took Motrin the first time and then it happened again about 6 hours later that evening and took Benadryl and Motrin (treatment) and it gone away. She had the first shot at 9:40 AM and then at 12:30 took Motrin and that helped his throat and the lip at 18:00 both symptoms came back again and took Benadryl and Motrin and that help and 06Mar2021 and 07Mar2021 had regular symptoms feeling ill, not really unwell no more sore throat. That evening about 6pm -7pm my throat began to feel tight and her lips tingly at the same time, took Benadryl and Motrin, it went away, on March 6 and 7th had regular usual side effects, nausea, tired, and overall not feeling well and no other reactions. Consumer stated, That was the first shot. Didn't get the second shot. She took Benadryl and Motrin as a treatment for event. Therapeutic measures were taken as a result of event tightness, my lips became tingly. The outcome of the event were recovered on an unspecified date and rest of the event were unknown. Information on the lot/batch number has been requested.
40 2021-06-27 taste impairment, loss of taste A few minutes after receiving the vaccine I felt like I was fainting. My hearth was speeded up and I... Read more
A few minutes after receiving the vaccine I felt like I was fainting. My hearth was speeded up and I got pale. Five hours after I still feel dizzy and have fever. Really tired. And have a really strong metal taste in my mouth from the moment I took the vaccine. Food doesnt have any taste.
40 2021-06-28 lacrimation increased Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Systemic: Allergic: Itch (s... Read more
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Chills-Mild, Systemic: runny nose and eyes-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: onset of adverse effects started about 30 minutes after vaccination
40 2021-06-29 loss of taste, mouth numbness This is a spontaneous report received from a contactable consumer, the patient. A 40-year-old female... Read more
This is a spontaneous report received from a contactable consumer, the patient. A 40-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via an unspecified route administration in the right arm on 12Mar2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient previously received levoquin Zithromax (Z-PAK) and echinacea (MANUFACTURER UNKNOWN) for unspecified indication and experienced drug allergy. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested positive for COVID-19. The patient underwent lab test and procedures, which included COVID-19 virus test on 22Mar2021 and tested negative. On16Mar2021, the patient experienced facial numbness on the outside of face and lasted 2-3 days, about a week after, the patient experienced numbness inside mouth and 9 days (20Mar2021) after the vaccine loss of taste, it was still present at the time of report. Therapeutic measures were not taken for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events facial numbness on the outside of face was resolved on an unknown date in Mar2021, while the clinical outcome of numbness inside mouth was unknown and loss of taste was not recovered at the time of report. Information about lot number cannot be obtained. No further information is expected.
40 2021-06-29 ear discomfort, ear pain, ringing in ears Constant louder tinnitus/ ear ringing; Inner ear pain; Ear fullness that will notgo away; Loss of ap... Read more
Constant louder tinnitus/ ear ringing; Inner ear pain; Ear fullness that will notgo away; Loss of appetite.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route in left arm on 13Mar2021 at 15:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included hemochromatosis, CHEK2 mutation, gastroesophageal reflux disease (GERD), thyroid nodules, interstitial cystitis and allergies (dust, cats, mold). Concomitant medications received within two weeks of vaccination included women's daily vitamins, CBD Oil (MANUFACTURER UNKNOWN) and ADVIL all taken for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 13Mar2021 at 20:00, the patient experienced constant louder tinnitus/ear ringing, inner ear pain and ear fullness that will not go away. It started within hours of the vaccine, worsened and continued, also had ongoing loss of appetite. Therapeutic measures for the events included lipo-flavonoid. The outcome of constant louder tinnitus/ear ringing, inner ear pain, ear fullness that will not go away and loss of appetite was not recovered. No follow-up attempts are needed. No further information is expected.
40 2021-06-29 sensitivity to light Chills/full body aches/ heavy head/sensitivity to light/Fever 101.7/Feeling hot.
40 2021-06-29 swollen tongue, mouth tingling Tingling Lips and face; Sweating; Fast Heart Rate; Tongue Swelling; Headache; This is a spontaneous ... Read more
Tingling Lips and face; Sweating; Fast Heart Rate; Tongue Swelling; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 20Mar2021 at 12:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included losartan (MANUFACTURER UNKNOWN), zolpidem (AMBIEN), montelukast (SINGULAIR), lisdexamfetamine (VYVANSE) and cetirizine (ZYRTEC), all for unknown indications from unknown dates. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received hepatitis B vaccine (MANUFACTURER UNKNOWN) on 26Feb2021 as immunisation, 4 weeks prior to the COVID vaccine. On 20Mar2021, the patient experienced tingling lips and face, sweating, fast heart rate, tongue swelling and headache. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse events tingling lips and face, sweating, fast heart rate, tongue swelling and headache. The clinical outcomes of the events tingling lips and face, sweating, fast heart rate, tongue swelling and headache were not recovered at the time of the report. Information about lot/batch number cannot be obtained. No further information is expected.
40 2021-06-30 dry throat Felt faint and body shaking immediately, after that sat during 15 min observation period. Had some... Read more
Felt faint and body shaking immediately, after that sat during 15 min observation period. Had some more body shaking and feeling faint. Thought it was a normal vaccine reaction. Went to the car w/daughter after observation period. As she was leaving the parking garage she started having palpitations, was holding her chest, starting "doing breathing techniques." Throat then "dried out," drank water, then after a while it was hard to drink the water. Daughter told her that her face was swollen. Pulled the car over, had daughter call family to come and help, daughter drove her to a pharmacy where they purchased Benadryl. Patient took the Benadryl. Family arrived, then swelling subsided. Then when they got home she had vomiting and diarrhea. All symptoms lasted about 5 hrs. Vomiting and diarrhea continued into 2nd day, then after that everything completely resolved. Next day she called the VA to report what happened, she was advised to have come back in. Symptoms: palpitations, throat and face swelling vaccine administration time: 11:00am symptoms started: 11:01am symptoms ended: next day at 6pm
40 2021-07-01 swollen tongue, lip swelling 20 min after shot, upper nasal passage, lips and tongue began swelling. I was driving from vaccine c... Read more
20 min after shot, upper nasal passage, lips and tongue began swelling. I was driving from vaccine clinic, stopped at pharmacy to get Benadryl (took it ~60min after shot). Called doctors office, and had appt ~90 min after shot. Benadryl relieved symptoms, doctor recommended another dose of Benadryl and switching to non-drowsy 24 hr allergy medicine for 48 hours. I followed those directions. No other anaphylactic reaction. Post shot, dairy intolerance discovered and still unable to eat dairy after almost 2 months.
40 2021-07-04 taste impairment Patient received vaccine and went to wait in the waiting room, she then notified staff that she had ... Read more
Patient received vaccine and went to wait in the waiting room, she then notified staff that she had a metal taste in her mouth. She waited thirty minutes in the clinic. She stated that the metal taste went away quickly. She guessed around the fifteen minute mark. She walked out of the clinic with no assistance needed.
40 2021-07-06 eye disorder, ear pain, eye pain Dose #1: Just a sore arm Dose #2: Within 24 hours my left ear hurt like I was getting an ear infec... Read more
Dose #1: Just a sore arm Dose #2: Within 24 hours my left ear hurt like I was getting an ear infection. I just assumed it was allergies. Within 48 hours my left eye began stinging and hurting, as well as continuation of a left earache. Within 72 hours I noticed that me left eye blinking was delayed and not symmetrical with that of my right. On May 1st I went to the ER and was diagnosed with Bell's Palsy. I had total loss of muscle/nerve control to the left side of my face. It affected my speech, ability to eat, and ability to drink. I was scared that I was having a stroke and went to the ER.
40 2021-07-06 eye pain, mouth numbness Symptoms Shot January 10 Sore arm Fever headache cough 7 days Brain fog persistent headaches No pe... Read more
Symptoms Shot January 10 Sore arm Fever headache cough 7 days Brain fog persistent headaches No period February lymph nodes under the armpit 3 days Persistent headaches No period March Persistent headaches No period One day of blood clots Er visit for upper gi severe pain ct clear April Headaches worsening No period May Headaches worsening No period Tremors in right hand ER VISIT migraine meds given no change June Headaches worsening No Period Stuttering and speech difficulty 6 10 15 16 dizziness and vomiting 6 10 difficult with walking Pain behind eyes moving side to side and up and down 6/19 carbonated sodas are flat can?t feel Carbonation in my mouth July Worsening head pain Consistent stutter Intermittent problems with walking July 5th hard time gripping items and equilibrium off. Treatments. EEG shows diffuse brain dysfunction, VERS shows optic nerve information. Intercranial pressure increased. No changes still testing
40 2021-07-07 dry eye, swelling of eyelid, dry mouth event 1. dry eyes and eye squinting treatment1.1: Loteprednol Etabonate. treatment1.1 period: 5/24-... Read more
event 1. dry eyes and eye squinting treatment1.1: Loteprednol Etabonate. treatment1.1 period: 5/24-5/31 outcomes: stopped using it due to feeling heavy in eye lid treatment 1.2: Xiidra treatment 1.2 period: 5/12-7/4 outcomes: stopped using it due to no effects and lots of side effects treatment 1.3: punctual plugs treatment 1.3 period: inserted on 5/12 outcomes: no obvious effect treatment 1.4 doxycycline treatment 1.4 period: 6/25-7/3 outcomes: stopped using it because of dry mouth 2. sucking and fish-like movements of the mouth, facial twitching, difficulty to drive since I can hardly open my eyes while driving, difficulty to do daily activities. suspect Meige syndrome No treatment yet
40 2021-07-07 dry throat notified RN that Pt was in the triage room and she needed help. Patient ID x 2, on assessment, Pt st... Read more
notified RN that Pt was in the triage room and she needed help. Patient ID x 2, on assessment, Pt stated her throat feels dried up and she cannot breath appropriately. V/S was done and Pt's BP was 116/69, Pulse 81, R 22, Oxygen saturation 100%. Pt stated she had just recently gotten her second shot of the COVID-19 vaccine, Pfizer. She stated she had a rxn to the first dose. Pt was placed on 2liters of oxygen and Provider was informed. Provider ordered Solumedrol and benadryl. Medications were given at 0835am IM. Pt was continued to be monitored. BP at 0840 was 113/58, oxygen 100%, pulse 79, R 20. Pt was informed she is having a rxn to the vaccine and would be monitored before she could go home. After 0910, Pt's BP was taken manually and BP was 110/72, Pulse 78, R 18, and Oxygen saturation 100%. Pt was observed for about an hour before been discharged. Provider asked RN to schedule Pt for a telehealth appointment for tomorrow. Pt was scheduled for the appointment. Pt stated she feels much more better and alright and she can breath well. Pt's husband at bedside. Patient aware and verbalized understanding of all instructions and patient to return PRN to the clinic.
40 2021-07-07 dry throat Staff notified RN that Pt was in the triage room and she needed help. Patient ID x 2, on assessment,... Read more
Staff notified RN that Pt was in the triage room and she needed help. Patient ID x 2, on assessment, Pt stated her throat feels dried up and she cannot breath appropriately. V/S was done and Pt's BP was 116/69, Pulse 81, R 22, Oxygen saturation 100%. Pt stated she had just recently gotten her second shot of the COVID-19 vaccine, Pfizer. She stated she had a rxn to the first dose. Pt was placed on 2liters of oxygen and Provider was informed. Provider, NP ordered Solumedrol and benadryl. Medications were given at 0835am IM. Pt was continued to be monitored. BP at 0840 was 113/58, oxygen 100%, pulse 79, R 20. Pt was informed she is having a rxn to the vaccine and would be monitored before she could go home. After 0910, Pt's BP was taken manually and BP was 110/72, Pulse 78, R 18, and Oxygen saturation 100%. Pt was observed for about an hour before been discharged. Provider asked RN to schedule Pt for a telehealth appointment for tomorrow. Pt was scheduled for the appointment. Pt stated she feels much more better and alright and she can breath well. Pt's husband at bedside. Patient aware and verbalized understanding of all instructions and patient to return PRN to the clinic. BSN, RN/PHN
40 2021-07-09 ear discomfort, ringing in ears, ear pain Immediately after receiving my shot I started having random thumping feelings in my left ear (2-7 be... Read more
Immediately after receiving my shot I started having random thumping feelings in my left ear (2-7 beats at a time) lasting steady for 3 days. Day 3 was the worst with beats every 10-15 seconds. Almost debilitating with pressure and slight pain. At day 6 now I have it only a couple times a day so it?s thankfully getting better to almost gone.
40 2021-07-10 loss of smell, loss of taste loss of smell; Loss of taste; High fever; chills; sweats; Aches; fatigue; Swollen hard arm; Broke ou... Read more
loss of smell; Loss of taste; High fever; chills; sweats; Aches; fatigue; Swollen hard arm; Broke out with fever blisters nose mouth and lips; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via the unspecified route of administration in the right arm on 24Mar2021 at 13:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks of the COVID vaccination. The patient did not receive any medications within two weeks of the COVID-19 vaccination. On 25Mar2021 at 03:00, the patient experienced high fever, chills, sweats, aches, fatigue, swollen hard red arm for five-plus days, fever blisters in nose mouth and lips. On 28Mar2021 (day 5), the patient experienced the loss of smell and taste. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events high fever, chills, sweats, aches, fatigue was resolved in 48 hours on 27Mar2021; while the events of the swollen hard red arm, fever blisters, loss of smell and loss of taste was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
40 2021-07-12 ear discomfort, ringing in ears Tinnitus, I've NEVER experienced it ever before and now it can get so bad, it'll wake me up at night... Read more
Tinnitus, I've NEVER experienced it ever before and now it can get so bad, it'll wake me up at night. I have this constant pressure / fullness feeling in my ears. I experienced a bout of vertigo 1.5 / 2 weeks after receiving my first shot that required an ER visit - another first in my life. I've never had any of these symptoms (the vertigo or tinnitus). I've seen ENTs and my primary care doc, they see no reason for me to be experiencing either of these symptoms.
40 2021-07-12 lip swelling Itchy throat, swollen lip, hives, dizziness. Disoriented
40 2021-07-12 ringing in ears Tinnitus
40 2021-07-14 swelling around the eyes, lip swelling The patient has stated that she has been having cases of minor swelling, puffiness, and slight numbn... Read more
The patient has stated that she has been having cases of minor swelling, puffiness, and slight numbness and tingling over the recent twelve days, following the first dose of the COVID vaccine. She reports having several different reactions to where she has swelling in her upper or lower lip, numbness near her cheek area, and slight puffiness under her left eye. Not all of these events occur at the same time, rather they seem to occur on seperate occasions. The sights of these events seem to rotate around the facial area as well. She reports that she has been self-medicating, taking chlorpheniramine 4 mg, as an over-the-counter oral tablet. This antihistamine medication appreas to help reduce the swelling and puffiness. An allergy specialist that she visited within the last week, also recommended that she continue to take that antihistamine medication. As per the current CDC recommendations, I have stated that it would be most appropriate for her to not receive the second dose of the COVID vaccine. She will continue to monitor her symptoms, and continue to take the antihistamine medication as she has been taking it previously.
40 2021-07-16 ringing in ears Dizziness, headache, body aches, increased heart rate with activity , fatigue, brain fog. Ordered m... Read more
Dizziness, headache, body aches, increased heart rate with activity , fatigue, brain fog. Ordered meclizine and propanolol and rest and to follow up with primary care. Completed follow up with primary care next day due to symptoms worsening. To follow up with primary care if symptoms not resolved by 4 days. Blood work completed and normal. Medications help manage symptoms. Symptoms not worsened today, but have not resolved. Have also had ringing in ears. Will follow up with primary care on Monday for further instructions.
40 2021-07-17 conjunctivitis auto immune hepatitis; drug induced liver injury; Primary Delivery Conjunctivitis; This is a spontan... Read more
auto immune hepatitis; drug induced liver injury; Primary Delivery Conjunctivitis; This is a spontaneous report from a contactable consumer via a Pfizer Sponsored Program. A 40-year-old female patient received BNT162B2 (Pfizer COVID-19 Vaccine, Solution for injection, Batch/Lot number and Expiration date were unknown), via an unspecified route of administration, on an unspecified date (at the age of 40-years-old), as dose number unknown, single for COVID-19 immunisation. No medical history and concomitant medications were reported. The patient was taking an unspecified medication for 2-months which she stopped before. It was reported that on an unspecified date, the patient had an increased INR, ALT and liver enzymes elevated along with jaundice, and Hepatitis. Patient was admitted to hospital for Hepatitis. The elevation of the liver enzymes reached to a point that she needed the liver biopsy which was more challenging to interpret. Then sent out at 7 PM to her medical surgery and they had reported neuropathologist, so they were saying that her Jaundice elevated function test and overwhelmed drug reaction. As per the expert pathologist report, the patient had only the drug (unspecified medication) that she had been on that for 2 months which she stopped before and she did have "elevated intestinal muscle antibody" (not clarified) but she was not consisting auto immune hepatitis, however, the serology suggested an auto immune hepatitis but the biopsy could not and then the liver biopsy shows patient has "Primary Delivery Conjunctivitis" (further not clarified) but the serology is not consisting with that, so the reporter stated that her concern was that mimicking this disease process. Pathologist said that it was a drug induced liver injury. The reporter stated that their doctor reporting that several patients after taking of Covid vaccine has had elevated liver function test and even had one that needed the liver biopsy, and he was asking if this was something that happening with the Covid vaccine or what are the study showing. The patient underwent lab tests and procedures which included: Liver Biopsy: Primary Delivery Conjunctivitis; INR (International normalised ratio): elevated; Liver function test: elevated; aminotransferase: elevated; antibody test: elevated intestinal muscle (not clarified); all tests on an unspecified date. The outcome of the events was unknown. Information on the lot/batch number has been requested.
40 2021-07-17 taste impairment Severe body aches; Nausea; Severe headache; Food tastes weird/bitter; This is a spontaneous report f... Read more
Severe body aches; Nausea; Severe headache; Food tastes weird/bitter; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Mar2021 at 10:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included HX breast cancer (remission 3y), fibromyalgia, migraine and gastroesophageal reflux disease (GERD). The patient had no known allergies to medications, food or other products. The patient had no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 29Mar2021 at 13:00, the patient experienced severe body aches, nausea, severe headache and food tastes weird/bitter. The patient did not receive any treatment for the events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events general body pain, nausea, headache and taste bitter were recovering at the time of this report. No follow-up attempts are possible; information about lot number cannot be obtained.
40 2021-07-17 eye swelling, lip swelling Swollen eyes, face, lips, hands, left leg and ankle; Swollen eyes, face, lips, hands, left leg and a... Read more
Swollen eyes, face, lips, hands, left leg and ankle; Swollen eyes, face, lips, hands, left leg and ankle; Swollen eyes, face, lips, hands, left leg and ankle; Swollen eyes, face, lips, hands, left leg and ankle; Swollen eyes, face, lips, hands, left leg and ankle; This is a spontaneous report from a contactable consumer. A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0177), dose 1 via an unspecified route of administration, administered in left arm on 30May2021 at 12:00 (at the age of 40-years-old) as dose 1, single for COVID-19 immunization. Medical history included orange allergy. The patient was not pregnant at the time of vaccination. The patient had not been tested for COVID-19 nor before neither since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient did not receive any other medication within 2 weeks prior to the COVID-19 vaccine. No concomitant medications was reported. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient experienced swollen eyes, face, lips, hands, left leg and ankle on 30May2021 at 17:00. Treatment include Benadryl. The outcome of the events were not recovered. Follow-Up (30Jun2021): Follow-up attempts are completed. No further information is expected. Follow-Up (05Jul2021): Follow-up attempts are completed. No further information is expected.
40 2021-07-17 taste disorder Terrible taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 40... Read more
Terrible taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Mar2021 at 10:00(at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included lupus SLE (systemic lupus erythematosus), hypothyroidism, narcolepsy and penicillin allergy. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), meloxicam (MANUFACTURER UNKNOWN), hydroxychloroquine sulfate(PLAQUENIL) and armodafinil (MANUFACTURER UNKNOWN), all from unknown dates and for unknown indications. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 27Mar2021 at 17:00, the patient experienced terrible taste. It was reported that the patient experienced terrible taste in mouth since a little while after the vaccine was given, vaccine administered around 10:00 and the taste developed later that day around 17:00. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event terrible taste was not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained
40 2021-07-18 loss of smell VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being ... Read more
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 03/27/21,pfizer,Lot#ER8733 2nd dose: 04/16/21,Pfizer,Lot# EW0162 Diagnosed covid positive:07/07/21 Exposure:Home exposure Symptoms:Fever,cough,loss of smell,abd pain. sore throat,runny nose,headache,chest pressure.
40 2021-07-19 dry eye Headaches; hot flashes; dry eyes; burning sending under skin on location where received fillers smil... Read more
Headaches; hot flashes; dry eyes; burning sending under skin on location where received fillers smile lines, cheeks; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 09:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any concomitant medication within two weeks of vaccination. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 10:15, the patient experienced headaches, hot flashes, dry eyes, burning sending under skin on location where received fillers smile lines, cheeks. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headaches, hot flashes, dry eyes and burning sensation was recovering at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
40 2021-07-19 ear pain Extreme fatigue, severe sinus pressure, headache, ears hurt, loss of memory. Tried Ivermectin and it... Read more
Extreme fatigue, severe sinus pressure, headache, ears hurt, loss of memory. Tried Ivermectin and it worked for 2 weeks, then I got sick again. Tried mucinex and resveratrol and it worked for 2 weeks, then I got sick again. Now I'm on singulair and it helps, but I get sick off and on.
40 2021-07-19 mouth discomfort chest started hurting; Fatigue; he couldn't move her mouth; her hands got real tight feeling; blood ... Read more
chest started hurting; Fatigue; he couldn't move her mouth; her hands got real tight feeling; blood pressure and heart rate was up/Elevated BP; couldn't breath; fast heart rate/heart rate and it was 140-145; bad dizziness/Lightheadedness; She had a pins and needles sensation in her fingers; her hands and mouth were frozen; her hands and mouth were frozen; fever of 100 degree F/Temperature elevation; headache; tired; anxiety attack; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9263), via an intramuscular route, administered in Arm Right on 09Feb2021 at 13:20 (at the age of 40-year-old) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient's historical vaccine first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL1283), via intramuscular route, administered in Arm Right on 19Jan2021 (at the age of 40-year-old) as single dose for covid-19 immunization. It was not provided that the patient was received any vaccine 4 weeks prior vaccination. On 09Feb2021 the patient experienced fast heart rate/heart rate and it was 140-145, bad dizziness/light-headedness, she had a pins and needles sensation in her fingers, her hands and mouth were frozen, her hands and mouth were frozen, fever of 100-degree F/Temperature elevation, headache, tired, blood pressure and heart rate was up/Elevated BP, couldn't breathe, Fatigue, he couldn't move her mouth, her hands got real tight feeling and on Feb2021 anxiety attack and on 12Feb2021 chest started hurting. She mentioned that she received the 2nd dose of the vaccine last Tuesday and experienced a fast heart rate, really bad dizziness within 5 minutes. She had a pins and needles sensation in her fingers and her hands and mouth were frozen. She went to the EMS and her symptoms were addressed. She went home but experienced it again and went to the walking clinic with a fever of 100-degree F. Her doctor said that it may be related to the vaccine. On Wednesday she said that she had a headache and was tired. On Thursday she said that she may had an anxiety attack with a heart rate of 145. Blood work was done, and it said that there was no evidence of clotting. The EKG revealed that her heart rate won't drop, and it was hurting her chest and her heart as it was beating fast. She has been prescribed with anxiety medications. She was asking if this was a common side effect because her doctors don't know. She reported she had her second COVID-19 Vaccine dose on 09Feb2021 at 1:20PM, and she has had side effects ever since. She said the side effects have her scared. She said she still has a rapid heart rate in the 90s. Reporter Type: Patient Reported 5 minutes after receiving her second COVID-19 Vaccine dose she got lightheaded and dizzy. She said she told one of the staff at the COVID-19 Vaccine facility that she thought she was dizzy and didn't feel right. She said she was moved to a private room at the COVID-19 Vaccine site. She said the staff put things on her chest and stomach and checked her blood pressure. She said the staff told her that her blood pressure and heart rate was up. She said she doesn't remember what her blood pressure or heart rate was at the time. She said a staff member taking care of her asked her if she was nervous. She said she told the staff member she had nothing to be anxious about. She said she told the staff member that she knows what the common COVID-19 Vaccine side effects are, and that she had gotten over any fear of needles a long time ago. She said she was fine before she got her second COVID-19 Vaccine shot. She said 5 minutes after getting the second COVID-19 Vaccine shot, she gets dizzy and lightheaded out of nowhere. She said her mother had died of breast cancer in Dec2020, and she had a Xanax prescription from during that time. She said she took a 1/2 of Xanax to see if the Xanax would help her blood pressure and heart rate. She said after a half hour had gone by, she got a pins and needles feeling down her arms. She said her blood pressure and heart rate were still up, and she could feel her heart beating in her chest. She said while she was still being attended to by the COVID-19 Vaccine facility staff member, and EMS person came in, and said 3 more people were down from that vaccine lot. She said the staff member asked if he could move her to another area outside of the private room she was in, and he told her he would have 2 cops keep an eye on her. She said she spoke to the 2 cops for a while, and then she called her director at work. She said she then called her husband, and her husband told her if she was feeling well enough to drive home. She said while she was driving home, her hands got real tight feeling, she couldn't move her mouth, her heart was hurting because her heart was beating so fast, and she couldn't breathe. She said she had to pull her car over, and have her husband get her. She said she went to the walk-in clinic at her work, and when her temperature was checked, it was 100 degrees. She said the doctor at the walk-in clinic told her she was having a reaction to the COVID-19 Vaccine. She said she got a headache that evening, and her breathing, blood pressure, and heart rate hadn't dropped. She said the next day she still had a headache, but she didn't want to take off from work. She said everyone she works with whom got the COVID-19 Vaccine had a fever, body aches, and a headache, and took off the next day from work. She said she had an episode at work that afternoon where she couldn't breathe, and her chest started hurting. She said someone checked her blood pressure, and heart rate and it was 140-145. She said she went to her doctor yesterday, and he did and EKG and told her she had an elevated heart rate. She said her doctor drew blood to check for blood clots and to check for something in her blood vessels in her heart. She said her doctor told her it may be anxiety, and for her to take a Xanax. She said her doctor said he wants to see how she was in the next week and see if anything changes. She said her heart rate today has been between 90-95. She said her heart was beating so fast that it was making her chest hurt. She said she told her doctor the EMS staff member that checked on her after she got lightheaded and dizzy at the COVID-19 Vaccine facility told her he had the same thing happen to him. She said there seems to be a difference of opinion between the walk-in clinic doctor, and her doctor. She said the walk-in clinic doctor was saying she was having a reaction to the COVID-19 Vaccine, and her doctor was saying it was anxiety, and for her to wait a week. She said she doesn't want any damage to her heart. She said her doctor told her no one has died from getting the COVID-19 Vaccine. Thinks she was experiencing a side effect to the COVID- 19 Vaccine. She said her other colleagues from work had some of the same side effects after getting the COVID-19 Vaccine. She, her doctor, said the COVID-19 Vaccine side effects only last 48 hours. She said Dr. was only telling her that because that was what was said about the COVID-19 Vaccine. She said was a younger doctor and doesn't know anything about the COVID-19 Vaccine. Reported she doesn't want to wake up and have to go to the emergency room because there was something wrong with her heart caused by the COVID-19 Vaccine. Treatment: Reported her doctor gave her allergy pills, clarified as Cetirizine. She said the Cetirizine was dispensed in a pharmacy bottle and she did not have the NDC, Lot, and Expiration Date. Reported her doctor also prescribed Naproxen 500mg for her headache. She said she did not have the Naproxen NDC, Lot, and Expiration Date. She said she did not take any of the Naproxen 500mg prescription. She said the doctor had given her a shot of Toradol when she was at the doctor's office. She did not have the Toradol NDC, Lot, and Expiration Date. Caller didn't have Xanax NDC, Lot, and Expiration Date to provide during call. Reported she doesn't take any medication unless she has to. Reported her doctor doesn't know why her heart rate was up. She said she was scared that she might have damage to her heart. Caller stated she had to pick up her daughter. Reported no one has any idea what was going on with her. She said her blood pressure didn't go up today, and she has been checking her heart rate. She said yesterday morning her heart rate was up there and then her heart rate subsided. She said she doesn't want any damage to her heart. Caller stated at the COVID-19 Vaccine administering site told her he thought he was going to die after he got his COVID-19 Vaccine. No further details provided. Reported her symptoms improved from yesterday, but she still has a headache. She said she has fatigue that started on 09Feb2021 and has stayed the same since that time. She said her heart rate today has been between 90-95. She said her heart was beating so fast that it was making her chest hurt. The patient underwent lab tests and procedures which included blood pressure measurement: blood pressure was up on unspecified date, blood test: no evidence of clotting on unspecified date, body temperature: 100-degree Fahrenheit on unspecified date, electrocardiogram: elevated heart rate on 11Feb2021, heart rate: 145 on unspecified date, heart rate: 140-145 on 11Feb2021 and heart rate: 90-95 on 12Feb2021. Patient not visited to emergency room for the events, visited to physician's office. Therapeutic measures were taken as a result of the events. The outcome of the events headache and fatigue was not recovered all others were recovering. Follow-up attempts completed. No further information expected.
40 2021-07-20 oropharyngeal discomfort Elevated heart rate; Light headiness; Throat felt scratchy; Throat felt weird; This is a spontaneou... Read more
Elevated heart rate; Light headiness; Throat felt scratchy; Throat felt weird; This is a spontaneous report from a contactable consumer via regulatory authority. A 40-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN), on 01Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not tested for COVID-19. The patient's medical history and concomitant medications were not reported. On 01Apr2021, the patient experienced elevated heart rate immediately after vaccination, which resolved 30 mins post vaccination and also the patient had a bit of light headiness and throat felt weird/ scratchy a few hours later which resolved in about 10 minutes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of elevated heart rate, light headiness, throat felt weird and throat felt scratchy was recovered on 01Apr2021. No follow-up attempts are needed; information about lot number cannot be obtained.
40 2021-07-21 oral mucosal blistering Starting on 12/24/2021 I broke out in rash on right side of torso and neck and arm, I also developed... Read more
Starting on 12/24/2021 I broke out in rash on right side of torso and neck and arm, I also developed blisters in the roof of my mouth, all this was happening on right side only. Lasted about 2 weeks and all side effects subsided at that point. Called doctor for consultation on 12/25/2021.
40 2021-07-21 visual impairment The evening of my 2nd vaccine, I had a 103 fever that lasted 2 days. I treated this with Tylenol. Si... Read more
The evening of my 2nd vaccine, I had a 103 fever that lasted 2 days. I treated this with Tylenol. Since then, I have experienced fatigue. 2 weeks later I woke up about midnight to shooting pains down both arms. This lasted about 5 minutes and then stopped. I didn't think anything of it at the time or linked it to the vaccine. Since that first time I have had that experience 3 more times in the middle of the night. I also have noticed vision changes in my left eye. As of now my fatigue has gotten better, but I am not back to my normal energy level.
40 2021-07-22 eye pain Within 2 hours of receiving the vaccine i had to leave work, abdominal pain, headache, exhausted, na... Read more
Within 2 hours of receiving the vaccine i had to leave work, abdominal pain, headache, exhausted, nauseated, neck pain. over the next weeks before my second dose, pain began to be all over, lots of nerve pain shooting down my legs. it got slightly better by the time i received my 2nd dose on May 20, 2021 BioNtech/Pfizer Lot# ER8736 also administered at a workplace clinic. within an hour the above symptoms came back stronger than before. I have not been able to work since. in addition to the above symptoms i have started getting dizzy, eyes hurt, and exhausted is putting it mildly. The beginning of July I started having memory issues.
40 2021-07-25 swollen lips approx 6 months after 2nd dose developed moderate/severe cheilitis. Awaiting dermatology consult. ... Read more
approx 6 months after 2nd dose developed moderate/severe cheilitis. Awaiting dermatology consult. Currently being treated with topical triamcinolone and bactroban. I wouldn't have connected this to the covid vaccine except a friend of mine who also had the pfizer vaccine developed the same condition. And I know MIS-C has been similar to kawasaki's and both have varying degrees of severe chapped lips/cheilitis. Nothing like this has ever happened to me. Nothing about my routines are new. No new products or sensitivities to products have been noted.
40 2021-07-26 eye irritation, lacrimation increased I have a weird tightening on the right side of my face. My right eye lid is droopy all the time and... Read more
I have a weird tightening on the right side of my face. My right eye lid is droopy all the time and the right corner of my lip always pulls up, its kind of the opposite of bells palsy and the mornings are much more prominent. I have had occasional chest pain and R arm tingling when this first started. My vision is fine but my eye is very irritated and watery.
40 2021-07-27 oropharyngeal discomfort 2 min after getting the vaccine I started to feel dizzy, my heart rate was high, nausea , vomiting a... Read more
2 min after getting the vaccine I started to feel dizzy, my heart rate was high, nausea , vomiting and my throat felt hot /cold.... it was something that I never experienced before.
40 2021-07-27 ringing in ears Extreme nausea; Vomiting; Stomach pain; Ringing in ears; Fever; Extreme muscle fatigue; Still sick; ... Read more
Extreme nausea; Vomiting; Stomach pain; Ringing in ears; Fever; Extreme muscle fatigue; Still sick; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 01Apr2021 at 08:15 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 15:00, the patient experienced extreme nausea, vomiting, stomach pain, ringing in ears, fever, extreme muscle fatigue and still sick 5 days later. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcomes of the events extreme nausea, vomiting, stomach pain, ringing in ears, fever, extreme muscle fatigue and still sick 5 days later were recovering at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
40 2021-07-28 deafness, ringing in ears I lost my hearing and I have 30% left; I had the tinkering sound in my ear; This is a spontaneous re... Read more
I lost my hearing and I have 30% left; I had the tinkering sound in my ear; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received bnt162b2 (Lot Number: EW0171), dose 2 via an unspecified route of administration on 05May2021 (at the age of 40 years old) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (Lot Number: EW0161), dose 1 via an unspecified route of administration on 14Apr2021 (at the age of 40 years old) as single dose for covid-19 immunization. The patient took last dose (second dose) on 05May2021, one months later she lost her hearing and she had 30% left and she didn't have another reason she was very healthy women and she didn't have any family problem of hearing loss. She was very active and anyway when she wake up on 25Jun2021 she had the tinkering sound in her ear she went to the specialist of ear, nose and throat (ENT) Specialist, did examine the geometry and she lost her hearing and the hearing loss was because of the shot and she couldn't find any other reason. The patient underwent lab tests and procedures which included the patient had the blood test the shot on 11May2021, ENT examination stated as 'I lost her hearing' on 25Jun2021. The outcome of events was unknown. Follow-up attempts are completed. No further information is expected.
40 2021-07-28 lacrimation increased extreme lower-body aches as if the patient had restless leg syndrome for 2 days; collarbone top ches... Read more
extreme lower-body aches as if the patient had restless leg syndrome for 2 days; collarbone top chest area hurt so bad it felt like it was punched in the collarbone; cold-like symptoms; runny nose; watery eyes; sore throat; cough; rash in anus and perineum that simulated a child's diaper rash; rash in anus and perineum that simulated a child's diaper rash; extreme fatigue where the patient could barely keep eyes open for 12 days; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the arm left on 15Apr2021 at 09:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis, sciatica, scoliosis, eczema, multiple allergies (year-round allergies), sensitive skin and allergy to topical drugs (sensitive to topicals). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC), probiotics (MANUFACTURER UNKNOWN), multi-Vitamin (MANUFACTURER UNKNOWN) from an unknown date for unknown indications. The patient previously took sulfa (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 15:00 the patient experienced extreme lower-body aches as if the patient had restless leg syndrome for 2 days, collarbone top chest area hurt so bad it felt like it was punched in the collarbone, cold-like symptoms which included a runny nose, watery eyes, sore throat and cough for 12 days and also the patient experienced rash in anus and perineum that simulated a child's diaper rash (anal rash and perineal rash) and also the patient experienced extreme fatigue where the patient could barely keep eyes open for 12 days. The clinical outcome of the event extreme lower-body aches as if the patient had restless leg syndrome for 2 days was recovered with sequelae on 17Apr2021. The clinical outcome of the event cold-like symptoms which included a runny nose, watery eyes, sore throat and cough for 12 days and extreme fatigue where the patient could barely keep eyes open for 12 days were recovered with sequelae on 27Apr2021. The clinical outcome of the event collarbone top chest area hurt so bad it felt like it was punched in the collarbone, rash in the anus and perineum that simulated a child's diaper rash (anal rash and perineal rash) were recovered with sequelae on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.
40 2021-07-28 oropharyngeal discomfort 1104 -Vaccine administer IM in L arm. 1110- PT states to complain of having something in her throat.... Read more
1104 -Vaccine administer IM in L arm. 1110- PT states to complain of having something in her throat. Denies having any SOB, chest tightness, itching, and no hoarseness. 1115- PT is clearing her throat more and states that she feels like she has to keep clearing her throat more and started to have Hoarseness denies having SOB but states that she is having a harder time breathing when positioning her head in certain ways. 1118- Minimal facial swelling noted clearing throat more often pt continues to talk to staff. Denies having SOB or chest tightness. Doctor notified of pt's symptoms and instructed to give Epi-Pen NOW. Epi-PEn(Lot #0FM407 exp: 02/2022) administered to Left Thigh by LPN. Pt tolerated and continues to talk to staff. 1120- Doctor in Room evaluating patient. Doctor instructed to continue monitoring in room for the remainder of 30 minute wait and advised patient that she could return back to work since pt works in the hospital. PT voiced understanding. Pt continues to deny SOB and chest tightness. 1125- PT states that she can tell her throat is starting to feel better states that she doesn't feel like she has to continue clearing throat. Continues to communicate with staff and continues denying any SOB. 1130- PT continues to states that feels like she is improving. Facial swelling has gone down. Continues to communicate and denies having and SOB and chest tightness. 1135- PT's 30 minute wait is up and Pt continues communicating with staff. Denies SOB states that she feels somewhat better. Informed patient that she could continue to be monitored by immunizations RN but pt denies and verbalized that ''Dr. said I could go back to work''. Informed patient that if symptoms do not improve and if she starts to have SOB, difficulty swallowing, swelling in throat or tongue to seek immediate attention at the ER. Pt verbalized understanding and ambulated out of area.
40 2021-07-28 taste disorder, eye floaters, vision blurred, ringing in ears, ear discomfort Effect On Ears - Evening of 3/13 tinnitus became louder and came in waves. - Tinnitus increased over... Read more
Effect On Ears - Evening of 3/13 tinnitus became louder and came in waves. - Tinnitus increased over the next couple of days to louder, constant, high-pitched buzzing, louder than TV and sound machine. - Feeling of fullness/pressure in/around ears. - Pain/discomfort in/around ear. - Sensitive to loud and high-pitched sounds, incl. kids, TV, music, dishes, loud talking. - Occasional popping in ears. - Occasional itching in ears. - Multiple sounds in ears (buzzing, tone), some times sound travels. - Tinnitus aggravated with exercise, hot showers, long exposure to sound (for example, low music, ocean waves, driving). Allergy shots cause flare ups with multiple symptoms (none of this happened prior to vaccine). - All symptoms above are new. Prior to vaccine I had a low baseline T that was easily ignored and only heard when silent. - Most symptoms eased after 10 - 12 weeks, but tinnitus (louder than pre-vaccine tinnitus) continues, as well as flare ups of all ear symptoms. Other Side Effects - GI: Significant loss of appetite, weight loss, stomach cramping, nausea, spit out food because of off taste, loose stool / diarrhea. All improved after 3 weeks. - Tremors / Shaking. Improved after 3 weeks. - Intense anxiety/depression began 3/14, including tightness in chest, difficulty breathing at times, increased heart rate, sleep disturbances, troubled thoughts. Eased after several weeks. Emotional upset from situation continues but at more appropriate level. - Pain/pressure (all over or shooting) in head and face, some times on one side of face, temples, forehead, base of neck. Eased after 1-2 months. - Prickly & numb sensations on face, similar sensation in toes and fingers a few times. Eased after 1-2 months. - Head fog. Eased after 1-2 months. - Fatigue. 3/26 Took walk and felt as though recovering from flu (heaviness in chest), unable to work out for 2 weeks, resumed since with less frequency & more modifications (continues like this). - 1-2 days after vaccine sore arm, aggravated arthritis and interstitial cystitis. - Other misc things experienced during the first 2-3 months post vaccine: neck and back pain, vision issues (trouble focusing, not as clear, floaters), hair loss (hair dresser noticed 3/23), increased pain in legs/veins, leg cramps.
41 2021-01-01 mouth numbness, mouth tingling perioral tingling, numbness
41 2021-01-03 lip swelling, swelling of eyelid 12/19/2020-12/20/2020 only experiences soreness of left arm where vaccine received. Woke up early mo... Read more
12/19/2020-12/20/2020 only experiences soreness of left arm where vaccine received. Woke up early morning 12/21/2020 with moderate swelling of eyelids, face, lips that progressed over several hours before seeking care at Hospital ED. Received IV Benadryl and IV solumedrol. Prescribed oral prednisone dose pack to start next day. Symptoms mostly resolved by that evening.
41 2021-01-03 taste disorder, taste impairment Taste buds went numb, metallic taste, slight swelling of throat, itchiness all to upper body, joint ... Read more
Taste buds went numb, metallic taste, slight swelling of throat, itchiness all to upper body, joint pain, and pain at injection site. Lasting about 12 to 24hours. Antihistamines treated at home.
41 2021-01-04 loss of smell, loss of taste I received the 1st Covid vaccine on December 23rd, 2020, then I was exposed to the coronavirus on t... Read more
I received the 1st Covid vaccine on December 23rd, 2020, then I was exposed to the coronavirus on the 25th of December, then I started having symptoms at 3:30 am on December 29th I went and got tested that morning and the test was positive for covid-19. I then went home to quarantine. I have experienced fever, body aches, headaches, nausea, diarrhea, sinus pressure, chills, loss of taste and smell, weakness and fatigue. But have been able to continue to recover at home.
41 2021-01-04 lip swelling, lip blister Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes. Nausea 12/26-12/27. Rash ... Read more
Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes. Nausea 12/26-12/27. Rash on flexural of both arms, started with just left then progressed to both arms 12/27; achy feeling still; "gross feeling;" swollen lip with blister, started 1/3; left supraclavicular lymph node swollen
41 2021-01-04 mouth tingling At around 0910, employee reported tingling on tongue and roof of mouth while in the monitoring area ... Read more
At around 0910, employee reported tingling on tongue and roof of mouth while in the monitoring area post vaccination. RN obtained V/S: 122/76; pulse 78; resp 18; pupils equal and reactive; skin pink. Employee was alert and oriented. She reported slight reaction about 30min. post vaccination. Dr. was notified and assess the employee. Dr. ordered Benadryl 25mg PO at 1001. This was administered by RN. Employee was monitored for another 20 minutes and then was aloud to leave. Employee was feeling better before leaving. She was instructed to seek medical attention if symptoms returned or new symptoms occured. She verbalized understanding.
41 2021-01-04 sensitivity to light Fatigue; Myalgia; Injection site pain; Headache (frontal)/Worsening headache; Joint pain; Chills; Na... Read more
Fatigue; Myalgia; Injection site pain; Headache (frontal)/Worsening headache; Joint pain; Chills; Nausea; Vomiting; Worsening headache w/ photophobia; Subjective fever; This is a spontaneous report from a contactable physician (patient). A 41-year-old female non-pregnant patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=59267-1000-1 /EH9899), via intramuscular on 28Dec2020 09:45 at single dose on her right arm for Covid-19 immunization. Medical history included psoriasis. The patient had no known allergies. Allergies to medications, food, or other products was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. It was reported that 6h after administration on 28Dec2020 16:00, the patient experienced fatigue, myalgia, injection site pain; 10h after (in addition to above) on 28Dec2020, the patient experienced headache (frontal), joint pain, chills and 12-28h after (in addition to above) in Dec2020, the patient experienced nausea, vomiting, worsening headache w/ photophobia, subjective fever, joint pain. The patient was not received any treatment for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
41 2021-01-04 enlarged tonsils 4 days the vaccine I got a high fever, body aches and tonsils were severly swollen and couldnt work
41 2021-01-05 taste impairment got a very metallic taste in my mouth; sleep a lot; tired; This is a spontaneous report from a conta... Read more
got a very metallic taste in my mouth; sleep a lot; tired; This is a spontaneous report from a contactable healthcare professional. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140/ELO140), via an unspecified route of administration, at the left arm on 30Dec2020 06:30 at a single dose for COVID-19 immunization at a hospital. Medical history included seasonal allergies and doesn't take medications. On the same day of 30Dec2020, about an hour after vaccination, patient got a very metallic taste in mouth, which lasted for about 12-18 hours and did sleep a lot, which she expected, but woke up about 11 at night and still had it and it was gone. Patient knew she slept longer than she normally does, went to bed at 1PM and slept until 11PM, which is not usually normal. Was up for about an hour or two and then went back to bed until 8AM of 31Dec2020. Patient was concern was if it was some type of reaction that it would mean she was going to have a stronger reaction to the second one and stated it was irritating but not a huge deal. Patient also felt tired and expected it as she worked five 12-hour shifts in a row. Patient was not sure if the metallic taste was connected to the COVID-19 vaccine. No prior vaccinations within 4 weeks. Outcome of the events was unknown.
41 2021-01-05 mouth tingling, lip itchiness Broke out in red rash on neck, chest and arms. Lips itchy and tinging.
41 2021-01-05 swollen tongue TOUNGE SWELLING , FELT HOT 5 MIN AFTER POST INJUCTION. EPINEPHRINE GIVEN. ED VISIT
41 2021-01-06 taste impairment Metallic taste in mouth
41 2021-01-06 ear discomfort, ear congestion Pfizer vaccine administered to associate 12/21 at 9:46am. Felt healthy and well prior. Felt fine unt... Read more
Pfizer vaccine administered to associate 12/21 at 9:46am. Felt healthy and well prior. Felt fine until about 3pm. Just typical arm pain. Moderate/Severe Fatigue set in around 3-6pm. Needed to nap from 4-5pm (extremely unsusual). Felt fine the next day. Moderate congestion in ears starting around the same time (6 hours after) and is persisting 30 hrs later. Feel like my ears will not pop and trying to yawn a lot. Also felt pretty bad sinus congestion starting at 7pm 12/21 (10 hrs after vaccine). Could not breathe through nostrils. Treated with sinus rinse and sudafed.
41 2021-01-06 pain in jaw, ear pain I Initially just had a sore left arm which felt better the next day. I woke up the morning after t... Read more
I Initially just had a sore left arm which felt better the next day. I woke up the morning after the Vaccine (1/6/21) and experienced right jaw pain which extend it to my ear which was worse during chewing and talking. Today on January 7 it is still present however seems milder
41 2021-01-06 mouth tingling PARATHESIA OF LOWER LIP
41 2021-01-06 swollen tongue Developed shortness of breath, swelling of tongue, persistent cough within 5 minutes of vaccination.... Read more
Developed shortness of breath, swelling of tongue, persistent cough within 5 minutes of vaccination. Was treated with EpiPen and kept in ER for observation overnight. Symptoms resolved.
41 2021-01-07 oropharyngeal discomfort Patient received COVID-19 vaccine. After receiving vaccine patient c/o nausea and feeling "something... Read more
Patient received COVID-19 vaccine. After receiving vaccine patient c/o nausea and feeling "something in throat". Vital signs obtained at 1853 175/96, HR 68, temp 98.3 and o2 sat 99%. Repeat VS at 1903 167/103, HR 78, O2 sat 100%. Having pulse ox desaturations while speaking. Patient transported to ED in stable condition. Patient monitored in ED with resolution of symptoms and was discharged.
41 2021-01-07 swollen tongue Employee received Pfizer COVID-19 vaccine and subsequently developed full body itching and reported ... Read more
Employee received Pfizer COVID-19 vaccine and subsequently developed full body itching and reported feeling like tongue was swelling. Patient was given 50 mg PO Benadryl. No improvement patient was escorted to ED by RN for evaluation
41 2021-01-07 ringing in ears Achy body, headache, ear ringing, chills and a temperature.
41 2021-01-08 lip swelling, taste impairment, mouth tingling, mouth numbness 1st event: Metallic taste in mouth; then felt like I had a 'fat lip' on left lower lip; and left hal... Read more
1st event: Metallic taste in mouth; then felt like I had a 'fat lip' on left lower lip; and left half of tongue- tip only- went numb Injected with 50mg of Benadryl in my left upper thigh 2nd event: 4.5 to 5 hours later- Metallic taste returned {Liken to cold house key metallic taste} in center of tongue- width of 1-2 mm, taste lasted 30-45 seconds. Left side of lips went numb (upper and lower) with lower again feeling swollen. Left upper part of tongue again went numb. Took 25 mg tablet of Benadryl. Odd feeling in tongue lasted for a few days after vaccine.
41 2021-01-08 mouth tingling Angioedema Tongue Tingling Narrative: Tingling decreased after 20 mins.
41 2021-01-08 drooling, taste impairment employee received the vaccine at 3:45 PM, and at 4:00 PM began feeling a sensation in her mouth of h... Read more
employee received the vaccine at 3:45 PM, and at 4:00 PM began feeling a sensation in her mouth of having lots of saliva. Did not get nauseated. Also experienced metallic taste in mouth. 5 minutes later felt dizzy, then 5 minutes later felt shaky BP was 159/93, HR 107 felt well enough to finish out shift, and went home. Following day felt lethargic, but recovered from that at home.
41 2021-01-08 swollen tongue Tingling in injection arm, fingers; tingling in face; tongue swelling 30 minutes- 1 hour after vacci... Read more
Tingling in injection arm, fingers; tingling in face; tongue swelling 30 minutes- 1 hour after vaccine. Visited immediate care; received IV of Benadryl, Pepcid & Steroid.
41 2021-01-08 tongue discomfort, mouth discomfort Oral dysaesthesia - scratchy throat morning after vaccination, then developed tongue burning and pro... Read more
Oral dysaesthesia - scratchy throat morning after vaccination, then developed tongue burning and progresses to full mouth Fatigue, headache, body aches
41 2021-01-09 mouth swelling About 5 min after getting the first dose, I felt numbness in my left hand. I was monitored for 60 m... Read more
About 5 min after getting the first dose, I felt numbness in my left hand. I was monitored for 60 min and they did blood pressure and oxygen check. about 10 min in, I felt a little funny in my mouth, like a little bit of swelling, but never to the point of issue with breathing or swallowing. Numbness seemed to have subsided by the 60 minute time and I went home. No other symptoms.
41 2021-01-10 mouth swelling, mouth discomfort cheeks were swollen; when I brushed my teeth, i felt a severe burning sensation inside my mouth and ... Read more
cheeks were swollen; when I brushed my teeth, i felt a severe burning sensation inside my mouth and the inside of my mouth started to swell; when I brushed my teeth, i felt a severe burning sensation inside my mouth and the inside of my mouth started to swell; so tired; This is a spontaneous report from a contactable healthcare professional, the patient. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection intramuscular in the left arm on 26Dec2020 at 09:30 (at the age of 41-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included allergic reaction with known allergies to sulfa, seafood. Concomitant medications included acetylsalicylic acid/caffeine/salicylamide (EXCEDRIN) and paracetamol (TYLENOL). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient stated, "I just finished a night shift from work and got home on 02Jan2021 around 07:45 when I brushed my teeth, I felt a severe burning sensation inside my mouth and the inside of my mouth started to swell. I didn't think much of it since I was so tired but then woke to get ready to work then my mouth and cheeks were swollen (02Jan2021 at 16:00) and barely could open my mouth." No treatment was provided for the events burning mouth, mouth swelling, cheeks were swollen and so tired. The outcome of the events burning mouth, mouth swelling, cheeks were swollen and so tired was not recovered. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
41 2021-01-10 photosensitivity reaction Severe headache with photosensitivity, soreness at injection site, malaise
41 2021-01-10 swollen tongue, lip itchiness Approximately 5 minutes after receiving vaccine, tongue began to swell with itching to lips and chee... Read more
Approximately 5 minutes after receiving vaccine, tongue began to swell with itching to lips and cheeks and stiffness to jaw. Notified vaccine team. Received Benadryl IM with return to baseline and transported to the ER for monitoring. Received 4 days of Prednisone and Pepcid PO.
41 2021-01-11 loss of smell, loss of taste 41-year-old woman who presents to the office on 1/12/2021 for fatigue, congestion of nose and eyes a... Read more
41-year-old woman who presents to the office on 1/12/2021 for fatigue, congestion of nose and eyes and lack of taste and smell. Patient's initial symptoms started on 1/8/2021 with some rhinorrhea. The following day on 1/9/2021 she went to the gym feeling fine. That evening she felt fatigued and attributed to her workout earlier in the day. The next day she developed a severe headache with fever, sweats, chills and body aches. Yesterday on 1/10/2021 she developed nasal congestion and eye symptoms. Patient presented to the office today on 1/12/2021 for testing and was Covid positive. Patient had a positive Covid test on 11/11/2020 with mild symptoms of headache, fatigue without congestion or loss of taste and smell. At that time the duration of her symptoms was 3 days. She had the first Pfizer Covid vaccine on 12/18/2020 with minimal muscle soreness. She had the second Pfizer Covid vaccine on 1/8/2021. Patient works in administration of a medical facility. She has minimal contact with clinical staff and patients. No one in her office has had Covid symptoms or infection. Patient's other contacts are at home and the gym. She does attend a gym class with 10 other participants. She does not know whether anyone in the gym class has had symptoms.
41 2021-01-11 dry throat Started coughing at 8:20 thought just a dry throat. By 8:25 throat became itchy. Assessed by EMT. Be... Read more
Started coughing at 8:20 thought just a dry throat. By 8:25 throat became itchy. Assessed by EMT. Benadryl 25 mg po given at 8:40 and manager called to take her from work due to Benadryl
41 2021-01-11 ear pain, toothache I developed a sharp pain on the back side of my left neck area; I developed a severe earache, which ... Read more
I developed a sharp pain on the back side of my left neck area; I developed a severe earache, which began to subside within about 2 days; my upper left molar started aching (toothache); I had a sharp intermittent pain in my left jugular/carotid neck area; felt a little "tipsy; I had intermittent numbness and tingling in my left jaw area; I had intermittent numbness and tingling in my left jaw area; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose in the left arm for COVID-19 immunization. Medical history included allergies to Sulfa antibiotics. The patient's concomitant medications were not reported. The patient previously took meperidine (DEMEROL) and experienced allergies. Within an hour of receiving the vaccine, the patient had a sharp intermittent pain in her left jugular/carotid neck area and felt a little "tipsy". This continued for about one day. Then last week (approximately 28Dec2020), her upper left molar started aching (toothache). This subsided within about 2 days. Then on 30Dec2020, she developed a severe earache, which began to subside within about 2 days. Around 31Dec2020 through 04Jan2021, she had intermittent numbness and tingling in her left jaw area. Last night (05Jan2021), she developed a sharp pain on the back side of her left neck area. She went to the doctor on 04Jan2021, and no treatment was prescribed. She began self-medicating with an old prescription of prednisone on the evening of 04Jan2020 due to being fearful of developing Bell's Palsy. Most of her symptoms have now improved after beginning the prednisone. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
41 2021-01-11 vision blurred Dose 1 -Headache for 4 days, and fatigue Given 12/21/2020 @ 0900am Dose 2-headache, shaky, fatigue... Read more
Dose 1 -Headache for 4 days, and fatigue Given 12/21/2020 @ 0900am Dose 2-headache, shaky, fatigue, light headed, blurred vision, high blood pressure and mental fogginess Given 01/11/2021 @ 1430pm
41 2021-01-11 visual impairment, sensitivity to light, vision blurred Onset of "kaleidoscope vision" at 10:50 AM, followed by headache, nausea, light sensitivity, and dif... Read more
Onset of "kaleidoscope vision" at 10:50 AM, followed by headache, nausea, light sensitivity, and difficulty focusing eyes (symptoms of ocular migraine). Severe symptoms lasted 5 hours, mild symptoms lasted through the evening and next day (today I still have a mild headache and nausea). I have previously had 1 migraine (~5 yrs prior) in the setting of repeated fume exposure during a renovation at my workplace, no other history of migraine.
41 2021-01-12 dry eye, dry mouth Excruciating headache, dry mouth and eyes, Nausea and vomiting
41 2021-01-12 eye pain, eye itchiness positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; After the shot i have he... Read more
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; A 48-years-old non-pregnant female patient, receivedBNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in left arm, on 18Dec2020 (at the age of 41 years-old) as a single dose for COVID-19 immunization. The vaccination was administered at a pharmacy/drug store. Medical history was not reported. Concomitant medication included sertraline hydrochloride (SERTRALINE HYDROCHLORIDE). The patient had not received any other vaccines within four weeks prior to the vaccination nor received any other medications withing 2 weeks prior. It was reported that the patient had been tested for COVID-19 prior to vaccination and was negative. On 18Dec2020, the patient experienced itchy sore eyes one hour after vaccination, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after. The patient was not hospitalized nor received treatment for the events. The clinical outcome of the events of Itchy, sore eyes 1 hour after, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after, was not recovered., the outcome of the COVID-19 positive was unknown. It was reported that the patient tested positive for COVID-19 via nasal swab, post vaccination on 31Dec2020. No follow-up attempts possible. No further information expected. Lot/batch number was not provided and unable to obtain
41 2021-01-12 eye itchiness 24 hours after the injection I had a sore arm, developed slight body aches and headache. Since the ... Read more
24 hours after the injection I had a sore arm, developed slight body aches and headache. Since the injection I had been getting headaches almost daily, mostly on my right side of my head. On Dec. 5, 2021 I noticed I was getting a sore eyebrow. Later that evening ok noticed swollen lymph nodes throughout my scalp, face, ear, jaw, neck and chest. My eyebrow also started to swell and was slightly pink. When the swelling was worse the next day - I went to urgent care and saw A doctor that diagnosed me with facial cellulitis. After a couple days my eye was not getting any better and started to itch severely. Called to urgent care over the weekend and takes to one of the providers who said to use cold compresses and elevate my head as much as I could. On Dec. 11, 2021 I called back to the provider I had seen on Dec. 6 - he told me he believed I had developed shingles and to go to the eye doctor that day. I saw a doctor on Dec. 11 & was diagnosed with shingles. They started me on antivirals along with the antibiotics they had prescribed on Dec. 6.
41 2021-01-12 feeling of choking, mouth numbness POST VAC. SHOT C/O OF THROAT TINGLING, TONGUE FEELING HEAVY AND NUMB. EMS PRESENT. 1427: VS: BP:... Read more
POST VAC. SHOT C/O OF THROAT TINGLING, TONGUE FEELING HEAVY AND NUMB. EMS PRESENT. 1427: VS: BP: 143/91, O2 SAT R.A.: 98%; P: 78. 1435: VS: 144/88; 02 SAT R.A.: 98%; P: 78; 1440: LEFT SITE, NO OTHER COMPLAINTS.
41 2021-01-12 tunnel vision Received the vaccine on a Wednesday afternoon. That evening I developed body aches, which got progre... Read more
Received the vaccine on a Wednesday afternoon. That evening I developed body aches, which got progressively worse over the course of the following day. I developed a persistent headache on Thursday that stuck around until Sunday. On Saturday morning I woke up feeling ok, still had the dull headache, but was ok enough to be up and around. At approximately 10:30 Saturday morning I was hit with stroke symptoms. I had weakness in my left hand, tunnel vision, couldn?t understand words that were spoke to me and was aphasic with garbled speech. Went to local ER and was worked up for stroke. Symptoms resolved Within approximately 45 minutes. All tests, lab results ok.
41 2021-01-13 loss of taste Patient developed loss of taste, fever 100.1, shivering , muscle ache and weakness within 24 hours a... Read more
Patient developed loss of taste, fever 100.1, shivering , muscle ache and weakness within 24 hours after second dose.
41 2021-01-13 eye pain Severe aches, chills, headache, stomach cramps, nausea, vomiting, diarrhea, sweats, eye pain, fatigu... Read more
Severe aches, chills, headache, stomach cramps, nausea, vomiting, diarrhea, sweats, eye pain, fatigue, skin sensitivity. Treated with Tylenol and CBD lotion. Mostly resolved within 36 hours of onset.
41 2021-01-13 lip swelling swollen lip
41 2021-01-13 mouth tingling, mouth numbness Pt Complained of numbness/tingling around the mouth . Red rash . Tenderness on the injection site/l... Read more
Pt Complained of numbness/tingling around the mouth . Red rash . Tenderness on the injection site/lower arm for 5 days.
41 2021-01-13 mouth tingling Approximately 20 minutes after the shot I became dizzy and nauseous. Followed my my upper lip and no... Read more
Approximately 20 minutes after the shot I became dizzy and nauseous. Followed my my upper lip and nose tingling and then the whole face tingling and numb feeling as if I had gotten a novacaine shot. This has continued all night but is currently more on my left side of face and down left forearm tingling/numb.
41 2021-01-13 mouth tingling Pt came to the COVID vaccination clinic today to receive her first dose of the Pfizer vaccine: EL324... Read more
Pt came to the COVID vaccination clinic today to receive her first dose of the Pfizer vaccine: EL3246. Pt states "I am very nervous about getting this". Pt brought a co-worker with her for support. Pt has "MS and Anxiety". Pt received her vaccine without any difficulty. While sitting for her observation time after the vaccine she began having some "tingling of her tongue and face feels hot". Pt denies any breathing difficulty. Pt states "I am not sure if this is from my anxiety or a reaction". Pt is drinking water with honey. Gave her some fresh water and monitored. Checked on her a couple minutes later. She was in the chair and then up to walk and was concerned "my legs are feeling tingly and a little cold". When asked if she ever takes BENADRYL for her previous medication reactions Pt states "yes". I asked her if she has someone who can drive her home and she made arrangements for her co-worker to take her. Gave Pt BENADRYL 25 mg po one for potential reaction symptoms at 15:05. Moved Pt to a quieter place to monitor and observe. Gave her a warm blanket and some juice. Vitals at 15:18: BP= 116/68, HR=80 Resp rate 16-18. Pt is alert, oriented and states "feeling a little better". Tingling sensation is "leaving". Pt denies any respiratory symptoms. Monitored by RN. Pt set up with telephone call with Employee Health Provider, PAC. Determined this is most likely symptoms caused by her anxiety. Pt left ambulatory with her co-worker and symptoms were resolved.
41 2021-01-13 taste disorder, mouth tingling Extreme hot flash that felt like needles all over the body, knees felt like they were on fire, lips... Read more
Extreme hot flash that felt like needles all over the body, knees felt like they were on fire, lips and tounge were tingling, bad taste in mouth, elevated blood pressure and heart rate, and dizzy. Dissipated after about 30 minutes, and left a headache.
41 2021-01-13 ringing in ears I was approached by a person in the center at approx 1000 stating she had an employee that received... Read more
I was approached by a person in the center at approx 1000 stating she had an employee that received their first COVID vaccine and was not feeling well. I went over to find the employee sitting in the person's office in a chair. She was able to tell me she received her first COVID vaccine approx 30 mins ago. She stated she stayed there for the 15 mins after the vaccine with no reaction. She is now having ringing in her ears, feeling lightheaded, hot, nauseaus, and "I feel like I am in a cloud." She denies allergies or past hx of vaccine reactions. Denies hx of anaphylaxis. She denied any sob or chest pain. Employee was holding her head. She stated she had only had some coffee and juice today and was feeling hot. BP was taken and was 112/90 and she is not tachy and no resp distress observed. Patient was able to speak to me in full complete sentences initially. Another person came over and the employee was asked if she could stand and walk. Employee stated she felt she could stand and walk and when she did this she had to hold onto something to avoid falling and she was sat back down. Emergency services was called and employees speech was slow and almost slurred at times. Emergency services arrived and transported employee.
41 2021-01-13 ringing in ears 1600 hrs. Stated throat burning and felt like it was closing up, hot flashes, ears ringing, and warm... Read more
1600 hrs. Stated throat burning and felt like it was closing up, hot flashes, ears ringing, and warm. Vitals monitored every 15 minutes with first set being within range with the exception of elevated BP at 150/90. Benadryl 25 mg given PO. Sitting in chair, able to answer all questions with no apparent distress in speaking. Continued symptoms above at 1630 administered an additional 25mg benadryl PO . Alert and oriented, able to call spouse for a ride home. Due to continued symptoms rapid response team was called for evaluation and took over care to be transferred to ER for further monitoring and evaluation.
41 2021-01-14 dry mouth Fatigue; Dry mouth; Low grade fever; Chills; Headache; Itchy rash at injection site; Itchy rash at i... Read more
Fatigue; Dry mouth; Low grade fever; Chills; Headache; Itchy rash at injection site; Itchy rash at injection site; Soreness at injection site; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 31Dec2020 12:45 at left arm, at single dose for covid-19 immunization. Medical history known allergies: penicillin, chocolate from an unknown date. Concomitant medication included acetylsalicylic acid (ASPIRIN) and Birth control pills. The patient previously took erythromycin and known allergies: Erythromycin. The patient was not pregnant at the time of vaccination. The patient experienced fatigue, dry mouth, low grade fever, chills, headache, itchy rash at injection site, soreness at injection site on 31Dec2020 15:00. No treatment was received for all events. The outcome of the events was recovered on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. No follow up attempts are possible. No further information is expected.
41 2021-01-14 mouth numbness Within ten minutes, I had a massive headache and the roof of my mouth went numb. Within one hour, I ... Read more
Within ten minutes, I had a massive headache and the roof of my mouth went numb. Within one hour, I had severe bruising, dark purple, the size of a half dollar, that JUST went away and I am due on 1/17/2021 for my next vaccine. I had no pain, only dark purple bruising and swelling. The headache and mouth issue went away after three days.
41 2021-01-14 pain in jaw, toothache Tooth pain across the entire lower jaw that lasted for about 18 hours. Treated with ibuprofen.
41 2021-01-14 pain in jaw, toothache Toothache across the entire lower jaw, which lasted for about 12 hours. Treated with ibuprofen.
41 2021-01-14 feeling of choking, mouth tingling Slight tingling sensation on tongue and part of throat Heart rate increased with anxiety
41 2021-01-14 sensitivity to light Headache, Myalgia, Fever, HYPERtension, employee stated after receiving vaccine had body aches, join... Read more
Headache, Myalgia, Fever, HYPERtension, employee stated after receiving vaccine had body aches, joint aches, photophobia, headaches, fever, hypertension Narrative: Employee stated H/A, body aches, joint aches, photopobia, fever, hypertension BP 170/100, employee sent to to ER due to elevated b/p. denies any other symptoms.
41 2021-01-14 tongue itchiness, mouth itchiness, lip swelling, mouth swelling, lip itchiness About 10 minutes after getting my vaccine I noticed the roof of my mouth itching as well as my tongu... Read more
About 10 minutes after getting my vaccine I noticed the roof of my mouth itching as well as my tongue and back of my throat. I waited to see if it would go away and then a couple minutes later noticed my lips started itching and swelling and from there it just got worse. I told the nurse practitioner that I think I was having a reaction, she had me take a seat told her my entire mouth throat & lips felt swollen and itching and she looked and said it was full blown anaphylaxis reaction. Administered EpiPen, benadryl and called ambulance where they took me to medial emergency department.
41 2021-01-15 dry mouth Immediately experienced racing heart and severe dry mouth. My KARDIA 6-lead EKG stated "Possible AFi... Read more
Immediately experienced racing heart and severe dry mouth. My KARDIA 6-lead EKG stated "Possible AFib" and heart rate was 145-155. Blood pressure became elevated much higher than baseline (Normal is 90/60). Paramedics came to evaluate and performed numerous 12-lead EKG's and noted multiple Premature Ventricular Contractions and transported me to the hospital where I was observed and consulted on from ED Physician. Later was evaluated by electrophysiology cardiologist with echocardiogram and EKG. Multiple physicians have advised not to get second vaccine.
41 2021-01-15 tongue itchiness I started itching while being monitored post vaccine administration within the 5 minutes of the vacc... Read more
I started itching while being monitored post vaccine administration within the 5 minutes of the vaccine being administered. The itching was everywhere including my tongue and throat, since this is my workplace and I was working I had to go home and was given Benadryl to take upon arrival, the Benadryl did not help so I did a virtual visit with a physician who recommended that I increase the dose of benadryl at the same time I called my PCP to inform them of the issue they ordered, Atarax 25 mg every 6 hours plus taking an over the counter antihistamine.
41 2021-01-16 oropharyngeal discomfort, teeth hypersensitivity, pain in jaw Within 25 minutes of receiving the vaccine, my left arm became very heavy and there was a tingling/n... Read more
Within 25 minutes of receiving the vaccine, my left arm became very heavy and there was a tingling/neuro sensation in left wrist/hand. A pressure began in the anterior of my throat which increased gradually. I sought treatment in our Urgent Care just after noon that same day. The Provider monitored my vitals which were good and administered liquid Pepcid. Said Provider chose not to give Benadryl as I had taken Zyrec that morning for my allergies. I was discharged from the Urgent Care and went back to work at 1245. At 1730 hours, I had a slight headache above my right eye and extreme right-sided jaw pain with tooth sensitivity. These lasted for only 10 minutes. At 1830, the anterior and bilateral portions of my throat began to feel "prickly" and I developed a wheeze. I used an albuterol inhaler to relieve the wheeze successfully. At this time I also developed an itchiness throughout my whole body, worse on left side than right side. I took 100mg of Benadryl with no relief. At 0300, I took another dose of 100mg of Benadryl with no relief. I also took an itch pill/antihistamine of my husband's which provided no relief. At 0800, I took 20 mg of Zyrtec. At 1030, I took 100mg of Benadryl. I continued to use Benadryl throughout the day, every 4-5 hours. At 1800, I had a fullness in my throat, a tightness in my chest and my left shoulder blade felt almost numb. I also had a hoarse voice which passed by the next morning. The chest tightness was intermittent over the next day or two. On Friday, the itchiness had improved some but was still prominent. I continued to use Zyrtec and Benadryl throughout the day. My Primary Doctor called in Prednisone if needed. By Saturday morning, I felt MUCH better. Today is Sunday and I am no longer itching and I feel so much better today.
41 2021-01-17 loss of smell Sore arm, body aches, headache, cough, loss of smell
41 2021-01-17 inability to speak Fatigued; Sore in her throat; Lost her voice (hoarse); Reddish nose; Intermittent coughs; she went t... Read more
Fatigued; Sore in her throat; Lost her voice (hoarse); Reddish nose; Intermittent coughs; she went to work to a COVID unit which she usually didn't do; described her symptoms as a chest cold; Feeling strange like coming down; swelling and soreness in the injection site for a day or two; swelling and soreness in the injection site for a day or two; This is a spontaneous report from a contactable nurse reported for self. This 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 07Jan2021 13:30 PM at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) for COVID-19 immunization on an unspecified date. On 07Jan2021 after second dose vaccination, the patient started experiencing swelling and soreness in the injection site for a day or two. On 08Jan2021 the next day, she went to work to a COVID unit which she usually didn't do. On 08Jan2021 the next day after her shift at 15:00 PM, she started feeling strange like coming down. On 09Jan2021, she felt totally fatigued. The symptom that bothered her the most is the sore in her throat which has gone 10Jan2021, she said she lost her voice (hoarse). She was also experiencing a reddish nose and intermittent coughs. She described her symptoms as a chest cold. The patient also stated she didn't have fever or chills. She's afraid she might be sick. The outcome of event the sore in her throat was resolved on 10Jan2021. The outcome of other events was unknown. Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported chest cold cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
41 2021-01-17 dry mouth headache, dry mouth, and arm pain
41 2021-01-17 eye pain, vision blurred, swollen tongue, mouth pain, ear pain Shot 1- shaky, weak, increased heart rate, mild swelling of mouth tongue and throat - resolved in a ... Read more
Shot 1- shaky, weak, increased heart rate, mild swelling of mouth tongue and throat - resolved in a day Shot 2 a shaky, weak, increased heart rate and blood pressure, moderate swelling of face, tongue, throat, intermittent dizziness and Left eye blurriest, left facial decreased sensation and pain from mouth to ear, pain behind Left eye - symptoms wax and wane throughout the day
41 2021-01-17 oropharyngeal discomfort, ear itchiness 5 minutes after vaccine- hot/dizzy, lasted less than 1 minute. Right side neck pain/ache, left arm p... Read more
5 minutes after vaccine- hot/dizzy, lasted less than 1 minute. Right side neck pain/ache, left arm pain/ache- lasted less than 5 minutes. 30 minutes after vaccine rash, itching- lasted 2 days. 1 hour after vaccine- severe headache lasted 4 days. 4 hours after vaccine- ears/throat itching. Took Benadryl 50mg, Tylenol 1000mg, Albuterol Inhaler 2 puffs, and Famotidine 20 mg 4 hrs after vaccine.
41 2021-01-17 pain in jaw Had sore arm quickly after Chills 24hours after 30 hours after woke up with serve left side jaw pain... Read more
Had sore arm quickly after Chills 24hours after 30 hours after woke up with serve left side jaw pain into cheekbone and facial swelling on left side of face. Sunday called my employee health who sent me to ER. Given steroids for 4 days for swelling and pain to left cheekbone and jaw area (especially at the joint) noted mild left side throat swelling on exam (internal)
41 2021-01-17 vision blurred tightness in my chest; sob/shortness of breathe; headache; chills; body aches; extreme fatigue; bloa... Read more
tightness in my chest; sob/shortness of breathe; headache; chills; body aches; extreme fatigue; bloating; shakes; blurred vision and couldn't focus on my cell phone; tachycardia/heart rate went up; dizziness/ felt dizzy; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: ER9231), via an unspecified route of administration in the right arm on 06Jan2021 at 10:00 AM at a single dose as COVID-19 vaccine. Medical history included anaemia and anaphylactic reaction to shellfish. The patient was not pregnant at the time of vaccination, did not receive any other vaccine within 4 weeks prior to the COVID vaccine, and had no other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. There were no concomitant medications. On 06Jan2021, within 2 hours (at 12:00 PM), the patient experienced blurred vision, within 4 hours tachycardia and dizziness, within 8 hours headache, chills, body aches, and extreme fatigue, and within 12 hours, tightness in her chest, SOB, extreme fatigue, and body aches. As treatment, the patient received ibuprofen. The patient stated that she had a pretty severe reaction. She also informed her employer but nobody helped. They observed her 15 mins. post-vaccination. She was fine within 15 minutes. It was also reported that within 2 hours, she had blurry vision, tachycardia, and felt dizzy. In the middle of the day, she felt chills, shivers, dizziness, bloating, and headache. The patient also stated that she experienced shakes and taking a shower hurt, also, chest was tight all day. It was further reported that when she was sent back home from work, she started having a severe body ache, fatigue, chills, and shivers. She experienced tightness in her chest , shortness of breath, and she could barely get out of bed. This lasted all day. She still had the blurred vision and couldn't focus on her cell phone. She felt a little bit better today but was still not 100%. She contacted her MD who advised her to report this to Pfizer. The patient wanted to know if it was safe to receive the second dose of COVID-19 vaccine. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Outcome of the event 'Vision blurred' was not recovered, for the event 'Tremor' was unknown, while for the rest of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
41 2021-01-18 eye swelling, eye itchiness 22 hours after the second dose started to have an allergic reaction, hives all over back and chest a... Read more
22 hours after the second dose started to have an allergic reaction, hives all over back and chest and neck. Took benedryl and pepcid at home OTC. The next morning woke up with hives, flushed feeling, and chest/throat tightening. Went to the ER was administered iv medications. Went home. 4 Hours later started again with chest and throat tightening and swelling of the eyes. Kept having break through reactions when medications were wearing off. The ER md that I saw called in some home medications that I started taking. Pepcid and Prednisone. 7 days later still having to take benedryl and pepcid due to eye itchiness and swelling.
41 2021-01-18 eye swelling 5 min after dose admin c/o of cheeks feeling funny, L eye puffy. HR 138, BP 140/80, pulse ox 98%. A/... Read more
5 min after dose admin c/o of cheeks feeling funny, L eye puffy. HR 138, BP 140/80, pulse ox 98%. A/o & talking w/friend. Over the course of 30 min cheeks feeling improved but felt that cheeks remained a bit numb. L eye puffiness gone. Left amb after 45 min HR 96, BP 112/70, pulse ox 99%.
41 2021-01-18 mouth numbness, taste impairment, lip swelling tip of tongue numb; Metallic taste; lower left lip felt swollen; This is a spontaneous report from a... Read more
tip of tongue numb; Metallic taste; lower left lip felt swollen; This is a spontaneous report from a contactable other health care professional (patient). A 41-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284 and expiration date not provided), via an unspecified route of administration (Right arm) first dose on 02Jan2021 10:30 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 02Jan2021, the patient experienced metallic taste, lower left lip felt swollen, and tip of tongue numb. The patient was treated with Injection 50 mg Benadryl L thigh. The outcome of the events was recovered in Jan2021. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient did not tested for COVID-19.
41 2021-01-18 swelling around the eyes, lip swelling, eye itchiness Mild skin rash/welts on face. 1cm sized itchy swelling on bottom lip. puffy eyes (mild) mildly scrat... Read more
Mild skin rash/welts on face. 1cm sized itchy swelling on bottom lip. puffy eyes (mild) mildly scratchy thoat. Mildly scratchy eyes. Was better by morning and gone by the next evening. Did not take Benadryl.
41 2021-01-18 swollen tongue, swelling of eyelid Decided to get second vaccine 1/11/21 even though she was still getting hives from 1st dose. Develop... Read more
Decided to get second vaccine 1/11/21 even though she was still getting hives from 1st dose. Developed swelling on inner canthus L eye. Saw Dr. 1/14/21 and famotidine was ordered. This reduced hives. In 1/16/21 developed swelling of R inner canthus. Took Benadryl and famotidine hs on 1/17/21. Took famotidine 1/18/21 before work, but developed hives under arms and tongue began to swell that evening. Took another dose of famotidine. Tongue improved within 40 minutes but L side of face began to swell. Took Benadryl 50mg. Facial swelling improved but did not go away. Called Dr. this am and was ordered a Medrol dose pack. If this is not effective then she will be referred to Dr., allergist.
41 2021-01-18 vision blurred Within 2 hrs- blurred vision, dizziness, sore arm Within 4hrs- tachycardia, lightheaded, headache, f... Read more
Within 2 hrs- blurred vision, dizziness, sore arm Within 4hrs- tachycardia, lightheaded, headache, fatigue Within 6hrs- headache, extreme fatigue, SOB Within 8hrs- tightness in chest, extreme fatigue, body aches, chills plus all others listed
41 2021-01-19 drooping eyelid My right eyelid drops for a second or two and then normalizes. This happens multiple times a day.
41 2021-01-20 oropharyngeal discomfort Employee c/o fullness in throat with difficulty swallowing. No SOB. Given 25 mg of Benadryl IM. Symp... Read more
Employee c/o fullness in throat with difficulty swallowing. No SOB. Given 25 mg of Benadryl IM. Symptoms resolve within a half hour and patient was released to return to work
41 2021-01-20 mouth tingling, swelling around the eyes, eye swelling, eye twitching, chewing disorder, eyelid function disorder, eye irritation, eye pain tingling in her right arm; I woke up on Monday very tired; she had symptoms of bells palsy; This is ... Read more
tingling in her right arm; I woke up on Monday very tired; she had symptoms of bells palsy; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female (no pregnant) patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686) on 05Jan2021 10:15AM at Upper Left Arm for COVID-19 immunization. Medical history and concomitant drug were not reported. She said she got Botox injections in her forehead, as well as, a little bit by each eye, a little less than 3 weeks prior to receiving the COVID-19 Vaccine. She clarified she believes she was injected with only 50cc's of a Botox 100mg vial. She said she does not have the Botox NDC, Lot, and Expiration Date from the Botox that was injected into her forehead and eye areas approximately 3 weeks earlier. Patient got the 1st shot of covid vaccine on 05Jan2021. On Monday she had symptoms of bells palsy and wanted clinic trials result for it. Reported her Bell's Palsy symptoms started on Monday, 11Jan2021, and she was formally diagnosed with Bell's Palsy in the right side of her face in the Emergency Room on 12Jan2021 was reported as worsened. She said the doctor told her the Bells Palsy could worsen before it improves. She said the doctors ruled out a stroke and diagnosed her with Bells Palsy. Stated she has tingling in her right arm that comes and goes on 12Jan2021. She doesn't have the right arm tingling all the time. Event details: On Saturday, 09Jan and Sunday 10Jan my right eye began to twitch from time to time. I woke up on Monday very tired and my eyes were swollen and I had bags under my eyes. I felt a little off but went to work. In the middle of the day my right eye began hurting with a burning sensation. I thought I needed to change my contact lenses. The following day, Tuesday 12Jan. I woke up and noticed that I can't fully close my right eye. I felt tired again and my eyes had bags under them. I went to work and felt like not myself. Around 10am, I ate cereal and noticed that I was chewing funny. At 1:30 pm I felt tingling around my right lip and at 4pm I noticed that smile is off and that I was not able to smile fully with my right side. That was when I went to the Emergency Room. She said she was given 3 Prednisone 20mg pills while she was at the hospital yesterday, as well as, a prescription for Prednisone 20mg tablets. She said she is to take 3 Prednisone 20mg tablets per day for 6 days. She clarified once she finishes the Prednisone 20mg prescription, she will have taken 7 days of Prednisone 20mg tablets. She stated the Prednisone 20mg tablets were dispensed in a pharmacy vial, and she does not have the NDC, Lot and Expiration Date. She said she also received a prescription for Valacyclovir 1gm tablets. She said she is to take 1 Valacyclovir 1gm tablet, three times a day, for 7 days. She said the Valacyclovir 1gm tablets are dispensed in a pharmacy bottle, and she doesn't have the Valacyclovir 1gm NDC, Lot and Expiration Date. She said she doesn't want to get the second COVID-19 Vaccine dose now. No Covid prior vaccination. Covid tested post vaccination (Nasal Swab): Yes- Negative. Outcome of reaction/event at the time of last observation was Not Recovered/Not Resolved. Follow-up attempts are completed. No further information is expected.
41 2021-01-21 ear discomfort Tightening of throat, facial swelling, and ear pressure 15 minutes post injection. Treatment given-e... Read more
Tightening of throat, facial swelling, and ear pressure 15 minutes post injection. Treatment given-epi 3mg via epi pen. Outcome- called 911 and medics took over
41 2021-01-21 eye discharge, eye pain I had eye pain and drainage, body aches, abdominal pain, headache and joint pain.
41 2021-01-21 eye discomfort, vision blurred Patient received Covid19 Pfizer dose 1 vaccination at 1pm. Advised to wait 15 minutes post injectio... Read more
Patient received Covid19 Pfizer dose 1 vaccination at 1pm. Advised to wait 15 minutes post injection. During waiting period experienced "vision blurring" and "pressure behind eye". Spoke with Dr, monitoring vaccine site. Advised to wait 15 more minutes before leaving. Left vaccination site and started driving home. (Around 1:40pm) Within a few minutes had "extremely sore neck, couldn't turn neck left or right without discomfort" , and felt "thickening of neck." Pain spread from neck to shoulders and mid back. Called Dr, advised to go to return if close or go to nearest ER. Was already miles away from original site so patient went to ER. Received Benadryl. Felt like "giant muscle spasm that wouldn't stop."
41 2021-01-21 mouth tingling Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to hav... Read more
Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to have rash to chest and neck. Patient stated she felt "warm in her neck and inner thighs". Rash progressed to ears and face. Patient stated she was having "tingling in the mouth w/progression to her face and eyes. Patient taken to triage area for observation, VS Q 5 mins. Patient noted to have tachycardia PR 103 and elevated BP 178/100 on initial VS. Pulse rate decrease after 5 minutes to 95. BP remained elevated. Patient placed on gurney in recumbent position and water given. Patient given a mirror to view face and patient stated " my face is swollen slightly". Absent selling to lips or tongue. EPI pen 0.3mg/0.3ml auto injector administered at 1339.patient transported to site ED for further evaluation. O2 applied enroute to ED at 4L/min via NC when patient stated she felt a little lightheaded. Patient care transferred to ED and report given.
41 2021-01-21 mouth tingling Pt began to feel tingling around mouth area and throat started feeling thick but not closing. Patie... Read more
Pt began to feel tingling around mouth area and throat started feeling thick but not closing. Patient had her own personal Benadryl on hand and administer 50 mg orally to self. Pt was watched for 20 minutes by EMT following administration- she reported her throat continued to feel scratchy. Patient was driven and advised to go to emergency room. hospital was contacted per EMT and informed that patient was in route to hospital following a reaction to COVID-19 vaccine.
41 2021-01-22 mouth numbness Numbness right side of throat, right side of tongue, right side of face and right side of neck. Sym... Read more
Numbness right side of throat, right side of tongue, right side of face and right side of neck. Symptoms still present at the time of release
41 2021-01-22 mouth discomfort Chest pain, lethargy, burning airway
41 2021-01-23 mouth numbness, taste disorder Reports tongue numbness and strange taste at 4:10PM 415pm Benadryl 25mg and water 422 pm patient rep... Read more
Reports tongue numbness and strange taste at 4:10PM 415pm Benadryl 25mg and water 422 pm patient reports has no numbness and can't describe the taste but feels good and was able to go home instructions of any more or worsen symptoms to go ER
41 2021-01-23 mouth numbness Sharp pain at bridge of nose that became a tightening across entire face and forehead, rapid heartbe... Read more
Sharp pain at bridge of nose that became a tightening across entire face and forehead, rapid heartbeat, nausea, numbness in lips, sinuses pushing on roof of mouth, difficulty swallowing for about 15 minutes about a half hour after taking vaccine. Then about 6 hours same symptoms but without rapid heartbeat, swallowing issues were worse, took Benadryl, after about an hour symptoms lessened and I fell asleep. Next morning roughly 13 hours later would randomly have tightness in face and under chin. Lasted off and on all day.
41 2021-01-24 lip itchiness Approx 15 minutes after receiving the vaccine she started c/o lip abd facial itching. She was given ... Read more
Approx 15 minutes after receiving the vaccine she started c/o lip abd facial itching. She was given Benadryl 50mg Im to L Deltoid. She said within 5 minutes she was feeling better already. She called a friend that is a nurse practicioner to come and pick her up. no other problems noted
41 2021-01-24 mouth tingling, swollen tongue At 1:12 pm, RRT was called and 4 RNs responded to the scene. Stethoscope, pulse ox, and emergency ki... Read more
At 1:12 pm, RRT was called and 4 RNs responded to the scene. Stethoscope, pulse ox, and emergency kit brought to scene. Client reports feeling pins and needles in the back of her head. She feels that her tongue and neck are swollen but as assessed, they were not swollen. She also reports feeling tingling in her tongue and neck. She was AAOx4, in no acute distress, no SOB noted. Skin and lip color normal, cap refill <3 seconds. Heart and lung sounds normal. Vitals: BP: 128/80, HR: 90, O2: 99% on RA, RR: 18. She did not report any pain. EMS was not called at this time. It was decided by RRT team that client can be monitored for an additional 30 minutes. RN stayed with client throughout 30-minute monitoring period. RN stated that during monitoring period, client was fine but kept reporting that she felt a lump in her throat. Husband talking with RN revealed that client is not diagnosed with anxiety but does have it. At the end of her 30-minute monitoring period at 1:40 pm, RRT was called again. RN already with client and client reported that she felt tingling everywhere again all over her body and felt like she could not breathe. Additionally, she had that feeling of being embarrassed with the sudden rush of heat throughout her body. Additional RN's arrived to scene at 1:41 pm. Upon assessment, she was not SOB but had rapid breathing associated with anxiousness and nervousness, which she reported. RN noticed client's hands and arms were shaking and client stated it was because she was nervous. Client speaking in full sentences. At this point, RRT RNs decided that client needs 911 assistance which was activated by Fire Chief on site. RNs also assessed that client's tongue was swollen again. Heart and lungs sounds were normal. Vitals at 1:49 pm: HR: 102, BP: 144/70, O2: 95%, RR: 21. At this point, on the basis of the symptoms she was experiencing, RN's decided to administer Benadryl 50 mg IM that was in the emergency kit. When the decision was made, client was asked if it was okay to administer Benadryl IM. She was explained the purpose of Benadryl, the side effects, and risks and benefits. Client consented to receiving Benadryl IM. Benadryl 50 mg IM administered to RA by RN at 13:51. By 13:53, her tongue was not swollen anymore. At 13:58, she was not SOB anymore, talking in full sentences, no acute distress, tingling stopped. By 13:59, the same symptoms of tingling throughout her body, feeling a sudden heat rush throughout her body started again. HR: 65, RR: 21, O2 95%. At 14:01, EMS arrives, truck number 341, vitals stable on their end. At 14:04, client decided to go to RUHS via ambulance. One of the paramedics stated that client's hands were "cold as ice". At 14:07, report was given to paramedics/ambulance and client was in the ambulance. Care assumed by ambulance/paramedics.
41 2021-01-24 swollen tongue This is a 41 y/o woman with who received her second COVID-19 vaccination today. Following this immun... Read more
This is a 41 y/o woman with who received her second COVID-19 vaccination today. Following this immunization, she appropriately stayed in the waiting area for the 30 minutes. She then got in car and 15 minutes after, she noticed that her tongue was feeling full/swollen and that was experiencing neck swelling. These symptoms persisted and resembled a prior allergic response to Tetracycline and Aleve. Wheezing and breathing difficulty ensued and EMS was activated. On arrival to the emergency department she was found to have wheezing with stridor. A dose of epinephrine was administered and she was monitored in the emergency department with an initial improvement in symptoms. Approximately one hour and 30 minutes after initial epinephrine administration patient reported that she was having continued difficulty swallowing and she was starting to feel a little worse. At this point a second dose of IM epinephrine was administered. The patient was subsequently admitted to inpatient medicine team for further monitoring.
41 2021-01-25 ear pain Pt developed swollen lymph nodes in neck and bilateral axilla, fever, body aches, and fever with Tma... Read more
Pt developed swollen lymph nodes in neck and bilateral axilla, fever, body aches, and fever with Tmax 100.4. Also states she had visual hallucinations, "wild" dreams, and seemed "incoherent" when talking with her husband. All symptoms have resolved but still has swollen lymph nodes in neck that wax and wane. Also c/o right side ear pain and right side sore throat x 2 days. Right side ear pain started on 1/24/21, 5 days after vaccine.
41 2021-01-25 swollen tongue, mouth tingling heart was racing; increased respiratory rate; tingling in the tongue; full/swollen feeling in the to... Read more
heart was racing; increased respiratory rate; tingling in the tongue; full/swollen feeling in the tongue; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot/batch number and expiry date unknown), intramuscular on12Jan2021 07:30 at single dose in the left arm for COVID-19 immunization. Medical history included PCN allergies from an unknown date. There were no concomitant medications. On 12Jan2021 07:45 about 15 minutes after the injection, the patient felt like heart was racing, increased respiratory rate and tingling in the tongue. Heart rate and respiratory rate quickly returned to normal but the tingling and full/swollen feeling in the tongue continued for about 1.5 hours post injection. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications within 2 weeks of vaccination. The vaccine was given in the Hospital. The outcome of the event "heart was racing" and "increased respiratory rate" was recovered on Jan2021 while outcome of the other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
41 2021-01-25 swollen tongue Hives, itching, tongue swelling
41 2021-01-25 visual impairment Itchy throat, sudden warmth, see spots, chest tightness.
41 2021-01-26 deafness, visual impairment, blindness seeing gray spots room started spinning felt nauseous collapsed on the table; loss of vision; loss o... Read more
seeing gray spots room started spinning felt nauseous collapsed on the table; loss of vision; loss of hearing; seeing gray spots room started spinning felt nauseous collapsed on the table; seeing gray spots room started spinning felt nauseous collapsed on the table; seeing gray spots room started spinning felt nauseous collapsed on the table; loss of the onion ability to stand up or walk; loss of the onion ability to stand up or walk; This is a spontaneous report from a contactable other health professional (patient), a 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) at left arm on 14Jan2021 08:30 AM at single dose for covid-19 immunization in a public health facility. Medical history was none. Allergies to medications, food, or other products was No. Patient was not pregnant at the time of vaccination. the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. the patient received within 2 weeks of vaccination included amphetamine salts 15 mg. Patient woke up in the middle of the night got out of bed walk down a set of stairs started seeing gray spots room started spinning felt nauseous collapsed on the table. Had to call her husband to carry her back up the stairs. she had loss of vision loss of hearing and the onion ability to stand up or walk. He laid her back in bed to pick up his phone and call emergency services within five minutes everything had gone back to normal. adverse event start date was 15Jan2021 03:00 AM. the adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The final outcome of the events was unknown (if patient recovered: Unknown). It was reported as non-serious. Seriousness criteria Results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect were all no.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
41 2021-01-26 eye bleeding Woke up on broken blood vessel in left eye: sub conjunctival hematoma
41 2021-01-26 eye irritation weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding... Read more
weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding snow with bare hands); her hands & feet were so cold they hurt (like when holding snow with bare hands); anxiety; dizzy; her body feels weird; sweating; b/p low; throat hurts; tachycardia (119-135); 100.4; chills; body ache; nausea; vomiting; pounding headache; eyes burning; face & neck felt flushed; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 11Jan2021 16:00 at a single dose on left arm for COVID-19 immunization. Medical history included asthma, hypoglycemia, vitamin d deficiency, migraines, and allergy to Ilizone (unspecified). The patient was not diagnosed with COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included loratadine (ALAVERT), phentermine, ibuprofen, and paracetamol (TYLENOL). The patient was administered with first dose of bnt162b2 on 21Dec2020 for COVID-19 immunization (product-COVID 19, brand-Pfizer, lot number-EH9899, administration time-11:45 AM, administrator route-intramuscular, vaccine location-right arm). The patient previously took salbutamol sulfate (VOLMAX) and experienced allergy. No other vaccines in four weeks prior to COVID vaccination. On 11Jan2021 17:00, the patient experienced body temperature of 100.4 (no unit reported), chills, body ache, nausea, vomiting, pounding headache, eyes burning, face and neck felt flushed, tachycardia (her watch kept alarming 119-135), weak, hot flashes, cramping, joints hurt, her hands and & feet were so cold they hurt (like when holding snow with bare hands), anxiety, dizzy, her body feels weird, sweating, b/p (blood pressure) low, and throat hurts. There was no treatment given for the events. The patient has not been tested for COVID post vaccination. The patient is recovering from the events. No follow-up attempts are possible. No further information is expected.
41 2021-01-26 mouth numbness severe left axillary, supraclavicular and anterior cervical lymphadenopathy; left hand numbness/left... Read more
severe left axillary, supraclavicular and anterior cervical lymphadenopathy; left hand numbness/left facial numbness; tongue numbness; This is a spontaneous report from a contactable physician (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 11Jan2021 at 09:45 at a single dose for COVID-19 immunization in a hospital. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Unknown lot number and expiration) on 21Dec2020 at 09:30 AM in left arm for COVID-19 immunization. Medical history reported as none. The patient has no allergies to medications, food, or other products. There were no concomitant medications. 48hrs post second dose, the patient woke up with severe left axillary, supraclavicular and anterior cervical lymphadenopathy on 13Jan2021 at 06:15 AM. She also woke up with left hand numbness which she initially attributed to the degree of axillary lymphadenopathy bug 2 hours after waking. The patient also experienced left facial and tongue numbness. She went to ER and was evaluated for stroke (all studies normal including labs, CT angio/perfusion and MRI brain) in Jan2021. Facial numbness resolved in about 12 hours, left hand sensory issue is lingering but improving. All lymphadenopathy is ongoing and quite significant. The events resulted in emergency room/department or urgent care. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient had not yet recovered from the events severe left axillary, supraclavicular and anterior cervical lymphadenopathy as well as tongue numbness; while recovering from the event left hand numbness/left facial numbness. The events were assessed as non-serious. Information on the lot/batch number has been requested.
41 2021-01-26 mouth tingling, swollen tongue Facial and mouth tingle initially. Day later dizzy-room spinning with light exercise. More facial a... Read more
Facial and mouth tingle initially. Day later dizzy-room spinning with light exercise. More facial and tongue swelling. Followed by 1 week of swollen glands and tender jaw.
41 2021-01-27 ear pain I noticed left ear, left face, and left TMJ pain ~ 48 hours post 2nd- Pfizer vaccine. I noticed he... Read more
I noticed left ear, left face, and left TMJ pain ~ 48 hours post 2nd- Pfizer vaccine. I noticed headaches and increasing ear/TMJ pain up until today (1/28). The TMJ and ear pain is less today, but it's still difficult to open my mouth. I have tried Tylenol and Ibuprofen to alleviate the discomfort, but the OTC meds to not help.
41 2021-01-27 oropharyngeal discomfort Patient felt flushed then cold and throat felt cold. No SOB nor difficulty breathing. Within ~22 mi... Read more
Patient felt flushed then cold and throat felt cold. No SOB nor difficulty breathing. Within ~22 minutes patients symptoms resolved and patient felt back to normal, leaving the clinic without further issues
41 2021-01-27 pain in jaw Headache, Jaw pain/stiffness.
41 2021-01-27 pain in jaw Shortness of breath with activity; night sweats; right jaw pain; This is a spontaneous report from a... Read more
Shortness of breath with activity; night sweats; right jaw pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), intramuscular in the right arm on 09Jan2021 at a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included thyroid cancer. The patient had no known allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medication included paracetamol (TYLENOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced shortness of breath with activity, night sweats, and right jaw pain on 11Jan2021. Right jaw pain resulted in physician office visit. No treatment was received for the adverse events. Outcome of the events was not recovered. The events were considered non-serious.
41 2021-01-27 mouth tingling, mouth numbness 15-20 minutes post vaccine administration, patient experienced numbness, tingling of cheeks and lips... Read more
15-20 minutes post vaccine administration, patient experienced numbness, tingling of cheeks and lips - "very subtle". Lasted one hour then subsided. No return to numbness or tingling as of 1/28/21.
41 2021-01-27 mouth tingling 40 min after vaccine, noticed that her throat red, hives, flushed, elevated heart rate to 120s-130s.... Read more
40 min after vaccine, noticed that her throat red, hives, flushed, elevated heart rate to 120s-130s. Took Tylenol and Benadryl which improved. Mild lip tingling. Symptoms now resolved. She believes the heart rate was due to "anxiety" After the first dose, only felt flushed.
41 2021-01-27 swollen tongue PATIENT FELT TONGUE SWELLING AND THROAT SWELLING. NEW ONSET HEADACHE. ADMINISTERED DIPHENHYDRAMINE 1... Read more
PATIENT FELT TONGUE SWELLING AND THROAT SWELLING. NEW ONSET HEADACHE. ADMINISTERED DIPHENHYDRAMINE 10ML. PATIENT SENT TO ED.
41 2021-01-28 taste impairment weird taste (bitter) in her mouth; Lymphadenopathy; significant myalgias; injection site soreness; T... Read more
weird taste (bitter) in her mouth; Lymphadenopathy; significant myalgias; injection site soreness; This is a spontaneous report from a contactable physician (patient). A 41-year-old female patient received the second dose of BNT162B2 via an unspecified route of administration on 11Jan2021 at a single dose as Covid vaccine. Medical history and concomitant medications were not reported. The patient previously had her first dose of BNT162B2 on an unspecified date as Covid vaccine. The patient experienced significant myalgias and injection site soreness, both on 11Jan2021; weird taste (bitter) in her mouth and lymphadenopathy, both on 13Jan2021. The patient received her second Covid vaccine on Monday and was having a weird taste in her mouth (weird taste as bitterness). She has significant myalgia that resolved and injection site pain (injection site pain as soreness) that was resolving. She looked it up and could not find anything. She wanted to know if this was something that they were getting a lot of. The outcome of the event significant myalgias was recovered with sequelae on 13Jan2021 while of the rest of events was recovering. Information on the lot/batch number has been requested.
41 2021-01-28 ear discomfort, ear pain It started with painful ears and pressure, nausea, sore throat, chills, sweats, general body aches a... Read more
It started with painful ears and pressure, nausea, sore throat, chills, sweats, general body aches and pain and a little trouble breathing. They started to subside four days after vaccine was administered.
41 2021-01-28 eye itchiness "Pfizer-BioTech COVID-19 Vaccine EUA" Received 1st dose of vaccine in left arm at 10:28 a.m. Drove h... Read more
"Pfizer-BioTech COVID-19 Vaccine EUA" Received 1st dose of vaccine in left arm at 10:28 a.m. Drove home and at 4:00 p.m. face, forehead, and neck turned bright red, facial tightness, feeling like face was on fire. Heart rate recorded between 112bpm and 115 bpm and began having shortness of breath. Then began feeling nauseous, eyes were itchy and had a headache. Took 10 ml Benedryl @ 4:40 p.m. and drank some water. 7:00 p.m. still have slight facial and neck redness and headache.
41 2021-01-29 mouth numbness Numbness of lips on 1/28/2021 and then developed numbness of tongue and eye would not close. Saw ph... Read more
Numbness of lips on 1/28/2021 and then developed numbness of tongue and eye would not close. Saw physician who treated her with steroids, anti-virals and OTC eye drops for lubrication of eye.
41 2021-01-30 mouth swelling, mouth discomfort At the 8 to 10 minute mark: Could not stop coughing Lips burning and itching At about 20 minute ma... Read more
At the 8 to 10 minute mark: Could not stop coughing Lips burning and itching At about 20 minute mark: Still coughing Swollen mouth Lips burning and itchy - took Flovent inhaler and drank water About 45 minutes Same and worse , nurse gave me 25 mg of Benadryl After about 20 minutes coughing reduces, Swelling reduces but still itchy in moisture Still swollen at about 30 minutes of the Benadryl and the nurse gave me another dose of Benadryl. Symptoms started to get somewhat better I was very tired from the Benadryl Next day my mouth was still swollen Next day chest was very very tight and took inhaler constantly Third day after vaccine had an asthma attack, hadn?t had an asthma attack since I was in middle school. Dr prescribed prednisone and to take Zyrtec along with my inhaler I cannot return to exercise until 10 days after the start of prednisone
41 2021-01-30 swelling of eyelid Itching on arms and chest began Jan 30 approximately 4pm. Got progressively worse throughout the n... Read more
Itching on arms and chest began Jan 30 approximately 4pm. Got progressively worse throughout the night. Hives covered 95% of body, including eyes which began to swell shut. Took 50mg Benadryl with little relief. Went to Urgent Care and was given: 01/31/2021 0836 famotidine (PEPCID) injection 40 mg 40 mg Intravenous 01/31/2021 0836 diphenhydrAMINE (BENADRYL) injection 25 mg 25 mg Intravenous 01/31/2021 0836 methylPREDNISolone sodium succinate (Solu-MEDROL) injection 125 mg 125 mg Intravenous 01/31/2021 0840 EPINEPHrine (EPIPEN) injection 0.3 mg 0.3 mg Intramuscular Raised lesions started to flatten 1.5 hours after medications were administered Dx to home with prescription for Epi Pen, prednisone PO 60mg 1dose/day and instructed to continue taking 50 mg Benadryl q4-6 hours and Pepcid OTC 1 dose per day. Instructed to follow up with PCP in 1 week.
41 2021-01-31 sensitivity to light, vision blurred 12/18/20: I recieved first dose Covid vaccine, 12/20/20: developed blurry vision, diminished color,... Read more
12/18/20: I recieved first dose Covid vaccine, 12/20/20: developed blurry vision, diminished color, altered depth perception, light sensitivity in right eye, 12/21/20: exam by opthalmologist (Dr), 12/23/20: MRI with and without contrast: showed active inflammation on right optic nerve, optic neuritis - referred to neuro opthalmologist, 12/29/20: examined by Dr. (neuro-opthalmologist), confirmed optic neuritis and referred to Dr. (neurologist) for further eval of possible MS, 01/18/21: virtual meeting with Dr., labs ordered. 02/01/21: no treatment to date and I am still experiencing all original symptoms, though have slightly improved since initial onset. Planned follow up with Dr. (neurologist) this week and follow up with Dr. (neuro-ophthalmologist) next week
41 2021-02-01 mouth numbness Patient had a covid vaccine at 9:25am. Please note the patient has no history of anaphylaxis, pani... Read more
Patient had a covid vaccine at 9:25am. Please note the patient has no history of anaphylaxis, panic attacks, or heart issues. She started saying her lips were feeling numb and kind of strange and her back hurting. 50mg of benadryl was given at 940am. Patient continued to decline. She complained of chills, chest pain, and n/v. She was visibly shaking. BP was 168/137 HR 99 and oxygen 96%. 911 was called at 9:45am. AMR arrived at 9:55am and took over. Patient was taken to ER.
41 2021-02-01 swollen tongue Patient reported to vaccine clinic to receive second dose of Pfizer Covid vaccine. First dose recei... Read more
Patient reported to vaccine clinic to receive second dose of Pfizer Covid vaccine. First dose received on 1/12/2021 without any problems or reaction. Patient reported history of anaphylaxis to shellfish so she was asked to wait 30 minutes post vaccination for observation. Around 15-20 minutes after receiving vaccination, it was noted patient was rubbing her throat. RN at vaccine clinic asked patient if she was ok and she reported she was fine, she thinks it is in her head. RN noted she continued to rub her throat and asked her to describe what it felt like. Patient felt sensation of tickle in her throat and asked for water. Patient also noticed began to itch all over. Patient provided water and 25 mg PO Benadryl. Patient noted it felt like her throat was starting to close and her tongue felt it might be swelling. Epinephrine 0.3 mg IM was administered at 12:07 and patient arrived in ER at 12:08. Patient received another dose of IV benadryl and famotidine and kept for observation. She was discharged home after a couple of hours.
41 2021-02-01 swollen tongue 4 minutes- severe dizziness 6 minutes throat and tongue swelling 8 minutes - asthma attack
41 2021-02-03 inability to speak, oropharyngeal discomfort My throat feels like its closing up, it doesn't feel very sore but my voice is very hoarse.
41 2021-02-03 extreme sound sensitivity, sensitivity to light Both times I received the vaccine on the third day I my migraine was triggered and I experienced se... Read more
Both times I received the vaccine on the third day I my migraine was triggered and I experienced severe migraines, nausea and vomiting with extreme pain and sensitivity to light and sound. I also experienced severe body pain after both shots. I did not see my physician who I listed but she has notes about my history or migraines. It was suggested on the CDC tracking app to report here too since my reactions were severe.
41 2021-02-03 mouth numbness Client presented for 1st dose of Pfizer Covid Vaccine. Patient's history was reviewed indicating his... Read more
Client presented for 1st dose of Pfizer Covid Vaccine. Patient's history was reviewed indicating history of anaphylaxis to iodine. 30 minutes after vaccination, client reported she had numbness of her tongue (anterior 1/3), some numbness of her lower cheeks/jaw. No difficulty breathing. BP120/85; HR 80. After a few minutes was reassessed and vitals were unchanged. Client felt anxious. No rashes, no breathing issues but continued anxiety and symptoms of numbness continued. 911 called. EMS assessed and vitals unchanged. Numbness lessened to just tip of tongue. Normal speech. EMS did not transport and father arrived to pick her up at 12:15 pm.
41 2021-02-04 swollen gums Had covid after 19 days got the vaccine; Had covid after 19 days got the vaccine; immediately lighth... Read more
Had covid after 19 days got the vaccine; Had covid after 19 days got the vaccine; immediately lightheaded dizzy; body aches; severe sore throat; gums swollen and red; gums swollen and red; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 15Jan2021 15:15 at single dose for COVID-19 immunisation. Medical history included covid-19 (covid prior vaccination: Yes). No known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID). No other vaccine in four weeks. The patient experienced side effects immediately lightheaded dizzy , body aches, severe sore throat, gums swollen and red on 15Jan2021, had covid after 19 days (as reported) got the vaccine. The events resulted in emergency room/department or urgent care. Events treatment included steroids and fluids. The outcome of events was not recovered. No covid tested post vaccination. The patient was not pregnant. Information about Lot/Batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported covid based on the known safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
41 2021-02-04 lip swelling Facial filler swelling in cheeks and lips; Facial filler swelling in cheeks and lips; fever; chills;... Read more
Facial filler swelling in cheeks and lips; Facial filler swelling in cheeks and lips; fever; chills; coughing; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (also age at vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number Not available/provided to reporter at the time of report completion, dose number: 1), via an unspecified route of administration in left arm on 21Jan2021 09:30 at SINGLE DOSE for covid-19 immunisation. The patient is not pregnant at the time of vaccination. Medical history included prior to vaccination the patient was diagnosed with covid-19 on unspecified date. However, since the vaccination the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products and no other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient's concomitant medications were not reported. The patient experienced Facial filler swelling in cheeks and lips, fever, chills and coughing on 21Jan2021 at 12:00 AM. No treatment was received for the events. The case was reported to be non-serious (not resulting to death, Caused/prolonged hospitalization, Congenital anomaly/birth defect, Disabling/Incapacitating or Life threatening). The outcome of the events was not recovered. Information on the lot/batch number has been requested.
41 2021-02-05 feeling of choking, mouth tingling Patient felt tightness and "tingly" in her throat about 15 minutes after vaccination. Hx of tachyca... Read more
Patient felt tightness and "tingly" in her throat about 15 minutes after vaccination. Hx of tachycardia after first dose - discussed with PCP who indicated unsure if this was a reaction or not. However, PCP felt pt should go ahead and take the second dose. Pt's baseline HR is around 66. HR taken - 73. Patient said it felt like pins on her tongue. Drank one bottle of water, denied SOB or throat issues. HR monitored for another 30 minutes and returned to baseline. Patient had another bottle of water and tinglyness dissipated. Declined to go to ED for further evaluation, and said she would follow up with PCP if she noticed any further issues.
41 2021-02-06 ear pain Within hours after 1st dose, felt foggy, L arm & neck pain & bad headache. Felt better the next morn... Read more
Within hours after 1st dose, felt foggy, L arm & neck pain & bad headache. Felt better the next morning. 2nd dose, felt foggy, L arm pain & bad headache hours after. Fatigue the same night, had chills, couldn?t sleep and woke up with a temp of 100.3, sinus & ear pressure/pain, congestion & then a runny nose, headache, L arm & neck pain, felt like I was swallowing rocks, sore throat, diarrhea
41 2021-02-08 mouth tingling I immediately felt nauseated and fatigued, but severe reaction occurred at 10 pm. Extreme weakness a... Read more
I immediately felt nauseated and fatigued, but severe reaction occurred at 10 pm. Extreme weakness and tingling on lips and tongue with difficulty breathing. Migraine and body aches not resolved with OTC meds. Lower back pain was notable and prevented me from sleeping. I passed out in the bathroom when trying to get Tylenol.
41 2021-02-08 mouth tingling Patient felt itchy throat and felt like her tongue was tingling about 12 minutes after vaccine admin... Read more
Patient felt itchy throat and felt like her tongue was tingling about 12 minutes after vaccine administration. Was evaluated in clinic and found to be AAOx3, NAD, nontoxic, no swelling of lips or tongue, lungs CTA with good air entry, regular rate and rhythm, given x1 dose of diphenhydramine and transported to the Emergency Center where she was evaluated again. Found to be in similar condition as above so given an additional 75 mg total of diphenhydramine. Sent home after short observation period.
41 2021-02-08 ringing in ears, ear discomfort Got second vaccine on Tuesday feb 2, by Wednesday evening I felt extremely tired and sore muscles. ... Read more
Got second vaccine on Tuesday feb 2, by Wednesday evening I felt extremely tired and sore muscles. By Thursday/Friday I noticed that it seemed as though the glands in my neck were swollen (slightly affecting my salivary glands especially on left side). My left armpit is very swollen and remains swollen to today. By Friday and into Saturday and currently I developed tinnitus in both ears. My ears feel stuffy, like I went up in an airplane and they need to pop. The tinnitus is really loud, especially at night and has triggered my anxiety. I?m so upset and scared I?ll have tinnitus for life now. I?m an avid bird watcher and I?ve also prided myself on excellent hearing, so I?m taking this hard. Very, VERY, scared.
41 2021-02-09 ear pain Head and nasal congestion; Head and nasal congestion; ear ache; body aches; fatigue; sore arm; This ... Read more
Head and nasal congestion; Head and nasal congestion; ear ache; body aches; fatigue; sore arm; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via an unspecified route of administration on 22Jan2021,16:30 at SINGLE DOSE (first dose, left arm) for COVID-19 immunization. Medical history included allergies: Latex from an unspecified date. Patient did not have COVID-19 prior vaccination. Patient is not pregnant. No other vaccine in four weeks. The patient's concomitant medications were not reported. The patient experienced head and nasal congestion, ear ache, body aches, fatigue and, sore arm all on 23Jan2021 01:00. No treatment was given. Patient was not tested for COVID-19 post vaccination. Outcome of the events was recovering.
41 2021-02-09 ear pain States shot felt weird going in to arm. Felt "thick". Ears began to ring and felt light headed 162... Read more
States shot felt weird going in to arm. Felt "thick". Ears began to ring and felt light headed 1625 BP 104/? O2 sat unable to obtain due to cold periphery 1630 BP 118/? O2 sat 97% cold periphery 1640 BP 137/86 HR 76 O2 sat 98% RR 16 lungs clear 1645 BP 127/75 HR 70 O2 sat 100% RR 16 1650 BP 130/79 HR 70 O2 sat 100% RR 18 lungs clear After 40 minutes stated felt better provided snack bar, apple and water was able to leave area at a baseline level.
41 2021-02-09 eye itchiness Light headedness; scratchy voice; itchy eyes and throat; itchy eyes and throat; pink and hot swollen... Read more
Light headedness; scratchy voice; itchy eyes and throat; itchy eyes and throat; pink and hot swollen circular hive/welt underneath injection site on left arm; pink and hot swollen circular hive/welt underneath injection site on left arm; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 at 07:30 (at the age of 41 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included seasonal allergies from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination, but did receive the first dose of BNT162B2, on 31Dec2020 in the left arm. On 21Jan2021 at 09:30, the patient experienced light headedness, scratchy voice, itchy eyes and throat, pink and hot swollen circular hive/welt underneath injection site on left arm. The patient did not receive treatment for the events. The clinical outcome of light headedness, scratchy voice, itchy eyes and throat, pink and hot swollen circular hive/welt underneath injection site on left arm was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
41 2021-02-09 mouth numbness, loss of taste, mouth tingling This 41 yo female received her first Pfizer COVID vaccine (Lot EL1284) on 1/7/2021. She reports be... Read more
This 41 yo female received her first Pfizer COVID vaccine (Lot EL1284) on 1/7/2021. She reports being in good health, had no illness exposures (does work in hospital with children), and had no recent travel. She reports following her Covid vaccination, she had a sore arm at vaccine site for 4-5 days with no other issues. On 1/31 (day24) while putting on lipstick to take a selfie to send to her friend she noticed the right side of her lower face (lip area) felt "weird"- tingled and the corner of her mouth would not smile symmetrically with left. Her friend commented something was off with this picture. The next day this droop worsened with loss of facial lines/wrinkles on right (nasolabial fold), had tingling/numbness to lips and corner of mouth and inability to smile on right. This prompted her husband to bring her to the ER on 2/1/2021. She denied any fever, headache, weakness to arms/legs, no SOB/CP, dysphagia or speech issues or trauma. ER providers exam noted normal CN evaluation but documented mild right sided decrease in nasolabial fold vs left and loss of taste to anterior right tongue. She had no involvement of eye or forehead. She was diagnosed with early Bell's Palsy and treated with oral steroids and anti-virals. AS of 2/10/2021 with use of medications, she advised her facial weakness/droop had resolved but still has tingling. Her smile is symmetrical at this time. No c/o on loss of taste. Has diagnosis of Bell's Palsy. IHD case 9967.
41 2021-02-09 toothache At 3pm the day I received the shot I was woken up from a nap with intense tooth pain. My top, front ... Read more
At 3pm the day I received the shot I was woken up from a nap with intense tooth pain. My top, front 4 teeth were in so much pain I cried. I took 100mg of Tylenol and the pain lessened in about 2 hours. At approximately 10am on 2/5/21, I became clammy with shivers yet I was feeling over heated. My temperature was 99.3 degrees. I did not take any medicine but instead took a nap. When I woke up, my temperature felt normal. I did feel dizzy until around 4:3pm that same day. I still get headaches in the front of my forehead since 2/5/21.
41 2021-02-10 ear itchiness, mouth itchiness Itchy mouth, swollen face, itchy scalp, itchy ears
41 2021-02-10 ringing in ears I suddenly developed Tinnitus after receiving Pfizer COVID-19 vaccine dose #2. It's so loud, I have... Read more
I suddenly developed Tinnitus after receiving Pfizer COVID-19 vaccine dose #2. It's so loud, I have difficulty concentrating and sleeping. I happened to tell someone else about this and she reported that her Tinnitus was significantly worse following dose #2 of Pfizer vaccine.
41 2021-02-11 eye irritation, eye itchiness Hard to breath right chest but took inhaler and was better. Hives took 50 mg of Benadryl at sight th... Read more
Hard to breath right chest but took inhaler and was better. Hives took 50 mg of Benadryl at sight then after one hour went to primary Dr to get checked out. Was told to take 25-50 mg of Benadryl every two hours and Pepcid 20 mg one tablet 2 time daily, itchy burning eyes use eye drops, come and go since 01/29/2021. I get really tired and upset stomach also 2/09/2021
41 2021-02-11 mouth pain, pain in jaw, toothache About 5 hours after the injection I got a strange sensation in my gums/teeth/jaw/pallet. Within abo... Read more
About 5 hours after the injection I got a strange sensation in my gums/teeth/jaw/pallet. Within about an hour of one tooth hurting, all of my upper molars and jaw hurt and had a nerve sensation. It was like the roots of all the molars were irritated. The nerve sensation also felt like it was in the upper jaw/face area. My entire pallet became irritated. This lasted for about two hours and then went away completely.
41 2021-02-12 mouth numbness Information reported by individual involved as follows. AFTER 2ND VACCINE OF PFIZER I HAD SEVERE MU... Read more
Information reported by individual involved as follows. AFTER 2ND VACCINE OF PFIZER I HAD SEVERE MUSCLE ACHES AND FEVER ABOUT 12 HOURS POST VACCINE WHICH IS EXPECTED DIAGNOSED MILD CASE OF BELLS PALSY. LEFT SIDED FACIAL NUMBNESS TO CHEEK, TONGUE, MOUTH GUMS, INCREASED SNORING, THESE SYMPTOMS WERE NOTED SHORTLY AFTER VACCINE #2. I DID NOT PUT IT TOGETHER AT THE TIME THAT I WAS HAVING REACTION TO THE VACCINE ONLY AFTER DOING SOME RESEARCH ON WHAT COULD BE LEADING TO LEFT SIDED TONGUE NUMBNESS DID I REALIZE I COULD BE HAVING BELLS PALSY A REACTION TO THE VACCINE. WENT TO EMPLOYEE HEALTH ON 2/1/21 AND THEY NOTED POSTIVE MILD CASE OF BELLS PALSY. AFFECTED IS LEFT SIDE OF FACE, GUMS CHEEK TONGUE AND SLIGHT DROOP
41 2021-02-12 mouth tingling 7 minutes after vaccine, I felt my heart pounding heavily and checked my iwatch. It indicated that m... Read more
7 minutes after vaccine, I felt my heart pounding heavily and checked my iwatch. It indicated that my Heart rate went from 88 to 141 in the past 5 minutes while sitting. I then felt flushing throughout my body. I had the sensation of tingling on my face and lips and told the present employees that I felt weird. They retrieved the doc, who then took my pulse ox - registered at 96/97. Then they took my blood pressure and it was 180/100 (I typically have low blood pressure 98/60). I started to feel disequalibrium and nauseous and the doc to be back to a room. She administered a dose of IM EPI and IM benedryl and called EMS. My symptoms persisted and the doc told the EMS workers I had urticaria on my face during her case presentation. I was transported to the ED, where I was monitored. My symtoms had reduced following epi and benedryl but returned when I was in the ED. The doctor administered pepcid and solu-medrol and zofran. They also conducted and EKG- reportedly normal. These medications helped control my symptoms and my BP had returned to normal (120/70) following meds. discharged on a tapering dose of steriod and zofran prn.
41 2021-02-15 mouth numbness Patient sat in our waiting area for 15 minutes and no obvious signs/symptoms of reaction to vaccine ... Read more
Patient sat in our waiting area for 15 minutes and no obvious signs/symptoms of reaction to vaccine were reported or noted. Per patient, after she left our office, at 12:20 pm, she experienced "chest tightness, racing heart rate, could not feel her tongue and throat was tight." She went home, took Benadryl (25 mg) and she was "ok" after that - symptoms subsided. She followed up with her primary care provider, who advised her not to receive the second vaccination due to this adverse reaction. Patient informed our office, of her adverse reaction on 2/15/21 - we are reporting today because she was able to provide more information regarding the event.
41 2021-02-17 dry throat 41 y old female received first dose of her COVID vaccination, she started feeling dizziness and mild... Read more
41 y old female received first dose of her COVID vaccination, she started feeling dizziness and mild sensation of dry / inflamed throat. she denied any sob, wheezing, chest pain, rash, or any other sx. denies pervious allergies. PE: lungs ; CTA bil , heart; RRR. neuro: alert and oriented. responding. 08;15: BP: 146/88, HR: 72 O2:100% 08:38: BP: 152/86 HR: 67 Sats: 100% - pt was feeling much better and denied any sx Pt was monitored for 30 mins and reported resolution of sx before she left the clinic. she was able to drink apple juice without any issues.
41 2021-02-17 lockjaw One day after the vaccine, I had chills, muscle aches, headache, and neck pain on the left side. Two... Read more
One day after the vaccine, I had chills, muscle aches, headache, and neck pain on the left side. Two days after the shot, my chills went away, and neck pain increased. The neck pain has persisted since then and only worsened. I have a hard time fully opening my jaw to eat.
41 2021-02-19 ear discomfort Dose 1: About 5 minutes after injection slight dizziness and ear felt stopped up. Later that night c... Read more
Dose 1: About 5 minutes after injection slight dizziness and ear felt stopped up. Later that night chest was flushed. Flushing lasted about 2 hours Dose 2: Due to flushing with last infusion, nurse told me to wait there 30 minutes after infusion. About five minutes after starting getting a headache and left ear was stopped up. Was told to take Benedryl if rash(flushing) came back with this infusion and to report symptoms to CDC. Headache and nausea felt till next day. Felt sick and headache riding in car. At 0130 am on 2/18/21 was awoken by pain under right arm. Very mild swelling noted but very sore to put arm down and tender to touch. Underarm still sore as of today Feb 20, 2021. Second day joint pain in shoulders, elbows, fingers, and knees. Joint pain improved but still there as of Feb 20, 2021. Ibuprofen and Tylenol did not help headache or joint pain. Third day headache off and on with nausea once, right hip pain. Feb 20, 2021 Fourth day underarm and joint pain improving , nasal and ear congestion
41 2021-02-20 taste disorder, lip swelling, tongue disorder got Shot about 8:30; immediately after getting the shot, I had the same feeling as my breath being t... Read more
got Shot about 8:30; immediately after getting the shot, I had the same feeling as my breath being taken away and the taste (just like after getting an IV cleaned with saline). Nurses told me to sit up front to be observed and waited 30 minutes. After the 30 minutes, I began getting very warm (went outside to get fresh air); went to vehicle, took mask off face, was still feeling very hot, Face was bright red, lips were very red (looked like I had on makeup and I didn't have any on). Took 4 children's Benadryl (dissolvable). Went back to work. redness started to go away. Throughout the morning, I continued having the feeling of breath being taken away and the taste. It wasn't as bad, so I didn't worry. My lips were not too swollen, face was still swollen. I have had MANY reactions to food allergies and didn't wanna "cause" a scene. By 1:30, I was in a meeting trying to talk and my tongue started to feel thick and it was harder to talk. I took 2 adult Benadryl's and tried to work some more to keep my mind off of the reaction. I ended up being very tired and laid down. I slept till about 5pm and seemed okay after. Nothing else was done. My muscle was sore, no other symptoms.
41 2021-02-21 lip itchiness, swollen tongue itchiness along left side, pain in neck on left side, itchiness of the lips, minor swelling in tongu... Read more
itchiness along left side, pain in neck on left side, itchiness of the lips, minor swelling in tongue and throat
41 2021-02-21 lip swelling During the 15 minute observation period, pt reported upper lip swelling and hives on face.
41 2021-02-21 mouth tingling Flushing, tachycardia, lip tingling
41 2021-02-22 swelling around the eyes, mouth tingling, eye itchiness, swollen lips Pfizer shot #1: She received the 1st COVID vaccine Pfizer on January 24th at 7:00 p.m.. The followi... Read more
Pfizer shot #1: She received the 1st COVID vaccine Pfizer on January 24th at 7:00 p.m.. The following day she noted a low-grade fever. On January 26 she noted edema of her eyes and lips associated with facial redness and itching that she treated with Benadryl intermittently for the past 2.5 weeks. She was seen in follow-up by her dermatologist who suspected an inflammatory reaction and prescribed anti-itch facial cream. She was also seen by her primary care who suspected angioedema and prescribed her an EpiPen which she has not needed to use. Pfizer shot #2: 2nd shot delayed due to snow. Above sx resolved before shot #2. She had her 2nd COVID injection February 20 at 3:50 p.m. About 1.5-2 hours later she noted onset of itching to her eyes and nipples along with itching of the skin in the locations of her usual eczema. She noted that her lips and eyes were a little puffy but less severe swelling to the eyes and lips than the 1st injection. She took 2 Benadryl shortly after onset of these symptoms. This seemed to lessen symptoms about 50%. Later she noticed that her voice sounded raspy and hoarse and she had a sensation of swelling to her tongue and throat but she was able to swallow. Her throat felt scratchy. She denies having lightheadedness, urticaria or GI symptoms. She went to the ED and was treated with benadryl, solumedrol and pepcid, monitored for a few hours and then discharged on 60 mg prednisone X 3 days and advised to continue benadryl 50 mg Q6h. She takes zyrtec 10 mg BID for seasonal/perennial allergies. Allergy history: She has a history of both idiopathic urticaria in early childhood and idiopathic angioedema in her early 20's. States she had extensive testing but the cause was never exposed. Took high dose prednisone for 4-5 months, angioedema resolved spontaneously and then flared again a few months later. Finally resolved with n additional 3 months of prednisone. She has both seasonal (feb-may) and perennial allergies to cat and dust, asthma and allergy to ampicillin--rash in childhood, and humira--fevers.
41 2021-02-24 mouth discomfort About 5 minutes after receiving the shot, I experienced a tickle in my mouth, and then shooting burn... Read more
About 5 minutes after receiving the shot, I experienced a tickle in my mouth, and then shooting burning waves down both sides of my spine (just to the left and right) starting in my neck and settling in my groin. It felt like intense burning and buzzing waves going down from my neck. The paramedics came, said there were no signs of anaphylaxis, and took me to ER. They gave me benedryl and pepcid in an IV, I felt drowsy. The waves eventually subsided and were gone around the time of the benedryl (not sure if before or after).
41 2021-02-25 ringing in ears Migraine, head pressure, ringing ears, dizziness. Now I have Vestibular migraines, I am off balance.... Read more
Migraine, head pressure, ringing ears, dizziness. Now I have Vestibular migraines, I am off balance. Still have dizziness, and head pressure. Headache comes and goes. First 2 days I also had inside vibration and energy zap in my whole body.
41 2021-02-25 tongue disorder Within 3 minutes, had facial tingling and numbness. Tongue felt ?thick? with it 30 minutes. Received... Read more
Within 3 minutes, had facial tingling and numbness. Tongue felt ?thick? with it 30 minutes. Received 50 ml injection at that time. All symptoms resolved within 5 hours.
41 2021-02-26 thirst Day of vaccine 2/20 to following day experienced injection site pain but no other symptoms. The nig... Read more
Day of vaccine 2/20 to following day experienced injection site pain but no other symptoms. The night of 2/25 (almost 6 days later) experienced flu like symptoms - chills, shaking due to cold, fever, thirst, joint and body aches, light headedness, fatigue. Morning of 2/26 chills and fever had subsided, had 8/10 severity headache that gradually decreased throughout the day. Body aches gradually subsided throughout the day and all symptoms were resolved by 6pm on 2/26. I had very similar symptoms after my first dose as well - initial injection 1/29 at 12:30pm, flu like symptoms began early morning of 2/1 that lasted about 15 hours.
41 2021-02-27 mouth numbness Numbness in tongue and lips six hours after taking the vaccine. I took a Benadryl and the symptoms s... Read more
Numbness in tongue and lips six hours after taking the vaccine. I took a Benadryl and the symptoms subsided after 60 minutes. I also experienced dizziness and weakness right after taking the vaccine, which lasted for 24 hours. Other symptoms include tiredness, headache, muscle pain, chills, low-grade fever, and nausea, which have lasted for 24 hours and continue now.
41 2021-02-28 double vision, visual impairment MRI showing inflammatory lesion of the Pons/Single lesion appearing inflammatory in nature found in ... Read more
MRI showing inflammatory lesion of the Pons/Single lesion appearing inflammatory in nature found in the pons at origin of cranial nerve 6; single lesion appearing inflammatory in nature found in the Pons at origin of Cranial Nerve 6; Development of double vision/double vision with right gaze and head turning; mild chills; headache; significant diarrhea; vision noted to be off; This is a spontaneous report from a contactable other health care professional, the patient. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), via an unspecified route of administration on 14Jan2021 at 01:15 (at the age of 41-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included spontaneous coronary artery dissection with stenting (reported as "five years ago") and complex migraines from an unspecified date. The patient is allergic to Tramadol, Codeine and Novocaine. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899) on 23Dec2020 at 01:15 AM as a single dose in the left arm for COVID-19 immunization.The patient was not pregnant at the time of vaccination. The vaccination was administered in a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included diltiazem (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN).The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported the development of double vision on 25Jan2021 at 06:00. She was hospitalized and remained hospitalized for three days. She reports having had an MRI (date not specified) which showed an inflammatory lesion of the Pons. She further described the events as follows: Initially mild chills and headache "the day after" developing into significant diarrhea for four days and on and off diarrhea for several weeks. One week after vaccine vision noted to be off but no official work up developing into double vision with right gaze and head turning three weeks after vaccine. She also stated that there was a single lesion appearing inflammatory in nature found in the Pons at origin of Cranial Nerve 6. Treatment received included Solumedrol and Pepcid infusion. Lab data included an MRI on an unspecified date which showed inflammatory lesion of the Pons and COVD-19 testing as follows: SARS-CoV-2 Nasal Swab PCR test on 20Jan2021 and on 11Feb2021 both of which were negative. The clinical outcomes of brain inflammation, double vision, chills, headache, diarrhea, vision decreased and cranial nerve disorder were reported as recovering. No follow-up attempts are possible. No further information expected.; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
41 2021-02-28 swollen gums when she woke up in the morning her gum on her right face was swollen; This is a spontaneous report ... Read more
when she woke up in the morning her gum on her right face was swollen; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 06Jan2021 at a single dose (at the age of 41-years-old) for COVID-19 immunization. Medical history included high blood pressure. Concomitant medication included amlodipine for high blood pressure. The patient took the COVID vaccine and worked at the hospital six days after the first dose, when she woke up in the morning her gum on her right face was swollen (12Jan2021) and she took the vaccine on left side. She figured it was something with her gum and it was not related. She went to the dentist and everything, and he (dentist) cleared that nothing was wrong with her gum. The patient did not receive treatment for the event. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the event "gum on her right face was swollen" with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
41 2021-02-28 swollen gums the second dose; I have headache; I noticed the gums are swollen but not as big as the first time.; ... Read more
the second dose; I have headache; I noticed the gums are swollen but not as big as the first time.; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received second dose of BNT162B2 (Lot number and expiry date not provided), via an unspecified route of administration on 26Jan2021 at single dose for COVID-19 immunization. Medical history included High Blood Pressure. Concomitant medication included amlodipine for High Blood Pressure. The patient previously took first dose of BNT162B2 on 06Jan2021 for COVID-19 immunization and experienced "gum on my right face was swollen". It was reported that patient received the second dose and when she woke up, she had headache and then noticed the gums were swollen but not as big as the first time in Jan2021. No treatment received for the events. The outcome of the events was unknown. Information on the lot/batch number has been requested.
41 2021-02-28 thirst Friday at 4pm I experience severe unquenchable thirst and mild injection site soreness. Saturday mor... Read more
Friday at 4pm I experience severe unquenchable thirst and mild injection site soreness. Saturday morning was restless sleep and headache with severe joint pain and thirst. All Saturday same. Skin hurt to touch and knees and finger knuckles hurt to touch. Vomiting. Throbbing injection arm pain and the urge to constantly stretch all limbs. Sunday all subsided except the throbbing arm pain. Sunday evening at 8 pm throbbing arm worse and headache. Monday 3am restless sleep and miserable comfortableness. Throbbing arm and restless painful shockwaves through entire body. Skin severely hurt to touch. Went to the ER. Treated with Atavan and prescription Motrin.
41 2021-02-28 ringing in ears ringing/buzzing in ear, pain/heaviness, headache
41 2021-03-01 eye swelling pt stated that soon after she received the covid vax she felt like the back of her neck was on fire.... Read more
pt stated that soon after she received the covid vax she felt like the back of her neck was on fire. She was flushed and itching. When she scratched her skin it would turn into a hive. Her eyes were swollen and looked bruised. She tried to eat a cracker but was not able to swallow. She became nauseous and winded. She went to the ER. Her entire back was red and inflamed. They administered Benadryl. Pt was released and to FU w/ PCP. That night she had some chills and fatigue. When she got up today 3/2/2021 she was super itchy, not able to swallow food and had diarrhea for two hours . She had a virtual appt w/ doctor and was referred to see her PCP. She made an appt w/ PCP. Her Dr. wrote her a RX for prednisone. Told her to take Benadryl as well and to stay off work for a couple of days.
41 2021-03-01 pain in jaw Sore arm Jaw pain Skin sensitive on face Headache
41 2021-03-01 mouth tingling, oropharyngeal discomfort Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vac... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vaccine on 2/19/21. Unknown where the patient got their vaccine administered. Immediately afterwards, the patient developed hives, cough, and lightheadedness and was sent to Hospital. They were treated with steroids and diphenhydramine. Their symptoms resolved and they were discharged. On 2/20/21 patient came to emergency room in the morning with allergic reaction. They woke up in the morning with hives, swelling in face, and feeling of thickness in throat and shortness of breath. They were given dexamethasone, diphenhydramine, and famotidine. Their symptoms resolved and they were discharged. While at home the patient developed hives and took diphenhydramine. They had tingling and a rash over their face. On 2/20/21 the patient returned to the emergency room in the evening with a rash. The symptoms were pain and burning. They also complained of abdominal cramping, mild nausea, and left sided chest pain. Their symptoms improved and they were discharged. On 2/22/1 the patient returned to the emergency and was subsequently hospitalized. They presented with face swelling, general pruritus, and hives. She reported chest tightness and paresthesia involving her lips. Admitted on 2/22/21 to 2/25/21. She was given diphenhydramine, famotidine, and hydrocortisone.
41 2021-03-02 taste impairment, eye itchiness face started to feel "hot and on fire"; face and neck turned bright red; face started to feel really... Read more
face started to feel "hot and on fire"; face and neck turned bright red; face started to feel really tight; Heart Rate then was elevated to 115 bpm; shortness of breath; itchy eyes; headache; nausea; Arm still felt sore; fatigued; At site of injection there was a warm sensation; metallic taste in my mouth; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) solution for injection, intramuscular at left arm on 29Jan2021 at 10:30 AM at single dose for COVID-19 immunization. Medical history included asthma. The patient has no known allergies. The patient's concomitant medications were not reported. The patient was not pregnant and has no other vaccines in four weeks. She will have a birth control in two weeks. It was unknown if the patient has COVID prior to vaccination. She was not tested with COVID post vaccination. The patient was given COVID-19 vaccine at a hospital. When she initially received the vaccine on 29Jan2021, the site of injection had a warm sensation which resolved within a minute. Then on the ride home, she had a metallic taste in her mouth. While at home around 4:00 PM, her face started to feel hot and on fire and then her face and neck turned bright red. Her face started to feel really tight and hot. Heart rate was then elevated to 115 bpm. She then started having shortness of breath, itchy eyes, headache and nausea. The patient sat down and took 10 mL of BENEDRYL (as reported) at 4:30 PM or 4:40 PM. Between 5:00 PM and 7:00 PM, her face and neck were still slightly red. Her arm felt sore and she was fatigued. She again took 10 mL of BENEDRYL at 7:30 PM. She woke up on 30Jan2021 and still felt fatigued and the back of arm (tricep area) was very sore. The patient also took paracetamol (TYLENOL) 600 mg. The outcome of the event vaccination site warmth was recovered with sequel on 29Jan2021 and recovered with sequel on Jan2021 for all other events.
41 2021-03-02 drooping eyelid, mouth numbness On 2/28/21 I began feeling numbness on the right side of my tongue and mouth. 3/1/21 numbness/weakn... Read more
On 2/28/21 I began feeling numbness on the right side of my tongue and mouth. 3/1/21 numbness/weakness began spreading to my right cheek and right side of lips. By 3/2/21 the numbness weakness covered the entire right side of my face and caused mouth and eye droop. Went to the ER and was diagnosed with Bell?s Palsy.
41 2021-03-02 mouth numbness, loss of taste, eyelid function disorder Patient received her second covid 19 vaccine on the 18th of February - about four hours after she de... Read more
Patient received her second covid 19 vaccine on the 18th of February - about four hours after she developed some soreness, fatigue and had a hard time moving her arm. Continued for a couple of days. Sunday 2/21 patient woke up without taste and her tongue was numb. That evening she began having some neck pain, below her ear, she massaged and didn't help all that well. At around 3 am that night, the pain was entirely on the right side of her neck and face, she took ibuprofen which mildly helped at night it was the entire neck. Monday 2/22 patient massaged area and it helped a little. She continued to have pain Tuesday 2/23 - Around 9am that morning patient noticed right sided facial drooping and her tongue was not working properly. She also noticed that her eye would not respond like her left eye. It was sluggish. When she went to brush her teeth, she noticed that the water would not stay in her mouth and it came out. At around 7pm that evening she went to the emergency room
41 2021-03-02 lip swelling My lips got swollen after 24 hour of vaccine, took Benadryl but lips are still swollen after takin i... Read more
My lips got swollen after 24 hour of vaccine, took Benadryl but lips are still swollen after takin it.
41 2021-03-02 swollen tongue Tongue swelling and palpitations and difficulty with speech and swallowing, and throat tightness. o... Read more
Tongue swelling and palpitations and difficulty with speech and swallowing, and throat tightness. onset within 30 minutes of vaccines. taken to Urgent care, received epinephrine injection, then transferred by ambulance to Hospital ER. given IV diphenhydramine and IV decadron. chest pain. normal ECG and troponin. They did not check tryptase.
41 2021-03-02 tongue disorder Reports symptoms began 6pm , 1 hour after receiving vaccination, headache and feeling bumps on her ... Read more
Reports symptoms began 6pm , 1 hour after receiving vaccination, headache and feeling bumps on her tongue and roof of mouth, taste was off. on 3/3/21 midnight was awakened from sleep from pain in all of her joints, back and neck. Experienced dizziness and fatique in the morning.
41 2021-03-03 taste impairment, mouth tingling After 10 minutes, patient reported metal taste in mouth and feeling faint. She also felt tingling in... Read more
After 10 minutes, patient reported metal taste in mouth and feeling faint. She also felt tingling in her arms and lips. She struggled to get up. Her breathing seemed fine but neck was red. She laid on floor with legs elevated until her dizziness subsided. She originally said she felt better but then dizziness returned. Called 911 and had Epi-pen ready. She was breathing fine when paramedics arrived. Her husband later called at 7:45pm and reported she was feeling fine. He said the emergency room gave her a steroid, anti-histamine, and pepcid. She is not going to receive the second covid shot. Her husband later stated she got a full body rash when she had covid. I also advised them to register on the v-safe site.
41 2021-03-03 lip swelling Pt developed a few hive-like lesions on her legs on 1/28/2021, 2 days following first COVID vaccinat... Read more
Pt developed a few hive-like lesions on her legs on 1/28/2021, 2 days following first COVID vaccination. Over the next 2 days developed more. Each lasted less than 24 hrs, but some lesions were always present. No other symptoms. Allegra resolved hives. On 1/17/2021 after second COVID vaccination, she developed headache, body aches, and low grade fever lasting 1 day. Three days later, hives returned, worse than with first vaccination. Allegra resumed up to qid. On 2/23/2021 developed severe chest pain, waxed and waned through night, resolved by next morning. Was hive-free between 2/24 and 2/28 when the hives recurred. Has had two bouts of lip swelling. Hives persist, despite antihistamine use, to the present.
41 2021-03-03 mouth tingling, mouth numbness With having MS, I have severe anxiety and I was anxious before going in- numbness and tingling in m... Read more
With having MS, I have severe anxiety and I was anxious before going in- numbness and tingling in my legs and tingling on my tongue. Took Benadryl - tongue tingling went away and the legs tingling and numbness was the same and started getting worse - they monitored my vitals and everything looked good and numbness remained. I had a driver and they allowed me to leave due to the Benadryl _ just took that one dose of Benadryl (didn't take anymore after that) and then the numbness in my legs remained for about two and a half weeks. I used a cane for two days. I had a fever and chills that first night, body aches and injection site pain and severe fatigue and those symptoms lasted one day except fatigue was for three days. The day after the shot was the worse of the symptoms. They followed up with me that evening and they followed up with me at work. I had the next dose - February 4, 2021 and experienced everything except the numbness in the tongue. Informal doctor visit because I work there.
41 2021-03-04 ear discomfort Flushing feeling in face 7 minutes after vaccine was administered, then over the next 7-8 minutes th... Read more
Flushing feeling in face 7 minutes after vaccine was administered, then over the next 7-8 minutes there was an increasing feeling of throat tightness. It started on the right side of throat, then the left a few minutes later. Eventually a feeling of pressure behind eardrums and a little trouble swallowing. Epi was given approximately 20 minutes after vaccine was administered, then a dose of Benadryl. Paramedics were called, transported to ED for observation for 4 hours. Symptom of tightness in throat improved within minutes of Epi, returned after a few hours with less severity. That feeling took a few days to completely subside.
41 2021-03-04 mouth tingling, taste impairment Progress Notes (Nurse Practitioner) Pt called to follow up s/p covid-19 vaccine done on 02/24/21.... Read more
Progress Notes (Nurse Practitioner) Pt called to follow up s/p covid-19 vaccine done on 02/24/21. She reports she took a nap yesterday after getting home and felt better afterwards. Today she feels well. Denies any other questions or concerns. She is appreciative of the phone call. Progress Notes at 2/28/2021 7:34 AM Expand AllCollapse All VACCINE CLINIC 2/24/2021 Subjective Patient is a 41 y.o. female who was seen at SVH COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness, headache, nausea, tingling lips and a metallic taste in her mouth. She denied rash, difficulty breathing, difficulty swallowing, throat tightness, facial swelling and lip swelling. She does mention having a history of anxiety and did take her duloxetine and Wellbutrin today. Denies use of her Ativan recently. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms, respiratory distress, tongue swelling and vomiting. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness and headaches Patient denies chills, facial swelling, chest tightness, shortness of breath and wheezing +nausea and metallic taste in mouth: Previous Reactions: Denies Objective Vitals Vitals: 02/24/21 1427 02/24/21 1434 BP: 126/70 112/68 Pulse: 81 80 SpO2: 99% 96% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic and atraumatic. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema. Comments: No swelling or lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Assessment/Plan Treatment included: Tylenol and water Follow up response to treatment: good. She noted some lightheadedness prior to discharge but other symptoms were improved. I walked patient around the bay area and she was feeling okay. Her vitals were stable. Pt was escorted out of the facility. Patient discharge: Stable to go home and follow up with PCP. Electronically Signed 2/24/2021 2:43 PM
41 2021-03-04 visual field defect About 10 minutes after her vaccine she started feeling throat thickness and was able to swallow so s... Read more
About 10 minutes after her vaccine she started feeling throat thickness and was able to swallow so she received 50mg of Benadryl PO. About 10 minutes later she said that she thought it was helping. About 20 minutes after the benadryl she started having dizziness/lightheadedness, visual field narrowing, worsening throat swelling with frequent throat clearing, and tingling in her hands, epinephrine pen given L thigh. After 5 minutes without improvement Epinephrine pen given R thigh. No rash/hives noted. Vitals were stable the entire time with SpO2 of 100%, RR 18-22, HR 84-98, BP 100-138/60-86.
41 2021-03-06 mouth tingling, taste impairment Metallic taste in the mouth, tingling of the mouth, nausea. Refused evaluation from EMS, cleared by... Read more
Metallic taste in the mouth, tingling of the mouth, nausea. Refused evaluation from EMS, cleared by medic on site.
41 2021-03-07 eye swelling, lip swelling o Complaint The patient is a 41 year(s) old Female complaining of allergic reaction, nausea. o Chief... Read more
o Complaint The patient is a 41 year(s) old Female complaining of allergic reaction, nausea. o Chief Complaint Quote Patient complained of allergic reaction that started about 45 mins ago. She got her 1st dose of Pfizer Covid vaccine yesterday morning. She complained of rash all over the body, swelling on the hands and face including eyes and lips. She denied chest pain, abdominal pain, fever, cough, vomiting and difficulty breathing. She complained of nausea that started 5 mins ago. She has not taken any meds yet for her symptoms. o Time Seen 02-18-2021 01:20 o Historian patient ADDITIONAL HPI: o Additional HPI Pt here with concerns of allergic reaction. Pt fell asleep on the couch approx 2200. She awoke 2 hours later with itching of her hands. Over the next hour she developed a full body rash, itching, and swelling of face. No wheezing, no difficulty swallowing. Upon arrival to ED pt started to feel nauseated. Pt had first dose of COVID vaccine approx 16 hours prior to onset of sxs. No h/o allergic reactions, no h/o asthma. Emergency Department Course and Clinical Decision Making: Patient presents with urticaria and swelling to her face eyes and lips. Shortly upon being roomed she started to feel very nauseated and started vomiting. No stridor or wheezing, no immediate airway compromise but given both cutaneous and GI symptoms, significant concern for anaphylaxis. Patient was immediately given epinephrine intramuscularly, 0.3 mg. An IV was placed and she was given Solu-Medrol, Benadryl, Pepcid, and Zofran. Patient's urticaria and swelling started to nearly immediately improved after the epinephrine. She is feeling much better though slightly anxious. To be reaction from the Pfizer vaccine, no other obvious triggers, patient has no history of allergic reactions or other sensitivities. We will observe in the emergency department in a monitored setting for several hours to assure no rebound symptoms, patient updated on plan. 0500 Pt has been resting. Urticaria resolved, swelling to face resolved. Discussed with pt reporting reaction to CDC, info provided. Also discussed the second dose of vaccine, recommended reaching out to Epi response team or PCP to get recommendations. Will give short course of prednisone, 4 days, Benadryl as needed, ED return precautions discussed, will dc home.
41 2021-03-07 hearing loss 1/9/21: second dose of vaccine administered at day 12 body chills, aches by 11pm 1/10/21: body ache... Read more
1/9/21: second dose of vaccine administered at day 12 body chills, aches by 11pm 1/10/21: body aches, low grade fever, woke up early morning (6 or 7am) with nausea, weakness- husband had to help me to bed, headach by 4pm fever was getting higher, body aches and chills worsen. Called Telehealth for support and was advised to go to ER At ER arrived with high fever, full rigor, bones felt like they were breaking one by one so bad body aches, chills 1/12/21: First day of cognitive issues - sever fatigue, could not comprehend anything, could not work or do school 1/17/21: Realized the cognitive issues were bad and needed to see DR, dizziness, audio distorted, couldn't follow directions 1/18/21: First Dr apt at medical center Currently still in Dr's care 2/23/21: First Nuro apt with specialist
41 2021-03-07 swollen tongue At approximately 10 hours after receiving my second injection of the Covid19 vaccine, I started noti... Read more
At approximately 10 hours after receiving my second injection of the Covid19 vaccine, I started noticing nausea, headache and a neck ache. Within 5 minutes of these symptoms, my tongue felt swollen and my speech was slowed and slurred. Within ten minutes of these symptoms occurring, my nausea went away as well as my swollen tongue and speech problems. The neck ache and headache progressed into a migraine. I took Tylenol and went to sleep. I woke four hours later with abdominal pain, nausea, head ache and neck ache as well as pain at the injection site. Again I took Tylenol. I experienced fatigue, migraine, neck and back ache, night sweats and axillary adenopathy over the next 5 days. Today is day 6 and I haven't gone a day without neck pain and headache yet. It usually occurs in the afternoon. I continue to take Tylenol and it feels better.
41 2021-03-08 oropharyngeal discomfort, eye irritation Flushing - entire body; like when you receive an injection of contrast for a CT Scan Burning - Eyes,... Read more
Flushing - entire body; like when you receive an injection of contrast for a CT Scan Burning - Eyes, face, abdomen Nauseous Pressure in head/face/ears Throat discomfort Headache Overall sick feeling Over the next couple days, my lips have broken out. I have some small mouth/tongue sores. Feeling of a cold coming on. Sinus pressure. Throat discomfort, congestion. Sneezing. Eyes burning. Face burning. Itchy patches on scalp. Face breaking out.
41 2021-03-09 lacrimation increased, vision blurred, ringing in ears, taste disorder Day of: fatigue, sob, weakness, coughing tasting blood, runny nose, watery eyes, pain at injection s... Read more
Day of: fatigue, sob, weakness, coughing tasting blood, runny nose, watery eyes, pain at injection site, fever, chills, rash around injection site, down arm ans up shoulder and neck Day after and progression: muscle weakness to the point of falling down and inability to hold onto items, SOB, fatigue, blurred vision, ringing in ears, dizziness. Pain, numbness, tingling throughout body. Cough tasting blood, flank pain, intermittent urinary incontinence and increase urination at night, nightmares, anxiety, depression. Today: SOB, cough tasing blood, extreme fatigue, dizziness, tinnitus, nightmares, anxiety, depression. 03/02/21 New onset diagnosis: Severe Asthma I have not been able to work since 01/08/2021
41 2021-03-09 swelling of eyelid I was 32 minutes past receiving the vaccine when my face felt hot. I looked in the mirror and saw th... Read more
I was 32 minutes past receiving the vaccine when my face felt hot. I looked in the mirror and saw that it was. After about thirty more seconds I had trouble breathing and eventually could barely breathe. My face was puffy and my eyes started to close. I received IV Benadryl and two other medications which I can't remember.
41 2021-03-10 mouth numbness She received the vaccine at 0930 and had itching her lips became numb shortly after starting around ... Read more
She received the vaccine at 0930 and had itching her lips became numb shortly after starting around 1200. She developed hives around her entire body on her left jaw, face, arms, and rack. Rash resolved within 24 hours with a lot of Benadryl.
41 2021-03-10 oropharyngeal discomfort, swollen tongue ITCHING ALL OVER, SCRATCHY THROAT, ANAPHYLAXIS PT PREMEDICATED WITH BENADRYL 50MG PO AT HOME PRIOR T... Read more
ITCHING ALL OVER, SCRATCHY THROAT, ANAPHYLAXIS PT PREMEDICATED WITH BENADRYL 50MG PO AT HOME PRIOR TO COMMING FOR SECOND VACCINATION AT 1125 12:57 PT STATES S/S OF ANAPHYLACTIC REACTION, SCRATCHY THROAT, TONGUE SWELLING, HIVES, ITCHING VS TAKEN: HR 120,RR 20,BP 150/78, SPO2 100% RA 1258: EPI PEN GIVEN X 1 IM TO LEFT VASTUS LATERALIS, PT TOLERATED WELL. 1259: SQUAD AND ER NOTIFIED FOR NEED OF TRANSPORT TO CPH. 1301:DEXAMETHASONE10 MG IM IN RT LETOID GIVEN X 1, PT TOLERATED WELL. 1305: 20 GUAGE SL PLACED TO RT WRIST. PT TOLERATED WELL. 1315: REPEAT VS TAKEN AND STABLE HR 95, RR 20, BP 140/74, SPO2 100% RA. 1315 RESCUE ARRIVED AND TRANSFERED TO CPH
41 2021-03-10 mouth tingling lips and tongue tingling, lump in throat. Evaluated by EMS-Cleared
41 2021-03-11 lip itchiness Anaphylaxis, swollen throat, itchy lips, hives.
41 2021-03-12 mouth tingling FEVER, MUSCLE PAIN, TIREDNESS, HEADACHE, SWELLING OF GANGLIA UNDER ARM AND NECK, SENSATION ON THE HA... Read more
FEVER, MUSCLE PAIN, TIREDNESS, HEADACHE, SWELLING OF GANGLIA UNDER ARM AND NECK, SENSATION ON THE HANDS AND LIPS WITH LIKE PADDING AND TINGLING. PAIN IN THE INJECTION SITE.
41 2021-03-13 lip redness, lip swelling The day after the vaccine, my top lip started to swell, burn a little and slightly red. I have had J... Read more
The day after the vaccine, my top lip started to swell, burn a little and slightly red. I have had Juvederm lip injections for almost 2 years but had recently gotten a touch up on only my top lip last November of 2020. Bottom lip is fine. Consulted with my doctor. Took Benadryl and was prescribed Claritin and steroids.
41 2021-03-14 ear discomfort 1124 PFIZER COVID VAC. GIVEN, 1133 C/O FEELING DIZZY. THEN C/O FEELING NAUSEATED WITH DRY HEAVES, ... Read more
1124 PFIZER COVID VAC. GIVEN, 1133 C/O FEELING DIZZY. THEN C/O FEELING NAUSEATED WITH DRY HEAVES, PRESSURE IN RT. EAR AND HEADACHE: 1145. 1150 LOWERED TO THE GROUND, STATING SHE COULD NOT BREATHE. EMS CALLED. EPI VIA IM (PEN) ATTEMPTED X3, 3RD DOSE SUCCESSFUL. EMS ARRIVED SHORTLY AFTERWARDS.
41 2021-03-14 swollen tongue Sensation of tongue swelling during observation-about 15 minutes after vaccine, Medical Emergency te... Read more
Sensation of tongue swelling during observation-about 15 minutes after vaccine, Medical Emergency team called and arrived less than 10 minutes after call, they assessed and brought pt to ED. Pt's vitals were recorded & stable and information sheet given to ED team. Copy scanned into pt's chart.
41 2021-03-14 visual impairment A day after the second dose, vision in my right eye was impacted. It progressively got worse. I saw ... Read more
A day after the second dose, vision in my right eye was impacted. It progressively got worse. I saw an eye doctor for an emergency visit on Saturday, 3/13. He did a full exam with dilation, and suspects it is an optic neuritis. Today, I had a visual field test, but I am unaware of the results yet. There has been no improvement in my vision since Saturday when I saw the doctor.
41 2021-03-15 swelling of eyelid very swollen eye lids for around 24-48 hours
41 2021-03-15 vision blurred Patient received her covid vaccine at 9:50am. She was in the observation area. She stated she couldn... Read more
Patient received her covid vaccine at 9:50am. She was in the observation area. She stated she couldn't breathe at 9:55am. She showed no signs of any breathing difficulty. Patient reported a past history of anaphylaxis to bee stings. At 9:57am 50mg of Benadryl was given. 9:58 am she reported she was sweaty, had blurred vision, and was hot. At 10:05, patient said she started to feel better. We asked that she wait the full 30 minutes. By 10:20am, she was feeling fine and the symptoms had resolved.
41 2021-03-17 sudden hearing loss Sudden hearing loss 02/27/2021
41 2021-03-18 loss of taste, loss of smell Loss of smell and taste, body achy, nausea,
41 2021-03-18 tongue discomfort, mouth discomfort I had dizziness and a headache that jumped around my head within 20 minutes of the shot. About two h... Read more
I had dizziness and a headache that jumped around my head within 20 minutes of the shot. About two hours in it felt like my tongue was increasingly getting heavier and heavier for around a 10 minutes timeframe. It then stopped but for two days it felt like I had burnt my tastebuds. Starting two days ago I have developed a red rash on my arms that burns at times and seems to come and go.
41 2021-03-19 oropharyngeal discomfort 10:54 Throat thick, report feeling "funny"/ strange. BP 110/60 10:57 EPI administered, BP 110/80 Th... Read more
10:54 Throat thick, report feeling "funny"/ strange. BP 110/60 10:57 EPI administered, BP 110/80 Throat feels better. Shaky. 11:02 Transported
41 2021-03-19 thirst, dry mouth Dry mouth and thirst
41 2021-03-19 tongue itchiness, mouth itchiness 25 minutes after vaccine shot: throat started to get itchy 30 minutes after vaccine shot: roof of mo... Read more
25 minutes after vaccine shot: throat started to get itchy 30 minutes after vaccine shot: roof of mouth and tongue started to get itchy - went to see nurse : took 50mg Benadryl 40 minutes after vaccine shot: difficulty swallowing: need to clear throat 50 minutes after vaccine shot: nurse suggested taking my EpiPen but I was still able to breathe (all other symptoms were still very present Approximately 25-30 minutes after taking Benadryl symptoms began to subside. No EpiPen was administered. Approximately 95 minutes after vaccine shot: symptoms were reduced enough to go home.
41 2021-03-20 bloodshot eyes Petechiae (red dots that didn't blanche) all over arms, legs, chest. Racing heart rate, flush face... Read more
Petechiae (red dots that didn't blanche) all over arms, legs, chest. Racing heart rate, flush face, red eyes, red web like moving up and down the arms and legs, injection site rash.
41 2021-03-21 eye pain, eye irritation Red eyes, painful and burning . Went to the ER and then was sent to ophthalmology and was diagnosed ... Read more
Red eyes, painful and burning . Went to the ER and then was sent to ophthalmology and was diagnosed with keratoconjunctivitis. The doctor said she has seen this in patients that receive the Covid shot.
41 2021-03-21 eye swelling Swollen eyes burning skin jittery feeling
41 2021-03-21 ringing in ears Tinnitus in left ear started less than 2 hours after vaccine and hasn?t let up since
41 2021-03-22 taste impairment, mouth tingling Within a couple minutes of receiving shot, felt pain at injection site that traveled up arm into nec... Read more
Within a couple minutes of receiving shot, felt pain at injection site that traveled up arm into neck. Heart rate went up to 122bpm. Left side of face felt puffy and numb. Left side of mouth and tongue were tingling. Reported this to vaccine giver, he had me wait about half an hour before suggesting Benadryl. Half an hour after 25mg Benadryl, symptoms were almost completely resolved. The next day (3/14) I felt tired. The day after (3/15) I felt hot and my skin was flushed. I was not running a fever. I generally felt unwell that day. I felt better by the time I woke up on 3/16. I also had a bad/metallic taste in my mouth through 3/21, which has resolved. My nurse practitioner suggested that I take Benadryl before I receive my second vaccine dose on 4/3/21.
41 2021-03-22 mouth numbness lip numbess and throat tightness
41 2021-03-22 oral mucosal blistering, oropharyngeal discomfort, ear discomfort, burning mouth syndrome I took a bite of an apple around 2 pm the day of the injection and the roof of my mouth immediately ... Read more
I took a bite of an apple around 2 pm the day of the injection and the roof of my mouth immediately blistered up. The glands at the back of my tongue were inflamed, my epiglottis hurt and my esophagus hurt the whole way down to my stomach in my chest. My inner ears felt pressure and throbbed. By that night my whole tongue hurt and I couldn't touch anything to it. This reaction stayed like this for 2 days and each time I tried to eat anything -even soft foods like yogurt- the roof of my mouth blistered up. My esophagus and epiglottis felt damaged. I ended up not eating much for a couple of days due to the pain and reactions.
41 2021-03-22 mouth tingling Lip tingling 15 minutes after vaccine administration, which then led to constant full body itching; ... Read more
Lip tingling 15 minutes after vaccine administration, which then led to constant full body itching; worse around lymph nodes (axillary, neck, and inguinal). No rash, fever, shortness of breath, swelling of tongue/throat/lips, eye redness, palpitations, fever. Erythematous skin.
41 2021-03-22 tunnel vision, ear discomfort About 2 hours after receiving the vaccine, I started to have kinda like tunnel vision, my ears felt ... Read more
About 2 hours after receiving the vaccine, I started to have kinda like tunnel vision, my ears felt cloggd. Tachycardia, palpitations, nausea/vomitting, extreme Fatigue, weakness, headache, dizziness, and loss of memory. I had this type of episode 2-3 times over 5 days, lasting about 20-30 minutes, last one being at work, all of a sudden, same type of episode. Went to ER after Coworkers stated I was " in coherent " or in and out, my BP upon arrival to er was in the 160's/90's. They ran multiple lab tests, CT head, CXR and ECG. By the time I was dicharged my BP was normal I believe it was 116/81. Some side effects like nausea lasted a week, I was given an antinuasea prescription
41 2021-03-23 mouth tingling, lip swelling, mouth numbness Developed lip swelling, mouth numbness/tingling, dizziness, and difficulty breathing within 30 minut... Read more
Developed lip swelling, mouth numbness/tingling, dizziness, and difficulty breathing within 30 minutes of receiving the vaccine. In light of the lip swelling (angioedema), she was given Benadryl and epipen at the clinic and transferred to ED for further evaluation. She received Solumedrol and Pepcid. Discharged on prednisone Pepcid, and Allegra, after about 2 hours of observation in ED with gradual decrease in swelling of her lips. No shortness of breath at discharge.
41 2021-03-23 ringing in ears Sore arm March 19-20 Fever began March 21 to present, ranging in 99 degree range daily. Lowest 99.2,... Read more
Sore arm March 19-20 Fever began March 21 to present, ranging in 99 degree range daily. Lowest 99.2, highest 99.6. Also experiencing chills, lymphnode on left side of neck, little to no appetite, diarrhea, full body aches, dizziness, ringing in ears, knee pain, headache, nausea, sweating, tiredness. I have not been to work this week.
41 2021-03-23 vision blurred, ringing in ears 3-23-21 4:16PM PT STATES 'EYES FEEL WEIRD, HARD TO REFOCUS QUICKLY AND EARS RINGING'. PT PLACED IN C... Read more
3-23-21 4:16PM PT STATES 'EYES FEEL WEIRD, HARD TO REFOCUS QUICKLY AND EARS RINGING'. PT PLACED IN CHAIR. A/O, PINK, W/D, RESP REG WITH EASE. PERLA. NO NEURO DEFICIT. GOOD MOTOR/SENSORY NOTED. COMFORT GIVEN. 4:17PM STATES SHE 'FEELS BETTER NOW'. 4:25PM AMBULATORY TO EXIT - GAIT BRISK AND STEADY. NO DISTRESS NOTED. 3-24-21 9:45AM PT STATES SHE 'FEELS MUCH BETTER'.
41 2021-03-24 ear swelling 5 days after the shot, severe rash appeared all over upper body. Scalp, face, neck, ears, upper back... Read more
5 days after the shot, severe rash appeared all over upper body. Scalp, face, neck, ears, upper back and upper chest. Also one small patch on lower arm. Ears became swollen. Swelling of lymph node in neck on left side (same side as the shot). Took Benadryl for 4 days but rash and swelling remained unchanged. Went to doctor on 4th day after the rash started (9 days after the shot) and she prescribed Hydroxyzine for rash. Follow-up visit scheduled for 3/31/2021.
41 2021-03-24 lip itchiness RN notified vaccine administrating RN from facility after pt. c/o itchy lips, weakness and feeling "... Read more
RN notified vaccine administrating RN from facility after pt. c/o itchy lips, weakness and feeling "fait" in post-vaccine waiting room. At 2:05 with pt. experienced difficulty breathing. RN gave epinephrine 0.5ml pt. on R deltoid. Then, 911 was called. Pt. was examined by paramedics refusing to go to ER. RNs encouraged pt. to see PCP. Pt.'s husband was called by pt. for ride home.
41 2021-03-24 feeling of choking Tingling in throat and a little dizzy feeling-VSS-All resolved.
41 2021-03-24 ringing in ears, double vision, eye discharge, vision blurred Ringing in ears; Urinary incontinence; Urinary frequency; Flank pain; inability to control temperatu... Read more
Ringing in ears; Urinary incontinence; Urinary frequency; Flank pain; inability to control temperature; Sweating; she was having hot or cold; Wheezing; falling down stairs; Muscle weakness; Blurred vision; Double vision; Inability to work; Rash; Injection site pain; Runny nose; runny eyes; cough with taste of blood; Shortness of breath; Fatigue; Fever; Chills; Dizziness; This is a spontaneous report from a contactable Nurse. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration in left arm on 08Jan2021 at 08:00 AM (at the age of 41-years-old) at single dose for covid-19 immunisation. The patient received the first dose vaccine BNT162B2 (LOT: EK5730 and EXP: Mar2021) on 18Dec2020. The subject had a history of ongoing Migraine. Relevant concomitant medications were unknown. The patient stated that after her second dose on 08Jan2021, the reaction started at 06:00PM that night. She says she had a rash and injection site pain that went her arm to her shoulder and neck. She says she had a runny nose, runny eyes, cough with taste of blood, shortness of breath, fatigue, fever, chills, and dizziness that night. She says she did not do any treatment that night, she thought the fever would run its course. Caller says that the next day she had severe fatigue, shortness of breath, wheezing, runny nose and eyes, and she also started to fall down stairs and had muscle weakness. She says she had blurred and double vision, and ringing in her ears. She says she progressed from that in a week to having urinary incontinence, intermittent frequency at night, flank pain, and an inability to control her temperature. She says she was having hot or cold sweats and chills which continued quite a while. She also reported that she has gained back muscle control, though she still has days where she is extremely weak, and her dizziness comes and goes. She says that the ear ringing has stayed the same, and her shortness of breath has stayed the same. She says that as of Mar 2nd she has been diagnosed with severe asthma, and she has never had any type of asthma or breathing problems before. The reporter stated that that this was disabling, she hasn't been able to work since 08Jan2021. The reported events were inability to work (impaired work ability) on 08Jan2021, rash on 08Jan2021, injection site pain (vaccination site pain) on 08Jan2021, runny nose (rhinorrhea) on 08Jan2021, runny eyes (eye discharge) on 08Jan2021, cough with taste of blood (haemoptysis) on 08Jan2021, shortness of breath (dyspnea) on 08Jan2021, fatigue on 08Jan2021, pyrexia on 08Jan2021, chills on 08Jan2021, dizziness on 08Jan2021, falling down stairs (fall) on 09Jan2021, muscular weakness on 09Jan2021, vision blurred on 09Jan2021, double vision (diplopia) on 09Jan2021, ringing in ears (tinnitus), urinary incontinence, urinary frequency (pollakiuria), flank pain, inability to control temperature (body temperature abnormal), sweating (hyperhidrosis), wheezing on 09Jan2021 and feeling of body temperature change. Clinical outcome of the event inability to work was not recovered, while clinical outcome of all other events was unknown. Laboratory data included pulmonary function test, result: 40%.; Sender's Comments: Based on the current available information, the event Inability to work is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
41 2021-03-24 visual impairment, lacrimation increased, vision blurred, ringing in ears Severe Asthma; pain at injection site; Rash at I she tin site the went down left arm, up shoulder an... Read more
Severe Asthma; pain at injection site; Rash at I she tin site the went down left arm, up shoulder and into neck; SOB; weakness; Coughing with taste of blood; running nose; watery eyes; fever; chills; muscle weakness to the point of falling down and dropping item; pain; numbness and tingling throughout body; numbness and tingling throughout body; flank pain; intermittent urinary inconstance; increased urination at night; nightmares; dizziness; blurred/double vision; ringing in ears; irregular body temperature; anxiety; depression; extreme fatigue; visual disturbance; I have been not been to work since second shot; This is a spontaneous report receive from a contactable consumer (Patient herself). A 41-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received first dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection with false Lot number: EK5730) via intramuscularly on 18Dec2020 at 08:00 am to right arm (at the age of 41-years-old) and second dose with lot number: EK9231 via intramuscularly on 08Jan2021 at 08:00am to left arm both at single dose for COVID-19 immunization. Medical history included Migraines. Concomitant medications were not reported. On 08Jan2021 at 06:00pm, the patient experienced pain at injection site, rash at injection site went down left arm, up shoulder and into neck, SOB, fatigue, weakness, coughing with taste of blood, running nose, watery eyes, fever, chills Day after and progression: muscle weakness to the point of falling down and dropping item, pain, numbness and tingling throughout body, flank pain, intermittent urinary inconstance, increased urination at night, nightmares, dizziness, blurred/double vision, ringing in ears, irregular body temperature, cough tasting blood, anxiety, depression Today: SOB, couch tasting blood, extreme fatigue, visual disturbance, nightmares, anxiety, depression and she said , that she had not been able to work since her second shot. On 13Jan2021 patient underwent lab test included swab test results as negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Mar21 new onset of severe asthma was diagnosed. Outcome of events was not recovered. Information about report seriousness has been requested; Sender's Comments: Considering the known safety profile of the drug and a plausible temporal association between the reported events and the suspect drug BNT162B2, a causal relationship cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
41 2021-03-25 dry mouth At approx. 1050 pt reported dry mouth, nausea, and feeling need to puke. Pt given emesis bag. Pt dry... Read more
At approx. 1050 pt reported dry mouth, nausea, and feeling need to puke. Pt given emesis bag. Pt dry heaved and reported not eating breakfast. Pt given water and stated she felt better after drinking water. Pt reported no hx of reaction to prior vaccinations. Pt denied throat irritation, itchiness, and rashes. Vital signs assessed at approx. 1056. BP 110/70 mmHg, PR 75 bpm, spO2 99% RA. Pt advised to wait 30 minutes for further observation. Vitals reassessed at approx. 1115. BP 120/80 mmHg, PR 75 bpm, spO2 99% RA. Pt reported no throat irritation and stated she felt fine. Pt advised to sign up on CDC V-safe. Pt left facility with steady gait and unlabored breathing at approx. 1120.
41 2021-03-25 ear discomfort, hearing loss Started with horrible skull pain behind my left ear(Like a bad headache) . Swollen Lymph Nodes so s... Read more
Started with horrible skull pain behind my left ear(Like a bad headache) . Swollen Lymph Nodes so swollen it caused pressure on my ear and pain in outer ear. My NP could not confirm it was from the vaccine. They put me on an antibiotic and steroids and no relief .. then ear drops... I still cannot hear out of my ear completely and the Lymph nodes in neck, collar bone and armpits are still there and it's been 16 days since I had the shot.... I am refusing the second injection because of this. Nothing on right side of body only on left which is the injection side.
41 2021-03-25 oropharyngeal discomfort, feeling of choking, mouth numbness, mouth tingling Severe allergic reaction to 1st does of the Pfizer vaccine. After 15 minutes "throat clearing" star... Read more
Severe allergic reaction to 1st does of the Pfizer vaccine. After 15 minutes "throat clearing" started and between 25-30 minutes my throat got "thick" and my body began tingling all over. My breathing became labored and difficult, my lips were numb. I was immediately administered an EPI pen, and was transported by ambulance to the ER . I was also treated with albuterol, solumedrol, and benedryl. I remained in the ER for the entire day, and was discharged in the evening. I was prescribed Claritin, and prednisone, and given an epi pen. I followed up with my doctor on the following Monday, still experiencing chest pressure and numbness/tingli