Pfizer

Nervous system symptom reports

Male, 40 - 59 years

Age Reported Symptoms Notes
40 2021-01-03 tingling, feeling hot, hot flush Pt entered observation around 1950. Around 2010, stated that "his body felt warm and tingling, thro... Read more
Pt entered observation around 1950. Around 2010, stated that "his body felt warm and tingling, throat was sore, and he had a flush feeling". Denies SOB or chest pain when asked. Continued to remain in observation. Stated that he felt somewhat better around 2015. Still had the same symptoms but they were letting up some. Around 2025, he stated that he felt better and the symptoms had stopped. Pt left observation @ 2027
40 2021-01-04 tingling, feeling cold, cold extremities, sensory loss COVID vaccine Tuesday. Some soreness at the site that resolved over 2 days. Over the past 24 hours... Read more
COVID vaccine Tuesday. Some soreness at the site that resolved over 2 days. Over the past 24 hours, developed some mild parasthesias [nonspecific]. Aren't painful, but tingling is annoying, contributed to restless night last night. Response 12/26: Acetaminophen, Start B-complex with Fe, report if not already done Chart 12/26: Reported. A bit better this am but will start vitamins Chart 12/29 [excerpt] Still having same symptoms of parasthesias. Started multivitamin as well as acetaminophen. I've noticed it affects only the right side of my body, and that it's purely sensory, no motor changes. Still mild, but not been sleeping well Responded, scheduled appt.   Vaccinated in L deltoid. Describes R side of body feels 'Cold' [dysesthesia] on R side of body and extremities. No weakness, no change in ROM. No joint swelling. No rash. Sensation feels less on R but still sense of touch. Thinks this is about the same- notices more when lies down in bed than in daytime. Symptoms persist 1/5/2021: Referred to Neurology at his request
40 2021-01-06 weakness Drowsy, injection site pain, chills, aches/pains, weakness
40 2021-01-06 feeling cold lost his sense of smell/cannot smell anything; Sore throat; sweating a lot; Fever; chills; body felt... Read more
lost his sense of smell/cannot smell anything; Sore throat; sweating a lot; Fever; chills; body felt cold; This is a spontaneous report from a contactable consumer (patient) reported that a 40-year-old male patient receives first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: EH9899 and Expiration Date: 31Mar2021) via an unspecified route of administration on 21Dec2020 14:30 at single dose in left arm for Precaution (covid-19 immunization). NDC number of Pfizer COVID Vaccine: 59267-1000-2. The patient's medical history and concomitant medications was reported as none. The patient works in a hospital and got the first shot. Before he got the vaccine, he did not have any symptoms and felt great. They told him he may feel some symptoms for a couple of days. Now, he was getting symptoms of COVID 2 nights ago (around 20:00 28Dec2020) such as fever, chills, body felt cold, fever. Last night (30Dec2020) when he slept, he sweated a lot. Maybe it is one of the reasons. He did not have a fever, but he sweated a lot. He felt like his shirt was wet in the morning. He also had sore throat and lost his sense of smell on 06:00 31Dec2020. It is weird. He never had that before. He doesn't know what the do. If it was normal or it was symptoms of COVID. Second one will be on 12Jan2020. Should he get tested for COVID. Wanted to know if he should get the second dose. The outcome of events, fever, chill, felt cold, sweating a lot was recovering. The outcome of sore throat and cannot smell anything was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
40 2021-01-06 tingling Employee returned to vaccination area at 13:45, reported mild intermittent tingling in hands and fee... Read more
Employee returned to vaccination area at 13:45, reported mild intermittent tingling in hands and feet bilat; primarily feet and primarily when he sat down. Also reported mild brief blotchiness to bilat lower forearms. Narrative: Mildly anxious, mild reactions to which he was unsure if he should return to vaccination site or not. Denied dizziness, light-headedness, palpitations. Reported mild feeling of a 'rush' "kind of feeling, like, stimulated". VS: at 13:46: BP 14977. O2 99%, P 79, T 36.3. Reported he had been continuing doing his duties without difficulty but didn't know if he should be concerned. Noted blotchiness on forearms under different lighting when he went to restroom. Blotchiness mild to moderate and mostly resolved before he left. VS at 14:02: BP 136/69, O2 99%, P 80, T 36.7. Reported tingling mostly resolved if he stretches his legs out some. Reported anxiety over "the whole thing. It's just weird and I've been excited about the vaccine". Reviewed S/S to be aware of, when to seek medical attention and that he was feeling completely stable and comfortable before he left. Positively reactive to increased information and seeing improvement in blotchiness. Left at 14:08.
40 2021-01-10 difficulty speaking AT APPROXIMATELY 1000, PATIENT BEGAN COMPLAINING OF FEELING "VERY NAUSEOUS" AND NEEDED A BIN. PATIE... Read more
AT APPROXIMATELY 1000, PATIENT BEGAN COMPLAINING OF FEELING "VERY NAUSEOUS" AND NEEDED A BIN. PATIENT WAS BROUGHT BACK INTO THE IMMUNIZATIONS CLINIC FROM THE WAITING ROOM. ONCE SEATED, PATIENT THEN BEGAN FEELING "HOARSE AND TROUBLE BREATHING", WHICH THEN EPI-PEN WAS GIVEN AT 1004. VITALS AFTER EPI PEN BP 133/77 O2 99% HEARTRATE 103. CODE WAS CALLED SIMULTANEOUSLY. PATIENT WAS THEN BROUGHT TO EMERGENCY DEPARTMENT VIA WHEELCHAIR WITHIN THE HOSPITAL BY CODE TEAM.
40 2021-01-10 pain in extremity Fatigue Sore throat, Arm pain-resolved 24hr
40 2021-01-11 migraine Migraine 26 hrs after shot, Nausea 20 hrs after shot
40 2021-01-11 pain in extremity Bad chills and muscle aches, intermittent for 30 hours, controllable with Tylenol and ibuprofen arou... Read more
Bad chills and muscle aches, intermittent for 30 hours, controllable with Tylenol and ibuprofen around the clock. No fevers. Mild localized arm pain. Mild cough.
40 2021-01-12 flushing, tingling Itchiness, flushing, tingling, redness
40 2021-01-12 numbness This patient experience left sided numbness (felt like left arm and left leg was heavy); This patien... Read more
This patient experience left sided numbness (felt like left arm and left leg was heavy); This patient experience left sided numbness (felt like left arm and left leg was heavy); This is a spontaneous report from a contactable pharmacist. A 40-year-old male patient received first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EL1284; expiration date: unknown), intramuscular left arm on 07Jan2021 11:00 at a single dose for covid-19 vaccination. The patient has no medical history. The patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not have any other medications the patient received within 2 weeks of vaccination. The patient received the most recent COVID-19 vaccine in a nursing home/senior living facility. This patient experience left sided numbness (felt like left arm and left leg was heavy) on 07Jan2021 11:00 AM. The event was reported as non-serious. The adverse event result in emergency room/department or urgent care visit. No treatment was received for the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was unknown.
40 2021-01-13 pain in extremity, weakness Per reporter: "I received the COVID vaccine on 12/29/2020 (first dose). The first couple days I had ... Read more
Per reporter: "I received the COVID vaccine on 12/29/2020 (first dose). The first couple days I had a really sore left arm, but didn?t feel any ?side effects? until about Wednesday, 1/6 (about a week later). I remember waking up to a sore left side of my upper body. The left side of my neck, chest, arm, and lymph node (under my left arm) felt weird. It was until about Saturday night, 1/9, that I felt my left under arm lymph node noticeably swollen. I had a bad headache and loss of energy, and overall feeling unwell. No fever or night sweats to report. I was absent from work on 1/11 and 1/12, as a result. 1/13 was my first day back and feel better. The swollen left lymph node is no longer present, but still slightly tired. I did not seek Medical Care for my symptoms.
40 2021-01-17 feeling cold Chill, malaise, malaise started that night. Headache/malaise next day. Slight runny nose 2 days lat... Read more
Chill, malaise, malaise started that night. Headache/malaise next day. Slight runny nose 2 days later. Nasal congestion starting 4 days later. Diagnosed with active COVID-19 infection 6 days later.
40 2021-01-17 pain in extremity Patient with PMH of depression and GERD who presented 1/8 with constipation, abdominal discomfort an... Read more
Patient with PMH of depression and GERD who presented 1/8 with constipation, abdominal discomfort and worsening dyspnea. Symptoms began around 12/29. COVID vaccine 12/19. Previously quite active, marathon runner, gained some weight over last couple years but was still in good enough shape to complete 10K in New Orleans in early February. In late February, had a flu-like illness, as did one of his friends from church. 2020 was hard on him - weight gain, decreased activity, stress, overall deconditioning. No issues apart from sore arm after COVID vaccine 12/19 but then starting getting abdominal fullness/discomfort around 12/29, which steadily worsened, also develop worsening dyspnea on slight exertion. No known sick contacts.. Work-up notable for pericardial effusion, pleural effusions. Echo with severe diffuse LV hypokinesis, concern raised for myocarditis. COVID PCR negative, serology negative. RVP negative. . Concern raised that COVID vaccine may have played a role in myocarditis. He was found to have the following conditions Acute heart failure with reduced EF NYHA FC II, non-ischemic cardiomyopathy. Myocarditis appears subacute per MRI hypertension obesity small pericardial effusion- asysmptomatic no pericarditis suspected obstructive sleep apnea. .Started on the following medications. Continue Carvedilol 12.5mg BID, Farxiga 5mg daily, Digoxin 0.125mg daily, Entresto 97-103mg BID, and Spironolactone 25mg daily. Per MD note. While it remains uncertain, team is doubtful COVID vaccine played a role in his cardiac issues. Given the MRI findings are not acute, more likely that the cardiac insult occurred weeks to months ago - potentially in the setting of the February 2020 illness. Perhaps his "deconditioning" in 2020 was related to worsening cardiac function. Nevertheless, will hold on 2nd COVID vaccine dose given absence of a clear explanation for his myocarditis. conversation with team will continue to determine if candidate for second covid vaccine. If consensus is that myocarditis pre-dated vaccine, might be able to proceed with dose 2 of vaccine.
40 2021-01-17 tingling to ed with chest pain, diaphoresis and arms tingling
40 2021-01-18 tingling, burning sensation I have had nueropathy induced by antibiotics in the past. I have been in remission for 6 weeks after... Read more
I have had nueropathy induced by antibiotics in the past. I have been in remission for 6 weeks after a one week reaction to St Johns Wort, but before that was in remission for a year or two. 25 hours after getting the covid vaccine last week, I started getting burning nerves, tingling, and pins and needles, which has only gotten worse in the last 3 days. There were no symptoms of this right before the vaccine.
40 2021-01-19 pain in extremity, numbness About 3 minutes after the shot I begin to taste it in my mouth and seconds after that my pinky and r... Read more
About 3 minutes after the shot I begin to taste it in my mouth and seconds after that my pinky and ring finger on my left hand went numb and has been like that ever since. At one point my whole hand tingled. I even had pain in my bicep on the same side
40 2021-01-20 weakness Drowsy; Weak; Pain in the knees/pain in his joints/joint pain from his Legs, Arms, and fingers; Both... Read more
Drowsy; Weak; Pain in the knees/pain in his joints/joint pain from his Legs, Arms, and fingers; Both of his eyes feel tired; could not lift arm; bruised under the arm; back pain; neck pain; could not turn neck; headache; Pain with bending head down; This is a spontaneous report from a contactable consumer. A 41-year-old male consumer received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm on 11Jan2021 at 07:45 at single dose for COVID-19 immunisation at the age of 40-year-old. Medical history included HIV infection, root canal in Dec2020, COVID-19 in Jun2020 or Jul2020. Concomitant medications were unknown. Vaccination history included first dose of BNT162B2 on 21Dec2020 for COVID-19 immunisation (could not lift arm, bruised under the arm, back pain with his neck he could not turn it, he could not be on his left side where he got the shot on left arm, headache). The patient experienced drowsy, weakness, knee pain, joint pain, could not lift arm, bruised under the arm, back pain, neck pain and could not turn neck, Headache, pain with bending head down, both eyes feel tired. In Jun2020/ Jul2020, the patient resulted positive to SARS-CoV-2 test; then, the patient had 3 negative SARS-CoV-2 test; weight: lost. The outcome of the events was unknown. Information on the lot/batch number has been requested.
40 2021-01-21 tingling, numbness Reports he has been diagnosed with Guillain Barre syndrome. Symptoms started with 2 fingers tingling... Read more
Reports he has been diagnosed with Guillain Barre syndrome. Symptoms started with 2 fingers tingling 1/11/21. Progressively increasing in severity. Now has numb fingers and toes. Initiating IV therapy 1/22/21.
40 2021-01-22 burning sensation, hypersensitivity of all senses, tingling Progressive Burning of fingers and toes followed by worsening tingling and hyperasthesia . Notable S... Read more
Progressive Burning of fingers and toes followed by worsening tingling and hyperasthesia . Notable Symptoms started 48 hrs post second dose of covid 19 vaccination , worsened over the next 7-10 days. Basic metabolic lab work done. Seen by neurology on 1/21/2021. Started on IV therapy on 1/22/2021. Ongoing transfusion treatment in an outpatient setting
40 2021-01-25 facial pain, facial paralysis Inmate seen in health services with complaint of left ear pain extending into left cheek and around... Read more
Inmate seen in health services with complaint of left ear pain extending into left cheek and around his mouth. He has some drooping of the left side of his mouth and he is not able to blink or close his left eye. He noticed symptoms on 1-23-2021, the Saturday after getting the COVID 19 vaccine on 1-21-2021 (Thursday). Had some trouble swallowing liquids without having them dribble out the left side of his mouth and he says that he is not able to chew on the left side without biting his tongue. Says that his left ear is causing him a great deal of pain.
40 2021-01-26 pain in extremity STARTED 1/27/2021 5AM WITH GENERAL MALAISE, BODYACHE, NAUSEA, EYE REDNESS, PHOTOPHOBIA, FEVER, LEFT... Read more
STARTED 1/27/2021 5AM WITH GENERAL MALAISE, BODYACHE, NAUSEA, EYE REDNESS, PHOTOPHOBIA, FEVER, LEFT ARM AND AXILLARY PAIN ,
40 2021-01-27 pain in extremity Fever; chills; nausea; vomiting; diarrhea; sore arm; This is a spontaneous report from a contactable... Read more
Fever; chills; nausea; vomiting; diarrhea; sore arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at right arm on 15Jan2021 16:00 at single dose for COVID-19 immunization. Medical history included COVID prior to vaccination. The patient has no known allergies. The patient's concomitant medications were not reported. The patient experienced fever, chills, nausea, vomiting, diarrhea, and sore arm on 16Jan2021. No treatment was received for the events. The patient was not tested for COVID post vaccination. The patient was recovering from the events.
40 2021-01-28 speech disorder Received COVID vaccine and within 2 minutes developed tongue "thickness", throat tingling, overactiv... Read more
Received COVID vaccine and within 2 minutes developed tongue "thickness", throat tingling, overactive salivary glands, light-headed. States speech was affected due to tongue swelling. No respiratory distress. Took Benadryl 25mg approx. 45 minutes after symptom onset. Symptoms improved 1 hour after taking Benadryl dose. Does NOT plan to receive 2nd dose due to immediate allergic reaction.
40 2021-01-31 feeling cold, feeling hot 30th January 2021-Am-rash-size od baseball, chills, HA-is this his from his tooth or COVID-19-he won... Read more
30th January 2021-Am-rash-size od baseball, chills, HA-is this his from his tooth or COVID-19-he wonders, PM-freezing & hot body. 31st January 2021-more of the same-chills, HA, hot body- freezing, rash still present on his left deltoid area 1 February 2021-less chills, moving slowly, Left deltoid less hot, not as freezing Taking Tylenol, motrin. Reminded IF he gets worse-go to the ER. Reminded him-does he need to contact his PCM-do so.
40 2021-01-31 tingling Headache, nerves in skin were raw and inflamed, agitated by touch. Fever, chills. Nausea. Chest co... Read more
Headache, nerves in skin were raw and inflamed, agitated by touch. Fever, chills. Nausea. Chest congestion, cough. Loss of taste and smell (this began on 01/31). All side effects symptoms are still present on 02/01.
40 2021-02-01 tremor About 2 to 3 minutes after receiving the injection I felt light headed and passed out. My wife said ... Read more
About 2 to 3 minutes after receiving the injection I felt light headed and passed out. My wife said my eyes were open but glazed over. I also started shaking. When I woke up I was confused and felt nauseated. A few minutes after I woke up the EMTs ran my vitals. My heart rate was in the 40s and my blood pressure was in the 90s. I have never had a reaction like this to any other shot/vaccines.
40 2021-02-04 cold sweat First day - Cold sweats, Fever, Chills, Headache, Nausea, Diarrhea, Body aches, Extreme back pain. S... Read more
First day - Cold sweats, Fever, Chills, Headache, Nausea, Diarrhea, Body aches, Extreme back pain. Second day - Back pain, Nausea, No fever
40 2021-02-04 numbness, tingling Guillain Barre syndrome/Symptoms started with 2 fingers tingling; This is a spontaneous report from ... Read more
Guillain Barre syndrome/Symptoms started with 2 fingers tingling; This is a spontaneous report from a contactable nurse reporting for a patient. A 40-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176), via intramuscular on 09Jan2021 at single dose in left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), via intramuscular on 22Dec2020 at single dose in left arm at the age of 39-year-old for COVID-19 immunization. Reported he was diagnosed with Guillain Barre syndrome. Symptoms started with 2 fingers tingling on 11Jan2021. Progressively increasing in severity. Now had numb fingers and toes. Initiating IV therapy on 22Jan2021. The adverse event result in Doctor or other healthcare professional office/clinic visit. The outcome of the event was unknown.; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset. More information such as complete medical history and concomitant medications are needed for fully medical assessment. 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 2021-02-05 flushing 40 y.o. male with PMHx including asthma and HLD presenting to the ED today with c/f allergic reactio... Read more
40 y.o. male with PMHx including asthma and HLD presenting to the ED today with c/f allergic reaction. Pt is coming in after about 35 minutes ago he had some extreme flushing he describes it as "feeling like he put his head in an oven and some skin itchiness on his arms. He notes he started taking niacin today. He also got his second dose of his Covid vaccine last night. He has no throat swelling or difficult breathing. He has not had any nausea or vomiting. He denies any recent fevers or chills. He did switch his asthma medications to Trelegy last week. He otherwise has no other allergies. The patient had just started taking Niacin which is more likely the etiology of the case in question and symptoms rather than the vaccine-pfizer. Most likely this was related to the niacin and not the pfizer vaccine.
40 2021-02-07 unresponsive to stimuli Patient presents to ED on 1/14/2021 with respiratory arrest and started around 1300. Per EMS, report... Read more
Patient presents to ED on 1/14/2021 with respiratory arrest and started around 1300. Per EMS, reportedly told fiance that he had taken some sleeping pills and was going to go to sleep. EMS was called after the patient was found unresponsive about 15 minutes later. Family attempted to do CPR. Upon EMS arrival to the patient's home, patient had a pulse, was in respiratory distress with agonal breathing. They also reported emesis in the airway. EMS performed nasal intubation and administered 10 mg IV Narcan en route. Upon arrival to the hospital, patient was moving arms more and gritting teeth. Patient had movements of decerebrate posturing of arms intermitting with a relaxed posture. GCS was 4 on arrival. Patient is currently still in ICU and has been extubated.
40 2021-02-08 hypersensitivity of all senses, feeling hot, pain in extremity, burning sensation Saturday evening experienced headache and nausea. Both symptoms continued and left upper arm began t... Read more
Saturday evening experienced headache and nausea. Both symptoms continued and left upper arm began to feel hot and very painful and sore to touch which started later in the evening. Sunday all day nausea, headache and sore arm continued with chills and whole body feeling hot. I may have had a fever but did not confirm with thermometer. Treatment included increase hydration with water and rest. I felt like my normal self on Monday morning.
40 2021-02-09 pain in extremity, night sweats Within 5 minutes of getting the shot on 2/6 I felt pain in the upper arm that moved down to forearm ... Read more
Within 5 minutes of getting the shot on 2/6 I felt pain in the upper arm that moved down to forearm into left pinky. At approximately 3 pm arm started to hurt at the injection site. Iced for the next 36 hours until the swelling went down. On 2/7/21 at 10 pm started feeling like sickness was starting. On 2/8/21 was lethargic with body aches, headache, dry cough, and temperature up to 101.5 degrees F. Took 325 mg of Tylenol every 6 hrs. 2/9/21 up dose of Tylenol to 500 mg every 6 hrs as fever increased. Experienced night sweating and severe joint pain in hips, lower back, and along the upper spine. Fever broke at approximately 7 pm 2/9/21. Joint pain continues through 2/10/21
40 2021-02-09 pain in extremity All body temperatures taken with the same infra-red thermometer at same site, center of forehead. Re... Read more
All body temperatures taken with the same infra-red thermometer at same site, center of forehead. Regularly Consume approximately 3/4 Gallon of water through the course of a day. 2/08/2021 3:30pm - Injection 4:30pm - Typical sore arm 2/9/2021 8:00am - Slept through the night, very drowsy, some body aches, temp 99.8 9:00am - Body aches growing in intensity, temp 101.1 12:00am - Chills, severe body aches, temp 102.6, went to lay down, fell asleep 6:00pm-11:00pm - Severe body aches continue, temp 103.9 - 104.3, monitored every hour. Went to bed 2/10/2021 Fever has come down, 99.7 at this time Body aches in my back continue, along with random chills. Research suggests not consuming any OTC medications such as NSAIDs, and other pain relievers/fever reducers, and allow the vaccination to run its course, as this may impede the body's immune response to the vaccination. No treatment was sought.
40 2021-02-10 pain in extremity Patient was observed for 30 minutes. After that time, patient stated to the observer, RN her left ar... Read more
Patient was observed for 30 minutes. After that time, patient stated to the observer, RN her left arm "hurt all the way down" and "chest felts heavy". Encouraged patient to go to ED, but patient declined. Nurse assessed patient who then felt short of breath. Two RNs took patient, via wheelchair, to ED. Husband was with patient. ED triage took patient back and husband checked in patient.
40 2021-02-12 sensory loss, mild one side paralysis CVA/thrombotic event. R sided weakness and sensory deficit. No preexisting risk factors. Hyperco... Read more
CVA/thrombotic event. R sided weakness and sensory deficit. No preexisting risk factors. Hypercoaguable work up negative. Managed conservatively. Improvement without resolution of symptoms to date.
40 2021-02-12 tremor Violent tremors or chills in the middle of the night for half an hour, followed by a burning electri... Read more
Violent tremors or chills in the middle of the night for half an hour, followed by a burning electric feeling in my muscles. Not able to sleep afterwards. Woke up and muscles in body are very tight and tense.
40 2021-02-16 pain in extremity Symptoms began at 6pm. Fever, headache, runny nose, chills, pain in left arm, nausea. Took 1 Advil a... Read more
Symptoms began at 6pm. Fever, headache, runny nose, chills, pain in left arm, nausea. Took 1 Advil at 7pm. Advil is cutting the pain.
40 2021-02-20 breast pain I had practically no side effects from shot #1....shot #2 was different. Starting about 6-8hrs after... Read more
I had practically no side effects from shot #1....shot #2 was different. Starting about 6-8hrs after injection I started to feel lethargic. By 10hrs, I started with varying chills/sweats that lasted all night, injection site soreness, and soreness in left breast area. The next day I was extremely exhausted and had trouble staying awake. Muscle aches in both shoulders and neck. Also had varying fever from 100 up to 104.1 throughout the day. At 36hrs after injection. I took 2 Advil to help with the muscle aches...nothing taken to this point. 48hrs After injection some energy returned, but still lethargic throughout the day, and occasion fever between 100-101. During shower, I noticed swelling under my left armpit, not present on the right side. At 60hrs after injection, fever gone, energy returned...lingering soreness of left shoulder and breast area and swelling under left armpit remains. At no point did I have any breathing or lung issues...but otherwise it felt like I had a bad flu (minus the coughing/wheezing) for 2 days.
40 2021-02-22 pain in extremity My arms felt sore soon after the injection I felt a little tired around 9:00 a.m on the 23rd. and th... Read more
My arms felt sore soon after the injection I felt a little tired around 9:00 a.m on the 23rd. and then extreme fatigue chills and body aches around 7:00 p.m.
40 2021-02-23 hot flush, numbness Felt fine during the 15min waiting period, but once I got back to work started getting hot flashes b... Read more
Felt fine during the 15min waiting period, but once I got back to work started getting hot flashes but no temp and face went numb. still had smell and taste just felt like I went to the dental where they numb your face. Went to the ER because Nurse Advice Line said to. ER gave me Benadryl and that is all. Had symptoms for about two weeks.
40 2021-02-23 pain in extremity very sore arm, could not lift it, fatigue hit almost 24 hours exactly after injection, rash the foll... Read more
very sore arm, could not lift it, fatigue hit almost 24 hours exactly after injection, rash the following day over chest and neck
40 2021-02-25 numbness Systemic: Numbness (specify: facial area, extremities)-Mild
40 2021-02-27 numbness Heart attack. Chest pain and numbness in both arms and back. The pain lasted from 3:00AM until 5:00A... Read more
Heart attack. Chest pain and numbness in both arms and back. The pain lasted from 3:00AM until 5:00AM at which time I as in the ER. Troponin levels were at 6.0 and I had a small abnormal finding on my EKG. The Cardiovascular physician on call said it could be something and they would do a cardiac cath to determine where a blockage may be. The angiogram cam back with no blockages. troponin levels reached a 10 by the end of the first day. The Echo the next day showed no issues in structure. The Cardiac MRI showed fluid and 4% of my heart had myocarditis from the issue. Troponin levels reduced to 7, then 6 by the end of the second day. On the third day I went home with new meds, an order for a follow up and cardiac rehab.
40 2021-03-02 pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA: Patient presents to urgent care one day after vaccination with... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Patient presents to urgent care one day after vaccination with fatigue, chest tightness, back pain, myalgias, headaches, right arm soreness, and decreased concentration. Patient states had COVID-19 illness in October 2020 and current symptoms are similar. Patient denies facial/throat swelling, palpitations, rash, or lesions and reports some symptom improvement with acetaminophen. Vitals within normal ranges except blood pressure 141/84 attributed to white coat syndrome. Advised to continue acetaminophen and discharged to home stable.
40 2021-03-02 pain in extremity Sore upper arm. Red ring around injection site. Tender, itchy, raised skin around injection site.
40 2021-03-03 numbness After 5 min of receiving the vaccine, client became diaphoretic, pallor observed and reported numbne... Read more
After 5 min of receiving the vaccine, client became diaphoretic, pallor observed and reported numbness to bilateral hands. BP taken using manual cuff at 14:26 hrs and recorded 68/42, HR 51 bpm with O2 saturation of 98 % on RA. LCTA, S1 and S2 audible to L apex 4th intercostal space. Water was provided to the client. EMS was notified; EKG was obtained. Last V/S: BP of 103/68, HR of 79 bpm and RR of 18. Client declined EMS care and declined to go to the hospital. Client was discharged home with wife; ambulated to car with steady gait. Alert/ Oriented x 3.
40 2021-03-03 pain in extremity Pfizer-bioNTech Covid-19 Vaccine Sore arm Tired
40 2021-03-04 feeling hot I got really hot and started sweating a few minutes after my injection and I have been getting hot a... Read more
I got really hot and started sweating a few minutes after my injection and I have been getting hot and sweaty for no reason since. I want to know if it's safe to get the second injection. And if this will go away.
40 2021-03-06 burning sensation, electric shock sensation, numbness and pain in extremities I have a history of neuropathy that has been dormant most of the last year. I went in with no nuerop... Read more
I have a history of neuropathy that has been dormant most of the last year. I went in with no nueropathy occuring to get my vaccines. After the 1st Pfizer shot I had neuropathy starting the day after that went away in about a week. After the 2nd about 3 days later it started with itching all over my body (neuropathic itch), and burning mostly in my feet, but random electrical shocks throughout my body 24/7 (while awake). It has not subsided and has actually gotten worse. There are at least a dozen people on the clinic message board saying the same thing happened to them, that the vaccine awakened or made worse their neuropathy exponentially. Here is the link to similar complaints.
40 2021-03-08 feeling hot, tremor, pain in extremity Within 8-10 minutes I had a wave of heat start from the back of my head to the front, like the feeli... Read more
Within 8-10 minutes I had a wave of heat start from the back of my head to the front, like the feeling you get right before you go under from anesthesia. My heart began to race and I was lightheaded. I reported the reaction and was given an oximeter to check oxygen and heart rate. Heart rate was 140, oxygen 99. BP was also checked and was normal. Was given water and sat for another 10 minutes. Felt better and heart rate was under 100 until another wave of lightheadedness came over me and heart rate spiked again to over 120. It came down again. A few minutes later lightheadedness came back, shaking started, and heart rate spiked again. It lasted about 10 minutes. After 55 minutes of staying at facility I was able to leave. However, did have one more brief episode of lightheadedness and heart rate spiking. Sore arm and extreme ringing in one ear were only side effect the following day.
40 2021-03-09 weakness Following 1 week of the normal symptoms, 2 weeks of weakness, muscle pain and mild depression.
40 2021-03-09 pain in extremity Muscle aches, chills, 100.4 temperature, headache, sore arm. All lasted approximately 12 hours
40 2021-03-10 numbness Jaw pain/tightness, tongue numbness (sides) within first 5 min after injection; mild and lasted for... Read more
Jaw pain/tightness, tongue numbness (sides) within first 5 min after injection; mild and lasted for 1-2 hours.
40 2021-03-11 numbness patient waited his 15 minutes for observation. he walked out of the vaccination clinic about 12:23 ... Read more
patient waited his 15 minutes for observation. he walked out of the vaccination clinic about 12:23 & returned at 12:25 due to feeling like his tongue was numb. he also felt shaky & dizzy
40 2021-03-13 tremor, cold sweat Systemic: Dizziness/ Lightheadness-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Syst... Read more
Systemic: Dizziness/ Lightheadness-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Additional Details: Patient warned immunizer that he was anxious about receiving vaccine because he is scared of needles. Once he received the vaccine, he became nauseous, sweaty, clammy, dizzy and lightheaded. Pt explained to immunizer that he was switched to night shift and had taken his diabetic meds without food soon before his shift at 5:30pm. An EMT was on scene and she proceeded to call more medics. I checked on the pt and he was vomiting and very pale. Medics checked pt vitals and okayed him for work.
40 2021-03-14 pain in extremity When I woke up the morning after I receive the vaccine, it was very painful to move my left arm. The... Read more
When I woke up the morning after I receive the vaccine, it was very painful to move my left arm. The pain increased if I moved my arm greater than perpendicular to my body. The worst pain though with with my back. I could not stand up straight without a sharp pain starting in my lower back. I was also extremely tired. So I called into work took some Tylenol and went back to bed. By 1 o?clock that afternoon I had felt fine as if nothing had ever happened.
40 2021-03-17 pain in extremity Headache, Sedation, Myalgia, Diarrhea, Tachycardia, "I feel like my heart is beating fast" "tired an... Read more
Headache, Sedation, Myalgia, Diarrhea, Tachycardia, "I feel like my heart is beating fast" "tired and sluggish and slow". Soreness in arm is painful and radiating to neck on left side Narrative: Advised to seek treatment from PCP or Emergency services if symptoms do not improve, worsen, or become severe Other Relevant History:
40 2021-03-17 tremor Metallic taste at 6 hours & headache 103 temp at 12 hours with chills and shakes 101 temp at 30 hou... Read more
Metallic taste at 6 hours & headache 103 temp at 12 hours with chills and shakes 101 temp at 30 hours
40 2021-03-19 weakness I had difficulty concentrating and focusing on Wednesday evening, a little over a day after getting ... Read more
I had difficulty concentrating and focusing on Wednesday evening, a little over a day after getting my first shot. The focusing/concentration issues went away by the next morning when I woke up, however I have been feeling very tired physically since then. I'm yawning all day and have very little energy or interest in doing things I need to be doing. I'm not certain that this is vaccine related, and I'm not super concerned about it yet as I'm on Spring break from school, but I start virtual classes again on Monday and will be concerned if I'm still super tired. If it doesn't go away by next weekend, I will likely resubmit/add on to this report if that is an option. It is not a serious concern yet so I haven't contacted medical professionals yet, but I thought it might be a good idea to at least report that this has been going on to VAERS
40 2021-03-20 muscle twitching Began with myokymia (twitch) in left eye which persisted for almost 2 months. Has since spread to r... Read more
Began with myokymia (twitch) in left eye which persisted for almost 2 months. Has since spread to right eye. Now experiencing blurred vision, double vision, and random muscle twitching in limbs.
40 2021-03-20 tremor, flushing Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: F... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild
40 2021-03-21 migraine Pfizer-BioNTech COVID-19 Vaccine EUA Severe headache & migraines without relief for approximately 72... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Severe headache & migraines without relief for approximately 72 hours.
40 2021-03-22 bell's palsy Bells Palsy
40 2021-03-23 seizure Patient had a seizure/convulsion immediately after the vaccination. I did not personally see them ha... Read more
Patient had a seizure/convulsion immediately after the vaccination. I did not personally see them have the convulsion, but his wife observed this. By the time I had made it to the vehicle he had come to and was fine. Patient was also extremely anxious about receiving the vaccination. We believe his anxiety may have manifested as a seizure/convulsion in some way. No other issues or allergic reactions.
40 2021-03-24 difficulty speaking, pain in extremity Starting at 8pm on vaccination day I got loopy and disoriented, and had a hard time speaking intelli... Read more
Starting at 8pm on vaccination day I got loopy and disoriented, and had a hard time speaking intelligibly. I also had trouble with balance and fine motor skills. Had some personality changes too: became very moody with erratic mood swings. The next day I slept all day because of exhaustion and aches. When I woke up on Wednesday (36hrs later) I was literally screaming in pain because of how bad my arm and shoulder hurt. It hurt to move it, and hurt not to move it. It was excruciating and ibuprofen didn't seem to help at all. Throughout Wednesday I could hardly move my left arm. Getting dressed or washing my hair was very difficult and very painful. I was also still very uncoordinated. My left armpits lymph nodes were so swollen that (1) it filled in my entire armpit so there was no more pit, just a very soft bulge, and (2) the fluid extended all the way to my chest and it looked like I had one breast and one pec.
40 2021-03-24 tingling Fatigue, headache, tingling feeling, mild vertigo and nausea
40 2021-03-24 tremor, night sweats, pain in extremity chills, body aches, uncontrollable shaking, fever, vomiting, night sweats, pain in left arm
40 2021-03-25 tingling the patient felt tingling in the vaccination arm.
40 2021-03-26 unresponsive to stimuli Patient came up to counter, stated he felt dizzy. Leaning to the left. Assisted patient into the cha... Read more
Patient came up to counter, stated he felt dizzy. Leaning to the left. Assisted patient into the chair. Patient proceeded to lose consciousness. Sternal rub ineffective. Weak pulse. Called for FNP (Clinic manager) who brought out Ammonia after assessing the patient. Patient came back around after approximately 60 seconds. Patient did lose control of bladder. Once patient came to, assited to lying down in an exam room for further observation. Patient ambulated out of clinic with father after about 45 minutes.
40 2021-03-27 hot flush Headache. Hot flashes. Cold flashes. Body aches. Dizzy
40 2021-03-28 weakness I was surprised that I am having any side effects due to the fact that I am so very lucky in that de... Read more
I was surprised that I am having any side effects due to the fact that I am so very lucky in that department, in most cases. The first day, following the shot, I had a bit of soreness at the injection site but it was gone by the following day, Friday, 3/26/21. I had a general feeling of weakness the afternoon and into the night on the day of the shot as well. However, it was about midday or a bit after the following day that I began feeling obvious side effects. These include, primarily, a general feeling of being ill. Headache (but that's not that abnormal & body aches and stiffness similar to a mild version of influenza. It appeared late in the day on Saturday, 3/27/21 and has continued since. (See next page)
40 2021-03-28 discomfort Tingle in Left side of tongue. Pressure on Left side of face. Left jaw muscle feels like I have been... Read more
Tingle in Left side of tongue. Pressure on Left side of face. Left jaw muscle feels like I have been clenching it for a long time.
40 2021-03-28 hypersensitivity of all senses 1/5 vaccination 1/7 I started feeling like hyperesthesia around R side of chest and abdomen; sensiti... Read more
1/5 vaccination 1/7 I started feeling like hyperesthesia around R side of chest and abdomen; sensitive to clothing. Persisted for few days. Is this Shingles? Lesion on my back. 1-2 more appeared. I started to take Valtrex for it. Took about 3 weeks to clear up.
40 2021-03-29 numbness, tingling awakened with sensation of numbness/tingling in all fingers of both hands on 3/28/2021 after having... Read more
awakened with sensation of numbness/tingling in all fingers of both hands on 3/28/2021 after having COVID vaccine in left arm on 3/26/2021. Sensation has been continuously present until 3/30/2021 at 5 pm when he is seen by me for a family medicine clinic visit. He had mild tenderness at injection site but otherwise no other effects. He has no weakness in his hands. No paresthesias in his feet. No clumsiness or motor problem of any time. No fever.
40 2021-03-30 weakness, cold extremities Systemic: Fainting / Unresponsive-Medium, Systemic: Pale, aware of surroundings-Medium, Systemic: Na... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Pale, aware of surroundings-Medium, Systemic: Nausea-Mild, Systemic: Weakness-Medium, Additional Details: Pt was sitting with wife about 10 minutes after vaccine became unresponsive. Wife got my attention. Had weak pulse, cold to touch, but was responsive to me. Knew his surroundings but said didnt feel 100%. Had NP from minute clinic look at him and called EMS for extra evaluation. Pt was transported to hospital
40 2021-03-30 slurring, unresponsive to stimuli Client got lightheaded when changing position from sitting to standing. SN noted client kneeled on a... Read more
Client got lightheaded when changing position from sitting to standing. SN noted client kneeled on all fours and laid on floor. He become confused and verbally non responsive. His breathing was irregular on our assessment. On arousal patient started to respond after 30-40 seconds. His speech was garbled and delayed and patient was aware that he had fainted. He admits to a history of fainting in the past at work. He was able to walk to observation bay to lay down for approximately an hour. Paramedics were called at the beginning of episode. Bp 129/78, Pulse 78 Resp16, O2 sat 98% temp 32 C temporal He rested in bay about a hour and was transported home via car by wife after refusing transfer to hospital by paramedics
40 2021-03-31 pain in extremity sore arm lasting through the next day
40 2021-04-01 weakness Body ache and difficulty sleeping beginning overnight after shot, increasingly unpleasant body aches... Read more
Body ache and difficulty sleeping beginning overnight after shot, increasingly unpleasant body aches, weakness, tiredness throughout following day.
40 2021-04-03 pain in extremity Initial symptoms first 48 hours first dose; Headache; Joint pain- hips and below (left knee locked u... Read more
Initial symptoms first 48 hours first dose; Headache; Joint pain- hips and below (left knee locked up and could not bare weight on it). Tiredness; Second dose 48 hours; Fever 101.8; Tiredness; Severe headache; Sore Arm; Approximately 1 month after 2nd dose unknown if related. Sudden hearing loss left ear; Tinnitus; Lightheaded.
40 2021-04-04 pain in extremity, difficulty speaking, flushing Spoke with pt 1/11/2021 at 1615 and he was doing well, speaks clearly, does have a mild headache, so... Read more
Spoke with pt 1/11/2021 at 1615 and he was doing well, speaks clearly, does have a mild headache, sore arm, and dizzy sensation if moves too fast. He was given NFW today and can return in am to fire house/station. ---- EVENT: This employee reports received 2nd shot and about 10 min later he felt nauseated. The nausea progressed to a gagging, which made him vomit, his throat was hoarse constantly trying to clear, had problems exhaling, could speak easily, felt flushed, mild headache, - staff checked vital signs (normal) and given epi. Taken to ER where skin noted bright red all over (torso, face, extremities), but no further n/v/gagging/sob. ER gave IVNS, IV Benadryl, Solu-medrol, Pepcid, and Zofran. Monitored forSpoke with pt 1/11/2021 at 1615 and he was doing well, speaks clearly, does have a mild headache, sore arm, and dizzy sensation if moves too fast. He was given NFW today and can return in am to fire house/station. ---- EVENT: This employee reports received 2nd shot and about 10 min later he felt nauseated. The nausea progressed to a gagging, which made him vomit, his throat was hoarse constantly trying to clear, had problems exhaling, could speak easily, felt flushed, mild headache, - staff checked vital signs (normal) and given epi. Taken to ER where skin noted bright red all over (torso, face, extremities), but no further n/v/gagging/sob. ER gave IVNS, IV Benadryl, Solu-medrol, Pepcid, and Zofran. Monitored for 2 hours and sent home with coworkers with resolution of all symptoms. 1/15/2021 f/u: advised doing well, no further issues. review as of 4/01/2021 shows he received flu vaccine on 1/22/21 w/o issues.
40 2021-04-05 cold sweat Patient received first dose Pfizer COVID vaccine and was sitting in observation area. Nurse came to... Read more
Patient received first dose Pfizer COVID vaccine and was sitting in observation area. Nurse came to get me and patient was found lying on the floor. Patient was cool, clammy, eyes closed but easy to arouse. Patient's friend states he sometimes has a seizure associated with feeling like this. Patient alert and oriented, able to converse, and states he did not fall but sat down in floor prior to lying down. 1119 VS: 98% RA, pulse 69 and regular, b/p 118/72. Ice pack applied to patient along with fanning of patient. Patient states feeling better and brought to sitting position without difficulty. Patient offered juice which he was able to drink without difficulty. Patient assisted into wheelchair and brought back to observation area. 1128 VS: 98% RA, pulse 79 and regular, b/p 122/72. Patient no longer clammy, able to converse and follow directions without difficulty. Patient states he is feeling much better, able to stand without feeling dizzy or lightheaded. Friends present with patient and will drive patient home. Patient transported to car via wheelchair. Able to transfer into car independently.
40 2021-04-06 numbness and pain in extremities Onset of all symptoms began on March 17, 2021. Symptom (1) Dry mouth: symptoms are still active; (2)... Read more
Onset of all symptoms began on March 17, 2021. Symptom (1) Dry mouth: symptoms are still active; (2) Extreme thirst: symptoms are still active; At the minimum, I consume 366 fluid ounces (2.859 gallons) of water per day. (3) Blurry vision: symptoms are still active; (4) Dizzy/lightheadedness: symptoms ongoing; (5) fatigued/tired/muscle fatigue: symptoms ongoing: (6) fever/chills: symptoms no longer present as of April 6, 2021. (7) Extreme weight loss (30 lbs/13.64 kgs); (8) Neuropathy of both left and right hands: symptoms still ongoing; (9) Mental fatigue: symptoms still ongoing.
40 2021-04-06 pain in extremity Arm pain, general muscle pain, body aches, headache, fatigue, nausea, and lethargy.
40 2021-04-06 tingling Thrombocytopenia (109,000); elevated D dimer (3960); fatigue; subjective fever; headache; sweats; in... Read more
Thrombocytopenia (109,000); elevated D dimer (3960); fatigue; subjective fever; headache; sweats; injection site pain; paresthesias of hand on side of injection; This is a spontaneous report from a contactable physician (reporting for a patient). A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), intramuscularly, administered in arm left on 15Mar2021 (at the age of 40-years-old) as single dose for COVID-19 immunization. Medical history included hypertension and COVID-19 prior to vaccination; patient had no known allergies. Concomitant medication included lisinopril. Patient had no other vaccine in four weeks and the COVID vaccine was received at a Public Health Clinic/Veterans Administration facility. On 15Mar2021, the patient experienced thrombocytopenia (109,000), elevated D dimer (3960), fatigue, subjective fever, headache, sweats, injection site pain and paresthesias of hand on side of injection. The adverse events resulted in emergency room/department or urgent care. The patient was tested for COVID post-vaccination through a nasal swab and Biofire PCR on 22Mar2021 which were both negative. Therapeutic measure taken as a result of the events included IV hydration. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect product bnt162b2 and all reported events. 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 2021-04-07 facial pain Sharp headache in that feels like it's "inside his brain." Also had unilateral ear and head/face pai... Read more
Sharp headache in that feels like it's "inside his brain." Also had unilateral ear and head/face pain on the left side the evening of the vaccine. H/A is recurrent and has not changed. Has treated with ibuprofen , Sudafed, and Nasacort. Was seen by PCM on 4/7 and diagnosed with Neuritis and given Prednisone 30mg taper.
40 2021-04-07 tingling, numbness Whole body Numbness and tingling, loss of feeling of lower right arm and lower right leg. Loss of co... Read more
Whole body Numbness and tingling, loss of feeling of lower right arm and lower right leg. Loss of control of lower right arm. Extreme fatigue unable to get up and move at times. Very light headed and on the verge of blacking out.. possibly Loss of consciousness. Extreme tightness in chest. Increase work of breathing. Confusion. Unable to keep eyes open and maintain alertness. Extremely tired Symptoms have gotten a little better throughout the day of april 8th with lots of rest and very little physical activity. I still have slight tightness in chest. Increase work of breathing. Still have tingling throughout body and am lightheaded. When doing any physical activity I become fatigued and lightheaded very fast and must stop after 5-10 minutes. Tongue is still tingling and metallic taste in moutg
40 2021-04-08 flushing light headed and heat rush from head down, history of feeling dizzy with needles. no breakfast/ lunc... Read more
light headed and heat rush from head down, history of feeling dizzy with needles. no breakfast/ lunch today. refused transport.
40 2021-04-08 tingling, cold extremities My feet are cold as well feeling of left foot tingling when sitting or laying down.; Chest pains; Li... Read more
My feet are cold as well feeling of left foot tingling when sitting or laying down.; Chest pains; Lightheadedness; My feet are cold as well feeling of left foot tingling when sitting or laying down.; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EM9810, Expiration date was not reported), via an unspecified route of administration, in left arm on 19Feb2021 12:45 as single dose for covid-19 immunisation. Medical history included gout. Concomitant medication included allopurinol taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced Known allergy. Patient did not receive other vaccine in four weeks. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. Patient experienced chest pains lasting 2 hours with light headedness, slow talking as well. Patient went to ER for this and when inlaid down the chest pain went away. ECG was normal as well as all blood work. Still feeling slight light headedness, the following day sporadically and my feet are cold as well feeling of left foot tingling when sitting or laying down on 23Feb2021 08:00 AM. Patient did not receive treatment for adverse events. The outcome of the events was recovering.
40 2021-04-09 feeling cold patient stated he was feeling cold and a tingling in his throat and started to have tunnel vision w... Read more
patient stated he was feeling cold and a tingling in his throat and started to have tunnel vision with a weird feeling. patient was assessed for vitals times 3 every 10minutes patient later after third set of vitals stated he was feeling back to normal patient was escorted back out to the exit of the building with his son also accompany him. patient was encouraged to encourage fluids, and to make sure to rest. patient vitals were as follows 9:19a b/p 135/92 p 93 r 18 o2 99% 9:25a b/p 134/84 p 83 r 18 o2 99% 9:30ab/p121/87 p86 r18 o2 98% patient was released and escorted to the car.
40 2021-04-11 muscle spasms Severe upper body muscle cramps, fever and chills, minor nausea. Cramping in chest and diaphragm cau... Read more
Severe upper body muscle cramps, fever and chills, minor nausea. Cramping in chest and diaphragm causing moderate to severe positional pain and some difficulty breathing. Self treated with advil and tylenol. Laid flat on the floor for several hours in a position causing least amount of pain, until cramping subsided. Cramping lasted a total of 10 to 12 hours starting some time overnight after injection.
40 2021-04-11 pain in extremity, hot flush Left arm soreness lasted several days Flush feeling, chills, temp of 99.5-100.5, headache, left armp... Read more
Left arm soreness lasted several days Flush feeling, chills, temp of 99.5-100.5, headache, left armpit itching, weakness when standing, soreness in upper thighs.
40 2021-04-11 seizure like phenomena Patient's behavior appears more in line with focalized or petit mal seizure activity. Gran Mal activ... Read more
Patient's behavior appears more in line with focalized or petit mal seizure activity. Gran Mal activity NOT witnessed.
40 2021-04-12 pain in extremity Sore Arm - lasted for 2 days Tinnitus in right ear - has been happening about 4 to 5 days after seco... Read more
Sore Arm - lasted for 2 days Tinnitus in right ear - has been happening about 4 to 5 days after second shot, has not stopped yet. No treatment.
40 2021-04-12 pain in extremity Sore Arm and Overall fatigue the next morning. Strange taste in mouth. Metallic like.
40 2021-04-13 bell's palsy bells palsy 8 days after administration of 1st dose
40 2021-04-15 tingling 4/10/21, Swollen/ sore lymph nodes left arm pit. 4/12/21, Trouble swallowing food. Flare up of EoE ... Read more
4/10/21, Swollen/ sore lymph nodes left arm pit. 4/12/21, Trouble swallowing food. Flare up of EoE 4/13/21, Dizziness, low grade headache, tingling of skin on face and hands. Elevated response to seasonal and food allergies . Ongoing 4/15/21, Swollen/ sore lymph nodes right arm pit.
40 2021-04-15 tremor On the evening of March 6, 2021, patient tried to exercise (consistent with regular routine) and cou... Read more
On the evening of March 6, 2021, patient tried to exercise (consistent with regular routine) and couldn't do more than 15 minutes. He was very winded. On March 7, we skipped exercise. On March 8, patient tried to do simple stretching exercise, and couldn't do it. He got winded and shaky. On March 9, he was seen at an urgent care where he was told he had an inverted T wave on his EKG and a very fast heart rate (125 resting pulse). He was told to not exercise and to make an appointment with a cardiologist. On March 9, I called the urgent care clinic to ask questions about monitoring his blood pressure and when to seek more medical care. I spoke with Dr, who prescribed Atenolol. Around 4:30 pm on
40 2021-04-16 flushing Metallic taste in mouth, shoulder/neck stiffness, headache and went flush. Returned to normal within... Read more
Metallic taste in mouth, shoulder/neck stiffness, headache and went flush. Returned to normal within two hours
40 2021-04-16 tremor note I was moderately anxious prior to getting the vaccine and had a busy day the next day which was... Read more
note I was moderately anxious prior to getting the vaccine and had a busy day the next day which was worrisome in case of side effects. dizzy first day, chills, fast heart. Everyday so far feel off and on tired, dry mouth off and on, dehydrated? Felt tired within an hour of injection on Tuesday. I don't remember if my stomach was growling on the first night on the day I got injected and I just went to bed. The next morning I woke up really thirsty/hungry and tired. I slowly made myself breakfast. Sat down to eat on a stool and felt dizzy. My heart raced for 30 sec as I carefully made my way to the flow to be safe. I had the chills, a bit shaky for a short period. I called my doc who told me to stay hydrated. The clinic where I got injected DID NOT inform me about dehydration. As of today, I still have off and on a dry mouth, feel more of an empty stomach at meal time, tired off and on, and maybe dehydrated. I work from home so I am not pushing myself. I have not felt dizzy again and am decent at taking in water now.
40 2021-04-17 numbness Numbness in some fingers; Numbness in some toes
40 2021-04-17 tremor, tingling Vivid/lucid dreaming with bright lights; Vivid/lucid dreaming with bright lights; light headiness a ... Read more
Vivid/lucid dreaming with bright lights; Vivid/lucid dreaming with bright lights; light headiness a feeling that i would pass out or die and tingling and shakimg; tingling and shaking throughout his body; tingling and shaking throughout his body; As he remained in a confused mental state; received bnt162b2 first dose on 10Mar2021, second dose on 24Mar2021; received bnt162b2 first dose on 10Mar2021, second dose on 24Mar2021; nocturnal panic attack with unknown trigger; Occasinally elevated blood pressure; slight markings of dehydration; hangover; This is a spontaneous report from a Contactable consumer (patient). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, brand: Pfizer), second dose via an unspecified route of administration, administered in arm left on 24Mar2021 11:30 at age of 40-year-old (Lot Number: ER8733) at single dose for COVID-19 immunization. The most recent COVID-19 vaccine was administered at Facility of Doctor's office/urgent care. Medical history included gout, anxiety, gastrooesophageal reflux disease, 'espoghutis'. The patient did not have allergies to medications, food, or other products. Concomitant medication within 2 weeks of vaccination included omeprazole; allopurinol; escitalopram. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 via an unspecified route of administration, administered in arm left on 10Mar2021 11:30 at age of 40-year-old (Lot Number: En6206) at single dose for COVID-19 immunization. On 02Apr2021, the patient had vivid/lucid dreaming with bright lights and unusual feelings as he initially fell asleep. He was able to wake himself up but remained in between sleep and awake. This was accompanied by light headiness a feeling that he would pass out or die and tingling and shaking throughout his body as he remained in a confused mental state while his wife called an ambulance. In 2021, his vitals were fine with occasionally elevated blood pressure and slight markings of dehydration ( during the day following his second dose he felt like he had a bad hangover). The ER doctor thought the most likely explanation is sometime of nocturnal panic attack with unknown trigger. He had not previously sufferer anything like it. The events were reported as non-serious. The adverse events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the adverse events which included: drugs to calm, fluids. 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 light headiness, tingling and shaking throughout his body, confused mental state, nocturnal panic attack with unknown trigger, vivid/lucid dreaming with bright lights, elevated blood pressure, slight markings of dehydration, hangover were resolving. Information on lot/batch number obtained. Further information is expected.
40 2021-04-18 cold sweat ER Nursing Intervention/Reassessment [Charted Location: EMR-Emergency Rm Service] [Authored: 04/16... Read more
ER Nursing Intervention/Reassessment [Charted Location: EMR-Emergency Rm Service] [Authored: 04/16/2021 15:18]- for Visit: 004092726008, Complete, Revised, Signed in Full, General IV: IV Intervention: ? IV IV INTERVENTION/REASSESSMENT ? IV 1 Date 04/16/2021 ? IV 1 Time 14:25 ? IV IV 1 ? IV 1 Size 20G ? IV 1 Type peripheral iv ? IV 1 Inserted By inserted per RN ? IV 1 Side right ? IV 1 Right antecubital ? IV 1 Actions flushes easily labs obtained ? IV 1 Dressing needleless valve placed, catheter secured, transparent dressing applied with date/time/initials transparent semi-permeable dressing applied ? IV 1 Response pt. tolerated well pt instructed to call RN for problems ? IV 1 Total Attempts 1 COVID Screening Questions: COVID Screening Questions: ? Have you had a COVID-19 vaccine in the last 7 days? Yes (1) ? Was this COVID-19 vaccine your: First dose (1) Assessment Date / Time: ? Date/Time 04/16/2021 14:25 History of Present Illness: Chief Complaint: ? History of Present Illness allergic reaction ? Onset Time/Last Seen Normal 04/16/2021 13:15 Skin Assessment: Skin Assessment: ? Skin cool diaphoretic ? Mucous Membranes moist intact COVID Screening Questions: COVID Screening Questions: ? Have you had a COVID-19 vaccine in the last 7 days? Yes ? Was this COVID-19 vaccine your: First dose ER Triage Note: ? Triage Date/Time 04/16/2021 14:21 ? Triage Chief Complaint medical, Allergic Reaction to Covid Vaccine ? Additional Triage Comments Pt states he went home after receiving his Covid Vaccine (Phizer) when he noticed he was itching on his back. Pt arrived to ED with generalized erythema, skin cool and clammy, and wheezing. Pt denies contact with chemicals or anything else. ? Have you been sexually assaulted? no ? Stroke Screening no ? Pregnant/Could be pregnant not applicable ? LMP not applicable ? Tetanus <5 years ago ? Immunization up to date yes ? CDC Early Warning Symptoms None Identified ? CDC Precautions standard precautions mask applied Infectious Disease: Infectious Disease: ? Have you traveled recently? No ? Do you have any of the following symptoms? none Mode of Arrival: ? Mode of Arrival private auto Height/Length - Weight for Calculation: Weight for Med Calculation: ? Height (ft) 6 Feet ? Height (remainder in inches) 0 Inch ? Height (cm) 182.8 cm ? Body Measurements stated ? Weight for Calculation (kg) 108 Kg ? Weight Method stated ? BSA (m2) 2.29 M2 ? BMI (kg/m2) 32.3 kg/m2 Triage Vital Signs: ? Temp (degrees F) 97.1 degrees F ? Temp (degrees C) 36.1 degrees C ? Method skin/temporal ? Heart Rate (beats/min) 118 bpm ? Respiration (breaths/min) 18 ? BP Systolic (mm Hg) 156 mm Hg ? BP Diastolic (mm Hg) 103 mm Hg ? Sitting BP right upper arm ? SpO2 Patient On room air ? SpO2 (%) 98 % Treatment Prior to Arrival: ? Treatment Prior to Arrival none Allergies: Allergies/Intolerances: Allergies: ?? Pfizer-BioNTech COVID-19 Vaccine: Anaphylaxis ?? tramadol: Hives Home Medications - OMR: Home Medications - OMR: * Patient Currently Takes Medications as of 04/16/2021 15:11 documented in Structured Notes ?? losartan 50 mg oral tablet: None, 1 tab(s) orally once a day, Hx, Status: Active, Quantity: 0, Refills: None, Last Dose Taken: ?? Albuterol (Eqv-ProAir HFA) 90 mcg/inh inhalation aerosol: None, 2 puff(s) inhaled every 6 hours, Hx, Status: Active, Quantity: 0, Refills: None, Last Dose Taken: Patient Seen Time: ? Patient Seen Time 04/16/2021 14:21 ? LMP not applicable ? Tetanus <5 years ago ? Immunization up to date yes Triage Vital Signs: ? Temp (degrees F) 97.1 degrees F ? Temp (degrees C) 36.1 degrees C ? Method skin/temporal ? Heart Rate (beats/min) 118 bpm ? Respiration (breaths/min) 18 ? BP Systolic (mm Hg) 156 mm Hg ? BP Diastolic (mm Hg) 103 mm Hg ? Sitting BP right upper arm ? SpO2 Patient On Pulseox: 98 % on RA @ bedside monitor -- normal ? SpO2 (%) 98 % ? Acuity Level 3 Preferred Pain Scale: Preferred Pain Scale Numeric Pain Scale© Numeric Pain Score - Rest© 0 - No Pain Numeric Pain Score - Activity© 0 - No Pain Treatment Prior to Arrival: ? Treatment Prior to Arrival none Nursing Documentation Review: ? Triage Review I have reviewed the above Vital Signs, Nursing Documentation and Triage Assessment. Arrived From: ? Arrived From home home after leaving vaccination clinic HPI: ? HPI CC: rash/itching HPI: history from patient He describes Covid just after receiving the Pfizer vaccine, his initial dose. By the time that he returned home he had opened up a soft drink was having some slight cough, trouble swallowing and had sensation of itching on his back. He asked his mother to check his back and it was discovered that he was starting to have rash over his body. This seemed to be persistent and he returned to ER for further evaluation/treatment. He has not had reaction to vaccination in the past. He does have allergy to tramadol. He denies having any allergy to soap, detergent, or other chemicals. He denies having exposure to any chemical, fume, dust, plant material after receiving the vaccination. He denies having any new foods or drinks recently. He is not having any nausea or vomiting. He has felt somewhat sweaty. Allergy: tramadol H/O LE muscle weakness/atrophy , COPD ROS Const: No fever, chills, sweats. No unusual weakness (he does note "my leg is atrophying" when he is speaking about his LLE) HEENT: No runny nose, congestion, ear ache. Perhaps some odd sensation in the throat due to swollen uvula. CV: No chest pain, palpitations. No unusual shortness of breath. No edema to the ankles / legs. No pain with breathing. Abdom: No nausea, vomiting, diarrhea, or constipation. No abdominal pain. Lymph: No swelling to glands. Physical Exam: ? Physcial Exam A&O, nontoxic. Pleasant. No pain distress. Mild physiologic distress. Appears to be overwt adult with component of chronic illness and with acute allergic reaction/process_. Eyes: EOMI, nonicteric, conjunctiva clear. Throat: Moist mucous membranes. Symmetric rise of palate. No pharynx erythema. Tonsils normal size and without erythema or exudate. His uvula is moderately edematous and elongated. He is managing his secretions well. There is no angioedema of the tongue, soft palate, lips. No stridor. No blood in the oropharynx. No rhinitis/runny nose. Neck: supple, normal ROM, nontender. trachea midline. No cervical or supraclavicular lymphadopathy. Thyroid nontender and normal size. Back: No pain on percussion. No muscle spasm. Nontender palpation. No kyphosis. Lungs: fair to good air movement with quiet, fine primarily inspiratory wheezes in the mid to lower lung fields. nl effort, no rales, crackles, rhonchi. Normal resonance on percussion. Cough clear. Cardiac: borderline tachy RRR S1, S2, without murmur or rub. Posterior tibial, Pedal pulses 2/4 bilaterally. No ankle or pretibial edema. Skin: cool & dry extermities. cool & moist (not diaphoretic) back skin. Normal turgor. He does have confluent macular rash to the neck, (somewhat on face), arms, back/chest/abdomen. Some mild hyperemia to the legs/ankles. No urticaria. The right deltoid injection site is involved with the hyperemia/macular rash but no urticaria at this location right now Abdom: Bowel sounds present x 4 Quadrants. Normal tympany to percussion. Soft. Non-distended. Nontender. Nonsurgical. Good muscle tone and moves all extremities. He notes he has his chronic weakness in his left lower extremity. Medical Decision Making: ? Discussed with another healthcare provider Discussed case with another healthcare provider ? Consultation Consultation 1, Consultation 2 ? Consultation 1 04/16/2021 15:54 ? Consultation 1 Comments discussed with RPh. He will come to ER to obtain additional information from patient. This is the hospital's first presumptive Pfizer vaccine reaction. ? Consultation 2 04/16/2021 15:41 ? Consultation 2 Comments discussed with Dr. we discuss presentation. he agrees pt will need monitoring with the persisting symptom/findings and the H/O COPD. 1617 Dr has been to ER and completed eval. pt to be placed on 2nd floor med/tele for additional monitoring and treatment. pt did have labs yesterday. ? Decision to Admit Based On 1446 Based on his symptoms and presentation presumptive acute anaphylaxis to component of the Pfizer Covid vaccine. We will begin treatment with 0.3 mg epinephrine IM once as well as dexamethasone, famotidine, diphenhydramine IV. We will continue to monitor with cardiac telemetry and pulse oximetry. He does have slight wheezing but this may be related to his chronic COPD. No respiratory distress at this time, but his symptoms seem to have been mildly progressive over the past hour (per his report). I believe inclusion of the epi to be prudent based on his presentation. Additionally, I will inform the vaccination clinic of this reaction. he agrees pt will benefit from continued monitoring and repeated IV antihistamine and IV steroid treatment. Pt will need IVFluid for hydration as well. Recheck: ? Recheck Recheck 1, Recheck 2, Recheck 3 ? Time 14:55 ? Recheck patient stable patient improving with treatment ? Comments He is improving. His skin is now warm and moist (not sweatty , not diaphoretic). The rash is receeding from the arms. Good coloration to the legs/ankles. Back & torso rash starting to recede. no nausea/vomiting. no difficulty breathing. still with fading macular rash on the torso and upper back. Lungs: improved air movement compared to the initial exam, nl effort, no rales, crackles, rhonchi. He has lower field (only) quiet fine inspiratory wheezes. Normal resonance on percussion. Cough mildly wheeze @ bases, with improved airflow. Cardiac: borderline tachy RRR S1, S2, without murmur or rub. Posterior tibial, pedal pulses 2/4 bilaterally. No ankle or pretibial edema. ? Time #2 15:05 ? Recheck #2 patient stable patient improving with treatment ? Comments #2 man from pharmacy is here and recognizes patient from the vaccination clinic. Patient rash has faded from his extremities fully and appears to have faded from his abdomen still somewhat at the malar area of the cheeks as well as the neck and torso portion of the chest. His pulse is 98?99 continues to have elevated blood pressure. Pulse oximetry 98-100% on room air, normal. Pharmacist will enter the reaction into the CDC/FDA/Pfizer database. Overall pt notes he feels tired (probably related to hydration & benadryl). He notes he has returned to home about 2 weeks ago after spending some time on the road in mountains playing guitar / touring with a small band , playing music. ? Time #3 15:37 ? Recheck #3 patient stable ? Comments #3 He has been resting. No respiratory distress. His blood pressure and pulse and pulse oximetry are reviewed at bedside and they are nonfocal at this time. Overall he is improving. He notes he still has malaise and feels about the same with itching in his back and the sensation in his throat. When I evaluate his back there is hyperemia/some macular rash that is in approximately the distribution of the trapezius muscle of the back this is where he notes he has the itching. Additionally when I evaluate his throat there is still some presence of uvula edema. There is no other angioedema. Perhaps he does have some mild hyperemia to the uvula and soft palate at this time. He is clinically improving but his symptoms have not resolved fully. Skin warm and dry normal turgor. No diaphoresis Lungs initially some coarseness/mucousy breath sounds to the mid lower fields but this clears after he coughs. Good air exchange at this time. No rales rhonchi wheezes or crackles. Cough initially mucousy then clear. managing secretions well. no stridor. no respiratory distress. Critical Care Times: ? Critical Care Time of minutes excluding, separately billable procedures 35 Disposition Summary: Arrival 04/16/2021 14:21 Disposition to be admitted Disposition Decision Date/Time 04/16/2021 15:54 Does an Emergency Medical Condition Exist at the time of D/C? yes Condition at Disposition Stable Alert and Oriented Guarded Emergency Diagnosis: ?? History of COPD (Z87.09): Entered Date: 04/16/2021 15:59, ICD-10: Z87.09 ?? Anaphylaxis due to immunization (T80.52XA): Entered Date: 04/16/2021 15:59, ICD-10: T80.52XA ?? Drug reaction, initial encounter (T50.905A): Entered Date: 04/16/2021 15:59, ICD-10: T50.905A PCP Summary: ? PCP , ? Select Follow-up Physician Follow Up Physician #1 Follow Up Physician #2 ? Follow-Up MD ? Group Name Primary Care ? Specialty ? Follow-Up MD ? Fax Number ? Follow Up In 04 days Instructions: ? Other Instructions Return to ER for worsening symptoms or other concerns ? Additional Instructions Patient has had clinical improvement and stabilization although he is not fully resolved of his symptoms. He is placed into the hospital for further evaluation and management under Dr. Note Complete: Note Complete This document is complete. Affix my electronic signature. Last Updated: 04/16/2021 16:19 by (MD) References: 1. Data Referenced From "ER MD Exam and Disposition" 04/04/2021 17:40 2. Data Referenced From "1. Vital Signs - Adult" 04/16/2021 14:30
40 2021-04-18 muscle spasms 4/10-1945 Caller states patient had flu like symptoms post vaccine. headache fatigue fever diarrhe... Read more
4/10-1945 Caller states patient had flu like symptoms post vaccine. headache fatigue fever diarrhea Cramps. Cramps and Diarrhea has continued and is still every 15 minutes . Advised to seek medically attention diarrhea every 15 minutes for days needs medical attention . 4/11-Patient's spouse returned call, patient continues with diarrhea, not as many bouts as yesterday, started taking Immodium as directed today. Will follow up tomorrow. 4/12-Follow Up: He stated he didn't go to the urgent care he just took Pepto Bismol and Loperimide to help with diarhea (which help tremendously). As of 4/11/21 he stated all his symptoms have subsided (diarrhea, headache, etc) and feels a lot better.
40 2021-04-19 flushing "Administered - 4/19, time unknown Adverse event started - 10:06 Patient had syncope, flushing/sweat... Read more
"Administered - 4/19, time unknown Adverse event started - 10:06 Patient had syncope, flushing/sweating. BP 109/53 -- > 114/55, HR 68 -- >64, RR 16 -- >16 , O2 100% -- > 99%, Temp 97.3F. Given PO juice, Graham crackers. Patient stable, released from vaccination site."
40 2021-04-19 pain in extremity, numbness dyspnea, tachycardia, pain in arm with swelling, numbness, bruising
40 2021-04-20 discomfort Shingles developed on back and arms. Painful, raised rash causing stinging and discomfort, Anti vir... Read more
Shingles developed on back and arms. Painful, raised rash causing stinging and discomfort, Anti viral meds prescribed as well as pain medication
40 2021-04-21 bell's palsy Bells Palsy
40 2021-04-21 bell's palsy Bell's Palsy diagnosis: can't move my right face muscles. Treatment: Prednisone (for 10 days) and Va... Read more
Bell's Palsy diagnosis: can't move my right face muscles. Treatment: Prednisone (for 10 days) and Valtrex (for 7 days)
40 2021-04-21 nerve pain 2nd dose of the vaccine was given on Thursday April 15 , Three days after the Injection. On Sun the ... Read more
2nd dose of the vaccine was given on Thursday April 15 , Three days after the Injection. On Sun the 18 , I started have painful rash and deep nerve pain on my upper forehead and left ear. After a visit to the doctors On Tuesday the 20 It was announced I had Shingles. It has been slowly spreading over my scalp and on my face.
40 2021-04-21 slow speech, numbness Ii got he vaccinator on 3/5 and went home. the first night around 9p, I started to feel chills, Had... Read more
Ii got he vaccinator on 3/5 and went home. the first night around 9p, I started to feel chills, Had a really big temporal headache. I thought it was a reaction to vaccination, I took Tylenol PM, layer down and woke up in the middle of the night, in a full body sweat. I went strait into chills, changed my clothes. Layed back own and awoke the next morning, with chills and temp of 101. I had body ache but proceeded with my day. I continued to have chills, I went out to my elderly parents, took them food and had dinner. Upon arrival home, had high fever 103...no Tylenol. Awoke still w/ chills and high fever and this was Sunday. Stayed in Sunday then the afternoon, felt like I needed to seek help. I went to get a rapid test at Medical Center and it came back Neg. Went back home, I could now sense that my taste was altered. I then continued to have a high fever but they would only come at night. Body sweat, aches, chills cont'd on Sunday. Monday still had same s/s and Tuesday, I thought that I should seek more medical attention. I went to an Urgent Care 3/9/21. They then did a nose swab and felt that it would come back Neg. I went home and on Thursday 3/11/2021 I got a call that I was positive. Did isolate. But from 3/5 to 3/11 then I lost taste/smell. Came out of isolation 3/20 and on 3/21 my whole left side of fact, shoulder and leg went numb for approx 1hr. Then my wife said that I was talking a little slow in my response. Next morning my left shoulder was hurting and I had pain. The Urgent care provider wanted to r/o TIA so he sent me to ER for full work up and that doctor said he saw nothing. He didi say that it could be Covid related and/or possible TIA. "I am feeling good today" There is no residual but because of the left shoulder pain I did go back to Urgent Care. Got cortisone inject and MRI. My PCP then told me that I had a partial "tear" in my left shoulder but I do exercise every day and could have done it then.
40 2021-04-22 pain in extremity Pain around injection site on the left arm one week after covid vaccine, with shingles developing at... Read more
Pain around injection site on the left arm one week after covid vaccine, with shingles developing at the same time on the left side of my neck chest and neck.
40 2021-04-23 migraine After 5-6 days I broke out into sever shingles in the buttocks area, several other symptons as well ... Read more
After 5-6 days I broke out into sever shingles in the buttocks area, several other symptons as well like difficulty urinating, chills, migraine
40 2021-04-23 tingling Pins and needles sensation through out my body, mainly in my feet
40 2021-04-24 numbness My leg was numb; Felt swollen from my right leg.; This is a spontaneous report from a contactable co... Read more
My leg was numb; Felt swollen from my right leg.; This is a spontaneous report from a contactable consumer. A 40-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Er8727), via an unspecified route of administration in Left Arm on 26Mar2021 04:30 PM as single dose for covid-19 immunization. Medical history included allergy to fish. The patient's concomitant medications were not reported. On 26Mar2021, 04:45 pm the patient reported his leg was numb and felt swollen from my right leg. Until he took a Benadryl, the feeling in leg came back after hour. The outcome of event was recovered on an unknown date in 2021. Information on the lot/batch number has been requested.
40 2021-04-24 pain in extremity Temporary symptoms include headache (gone the next day), sore arm (lasted a few days), chills (the n... Read more
Temporary symptoms include headache (gone the next day), sore arm (lasted a few days), chills (the next day only), and tiredness (for a couple days). However, I have experienced tinnitus starting the evening of injection, and it hasn't disappeared or even dampened since.
40 2021-04-24 tingling Pins and needles, tingles in fingers, both hands, arms, and sometimes other parts of the body, inclu... Read more
Pins and needles, tingles in fingers, both hands, arms, and sometimes other parts of the body, including neck, feet. The sensation comes and goes multiple times per day, sometimes severe, and feels strong during the night / morning.
40 2021-04-25 migraine with aura Severe Migraine with major Aura. Severe for 24 hours then minor for an additional 48 hours.
40 2021-04-25 pain in extremity Sore arm. Headache, dizziness, fever (treated with Tylenol), fatigue. Sore arm a few hours after inj... Read more
Sore arm. Headache, dizziness, fever (treated with Tylenol), fatigue. Sore arm a few hours after injection worsening the next day (not treated). Headache starting about 8am the next morning. Fever starting about 9am. Did not slow down or rest all day. Performed mentally challenging tasks. Drank plenty of fluids. Fatigue hit hard about 8pm.
40 2021-04-26 flushing, weakness Systemic: Fainting / Unresponsive-Medium, Systemic: Fell from chair and hit head on floor - small ga... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Fell from chair and hit head on floor - small gash on bridge of nose-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Systemic: Weakness-Medium, Additional Details: Within 5 minutes of vaccination, pt fell from sitting position in chair to the ground. Pt hit his head and had small gash on bridge of nose. When I got to him, his eyes openned and he knew what happenned. Called 911. He laid on ground while we had NP check blood pressure, pulse, and O2 levels. Pt was stable and walked out with EMS to be checked out.
40 2021-04-26 tremor, pain in extremity Hit by a train (figuratively), Sore Arm, High Fever (102.1), Vomiting, Diarrhea, Headache, Close to ... Read more
Hit by a train (figuratively), Sore Arm, High Fever (102.1), Vomiting, Diarrhea, Headache, Close to fainting, Shake, Chills, Loss of Appetite (didn't eat for 10 days), Fatigue. Symptoms were intense for 2 days, then were mild for 2 days.
40 2021-04-26 unresponsive to stimuli, brain damage Patient found unresponsive and transported to ED. Currently hospitalized and admitted with following... Read more
Patient found unresponsive and transported to ED. Currently hospitalized and admitted with following issues: Present on Admission: ? Intraventricular hemorrhage (HCC) ? Bilateral thalamic hemorrhage ? Acute encephalopathy ? Abnormal eye movements ? Respiratory failure requiring intubation (HCC) ? Mucoid impaction of bronchi
40 2021-04-26 unresponsive to stimuli Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Fainting / Un... Read more
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Medium
40 2021-04-27 weakness 4/24 - low-grade fever (99.5 F), muscle aches, headache, lasted all day + all night 4/25 - low grade... Read more
4/24 - low-grade fever (99.5 F), muscle aches, headache, lasted all day + all night 4/25 - low grade fever continued (99.5 F), sweats/chills, sharp headache, fatigue, muscle aches 4/26 - low grade fever continued (99.5 F, dropped to 99.3 F in evening), sweats/chills continued, sharp headache continued, fatigue + aches continued 4/27 - low grade fever (99 F), sharp headache, chest pain when coughing, developed sinus congestion, wet cough which produced mucous (clear), slight fatigue and aches (lessened), new symptom of low humming tinnitus in left ear only (when surroundings quiet) 4/28 - fever gone for 18 hours w/o fever-reducing medication, fatigue still present, cough with phlegm still present, slight headache, slight sinus congestion, low humming tinnitus in left ear continues (when surroundings are quiet)
40 2021-04-27 tingling Tingling, pins-and-needles feeling on the bottoms of the feet.
40 2021-04-28 numbness Numbness in my left hand and fingertips
40 2021-04-28 pain in extremity Fatigue on 2nd day and 9 days later still have Covid arm (dull pain) in right upper arm and deltoids
40 2021-04-28 tremor Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Fa... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Shakiness-Mild
40 2021-04-30 weakness, pain in extremity Mild headache; overall body soreness, worse in left arm; overall body soreness, worse in left arm; L... Read more
Mild headache; overall body soreness, worse in left arm; overall body soreness, worse in left arm; Lack of energy; This is a spontaneous report received from a contactable consumer. A 40-year-old male received received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot number EP6955 and expiry date was not reported) via an unspecified route of administration, in the left arm, on 14Apr2021 at 14:00 (at the age of 40-years-old) as a single dose for covid-19 immunisation. Patient's medical history was not reported. Concomitant medications included tadalafil, allium sativum bulb (GARLIC EXTRACT), fish oil, colecalciferol (VITAMIN D3) and multi vitamin. Patient had previously received first dose of vaccine on 24Mar2021 at 14:00. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications within 2 weeks of vaccination included tadalafil, allium sativum bulb (GARLIC EXTRACT), fish oil, colecalciferol (VITAMIN D3) and multi vitamin. Patient did not have covid prior vaccination. Patient did not test covid, post vaccination. Patient was not diagnosed with COVID-19, prior to vaccination. Patient has not been tested for COVID-19, since the vaccination. On 15Apr2021 at 09:00, patient experienced mild headache, overall body soreness, worse in left arm and lack of energy. The events were considered non serious. No treatment was received. The outcome of events was recovering. Follow up(21Apr2021): This is a follow up-spontaneous report from a contactable Consumer. This Consumer (patient) reported in response to a letter sent which included that: No new information received. No follow-up attempts are needed. No further information is expected.
40 2021-04-30 pain in extremity Sore Arm after first vaccine; This is a spontaneous report from a contactable consumer (patient). A ... Read more
Sore Arm after first vaccine; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received BNT162B2 first dose on 23Mar2021 10:20 Intramuscular on left arm at single dose for COVID-19 immunization. Medical history and Concomitant medications were none. Prior Vaccinations (within 4 weeks) were none. AEs following prior vaccinations were none. Family Medical History Relevant to AEs was None. None Additional Vaccines Administered on Same Date of the Pfizer Suspect. Patient Says with his first dose he had no blood at the injection site he only had a sore arm the next day (24Mar2021) and that was it. Only lasted a couple of hours then it was gone the same day. No AE require a visit to Emergency Room or Physician Office. The outcome of the event was recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
40 2021-05-01 feeling of body temperature change Hit quickly and strongly. Dizziness, nausea, waves of hot and cold, with profuse sweating. This was ... Read more
Hit quickly and strongly. Dizziness, nausea, waves of hot and cold, with profuse sweating. This was followed a couple of hours later by body aches, alternate hot and cold spells and headache. Injection site was sore, which started the previous day. Massive headaches from 4/9 to 4/11. NSAIDs somewhat helped symptoms. Began feeling human on 4/12. Was like a bad influenza, but no one else in household had any symptoms subsequently, so assume it was the vaccination.
40 2021-05-02 weakness patient experienced onset of fevers, headache, neck pain, generalized malaise/fatigue/weakness, diar... Read more
patient experienced onset of fevers, headache, neck pain, generalized malaise/fatigue/weakness, diarrhea/abd pain, with 2 ED visits ultimately admitted to hospital and diagnosed with MIS-A with elevated bnp, troponin, and inflammatory markers, and treated with dex 6mg x 10 days with complete resolution on follow-up.
40 2021-05-03 bell's palsy, numbness Patient called today and told me that he experienced some numbness on the left side of his face appr... Read more
Patient called today and told me that he experienced some numbness on the left side of his face approximately 15 minutes after receiving his vaccine. He stated that he thought he was just having a hysterical reaction and overthinking it. The numbness continued and he went to the emergency room later that same day. He was seen by an ER physician and told that he was experiencing temporary Bell's Palsy from the vaccine. He described the numbness as being below his eye, in front of his ear and halfway down his jaw. He said it lasted approximately 36 hours and then it was gone.
40 2021-05-03 hot flush Since shot last Thursday April 29 at 930 am I cannot sleep at all and have a hard time breathing. Bo... Read more
Since shot last Thursday April 29 at 930 am I cannot sleep at all and have a hard time breathing. Body will not let me fall asleep. I get a rush of nervous or anxious energy and hot flashes
40 2021-05-04 bell's palsy I've developed bell's Palsey; This is a spontaneous report from a contactable consumer. A 40-years... Read more
I've developed bell's Palsey; This is a spontaneous report from a contactable consumer. A 40-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 10Apr2021 (Batch/Lot Number: EW0162) as a single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any other vaccinations within 4 weeks. The patient reported that on 17Apr2021, he developed bell's palsey. The outcome of the event was not reported. The patient did not have COVID prior to vaccination not was tested post vaccination.
40 2021-05-04 migraine Fatigue. Severe headache, frequent migraine
40 2021-05-04 muscle spasms Severe cramping, diarrhea, vomiting, fatigue like I have never experienced before. This should not b... Read more
Severe cramping, diarrhea, vomiting, fatigue like I have never experienced before. This should not be injected into humans
40 2021-05-04 seizure Had seizures and ended up in emergency room; Had seizures and ended up in emergency room; scar in le... Read more
Had seizures and ended up in emergency room; Had seizures and ended up in emergency room; scar in left arm/scar in his left arm before he had a seizure; 'he could feel a bump, it was like a bump in there. So, it was between his armpit his heart where he felt the bubble; This is a spontaneous report from a contactable consumer (parent). A 40-year-old male patient received the second dose of BNT162B2 (lot number and expiry date were not reported), via an unspecified route of administration, administered in left arm on 14Apr2021 (at the age of 40-year-old) as single dose indicated to prevent from Corona virus (Covid-19 Immunization). Medical history included seizures and gout. The patient's concomitant medications included unspecified medication for seizures. The patient previously received the first dose of BNT162B2 (lot number: ER8730) on 24Mar2021 for Covid-19 Immunization. The patient got the second Pfizer shot later this month, left the office, 45 minutes later (on 14Apr2021) he had seizures and ended up in emergency room. He has had small seizures but they are not back to back, of and on throughout the years and now we are saying that maybe COVID Vaccine shot is what provoked him to, what made him had seizures. Reporter stated, even though he has had seizures in the past like it could be 2, 3 years apart for one. But the shot it caused him to have another seizure, but he is not going to continue to have seizures, as he is on medication (unspecified medication) right now. But the medication is on, if they take him off it, he could have multiple seizures constantly (name of medication not clarified further). Also on 14Apr2021, the patient also had a scar in left arm, it is another symptom he had. He had the scar in his left arm before he had a seizure, he said over here between his heart and his arm felt like a (incomplete sentence), now they don't know if he had a one scar or what it says but he says that 'he could feel a bump, it was like a bump in there. So, it was between his armpit his heart where he felt the bubble' (not clarified further). The patient underwent laboratory test which included: blood work, a urine sample and they did a CAT scan to see knowing the problem in his brain, all on 14Apr2021 with unknown result. The day of the test was on the 14th, it would have been on a Wednesday. It was the same day that he got the second shot. So, he had these test done on 14Apr (14Apr2021). Reporter confirmed of getting the test results on Thursday, so did not have the details. Therapeutic measures were taken as a result of seizures which included Levetiracetam 500 mg tablet, he takes one tablet twice a day, so he takes two tablets a day. This was ordered by his doctor in emergency room. The outcome of the events was unknown. Information on the lot/batch number has been requested.
40 2021-05-04 unresponsive to stimuli, involuntary muscle movements, feeling hot Pt was given the 1st Pfizer Covid 19 shot and asked to sit in the lobby for 15 minutes per protocol... Read more
Pt was given the 1st Pfizer Covid 19 shot and asked to sit in the lobby for 15 minutes per protocol. After 10-15 minutes, he came to the pharmacy counter stating he felt hot and sweaty. His eyes then rolled backwards and he collapsed on to the floor. He was unresponsive, his head and back arched and he slightly rocked while on the ground. I went to make sure he didn't hit his head and patient became responsive. We tried to have pt stay on the ground, but he refused. Therefore we moved him to a chair and elevated his legs. 911 and store medical assistance were called. After the ER services arrived and examined pt, left on his own and stated he felt fine now.
40 2021-05-05 pain in extremity, tingling The morning after the vaccine, I began experiencing chills, injection site pain, and pain in both ca... Read more
The morning after the vaccine, I began experiencing chills, injection site pain, and pain in both calves. The chills and injection site pain went away within a couple of days, but the pain in both calves did not go away and continues to the present. It has not affected by ability to walk, but I continue to experience pain, as well as some throbbing and tingling in both calves. There has also been occasionally tingling I my feet. After extensive consultation with several doctors, and a variety of tests, it is suspected that this is a small fiber neuropathy that was caused by the vaccine.
40 2021-05-06 weakness, tingling, flushing Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Confusion-Se... Read more
Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Confusion-Severe, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: vivid dreams-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Joint Pain-Severe, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Mild, Additional Details: general feeling of increased inflammation of joint pain
40 2021-05-06 discomfort Employee presents today after receiving his second pfizer covid vaccine. Pt. received 1st vaccine on... Read more
Employee presents today after receiving his second pfizer covid vaccine. Pt. received 1st vaccine on 4/2/21 and 2nd vaccine on 5/7/21 around 1500 pm today. Pt. received 2nd vaccine in left arm. Symptoms started twelve minutes in 1522 pm and in cluded: headache, back of shoulders feel "super tight", soreness to the back of neck, and headache is b etween patient's eyes as well as blurry vision. Pt. states that his shoulder pain is 10/10 and headache is an 8/10 Pt. denies shortness of breath, denies chest pain, denies trouble breathing. Pt. denies numbness, d enies tingling. Instructed patient to go to the Urgent care for evaluation.
40 2021-05-07 weakness Phizer shot 1 of 2 in the left arm on Thursday 5/6. I arrived home 45 minutes after the shot was ad... Read more
Phizer shot 1 of 2 in the left arm on Thursday 5/6. I arrived home 45 minutes after the shot was administered and went to the bedroom as my heart rate continued increasing until it was racing non-stop. As my rate increased, so did my breathing until it became rapid and shallow. It is difficult to describe how fast my heart was beating. The rapid heart rate and shallow breathing reminded me of how my breathing changed when I summited a 5800-meter volcano and there was insufficient oxygen near the peak. As my pulse increased I became weak and fell asleep, or fell unconscious. I awoke at 11:00 PM and my breathing was normal however my heart continued racing for an additional hour until midnight. I have experienced no other side effects except heart rate and breathing.
40 2021-05-08 bell's palsy Bell's Palsy
40 2021-05-09 concussion Fatigue, nausea, dizzyness, headache, difficulty concentrating, generally feeling like I have a conc... Read more
Fatigue, nausea, dizzyness, headache, difficulty concentrating, generally feeling like I have a concussion
40 2021-05-10 tingling, burning sensation He got his vaccine, he had a burning sensation and tingling sensation and broke out really bad on hi... Read more
He got his vaccine, he had a burning sensation and tingling sensation and broke out really bad on his arms, and the back of his neck and his back. He went to the doctor who send him to the drug store and was given OTC topicals to help with the rash. These medications are helping but it is still not clearing up. He is being sent to the dermatologist for this rash.
40 2021-05-11 discomfort part of my left kidney was no longer receiving blood; blood clot; placed on stroke protocols.; I dev... Read more
part of my left kidney was no longer receiving blood; blood clot; placed on stroke protocols.; I developed severe abdominal pain in my left side during the evening; lack of appetite; bouts of severe discomfort; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0167) via an unspecified route of administration, administered in Arm Left on 28Apr2021 12:15 (40-years-old) as 2nd dose, single for COVID-19 immunization. The patient medical history was not reported. Vaccination Facility Type was clinic. Concomitant medications included ibuprofen (ADVIL); desloratadine (CLARINEX). The patient previously took first dose of BNT162B2 (lot number=EN6208) on 07Apr2021 01:15 PM (40-years-old) on Left arm for COVID-19 immunization. It was reported that the patient developed severe abdominal pain in my left side during the evening of Wednesday, 28Apr2021 19:00. The pain appeared sporadically throughout the evening and continued through Friday, April 30. During this time, he experienced a lack of appetite and bouts of severe discomfort. Tried treating with GasX and Tylenol. Duration of Hospitalization reported as 3 days. On Saturday, 01May2021, starting around 10:30 a.m., the pain in his left-side abdominal area intensified and did not diminish. After 6 hours, he visited the ER at hospital. After being admitted to the ER, a series of blood, urine and imaging tests were performed on me. The doctor on duty reported that a CT scan showed that part of my left kidney was no longer receiving blood (disability). He was placed on Heparin and admitted to the hospital. He was diagnosed with a blood clot and placed on stroke protocols. The adverse event result in Emergency room/department or urgent care. Treatment received for the adverse events was Heparin, fluids, blood work, urine analysis. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events abdominal pain, lack of appetite, and bouts of severe discomfort was recovering; while other events was unknown. Events reported as serious due to hospitalization and life threatening.
40 2021-05-11 tenderness Severe nausea and vomiting. Headaches. Fever, chills. Widespread body aches (extremely tenderness a... Read more
Severe nausea and vomiting. Headaches. Fever, chills. Widespread body aches (extremely tenderness and soreness).
40 2021-05-14 weakness Nausea, vomiting, severe fatigue, fever, chills, weakness ongoing for over 2 weeks. Have not repor... Read more
Nausea, vomiting, severe fatigue, fever, chills, weakness ongoing for over 2 weeks. Have not reported to doctor because I felt ok before I got the vaccine and I can?t miss work. The first dose didn?t make me feel sick.
40 2021-05-17 numbness, tingling Started 5/11 in the morning with headache and dizziness. Left arm started feeling heavy and numb als... Read more
Started 5/11 in the morning with headache and dizziness. Left arm started feeling heavy and numb also finger tips got tingling. Started to get sharp chest pains near my heart then started to feel fatigue. Then my tongue started to get swollen/numb and I couldn't really talk. Went to urgent care and due to my condition they called the ambulance and went to hospital. They did an EKG/chest x-rays and blood work. Couple hours later they send me home with no diagnosis just to see primary doctor. Symptoms were mild for 2 days then again on 5/14 symptoms came back and went back to urgent care. They did an EKG/Covid test/ only and doctor just said it was a panic attack. I disagree I still don't feel completely right.
40 2021-05-17 pain in extremity, weakness, tingling, numbness Right forearm, bicep, and shoulder pain, weakness, tingling/numb fingers, tendinitis, cubital tunnel... Read more
Right forearm, bicep, and shoulder pain, weakness, tingling/numb fingers, tendinitis, cubital tunnel syndrome
40 2021-05-17 pain in extremity 40 y/o M with no PMHx, non smoker, takes Finasteride 1 mg for hair growth, nonsmoker, received firs... Read more
40 y/o M with no PMHx, non smoker, takes Finasteride 1 mg for hair growth, nonsmoker, received first Pfizer COVID-19 vaccine on 4/12/21 to left deltoid (had mild soreness x 2 days, without other sx) presented to ED 4/15/21. Presented to ED 4/20/21 with L calf pain x 4 days starting around the evening of 4/15 and into 4/16. Initially attributed symptoms to a muscle strain given pt bikes 25 miles a day and lifts/frequent exercise- was able to exercise on 4/16 but stopped after that to try to rest the leg. Has been applying ice and taking Aleve with no relief. Shortly after, noticed new swelling in the calf and this morning noted that swelling had also spread to the front of his shin. Denied numbness, tingling, weakness in the leg. Was advised by a family member who is radiologist to present to ED for further evaluation. Found on exam to have left calf swelling, Ultrasound Doppler with extensive deep venous thrombosis of the left lower extremity from the level of the posterior tibial extending proximally to the common femoral vein with areas of both occlusive and nonocclusive thrombus. Evaluated by interventional radiology, deemed no need for intervention. Initially treated with lovenox and then discharged from the ED on apixaban 5mg daily. Symptoms resolved in days after and as of 5/18 remains on apixaban symptom-free.
40 2021-05-20 numbness, tingling, pain in extremity The day after having my first dose my right arm had soreness and discomfort. Then following my secon... Read more
The day after having my first dose my right arm had soreness and discomfort. Then following my second dose my right arm has now been experiencing numbness & tingling for the past three days consistently.
40 2021-05-20 muscle spasms Severe nausea and vomiting for an entire day. Could not keep any fluids down. Severe burning pain i... Read more
Severe nausea and vomiting for an entire day. Could not keep any fluids down. Severe burning pain in muscles all throughout the body for 3 days. Severe muscle spasms and cramps all throughout the body. Could not stand or walk for 12 hours. Severe burning sensation on the skin all over the body, felt like a sunburn. Severe headache for 3 days. Minor muscle spasms for an additional 5 days after the severe ones diminished. Moderate fatigue for 10 days. Had tested positive for COVID 4 months prior to being vaccinated, but only had minor symptoms for 2 days.
40 2021-05-21 feeling cold Shortly after I received the shot, I had minor soreness in the spot of the injection. This was the o... Read more
Shortly after I received the shot, I had minor soreness in the spot of the injection. This was the only symptom for about 12 hours. At the twelve hour mark, about, I almost immediately started shivering uncontrollably. I was very cold ad sweating. I wasnt able to think clearly. My wife said I had a fever. Also, I had a headache. This occurred for about 6 hours. I was still cold and sweating, with a headache, for about another 4 hours, but it wasn't as extreme. I was still unable to think well. I had a desire to drink gatorade, not water, at this time. This was unusual. I drank about 2L of gatorade. I began to not feel cold, and only had a minor fever. Not sure how correlated these are. Over the next 10hrs or so, I slowly improved and was able to carryon daily activities.
40 2021-05-24 numbness, facial paralysis woke up in the middle of the night with right side numbness, and drooping face. Was rushed to the ER... Read more
woke up in the middle of the night with right side numbness, and drooping face. Was rushed to the ER. Stroke team diagnosed and began treatment of stroke. Had multiple tests run to include arterial ultrasounds, internal echo cardio, and CT and MRI of the brain. Confirmed left side of brain stroke but causes are still unknown. all tests and bloodwork came back normal and within range of an above average healthy adult.
40 2021-05-25 cold sweat Stomach cramps; Diarrhea; Cold sweats; This is a spontaneous report received from a contactable cons... Read more
Stomach cramps; Diarrhea; Cold sweats; This is a spontaneous report received from a contactable consumer, the patient. A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: Ep6955) via an unspecified route of administration in the left arm on 15Mar2021 at 12:00 PM (at the age of 40-years-old) as a single dose for COVID-19 vaccination. The patient medical history and concomitant medications 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 receive any other vaccines within four weeks prior to the vaccination. On 16Mar2021, the patient experienced Diarrhea, cold sweats and stomach cramps. The patient was not treated for the adverse events. The clinical outcome of the events Diarrhea, cold sweats, and stomach cramps was resolved on an unknown date at the time of the report. No follow-up attempts are needed. No further information is expected.
40 2021-05-26 slurring, tingling 50% loss of vision; Tingling on one side of body; Experienced Transient Ischemic Attack 1 week after... Read more
50% loss of vision; Tingling on one side of body; Experienced Transient Ischemic Attack 1 week after vaccine 2nd dose (April 27, 2021).; Strong pressure in head; loss of ability to support body in RL; Slurred speech; Difficulty in breathing; Cognitive difficulties; Extreme headache; This is a spontaneous report from a contactable consumer (patient) reported for himself that a 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EL7533) via an unspecified route of administration, administered in Arm Left on 20Apr2021 14:00 as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (Lot number EL8727) in the Left arm on 29Mar2021 16:00 at the age of 40 years for covid-19 immunisation. No known allergies. No vaccines were received within 4 weeks prior to the COVID vaccine. Healthy and no prior adverse event history. The patient experienced transient ischemic attack 1 week after vaccine 2nd dose, strong pressure in head, loss of ability to support body in RL, slurred speech, difficulty breathing, cognitive difficulties, extreme headache on 27Apr2021 16:30; visited emergency department. 2nd incident 02May2021- 50% loss of vision, tingling on one side of body, slurred speech, cognitive difficulties, extreme headache. The adverse events resulted in emergency room and healthcare professional office visit. Patient was treated with headache medications. It was reported that patient was recovered from events. 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 events was recovered in 2021. Information on Lot/Batch number was available. Additional information has been requested.
40 2021-05-27 pain in extremity I was awoken from sleeping on the morning of Good Friday at 4:00 am. i had a very sharp pain at the ... Read more
I was awoken from sleeping on the morning of Good Friday at 4:00 am. i had a very sharp pain at the front of my left shoulder that went about halfway down my left arm. Additionally, I couldn't breath - it was very painful to attempt to fully fill my lungs. This condition lasted for about 45 minutes as I tried changing positions in bed to make the pain change (either worse or less) but it was consistent and would not go away. At that time my wife and I thought I may have been having a heart attack so we went to the Emergency Room.
40 2021-05-28 cold sweat, unresponsive to stimuli, flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium, Additional Details: pt's forehead felt cold and sweaty and he tried to lift his legs up and kept his hands high - he described that he faints after a blood taken for a test or after a vaccing, and this might be a mental predisposition to this reaction. we called an embulance, but patient felt better in 5-7 min and requested to cancel embulance. He spent 10-20 min on the chair and felt ok to get up and walk around. He left stating he fill better.
40 2021-05-28 numbness, tingling Walking to the observation room approximately 2 minutes post shot I felt extreme dizziness. Felt li... Read more
Walking to the observation room approximately 2 minutes post shot I felt extreme dizziness. Felt like I could potentially pass out so I waited 30 minutes in the observation room before leaving. After I was fairly confident I would not pass out I left the facility. When I made it outside it felt like the right side of my brain was "not there," like a portion of my brain was dead. While driving home approximately 45 minutes post shot I felt numbness and tingling on the right side of my face. Mental confusion also started. I don't recall the numbness and tingling in my face continuing at this time. Proceeded home, laid down on the couch to relax and about 3 hours post shot felt my heart racing. Checked heart rate with pulse oximeter and heart rate was 120 w/98 oxygen. 5 minutes later the heart rate went down to around 90 but blood oxygen went to 90. I sat up, drank water and pulse/oxygen returned to normal. The next day the mental confusion continued. Approx. 24 hours post shot tingling and numbness felt on right side of face. Couldn't move lips properly, communicate to my facial muscles. This lasted around an hour or two. 30 hrs post shot short term memory loss caused confusion when typing texts, following conversation, etc. Symptoms improved greatly over the next couple of days. Tiredness/general unwell feeling approximately 48hrs post shot but unremarkable. By the time I went to a GP 84hours post shot I felt 95%. Went to a neurologist 108hrs post shot who performed standard tests and all was well. 1 week post shot got into an argument and felt tingling and numbness on right side which lasted approximately 10 seconds.
40 2021-05-31 pain in extremity Pain in arm for about 48hrs/Pain was moderate; This is a spontaneous report from a non-contactable c... Read more
Pain in arm for about 48hrs/Pain was moderate; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number; Unknown) via an unspecified route of administration on the right arm on 14Mar2021 at 16:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient included GERD and asthma. The patient was allergic to Penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included Omeprazole since an unknown date for an unknown indication. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccine. The patient took penicillin on an unknown date for an unknown indication and experienced allergy. On 14Mar2021, the patient experienced pain in arm for about 48hrs.The patient also reported that the pain was moderate. No treatment received for the event. Therapeutic measure taken for the adverse event was unknown. The outcome of the event pain in arm was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained Amendment: This follow-up report is being submitted to amend previously reported information: Patient first name added. Patient's Age/Units captured as 40 years per event's onset 14Mar2021. Vaccination Facility added. "Unknown" removed from Lot# field. For both events: "Treatment Received?" captured as "No" per source "if treatment ae: No". Final sentence "Information about lot/batch number cannot be obtained. No further information is expected." updated as "No follow-up attempts are possible; information about lot/batch number cannot be obtained." Patient's Ethnic Group captured "Unknown" removed from Lot# field "OMEPRAZOLE". Event stop date captured as 16Mar2021 per verbatim "Pain in arm for about 48hrs". Yes removed from Concomitant Therapy since already coded out. In narrative, "This is a spontaneous report from a non-contactable consumer, the patient". In narrative, "Therapeutic measure taken for the adverse event was unknown" should be "no" per source "if treatment ae: No". Initial information need be updated in consolidated narrative: adverse event: Pain in arm for about 48hrs. Nothing more. Pain was moderate. if treatment ae: No
40 2021-06-01 hot flush Immediate nausea, hot flash and heart palpitations at time of injection, soreness for 3 days, and on... Read more
Immediate nausea, hot flash and heart palpitations at time of injection, soreness for 3 days, and on the 4th day I had a general feeling of malaise, which worsened until I developed a fever. Severe fatigue and constant fever as high as 105 for three days, and finally went to the ER. Immediately treated for sepsis. Full blood panel, blood cultures, x-ray and CT scan. Also ran some additional cultures for respiratory pathogens. The Dr?s had a tough time determining what it was. They saw a very small area which they called pneumonia, however, I?ve had pneumonia and this was not what it was. Final discharge paperwork stated Systemic Inflammatory Response Syndrome.
40 2021-06-02 pain in extremity Per Client received COVID 19 in right arm on 5/24/2021, soreness at injection site on same day of va... Read more
Per Client received COVID 19 in right arm on 5/24/2021, soreness at injection site on same day of vaccine. On 5/25/2021 around 4 am, started having chills and headache. On 5/26-5/27/2021 headache worsened and by Friday on 5/28/2021, along with headache, left sided pain in chest and arm. Per patient was taken to ER by wife and admitted to hospital on 5/28/2021. Per Client, was told first by hospital that he was having a heart attack. Client reported having labs collected, EKG, Catheterization and Ultra Sound. Per Client, later diagnosed with "myocarditis" and is now taking multiple mediations. Per Client was discharged from hospital on 5/29/2021, that evening. Will be following up with PCP in one week.
40 2021-06-03 pain in extremity Sore arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male pat... Read more
Sore arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN6205, Expiration Date: not reported), via an unspecified route of administration on 04Mar2021 at 09:15 (at the age of 40 years old) as first dose, single for COVID-19 immunisation in a Pharmacy or Drug Store.Medical history included high blood pressure from an unknown date. The patient's concomitant medications were not reported. The patient did not receive any other vaccines in 4 weeks, has no known allergies and prior to vaccine the patient was not diagnosed with COVID-19. On 04Mar2021 at 14:00 (reported as 02:00PM), the patient experienced sore arm. No treatment was received for the adverse event and since vaccination, the patient has not been tested for COVID-19. Outcome of the event was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
40 2021-06-06 night sweats Loss of appetite, fever (102/103) and night sweats for the first 3 days. my chest pain on the left ... Read more
Loss of appetite, fever (102/103) and night sweats for the first 3 days. my chest pain on the left started the night of the shot around 2 am. The pain kept getting worse and worse each day. I finally had to drive myself to the emergency room (5/4/201) to get it checked out. It felt like something was squeezing my heart. i was super light headed and felt like i was going to drop on the floor dead. They gave me a chest x ray and took blood work. Everything cam back good and the doctor said if i kept getting those chest pain i should return. so they let me go. i still kept getting my chest pain for another week. however i didnt go back to the ER, because i was scared of getting a second bill as im not insured.
40 2021-06-06 seizure, feeling hot, weakness Within about 5 minutes of patient of patient receiving the vaccine, he had a seizure in the lobby of... Read more
Within about 5 minutes of patient of patient receiving the vaccine, he had a seizure in the lobby of the pharmacy. The seizure was not witnessed by any employee, but by his companion and a customer. I immediately had a technician call 911 and ran out with our emergency kit when I heard the patient's companion screaming for help. When I got to the patient he was in a seated position in a chair in the lobby and was coming to. He was disoriented and looking around. I asked if he knew his name and what day it was, he did know. I asked if he knew where he was and he responded correctly. He said he felt week and hot, he appeared sweaty. I checked his blood pressure (100/58) and pulse (50 bpm). His temperature was 97.1. His companion stated he had never had a seizure before when asked. I gave him some water and sat with him until EMS arrived. He remained seated the entire time and said he felt week. A few minutes after EMS arrived, the patient left via stretcher by ambulance, but remained conscience.
40 2021-06-07 numbness 40 year old male without any prior medical history, followed by PCP for yearly exams, who presents w... Read more
40 year old male without any prior medical history, followed by PCP for yearly exams, who presents with complaints of chest pain for the past few days. Pain is described as left sided chest discomfort, first associated with exertion as it started with walking 2 days ago, symptoms resolved when he got home. Again yesterday symptoms returned with walking but after symptoms improved but remained, described some numbness to left hand. He denies SOB, DOE and syncope. He does report palpitations. He was seen by PCP and underwent EKG which was unremarkable however symptoms continued so he came to ED for evaluation. EKG with ST elevations ECG: Sinus tachycardia:Otherwise normal ECG Normal sinus rhythm with sinus arrhythmia:ST elevation, consider early repolarization, pericarditis, He had a stress test and an echocardiogram which were reassuring (see results below). Pain/ discomfort had almost entirely dissipated. He was discharged home with NSAID.
40 2021-06-08 pain in extremity Pericarditis/ pericardial effusion- chest pain that radiated to arm. difficulty breathing in. went t... Read more
Pericarditis/ pericardial effusion- chest pain that radiated to arm. difficulty breathing in. went to ER and had CT scans to verify this diagnosis. Was treated with Ibuprofen and colchicine
40 2021-06-10 involuntary muscle movements Insomnia; Cough; his body start jerking; This is a spontaneous report received from a contactable co... Read more
Insomnia; Cough; his body start jerking; This is a spontaneous report received from a contactable consumer. A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, on 03May2021 (at the age of 40 years) and second dose of BNT162B2 on 26May2021, as a single dose for COVID-19 immunization. The patient medical history included Ventricular tachycardia and concomitant medications included Amiodarone used for Ventricular tachycardia on an unknown date. Reporter stated that he took the highest dose in that medicine, yes the highest, I do not know what the highest is that he is taking I know it is the highest since they said they cannot give him anything now". Reporter stated, "My son might be having a reaction to the Pfizer vaccine and he has a test in the morning, but he already been into the emergency room and all these and I need to ask or talk to somebody that can medically give me some advice before his test specifically we do not know he can actually have this test now. Reporter added, "Now do you need to know his side effects that he is having from the vaccine that came from the vaccine. Okay the side effects he is having started right after his first vaccine on 03May2021 he started getting the sleep apnea well not sleep apnea sorry about that he started getting insomnia and he cannot sleep and he ended up getting a cough so when he went back to his second vaccine his insomnia started getting worse, he is like he cannot sleep at all and when he does fall asleep its only for 2 hours and he gets so tried, his body start jerking and makes him wake up. Report-er stated, "They are worsening". The patient underwent laboratory test and procedures which included chest X-ray, Nuclear test on Friday and have not got results for that test. Outcome of events was reported as unknown. Reporter seriousness for Insomnia, Cough, his body start jerking was unspecified.
40 2021-06-13 numbness I immediately had numbness in my mouth and face as well as a metallic taste in my mouth. Since recei... Read more
I immediately had numbness in my mouth and face as well as a metallic taste in my mouth. Since receiving the first shot I have had allergic reactions to various foods at an alarmingly increased rate. I have not been able to isolate which foods/ingredients. Symptoms include swollen lips and tongue, splotchy red face and the slight constricting of my esophagus.
40 2021-06-16 cold sweat, pain in extremity His arm felt like it was punched 100 times; He had cold sweats; This is a spontaneous report from a ... Read more
His arm felt like it was punched 100 times; He had cold sweats; This is a spontaneous report from a contactable consumer (reported for himself). A 40-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date (at the age of 40-years-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date for COVID-19 immunisation. With his 1st dose, consumer said he did not feel anything, and did not have any side effects. On an unspecified date in 2021, the consumer stated that his arm felt like it was punched 100 times and he also said he had cold sweats. He wanted to know if it is possible that the arm would hurt worse after the 2nd dose. He said he known that the cold sweats are worse after the 2nd dose. The consumer wanted to know if it is possible that he did not receive the 1st dose since he did not feel anything. He also wanted to know if his arm should have hurt after the 1st dose. The consumer wanted to know if there is a way to test immunity after receiving both doses of the Pfizer-BioNTech COVID-19 Vaccine in response received 'Antibody tests are used to see if you have some level of protection against the virus. If your body developed an immune response, which was the goal of vaccination, there was a possibility you might test positive on some antibody tests after receiving the Pfizer-BioNTech COVID-19 Vaccine'. The outcome of the events was unknown. Additional information about Batch/Lot number has been requested.
40 2021-06-17 weakness, cold sweat Extreme discomfort/pressure in chest for 4 hours. Three weeks later the same intense pressure with n... Read more
Extreme discomfort/pressure in chest for 4 hours. Three weeks later the same intense pressure with nausea and cold sweat. Low energy and short of breath.
40 2021-06-20 nerve injury, seizure Following the vaccination on 2/23/21, Pt had fever, chills, fatigue the first two days. On the third... Read more
Following the vaccination on 2/23/21, Pt had fever, chills, fatigue the first two days. On the third and fourth days, he added diarrhea and headache to those symptoms. He felt awful over the weekend and spoke to his doctor on Monday, 3/1. The doctor began him on steroids and ivermectin. Over the next 24 hours his breathing began to worsen. He entered the hospital on Tuesday, 3/2, for supplemental oxygen. Things continued to get worse. He was intubated and put on a ventilator on 3/6/21 and ultimately spent 13 days in a coma. He was extubated on 3/19/21 but then had seizures on 3/20/21 and had to be reintubated to secure his airway. Pt was taken back off the ventilator on 3/24/21. He suffered vocal cord paralysis and ultimately wound up with both a PEG tube and tracheotomy. He was discharged from the hospital after 43 days and then spent 10 days in an inpatient rehab center. He continues to deal with vocal cord issues, tracheal stenosis, nerve damage in his neck and shoulder, muscle atrophy, and damaged lungs.
40 2021-06-22 migraine Altered migraine, elevated Cardiolipin IgM (83, 97), possible CVA (stroke). Sought medical treatm... Read more
Altered migraine, elevated Cardiolipin IgM (83, 97), possible CVA (stroke). Sought medical treatment after altered migraine which led to discovery of brain stem lesion requiring further characterization. Currently, no diagnosis and awaiting additional testing to confirm nature of brain stem lesion.
40 2021-06-24 cold sweat 6/25/2021 Patient was observed post Covid-19 immunization for 15 minutes . During the observation... Read more
6/25/2021 Patient was observed post Covid-19 immunization for 15 minutes . During the observation period, he experienced an adverse reaction with the following symptoms: loss of consciousness. Assessment : Time of assessment 0831am. Pallor, Clammy and disoriented. Actions taken: Vitals sign taken EMS called at 0831. VAERS form obtained and completed by RN. Hand off to EMS upon arrival at 856am. Patient refuses EMS transport. Water given 0835- BP- 67/44, P- 39, O2- 100 %, recheck- at 0839- BP- 105/66 , 0915- bp 012/82, P- 44, O2- 100% Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. EMS accessed patient, patient refuses transport. Wife with patient. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 6/25/2021 8:27 AM 0.3 mL 2/25/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER8736 NDC: 59267-1000-2
40 2021-06-24 muscle spasms Chest pains, left rib area won't stop hurting, a few days after shot felt like my abs were having a ... Read more
Chest pains, left rib area won't stop hurting, a few days after shot felt like my abs were having a charley horse. Back pain, nausea dizziness and confusion on a daily basis. Doctors have no idea what's wrong with me suggesting upset stomach, ulcer, heartburn, spinal issues., anxiety, depression. They are just guessing.
40 2021-06-24 pain in extremity Date of start of drug 23May2021 06Jun2021; Dolor en el brazo donde fue aplicada la vacuna (Pain in t... Read more
Date of start of drug 23May2021 06Jun2021; Dolor en el brazo donde fue aplicada la vacuna (Pain in the arm where the vaccine was given).; Dolor en el brazo donde fue aplicada la vacuna (Pain in the arm where the vaccine was given).; This is a spontaneous report from a contactable consumer, the patient. A 40-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, (Batch/Lot Number: EW0187), via unspecified route, in left arm on 23May2021 at 12:00 (at 40-years age) as 1st dose, single for covid-19 immunization at pharmacy or drug store. The patient medical history was 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 had not received any other vaccines within 4 weeks prior to the COVID vaccine. The concomitant drugs were not reported. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, (Batch/Lot Number: EW0196), via unspecified route, in left arm on 06Jun2021 at 01:45 PM as 2nd dose, single for covid-19 immunization. On 23May2021 at 19:00 the patient had experienced Dolor en el brazo donde fue aplicada la vacuna (Pain in the arm where the vaccine was given). The device date was reported as 16Jun2021. The patient had not received the treatment. No other medications were taken by the patient within 2 weeks of vaccination. The patient was not hospitalized. The outcome of the events was recovered in 2021.
40 2021-06-24 pain in extremity the right arm pit is more swollen than the left arm pit. He says there are no bumps in the arm pit, ... Read more
the right arm pit is more swollen than the left arm pit. He says there are no bumps in the arm pit, just swelling./swollen and there is little bumps present.; Concerned about the inflammation; That evening he had pain in his arms; and body aches which today have resolved; This is a spontaneous report from a contactable consumer (patient) reported for himself for the 1st Dose administered. A 40-years-old male patient received bnt162b2 (BNT162B2, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 13Jun2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced the right arm pit is more swollen than the left arm pit and said there are no bumps in the arm pit, just swelling. swollen and there is little bumps present. (swelling on 15Jun2021 with outcome of not recovered , that evening he had pain in his arms on 13Jun2021 with outcome of recovered , and body aches which today have resolved on 13Jun2021 with outcome of recovered , concerned about the inflammation on 15Jun2021 with outcome of not recovered.
40 2021-06-29 discomfort, facial pain, tingling, tenderness, speech disorder I got the vaccine shot on a Thursday, and woke up the next Friday morning feeling strong tingles on ... Read more
I got the vaccine shot on a Thursday, and woke up the next Friday morning feeling strong tingles on my face, weird sensations, & some swelling of lymph nodes had started. i thought i might be having a minor reaction, or it felt like i might. Saturday morning i woke up w' some bumps & inflammation w' a painful red sore on my nose bridge next to my right eye. i almost went to urgent care Saturday night but talked myself out of it, then Sunday woke up & had more inflammation & swelling, tenderness, & pain & discomfort. i went to my doctor on Monday as it felt intolerable & was getting worse, i told him about getting the vaccine, reporting it felt like my immune system was confused or something, he said there were some vaccine reactions, that it was possible for it to affect people differently, that it was rare, that he didn't know, but he said it looked like shingles was attacking me & referred me to the Eye Institute to see Dr, who tested me even as my eye was swelling shut. There was a danger it could get in the eye. Prescribed Acyclovir antiviral. My condition kept worsening but i kept taking the antivirals & eventually responded well to them. It hurt everywhere, & the pain was indescribable, at almost every level. It was excruciating. i was fighting off the attack by the 3rd week & could open my eye, but was still in a lot of pain, had to rest almost all the time, could barely eat & speak for weeks, or go outside in the sun for more than a couple minutes, because of the brightness etc. & was overall incapacitated for about 5 weeks. It was completely disabling. The doctors were very impressed w' how intense the condition was, & showed me to all the students at the Eye Institute. They were pleased w' how well i have been healing up. My immune system feels strong too. It was just brutal but i am recovering now, thankfully. i still feel prolonged effects though, w' even some pain at times during the day, or if i am active then i feel like i have to rest. i am just really thankful it doesn't hurt like that now. There is probably gonna be some permanent scarring because of the damage to my face from the nervous system inflammation, as my face is heavily scarred now because of the attack, i could maybeget plastic surgery for the scarring on the right side of my face.
40 2021-06-29 pain in extremity Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male ... Read more
Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE BIONTECH, Lot number: unknown) via an unspecified route of administration in the left arm on 20Mar2021 at 15:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced arm pain on 20Mar2021 at 22:45. 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 event. The outcome of the event arm pain was unknown. Information about lot/batch number cannot be obtained. No further information is expected.
40 2021-07-01 involuntary muscle movements insomnia started getting worse; he gets so tried; his body start 'jerking'; feels like he is suffoca... Read more
insomnia started getting worse; he gets so tried; his body start 'jerking'; feels like he is suffocating; it's like somebody is choking him/choking sensation/feels like somebody has his thumb in the middle of his adam's apple and his throat; light headed; This is a spontaneous report from a contactable consumer (patient's mother). A 40-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 26May2021 as the 2ND dose, single for COVID-19 immunization. Medical history included ongoing ventricular tachycardia. Concomitant medication included amiodarone (manufacturer unknown) taken for ventricular tachycardia, start and stop date were not reported, taking the highest dose (as reported). The patient previously received the first dose of bnt162b2 (lot number and expiry date unknown) on 03May2021 for COVID-19 immunization and right after the patient experienced insomnia and cough. When the patient went back to his second vaccine, his insomnia started getting worse. He can't sleep at all and when he does fall asleep it is only for 2 hours and he gets so tired, his body starts 'jerking' and it makes him wake up. Since the second vaccine, the patient said it's like somebody is choking him, he said it feels like he is suffocating and he said it feels like somebody has his thumb in the middle of his adam's apple and his throat and so they send him to the emergency room and they told him to go home and just take sleeping pills. However the reporter stated that the patient can't take the sleeping pills because of his ventricular tachycardia and the medicine that he is on. They were getting the patient setup for his test the following morning from the day of the report and when he woke the morning of the day of the report he experienced the choking sensation and all that kind of stuff but he is light headed and they don't know if he should be taken to that test the following morning but yes the test is really important because of his heart and they don't know if he can take the medication that they are going to give a 'nuclear' medication with having all these side effects like these if it is from the Pfizer vaccine so that was why the patient's mother was reaching out for somebody with medical knowledge about the vaccine and the side effects and if someone could tell them if the patient could continue with his test. They wanted to know how long the side effects will last and if the side effects need treatment. The patient had a lab test (unspecified) and a chest x-ray both on unspecified dates but they did not have the results at the time of the report. The outcome of the events was unknown. Information on lot number/batch number was requested.
40 2021-07-06 weakness, flushing Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Weakness-Severe, Additi... Read more
Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Weakness-Severe, Additional Details: Patient fainted 5 minutes after vaccine administered. Patient came to within a minute. Refused to be sent to the hospital. Patieent was given water and a ice pack. Girlfriend picked up patient.
40 2021-07-07 numbness PT states that immediately upon receiving vaccine that he experience extreme pain of the right arm, ... Read more
PT states that immediately upon receiving vaccine that he experience extreme pain of the right arm, and "immediate pain, pressure at the cartiledge of the injection site. Has had pain of the right shoulder since this time and also says that he has had limited rom of the arm. Has taken motrin, used ice and Tylenol with no relief of symptoms. Has normal grip strength, reports intermittent numbness of forearm to his PCP, who he followed up with on 6/14/21
40 2021-07-08 pain in extremity, slurring Increased yawn reflex to find air.; Chills immediately after/ cold body; Sweaty hands; Tight throat ... Read more
Increased yawn reflex to find air.; Chills immediately after/ cold body; Sweaty hands; Tight throat muscles; Sore upper left arm; Weird feeling in the body; Very slight difficulty breathing; Very slight difficulty articulating some words; Nausea; Difficulty sleeping; Loss of appetite; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EK8727) via an unspecified route of administration in the left arm on 24Mar2021 at 16:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. The patient had known allergies to penicillin and amoxicillin. 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 had not been tested for COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN) 20mg once a day for unknown indication and from an unknown date. On 24Mar2021 at 16:45, the patient experienced increased yawn reflex to find air, chills immediately after / cold body, sweaty hands, fatigue, tight throat muscles, sore upper left arm, weird feeling in the body, very slight difficulty breathing (but SPO2 ok at 98%), very slight difficulty articulating some words, nausea, difficulty sleeping and loss of appetite. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab tests which included oxygen saturation test on an unknown date and the result was SPO2 at 98%. The clinical outcome of events increased yawn reflex to find air, chills immediately after / cold body, sweaty hands, fatigue, tight throat muscles, sore upper left arm, weird feeling in the body, very slight difficulty breathing, very slight difficulty articulating some words, nausea, difficulty sleeping and loss of appetite was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
40 2021-07-08 cold extremities Client reported feeling dizzy and nauseous after vaccination. On assessment client appeared pale, an... Read more
Client reported feeling dizzy and nauseous after vaccination. On assessment client appeared pale, and his skin was cold and moist. Client blood pressure was 98/54. Client responded appropriately to all questions. Client was given ammonia ampule, water and a lollipop. Client reported having eaten a sandwich earlier in the day. Client reported increased dizziness. Client was instructed to lie down and his legs were elevated. Client was monitored. Client's coloring improved and client reported feeling "better". Client's Blood pressure was taken again 140/80, Pulse 67.
40 2021-07-11 migraine, mild one side paralysis, numbness, nerve pain Patient began experiencing symptoms approximately 1 week (7 days) after receiving the 2nd dose of th... Read more
Patient began experiencing symptoms approximately 1 week (7 days) after receiving the 2nd dose of the Pfizer/BioNTech vaccine series. These symptoms included severe weakness/numbness of right hand and right food, moderate headache every day, migraine lasting 3 days resulting in emergency room visit, sharp nerve pain in back and neck. Patient has been undergoing physical therapy for right hand weakness/numbness that is still continuing 30 days later, but improving slowly. Per MRI and diagnosis from neurologist, concluded that patient has nerve inflammation secondary to receiving the vaccine.
40 2021-07-11 numbness and pain in extremities, weakness, pain in extremity, nerve injury Following my second Pfizer dose on on 4/2/21 I began having a strong burning pain in my right forear... Read more
Following my second Pfizer dose on on 4/2/21 I began having a strong burning pain in my right forearm and wrist area. I perceived this initially to be carpal tunnel and it started on 4/5/21. I self treated with ibuprofen for a few days with no improvement, then saw my PCP on 4/9. My PCP thought this to be tenosynivitis, and prescribed Methylprednislone. The steroid treatment helped for the first few days but then the pain quickly spread to my right leg in the thigh area. Same type of pain, burning and intense. I was able to walk, but with a slight limp. I saw my PCP again on 4/15 to discuss the new symptoms. He began researching possible conditions and also ordered some blood tests for common auto-immune diseases (Uric Acid, C-Reactive Protein, CMP, ANA). Everything returned normal except for C-Reactive (value- 50+). To be sure it wasn?t a case of septic arthritis, I was placed on an antibiotic on 4/17 (Keflex) for 7 days. The Keflex did not help and actually gave me a slight fever (100.1) and I missed work on 4/19,20,21. I started to improve on 4/16 but the symptoms were still present. As a followup, my PCP ordered a more comprehensive blood panel to be reviewed at my next appointment on 4/30. The following blood tests were ordered: TSH 3rd Gen Blood, CBC, CMP (BAMP, TP ALB TBIL,ALK, AST, ALT), and LIPID Panel. On PCP appointment on 4/30, my symptoms continued to present in legs and right arm. All values from blood tests were normal. He ordered a lower back xray, which was scheduled for 5/11. At this point, my PCP referred me to a rheumetologist as he had exhausted his options. Unfortunately, the earliest rheumatology available was 5/18. On 5/18 appointment with rheumatology resulted in more tests: Parvovirus B19, Rheumatoid Factor, Serum Protein Electrophoresis, Urine PRotein/Creatinine Ratio, Immunoglobulin Assay-Blood, Immunofixation Procedure Blood, ASO- Blood, CPK Blood, Cyclic Citrullinated Peptide Antb, Hep B Surface AG, Hep C AB- Blood, Microalbumin urine random. All tests read as negative or normal except ASO. Rheumetologist referred me to Infectious Disease for further testing on 5/26, which resulted in the following blood tests: Ehrlichia Chaffeensis AB IGG, DNASE B Antibody, HLA Typing A B C Single - Blood, Legionnella -Blood, Prostate Specific Antigen, Unrinanalysis with Microscopic, Chlamydia and GC RNA AMP, Upper respiratory throat culture. He also ordered an ECG, a chest XRAY (PA and Lateral), CT scan of the pelvis. On 6/4 at a followup appointment, he ordered Crypto AG and C-Reactive Protein. At this point, CRP value was 180.74. I worked my last day of work on 5/14 as the pain became too intense to manage. As the week progressed, I slowly lost my ability to walk and care for myself. I could walk only 10-15 feet at a time, and doing so would cause a severe flare-up of pain in my legs. I was mostly bedridden for 2 weeks starting on 5/20 and was only getting up very minimally. I needed a wheelchair for transport to my appointments on 5/25, 5/26, 6/2, 6/3. By 6/4, I was barely able to walk to that appointment, but the office is very small so I was able to make a short distance. My rheumetologist, having reviewed all my normal test results ordered an EMG on my legs and right arm and also an MRI on my lumbar and cervical. EMG conducted on 6/24 and revealed some nerve damage and signs of neuropathy in my legs; and also carpal tunnel in the right wrist. MRI Lumbar (6/25) revealed some common lower back issues, but nothing affecting the nerves that may be the cause of my symptoms. MRI Cervical (7/12) completed but yet to be analyzed. As of today, July 12, I?m feeling much improved over how I felt in early June. I can walk a short distance of ? mile without needing a break. I have lost muscle tone and need to work on getting my strength back. My right arm has minimal pain but will flareup with heavy computer usage. However, for the past 2 weeks, my left arm (which has been symptom free since April) now has a similar burning pain that starts at the funnybone of the elbow and runs up to my wrist. The pain comes and goes but is sometimes very intense and can be debilitating. It is hard for me to open some doors with this hand or even hold a heavy cup of water. As a previously healthy person, and having done exhaustive testing, myself and my PCP believe I had a rare and negative reaction to the vaccine.
40 2021-07-14 pain in extremity SORE RIGHT ARM, TIREDNESS
40 2021-07-15 cold sweat, tension headache, feeling cold Patient came into pharmacy on 7/ 14/21 and described the following: Severe body pain in areas where ... Read more
Patient came into pharmacy on 7/ 14/21 and described the following: Severe body pain in areas where he has "recent" injuries (vasectomy, back issues). No control over bowel movements. Disoriented/ motor skills severely lacking; couldn't walk down steps or down the hallway. had to call for help to family to do normal tasks. mild hallucinations. mental anguish; things were true in his head but not true in reality; mental dysphoria. Thinking this was the end; was able to recognize it but also very concerning. 3:30 am saturday this started; not all gone yet (7/14). Tension headaches (not prior). Extremely cold, clammy, sweaty; had to change clothes based on the amount of sweat. Not drug user, not alcohol, active military, not 48 hrs prior till recent. no pre workout. no medications. ibuprofen later saturday morning. First vaccine he just had local pain at shot site, some pain to the older issue sites and tiredness but nothing more than 24 hours. No mental illness dx at this time; possible ptsd but never diagnosed, not something he suffers from on a daily basis.
40 2021-07-16 pain in extremity Chest pain persisted for ~3 day. Chest congestion for ~7 days with occassional heartburn-like pain. ... Read more
Chest pain persisted for ~3 day. Chest congestion for ~7 days with occassional heartburn-like pain. On 3/31/21, sharp pain in left arm and back.
40 2021-07-16 sensory loss, slurring I was hospitalized on 6/2/2021 due to viral Meningoencephalitis. Althought this was 6 weeks after 2... Read more
I was hospitalized on 6/2/2021 due to viral Meningoencephalitis. Althought this was 6 weeks after 2nd shot, was told I should still report it since it was caused by a virus that the hospital was unable to determine after negative tests for other viruses. Had high fever, which led to loss of consciousness and possible seizure. Experienced hallucinations and loss of self-awareness (forgot who I was). Taken to hospital, entered into ICU for 5 days. Spinal tap revealed viral infection. Throat culture revealed strep throat. Given antibiotics and IV fluids for several days. Restored self-awareness and fever disappeared after a few days. Intense headaches persisted for days. Was discharged from hospital on June 7, 2021 after 7 days. Experienced possible repeat seizure 5 days later in public, loss of sensation in legs, slurred speech. Was re-administered into different hospital on June 13, 2021. Spent ~5 days in that hospital, received EEG which showed brain damage on right temporal lobe. Received another spinal tap which showed infection was improving. Discharged on June 16, 2021.
40 2021-07-17 pain in extremity, tremor He experienced some leg shaking; Can not sleep; His legs started shaking and Friday it got worse; he... Read more
He experienced some leg shaking; Can not sleep; His legs started shaking and Friday it got worse; he went from 180 to, when he was at the doctor, they said 175; Nausea; After getting both doses he experienced Chills; Vomiting; Arm was a little sore; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number, NDC number, Expiry Date of Pfizer Covid-19 Vaccine: Unknown), via an unspecified route of administration on 15Jun2021 at 10:00 AM (vaccinated at the age of 40 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing diabetes and reported as patient has had since he was 22 he thinks. He went with his ex-wife on vacation and came back, so probably 22, Caller clarifies that he thinks he is a type 1 diabetic but he is not sure, he takes insulin. Ongoing smoker and reported as I smoke and occasionally drink on the weekend maybe but nothing crazy. He has been smoking since he was 17 he guesses. Ketoacidosis and reported as caller adds that he did have ketoacidosis last year and they did do everything, CAT scans and all the blood work and everything. This was this past year. Caller does not know additional information but states it was prior to receiving the vaccine. The patient doctor a year ago gave some heart medication because patient had high blood pressure. The time before he saw him, he said it was too low and stop taking it. Family medical history reported as nobody has diabetes in his family, and he is the first. His dad had cancer and passed away when he was 58. Concomitant medications included insulin human injection, isophane (NOVOLIN N) and insulin human (NOVOLIN R) both were taken since he was 23 years for diabetes from an unspecified start date and ongoing. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: unknown) on 25May2021 for Covid-19 immunization and he got sick, it made him throw up, experienced chills. The first dose appointment was at 9:30 am. The patient states he got the second shot last Wednesday. Then, he went to work on Thursday. Friday on 18Jun2021, his legs started shaking and Friday it got worse. Saturday it got worse. Sunday, they felt a little better. Monday, or actually yesterday, he went to the doctor and the doctor said he has to go see a neurologist because the doctor kept him there for 3 hours looking at his legs and feeling them. They were moving out of control. Caller added as, considering his job, he walks 20-30,000 steps a day and he has never had trouble with his legs but he was diabetic. Caller adds that right now he kind of walks, like his girlfriend and son explained it, like a gimp and when he walks his legs pop. The patient cannot sleep. He slept maybe 6 or 7 hours since last Friday 18Jun2021. On an unspecified date the patient went from 180 to, when he was at the doctor, they said 175. Caller confirms this was new since receiving the vaccine. He has been 180 my whole life. He has not been able to work in a couple of day because he cannot walk. He guesses the weight loss is because of the vaccines. But, he is diabetic too, and was in pretty good health before this. Caller adds he has to pay for doctor appointments, his doctor kept him there for close to 4 hours and he looked at his legs for 45 minutes. He did not understand what was going on, and he sees him all the time for his diabetes. The doctor said that he has to see a neurologist, but none of these symptoms happened in his life until he got the shot. The patient arm of course was a little sore like when you get a shot and it hurts. Caller went to work and was fine, went to work the next day and was fine. This past Friday, his legs started shaking and he does not know. He could not sleep, they would not stop moving. He can control them if he uses muscle and really tries to control them. caller adds this is not going on still, he just thinks the pharmacist who gave the shot gave it rough. Also, his job is to walk a lot and lift stuff so that could be contributing to that part. Legs shaking, The patient spoke as per attached document in terms of nausea and vomiting. Treatment; cannot not sleep: caller adds he has a pool and when he goes swimming it feels better. If he walks around too much, how can he explain it, it gest worse but he can control it. If he flexes his muscles he can stop it, like flexing his legs that is how he stops it. If he does not, they just shake. He cannot not sleep because they shake so much they wake him up. The patient was diabetic and uses insulin and the same medication he has taken for years. The patient has been fine. His doctor a year ago gave him some heart medication because he had high blood pressure. The time before he saw him he said it was too low and stop taking it. The patient walks a lot and exercises or swims and uses insulins. One was long and one was short acting. Investigations were none, the patient saw a doctor yesterday who was trying to get him into a neurologist. He thinks it has to do with his nerves. He is trying everything he can. Adverse events do not require a visit to emergency room, but the doctor said if he cannot get him in to a neurologist in the next day or two, that he wants him to go to the emergency room. Needs visit to physician office. The patient doctor did not know what to do and just referred him to a neurologist. Caller just wanted to report this because none of these symptoms occurred until the second shot, or, well, it was the first shot that made him throw up and the other things with the second shot. his doctor did not know what to do and just referred him to a neurologist. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccines was none. Adverse events following prior vaccinations was none, he has not had a vaccine since he was a kid or teenager he guesses. The patient underwent lab tests and procedures which included weight loss: went from 180 to 175 lbs on an unknown date and reported as He went from 180 pounds to 175 pounds. Outcome of the event cannot sleep and his legs started shaking and Friday it got worse were not resolved and event arm was a little sore was resolved on an unspecified date, and remaining events were unknown. Information about lot/batch number has been requested.
40 2021-07-17 pain in extremity He felt like throwing up; After the first shot, he got sick; He reported that after getting both dos... Read more
He felt like throwing up; After the first shot, he got sick; He reported that after getting both doses he experienced CHILLS; arm was a little sore; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, patient was 40-year-old at the time of vaccination), via an unspecified route of administration on 25May2021 at 09:30 as single dose for COVID-19 immunisation. It was reported that patient works at withheld Center and they get stuff from all over the country, out of the country, and they distribute to all withheld. He touches a lot of stuff and is diabetic. He was not wanting to get it but his sister and girlfriend and son told him he should to be safe. He just kind of listened to them. Medical history included diabetes; he has had since he was 22 he thinks, Smoker; he has been smoking since he was 17 he guesses, Occasionally drink on the weekend, ketoacidosis, He had high blood pressure. Family history included his dad had cancer and passed away when he was 58. Concomitant medication(s) included insulin human injection, isophane (NOVOLIN N, patient had been on since he was 23); insulin human (NOVOLIN R, patient had been on since he was 23); insulin (INSULIN) all taken for diabetes mellitus. Reported that he is diabetic and uses insulin and the same medication he has taken for years. He has been fine. His doctor a year ago gave him some heart medication because he had high blood pressure. The time before he saw him he said it was too low and stop taking it. He walks a lot and exercises or swims and uses insulins. One is long and one is short acting, he thinks he is a type 1 diabetic but he is not sure, he takes insulin. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior Vaccinations within 4 weeks. On an unspecified date in May2021, the patient experienced he felt like throwing up, after the first shot, he got sick, he reported that after getting both doses he experienced chills, arm was a little sore. Reported that Arm was a little sore because he just thinks the pharmacist who gave the shot gave it rough. Also, his job is to walk a lot and lift stuff so that could be contributing to that part. Reporter seriousness for After the first shot, he got sick and it made him throw up, arm was a little sore was unspecified. On an unspecified date in 2020, the patient underwent lab tests and procedures which included blood test and CAT ketoacidosis, Reported that patient had ketoacidosis last year and they did do everything, CAT scans and all the blood work and everything. This was this past year but states it was prior to receiving the vaccine. No treatment received because his doctor did not know what to do and just referred him to a neurologist. The outcome of events (He felt like throwing up, After the first shot, he got sick, He reported that after getting both doses he experienced CHILLS) was recovered on an unspecified date in 2021 and the outcome of event (arm was a little sore) was recovered on an unspecified date in May2021. Information about lot/batch number is requested.
40 2021-07-18 hot flush The time of the schedule appointment was for 3:00pm at the local Pharmacy). Once the vaccine was in... Read more
The time of the schedule appointment was for 3:00pm at the local Pharmacy). Once the vaccine was injected into my left arm, I was placed into a different seating placement, to be observe for any signs of side-effects that may occur form the injection. This seating area also displayed a digital clock to notify how long each patient must be stationed for (each station is registered for each patient to wait approximately 15 minutes after injection). Once placed in the seating area and the clock was started to examine my treatment, within the six minutes of observation, the following signs occurred: Rapid-Heart Rate, Short and Shallow Breathing, Sweaty Palms including Hot Flashes (lasting 4 seconds).
40 2021-07-21 inability to speak Hallucinated after 1st shot then blacked out. Lost control of bladder functions. Disoriented and una... Read more
Hallucinated after 1st shot then blacked out. Lost control of bladder functions. Disoriented and unable to speak or hear for several minutes. Transported to emergency room. Still have hearing issues and headache a week later.
40 2021-07-21 pain in extremity Vomiting; Massive headache; Incredibly tired; Sore right arm; This is a spontaneous report from a co... Read more
Vomiting; Massive headache; Incredibly tired; Sore right arm; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the right arm on 31Mar2021 at 14:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient was not allergic to food, medications, or other products. The patient did not receive any medications within two weeks prior to the COVID-19 vaccine. 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. On 31Mar2021, after about 3 hours from the first dose of vaccine, the patient was incredibly tired and slept. The event of incredibly tired was not that bad. The patient woke up for a little while and then went back to sleep again. On 01Apr2021 at around 06:15, the patient woke up with a massive headache. He took a couple of ibuprofen and tried to relax. About fifteen minutes later, at 06:30, the patient could tell he was about to vomit and did. He kept vomiting for about the next 20 minutes or so till there was nothing left. He slowly sipped water for the next hour. After that he had no adverse reactions. The patient stated that, he had not vomited in at least the past 7 years and that episode of vomiting was violent and also stated he could not control that. On the same day, in the evening, the patient only had a slight sore right arm and episode of tiredness. On 02Apr2021, after vomiting the patient slept for the next five or so hours. His arm was still slightly sore but really did not bother him. After around 2 PM (about 24 hours later), he had felt totally fine. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the events of tiredness, vomiting and sore right arm. The clinical outcome of the event tiredness, headache, vomiting and sore right arm were resolved in 02Apr2021. No follow-up attempts are needed. No further information is expected.
40 2021-07-22 myelitis transverse Transverse Myelitis; This is a spontaneous report from a contactable pharmacist. A 40-years-old adul... Read more
Transverse Myelitis; This is a spontaneous report from a contactable pharmacist. A 40-years-old adult male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: El3249) via an intramuscular route of administration in Arm Right on 20Jan2021 03:15 (age at vaccination 40years old) as Dose 2,Single for COVID-19 immunization. Medical history included diabetes mellitus from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, HTN, hyperlipidaemia from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility the most recent COVID-19 vaccine was administered in Workplace clinic. Concomitant medication(s) included semaglutide (OZEMPIC); metformin (METFORMIN); hydrochlorothiazide, losartan potassium (HYZAAR); rosuvastatin calcium (CRESTOR). All taken for an unspecified indication, start and stop date were not reported. The patient was allergic to the drug Amoxil.Since the vaccination, the patient had not been tested positive for COVID-19. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: El0142) via an intramuscular route of administration in Arm Right on 30Dec2020 03:15 as Dose 1,Single for COVID-19 immunization. The patient experienced transverse myelitis in Jun2021. The patient was hospitalized for transverse myelitis for 3 days. The patient received any treatment for the adverse events. Therapeutic measures were taken as a result of transverse myelitis. The clinical outcome of the event recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug 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 2021-07-23 tingling As soon as she injected me my lips, throat and face started tingling.
40 2021-07-29 feeling hot Within 3 hours headache.; Within 30 min: Warm sensation from left cheek down left arm.; Inappropriat... Read more
Within 3 hours headache.; Within 30 min: Warm sensation from left cheek down left arm.; Inappropriate schedule of vaccine administered; Joint pain; Significant body aches; Lethargy; Dry mouth; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151), via an unspecified route of administration in the left arm on 06Apr2021 at 15:00 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN); all from an unknown date for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613), via an unspecified route of administration in the left arm on 19Mar2021 at 15:00 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. The patient previously took augmentin (MANUFACTURER UNKNOWN) on unknown date for an unspecified indication and experienced drug allergy. 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 06Apr2021 at 15:30, within 30 min the patient experienced warm sensation from left cheek down left arm. Within 3 hours headache. Within 12-18 hours post: dry mouth, significant body aches, joint pain, headache and lethargy. No therapeutic measures were taken as a result of the reported events. 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 warm sensation from left cheek down left arm, headache, dry mouth, significant body aches, joint pain, headache and lethargy were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
40 2021-07-29 cold extremities Ice cold hands and feet since being vaccinated.; This is a spontaneous report from a contactable con... Read more
Ice cold hands and feet since being vaccinated.; This is a spontaneous report from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route, administered in left Arm on Mar2021 at 10:00 (Lot Number: ER8732; at the age of 40-year-old) as a dose 2, single via an unspecified route, administered in left Arm on Mar2021 at 10:00 (Lot Number: ER8732; at the age of 40-year-old) as dose 1, single, both doses for COVID-19 immunization. The patient's medical history included heart arrhythmia and Hashimoto's. No past drug was reported. The patient's concomitant medications included levothyroxine sodium within 2 weeks of vaccination. 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 16Apr2021 at 20:00, the patient experienced ice cold hands and feet since being vaccinated. Since the vaccination, the patient had not been tested for COVID-19. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient had not received any treatment medication for the reported event. The outcome of the event was not recovered. Follow-up attempts are completed. No further information was expected.
41 2020-12-31 numbness, pain in extremity I have metal in my right shoulder, whole right arm went numb for half a day and was week. Metal in m... Read more
I have metal in my right shoulder, whole right arm went numb for half a day and was week. Metal in my left foot, whole left let=g is swollen and hurts, saw 3 doctors and they didn't know what to do, one doctor gave me Ibuprofen
41 2021-01-01 pain in extremity Soreness and weakness of left arm for more than 5 days. Intermittent headaches and runny nose
41 2021-01-02 weakness, feeling cold My entire body felt really cold for the whole day on Tuesday. I couldn't get warm and had to put on ... Read more
My entire body felt really cold for the whole day on Tuesday. I couldn't get warm and had to put on extra clothing during the day and extra blankets when I went to sleep. I think this is considered to be chills. On both Tuesday and Wednesday, I ran out of energy by the afternoon. On both Tuesday and Wednesday, my head felt heavy.
41 2021-01-04 night sweats Fever of 101.0 F; chills with fever; fatigue; night sweats; This is a spontaneous report from a cont... Read more
Fever of 101.0 F; chills with fever; fatigue; night sweats; This is a spontaneous report from a contactable Nurse (patient). A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EH9899), via an unspecified route of administration on 20Dec2020 15:00 at single dose for COVID-19 immunization. Vaccine location provided as Left arm. Medical history included Scleroderma, interstitial lung disease. There were no Known allergies to medications, food, or other products. Concomitant medication (reported as other medications the patient received within 2 weeks of vaccination) included ibuprofen, ergocalciferol (VITAMIN D), cetirizine hydrochloride (CITIRIZINE), famotidine. There were no other vaccines received within 4 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19 prior vaccination. The patient experienced Fever of 101.0 F, chills with fever, fatigue, night sweats on 21Dec2020 20:00. No treatment received for all reported events. The patient had Covid tested via Nasal Swab post vaccination with PCR result negative on 23Dec2020. The outcome of the events was recovered in Dec2020. This case was assessed as non-serious.
41 2021-01-06 weakness injection site pain, triedness, headache, muscles pain, chills, fever, joints pain feeling unwell, w... Read more
injection site pain, triedness, headache, muscles pain, chills, fever, joints pain feeling unwell, weakness.
41 2021-01-06 migraine Headache migraine
41 2021-01-07 flushing 1145 Patient received vaccine 1150 Patient reported feeling flushed and lightheaded. Denied shortnes... Read more
1145 Patient received vaccine 1150 Patient reported feeling flushed and lightheaded. Denied shortness of breath, difficulty breathing and hives. Patient instructed to lie down. Vital signs taken and within normal limits. Patient drank 4 oz of orange juice. After, patient reported feeling better. Observed patient for 15 minutes following episode. Patient denied any symptoms prior to leaving
41 2021-01-08 weakness, pain in extremity About 12 hours after admin; arm, shoulder, neck pain, progressed to generalized body aches, nausea, ... Read more
About 12 hours after admin; arm, shoulder, neck pain, progressed to generalized body aches, nausea, severe headaches, cough, mass weakness, diarrhea, joint pain. Symptoms started subsiding about 15 hours after onset. Minor cough still persist with minor shortness of breath.
41 2021-01-08 migraine Headache migraine, red/sore, warm at site of injection,body aches
41 2021-01-10 feeling cold, hot flush Patient received first vaccine 12/29/2020. While in waiting period post-vaccination, he developed ti... Read more
Patient received first vaccine 12/29/2020. While in waiting period post-vaccination, he developed tinnitus and was hot, flushed, and diaphoretic. He felt very cold and "wobbly" after other symptoms subsided. He had sharp pains in the joints on the side of injection which continued through 1/1/21 later that day. He was tired and had a minor headache 12/29/2020-12/31/2020. Patient had a bout of severe depression and "not caring about anything" beginning 12/29/2020 and lasting about 16 hours. He has no history of depression. He awoke 1/1/2021 and the depression was gone. Patient states all these symptoms disappeared when his arm pain resolved. He developed a "strained" throat on 1/1/2021 which is the only symptom that has continued to the day of this report.
41 2021-01-10 migraine 1. Lethargy 2. Intense Migraine 3. Joint pain 4. Foggy Brain 5. Heavy Chest 6. Chills
41 2021-01-10 pain in extremity Symptom: Headache | Treatment: Tylenol | Outcome: No resolution thus far; Symptom: Fatigue | Treatme... Read more
Symptom: Headache | Treatment: Tylenol | Outcome: No resolution thus far; Symptom: Fatigue | Treatment: Sleep | Outcome: Slight improvement in fatigue; Symptom: Left arm muscle soreness (same arm as injection) | Treatment: Tylenol | Outcome: No resolution thus far; and Symptom: Back pain (upper-left quadrant) | Treatment: Stretching and Tylenol | Outcome: No resolution thus far
41 2021-01-11 weakness Lethargic not hungry Headache Weak Cloudy head
41 2021-01-12 weakness Nose is stuffy; Shortness of breath; Felt not really ok; itchy; Muscle soreness, like arms would fal... Read more
Nose is stuffy; Shortness of breath; Felt not really ok; itchy; Muscle soreness, like arms would fall off; Couldn't sleep; joint pain; had to miss work; fever reaching 104 degrees; chills; muscle ache; headache; tiredness; weakness; This is a spontaneous report from a contactable consumer (patient). This 41-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) via an unspecified route of administration on at arm left 05Jan2021 at single dose (lot number: EK9231) for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient previously received flu vaccine and felt a little tired and sore with Flu vaccine. The patient got his first dose and then worked all day on 05Jan2021. Around 18:00-19:00 on 05Jan2021, he had fever, chills, muscle aches, headaches, joint pain, tiredness, and weakness. Fever was up to 104. The patient was referring to the Pfizer COVID-19 Vaccine first felt short of breath on 05Jan2021. He was wearing a mask and felt like he couldn't breathe. He did not feel really ok on 05Jan2021 like with a flu shot. He was working and felt a little itchy. He came home around 18:00-19:00 and had chills, headache, muscle soreness like arms would fall off. He couldn't sleep. He had fever and chills through the night. He had fever up to 104 on 05Jan2021 and had to miss work. The patient stated his nose was stuffy on an unspecified date. No additional vaccines administered on same date of pfizer suspect. No prior vaccinations within 4 weeks. Outcome of all events was unknown.
41 2021-01-12 numbness, pain in extremity 2 days later I developed pain in my chest, back, lats, and entire arm. I have sharp numbing pain per... Read more
2 days later I developed pain in my chest, back, lats, and entire arm. I have sharp numbing pain periodically from my armpit to my pinky finger. This pain has only grown worse since onset despite my doctor prescribing oral steroids and pain meds. Painful to sneeze, cough and laugh
41 2021-01-13 weakness Fever 103.8 Perspiration Generalized fatigue and weakness Mild dyspnea without cough- now resolved.... Read more
Fever 103.8 Perspiration Generalized fatigue and weakness Mild dyspnea without cough- now resolved. Soreness at injection site right arm.
41 2021-01-13 cold sweat Slight fever, cold sweats, chills
41 2021-01-13 tingling, numbness Severe scapular pain that progressed to severe deltoid pain. and that developed to elbow pain over t... Read more
Severe scapular pain that progressed to severe deltoid pain. and that developed to elbow pain over the course of 3 days. Resulting in left index finger numbness and tingling. Still experiencing numbness and tingling and mild pain.
41 2021-01-14 tingling pins and needles throughout body. started 3 days post vaccination and continues 1 week after. had... Read more
pins and needles throughout body. started 3 days post vaccination and continues 1 week after. had low grade fever and fatigue in 24hrs post.
41 2021-01-15 pain in extremity The day after had myalgias and fatigue and arm pain. But on 1/10/21 began developing mild 2/10 head... Read more
The day after had myalgias and fatigue and arm pain. But on 1/10/21 began developing mild 2/10 headaches. On 1/11/21 the headache worsened to 4/10 and was associated with myalgias and neck stiffness. After a jog, I was in the shower and noticed a rash all over my body that had been pruritic. I went to the ER that night where I tested negative for flu A/B and also tested negative for covid (Antigen then PCR). Got a CMP, CBC, and coags to rule out ITP. everything was normal. The symptoms were so bad I stayed home from work on 1/12/21. Over the next few days the rash improved and the headache slowly went away
41 2021-01-17 tremor Patient received vaccine the day prior to my evaluation with him. He drank alcohol then had an episo... Read more
Patient received vaccine the day prior to my evaluation with him. He drank alcohol then had an episode where he fell, seemed to not be breathing normally, then had several episodes of tremors and shaking movements, though he was able to talk through these and did not have a postictal period. Concern for anxiety reaction or reaction to alcohol, but also feel could be related to vaccine.
41 2021-01-18 inability to speak 1/16/21, Covid vaccine injection at 12:09 PM Minute 1: dizzy and light headed (like drinking a beer ... Read more
1/16/21, Covid vaccine injection at 12:09 PM Minute 1: dizzy and light headed (like drinking a beer on an empty stomach) Minute 10: Nausea Minutes 23-25: Neck tightness (like doing unsupported crunches and holding my head up) Minute 27: Inability to swallow and inability to speak EMS on site administered EpiPen auto-injection to left thigh, immediate improvement in symptoms Transport to hospital via ambulance Hospital monitored me for several hours and discharged same day
41 2021-01-20 feeling hot Within 30 min observation period post vaccine, Ten minutes after vaccine injection patient began fee... Read more
Within 30 min observation period post vaccine, Ten minutes after vaccine injection patient began feeling dizzy and hot. Monitor VS all within normal range. Gave water and allowed to lay and rest for full 30 min. Dizziness and hot feeling resolved discharged home @ 1234 with EC precautions.
41 2021-01-24 bell's palsy, facial paralysis, tingling Bell's Palsy, right side facial droop, facial tingling, and feeling of facial fullness on 1/25/21.
41 2021-01-26 weakness Feeling weak; Muscle pain; Chills; Not been able to work for last 3-4 days; Please specify other loc... Read more
Feeling weak; Muscle pain; Chills; Not been able to work for last 3-4 days; Please specify other location: Right shoulder; Shortness of breath; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231, Expiry Date: 30Apr2021) via an unspecified route of administration in right shoulder on 30Dec2020 20:30 at single dose for COVID-19 immunisation. The medical history was not reported. There were no concomitant medications. The patient previously took influenza vaccine on 2020 for immunization 2-3 months before this BNT162B2 vaccine, previously took flu shot in the past for immunization and got sick from it. That was about 3 years ago (2018). The patient went and got the Pfizer BioNTech about 2 weeks ago. Wants to know if side effects can start then after the vaccine. He has had chills, muscle pain, shortness of breath, and dizziness. Got this at hospital and has not been able to go to work on Jan2021 that last 3-4 days due to feeling weak. Received the vaccine on 30Dec2020 and the dizziness and shortness of breath kind of started days after that on Dec2020. The chills started a couple of days ago, about 3 days ago (Jan2021) and has been off and on. The muscle pains started today (13Jan2021). Just got a text message about getting the second dose next Wednesday. He did not get any other vaccines that day or 4 weeks prior. He got the shot to protect himself from the virus, but feels like he has the virus or something. The events did not require a visit to emergency room, but may go to be seen tomorrow. Events outcome of chills, muscle pain, shortness of breath, dizziness, and not been able to go to work that last 3-4 days due to feeling weak was not recovered.
41 2021-01-27 weakness, pain in extremity Headache, Myalgia, NauseaVomiting, weakness, sore arm Narrative:
41 2021-01-27 bell's palsy Sudden onset right sided Bell's Palsy with tinnitus upon awakening in the morning. Proceeded to see... Read more
Sudden onset right sided Bell's Palsy with tinnitus upon awakening in the morning. Proceeded to see PCP in the afternoon where I was prescribed Prednisone 60mg/day x 7 days and Valacyclovir 500mg BID x 7 days.
41 2021-01-27 flushing dizziness, sob, dry mouth, nausea, flushed, itchy jaw
41 2021-01-28 pain in extremity join pain initially in bilateral shoulders then within a few hours hurt all different areas around b... Read more
join pain initially in bilateral shoulders then within a few hours hurt all different areas around body especially in joints; Within first hour of injection slight nausea that lasted a few hours; pain in hands; This is a spontaneous report from a contactable healthcare professional. A 41-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EK5730), via an unspecified route of administration in the left arm on 28Dec2020 10:15 at a single dose for covid-19 immunisation. Medical history included food allergies to dairy and nuts. Concomitant medication was not reported. On 28Dec2020 11:00, the patient experienced slight nausea that lasted for few hours, along with join pain initially in bilateral shoulders then within a few hours hurt all different areas around body especially in joints. By end of day the patient could not type on phone due to pain in hands. Ongoing joint pain for almost three weeks now. The patient did not receive treatment for the events. The outcome of event nausea was recovered in Dec2020; all other events was not recovered.
41 2021-01-28 pain in extremity his eye felt irritated; swollen eye; red eye; Sore arm; This is a spontaneous report from a contacta... Read more
his eye felt irritated; swollen eye; red eye; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: Apr2021), via an unspecified route of administration in arm on 13Jan2021 02:00 at single dose for COVID-19 immunisation. Medical history included blood pressure (as reported). Concomitant medication included hydrochlorothiazide and lisinopril, both for blood pressure. The patient just took the vaccine on Wednesday (13Jan2021) and had a reaction, not sure if it was from the vaccine or not and he was just calling that in to report that as it can be related. The patient got vaccinated on Wednesday at 2 O' clock and no major issues, just sore arm. However, Friday (15Jan2021) afternoon he had woke from a nap and his eye felt irritated. He was still experiencing a swollen eye. So, he was calling about the swollen eye, red eye. He never had something like this before, didn't take anything that might cause it, the only thing unusual was because he got the vaccine. Treatment included using a cold compress only, not ingesting anything. The outcome of events sore arm, eye felt irritated and red eye was unknown, swollen eye was not recovered.
41 2021-01-31 weakness 17h post the second dose of vaccination I have experience fever 38.1 C (100.6 F), persistent headac... Read more
17h post the second dose of vaccination I have experience fever 38.1 C (100.6 F), persistent headaches, chills, muscle pain, low energy and lost of appetite. Fever does not respond well with Tylenol (1000mg) and is persistent.
41 2021-02-03 cold sweat Syncopal event after shot given . Clammy and diaphoretic , ashen appearance and announced he was abo... Read more
Syncopal event after shot given . Clammy and diaphoretic , ashen appearance and announced he was about to pass out before he passed out . Has had between 15-20 similar episodes describable and recallable in his lifetime . Awoke after a brief 10 sec loss of consciousness. Felt immediately better and no different than any other episode that occurred after seeing needles and getting shots. Drank some water and dc home after observation . Drove himself home . No sequelae.
41 2021-02-06 pain in extremity, night sweats Fever (101), night sweats, chills, sore arm
41 2021-02-07 facial paralysis Belly's palsy, right side of face; This is a spontaneous report from a contactable physician. This p... Read more
Belly's palsy, right side of face; This is a spontaneous report from a contactable physician. This physician reported for a 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. The patient medical history included anxiety, cervical myofascial pain syndrome, gastrooesophageal reflux disease (GERD), known allergies: eggs, detergent. The patient's concomitant medications were not reported. The patient previously took salbutamol (ALBUTEROL), diphenhydramine hydrochloride (BENADRYL), esomeprazole (NEXIUM), prochlorperazine (COMPAZINE) and experienced allergies. The patient experienced Belly's palsy, right side of face on 25Jan2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included prednisone and valaciclovir (VALACYCLOVIR). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the reasonable temporal association and lacking alternative explanations, the Company cannot completely exclude the possible causality between the reported Belly's palsy, right side of face and the administration of the COVID-19 vaccine, BNT162B2. 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 RA, IEC, as appropriate.
41 2021-02-07 feeling hot Patient screened for first dose of Pfizer vaccine. He checked no history of allergies or reactions t... Read more
Patient screened for first dose of Pfizer vaccine. He checked no history of allergies or reactions to medications or vaccines. In the initial screening he informed me he had a phobia of needles but this is usually with blood draws. He reported he should be fine with vaccinations. I inquired on previous reactions and he denied any allergic reaction just that he does not like them. I asked him how I can help give the vaccine. We had him look away and to think of a different situation. I asked him if he would like to know when I am administering or just use distraction. He chose to be informed when he would feel a slight poke. Vaccine was administered with no issues. Within the minute following the vaccine patient started to feel dizzy. Hung his head a bit but was responsive. I requested staff assistance to help the situation including RN to prevent any episodes of syncope. We provided water which he was able to drink. He was still seated and we suggested putting head between legs. This was not comfortable for him so we moved him to the floor. About 3-4 min in he began to sweat a bit more and appeared Pale. We obtained a BP and pulse. BP was 112/60 and pulse around 60. When he felt hot, sweaty and appeared pale we all decided to call EMS to be cautious. He maintained BP, no SOB, did not lose conscious. EMS evaluated him, med list provided and vitals. He was on medications for anxiety. They released him after about 30min and reported a panic attack and not related to the vaccine. Patient walked out of the clinic with his partner and was stable. He is requesting 2nd dose of the vaccine. I informed him nurse would review and would have a plan for future injection.
41 2021-02-07 pain in extremity Shooting pain down left arm, Swollen Lymph node in neck, slight fever, hand pain between ring and m... Read more
Shooting pain down left arm, Swollen Lymph node in neck, slight fever, hand pain between ring and middle fingers, Tylenol , appointment with PCP
41 2021-02-09 facial paralysis, bell's palsy, numbness Bells Palsy DX on 2/9/2021 Started feeling right sided facial numbness on 2/8/2021 at 4:00 pm. Then ... Read more
Bells Palsy DX on 2/9/2021 Started feeling right sided facial numbness on 2/8/2021 at 4:00 pm. Then noticed slight right eye droop.
41 2021-02-10 feeling of body temperature change, tremor, discomfort Within our injection shot sore. No other adverse effects until 5:00 a.m. Woke up because body was ve... Read more
Within our injection shot sore. No other adverse effects until 5:00 a.m. Woke up because body was very hot similar to being in a sauna. Removing for changing the blanket to a thinner one resulted in extreme chills within one minute. Covering with blanket resulted in extreme hot within 10 minutes. Repeated this cycle for several hours until fall asleep. High discomfort throughout body. Woke up at 10:00 a.m. with mild grade fever of 99.5° (average resting temperature is 96.5). Felt extreme cold and chills shivering body aches headache until 6:00 p.m. felt hungry and okay enough to eat. Main concern is the extreme hot to extreme cold cycle in early morning. It felt as though the body was not in sync. During fever throughout day/afternoon body's reaction was normal - fever meant chills and shivering, putting on a blanket meant comfortable warmth (after long periods of time). But in early morning no no fever yet body burning hot almost suffocating sauna heat insider body, and removing the blanket a immediate and severe chills with uncontrollable shaking, instead of relief from heat... Concerned if vaccine affects body's heart regulation system (hypothalamus, thyroid, etc). General malaise during this period is an understatement... It was not a single spot or feeling pain it was the whole body wanting to twist itself and feeling 'deprssed' and very 'ill' all over all at once.
41 2021-02-11 numbness Again fatigue and just feels awful but also leg numbness which is new.
41 2021-02-12 unresponsive to stimuli, pain in extremity Swollen leg/pain- taken to urgent care- became unresponsive - CPR initiated- expired
41 2021-02-14 pain in extremity Chills; Body aches; Barely able to move his arm; He feels horrible/not feeling well; He can't sleep;... Read more
Chills; Body aches; Barely able to move his arm; He feels horrible/not feeling well; He can't sleep; Ringing in the ears; Nausea; Flu like symptoms; Bad sore arm; Muscle aches; Joint pain; This is a spontaneous report from a contactable consumer (mother of the patient). The same consumer reported information for 3 patients. This is the first of 3 reports. A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Jan2021 at single dose for COVID-19 immunisation at the age of 41-year-old. Medical history and concomitant medications were unknown. On 25Jan2021, the patient experienced Flu like symptoms, He had a bad sore arm, barely able to move his arm, Nausea, Muscle ache, Joint pain; no fever. On unknown date, the patient experienced not feeling well/ feels horrible, chills, body ache. Patient stayed home from work one day. On 27Jan2021, the patient felt a little better, but he still would have the symptoms. On 28Jan2021, the patient had ringing in the ears, he has muscle aches, he could not sleep. Patient reportedly as very well young man and he has no medical problems. The patient was recovering from the events. Information about lot/batch number has been requested.
41 2021-02-16 muscle spasms The initial symptoms exp stomach cramping. Then on 12/31 I started exp pain in lower back felt like... Read more
The initial symptoms exp stomach cramping. Then on 12/31 I started exp pain in lower back felt like muscle spasm. I went to ER got Chest Xray,Flu (results negative)and Covid test (result positive).
41 2021-02-18 grand mal seizure Tonic clonic seizure; This is a spontaneous report from a contactable physician. A 41-year-old male ... Read more
Tonic clonic seizure; This is a spontaneous report from a contactable physician. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 01Feb2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tonic clonic seizure on 01Feb2021, the same day. The patient received the dose at 14:00 and had the seizure around 19:00. Patient has recovered from the event on an unspecified date. No treatment was received for the event. Information about lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported tonic clonic seizure and the administration of the COVID-19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. 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 RA, IEC, as appropriate.
41 2021-02-18 night sweats Initial adverse events: night sweats, fever, body aches, muscle aches (Back pain). These all occurr... Read more
Initial adverse events: night sweats, fever, body aches, muscle aches (Back pain). These all occurred about 12 hours after the second shot and subsided around 36 hours after the second shot. 8.5 days after the second shot I had throat and chest pain. This pain then continued and got worse to the point I went to the ER and was evaluated for potential heart attack. After testing - results were that I did not have a heart attack. I was still experiencing this pain, so the ER took a strep test. This was also negative. The diagnosis was "pulled chest muscle". I've had pulled muscles, I know what those feel like and it sure didn't feel like what I experienced on the night of the 16th and the day of the 17th of Feb. 2021.
41 2021-02-19 flushing Flushing/sweating, right-sided warmth (right arm at injection site). Patient has a history of anxiet... Read more
Flushing/sweating, right-sided warmth (right arm at injection site). Patient has a history of anxiety and hypertension. Initial BP 161/102 (pulse 102); final BP 132/88 (pulse 95).
41 2021-02-21 unresponsive to stimuli Patients spouse reports he started to feel "funny" 5 mins post vaccination administration. Patients ... Read more
Patients spouse reports he started to feel "funny" 5 mins post vaccination administration. Patients spouse called for assist when he he became unconscious at 7:25pm. He was found unconscious and failed to respond to a sternal rub. EMS called. Initial assessment: HR-weak pulse-not palpable, agonal, shallow breathing, and unresponsive. VS- BP 160/100 HR- 100 Wife used smelling salt to arouse the patient. He was confused after regaining consciousness. 7:37pm- EMS arrived and assumed care, transferring patient to a higher level of care.
41 2021-02-22 muscle spasms Nausea, vomiting, cramping, fever, chills, lethargy, headaches, and body aches
41 2021-02-24 weakness Full body aches all night long, then fever of a 102.3 followed by chills, also headaches, feeling of... Read more
Full body aches all night long, then fever of a 102.3 followed by chills, also headaches, feeling of low energy
41 2021-02-24 migraine Persistent migraine not responsive to medication with onset approximately 48 hours after vaccine and... Read more
Persistent migraine not responsive to medication with onset approximately 48 hours after vaccine and proceeding to this report. I am a sufferer of migraines, but this is especially intense and persistent.
41 2021-03-03 nerve injury, pain in extremity, tingling Burning pain immediately after injection. Pain and redness has persisted. Pain in the left arm rad... Read more
Burning pain immediately after injection. Pain and redness has persisted. Pain in the left arm radiating down the arm in the elbow, forearm, and wrist. Tingling sensation in the pinky and ring finger. Burning pain and ache in the left arm. Feeling of burning and cold felt in the arm.
41 2021-03-05 tingling I have shingle like skin rash on my neck for more than 13 days. it is itching all over my body and ... Read more
I have shingle like skin rash on my neck for more than 13 days. it is itching all over my body and tingling kind of pain on my neck and back. I have been using 10% benzoyl peroxide but not getting improvements. I am planning to go to dermatologist next week.
41 2021-03-09 face paralysis, numbness He received first dose of Pfizer COVID vaccine 1/15. Next day, he felt right axilla and trunk numbne... Read more
He received first dose of Pfizer COVID vaccine 1/15. Next day, he felt right axilla and trunk numbness after that which lasted 2-3 weeks and was resolving. After the second dose early Feb 5th, he started having difficulty swallowing and SOB and felt a little better after a course of steroids and antibiotics but got a lot worse after finishing the course and presented to ED 2/16 and was found to have supraglottic edema requiring intubation and treatment with IV steroids. Was extubated on 2/19, in ICU until 2/21. He did well with treatment and was discharged 2/22. Patient received a dose of influenza vaccine (FLULAVAL - GSK lot: 7N43B) on 2/22/21 3/2 he started having burning pain in the right midthoracic area, the next day he noticed right hand weakness/numbness (4th and 5th digits), gradually progressed. 3/4 noticed right facial weakness, initially was lower face, Unable to drink without drooling. MRI brain was done 3/5 and was normal. 3/5 facial weakness progressed to upper face. Unable to close right eye for the last 24 hrs. He also reports numbness left 5th digit. Presented to the ED on 3/6. Found to have elevated transaminase in ED. Hospitalization continues at this time. Etiology of symptoms is unknow, but includes vaccine reaction, shingles or early stages of autoimmune disease.
41 2021-03-10 numbness, weakness Dizziness, numbness of left arm and leg, along with weakness. BP 150/95, pulse 78, O2 sat 99%. Given... Read more
Dizziness, numbness of left arm and leg, along with weakness. BP 150/95, pulse 78, O2 sat 99%. Given juice, water and crackers. Rested.
41 2021-03-10 tingling, pain in extremity Tingling/itching sensation over right side of face and scalp, starting approximately 10 minutes afte... Read more
Tingling/itching sensation over right side of face and scalp, starting approximately 10 minutes after vaccination and lasting approximately 20 minutes. Resolved without treatment Intermittent, then sustained muscle soreness in the right arm starting approximately 6 hours after vaccination and lasting until approximately 48 hours after. Resolved without treatment. Fatigue the day following vaccination, and the day following that, but not on the day of vaccination. Resolved without treatment.
41 2021-03-11 flushing 20 minutes of monitored and recorded tachycardia (peak heart rate of 188) while at rest. Accompanied... Read more
20 minutes of monitored and recorded tachycardia (peak heart rate of 188) while at rest. Accompanied with perspiration, flushing, myalgia and malaise. Tachycardia resolved, other symptoms persisted for 12+ hours.
41 2021-03-14 pain in extremity Fever, Pain (Mostly My legs), Cough, Shortness of breath, and Phlegm. took Tylenol Severe Cold and F... Read more
Fever, Pain (Mostly My legs), Cough, Shortness of breath, and Phlegm. took Tylenol Severe Cold and Flue and Claritin - D 12 hrs. Lasted 24 hr. Started Saturday Night and ended Monday Morning. Feeling exhausted after the events.
41 2021-03-15 tremor Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: LEFT ARM TREMERS-Mil... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: LEFT ARM TREMERS-Mild, Systemic: Nausea-Mild
41 2021-03-16 tingling Tingling in ears and extremities, heart was racing, tickle in throat, dizzy, short of breath, nauseo... Read more
Tingling in ears and extremities, heart was racing, tickle in throat, dizzy, short of breath, nauseous
41 2021-03-17 migraine Swelling at injection site and swelling of hands. Next day migraine, vertigo and rash on right leg. ... Read more
Swelling at injection site and swelling of hands. Next day migraine, vertigo and rash on right leg. The vertigo has consisted and the rash has spread throughout my whole right leg and now on my left leg.
41 2021-03-18 burning sensation Sunburn like feeling starting on stomach, forearms and but cheeks. Head pain on left side Sunburn li... Read more
Sunburn like feeling starting on stomach, forearms and but cheeks. Head pain on left side Sunburn like feeling now in armpits and neck pain running down thru back
41 2021-03-18 pain in extremity For the first 24 hours I had no symptoms other than arm pain. For the next 6 days experienced debili... Read more
For the first 24 hours I had no symptoms other than arm pain. For the next 6 days experienced debilitating headaches, which led to nausea (because they were so severe). Elevated blood pressure also coupled with headaches. I initially took Ibuprofen (which helped somewhat), whereas Tylenol did nothing. I also have a flexible ice pack that I placed over my head. That also helped a little. I went to the doctor on March 17th, but he was dismissive of the headaches being related to the vaccine. I have since been referred to a neurologist (April 1st appointment).
41 2021-03-22 pain in extremity Headache, nausea, fever, chills, soreness in right arm, and insomnia. No treatment provided. Symptom... Read more
Headache, nausea, fever, chills, soreness in right arm, and insomnia. No treatment provided. Symptoms ongoing as of 9:45am 03/23/2021
41 2021-03-23 feeling cold, numbness The patient is a 41 yo male with a history of seasonal allergic rhinitis who experienced DVT and PE ... Read more
The patient is a 41 yo male with a history of seasonal allergic rhinitis who experienced DVT and PE temporally related to Pfizer BioNTech COVID vaccine dose #2 receipt. He is a Service Member and reported high levels of baseline activity, including running 10 miles each Saturday. He received vaccine #1 25 JAN 21 (EN5318) without AE. He received dose #2 on 16 FEB 21, (EN6200). He experienced no immediate symptoms suggestive of IgE event. On day 1 he reports feeling cold, mild fatigue but no other symptoms. On day 2 he was baseline. On day 3 he noted numbness, tightness and discomfort to his right calf. On day 4 (Saturday), his usual long run day, he experienced dyspnea and lightheadedness after running 20-30 feet. He states he noted tightness in his calf and instead walked the track while his wife completed her run. He rested day 5. Day 6 he noted significant edema to his calf, which he describes as double normal in size, and iced it. Day 7, he tried to schedule with PCP and based on triage was sent to ER. ER diagnosed R DVT and bilateral PE's. He was admitted overnight, started anticoagulation therapy. He saw hematology, and the workup was negative for other causes.
41 2021-03-23 pain in extremity, feeling hot woke up warm/sweaty; mild general body aches/stiffness; Mild arm soreness; trouble sleeping; This is... Read more
woke up warm/sweaty; mild general body aches/stiffness; Mild arm soreness; trouble sleeping; This is a spontaneous report from a contactable healthcare professional (patient). This 41-year-old male patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route on 18Feb2021 at 09:15 (at the age of 41-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included psoriasis for which he received guselkumab (TREMFYA) injections every 2 months. The patient had not received any other vaccines within 4 weeks prior to the vaccine. The patient had not been diagnosed with COVID-19 prior to the vaccine. The patient did not receive any concomitant medications. The patient did not have any allergies to medications, food, or other products. The patient previously received dose 1 of BNT162B2 on 27Jan2021 at 01:30 as a single dose in the right arm for COVID-19. On 19Feb2021 at 00:00 after dose 2 of BNT162B2 the patient experienced mild arm soreness, woke up warm/sweaty, had trouble sleeping, and mild general body aches/stiffness. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of mid arm soreness, woke up warm/sweaty, had trouble sleeping, and mild general body aches/stiffness were recovered. It was also reported that since the vaccine the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
41 2021-03-23 pain in extremity Soreness in arm, started about 1/2 hrs lost injection, lasted about 24 hours. Headache, started abou... Read more
Soreness in arm, started about 1/2 hrs lost injection, lasted about 24 hours. Headache, started about 6/7 hrs post injection. Increased in severity the next day. Non-issue as of 3/24
41 2021-03-23 pain in extremity Persistent sore arm for over a month now
41 2021-03-24 cold sweat felt heart was racing, comes and goes. clammy hands, anxious. HR 92 BP 136/82
41 2021-03-24 tingling, numbness, burning sensation, muscle twitching Numbness and tingling in feet and hands. Burning sensation all over body and muscle twitching all o... Read more
Numbness and tingling in feet and hands. Burning sensation all over body and muscle twitching all over body. Roof of mouth burning. Tingling on lips and tongue. Bruising and gum bleeding.
41 2021-03-28 numbness Mild body aches, mild headaches, numbness and tingling down the arm injected, little light headed
41 2021-03-28 muscle spasms, pain in extremity, feeling hot Dull pain in calf, cramping legs , tired , warm sensation
41 2021-03-29 discomfort I felt fine at first for the 15 minutes they held me for observation. But as I walked out to my car ... Read more
I felt fine at first for the 15 minutes they held me for observation. But as I walked out to my car I quickly got heavy and tired and started to ache and have a headache. I had to rest in my car for a while before driving home. Once home I crashed immediately for around 4 hours in the middle of the day which is not like me. I had an important dinner meeting i had to attend for my livelihood. I thought I was feeling better but half way through Dinner I started feeling bad again. Got to the point that I stopped eating and excused myself to get home and rest. Symptoms progressed rapidly. Unfortunately I was pulled over for a minor traffic stop and tried to explain that I was having a bad reaction to the vaccine and needed to get home. They wouldn?t believe me and torturously treated me like an OVI. I?m hoping that I can get some kind of documentation and or assistance. I have court on the 1st and it will be devastating if I am convicted. I was not intoxicated and was not warned about the dangers of driving after the vaccine. Please call me. I need help
41 2021-03-30 weakness Low grade fever (100.9); Tiredness; headaches; muscle pain; chills; joint pain; nasal congestion; Di... Read more
Low grade fever (100.9); Tiredness; headaches; muscle pain; chills; joint pain; nasal congestion; Dizziness/Weakness; Dizziness/Weakness; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 29Jan2021 14:00 (Batch/Lot Number: EL1283) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that since Saturday at 10AM. Low grade fever (100.9). Tiredness, headaches, muscle pain, chills, joint pain, nasal congestion, Dizziness/Weakness. Scale of 1-10, 10 being the worst= Level 9 on 30Jan2021 at 10:00 AM. The patient not received treatment for the events. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The report considered as a non serious. The outcome of the events was reported as not recovered.
41 2021-03-31 cold sweat NAUSEATED, BLACKED OUT, COLD SWEAT. CAME TO FINE WITHIN A FEW SECONDS EPISODE RESOLVED QUICKLY CLIEN... Read more
NAUSEATED, BLACKED OUT, COLD SWEAT. CAME TO FINE WITHIN A FEW SECONDS EPISODE RESOLVED QUICKLY CLIENT MONITORED FOR 30 MINUTES AND LEFT WITHOUT FURTHER INCIDENT.
41 2021-03-31 pain in extremity Aches in my arms and shoulders began a few days before the second vaccination in the series. After ... Read more
Aches in my arms and shoulders began a few days before the second vaccination in the series. After receiving the second vaccination, the aches progressed to full upper body aches. They have since progressed to full body aches. I also had major chills 2 nights ago.
41 2021-03-31 tingling Patient is 41 years old, male. Alert, oriented X3, clear speech, able to answer to the questions. Un... Read more
Patient is 41 years old, male. Alert, oriented X3, clear speech, able to answer to the questions. Underlying medical conditions include Down Syndrome, high cholesterol, and asthma. History of allergic reaction to bethanechol ? swelling, no anaphylactic shock. Denied having allergies to food, other vaccines, or components of COVID-19 vaccine. Patient was tested positive for COVID- 19 in December 2020, was hospitalized for 11 days but was not admitted to ICU or intubated. At 11:50 am, patient received first dose of Pfizer, lot number EW0150, expired on 07/2021 on right deltoid, given by RN. At 12:08, while waiting in observation area, patient reported of tingling and swelling in right hand. EMTs and RN responded. Vial signs were taken every 5 minutes. At 12:08, BP 121/82, Sp02 at 95% room air, HR 110bpm; skin was warm to touch, normal skin color on face and lower extremities. At 12:13 pm, BP 123/82 sitting, HR 107 bpm, 2+, RR 22 res/minute, unlabored, patient was moved to anti-gravity chair. Per sister, patient hasn?t eaten anything this morning. Water and cookies were offered, patient ingested 250 ml and 100% of cookies, patient stated ?I?m feeling a lot better, no more tingling?. Upon assessment, noted significant decreased swelling on right hand, normal skin color, capillary refill <3s bilaterally. At 12:24 pm, BP 121/80, SpO2 92%, RR 20 res/min, unlabored, no acute distress noted. At 12: 28, BP 121/79, HR 104, strong, RR 20 res/min, unlabored, SpO2 95%. At 12:34 pm, BP 121/78, SpO2 95%, HR 102 bpm, RR 20 res/min, unlabored, patient ingested 250 ml of water, denied any discomfort. Patient?s education was provided to patient and his sister, they verbalized understanding. At 12:45 pm, patient left facility, he was accompanied by family members and EMT to their car. Patient was able to walk without assistance, gait was balance.
41 2021-04-01 burning sensation I EXPERIENCED A BURNING SENSATION AFTER URINATION FOR THE REMAINDER OF THE DAY YESTERDAY, AFTER I RE... Read more
I EXPERIENCED A BURNING SENSATION AFTER URINATION FOR THE REMAINDER OF THE DAY YESTERDAY, AFTER I RECEIVED THE VACCINE.. I URINATED THIS MORNING AND THE SENSATION WENT AWAY.
41 2021-04-01 discomfort Within 5 mins of the shot, I got dizzy but I sat down and that feeling went over. After dinner the s... Read more
Within 5 mins of the shot, I got dizzy but I sat down and that feeling went over. After dinner the same day, I had vertigo and had to vomit. Since then there has been nausea and headache, and I have trouble sleeping in. I feel some more discomfort after eating food. I have intermittent fever also. It has been about 10 days today since I got my COVID Pfizer shot and I still don't feel physically well. I just wanted to report this, as the impression from documentation I read is that symptoms should go away in 3-4 days.
41 2021-04-01 tingling Tingling in feet and lower calf muscle a few hours after injection. Some calf swelling and light thr... Read more
Tingling in feet and lower calf muscle a few hours after injection. Some calf swelling and light throbbing two days later, continued tingling in feet (pins and needles) now on day 4 after injection and unresolved. Tingling increases after physical activity. Swelling has subsided on day 4. Treated only with rest, compression socks, and keep legs raised when possible, so far. Some swelling of the lymph nodes in groin area.
41 2021-04-02 pain in extremity Dose 1: Severe headache for the next day, minor pain and moderate stiffness of R arm over the next 2... Read more
Dose 1: Severe headache for the next day, minor pain and moderate stiffness of R arm over the next 24 hours. I am *not* submitting this report for the first dose. Dose 2: Moderate headache over next day, mild fatigue over next day, moderate joint pain over next day, same discomfort/stiffness of R arm. The one thing I wanted to report was my L shoulder. I had pulled/torn it around Wednesday of the week and it hurt quite a bit when I put it in the wrong position, but it was otherwise fine. However, post-second Pfizer shot, the pain in my L shoulder easily double or tripped for some reason as a reaction to the vaccine. Basically, Friday before the shot, my should hurt a little bit but had been getting progressively better. But post-second Pfizer shot, the same area that had mild pain before now felt like I had been stabbed in the shoulder or that I had re-torn the muscle and had done so in a significantly worse way. It's not a big thing, but you may want to start asking people if they've recently had any muscle injuries prior to vaccination. I'm now ~30 hours post vaccine and it is decreasing in pain, but the shot obviously had some type of impact on what bruising/swelling/tearing of my L shoulder that I had. (Note that both vaccine shots were to the R arm and the L should was not related to that in any way.)
41 2021-04-03 feeling cold, cold sweat 6pm April 2 - began feeling nauseous and chilled, began shivering. 8pm April 2 - began vomiting...bo... Read more
6pm April 2 - began feeling nauseous and chilled, began shivering. 8pm April 2 - began vomiting...bouts of vomiting every 1.5 hours from 8 pm April 2 until 12 noon on April 3. An acute stomach ache followed and continued until the morning of April 4th. After vomiting stopped, I laid in bed from about 3pm on April 3 until 9 am on the 4th...I would sleep for 45 minutes at a time and wake in a cold sweat...I physically felt very cold, but was drenched in sweat. The chills and cold sweats stopped on the morning of the 4th and gave way to a lingering but persistent headache and dull stomach ache which are continuing now (3pm on April 4), but seem to be slowly fading.
41 2021-04-03 pain in extremity Aches in the lower back and legs.; Aches in the lower back and legs.; This is a spontaneous report f... Read more
Aches in the lower back and legs.; Aches in the lower back and legs.; This is a spontaneous report from a contactable consumer or other non hcp. A 41-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL3247, Expiration date unknown), via an unspecified route of administration, anatomical location arm left on 12Feb2021 09:15, at single dose for Covid-19 immunization. The patient Medical history included hyperaldosteronism. concomitant medication included omeprazole (PROTONIX [OMEPRAZOLE]), spironolactone (ALDACTONE [SPIRONOLACTONE]), amlodipine besilate (NORVASC), nebivolol hydrochloride (BYSTOLIC). Historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL3247, Expiration date unknown), via an unspecified route of administration, anatomical location Left arm on 23-JAN-2021 09:00 AM, at single dose for Covid-19 immunization. on 12Feb2021 at 14:00 patient experienced aches in the lower back and legs. The patient did not receive any treatment for the event 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 not tested for COVID-19. The outcome of event was recovering.
41 2021-04-04 bell's palsy Bell's palsy on right side of my face.
41 2021-04-04 numbness Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Numbness (specify: facial area, extremiti... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient experienced numbness in arm a few minutes following COVID vaccine. He was instructed by the pharmacist to sit for 30 minutes for monitoring instead of the usual 15 minutes. After about 30 minutes, he said he was experiencing difficulty breathing (he was alert and orientated and was able to talk but he said he was laboring to breathe). EMS was called. No treatment was given on site by EMS and the patient elected to be brought to the hosptial.
41 2021-04-06 weakness Extreme fatigue, extreme weakness, extreme soreness.
41 2021-04-07 feeling hot Patient reported he started feeling hot, dizzy, nauseous, lightheaded and faint within a few minutes... Read more
Patient reported he started feeling hot, dizzy, nauseous, lightheaded and faint within a few minutes of receiving the vaccine. We sat him down and grabbed our nurse practitioner. She monitored his pulse. He began to feel so faint that he asked to lay on the floor. We called 911. When paramedics arrived he was starting to feel much better. By the time it was over he left the store (was not transported to the hospital).
41 2021-04-07 numbness Starting 12 hours after dose: Rotating between fever and chills Fever of 103+ Numbness / loss of fee... Read more
Starting 12 hours after dose: Rotating between fever and chills Fever of 103+ Numbness / loss of feeling in tips of fingers / thumb Tinnitus Lower back pain Lack of focus / irritable Overall random shots of pain through body Diarrhea legs and feet turned purple Constant frontal headache Lack of appetite/ nausea Some foods taste metallic
41 2021-04-08 weakness Headache, stiffness, body aches, diarrhea, heartburn, fever 101.4 , feel extremely weak!!!
41 2021-04-08 cold sweat Woke up with cold sweat, nausea and vomiting, fatigue.
41 2021-04-08 flushing Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Flushed / Sweating-Mild,... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Lymph Node Swelling-Mild, Additional Details: patient felt like his throat was itchy and felt flushed and sweating. he had no other apparent symptoms, we gave him a benadryl and he appeared to be fine
41 2021-04-08 tremor, feeling cold patient felt chilled through out body immediately after receiving vaccine with full body shaking sho... Read more
patient felt chilled through out body immediately after receiving vaccine with full body shaking showed signs of low blood sugar but said he did eat lunch he was unsure of what medications or insulins doses that he had taken today. gave sugar and water and no improvement symptoms progressed oover 10 minutes patient developed ragged breathing 911 was called and epi pen administered. was taken to hospital by ems.
41 2021-04-09 cold sweat Patient reported feeling clammy, lightheaded, short of breath, anxious, and nauseated after vaccinat... Read more
Patient reported feeling clammy, lightheaded, short of breath, anxious, and nauseated after vaccination Patient seen by medical team and vitals improved after patient drank Gatorade Patient reported not having anything to eat in the morning Patient has history of anxiety Patient refused medical transport and signed medical form, patient stated symptoms improved Patient will have a family member pick him and his daughter up to drive home
41 2021-04-10 cold sweat on 4/11/2021 approximately 1pm , just left home from lunch and went back to work. started having c... Read more
on 4/11/2021 approximately 1pm , just left home from lunch and went back to work. started having chest tightness, chest pain, called wife -- he felt clammy and all around not feeling well and above symptoms. Advised him to come home- stayed on phone with him til he arrived home. took his blood pressure with wrist bp machine while sitting at dining table and it was 171/85 and pulse was 85 so called EMS.
41 2021-04-10 tenderness, night sweats Severe muscle aches and joint pain; shakes and chills; intense night sweats; and large mass under le... Read more
Severe muscle aches and joint pain; shakes and chills; intense night sweats; and large mass under left arm (injection arm). All started the morning after the second dose, and lasted until the following morning. The mass in my armpit is still present and is slightly sore to the touch.
41 2021-04-11 seizure I immediately past out twice and was told I had two minor seizures. I declined ambulance and have fe... Read more
I immediately past out twice and was told I had two minor seizures. I declined ambulance and have felt dizzy spells since. I have appointments to get checked out.
41 2021-04-12 feeling hot, tremor pt began feeling "hot" nad was sweating moments after reviewing vaccine. Vitals BP 161/97, HR 110, ... Read more
pt began feeling "hot" nad was sweating moments after reviewing vaccine. Vitals BP 161/97, HR 110, O2 sat 99%. Pt's entire body began shaking. Pt was unable to walk. EMS called, transported to hospital.
41 2021-04-12 tingling, numbness Shingles. The day after the second dose of my Pfizer vaccine I felt numbness and tingling on the le... Read more
Shingles. The day after the second dose of my Pfizer vaccine I felt numbness and tingling on the left side of my body. Specifically on the left side of my left arm and down through the left pinky finger. I also had the same sensation/numbness down the left side of my left leg and into my left pinky toe. The sensation is intermittent and typically on the left side (the same side of the body as the injection). Two weeks later I began to feel more tingling on the left side including up through my left jaw and on the left side of the top of my head. The following day I realized I had two blisters under my left arm pit which made it clear I had shingles. Today is 3 weeks since my second shot and I still continue to feel numbness and tingling.
41 2021-04-13 pain in extremity Soreness in arm for first 2-3 days Fatigue for 1 week so far, still ongoing
41 2021-04-15 feeling cold Cold chills, sore body and muscles, debilitating headache.
41 2021-04-15 mild one side paralysis, myelitis transverse Transverse myelitis presenting with Urinary retention and hyperreflexia as well as left sided weakne... Read more
Transverse myelitis presenting with Urinary retention and hyperreflexia as well as left sided weakness. Treated with high dose steroids
41 2021-04-16 pain in extremity, muscle spasms Vaccine on the 6th Sore arm that day. That night before bed dizzy, tired, back muscles tightenin... Read more
Vaccine on the 6th Sore arm that day. That night before bed dizzy, tired, back muscles tightening. 7th. Dizzy , tight muscles, sore arm, that late afternoon i sneezed. My back went out. Severe spasms and pain from The 7th-16th. Late night on the 16th. Chest neck and shoulder pain. Heart flutters, tachycardia, oxygen levels dropping to 89. Hovering around 95. Severe nausea. Abdomen pain. Tight painful muscles in legs Same and worse today on the 17th , had ER visit Been taking Valium and Tylenol for pain and spasms per my PCP since April 15
41 2021-04-17 weakness Sleep for a few minutes, I didn't pass out but it was similar; Was pulled over "for minor traffic v... Read more
Sleep for a few minutes, I didn't pass out but it was similar; Was pulled over "for minor traffic violation." He was told "to get out of the car and had a field sobriety test, and I looked intoxicated."; Felt heavy and tired/Run down; Had a headache; Upset stomach; sleep for a few minutes, I didn't pass out but it was similar/crashed for 4-5 hours in the middle of the day which I never do; aching; Over all weakness; Started feeling sick again at dinner; Woke up feeling really bad; Bad diarrhea; This is a spontaneous report from a contactable consumer or other non hcp. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing Allergic to sulfa, PCN and amoxicillin. The patients concomitant medications were not reported. On an unspecified date the patient experienced sleep for a few minutes, I didnt pass out but it was similar, was pulled over for minor traffic violation. He was told to get out of the car and had a field sobriety test, and I looked intoxicated, felt heavy and tired/run down, had a headache, bad diarrhea, upset stomach, sleep for a few minutes, I didnt pass out but it was similar, crashed for 4 to 5 hours in the middle of the day which I never do, aching, overall weakness, started feeling sick again at dinner, he went to the bathroom a few times, woke up feeling really bad. The patient was worried because everything was coming to a head right now. The caller got the first shot, he waited for 15 minutes and felt fine. As the caller walked to his car he began feeling heavy, had severe diarrhea, headache, aching, it was almost like he passed out, it felt like he went to sleep. The patient got home and crashed 4 to 5 hours in the middle of the day and woke up feeling really bad. The patient went to a very important dinner meeting that night. While the patient was at the meeting he went to the bathroom a few times and then excused himself because he felt so bad. The patient did not even finish one cocktail with dinner. The caller got pulled over for a minor traffic stop, cutting the corner and crossing the line or something small. The officers believed the caller was driving under the influence and started making him do a sobriety test with 40 degree wind gusts, the patient was miserable. The caller told the officers that he needed to seek medical attention but they ignored him. The officers forced the caller to do the urine test. It has been 5 days since his vaccination and he is just now feeling better. The outcome of events was recovering. No follow-up attempts are needed. No further information is expected.
41 2021-04-17 weakness Covid test result Positive; Covid test result Positive; Steadily increasing headache; Muscle ache; w... Read more
Covid test result Positive; Covid test result Positive; Steadily increasing headache; Muscle ache; weakness; feverish; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCCINE; Lot Number: UNKNOWN- reported as misplace/discarded), dose 1 via an unspecified route of administration, administered in left arm (at the age of 40 years) on 21Dec2020 at 12:15 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. There was no patient medical history. The patient had no known allergies to medications, food, or other products. There were no concomitant medications (no medications within 2 weeks prior to vaccination). The patient did not received any other vaccine within 4 weeks prior to the COVID-19 vaccine. On 21Dec2020 at 14:30, 2.5 hours after the vaccine, the patient had steadily increasing headache, muscle ache, weakness and feverish. He took 250mg Tylenol. At 5.5 hours after the vaccine, his headache was so severe that he went to the Emergency Department of the facility he works in. Treatment for the adverse event included 1gram Tylenol, IV with saline and another drug (unspecified). The patient did not have COVID-19 prior to vaccination. On 24Mar2021, post vaccination, he was tested for COVID-19 via nasal swab with a positive result. The outcome of headache, muscle ache, weakness and feverish was recovered. The outcome of COVID-19 was unknown. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
41 2021-04-17 pain in extremity Sore arm starting 12 hours after shot Body aches, chills, fatigue, headache starting 26 hours after ... Read more
Sore arm starting 12 hours after shot Body aches, chills, fatigue, headache starting 26 hours after shot and lasting for 6 to 8 hours
41 2021-04-17 paralysis complete body went paralyzed; lost vision; throwing up; fever; This is a spontaneous report from a c... Read more
complete body went paralyzed; lost vision; throwing up; fever; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6207), dose 1 via an unspecified route of administration, administered in left arm on 23Mar2021 08:30 as single dose for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient started throwing up, fever, complete body went paralyzed and lost vision all it the ER on 05Apr2021 13:00. The events were resulted in emergency room /department or urgent care. There is some treatment (saline and ondansetron) for the events. The patient did not have covid prior vaccination, did not test covid post vaccination. The patient received Covid test post vaccination via Nasal Swab on 05Apr2021, covid test result was negative. There is no known allergies, no other medical history, no other vaccine in four week, no other medications in two weeks. The outcome of the events was resloving.
41 2021-04-18 hot flush Metal taste in mouth within 30 minutes of injection., similar to injection 1. I otherwise felt fin... Read more
Metal taste in mouth within 30 minutes of injection., similar to injection 1. I otherwise felt fine and had a normal day of moderate physical activity. I awoke in the middle of the night with chills and body aches and a strong feeling of anxiety. I was able to fall back asleep and woke up as normal a few hours later. I had a very strong head ache centered behind my sinuses, body aches in my pelvis and legs, and hot flashes mixed with chills. Aches were manageable with Tylenol. As the day progressed those continued and I was very fatigued. I went to bed earlier than normal and after a full night's sleep symptoms subsided.
41 2021-04-18 migraine Starting after leaving pharmacy (receiving second vaccination), sunlight sensitivity causing migrain... Read more
Starting after leaving pharmacy (receiving second vaccination), sunlight sensitivity causing migraine like headaches and nausea. Symptoms are lessened with sunglasses. Onset is within minutes of being in direct or overcast sunlight. Symptoms have persisted for 8 consecutive days since vaccine.
41 2021-04-18 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium
41 2021-04-19 weakness, pain in extremity A few hours after my 2nd shot I got dizzy then a headache. My arm hurt too, quite a bit. The next mo... Read more
A few hours after my 2nd shot I got dizzy then a headache. My arm hurt too, quite a bit. The next morning I woke up with a fever of 101.5 and kept that fever for 2 more days. I felt weak, dizzy, but the physical pain was the worst. My head was pounding, my neck, back, and legs all hurt. That passed after a day except the headache. 3 days later I still have a low fever, headache, but mostly dizziness. I've never been seriously ill in my life. Ive never been sick enough to get antibiotics prescribed. I eat healthy, don't drink or smoke. This vaccine floored me though. Like getting run over by a truck.
41 2021-04-19 bell's palsy Bell Pasly on left side of face.
41 2021-04-19 seizure Patient had an episode with convulsions and loss of consciousness lasting a couple seconds after eat... Read more
Patient had an episode with convulsions and loss of consciousness lasting a couple seconds after eating a marijuana edible.
41 2021-04-20 feeling hot Pt was vaccinated with Pfizer-BioNTech COVID-19 vaccine EUA and told the vaccinating nurse that he "... Read more
Pt was vaccinated with Pfizer-BioNTech COVID-19 vaccine EUA and told the vaccinating nurse that he "always faints around needles." Pt was vaccinated and moved to post-vac area; he then began complaining of feeling "sweaty and hot." Pt chose to lie on the floor. Pt's vitals were within normal limits. Pt denied any chest pain, SOB, or other discomfort. Pt lied on the floor for approximately 15 minutes and then stated that he was feeling better. Pt was able to stand without assistance or dizziness and ambulate with a steady gait. Pt left clinic in care of his wife and stated that he felt "back to normal." Pt was advised to seek medical assistance if he began experiencing the same feelings again.
41 2021-04-20 flushing Patient had received his 2nd dose of Pfizer vaccine at 1020. After about 5-7 minutes he started to ... Read more
Patient had received his 2nd dose of Pfizer vaccine at 1020. After about 5-7 minutes he started to feel "flush". He spoke with medical personnel onsite and it was explained that reactions like that are common. Was advised to remain onsite for further observation. Approximately 10 minutes later PT started to feel a tingling in his lips, face and a little on his tongue. Medic on site administered 0.5ml of liquid antihistamine, and was advised to wait another 10 minutes for more observation. After next block of time PT stated that he "felt well enough to leave and was comfortable with everything" PT left site at 1108
41 2021-04-21 bell's palsy Bell Palsy
41 2021-04-21 burning sensation Headache, fatigue, sore muscles, lungs burning, fever, cough and I was all ways hungry
41 2021-04-21 tingling Tingling towards extremity (distal) left arm. BPs 149/86 (pulse 96), 147/88 (pulse 89). O2 sat 99%-1... Read more
Tingling towards extremity (distal) left arm. BPs 149/86 (pulse 96), 147/88 (pulse 89). O2 sat 99%-100%.
41 2021-04-22 feeling hot About 10 minutes after receiving the vaccine. I felt hot and sick to my stomach. I couldn't breathe.... Read more
About 10 minutes after receiving the vaccine. I felt hot and sick to my stomach. I couldn't breathe. I took my mask off and fanned myself. I started to feel dizzy and then I fell to the floor and passed out. The paramedics did an ekg and thought I was having a heart attack. They rushed me to the Emergency Room and they performed more tests. The tests showed their was nothing wrong with my heart previously.
41 2021-04-22 feeling hot Approximately 5 minutes after injection, pt began complaining of "feeling warm." He was provided wit... Read more
Approximately 5 minutes after injection, pt began complaining of "feeling warm." He was provided with water by a staff member. The patient then fell to the floor from a seated position in a chair in the observation area. The EMT and Paramedic immediately responded to the patient. They assessed the patient and brought him into a wheelchair once he was feeling well enough to do so. The patient never lost consciousness. Initial vitals: BP 96/60, O2 95% on room air, RR 24, HR 64. The Paramedic took a 12-lead EKG, result was Sinus rhythm with apparent ST elevation. Subsequent EKG was sinus brady with apparent ST elevation. The patient was free of contusions or scrapes from his fall from the chair. PT initially refused transportation to the emergency department. After some convincing, the patient was agreeable to seek elevated medical treatment and was transported by ambulance.
41 2021-04-22 muscle twitching Eye twitching in left eye - never had one since birth, started on the day following the shot. Occurs... Read more
Eye twitching in left eye - never had one since birth, started on the day following the shot. Occurs a few times a day. Not impacting day to day life. Headache - lasted for 5 days.
41 2021-04-22 tingling Patient states he was sitting when he got very hot and nauseated before fainting. Staff saw patient ... Read more
Patient states he was sitting when he got very hot and nauseated before fainting. Staff saw patient fall to carpeted floor face first and ran to his side. Patient briefly non-responsive but almost immediately regained consciousness and turned over onto his back. Legs elevated to chair and patient instructed to remain supine. Vitals at 1:35pm 120/80, HR 91%, O2 level 97%. Patient states he tends to get very hot and nauseated with shots. 1:37 pm: c/o tingling in both hands and requested an ice pack. Obtained his wife's phone number and contacted her using his phone. Attempted to cleanse abrasions to (L) forehead and bridge of nose but he was not able to tolerate the smell. Drinking bottled water provided by staff. EMS enroute. 1:40 EMS arrived; BP 112/72, HR 89, O2 98%. Patient remains alert and oriented. Kept supine. Using his ice packs to hands. 1:57pm: Still has tingling and slightly nauseated. EMS requested privacy with patient.
41 2021-04-23 pain in extremity Sore arm, whole body muscle soreness, dizziness, fatigue, chills. Symptoms started 6 hours after va... Read more
Sore arm, whole body muscle soreness, dizziness, fatigue, chills. Symptoms started 6 hours after vaccine shot and lasted 2 days.
41 2021-04-24 inability to speak I developed full anaphylaxis within 30 minutes of receiving my Covid-19 vaccine.; dizziness; nausea;... Read more
I developed full anaphylaxis within 30 minutes of receiving my Covid-19 vaccine.; dizziness; nausea; inability to swallow; mouth going dry; unable to speak; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Jan2021 12:00 (Lot Number: el3248) as single dose (at the age of 41-years-old) for covid-19 immunisation. Medical history included Heart disease, hyperlipidaemia, hypertension, pituitary adenoma. It was reported that patient received concomitant medications in two weeks prior to the vaccination, no details reported. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Patient stated that he developed full anaphylaxis within 30 minutes of receiving his Covid-19 vaccine on 16Jan2021 (Adverse event start time reported as 12:00 P.M.). It started with dizziness, then nausea, then inability to swallow and mouth going dry, finally unable to speak. 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). Patient was treated for the events with epinephrine (EPIPEN) on site by emergency medical services (EMS) and transport to hospital. The patient was not diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 post vaccination. The patient underwent laboratory tests and procedures which included sars-cov-2 test (Nasal Swab) negative on 11Feb2021. Patient had no known allergies other than the Covid-19 vaccine. Patient recovered from the events on unknown date.
41 2021-04-24 weakness collapsed; weak/weakness; muscle pain; Confusion; Fatigue; Shortness of breath; This is a spontaneou... Read more
collapsed; weak/weakness; muscle pain; Confusion; Fatigue; Shortness of breath; This is a spontaneous report from a contactable physician. A 41-year-old male 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 04Apr2021 at a single dose for covid-19 immunization. Medical history included G72.3 periodic paralysis. Concomitant medication included diclofenamide (KEVEYIS) taken for an unspecified indication, start and stop date were not reported. It was unknown if the patient received other vaccines within four weeks. It was unknown if the patient had covid prior vaccination. The physician stated that the patient received the Pfizer vaccine on Sunday 04Apr2021. The patient collapsed about an hour and half later and, has felt very weak and was experiencing muscle pain since then - all experienced on 04Apr2021. The patient has also been experiencing weakness, confusion, fatigue, and shortness of breath all since Sunday 04Apr2021. The physician reported that there were two different kinds of potassium in the vaccine which he felt was contributing to this. It was informed that the patient has been currently resting and will follow-up if his symptoms don't improve. The outcome of the adverse events was unknown. It was unknown if treatment was received for the adverse events. It was unknown if the patient was tested for covid post-vaccination. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information and temporal relationship, a possible contributory role between BNT162B2 vaccine and the reported events can not be excluded. Case will be re-assessed upon the additional information provided. 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 2021-04-24 burning sensation, night sweats Day 1: Symptom a) Severe Abdominal and Back Muscle pain for two to three hours before taking acetami... Read more
Day 1: Symptom a) Severe Abdominal and Back Muscle pain for two to three hours before taking acetaminophen. Pain consisted of sharp pain wrapped around my torso. Symptom b) Nausea. Symptom c) Tiredness Day 2: Mild chills in the evening and night sweats Day 3: Mild chills in the evening and night sweats Day 4: Abdominal and Back pain for approximately one hour (pain reduced after taking acetaminophen. Pain continued overnight. Day 5: Tiredness Day 6: Felt great Day 7: Severe Abdominal and back pain wrapped around my torso and burning sensation in my back
41 2021-04-24 numbness, tingling Ive been diagnosed with ADEM by findings from a MRI inflammation of cervical spine and brain , symp... Read more
Ive been diagnosed with ADEM by findings from a MRI inflammation of cervical spine and brain , symptoms began around a week after 2nd shot and got worse for about a month , pain in neck ,tingling though body , headaches, sunburn feeling in torso , fatigue , bilateral numbness in hands, loss of bladder pressure, erectile dysfunction
41 2021-04-25 numbness Numbeness started in LUA, traveled up to skull to chin/cheek feeing like a Novocain shot
41 2021-04-25 pain in extremity, burning sensation My husband it was for his second dose of the vaccine, bit at the next day at the morning got a kin... Read more
My husband it was for his second dose of the vaccine, bit at the next day at the morning got a kind of burn like a water pump which at first there were some in that area but the next day it became a big pump like water inside, today, Monday, April 26, that pump woke up. and it has been like when you have a burn you have not had a fever only muscle pain in your arm, and have taken tylenol
41 2021-04-26 bell's palsy Dr., reports that pt experience Bells Palsy 12 days post-vaccination. Dr., reported that pt went to ... Read more
Dr., reports that pt experience Bells Palsy 12 days post-vaccination. Dr., reported that pt went to Hospital on 4/17/2021 and released same day; pt was prescribed Medrol dose Pak and Acyclovir. Pt was seen by Dr., (general practitioner & ophthalmologist), Dr., discontinued the Medrol dose Pak and Acyclovir and prescribed Prednisone 60/40 to be taken for a week and Valtrex 1 mg to be taken TID x7 days; Dr., also ordered protein spikes for IgM and IgG Herpes Zoster & Herpes Simplex, basic blood test. Pt have follow up appt today with Dr., since pt is starting to develop dry eyes and he cannot close his eyes, pt is prescribed artificial tears drop for use during the day and CELLUVISC eye ointment to used during the night. Dr., recommends that pt refrained from getting the 2nd dose until more is known based on pt.'s condition; from his professional experience Bell's Palsy can dissipate in 4-6 months and not uncommon after post flu vaccination. Advised Dr. per CDC Bell's palsy is not a contraindication to getting 2nd dose of the vaccine. Advised we agreed with his recommendations that pt should postpone his second dose to see if his symptoms dissipate first. 4/21-Spoke to Dr. and he had concerns of patient receiving second vaccination shot. I advised currently per CDC there are no contraindications with vaccine and Bell's Palsy. Recommended for him to contact CDC hotline for further advice and transferred his call to CDC Covid hotline. Dx with Bell's Palsy; feeling more movement on the face today. Working with Dr. in regards to treatment and second dose of Pfizer vaccine. Will contact next week to follow up.
41 2021-04-27 muscle twitching, weakness, tremor, involuntary muscle movements, tingling, mild one side paralysis 3/26 @ 3:15pm ? Got the first dose of Pfizer COVID-19 vaccine for the 1:10pm appointment. However ac... Read more
3/26 @ 3:15pm ? Got the first dose of Pfizer COVID-19 vaccine for the 1:10pm appointment. However actual time received was around 3:15pm. No vaccine reaction was observed and drove back home. However did not eat or drink much from morning till 4:30pm due to the long line at the vaccination center 4/4 @ 9:00pm ? Experienced first sign of near-syncope at the dinner table upon picking up a glass of milk 4/6 @ 8:45am ? Experienced brain fog, to be exact head felt like it was filled with cotton candy, at the back and top of the head. Felt this way the entire day. Went to work as usual. Logged out at around 5:30pm 4/7 @ 9:00am ? dizziness started getting worse. Started feeling imbalance and started losing depth perception which climbing down staircase 4/8 @ 10:00am ? started to get easily startled by any unexpected trigger. Whole body would ?twitch? or ?startle? upon slightest unexpected event. For e.g., sound, touch, taste (hot/cold) 4/10 @ 12:00pm ? Went to ER. ER ordered series of book tests, EKG, chest x-ray. Everything came out normal. ER doctor said to wait it out and after a week symptom may go away. ER doctor felt body?s immune response was over-working due to the vaccine immune response and possibly pollen allergy I may have experienced right after getting the vaccine. No prescription meds give. Advised to take Meclizine 25mg and Zyrtec. Below are the symptoms experienced on 4/10: ? Lightheadedness/Sudden Jerking body movements when triggered/passing out momentarily for a second when taking strain/not in my elements ? Feeling extremely fatigued. Did not sleep well at night on 4/8 and 4/9 ? Head feels Intoxicated, foggy, lightheaded, as if stuffed with cotton candy. Startled when unexpected things happen like a sudden jerking movement along with momentary passing out while anything unexpected happens. E.g., when I am pushing myself on the sofa to re-position, I feel my whole body is turning off for a second. Simply does not feel normal ? Rubbery legs ? Worsens after shower. I feel like I need to lay down as the foggy feeling worsens after shower ? Lightheadedness. Losing control sometimes. ? I am easily startled when climbing down the stairs - no Depth perception. ? Don?t have the strength to blow nose or cough. Feels like momentary fainting when doing these activities ? Dis-equilibrium. Whole body is twitching when something unexpected happens to my senses. ? Unable to control while laughing feels like momentary faint. I have felt like this when I was down with a fever. Tickled easily ? Difficulty pulling myself out of bed. Felt like muscle was giving away ? Tingling feeling in the right abdomen area ? Difficulty staying alert or focused and random rather unpleasant thoughts constantly coming to mind. Felt a bit of panic attack. 4/11 ? Went to PCP. Body weakness and fatigue got worse. PCP did blood sugar test and flushed out the left ear. Ordered Brain MRI to see if structurally anything was wrong. Brain MRI came out OK as well however noticed minor sinusitis. Prescribed Amoxicillin antibiotics and nasal spray. Referred me to Neurologist and Head and Neck Specialist. 4/11 ? 4/15 - Above symptoms progressively got worse. Especially weakness in the arms and shoulders. Arms quivered every time trying to stand up and felt like fainting. Hand-eye coordination progressively got worse. For e.g., could not pick up water bottle, hands were quivering badly 4/15 ? Neurologist conducted certain diagnostic tests and concluded that there are no neurological issues. Said with rest and plenty of fluids it should get better. Spinal tap was not recommended and said if symptoms got worse a spinal tap can be done during the next visit. Follow up visit with neurologist scheduled on 4/27 4/15 ? 4/27 ? Weakness in arms got better. Arm strength and coordination has improved however it?s still not back to normal. Brain fog and dizziness still persists with no improvement. Left limb and arms are stronger than the left. Difficulty climbing up and down stairs. Dizziness worsens after shower. Not feeling myself. In addition, not able to multitask - getting startled and need to be deliberate about having to do everyday chores need to just focus on one task 100% completely and if something else comes up then my body just goes into a momentary shock. Mostly I can feel my head feeling heavy and my eyelids shutting down when something shocking happens ? a feeling like body is ?turning off?, almost a fainting or passing out feeling. Sometimes when I turn to one side and sleep, I can feel a flickering sensation in the ear. Still always feeling woozy and as if there is something in my head ? a medicated or intoxicated feeling in the head 4/27 ? Neurologist said she sees a lot of improvement and reiterated again that I don?t have any neurological issues. She said I can go back to work starting 5/1. She said I may have Conversion Disorder / Disequilibrium. It?s hard for me to fathom why she would diagnose me with Conversion Disorder when so many people are reporting very similar symptoms that I am facing on the below forum: https://www.drugdiscoverytrends.com/dizziness-among-common-covid-19-vaccine-side-effects/ 4/30 ? Next appointment with Head and Neck / Audiology
41 2021-04-28 bell's palsy, facial paralysis Patient developed right facial paralysis and no other symptoms on 4/4/21, pt. was given an injection... Read more
Patient developed right facial paralysis and no other symptoms on 4/4/21, pt. was given an injection of Solumedrol 125 mg IM. Patient was seen in clinic on 4/5/21 and diagnosed with Bell's Palsy and treated with high dose of prednisone 60 mg with a 13 day taper. Patient was seen again on 4/13/21 with a slight improvement of symptoms. High dose steroids was extended for another 13 day taper. Patient was seen again on 4/29/21, with symptoms about the same as last appointment. Patient will be given some ibuprofen, no real benefit for more steroids at this time. Patient will continue to have follow ups. It has been less than a month since first symptoms were reported, and may take up to 6 months for symptoms to resolve.
41 2021-04-29 flushing Patient had nausea, flushing and sweats approximately 5 minutes after vaccination
41 2021-04-29 tremor, feeling cold Felt extremely tired around 7:30pm. Went to bed. Woke up at 6:00am to get kids ready for school, fel... Read more
Felt extremely tired around 7:30pm. Went to bed. Woke up at 6:00am to get kids ready for school, felt intense headache joint pain, and intense cold feeling to the point of shaking. Went to bed again around 7:45 am. Slept most of the day with headache getting worse. Next day symptoms lessened slightly still bad headache and brain fog which I still have as of today but getting better.
41 2021-05-02 feeling hot fatigue, loss of appetite starting around 12:30 PM 5/2 napped from 2:00PM until 3:30 PM, no more fat... Read more
fatigue, loss of appetite starting around 12:30 PM 5/2 napped from 2:00PM until 3:30 PM, no more fatigue fatigue, irritability, confusion, body aches set in around 6:00 PM around 8:00 PM started alternating between feeling hot and chills, and presumabliy a fever (did not take temperature) went to sleep for the night around 1:30 AM on 5/3. Sometime between then and 7:00 AM woke up in a sweat, so fever presumably broke awoke for the day around 8:20 AM but was still too fatiuged to go to work as of now still feel some fatigue and headache
41 2021-05-04 weakness, tremor Woke up at 0700 drenched in sweat with chills. Slight fever of 99.7F . Started my work day from home... Read more
Woke up at 0700 drenched in sweat with chills. Slight fever of 99.7F . Started my work day from home with a meeting at 0900 and knew by 0920 that I had to take the day off. Spent the entire rest of the day and night in bed. Fever peaked at 101.1F , nausea, constant headache, shaking chills and then sweats, extreme fatigue and full body severe muscle soreness. Light headed and very weak. I slept all day until almost 1500. When I woke up my fever was gone. I'm left tonight feeling hungry again along with some residual sore muscles and aches. The fever responded well to Ibuprofen. I hydrated with water and Gatorade. It pretty much felt like influenza for just under 48 hours. I feel like I'm past the worst of it now, but I'm not fully recovered.
41 2021-05-04 nerve pain, tingling, pain in extremity, numbness Severe pain in neck and bilateral arms radiating all the way down to hands. Pins and needles feelin... Read more
Severe pain in neck and bilateral arms radiating all the way down to hands. Pins and needles feeling in bilateral arms with numbness and tingling. Feels like Nerve pain unbeliever by Tylenol and motion. Unable to sleep in either sidelying position since numbess, tingling and pain develops in corresponding arms and then quickly moves to hands. Unable to make a fist with right hand where vaccine was administered. Fine motor and gross motor strength decrease.
41 2021-05-04 tremor, migraine First day after vaccine (4/30/21): 102 fever, chills, severe nausea, vomiting, aches, migraine-like ... Read more
First day after vaccine (4/30/21): 102 fever, chills, severe nausea, vomiting, aches, migraine-like headache pain, malaise, and fatigue (took Tylenol with minimal effect). Second day after vaccine (5/1/21): aches, shakiness, fatigue, mild nausea, medium-intensity headache, diarrhea, malaise (took Tylenol, which helped with headache pain). Third day after vaccine (5/2/21): aches, mild nausea, shakiness, mild fatigue, mild headache, and mild malaise. Fourth day after vaccine (5/3/21): mild nausea, shakiness, mild headache, and mild fatigue. Fifth day after vaccine (5/4/21): mild nausea, mild headache. Sixth day after vaccine (today 5/5/21): mild nausea, mild headache.
41 2021-05-09 pain in extremity On April 18 and 19, following my 2nd injection, I had very bad chills and could not get warm. I was ... Read more
On April 18 and 19, following my 2nd injection, I had very bad chills and could not get warm. I was nauseous although I did not vomit. On April 22, I began having severe sharp stabbing pains just to the right of my belly button. It felt like I was being stabbed with a very hot knife, and after about 15-90 seconds, it would go away. Anytime I reached for something, bent over, twisted, turned or tried to hug someone, I would get this same pain and it would double me over in pain. On Monday April 26 at 7pm, I finally checked into the Emergency Room at the direction of my Primary Doctor. They did a bunch of blood work on me and sent me for a CT Scan of my abdomen. All of the blood work came back in normal ranges, and the CT Scan showed my appendix was "borderline" according to the surgeon. They consulted with Dr and decided to admit me for a surgical consult and further examination. They gave me fluids and morphine through an IV for the first 24 - 36 hrs, and then switched to Norco by mouth. I continued having pain throughout my stay. On Thursday, April 29, they took me to surgery for "exploratory surgery" with the intention of removing my appendix and looking around to see if anything else stood out to them that would cause me this pain. They stated my appendix had scar tissue on it and they removed it, but said they did not know if this would stop the pain I was having. On Friday April 30, I was released from the hospital at approximately 6pm. By 9pm on Friday, I began having those same sharp, stabbing, burning pains in my abdomen again, now to the right of my belly button again and further towards my right side. I also had sharp burning pain in the inside of my upper right arm, between my bicep and tricep muscles. This pain continued on through the weekend occurring more frequently and more severe. On Monday morning at about 1:30am, I woke up with severe abdominal pains all over and went into the bathroom. I had diarrhea and nausea and felt like I was going to vomit. Between 1:30am and 7:30am, I went to the bathroom 6 times. I went to work on Monday and continued having abdominal pains and diarrhea all day and night. On Tuesday, I went to the bathroom a total of 17 times. On Wednesday, I saw my primary Dr., who examined my abdomen and pains. He suggested I take immodium for the diarrhea and a supplement for muscle pain, as he felt this was the cause of my pain. On Wednesday, I went to the bathroom 21 times and was very nauseaus. I started the Imodium and it had no effect on me whatsoever. On Thursday, I had to call off work because I couldn't stop using the bathroom. By 4pm, I had been to the bathroom 18 times. I returned to the ER. They took a stool sample and did an ultrasound in the ER. They decided to admit me again for surgical consult and pain management. On Friday, Dr ordered another ultrasound of my abdomen, specifically my gallbladder, kidney, and liver. He also sent me for a CT Scan with contrast. They completed a total lab workup of my blood. All of these results came back normal, and nothing on the images showed anything wrong with my organs. On Saturday May 8, Dr came to the hospital to examine me. He stated everything related to my GI was fine. He asked if I have back pain, which I told him I do. At this time, I was in extreme pain and I couldn't even touch my skin. Dr attempted to examine my abdomen, and just by placing his hand on my stomach, I screamed in pain. He then put his hand behind my back and pushed a little, and it cause extreme pain in my abdomen. At this time, Dr suggested that maybe the pain is caused by something going on in my back. Maybe a pinched nerve or something. He ordered an X-ray of my upper and lower spine. Later that day, the results of the X-ray came back and showed there was nothing wrong with my spine. With these results, Dr then ordered an MRI of my lumbar and thoracic spine. On Sunday May 9 at 1030am, I was taken to radiology for an MRI. The initial report shows that I do not have any pinched nerves and nothing notable that would cause this type of pain in my body. As of now, no diagnosis or explanation for the pain I am experiencing. The pain is gradually getting worse and at times I am unable to move at all without extreme severe pain in my body. At times, my right groin hurts and I am unable to stand on my feet, as it feels as if I have pulled a groin muscle. The pain in my abdomen takes my breath away and feels like I am being set on fire in that area of my body. The pain no longer goes away and is constant, but moves throughout my right side from my groin to my shoulder only. I am not able to put my right arm behind my back because I get this pain in the back of my shoulder area. This pain is only on my right side at this time. So far, there is no explanation for this pain. I never had anything like this until I got the vaccine.
41 2021-05-10 bell's palsy Bells palsy, complete, right sided
41 2021-05-11 pain in extremity sore upper arm; This is a spontaneous report received from a contactable consumer (Patient). A 41-ye... Read more
sore upper arm; This is a spontaneous report received from a contactable consumer (Patient). A 41-year-old male patient received first dose of BNT162B2 (Pfizer COVID-19 Vaccine, Solution for injection, lot numbe: unknown), via an unspecified route of administration, administered in left arm on 08Mar2021 at 01:15 PM (at the age of 41-years-old) as 1st, single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. Patient had no known allergies. The patient did not receive any other vaccine in four weeks of vaccination. The patient did not receive any other medications in two weeks. The patient was not diagnosed with COVID prior vaccination. On 8Mar2021 (same day of vaccination), patient had sore upper arm. The patient did not receive any treatment for event. The patient was given vaccine at workplace clinic. The patient had not been tested for COVID post vaccination. The outcome of the events was recovering. Information on the lot/batch number has been requested.
41 2021-05-14 pain in extremity a potential false blood pressure readings/The readings were over 200/140/took it on his wrist and me... Read more
a potential false blood pressure readings/The readings were over 200/140/took it on his wrist and measured at 215/147; the pain at the location of the lower arm got near tremble; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 28Apr2021 16:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included blood pressure abnormal, blood cholesterol abnormal, deafness. The patient's concomitant medications included unspecified products received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 on 06Apr2021 01:15 PM at arm left for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, he has not been tested for COVID-19. The patient reported a potential false blood pressure readings on 29Apr2021, a day after administered 2nd dose. The readings were over 200/140 and he took it at home using a blood pressure reading device. He took it on his wrist and measured at 215/147. In his recent doctors visit prior to administer the 2nd dose, the accurate readings was 183/136 (estimated). With the false blood pressure readings, the pain at the location of the lower arm got near tremble due to the fact of the false readings has been taken. The events outcome was unknown. Information on the Lot/Batch number has been requested.
41 2021-05-18 burning sensation burning sensation up to the back of the neck and scalp and part of the feet and leg area on the left... Read more
burning sensation up to the back of the neck and scalp and part of the feet and leg area on the left side; burning sensation at the injection site in the left arm; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number; ER8734), via an unspecified route of administration, Left arm on 02Apr2021 at 14:00 (at the age of 41-years-old), as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included ongoing heart problem (all of his life). The patient was not receiving concomitant medications. The vaccine was administered at pharmacy. No other vaccine was administered on the same day as COVID-19 vaccine. On an unspecified date in Apr2021, 2 or 3 days after the vaccine, the patient had a burning sensation. Has started in more places, so has gotten worse. It first started at the injection site in the left arm, then up to the back of the neck and scalp and part of the feet and leg area on the left side. Therapeutic measures taken as a result of the events included Advil, but it hasn't been working. The events resulted in physician's office visit, the patient went to the doctor on 29Apr2021. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
41 2021-05-18 pain in extremity Patient presented to ER with flu sx that began after vaccine. Pt reports a constant fever (102 F PTA... Read more
Patient presented to ER with flu sx that began after vaccine. Pt reports a constant fever (102 F PTA), constant generalized myalgias and a constant HA that all began on onset. He also reports multiple intermittent diarrhea episodes since onset. Pt c/o constant and non-radiating left foot pain with associated swelling that began yesterday. Left foot pain noted to be gout in ER.
41 2021-05-19 facial paralysis temporary facial paralysis; This is a spontaneous report from a non-contactable consumer (patient). ... Read more
temporary facial paralysis; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 30Apr2021 14:00 (Batch/Lot number was not reported) (at the age of 41 years old) as unknown (dose number), single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No other vaccine in four weeks. On 02May2021, the patient experienced temporary facial paralysis. There was no treatment for the event. No COVID prior vaccination and patient had not been tested for COVID post vaccination. The outcome of the event was recovered on unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
41 2021-05-19 pain in extremity, seizure Arm soreness started on May 18 @ 3:30pm. Went to sleep with same arm soreness at 11pm. Woke up at ... Read more
Arm soreness started on May 18 @ 3:30pm. Went to sleep with same arm soreness at 11pm. Woke up at 1:15am on May 19, walked approximately 12 feet started experiencing cold chills. At 1:20am, while standing and holding cellphone in right hand, started experience of convulsive seizure to the point of cellphone health stats saying i walked 103 steps while standing still convulsing. After calming down enough to sit, i sat on couch to sleep. Heart rate was still registering in 200 bpms for next couple hours. May 20, 2021 started experiencing sore throat at 5:30am. As day progresses am experiencing flu type symptoms.
41 2021-05-20 pain in extremity Since the second shot, on March 31st, I've had consistent pain and very limited movement in my left ... Read more
Since the second shot, on March 31st, I've had consistent pain and very limited movement in my left arm. I went to urgent care on May 19th, where the attending physician told me that it was likely that injection had been too high, which caused inflammation between the the joints of my shoulder. She prescribed an anti-inflammatory, and said it's likely I'll need physical therapy. I have an appointment with my PCP on June 1st to get an ultrasound done (at her suggestion) and then plan a course of action.
41 2021-05-21 weakness Shortness of breath weakness tired chills achey heart palpitations headache dizzy confused lasted 2 ... Read more
Shortness of breath weakness tired chills achey heart palpitations headache dizzy confused lasted 2 weeks
41 2021-05-22 burning sensation, tingling I felt faint about 20 minutes after I took the first vaccine shot on 4/1/2021. I felt like I had hea... Read more
I felt faint about 20 minutes after I took the first vaccine shot on 4/1/2021. I felt like I had heart palpitations, then a tingling feeling in my left arm. After the second shot, I felt like my balance was off if I laid down or looked down and then pulled my head up. That went away after the first day. Starting the following day, I had some chest pain over my heart, and at times, I would have a burning sensation in my heart. At times, I also felt a tingling down my left arm (sometimes out of nowhere). I would be very short of breath. These symptoms were on and off for the first two weeks after I took my shot. They have since completely gone away.
41 2021-05-22 tremor, feeling cold Felt a minor headache, and tiredness directly afterwards. At 7:30 pm 12 hrs later I went through 3 h... Read more
Felt a minor headache, and tiredness directly afterwards. At 7:30 pm 12 hrs later I went through 3 hrs. of violently shaking along with feeling very chilly. Woke up with every muscle aching and a pounding headache, after 3-4 hrs. I started to feel better. The 3 hrs. of violently shaking is what I'm reporting.
41 2021-05-22 unresponsive to stimuli, tremor, weakness Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainti... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe
41 2021-05-23 numbness, muscle spasms, tingling Since my 2nd dose of my Covid shot, I experienced an inflamed lymph node in my left armpit. It laste... Read more
Since my 2nd dose of my Covid shot, I experienced an inflamed lymph node in my left armpit. It lasted about a week and eventually passed. But since that event, I have been experiencing sharp pains on the left side of my body (arms, legs, buttocks), such as shocks, tingling, and numbness in my extremities. If I lift my left arm up, I get the sensation the arm and hand is falling alseep. But it's not the normal falling asleep sensation, more of a shocking pain running to my hands. My buttocks/back thigh area is constantly cramping up.
41 2021-05-23 migraine, night sweats Recurrent tinnitus, ringing in the ears, which worsened about 2-3 days after second shot and made me... Read more
Recurrent tinnitus, ringing in the ears, which worsened about 2-3 days after second shot and made me question whether to get the second dose; Severe headache 30 hours after first dose, then sporadically especially if fatigued, need to rule out whether they are migraines which I have never been diagnosed with before, continued and worsened after second dose. Malaise; Night sweat about 36 hours after first dose; Chills all night one night after the second dose. Soreness at injection site for first 30 hours after first dose, not as much after second dose. Fatigue, depression and irritability in the weeks after the first dose. After the second dose it is too soon to tell.
41 2021-05-23 migraine, pain in extremity Sever chills, headache, extreme fatigue, sore arm, worse migraine ever suffered and never had a migr... Read more
Sever chills, headache, extreme fatigue, sore arm, worse migraine ever suffered and never had a migraine before, nausea, exhaustion. All of these lasted 48 hours and the migraine did not occur until 72 hours later.
41 2021-05-23 migraine Patient states he has had a "migraine" since he received the vaccines. He said the pain started abou... Read more
Patient states he has had a "migraine" since he received the vaccines. He said the pain started about an hour after he received the vaccine and has had no relief even with taking ibuprofen. He says the pain is mostly in his neck and the base of his skull.
41 2021-05-23 seizure ~15-30 mins post vaccine dose, patient developed seizure and transferred to outside hospital emergen... Read more
~15-30 mins post vaccine dose, patient developed seizure and transferred to outside hospital emergency room via ambulance. Unknown if patient admitted.
41 2021-05-24 tingling Patient complains of itching and tingling. Benadryl was given patient stated feeling better and lef... Read more
Patient complains of itching and tingling. Benadryl was given patient stated feeling better and left.
41 2021-05-26 cold sweat, feeling cold Got LURRY, DIZZY, COOL, CLAMMY- legs raised, icepack applied to neck, apple juice and crackers give... Read more
Got LURRY, DIZZY, COOL, CLAMMY- legs raised, icepack applied to neck, apple juice and crackers given, fan air patient felt better, patient mentioned not eating much earlier today
41 2021-05-26 migraine Labile BP; Rapid heart rate; Migraines; Body aches; Chest pain and tightness; Chest pain and tightne... Read more
Labile BP; Rapid heart rate; Migraines; Body aches; Chest pain and tightness; Chest pain and tightness; Inflammation; This is a spontaneous report from a contactable other hcp (parent). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), dose 1 intramuscular, administered in right arm on 22Dec2020 15:00 as 1st dose, single for covid-19 immunisation. Medical history included covid-19. The patient's concomitant medications were not reported. There is no other vaccine in four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, covid test type post vaccination was Nasal Swab on 29Dec2020, covid test result was negative. Starting 5 days post vaccine (26Dec2020 18:00), ongoing symptoms of labile BP; rapid heart rate; migraines; body aches; chest pain and tightness; inflammation. Now going on 6 months of ongoing issues that have resulted in 4 ED visits, multiple tests and numerous doctor's office visits. There is some treatment (Medication) for AE. The adverse event result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of the events was resolving.; Sender's Comments: Based on known safety profile it is unlikely that the reported events were causally related to bnt162b2. These are probably intercurrent medical conditions. Case will be reassessed if additional information is received. 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 Committees and Investigators, as appropriate.
41 2021-05-26 nerve pain nerve pain from his ulnar nerve to his elbow and his hand and it came around to his chest, and his c... Read more
nerve pain from his ulnar nerve to his elbow and his hand and it came around to his chest, and his chest was on fire and his abdomen and his hip and foot; arm at the injection site was sore; Neck stiff; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 41-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262; Expiration Date: 31May2021), dose 1 via an unspecified route of administration, administered in Arm Left on 07Feb2021 (at the age of 41-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medications was not reported. The reporter said the first day he didn't feel anything. The caller states that on the second day after getting the vaccine, arm at the injection site was sore and neck stiff on 08Feb2021. Caller states that the Tuesday after his vaccine, he was fine most of the day but in the afternoon the patient experienced nerve pain from his ulnar nerve to his elbow and his hand and it came around to his chest, and his chest was on fire and his abdomen and his hip and foot on 09Feb2021. Caller woke up the next day with no pain, but his left arm was weak. Caller states that the day after that, everything seemed fine except whenever he uses his left arm, the triceps and armpit still hurt. Caller was scheduled for his second dose this coming Sunday, and he was wondering what the recommendations are for getting the second dose with having had symptoms like this following the first dose. Caller reported that the pain to the injection site on his left arm has resolved but he is still having nerve pain in his left arm. It was stated that nerve pain that right now it did not hurt, but if he were to use his arm, and do labor, that was when the nerve pain flare ups. Caller states that when he was resting it was good, but when he uses his arm, it flares up. Caller states the nerve pain was persisting, because it was not worse, but it was not going away. The patient underwent lab tests and procedures which included blood test: everything was good on Nov2020 everything was good. Outcome of the event (nerve pain from his ulnar nerve to his elbow and his hand and it came around to his chest, and his chest was on fire and his abdomen and his hip and foot) was not recovered, arm at the injection site was sore was recovered on an unspecified date and neck stiff was recovered on 10Feb2021. Follow-up attempts completed. No further information expected.
41 2021-05-28 weakness had diarrhea; a fever of 103*F; He was shivering due to lack of energy; He was shivering due to lack... Read more
had diarrhea; a fever of 103*F; He was shivering due to lack of energy; He was shivering due to lack of energy; lost his voice; threw up; sleeping for 48 hours; terrible pain in his stomach which made him scream to the point where he lost his voice; metallic taste in the mouth; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 23Apr2021 14:15 (Batch/Lot Number: EW0171, not sure if the 0 is a O or a 0) as single dose at the age of 41-year-old for covid-19 immunisation, administered not at a military facility. Medical history included ongoing Hashimoto's disease diagnosed about 10 years ago, ongoing vitamin D deficiency diagnosed about 8 years ago, ongoing vitamin b12 deficiency diagnosed about 8 years ago, lung neoplasm malignant. Family history included: dad had lung cancer, mother had thyroid issues and Alzheimer's. The patient's concomitant medications were not reported. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of BNT162B2. No prior vaccinations (within 4 weeks). No adverse events following prior vaccinations. The patient experienced terrible pain in his stomach which made him scream to the point where he lost his voice on 24Apr2021 with outcome of recovered on 27Apr2021, metallic taste in the mouth on 23Apr2021 with outcome of recovered on 24Apr2021, had diarrhea on 24Apr2021 with outcome of recovered on 26Apr2021, a fever of 103°F on 24Apr2021 with outcome of recovered on 26Apr2021, he was shivering due to lack of energy on 24Apr2021 with outcome of recovered on 27Apr2021, lost his voice on 24Apr2021 with outcome of recovered on 27Apr2021, threw up on 24Apr2021 with outcome of recovered on 27Apr2021, sleeping for 48 hours on 24Apr2021 with outcome of recovered on 27Apr2021. The patient underwent lab tests and procedures which included body mass index: 37 on an unknown date, body temperature: 103 Fahrenheit on 24Apr2021. Therapeutic measures were taken as a result of terrible pain in his stomach which made him scream to the point where he lost his voice, had diarrhea, threw up. The course of events was as follows: Within the 1st 24 hours, he mentioned that he was fine and easy but had a metallic taste in the mouth for 24 hours. He mentioned that the next 72 hours were really bad for him. On 24Apr2021, that night, he started to feel terrible pain in his stomach which made him scream to the point where he lost his voice. It was like knives cutting his stomach. He threw up everything he ate, had diarrhea for 2 days along with a fever of 103 degree F for 2 days. He would try to go to the bathroom and he was shivering due to lack of energy that he could not go to the bathroom. He slept for 48 hours after the 1st 24 hours after vaccination due to the side effects. By Monday afternoon, 26Apr2021, he noticed that his side effects were subsiding and by Tuesday, 27Apr2021, he was a different person and was like nothing happened, he was able to resume a normal life and go back to work. The events did not require a visit to Emergency Room or physician Office. He did not go he was taking orange juice and ibuprofen to treat himself. No relevant tests. He asked if this was contraindicated with him to get the 2nd dose. He has not spoken to his doctor yet. He queried if he should get the second dose or is it contraindicated. Patient mentioned he is very large at 6'6" and 320 lbs. He is wondering if he should have a different dose because he is so big. This report is not related to a study or program. Information on Lot/Batch number was available. No further information is expected.
41 2021-05-31 weakness Rare Diagnosis of Ramsay Hunt Syndrome (Shingles in the inner & outer of the left ear & throat) aka ... Read more
Rare Diagnosis of Ramsay Hunt Syndrome (Shingles in the inner & outer of the left ear & throat) aka Herpes Zoster Oticus. Bedridden, Extreme fatigue, weight loss, weakness, body aches, pain in throat & ear, lymphodema, severe virtigo, tonsillitis, and permanent hearing lose.
41 2021-06-01 tremor About 8 hours after the 2nd dose my husband became very ill. Uncontrollably shaking, fever, terrib... Read more
About 8 hours after the 2nd dose my husband became very ill. Uncontrollably shaking, fever, terrible headache, nausea, etc. for 24 hours.
41 2021-06-02 pain in extremity Muscular pain in both upper arms well after initial vaccine reaction had subsided, normal movement o... Read more
Muscular pain in both upper arms well after initial vaccine reaction had subsided, normal movement of arm up and/or back and rapid movements in other axes cause intense muscle pain followed by severe minutes of pain fading to dull ache. The pain issue has only worsened since it's onset. The pain in each arm is proportionate to the initial vaccine reaction, meaning the arm that got the second dose experiences more sever pain than the one that got the first. The pain in both is preventing normal activities and affecting quality of life.
41 2021-06-03 pain in extremity Foot pain that lasted over a month. Went to see pcp and couldn?t be resolved.
41 2021-06-05 night sweats I received the first vaccine without a single side effect. However, the evening after receiving my s... Read more
I received the first vaccine without a single side effect. However, the evening after receiving my second dose, I began to get chills, a fever of 101.7, and night sweats. The next morning I woke up to two rashes on my chest. I continued to experience chills, a fever of 102, and the rash now covers my entire body, including my face. The rash is painful, itchy, and bumpy. This is day two. I have swollen lymph nodes in my neck. The urgent care I saw today told me to watch my throat to make sure it doesn't close up.
41 2021-06-07 pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA: Myocarditis, STEMI Patient received Pfizer COVID vaccines on 4... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Myocarditis, STEMI Patient received Pfizer COVID vaccines on 4/15/21 and 5/6/21. Patient presented to ED on 5/9/21 with complaints of acute onset substernal chest pain that woke him from sleep. Patient also endorses left arm pain, diaphoresis and nausea. No significant past medical history or family history of heart disease. ECG demonstrated inferior ST elevations. Patient was taken to cath lab and found to have no angiographic evidence of CAD. Patient discharged on aspirin 81 mg QD, Clopidogrel 75 mg QD, Metoprolol 12.5 mg BID, Rosuvastatin 5 mg QD.
41 2021-06-08 numbness, tingling He has had a lot of symptoms since second COVID-19 vaccine 5 weeks ago-Pfizer vaccine. Notes tinglin... Read more
He has had a lot of symptoms since second COVID-19 vaccine 5 weeks ago-Pfizer vaccine. Notes tingling and numbness in his left arm, dizzy, nausea, "brain fog" and "loosing motor skills". Headaches are tapering off. He is on Amantadine from Neurology. His symptoms came on immediately after the 2nd shot. Severe symptoms- headache , brain fog. Had been in ED- had CT head. Saw neurology and then sent to Headache clinic. He has several people he knows with similar symptoms and had gone thru long term
41 2021-06-09 mild one side paralysis Blood clot in left side of brain resulting in stroke and reduced functionality of the right side of ... Read more
Blood clot in left side of brain resulting in stroke and reduced functionality of the right side of my body.
41 2021-06-12 numbness Tachycardia, numbness in extremities, dizziness, shortness of breath. All intermittent for about 8 ... Read more
Tachycardia, numbness in extremities, dizziness, shortness of breath. All intermittent for about 8 hours following shot. Intense for a 2 hour period 4:30-6:30.
41 2021-06-14 inability to speak 1.Swollen right lymph node, can be seen in a mirror. intense pain right side of neck. Right ear, pai... Read more
1.Swollen right lymph node, can be seen in a mirror. intense pain right side of neck. Right ear, pain hearing is effected, sometime hear pulse in ear other times ringing. , very bad headache. 2. hard to swallow anything, mouth producing saliva at a rapid rate. 3. nothing over the counter is helping with the fever or body aches, they come and go thru the day/night. 4. body aches/ joints hurt . 5. breathing thru nose hurts right lymph node area. 6. hard to talk. 7. when seeping /lying down, fell like i am chocking on by own Silvia.
41 2021-06-14 numbness On May 18, 2021, Patient said he was experiencing severe back pain and that both of his arms had gon... Read more
On May 18, 2021, Patient said he was experiencing severe back pain and that both of his arms had gone numb and he had vomited. Patient called his mother to come help him with the baby because he wasn't feeling well. When she got there 30 minutes later he was not breathing. They were not able to revive him. He died of a blood clot in the front of his heart.
41 2021-06-14 tremor 3 hours after vaccine, he experienced acute symptoms - dizziness, lightheadedness (described as room... Read more
3 hours after vaccine, he experienced acute symptoms - dizziness, lightheadedness (described as room spinning around), anxiety (not problematic before), profuse sweating, feeling of doom, nausea/wretching, pronounced shaking. called 911, taken by ambulance to ER, prior symptoms continued in varying intensity for the next 3 - 4 hours. He was given IV fluids, antibiotics, then admitted to the hospital. He had loss of balance, continued lightheadedness, loss of appetite. Hospitalized for 3 days. Went home with a walker (not used before). He gradually improved over a two week period.
41 2021-06-15 tenderness My arm was tender for a couple days. I had a slight deal with my eye where I had swelling in my righ... Read more
My arm was tender for a couple days. I had a slight deal with my eye where I had swelling in my right eye lid. I went to the Family Clinic and was given some lubricant to put in my eye.
41 2021-06-16 pain in extremity Patient just reported that he had experienced moderate to severe arm soreness after 1st dose which h... Read more
Patient just reported that he had experienced moderate to severe arm soreness after 1st dose which he felt affected normal range of motion. He nonetheless requested to be given the 2nd dose 3 weeks later in the same arm, and stated that the soreness got worse so he decided to go to Dr. for evaluation. Dr. told him he had shoulder/joint injury due to the COVID-19 vaccine, and patient states was administered two injections to relieve pain and setup for physical therapy. Patient says he is now okay and getting better and back to normal.
41 2021-06-17 pain in extremity, numbness, tingling About three days post-injection, I experienced dull aching, tingling, and numbness in my left should... Read more
About three days post-injection, I experienced dull aching, tingling, and numbness in my left shoulder, the left side of my back, and left arm. The symptoms lasted for four weeks and slowly improved during that timeframe. The symptoms seem to have cleared up at this time.
41 2021-06-19 numbness, discomfort, pain in extremity, tingling Pain in both arms and hands. Numb fingertips. Feels like what i would expect carpel tunnel syndrome ... Read more
Pain in both arms and hands. Numb fingertips. Feels like what i would expect carpel tunnel syndrome to feel like. FIngers constantly swollen and tingly. Can't bend fingers at night or when i first wake up. Nothing takes the discomfort or pain away.
41 2021-06-19 tingling After about 15 Minutes after the injection, My Hands and Feet broke into a sweat, about 1 minute aft... Read more
After about 15 Minutes after the injection, My Hands and Feet broke into a sweat, about 1 minute after that the top of my head started to tingle ( like pins and needles) after about another minute it felt like I had to keep breathing on purpose. ( what I mean by that is I was aware of my breathing and had to knowingly take breaths it was like I had been under water and just come up for air) I don't remember the exact time maybe another minute or so, my heart started to race. This All went on for about 45 Minutes. When this first happened the Pharmacist told me that what was happening was common with vaccinations and had nothing to do with the covid 19 vaccination, I asked for the nurse that had provided the vaccine to me and was told she went to lunch. So there was no healthcare professional there to help me. The pharmacist just had me sit in a chair and told me to sit there until I felt better. This happened for both injections. I have never experienced this type of reaction with any other vaccine in my life.
41 2021-06-21 hot flush headache, itchy/burning eyes, muscle aches, bone pain, cold chills/hot flashes, insomnia, diarrhea, ... Read more
headache, itchy/burning eyes, muscle aches, bone pain, cold chills/hot flashes, insomnia, diarrhea, pain in testicals, and nausea
41 2021-06-21 seizure Patient experience short duration seizure after receiving his 2nd dose of Pfizer vaccine. Per patien... Read more
Patient experience short duration seizure after receiving his 2nd dose of Pfizer vaccine. Per patient, no reaction in his 1st dose. Seizure lasted less than 30 seconds and patient recovered fully. Patient denied calling 911 for help.
41 2021-06-23 flushing Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium
41 2021-06-23 pain in extremity, tingling within 1 hour of taking the dose, I started feeling tingling on my face. I also got nervous and anxi... Read more
within 1 hour of taking the dose, I started feeling tingling on my face. I also got nervous and anxious. Tingling stayed for a couple of hours.also there was some pain in the right arm but at night...there was a lof of pain. I took Tylenol for pain. Next day pain disappeared. Although it was still sore.
41 2021-06-24 weakness About 1-week post second injection, patient developed Pulsatile Tinnitus in (R) side. This has conti... Read more
About 1-week post second injection, patient developed Pulsatile Tinnitus in (R) side. This has continued for two (2) months after the second injection. Additionally, patient has complained of excruciating headaches on the right side of the head, behind the eyes and behind the ear. Patient has throbbing head pain, and becomes lightheaded easy. Blood pressure has increased to a perceived new normal of 140/90+ on most days, even at rest. Patient is normally very active, exercising at least six (6) days per week doing cardio and strength workouts, however has not been feeling well since the second shot. Patient is very fatigued by the end of the day, which is not normal. Patient wakes up in the morning to pounding headaches, pain level 5-7, every single morning with a perceived fast heart rate. Pulsating tinnitus is very loud for patient, and he cannot hear out of that ear, and difficult to understand speech or other sounds. No change in diet, working conditions or lifestyle other than receiving the COVID-19 vaccination. Patient has been monitoring blood pressure at home with a machine and at the clinic. Average blood pressure is 143/90 with some readings as high as 160/95 and as low as 118/80 (after waking up on day 3 of a hospital stay). Patient was admitted to a hospital on 21JUN21 for abnormal ECG, high blood pressure and complaint of chest tightness, debilitating headache as well as pulsating tinnitus in head.
41 2021-06-24 seizure As soon as the vaccine was completed and the bandaid was put on, the patient started having what loo... Read more
As soon as the vaccine was completed and the bandaid was put on, the patient started having what looked like seizures. He arched his back and reached his arms out to either side, lifted his head and started making a noise. He was sweating profusely. I held him and kept him from falling out of the chair and called for my technician to call 911. Once he called the patient came to after about 2 minutes. His breathing was not hindered so I felt it was not an allergic response. I checked his pulse and started asking him questions such as if he knew who he was and what was going on. I gave him some water and kept checking his pulse. I laid him on the ground while we waited for EMTs to arrive. Once they arrived they took over and checked his pulse and heart rhythm. His pulse was low (in the 40s and 50s) and his pressure was low. He denied going on the ambulance and his brother came and picked him up and took him to the hospital. Total time from beginning to end was about an hour.
41 2021-06-24 tremor, feeling cold Patient walked out the vaccination room for about a minute or so after 1st dose of Pfizer then sudde... Read more
Patient walked out the vaccination room for about a minute or so after 1st dose of Pfizer then suddenly blacked out, fell chin down to floor, got a cut on the chin and bleeding; patient sit up after the fall, was responsive, pain level 3-4 due to the cut on the chin, chilling and shaking. Paramedic arrived after 5 minutes and transferred patient to hospital
41 2021-06-26 pain in extremity The 2nd dose of Pfizer vaccine was injected on May 3rd, 2021 at a clinic. Minor arm ache, fatigue, f... Read more
The 2nd dose of Pfizer vaccine was injected on May 3rd, 2021 at a clinic. Minor arm ache, fatigue, fever/chills felt for approx. ~1day post vaccination and then felt back to normal. Around day 3 post vaccination felt sudden, sharp, stabbing pain within chest cavity which forced me to take shallow, rapid breaths to avoid triggering pain. Lasted a few minutes before subsiding. Following day or so pain returned as a dull, diffused pain and was felt intermittently for several weeks. Generally I run fairly often for fitness, however activity level was reduced due the ongoing chest pain. Wanted to resume normal activity levels, but decided to consult a Doctor for peace of mind due to pain taking so long to resolve. Scheduled virtual appointment (06/24/21) who advised an ER visit due to it being a potentially risky chest issue, and the fact that they could run the appropriate tests to diagnose it relatively quickly. Walked over to a nearby ER that afternoon and was hospitalized for 1 night, who diagnosed an "Unprovoked VTE" with a "Pulmonary Embolism" in Right lung. Was treated with Lovenox injections at hospital and currently taking Eliquis medication. As a side note: my brother (43yrs old) who lives in another country, was administered the 1st dose of the AstraZeneca vaccine on 05/24/2021 and subsequently fell ill, went to the ER twice and was eventually diagnosed with VTE/Bilateral PE. He is also currently taking Eliquis medication.
41 2021-06-26 seizure vaccine was administered and patient lost consciousness. he began to turn red and did not breathe fo... Read more
vaccine was administered and patient lost consciousness. he began to turn red and did not breathe for several seconds at which we were about to administer an EpiPen. He then took a breath and started to convulse. he regained consciousness and was not coherent at first. He was sweaty and pale. Pt became alert and oriented and stayed in the room while we waited for the emt to arrive. He declined to be taken to the hospital. He moved to the waiting room and was monitored for 30 minutes before leaving
41 2021-06-28 weakness Pt reports lymph node swelling to left side of neck began 5 days after initial dose of Pfizer vaccin... Read more
Pt reports lymph node swelling to left side of neck began 5 days after initial dose of Pfizer vaccine (3/25/2021); reports node was firm and "Pistachio size, swelling to a Pecan size." Pt reports muscle pain, and bilateral lower extremities "extremely hot and sweaty." "extreme fatigue and weakness." Pt was seen by his primary provider at local HCF and was prescribed "2 rounds of antibiotics, Zithromycin and steroid." Dr. also had an ultrasound at another HCF which he reports showed lymph note "reactive and inflamed." Pt continued to follow up with medical provider and waited 3 months to received Pfizer booster vaccine (6/23/2021), which he did receive and subsequently reports reaction is "worse." He reports left side of neck lymph node swelled to "Pecan size" and this time left under arm lymph node palpable "pea size" and he became "loopy;" "not fully present" described it as driving as in a fog "dissociated." Extreme fatigue and weakness continue. Pt reports he then again saw his primary medical provider and was prescribed more antibiotics (Rocefin I.M.) and steroids. He is being referred to an ENT MD and infectious disease MD for follow up. Pt reports he tested multiple times in the past for COVID-19 via rapid testing (No PCR confirmatory test done), he reports he never tested positive for COVID-19 but reports he had all the symptoms including loss of taste and smell back in July 2020.
41 2021-06-28 numbness, tingling Fatigue, ache, Extreme swelling of the lips. 4 occurrences so far covering all 4 quadrants randoml... Read more
Fatigue, ache, Extreme swelling of the lips. 4 occurrences so far covering all 4 quadrants randomly. Numbness, tingling, itchy sensation. Last episode involved swelling of the cheek and eye on same side as lip. Chest and back tightness
41 2021-07-01 pain in extremity After shot there was a soreness in the left arm that slowly radiated out to the rest of the body. Mo... Read more
After shot there was a soreness in the left arm that slowly radiated out to the rest of the body. Morning of 4/4/2021 body was covered with an itchy rash, Dr. tried OTC antihistamines. 4/7/2021 Dr. prescribed steroids and stronger antihistamines. 4/20/2021 ER visit had more steroids and antihistamines prescribed. 4/292021 Dr. prescribed steroids and stronger antihistamines. 5/10/2021 Dr. stopped steroids and tried new cocktail of antihistamines. 6/1/2021 Dr. prescribed visiting allergy clinic and had blood test run. 6/9/2021 Allergy clinic Dr. could not run test as i am on a coattail of antihistamines, have to wait until i can go 5 days without antihistamine and hives before testing can start.
41 2021-07-01 pain in extremity arm soreness; fatigue; fever (100 degrees); chills; This is a spontaneous report received from a con... Read more
arm soreness; fatigue; fever (100 degrees); chills; This is a spontaneous report received from a contactable consumer, the patient. A 41-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route administration on 24Mar2021 at 10:00, (at the age of 41-years-old) as a single dose, for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications within two weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route administration on 01Mar2021, (at the age of 41-years-old) 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 positive for COVID-19. On 24Mar2021 at 21:00 (11 hours after the dose), the patient had very predictable response to the 2nd dose as he experienced severe arm soreness, fatigue, mild fever (100 degrees, units unspecified), chills. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measure was taken as result of events and included the treatment with Tylenol and slept. It was reported that, one day after vaccination only mild arm soreness remained. The clinical outcome of the event arm soreness was not resolved and for events fatigue, fever (100 degrees) and chills were recovering at the time of this report. No follow-up attempts are needed. No further information was expected.
41 2021-07-02 pain in extremity, burning sensation Patient reports to pharmacy on June 29th 2021 that he had pain and inflammation in both arms after b... Read more
Patient reports to pharmacy on June 29th 2021 that he had pain and inflammation in both arms after both covid vaccines. He switched vaccine administration sites but still had pain/burning after both vaccines. He told the technician that he has myocarditis from the covid vaccine and that he saw a cardiologist.
41 2021-07-04 numbness patient fell dizzy and numb on right side of face
41 2021-07-05 tingling Started with Tingling in Upper Right Leg, Chest Pain and Shortness of Breath, Constant Headaches. Pa... Read more
Started with Tingling in Upper Right Leg, Chest Pain and Shortness of Breath, Constant Headaches. Passing out, Light headed and dizziness. Joint Pain and All Day Headaches. More recently Been having Sharp pain in kidney areas and back pain and Constant headaches. Tingling throughout whole body at times.
41 2021-07-06 tremor, nerve pain, muscle twitching, tingling The night of July 3rd, I started getting severe chest pain, that was worse than before. As well as f... Read more
The night of July 3rd, I started getting severe chest pain, that was worse than before. As well as full body nerve pain, obsessive sweating, shaking, my back was twitching, which led to uncontrollable shaking that went into my legs like they were vibrating. It went all over my body, hands, feet, legs, arms, all over. When I tried to stand up I could barely walk, I went to the ER. They took at CT Scan, blood tests, and just sent me home to get checked by a Neurologist. Since then I continue to have these symptoms. Such as trimmers, in my hands and feet. Heat on my skin all over my body at random times of the day. As well as the sensation that I have water or sweat on random parts of my body. I go to the Neurologist, July 15th to do further testing.
41 2021-07-09 bell's palsy Bells Palsy started on 7/7/2021 Emergency room diagnosed on 7/8/2021
41 2021-07-12 migraine Vertigo, GI, migraine s/s - intermittent x 4-5x since vaccination, lasting 2-4d
41 2021-07-14 numbness, muscle spasms, nerve pain, pain in extremity, tingling, burning sensation About two weeks after second dose. I started having pain in one leg, after a few days it was both le... Read more
About two weeks after second dose. I started having pain in one leg, after a few days it was both legs, then the numbness from waist down, tingling and burning sensation on both feet. Muscle spasms, nerve pain. Since then its been really hard to do my job. I completely stop working on May 18. Doctors orders. I been going to physical therapy, but not helping, My doctor recommended me to report , because, of all the testing and Xrays have got, nothing comes up. He referred me to see a Neurologist and Allergist to further make exams, to make sure its not Guillen Barre Symdrome. I have been in medication for pain , disinflamatory medication, but until now everything is the same.
41 2021-07-15 weakness, feeling cold, feeling hot Day 1-2 post injection: Severe body aches (whole body - hurt to even try to pick up cell phone), vi... Read more
Day 1-2 post injection: Severe body aches (whole body - hurt to even try to pick up cell phone), visibly swollen left armpit painful to touch and with arm movement, severe rigors, fever ~101, rapid temperature changes (burning up to freezing), sweating, headache, nauseousness, dizziness, exhaustion/low energy, no appetite, brain fog Day 3: above started to slowly subside Majority of symptoms have gone away. Still get nauseous and dizzy at some point every day. Low energy, lethargic still, no real appetite, still have brain fog.
41 2021-07-17 feeling cold Atrial fibrillation was detected but not sure yet if it was an underlying condition or caused by vac... Read more
Atrial fibrillation was detected but not sure yet if it was an underlying condition or caused by vaccine.; Tunnel vision; Extreme sense of coldness; Face planted to the floor.; This is a spontaneous report from a contactable consumer or other non hcp. This consumer(patient) reported for himself thata 41-years-old male patient received first dose of BNT162B2 (Formulation: Solution for injection, Batch/Lot number: 59267-1000-01), via an unspecified route of administration, administered in Arm Right on 25Jun2021 18:00 (Age at vaccination 41 years) as single dose for COVID-19 immunisation. Medical history included hiatus hernia and diverticulitis. Concomitant medication(s) included paracetamol (TYLENOL). Patient had no known allergies. On 25Jun2021 18:00, the patient experienced atrial fibrillation was detected but not sure yet if it was an underlying condition or caused by vaccine; tunnel vision; extreme sense of coldness and face planted to the floor. Patient was received treatment for events. It was reported that after patient received shot and exited the medical room, he had extreme sense of coldness come over me, tunnel vision, then face planted to the floor. Ambulance was called, patient regained consciousness about a minute or so later, and my chin was split open. They took me to ER, stapled my chin, and ran tests. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Other medications the patient received within 2 weeks of vaccination include Tylenol. Patient received Cardizem 1/day till doc follow-up visit. The clinical outcome of all events were unknown. Information on the lot/batch number has been requested.
41 2021-07-17 flushing (MANUFACTURER UNKNOWN) in the past and experienced vaccine allergy. Prior to vaccination, the patien... Read more
(MANUFACTURER UNKNOWN) in the past and experienced vaccine allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. On 20Mar2021, the patient experienced facial flushing, fatigue, dizziness, mild headaches and nausea with dizziness. No therapeutic measures were taken as the result of adverse events. The adverse event resulted in visit to the doctors or other healthcare professional office/clinic visit. The clinical outcomes of the events facial flushing, fatigue, dizziness, mild headaches and nausea with dizziness were recovering at the time of this report. No follow-up attempts are possible. No further information is expected.
41 2021-07-17 muscle spasms Upper lip spasm; This is a spontaneous report from a contactable nurse, the patient. A 41-year-old m... Read more
Upper lip spasm; This is a spontaneous report from a contactable nurse, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route of administration in the left arm on 04Mar2021 at 08:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Relevant medical history included COVID-19. Concomitant medications included fluoxetine hydrochloride (PROZAC) and multivitamin (MANUFACTURER UNKNOWN) taken for unknown indications from unspecified dates. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient had tested positive for 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-19 vaccine. On 14Mar2021, the patient experienced lip spasm which started about two weeks after having had received the vaccine. Therapeutic measures and treatment were not taken for the adverse event lip spasm. The 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 clinical outcome of the event lip spasm was unknown. No follow-up attempts are needed. No further information is expected.
41 2021-07-20 pain in extremity Don't know if this is from my vaccine or not, but the person who called me about my latest survey up... Read more
Don't know if this is from my vaccine or not, but the person who called me about my latest survey update told me to report it just in case. Since early May I've been having muscle soreness in my wrists. Like a pulled tendon. Sometimes the pain is very bad if I try to lift heavy onjects over 10 pounds. This sometimes extends to the backs of my hands and knuckles. I've only recenty had a doctor look at my wrists, and they think it is strained and needs a brace for a while to see if it gets better (x-rqays ruled out bone issues). I also had a major dental issue in April. I had a large abscess grow that wasn't there 6 months before (previous x-ray reviewed). The abcess required two root canals and a biopsy of the jaw bone (found nothing but normal infection). Dentist theorized that my body was so focused on fighting the vaccine and developing antibodies for COVID-19, that it didn't have the resources to fight off the infection.
41 2021-07-20 pain in extremity Painful and extreme weakness in left hand. Specifically, the palm. I cannot make a tight fist or gri... Read more
Painful and extreme weakness in left hand. Specifically, the palm. I cannot make a tight fist or grip anything for long. I took sleeve to help with the pain for 10 days but it has not gone away.
41 2021-07-25 inability to speak, pain in extremity, tingling wife called on 7/26 stating her husband quickly felt arm pain and fatigue on 7/24. At 9pm pt was un... Read more
wife called on 7/26 stating her husband quickly felt arm pain and fatigue on 7/24. At 9pm pt was unable to speak and taken to the hospital. CT scan was performed and while that was happening patient lost feeling in arms and legs. Ct scan ruled out acute stroke. Pt must have been well enough to be discharged b/c wife then mentioned she was still concerned and brought him to hospital. He was admitted and as of this morning was waiting for the MRI results.
41 2021-07-26 weakness, tremor Loss of equilibrium, aching muscles, soreness, shaking, symptoms of vertigo, anxiety, weakness, loss... Read more
Loss of equilibrium, aching muscles, soreness, shaking, symptoms of vertigo, anxiety, weakness, loss of balance, loss of dexterity, loss of muscle memory,
41 2021-07-27 numbness A small triangular patch was still swollen under my left eye; a racing heart; severe headache.; Dizz... Read more
A small triangular patch was still swollen under my left eye; a racing heart; severe headache.; Dizzy moments,; feelings of clumsiness; Chills; pain in right knee; pain in left shoulder; mouth and left side of face felt numb; mouth and left side of face started swelling; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: ER8737) via an unspecified route of administration in the arm left on 03Apr2021 at 09:15 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and general allergies. Patient had birch allergy (as child) and had reactions (fever) after vaccines as a young child. The patient did not have any concomitant medications. 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 03Apr2021 at 09:45, the patient experienced numbness, swelling face, dizziness, clumsiness, chills, pain in knee and pain in shoulder and at 3:00 he experienced severe headache. On 04Apr2021, the patient experienced a racing heart and on 05Apr2021, the patient experienced eye swelling. 30 minutes after the vaccine, the patient noticed his mouth and left side of face felt numb and started to swell as he was driving. The sensation felt similar to dental work. It seemed to improve after 1-2 hours (went for a walk and started to do yard work). General numbness and swelling lasted all day. On day 2, a small triangular patch was still swollen under his left eye. In the night (of day1) he woke up at 3:00 with a racing heart and severe headache and had a restless night thereafter (which is highly uncommon). Heart beat went back to normal after waking up and walking outside. Other less severe and persistent symptoms included dizzy moments, feelings of clumsiness (fell playing sports with son, missed a stair), chills, pain in right knee, pain in left shoulder, The patient did not receive any treatment for the events. 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 event headache, dizziness, clumsiness, chills, pain in knee, pain in shoulder and eye swelling was recovering at the time of this report. The clinical outcome of the event numbness and swelling face was recovered on 03Apr2021 and racing heart recovered on 04Apr2021. No follow-up attempts are needed. No further information is expected.
41 2021-07-27 nerve pain rash became more and in a few more places on my right leg; Shingles; blistered after 2 days.; Nerve ... Read more
rash became more and in a few more places on my right leg; Shingles; blistered after 2 days.; Nerve pain; muscle soreness; pain in my Hip Flexor tendon and in my quardiceps tendon; few spots on my thigh; This is a spontaneous report from a contactable consumer or other non hcp. A 41-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 26Apr2021 15:45 as 1st dose, single for covid-19 immunisation. Medical history included hypothyroidism ongoing. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE); thyroid (ARMOUR THYROID). The patient had not known allergies. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that, Received first dose of Pfizer on 26Apr2021. On 13May, she started developing nerve pain, muscle soreness, pain in my Hip Flexor tendon and in my quadriceps tendon. I also had a few spots on my thigh. As the next 4 days progressed, the rash became more and in a few more places on my right leg. Became blistered after 2 days. Went to the doctor on 17May and was diagnosed with Shingles. The nerve pain on, muscle soreness, pain in my hip flexor tendon and in my quadriceps tendon, few spots on my thigh on 13May2021 08:00 with outcome of recovering, rash became more and in a few more places on my right leg on 17May2021 with outcome of recovering, blistered after 2 days, on 15May2021 with outcome of recovering , shingles on 17May2021 with outcome of recovering. Therapeutic measures were taken Antiviral meds as a result of nerve pain (neuralgia), muscle soreness (myalgia), pain in my hip flexor tendon and in my quadriceps tendon (tendon pain), few spots on my thigh (rash macular), rash became more and in a few more places on my right leg (rash) , blistered after 2 days. (rash vesicular), shingles (herpes zoster).
41 2021-07-27 tingling Swelling in calves; Tingling/pins and needles in feet and lower calves; Swollen lymph nodes; This is... Read more
Swelling in calves; Tingling/pins and needles in feet and lower calves; Swollen lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8734) via an unspecified route of administration in the left arm on 29Mar2021 at 18:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included meniere's disease and anxiety. The patient did not have any allergies to food, medications, or other products. Concomitant medication included hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ). 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 29Mar2021 at 22:00, 4 hours after injection, the patient started feeling tingling in feet (pins and needles) and lower calves, the patient had swelling in calves two days later on 31Mar2021. Swelling subsided but tingling in feet persisted a week later. It was accompanied with swollen lymph nodes in groin area on an unknown date in Mar2021. Tingling increased with physical activity such as walking or temperature changes (hot shower etc). The events resulted in doctor or other healthcare professional office or clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the event swelling in calves (calf swelling) was recovered on an unknown date in 2021. The clinical outcome of the events swollen lymph nodes and tingling in feet and lower claves were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
41 2021-07-28 bell's palsy Herpes virus onset and flare up with Bell's Palsy; inflammation of cranial nerve 7; Herpes virus ons... Read more
Herpes virus onset and flare up with Bell's Palsy; inflammation of cranial nerve 7; Herpes virus onset and flare up with Bell's Palsy; inflammation of cranial nerve 7; Herpes virus onset and flare up with Bell's Palsy; inflammation of cranial nerve 7; This is a spontaneous report from a contactable other hcp. A 41-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via intramuscular route of administration in Arm Left on 04Apr2021 12:00(age at vaccination:41 Years) as DOSE 2, SINGLE for COVID-19 immunization. Patient didn't received other vaccines within 4 weeks prior to vaccination and patient didn't received within 2 weeks prior to vaccination. Medical history included gluten sensitivity from an unknown date and unknown if ongoing, food allergy was corn and dairy allergy from an unknown date and unknown if ongoing, papilloma viral infection from an unknown date and unknown if ongoing, epidermolysis bullosa from an unknown date and unknown if ongoing. Concomitant medication were not reported. The patient previously received first dose of bnt162b2(BNT162B2, Solution for injection, lot no: unknown) via intramuscular route of the administration in Arm left on 14Mar2021 12:00 (age at vaccination:41 Years) as DOSE 1, SINGLE for COVID-19 immunization. The patient experienced herpes virus onset and flare up with bell's palsy; inflammation of cranial nerve 7 on 07Jul2021. The Patient didn't had COVID-19 prior to vaccination patient was tested to COVID-19 to post vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 25May2021 Nasal Swab. Patient had disability for the events. Therapeutic measures were taken as a result of herpes virus onset and flare up with bell's palsy; inflammation of cranial nerve 7 was antivirals and steroids. The outcome of the events bell's palsy, cranial nerve infection, herpes virus infection was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the events Bell's palsy, Cranial Nerve Palsy, Herpes Viru infection and the suspect BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer drug 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 2021-07-28 migraine Migraine for 2 days since few ours after the shot and left lymph nodes tenderness and swollen. The m... Read more
Migraine for 2 days since few ours after the shot and left lymph nodes tenderness and swollen. The migraine is gone after 2 days but the lymph nodes still swollen and tender. I never any reaction so ever and I very healthy person.
41 2021-07-28 pain in extremity Swelling in left armpit and it is painful; Continues mild pain and feels heavy/left arm is feeling h... Read more
Swelling in left armpit and it is painful; Continues mild pain and feels heavy/left arm is feeling heavy; Swelling in left armpit and it is painful; soreness at the left arm where took vaccine; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 02May2021 at 08:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Patient medical history was provided as no. Patient past drug history was provided as no. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 11Apr2021 at 08:30 (at the age of 41-years-old) 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. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 03May2021 at 11:00, the patient experienced swelling in left armpit and it was painful. The patient also stated that left arm was heavy and there was soreness at the left arm where the patient had vaccine. The 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 swelling in left armpit, it was painful/armpit pain, and left arm was heavy and there was soreness at the left arm were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
41 2021-07-28 tingling, muscle spasms, pain in extremity Chest pain; Headache; muscle fatigue; joint pain; muscle pain; muscle cramps; arm soreness; dizzines... Read more
Chest pain; Headache; muscle fatigue; joint pain; muscle pain; muscle cramps; arm soreness; dizziness; vertigo; blurry vision; tingly sensation in arm and leg; sharp toe pain; out of body experience; brain fog; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 02May2021 at 14:15 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension and acid reflux. The patient did not take any concomitant medications. The past drug history was reported as no. 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 02May2021 at 18:45, the patient experienced chest pain, headache, muscle fatigue, joint pain, muscle pain and cramps, arm soreness, dizziness, vertigo, blurry vision, tingly sensation in arm and leg, sharp toe pain, out of body experience and brain fog. The clinical outcome of the events chest pain, headache, muscle fatigue, joint pain, muscle pain, muscle cramps, pain in arm, dizziness, vertigo, blurry vision, tingling sensation, pain in toe, out of body experience and foggy feeling in head were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
42 2021-01-04 flushing, weakness, feeling of body temperature change Red rash at injection site (left shoulder) and red rash on left, middle and right neck 9 hours after... Read more
Red rash at injection site (left shoulder) and red rash on left, middle and right neck 9 hours after administration, also weakness, flushed, hot and cold chills without fever 26 hours later. Red rash disappeared within 1.5 hours after taking ibuprofen.
42 2021-01-04 flushing, feeling cold Empoyee received his 1st dose of Covid-19 vaccine around 1535 on 12/17 at our vaccination clinic. A... Read more
Empoyee received his 1st dose of Covid-19 vaccine around 1535 on 12/17 at our vaccination clinic. Around 1545, while being monitored by a registered nurse, he leaned over and grabbed his head. The nurse asked if he was okay and he reported, "no". He stated that he felt nauseated. V/S obtained: B/P 158/80; pulse 99; resp 24; O2 sat 99% on RA; FSBS 267. Pupils were slow to react. Skin was flushed and red. Dr. was notified and assessed the employee. At 1558, the Dr. ordered Benadryl 50mg IM. This was given to employee in Left Deltoid IM at 1558 by RN. At 1559, patient complained of heache, chest tightness, being cold. At 1606, O2 sat was 99% on RA; B/P was 126/90. He reported that his headache was going away at that time and that the chest tightness was going away as well. Headache at that time was a 4/5 on pain scale. Recommended that he be checked at the ER. Between 1620-1625, first responders on site. At 1630, employee was transported to ER for evaluation. Status at time of transfer: Alert and Oriented; headache better, nausea getting better.
42 2021-01-06 tingling Scaled 0-10 Pain at the injection site (6): Can not raise left arm higher than shoulder level Fatigu... Read more
Scaled 0-10 Pain at the injection site (6): Can not raise left arm higher than shoulder level Fatigue (8) New or worsened muscle pain (8) New or worsened joint pain (8) Nausea (9): took zofran Vomiting (8) Fever (7): 101F: took tylenol 650 mg Q3 hours since 23:00 on 1/6/2021, 3:00, 6:00, 8:00, 11:00 Chills (8) Other: Burning on urination, eyes burning, left side face tingling,
42 2021-01-07 numbness complaints of a headache, right side face swelling and numbness, and right sided chest pain
42 2021-01-08 pain in extremity Fever, uncontrolled rigors, extreme/uncomfortable aching of the feet and hands that awoke from sleep
42 2021-01-10 tingling, numbness slight fever sweatiness after 15-30 minutes throat started to close up, difficult to swallow and bre... Read more
slight fever sweatiness after 15-30 minutes throat started to close up, difficult to swallow and breath tingly and numb around nose this lasted for about an hour
42 2021-01-11 flushing Approximately 30 minutes after receiving his 2nd dose of the Pfizer COVID vaccine he had sudden onse... Read more
Approximately 30 minutes after receiving his 2nd dose of the Pfizer COVID vaccine he had sudden onset of dizziness, nausea, and feeling flushed. He went to Emergency Department for treatment. He was discharged from the Emergency Department to home. On 1/12/21 he states nausea and dizziness gone. Slight headache. Feels better.
42 2021-01-12 weakness DEVELOPED DIZZINESS, EXTREME FATIGUE, CHILLS, WEAKNESS, NIGHTMARES AND ELEVATED BLOOD PRESSURES SINC... Read more
DEVELOPED DIZZINESS, EXTREME FATIGUE, CHILLS, WEAKNESS, NIGHTMARES AND ELEVATED BLOOD PRESSURES SINCE 1/12/2021 AT NIGHT. UNABLE TO GO TO WORK.
42 2021-01-13 feeling hot Pt complained of "warm rush feeling" similar to after first dose. No reports of pain or shortness of... Read more
Pt complained of "warm rush feeling" similar to after first dose. No reports of pain or shortness of breath, dizziness, rash, or itchiness. VS monitored, BP initially 196/106, resolved to 137/94 upon recheck. HR 90s- 120 sinus rhythm. PO fluids and supine position for one hour until resolution of symptoms. Discharged and advised to follow up with primary care and allergist as needed. Safety maintained.
42 2021-01-13 hot flush Systemic: hot flashes since receiving vaccine, otherwise feels fine-Mild
42 2021-01-16 pain in extremity The day after the vaccine i started to feel this sharp pain in the right side of my lower back in th... Read more
The day after the vaccine i started to feel this sharp pain in the right side of my lower back in the area of the right kidney and today being 12:49 am on 01/17/2021 the pain is located in both sides of my back in the kidney are but is going to the front of my stomach and giving me chills every now and then i have muscle pain from my back al the way to the legs no fever or problems to breath
42 2021-01-18 hot flush Last night had heart burn worse then had in years. hot flashes with no temp. muscles soreness and so... Read more
Last night had heart burn worse then had in years. hot flashes with no temp. muscles soreness and soreness in joints. symptoms are still happening currently
42 2021-01-19 tremor, feeling cold, pain in extremity The evening of receiving the vaccine developed body aches, chills, fever, fatigue, headache and sore... Read more
The evening of receiving the vaccine developed body aches, chills, fever, fatigue, headache and sore throat. tested on 12/24/20 for covid results negative. After 10 days developed full body tremors, now improving and then after 2.5 weeks had difficulty walking and leg pain/discomfort. Blood work on 1/13 revealed CPK of 934
42 2021-01-20 muscle spasms Fever, body aches, and headache as expected starting about 9 pm on 1/17. On 1/18 in late afternoon ... Read more
Fever, body aches, and headache as expected starting about 9 pm on 1/17. On 1/18 in late afternoon developed severe cramping in stomach, chest and upper back. Did not eat after cramping started. Got worse at approx 11 pm. Resolved by at approx 3 am on 1/19, after fever broke. Have continued to have headache through time of this report submission.
42 2021-01-20 pain in extremity 01/20/2021: Headache and light headedness 10 mins after receiving vaccine. Waited and completed the ... Read more
01/20/2021: Headache and light headedness 10 mins after receiving vaccine. Waited and completed the 30 mins observation period before returning to work, then took ibuprofen for the headache. About an hour later post nasal drip started, lasted about 2-3 hours or so. Around 4-5pm headache returned, left arm soreness increased (felt like the arm was swung on by a bat), persisted all night. Took ibuprofen around 11 pm before going to bed. 01/21/2021: Woken up at 5 am with a headache and joints were sore especially my troubled joints (knees and lower back). Generalized fatigue experienced as well. Took Ibuprofen at 08:20 for the headache, joint soreness and fatigue still present.
42 2021-01-21 migraine 01/13:BODY ACHES, HEADACHE,FATIGUE, 01/14: FEVER AND CHILLS, 01/15: HIGH BLOOD PRESSURE,NAUSEA 01/1... Read more
01/13:BODY ACHES, HEADACHE,FATIGUE, 01/14: FEVER AND CHILLS, 01/15: HIGH BLOOD PRESSURE,NAUSEA 01/16: HEADACHE AND MINDGRAINE
42 2021-01-21 tremor Severe chills, shaking, pain in right hip, ribs, headache, fever 101.3, body aches
42 2021-01-21 tremor for roughly 40 hours I experienced a fever as high as 102.9, shaking, chills, body aches, headache, ... Read more
for roughly 40 hours I experienced a fever as high as 102.9, shaking, chills, body aches, headache, right kidney pain
42 2021-01-25 throat numbness Entered observation @ 1832. @ 1836, stated that his throat was numb. Pt was with the nurse into cl... Read more
Entered observation @ 1832. @ 1836, stated that his throat was numb. Pt was with the nurse into clinic and had pt sit on the bed in clinic. @ 1838 Benadryl 25mg was given. Denies SOB or Trouble Breathing. @ 1843 pt states that s/s had been alleviated. Insist to this nurse that he has no trouble swallowing nor breathing. States that his throat does not feel as if it is closing up. Just states that his throat feels numb. @ 1850 remains to voice that he has no s/s of throat feeling numb. Pt left observation @ 1855. Denies this to this nurse SOB or Trouble Breathing.
42 2021-01-27 facial pain, nerve pain mild to moderate neuropathic pain starting at injection site, shooting distally towards the dorsum o... Read more
mild to moderate neuropathic pain starting at injection site, shooting distally towards the dorsum of arm and hand, has progressively worsen over the past day and starting today towards neck (L) and left side of face.
42 2021-01-28 numbness This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient recei... Read more
This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248, expiration date 30Apr2021), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. Medical history included asthma. Concomitant medication included salbutamol (ALBUTEROL) for asthma. The patient experienced left side of his face went numb, his eye became swollen on 09Jan2021 with outcome of recovered. Caller stated this lasted 8 hours and then went away. Caller stated he used an ice pack during the reaction. The outcome of the events was recovered on 09Jan2021.
42 2021-01-28 tingling, weakness Tingling hands, Feeling weak and tired Patient alert and oriented noted with tingling sensation in b... Read more
Tingling hands, Feeling weak and tired Patient alert and oriented noted with tingling sensation in both hands at around 5:35 pm, 6 minutes after being vaccinated for 1st dose of PFizer CoviD 19 vaccine. Vitals signs taken BP 156/96, HR 115, RR 20, T 98, O2 sat 98% RA. Patient offered beverage and tolerated well. Patient was monitored, Vitals re checked as Follows: BP 129/80, HR 105, RR 18, O2 sat 99% RA. At around 6:05 PM Patient verbalized that tingling was gone, monitoring continues, pt. noted anxious at all times. Patient states that he is taking Citalopram 30 mg For 2 years. Vitals rechecked at 7 PM BP 148/88, P 134, RR 20 MD evaluated pt with recommendation to send pt to ER For Further (monitor) evaluation. EMS arrived at 7:22 pm and take over the pt. Patient left Ambulating with Wife and EMS.
42 2021-01-29 tremor, pain in extremity Woke up at 1:30am with stomach pain, then chills followed by uncontrollable shaking - No fever - Lef... Read more
Woke up at 1:30am with stomach pain, then chills followed by uncontrollable shaking - No fever - Left arm pain and constant head ache for 36hrs after second vaccine - No reaction after the first round of vaccine
42 2021-01-31 unresponsive to stimuli 1/28/2021- Seen by FNP for indigestion, chest pressure and palpitations. EKG reviewed and referral ... Read more
1/28/2021- Seen by FNP for indigestion, chest pressure and palpitations. EKG reviewed and referral made to Cardiology. 1/29/2021-1800 Presented to ED in cardiac arrest-onset PTA. Patient was found unresponsive by his wife at their home. The last known well was at 1530 when she called him on the phone. The patient was pronounced at ~1850.
42 2021-02-04 feeling cold, tremor I didn't have any symptoms all day, then I woke up at 1:30AM with my left arm (injection site) hurti... Read more
I didn't have any symptoms all day, then I woke up at 1:30AM with my left arm (injection site) hurting and swollen and I was violently shaking. Hypothermia. Couldn't get warm. It's like my body forgot how to regulate temperature. I've only ever experienced similar coming out of anesthesia after surgery. Took wearing multiple layers of clothes AND multiple blankets just to stabilize my body temp. It lasted for around 2-3 hours. This wasn't normal "chills". This was whole-body shaking hypothermia. Entire body sore afterwards from the involuntary shaking. Unfortunately, I didn't get an actual reading as anything to measure body temp was downstairs and I didn't want to risk falling.
42 2021-02-05 weakness On January 18, two days after getting the first dose of the vaccine I woke up with a sense of fullne... Read more
On January 18, two days after getting the first dose of the vaccine I woke up with a sense of fullness or pressure in my left ear, mild sinus congestion, and chills. The congestion and chills ended after one day, but the feeling of fullness in the ear has persisted to this day. Then, on January 29, I had a bout of positional vertigo and vomiting that lasted two to three hours. I also experienced ringing or roaring in my left ear. Ever since, I have a bout of vertigo approximately every 24 hours, and the ringing and sense of fullness in the ear ebb and flow on 24 hours cycles as well. This experience has been debilitating and affected my ability to work. My doctor has diagnosed Meniere's disease and says he has been seeing similar symptoms apparently linked to the COVID vaccines. I started taking prednisone on doctor's orders yesterday (February 5), which has stopped the vertigo. Ringing and occasional fullness in the ears persist.
42 2021-02-06 feeling cold Flu-like symptoms. Aches, fever, chills. Began the morning after the shot. Ended the following mo... Read more
Flu-like symptoms. Aches, fever, chills. Began the morning after the shot. Ended the following morning.
42 2021-02-07 night sweats Increased soreness at injection site. Followed by nausea. For next two days: nausea, chills, night s... Read more
Increased soreness at injection site. Followed by nausea. For next two days: nausea, chills, night sweats, fever, Diarrhea
42 2021-02-07 pain in extremity My shoulder started having a light burn and after the next six days it got worse and worse - my left... Read more
My shoulder started having a light burn and after the next six days it got worse and worse - my left shoulder. I got x-rays and started doing physical therapy. I took Tylenol for pain. Started improving - I'm probably about 40% better. I received the second dose on January 20th - just had a slightly sore arm.
42 2021-02-07 tingling, numbness numbness and tingling in left arm and leg
42 2021-02-07 tingling, cold extremities Prior to vaccination, patient admitted to taking 25MG of benadryl PO. 3:30 PM: patient received his ... Read more
Prior to vaccination, patient admitted to taking 25MG of benadryl PO. 3:30 PM: patient received his 2nd dose of the Pfizer COVID-19 vaccine. 3:48 PM: Onset of throat itching and tingling sensation of the right lower extremity. 3:48 PM vitals: BP 137/76, spO2 100%, HR 108, T 98.3F 3:48 PM: Benadryl 25MG IM was given in the left deltoid. 4:03 PM vitals: BP 116/67, spO2 98%, HR 95, T 98.4F. Patient said that he felt a headache that was 2/10 on the pain scale, reported less tingling in his his leg that was mostly felt in his R big toe, and felt some tingling left in his throat but says that "it's nothing." 4:50 PM: Patient's hands felt cold compared to his arms. Patient reported feeling cold in his arms and very tired. 4:55 PM: Patient was transported to the emergency department for further evaluation.
42 2021-02-09 migraine Minor swollen lymph nodes were first observed on day 3 pm at the patient?s neck same side as the inj... Read more
Minor swollen lymph nodes were first observed on day 3 pm at the patient?s neck same side as the injection (left arm). Since then severe swollen lymph nodes have been developing on multiple areas from shoulder, along the neck, to face/back of ear, same side (left) of the shot. Sizes of some areas are more than 1 square inch. Other symptoms including, migrate, mild fever and fatigue.
42 2021-02-15 feeling hot, tremor Tremors, feeling hot. Diagnosed with autoimmune disorder graves disease.
42 2021-02-16 cold sweat, feeling cold 13:35 pm - Pt found as beginning to slump over in chair. Assisted from chair to floor. Pt lying down... Read more
13:35 pm - Pt found as beginning to slump over in chair. Assisted from chair to floor. Pt lying down, responding to stimuli, eyes opened and closed. Answered questions appropriately. Episode lasted approximately 2-3 minutes. Pt cold and clamy. V/S taken BP 144/113, pulse 59, temp 96.7. O2 98%. Pt stated had hx of lightheadedness once as a teenager when having blood drawn. 13:46 V/S BP 151/106, pulse 72. Patient stated feeling comfortable. 13:50 Pt sitting up in chair. 2 pm BP 146/105, pulse 72. Pt states feeling better and cooler. given bottled water. 14:20 pm Pt left on own stated friends to meet him at site.
42 2021-02-17 feeling hot Complaining of feeling warm at head/chest, feeling need to take deep breaths about 5-10 minutes post... Read more
Complaining of feeling warm at head/chest, feeling need to take deep breaths about 5-10 minutes post vaccination. Was given an ice pack and allowed to lie down on gurney. Afterwards, individual felt significantly better with the cold therapy and resting, reported symptoms had resolved by 1611 same day.
42 2021-02-23 feeling hot Felt immediate headache, followed by extreme exhaustion, fatigue, body aches (the same day as the 2n... Read more
Felt immediate headache, followed by extreme exhaustion, fatigue, body aches (the same day as the 2nd dose) within about 10 minutes after it; and for the next two days. Felt better by 02/14/2021. Began feeling ill again on 02/17/2021, body aches, extreme fatigue, feeling very hot but not having a fever, nausea. It seemed to get better on about 02/21/2021, but then on 02/22/2021, all of the same feelings and symptoms came back and are still present today. I have reached out to my primary doctor to let him know and he suggested that I submit this information here as well.
42 2021-02-24 difficulty speaking Patient became diaphoretic, reported tingling on tongue, hoarse voice. Hx. of allergies. Epi admin... Read more
Patient became diaphoretic, reported tingling on tongue, hoarse voice. Hx. of allergies. Epi administered on site. Patinet transferred to ED and discharged with prednisone.
42 2021-02-24 muscle twitching, tingling, numbness Since receiving the vaccine on 02/23/2021, my left arm muscle has been twitching. I have been havin... Read more
Since receiving the vaccine on 02/23/2021, my left arm muscle has been twitching. I have been having tingling down my left arm with my hand and fingers going numb.
42 2021-02-25 flushing, tremor Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Medium,... Read more
Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild
42 2021-03-02 burning sensation random heart-racing; random dizziness; occasional headaches; Temperature between 100-102 for 30hrs; ... Read more
random heart-racing; random dizziness; occasional headaches; Temperature between 100-102 for 30hrs; flu-like symptoms; extreme burning resulting in fainting; extreme burning; This 42-year-old male patient contactable consumer (reported for himself) received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (lot EN5318,; expiration not provided), via an unspecified route of administration, on 14Feb2021, 12:00 PM (at the age of 42-year-old) as a single dose for COVID-19 immunization, in Left arm. The facility where COVID-19 vaccine was administered was at a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. Historical Vaccine included first dose of BNT162B2 (Lot number: el8982) intramuscularly on 24Jan2021 at 09:00 am for COVID-19 immunization on left arm. The patient did not have any other vaccine within four weeks prior to the vaccination. No relevant medical history reported. Concomitant medication included: Levothyroxine 125 "mg", once a day. On 14Feb2021 at 12:15pm, the patient experienced extreme burning resulting in fainting. Ekg normal in ER. Day-2 flu-like symptoms, temp between 100-102 for 30hrs. Day-2 and now day-3, random dizziness, feeling of heart beat, random heart-racing, occasional headaches, no current fever. Events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The clinical outcome of the events extreme burning resulting in fainting, flu-like symptoms, temp between 100-102 for 30hrs, random dizziness, random heart-racing, occasional headaches, was unknown. It was reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
42 2021-03-02 tingling, hypersensitivity of all senses, numbness, bell's palsy Shortly after receiving shot in left shoulder, I began to feel sensitivity/tingling in left jaw. A ... Read more
Shortly after receiving shot in left shoulder, I began to feel sensitivity/tingling in left jaw. A few minutes later, the left side of my face felt heavy/full/numb/tingling. This persisted throughout the remainder of the day along with feeling woozy and having a bad headache. Headache and wooziness were gone by next day but left facial heaviness, fullness, numbness and tingling persisted and is still present today. Not as bad today but still under left eye, along left jaw and mouth, and parts of left cheek. Had teledoc visit with doctor the evening of the shot and he diagnosed as Bell's Palsy.
42 2021-03-02 tingling 15 minutes after injection, both arms and hands experienced a tingling sensation similar to when a l... Read more
15 minutes after injection, both arms and hands experienced a tingling sensation similar to when a limb "falls asleep". This continued for about 8 hours. When I went to sleep and woke up, the tingling sensation was gone. Tingling on the lower arms (below elbow) and hands.
42 2021-03-03 pain in extremity Headache, body ache, fatigue, high temp but not fever level, sore arm.
42 2021-03-07 flushing Pre syncopal , dizzy, flushing, diaphoretic. Evaluated by EMS-Cleared
42 2021-03-07 nerve pain shingles; rash; shoulder pain; little nerve pain thing; This is a spontaneous report from a contacta... Read more
shingles; rash; shoulder pain; little nerve pain thing; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: from vaccine card: EL then either 0 or O 142), via an unspecified route of administration by injection once to left arm on 13Jan2021 at single dose for prevention (covid-19 immunisation). Medical history was none. There were no concomitant medications. Patient was diagnosed with shingles about 3 weeks after receiving his first injection of the Pfizer covid-19 vaccine. This male consumer received his first injection of the Pfizer-BioNTech COVID-19 vaccine on 13Jan2021. He reported being diagnosed with shingles last Thursday (04Feb2021) and stated his symptoms started that same week (Feb2021), which were described as rash and shoulder pain. He reported his shingles are improved and are scabbing over. The consumer was prescribed and was taking valacyclovir for treatment of the shingles. Shingles was now (base on 09Feb2021) healing. Shingles occurred after the first dose, he was not blaming the vaccine, he did fine, he had no reaction, his first dose was on 13Jan2021, and shingles came up last week (on 04Feb2021). The consumer's second dose of the covid-19 vaccine was supposed to be last week (base on 09Feb2021) but this physician recommended he delay due to the shingles. Currently on an antiviral, getting better, feels great, wondering if he can proceed with second dosage. The consumer was wanting to get his second dose this week (base on 09Feb2021). No investigation Assessment. Outcome: he scabbed up, he never had fever, just a rash and the little nerve pain thing (Feb2021), that's it. Stated he had no reaction to the vaccine whatsoever. The outcome of shingles was recovering, of other events was unknown. Information on the lot/ batch number has been requested.
42 2021-03-08 pain in extremity On February 11, 2021 aprox 1pm, I received first dose of Pfizer COVID-19 Vaccine. Developed left arm... Read more
On February 11, 2021 aprox 1pm, I received first dose of Pfizer COVID-19 Vaccine. Developed left arm pain specially at movement that started around 6-7pm but did not limited movement. Symptom was completely resolved in less than 24 hours. On March 4, 2021 aprox 1pm, I recieved second dose of Pfizer COVID-19 Vaccine. Developed left arm pain specially at movement that started around 6-7pm but did not limited movement. Pain was less intense than with first dose. Symptom was completely resolved in less than 24 hours.
42 2021-03-08 tenderness swelling; red spots; tenderness on my right big toe and the toe next to it; This is a spontaneous re... Read more
swelling; red spots; tenderness on my right big toe and the toe next to it; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot #: EL3247) via an unspecified route of administration on 19Jan2021 (at the age of 42-years-old) as a single dose for COVID-19 immunization. Medical history was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any known allergies. The patient did not receive any other medications within two weeks prior to the vaccination and did not receive any other vaccines within four weeks prior to the vaccination. On 30Jan2021 the patient experienced swelling, red spots and tenderness on my right big toe and the toe next to it. The clinical course was reported as follows: "two weeks after my COVID-19 vaccination I noticed swelling, red spots, and tenderness on my right big toe and the toe next to it. I visited my podiatrist who recommended NSAIDs for a week. Today, my sister in law who is a nurse said it looked like COVID toes. When I googled an image of COVID toes, the spots looked identical to my own." The adverse events required a physician office visit. The patient received treatment for the events which included NSAIDs. The clinical outcomes of the events swelling, red spots and tenderness on my right big toe and the toe next to it were all not recovered/not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
42 2021-03-10 bell's palsy PATIENT RECEIVED SHOT ON 2/25/2021 AND ON 3/7/2020 PT STARTED SHOWING SIGNS OF BELL'S PALSEY
42 2021-03-11 feeling hot, flushing Flushed, hot, dizzy started at 12:10 after shot.
42 2021-03-11 sensory loss, feeling cold Stomach tightness upon waking at 6am. At 12pm felt cold and like was about to get sick. By 1pm in be... Read more
Stomach tightness upon waking at 6am. At 12pm felt cold and like was about to get sick. By 1pm in bed with multiple layers of clothes, under multiple blankets with heat cranking. Uncontrollable chills, shivering and teeth chattering. Hands white and lost sensation in fingers. 105 fever. Chills lasted a couple of hours, fever lasted 3 full days. Day 1: 105; Day 2: 102; Day 3: 100; Day 4: No fever. Stomach tightness remains.
42 2021-03-11 tremor, weakness After about 12 hours, I was woken up from sleeping with extreme body aches/headache and starting get... Read more
After about 12 hours, I was woken up from sleeping with extreme body aches/headache and starting getting the chills and shaking. I lost all energy and struggled to get out of bed and walk. Laid in bed all day, took Tylenol, slept off and on. Didn't subside until 6:00pm the next evening when I broke out in a sweat and got some energy back.
42 2021-03-12 pain in extremity Fever, body aches, headache, dizzy, no appetite, arm pain
42 2021-03-12 tremor Excessive swelling at injection site (golf ball sized knot) with tenderness to the touch 103.8 temp ... Read more
Excessive swelling at injection site (golf ball sized knot) with tenderness to the touch 103.8 temp started 12hrs after injection and lasted for 48hrs Blurred vision during onset of Temp. Muscle pain/ fatigue during onset of Temp. Full body aches during onset of Temp. Chills with moderate spells of hands shaking during onset of Temp Loss of appetite during onset of Temp.
42 2021-03-13 tingling paresthesia
42 2021-03-15 speech disorder, numbness Patient was given vaccine at approximately 10:20am and completed 15 minute monitoring in office. Pat... Read more
Patient was given vaccine at approximately 10:20am and completed 15 minute monitoring in office. Patient returned to clinic at approximately 10:45 with complaints of left arm numbness, tongue tingling, tongue swelling, and speech difficulty. 0.3mg Epipen and 50mg benadryl was administered and patient immediately reported resolution of tongue swelling and speech difficulty. Patient was transported via EMS per clinic protocol.
42 2021-03-21 weakness Intense flu symptoms for three days, to include fever chills, aches, swelling of face and neck. Subs... Read more
Intense flu symptoms for three days, to include fever chills, aches, swelling of face and neck. Subsequent to flu, low oxygen rates of 82-91, low resting heart rate of 48-54, extreme exhaustion, swelling of face and neck. General weakness.
42 2021-03-22 seizure like phenomena Patient was normal upon administration. Was given instruction to wait 15 minutes in the pharmacy to ... Read more
Patient was normal upon administration. Was given instruction to wait 15 minutes in the pharmacy to monitor for adverse reaction, per protocol. Pharmacy staff was alerted by customer that patient was "not looking good". As we walked to patient, we slipped out of his chair and appeared to loose consciousness and/or have seizure-like symptoms. Patient looked very pale, perhaps had some minor foam at the mouth and was extremely hot. We stayed by patient, protected his head, allowed him to come to, took coat off and applied ice packs, took BP/pulse (normal) and patient was oriented x3. EMS arrived and took over.
42 2021-03-23 unresponsive to stimuli Description of event: Patient received vaccine in his LUE and was instructed to wait in line to sche... Read more
Description of event: Patient received vaccine in his LUE and was instructed to wait in line to schedule next dose. While standing in line, patient was witnessed falling to the floor. He appeared to land on his hands, denies injury at this time. Patient responded verbally when asked if he was okay. Vitals recorded while patient sitting on floor 1500. Patient stated he was ok to sit in chair. Upon sitting in chair for approximately 30 seconds his head fell forward and he was unresponsive. Patient began agonal breathing, eyes were open with fixed pupils, pulse was weak. Staff assisted patient to floor where he regained consciousness after approximately one minute. Patient appeared diaphoretic and pale, but was responding appropriately. An ambulance was called during this time. The patient was able to give contact information for his wife. The patient personally spoke to her on the phone. Meanwhile patient was resting supine on the floor. Vitals at 1552 146/94 P 70, R 20, 98% RA. Approximately 15 min later patient returned to the chair and has been resting since. BP at 1615 119/65. He refused treatment from EMS and is currently calling his wife to pick him up as staff has advised him not to drive. Patient currently eating a snack and drinking water, states he is feeling better.
42 2021-03-24 numbness Approximately 15 minutes after injection, I first felt tightness in my left neck area, followed by a... Read more
Approximately 15 minutes after injection, I first felt tightness in my left neck area, followed by a numbness sensation on the left side of my face and abdomen. Sensation has subsided in the abdomen area but remains on the left side of the face. Lower left eyelid twitches on its own throughout the day.
42 2021-03-24 pain in extremity 3/4 Moderate stomach cramps day after vaccine. Much less arm pain then following first dose but stil... Read more
3/4 Moderate stomach cramps day after vaccine. Much less arm pain then following first dose but still present. 3/9 Work up with terrible thoracic back pain with every breath. Went to ER and received shot of Toradol and chest x-ray (negative). Shortly thereafter, had chills and low grade fever. Alternated naproxen and tylenol for the next two days as fever persisted. 3/11 Moderate chest pressure when breathing. Went back to ER. Received COVID test (negative). No fever or chills. 3/12 Light headedness, racing heartbeat and chills early afternoon. Went back to ER. Received Flu test (negative). Blood work showed positive d-dimer test. CT scan showed small pneumonia in lower left lung. Started Amoxicillin and Z-pack. Symptoms improved over course of following 7 days.
42 2021-03-24 tingling Complained of feeling weird/ tingly. No sense of pain to pinch. Dulled responses. Acting without ... Read more
Complained of feeling weird/ tingly. No sense of pain to pinch. Dulled responses. Acting without inhibition- wanted to pour water all over self, sleep face down in the grass, fly a plane. Acting inebriated or drugged.
42 2021-03-25 weakness Diaphoretic, felt weak. Vitals wnl. Did not eat as usual in the morning. Offered water, juice, and c... Read more
Diaphoretic, felt weak. Vitals wnl. Did not eat as usual in the morning. Offered water, juice, and crackers.
42 2021-03-26 tremor Started was a very cramped stomach and then the rest followed. Whole body turned red including eyes.... Read more
Started was a very cramped stomach and then the rest followed. Whole body turned red including eyes. Upset stomach with vomiting and diarrhea. Body was shaking and didn?t have a fever. Skin felt like it was burning whole body felt swollen. Started around 2:30am with the cramping. It woke me up. Once I got up everything came so fast. Was rushed to hospital where I was admitted very quickly. I was blacking out on the drive there and blacked out while in their care. This was from one dose of Pfizer vaccine for Covid. I was put on a GI, Allergy, and steroid medications. I was hooked up to an IV and 3 drugs were injected. I passed out numerous times but was discharged at 5am.
42 2021-03-27 burning sensation Itchy/burning rash formed on both wrists and back of hands. Symptoms started easing on their own ab... Read more
Itchy/burning rash formed on both wrists and back of hands. Symptoms started easing on their own about an hour after they started. Diphenhydramine 25mg was taken a couple hours after the event started and seemed to help reduce the symptoms further and cleared them up. No re-emerging of symptoms have occurred since.
42 2021-03-27 unresponsive to stimuli, seizure, depressed level of consciousness Patient received the vaccination and after he got up from the chair, he passed out and fell to the f... Read more
Patient received the vaccination and after he got up from the chair, he passed out and fell to the floor. The intern notified the pharmacist. When I went to see that patient, he was laying on the floor with his eyes rolled in the back of his head and was unresponsive. He was not alert. He started having a mild seizure and I rolled him over on his left side. While I was bracing the patient, pharmacist came in and administered an Epi-pen to his left thigh. Patient stopped seizing so I rolled him back on his back. He became alert and was able to provide me his name, DOB and what he was at the pharmacy for. I rested my hand under his head and monitored his pulse until the paramedics arrived
42 2021-03-28 migraine Chills, body aches, migraine headache, nausea. Nausea has continued to be a big issue from the night... Read more
Chills, body aches, migraine headache, nausea. Nausea has continued to be a big issue from the night of injection until today, which is Monday, 3/29/2021. On Saturday night (3/27) I experienced overwhelming stomach pain and nearly passed out on my toilet multiple times during a bout of diarrhea.
42 2021-03-30 bell's palsy 2 weeks after the 1st vaccine shot I was diagnosed with bell's palsy. The right side of my face shut... Read more
2 weeks after the 1st vaccine shot I was diagnosed with bell's palsy. The right side of my face shut down. I lost the sense of taste on that side. I was prescribed Valacyclovir HCL 1 gram tablets and Prednisone 20 MG tablets on 3/15/21.
42 2021-03-30 slurring Equatable to the description of Alzheimer's or dementia patients; disorientation; confusion; Knowing... Read more
Equatable to the description of Alzheimer's or dementia patients; disorientation; confusion; Knowing your doing something wrong and unable to correct it; Motor skills slowed; Fuzzy tongue; generally out of sorts feeling; This is a spontaneous report from a contactable consumer (patient). This consumer reported that a 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) at the age of 42-years, via an unspecified route of administration in left arm at 12:15 AM on 16Mar2021 at single dose for COVID-19 immunisation, in Public Health Clinic. Medical history was reported as none. No other vaccine in four weeks. No COVID-19 prior vaccination. No known allergies. Concomitant medications were not reported. At 08:30 AM on 17Feb2021, the patient had periods of disorientation, confusion. Equatable to the description of Alzheimer's or dementia patients. Knowing you doing something wrong and unable to correct it. Motor skills slowed. Fuzzy tongue, and generally out of sorts feeling. Punctuated by periods of lucidity. No treatment received. Outcome of the events was recovering. No Covid-19 tested post vaccination.
42 2021-03-30 feeling of body temperature change, night sweats Flu like symptoms next day. Vomiting and diarrhea. Body aches. Hot and cold sweats and chills. N... Read more
Flu like symptoms next day. Vomiting and diarrhea. Body aches. Hot and cold sweats and chills. Night cold sweats during brief sleeping periods. Third day was the same. Loss of appetite and dehydrated. Severe itching on my back. Today is the fourth day and I broke out with a rash on my back. Cortisone has relieved it thus far. My appetite is back. I did not vomit but still experiencing diarrhea.
42 2021-03-30 hot flush Fatigue/More fatigue; slight dizziness; slight nausea; slight fever; hot and cold flashes; This is a... Read more
Fatigue/More fatigue; slight dizziness; slight nausea; slight fever; hot and cold flashes; This is a spontaneous report from a contactable consumer(patient). A 42-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EN5318), first dose via an unspecified route of administration, administered in Arm Left on 02Feb2021 09:30 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 02Feb2021, the patient experienced Fatigue, slight dizziness, slight nausea, slight fever, hot and cold flashes. More fatigue then anything. The patient's lab tests included body temperature: slight fever on 02Feb2021. The outcome of the event was recovering for Fatigue, unknown for Dizziness, Nausea, Pyrexia, Hot flush.
42 2021-03-30 tingling, numbness Shortly after injection, the pt developed dizziness and tingling/numbness in extremities. He was not... Read more
Shortly after injection, the pt developed dizziness and tingling/numbness in extremities. He was noted to be diaphoretic. HR 70, SP02:99%, BP 110/70. Symptoms resolved after appx. 15 minnutes. The pt was feeling completely back to normal before he departed. Family drove him home.
42 2021-03-30 paralysis Loss of hearing to last less than 5 min. followed by ringing ears through the following day. Uncon... Read more
Loss of hearing to last less than 5 min. followed by ringing ears through the following day. Uncontrolled palsy for head and neck intermittently through the injection day. I lost my voice and had spasms in my larynx. For several hours I had a hard time choosing my words and speaking which was the scariest. I could not focus enough to even wash my hands on injection day and had to be driven home from work. I got dehydrated because water tasted horrible. The next morning I am better on all fronts except the ringing in my ears wont stop
42 2021-03-31 burning sensation I got my 2nd shot on March 26th. On Monday March 29th 6:00pm, my elbows started to itch and develop... Read more
I got my 2nd shot on March 26th. On Monday March 29th 6:00pm, my elbows started to itch and develop hives/rashes. Then my knees and then foot and hands by the night. It was burning and itching and it swelled up a little. Oddly the itchiness and redness goes away and then comes. Taking Allegra does help but its not making the symptoms go away.
42 2021-03-31 feeling of body temperature change Headache began 12 hours after shot. Fever Hot/cold sweats Severe nausea Body aches Extreme fatigue
42 2021-03-31 numbness Right hand numbness. Refused TRANSPORT BP 183/102 88 16. Has an appt with Cardiologist
42 2021-03-31 tingling Pfizer-BioNTech COVID-19 Vaccine EUA Tiredness, soreness at injection site, body aches, tingling, fe... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Tiredness, soreness at injection site, body aches, tingling, fever up to 101 degrees
42 2021-04-01 migraine 1 ? I had really bad headaches the night the vaccination was administered. 2 ? The next morning I ha... Read more
1 ? I had really bad headaches the night the vaccination was administered. 2 ? The next morning I had a REALLY bad ocular migraine when I woke up. The duration was 24-36 hours.
42 2021-04-04 numbness, numbness and pain in extremities Although I had symptoms of Erythromelalgia prior to the vaccine, flares have increased over last few... Read more
Although I had symptoms of Erythromelalgia prior to the vaccine, flares have increased over last few weeks. Symptoms include daily: 1) Erythromelalgia flares (numbness, redness, searing heat from hands and feet, particularly in PM) 2) peripheral neuropathy (wrist, hands, knuckles, feet). 3)Joint pain, numbness, and swelling (knees, wrists, knuckles)
42 2021-04-05 bell's palsy Bell?s Palsy
42 2021-04-05 tremor, feeling hot Patient was given first dose of Pfizer COVID-19 vaccine. I counseled the patient on side effects an... Read more
Patient was given first dose of Pfizer COVID-19 vaccine. I counseled the patient on side effects and asked him to wait 15 minutes afterwards in our waiting area. After about 5 minutes, the patient starting complaining of feeling dizzy. We asked him to sit back in the chair and brought him a bottle of water. I asked the patient if he had eaten today and he replied no. I offered a snack and also a glucose tablet to help with shakiness. As I went to get a bottle of glucose tablets off the shelf, the patient fainted and fell out of his chair. I immediately ran to get an Epipen while my technicians called for a Code White and 911. I was about to inject the patient with the Epipen when he came to about 10 seconds later. He said he was really hot, sweaty, dizzy, and nauseous. Paramedics and AP arrived to evaluate him and take a statement. Patient left on his own will and received a ride home from his mother-in-law, who is an associate at our store.
42 2021-04-06 burning sensation Patient was in clinic parking lot post observation after first dose of covid vaccine when he decided... Read more
Patient was in clinic parking lot post observation after first dose of covid vaccine when he decided to return to the clinic for what felt to him as "burning sensation" to back of neck and head. Patient was observed to have raised reddened spots behind neck and on scalp(patient is bald). Patient was also observed to have reddened spots on his back--but patient was unsure if those were there prior to vaccine.
42 2021-04-06 discomfort 1 minute after vaccine injection I experienced a tightening of my throat. It was very uncomfortable... Read more
1 minute after vaccine injection I experienced a tightening of my throat. It was very uncomfortable and made it difficult to swallow and felt like a "lump in my throat". I asked an onsite nurse if this was a common reaction, and she offered medical attention. I denied it because it was not getting worse. She gave me a bottle of water and it seemed to help it a bit while drinking. But, quickly returned after water was swallowed. I was monitored for 30 minutes as recommended. The tightness remained for 1 hour post vaccine injection and disappeared as quickly as it started. I fear the second dose may be worse.
42 2021-04-07 tingling Twenty minutes after injection patient reported tingling to left arm and back. Faint pale pink macu... Read more
Twenty minutes after injection patient reported tingling to left arm and back. Faint pale pink macular rash to left forearm. VSS. No reported distress. Within 20 min patient reported decreased tingling. Faint rash remained. D/C'd home.
42 2021-04-08 night sweats I have had Night sweats every night since the second vaccine. no other symptoms during the day. ju... Read more
I have had Night sweats every night since the second vaccine. no other symptoms during the day. just at night. Had no issues prior to vaccine. Today would be 2 weeks post. Woke up 3 times drenched last nights and had to sleep in different locations in the home becuase the bed was wet with sweat.
42 2021-04-08 pain in extremity I had a strange feeling in the left side of my face that I wasn't sure if it was a reaction or not. ... Read more
I had a strange feeling in the left side of my face that I wasn't sure if it was a reaction or not. It happened within the first 15 minutes but did not last more than 30 minutes. I did not experience anything else until the first evening when my arm was very sore. The next day my arm was more sore and I had a mild circular red mark around the injection site and the arm was much harder on that side. I also felt a little in my back and neck. By the second day in the evening the only thing I felt was pain in the arm which eventually traveled into my armpit by day 3. It wasn't until day 5 that all the pain was completely gone. I may have experienced fatigue the first two days also.
42 2021-04-09 feeling cold Experienced normal soreness the evening of 4/9/2021. At 2:30 pm on 4/10/21, started having generaliz... Read more
Experienced normal soreness the evening of 4/9/2021. At 2:30 pm on 4/10/21, started having generalized soreness. Temp at that point was 98.6. Within ten minutes, started having congestion in chest (rattles). This caused strong bouts of coughing with pain radiation through my lungs. I then started vomiting (x3). I started feeling fatigued so I went to lie down, when I had a cold chill. At 3:00 pm, my temp was 102 F. At 3:15, it was 102.5 F, and then crested at 103 F at 3:30. In the past five hours, the only symptom to subside was vomiting; all the others are still present with my current temp 102.1 F at 8:41 pm.
42 2021-04-09 pain in extremity High fever, chills, body aches, extremely sore arm, heart racing.
42 2021-04-09 pain in extremity small pneumonia in lower left lung; Light headedness; racing heartbeat; Moderate chest pressure when... Read more
small pneumonia in lower left lung; Light headedness; racing heartbeat; Moderate chest pressure when breathing; work up with terrible thoracic back pain with every breath; chills; low grade fever; Moderate stomach cramps; Much less arm pain then following first dose but still present; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received second dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6203) via an unspecified route of administration in left arm on 03Mar2021 (at the age of 42-year-old) at single dose for COVID-19 immunisation. There was no medical history. The patient had no known allergies. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9267) on 10Feb2021 at 11:30 am in left arm for Covid-19 immunisation. There were no other vaccines in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had 3/4 moderate stomach cramps day after vaccine on 04Mar2021. Much less arm pain then following first dose but still present on 04Mar2021. The patient 3/9 worked up with terrible thoracic back pain on 09Mar2021 with every breath and went to emergency room and received shot of Toradol and performed chest x-ray which was negative. Shortly thereafter, the patient had chills and low grade fever on 09Mar2021. Alternated naproxen and tylenol for the next two days as fever persisted. The patient had 3/11 moderate chest pressure when breathing and went back to emergency room on 11Mar2021. There was no fever or chills but had 3/12 light headedness, racing heartbeat and chills early afternoon on 12Mar2021. The patient went back to emergency room. The patient's symptoms improved over course of following 7 days. The patient underwent lab test and procedure which included flu test and resulted negative; blood work which showed positive D-dimer test on an unknown date and CT scan showed small pneumonia in lower left lung on 12Mar2021. The patient started to receive amoxicillin and Z-pack. Since the vaccination, the patient had been tested for COVID-19 by nasal swab on 11Mar2021 and tested negative. Events resulted in emergency room/department or urgent care. The outcome of event pneumonia was unknown; for other events was recovering. No follow-up attempts are possible. No further information is expected.
42 2021-04-09 pain in extremity Dizziness, bad headaches, severe soreness in arm, blurred vision, drowsiness.
42 2021-04-10 tremor severe trembling and chills (rigors) for minutes in 3 waves.
42 2021-04-11 pain in extremity Joints became sore and right foot very tight the night following shot (4/3/2021). Pain continued to... Read more
Joints became sore and right foot very tight the night following shot (4/3/2021). Pain continued to build following day (4/3/2021 aka Easter). By 9:30 PM on the night of 4/3 the large right toe had swollen and was unable to move. By the morning of 4/4/2021 no pressure could be placed on the right foot without extreme pain. Pain reached highest pain by 4/7/2021 and has slowly tapered but remains. Swelling has reduced to point where a lose shoe can be placed over foot and some walking can occur with effort. Joint pain continues in shoulders, knees and hips. I become winded after walking only a few hundred feet. (typically jog 2 miles/day and walk an additional 5 miles)
42 2021-04-11 pain in extremity felt tiredness on 3/28; sore arm showed up on 3/29 and disappeared in about 2 days. However, the vac... Read more
felt tiredness on 3/28; sore arm showed up on 3/29 and disappeared in about 2 days. However, the vaccine arm pain comes back on 4/11, 2 weeks after the vaccine. it is occasional sharp pain around the injection area. still have ongoing pain.
42 2021-04-12 cold sweat PATIENT REPORTED FEELING SWEATY, CALMMY, AND FELT LIKE HE WAS GOING TO PASS OUT. HE WAS LAID DOWN AN... Read more
PATIENT REPORTED FEELING SWEATY, CALMMY, AND FELT LIKE HE WAS GOING TO PASS OUT. HE WAS LAID DOWN AND FEET ELEVATED. NO C/O PAIN OR DISCOMFORT. VITAL SIGNS AS FOLLOWS: 14:15 HR- 68 RESP 18 BP 138/85 O2 @ 96% RA 14:20 HR- 69 RESP 18 BP 138/82 O2 @ 97% RA 14:25 HR- 75 RESP- 18 BP- 132/82 O2 @ 98% RA. 14:30 HR- 71 RESP- 18 BP- 139/81 O2 @ 97% RA. PATIENT WITH NO C/O PAIN OR DISCOMFORT. RELEASED BYSELF TO HOME.
42 2021-04-12 numbness, bell's palsy Started having neck pain on a Thursday, my taste buds became less sensitive but I could still taste ... Read more
Started having neck pain on a Thursday, my taste buds became less sensitive but I could still taste on Friday and late Saturday night my left side of face started feeling numb. Went to hospital on Sunday morning when I woke up since left side of face was completely numb. Diagnosed with Bell's Palsy.
42 2021-04-12 tremor Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadedness-Medium, Systemic: Shakiness... Read more
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadedness-Medium, Systemic: Shakiness-Mild.
42 2021-04-13 numbness Patient received 2nd dose of covid vaccine and stated that fingers felt numb and tongue was slightly... Read more
Patient received 2nd dose of covid vaccine and stated that fingers felt numb and tongue was slightly numb. After 20 minutes EMTs were called and patient was checked out clear and refused services
42 2021-04-14 burning sensation Experienced pain in lower back, lower spine area one day after shot #1. That went away after about ... Read more
Experienced pain in lower back, lower spine area one day after shot #1. That went away after about a week. After second dose (3 weeks after 1st one), I had no side effects until a few days after when I got the same lower back / spine aching and pain. About a week and a half after second dose, the lower back pain moved to my left hip area and red spots appeared shortly after (a day or two after the hip pain). The spots on my left hip and butt area started to burn and feel irritated... I had mild aching in my pelvis area and lower back (spine) a few days after the shot and still today. I went to the doctor 2 days ago and am currently being treated for shingles. I am a runner, and ever since I got the 1st covid vaccine shot, my running performance has been worse... my pace per mile is about 20% worse (consistently) since the 1st shot. I feel like it did something to my immune system and am still getting over it.
42 2021-04-14 numbness Patient received 2nd dose of covid vaccine and stated that fingers felt numb and tongue was slightly... Read more
Patient received 2nd dose of covid vaccine and stated that fingers felt numb and tongue was slightly numb. After 20 minutes EMTs were called and patient was checked out clear and refused services
42 2021-04-14 numbness Starting the night of the injection, my left arm gets numb from my elbow to my fingertips. Only my r... Read more
Starting the night of the injection, my left arm gets numb from my elbow to my fingertips. Only my ring and pinky finger are affected. The color and temp of the fingers are normal, but it feels like the circulation is cut off. If I get up and work it for about a half-hour it is completely normal (and stays so throughout the day). This wakes me up 3-4 times a night and continues to this day >3 weeks later. I started Zeposia medication a few days before this shot. I didn't have this effect with my 2nd shot in my other arm. I did use an ax to chop wood for 4 hours 2 days before the shot, and my arm was sore from that before the injection. It's possible this is unrelated to the shot altogether, and I did something to trigger some sort of carpal tunnel with the ax. I plan on discussing with my Dr at some point.
42 2021-04-15 feeling cold, feeling hot Extreme soreness and discomfort at base of skull, sinus cavity?s below eyes felt inflamed and dried,... Read more
Extreme soreness and discomfort at base of skull, sinus cavity?s below eyes felt inflamed and dried, unable to sleep or get comfortable, alternated between feeling chills and feeling overheated, vomiting
42 2021-04-15 feeling hot - Sore arm around the injection area for approximately 4 days after shot. - Very mild body warming a... Read more
- Sore arm around the injection area for approximately 4 days after shot. - Very mild body warming and aches app. 12 hours after shot that lasted for 2-3 hours.
42 2021-04-15 flushing, unresponsive to stimuli, cold extremities Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Swe... Read more
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: AFTER 5 MINUTES OF BEING VACCINATED, PATIENT WAS SEATED WAINTING FOR THE 15 MINUTES AND FAINT LOSSING CONSCIOUSNESS FOR 5 MINUTES, THEN AFTER RECOVERED HE WAS PALE, SWEATING, COLDNESS OF THE HANDS AND DIZZY. WHEN 911 ARRIVED, HE SAID THAT HAD NOT EATEN ANYTHING SINCE 5:00 AM, 10 HOURS BEFORE THE EVENT HAD PLACE, SO MAYBE HE EXPERIENCED A HYPOGLYCEMIC EVENT.
42 2021-04-18 discomfort I developed Shingles approximately 1 week after vaccine was administered. My PCP placed me on 7-day... Read more
I developed Shingles approximately 1 week after vaccine was administered. My PCP placed me on 7-day antiviral course. Still having itching and discomfort even after rashes cleared up.
42 2021-04-18 slurring Pt was found in severe distress in the bathroom by his wife. He couldn't walk or stand, complained ... Read more
Pt was found in severe distress in the bathroom by his wife. He couldn't walk or stand, complained of being dizzy with slurred speech and was throwing up a lot. 911 was immediately called. The EMTs during their assessment said his BP was normal but when he was asked his name, he started saying the alphabet"ABC... XYZ". He was transported by ambulance to ER. Cat scan showed he had a bleed on the brain. The doctors told us it was because he had very high blood pressure, however where the bleed was, they said he wouldn't need surgery and that the body would reabsorb it over time. He was admitted to the ICU and has been there ever since. Several days later, he started having difficulty breathing and they discovered several blood clots in his right leg that had broken off into his heart and lungs. He had emergency surgery to remove the clots in his heart (approximately 10) and was given heparin in small doses over an 8 hour period so that it wouldn't cause the bleed in his brain to increase. The doctor should fill in the rest.
42 2021-04-19 seizure like phenomena While in waiting area client experienced loss of consciousness and seizure-like activity lasting app... Read more
While in waiting area client experienced loss of consciousness and seizure-like activity lasting approximately 48 seconds per nurse that responded to incident. Loss of bladder control noted. Squad responded and transported patient to the hospital via ambulance. Patient was coherent prior to transport. He states he was admitted to the hospital and Observation x 24 hours. He had a CT scan and bloodwork, both normal. Neurologist at the hospital told him he experienced syncope and no seizure activity was suspected. He states a history of feeling faint when he sees blood. He sates the Neurologist advised he get the second dose and lay down after the shot.
42 2021-04-20 discomfort Tightness/squeezing's sensation in both arms occurring around a minute after injection VS 125/76 mm ... Read more
Tightness/squeezing's sensation in both arms occurring around a minute after injection VS 125/76 mm hg, 90 bpm, 96% RA No CP, SOB, pruritis, hives abdominal pain or diaphoresis. Heart lungs clear to auscultation, no oropharyngeal/lip/face/tongue swelling, no hives, no stridor. No significant PMH, no allergies Resolved by 13:13 without intervention, no meds given Pt advised to seek immediate evaluation if symptoms returns or if developing CP or SOB
42 2021-04-20 facial paralysis, bell's palsy I developed loss of taste and mild paralysis of the left side of my face about 8 hours after receivi... Read more
I developed loss of taste and mild paralysis of the left side of my face about 8 hours after receiving the vaccine. I went to urgent care. Was diagnosed with Bell's Palsy. I had Bell's Palsy about 20 years ago and went away after a couple weeks. Haven't had any symptoms since.
42 2021-04-20 tingling, numbness I woke up on Monday morning with both feet feeling like they were asleep. Tingling in the toes. Th... Read more
I woke up on Monday morning with both feet feeling like they were asleep. Tingling in the toes. This has continued for the last three days and it has gone up my legs to my waist over the last 2 days. Both legs feel numb most of the day. I can still function but it is very noticeable.
42 2021-04-21 tenderness Right side of bottom lip is swollen and painful to the touch.
42 2021-04-22 seizure, unresponsive to stimuli 42 y/o male, past medical history of Anxiety, who presents with possible seizure post vaccination. P... Read more
42 y/o male, past medical history of Anxiety, who presents with possible seizure post vaccination. Patient notified one of the observation nurses that he was not feeling well. The NP was assisting another patient but saw that the patient with his head back and pale. As soon as the NP was at the patient side, it was noted that the patient?s eyes were rolling back, his face was pale, and his lips were blue. The NP attempted a sternal rub with no response from patient. NP instructed police to please call Fire Rescue to transport patient to the ER. Patients left upper extremity was flexed at the elbow and stiff. At that time the patient was placed on the floor by several nurses and the paramedic and patient legs were elevated. Within 10-15 mins patient immediately sat up but was instructed to lay down. Patient was placed on 3L of O2 by nasal cannula and vitals were taken. Patient initial vitals 166/94 L Arm, 98% 3L O2, 84 Pulse and EKG was NSR. Patient no longer with pallor and lips were pink. Patient states that he isn?t feeling well and feels a nervousness throughout his body. Patient placed on stretcher in Trendelenburg. Vitals retaken, 137/97 BP, 98% 3L O2, 80 P. Patient pulses were thready and patient became diaphoretic. Fire Rescue arrive to site and transported patient to the ER. CNO and PM present during event and aware that patient transported to the ER for further evaluation
42 2021-04-23 pain in extremity About six hours after receiving my shot, my arm became extremely sore, as to be expected. Circa 9pm... Read more
About six hours after receiving my shot, my arm became extremely sore, as to be expected. Circa 9pm I began to have significant trouble breathing, experienced acute pain in my abdomen, and began to hear ringing in my ears combined with feeling like I was going to pass out. I didn?t feel dizzy, rather I started getting tunnel vision that blocked out more of my field of view as the ringing increased. Circa 11pm, I lost consciousness while trying to move and collapsed on the floor. My wife called 911 while I was unresponsive, and I regained consciousness while being attended to by EMTs who checked my vitals. Around 12am I didn?t feel like I was going to lose consciousness again, and the EMTs recommended I be taken to the hospital. Since I was feeling better I politely declined. Today I am still feeling foggy and have joint pain (in addition to some bruising from falling after losing consciousness , but I no longer have the acute abdominal pain.
42 2021-04-24 bell's palsy Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 42-years-old mal... Read more
Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 42-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: ER8732), via an unspecified route of administration, administered in Arm Right on 26Mar2021 14:30 (at 42-years-old) as single dose for COVID-19 immunization. Medical history included Ankylosing Spondylitis and Iritis. Patient had no known allergies. Patient had no covid prior vaccination. Patient was not tested with covid post vaccination. Vaccination facility type was School/Student Health Clinic. Concomitant medications included certolizumab pegol (CIMZIA); brimonidine tartrate. The patient experienced bell's palsy on 06Apr2021 08:00 with outcome of not recovered. Event resulted in Emergency room/department or urgent care. Treatment given was Methylpred Na Succinate, Prednisone, and Acycolvir.
42 2021-04-24 bell's palsy Right sided Bell's Palsy Grade IV; This is a spontaneous report from a contactable physician. A 42-Y... Read more
Right sided Bell's Palsy Grade IV; This is a spontaneous report from a contactable physician. A 42-Year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: Unknown) intramuscular, administered in left arm on 15Mar2021 (at the age of 41-years-old) as SINGLE DOSE, dose and second dose was intramuscular, administered in left arm on 05Apr2021 as SINGLE DOSE for covid-19 immunization. Medical history included covid-19 and ongoing allergies. Concomitant medication was Benadryl PRN for allergies. On 09Apr2021,the patient experienced right sided bell's palsy grade iv. The patient underwent lab tests and procedures which included sars-cov-2 test was pending on 09Apr2021 Covid test type post vaccination done by nasal swab. Therapeutic measures were taken as a result of right sided bell's palsy grade iv included Prednisone Taper and pain medication. The outcome of event was not recovered. Information about the Lot/batch number has been requested. ; Sender's Comments: Considering a plausible temporal relationship, a possible contributory role of suspect vaccine BNT162B2 to the reported event facial paralysis cannot be completely 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.
42 2021-04-24 cold sweat Patient warned us before his covid vaccine that he has a severe needle phobia and has fainted after ... Read more
Patient warned us before his covid vaccine that he has a severe needle phobia and has fainted after vaccines. I gave him his immunization quickly and he did well. He stood up and watched as I immunized his wife. He said he was feeling okay afterwards so both him and his wife left the immunization room. Shortly after leaving he must have started getting dizzy, because next thing I hear is that there is an unconscious man in the waiting room. He is sitting in a chair with his head back unresponsive. His wife if rubbing his arms and lightly slapping his face. He comes to, and we decide to move him to the room that the clinic uses (we have a walk in clinic staffed with a NP). He lays on the floor, and within a minute he proceds to vomit approximately 4 times. He also lost control of his bladder. He was pale with cold and clammy skin. we moved him so we could put his feet up on a chair and allowed him to rest. Someone went to get him an ice pack to put on his head and chest. His blood pressure was low (90/50ish). He still was not feeling better after 30 minutes so we called the ambulance. He did not want to go to the hospital so the paramedics monitored him. his blood pressure slowly started going up and normalizing, and he left with his wife.
42 2021-04-25 bell's palsy Bell's Palsy - predniSONE 40 MG for 7 days valACYClovir Take 1 tablet (1,000 mg total) by mouth 3 ti... Read more
Bell's Palsy - predniSONE 40 MG for 7 days valACYClovir Take 1 tablet (1,000 mg total) by mouth 3 times daily
42 2021-04-26 pain in extremity Right axillary lymphadenopathy still present. Right arm pain still present. Bilateral hand rash s... Read more
Right axillary lymphadenopathy still present. Right arm pain still present. Bilateral hand rash still present.
42 2021-04-28 tingling, muscle twitching initially began as what felt like jolts to my chest area from inside my chest over five days beginni... Read more
initially began as what felt like jolts to my chest area from inside my chest over five days beginning on March 31, 21 @ 1:20am; next on April 01, 2021 @ 12:02am; then April 02, 2021 @1:02am; then April 03, 2021 @ 1:36am; and on April 04, 2021 @ 2:46am. I ended up in the emergency room the afternoon of Sunday March 04, 2021 with severe chest, abdominal, and intestinal pain. I followed up with doctors on April 05, 2021; April 09, 2021; and April 28, 2021 with continued painful symptoms described below. All they has done so far is 1) took a chest X-ray, 2) taken blood, and 3) referred me to a sleep laboratory. The X-ray and blood work came back negative per ER. Symptoms: 1. Inability to sleep. most nights feels as if I just drank five cups of coffee before bed. When I am able to fall asleep, pain and/or jolts coming from inside my trunk/core area wake me up within about an hour. 2. Constant pain coming from my chest, abdomen, and intestines. Intestinal and abdominal pain (gut wrenching, pain/burning sensation, cramps). At times feels like radiation or waves/currents are passing through my intestines/trunk. I wake up with intestines feeling sore. I also have discomfort when I eat or drink something the following morning. Also, my trunk/core area feels tight all day and night. I constantly feel a burning sensation in my chest and gut areas. The discomfort in my chest area (tightness, burning sensation) with occasional burst of pain the size of a nickel that comes from the left side of my chest and underneath my rib cage. 3. Limbs twitch/jerk on their own (both hands, both feet, neck, both shoulders, both legs, fingers) during the day and during the night. tingling sensations in legs. 4. ringing in the ears with headaches. 5. Woke up from sleep due to both nostrils getting clogged while I slept; woke up gasping for air. 6. Penis no longer has the same sensation and difficulty with erection.
42 2021-04-28 tingling Severe insomnia, severe brain fog, sinus pain, sore throat, shortness of breath, body aches and ting... Read more
Severe insomnia, severe brain fog, sinus pain, sore throat, shortness of breath, body aches and tingling, eye irritation, blurred vision, headaches, stomach discomfort.
42 2021-04-29 muscle spasms Spiking fever, strong chills with muscle cramping all over body and headache.
42 2021-04-29 tremor, pain in extremity continuous sore arm, almost two weeks after the second pfizer vaccine shot. couldn't raise the arm, ... Read more
continuous sore arm, almost two weeks after the second pfizer vaccine shot. couldn't raise the arm, even for an empty dish plate, i can feel my arm is shaking when i hold it. similar situation happens after the first pfizer vaccine shot. about two weeks after the first shot, my arm had occasional sharp pain for about 3 days. no rash no swollen on arm.
42 2021-05-01 weakness, electric shock sensation On April 12th, I felt body weakness and body aches. Four days later the symptoms still persisted bod... Read more
On April 12th, I felt body weakness and body aches. Four days later the symptoms still persisted body aches in the mornings and late nights. Seven days later the symptoms still persisted including muscle irritation, body aches and 'electricity' like feelings throughout the body. Two weeks later, the symptoms still persisted with milder body aches in the mornings which lasted for about 4-5 hours a day that got better in late afternoon. The symptoms still persist which are milder than at the beginning. I had the second COVID shot on April 30th 2021, 19 days after the first shot.
42 2021-05-01 weakness Flu like symptoms (very achy and cold) 12 hours post injection. Headache, neck pain, achy ness beg... Read more
Flu like symptoms (very achy and cold) 12 hours post injection. Headache, neck pain, achy ness began 24 hours post injection. Significant tiredness and weakness throughout at least 48 hours post injection. Still have mild neck pain 48 hours post injection.
42 2021-05-01 pain in extremity moderate headache, fever, arm pain, fatigue, body pains for last approximately 2 days and continuing
42 2021-05-02 weakness On 25 April I woke up and felt fine and then at 10:30 am I started to feel weak. I had fever and chi... Read more
On 25 April I woke up and felt fine and then at 10:30 am I started to feel weak. I had fever and chills and couldn't get out of the bed until 4:00pm that day. I was dizzy and drove to the hospital. They did blood work and did two Covid 19 tests. They released me and the next day I developed Heavy pains. On 27 April I woke up and went back to the hospital. They said I had elevated enzyme levels when they drew blood and they started three iv?s. They said I was having a non emergency heart attack. They had me transferred by ambulance to the another Hospital. They drew more blood and did elf?s and ultra sounds. The next day they said they were going to put a stint in my heart. The next day I was prepped for the procedure and they went in and said my heart didn?t need it. The surgeon said I had Myocarditis and at 7:00 pm that night I was released. My nose broke out with acne bumps and it feels like I have a chest cold and cough.
42 2021-05-02 tingling Pt c/o of tingling in tips of fingers, pins/needles.
42 2021-05-02 seizure, pain in extremity Pt had some pain in his right arm and fever after taking the vax. Next day he woke up, went to the... Read more
Pt had some pain in his right arm and fever after taking the vax. Next day he woke up, went to the wash room and then had a seizure. His father gave him a cold compress and provided him with water and extra seizure medicine. His father called the Neurologist. He was told to give him some Tylenol for his fever and extra seizure meds if needed and to FU w/ an office appt if he has another seizure. It had been more than a year since he has had a seizure but had one on 4/14/21 that was 3 days after taking the 1st Covid Vax.
42 2021-05-02 seizure Pt had a seizure about 3 days after taking the vax. Pt had not had a seizure for over a year. His ... Read more
Pt had a seizure about 3 days after taking the vax. Pt had not had a seizure for over a year. His father gave him a cool rag and extra seizure medicine. His father contacted his Neurologist. He was told just to keep and eye on him and give him extra seizure medicine if needed.
42 2021-05-03 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Det... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: pt was not feeling well, pharmacist saw patient slumped over in chair, we lowered patient to floor, flat on back, and pulled his knees up. Blood pressure was monitored. 911 was called, paramedics monitored pt and advised him to go to hospital. Patient refused to go to hospital. Pt was lucid, was given saltines/water, was monitored for 30-45 min longer, and was driven home by female companion.
42 2021-05-04 numbness, cold sweat About 90 seconds after my technician gave the COVID19 second dose the patient felt dizzy and sat dow... Read more
About 90 seconds after my technician gave the COVID19 second dose the patient felt dizzy and sat down in the lobby immediately. He began to drip sweat and his hands looked clammy. Patient said his hands were numb. He seemed to be breathing fine and when I asked if he felt tightness in his airway or chest he said no. I observed the patient and called down the street to urgent care to see if they could see him. I did no suspect an allergy so I did not use the epi pen, but I thought it could be an adverse reaction. The patient returned after urgent care and said since it was less then a minutes when it happened the provider thought it was actually a panic attack and not an adverse reaction, but I thought it deserved a report just in case.
42 2021-05-04 numbness Numbness in right hand 2 hours after shot. Cotton mouth about 20 min after shot
42 2021-05-04 seizure Seizure
42 2021-05-05 coordination abnormal, numbness, pain in extremity The morning after injection my left arm had the expected soreness but additional numbness, weakness,... Read more
The morning after injection my left arm had the expected soreness but additional numbness, weakness, and poor coordination in my arm, hand, and fingers progressively moreso toward my pinky. It has been consistently the same for 17 days.
42 2021-05-05 facial pain Patient experience pain and numbing and tingling from the injection site in right arm up through th... Read more
Patient experience pain and numbing and tingling from the injection site in right arm up through the neck and into the face. Numbness did not affect breathing but did last 12-18 hrs and stayed strictly on the right side of the body (arm, neck, face). There has also been severe joint pain throughout the body that started approx 24 hrs after injection and still lingering 10 days later.
42 2021-05-05 pain in extremity Developed severe ongoing pain in left shoulder and arm which has persisted to current date. I had mi... Read more
Developed severe ongoing pain in left shoulder and arm which has persisted to current date. I had minor pain prior to second vaccination but beginning in the hours immediately following the second dose it became much worse. It migrates throughout the arm and shoulder throughout the day. I am taking prescription pain medication and muscle relaxers for the first time in my life. I could not go to work for 5 days, I now can make it through the day with heavy medication. I have also been prescribed physical therapy for 7 more weeks.
42 2021-05-06 bell's palsy, numbness Beginning the 17th increased numbness. By the 20th total left side facial paralysis (Bell's Palsy).
42 2021-05-06 night sweats, flushing, tingling Got covid vaccine, had 2nd dose on March 3rd. Had about 2 days of fevers, aches, night sweats and f... Read more
Got covid vaccine, had 2nd dose on March 3rd. Had about 2 days of fevers, aches, night sweats and fatigue. About 1 1/2 weeks after the dose, he started to get significant fatigue. He started to sleep poorly. He developed arthralgias described as bilateral, distal joints (hip down, wrists mainly). He developed tingling sensations in his arms and legs. He has had mental fog. He had some HA and eye pain. His PCP sent him to the ED for evaluation. He was evaluated by neuro consult on 4/4, had an LP. THe LP only showed some elevated protein (somewhat traumatic tap based on 10 RBC in tube 4). MRI brain, cervical/thoracic spine was unremarkable. He was dx w/ possible post-infectious polyneurophathy, and suggested f/u w/ neuro clinic for further eval. Pt reports his paresthesias lasted 2 days and has since resolved. He has not been seen by outpatient neuro clinic yet. He did have a post LP HA which he returned to the ED for. He reports that the HA has resolved. In the past 2-3 days he has had felt less fatigue. He still has arthralgias, continuous. They do not seem to be worse in AM or PM. He can do most activities and just tired working out this week. Activity does not seem to make it better or worse. The joints are not red or swollen but feel "tight". He has not noticed any fevers but gets occasional nightsweats or sometimes feels flush and measures only a low grade temp that does not last (<100F). He has had slight decrease in wt but no change in appetite. No n/v/d. NO cough, sob, CT/CP, wheezes. No rash. He does have some sinus sx's which he thinks could be c/w seasonal allergies. Got covid vaccine, had 2nd dose on March 3rd. Had about 2 days of fevers, aches, night sweats and fatigue. About 1 1/2 weeks after the dose, he started to get significant fatigue. He started to sleep poorly. He developed arthralgias described as bilateral, distal joints (hip down, wrists mainly). He developed tingling sensations in his arms and legs. He has had mental fog. He had some HA and eye pain. His PCP sent him to the ED for evaluation. He was evaluated by neuro consult on 4/4, had an LP. THe LP only showed some elevated protein (somewhat traumatic tap based on 10 RBC in tube 4). MRI brain, cervical/thoracic spine was unremarkable. He was dx w/ possible post-infectious polyneurophathy, and suggested f/u w/ neuro clinic for further eval. Pt reports his paresthesias lasted 2 days and has since resolved. He has not been seen by outpatient neuro clinic yet. He did have a post LP HA which he returned to the ED for. He reports that the HA has resolved. In the past 2-3 days he has had felt less fatigue. He still has arthralgias, continuous. They do not seem to be worse in AM or PM. He can do most activities and just tired working out this week. Activity does not seem to make it better or worse. The joints are not red or swollen but feel "tight". He has not noticed any fevers but gets occasional nightsweats or sometimes feels flush and measures only a low grade temp that does not last (<100F). He has had slight decrease in wt but no change in appetite. No n/v/d. NO cough, sob, CT/CP, wheezes. No rash. He does have some sinus sx's which he thinks could be c/w seasonal allergies. Got covid vaccine, had 2nd dose on March 3rd. Had about 2 days of fevers, aches, night sweats and fatigue. About 1 1/2 weeks after the dose, he started to get significant fatigue. He started to sleep poorly. He developed arthralgias described as bilateral, distal joints (hip down, wrists mainly). He developed tingling sensations in his arms and legs. He has had mental fog. He had some HA and eye pain. He was dx w/ possible post-infectious polyneurophathy, and suggested f/u w/ neuro clinic for further eval. Pt reports his paresthesias lasted 2 days and has since resolved. He has not been seen by outpatient neuro clinic yet. He did have a post LP HA which he returned to the ED for. He reports that the HA has resolved. In the past 2-3 days he has had felt less fatigue. He still has arthralgias, continuous. They do not seem to be worse in AM or PM. He can do most activities and just tired working out this week. Activity does not seem to make it better or worse. The joints are not red or swollen but feel "tight". He has not noticed any fevers but gets occasional nightsweats or sometimes feels flush and measures only a low grade temp that does not last (<100F). He has had slight decrease in wt but no change in appetite. No n/v/d. NO cough, sob, CT/CP, wheezes. No rash. He does have some sinus sx's which he thinks could be c/w seasonal allergies. Now experiencing substantial disruption of the ability to conduct normal life functions, including the ability to work.
42 2021-05-06 pain in extremity, burning sensation, limb paralysis Joint pain in shoulder; It felt like bursitis when he had it before on another part of his shoulder;... Read more
Joint pain in shoulder; It felt like bursitis when he had it before on another part of his shoulder; his arm was paralyzed and was hurting a lot/arm was painful; It is a sharp, burning, stabbing pain; Arm was paralyzed; Muscle pain at the deltoid/intense muscle pain" in the deltoid muscle; Injection was too low/Injection point was a little lower than expected; he had shoulder pain; This is a spontaneous report from a contactable consumer. A 42-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE (at age of 42 year old )for covid-19 immunisation. Medical history included he's had bursitis previously and that the symptoms lasted 6 weeks to 6 months (reported both lengths of time, unsure which is correct duration). The patient's concomitant medications were not reported. On 16Apr2021, the patient experienced he had shoulder pain and the injection was too low/Injection point was a little lower than expected. On 17Apr2021, the patient experienced muscle pain at the deltoid/intense muscle pain in the deltoid muscle. On 20Apr2021, the patient experienced arm was paralyzed , Joint pain in shoulder, It felt like bursitis when he had it before on another part of his shoulder, his arm was paralyzed and was hurting a lot/arm was painful, It is a sharp, burning, stabbing pain.Outcome of the events Muscle pain at the deltoid/intense muscle pain" in the deltoid muscle, Joint pain in shoulder, his arm was paralyzed and was hurting a lot/arm was painful, he had shoulder pain was not recovered. Outcome of Arm was paralyzed, Injection was too low/Injection point was a little lower than expected, It felt like bursitis when he had it before on another part of his shoulder, It is a sharp, burning, stabbing pain was unknown. Information about lot/batch number has been requested.
42 2021-05-10 weakness Patient became diaphoretic, weak and pale. Blood sugar 254, B/P-134/85, P-62, O2 SAT-96% on room air... Read more
Patient became diaphoretic, weak and pale. Blood sugar 254, B/P-134/85, P-62, O2 SAT-96% on room air. Assisted patient to floor and elevated legs. Patient stated, "I'm ok." Wife present and stated, "He has done this before but he didn't do this with his first shot." Patient vomited once. Staff called EMS. Patient refused to go to the hospital. Wife drove patient home.
42 2021-05-10 facial paralysis, facial pain, bell's palsy Started with tongue becoming numb (4/27)and by next day (4/28) his face was sagging and he couldn't... Read more
Started with tongue becoming numb (4/27)and by next day (4/28) his face was sagging and he couldn't feel the left side of his face - called PCP and they suggested he go to the ER to rule out stroke . While there they diagnosed him w Bell's Palsey and issued prednisone and an anti viral ( not sure of name). said to reschedule 2nd does 10 days out so rescheduled for 5/10. On 5/10 Husband called PCP office as his ear has been bothering him to see if he should still get his 2nd dose - Nurse called back and said they don't suggest it . He has PCP follow up on 5/13 - rescheduled 2nd does later that day in hopes he can receive it for full vaccination . As of 5/11 he can kind of blink on left side and can open his mouth more . mentioned that side of his face feels sore / bruised
42 2021-05-11 weakness 103* F fever, weakness, dizziness, and a severe rash/welts/hives all over the body. I began taking 2... Read more
103* F fever, weakness, dizziness, and a severe rash/welts/hives all over the body. I began taking 20mg of Cetrizine HCl daily in the evening of 3/27 for the rash/hives and it cleared up in 2 days. I visited the Emergency Room on 4/1 for the remaining symptoms. I was prescribed a 5 day dose of Azithromycin and I do not know what else I was administered through my IV.
42 2021-05-11 flushing Pt experienced flushing/sweating and light headedness 5 minutes post vaccination. BP 102/57; HR 55;... Read more
Pt experienced flushing/sweating and light headedness 5 minutes post vaccination. BP 102/57; HR 55; RR 20; O2 Sat 100%. 10 minuts later BP improved to 119/76; HR 71. Pt was stable and released from vaccination site
42 2021-05-15 pain in extremity pain in the bones of the left arm and leg and chest persistent for 9 days so far, an e.k.g. was done... Read more
pain in the bones of the left arm and leg and chest persistent for 9 days so far, an e.k.g. was done showed abnormalities not seen in previous e.k.g. done about 2 weeks prior further testing has been set up echo an stress and ultrasound of the leg .
42 2021-05-16 grand mal seizure Taken to ER with Grand mal seizures & possible stroke; admitted to hospital with seizures
42 2021-05-16 pain in extremity, burning sensation At first it was a lot of joint and muscle pain all over, and then I got shingles by the weekend. I t... Read more
At first it was a lot of joint and muscle pain all over, and then I got shingles by the weekend. I thought they were bug bites and I wasn't sure where all the pain was coming from and I ended up in the emergency room where I was diagnosed with shingles. After my second shot I started getting shingles by laterally on my right side, but I was already on medication so it didn't get that bad. I also have a lot of joint pain and burning pain in my hands and wrists that shoot up my arms and haven't stopped since the symptoms started. It's much worse at night and keeps me up from sleeping. I have also have been very forgetful and my mind is always cloudy.
42 2021-05-17 muscle spasms Pt first began to notice left leg "stiffness" after receiving his first COVID vaccine (Phizer) sever... Read more
Pt first began to notice left leg "stiffness" after receiving his first COVID vaccine (Phizer) several weeks ago. Pt states that after receiving his 2nd dose on 05/06, he noticed his leg stiffness got significantly worse. He tells me that he tried to "push through the pain" and mow his lawn but had to stop d/t severe cramping of the LLE and pelvis. He states he rested his leg and went to bed, and when he woke up he noticed that his left leg was severely swollen. Pt decided to take 3 days off work to continue to rest the leg, but ultimately came in for evaluation at the suggestion of his coworkers. Pt denies fever, chills, chest pain, or SOB. He denies history of smoking, prior clotting, long car travel, air travel, leg injury, or recent surgery. On exam, the left lower extremity is significantly swollen, erythematous, and hot to the touch. Physical exam otherwise unremarkable. Will admit to the hospitalist service for further medical management. ED Course: Hypertensive with BP 170/93. Initial workup significant for WBC 13, K 3.3, glucose 159. CT chest/a/p with findings suggestive of multiple PE's of the left and right lower lobes as well as extensive LLE DVT extending slightly into the IVC. Trop <0.03. BNP 66. ECG shows sinus tachycardia.
42 2021-05-17 muscle twitching Right upper forearm likely the flexor carpi ulnaris muscle involuntary near constant twitching. St... Read more
Right upper forearm likely the flexor carpi ulnaris muscle involuntary near constant twitching. Started 20 hours post injection. And persistent even at night.
42 2021-05-17 pain in extremity After receiving my second Pfizer Covid Vaccine shot last week (11-May-2021), I suffered nose bleed (... Read more
After receiving my second Pfizer Covid Vaccine shot last week (11-May-2021), I suffered nose bleed (left nose) on Saturday morning (15-May-2021) and didn't think much about it. This continued Sunday (16-May-2021), Monday (17-May-2021) and also today Tuesday afternoon (18-May-2021). The amount of bleeding increased significantly through to today and the last 3 times I noticed bleeding in the back of my throat. And I initially tried applying pressure to the nose section and now it is taking more than 15 - 20 minutes for this to stop. I am very concerned and will be contacting my Primary physician as soon as possible. Actually I had 2 other instances of nose bleeds after the first shot (14-Apr-2021) but I brushed it aside thinking it was due to cold weather or irritation from picking. I have not had nose bleeds prior to this event. I did not have any fever or chills from both vaccinations other than the sore left arm so this was not weighing my mind much. However, now I am concerned at the adverse events following Pfizer Covid vaccination shots.
42 2021-05-19 weakness About 5 minutes AFTER RECIEVING THE PFIZER VACCINE 1ST DOSE, THE PATIENT STARTED TO SWEAT, FELT DIZZ... Read more
About 5 minutes AFTER RECIEVING THE PFIZER VACCINE 1ST DOSE, THE PATIENT STARTED TO SWEAT, FELT DIZZY AS HE SAT IN HIS CHAIR & PASSED OUT FOR 5-10 SECONDS... CAME BACK GAIN CONSCIENCE AS THE PERSON NEAR BY TAP HIM HIS SHOULDER & ASK IF HE WAS OK. SHE CAME TO GET ME & I GAVE THE PATIENT SOME WATER TO SIP A LITTLE WATER. HE SAID HE FEELS BETTER THAT HE'S OK, HAD NO SHORTNESS OF BREATH. I TOLD HIM I WILL CHECK ON HIM IN A FEW MINUTES AGAIN. A FEW MINUTES LATER, HE DECIDED TO GET UP SUDDENLY FELL TO THE FLOOR. 911 WAS CALLED & FRONT STORE SUPERVISER & I MONITOR UNTIL AMBULANCE CAME FOR HIM. PT JUST FELT WEAK, BUT O SHORTNESS OR BREATH . I HAD THE PATIENT STAYED LYING DOWN ON ONE SIDE, SO AIRWAY IS NOT BLOCKED. A CUSTOMER HELP TALK TO HIM TO MAKE SURE HE STAY CONSCIENCE UNTIL AMBULNACE ARRIVED & TOOK OVER.
42 2021-05-19 weakness Fever, tightness in chest, loss of energy, difficulty breathing
42 2021-05-19 cold sweat Within 10 minutes i felt clammy and light headed. I passed out in my chair. I awoke moments later ... Read more
Within 10 minutes i felt clammy and light headed. I passed out in my chair. I awoke moments later to fellow patients and staff tending to me. They attempted to move me to a place to lay down. I immediately passed out again trying to stand. I woke up covered in sweat lying flat on the concrete. Staff and customers did not let me fall so no trauma. They called an ambulance. My bp dropped fo 88/50 in the ambulance with a pulse as low as 36bpm. Chills and uncontrollable shivers started about 30 minutes in and lasted for 2 hours. By 3pm I felt better. 2 bags of IV, chest x-ray, and blood work showed everything normal. Home now and will update my report if anything changes. Feeling much better as of 7pm. I belive they called it normal Sinus rhythm with sinus arrythmia
42 2021-05-19 numbness Pt got vaccine in R arm and began to feel arm and shoulder pain five minutes after. Pt also began to... Read more
Pt got vaccine in R arm and began to feel arm and shoulder pain five minutes after. Pt also began to feel lip and facial numbness. NO sob. No rashes noted vitals assessed and patient released. Last VS: T: 1259, P: 76, BP: 136/99, SpO2: 98%.
42 2021-05-19 pain in extremity 4/22--HA, vomiting, fatigue, sinus congestion, nonproductive cough; symptoms started mildly and prog... Read more
4/22--HA, vomiting, fatigue, sinus congestion, nonproductive cough; symptoms started mildly and progressively got worse i.e. sinus congestion and cough then HA, and finally vomiting. Symptoms resolved 4/24 5/13--severe myalgia, arthralgia, fatigue, slight sinus congestion; 5/15--severe radiating left arm pain; 5/16--myalgia and arthralgia improved; severe left arm pain continues today APAP and ibuprofen tried for pain without improvement in symptoms.
42 2021-05-19 pain in extremity On both events, I had stomach cramps that lasted about a week after both shots. The pain went away o... Read more
On both events, I had stomach cramps that lasted about a week after both shots. The pain went away on its own. In addition, I currently have pain on the arm I received the shot on. This recently started and occurred several weeks after receiving the second dose. The pain is similar to a burn from a sunburn and itches. It varies throughout the day in pain and stretches sometimes from my hand up to the side of my left check. Also on my upper back and back of neck.
42 2021-05-20 slurring Pt appeared altered. Unable to articulate correctly. Evaluated by EMS-Cleared
42 2021-05-20 tingling, inability to speak, weakness, discomfort, facial paralysis, speech disorder, severe one side paralysis, seizure, sensory loss Within 3-5 minutes developed dizziness, tingling in feet and hands, elevated blood pressure, mild na... Read more
Within 3-5 minutes developed dizziness, tingling in feet and hands, elevated blood pressure, mild nausea. Within an hour started having trouble with focusing his vision. Was given IV fluids at hospital in ER 5 hours after the injection, while leaving the hospital developed a slight limp on right leg Felt feverish when he got home, took Tylenol when he got home. Noted extreme fatigue. The next morning was lethargic, dizzy and right side of face felt heavy, around 11 am. Called for a telemedicine visit around 12:30p. Became weak and unable to use right side of body, upper and lower extremities and right side of face was drooping, visible to wife. Wife had support of right side of body to move around. Went to urgent care around 2p. During urgent care evaluation, his vision became more impaired and speech became unclear, had to really focus to speak. Transferred to ER. Lost ability to write name, couldn't respond when asked for SSN. Admitted as a "stroke 4". Had CT scan, CT angiogram, MRI, blood labs, cognitive tests, neurologic tests. Neurology consult. Had lost sensation to heat and pressure. All imaging and labs were normal. After MRI, had convulsions. Wasn't dx'd as a seizure. Neck felt tight afterwards. Admitted to hospital x 1 week. Had a burning, red, rash on hands, feet. No bumps, hives, but just a "splotchy" red discoloration on surface of skin that would burn and itch, often flaring at night. Rx'd ativan. Checked for autoimmune disease, Bell's palsy, followed by neurologists, repeat MRI normal. Started to improve, discharged after one week with no clear diagnosis. Discharged to rehab facility. Patient preferred to transfer care to outpatient rehab service closer to home with more social support. Repeat hospitalized 3 weeks later, less extreme, went back to ER, stroke eval neg. Developed more aphasia. Called back to ER for further evaluation of C-spine due to mild abnormality on first scan. On further evaluation not thought to be connected to symptoms. EEG report pending. +Right hemiplegia, aphasia persists. +Rash, itching, burning persist.
42 2021-05-22 weakness, pain in extremity ? Wednesday, May 19, 2021: ? 14:00 EDT - Patient got 2nd Pfizer vaccine. ? 17:00 EDT - arm s... Read more
? Wednesday, May 19, 2021: ? 14:00 EDT - Patient got 2nd Pfizer vaccine. ? 17:00 EDT - arm started to get sore. ? 17:30 EDT - dizzy after sparring class. Blood pressure 107/71. Pulse 59 BPM. Burping. Gassy. A bit nauseous. Watermelon smelled like cut grass (awful). Forcing myself to drink orange juice. Tastes terrible, like Sweet Tarts (My wife says it's just me). ? 20:30 EDT. Found antidote. Antidote is pie. Cherry pie. After kimchi chicken and smokra. Update: Feelin' fine. ? Thursday, May 20, 2021: ? ~ 05:00 - hard relapse. Arm very sore (8/10). Fairly nauseous. Almost regurgitation level. At the same time I do feel hunger so I know it's not real nausea, yet I still can't eat. Bad headache (7/10). Muscle stiffness up the back and up to the neck, getting worse the higher you go; the neck is particularly bad. ? By 9:40, temperature up to 99.6. ? 11:57 temperature 100.7, blood pressure 125/66, pulse 79 ? 2:50 temperature 99.7 ? 3:30 temperature 99.6 ? Friday, May 21, 2021: ? Update about yesterday (Thursday): I ended up spending the entire day in bed. Very nauseous. Couldn't eat. Spiked a high fever (my baseline is around 97.5° F). Blood pressure fluctuated. High pulse (mine is usually around 50 bpm). Sore muscles on entire torso; pain in my lower back (above pelvis) makes it too uncomfortable to sit up. Except for not vomiting or coughing, it felt like the flu. ? Head still hurts (4/10). Weak. Tired. Arm still pretty sore (3/10). Was able to eat kimchi chicken for lunch and shawarma for dinner, but still not completely over the nausea. ? Saturday, May 22, 2021: ? Left arm still sore in a 2" radius from injection site (2/10), but the rest of the arm is fine. Still have the headache (2/10). ? Sunday, May 23, 2021: ? About mid-afternoon, the headache finally receded. Left arm still sore in a 1/2" radius from the injection site (1/10).
42 2021-05-22 burning sensation, pain in extremity First series of symptoms started 7 hours after the 2nd vaccine shot, including intense fatigue, very... Read more
First series of symptoms started 7 hours after the 2nd vaccine shot, including intense fatigue, very strong headache (different from any headache I have experienced before), feverish (although no high temperature). Symptoms lasted about 30 hours. Second series of symptoms started 5-6 days after the 2d shot, including intense fatigue, burning feet, pain in right leg, then left leg (location of pain changed but mostly behind the leg). Pain felt similar to the beginning of a cramp. Headache for over 48 hours again, feverish with some temperature from 99.5 to 100.5. Since then, pain in the leg has been on and off. Headache is gone, and fatigue is not as intense although still not back to normal.
42 2021-05-23 night sweats 3 weeks of fever, night sweats and ABN LFT otherwise unexplained.
42 2021-05-23 pain in extremity, weakness At about noon on 01/28/21, I started to experience some fatigue. At about 9:30-10:00 PM, I started ... Read more
At about noon on 01/28/21, I started to experience some fatigue. At about 9:30-10:00 PM, I started to experience fever, chills, and I was very weak and fatigued. This lasted for about 3 days. I took 800 mg ibuprofen every 6 hours to manage the fever and chills. The left arm was very sore from the shot. The symptoms reminded me of what I had experienced when I had COVID in 4/2020, so I went to the doctor on 1/29/2021. I went urgent care at about 10 AM. The doctor told me to not be alarmed, because the symptoms were normal effects of the vaccine. He advised me to keep taking the ibuprofen and to possibly also take Tylenol and to monitor the symptoms. On the third day, I woke up feeling better. I didn't have chills or fever anymore. This was on 1/31/2021.
42 2021-05-24 facial paralysis Facial paralysis.
42 2021-05-25 pain in extremity 3 pulmonary embolisms; he started having really bad headaches; he was complaining of the back of his... Read more
3 pulmonary embolisms; he started having really bad headaches; he was complaining of the back of his leg hurting; his left shoulder started bothering him and it was radiating from his shoulder up to his chin as well as; This is a spontaneous report from a contactable consumer. A 42-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EW0172, Expiration Date 31Aug2021) via an unspecified route of administration, on 28Apr2021 at 09:00 (at the age of 42-years-old) as a single dose in the left "shoulder" for COVID-19 immunization. The patient's medical history and concomitant medications were denied (reported as "He has no medical conditions and does not take any regular medications"). The patient did not receive any other vaccinations within four weeks prior to the vaccine. The reporter says she is reporting on behalf of her husband with regard to the Pfizer COVID vaccination. She just wanted to report that her husband got the first shot 28Apr2021 and Friday 07May2021 he was admitted to the hospital with 3 pulmonary embolisms. When asked when the pulmonary embolism began she says the week before the hospitalization, so the week he actually got the first dose, he was complaining of the back of his leg hurting, in the upper calf area. She says it was either the day after the shot or the next day that he said his leg hurt but he did not think too much about it and it resolved after a couple days and then Wednesday, 05 May 2021 he started getting discomfort in his left upper quadrant, she clarifies his abdomen and rib cage area, and he started having really bad headaches Thursday that continued and during the night Thursday night his left shoulder started bothering him and it was radiating from his shoulder up to his chin as well as he had the severe headache so the doctor told him to go to the ER. The patient experienced three pulmonary embolisms on an unspecified date with outcome of not recovered. The patient was hospitalized for 3 pulmonary embolisms from 07May2021 to 08May2021. He also started having really bad headaches on an unspecified date with outcome of unknown and he was complaining of the back of his leg hurting on an unspecified date with outcome of recovered, his left shoulder started bothering him and it was radiating from his shoulder up to his chin on an unspecified date with outcome of unknown. The reporter commented that she and her husband wanted to report this because of the timing of getting the shot and they are waiting now to go see his primary care they are supposed to be calling to set up an appointment because he is supposed to be having the second dose 19May2021 so they do not know what is going to happen. Therapeutic measures were taken as a result of pulmonary embolism and included Eliquis which he would be on for at least 3 months.
42 2021-05-25 sciatica, discomfort Most, if not all, of my pain from my lower back surgery was gone. 1 week after the shot I started ha... Read more
Most, if not all, of my pain from my lower back surgery was gone. 1 week after the shot I started having pain in my left sciatic nerve again. It isn't as bad as it was but definitely painful. The upper back pain has came back and isn't terrible painful but is uncomfortable. Pain in most of my joints: knees, elbow, fingers... Most noticeable in my knees. (I weigh 150 pounds). I have been tired a lot. I did not have any issues with the bells palsy in my face. I received allergy shots for years and stopped getting them when I had surgery. After the surgery, I started getting the allergy shots again, it made me swell and my back pains were increased because of it. So I stopped getting them. So the issue may be that the COVID shot is making me swell.
42 2021-05-26 weakness Weakness began after first dose and was accompanied by malaise. Second dose intensified symptoms an... Read more
Weakness began after first dose and was accompanied by malaise. Second dose intensified symptoms and progressed to body aches, loss of taste and smell, episodes of sweating, shivering and brain fog.
42 2021-05-26 tremor pain at injection site 24 hours later; Fever; chills/shakes; joint pain; muscle pain; fatique; restl... Read more
pain at injection site 24 hours later; Fever; chills/shakes; joint pain; muscle pain; fatique; restlessness; difficulty concentrating; gas; extreme thirst; headache; shakes; This is a spontaneous report from a non-contactable other hcp (health care professional). A 42-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9262) via intramuscular route of administration, administered in left arm on 02Feb2021 at 09:00 (at the age of 42-year-old), at a single dose for covid-19 immunization in doctor's office/urgent care. The patient had no allergies and medical history. Concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3246) via intramuscular route of administration, administered in left arm on 11Jan2021 at 11:45, at a single dose for covid-19 immunization and received Influenza vaccine (within 4 weeks of vaccine) on an unknown date for immunization. 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 02Feb2021 at 19:00, after receiving the second dose of vaccine the patient experienced fever, chills, joint pain, muscle pain, fatigue, restlessness, difficulty concentrating, gas, extreme thirst, headache, shakes and on 03Feb2021 (24 hours later), the patient experienced pain at injection site. The patient did not receive any treatment for the events. The outcome of the events was recovering. No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
42 2021-05-27 pain in extremity 1st day - very sore arm of injection, dizziness, and fatigue. 2nd day - very sore arm, dizziness, e... Read more
1st day - very sore arm of injection, dizziness, and fatigue. 2nd day - very sore arm, dizziness, extreme muscle fatigue, headache, nauseous, shortness of breath, and chest pains radiating to my left shoulder/arm. At one point late in the evening of the 2nd day after the vaccine, I considered calling for medical assistnce. I was unable to sleep well for the first 3 days after the vaccine. 3rd day - sore arm, dizziness, extreme muscle fatigue, neck pain, headache, and nauseous. 4th day - fatigued and somewhat dizzy from time to time.
42 2021-05-27 pain in extremity He got his vaccine, his arm was a little bit sore. The next day he was unbelievably tired, wiped ou... Read more
He got his vaccine, his arm was a little bit sore. The next day he was unbelievably tired, wiped out at around 1:00 He also had a headache and also his blood sugar was elevated quite a bit, in the high 200's. Normal BS's are from 35-150. This lasted for approximately 8-9 hours after that, and was back to his normal self by 9-10:00 PM. He has done well since.
42 2021-05-27 pain in extremity I almost immediately started getting soar in my arm. After a few hours my arm down to my elbow was ... Read more
I almost immediately started getting soar in my arm. After a few hours my arm down to my elbow was VERY soar, my back around my shoulder blade became soar, and over my shoulder up to my neck into the left side of my head was very soar and achy. Headaches were present most of the first day. That night, around supper time I felt nauseous and then had some severe stomach cramps. I didn?t sleep well and woke up with the same bad pain from my elbow to my shoulder and also my shoulder blade to my neck and head. Most of the symptoms were gone after 48 hrs.
42 2021-05-28 tingling The day after the vaccine I woke up with tingling in my right hand thumb and forefinger. over the... Read more
The day after the vaccine I woke up with tingling in my right hand thumb and forefinger. over the next couple of weeks the tingling would move around the hand and forearm. I also started experiencing my face turning red. I had been building a playground in the backyard with power tools and plenty of sun during the unseasonably warm March, so i assumed the symptoms were related to some sort of physical strain. However, after an appointment in April to review symptoms, and follow-up with my primary doctor in May, i'm not being referred to neurology for review. I don't have a diagnosis, only symptoms at this moment that line up closely to the vacation but also line up closely to an out door home project. The symptoms are intermittent but are moving to more of a daily basis.
42 2021-05-31 muscle spasms Patient received vaccine at 14 days after first dose rather than at 21 days after first dose. Patien... Read more
Patient received vaccine at 14 days after first dose rather than at 21 days after first dose. Patient reported that he experienced left sided body muscle aches/spasms, fatigue, neck pain and visual disturbances on 5/29/21. Stated his heart felt like it was racing for a short time but it may also have been anxiety because he knew his dose was given early. Symptoms resolved by 5/30/21.
42 2021-05-31 seizure Seizure immediately following injection
42 2021-06-01 feeling hot, tingling, weakness Patient was given has second dose of Pfizer. He did not have any reactions with his first dose. He f... Read more
Patient was given has second dose of Pfizer. He did not have any reactions with his first dose. He felt dizzy, nauseous and had a stomachache. He was also feeling hot and complained of feeling a tingling sensation in his fingers. This was a few minutes after the vaccine was given and he was sitting at the post-immunization area. We directed him to sit on the floor and gave him 2 cold packs to put on his neck. Patient looked pale and weak so we also gave him some cold water. After a few minutes of sitting, he asked for us to call 911. We called 911 and alerted management. After paramedics came, patient was taken away. Patient seemed to be doing fine as he was leaving. He regained color in his lips, but was still feeling the other symptoms.
42 2021-06-01 pain in extremity Caller states before with the first and second shot he got no symptoms except a sore arm; This is a ... Read more
Caller states before with the first and second shot he got no symptoms except a sore arm; This is a spontaneous report from a contactable consumer or other non hcp. A 42-years-old male patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient stated, before with the first and second shot he got no symptoms except a sore arm. Caller would like to know if he can go outside. Caller stated he doesn't want to make other people sick and right at the time of report he was in quarantine since he does not know if he has COVID-19 or not. Caller stated he was not going to work right now either. Caller stated he does not have a health care provider and he does not have any health insurance. Caller stated he will just be calling and going to a primary care center. Caller stated okay for someone to call him back at a later time to get more information. The outcome of the event was unknown. Information on the lot/batch number has been requested.
42 2021-06-02 pain in extremity unable to put pressure on left arm where vaccination was administered. Pain rotates from elbow to ba... Read more
unable to put pressure on left arm where vaccination was administered. Pain rotates from elbow to back shoulder plate.
42 2021-06-03 pain in extremity I have had arm soreness with previous vaccines. This was unbelievable, went beyond "soreness" - it ... Read more
I have had arm soreness with previous vaccines. This was unbelievable, went beyond "soreness" - it was severe pain. It lasted 2 days, getting a big better each day, but the amount of pain was very high. I also think the provider who gave me the injection gave it too high. When giving me the injection, he said something about the "magic bone" which does not sound right at all. It seemed definitively higher than dose 2, which I received from a nurse, and had no severe side effects.
42 2021-06-07 pain in extremity Sore Arm; This is a spontaneous report from a contactable consumer (patient himself). A 42-year-old ... Read more
Sore Arm; This is a spontaneous report from a contactable consumer (patient himself). A 42-year-old male patient received bnt162b2 (BNT162B2) via an unspecified routes of administration, administered in left arm (at the age of 42 years old); on 10Mar2021 at 13:30 (Batch/Lot Number: EL3247) as 1st dose, single dose, then on 31Mar2021 at 13:45 (Batch/Lot Number: EP6955) as 2nd dose, single dose; both for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and he was not tested for COVID post-vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 10Mar2021 at 14:00, it was reported that the patient experienced sore arm. The patient also experienced sore arm on 31Mar2021 at 13:45. The patient did not receive a treatment for the adverse event. The outcome of the event was recovering. No follow-up attempts are needed. No further information is expected.
42 2021-06-08 seizure Medical assistant gave an initial Covid vaccination to her patient. While he was waiting his 15 minu... Read more
Medical assistant gave an initial Covid vaccination to her patient. While he was waiting his 15 minutes post vaccination to monitor for reactions, she noticed he was staring blankly at her. She asked if he was ok. Site Lead overheard her ask the patient and came into the room. RN noticed that he was slumped over and having a seizure. RN picked him up and placed him on the floor on his side. RN told MA to get an onsite MD and advised another RN in the room to call 911. Patient continued to seize. Blood pressure, oxygen level, and glucose levels were checked. All were within normal limits. Patient awoke and told RN he has a history of seizures but has not had his medication for a couple months. He stated that he has seizures when he gets nervous or upset. His last seizure that he could recall was a month ago. He then went into another seizure. EMS was on the scene. He came out of that seizure quickly. They placed oxygen on the patient. He wanted to sit up. RN helped him to sit up and helped him walk to the stretcher. He was awake, alert and oriented to person, place and time when he left the clinic. He was transported to Hospital per his request.
42 2021-06-08 tremor I was in the hospital I couldn't breathe and I was running a fever. I was shacking . While being in ... Read more
I was in the hospital I couldn't breathe and I was running a fever. I was shacking . While being in the hospital I am now on oxygen and I also got rhino virus while at the facility.
42 2021-06-09 pain in extremity muscle aches, stiffness and joint pain in hands
42 2021-06-13 seizure seizure almost immediately after covid vaccine,
42 2021-06-15 numbness, weakness Dizziness, feeling weak and feverish, chills, headache, numb hands and fingers, and pain in right sh... Read more
Dizziness, feeling weak and feverish, chills, headache, numb hands and fingers, and pain in right shoulder at administration site, especially when lifting my right arm.
42 2021-06-15 seizure Site: Pain at Injection Site-Mild, Systemic: Seizure-Medium, Additional Details: 5-10 minutes after ... Read more
Site: Pain at Injection Site-Mild, Systemic: Seizure-Medium, Additional Details: 5-10 minutes after vaccination, patient felt faint. When pharmacist walked over, patient had an absent stare, was unresponsive to questioning, and mild convulsions. Unresponsiveness lasted 30 seconds to a minute. Patient also lost control of urinary tract and relieved himself.
42 2021-06-17 bell's palsy, pain in extremity I had elevated level. I get feedback term but it appeared that my liver that is been stressed.; Bod... Read more
I had elevated level. I get feedback term but it appeared that my liver that is been stressed.; Body aches in my legs and more over back; Body aches in my legs and more over back; Body aches in my legs and more over back; Prolonged headache for about 2 weeks; Fatigue of head; Sore arm at the injection site; At my second ER visit they told me I had something called the bell's palsy; after taking the first vaccination on 29May2021 at 2 PM, the next day patient had stage 3 hypertension; I have history of hypertension but it was under control prior to the taking vaccination."; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 intramuscular, administered in Arm Right on 29May2021 14:00 as (At the age of 42-years) 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included hypertension. It was reported that patient had history of hypertension, but it was under control prior to the taking vaccination. Concomitant medication included hydrochlorothiazide taken at a dose of 50 mg once per day for hypertension; amlodipine taken at a dose of 5 mg once per day for High blood pressure. Patient did not take any vaccination 4 weeks prior to covid-19 vaccine. It was reported that patient have experienced side effects after taking the first covid vaccination and he visited the ER two times. Reportedly, after taking the first vaccination on 29May2021 at 2 PM, the next day patient had stage 3 hypertension. He had a prolonged headache for about 2 weeks. Patient experienced fatigue of head, body aches in his legs and more over back. He had sore arm at the injection site and at his second ER visit they said that he had something called the bell's palsy. It was reported that when he went to ER they perform blood tests and COVID test which tested negative. It was reported that he visited his doctor, primary care physician, he ran another lab and he had elevated level. He got feedback term, but it appeared that his liver that was been stressed. It was reported that patient was not treated for liver, he was only treated for the hypertension, for the headache and body ache he was taking ibuprofen over the counter, ibuprofen and the hospital prescribed for the bell's palsy, there are three different medication here valacyclovir, its 1-gram tablet and he take 3 per day. Prednisone, its 20 mg tablet 3 times per day, Erythromycin. The patient underwent lab tests and procedures which included blood test, covid-19: negative, liver function test increased: elevated level on unspecified date. Reporter seriousness for the events was Unspecified. Patient did not got his vaccination card yet as he was not fully vaccinated. The outcome of events was unknown. Follow-up attempts are needed. Information on the lot/batch number has been requested.
42 2021-06-22 discomfort About 24 hours after receiving my second COVID-19 vaccination (Pfizer) on 4/30/21, I began feeling i... Read more
About 24 hours after receiving my second COVID-19 vaccination (Pfizer) on 4/30/21, I began feeling intense pain in my lower back. It was so painful that I could not even sit down or lie down without intense discomfort. I was unable to sit for periods longer than 10 minutes. I did not do anything physically demanding after getting the vaccine, so I'm convinced the vacccine caused the pain. I have had lower back soreness for several years and two doctors have diagnosed it as a possible torn disk. It took a full 30 days for the pain to subside. I also got severe flu-like symptoms from the shot beginning 12 hours after the second shot. These cleared up after about 8 hours. I also began feeling heart burn about 10 days after my first shot. It intensified after my second shot. I've never had heart burn before. I had to go on Omeprazole prescribed by my physisican. Abo
42 2021-06-22 muscle twitching The pharmacist carelessly gave me the second shot of my Pfizer.Some dribbled out of the arm.. withou... Read more
The pharmacist carelessly gave me the second shot of my Pfizer.Some dribbled out of the arm.. without asking my permission he gave me a second dose Basically overdosing me. My tongue felt strange my lips sweated. The injection site hurt for 7 days and is still uncomfortable. My lungs have been extra congested with mucus. I missed 3 days of work due to the inability to use my left arm (sore) and general fatigue. Experienced strange twitching of the left arm muscle at injection site on the third day.
42 2021-06-22 pain in extremity chills, fever, muscle pain, swollen lymph nodes, head ache, arm pain
42 2021-06-24 tremor For 1st vaccine- I experienced first vaccine- one week later I got sick for 15 days, symptoms like I... Read more
For 1st vaccine- I experienced first vaccine- one week later I got sick for 15 days, symptoms like I had Covid, body aches, chills. For 2nd vaccine- after one week I experienced had excruciating headaches and shakiness that do not go away. I take Tylenol for pain and as a result have upset stomach. I went to see my PCP who performed exams, lab work, x-rays, CT scan of the head, CT scan of the abdomen and my doctor does not find anything wrong for me. To this day I continue wit the headaches that do not go away. I do not feel well to do my daily living activities and I get anxiety. I feel very tense and frustrated due to my symptoms. I do not have the lot # for my vaccines to provide.
42 2021-06-27 pain in extremity I was given a double dose of the second shot of Pfizer my arm is still hurting today. Blurry vision ... Read more
I was given a double dose of the second shot of Pfizer my arm is still hurting today. Blurry vision as well.
42 2021-06-28 cold sweat, pain in extremity Severe pain in left arm and chest. Labored breathing. Cold sweats.
42 2021-06-29 seizure Seizure; This is a spontaneous report from a contactable physician reported for a 42-years-old male ... Read more
Seizure; This is a spontaneous report from a contactable physician reported for a 42-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 15Jun2021 at 18:00 (Batch/Lot Number: Ew0191), at the age of 42-years-old, as dose 2, single for Covid-19 immunisation. The patient has no medical history and no know allergies. The patient has no Covid prior to vaccination. Concomitant medication included benzylpenicillin potassium (PFIZERPEN) taken for an unspecified indication from 05May2021 to 05May2021. The patient previously took first dose of BNT162B2 on 05May2021 (Lot number EW0177) for Covid-19 immunisation. The patient experienced seizure on 15Jun2021 at 18:00 with outcome of unknown. The patient underwent lab test which included Covid-19: negative on an unspecified date. Therapeutic measures were taken as a result of seizure. The event resulted to visit emergency room/ department or urgent care. Patient was not Covid tested post vaccination. Information about lot/batch number is available; Follow-up attempts are needed
42 2021-07-01 weakness generally feeling unwell with weakness, body aches, headache since 2nd vaccine on 6/9/21 dizziness s... Read more
generally feeling unwell with weakness, body aches, headache since 2nd vaccine on 6/9/21 dizziness started 7/1/21. presented to ED on 7/2/21 and found to have low Hgb, elevated liver enzymes
42 2021-07-01 pain in extremity Arm really sore; Felt like he had a cold and felt like he was coming down with the flu; Felt like he... Read more
Arm really sore; Felt like he had a cold and felt like he was coming down with the flu; Felt like he had a cold and felt like he was coming down with the flu; Tired; Got pretty sick after the second vaccine; He just felt blah; This is a spontaneous report from a contactable consumer (patient wife). A 42-year-old male patient received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date, at the age of 42-year-old, (Lot number and expiration date was not reported) as dose 2, single for COVID-19 immunization. The vaccine was administered at airforce base. The patient medical history and concomitant medications were none. No other additional vaccines administered on same date of the suspect. No other vaccine was administered within 4 weeks. Historical vaccine included first dose of BNT162B2 (as reported), via an unspecified route of administration on an unspecified date, at single dose for COVID-19 Immunization and the patient had no reaction. The reporter mentioned that her husband got pretty sick after the second vaccine. The patient was still able to work but his arm was really sore, felt like he had a cold and felt like he was coming down with the flu, and he was tired but not throwing up or anything. He just felt blah. This only lasted 24 hours and then he was fine. The patient did not take any treatment and did not had emergency room/physician office visit and it was gone the next day (as reported). The patient did not have any relevant tests performed. The reporter stated that she guessed it is normal for the second one (second dose of vaccine). The outcome of the events was recovered. Information on the lot/ batch number has been requested.
42 2021-07-02 numbness, pain in extremity Patient said his arm has been sore since he received the second dose and the pain has now moved down... Read more
Patient said his arm has been sore since he received the second dose and the pain has now moved down his arm and his thumb has become numb.. travels a lot so couldn't let us know til now.. Did not consult a md yet
42 2021-07-05 tingling, weakness, tremor, flushing Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Systemic: T... Read more
Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Mild, Additional Details: 10 minutes after receiving vaccine patient experienced shakiness, tingling, weakness, sweating and appeared pale. Checked blood pressure initial reading 96/68. Second BP taken 15 minutes later BP 107/72. Pulse stable at 68 BPM. Patient stayed 35min for oberservation and seemed to feel much better when he left. Water provided to patient.
42 2021-07-08 muscle spasms muscle spasms in legs, moved to ribs, hands, feet, forehead, back, and arms.; This is a spontaneous ... Read more
muscle spasms in legs, moved to ribs, hands, feet, forehead, back, and arms.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 02Mar2021 at 15.45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included alprazolam (XANAX) and sulfasalazine (MANUFACTURER UNKNOWN); both from unknown date for unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID 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 03Mar2021 , the day after the received the first shot, the patient experienced muscle spasms on his legs which had moved to his ribs, hands, feet, forehead, back, and arms and it was reported that there had not been a day since the initial shot that the patient had not experienced the event. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. The clinical outcome of the event muscle spasms was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
42 2021-07-08 tremor Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Chest Tightnes... Read more
Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Additional Details: patient describes shakiness, anxiety, swelling under and around arm, and pain. Reports taking 600 mg ibuprofen on tues and wed (600 mg po bid on Tues and Wed) "went away a bit and came back a little bit"
42 2021-07-09 pain in extremity, muscle spasms 2nd day after final dose woke up with severe vertigo. Lasted for 5 days. Since then have had inc... Read more
2nd day after final dose woke up with severe vertigo. Lasted for 5 days. Since then have had increasing chest discomfort and muscle spasms. Left shoulder and arm still hurt 2 and a half weeks after dose.
42 2021-07-09 pain in extremity Pfizer BioNTech Covid-19 Vaccine Adverse Effect. Upon submitting the completion of his Pfizer vaccin... Read more
Pfizer BioNTech Covid-19 Vaccine Adverse Effect. Upon submitting the completion of his Pfizer vaccine series to the state registry, the Pharmacist on Duty checked system to ensure the administration was properly reported. At this time, he realized the patient had received the Janssen Covid-19 Vaccine on 3/5/21 Lot #1805025. When asked prior to administration if he had received a previous COVID-19 vaccine, the patient denied previously receiving any doses of Covid-19 vaccines. When the pharmacy manager called to follow up with the patient and inquire about the J&J vaccine, the patient stated he would have to look for the paperwork and get back to the pharmacy about whether or not he received the J&J vaccine. He stated he was not experiencing any additional side effects beyond a sore arm at this time.
42 2021-07-14 weakness, hypersensitivity of all senses, pain in extremity, tingling, numbness, night sweats, muscle twitching Two weeks after second dose I started experiencing pain in my right hand and muscle twitching. By we... Read more
Two weeks after second dose I started experiencing pain in my right hand and muscle twitching. By week 3 the pain began in my left hand and wrist. By June 22nd, I began having severe hand and wrist pain, numbness and tingling in my fingers toes, left pain in my forearm that is sensitive to touch. On June 30th, I had to go to ER due to chest pain and severe night sweats. On July 8th, I developed Shingles. As of today, July 15th, I am experiencing debilitating pain in my hands, wrists and am still recovering from Shingles.
42 2021-07-15 pain in extremity Burning pain in the middle of my chest along with shortness of breath. Pain spreads from my chest t... Read more
Burning pain in the middle of my chest along with shortness of breath. Pain spreads from my chest to my right arm and makes the muscles in my right arm sore.
42 2021-07-17 burning sensation Burning sensation on the right hand; Sudden rash on the right hand; Itching sensations on the right ... Read more
Burning sensation on the right hand; Sudden rash on the right hand; Itching sensations on the right hand; This is a spontaneous report received from a contactable healthcare professional, the nurse. A 42-years-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot number: EP6955) via intramuscular route in left arm on 19Mar2021 at 11:45(at the age of 42 years) as single for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was other. Medical history reported as none. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not received any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medication within two weeks prior to the vaccination. The patient experienced burning sensation on the right hand, sudden rash on the right hand, and itching sensations on the right hand on 20Mar2021 at 02:00. The events didn't resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of events burning sensation, rash and pruritus was unknown at the time of this report. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Medical history captured as None in patient tab; patient age updated as 42 years old per source; facility name captured.Verbatim updated as "Since the vaccination, the patient had not been tested for COVID-19" in narrative.
42 2021-07-17 numbness, pain in extremity his arms and legs wouldn't move/when they wouldn't move they hurt and were numb at same time; Lighth... Read more
his arms and legs wouldn't move/when they wouldn't move they hurt and were numb at same time; Lightheaded; limbs are in a little pain but they recover quickly; dizziness; This is a spontaneous report received from a contactable consumer (patient) via Medical information team. A 42-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0198, Expiration Date: Sep2021), via intramuscular route, administered in Arm Left on 26Jun2021 (at the age of 42-years) as single dose for covid-19 immunization. The patient had no relevant medical history and family history. The patient did not receive prior vaccinations (within 4 weeks), any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient's concomitant medications were not reported. On 26Jun2021, the patient experienced lightheaded. On 28Jun2021, the patient's arms and legs wouldn't move/when they wouldn't move, they hurt and were numb at same time. On an unspecified date in Jun2021, the patient experienced dizziness and limbs were in a little pain, but they recover quickly. Clinical course included: the patient stated he received his first dose of the Pfizer COVID 19 vaccine on Saturday 26Jun2021 and after a few minutes of receiving it he felt lightheaded. He stated that passed. Caller stated that he had lightheaded from the 26Jun2021 through today it had worsened but now its levelling off. It was persisting at moderate level. He stated that when he woke up on Monday (28Jun2021), he experienced a rather high level of dizziness, his arms and legs wouldn't move, and he was dizzy. The numbness in his arms and legs passed but the dizziness has been getting worse. Patient stated that his arms and legs recovered completely but stated when they wouldn't move, they hurt and were numb at same time. He stated that this stopped about 4 hours after he woke up. He stated that his limbs are recovered completely but he still wakes up in a little pain in his limbs, but they recover quickly. The patient ended up in urgent care because of the dizziness that he had experienced from the vaccine. He was prescribed meclizine 12.5 mg and he said that it isn't working. Caller wanted to know if Pfizer has any treatment recommendations or any OTC (over the counter) medication that he could take for his dizziness. Caller said that he had to take leaves of absence in the work that he has just started because of his dizziness. Caller wanted to know what can be done to stop the adverse events that he had with the vaccine. When providing weight caller says he has lost that much weight. No further information provided. The only medicine he has had is the meclizine 12.5 mg. The date on the bottle 28Jun. He sees the description of the pill. He does not see a lot number on the bottle. may cause drowsiness and dizziness. Discard after 28 Jun 2022. He received this for the reported dizziness. He states he wants to know what can be done about the dizziness. Therapeutic measures were taken as a result of dizziness. No investigation assessment performed. The event dizziness resulted in emergency room for urgent care. The outcome of events was unknown. Follow-up attempts are possible. Further information is expected.
42 2021-07-17 tremor Muscle pain; tremor; This is a spontaneous report received from a contactable consumer, the patient.... Read more
Muscle pain; tremor; This is a spontaneous report received from a contactable consumer, the patient. A 42-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247) via an unspecified route of administration on the left arm on 24Mar2021 at 10:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to medications, food or other products. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks of receiving the second dose COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. 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 unspecified date as a single dose for COVID-19 immunisation. The patient experienced muscle pain and tremor on 24Mar2021 at 22:00. The patient did not receive any treatment for the reported events. 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 event muscle pain and tremor was resolving at the time of reporting. No follow-up attempts are needed. No further information is expected.
42 2021-07-19 tenderness, pain in extremity Neck, shoulder and all the way down to hand, dull most of the time but when moved or put pressure it... Read more
Neck, shoulder and all the way down to hand, dull most of the time but when moved or put pressure it was sharp. Was given physical therapy and gabapentin, ibuprofen, for the course. Still light pain but bad if moved or put pressure.
42 2021-07-20 pain in extremity Had typical sore arm 1-2 days after. Then went away. Started noticing my arm was sore again April 9-... Read more
Had typical sore arm 1-2 days after. Then went away. Started noticing my arm was sore again April 9-10th. However, woke up on April 11th with a high pitched changing ringing in my right ear. Over the course of about 3-4 weeks ringing became louder and more intense. Culminating to such a loud ringing in my ear April 29-May 5 or so. Was so loud I could not get normal sleep for almost a month. Went to see my primary doctor who didn't seem worried about it. Was told it was anxiety. Went to see an Audiologist to have my hearing checked. Hearing was fine. Went to see an ENT and confirmed hearing was fine and no infection. Was told the Tinnitus would go away or not go away. No likely cause. Over the last 3 months since the loud ringing the sound has abated ever so slightly week by week. I can tolerate quieter environments ever so slightly. I hear multiple tones. At first it was a loud screeching modem type sound. Then that went away/got quieter. Was replaced with a loud EEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEE. That got quieter as well then was replaced with a high pitched hissssssssssssssssssssssssssssssssssss, which has changed/got quieter but is still around. There is a third sound that sounds like grinding metal ever so slight. I noticed as the sounds dissipated I could pick up sounds that were not audible. I first remember hearing the fridge running, then hearing crickets, to my PC fan etc. As the ringing got quieter I could pick up minute sounds again in my right ear. Still the ringing is there.
42 2021-07-20 tingling, pain in extremity Body aches; Sore arm; Tiredness; Tingling all over; Slight fever up to 101 degrees; This is a sponta... Read more
Body aches; Sore arm; Tiredness; Tingling all over; Slight fever up to 101 degrees; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP 7543) via an unspecified route of administration in the left arm on 26Mar2021 at 15:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6198) via an unspecified route of administration in the left arm on 05Mar2021 at 09:30 (at the age of 42-years-old) 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. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 27Mar2021 at 11:00, the patient had sore arm, tiredness, body aches, tingling all over and slight fever up to 101 degrees. The events did not result in a visit to the 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 sore arm, tiredness, body aches, tingling all over and slight fever up to 101 degrees. The clinical outcomes of the events sore arm, tiredness, body aches, tingling all over and slight fever up to 101 degrees were resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.
42 2021-07-21 numbness abrasions to my chest and left leg.; swelling; dramatically decreasedsensitivity to pain.; after rec... Read more
abrasions to my chest and left leg.; swelling; dramatically decreasedsensitivity to pain.; after receiving the vaccine Ifell; This is a spontaneous report received from a contactable consumer, the patient. A 42-year-old male 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 01Apr2021 at 12:45 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were reported as no. The patient had no known allergies. The patient did not receive any other vaccine 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 02Apr2021 at 08:00, the patient experienced decreased sensitivity to pain, abrasions to chest, fall and left leg swelling. The patient reported that he experienced dramatically decreased sensitivity to pain and while jogging on morning after receiving the vaccine he fell and suffered abrasions on his chest and left leg. Despite clearly visible abrasions and swelling he experienced no pain at all. The patient did not receive any treatment for the reported events. The 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 event fall, swelling, abrasions to chest and left leg and decreased sensitivity to pain were unknown at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
42 2021-07-21 pain in extremity Dizziness from 20 minutes after vaccination to 6 hours after vaccination. Headache started 1 hour af... Read more
Dizziness from 20 minutes after vaccination to 6 hours after vaccination. Headache started 1 hour after vaccination and lasted 3 days. Sore arm for 3 days. Fatigue starting 1 day after vaccination and ended 4 days later Body aches and pains for 6 days after vaccination Rash on head, shoulders, and neck that started on day 3 after vaccination and lasted 5 days.
42 2021-07-21 pain in extremity Have not yet sought out medical attention, joint pain, fatigue (had these issues, but they were exac... Read more
Have not yet sought out medical attention, joint pain, fatigue (had these issues, but they were exacerbated). Pain in knees, back, and hands (marked increase in pain). Depression has been getting much worse, have sought therapy (father died recently, so can't point to vaccine specifically, may be a coincidence).
42 2021-07-22 feeling hot Body aches; Chills; Dizzy; Felt like the flu was coming on; Felt very hot; Very blurry eyes; This is... Read more
Body aches; Chills; Dizzy; Felt like the flu was coming on; Felt very hot; Very blurry eyes; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: TW0150) via an unspecified route of administration in the left arm on 03Apr2021 at 14:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder, depression and COVID-19. Concomitant medications included clonazepam (KLONOPIN) 10 milligram (mg) and testosterone (MANUFACTURER UNKNOWN) 200 mg. The patient did not have any known allergy to any medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021, immediately after vaccination, the patient experienced very blurry eyes. On the same day at 17:00, about 3 hours later, the patient experienced chills, dizzy and felt like the flu was coming on and all the night, the patient felt very hot with chills. Next day, on 04Apr2021, the patient had chills and body aches. 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 patient did not receive any treatment for the events very blurry eyes, chills, dizzy, felt like the flu, felt very hot and body aches. The clinical outcomes of the events very blurry eyes, chills, dizzy, felt like the flu, felt very hot and body aches were resolving at the time of report. No follow-up attempts are needed. No further information is expected.
42 2021-07-24 weakness The first was the Janssen on 3/19/21 in which I felt fever-like symptoms that was mainly an achy, we... Read more
The first was the Janssen on 3/19/21 in which I felt fever-like symptoms that was mainly an achy, weak body that begin about 12 hours since the shot and lasted for 36 hours. This was the most sever experience. The second was the Pfizer on 6/30/21 in which I felt fever-like symptoms again in the same way as above 12 hours after getting the shot, which lasted for about a day. The third was the second Pfizer on 7/21//21 in which I felt the same as above except it began 6 hours after the shot and, though less sever than the previous two, it lingered for 2 and a half days.
42 2021-07-27 numbness All issues are still present to this day: Fatigue, lethargic, Brain fog, mild Vertigo, hands and le... Read more
All issues are still present to this day: Fatigue, lethargic, Brain fog, mild Vertigo, hands and leg numbness (feels like they are asleep), out of breath, can't think of simple words or statements, forgetting what I am doing in the middle of a process (simple stuff), heart arrhythmia.
42 2021-07-27 seizure Seizure; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A ... Read more
Seizure; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 42-years-old, via an unspecified route of administration, administered in upper arm right on 09Jul2021 14:15 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. Patient's weight: 83.91 kg and Height: 174 cm. Medical history included ongoing visually disabled, scarred kidneys, one side of body shorter than other half and epilepsy. Concomitant medication included levetiracetam (KEPPRA) taken for epilepsy from an unspecified start date and ongoing. The patient experienced seizure on 10Jul2021 16:30 which did not require emergency room of physician's office visit. Someone in the background of the call could be heard sounded like stating patient gets a seizure when he gets sick. He just rested at home and took care of himself at home. He just treated the seizure like he would any other time and rested. He commented his seizure was due to visual disability. The patient had no previous immunization and no other vaccines administered within 4 weeks. The outcome of the event was unknown. Information on the lot/batch number has been requested.
42 2021-07-28 migraine Dry eyes; Small Migraine; Haziness; Soreness; This is a spontaneous report from a non-contactable ph... Read more
Dry eyes; Small Migraine; Haziness; Soreness; This is a spontaneous report from a non-contactable pharmacist. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8131) via intramuscular route of administration in the left arm on 05Apr2021 at 09:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient had no allergies to medications, food, or other products. Concomitant medications included amlodipine 10 with unspecified units (MANUFACTURER UNKNOWN), perindopril 8 with unspecified units (MANUFACTURER UNKNOWN) and finasteride 1 with unspecified units (MANUFACTURER UNKNOWN), all from unknown dates for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via intramuscular route of administration in the left arm on 09Mar2021 at 10:30 (at the age of 42-year-old) 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 00:00, the patient experienced dry eyes, small migraine, haziness and soreness. 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 outcome of the events of dry eyes, migraine, hazy vision and pain was not recovered at the time of this report. No follow-up attempts are possible. No further information is expected.
42 2021-07-28 pain in extremity Around July 1st, 2021 I started having pain in my right upper quadrant in my stomach, with nausea an... Read more
Around July 1st, 2021 I started having pain in my right upper quadrant in my stomach, with nausea and vomiting. I saw Dr., to do some regular bloodwork. My liver tests came back abnormal. Dr. did a lot of bloodwork, he was calling all of my other doctors to go over the test results. Some of medications may have to be switched out if they are harmful to my liver. They are working on getting my liver numbers down. On July 26th, 2021 I went to the ER for pain in the right back of my leg, thinking it may be a blood clot. At the ER, they did an ultrasound. I gave myself a shot of Lovenox before hand that may have broken up the blood clot if it had been there.
42 2021-07-29 facial paralysis, face paralysis, speech disorder, bell's palsy Diagnosed with Bell's Palsy. My face paralyzed and droops on the left side . My eye, mouth, and al... Read more
Diagnosed with Bell's Palsy. My face paralyzed and droops on the left side . My eye, mouth, and all facial muscles on the left side are weak and won't move. My tongue felt numb and and I have no sense of taste. I have a hard time talking because the left side of my mouth doesn't move. My eye is watering a lot and I can't shut my left eyelid all the way. I have headaches and jaw pain. I went to the ER and then to my primary doctor and was given an antiviral medicine and prednisone. I am still currently having all of these symptoms and the jaw pain is worse.
43 2021-01-03 pain in extremity, depressed level of consciousness, feeling hot 10 min after injection, my mouth started getting hot, then it moved down my throat and it was diffic... Read more
10 min after injection, my mouth started getting hot, then it moved down my throat and it was difficult and painful to swallow. I got quite dizzy. They initiated rapid response, when they came they simply monitored symptoms and Vitals. Blood pressure and Heart rate were elevated. after about 10 min the symptoms eased, but swallowing was still difficult and slightly painful. then a second wave of dizziness hit me and I nearly passed out. my heart rate was elevated once again and had ringing in ears. these symptoms lasted another 5-10 min then eased. I then had a headache. The symptoms didn't return, just a headache and fatigue the rest of the day. i was then given option to go to ED, which i didn't feel at that time I needed, so I left. The next day, i had some standard symptoms of pain in left arm from injection, and fatigue, but then toward the evening i developed a fever of 101 deg F than continued for a couple of hours. I used ibuprofen and Tylenol rotating to keep the fever down. On day 3 only mild fatigue.
43 2021-01-04 weakness Felt weak, dizzy, blurred vision and nausea Vitals normal except for several episodes of O2 stat 89-... Read more
Felt weak, dizzy, blurred vision and nausea Vitals normal except for several episodes of O2 stat 89-90. No wheezing . One dose of Diphenhydramine 25 mg dose. Back to normal in 1 hr.
43 2021-01-04 feeling jittery Anaphylaxis Narrative: Pt reported trouble swallowing around 20 minutes into the observation period ... Read more
Anaphylaxis Narrative: Pt reported trouble swallowing around 20 minutes into the observation period and was transferred to the treatment area in the vaccine clinic. Vital signs were assessed by a Registered Nurse and a Physician. Oxygen saturation was noted to be 88% on 2 liters of O2 by nasal cannula. Verbal order received at 10:03am from Physician and EpiPen administered to right thigh with improvement of symptoms. She was transferred to the Emergency Department (ED) via stretcher. In the ED, she was re-dosed with an EpiPen secondary to her airway type symptoms. She was reevaluated after 15 minutes and received Solu-Medrol, Pepcid, Benadryl IV, as well as IV fluids. She also received Ativan for her generalized jitteriness and anxiety. She improved and felt significantly better at approximately 11:43am. She was monitored for 3 hours in the ED and was discharged home at 3:34pm in good clinical condition and advised to continue to take Benadryl as needed. She carries and EpiPen on her person and was advised to return immediately if symptoms return.
43 2021-01-07 feeling hot Palpitations facial warmth Narrative:
43 2021-01-07 tingling Patient had onset of parasthesia and itching distal to right elbow down to right wrist. No other com... Read more
Patient had onset of parasthesia and itching distal to right elbow down to right wrist. No other complaints, denies itchy throat or shortness of breath. No hives or rash noted. Contacted medical director and observed for 1 hour. Will have patient recontact MD for any change in symptoms.
43 2021-01-09 weakness Woke up in the morning with soreness in wrist and elbow and practically zero use of my left hand. W... Read more
Woke up in the morning with soreness in wrist and elbow and practically zero use of my left hand. Woke up on left side so just assumed hand was asleep. After 15 minutes of no improvement, I started to panic thinking I was having a stroke. Realizing I had no other symptoms and was feeling fine otherwise I knew that likely wasn't the case. Besides having zero strength (I did have feeling) my hand would curl inward toward my body. I could manipulate with my right hand by it would always curl back in. I was barely able to grip, would actually have to manipulate my fingers into a grasp, couldn't do it on it's own, and holding something as light as my cellphone would cause my hand to turn down towards the floor. Pain level I would only describe as soreness in my wrist and elbow. Annoying but not painful. It's now over 24 hours since symptoms first appeared and besides some slight weakness in the hand I would say I'm 95% better.
43 2021-01-10 pain in extremity Headache, Myalgia, Left arm soreness, headaches, decreased appetite Narrative:
43 2021-01-10 tingling, burning sensation Recurrence of burning and tingling on right side of face in trigeminal nerve area (5th cranial nerve... Read more
Recurrence of burning and tingling on right side of face in trigeminal nerve area (5th cranial nerve, 2nd branch). No rash. Moderate intensity. Still ongoing. Prescription for Valacyclovir to be started today
43 2021-01-10 tingling Confusion, Dizziness, 11:33 Tingling in forehead BP 137/87 HR 91 O2 98% 11:48 138/84 HR 79 O2 100%.... Read more
Confusion, Dizziness, 11:33 Tingling in forehead BP 137/87 HR 91 O2 98% 11:48 138/84 HR 79 O2 100%. Felt better Narrative:
43 2021-01-10 tingling Right Fifth Cranial Nerve, second branch distribution, burning and tingling , no rash. Presumed to ... Read more
Right Fifth Cranial Nerve, second branch distribution, burning and tingling , no rash. Presumed to be mild herpes zoster (shingles). Treated with Valacyclovir 1000mg TID for 7 days with resolution.
43 2021-01-11 bell's palsy Patient developed Bells Palsy on day 19 after vaccine #1
43 2021-01-11 pain in extremity myositis; This is a spontaneous report from a contactable physician. A 43-year-old male patient re... Read more
myositis; This is a spontaneous report from a contactable physician. A 43-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on an unspecified date in Dec2020 reported as around the end of December, at single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On an unspecified date after he received the vaccine he had right arm pain and swelling (states it was in his bicep brachial radialis in the muscle) which is the opposite arm of the injection site. He had an MRI done on an unknown date that showed myositis. He thinks could be due to the vaccine since it started two days after he received the vaccine. His pain peaked at about a week and a half and now the pain was improving and the swelling was down. He still had function in the right arm but when he strained it would hurt. His concern was that the reaction may be an autoimmune reaction and the first response was muted. He was worried the second dose may elicit a larger response. At the time of the reporting the patient was recovering from the events. Information on Lot/Batch number has been requested.; Sender's Comments: Based on the available information, the company considers that a causal relationship between the myositis and vaccination with BNT162B2 cannot be excluded. Additional information regarding onset latency, relevant medical history, concomitant medications and detailed clinical course around the event onset will aid in comprehensive assessment of the case. 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.
43 2021-01-12 feeling hot heart is racing; face felt hot; irregular heartbeat; This is a spontaneous report from a contactable... Read more
heart is racing; face felt hot; irregular heartbeat; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male 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 shoulder on 06Jan2021 at a single dose for covid-19 protection. Medical history included with irregular heartbeat (diagnosed years ago). There were no concomitant medications. The patient stated that his heart was racing. He was sleeping and woke up to heart racing 130-140. He had irregular heartbeat and his face felt hot the morning of 07Jan2021. He did not know if it was his heart, nerves or what. was his first dose. He got the vaccine on his job and stated that sometimes his heartrate goes up and down not to this magnitude and not while sleeping. He had asked one of the nurses during vaccination about having irregular heartbeat and taking the vaccine and was told that one could die of much worst than this. Patient wanted to know if he should go to the doctor and what to do. Outcome of the event heart racing was recovering while for face felt hot was recovered on the same day of 07Jan2021, and for the remaining event was unknown. Information on the lot/batch number has been requested.
43 2021-01-13 tenderness Lymph nodes on left side are swollen. When extending arm upwards (hand above my head), I can see a ... Read more
Lymph nodes on left side are swollen. When extending arm upwards (hand above my head), I can see a bump right under my armpit. Bump is probably 3" diameter and approximately .75" in thickness (as thick as my fingers, not as thick as the palm of my hand). It's tender to the touch, but not painful. Lymph nodes on right side do not seem to be affected.
43 2021-01-14 burning sensation 2nd vaccine on Saturday. Sunday, burning feet, leg, thigh. Went to ER to check if it was cause by ... Read more
2nd vaccine on Saturday. Sunday, burning feet, leg, thigh. Went to ER to check if it was cause by diabetes, was told its probably not Gulliam Barre. Still having the symptoms. Worsen when laying down, better with movement.
43 2021-01-15 pain in extremity started 1.15.21 at midnight-Fever, chills,muscle ache and pain in left arm where vaccine was adminis... Read more
started 1.15.21 at midnight-Fever, chills,muscle ache and pain in left arm where vaccine was administered. Tylenol taken on 1.15.21
43 2021-01-17 bell's palsy, facial paralysis Right side lip paralysis noticed on January 2. It has spread to my face and eye since then. Had k... Read more
Right side lip paralysis noticed on January 2. It has spread to my face and eye since then. Had knee surgery on December 30.
43 2021-01-17 night sweats 72 hours of body aches, fatigue, uncontrollable chills, fever and night sweats. Got vaccine 8am an... Read more
72 hours of body aches, fatigue, uncontrollable chills, fever and night sweats. Got vaccine 8am and symptoms appeared at 4am next morning.
43 2021-01-18 pain in extremity, numbness Patient could not open and close hand after the first day of vaccination. On the third day his arm t... Read more
Patient could not open and close hand after the first day of vaccination. On the third day his arm turned purple and could not be moved and was numb. A week and a half after vaccine, arm hurt and was numb. Patient was hospitalized.
43 2021-01-19 cold sweat, tingling A few hours after the shot my hands and feet where tingling and felt clammy/ swollen. After work i ... Read more
A few hours after the shot my hands and feet where tingling and felt clammy/ swollen. After work i noticed that my heart rate would increase when walking around and that the heart beat felt heavy. If i was lying down the heart rate would be slightly elevated compared to normal resting heart rate. The heart rate beat felt heavy. I went to bed early and slept through the night. I woke up the next morning and felt fatigued, dizzy, slight body ache and nauseated. no fever, no headache. i tried to take a shower but symptoms got worse. i was unable to go to work that day. I took a few naps during the day and by late afternoon most symptoms where going away. the last symptom was the issue with the hands and feet. Heart rate returned to normal. The next day i was able to return to work.
43 2021-01-19 migraine Soon after the injection he noted a slight fever, body pain, migraine, slight nausea. These symptoms... Read more
Soon after the injection he noted a slight fever, body pain, migraine, slight nausea. These symptoms lasted for 2 days
43 2021-01-20 muscle spasms Severe right tibialis anterior muscle cramp; low level fever; This is a spontaneous report from a co... Read more
Severe right tibialis anterior muscle cramp; low level fever; This is a spontaneous report from a contactable physician (patient). This 43-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899 and expiry date unknown, vaccine location: left arm), intramuscular on 05Jan2021 08:00 at a single dose for COVID-19 immunization. Medical history included hypertension. The patient has no known allergies. Concomitant medication included valsartan and loratadine (other medications in two weeks include valsartan and loratadine). The patient took the first dose of bnt162b2 on 16Dec2020 01:00 PM (lot number: EH9899) intramuscular, vaccine location: left arm. The patient experienced severe right tibialis anterior muscle cramp on 06Jan2021 12:00 PM, 30 hours after second injection (as reported) with onset of low level fever. The fever resolved within 2 hours. Muscle cramping persisted for 30 hours with complete resolution. No treatment was received. Outcome of the event low level fever was recovered on 06Jan2021 14:00 and of the event muscle severe right tibialis anterior muscle cramp was recovered on 07Jan2021 18:00. The patient had no COVID prior to vaccination. The patient was not tested for COVID post-vaccination. The patient had no other vaccine in four weeks.
43 2021-01-20 numbness and pain in extremities Continued left arm injection site pain, left sided neck neuropathy, and feeling of very mild ache to... Read more
Continued left arm injection site pain, left sided neck neuropathy, and feeling of very mild ache to the anterior throat (feeling of swelling) but not having short of breath or trouble talking.
43 2021-01-21 feeling hot Woke up 0230 with severe chills but skin was hot (according to my wife). After several hours of slee... Read more
Woke up 0230 with severe chills but skin was hot (according to my wife). After several hours of sleep I got out of bed around 0600 and noticed severe body and joint ache and a headache. Once I began moving around I also noticed I would fatigue very quickly. Reminded me of how one feels when they get a good case of the Flu. As the day progressed all symptoms lessened in severity and I went to bed at about 20% of what I felt that morning. I woke the following morning and felt no residual symptoms.
43 2021-01-21 seizure coughing quite a bit; seizure; his whole body feels sore; This is a spontaneous report from a contac... Read more
coughing quite a bit; seizure; his whole body feels sore; This is a spontaneous report from a contactable consumer (patient's mother). A 43-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3248) in right deltoid, on 11Jan2021 around 10:30, for COVID-19 immunisation. The patient was in high risk group, was living in senior facility and was disabled. Medical history included also ongoing hydrocephalus diagnosed when he was less than a year old, ongoing shunt (the first one when he was 11 months old, has had multiple revisions since then, the last in 2017), vagal nerve stimulator implantation ongoing from 2003 (for epilepsy; has had multiple since then, last one in 2015), ongoing hemiparesis since he was a baby and epilepsy (he was taking epilepsy drugs but it was well controlled). Concomitant medications included oxcarbazepine (TRILEPTAL) ongoing from 2000, at 1800 mg daily (600 mg in the morning and 1200 mg at night), for epilepsy and levetiracetam (KEPPRA XR) ongoing from 2000, at 1500 mg twice daily (in the morning and at night), for epilepsy. He was on prior medications to these, since he was young. Over the years he has changed to newer and better medications. On 11Jan2021 around 8-9 PM the patient experienced seizure. The patient has not had a grand mal seizure in over 5 years. On an unspecified date in Jan2021, after the vaccine, his whole body felt sore. He was unsure if it was from the seizure or the vaccine. The reporter also noticed that the patient had been coughing quite a bit on 12Jan2021 morning. Events outcomes were unknown.
43 2021-01-22 pain in extremity Arm pain that lasted 3 days, chills and diarrhea that lasted 24 hours, I didn't take any treatment.
43 2021-01-24 tenderness Lump under right arm with tenderness
43 2021-01-24 tremor 1/14, 2200 - chills 1/14, 2300 - onset of fever 1/15, 0100 - tremors, chills, fever, onset of headac... Read more
1/14, 2200 - chills 1/14, 2300 - onset of fever 1/15, 0100 - tremors, chills, fever, onset of headache 1/15, 0300 - peak fever @ 100.7 F (baseline is 96.5) 1/15, 1000 - fever resolved 1/15, 1200 - chills resolved 1/15, 2000 - headache resolved
43 2021-01-25 pain in extremity arm pain for 3 days at injection site. Shivers and chills in first 24 hours. Mild fever first 24 hou... Read more
arm pain for 3 days at injection site. Shivers and chills in first 24 hours. Mild fever first 24 hours Ongoing persistent lymph node inflammation in neck for 7 days and counting
43 2021-01-26 numbness numbness in right side of face and right arm; hard time swallowing; felt foggy; dizzy; disoriented; ... Read more
numbness in right side of face and right arm; hard time swallowing; felt foggy; dizzy; disoriented; This is a spontaneous report from a contactable consumer. A 43-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on arm left from 11Jan2021 to 11Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included was reported as none. There were no concomitant medications. The patient states about 24 hours later he felt foggy, disoriented, and dizzy (all three occurred on 12Jan2021), states he then woke up at 3 am this morning and had a lot of numbness on right side of face and arm and had a hard time swallowing (both occurred on 13Jan2021), states a couple hours later he went to hospital, went to ER and had to do an MRI, states the MRI of brain and neck came back clear and checked out, states doctors concluded it was an adverse reaction to vaccination. Outcome of the events was recovered on 13Jan2021. Information on the batch/lot number has been requested.
43 2021-01-26 pain in extremity Malaise, nausea, headache, mild fever, arm pain. took one dose of acetaminophin,. Symptoms. have res... Read more
Malaise, nausea, headache, mild fever, arm pain. took one dose of acetaminophin,. Symptoms. have resolved 01/23/2021
43 2021-01-26 tingling Blurred vision/ loss of peripheral vision/ Optical migraine followed by headache 45 minutes after va... Read more
Blurred vision/ loss of peripheral vision/ Optical migraine followed by headache 45 minutes after vaccine. Some tingling on face and left had Resting to see if it goes away.
43 2021-01-31 numbness, slurring face numbness unable to make complete sentences called 911 they thought he was having a stroke disch... Read more
face numbness unable to make complete sentences called 911 they thought he was having a stroke discharge from the hospital with all bloodwork normal
43 2021-01-31 muscle spasms, numbness, pain in extremity 5 hours after vaccination: body aches and light headache, left arm soreness, cramps and numbness for... Read more
5 hours after vaccination: body aches and light headache, left arm soreness, cramps and numbness for 2 days. Feeling well and resolved except arm numbness.
43 2021-01-31 tingling, burning sensation, numbness Numbness and tingling in left leg; Numbness and tingling in left leg; burning sensation all over leg... Read more
Numbness and tingling in left leg; Numbness and tingling in left leg; burning sensation all over leg; unable to walk; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302 and expiration date not provided), via an unspecified route of administration (right arm) second dose on 09Jan2021 17:15 at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140) via an unspecified route of administration (left arm) first dose on 21Dec2020. On 09Jan2021 22:30, the patient experienced Numbness and tingling in left leg, burning sensation all over leg, unable to walk. The patient did not received treatment for the events. The outcome of the events was not recovered.
43 2021-02-02 weakness, pain in extremity Sore arm, body weakness, fever, chills
43 2021-02-02 discomfort, tingling, feeling cold, muscle spasms, numbness I had some sort of reaction. I was glad to get the shot and was not nervous about getting the shot.... Read more
I had some sort of reaction. I was glad to get the shot and was not nervous about getting the shot. 5 minutes after the shot I felt something cold go down my left arm from my shoulder to my hand. A minute or two after that both my hands went numb, then both my arms went numb. I asked others around me if anyone felt anything and everyone else was fine. A minute or two after that both my legs went numb. I started to black out but made it to a chair before this happened, I drank some cold water and felt awake about 5 minutes later. 30 minutes after that i felt comfortable enough to walk. For the rest of the day i felt like i was legally drunk and felt lots of pins and needles on the back of my hands and feet. I did not feel dizzy or nauseous at that time. i also felt a lot of pressure on the inside of my skin all over my body. I've never felt anything like that and it was a bit uncomfortable. The next day i was too dizzy to walk without becoming very nauseous. I still had pins and needles on my feet. i had chills as well which i guess is a good sign. my appetite was fine. i felt clear-headed as well. Two days after the shot i felt slightly dizzy and by the third day i felt fine except for minor muscle cramps all over my body. For the three days after the shot i also had some pretty strong forearm and calf muscle cramps and my arms (biceps and triceps) felt pumped up like i just had a great arm workout, but they weren't swollen at all.
43 2021-02-03 weakness Continued total body myalgias; weakness; This is a spontaneous report from a contactable Other Healt... Read more
Continued total body myalgias; weakness; This is a spontaneous report from a contactable Other Health Professional, the patient. A 43-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3246), via an unspecified route of administration in the left arm on 08Jan2021 at 13:00 PM (at the age of 43-year-old) as a single dose for COVID-19 immunization. Medical history included gastrooesophageal reflux disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had sars-cov-2 test on 04Jan2021 which was negative. Concomitant medication taken within two weeks of vaccination included dexlansoprazole (DEXILANT). The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EJ1685), left arm on 19Dec2020 for COVID-19 immunization. The patient reported that he continued total body myalgias and weakness 11 days post injection. The events began on 11Jan2021. The events was reported as non serious. The patient did not receive treatment for the events. The clinical outcome of the events continued total body myalgias, and weakness was not recovered. It was also reported that since the vaccination, the patient had been tested for COVID-19.
43 2021-02-04 cold extremities Patient had vasovagal syncopal event. This event was not a vaccine side effect but a vasovagal respo... Read more
Patient had vasovagal syncopal event. This event was not a vaccine side effect but a vasovagal response (previous history of syncope with vaccinations/procedures). Patient received 1st dose of Pfizer vaccine around 11am today. Within 2 minutes of receiving the vaccine, he started to feel dizzy and passed out for around 45 secs. He had cold extremities, looked pale and was sweating. He was immediately transferred from chair to floor and his legs were raised. Cold towel was placed on his head. He regained consciousness but was confused for less than a 1min. Vitals were checked and his BP was 95/50's and HR was around 56. Pulse O2 was 99% during entire event. He was able to converse well after that and was oriented. He informed having anxiety/panic attacks, had taken his medication that morning. He reported similar syncopal episodes in the past. He was monitored in same posture. He was gently hydrated orally with water and soda. He was given sublingual zofran due to nausea and retching. He did not vomit. We continued to monitor his BP on regular intervals. He had slow improvement in BP and after 2 hrs while sitting his BP was 104/65, pulse 56/min (reports being an athlete and previous records show baseline bradycardia). He denied any symptoms and was awake, alert, oriented. As he was not accompanied by anyone, his wife was contacted who came to clinic in 10mins and helped to drive him home. He was transported by wheelchair till entrance of clinic. He reported feeling better and thanked for helping. He does not have any contraindications to receive 2nd dose of vaccine.
43 2021-02-06 tremor 11/17/20 J&J Ad26.CoV2.S vaccination. The next morning patient began mild achiness & fatigue that ... Read more
11/17/20 J&J Ad26.CoV2.S vaccination. The next morning patient began mild achiness & fatigue that lasted 48 hours and mild arm pain that lasted 72 hours. severity: Gr 1 1/5/21 Pfizer #1. Sudden onset at 10 hours of shaking chills, temperature 103+, severe myalgias and malaise. Severe for 36 hours. 80% better at 48 hrs; at baseline by 72 hours. 1/26/21 Pfizer #2. 10 hours later again noted shaking chills, temperature >103, severe myalgias and malaise. 1/27 could not work. Worked 1/29 & 1/29 at half capability. 1/30 & 1/31 felt worse with temperature >103 both days. 2/1 had to leave work early; noted multiple aphthous ulcers on palate and tongue. Continued to have myalgias and temperature 102-3 through 2/3; tempera
43 2021-02-11 weakness Woke up the next morning feeling a little weak, muscle soreness, and slight sore throat. About 30 mi... Read more
Woke up the next morning feeling a little weak, muscle soreness, and slight sore throat. About 30 minutes after waking up I passed out and fell while taking a shower. I have no history of passing out for any reason and have had no side effects with any other prior vaccinations.
43 2021-02-18 pain in extremity Fever, headache, pain in arm; feeling better by 2/16/21, but still dizzy and fatigued. Now has a sor... Read more
Fever, headache, pain in arm; feeling better by 2/16/21, but still dizzy and fatigued. Now has a sore and itchy throat and pain has returned. Symptoms are "off and on."
43 2021-02-19 weakness Entire body rash for 7 days, started at my neck and then to involve my entire body. Fever 101.8-102... Read more
Entire body rash for 7 days, started at my neck and then to involve my entire body. Fever 101.8-102.9 for 3 days with 1 gram Tylenol and Benadryl. Weakness for a week, unable to work.
43 2021-02-20 numbness Lips went numb, partial tongue numbness, spread to the face, elevated blood pressure 180/130, elevat... Read more
Lips went numb, partial tongue numbness, spread to the face, elevated blood pressure 180/130, elevated heart rate 131 at its highest.
43 2021-02-22 muscle spasms left forearm cramping, progressed to left shoulder and upper back over next week; symptoms have pro... Read more
left forearm cramping, progressed to left shoulder and upper back over next week; symptoms have progressively worsened since that time
43 2021-02-22 tingling Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Hypertension-Medium, ... Read more
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Hypertension-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
43 2021-02-23 numbness, numbness and pain in extremities, nerve pain Woke up at 4 am on 01/31/2021 with muffled hearing and numbness on left side of body. BP increased t... Read more
Woke up at 4 am on 01/31/2021 with muffled hearing and numbness on left side of body. BP increased to 150/100. Vomiting and diarrhea. Went to ER on 02/01/2021 and had MRI of the brain to check for stroke/TIA. Had an EKG and carotid artery scan. All tests came back normal. Continued to have neuropathy only on the left side of the body since 01/31/21. Pain travels from nerve to nerve. Occasional HA with pain only on the left side of the head. Cold tightness in chest. Seen PCP numerous times and had bloodwork done, Symptoms have continued since onset on 01/31/21 with no increase or decrease in severity. PCP has referred him to a neurologist.
43 2021-02-28 bell's palsy Bell's Palsy
43 2021-03-01 numbness, discomfort Numbness on right side of face (same side as shot). Numbness around neck, especially the base of ne... Read more
Numbness on right side of face (same side as shot). Numbness around neck, especially the base of neck with a "heavy" feeling. No loss of functioning. Improvements seen approximately 20 hours following shot with reduced symptoms in these areas still persisting.
43 2021-03-02 burning sensation After about 10 minutes I started feeling weird. I became light headed. Then I felt a burning sensati... Read more
After about 10 minutes I started feeling weird. I became light headed. Then I felt a burning sensation done both arms and my tounge. My heart was beating fast and I was struggling to get my breathing under control. My throat also got tight or warm and that feeling seem to go down through my chest. The monitor told me to take off my mask and gave me water. Shortly after I started to gag and almost vomited. The monitor checked my blood pressure and it was 180 over 120. I was admitted to the ER. I stayed there for about an 90 minutes as was released as the symptoms seemed to leave. While driving home many of the symptoms resurfaced. When I returned home I took a zyrtec and an anxiety medication. A day after I am light headed and a little nautilus but otherwise ok.
43 2021-03-02 cold sweat Patient found on ground by bystander. Patient responsive, alert and oriented. States does not know w... Read more
Patient found on ground by bystander. Patient responsive, alert and oriented. States does not know what happened. Patient stood and sat in chair. A few seconds later patient had syncopal episode and nursing staff assisted him to the ground. BLS provided, airway maintained. Patient pale, diaphoretic and clammy. BP 110/60, P 51, O2 98%, T 96.3. Monitored until EMS arrived. Paramedics on scene. Vitals BP 89/60, P 67, O2 100%, Blood sugar 81. Patient taken to hospital via ambulance.
43 2021-03-02 feeling cold felt a little colder than usual; trouble falling asleep; general feeling of malaise; pressure buildi... Read more
felt a little colder than usual; trouble falling asleep; general feeling of malaise; pressure building in my head and abdomen; pressure building in my head and abdomen; left shoulder became increasing sore over 24 hours; This is a spontaneous report from a contactable consumer reported for himself that: 43-years-old male patient started to receive the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 16Feb2021 15:45 at single dose at left arm for covid-19 immunisation. The patient previously took the first dose bnt162b2 on 26Jan2021 at 43 years old for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced left shoulder became increasing sore over 24 hours on 16Feb2021 15:45, trouble falling asleep on 17Feb2021 04:00, general feeling of malaise, pressure building in my head and abdomen on 17Feb2021, felt a little colder than usual on 17Feb2021 08:30. No treatment was received for the adverse events. Under the tongue temperature reading was 97.9 (The patient was usually 97.5 with this thermometer) on 17Feb2021. The outcome of events was not recovered. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination Information on the lot/batch number has been requested.
43 2021-03-02 pain in extremity, feeling cold Day after second vaccine dose, patient began having extreme fatigue, overall body chills on/off thro... Read more
Day after second vaccine dose, patient began having extreme fatigue, overall body chills on/off throughout every day, joint aches in fingers and ankles, bilateral calf pain, wheezing, heart burn, brain fog, cold feeling in feet. These occur throughout every day, on and off. We are now at week 5.
43 2021-03-04 tenderness fatigue, low grade fever and chills began ~24 hours after the second shot. ~36 hours after second sh... Read more
fatigue, low grade fever and chills began ~24 hours after the second shot. ~36 hours after second shot right armpit lymph node was visibly swollen and very tender. Swelling went down over the course of 24 hours and was unnoticeable within 48 hours of appearing.
43 2021-03-05 pain in extremity Initially had deltoid pain and swelling for 1 day, improved, then 2 days after vaccine started with ... Read more
Initially had deltoid pain and swelling for 1 day, improved, then 2 days after vaccine started with swelling and pain over medial elbow. Today still has some swelling in deltoid in addition to pain/swelling in medial elbow. Symptoms also consistent with medial epicondylitis, uncertain if vaccine is contributing.
43 2021-03-06 tingling Threw up foam and saliva in middle of night. Felt like I was choking, woke from a sleep coughing and... Read more
Threw up foam and saliva in middle of night. Felt like I was choking, woke from a sleep coughing and spit up foaming mucus. Right leg was tingling as well.
43 2021-03-09 bell's palsy, facial paralysis Headache in back/right of head began on 3/5/2021, on 3/7/21 began experiencing facial paralysis in l... Read more
Headache in back/right of head began on 3/5/2021, on 3/7/21 began experiencing facial paralysis in lips which progressed to the rest of right side of face. Went to Emergency Department that evening. CT scan was "unremarkable" and blood work was normal. Was diagnosed with Bells Palsy. Prescribed Valtrex and Prednisone. 3/10/2021 still experiencing partial facial paralysis and headache in same location.
43 2021-03-10 weakness Narrative: As written per ED notes dated 3/9/2021: This 42-year-old female is here for evaluation ... Read more
Narrative: As written per ED notes dated 3/9/2021: This 42-year-old female is here for evaluation of increasing nausea and vomiting. The patient has gotten worse the past 24 hours. She got her second COVID-19 shot yesterday here at the VA Medical Center. She is complaining of consistent nausea and vomiting and can't keep any fluids down. She is here for evaluation of possible dehydration and weakness. The patient feels markedly improved after oral Zofran. I counseled her at length about this is a possible intolerance to the second Covid 19 immunization. She will be discharged home with Zofran 4 mg tablets 3 times a day as needed for nausea #20, increase fluids and rest, no work until Thursday, March 11, 2021. First covid19 vaccine: 2/15/2021, no adverse events Second covid19 vaccine 3/18/2021: presented to ED
43 2021-03-10 night sweats, weakness Patient experiencing shortness of breath, on Friday 3/5 heart beating real hard, felt weak, fatigue,... Read more
Patient experiencing shortness of breath, on Friday 3/5 heart beating real hard, felt weak, fatigue, lasted about 15 minutes, called ems went to ed, was given prednisone, calmed down, helped with inflammation but still lethargic, chest pressure, and pain, stomach pain, feels like a weight and pressure in chest, feels like sinus infection in head, mucus in them morning was red and thick, also having night sweats
43 2021-03-11 cold sweat Pt. looked pale & sweating, RN asked if he was okay, stated he felt like he was going to pass out. ... Read more
Pt. looked pale & sweating, RN asked if he was okay, stated he felt like he was going to pass out. Pt clampy and sweating. HR 47, Osat 97%. Pt had difficulty breathing with conversation. @1354 Lowered to the floor to lay flat. 1355 BP 101/62, HR 78, O2Sat 98%. @ 1403 BP 100/68, O2Sat 96%, HR 79, pt sitting. @ 1405 pt states "feels ok now" Sitting on the floor 1410 HR 85, O2Sat 94%, Pt remained talkative, alert & oriented sitting on the floor until 14:32. Pt standing 1433 "feels fine" alert and oriented x 3. Pt discharged 14:42. HR 82, Osat 98%
43 2021-03-12 facial pain, numbness Right sided facial pressure, pain and numbness. Ear and Neck pain/pressure. Treatment- pain medicati... Read more
Right sided facial pressure, pain and numbness. Ear and Neck pain/pressure. Treatment- pain medications and consultation/follow up instructions.
43 2021-03-17 weakness, pain in extremity About an hour after getting my first shot i started to have back and leg pain, a headache was develo... Read more
About an hour after getting my first shot i started to have back and leg pain, a headache was developing. about an two and a half hours I started feeling weak. It was hard for me to lift and carry things, I was getting winded walking across the building and the i would feel a little nauseous but that would go away after standing still for a few minutes.
43 2021-03-17 tremor @ 0830, Mr. Started complained of feeling chills, and burry vision. Upon assessment, patient was dia... Read more
@ 0830, Mr. Started complained of feeling chills, and burry vision. Upon assessment, patient was diaphoresis, minimum tremors, AO x 4 time, place, date and situation. VS taken @ 0830 BP 56/38, HR 65, O2 sat 98%. Patient was offered water to drink and wet towel was applied to front head. Another set of VS was taken @ 0837 with BP 92/50. 911 was called @ 0850 and AMR (department #338) arrived @ 0855. Patient was assessed by medic, 12 leads EKG was done NSR. Patient denied transfer to the hospital. Medic left @0900 after explaining to the patient the risks and need to go to the hospital. Patient called his wife. Wife came at 0903. Patient was assessed, no complains of dizziness, was able to walk steadily, before leaving with wife @ 0905.
43 2021-03-20 muscle spasms, pain in extremity I had experience of muscle cramps of left calf muscle in Feb / march and observed 3-4 times over a ... Read more
I had experience of muscle cramps of left calf muscle in Feb / march and observed 3-4 times over a period of 2 months . I was thinking that could be due to dehydration . On 03/ 14 /21 morning , I got severe left leg pain and could not able to walk. I took pain killers and did not subside and that end up going to hospital emergency . I was diagnosed with 2 blood clots in left leg . I do not have family history of clots nor any h/o major medical issues . All my previous and recent blood reports normal . I am currently in use of blood thinners
43 2021-03-22 pain in extremity Day 1 none 3/21/21 at approx 8pm Dizziness Nausea Joint pain Light fever Dehydrated Insomnia 3/22... Read more
Day 1 none 3/21/21 at approx 8pm Dizziness Nausea Joint pain Light fever Dehydrated Insomnia 3/22/21 all day Joint pain Dizziness Nausea Vertigo Foot pain Insomnia
43 2021-03-24 bell's palsy, facial paralysis experiencing facial paralysis in lips which progressed to the rest of right side of face; Bell's Pal... Read more
experiencing facial paralysis in lips which progressed to the rest of right side of face; Bell's Palsy; Headache in right back portion of head; This is a spontaneous report from a contactable consumer (the patient). A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #: EN6202) via an unspecified route of administration, in the right arm on 02Mar2021 at 14:30 PM (at the age of 43 years). Medical history included high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included hydrochlorothiazid. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took ibuprofen and experienced hypersensitivity. It was reported that the patient experienced headache in right back portion of head which started in PM on 05Mar2021. On 07Mar2021 the patient began experiencing facial paralysis in lips which progressed to the rest of right side of face. The patient went to the hospital emergency department. Bloodwork was normal. Computerized tomogram (CT) scan was noted as "unremarkable". He was diagnosed with Bell's Palsy and prescribed Valtrex and Prednisone. On 10Mar2021 he was still experiencing facial paralysis and headache. The clinical outcome of the events was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
43 2021-03-24 flushing Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patie... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient experienced syncope briefly he thinks due to sudden drop in blood pressure but recovered within minutes.
43 2021-03-24 migraine with aura Rapid onset of blurred vision and partial blindness, confusion, inability to form complete or cohere... Read more
Rapid onset of blurred vision and partial blindness, confusion, inability to form complete or coherent thoughts or sentences. Started with blurred vision around 5:45pm. I immediately sat down on the couch, and tried to explain to my wife what was going on. However, I was unable to complete the thoughts I was trying to form. Eventually I began confusing words (such as saying "king" when I wanted to say "kind" or "kite") and was unable to produce more than one word every 1-2 seconds with great difficulty. Then a headache came that was both extremely painful and somehow "painless," as if I was observing myself having the pain as a bystander. All of this happened within one minute of onset. I laid down and after about 10 minutes from onset the difficulty speaking subsided and I could make complete sentences, although with some difficulty. After around 20 minutes from onset my vision had fully returned. I called 911 out of concern for stroke-like symptoms. The dispatcher sent an ambulance, and I was taken to the Hospital Emergency Department for treatment. Around three hours after the onset of the incident I was diagnosed with a complex migraine and discharged.
43 2021-03-24 migraine Experienced two occular migraine events in the past 24 hrs: first at 3 days after first dose, and se... Read more
Experienced two occular migraine events in the past 24 hrs: first at 3 days after first dose, and second at 4 days after first dose I've had occular migraines in the past, but haven't had one in the past 10 years. I've had two in the last 24 hours. Occular migraine event for me is temporary blindness with floating bright object in line of vision with mild dizziness. Requires about 20 minutes to fully subside.
43 2021-03-27 inability to speak Extreme fatigue starting day following the vaccination. Slept for three days nearly continuously. L... Read more
Extreme fatigue starting day following the vaccination. Slept for three days nearly continuously. Loss of appetite. Did not eat for three days. Decreased cognitive functions. Sweats and chills (sometimes simultaneously)
43 2021-03-29 unresponsive to stimuli, tremor, flushing Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsiv... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Syncope-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Bradycardia
43 2021-03-30 hot flush report hot flush w/ light headedness. Had observer summons medical help. reported never doing wel... Read more
report hot flush w/ light headedness. Had observer summons medical help. reported never doing well w/ needles. TX -reclined car seat. removed mask- fresh air; emotional mask- fresh air; emotional support & water. increased wait time. Symptoms resolved / abted. pt. drove off lot after 15 mins. wait time.
43 2021-03-30 numbness, tingling Hearing a high pitch noise in my head that will not go away. Pointer finger on left arm is numb an... Read more
Hearing a high pitch noise in my head that will not go away. Pointer finger on left arm is numb and tingles with movement or touch. Both symptoms started on the afternoon of the 21st. Both came on at the same time and were very noticeable together.
43 2021-03-30 muscle spasms Patient reports he has noticed over the past week increased shortness of breath on exertion--at base... Read more
Patient reports he has noticed over the past week increased shortness of breath on exertion--at baseline able to exercise with walking 45-60 minutes without dyspnea, however noticed over the last week getting some shortness of breath even walking to the garage. No chest pain, no fevers, chills, cough. He saw his PCP for these symptoms who ordered EKG and CXR 1 day PTA which per patient were normal--plan was for referral to cardiologist. However on the morning on presentation around 6:45 AM after taking an elevator for work he began feeling lightheaded and lost consciousness, awakening on the floor. He went home as he was not feeling well however proceeded to have another 2-3 episodes of loss of consciousness at home witnessed by his girlfriend--the later 2 occurred while lying down and were not clearly associated with any presyncopal symptoms.
43 2021-03-30 night sweats pneumonia; had an infection; getting really sick; Night sweats to chills; Night sweats to chills; Ve... Read more
pneumonia; had an infection; getting really sick; Night sweats to chills; Night sweats to chills; Very fatigued; I was running 102-103 fever/very high fever; This is a spontaneous report from a contactable consumer. A 43-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 19Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient took the first dose of the Pfizer vaccine and ended up getting really sick and going into the hospital. They determined he had an infection and pneumonia. Things spiraled in the wrong direction. In the afternoon then by the next morning the patient was quite ill. He was sick for like 15 days. Temps for 102-103F. Night sweats to chills. Very fatigued. He would get better, then sick again, then better again and then ended up in the hospital. The events started on 20Feb2021. The patient was hospitalized for the events pneumonia, infection, and getting really sick from 07Mar2021 to 10Mar2021. The patient underwent lab tests and procedures which included body temperature: 102-103 fahrenheit on an unspecified date, investigation: unknown result on an unspecified date. Therapeutic measures were taken as a result of pneumonia, had an infection, getting really sick, i was quite ill, temps for 102-103f, night sweats to chills, night sweats to chills, very fatigued, i was running 102-103 fever/very high fever. Treatment for severe infection and Pneumonia : the patient had "a lot of injection going in his arm, they gave him fluids they gave medications, they tried to bring the Fever Down, they tried to bring the infection down to help clear out the Pneumonia." The outcome of the events was recovering. Information on the lot/batch number has been requested.
43 2021-03-30 pain in extremity Fatigue Soreness in left arm; Fatigue Soreness in left arm; This is a spontaneous report from a cont... Read more
Fatigue Soreness in left arm; Fatigue Soreness in left arm; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 02Feb2021 at 06:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient had no known allergies. The patient concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for COVID-19 immunisation. 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. On an unspecified date in Feb2021, the patient experienced fatigue soreness in left arm. The patient did not receive any treatment for the events. The outcome of the events was recovering.
43 2021-03-30 tingling 3/31/2021: Patient was observed post COVID-19 immunization for 30 minutes based on pre-vaccination s... Read more
3/31/2021: Patient was observed post COVID-19 immunization for 30 minutes based on pre-vaccination screening. During the observation period, he experienced an adverse reaction with the following symptoms: Tingling and swelling of face and throat. Tightening sensation to the face including mouth. Sweating, with redness to the face. Mild nonproductive cough. Assessment : Time of assessment 0932am. Alert and oriented. Nurse assessed lung sounds, VS monitored for 30 minutes. Actions taken: assessment of face and mouth, no swelling seen, face is red and he has sweating forehead. Vitals sign taken at 0932 with BP- 185/131, P- 89. R-17 O2- 98% , Benadryl 12.5 mg liquid given po x 1, VS rechecked at 0937, BP - 190/134, P- 84, T- 98.4. R- 18, O2- 98%, Benadryl 12.5 liquid given PO at 0927. EMS on site due to another issue, assessed pts lung sounds and assessed for auditory stridor to neck, patient with slight cough, voices that he is feeling some better, he remains sitting in wheelchair. VS at 0947 , BP- 166/127, P- 82. O2- 98%, VS at 1002- BP_ 154/110, P- 85, O2- 96%. Medications administered: Diphenhydramine (Benadryl) 12.5 ml (25 mg) by mouth. Time: 0932 and 0937. Administered by RN. Disposition:Reports swelling to face and mouth has improved, he is advised to follow up with PCP for elevated BP AND SYMPTOMS ASSOCIATED WITH VACCINE/ Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/31/2021 9:08 AM 0.3 mL 12/11/2020 Intramuscular
43 2021-03-31 feeling cold, tremor Shaking - cold, Nauseated, Headache, fatigue
43 2021-03-31 feeling of body temperature change hot and cold, restless sleep the night of vaccination. Next day felt fatigue, sick
43 2021-03-31 pain in extremity 102 FEVER, HEADACHE, CHILLS, ARM SORENESS, BODY ACHES FOR 30 HOURS
43 2021-03-31 pain in extremity I had soreness in the left arm initially. The morning after the vaccine, I woke up feeling sick. M... Read more
I had soreness in the left arm initially. The morning after the vaccine, I woke up feeling sick. My body was achey and I felt lethargic and flu-like. I did not have fever. This largely cleared up by the evening.
43 2021-04-01 weakness Upon presentation to Tent 4, participant identified himself as being, "a big baby when it comes to n... Read more
Upon presentation to Tent 4, participant identified himself as being, "a big baby when it comes to needles". Received vaccine to LUE and was waiting in Obs area with son (who reported only being seated for approx 5 mins.). A loud noise was heard and participant was observed laying out prone on the floor. Clinicians assisted him to roll over where his eyes were red, wide-open gaze, and diaphoretic but was not responding to commands. After turning him to his Rgt side he began to sit up and became slightly combative and was able to be calmed down. Moved to Tent 6 to cot via wheelchair where is RUE BP was 180/100 at 11:09, and Lft radial pulse taken by MD was "60 and weak", Resp 16 and unlabored so no oxygen in use but nearby. Upon further assessment, participant repeatedly stated that, "he just did not feel well" and when probed, c/o frontal headache, nauseated (but did not vomit), and weak. Offered water to sip and by now lip no longer bleeding. When asked, "what did you feel prior to falling out of your seat?", he stated, "I just remember that you all were around me asking me questions...hence could not recall moments leading up to being found on the floor and no type of aura was identified as well. Reported a h/o HTN but did not take his medication today...other history is unremarkable. Ambulance arrival approx 11:13, VS taken, assessed and transported to nearest facility. Family returned and later reported that he sustained only a large "goose-egg" on the forehead and fat lip but otherwise was treated and released.
43 2021-04-01 migraine I got a severe headache/migraine soon after the shot and it lasted for about 72 hours. It did seem w... Read more
I got a severe headache/migraine soon after the shot and it lasted for about 72 hours. It did seem worse than usual and lasted longer than is typical, but it might have been a coincidence since I do get frequent headaches or might have something to do with the vaccine.
43 2021-04-01 pain in extremity Starting at approximately 08:45PM on the night of the shot 03/29 (6 hours after the shot) and persis... Read more
Starting at approximately 08:45PM on the night of the shot 03/29 (6 hours after the shot) and persisting until about 03/31 between 2am and 4am, I had muscle aches and joint aches with occasional shooting pain in the elbow joints. My arm was also sore. The effect cleared up while sleeping. I had sweated enough to dampen my clothes and sheets. Upon waking, I felt fine.
43 2021-04-01 pain in extremity SORE ARM, PAIN IN THE LEG, ARMPIT, FATIGUE
43 2021-04-02 pain in extremity Severe arm pain, pain level 6, otc pain meds taken (muscle relaxer, Vicodin, Tylenol, ibuprofen all ... Read more
Severe arm pain, pain level 6, otc pain meds taken (muscle relaxer, Vicodin, Tylenol, ibuprofen all tried) Going on 2 weeks Pain spans from bicep, up to base of skull, down left side of mid back
43 2021-04-03 tremor, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: After patient had vaccine sat down, then felt light headed and broke out into a sweat. Pulse very shallow = 60bpm. Would get better than worse again. Called emt's, came w/i 15 minutes. Said had high bp, but on no meds. when emt's came he passed out and pulse down to 40bpm, emt's gave epinephrine. pulse back up to 60, put on stretcher, passed out again. Took to local hospital/ER
43 2021-04-04 feeling hot A phone call was made to the patient a couple days after his second vaccination and he reported that... Read more
A phone call was made to the patient a couple days after his second vaccination and he reported that he had experienced feeling hot, nausea and fatigue starting the night of his vaccination.
43 2021-04-04 flushing, cold sweat Patient states that his skin is clammy and he feel flushed. Patient was transported to ER by ambul... Read more
Patient states that his skin is clammy and he feel flushed. Patient was transported to ER by ambulance.
43 2021-04-04 pain in extremity Pain and swelling in big toe.
43 2021-04-04 tingling I?m having severe tingling in both legs both arms and torso along with face. Worried the paresthesia... Read more
I?m having severe tingling in both legs both arms and torso along with face. Worried the paresthesia is going to turn into Guillan-barre.
43 2021-04-06 pain in extremity After initial soreness wore off, shot arm (left) has been partially disabled from full range of moti... Read more
After initial soreness wore off, shot arm (left) has been partially disabled from full range of motion. Can't lift arm up high or backwards without extreme pain. Almost feels like a nerve is pinched.
43 2021-04-06 tenderness, discomfort Next day fatigue, and brain fog. Within 24 hours noticed swollen lymph node in left armpit and tend... Read more
Next day fatigue, and brain fog. Within 24 hours noticed swollen lymph node in left armpit and tenderness (same side as shot). Swelling about the the size of a fist. 7 days later swelling remains, but reduced by 1/2 the size. Within 48 hours notices pain and swelling lymph node under right collar bone and tenderness (opposite side of shot). Swelling is minimal, but collar bone discomfort. 6 days later since onset and collar bone discomfort remains.
43 2021-04-07 weakness, pain in extremity Tired headache sore arm no energy diarrhea and not sure if this is just a coincidence but my mouth s... Read more
Tired headache sore arm no energy diarrhea and not sure if this is just a coincidence but my mouth swelling on April 8th about 2 in the morning.
43 2021-04-07 cold sweat Reported onset of frontal headache before leaving vaccination observation area on 5 April; headache ... Read more
Reported onset of frontal headache before leaving vaccination observation area on 5 April; headache later resolved after taking Naproxen and has not returned. Patient also experienced feeling sweaty and clammy evening of vaccine receipt; did not measure temperature; no chills; symptoms did not interfere with sleep and were resolved upon awakening on 6 Apr.. On evening of 5 Apr and on 6 Apr, patient reported generalized achiness diminished after taking Naproxen; aching did not change much between 5 and 6 Apr (no worsening); no joint swelling, warmth, or redness. Also noted "rash" within 2-3 hours of vaccine receipt - not pruritic and only located in antecubital area of left (vaccinated) arm (review of photo showed round/oval, erythematous patch about 3x3, possibly Herald patch); no significant local vaccination site reaction of left upper extremity or axillary tenderness and swelling. Denied symptoms c/w immediate allergic reaction [any hypersensitivity-related signs or symptoms consistent with urticaria, angioedema, respiratory distress (e.g., wheezing, stridor), or anaphylaxis that occur within four hours following administration On 8 Apr, patient reports all symptoms gone except red area on left antecubital, which seems to be getting better
43 2021-04-07 flushing Flush, faint, sweaty and pale
43 2021-04-07 numbness Numbness on left side, mainly in lips, tongue, face and arm. No treatment sought. Seems to have reso... Read more
Numbness on left side, mainly in lips, tongue, face and arm. No treatment sought. Seems to have resolved next day.
43 2021-04-08 pain in extremity vaccine number 2 injection in right arm and complains of pain in left arm. Able to move and feel lef... Read more
vaccine number 2 injection in right arm and complains of pain in left arm. Able to move and feel left arm.
43 2021-04-09 numbness, tingling 44 y/o male presents for HA, fast heartbeat and L arm numbness/tingling 10 min. Pt has hypertension... Read more
44 y/o male presents for HA, fast heartbeat and L arm numbness/tingling 10 min. Pt has hypertension and DM2. BP 178/96, HR 105, o2 98% RA BP 156/85, HR 100, 02 98% RA Pt states he feels better and ready to go.
43 2021-04-10 weakness Fever 100.5, chills, shortness of breath, severe muscle and joint aches, weakness. Pain at injection... Read more
Fever 100.5, chills, shortness of breath, severe muscle and joint aches, weakness. Pain at injection site.Headache.
43 2021-04-10 muscle spasms, pain in extremity The adverse event that led me to fill out this form: Temperature of 99.4, in the evening two days la... Read more
The adverse event that led me to fill out this form: Temperature of 99.4, in the evening two days later; I measure my temperature daily in the evening and it's usually in the range 97.2-98.3. Temperature was normal the first two evenings. I also checked the following morning (today) and it's normal again. Other adverse events: Ache, soreness, etc in left arm, for about two days. Ache in left wrist, right after the vaccination; I'd had pain there the previous week. Muscle spasms in my left flank, not uncomfortable, just weird; intermittently for the rest of the day.
43 2021-04-10 muscle spasms Severe muscle spasms from muscle scarring from an accident 20 years ago. See earlier accident histo... Read more
Severe muscle spasms from muscle scarring from an accident 20 years ago. See earlier accident history for more details.
43 2021-04-11 weakness Patient received dose at 1:19pm walked to OBs area, sat in chair. Started texting, noted weakness, ... Read more
Patient received dose at 1:19pm walked to OBs area, sat in chair. Started texting, noted weakness, c/o sweaty feeling, alerted staff. Placed in WC, back to Med Eval tent where he was diaphoretic, pale. Did not lose consciousness. Patient admits to not eating or drinking today at all, very stressed about vaccine. Drank a bottle of water, and gatorade, fan for air circulation. Patient recovered well on cot in supine position, walked out without incident. Likely vasovagal response without syncope. NP
43 2021-04-12 feeling hot, numbness Felt immediate warmth in injection site. Pain at injection site. Warmth spread rapidly up my shoulde... Read more
Felt immediate warmth in injection site. Pain at injection site. Warmth spread rapidly up my shoulder neck and around the left side of my face. Within another few minutes the warm area became slightly numb. I could move my face and feel my skin but it felt like it had gone asleep. Over the next few hours it spread down my body, only me left side, all the way to my foot. Groin area also felt numb, like when you sit on a bike too long and my penis also felt numb. Called a teledoc service on Monday as this lingered. They told me that if it had not dissapated after 2 days to let them know. Symptoms went away on Wednesday March 31st.
43 2021-04-12 flushing Within 5 min of getting the shot my face became flush. That lasted for about 30 seconds. A few minut... Read more
Within 5 min of getting the shot my face became flush. That lasted for about 30 seconds. A few minutes later my neck became very itchy. This lasted for maybe a minute or two.. about an hour later my legs became very itchy. This lasted maybe a minute and was immediately followed by my face getting flush again. This also lasted about a minute. Maybe 15 minutes later the same two events repeated in the same order. Both again lasted maybe a minute. During this time there was a little bit of tingling around my lips. This came and went for a few hours. 15 or so minutes after the 2nd round of itchy legs/face flush, my throat became itchy for a couple of minutes. I did go to the urgent care and while was told by that doctor that as all of these had come and gone within a minute or so and that my breathing had not become an issue that I didn't need an epi shot and that I could just go home. I didn't experience any further allergic reactions, just the expected ones.
43 2021-04-12 pain in extremity Sore arm, headache, very tired. No treatment. Started approximately 18 hrs after vaccination.
43 2021-04-12 tingling Bilateral arm and feet paresthesias without numbness or muscular weakness that started several days ... Read more
Bilateral arm and feet paresthesias without numbness or muscular weakness that started several days after initial vaccine. Patient also started taking Xyzal at the same time. We are stopping Xyzal. His neurological and musculoskeletal exam is normal.
43 2021-04-12 throat numbness Face swell and eyes swell shut. Huge bumps all over body and face. I took pics. Throat was also f... Read more
Face swell and eyes swell shut. Huge bumps all over body and face. I took pics. Throat was also feeling numb
43 2021-04-13 cold sweat Cold sweats starting Thursday evening, Friday sweating at night, and Saturday morning ~6:00 am with ... Read more
Cold sweats starting Thursday evening, Friday sweating at night, and Saturday morning ~6:00 am with chest pain and sweats. Pain intensified and brought to Urgent Care at 8 am where an EKG was completed and showed signs of a heart attack. Was rushed to Hospital Emergency room. Admitted and examined. Completed an angiogram and noted that there was a blood clot that appeared to dissolve. Troponin levels were high showing damage to the left artery. Spent the night in the hospital. Prescribed medication for cholesterol, blood thinners, and seeing a cardiologist.
43 2021-04-13 hot flush, feeling cold Hot Flashes, Cold Flashes, Fatigue, Muscles Aches, Headache/sharp pain down to right shoulder, diarr... Read more
Hot Flashes, Cold Flashes, Fatigue, Muscles Aches, Headache/sharp pain down to right shoulder, diarrhea
43 2021-04-13 night sweats, tremor Nausea, vomiting, muscle aches, high fever, severe fatigue, chills, night sweats, shaking, funny tas... Read more
Nausea, vomiting, muscle aches, high fever, severe fatigue, chills, night sweats, shaking, funny taste, weird feeling lips
43 2021-04-13 night sweats Vivid Dreams Body felt like I was hit by a truck. Had trouble getting around. Pain and stiffness thr... Read more
Vivid Dreams Body felt like I was hit by a truck. Had trouble getting around. Pain and stiffness throughout body. This was at 3am At 6am when I woke up, I felt like there was a band around my right calf, and there was shooting pains through my left foot / ankle The second night, I woke up at 3am in a night sweat and feverish. Headache and vivid dreams.
43 2021-04-14 bell's palsy, facial paralysis Sunday April 11th around 2 p.m., tongue numbness and pain behind left ear going down the neck Monday... Read more
Sunday April 11th around 2 p.m., tongue numbness and pain behind left ear going down the neck Monday April 12th 715 a.m. left side of face paralysis Monday April 12th 740 a.m. went to e.r. and went through tests for stroke or bell's palsey and was determined it was bell's palsey, also had a CT scan and was determined to be ok, was prescribed 5 days worth of prednisone and 7 days worth of antiviral valacyclovir
43 2021-04-14 numbness 43 y/o male, past medical history of Hypertension (untreated) presents with numbness to the left ear... Read more
43 y/o male, past medical history of Hypertension (untreated) presents with numbness to the left ear, left neck and left upper arm shortly after vaccination. Vaccination site was the left deltoid. NP and Paramedics at side. Negative Stroke Scale. Vitals taken and patient noted to be hypertensive with BPs ranging between 145/94-166/114, all other vitals normal. Advised patient on the need to transport to the ER via Fire Rescue due to symptoms and bps. Fire rescue arrive on scene where patient refused transport. Patient signed our AMA form in addition to Fire Rescues AMA form. Patient left on his own account.----------------------End.
43 2021-04-14 tingling, pain in extremity Malaise, sinus congestion, dizziness, mild fever (99.4 degrees F), increasing in severity since waki... Read more
Malaise, sinus congestion, dizziness, mild fever (99.4 degrees F), increasing in severity since waking at 5:45 am April 15 Sore left arm, including some tingling along left forearm and back of left hand (diminished within a few minutes of waking)
43 2021-04-15 cold sweat Patient received COVID19 Pfizer BioNTech vaccination approximately 1:10p. After vaccination administ... Read more
Patient received COVID19 Pfizer BioNTech vaccination approximately 1:10p. After vaccination administering RPH requested patient wait for 15 minutes prior to leaving. Approximately 1:20p patient began to feel faint - lightheadness, clammy skin, and pale skin. RPH took pulse over 30 second time period and reported HR of 44. Patient was offered water and RPH assisted patient to lay on the floor with legs raised above head. Skin color slowly returned. Pulse was taken again and came back up to the low 90s. Patient laid on floor for 15 minutes prior to being assisted by RPH to sit in chair. Patient then sat in chair for approximately 10 minutes prior to feeling comfortable leaving. EMS was not called to scene. Patient stated that he had not eaten prior to vaccination. RPH counseled patient to eat prior to receiving second vaccine and to inform vaccinator prior to second dose of previous reaction.
43 2021-04-15 pain in extremity Chills, Arm Pain, Fatigue, Muscle Soreness
43 2021-04-18 bell's palsy Bells Palsy, onset on 4/17/2021
43 2021-04-18 muscle spasms received vaccine pfizer 4/18 reports cramping to forearms and calves; soreness to neck, shoulders, c... Read more
received vaccine pfizer 4/18 reports cramping to forearms and calves; soreness to neck, shoulders, chest. Used no meds to Tx. Denies SOB, flutters, palpitations. States his chest discomfort feels like muscle pain after lifting or a rigorous workout rather than cardiac in nature. Referred to ER
43 2021-04-18 tingling, weakness Pfizer-BioNTech COVID-19 Vaccine EUA - About 10 minutes after receiving the first dose of the Pfizer... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA - About 10 minutes after receiving the first dose of the Pfizer COVID-19 vaccine, pt complained of being dizzy and faint. Pt broke out in a sweat and complained of tingling down his left arm (site of administration was left deltoid) and into his fingers. Pt was instructed to lay down on his side and was given an ice pack to apply to his wrist for the sweating. He was also offered water and to call EMS, which was refused. At this time his blood pressure was checked reading, 102/63 pulse 62. Pt continued to be closely monitored for 30 minutes. During this time he was able verbalize symptoms and continued to complain of dizziness and generalized weakness. After 30 minutes pt sat up and waited an additional 15 minutes before he decided to stand up and at that time decided he was fit to leave. Another blood pressure reading was taken 110/64 pulse 67. He stated that a normal blood pressure reading for him was around 135mmHg systolic.
43 2021-04-19 pain in extremity The same day, I was exhausted. It lasted 2 days. After that, on the 2nd or 3rd day after my shot, my... Read more
The same day, I was exhausted. It lasted 2 days. After that, on the 2nd or 3rd day after my shot, my right calf began to hurt. I knew it was connected to the vaccine, but I figured it would go away. Once the information came out about blood clots and my calf still hurt and didn't get better, I decided to go and get it checked out.
43 2021-04-19 unresponsive to stimuli, seizure, feeling hot 1110: Alerted that we had a medical patient. 1111: At patient side to find the patient wa slouched ... Read more
1110: Alerted that we had a medical patient. 1111: At patient side to find the patient wa slouched over and having snoring respiration?s. The patient appeared pale and diaphoretic. 1112: Contacted Safety Supervisor and also contacting 911. 1113: The patient was seated upright to open airway and asked if he could wake up. Patient was breathing on his own, eyes open, but not tracking. The patient was not responding to painful stimuli. 2 person lift assist to get the patient off the chair and laying on the floor. The patient then had seizure like activity, arms clenched at his side. 10 second passed by, the patient having minimal postictal phase, and the patient immediately sat upright, asking what happened. The patient informed mobile crew that he started to feel hot and dizzy before he started to dream. Vitals taken: BP: 110/54, HR: 40, R: 18, SPO2: 99%, CBG: 108. 1116: Patient care transferred to paramedic unit to transport to closest hospital.
43 2021-04-20 nerve pain extreme fatigue; joint pain; muscle pain; nerve pain; hives; large red skin blotches on arm where va... Read more
extreme fatigue; joint pain; muscle pain; nerve pain; hives; large red skin blotches on arm where vaccinated; Swelling in limbs; Headache; head pressure; This is a spontaneous report received from a contactable consumer (patient). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW6208), in left arm on 18Mar2021 04:30 PM (at the age of 43-year-old) at single dose for COVID-19 immunization. The patient's medical history included post-traumatic stress disorder (PTSD) and seborrhea. No allergies to medications, food, or other products were reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported, no other medications were received by the patient within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 18Mar2021 06:30 PM the patient experienced extreme fatigue, joint pain, muscle pain, nerve pain, hives, large red skin blotches on arm where vaccinated, swelling in limbs, headache and head pressure. The events were reported as serious since resulted in disability or permanent damage. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment was received for the adverse event as steroid pills, ibuprofen, aspercreme rubs and ice pack. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not resolved.
43 2021-04-20 seizure Patient given vaccine, was 10 minutes into the waiting period, passed out of his chair, appeared to ... Read more
Patient given vaccine, was 10 minutes into the waiting period, passed out of his chair, appeared to have a seizure. Myself and the RN on duty giving vaccines provided first aid to make sure breathing, heartbeat, etc. Kept airway open. He came out of it in about 3-4 minutes and was coherent before the paramedics arrived (6-7 minutes) and was conversing with us and the paramedics. They took him to the ambulance to be checked out.
43 2021-04-20 tremor Patient while sitting in the post-vaccination area for 15 minutes, started experiencing lightheaded ... Read more
Patient while sitting in the post-vaccination area for 15 minutes, started experiencing lightheaded and faint when he got up. I instructed the patient to sit back down and he complied. I went to grab the patient water and calm him because he seemed a little anxious and then he started shaking, so we immediately called 911. I tapped him to see if he was okay, and he said yes was okay but really faint and the patient was sweating. I asked if he was having trouble breathing, but he denied. He drank the water and had chocolate and I kept conversing with him to assess for any physical/mental status changes, and during the conversation the patient said he usually feels faint and anxious when he gets blood drawn but did not mention it during the screening because he never has when receiving vaccinations. The patient was appearing to improve, less anxiousness, less sweating, and getting more color back to his face. When the EMS arrived within 5-10 mins, they assessed his vitals which were all normal and the patient requested not to be taken to the hospital. The EMT personnel felt the patient was doing okay and left. I had the patient stay for another 30 minutes to make sure he was remaining okay before he left.
43 2021-04-21 feeling hot The patient was sitting in a chair on the sidewalk. He received the Pfizer vaccine lot # EW0172 exp... Read more
The patient was sitting in a chair on the sidewalk. He received the Pfizer vaccine lot # EW0172 exp 04/25/2021 in the right arm at 10:40am. At 10:41am the patient said ?my arm feels hot,? as he motioned to his right arm where he received the vaccine. RN checked the patients arm. There was no sign of rash or redness. At 10:42am the patient stated, ?Now my whole body feels hot.? The patient denied feeling dizzy or nauseous. Per RN's assessments, patient was not flushed, no rash was present, skin was dry. Skin appeared appropriate color for race. The patient insisted on standing up but reported feeling ?dizzy? and looked unsteady as soon as he stood up. RN assisted the patient to sit back down. The patient was given a mat to lay down on but he refused to lay down or put his head between his legs. He sat up with his hands in his hands covering his face. Vitals were taken at 10:45am by RN. RR 18 and no signs of respiratory distress, BP 130/82, HR 68 with regular rhythm per palpation. Patient was offered Benadryl but he refused and still refused to lay down. At 10:50am the patient said, ?I feel all better now.? The patient was advised to stay for the remainder of his 30 minute observation period but he refused and walked off with a steady gait.
43 2021-04-21 hypersensitivity of all senses, cold sweat I awoke at approximately 02:00 of the morning following the second dose, in a cold sweat and shiveri... Read more
I awoke at approximately 02:00 of the morning following the second dose, in a cold sweat and shivering so hard that I could not move (locked in a fetal position). This lasted about 30 minutes, after which I fell back asleep, exhausted. The next time that I woke up, I was walking into wall between the bedroom and the bathroom (I have no history of sleepwalking). For much of the remainder of the night I experienced multiple episodes of somnambulance, each time awakening when I ran into some object (bathroom counter, television, bookcase). The last time that I woke up, at approximately 07:00, I must have been standing and simply fell over; my head bouncing off the ground is what caused me to wake up. For the entirety of the day after vaccination (04/12/21) I felt as if I had the flu: chills (though no/very mild fever < 99 F) accompanied by shivering, sometimes convulsive; sore muscles; hyperalgesia (light touch perceived as painful); lethargic; strong sense of malaise; loss of appetite. As stated, this lasted for the entire day, through the time that I went to sleep for the night (2300). The next day, 04/13/21 I felt completely back to normal with the exception that some muscles were slightly sore, possibly due to the exercise of an entire day spent shivering.
43 2021-04-22 pain in extremity The next day after the second shot, my right foot got acute pain. I had some fatigue on my left fo... Read more
The next day after the second shot, my right foot got acute pain. I had some fatigue on my left foot on the day I took vaccine and I had got it examined by the doctor, He did. To find any issue on my left foot and suggested it might be a regular sprain. He also examined throughly the right foot and it was perfectly fine in the day time of vaccinations. The pain on right foot joints got so acute that I could not move out of my bed. I waited for two days hoping that the vaccine effect will go in couple of days.but it became unbearable. I saw my pcp and the blood work showed erratic inflammatory markers and unusable high glucose very low platelets and I was given steroid for six days. The inflammation was coming down when I was on med and bed rest, last Saturday my right heel started showing a new and sharp throbbing pain. I went the ortho and they found that possibly my burssaties sack is inflameated. The pain is so unbearable that I am, prescribed some opioid based pain killers, the PCP and hematologists had a discussion , I was told that I may be developing auto immune disorder. I never had a history of ITP. I am still hopi g it is a shock and body will calm down soon but I am on so much in pain and in a small place to get an immediate medical attention is so hard.
43 2021-04-22 sensory loss The patient received the injection, was monitored for 15minutes. He returned to his station at work.... Read more
The patient received the injection, was monitored for 15minutes. He returned to his station at work. He had a sensation that he could not get an adequate breath. He says this started about fifteen minutes after the shot and observation had been done. He was assessed at 5:55pm on Friday (4/23/21). The pt had his vitals done at the area of injections. He was found to be stable. The pt walked under his own power to the medic clinic. There he was placed on a stretcher and vitals performed again. He was given a epic-pen injection in the left thigh, per author. This was a 6:35pm, approximately. He had no adverse effects from the epinephrine shot, with vitals still monitored. An ambulance arrived, report given and he was to be taken to the medical center for further observation.
43 2021-04-23 weakness Injection site pain Extreme fatigue Muscle and joint pain Earache Fever Chills Nausea Weakness Swoll... Read more
Injection site pain Extreme fatigue Muscle and joint pain Earache Fever Chills Nausea Weakness Swollen lymph nodes 24 hours of moderate symptoms followed by mild lingering symptoms
43 2021-04-23 burning sensation Fever overnight following the second injection. Lymph node swelling on left side of head and neck wa... Read more
Fever overnight following the second injection. Lymph node swelling on left side of head and neck was noticed the first morning along with a burning sensation along the scalp on the left side of head. Lumps formed under hair line on left side of head by second morning after the shot. Lymph nodes still swollen on left side of head and neck. Lumps on left side of head became tender to the touch by third morning after the shot. Sought help at "On Demand Care" on 10th day after Vaccine was given due to pain. The following issue was addressed by CNP: Herpes zoster without complication. Prescribed: acetaminophen, capsaicin and valACYclovir on April 23, 2021.
43 2021-04-23 flushing Post vaccination patient started to feel flushed, light headed and dizzy- Patient skin pale vitals T... Read more
Post vaccination patient started to feel flushed, light headed and dizzy- Patient skin pale vitals T 98.7, 113/56, HR51, B/S144, 02 96
43 2021-04-24 feeling cold Fever, chills, body aches, fatigue, tiredness, injection site soreness, lump feeling like bruise in ... Read more
Fever, chills, body aches, fatigue, tiredness, injection site soreness, lump feeling like bruise in armpit.
43 2021-04-24 pain in extremity myocarditis; severe pain in my left shoulder, radiating down my left arm all the way to my fingertip... Read more
myocarditis; severe pain in my left shoulder, radiating down my left arm all the way to my fingertips; severe pain in my left shoulder, radiating down my left arm all the way to my fingertips; severe pain in my left shoulder, radiating down my left arm all the way to my fingertips; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration at the age of 43-years-old, administered in Arm Right on 26Mar2021 12:30 (Lot Number: EA8732) as single dose for COVID-19 immunization. Medical history included allergies, asthma, genetic predisposition to heart disease. Concomitant medication included unspecified medications. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 43-years-old, administered in Arm Right on 05Mar2021 12:30 (Lot Number: EN6199) as single dose for COVID-19 immunization. The patient reported, "I had severe pain in my left shoulder, radiating down my left arm all the way to my fingertips. The pain was severe enough to be admitted to a hospital, where they performed an angiogram and MRI, resulting in a myocarditis diagnosis. The doctors suspect that these symptoms may have been at least partially triggered by." The patient experienced myocarditis and severe pain in my left shoulder, radiating down my left arm all the way to my fingertips on 28Mar2021 18:00. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for the events for 3 days. The patient underwent lab tests and procedures which included angiogram: myocarditis diagnosis on 28Mar2021, MRI: myocarditis diagnosis on 28Mar2021, SARS-CoV-2 test: negative on 02Mar2021. Therapeutic measures were taken as a result of the events which included Ibuprofen, Colchicizine, and Metoprolol. The outcome of the events was recovered/resolved with sequel on an unspecified date. No other vaccine in 4 weeks. Not diagnosed with COVID prior vaccination.
43 2021-04-24 seizure Patient experienced a seizure resulting in cardiac arrest. Witnesses described patient "began convul... Read more
Patient experienced a seizure resulting in cardiac arrest. Witnesses described patient "began convulsing and then tipped over". AED applied with no shock advised. Unknown down time prior to initiation of CPR. Rhythm PEA upon arrival of EMS. 7 mins CPR before ROSC obtained. Initial troponin 12. 12 lead EKG without ischemic changes, arrhythmia, etc. Transthoracic echo without regional wall abnormalities or significant findings. CT of head negative for acute intracranial process. No history of seizure, cardiac issues, drug use, etc.
43 2021-04-24 tremor, flushing, weakness, unresponsive to stimuli Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespons... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient was coherent after shot sat down passed out. Hit head trauma scrape on head and knees and called ems showed up 5 minutes took pt walking away.
43 2021-04-25 weakness, numbness, tingling Dizziness and weakness, "Numbness and tingling; Hypertoniciy in legs, ringing in ears, riaght hand... Read more
Dizziness and weakness, "Numbness and tingling; Hypertoniciy in legs, ringing in ears, riaght hand very numb, loss of bladder contorl, basically every MS exacerbation symptom I've ever had showed up simultaneously."
43 2021-04-25 feeling hot, flushing felt hot, flushed face and felt itchy. Hives on hands. Rash on face and torso.
43 2021-04-27 pain in extremity, weakness PT called call center 4/28/2021. Verified pt with 2 identifiers. Pt denies emergency s/sx. Pt report... Read more
PT called call center 4/28/2021. Verified pt with 2 identifiers. Pt denies emergency s/sx. Pt reports he got 1st vaccine Pfizer 4/14/2021 and ili symptoms; sore throat, nasal congestion, left back(pressure pain but not chest pain or SOB per pt) and both legs pain(weakness but pt is able to walk around in his house without difficulties per pt) since Sunday evening 4/25/20201. Pt said his temperature 99F at noon 4/28/21. Pt is taking tylenol, lozenges and resting a lot and it's helpful. Pt scheduled at 8:45 am 4/29/2021 @ urgent care for evaluation. Pt is educated covid vaccine side effect and flu. Pt agreed and verbalized understanding.
43 2021-04-27 pain in extremity Sharp, quick pain in L pinky finger, repeating at intervals over the course of the day. Slight L-sid... Read more
Sharp, quick pain in L pinky finger, repeating at intervals over the course of the day. Slight L-side chest pain.
43 2021-04-27 tremor Pt called to c/o adverse effect to pfizer vaccine received at stadium on 4/22/21. Pt said evening of... Read more
Pt called to c/o adverse effect to pfizer vaccine received at stadium on 4/22/21. Pt said evening of Thursday 4/22/21, he felt tingling on tongue and back of throat. Friday tingling increased and by evening, per pt, increased tingling, shaking of lips, itchiness all over body. Pt called PCP advise nurse and was advised to take benadryl, Per pt, he took benadryl on Friday evening. On Saturday, there was increased tingling and itchiness, took another benadryl and eventually symptoms subsided on Sunday. Pt advised to f/u with PCP.
43 2021-04-28 burning sensation Extreme burning sensation on left arm with burning sensation travelling up to left ear Arm was late... Read more
Extreme burning sensation on left arm with burning sensation travelling up to left ear Arm was later swelling and difficult to clinch fist Tight tension turning arm Arm had a small scratch from a rose thorn later and became very itchy No muscle soreness in arm
43 2021-04-28 discomfort Mental and physical fatigue, headache, pain in both jaws and at injection site, sleepless night afte... Read more
Mental and physical fatigue, headache, pain in both jaws and at injection site, sleepless night after shot due to headache and inability to get comfortable
43 2021-04-28 pain in extremity left pinky toe became very sore, deep purple & red during night following vaccine received in the mo... Read more
left pinky toe became very sore, deep purple & red during night following vaccine received in the morning. Symptoms gradually subsided on their own during the next five days.
43 2021-04-29 weakness, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hype... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypertension-Severe, Systemic: Hyperventilation-Medium, Systemic: Tachycardia-Severe, Additional Details: Patient was unconscious for few seconds after the shot administration. he then became conscious but was dizzy, weak, pale. He was given water and sat down for few minutes. we called 911 and he continued to feel weak and dizzy. EMS said he had high blood pressure, high heart rate , they thought he possibly was in cardiac arrest. Patient was taken to the hospital via ambulance
43 2021-04-29 pain in extremity Received vaccine on 4/9/21 and had arm pain for 24-48 hours. This morning 4/30/21 started having se... Read more
Received vaccine on 4/9/21 and had arm pain for 24-48 hours. This morning 4/30/21 started having severe arm pain in left arm constant dull ache and stabbing sensations severe that comes and goes. No redness or swelling today at the site. Reports received first dose on 3/10/21 and 5 days later had bruise for 2 weeks. Spoke with Dr and advised to follow up with PCP.
43 2021-04-30 weakness Systemic: Pt had a panic attack and felt weak, laid on floor to avoid fainting-Mild, Additional Deta... Read more
Systemic: Pt had a panic attack and felt weak, laid on floor to avoid fainting-Mild, Additional Details: PT has severe vaccine anxiety. Pt always passes out after vaccination from the anxiety and adrenaline. Pt took a valium at some point prior to receiving vaccination at home.
43 2021-04-30 weakness Pain at injection site; Fever; Body aches; Headache; Weakness/lethargy; Weakness/lethargy; This is a... Read more
Pain at injection site; Fever; Body aches; Headache; Weakness/lethargy; Weakness/lethargy; This is a spontaneous report received from a contactable consumer (patient). This 43-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8729) on 11Apr2021 14:15 in left arm at single dose for COVID-19 immunization. Medical history included high cholesterol, high blood pressure. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8727) in Mar2021 14:30 in left arm at single dose for COVID-19 immunization and after the first dose, experienced strong soreness at injection site. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After second dose, starting 12 hours after injection, on 12Apr2021 15:00, patient experienced pain at injection site, fever, body aches, headache, weakness/lethargy. Symptoms fully resolved 48 hours after injection. No treatment received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovered on 13Apr2021. No follow-up attempts are needed. No further information is expected.
43 2021-04-30 bell's palsy Bells palsey; This is a spontaneous report from a contactable consumer, the patient. A 43-years-old ... Read more
Bells palsey; This is a spontaneous report from a contactable consumer, the patient. A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the right arm on 26Mar2021 at 08:15 (Batch/Lot number was not reported) as a single dose (at the age of 43 years-old) for COVID-19 immunisation. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Medical history included high blood pressure from an unknown date and unknown if ongoing and penicillin allergy from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisinopril, metoprolol, hydrochlorothiazide, and clarithromycin; all from unknown dates for unknown indications. The patient previously received bnt162b2, dose 1 via an unspecified route of administration, administered in the right arm on 05Mar2021 at 10:15 (Batch/Lot number was not reported) (at the age of 43 Years-old) for COVID-19 immunisation. On 11Apr2021 at 14:00 the patient experienced bells palsey (Bell's palsy). The event resulted in emergency room visit. Therapeutic measures were taken as a result of Bell's palsy and included prednisone and valacyclovir. The clinical outcome of the event Bell's palsy was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
43 2021-04-30 tingling, numbness Loud ringing in ears; numb/tingle in left pointer finger; numb/tingle in left pointer finger; This i... Read more
Loud ringing in ears; numb/tingle in left pointer finger; numb/tingle in left pointer finger; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN6204), via an unspecified route of administration in the left arm, on 18Mar2021 at 15:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no allergies to medications, food, or other products. The patient did not have any concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced loud ringing in ears and numb/tingle in left pointer finger on 21Mar2021 at 17:00. The events were reported as non-serious. The clinical outcome of experienced loud ringing in ears and numb/tingle in left pointer finger 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. No further information is expected.
43 2021-05-01 pain in extremity, feeling of body temperature change Extreme Tiredness, Headache, Muscle pain everywhere, Cold and Hot Flashes, Fever, Nausea, pain on le... Read more
Extreme Tiredness, Headache, Muscle pain everywhere, Cold and Hot Flashes, Fever, Nausea, pain on left arm, congestion, coughing up mucus, and coughing.
43 2021-05-02 flushing About 10 minutes after first dose (lot EN 6202, 2/25/21), briefly felt very flush in the face and fa... Read more
About 10 minutes after first dose (lot EN 6202, 2/25/21), briefly felt very flush in the face and faint. That passed quickly. Then had extreme burning sensation near injection site for about a minute. Did not report this at the time or before the second vaccine for fear of not being given the second injection. About 10 minutes after second dose, suddenly realized it was difficult to breathe. Removed mask. Started to feel better after a few minutes, replaced bottom, more breathable mask (did not report to observers). Was urged to leave vaccination site due to backlog of patients, so walked back to car. Began to feel pretty out of it (faint again, plus heart racing) on the way back to the car. Considered getting the shuttle back to the injection site, but instead sat in the car until it passed. About 25 minutes after the vaccine, started feeling very hot all over. 30-40 minutes after the vaccine, all reactions seemed to have passed and drove home without incident.
43 2021-05-02 tingling, throat numbness 1. Immediately upon injection, my tongue started to go numb, and it was numb/tingly within 10 second... Read more
1. Immediately upon injection, my tongue started to go numb, and it was numb/tingly within 10 seconds. 2. Over the 15 minutes I sat and waited, the sensation spread to much of my mouth and started to go down into my throat. I did not feel like anything was swelling per se, but definitely numb. 3. At 15 mins, it still seemed to be progressing, so I notified staff and went back to the first aid area. I was monitored and we waited to see what would happen. The numbness went a good way down my throat. 4. When I had some water, I noted that I was able to swallow fine but could barely feel the water going down. I also noted the tingling sensation had spread to the lower part of my face (that had been covered by my mask), though my face was not completely numb -- it felt like when local anesthetic is wearing off. 5. I stayed for a while longer, was evaluated by a doctor, and was eventually released. The numbness largely subsided by 4-5 hours after injection. 6. Notably, I have never had any sort of reaction to a vaccine before. 7. Concerned at a stronger such reaction to the second injection, an immunologist suggested I skip it and instead.
43 2021-05-03 weakness Day of 2nd dose of vaccine received: mild soreness in shoulder, neck and back, around the area where... Read more
Day of 2nd dose of vaccine received: mild soreness in shoulder, neck and back, around the area where the shot was given. Day after vaccine: lower than normal energy, but otherwise fine. Two days after vaccine: low energy, body aching, occasional cough. Three days after vaccine: similar symptoms of the previous day. Four days after vaccine: lower energy, body aches, coughing, persistent headache, eyes feeling tired and burning, and congestion starting in my chest, all worsened in the evening. Five days after vaccine: congestion in chest, regular cough, sore throat, runny nose, eyes feeling dry and burning, shortness of breath. Was tested for Covid on the fifth day after the vaccine. Six days after vaccine, chest congestion, coughing, sore throat, runny nose, shortness of breath, and still low energy. Covid test result came back as negative.
43 2021-05-03 numbness Left arm was completely numb for 1 day
43 2021-05-03 tingling Pt had sudden onset of diaphoresis, pallor to face, left hand tingling and nausea @ 1135.BP 99/69, H... Read more
Pt had sudden onset of diaphoresis, pallor to face, left hand tingling and nausea @ 1135.BP 99/69, HR 78, RR 16, temp 97.8. Pt provided bottled water and consumed 2 bottles, tolerated well. Color returned to normal and no longer diaphoretic. Patient nausea and left hand tingling resolved.
43 2021-05-04 bell's palsy Bell's palsy; This is a spontaneous report from a contactable consumer, the patient. This 43-year-ol... Read more
Bell's palsy; This is a spontaneous report from a contactable consumer, the patient. This 43-year-old male patient, height: 66.22 cm & weight: 175 kg, received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734), via an unspecified route of administration in the left arm on 10Apr2021 17:00 (at the age of 43-year-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not enrolled in the clinical trial. Medical history included LASIK eye surgery. Concomitant medication(s) included prednisolone acetate (manufacturer unknown) and moxifloxacin (manufacturer unknown) both were taken after LASIK eye surgery. On 19Apr2021 12:30, the patient experienced Bell's palsy. The clinical course was described as follows: On 19Apr2021 at 12:30, the patient was eating lunch and he noticed the left side of his face was a little numb. The patient states he thought originally that he might be having an allergic reaction, but he was eating the same food that he always eats so it couldn't have been that and sort of ignored it. About 21:30, 22:00 at night (19Apr2021), he realized in the shower that he could not open his right eye, right eyelid, then his face was numb and he couldn't form his mouth to make a whistle, and he still can't, and he thought he was having a stroke because his face was all messed up. So that's when he went to the emergency room and they did a CAT scan that determined it was not a stroke, it is Bell's Palsy. The patient stated they prescribed him medications to take, and he was not hospitalized and discharged home. The patient stated his eyelids, they don't blink at the same rate and his left eye doesn't close all the way, he had to force it closed and it's very annoying. The patient verified that all his symptoms began on 19Apr2021 at 12:30 and all symptoms have worsened. The patient stated that he is perfectly healthy, not overweight and he's never had it before, and it came right out of the blue. The clinical outcome of the Bell's palsy was not resolved.
43 2021-05-06 feeling cold during the following 3 weeks, I'd experienced weird things like anxiety( excessive worries about any... Read more
during the following 3 weeks, I'd experienced weird things like anxiety( excessive worries about anything, feeling of my heart beating fast, sometimes feeling my breathing is very fast, chest tightness or heaviness, and feeling that I'm losing control for few seconds, feeling cold that I put on the heavy jacket that I never used except in cold winter! feelings of boneaches especially in my fingers joints, some days I'd nausea and feeling that my stomach torture me! All the previous symptoms were on and off many times per day, I was using Tylenol and Ibuprofin almost every day. lately, I'd 4 days of continuous symptoms, that I feel like panic and cold with all the above symptoms.(from 29th April to May 3rd).
43 2021-05-06 seizure syncopal episode; mild seizure activity; This is a spontaneous report from a contactable healthcare ... Read more
syncopal episode; mild seizure activity; This is a spontaneous report from a contactable healthcare professional. A 43-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ew0161) at the age of 43-years-old, intramuscular in left arm on 20Apr2021 at 11:00 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were reported as none. He has no COVID prior to vaccination and denied being allergic to anything. There was no other vaccine in four weeks and no other medications in two weeks. The patient received his first dose of COVID-19 vaccine in a workplace clinic on 20Apr2021 and experienced syncopal episode with mild seizure activity at 11:15, within the 15-minute period post vaccination (as reported). No treatment was given in response to the events. It was unknown if the patient was tested for COVID post vaccination. The outcome of the events was unknown.; Sender's Comments: A contributory role of BNT162B2 to the reported events cannot be fully excluded based on close temporal relationship and lack of alternate explanation at this time. However, the information provided is very limited and does not allow for a complete medical assessment. Case will be reassessed if additional information is received. 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.
43 2021-05-07 cold sweat The night after getting the vaccination I had extreme pain in the joints and muscles as well as head... Read more
The night after getting the vaccination I had extreme pain in the joints and muscles as well as headache and fatigue. The pain kept me from sleeping, and woke me up at night for several nights in a row. The joint pain didn?t completely subside for over two weeks. I was also very fatigued, sleeping 10 to 12 hours a night for two weeks. I normally sleep 7 to 8 hours a night. My muscles also felt weak and sore for over a week. Shot one messed me up bad. The first night I also had clammy feeling skin and a slight feverish feeling, although I didn?t take my temperature.
43 2021-05-08 tingling, hypersensitivity of all senses Shingles. I received the second dose of covid vaccine on Wed, April 28. Three days later, Saturday ... Read more
Shingles. I received the second dose of covid vaccine on Wed, April 28. Three days later, Saturday May 1, I woke up with intense abdominal pain, spanning the entirety of my stomach, and wrapping around my right oblique and kidney area. I had thrown out my back one week prior, assumed this was more muscle pain, and treated it as such. The Monday following, May 3, I went to the chiropractor, still in intense pain, but also with a tingling sensation on the affected area, sensitivity to the touch without pain. I assumed that I had burned myself with the heating pad. Wednesday a rash began to form in the affected area. My pain was nearly gone, I no longer felt muscle tightness, and assumed that the condition was resolving itself, and that the rash was heat rash from the heating pad. Friday the rash was redder and my abdomen showed signs of significant swelling. I still thought this was muscular, that perhaps I had pulled the abdomen, treated with ice and decided to visit Orthopedic urgent care Saturday. Saturday the pain had increased. I went to Urgent care, and was told I have shingles. I asked if the covid vaccine could have caused shingles to flare, was told "theoretically", but thar we do not really know enough to say whether the vaccine contributed, or whether it was coincidence. At home, I read a bit on the covid vaccine qnd shingles, saw what appeared to be anti-vaccer propaganda, but also read about this self-reporting system...so, I thought that I might as well submit my info.
43 2021-05-10 slurring Patient drinking beer prior to vaccination earlier in the day. Didn't eat. Felt dizzy with headach... Read more
Patient drinking beer prior to vaccination earlier in the day. Didn't eat. Felt dizzy with headache and noticed slurred speech. No other symptoms. Monitored and felt better < 20 minutes. Ambulating independently and had a ride home, able to leave after monitoring.
43 2021-05-10 numbness, burning sensation Per patient: Patient received vaccine around noon on the 12 of March 2021 at Community Church. Patie... Read more
Per patient: Patient received vaccine around noon on the 12 of March 2021 at Community Church. Patient states about 10 -12 hrs later, began an adverse cardiac event. Patient states the day before he injured his knee at work and went to ED from an injury the day before. At the ED they gave Fentanyl and he got sick and told the nurse that he was experience chest pain. Felt burning or falling asleep sensation in arm and chest. Told the nurse he felt like he was having a heart attack. They came in ED with crash cart and confirmed that he was having a heart attack while in ED. Transported from church to hospital.
43 2021-05-11 facial paralysis right facial droop
43 2021-05-12 pain in extremity Nausea, fatigue, sore arm, diarrhea, malaise
43 2021-05-13 weakness Patient developed acute kidney injury 3 days after he received the vaccine. He initially presented ... Read more
Patient developed acute kidney injury 3 days after he received the vaccine. He initially presented with emesis, myalgias and weakness and then found to have acute renal failure
43 2021-05-14 bell's palsy Diagnosed with Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 4... Read more
Diagnosed with Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration at the age of 43-year-old administered in left arm on 24Mar2021 18:00 (Lot Number: ER8730) as single dose for covid-19 immunisation. The patient previously took the first dose of BNT162B2 and administered in left arm at the age of 43-year-old on 24Feb2021 18:00 (Lot Number: EL9261) for covid-19 immunisation. Medical history included hypertension. No known allergies. Concomitant medication included bisoprolol fumarate, hydrochlorothiazide (ZIAC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with bell's palsy on 06May2021 05:00. Event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not have Covid prior vaccination and did not have Covid tested post vaccination. Therapeutic measures were taken as a result of diagnosed with bell's palsy as treatment of antiviral and steroids. The outcome of the event was recovering.
43 2021-05-16 bell's palsy Bells Palsy, onset 5/16/2021. Treatment started with prednisone, unknown outcome at this time.
43 2021-05-16 tingling received the first dose of Pfizer COVID-19 (Lot#: EN6207) in the left deltoid in the early afternoon... Read more
received the first dose of Pfizer COVID-19 (Lot#: EN6207) in the left deltoid in the early afternoon of March 24, 2021. He immediately felt left hand tingling/numbness at his left thumb and first finger that has intermittently worsened with flexing his arm. There was no local reaction. The next morning, he experienced severe fatigue, headache, muscle aches/soreness, fever and mild chest congestion that resolved after 5 days. He also developed itching and hives that occurred from his chin downward on his neck, bilateral shoulders, back, chest and abdomen with no hives below his waist. He had photo showing erythematous blotchy rash scattered over this neck, anterior shoulders, chest and upper abdomen. The hives continued daily despite Claritin 10 mg daily and have gradually subsided. There was no nausea, vomiting, diarrhea, abdominal pain, dysphagia, swelling, cough, wheeze or shortness of breath. HIs last hives was 2 days ago and no hives today. Prior to the vaccine he was well without colds or flu-like symptoms in his usual state of health. He had not taken NSAIDs or other medications or supplements.
43 2021-05-17 nerve pain In between my first and second shots I started having pain in my right side back and right side fron... Read more
In between my first and second shots I started having pain in my right side back and right side front. Dull kinda pain, soreness...not super sharp or anything. It was severe enough that I couldn't sleep at night. I still kept my second vaccine appointment which was in a couple days and booked an appt. with my doctor. It was about a week until I could get in to the office. In that time I got a small herpetic rash about the size of two fifty cent pieces on my right side. I went to the office and the doctor identified it as Shingles...which is not something I've had before. He put me on an oral steroid for 6 days, anti-viral medicine(Valacyclovir), and something for nerve pain (Gabapentin). All of which helped and I appear to have recovered so far.
43 2021-05-18 hot flush Severe cough, runny nose, hot flashes, pain in chest
43 2021-05-18 nerve pain My memory, my cognitive skills has declined/severe cognitive and neurological decline within a day o... Read more
My memory, my cognitive skills has declined/severe cognitive and neurological decline within a day or so of getting it; Neurological decline; I haven't been able to walk/can't even walk unassisted; My skin feels like it's on fire all the time; Very bad nerve pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8731; Expiration Date: Jul2021), via an unspecified route of administration, administered in arm left on 10Apr2021 at 13:00 (at the age of 43-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included fusion of C-spine, and problems with C spine from an unknown date and unknown if ongoing. Concomitant medication included oxycodone taken for spinal disorder, start and stop dates were not reported. On 11Apr2021, the patient stated, 'I haven't been able to walk, my skin feels like it's on fire all the time, I've got like very bad nerve pain and, my memory, my cognitive skills has declined. I was able to walk and I was functionable before I got the COVID 19 vaccination.' The patient's wife stated, "He was actually admitted in to hospital for 4 days, 2 weeks ago and they did lot of different lab work and medical tests, MRI, CT scans and full blood work as far as the actual individual details of what they ran, it's a long list and I don't have that handy." Further added, "They gave him a lot of new medications to try to treat the burning in the skin and the nerve pain and he is also has now been admitted into an extensive long outpatient recovery program for cognition, we are working with the occupational therapy and his speech therapy." Her husband had only the first Pfizer vaccine and has severe cognitive and neurological decline within a day or so of getting it. He can't even walk unassisted. He's between a walker and a wheelchair right now and cognition is so bad that some days he can't even process how to feed himself. It was reported that the adverse events started on 11Apr2021. The patient was hospitalized for the events from Apr2021 to Apr2021. The patient underwent lab tests and procedures which included blood test, computerised tomogram and magnetic resonance imaging, all with unknown results on Apr2021. Therapeutic measures were taken as a result of my memory, my cognitive skills has declined/severe cognitive and neurological decline within a day or so of getting it, neurological decline and i haven't been able to walk/can't even walk unassisted. The outcome of the events 'My skin feels like it's on fire all the time' and very bad nerve pain was unknown, while of the rest was not recovered.
43 2021-05-19 migraine Migraines 5 days after 1st dose Head Pressure Tinnitus Headaches Brain Fog Eye Floaters
43 2021-05-19 tingling arm where injection occurred has had pain since injection. Can be enough to wake him from sleep. ... Read more
arm where injection occurred has had pain since injection. Can be enough to wake him from sleep. Better if avoids using arm, worse if exercises or uses arm in other ways. Also tingling from upper arm to fingers, off/on with no clear pattern
43 2021-05-20 muscle spasms, restless legs syndrome I had an extremely sore body and couldn?t lift my left arm over my head (I have some should problems... Read more
I had an extremely sore body and couldn?t lift my left arm over my head (I have some should problems anyway, but it made it worse). I had a slight headache, but it wasn?t too bad at that point (maybe about 9:30pm). By 12:30am I was feeling pretty crummy in a general sense and decided to go back to bed (I work nights and normally stay up, even on my nights off). I ended up with severe chills and shivering and shuddering by 1:30am. My legs were so restless and I was shuddering so hard I gave myself charlie horses. By 2:30am I started to warm up but because especially nauseated as I got warmer and warmer. I tried to sleep off and on, but ended up in a chair sitting up and dozing with a bucket in case of getting sick. I was panting heavily for some reason. It felt like it was making the nausea less severe (I also sipped on an Alka-Seltzer and took a meclizine). For three hours I was panting and trying not to vomit. Then I kind of settled down and got an hour or two of sleep, still extremely sore and by this time my head was pounding severely. I got up at 6:30am to take my Mirilax in orange juice (I forgot to mention I take a magnesium supplement and senna on a semiregular basis, as well). The combination of Mg, senna, and OJ didn?t sit well. By about 7:30am I began to get the chills again, but it only lasted about a half hour. Again, an episode of nausea after, but more Alka-Seltzer. I tried to eat small amounts of plain salty tortilla chips, but it didn?t help. It?s now 8:20am and the nausea seems to have passed.
43 2021-05-22 muscle spasms Difficulty injecting vaccine into muscle (person giving shot seemed to be having some issues). 16 ho... Read more
Difficulty injecting vaccine into muscle (person giving shot seemed to be having some issues). 16 hours after - moderate headache, pulsing and especially painful when bending over or moving quickly 24 hoyrs after- tightness, muscle spasms spreading from left lower back to right diaphragm. 40 hours after- fever (at first 99.8; 100.6 at 10:00 PM on 5/19, 101.7 at 10:00 PM on 5/20, 102.4 at 10:00 PM on 5/21, 103.2 at 10:00 PM on 5/22. 60 hours after - slight (mostly unproductive) cough with occasional faint bubbling/buzzing when laying down and breathing. From 30 hours later to 60 hours later- Ibuprofen 400 mg 5 times daily - some relief in fever, but very temporary After appointment with clinic: Acetaminophen 1 mg 3 times daily. Just started on 5/22- has not helped yet.
43 2021-05-22 pain in extremity Diarrhea within 5 hours, arm sore at 8 hours, fever (100.2), headache and chills and body aches at 1... Read more
Diarrhea within 5 hours, arm sore at 8 hours, fever (100.2), headache and chills and body aches at 18 hours. The fever kept increasing from 100.2 to 103.5 from hours 18- 36. At hour 36 the fever dropped to 100.7. I'm still fevering with a headache and body ache. It's now 53 hours after the shot. I also had covid badly for 28 days straight. It turned into pneumonia and bronchitis. My bout with covid and did 33 days before my vaccination.
43 2021-05-24 nerve pain Mild case of shingles. Scalp tenderness, small rash around eye. Nerve pain. Antiviral valocyclovi... Read more
Mild case of shingles. Scalp tenderness, small rash around eye. Nerve pain. Antiviral valocyclovir prescribed 4 days after onset of symptoms. Cleared up after 2 weeks.
43 2021-05-25 hot flush Pt. Had glucose level drops. Down into 60's with no previous issue with hypoglycemia, pale skin in f... Read more
Pt. Had glucose level drops. Down into 60's with no previous issue with hypoglycemia, pale skin in face. Severe fatigue, low blood pressure readings of 112/60 and 110/90. Hot flashes and nausea. Non-coherent with glassy eyes with no awareness. Fluctuations in symptoms and slept for Three days in and out. Pt. Took approx. Three days to feel back to himself.
43 2021-05-25 tingling Within 10 min after receiving the first dose of Pfizer Vaccine. Patient started sweating, tingling i... Read more
Within 10 min after receiving the first dose of Pfizer Vaccine. Patient started sweating, tingling in his hands. His BP was low (98/60) Temp: 96.6.
43 2021-05-26 tingling, pain in extremity Three days after my second shot (on 05/03/2021) I started to feel pain in my left arm, tightness in ... Read more
Three days after my second shot (on 05/03/2021) I started to feel pain in my left arm, tightness in chest, and I became very light headed. I tried to go to shower but I could not walk and laid down. My ears felt very tingly and I thought I was going to pass out but as far as I know, I did not. I went to my primary care doctor and he has me taking baby aspirin daily (in case blood clot) and wanted to see if it got better I am going to follow up with a cardiologist. I've never had a problem with heart before and get an annual physical at work.
43 2021-05-28 pain in extremity The events have been injection site pain, arm soreness, headaches, dizziness, nausea, diarrheas, swe... Read more
The events have been injection site pain, arm soreness, headaches, dizziness, nausea, diarrheas, swelling, and vomits.
43 2021-05-30 pain in extremity Upper arm pain and decreased range of motion remaining at 5 weeks post shot. Unable to do typical a... Read more
Upper arm pain and decreased range of motion remaining at 5 weeks post shot. Unable to do typical activities of daily living as pain is restrictive and severe.
43 2021-05-31 unresponsive to stimuli During observation period, patient became unresponsive to verbal and non-verbal cues. Patient had a... Read more
During observation period, patient became unresponsive to verbal and non-verbal cues. Patient had a briwf period of loss of consciousness less than 5 seconds in length. Patient regained consciousness. EMS called. Patient observed for an extra 10 minutes. Patient returned to homeostasis. Patient left.
43 2021-06-01 muscle twitching chest pain made him go to the emergency room because it was too much, it was multiple throughout the... Read more
chest pain made him go to the emergency room because it was too much, it was multiple throughout the day not just one time; his penis sensations are a lot different; has had a bad headache where it feels like he has vibrating inside of his head, in his chest and in his abdomen; when he falls asleep he wakes up in an hour; getting shocked in the middle of the night when he is sleeping- in his chest and intestines; getting shocked in the middle of the night when he is sleeping- in his chest and intestines; limbs twitch; This is a spontaneous report from a contactable consumer. A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: ER8732; Expiration Date: 31Jul2021), 1ST DOSE SINGLE via an unspecified route of administration, administered in Arm Left on 27Mar2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced chest pain made him go to the emergency room because it was too much, it was multiple throughout the day not just one time, has had a bad headache where it feels like he has vibrating inside of his head, in his chest and on 31Mar2021, when he falls asleep he wakes up in an hour 31Mar2021, getting shocked in the middle of the night when he is sleeping- in his chest and intestines on 31Mar2021, getting shocked in the middle of the night when he is sleeping- in his chest and intestines on 31Mar2021, limbs twitch on 31Mar2021, his penis sensations are a lot different. It was reported that 5 days after he got the first dose of the COVID vaccine he started getting pains and the major thing is at night. If he falls asleep, he wakes up in an hour and that has been every night for a month and a half. That is the main thing that is pissing him off. He confirms that he is having issues with his chest and his intestines like he mentioned previously and he has started keeping track and has kept a journal of the pains. This stuff is new. He has never experienced this before and it has been happening every day starting 5 days after when he got the COVID vaccine. He had the COVID vaccine on 27Mar2021 and on 31Mar2021 he got the first shock in his chest at 0120 in the morning when he was sleeping. Then that went on for a week, he had it on 31Mar2021, 01Apr2021, 02Apr2021, 03Apr2021 and 04Apr2021 where he was getting shocked in the middle of the night when he is sleeping. On 04Apr2021 he had to go to the emergency room and have them look at him. But since 31Mar2021 he has been getting up every hour after he falls asleep. This was all worse when it first started because he has never experienced anything like this. The first shock he had was a hard feeling in his chest and then he couldn't go back to sleep. It is so bad. After he went to the emergency room, that is when it started being not as much of a shock pain that woke him up but he was still waking up every hour. The pains are in his upper chest and in his intestines. Also his limbs twitch and he has had a bad headache where it feels like he has vibrating inside of his head, in his chest and in his abdomen. He confirmed that these also began on 31Mar2021 and have been happening whenever they want and he has never experienced all of that before. Never. Everything has all stayed the same. The sad part is that he just thinks that he is getting used to this "new normal" because he is now going on the second month of this and his body is adapting but this is not normal. Also, he guesses that he shouldn't be shy now but the last thing is that his penis sensations are a lot different and he didn't notice until the first time that he was having relations with his wife after the COVID vaccine and it is all different. He noticed and she did too as far as whenever they were trying to have relations. It has been more than once, it has been every time they have tried afterwards. He says his doctor is going to send him to a sleep lab but he wasn't expecting that. He thought that maybe he would need to go somewhere else. But there he will go to sleep and be hooked up and they will read his whole body and tell the reason why he is waking up every hour. The outcome of the event headache, sleep disorder, chest discomfort, muscle twitching was not recovered and penis order, headache was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
43 2021-06-01 pain in extremity, numbness On 5/3/2021, patient called hospital call center to report side effects experienced 4/17 from 1st do... Read more
On 5/3/2021, patient called hospital call center to report side effects experienced 4/17 from 1st dose Pfizer vaccine. Patient denied emergency symptoms at time of call. Patient only wanted to report symptoms experienced in the past. Advised by PCP to report side effects. 3 days after 1st dose Pfizer vaccine on 4/13, patient reported having pain and numbness in both arms and hands, pain in legs after walking and chest pain. Patient states he did not seek emergency attention on 4/17, but later scheduled an appointment with his outside PCP. Patient underwent blood tests and reports being prescribed a stronger dose of Ibuprofen for 2 weeks.
43 2021-06-01 unresponsive to stimuli PATIENT DID WELL UPON IMMEDIATE RECEIPT OF VACCINE. MOVED PATIENT TO OBSERVATION AREA. WITHIN 10 MI... Read more
PATIENT DID WELL UPON IMMEDIATE RECEIPT OF VACCINE. MOVED PATIENT TO OBSERVATION AREA. WITHIN 10 MINUTES PATIENT FAINTED ONTO FLOOR,HIT HEAD AND BECAME NONRESPONSIVE. WE CALLED 911. WITHIN SECONDS HE BECAME RESPONSIVE AND DID NOT WANT EMS TO COME. WE GOT ICE PACKS FOR THE BACK OF HIS NECK AND FOREHEAD AND MADE HIM COMFORTABLE ON THE FLOOR. HE CONTINUED TO SAY HE WAS FEELING BETTER AND THAT IT JUST CAME ON VERY QUICKLY. AFTER 20MINUTES HE WANTED TO SIT UP IN THE CHAIR. AFTER A FEW MINUTES WE MOVED HIM TO A MORE COMFORTABLE CHAIR. PATIENT CONTINUED TO TALK AND RESPOND. AFTER 15 MORE MINUTES HE DECIDED HE WAS GOOD ENOUGH TO LEAVE.
43 2021-06-02 sensory loss This is a spontaneous report from a contactable consumer (patient). A 43-years-old male patient rece... Read more
This is a spontaneous report from a contactable consumer (patient). A 43-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had dizziness like someone is pushing me off sensation. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
43 2021-06-06 flushing, tremor Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Severe, S... Read more
Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Severe, Systemic: Diarrhea-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium
43 2021-06-07 pain in extremity Very strong pain in the soles of the feet, especially the left foot. Pain is intermittent, it comes ... Read more
Very strong pain in the soles of the feet, especially the left foot. Pain is intermittent, it comes and goes.
43 2021-06-09 weakness Developed right neck swelling/adenopathy which spread to the left. Significant to impair neck mobil... Read more
Developed right neck swelling/adenopathy which spread to the left. Significant to impair neck mobility. Developed high fevers roughly 12 hours later with rigors. Was seen in the emergency department. Found to be febrile, significantly tachycardic (sinus) . Was given vancomycin, ceftriaxone empirically. Felt ill for the next 48 hours afterwards with weakness, slow to resolve tachycardia and cough. Neck swelling subsided however, right neck lymphadenopathy persisted for well over a month. Was sent home from ED with Bactrim and keflex for coverage of possible neck cellulitis. However, I do not believe it was a cellulitis. Neck was not tender, not indurated nor erythematous. I am a hospitalist and had colleagues take a look as well.
43 2021-06-09 numbness Left foot became swollen the day after first dose then continued to swell with numbness in both fee... Read more
Left foot became swollen the day after first dose then continued to swell with numbness in both feet then by the 5th day my right foot became extremely swollen and i went to medical center. A rash formed I also on my ankle area . I took pictures if needed. Spent 2 night in observation at hospital. Still have numbness and raised skin on my right toe.
43 2021-06-09 migraine Quick onset photo and sound sensitivity, nausea, vomiting on 4/16 from 4/16 through 6/5, continued t... Read more
Quick onset photo and sound sensitivity, nausea, vomiting on 4/16 from 4/16 through 6/5, continued tinnitus and migraine symptoms (photo sensitivity and sound sensitivity, sinus pressure, intermittent headaches)
43 2021-06-10 tingling Loss of hearing in my right ear. Tingling sensation then couldn't hear anything. Had annual physical... Read more
Loss of hearing in my right ear. Tingling sensation then couldn't hear anything. Had annual physical with primary care physician first , then waited a week or two to see if there was improvement. Went to ENT physician for audiology exam. Ear structure and everything internally appears to be normal. Audiology exam had abnormal results in the right ear. Left ear was fine. Physician injected a steroid into the inner ear. Then prescribed methylprednisolone for a six-day course of therapy. Will see physician again in less than three weeks. No improvement. Only less and less hearing in the right ear.
43 2021-06-10 seizure I started having pain 2-3 hours after receiving the vaccine. I started having convulsions late at ni... Read more
I started having pain 2-3 hours after receiving the vaccine. I started having convulsions late at night from 12:15AM-12:45AM. I put my symptoms in my app, for the hospital, and my doctor called me and told me to go to the hospital. I went to the hospital and had my appointment. They did a detailed check-up and did not find anything wrong. My doctor told me that if I have these episodes anymore, then I need to contact her and go to the hospital. I have not had any other episodes except for that night.
43 2021-06-14 tremor Chest tightness, shakiness, OFF balance (almost fell when trying to go to bathroom), Fever <100F,.
43 2021-06-20 numbness and pain in extremities, numbness With my 1st vaccine I just had soreness around the injection site. After the 2nd vaccine I woke up a... Read more
With my 1st vaccine I just had soreness around the injection site. After the 2nd vaccine I woke up at 4am on 1/31/2021 with muffled hearing in my left ear and mild numbness in the entire left side of my body from top of my head to bottom of my feet. I experienced vomiting and diarrhea also. I had blood pressure of 150 /105 and pulse rate of 100. My doctor was afraid I had a stroke, so I went to the ER and had a CT scan in brain. I tried to go to work the next day but my head was foggy so I had to leave work. I had a test for carotid arteries and heart test that came back fine. I was sent to a neurologist. He suspected I had possible swelling in the spinal cord, but since I was feeling a little better he thought it was ok to wait to have a spinal tap. He described that the symptoms were MS dialed symptoms but did not feel I had MS. I've gotten better but continue to have a neuropathy pain in my left foot, left hand, and left side of my face. It tends to get worse at night but in the morning it is ok. It continues through the day. None of these symptoms were there before the vaccine.
43 2021-06-20 tingling, numbness and pain in extremities neuropathy of both legs few hours after shot - it went away after 12 hours few days after the shot I... Read more
neuropathy of both legs few hours after shot - it went away after 12 hours few days after the shot I start to have occassional pins and needles in little finger on left arm (the injected arm)
43 2021-06-21 flushing At 1258. Patient started feeling itch, slightly lightheaded when sitting up, "weird tingle" in throa... Read more
At 1258. Patient started feeling itch, slightly lightheaded when sitting up, "weird tingle" in throat, dizziness, slight confusion. Vital sings 140-78/HR76 /R16, 93@ O2Sat. Skin warm and dry. Forehead is slightly flushed and war, Cap refill good, breath sounds clean bilaterally. Had patent lay down for vital signs, sat up and given water. Patient became dizzy upon sitting, returned to supine position. 1313 vital signs 122/80/HR76/R20. Skin warm and dry, good cap refill, breath sound clear bilaterally. 1328 had patient sit up, no initial dizziness orthostatic vital signs: Supine 118/80/HR80/R20. Sitting 140/100.. Patient discharged in stable condition in the company of his wife. Pt is alert and oriented times 3. Skin pink, warm and dry. Agrees to follow up with PCP or EMS if any signed of diff breathing, throat tightness were to occur on his arrival home.
43 2021-06-22 muscle spasms Developed mild pain in the chest the day following the first vaccine dose, painful muscle cramps at ... Read more
Developed mild pain in the chest the day following the first vaccine dose, painful muscle cramps at arm/injection site, muscle cramps in feet, and very painful colon inflammation which made it difficult to move around. Also felt feverish for two nights after the injection but did not take temperature to confirm. All other symptoms and body inflammation appeared to have resolved with the exception of painful inflammation in the knees which appeared after all other inflammation symptoms at various other body sites dimminished.
43 2021-06-23 discomfort Patient reported he received a dose of the Pfizer COVID vaccine 1 day before onset of increasing fir... Read more
Patient reported he received a dose of the Pfizer COVID vaccine 1 day before onset of increasing firm nontender swelling of the left costochondral junction at the level of the 2nd rib. On exam, this area was nontender and palpated similar to a skeletal prominence but patient endorsed that this was entirely new to him. He felt discomfort deep to the swelling, but this was not worsened by touching the area.
43 2021-06-28 feeling hot, cold sweat tired / fatigue; headache; soreness; chest had a weird feeling like pressure, along with some stingi... Read more
tired / fatigue; headache; soreness; chest had a weird feeling like pressure, along with some stinging sensations localized; chest had a weird feeling like pressure, along with some stinging sensations localized; passed out while he was sitting and hit his head that left a bloody scrape; felt dizzy, hot, clammy; felt dizzy, hot, clammy; felt dizzy, hot, clammy; heart rate increased; felt anxious; passed out while he was sitting and hit his head that left a bloody scrape; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old male patient received BNT162B2 (Lot Number: EW0178), dose 1 via an unspecified route of administration, administered in arm right on 11Jun2021 15:00 (at the age of 43-year-old) as single dose for covid-19 immunisation. Medical history included slight heart myopia, high tryglicerides that medicine was keeping at normal levels. No past drug history. Concomitant medication included atorvastatin and fenofibrate. 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 had not been tested for COVID-19. Within 5 minutes of the injection (11Jun2021 15:05), the patient felt dizzy, hot, clammy, his heart rate increased and felt anxious, then he passed out while he was sitting and hit his head that left a bloody scrape. Then it took about 45 minutes to feel a little better. Then 24 hours later (12Jun2021) the patient really was tired, headache, fatigue, soreness, and his chest had a weird feeling like pressure, along with some stinging sensations localized. The outcome of events felt dizzy, hot, clammy, heart rate increased, felt anxious, passed out while he was sitting and hit his head that left a bloody scrape were recovering, the rest of events were unknown. No follow-up attempts are possible. No further information is expected.
43 2021-06-29 discomfort, tremor First four days normal symptoms. Patient started having tremors and shakes. Patient felt somethin in... Read more
First four days normal symptoms. Patient started having tremors and shakes. Patient felt somethin in his lung almost like he had Pneumonia. Patient stated that he would go to sleep and wake up disorientated. patient is experiencing neck stiffness and tightness in his right arm.
43 2021-06-29 pain in extremity The day after this first vaccine the muscle soreness started to set in. That was expected. I felt ... Read more
The day after this first vaccine the muscle soreness started to set in. That was expected. I felt soreness in my hands that i've never experienced before. It moved up to include the forearms. I've been dealing with this pain ever since. i've been through 2+ months of physical therapy. That doesn't seem to be curing it. I'm heading to an Ortho doc next week. My GP ruled out carpal Tunnel Syndrome.
43 2021-06-30 difficulty speaking Almost about 1 week after getting second shot of covid-19 vaccine I started feeling weird on right s... Read more
Almost about 1 week after getting second shot of covid-19 vaccine I started feeling weird on right side of my body. Swollen right side of my body specially facial area, which got worse over the period of time. Now main symptoms i am having are tender facial muscles , hoarseness, loss of voice and blurry vision on right side. Symptoms got worse last week.
43 2021-07-06 bell's palsy I got Bell's Palsy. Over 5 weeks later and still no improvements. Also have severe vertigo from t... Read more
I got Bell's Palsy. Over 5 weeks later and still no improvements. Also have severe vertigo from the Bell's Palsy and cannot work.
43 2021-07-07 tremor Patient said he was feeling lightheaded and shaky. He was asked if he had trouble breathing and he s... Read more
Patient said he was feeling lightheaded and shaky. He was asked if he had trouble breathing and he said yes. One dose of Epipen was given and 911 was called.
43 2021-07-09 burning sensation Hematoma was noted immediately after giving vaccination. Patient was advised to use ice packs or OTC... Read more
Hematoma was noted immediately after giving vaccination. Patient was advised to use ice packs or OTC pain relievers if necessary. After 15 minutes of post-vaccination monitoring, patient reported feeling burning sensation up and down the arm and side of neck. Aside from the vaccination site no redness, swelling, or hives were visible. Patient stated no trouble breathing or lightheadedness and was told to monitor for another 15 minutes. After the 15 minutes had passed, patient reported sensation was slowly dissipating but still noticeable. Patient was advised to continue monitoring at home for the next 24 hours and to seek medical attention if symptom worsens or new unusual symptoms develop.
43 2021-07-10 pain in extremity I had normal muscle soreness in my left arm (arm I received the vaccine). When that soreness subsid... Read more
I had normal muscle soreness in my left arm (arm I received the vaccine). When that soreness subsided, I started having pain in the inside of my elbow? at the bone/joint. It feels like throbbing arthritis. I have not yet sought any treatment for this, but plan to see an orthopedic
43 2021-07-10 pain in extremity A few hours after vaccine , tendon in left foot started flaring causing pain. 5 hours after, severe ... Read more
A few hours after vaccine , tendon in left foot started flaring causing pain. 5 hours after, severe pain, cannot even walk , pain while sedentary , feels like a broken foot so much pain in tendons .
43 2021-07-12 tremor, weakness Kind of fainted because he was not able to say anything/severe pass out and couldn't see anything li... Read more
Kind of fainted because he was not able to say anything/severe pass out and couldn't see anything like everything was black/Suddenly all stuff fell off on floor, started reacting very bad; Blood pressure went down; Suddenly he started sweating/sweat the entire body; He started shaking his body head, hands and feet; Dizzy/Kind of fainted because he was not able to say anything; Slight headache on and off; Weakness; This is a spontaneous report from a contactable consumer (wife of the patient). A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0171), via an unspecified route of administration, administered in Arm Left on 27Apr2021, at 12:30, as dose 1, single (age at the time of vaccination: 43 years), for covid-19 immunization. Medical history was not reported. The patient concomitant medication included multivitamins (he just takes multivitamin) taken for an unspecified indication, start and stop date were not reported. The patient experienced kind of fainted because he was not able to say anything/severe pass out and couldn't see anything like everything was black/suddenly all stuff fell off on floor, started reacting very bad, blood pressure went down, suddenly he started sweating/sweat the entire body on 27Apr2021 12:45, he started shaking his body head, hands and feet, dizzy/kind of fainted because he was not able to say anything, slight headache on and off, weakness on 27Apr2021. The wife stated that, her husband took covid19 vaccination and it was his first dose. When he had his vaccine he came out and was sitting on the chair, as was asked to stay for 15 minutes. After 5 minutes of chitchat, he was just kind of holding some stuff, the paper they gave and water bottle and some stuff in his hands and suddenly all of the stuff fell off on the floor and he started reacting very bad to the vaccination and he started shaking his body head, hands and feet. Reportedly, the pharmacist was there and he came and asked the patient whether he need water or juice something and after few seconds he responded that he would have juice, but then again like second time the patient could not see anything like everything was black and got dizzy and kind of fainted because he was not able to say anything. Reportedly, within 5-10 minutes of vaccine, at 12:45 PM, the patient had a severe pass out and his blood pressure went down and suddenly he started sweating and sweat the entire body. The pharmacist was really not sure what to do for that. Adverse events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Upon further inquiry, it has been reported that the patient was just having the normal side effects like slight headache on and off and some weakness. Reportedly, no other lab tests were done. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, patient has not been tested for COVID-19. The seriousness criteria was reported as non-serious. The patient underwent lab tests and procedures which included blood pressure measurement: went down on 27Apr2021 within 5-10 min. severe pass out, Blood pressure went down. Treatment was reported as Monitoring of all the body in the hospital for the events: the patient had a severe pass out and his blood pressure went down and suddenly he started sweating and sweat the entire body and no treatment was received for the rest of the events. The outcome of the events: the patient had a severe pass out and his blood pressure went down and suddenly he started sweating and sweat the entire body was recovered and recovering for the rest of the events.
43 2021-07-16 night sweats Rash on chest and stomach. chills, night sweats, runny nose, stuffy nose, body aches, fever
43 2021-07-16 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
43 2021-07-26 flushing, weakness, unresponsive to stimuli Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Med... Read more
Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: Patient received vaccine and 10 minutes later, he fainted. We sat with patient until emergency services arrived. Patient reporst history of fainting for the past 10 years and takes no medication. Patient was breathing normally and regained consciousness fully AxO x3 after recovering from fainting. Patient drank water. After emergency services arrived, patient began vomiting under their care. Patient ended up leaving with the emergency crew.
43 2021-07-26 tingling, tremor, muscle twitching Dizzy, rapid heart beat, nausea, ended of having a ?zombie like episode? according to my 10 year old... Read more
Dizzy, rapid heart beat, nausea, ended of having a ?zombie like episode? according to my 10 year old daughter who was with me. Apparently I fainted but she described me as twitching and having my hands up and my head to the side with my eyes closed. I can remember a repetitive loop that I was experiencing. It was an image that was distorted and I could not control it and I could not get out of it I could hear my daughter but not control my actions. After I came to a few moments later my legs felt tingly and tired and were shaking like they had the chills. Was advised to go to hospital by EMS Still having very achy joints all over my body. Diarrhea, sweats/chills
43 2021-07-27 hot flush Fever,; Chilis/shivering; tiredness; headache; feeling unwel; hot flashes; muscle pain; This is a sp... Read more
Fever,; Chilis/shivering; tiredness; headache; feeling unwel; hot flashes; muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7533) via an unspecified route of administration in the arm right on 31Mar2021 at 10:15 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Concomitant medications included vitamin c [abscorbic acid] (MANUFACTURER UNKNOWN) and vitamin b12 (MANUFACTURER UNKNOWN). 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 31Mar2021 at 12:00 the patient experienced fever, chills, shivering, tiredness, headache, feeling unwell, hot flashes and muscle pain for 5 days with those symptoms. On 04Apr2021, the patient underwent a COVID-19 rapid test (Nasal Swab) and the result was Pending. The patient did not receive any treatment for the reported event. The events did not result in doctor or other healthcare professional office/clinic visits, and the emergency room/department or urgent care. The clinical outcome of the events Fever, Chilis, shivering, tiredness, headache, feeling unwell, hot flashes and muscle pain was recovering at the time of the report. No follow-up attempts are possible. No further information is expected.
43 2021-07-27 tremor He began to have lower extremity weakness on Sunday 7/18/21. He went to an outside hospital ER on S... Read more
He began to have lower extremity weakness on Sunday 7/18/21. He went to an outside hospital ER on Sunday due to LE weakness and diagnosed with a heat stroke and discharged home. On 7/20/21, he came to ED and reported the weakness had moved up into his upper extremities. Admitted to the hospital on 7/20/21. He has been unable to stand or use his upper extremities for the past 3 days. On exam he has tremor of the jaw, he reports he does not notice this. He does have sensation intact. Intubated and placed on ventilator on 7/20/21 for respiratory distress. Diagnosed with Guillan-Barre syndrome requiring a trialysis catheter placement acutely for plasmapheresis. Plan plasma exchange 6 times, with treatment every other day. As of today, 7/28/21 patient remains hospitalized.
44 2021-01-05 numbness, nerve pain Brachial neuritis Right side with moderate pain along myotome, anesthesia right medial elbow and for... Read more
Brachial neuritis Right side with moderate pain along myotome, anesthesia right medial elbow and forearm, and decrease in grip strenth/dexterity digits 3, 4 right hand
44 2021-01-05 numbness PRESYNCOPE, RIGHT SIDED FACAIL NUMBNESS
44 2021-01-06 tenderness Client noticed this afternoon when showering that his left armpit region was swollen approximately t... Read more
Client noticed this afternoon when showering that his left armpit region was swollen approximately the size of a tennis ball and tender. Client declines any fever, redness, not warm to the touch either. Client states that he thinks it feels like enlarged lymph node
44 2021-01-09 pain in extremity Myalgia, Arthralgia, Fever, NauseaVomiting, chills, fatigue, , pain arm Narrative:
44 2021-01-11 flushing, numbness, discomfort extremely bad dry mouth; lips were going numb; facial numbness; rash from his neck to his nipple lin... Read more
extremely bad dry mouth; lips were going numb; facial numbness; rash from his neck to his nipple line; BP was 180/110 / BP stayed around 160/100; felt an "amped" feeling; felt flush; uncomfortable; This is a spontaneous report from a contactable healthcare professional. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), dose number 1, intramuscularly on 21Dec2020 14:00 at a single dose on the right arm for COVID-19 immunization. Medical history included gluten allergy with causes dermatitis herpetiformis, osteoporosis, and fibromyalgia. The patient previously took Benadryl and experienced allergies. Concomitant medications were not reported. The patient reported that immediately after receiving vaccine on 21Dec2020, he felt an "amped" feeling and felt flush. It was uncomfortable but not alarming at first. About ten minutes after shot, he started to have extremely bad dry mouth. He went back to work, but he went back downstairs after feeling like he was getting seriously ill and his lips were going numb. His BP was 180/110. The facial numbness went away but his BP stayed around 160/100. He was asked to go to ER, but he refused because he would have to pay for it and he was feeling better. He also noticed after going back upstairs that he had a rash from his neck to his nipple line. The doctor asked for Benadryl, but he was not given due to possible Benadryl allergy. He went home and his BP returned to normal 2 hours later. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested for COVID-19 since the vaccination. The outcome of the events was recovered in 21Dec2020 for blood pressure increased and facial numbness, and recovered on an unspecified date for the other events. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the BP increased and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is 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.
44 2021-01-11 pain in extremity pain in both big toes, severe pain in the left big toe; acute gouty attack; acute gouty attack; This... Read more
pain in both big toes, severe pain in the left big toe; acute gouty attack; acute gouty attack; This is a spontaneous report from a contactable physician (patient). A 44-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular (left arm) on 17Dec2020 15:30 at single dose for Covid-19 immunization. Patient's medical history included gout and shellfish allergy. Concomitant medications included magnesium glycinate (MAGNESIUM GLYCINATE), colecalciferol (VITAMIN D), and finasteride. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported he got his vaccine on 17Dec2020, a week later on 03Jan2021 (04:30 PM) he started having some pain in both big toes and then 3 days ago, he had severe pain in the left big toe with what appears to be acute gouty attack. The patient reported he has a history of gout previously but had controlled it for a long time. There were no other changes that happened. The patient was treated with ibuprofen and colchicine. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
44 2021-01-11 pain in extremity Dizziness-10 min post injection resolved within 60 min, headache-10 min post injection resolved with... Read more
Dizziness-10 min post injection resolved within 60 min, headache-10 min post injection resolved within 60 min Rash, neck and chest area 50 min post injection resolved with 30 mg Claritin reditabs 90 mins post injection Body ache- few hours post injection resolved in 24 hrs Injection site/arm pain 20 min post injection resolved in 3 days Blood pressure increased to 170/100 30 min post injection resolved 60-90 min
44 2021-01-12 muscle spasms Severe epigastric abdominal pain (cramping/boring, radiating to back) with associated nausea and vom... Read more
Severe epigastric abdominal pain (cramping/boring, radiating to back) with associated nausea and vomiting - 4 hours Fever, chills, myalgia, malaise - 12 hours (treated with acetaminophen)
44 2021-01-12 night sweats, weakness, flushing, pain in extremity Arm soreness 1st day, 3pm next day body aches, weakness and fatigue, heavy head, fever 102. Next da... Read more
Arm soreness 1st day, 3pm next day body aches, weakness and fatigue, heavy head, fever 102. Next day, still experiencing fatigue and body aches but not as much. 1/12/21 feeling flu type symptoms again body aches, muscle, nausea, chills, severe sweating during night sleeping awoke several times . 1/13/2021 feeling flushed and sweating again while working, stomach cramps, nausea and then vomited x1. Tiredness and extreme fatigue, almost hard to walk, heavy head, chills, fever 100. Has taken Tylenol some relief
44 2021-01-12 tingling Mild Tachycardia, small SOB, diaphoretic for 5 min, digits tingly , very dizzy
44 2021-01-13 cold sweat Shivers, cold sweats, and body ache. Treatment: none. Outcome: mild improvement
44 2021-01-14 cold sweat Symptoms - ? EE reports he woke up with chills and cold sweats, EE reports he didn?t feel like he ha... Read more
Symptoms - ? EE reports he woke up with chills and cold sweats, EE reports he didn?t feel like he had a fever, but no thermometer at his house. EE reports he bought a thermometer later in the day and temp was 98.7. Friday am, feelings of generalized achiness. Last day of work and shift - ? Monday Home remedies? - rest Any improvement? - mild Recommendation? EE encouraged to take ibuprofen as outlined in the Medical Directive. EE encouraged to continue to monitor his symptoms and to contact the Vaccine support line with additional questions and concerns. EE reports he is not feeling well and is scheduled to work today. EE educated to manage his RTW according to the Illness in the Workplace policy. EE verbalized back understanding and denied further questions at this time.
44 2021-01-14 muscle spasms vomiting, diarrhea, cramps. called in sick to work.
44 2021-01-14 pain in extremity right arm became red and swollen and painful. Right arm redness/rash spread to triceps. Denies treat... Read more
right arm became red and swollen and painful. Right arm redness/rash spread to triceps. Denies treatment. Patient states that it resolved on 01/14/21.
44 2021-01-15 muscle twitching About an hour after the injection, I had muscle twitch around left eye. I asked the coworker if they... Read more
About an hour after the injection, I had muscle twitch around left eye. I asked the coworker if they could see it and they could. The twitch in that muscle stopped that evening. Both of my eyelids occasionally twitch for the past few days
44 2021-01-18 nerve pain, burning sensation BURNING, ITCHING, NEURALGIA, SHINGLES.
44 2021-01-21 muscle twitching 10 min after vaccine-twitch in left calf, quad twitching, bicep, glute--only twitching on left side ... Read more
10 min after vaccine-twitch in left calf, quad twitching, bicep, glute--only twitching on left side for first 30 min following vaccination Then after 30 minutes it switched to right side twitching (twitching not painful) Employee also had trouble breathing at that moment and was diaphoretic--Rapid Response Called VSS--employee returned to work Two hours later employee experienced diaphoresis, presyncope--went to Emergency Dept at this time--all labs and tests came back WNL 1/7: Fever 100, twitching continues (superficial) 1/7-14-superficial twitching throughout body 1/14-1/15?twitching seems to go deeper--in intestine, deep in LRQ 1/22 still having these twitches (not painful, just disturbing/odd)--Employee estimates these twitches happen 20x an hour
44 2021-01-21 pain in extremity About 5 minutes after getting the vaccine injection my heart rate suddenly increased (My heart rate ... Read more
About 5 minutes after getting the vaccine injection my heart rate suddenly increased (My heart rate went back down to normal about 2 or 3 minutes after it initially increased), I was short of breath, and slightly dizzy. The night of and the next morning after the injection, I have been tired, my left arm of the injection site, left shoulder, and lower back have been aching. The next day after the shot, I have been unusually tired, also.
44 2021-01-23 mild one side paralysis, muscle spasms, numbness, tenderness On same day of the first Pfizer COVID-19 vaccine, patient developed left facial numbness, left arm a... Read more
On same day of the first Pfizer COVID-19 vaccine, patient developed left facial numbness, left arm and left leg weakness with difficulty negotiating stairs, and left arm > left leg involuntary muscle "spasms." Symptoms have improved, but not totally gone away. Patient also complained of severe "brain fog," and severe left arm tenderness after Pfizer vaccine.
44 2021-01-24 numbness numbness developed in bilateral cheeks of face and cheeks became red
44 2021-01-25 cold extremities, tingling As soon as I received the shot and went into the waiting area, I experienced a tingling sensation do... Read more
As soon as I received the shot and went into the waiting area, I experienced a tingling sensation down my right arm where the injection was administered. Throughout the 15 minutes the sensation began to radiate throughout my body and extremities. I waited about 20 minutes before deciding to leave the facility and proceed with my afternoon. Once I got home, I experienced chills, which I read on the pamphlet was an expected side effect. Both hands and feet were cold and I put on additional layers and lied on the couch and rested. During that time I began to notice the tingling sensation/paresthesia predominantly in the injected (right) arm, but also sporadically in other parts of my body including thigh (front/back), left arm, elbow, back, torso, neck, head, wrists, buttocks, etc. This sensation continued as I prepared for bed and continues as of this writing. It's difficult to say whether the sensation is getting better or worse, but it is consistent best described as someone pricking you every so often.
44 2021-01-26 weakness Elevated blood pressure (180/116 highest recorded); dizziness; weakness lasting several hours; This ... Read more
Elevated blood pressure (180/116 highest recorded); dizziness; weakness lasting several hours; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 20Jan2021 14:15 at single dose for COVID-19 immunisation at Public Health Clinic/Veterans Administration facility. The patient medical history was not reported. Concomitant medication included atorvastatin (LIPITOR), 40 mg daily, butalbital, caffeine, paracetamol (FIORICET). The patient experienced elevated blood pressure (180/116 highest recorded), dizziness and weakness lasting several hours on 20Jan2021 14:30 with outcome of recovering. The events were considered life-threating (immediate risk of death from the event) and resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit. No treatment was performed. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
44 2021-01-27 feeling cold At approximately 2 AM, the next day, I started to have uncontrollable chills which results in excess... Read more
At approximately 2 AM, the next day, I started to have uncontrollable chills which results in excessive chattering of my teeth. I had trouble getting warm and had to utilize multiple blankets to gain heat, which is not normal. I was very warm and most likely developed a fever. I did not eat until 2 PM that day and the started feeling better later that night. I was forced to miss work to recover. I returned to work today, 1/28 but I remain tired and a little lethargic.
44 2021-01-27 muscle twitching, tremor Little muscle twitches; felt muscle twitches really deep in his abdomen, almost like in the intestin... Read more
Little muscle twitches; felt muscle twitches really deep in his abdomen, almost like in the intestines; Low grade fever; Muscle soreness; Muscle tiredness; Hands were a little shaky; Very diaphoretic; This is a spontaneous report from a contactable other Nurse. This 44-year-old Nurse (Patient) reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) at single dose for vaccination in Jan2021 around 9:45am. Relevant medical history included ongoing Mild shrimp allergy and ongoing Hypertension. Relevant concomitant drugs included amlodipine at 10 mg once daily for Hypertension since Feb2020 and ongoing. Prior Vaccinations (within 4 weeks): None. Family Medical History Relevant to AE(s) was None. The patient was administered the COVID Vaccine around 9:45am; about 10 minutes later he had onset of little muscle twitches on the left side of his body that started in the calf then the glute, then the quadricep, then the bicep and then just started bouncing around everywhere on left side. Approximately a half an hour after that those little muscle twitches started on the right side of his body. Now the little muscle twitches are just everywhere; his hand, his heel, right now as he is speaking he is having the little muscle twitches in his heel; This event has been ongoing since onset; but changed today around 5:00am when he felt muscle twitches really deep in his abdomen, almost like in the intestines which is probably impossible, but it feels like it is not just muscular now, like it is happening in his intestines which concerns him. The little muscle twitches do not hurt, he thinks that is probably why he has waited a week to call; but the fact that they are ongoing and changed today, worsened is unsettling. He reported since that first dose of COVID Vaccine was administered he has also had low grade fever; muscle soreness; muscle tiredness. He reported that a rapid response team was called immediately because of the initial reaction he had. Later that day his hands were a little shaky, he got very diaphoretic and the nurses on the unit of the hospital said he almost fell which he does not recall at all; in response to those events he was taken to the emergency department where they did a complete workup including labs: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), checked his heart and everything was fine; no notable results from any of those tests. The patient was not admitted to the hospital; under observation in emergency room only. Outcome of events Little muscle twitches, Low grade fever, Muscle soreness and Muscle soreness was not resolved, outcome of other events was unknown. Information about lot/batch number has been requested.
44 2021-01-27 pain in extremity Pt reports that from day 7-10 (post vaccine) he had a 'cytokine like response" with redness, swellin... Read more
Pt reports that from day 7-10 (post vaccine) he had a 'cytokine like response" with redness, swelling and pain extending from left shoulder to under arm and chest area. Did not see PCP. Took OTC analgesic, resoled on day 10 post vaccine the response dissipated.
44 2021-01-28 pain in extremity significant sore arm 48 hours body chills lasted 12 hours muscle pain lasted 48 hours headache 24 h... Read more
significant sore arm 48 hours body chills lasted 12 hours muscle pain lasted 48 hours headache 24 hours sore throat- 3+ days (still experiencing) generalized malaise for 3+ days (still experiencing)
44 2021-02-01 pain in extremity woke up next day with "splotches" right side nipple area. Progressed to right under arm & right back... Read more
woke up next day with "splotches" right side nipple area. Progressed to right under arm & right back area. Itchy & painful. He went to his PCP's office & saw NP. Diagnosed with shingles & started on medication. In process of recovering now.
44 2021-02-01 sciatica Sciatica with no apparent cause. Patient not injured.
44 2021-02-02 facial paralysis bell palsy; Headache; rash; This is a spontaneous report from a contactable consumer (patient) repor... Read more
bell palsy; Headache; rash; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 44-years-old male patient received the first dose of BNT162B2 via an unspecified route of administration on 15Jan2021 15:30 at single dose in deltoid left for COVID-19 immunisation. Medical history included ongoing hypertension, Lactose intolerance, and lipids were a bit elevated on 14Jan2021. Family history included mother has diabetes and hypertension. The patient was allergic to Olives. There was no other vaccine in four weeks. Concomitant medication included ongoing lisinopril daily for blood pressure, ongoing colecalciferol (VITAMIN D) weekly, ongoing duloxetine to help with the blood pressure control, and ongoing Multivitamins daily. On Friday 15Jan2021 night around 11:00 PM he started experiencing headaches and rash. On Sunday night (17Jan2021) he experienced the bell palsy/Facial Paralysis and went to the ER. For bell palsy, the patient first had a shot of steroid, then was given oral Methylprednisonole and oral Famcyclovir. Treatment also received for headache and rash. He is still taking Still taking Methyl-prednisolone and the Famcyclovir and he will end these medications tomorrow. The patient had blood work on 14Jan2021 with normal result, lipids were a bit elevated. Events outcome was not recovered. The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
44 2021-02-02 pain in extremity C/O lightheaded, headache, arm soreness, did not eat before taking vaccine
44 2021-02-03 migraine Migraine; body aches; a headache; nausea; right ear became clogged, and today he can hardly hear any... Read more
Migraine; body aches; a headache; nausea; right ear became clogged, and today he can hardly hear anything out of his right ear.; sluggish; kind of tired/felt fatigued; The injection site was sore; This is a spontaneous report from a contactable consumer. This 44-year-old male consumer (Patient) reported that he received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK4176) at single dose for COVID-19 immunisation on 19Jan2021. The vaccination was given at 08:15-08:30. He assumed the anatomical location of administration was the muscle in his left shoulder (left arm). Relevant history included back surgery with nerve impact. He was just a big guy. Family medical history was none. Relevant concomitant drugs included Gabapentin 600 mg due to back surgery with nerve impact for 2 years, and Generic cholesterol medication for High cholesterol for years. The patient received the vaccine on Tuesday morning (19Jan2021). He reported that he was kind of tired and the injection site was sore, but nothing significant. He experienced being tired and fatigued at 20:00 and progressively got worse, by Wednesday (20Jan2021), he was more sluggish. On 20Jan2021, he had a headache, nausea and body aches at 10:00. In the evening, his right ear became clogged/"clouded" or muffled, and on 21Jan2021 he could hardly hear anything out of his right ear at 17:00- 18:00. The tiredness got significantly worse on Wednesday, but it had improved on 21Jan2021. The headache lasted about 12 hours, but it was better. The nausea also started with the headache. It was persisting, but mild. The body aches progressively got worse and were gone at the reporting time. He took Treximet for Migraine around 14:00 on 20Jan2021. NO ER or physician's office required. Depending on what he finds out on 21Jan2021, he will go see someone. The outcome of events Tired and fatigued, Body aches, headache, injection site was sore was Resolving, the outcome of events Nausea, Right ear became clogged and can hardly hear anything out of it was not resolved. The muffled ear maybe even worse on 21Jan2021. The outcome of other events was unknown. There was no additional Vaccines Administered on the Same Date of the Pfizer Suspect. No history of previous immunization with the Pfizer vaccine considered as suspect. Prior Vaccinations (within 4 weeks) was none. Relevant test was none.
44 2021-02-04 feeling of body temperature change Lost taste Body and joint ache Shivering at first 2 nights Feel cold and hot.
44 2021-02-07 feeling cold I have had fever, chills, body aches, congestion, headaches, slight nausea, loss of appetite, almost... Read more
I have had fever, chills, body aches, congestion, headaches, slight nausea, loss of appetite, almost every day since the injection. I sleep at night, and wake up around 2am with sever chills, take 800mg Ibuprofen, and within an hour my chills break and I start feeling better. The process repeats itself in the afternoon and then again in the evening. I'm constantly tired and fatigued, and have been unable to exercise or work out since. I'm still experiencing the symptoms as of today.
44 2021-02-07 tingling Tingley feet; light headed; This is a spontaneous report from a contactable Other Health Professiona... Read more
Tingley feet; light headed; This is a spontaneous report from a contactable Other Health Professional reported for himself. This 44-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at right arm on 26Dec2020 09:30 at single dose for COVID-19 immunization. Medical history included asthma. Patient not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. No other vaccines within 4 weeks prior to the COVID. The patient experienced tingley feet and light headed for days after getting the vaccine on 06Jan2021. No treatment received for the adverse event. Events outcome was recovering and reported as non-serious. Patient has not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.
44 2021-02-09 tenderness Swelling under right armpit near the pectoralis. Soft and tender to the touch. About the size of a c... Read more
Swelling under right armpit near the pectoralis. Soft and tender to the touch. About the size of a chicken egg cut in half lengthwise.
44 2021-02-10 weakness Twelve hrs. after the second dose on 1/7/2021; I developed fever of 103 with severe chills, headache... Read more
Twelve hrs. after the second dose on 1/7/2021; I developed fever of 103 with severe chills, headache,bodyaches faligue,nausea,loss of appetite ,joint pain, unable to get out of bed due to weakness. Severe symptoms lasted around 24 hrs , better next day but persisted for another 24 hrs then fatigue lasted another 7-10 days
44 2021-02-12 numbness Developed right scapula area pin 2 weeks after first dose. Became severe the day after the 2nd dose.... Read more
Developed right scapula area pin 2 weeks after first dose. Became severe the day after the 2nd dose. Then noted right axilla numbness on 1/18/76.
44 2021-02-16 sensory loss loss of feeling in legs as well as incoherent behavior; loss of feeling in legs as well as incoheren... Read more
loss of feeling in legs as well as incoherent behavior; loss of feeling in legs as well as incoherent behavior; Upon a CT scan an aneurysm was discovered that was actively bleedings.; extreme headache/severe headaches; went to ER via ambulance in 31Jan2021 for extreme headache and body lameness; This is a spontaneous report from a contactable Consumer. A 44-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medication included allergy pills. Patient went to emergency room (ER) via ambulance on 31Jan2021 for extreme headache and body lameness, which started on 31Jan2021 22:00. Patient was discharged from ER on 01Feb2021. Patient returned to ER via ambulance on 09Feb2021 due to severe headaches and loss of feeling in legs as well as incoherent behavior. Upon a Computerised tomogram (CT) scan an aneurysm was discovered that was actively bleedings. Patient was transferred to medical center and is currently waiting surgical procedure. Adverse events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was unknown. Information on the lot/batch number has been requested.
44 2021-02-17 inability to speak expressive aphasia. Improved without directed therapy
44 2021-02-17 facial paralysis, bell's palsy 10 days following vaccination with first dose of Pfizer-BioNTech vaccine, individual reported to the... Read more
10 days following vaccination with first dose of Pfizer-BioNTech vaccine, individual reported to the vaccine clinic that he developed symptoms of Bell's Palsy. Specific symptoms included facial droop and inability to close eye on one side. Individual sought urgent medical treatment and was diagnosed with Bell's Palsy and placed on a course of antiviral and steroids. Individual was advised by outside provider to not receive second dose of vaccine.
44 2021-02-17 facial paralysis Patient developed slight droop of the right side of the face 27 days after vaccination. Patient also... Read more
Patient developed slight droop of the right side of the face 27 days after vaccination. Patient also has some numbness of the right side upper lip. Denies other symptoms.
44 2021-02-20 facial paralysis, weakness The night of the injection, I woke up with a 10/10 headache, tinnitus, and shortness of breath. I t... Read more
The night of the injection, I woke up with a 10/10 headache, tinnitus, and shortness of breath. I thought nothing of the shortness of breath as I am asthmatic. The next couple of days I felt completely drained, fatigued. Ten days later I have partial facial paralysis. I saw the emergency physician at the hospital who prescribed prednisone, acyclovir, over the counter eye drops, and an eye patch to wear at night.
44 2021-02-21 weakness The morning after receiving vaccine I worked out lifting weights and jumping rope. After about a ha... Read more
The morning after receiving vaccine I worked out lifting weights and jumping rope. After about a half hour I suddenly stopped sweating became very chilled (shivering), weak, very nauseous, felt rapid heart rate.
44 2021-02-22 muscle twitching Patient states he had vaccination at 1030 today and did not want to wait the recommended observation... Read more
Patient states he had vaccination at 1030 today and did not want to wait the recommended observation time of 15 minutes in the hospital lobby. He is currently a highway patrol officer. While driving in his patrol car, at 1035, he felt tightness in the back of his neck and tightness to his airway- he described it feeling like someone hit him in the neck. He denied having any trouble breathing. Later, he noted his hand was twitching. 1045, he came back to lobby and made an RN aware who brought him to employee health. He declined to go to ED (I found out later). BP was 153/115 HR 102 initially, no hx of high bp. No noted hives or swelling to face or mouth/tongue or L deltoid region. Pt. denied feeling any itching anywhere. Pt. rested for about 15 minutes on exam table. Re-check of BP was 151/113 HR 84. Pt. states he feels better and feel like that feeling of tightness in his neck is decreasing. Made aware to follow up with PCP regarding BP and giving informational handout regarding blood pressure. RN recommended he go to any ED if he has any trouble breathing, swelling of tongue, etc at any time after he leaves this hospital. Pt. verbalized understanding.
44 2021-02-23 seizure Patient had seizure, provider could not find pulse, administered 2 rounds CPR and applied AED, EMS n... Read more
Patient had seizure, provider could not find pulse, administered 2 rounds CPR and applied AED, EMS notified. Patient alert and awake after 2 rounds CPR and was admitted to hospital.
44 2021-02-24 numbness Around 4 hrs after vaccine, he felt down and tired. that night he had worsening flu like symptoms. S... Read more
Around 4 hrs after vaccine, he felt down and tired. that night he had worsening flu like symptoms. Since the vaccine he endorses having a fever, feeling tired and aches all across the body. He also complains of being dizzy and numbness of both his hand that developed since the vaccine. He has taken tylenol and it resolves all the symptoms, however he says that the symptoms return as soon as the tylenol wares of. Denies constipation, diarrhea, chest pain, SOB but endorses nausea. Suggested to contact PCP and to see a doctor, also advised that if symptoms worsen, he should visit an ED.
44 2021-02-25 electric shock sensation, burning sensation On the 8th day after shot I started getting pain under left armpit. The pain became worse over the n... Read more
On the 8th day after shot I started getting pain under left armpit. The pain became worse over the next several days resulting in what I'd describe as an electrical shock/burning feeling whenever I moved my left arm the wrong way (seemingly pinching the lymph nodes). I'm currently on day 5 of the pain and it's still present although it has lessened on the 5th day. On the 2nd day the pain started to move down from the armpit closer to the pectoral.
44 2021-02-26 flushing, tingling My blood pressure shot up to 155/105, I got flush, dizzy and had a headache. I had a tingling sensa... Read more
My blood pressure shot up to 155/105, I got flush, dizzy and had a headache. I had a tingling sensation around my nose and upper lip. Prior to this, my blood pressure had been in the 120's / 70's. I went to the emergency room and was sent home 4 hours later. I had headaches every day, multiple times a day, for the next 10 days and my blood pressure was fluctuating between 130/90 to 150/99 during that time. On February 25, my blood pressure dropped back down to 123/88 in the morning, but shot back up to 152/93 by the evening. My blood pressure continues to fluctuate from 124/89 to 146/106.
44 2021-02-28 weakness Nausea Dizziness / lightheaded Weakness Anxiety
44 2021-02-28 tingling, pain in extremity, numbness Bilateral lower extremity numbness; Tingling; Foot pain; This is a spontaneous report from a contact... Read more
Bilateral lower extremity numbness; Tingling; Foot pain; This is a spontaneous report from a contactable nurse (patient). A 44-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), via an unspecified route of administration on the left arm, on 22Dec2020, at single dose, for covid-19 immunization. The patient has no medical history. Concomitant medication included ibuprofen. The patient received the vaccine on 22Dec2020 at the hospital. The patient was not diagnosed with COVID-19 prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 30Dec2020 18:00 sudden onset of bilateral lower extremity numbness, tingling, and foot pain. These continued to present day. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received gabapentin as treatment for these adverse events. At the time of the report, the patient had not recovered from the adverse events. The patient has not been COVID-tested post-vaccination.
44 2021-02-28 tingling Tingling sensation bilateral upper extremities; This is a spontaneous report from a contactable nurs... Read more
Tingling sensation bilateral upper extremities; This is a spontaneous report from a contactable nurse. A 44-year-old male patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) on her left arm, via an unspecified route of administration on 12Jan2021 17:45 at a single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included ibuprofen. Historical vaccine included on 22Dec2020 (first dose) and experienced Bilateral lower extremity numbness, Tingling and Foot pain. It was reported that the patient had tingling sensation bilateral upper extremities on 12Jan2021 18:00. Continues to present day. PCP following prescribed gabapentin. The outcome of the event was not recovered.
44 2021-03-02 unresponsive to stimuli, seizure Patient received a dose of the Pfizer COVID-19 vaccine. Before he could exit the room to begin the o... Read more
Patient received a dose of the Pfizer COVID-19 vaccine. Before he could exit the room to begin the observation period, the patient became unconscious and slipped into a seizure. Uncertain if it was hypersentivity coupled with vasovagal response, an epi pen was primed but not administered. The patient was unresponsive for a minute then came out of his apparent seizure
44 2021-03-03 night sweats Sudden onset of fatigue followed by body aches, chills, fever 102.5F, night sweats, headache
44 2021-03-04 facial paralysis Started at 3:30 pm on 2/26/21 with neck tightness and eye pressure. Approximately around 6:30 pm, ex... Read more
Started at 3:30 pm on 2/26/21 with neck tightness and eye pressure. Approximately around 6:30 pm, experienced lip burning/numbness/swelling and facial swelling and drooping. Went to ER and given IV Benadryl and IV Pepcid. Discharged a few hours later. All symptoms have since resolved.
44 2021-03-05 weakness Dry mouth, tachycardia, weakness, lightheaded. Cleared by medics.
44 2021-03-07 migraine I had four days after the vaccine I got serve migraine headaches. I've never had these in my life, t... Read more
I had four days after the vaccine I got serve migraine headaches. I've never had these in my life, these headaches lasts two weeks. They would be non-stop unless I took Excedrin. I went to see my PCP and he put me on stronger headache medication but they had no effect on me and went back to Excedrin. He observed me to make sure I was ok and had me take a Covid test to make sure I was ok , test was negative.
44 2021-03-07 muscle twitching Arm and hand twitchy, extreme fatigue, double vision, mental confusion
44 2021-03-07 pain in extremity I have been experiencing extreme pain in both of my arms, starting from my fingers and ending at my ... Read more
I have been experiencing extreme pain in both of my arms, starting from my fingers and ending at my shoulders. The pain come when I move my arms for more than two minutes at a time. This has never happened to me before until after I had taken the vaccine.
44 2021-03-09 pain in extremity sore arm; restlessness; Body aches; chills; fatigue; Swollen lymph node under left clavicle; This is... Read more
sore arm; restlessness; Body aches; chills; fatigue; Swollen lymph node under left clavicle; This is a spontaneous report from a contactable consumer (reported for himself). A 44-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: 9262), on Left Arm via an unspecified route of administration on 26Jan2021 13:30 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose of PFIZER-BIONTECH COVID-19 VACCINE (Lot no: 3248) on left arm on 07Jan2021 12:00 PM for Covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 10:00 PM No symptoms besides a sore arm and restlessness for first 12 hours. Body aches, chills, fatigue for following 24 hours. Fatigue for an additional 24 hours. Swollen lymph node under left clavicle starting at 36 hours and still present. Outcome of the events was not recovered.
44 2021-03-10 pain in extremity, muscle twitching, tingling 1) Sharp pain in arm near elbow (left arm) the pain comes and goes. Pain scale 8-9 at times. It has... Read more
1) Sharp pain in arm near elbow (left arm) the pain comes and goes. Pain scale 8-9 at times. It has woken me up the last two nights. Enough pain I can?t fall back asleep. 2) Tingling in index finger (left) feels like hit funny bone 3) Muscle twitching ? tricep, area underneath arm, upper chest (left side) See phone videos
44 2021-03-13 difficulty speaking nasal congestion, throat tightness, hoarseness
44 2021-03-14 weakness Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Patient ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Patient was feeling paralized. However, we can cleary see the patient moving all his extremities-Mild, Systemic: Headache-Mild, Systemic: Weakness-Mild
44 2021-03-14 numbness, pain in extremity sitting in car in 30 min line, got dizzy, thought was because of playing on phone, then mouth went n... Read more
sitting in car in 30 min line, got dizzy, thought was because of playing on phone, then mouth went numb, tongue swelling and lower jaw numbmess. Notified the MD's taken out of car had BP given claritin was being monitored and BP kept rising given epipen. The epipen helped felt swelling go down started to relax. Taken by ambulance to hospital. Treated with Steroid and benadryl and prevacid. No breathing treatments given epipens there and taken home prescribed. after he went home sore arm, dizzy, tired then symptoms started to come back took steroids and bendadryl which helped the reaction to go away. sx lasted 2-3 days. mild towards the end.
44 2021-03-15 tenderness two days of left side dull pain and tenderness from the base of my skull to my elbow
44 2021-03-16 pain in extremity Severe pain in the shoulder, back (shoulder blade), and arm.
44 2021-03-18 weakness Five minutes after receiving the vaccination on her left arm, she developed nausea and lightheadedne... Read more
Five minutes after receiving the vaccination on her left arm, she developed nausea and lightheadedness and weakness. No vomiting or syncope. She was escorted to a private session of the arena and monitored. Her initial blood pressure was 140/80. She was given water to drink and ate an apple.
44 2021-03-18 tingling Tongue felt numb -- "Like he burned his tongue" Tingly sensation. At 6 p.m. on 3/19/2021 his tongu... Read more
Tongue felt numb -- "Like he burned his tongue" Tingly sensation. At 6 p.m. on 3/19/2021 his tongue still feels the same. No swelling in his tongue. Denies other symptoms
44 2021-03-18 tremor pt got vaccine and was sitting for observation. Pt thought he was having a panic attack so he put h... Read more
pt got vaccine and was sitting for observation. Pt thought he was having a panic attack so he put his head between his knees, he fainted, hit is head on the floor, and a witness said he was shaking on the floor. The patient came to quickly and said he passed out due to stomach cramps . EMS was on site and did an evaluation. Pt was given ice for his head and had vitals checked and and EKG done. EMS recommended hospital transport but patient refused.
44 2021-03-19 discomfort Severe ringing sound in both ears. Feels like head is being squeezed.
44 2021-03-21 numbness RACING OR ACCELERATED HEART BEAT EARLY AM LASTING BETWEEN 30-40 MINUTES NUMBNESS OF TONGUE AND FINGE... Read more
RACING OR ACCELERATED HEART BEAT EARLY AM LASTING BETWEEN 30-40 MINUTES NUMBNESS OF TONGUE AND FINGERS LASTING ABOUT FORTY FIVE MINUTES. SEVERE VERTIGO LASTING AROUND ONE MINUTE PER EPISODE EXPERIENCING FIVE EPISODES SO FAR OCCURRED AFTER FIRST WEEK OF VACCINATION 1ST DOSE.
44 2021-03-21 migraine tinitus, migraines
44 2021-03-22 bell's palsy Bell's palsy
44 2021-03-22 hot flush, weakness Fatigue, weakness, red eye, headache, hot flashes, nausea, stomach pain
44 2021-03-23 numbness Left arm pain that starts at the injection site from the second shot and then radiates down the len... Read more
Left arm pain that starts at the injection site from the second shot and then radiates down the length of the arm to the fingers causes the pinky and ring fingers to go numb . This started about 2-3 weeks after the second vaccination right after the bruise at the injection site resolved. It gets worse if I use the arm a lot . It also hurts if I don't use the arm too but not as frequently. I have demonstrably less strength in the pinky and ring fingers when comparing left to right hand. I went to the doctor and have been referred to a neurologist but the earliest appointment available is in April. No treatment for the pain was initiated until evaluation from the neurologist in April. The pain is getting worse and the numbness in the fingers is getting worse as well as time progresses to the point it is interfering with sleep and normal activities.
44 2021-03-24 burning sensation small rashes inner left arm; burning sensation inner left arm; This is a spontaneous report from a c... Read more
small rashes inner left arm; burning sensation inner left arm; This is a spontaneous report from a contactable healthcare professional (patient). This 44-year-old male patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number ENG201) via an unspecified route of administration on 19Feb2021 at 16:30 (at the age of 44-years-old) as a single dose in the left arm for COVID-19 immunization. The patient had no medical history. Prior to the vaccine the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included fexofenadine (ALLEGRA) from an unknown date for an unknown indication. The patient had no allergies to medications, food, or other products. On the first day (also reported as 12Feb2021) at 18:00, the patient experienced burning sensation on the inner left arm. On the second day, the patient experienced small rashes on the inner left arm but different spots from the first day. The events were reported as non-serious. The patient was not hospitalized for the events and did not receive any treatment for the events. The outcome of burning sensation on the inner left arm and small rashes on the inner left arm were recovering. It was also reported that since the vaccine the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
44 2021-03-25 pain in extremity Arthralgia, NauseaVomiting, NAUSEA, HA, CHILLS, KNEE, HIP AND HAND PAIN Narrative: NAUSEA, HA, C... Read more
Arthralgia, NauseaVomiting, NAUSEA, HA, CHILLS, KNEE, HIP AND HAND PAIN Narrative: NAUSEA, HA, CHILLS, KNEE, HIP AND HAND PAIN after 2nd Covid Pfizer vaccine
44 2021-03-26 tingling Random itching throughout body - started on arms and legs and then was all over body, no hives, no r... Read more
Random itching throughout body - started on arms and legs and then was all over body, no hives, no rash. Additionally sharp, random pains - feels like pins and needles - started on the next day
44 2021-03-29 weakness, unresponsive to stimuli 3:03PM: Patient received Pfizer Covid vaccine and went to waiting room for 15-minute observation pe... Read more
3:03PM: Patient received Pfizer Covid vaccine and went to waiting room for 15-minute observation period 3:17 PM: Nurse Called to waiting room; patient states of warmness and dizziness, alert with eyes half open 3:17 PM: Non-responsive to name; head back and nonresponsive; Eased to floor; remains non- responsive for approximately 22 seconds. Opens eyes and responds to name. 3:18 PM: NP present. Neuro assessment completed. Pt remains alert and responsive, skin warm and moist. B/P 132/78 3:24 PM: Remains alert and oriented; states of feeling better; assisted to sitting position 3:25 PM: B/P 110/62 Pulse remains strong at 68, denies dizziness; placed in chair with supervised presence in waiting room 3:35 PM: Offered juice and granola bar; eating without discomfort 3:40: B/P 112/62, 68 and regular, skin warm and dry; encouraged to find ride home or back to work 3:50 PM: B/P 118/72, pulse 72 and regular, continues to state of feeling weak, oriented and alert 4:08 PM: Walked around waiting room without dizziness or dyspnea. Pulse 78 and regular; B/P 112/62 4:18PM: walking around room without discomfort or change in consciousness; B/P 116/72, pulse is 72 and regular. 4:30 PM: Remains alert, skin warm and dry, Pulse 74 and regular.
44 2021-03-30 weakness 03-31-2021 COVID-19 PCR POSITIVE, PT REPORTS SINUS PRESSURE, TIRED, DECREASED ENERGY AND LIGHT HEADE... Read more
03-31-2021 COVID-19 PCR POSITIVE, PT REPORTS SINUS PRESSURE, TIRED, DECREASED ENERGY AND LIGHT HEADED. PT STATES HE COMPLETED THE COVID-19 VACCINE SERIES. PRIME DOSE 12-30-2020 AND BOOSTER DOSE 01-20-2021.
44 2021-03-31 tremor Shaking chills for over 12 hours then diminished then came back 2 hours later for another 5 hours. B... Read more
Shaking chills for over 12 hours then diminished then came back 2 hours later for another 5 hours. Began 9 hours after injection. Rash on both forearms within 4 hours. Headache and body aches same time as chills.
44 2021-04-02 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Det... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient received a pfizer covid19 vaccine and sat on the floor during the monitoring period due to dizziness. Patient was given a bottle of water and reported fainting briefly before resuming consciousness. Patient waited at the pharmacy and was given a protein bar and gatorade to help because he reported not eating or sleeping. Blood pressure was taken and was 155/75 mmHg which then decreased to 119/82 mmHg a few minutes later and then normalized to 121/82 before the patient left. Full recovery
44 2021-04-04 numbness, tingling numbness and tingling in feet and legs like they are asleep
44 2021-04-05 pain in extremity After the shot, which I received on a Saturday, I developed pain and redness in my right leg. Two da... Read more
After the shot, which I received on a Saturday, I developed pain and redness in my right leg. Two days later, on Monday morning, I contacted my primary care physician's office, who told me to go to the ER to be evaluated for a blood clot. At the ER, they performed a doppler ultrasound on my right leg and found a superficial clot in the greater saphenous vein of my right leg. There was no evidence of a DVT in the right leg.
44 2021-04-06 pain in extremity, muscle spasms, numbness With in a few hours of the shot I had pain up and down my right arm, up and down my right side and i... Read more
With in a few hours of the shot I had pain up and down my right arm, up and down my right side and into my shoulder/ neck. I went to home and had a slight fever with chills and could not sleep that night. I called off from work and stayed home. Over the weekend the pain in my neck. shoulder and arm continued. I went to a chiropractor treatment that Tuesday 3/2/21. He made some adjustments and the shoulder / upper arm still did not feel better. My right arm became more numb and weak on Thursday 3/4/2021 . My wife was sitting next me on our couch when I suddenly had a spasm in the upper arm. The next morning I waking and had even more trouble lifting the arm or moving it. I attempted to suffer through it thinking it would get better. Over that weekend conditions with the arm became even worse and was unable to lift it. I returned to chiropractor. He evaluated me and i described what had happened after the second covid shot. He recommend an MRI and I attempted to contact my PCP. With no answer from the PCP i went to the ED who said My PCP would need to order a MRI. I was then sent to physical therapy and Orthopedics. They ordered an X ray and MRI. Both showed nothing. Still seeing physical therapy with some improvement and movement. Have a EMG scheduled for April 22,2021
44 2021-04-06 pain in extremity Mild but constant pain in the opposite arm (right), MIld but constant pain in the area between neck ... Read more
Mild but constant pain in the opposite arm (right), MIld but constant pain in the area between neck and back. Pain lasted for about week and slowly went away.
44 2021-04-06 seizure seizure; I fell of my hight; headache; total amnesia; my waking is wobbly and not steady; This is a ... Read more
seizure; I fell of my hight; headache; total amnesia; my waking is wobbly and not steady; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ER8727) via an unspecified route of administration, administered in Arm Left on 22Mar2021 12:30, at the age of 44-year-old, as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient was not diagnosed with COVID prior to vaccination. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); colecalciferol (VITAMIN D [COLECALCIFEROL]); fish oil (OMEGA 3 [FISH OIL]). On 23Mar2021, at 03:00 AM, the patient fell off his height and had a seizure. This was his first seizure in his life. The patient was rushed to the ED where a CT of the head and neck was done in Mar2021. The CT did not show any bleeding or fracture. The Neurologist dismissed the patient home and had the patient go back and see him in 2 days. The patient has been complaining of headache and taking Tylenol PRN for it. His walking was wobbly and not steady. The patient had a total amnesia of the accident. The patient did not receive treatment for seizure, fall, total amnesia and walking was wobbly and not steady. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for COVID since the vaccination. Outcome the events was not recovered.
44 2021-04-07 flushing Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Sys... Read more
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: ANXIETY-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient drank water as we talked to him. He started to look and feel better after a few minutes. He was able to hold a steady conversation throughout event. Within 5 minutes of being notified of event, patient was scrolling through his phone with no difficulty. We made patient wait for 20 additional minutes while monitoring him and patient stated \"I feel back to normal\" before leaving.
44 2021-04-10 inability to speak, weakness, seizure, tremor He had his first vaccine March 19th, 2021 at 12:15, same lot as above, and 24 hours later he had dif... Read more
He had his first vaccine March 19th, 2021 at 12:15, same lot as above, and 24 hours later he had difficulty breathing, shortness of breath, fatigue, shakes, chills and feeling of weakness/dizziness. It lasted a few days. Then, April 9, 2021, he received his second Covid19 Pfizer shot, same lot at 12:15 pm and the next morning, Saturday, April 10th around 9 am Ira felt the same symptoms from shot 1, but more intense. He was feeling weak, had chills, shakes, profuse sweating, difficulty breathing, shortness of breath, dizziness and vomiting. He was unable to keep water down and stayed in bed. A little after 12pm, he complained of difficulty breathing and possibly not getting enough oxygen so I grabbed my equipment (since I'm a CNA) and checked his vitals. His B/P was very high ( 166/107), no fever (96.7), pulse was normal 72, and low respiration but oxygen was above 90. He said he needed to use the bathroom, I suggested using his urinal but he said he needed to have a bowel movement. Once he was in the bathroom, I went downstairs for a glass of water and then suddenly I heard a huge thump. I ran upstairs, knocked on the bathroom-no response but I could hear noises, so I opened the door and I saw he was face down on the floor, head under the bathroom sink counter, blood everywhere, and he was convulsing. I grabbed him immediately and moved him to his side (I had my fitbit on, it said it was 12:30pm), and he kept seizing. He looked discolored almost blueish color. I held him on his side, he vomited, making noises, but unable to speak, continuing to have a seizure. Seizure lasted three minutes. At 12:33pm, once he had calmed, I ran downstairs to find my phone. I was back at his side calling 911 at 12:35. Paramedics arrived 9 minutes later and took him to the hospital. My brother picked me up and took me to the hospital. Once outside his door, I noticed he was finishing taking X-Rays when he suddenly had another seizure.
44 2021-04-11 weakness 4/9 - No issues 4/10 - Woke up with alternating sweats/chills throughout day. Temp never above 99.6.... Read more
4/9 - No issues 4/10 - Woke up with alternating sweats/chills throughout day. Temp never above 99.6. Slight headache and nausea. No energy at all. Took doses of ibuprofen throughout day. 4/11 - Continued with alternating sweats/chills. Continued taking ibuprofen and generally able to function. 4/12 - Morning of 4/12 similar to 4/11.
44 2021-04-11 bell's palsy, facial paralysis Severe headache that started the day after the shot, developed change in taste, neck muscle pain. S... Read more
Severe headache that started the day after the shot, developed change in taste, neck muscle pain. Symptoms progressed until 4/8/2021 and woke up with left sided facial drooping. He was seen and in the ER and diagnosed with bell's palsy. Was hypertensive 180/110
44 2021-04-11 numbness Following injection, patient reported arm and hand numbness and feeling "dizzy" and stated they "Fel... Read more
Following injection, patient reported arm and hand numbness and feeling "dizzy" and stated they "Felt weird in my head." Patient was given water and noted that they had not eaten anything this morning. Vital signs at 11:30am - Blood pressure :140/80, Heart rate: 80, temperature 99.1, O2 sat: 98% on Room air. EMS was called. Assessed by EMS, vital signs reassessed by RN at 11:43, standing blood pressure: 150/100, heart rate:82, O2 sat: 98%. Patient released by EMS to home with partner driving car. Patient stated "I will be okay"
44 2021-04-12 bell's palsy Severe headache the day after the vaccine, followed by a regular headache until present, worsening i... Read more
Severe headache the day after the vaccine, followed by a regular headache until present, worsening intensity. Then on 4/10/2021, he developed changes on the right side of his face that were diagnosed in ED as Bell's Palsy.
44 2021-04-12 facial paralysis Intermittent facial palsy on left cheek, about one inch below the eye; This is a spontaneous report ... Read more
Intermittent facial palsy on left cheek, about one inch below the eye; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EN6205), via an unspecified route of administration in the left arm on 03Mar2021 16:00 (at the age of 44-years-old) at single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EB8727), via an unknown route, in the left arm on 25Mar2021 08:00 (at the age of 44-years-old) at single dose for COVID-19 immunization. Medical history included Slight gluten interance. Concomitant medications were not reported. The patient experienced Intermittent facial palsy on left cheek, about one inch below the eye on 04Mar2021 and intensified after second dose. Therapeutic measures were taken as a result of event are not reported. Treatment received was reported as no. The outcome of the event was not recovered.
44 2021-04-12 migraine severe migraine severe body/joint aches chills
44 2021-04-13 cold sweat fever, fatigue, headache, nausea, cold sweat
44 2021-04-13 migraine Bad Migraine with sensory issues - sensitivity to sounds, Trouble sleeping, Acidity, Sweating
44 2021-04-13 seizure Patient was seen at Hospital for seizure, fall and head injury. Subsequent workup following transfe... Read more
Patient was seen at Hospital for seizure, fall and head injury. Subsequent workup following transfer to another hospital revealed L frontal lobe parenchymal hematoma with overlying subarachnoid hemorrhage, no underlying aneurysm or vascular malformation. He had MRI with and without contrast revealing partial occlusion and thrombus of the superior sagittal sinus with adjacent hemorrhage and edema. Treated with heparin, transitioned to coumadin.
44 2021-04-13 tenderness Extremely sore back. Soreness is occurring in mid right side of back near ribs. Very minor red ras... Read more
Extremely sore back. Soreness is occurring in mid right side of back near ribs. Very minor red rash has occurred in this location as well. It is very tender in this spot and has slight ichyness at times.
44 2021-04-14 weakness, pain in extremity March 14 2021 - 2 days after first vaccine shot, leg pain, 1-3 days later diagnosed with superficial... Read more
March 14 2021 - 2 days after first vaccine shot, leg pain, 1-3 days later diagnosed with superficial blood clot in left leg via ultrasound, treated with baby aspirin for 3 days and heat pad, symptoms slowly lessened till 2nd dose of vaccine on April 2nd, after second dose symptoms worsened again, both legs still fatigue very quickly to this day (April 15 2021) when I'm sitting down on chairs, seats etc. April 8 2021, 12:30pm - heart pain for 30 minutes, felt very weak, similar to light heart attack, ER visit later that day couldn't find any explanation
44 2021-04-14 pain in extremity Patient c/o shooting pain (8/10 on pain scale) which migrates in location from his posterior shoulde... Read more
Patient c/o shooting pain (8/10 on pain scale) which migrates in location from his posterior shoulder, his acromion, and his left bicep s/p second COVID injection.
44 2021-04-15 flushing As I was administering the vaccine I was discussing with the patient the adverse reactions I wanted ... Read more
As I was administering the vaccine I was discussing with the patient the adverse reactions I wanted to monitor after the injection. The patient winced as the vaccine was being injected and said it was more painful than the last time he go it. He immediately stated he didn't feel well. I applied a little pressure to the injection site which he said made it feel better but he was starting to feel flushed and faint. I kept the patient in the chair and got him some water. He reported that he had experienced this before with vaccines but it had been a long time. He asked to lay on the floor so we got him into a prone position on the floor on his right side. He laid there for a few minutes then drank some more water and laid back down. After a few more minutes he was ready to sit up. He moved to a chair in our waiting area left when he felt well enough. I called patient 2 hours later to check on himand he reports he is doing fine.
44 2021-04-15 unresponsive to stimuli Client got Pfizer COVID vaccine at 1405, started feeling light headed, dizzy, and sweaty with a rapi... Read more
Client got Pfizer COVID vaccine at 1405, started feeling light headed, dizzy, and sweaty with a rapid pulse at around 1410. Client was unresponsive and out of it like he passed out for a few seconds and came out of it and was coherent and responsive again. Client was safe, with three EMTs and lead nurse alongside him. Vital signs taken at 1414, BP 138/88, O2 99%, and P 80. Client started feeling better, no longer sweaty or dizzy at around 1415. Client informed healthcare staff that he had not eaten or had any water since 0800. Vital signs taken again 1425, BP 140/90, O2 100%, and P 72. Client was stabilized and ambulated out of the facility and driven home by his mother at 1430.
44 2021-04-16 facial pain pain in the right TMJ joint But has a sharp pain toward the right forehead, cheek and chin Not a num... Read more
pain in the right TMJ joint But has a sharp pain toward the right forehead, cheek and chin Not a numbness Just a pain Improves when not chewing and opening jaw, feels fine. No fevers or chills Denies any tooth/gum pains. This occurred after taking the covid pfizer shot, 2nd does, didn't really notice Didn't really notice his face was swollen until today. No heat/itch.
44 2021-04-16 pain in extremity Soreness in left arm lasting about 24-28 hours (started around 8PM 4/15/2021) and fading around 10PM... Read more
Soreness in left arm lasting about 24-28 hours (started around 8PM 4/15/2021) and fading around 10PM 4/16/2021 Fever peaking at 100.3 starting at 4PM 4/16/2021 and lasting until around 12AM 4/16/2021, mild chills Mild body aches during fever in both shoulders, back and neck, gone by 10PM as fever started to recede.
44 2021-04-17 migraine Extreme fatigue, migraine, fever, chills & nausea.
44 2021-04-19 flushing Vaccine administered 13:54, adverse event started 13:55 same day. Patient had syncopy, flushing/swea... Read more
Vaccine administered 13:54, adverse event started 13:55 same day. Patient had syncopy, flushing/sweating. BP 115/72 -- > 101/67 -- > 110/78, HR 64 -- > 58 -- > 60, O2=100% -> 97% -- > 98%, RR = 16, Temp 95.1F -- > 96.6F -- > 97.3F. At 15:01, Patient stated no longer lightheaded, patient stable, released from vaccination site.
44 2021-04-19 pain in extremity, numbness Numbing in left arm, within 5 minutes, that traveled halfway up the left side of my face. Once it fi... Read more
Numbing in left arm, within 5 minutes, that traveled halfway up the left side of my face. Once it finished traveling, approximately 10 minutes after shot, the taste of metal appeared on the back of my tongue. The numbness passed within 15 minutes of the shot and then pain began radiating from the shot to my elbow every few minutes. I had a feeling that could be best described as inebriation after about 15 minutes and could smell pizza to be specific. There was no pizza around. This went away within about 10 minutes of onset. I slept for about 4 hours, woke up with a headache, and arm pain for 2 days.
44 2021-04-19 pain in extremity, muscle spasms Woke up 4/6/21 with minor, dull cramping feeling in my left calf. Pain increased each day and occur... Read more
Woke up 4/6/21 with minor, dull cramping feeling in my left calf. Pain increased each day and occurred during rest and activity, although walking was the most painful.
44 2021-04-20 cold sweat Pt fell out out of chair onto floor. Was pale and clammy. 4:26 BP 89/50, P 83, o2 95% 4:28 BP 91/54... Read more
Pt fell out out of chair onto floor. Was pale and clammy. 4:26 BP 89/50, P 83, o2 95% 4:28 BP 91/54, P 83, O2 95% 4:31 BP 120/82 4:39 92/62 , BG 113 Vaccine site closed at 5 , Pt had no one to contact for a ride home. Transported to hospital via ambulance for further eval, discharged home from ER.
44 2021-04-20 numbness, cold sweat, tingling 4/21/2021 was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening ... Read more
4/21/2021 was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, he experienced an adverse reaction with the following symptoms: nausea and tingling and numbness to cheeks and tongue/ c/o of tiredness. Assessment : Time of assessment *1634. Alert and oriented, Tachycardia, Pallor, Diaphoretic, Clammy and Nausea. Actions taken: Vitals sign taken VAERS form obtained and completed by RN. Water x 2 and 1 juice, VS taken at 1634- BP- 141/89, P- 110, O2- 98%, 1642, BP- 139/88, P- 102, O2- 100 %, 455pm, BP- 123/78, P- 97, O2- 100%, 514pm, BP- 123/81, P- 100, O2- 100% Medications administered: Loratadine (Claritin) 10 mg by mouth. Time: 1645. Administered by RN. Famotidine (Pepcid) 10 mg by mouth. Time: 1645. Administered by RN. Diphenhydramine (Benadryl) 12.5 ml (25 mg) by mouth. Time: x 2 doses at 1634 and 1645. Administered by RN. Disposition: Reports no further symptoms of adverse reaction after observation for 60 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system. Wife with patient. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 4/21/2021 4:16 PM 0.3 mL 2/25/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER8735 NDC: 59267-1000-2 Electronically signed at 4/21/2021 5:33 PM Immunization on 4/21/2021 Detailed Report Note shared with patient
44 2021-04-20 tingling, migraine Woke up with extreme severe migraine dizziness, vertigo nausea and loud tinnitus! Scalp and face ti... Read more
Woke up with extreme severe migraine dizziness, vertigo nausea and loud tinnitus! Scalp and face tingling. Ear fullness, head pressure, sinus pressure, visual haze, brain fog. Never experienced this in my life! Persisting for weeks and weeks and continues. Still ongoing. Please help!
44 2021-04-21 weakness, seizure Pt became diaphoretic and light-headed 5 minutes after vaccine was administered. He requested water... Read more
Pt became diaphoretic and light-headed 5 minutes after vaccine was administered. He requested water and as I was giving it to him he started to pass out. He was conscious but slightly convulsing. He appeared to have a minor seizure for approximately 5-10 seconds. He was transferred to a wheelchair and sent into our recovery room. As we were transporting him, he had two episodes of vomiting and continued to feel diaphoretic and weak. He rested laying down but was not feeling better. He could not tolerate any water or juice.
44 2021-04-21 pain in extremity Patient presents to the ED with chief complaint of swollen lymph nodes in the area of the left clavi... Read more
Patient presents to the ED with chief complaint of swollen lymph nodes in the area of the left clavicle with pain radiating down his left arm.
44 2021-04-21 tingling Site: Itching at Injection Site-Mild, Systemic: Complained of \" tingling all over \" at 5:25 PM-Mil... Read more
Site: Itching at Injection Site-Mild, Systemic: Complained of \" tingling all over \" at 5:25 PM-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Complained of tingling approx 15 minutes after the injection. No rash noted. Stated some brief itching on left forearm, no rash noted. Refused Benadryl, stated he would take some at home. Vital signs at 5:30 PM, T 96.2, P 64 Regular, R 18, BP 128/80. No stridor, Vital signs at 5:53 PM, T 96.6 temporal, P 64 regular, R 20, no stridor, BP 110/80, no rash, went home at 5:55 PM. Stated he would take some Benadryl at home. Advised to pull over and dial 911 if any signs of respiratory distress/shock
44 2021-04-21 unresponsive to stimuli, pain in extremity Pharmacy was contacted by an aunt, who is also a healthcare provider. This contact was requested by ... Read more
Pharmacy was contacted by an aunt, who is also a healthcare provider. This contact was requested by the family. Per nurse practitionar who is the aunt of the deceased), patient passed away on Monday, 4/19/2021. He was found unresponsive on a jogging trail, where he had been jogging, by a third party person. They had called an ambulance and could not revive him. Family requested a VAERS report due to the proximity in time to his 2nd Pfizer vaccination. He had received his vaccination at 9:56am on 4/14/21 (lot ER8730) and per father the only side effect he indicated was a sore arm. Autopsy pending per family.
44 2021-04-22 cold sweat Dizziness, light headedness, nausea, cold sweat, fatigue, sleepiness accompanied by low blood pressu... Read more
Dizziness, light headedness, nausea, cold sweat, fatigue, sleepiness accompanied by low blood pressure of 90/59 and a low pulse rate of 50 bpm 10 minutes following injection. Symptoms alleviated within 30 minutes of onset except fatigue without further intervention.
44 2021-04-24 bell's palsy Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male ... Read more
Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 02Apr2021 15:00 (Lot Number: Er8737) as single dose (at the age of 44-years-old) for covid-19 immunisation. Medical history was reported as none. Patient had no known allergies. There were no concomitant medications in two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Patient had no COVID prior vaccination. Patient was not tested for Covid post vaccination. On 08Apr2021 06:00 patient experienced bells palsy. Event resulted Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Prolongation of existing hospitalization (vaccine received during existing hospitalization). Therapeutic measures taken as a result of bells palsy included antibiotics and steroids. Patient had not recovered from the event, at the time of the report.
44 2021-04-24 feeling cold 12 hours after first shot, had 48 hours of chills and nausea, recovered, 8 days after first shot had... Read more
12 hours after first shot, had 48 hours of chills and nausea, recovered, 8 days after first shot had 5 days of chills, fever, nausea, headache. 12 hours after second shot, had 24 hours of chills, nausea, fever, headache, recovered. 13 days after second shot, all symptoms returned for the 4th time
44 2021-04-24 tenderness Bruise and tenderness underside of arm
44 2021-04-25 weakness Awoken the very next day by body aches and headache. Weakness. Over the next day or so, started to e... Read more
Awoken the very next day by body aches and headache. Weakness. Over the next day or so, started to experience light pain in scrotum area (first two weeks strong pain), and unable to empty bladder completely (always an urge to urinate even right after urinating). This bladder issue is ongoing, joint pain at times.
44 2021-04-25 weakness 45 y/o male with no medical history seen today complaining of dizziness, and left arm weakness. Pati... Read more
45 y/o male with no medical history seen today complaining of dizziness, and left arm weakness. Patient denies any allergy. Per patient this is his first dose of the vaccine series. NP and paramedics at patient side. Vital sign obtained BP 149/97, bs 105, 98%, 19 RR, NSR on the monitor. Patient provided with a bottle of water and legs were elevated on a chair. Vital sign rechecked. 132/94, 96, 99% 19. Patient states he felt better. Patient discharge home accompanied by his wife.
44 2021-04-25 slurring This is sharing a concern / reporting a concern. This is not a complaint against anyone. This is not... Read more
This is sharing a concern / reporting a concern. This is not a complaint against anyone. This is not reporting side effect. The adverse effect date and time is a mandatory field. This is the reason I filled adverse date and time. I had my 2nd dose of vaccine on April 25, 2021 at campus at 1.20 PM. I just felt the syringe just touched the peripheral of my skin. I told the nurse that I do not feel I get the shot. Later, I do not feel any side effect any effect. I had no pain, or the site of injection was not swollen. I am worried I did not get the 0.3ml dose. During the first shot on April 4, 2021 at 1.43 PM, I felt pain on shoulders. I felt my tongue got thickened/ some tingling sensation on tongue and a little slur in speech. After 6 hours, I felt headache, a little chill, light head, nausea, more pain on shoulders and the next day, I felt light headedness and I felt tired for few days. I consider these as normal side effects and nothing unusual from what I read in internet and what I heard from others. So, I did not report it and it was a normal thing for me. Since I experienced this in first dose, I expected a more severe reaction than first dose. But I did not even feel pain at the site of injection nor any usual symptoms that usually appear. This made me to doubt I got required dose or the vaccine was correctly withdrawn from the vile. I do not know how to confirm that I got correct dosage. If I have not received the full dose, I am ready to take an additional shot and I would be flexible to take the shot at the available time near to my living place on any day. Again, I am not complaining anything. Probably the nurse is very proficient in taking shot with no pain. I do not know why my body does not react to the second dose.
44 2021-04-25 feeling hot Pt received Covid vaccine complained of pounding headache, dizziness, chest pressure, feeling hot a... Read more
Pt received Covid vaccine complained of pounding headache, dizziness, chest pressure, feeling hot all over. BP 131/87. HR 82, RR 18, O2 sat 98%, temp 98.3. Pt taken to Emergency Department to further care required.
44 2021-04-25 feeling hot Patient began to feel hot and sweaty after injection. Pharmacist took patient's temperature, which w... Read more
Patient began to feel hot and sweaty after injection. Pharmacist took patient's temperature, which was 96 F. Patient still felt hot and was lethargic but remained responsive. 911 was called when patient stared to droop head to side as if he was falling asleep. We provided cooling measures and kept patient awake until paramedics arrived.
44 2021-04-26 weakness Two days following the shot I was unable to put weight on my left arm. I went to an orthopedic speci... Read more
Two days following the shot I was unable to put weight on my left arm. I went to an orthopedic specialist and she said it was likely that the shot had weakened my deltoid and the connective tissue in the shoulder was irritated trying to compensate.
44 2021-04-27 pain in extremity Dizziness, body aches, headache, strong fatigue, sweating and chills at night, vibration feeling thr... Read more
Dizziness, body aches, headache, strong fatigue, sweating and chills at night, vibration feeling throughout body, sore arm
44 2021-04-28 weakness Delirium; Severe fever 102+; Aches; chills; Restlessness; Headache; Weakness; This is a spontaneous ... Read more
Delirium; Severe fever 102+; Aches; chills; Restlessness; Headache; Weakness; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration administered in arm right on 14Apr2021 09:30 AM (Lot Number: EW0158) at vaccination age of 44 years old as single dose for covid-19 immunisation. Medical history included hypertension, high cholesterol, Cephalosporin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications within 2 weeks of vaccination included atorvastatin calcium (LIPITOR) taken for blood cholesterol increased; tadalafil (CIALIS). The patient previously took 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EN6206) via an unspecified route of administration administrated in Left arm on 24Mar2021 at time of 09:45 AM at vaccination age of 44 years old as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe fever, 102+, aches, chills, delirium, restlessness, headache, weakness on 14Apr2021 at time of 11:00 PM. No treatment received for the adverse event. The patient underwent lab tests and procedures which included body temperature: greater than 102 fahrenheit on 14Apr2021. The outcome of events was recovering. Since the vaccination, the patient had not been tested for COVID-19.
44 2021-04-28 feeling cold, cold sweat Patient started feeling sweaty and clammy about 20 minutes after his second vaccination. We were wat... Read more
Patient started feeling sweaty and clammy about 20 minutes after his second vaccination. We were watching him for 30 minutes. He asked to have his blood pressure checked. He was cold and sweating and said he was having chest pain. We called 911. his blood pressure was high but his pulse was normal. The EMT took the patient to run tests.
44 2021-04-29 pain in extremity Sore arm.
44 2021-05-01 tremor It started earlier in the day, just tired, then around the time stated I got intense chills to the p... Read more
It started earlier in the day, just tired, then around the time stated I got intense chills to the point of shuddering. Ran a slight temperature but it cooks have been all the blankets I was under. With it being about two weeks after the first injection im not sure if it was a reaction or a bug but it was very intense and the same as other reported symptoms but 2nd dose symptoms not first dose.
44 2021-05-03 numbness Back of hand numb on vaccination side, both feet numb. Lasted 10 days
44 2021-05-03 pain in extremity Left side supraclavicular lymphadenopathy. Lymph node swollen, soft and painful, measuring about 1 i... Read more
Left side supraclavicular lymphadenopathy. Lymph node swollen, soft and painful, measuring about 1 in wide and 0.7 in high. Sore left arm after administration of the vaccine which resolved without any treatment on the second day after administration.
44 2021-05-05 weakness High fever, bad chills, bad body aches, loss of appetite, coughing up mucus infection from chest, na... Read more
High fever, bad chills, bad body aches, loss of appetite, coughing up mucus infection from chest, nasal congestion and infection, very weak and tired
44 2021-05-05 pain in extremity May 1 18:15 dose 2 of vaccine received. No immediate adverse effects. Shot hurt less than first one.... Read more
May 1 18:15 dose 2 of vaccine received. No immediate adverse effects. Shot hurt less than first one. May 2 09:00 woke up with severe muscle soreness, joint pain, mental fog, extreme fatigue and a slight temp. Took Advil and went back to sleep. Didn't get out of bed majority of the day due to continued fatigue and muscle soreness and joint pain. May 3 went to work with continued mental fog, extreme fatigue, muscle soreness (still everywhere), and joint pain. Continued taking Advil to keep working. Condition did not get better at all throughout this day. May 4 woke up with mental fog lifted, fatigue gone, however; the muscle soreness and joint pain continued... but ONLY from my lower back all the way down both legs. I have never felt anything quite like this before. Continued to take Advil to deal with the pain May 5 aching and pain still present in lower back and both legs May 6 aching and pain still present and annoying in lower back and both legs and is not getting better. At this point I'm concerned as I was completely healthy before receiving the second dose of the vaccine with ZERO health problems and ZERO pain. Please tell me what is going on and if this will pass with time. I was healthy before and want to be healthy again. I'm dealing with the pain and will not miss work if I can help it. My wife is a pharmacist and insisted I get the vaccine.
44 2021-05-06 numbness, burning sensation burning in privates/groin, both arms felt numb, and pain in both shoulders
44 2021-05-06 pain in extremity Stinging in pinky on hand opposite of vaccine. It would happen once or twice a day up to about 10 ti... Read more
Stinging in pinky on hand opposite of vaccine. It would happen once or twice a day up to about 10 times a day. The pain has dulled over the past two weeks, but still occurs.
44 2021-05-07 bell's palsy got Bell's palsy, On the right side of his face; This is a spontaneous report from a non-contactable... Read more
got Bell's palsy, On the right side of his face; This is a spontaneous report from a non-contactable consumer. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0150, first dose) solution for injection intramuscular on 05Apr2021 (at the age of 44-years-old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient got Bell's palsy, on the right side of his face on 19Apr2021 with seriousness criteria of hospitalization. Treatment for the event Bell's palsy included prednisone at 20 mg tablet, 3 tablets by mouth daily; and acyclovir 800 mg tablet, orally one tablet by mouth 5 times daily for 10 days from 19Apr2021. The outcome of the event Bell's palsy was not recovered.
44 2021-05-07 numbness Systemic: complaints of numbness in injected arm and side of face lasted 5 hours and then subsided-... Read more
Systemic: complaints of numbness in injected arm and side of face lasted 5 hours and then subsided-Medium, Additional Details: Contacted patient the following day and he reported feeling fine. Was getting ready to go to work.
44 2021-05-07 tingling, numbness I had a stroke affecting the left side of my body. The stroke was in the pons area of my brain stem... Read more
I had a stroke affecting the left side of my body. The stroke was in the pons area of my brain stem. I noticed tingling in my left hand and the bottom of my left foot. I assumed it was just my back being out a bit and was going to get it put back in line the next day. When I woke up on Friday 4-23-21 my left side from the top of my head to the bottom of my left foot was numb and tingling. I went to the ER at that point to find out about the stroke.
44 2021-05-10 muscle spasms, migraine, night sweats Continued issues - Burning in left hip, clicking in left pointer finger, night sweats, migraines, l... Read more
Continued issues - Burning in left hip, clicking in left pointer finger, night sweats, migraines, light sensitivity in right eye. Recovered - muscle spasm and cramp in right thigh
44 2021-05-10 tingling, numbness Loss of feeling in right foot and blurred vision on evening of second day after vaccination. Sympto... Read more
Loss of feeling in right foot and blurred vision on evening of second day after vaccination. Symptoms developed at same time as fever started. Fever lasted the evening with bed soaked in sweat then broke by the morning. Lose of feeling in foot improved by next day and feeling returned entirely after 5 days. Blurred vision improved by next day but has been lasting one and off for two weeks. After feeling returned in right foot there was one evening of right ankle cramping. Finally fasciculations and "pins and needles" feeling happened in the face, right wrist, and right leg happened during the 2nd week after the shot but improved by the third week.
44 2021-05-12 numbness Fingers are "going to sleep" often and my shoulder has dull pain which, is recurring and not somethi... Read more
Fingers are "going to sleep" often and my shoulder has dull pain which, is recurring and not something that I have experienced often
44 2021-05-13 numbness and pain in extremities since 4/19/2021 - 2 hours after shot - I have had peripheral neuropathy in my hands and feet and leg... Read more
since 4/19/2021 - 2 hours after shot - I have had peripheral neuropathy in my hands and feet and legs for the last 3 weeks and still til today, because of this I did not take my 2nd shot that was due on 5/10/2021
44 2021-05-13 tremor Severe headache/His headache is severe it feels like he is being hit on one onside of his head; Feve... Read more
Severe headache/His headache is severe it feels like he is being hit on one onside of his head; Fever; Fatigue; He feels like its shocking his body because of the pain all over, his body shakes because of the pain.; He feels like its shocking his body because of the pain all over, his body shakes because of the pain.; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 22Apr2021 at 44 years old as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache, fever, fatigue, shaking, pain and diarrhea in Apr2021 with outcome of not recovered. The patient reported severe headache, a fever and fatigue, not sure when he will get relief. The patient wanted to know when he will get some kind of relief. His headache was severe it feels like he was being hit on one onside of his head. He felt like it was shocking his body because of the pain all over, his body shaked because of the pain. He was surviving on Tylenol and Ibuprofen right now. The patient clarified having a maybe a little diarrhea along with the pain all over, fever, fatigue and severe headache. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
44 2021-05-14 hot flush I had a 102.5 degree fever off and on for two days; severe body aches; chills; headaches; injection ... Read more
I had a 102.5 degree fever off and on for two days; severe body aches; chills; headaches; injection site soreness; redness; skin sensitivity; brain fog; hot flashes; fatigue; swollen lymph nodes (left armpit); This is a spontaneous report from a contactable other hcp. A 44-year-old male patient reported for himself that he received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9268), via an unspecified route of administration, administered in Arm Left on 12Feb2021 14:00 (at the age of 44-year-old) as 2nd dose, single for COVID-19 immunization. Medical history included migraines. Patient had no known allergies. Patient had not covid prior and post vaccination. Concomitant medication(s) included ibuprofen (ADVIL LIQUI GELS); acetaminophen (ACETAMINOPHEN). Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 26Jan2021 02:45 (at the age of 44-year-old) as 1st dose, single for COVID-19 immunization. The patient stated that on 13Feb2021 02:00, he had a 102.5 degree fever off and on for two days, severe body aches, chills, headaches, injection site soreness, redness, skin sensitivity, brain fog, hot flashes, fatigue, and swollen lymph nodes (left armpit). Patient did not received any treatment for the events. The outcome of the events was reported as recovering. Follow-up attempts have been completed and no further information is expected.
44 2021-05-14 pain in extremity Full body rash with swelling and hives and pain in his foot hands torso legs. He was given 100 mg of... Read more
Full body rash with swelling and hives and pain in his foot hands torso legs. He was given 100 mg of Benadryl by mouth and partial Medrol pack by family. Then later that day he went to the emergency room and was only treated with Decadron 10 mg and Benadryl 50 mg. He was discharged with a Medrol dose pack. Continues to have hives and pain all over his body.
44 2021-05-16 weakness Severe body ache, chills, sweating, nausea, and vomiting. Vomited 9 times in a row and spent the ent... Read more
Severe body ache, chills, sweating, nausea, and vomiting. Vomited 9 times in a row and spent the entire night with a bucket. For the next week every morning, diarrhea and unsettled stomach, lack of energy, excessive sleep, no ability to exercise without severe fatigue or a return of digestive problems. This lasted a week. Sexual activity also impossible, erection quality greatly reduced. Many of these symptoms got better but have now returned with my second dose. Second dose has given me significant fatigue, digestive problems again, diarrhea, and reduced erection quality once more. I hope these problems resolve themselves. The vaccine has made going to work very difficult and I will seriously reconsider taking any vaccine in the future.
44 2021-05-16 numbness Client presented to Community Center at his scheduled appointment time to receive his 2nd dose of th... Read more
Client presented to Community Center at his scheduled appointment time to receive his 2nd dose of the COVID Pfizer vaccine. While being processed for 2nd dose vaccination, the client reported that he experienced left arm and left leg weakness and numbness about 10 hours after vaccination. Client admits he received his first Pfizer COVID vaccination to his left arm. Client reports he was asleep and woke up to use the restroom. At that time, the client noticed he had a hard time walking on his left leg. He also noticed left trapezius muscle soreness, but denied any other symptoms at the time of the incident. Client reports he does not recall the time his symptom resolved, but notes he fell asleep and woke up with out any numbness or weakness to left side. Client reports left trap pain resolved after 2 days. He denies following up with PCP.
44 2021-05-16 pain in extremity, breast pain Intermittent pain in left arm/shoulder and left breast, internal, feeling like spasm in vein or simi... Read more
Intermittent pain in left arm/shoulder and left breast, internal, feeling like spasm in vein or similar, middle of night, woke me up from sleep, also slight heaviness in chest feeling, but no other symptoms
44 2021-05-16 pain in extremity, tingling Constant pain from my neck to my fingers, tingling in fingers and terrible shoulder pain.
44 2021-05-17 nerve injury Sudden loss of hearing in right ear in upper frequencies, pressure and fullness in inner ear for 2 w... Read more
Sudden loss of hearing in right ear in upper frequencies, pressure and fullness in inner ear for 2 weeks straight now. Nerve damage to left ring finger tip with less feeling to touch.
44 2021-05-18 muscle spasms possible hallucinations; severe chills; severe back spasm; nausea; dizziness; the lymph node under m... Read more
possible hallucinations; severe chills; severe back spasm; nausea; dizziness; the lymph node under my right arm (the arm that was injected) was swollen to the size of a softball.; This is a spontaneous report from contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EP7533) via an unspecified route of administration, administered on the right arm on 30Apr2021 09:15 (Batch/Lot Number: EP7533) as unknown, single for COVID-19 immunization. The patient had no medical history. Concomitant medication included ascorbic acid, betacarotene, biotin, boron, calcium, calcium pantothenate, chloride, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, iron, lycopene, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine, tin, tocopheryl acetate, vanadium, vitamin k nos, zinc (CENTRUM MEN). The patient had severe chills, severe back spasm, nausea, dizziness, possible hallucinations, and the lymph node under my right arm (the arm that was injected) was swollen to the size of a softball on 30Apr2021 07:00 PM. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The facility where the vaccine was administered was in a Public Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies. Outcome of the events was recovering.
44 2021-05-19 nerve pain, numbness Pt w/ hx of medication allergies PCN (rash), ciprofloxacin (rash), "septrum" (anaphylaxis). Pt c/o... Read more
Pt w/ hx of medication allergies PCN (rash), ciprofloxacin (rash), "septrum" (anaphylaxis). Pt c/o pinched nerve pain, arm numbness on left side (neck and arm). BP 142/84, HR 90, RR 12 -- > 125/84, 70, 14 -- > 127/84, 72, 12. Pt provided juice and crackers. Pt improved. Pt stable and released from the vaccination site.
44 2021-05-21 discomfort Tinnitus and loss of some hearing in right ear.
44 2021-05-23 inability to speak, slurring 5/24/21 - 44-year-old male with a past medical history significant for nicotine dependence, marijuan... Read more
5/24/21 - 44-year-old male with a past medical history significant for nicotine dependence, marijuana use, who presents for slurred speech. Accompanied by wife. Patient was in his normal state of health until Friday when he got his Pfizer Covid vaccine. About 5 hours later he was noted to have a headache and some slurred speech but patient and wife did not think anything of it. They went to some graduation parties this weekend and his speech continued to get worse which is what prompted them to present to the ED today. He denies that this is happened before. Feels like it is difficult for him to find words but not to actually say words. He does surf but denies being in murky water or swimming in fresh water. He denies IVDU. No underlying coagulopathy or cardiac history.
44 2021-05-23 numbness, facial pain, tingling Tingling and numbness from head through tie on the right side within 15 minutes of the injection. Ox... Read more
Tingling and numbness from head through tie on the right side within 15 minutes of the injection. Oxygen levels and blood pressure was normal taken by local EMT. Tingling and numbness went away about two hours later. Tingling, pain and numbness on the right side of the face two days later. Theirs symptom lasted several hours and came back later in the day for a few of hours. No treatment given.
44 2021-05-24 pain in extremity patient called pharmacy and complained that his arm still hurt 6 days after initial vaccination
44 2021-05-25 pain in extremity Pain and limited range of motion in left upper arm/shoulder.
44 2021-05-27 pain in extremity, numbness and pain in extremities Neuropathy in the right arm (not the arm I got the shots), irradiating to head and left foot.
44 2021-05-27 tingling, flushing, numbness Patient experienced apprehension, flushing and numbness and tingling. Patient verbalized "Throat ti... Read more
Patient experienced apprehension, flushing and numbness and tingling. Patient verbalized "Throat tightness" and elevated BP even though pt reports being on BP medications. O2 sat and pulse remained normal. Lungs CTA. Patient has a history of reactions to bee stings. Pt was given 50mg Diphenhydramine observed by staff and released
44 2021-05-27 unresponsive to stimuli, tremor Pt felt dizzy immediately after injection, pt had a slight tremor and labored breathing, counselled ... Read more
Pt felt dizzy immediately after injection, pt had a slight tremor and labored breathing, counselled pt to take deep breaths and stay seated, pt tried to stand and fell to the floor unconscious where he remained breathing but unresponsive for over 1 minute, came to on his own.
44 2021-05-31 weakness 1st shot 4/13, no issue with injection site. About a week later had trouble breathing, chest pain, f... Read more
1st shot 4/13, no issue with injection site. About a week later had trouble breathing, chest pain, felt like lungs were hurting in my back, weak, tired, couldn't catch my breath when i went upstairs and almost passed out. 2nd shot 5/04, felt pain at injection site (that was expected), that night started to get a bad headache and got worse and worse. Next morning, whole body aching, upper body, lower back, bad headache, Left underarm (lymph) swollen. 2nd day slight headache, neck ache, left underarm swollen. That night had rash on arms, chest, and stomach. 3rd day, nighttime rash arms, chest, stomach. Still red where band aid was over injection site. Over a week later still have redness shape of band aid, Seems I have sensitive skin since the 2nd covid shot. 10 days after 2nd shot I still have redness the shape of the Band Aid on my left arm. Got a red spot on my nose (looks like Rosacea). 4 weeks later, still have a red spot on my nose. I have itchiness between fingers left hand, on my face left side, neck, arms (left wrist, right arm in places) redness on chest, and rashes on back, left buttocks, and itchiness on legs. i noticed that it gets worse at night. As far as i know i did not get the Covid Virus, i did the rapid test and regular test and both were negative. But i was very sick with my stomach and had issues breathing in late 2019 and again early 2020, took medication (antibiotics) both times. I had to write on this form over and over again kept getting frozen with error from the PDF. Even if I hit OK, it keeps popping up and does not let me finish, so I can imagine that lots of people gave up, like I may. Pfizer 4/13/2021 EW0162. After 5pm Pfizer 5/04/2021 EW0170. After 2pm
44 2021-05-31 tingling Patient presented to the ED on 5/8/21 with hypertensive emergency. Per ER provider's notes: He was a... Read more
Patient presented to the ED on 5/8/21 with hypertensive emergency. Per ER provider's notes: He was at the VA today getting his 2nd Covid vaccine (Pfizer) and during the post vaccine waiting period, he developed frontal headache and transient L arm tingling. He was sent to ED in Superior and BP was as high as 219/114. He was given amlodipine and toradol and dilaudid and BP did not come down. He also had a slight elevation in troponin and had second episode of L arm tingling. Decision was made to not give ntg since he already had a headache. No chest pain or other neuro sx. Head CT neg for bleed. No chest pain. Patient presented to the ED again on 5/11/21 with similar symptoms as previous visit.
44 2021-06-01 pain in extremity rash on arms; little restless; noticed how sore his arm was/pain in his arm; trouble sleeping/proble... Read more
rash on arms; little restless; noticed how sore his arm was/pain in his arm; trouble sleeping/problems with sleep; felt movements in his chest at times; felt like he had COVID all over again/ if he possibly has COVID-19 again; soreness; heart rate accelerated; some swollen in lymph nodes; This is a spontaneous report from a contactable pharmacist (patient) via a Pfizer sponsored program. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Mar2021 at around 13:00 or 13:30 (at the age of 44 years old) (Lot Number: EP7534, unknown expiration) as 1st dose, single for COVID-19 immunisation. Medical history included COVID-19 in Nov2020; sneezing and runny nose both on 21Mar2021. The patient's concomitant medications were not reported. The patient reported that he received his first dose of Pfizer COVID vaccine on 22Mar2021. He felt fine after receiving the vaccine, but there was little bit rash on arms just afterwards and felt maybe a little restless but felt fine and went for a walk on 22Mar2021. As the night went on, he really noticed how sore his arm was/pain in his arm and when he was sleeping, he had trouble sleeping/problems with sleep (Mar2021) and felt movements in his chest at times (Mar2021). It felt like he had COVID all over again and had chills, soreness, and his smell was kind of gone in Mar2021. He was previously feeling pretty good. He had COVID-19 in Nov2020, and his symptoms feel very similar including loss of sense of smell but no coughing. He had a fever but that has gone away in Mar2021 and he did not take aspirin or anything for it. He also had fatigue, some swollen in lymph nodes, and his heart rate accelerated in Mar2021. He had sneezing and runny nose the day prior to receiving the vaccine. The patient would like to know if his symptoms are related to the vaccine or if he possibly has COVID-19 again. His symptoms are the same as COVID as far as what he can see, and his symptoms are really high. He would like to know if he can still receive the second dose of the vaccine if he has a positive COVID test after the first dose of the vaccine. The patient mentioned that there was very pretty high percentage of people having the symptoms after having the vaccine, kind of virus "causing". The patient asked if he needs to be tested to see if he had the virus before he was vaccinated and to know if these are one of the side effects or one of the symptoms of the virus, and to make sure that these are not actually corona virus. The patient recovered from fever in Mar2021, while unknown outcome for the remaining events. No follow-up attempts are possible. No further information is expected.
44 2021-06-04 feeling cold Very cold and full body aches; Very cold and full body aches; This is a spontaneous report received ... Read more
Very cold and full body aches; Very cold and full body aches; This is a spontaneous report received from a contactable consumer (Patient, self-reported). A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date: not reported), dose 2 via an unspecified route of administration, in the left arm, on 24Feb2021 at 15:30, as single dose for COVID-19 immunisation in the school or student health clinic. The patient's medical history and concomitant medications was not reported. The patient was not allergic. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date: not reported), dose 1 via an unspecified route of administration, in the left arm, on 03Feb2021 at 17:30, as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medication within 2 weeks. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Feb2021 09:00, the patient experienced very cold and full body aches. No treatment was received. The patient not tested for COVID-19 since the vaccination. The outcome of the events was recovered on an unknown date in 2021. No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
44 2021-06-06 migraine sensitivity to light, nausea, migraine (5 days), lightheadedness overall lasted for approximately 1... Read more
sensitivity to light, nausea, migraine (5 days), lightheadedness overall lasted for approximately 15 days with various symptoms
44 2021-06-07 feeling hot I was driving home from my town to another town. About 15 mins I thought I had to take leak and my g... Read more
I was driving home from my town to another town. About 15 mins I thought I had to take leak and my groin area was warming up on the inside and then it started to burn up on the inside and it was painful I was thinking what could have caused and it then I realized I had the pfizer vaccine and then I have implant all of sudden I loss use of arms and it took about 20 mins for me to get use in them and then they started to burn up on the inside. Later on that night I started to cough really bad and my lungs had a hard time keeping me breathing and then I knew I had got the covid from the shot and it was much worst than the actual covid. This was the first dose of the pfizer that I got these reactions and plus I heard about how the vaccine has been sterlizing people from having kids. I knew that the pfizer vaccine is 100% unsafe for anybody to take and that it was a bad batch or wrong vaccine. But I am letting you know that you need to keep money set aside for damages from the vaccine. But please do not be like the other states giving people money, guns, trucks for getting the vaccine. I am warning people not to get it because I almost die in the first dose of the pfizer vaccine.
44 2021-06-07 muscle spasms Woke up day after with headache 2nd day after severe muscle spasms in arms , legs, chest and back ... Read more
Woke up day after with headache 2nd day after severe muscle spasms in arms , legs, chest and back 3rd days after muscle spasms over entire body
44 2021-06-08 discomfort fainted three times felt heavy tunnel vision and ringing in my ear 10 minutes after receiving the va... Read more
fainted three times felt heavy tunnel vision and ringing in my ear 10 minutes after receiving the vaccine
44 2021-06-08 tingling Systemic: Joint Pain-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
44 2021-06-10 bell's palsy I had history of Bells Palsy and it occurred in Dec2009.Similar symptoms of Bells Palsy started on 2... Read more
I had history of Bells Palsy and it occurred in Dec2009.Similar symptoms of Bells Palsy started on 29May2021, 2 weeks after the Covid 2nd dose; I had history of Bells Palsy and it occurred in Dec2009.Similar symptoms of Bells Palsy started on 29May2021, 2 weeks after the Covid 2nd dose; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 12May2021 10:45 (Batch/Lot Number: EW0177) as single dose for COVID-19 immunisation. Medical history included bell's palsy in Dec2009. The patient had no known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 21Apr2021 10:15 (Batch/Lot Number: EB8731) for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported that he had history of Bells Palsy and it occurred in Dec2009. Similar symptoms of Bells Palsy started on 29May2021 at 7:00 AM, 2 weeks after the Covid 2nd dose. The patient consulted his physician and on medications (Steroid and Anti-infamotroy(inflammatory)) now. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was recovering.
44 2021-06-10 tingling Tingling hands and feet started same day. Continues off and on for 6 weeks now. Chest pain upon eve... Read more
Tingling hands and feet started same day. Continues off and on for 6 weeks now. Chest pain upon even mild exertion like walking around the block. Lasted for a few weeks. Right arm bone pain severe lasted for about 3 weeks Spine felt swollen near coccyx/sacrum and C7-C6 pain. Feeling of Lower spine swelling and pain started less than 24 hrs. after. Lasted approx 2 weeks. Extreme tiredness lasted 2 weeks Baseball shaped raised area on chest near right arm(vaccinated arm) started perhaps a week in and lasted about a week.
44 2021-06-12 numbness WITHIN MINUTES OF TAKING THE FIRST DOSE, MY BLOOD PRESSURE AND PULSE DRAMATICALLY INCREASED. I FELT ... Read more
WITHIN MINUTES OF TAKING THE FIRST DOSE, MY BLOOD PRESSURE AND PULSE DRAMATICALLY INCREASED. I FELT DIZZY, AND MY FACE WAS NUMB. WITHIN MINUTES OF TAKING THE SECOND SHOT, MY BLOOD PRESSURE AND PULSE SPIKED. SINCE THE SHOTS, I HAVE EXPERIENCED DIZZINESS, FEELING OF FAINTING AND ELEVATED BLOOD PRESSURE. I HAVE EXPERIENCES PIERCING PAIN IN MY HEART, PRESSURE IN MY CHEST AND INCREASED PULSE EVEN WHEN RESTING. I HAVE EXPERIENCED HEADACHES, BLURRED VISION.
44 2021-06-13 tenderness Client came to vaccination site at 1715 for his 2nd Pfizer dose on 06/13/21. After being seated wit... Read more
Client came to vaccination site at 1715 for his 2nd Pfizer dose on 06/13/21. After being seated with RN, he expressed concern about receiving his 2nd dose due to the reactions he experienced after receiving his 1st dose. RN requested Lead RN speak with the client regarding his concerns. At 1720 Lead RN spoke to client. Client stated that 1 ½ days after getting his 1st dose, he experienced soreness & tenderness in the axillary area of the left arm. Client stated that 3 days later his axillary area began swelling. The swelling continued below his axillary down the left side of his abdomen and onto the left side of his back. Client stated the pain level was a 4 on a scale of 0-10. He also stated there was no discoloration or redness in any of the areas where he experienced swelling. On day 10 the left side of the client?s neck began to swell. He also started to experience discomfort at the injection site and arm fatigue. Client stated at no time did he experience any trouble breathing, shortness of breath, or chest pain. Client stated he has been dieting and lost 145 lbs. in the last year. He previously had high blood pressure, but no longer does. He also stated the only other underlying conditions he has is a thyroid problem (hypothyroidism), and he is not medication compliant. Over the last 6 months he has only taken his levothyroxine intermittently. In the last 2 months he has not taken any of his levothyroxine until a few days ago. Client takes no other medication, but is allergic to penicillin-based antibiotics. Client stated he gets dizzy, hallucinates, and swells up in various places on his body. However, he does not experience shortness of breath or trouble breathing. Client did not take any medication for the side effects he experienced after receiving his first Pfizer injection or seek medical treatment. Client stated all the swelling began to subside on day 17. Lead RN performed a medical consult with Clinical Care Coordinator who authorized moving forward with administering client a Pfizer 2nd dose in the opposite arm with a 30-minute observation. Prior to RN administering vaccine, Lead RN educated client on normal vs adverse effects of the vaccine. Lead RN confirmed with client that he has access to a HCP for follow-up, if needed. Lead RN also recommended client follow-up with his HCP regarding his hyperthyroid condition. Lead RN instructed client to seek emergency care if he experienced shortness of breath, trouble breathing, or chest pain at any time after leaving the vaccination facility.
44 2021-06-14 burning sensation A few days after my first shot I came down with shingles on my buttocks. They were typical shingles ... Read more
A few days after my first shot I came down with shingles on my buttocks. They were typical shingles blisters that burned and itched unlike any other pain I have ever experienced. It occured on Sunday so I had to do a virtual Doctors visit. I was prescribed 2 different drugs to counter act the shingles. I do not remember what they were but my doctor should have a record of it.
44 2021-06-15 numbness center of left upper arm needle pain (shock feeling), numbness shooting down arm to fingers. loss of... Read more
center of left upper arm needle pain (shock feeling), numbness shooting down arm to fingers. loss of squeeze motion. these effects are intermittent. went to chiropractor for adjustment before i found out others were having similar problems.
44 2021-06-16 bell's palsy Bells Palsey on right side of face
44 2021-06-22 weakness, cold sweat 1st shot Reactions- shot was at 3:30 in the afternoon of 5/7/21. No immediate reactions to note. Aro... Read more
1st shot Reactions- shot was at 3:30 in the afternoon of 5/7/21. No immediate reactions to note. Around midnight of that night though, sweating, hot & cold, chills, Next day- nausea, diarrhea, and headaches. Could also feel soreness in my jaw. Intermittent lightheaded. Gradually started to notice swollen joints, achy bones. Popping/crackling of joints when moving/especially doing stairs. At a couple points, felt like I had frostbite while in the shower. Worst Joint pain of round 1 was May 27-31st. 6/1/21 Went to Dr. at hospital Reported symptoms. Was told that it could be from the vaccine but could be something else. Ran bloodwork. Liver levels came back elevated. 6/9/21 Still having joint p See Continuation Page- 6/9/21 Still having joint pain. Also noticing frequent urination/urgency to pee. Bones feel fragile, like living with the skeleton of a 95 year old man. Dr. ran blood work and I asked him how he felt about me getting the second shot- Worried that if my issues were vaccine caused, that I might be pouring gas on a fire by getting the second shot? He said that it's possible but the chances were small. Told me to see how the blood work came back and proceed if all clear. Blood work came back and was normal. Second shot (6/11/21) Friday afternoon- shot at hospital at 3:30. No immediate reaction. Spoke with nurse at location and she had not heard of anyone having my symptoms. Only numbness. Friday night around midnight, couldn't get comfortable. Skeletal pain grew unbearable in bed so I took a salt bath around 5am. Literally couldn't move my body/unable to get out of bathtub. Stayed in there for about an hour and a half. Drank 3 bottles of coconut water. Couldn't make a fist. Pains shifted all throughout my body. Quick sharp pains. Had a slight cough and when i did cough, it blasted pressure from the inside of my skull, out. I've never felt that before. Slowly made progress and went to see a Reflexologist. She helped but the issues continued throughout the day. No energy, couldn't move much without groaning. Couldn't get out of a chair on my own without pulling/pushing on something else. Had the chills but never a fever. Cold sweats. Hydrated with electrolytes. Got some sleep Saturday night and felt much better Sunday.
44 2021-06-22 tingling, pain in extremity, night sweats, numbness Altered sense of taste and smell. Things tasted different. I had a very dry mouth as well. I also sm... Read more
Altered sense of taste and smell. Things tasted different. I had a very dry mouth as well. I also smelled things that were not there. I lost my sense of smell 10 years ago due to sinusitis. I experienced lethargy about 5 days after the shot up to 4 weeks after. I had some tightness in my chest, my albuterol inhaler helped with that. The tingling in my hand and feet happened on a few occasions. I had numbness that lasted about an hour. I had frequent night sweats that woke me. I had muscle tightness in my leg and abdomen. I also had soreness in my arm, which made it hard to grasp a pen. I did test my reflexes which were normal.
44 2021-06-23 breast pain Small, hard mass started 2 days after the 2nd vaccine shot in left breast and turned into a mass the... Read more
Small, hard mass started 2 days after the 2nd vaccine shot in left breast and turned into a mass the size of a golf ball after 3-4 weeks, that is painful and has not gone down in size.
44 2021-06-24 weakness, hot flush weakness; sweat; feverish; dizziness; hot flashes; This is a spontaneous report from a contactable c... Read more
weakness; sweat; feverish; dizziness; hot flashes; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 44-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL8982 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 21Jan2021 (age at vaccination: 44 years) at 12:24 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. There was no Additional Vaccines Administered on Same Date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks prior to the first administration date of the suspect vaccine and Adverse events following prior vaccinations was reported as none. The Pertinent Details (include surgical procedures and dates) was reported as not applicable. There was no Family Medical History Relevant to Adverse events. On 21Jan2021, The patient experienced dizziness after a couple minutes of receiving the injection, hot flashes, broke out into a sweat which lasted about 15 minutes after receiving the first dose of the Pfizer COVID-19 vaccine and experienced weakness and felt that he had to roll down window, turn on AC, drink water and felt whole car spinning and experienced feverish. It did clear up before he left, however he felt dizzy on the drive home. He noticed that dizziness was on the list of potential severe allergic reactions. He states he has never had an allergic reaction to any other vaccines. He states that he has only been allergic to one antibiotic in the past (he did not name the medication) and he checked the list of ingredients prior to receiving the Pfizer COVID-19 vaccine and it was not a listed ingredient. The patient was concerned about the potential for a more severe reaction after receiving the second dose of the Pfizer COVID-19 vaccine because he has heard that the second dose is "more potent" than the first dose and if he should receive the second dose of the vaccine considering the side effects he experienced immediately after receiving the first dose. The nurse walked by his vehicle to check to see how he was feeling and he was fine and didn't feel anything. After she walked away, he felt as though the whole car was spinning and he had hot flashes. He called the nurse back over and told her what was going on and that he felt dizzy and a little weak, really hot and he broke out in a sweat. He rolled down window, turned on AC and he was given water. Was monitored for some time at least 5-10 minutes before he felt a little better. Still had a little dizziness up until the end, but they continued to monitor him. He was felt better after that and was able to drive home. Because dizziness and weakness is listed as severe side effects, does this mean that they will last more than 10-15 minutes because he is concerned about getting the second dose. Knows and heard the second dose is a little more potent and if he had these reactions 2 minutes post injection should he be concerned about getting the second dose. No other vaccines given the same day or 4 weeks prior. Had a flu shot 2 months prior, but unable to provide NDC, Lot, or expiry for flu shot. No problems with vaccines in past. Again, mentions the only thing that concerned him was the dizziness and hot flashes he had 2 minutes post injection. No further details provided. The events has not resulted in emergency room or physician visit. The relevant lab test was reported as none. Therapeutic measures were taken as a result of fever and treatment included over the counter Ibuprofen to help him feel better. Outcome of the event feverish was recovered and while all other events was recovering. Follow-up attempts are completed. No further information is expected.
44 2021-06-24 tenderness Two weeks to the day after having second injection of Pfizer Vaccine a lump began to grow behind my ... Read more
Two weeks to the day after having second injection of Pfizer Vaccine a lump began to grow behind my right nipple inside my chest/breast. The lump is very painful when pressed on and is shaped like a Cylinder closely resembling a small tootsie roll. The length is approximately 2 inches long and the diameter is maybe 1/4 an inch.
44 2021-06-28 nerve pain, numbness and pain in extremities 4 days following vaccination, I awoke with severe pain, swelling, and immobility in my right ankle. ... Read more
4 days following vaccination, I awoke with severe pain, swelling, and immobility in my right ankle. No prior trauma or injury. X-rays and MRI showed no injury. Severe bruising in the ankle developed over the next week with nerve pain attacks at night. Over the next two months, I began having pain in both ankles and neuropathy in both feet and arms. Have since had full exams by an orthopedist and rheumatologist, but neither can find an underlying cause. All rheumatology related blood work returned normal, but for presence of HLA-B27 marker. Neuropathy continues. Recent occurence of episcleritis in left eye. Awaiting neurology consult as next step.
44 2021-06-29 involuntary muscle movements, facial paralysis, bell's palsy Approximately one month after my second shot, beginning around 5/20, I began to lose the sense of ta... Read more
Approximately one month after my second shot, beginning around 5/20, I began to lose the sense of taste on the right side of my tongue. I thought it would go away but by 5/23 I had partial paralysis on the right side of my face. Fearing a stroke I went to the ER and after a full battery of tests I was diagnosed with Bell's Palsy. The symptoms worsened for a few days and I was unable to close my right eye, had difficulty breathing out of my right nostril and both eating and drinking were difficult because my lips would not close fully. The symptoms stabilized and then finally began to improve after steroid and antiviral treatment for a week, then on to regular aspirin.
44 2021-06-29 pain in extremity NOTICE PAIN UNDER ARM PIT. LYMPH NODES; PAIN LIFTING ARM.; NOTICE PAIN UNDER ARM PIT. LYMPH NODES; T... Read more
NOTICE PAIN UNDER ARM PIT. LYMPH NODES; PAIN LIFTING ARM.; NOTICE PAIN UNDER ARM PIT. LYMPH NODES; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208) via an unspecified route of administration in left arm on 17Mar2021at 13:15 (at an age of 44-year-old) as a single dose for Covid-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 05Mar2021 the patient underwent COVID-19 nasal swab test and the test result was found to be negative. On 19Mar2021 at 17:00, the patient experienced events of pain lifting arm, pain under armpit and lymph nodes pain. The patient did not receive any treatment for the reported events. Events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain lifting arm and pain under armpit were not recovered. No follow-up attempts are possible. No further information is expected
44 2021-06-30 feeling of insects crawling on skin phantom nerve sensation; a feeling like something was crawling on my skin (leg); sensations began oc... Read more
phantom nerve sensation; a feeling like something was crawling on my skin (leg); sensations began occurring occasionally a couple of weeks after fully vaccinated but but stopped occurring several weeks after fully vaccinated.
44 2021-06-30 muscle spasms Interrupted his sleep; Stuff in his throat/weird stuff on his throat; Cough; weird stuff on his thro... Read more
Interrupted his sleep; Stuff in his throat/weird stuff on his throat; Cough; weird stuff on his throat; Rapid heart rate; really bad chest pains; vomit; nausea; gasping for air; Neck spasms; Blood pressure, clarified as low blood pressure; It was like he was catching pneumonia but then his nose was running,; severe congestion, like bad stuff in his chest and lungs; severe allergies; tired; he got really sick; It was like he was catching pneumonia but then his nose was running,; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team and from a Pfizer sponsored program. A 44-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0167, Expiry date: UNKNOWN, NDC number: Unknown), via an unspecified route of administration at the right arm on 29May2021 11:15 as a SINGLE DOSE for covid-19 immunization. Medical history included myocardial infarction from an unknown date and unknown if ongoing, illness from Feb2020 to an unknown date, whole family was sick in February, palpitations from an unknown date and unknown if ongoing. History and investigation included "he said he had nothing to add during that time. But about a year ago he had gone to the emergency room for a heart attack scare. he thought, because this was when COVID first started happening, his whole family was sick in February and they would not test them at that time because they had not been to China and they never found out if they had it but he ended up getting tested for COVID when he was sick like 6 months later and then that went away and he started having heart palpitations and then after that he thought he would get a COVID antibody test and that came back negative, they told him by the time he got the antibody test, they told him he could have had it but it is not showing up on their antibody rapid test thing. He confirms this all occurred last year in 2020, he thinks it was almost a year ago. He would be sitting on the couch and his heart started racing like crazy. He did not know what that was all about". He said he had no discomfort at all. Concomitant medications were not reported. On an unspecified date in 2021 patient experienced it was like he was catching pneumonia but then his nose was running, neck spasms, blood pressure, clarified as low blood pressure, tired, he got really sick, severe congestion, like bad stuff in his chest and lungs, it was like he was catching pneumonia but then his nose was running, on an unspecified date in 2021 severe allergies, on 29May2021 rapid heart rate, really bad chest pains, stuff in his throat/weird stuff on his throat , cough, on an unspecified date in May2021 vomit, nausea, on an unspecified date in May2021, gasping for air, on an unspecified date interrupted his sleep. Caller received his first dose and was experiencing symptoms such as rapid heart rate and neck spasms and blood pressure. He was too tired to go to the emergency room. He had the weird cough and also stated he had weird stuff on his throat and severe allergies. Regarding his second dose, he wanted to receive but he wanted to know if he could receive a half dose. He also had really bad chest pains and he was going to go to the emergency room but he was too tired to even go. The other reason for calling, he was trying to find out because he was afraid to take the second dose, he wanted to know if he could take a half dose or something, he was trying to find out what he should do. Severe allergies, caller clarified it was like severe allergies or like hay fever kind of, but it was different. Rapid heart rate: He said this began happening the same day as the dose was given, 29May2021, 4 hours after he got the shot. It was not ongoing, it lasted about a day. The rapid heart rate went away the next morning, it stopped doing the crazy things it was doing the next morning, 30May2021. He confirmed that has recovered completely. The chest pain coincided with the rapid heart rate. It went way the same time as the rapid heart rate. It seemed like they both would come and go until the next morning, He confirmed that had recovered completely. He said then the low blood pressure was going on too. It was like it interrupted his sleep, he did not know how to explain it, like he had low blood pressure or like his heart would stop beating and he would wake up gasping for air. It was kind of like a nauseous feeling, he wanted to vomit. It happened with the low blood pressure and was mostly when he was sleeping and a little through the day, the nausea he means, it lasted about a day and a half. The nausea went away on the 30May or the 31May he cannot remember for sure. The cough and stuff in his throat began at the same time the heartbeat stuff started and the cough went away after 2 days. He felt pretty good for about 3 days and then he got really sick, with severe congestion, like bad stuff in his chest and lungs. It was like he was catching pneumonia but then his nose was running, it felt weird like a sickly poison kind of feeling like after he got the shot, he could not tell but it seemed like severe allergies or like hay fever kind of but it was different, it was a weird feeling. He had taken a bunch of herbal remedies Benadryl took herbal allergy stuff and it worked really fast and after like 3 days it was gone. He does not know what that was but it was pretty intense. No further information provided. It was reported that, caller got his first dose of the Pfizer Covid-19 vaccine on 29MAY2021 and had side effects. He wanted to know if he could get only a half dose of the COVID-19 vaccine. He also wanted to know if there was any correlation to having COVID-19 and having more of a reaction. Caller wanted to know if there was a correlation between having COVID-19 and having more side effects to the vaccine. He stated that his Pharmacist said there might be a correlation to people having COVID before getting the vaccine and having more problematic side effects from the first vaccine instead of the second. Response was given as "he should not get the Pfizer-BioNTech COVID-19 Vaccine if he had a severe allergic reaction after a previous dose of the vaccine or if he had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. He was referred to speak to healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Healthcare provider would have known the health situation and could access to information that better help inform the decision. From the CONS document on efficacy. Two shots were generally needed to provide the best protection against COVID-19 and the shots were given several weeks apart. The first shot primes the immune system, helping it recognize the virus, and the second shot strengthens the immune response. Side effects after the second shot might be more intense than the ones experienced after the first shot. The side effects are normal signs that body is building protection and should go away within a few days". The patient underwent lab tests and procedures which included sars-cov-2 antibody tested negative. Therapeutic measures were taken as a result of severe allergies (drug hypersensitivity). He visited emergency room due to the event chest pain. On an unspecified date in 2021 the outcome of the events it was like he was catching pneumonia but then his nose was running, neck spasms, blood pressure, clarified as low blood pressure, tired, he got really sick, severe congestion, like bad stuff in his chest and lungs, it was like he was catching pneumonia but then his nose was running was unknown, on an unspecified date in 2021, severe allergies was recovered, rapid heart rate, really bad chest pains, cough was recovered on 30May2021, on an unspecified date in May2021 vomit, nausea was recovered, gasping for air, interrupted his sleep and stuff in his throat/weird stuff on his throat was unknown. Information on the lot/batch was available, Additional information has been requested.
44 2021-06-30 tingling At the 25 minute mark I started feeling my left ?go to sleep? like when your feet go to sleep. It wa... Read more
At the 25 minute mark I started feeling my left ?go to sleep? like when your feet go to sleep. It was tingling from should to finger tip. Since then I have had tingling on the left side of my face from my left eye straight down to the left side of my jaw. I can smile and speak and have full motion of my left side.
44 2021-07-01 weakness, pain in extremity Right side of the head has pressure, ringing in the right ear, right arm sore, and no energy. Was pr... Read more
Right side of the head has pressure, ringing in the right ear, right arm sore, and no energy. Was provided medication by healthcare professional. (Prednisone 10mg)
44 2021-07-01 weakness Headache, congestion, aches and pains, joints, loss of energy, Concentration, loss of testosterone, ... Read more
Headache, congestion, aches and pains, joints, loss of energy, Concentration, loss of testosterone, chest pain, heart
44 2021-07-11 numbness By 2/11/2021 i had developed back pain and leg numbness. Progressed to right then left foot drop.
44 2021-07-11 seizure Cardiac arrest, followed by seizure and death. Pt was hospitalized, undetermined cause of death, ca... Read more
Cardiac arrest, followed by seizure and death. Pt was hospitalized, undetermined cause of death, case send to a medical examiner. Case was noted upon chart review by reporter.
44 2021-07-15 electric shock sensation Large rash on chest, pain through the body, wakes up drenched in sweat, low grade fever and chills, ... Read more
Large rash on chest, pain through the body, wakes up drenched in sweat, low grade fever and chills, sensations throughout body, feels as though electricity is going throughout body, stabbing pains in veins, heart pains, organ pains, reflux in veins and legs stabbing pains in eyes, double vision, blurred vision, light headed and dizzy, allergic reactions to foods. Doctor's were unable to diagnose him with anything. He stated that he has a history of mental illness,
44 2021-07-17 feeling hot Pain in between shoulder blades, pain in right shoulder; Warmness in corner of the right eye.; Runny... Read more
Pain in between shoulder blades, pain in right shoulder; Warmness in corner of the right eye.; Runny nose; Warmness in the right tricep; This is a spontaneous report received from a contactable consumer, the patient. A 44-year-old male patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: BN6201) via an unspecified route in the left arm on 24Mar2021 at 08:30 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any 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. Concomitant medications included difluprednate (DUREZOL) for unknown indication received within two weeks of vaccination. The patient did not receive any vaccines within four weeks prior to the COVID-19 vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9265) via an unspecified route of administration in the left arm on 03Mar2021, as a single dose for COVID-19 immunisation. On 24Mar2021 at 19:00, the patient had pain in between shoulder blades, pain in the right shoulder, warmness in corner of the right eye, warmness in the right tricep, and runny nose. The events did not result in doctor or other healthcare professional office/clinic visit, and the emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the pain in between shoulder blades, warmness in corner of the right eye, warmness in the right tricep and runny nose was not resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
44 2021-07-17 pain in extremity, numbness Numb face for ~2 hours. Heart fluttering. Right calf pain.
44 2021-07-18 unresponsive to stimuli The patient stated he was getting tunnel vision. At this point I came to the site of the patient and... Read more
The patient stated he was getting tunnel vision. At this point I came to the site of the patient and his pupils dilated. He became unresponsive. The patient started responding after about 1 minute. When the patient finally became responsive he began sweating quite a bit. We immediately began the emergency response and called 911 and called for store help. I stayed with the patient and when the paramedics got there they took over in the patient's care. The patient remained hypotensive, so the paramedics advised him going to the hospital. The patient agreed and was taken to the hospital.
44 2021-07-19 pain in extremity I experienced nothing but arm soreness and some fatigue after the second dose. Four months after the... Read more
I experienced nothing but arm soreness and some fatigue after the second dose. Four months after the second dose I got a Prodromal Headache which progressed to Herpes Zoster which was isolated to my face. I had to get eye drops for my eye. It has healed with treatment but I have some scarring.
44 2021-07-20 throat numbness Patient felt numbness in throat, no difficulty breathing or swelling. Waited for an hour, no worseni... Read more
Patient felt numbness in throat, no difficulty breathing or swelling. Waited for an hour, no worsening but still felt numbness.
44 2021-07-23 mild one side paralysis, tingling About 15 minutes after vaccine was given, patient started feeling numbness and pain in right upper a... Read more
About 15 minutes after vaccine was given, patient started feeling numbness and pain in right upper arm where vaccine was given. Patient has a PMH of stroke on the right side and diabetes. Patient also reported itchiness in right leg and dizziness. Vitals were taken and neuro exam performed. Patient given water and snack but started feeling stiffness in neck. Referred to ED for evaluation of symptoms.
44 2021-07-23 muscle twitching passed out; twitching; Gasping for air on the ground for less than a minute.; This is a spontaneous ... Read more
passed out; twitching; Gasping for air on the ground for less than a minute.; This is a spontaneous report received from a contactable consumer or other non hcp. A 44-years-old male patient received the second dose of bnt162b2 (COMIRNATY,Batch/Lot Number: Ew0168), via an unspecified route of administration, administered in Arm Left on 27May2021 09:00 as a single dose, and dose 1 via an unspecified route of administration, administered in Arm Right on 06May2021 09:15 (Batch/Lot Number: Ew0171) as a single dose for COVID-19 immunization . Medical history included blood cholesterol increased from an unknown date and unknown if ongoing and High cholesterol and triglycerides , blood triglycerides increased from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On the third day after the second shot the patient did some yard work and then after coming inside passed out and was twitching and gasping for air on the ground for less than a minute. I then sat up took some juice and was fine. The patient experienced passed out (loss of consciousness) , twitching (muscle twitching) and gasping for air on the ground for less than a minute (dyspnoea). patient underwent lab tests and procedures which included blood cholesterol: high on High cholesterol and triglycerides , blood pressure measurement: fine and blood triglycerides. Prior and since the vaccination, patient was not tested for COVID-19. The patient didn't take any other vaccines 4 weeks before the COVID vaccine. The patient took the covid19 vaccine in hospital. Device date reported to be 11Jul2021. Follow-up actions are needed. Further information has been requested. Follow-Up (16Jul2021): Follow-up attempts are completed. No further information is expected.
44 2021-07-26 seizure like phenomena 10 minutes after administration patient experienced a mild seizure-like reaction
44 2021-07-27 weakness, discomfort Hypertension; Tiredness; Weakness; losing some muscles; He is also experiencing muscle deterioration... Read more
Hypertension; Tiredness; Weakness; losing some muscles; He is also experiencing muscle deterioration (no muscle pain); he's been feeling a light body (not hard to move); elevated liver enzymes; he told him he doesn't get enough sleep; nervous; This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration on 22Apr2021 (at the age of 44-year-old) as dose 2, single for covid-19 immunisation. Medical history included, hypertension from 29Apr2021 to an unknown date, glucose tolerance impaired from 2010 to an unknown date Verbatim: Prediabetes, haemorrhoids from 09Mar2021 to an unknown date Verbatim: Hemorrhoids, hypovitaminosis from an unknown date and unknown if ongoing, asthenia from an unknown date and unknown if ongoing, pain from an unknown date and unknown if ongoing. Concomitant medications included paracetamol (TYLENOL) taken for haemorrhoids, pain, start and stop date were not reported; ascorbic acid, biotin, folic acid, iron, nicotinic acid, pantothenic acid, pyridoxine, riboflavin, vitamin b1 nos, vitamin b12 nos, vitamin e nos (CENTRUM ADULT B+ IRON) taken for hypovitaminosis from an unspecified start date and ongoing; ascorbic acid, bioflavonoids nos, hesperidin, malpighia glabra, rosa canina, rutoside (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN;MALPIGHIA GLABRA;ROSA CANINA;RUTOSIDE]) taken for covid-19 immunisation from an unspecified start date and ongoing; vitamin b complex (VITAMIN B) taken for asthenia from an unspecified start date and ongoing. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration on 01Apr2021 (at the age of 44-year-old) as dose 1, single for covid-19 immunisation. On 25Apr2021, patient experienced losing some muscles, 0n 26Apr2021, patient experienced weakness, on 27Apr2021, patient experienced tiredness, on 29Apr2021, patient experienced hypertension. on an unspecified date in 2021, patient experienced muscle deterioration, he's been feeling a light body, elevated liver enzymes, he told him he doesn't get enough sleep, nervous. The patient underwent lab tests and procedures which included aspartate aminotransferase: 28 on 22Sep2020 Normal, aspartate aminotransferase: 46 on 30Apr2021 slightly elevated, blood test: elevated liver enzymes on 30Apr2021. Therapeutic measures were taken as a result of hypertension included losartan 25mg. The outcome of the events losing some muscles, tiredness, weakness were not recovered and the outcome of the remaining events were unknown.
44 2021-07-27 pain in extremity 21 hours after; hives all over left side chest, waist, ankles, inner thighs. Although after a Benadr... Read more
21 hours after; hives all over left side chest, waist, ankles, inner thighs. Although after a Benadryl it subsided, it did come back several days again. Otherwise 24 hours after the shot exprienced, slight fever, chills, muscle aches, headache, head sinus pressure, joint pain, diarrhea and nausea. Also several days later arm still hurts. 3 days after had shooting pain in injection arm, leaving me to not use my left arm. 4th day much better.
45 2020-12-31 numbness LEFT HAND NUMBNESS, FEELS DIFFERENT. 97.8, 118/77, 80
45 2021-01-03 unresponsive to stimuli, cold sweat Patient became unresponsive for 10-15 seconds. Medical emergency called, along with 911. Upon reob... Read more
Patient became unresponsive for 10-15 seconds. Medical emergency called, along with 911. Upon reobtaining consciousness, patient was diaphoretic and clammy. Vital signs obtained - SBP in the 70s and HR in the 40s. Patient transport to the ED.
45 2021-01-04 breast pain 12/23/2020 sharp pain left lower breast, chest constriction lasted approx for 2 days on and off. 12/... Read more
12/23/2020 sharp pain left lower breast, chest constriction lasted approx for 2 days on and off. 12/26/2020 swollen left armpit, resolved 01/04/2020. Antibiotic prescription provided.
45 2021-01-04 flushing received vaccine 12/21 and on 12/29 noted bilateral ear lobe swelling redness and facial flushing. o... Read more
received vaccine 12/21 and on 12/29 noted bilateral ear lobe swelling redness and facial flushing. on 12/30/2020 patient reports increased hive like rash on abdomen, trunk arms, and neck redness. Patient seen at her PCP and diagnosed with allergic reaction. Patient has taken benadryl and clariten and symptoms resolving.
45 2021-01-06 pain in extremity, night sweats joint pain; it doesn't seem to be feeling well; sweating; Fever; chills; night sweats, that he will ... Read more
joint pain; it doesn't seem to be feeling well; sweating; Fever; chills; night sweats, that he will randomly start sweating; headache; muscle pain/mild muscle aches; gastric upset; Fatigue; he had mild arm soreness right after he got the vaccine; This is a spontaneous report from a contactable Other-HCP (patient). This 45-year-old male Other-HCP received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685, NDC number: 59267-1000-1) on 22Dec2020 at single dose in his right arm for COVID-19 immunization. Medical history and concomitant drug were not reported. It was reported that patient experienced Fever on 27Dec2020 with outcome was recovered on 29Dec2020, chills and night sweats on 27Dec2020 with outcome was not recovered, Headache on 27Dec2020 with outcome was not recovered, muscle pain 27Dec2020 with outcome was not recovered, gastric upset on 27Dec2020 with outcome was Recovering, Fatigue on 27Dec2020 with outcome was unknown, arm soreness on 22Dec2020 with outcome was not recovered, joint pain with outcome was unknown, it doesn't seem to be feeling well with outcome was unknown, sweating with outcome was unknown. All events were serious (medical significant). Caller stated that he thought having a reaction to the vaccination, spoken with Occupational Health at his job and with a doctor, stated everyone is a bit stumped. Caller stated he has had for over a week now, fever, chills, night sweats, that he will randomly start sweating, headache, joint pain, gastric upset, and it doesn't seem to be feeling well. Stated the joint pain is actually more muscle pain. Stated he got the vaccination on Tuesday 22Dec2020, stated he has been having these symptoms for over 5 days now. Stated he does not think this is something infectious, that no one in his family is getting sick, his wife or child are not catching it from him. Stated he tried to do research online for data about delayed side effects, would like to know if we have any information on delayed side effects. Stated he considers these events medically significant because he cannot be cleared to go back to work. Stated he had mild arm soreness right after he got the vaccine, states he had mild muscle aches Wednesday and Thursday, then they went away and came back all on Saturday night and Sunday. Stated he is worried about getting a second vaccine. Stated he tested negative for the COVID on 29Dec2020. Stated he has a CBC and other blood work scheduled for today, results unknown at this time. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events. 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.
45 2021-01-07 weakness While on duty and in uniform as an emergency paramedic I received my second scheduled covid19 vacci... Read more
While on duty and in uniform as an emergency paramedic I received my second scheduled covid19 vaccination. Approximately five minutes after receiving C19 dose 2 vaccination (1335hrs). I experienced a syncopal episode while walking back to my work area and was lowered to the ground by another EMS provider. I was then placed in a wheelchair by the EMS provider and an RN and taken to the emergency department at Medical Center. (1337hrs) I regained alertness and felt severe nausea and general weakness and was assisted into in ER bed. Staff doctor attended along with RN . An assessment was completed, 12 lead EKG completed, IV established, 8mg Zofran administered, 1000ml of Normal Saline was bolused. Labs were drawn. ED staff continued to monitor me for the next 2 plus hours I was monitored for anaphylaxis and other symptoms. My symptoms of nausea mostly resolved and my strength returned. A Resident MD completed a final evaluation and determined it was safe for me to be discharged. (1607hrs)
45 2021-01-07 tingling polyneuropathy; facet joint diagnosis/new left forefoot paresthesia; This is a spontaneous report fr... Read more
polyneuropathy; facet joint diagnosis/new left forefoot paresthesia; This is a spontaneous report from a contactable physician (patient). A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot EJ1685) at the first dose in left arm on 17Dec2020 12:45 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered at Doctor's office/urgent care. Medical history included ongoing back pain (thinking it was due to running/physical therapy overuse injury). No allergies to medications, food, or other products. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. It was reported that 20Dec2020 morning: new left forefoot paresthesia. no weakness. Patient thought this might be due to the back pain he had been watching for 3 months, thinking it was due to running/physical therapy overuse injury. On 21Dec2020 sports medicine physician evaluation. numbness was gone, facet joint diagnosis, MRI lumbar ordered (still pending). On 24Dec2020 9 pm, paresthesia both hands and feet, no weakness nor other symptoms those continued and were slightly worse on 27Dec2020 morning, including face/teeth. no other symptoms; 27Dec2020 afternoon: internal medicine physician evaluation, working diagnosis polyneuropathy. Neurologist appointment will be 07Jan2021, 2 hours before 2nd shot was scheduled. The patient had been tested for COVID-19 test type post vaccination: negative on 22Dec2020. No treatment for event. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of events was not resolved.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of polyneuropathy and facet joint diagnosis/new left forefoot paresthesia due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including nerve conduction tests, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is 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.
45 2021-01-07 tingling LEFT ARM PARASTHESIA HAD MILD TINGLING DOWN LEFT ARM
45 2021-01-09 pain in extremity After first dose: arm pain a few hours after and chills 24 hours later that lasted 24hrs. Some join... Read more
After first dose: arm pain a few hours after and chills 24 hours later that lasted 24hrs. Some joint pains persisted. After second dose: arm pain a few hours after. Twelve hours later I had chills, low grade fever 100.5, body aches, arthralgias, fatigue. These symptoms lasted for 24 hours continuously. 48 hrs later I still had fatigue and early morning chills. The body aches have continued to present time.
45 2021-01-09 tingling Increased bp, diaphoretic, skin turned red, pins and needle sensation, increased heart rate , swoll... Read more
Increased bp, diaphoretic, skin turned red, pins and needle sensation, increased heart rate , swollen lower lip, nauseated, weird sensation of not feeling right almost like out of body
45 2021-01-09 tingling Patient developed chills/shivering/tingling day 4 post-injection. The episodes are occurring every ... Read more
Patient developed chills/shivering/tingling day 4 post-injection. The episodes are occurring every 10 minutes and last 30-45 seconds. Symptoms continue at day 11 post injection. Symptoms are similar to the patients pre-ictal aura. However, no generalized seizures have occurred.
45 2021-01-11 cold sweat Patient had vertigo, dizziness, cold sewats, redness near side of neck repoerted agter 15 minutes of... Read more
Patient had vertigo, dizziness, cold sewats, redness near side of neck repoerted agter 15 minutes of observation. HR was nor remarkable, went from 80's to 90's. After addiitonal 10 minutes rapid response was iniciated and patient was given water
45 2021-01-11 feeling cold HA, Nausea, fever, chills, stayed home
45 2021-01-11 pain in extremity loss of smell and taste; loss of smell and taste; low grade fever; Flu-like aching; headache; coughs... Read more
loss of smell and taste; loss of smell and taste; low grade fever; Flu-like aching; headache; coughs; soreness of the arm; This is a spontaneous report from a contactable consumer (patient work in detention center). A 45-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL1284, Expire Date: 30Apr2021), via an unspecified route of administration on 05Jan2021 07:45 in the right arm at single dose for covid-19 immunisation. Medical history included covid-19 from 26Dec2020 was recovering. The patient's concomitant medications were not reported. The patient experienced soreness of the arm on 05Jan2021 with outcome of recovering, loss of smell and taste on 06Jan2021 04:00 with outcome of not recovered, headache on 06Jan2021 with outcome of recovered, coughs on 06Jan2021 with outcome of not recovered, low grade fever on 06Jan2021 02:30 with outcome of unknown, flu-like aching on 06Jan2021 01:00 with outcome of recovering. The detail clinical course was provided as consumer calling regarding the COVID 19 vaccine. He received first dose of the Pfizer COVID 19 vaccine on 05Jan2021 07:45am in the right arm. He noticed by the afternoon his arm was sore. He worked overnight so at 01:00AM 06Jan2021 he noticed achy, like flu ache in his muscles. He took his temperature and it was 99.4 around 02:30 in the morning. Then at 04:00am he noticed he couldn't smell or taste anything. He went home and fell asleep. When he woke up he had a headache and coughing. He took Dayquil which helped with the coughing and then the headache went away. He has had the coughing all through the COVID infection. The patient underwent lab tests and procedures which included body temperature: 99.4 on 06Jan2021 02:30, COVID 19 test PCR positive 26Dec2020. The events were reported as non-serious. Mentioned he was told if you already had COVID the side effects of the vaccine may be worse. He was planning to receive the second dose 26Jan2021.
45 2021-01-11 pain in extremity Chills/rigors starting about 16 hours post-vaccine (second dose), lasting intermittently for 24 hour... Read more
Chills/rigors starting about 16 hours post-vaccine (second dose), lasting intermittently for 24 hours, improved with a Tylenol. Sore arm starting about 2 hours post-vaccine, lasting about 24 hours, improved with Tylenol.
45 2021-01-12 feeling hot Rash/rash on his forearm that went to both forearms; elevated blood pressure/He already has high blo... Read more
Rash/rash on his forearm that went to both forearms; elevated blood pressure/He already has high blood pressure and it was elevated after the vaccine; felt warm inside; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiry date unknown), via an unspecified route of administration in left arm, on 06Jan2021, at single dose, for COVID-19 immunization. Medical history included high blood pressure from Apr2020 and ongoing. Ongoing concomitant medication included lisinopril from Apr2020 for blood pressure/high blood pressure. The patient received the vaccine between 1:30-2:00pm yesterday afternoon (06Jan2021). He waited for 15 minutes after receiving the vaccine and he was ok. Later, on 06Jan2021, he developed a rash on his forearm that went to both forearms. He already has high blood pressure and it was elevated after the vaccine. During the night he felt like he was warm inside. He took a low dose Bayer Aspirin. The outcome of the event rash and hypertension was not recovered, and the outcome of the event feeling hot was recovered on 07Jan2021. Information on the lot/batch number has been requested.
45 2021-01-13 night sweats Pfizer-BioNTech COVID-19 Vaccine EUA - I woke up in the middle of the night sweating, and felt tired... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA - I woke up in the middle of the night sweating, and felt tired the next morning with slight brain fog. Otherwise, I felt fine.
45 2021-01-17 weakness Very weak and tired immediately after vaccine.
45 2021-01-17 burning sensation Approximately 2 days after 2nd injection I started developing itchy hands with associated swelling a... Read more
Approximately 2 days after 2nd injection I started developing itchy hands with associated swelling as well. 4 days after injection I developed a rash to feet, legs, groin and parts of torso with associated swelling. No shortness of breath but do have some slight burning to hands and legs with mild pain.
45 2021-01-19 pain in extremity Swollen and painful lymph nodes in left armpit. Swelling lasted 2 days. Pain lasted 3 days. Symptoms... Read more
Swollen and painful lymph nodes in left armpit. Swelling lasted 2 days. Pain lasted 3 days. Symptoms were treated with Tylenol, Advil, and propping left arm up with a pillow to prevent pressure on under arm area.
45 2021-01-19 tingling, numbness lightheadedness; tingling, slslight numbness right arm andd face. informed patient that if it contin... Read more
lightheadedness; tingling, slslight numbness right arm andd face. informed patient that if it continues to go to ER. Pataient leeft with understanding above.
45 2021-01-21 numbness Received second dose of Pfizer COVID vaccination on January 9, 2021. At the time of the vaccinatio... Read more
Received second dose of Pfizer COVID vaccination on January 9, 2021. At the time of the vaccination he experienced discomfort of left deltoid (site of injection) as well as paresthesia at the injection site. He also experienced systemic symptoms of fatigue, myalgias, and arthralgias for 24 to 36 hours. Over the course of the next several days he experienced continued significant numbness and weakness in left upper extremity, specifically in left deltoid muscle. By Sunday 1/17/2021 the significant left deltoid weakness and numbness persisted, specifically not being able to lift his arm greater than 45 degrees using his deltoid. He contacted health on 1/17/2021. On 1/19/2021 he had a consultation with a physician. Based upon his clinical examination, and symptom complex, physician does not believe that this is a cervical spine issue but rather a local nerve injury related to the injection site. He was prescribed a steroid taper. Unclear whether this is temporary or permanent issue.
45 2021-01-25 weakness He has a fever of 102.2 and having chills and body aches complaint about lack of energy .
45 2021-01-25 tingling PT C/O FLUTTERING HEART, HEART BEATING FAST, DRY MOUTH, TINGLING IN CHEEKS. 1140: V/S TAKEN BP:158/1... Read more
PT C/O FLUTTERING HEART, HEART BEATING FAST, DRY MOUTH, TINGLING IN CHEEKS. 1140: V/S TAKEN BP:158/100 P: 110 RESP 16 SPO2 99%, ELEVATED BP AND PULSE. 1145: ADMIN OTC BENADRYL x 2 CAP PO. PT TOLERATE WELL. 1148: V/S TAKEN BP:150/96 P: 92 RESP 12 SPO2 99%. 1150: PT STATES THAT HE IS FEELING BETTER. A&Ox4. 1153: V/S TAKEN BP:150/96P: 92RESP 12 SPO2 99%. 1200: V/S TAKEN BP:146/92P: 91RESP 12 SPO2 98%. PT INSTRUCTED NOT TO DRIVE, AND F/U WITH PCM IN REGARDS TO H/O OF TIA WITH TODAYS V/S ELEVATED BP AND PULSE. PT WAS FEELING BETTER AND STABLE.
45 2021-01-26 burning sensation coronary spasm; STEMI COVID vaccine induced; slight 1-2/10 substernal chest pain on/off; fever of 10... Read more
coronary spasm; STEMI COVID vaccine induced; slight 1-2/10 substernal chest pain on/off; fever of 101 to 101.7; diffuse severe muscle aches; tachycardia of 110 to 130; painful lymphadenopathy of the ipsilateral axilla and clavicular lymph node (LN); This is a spontaneous report from a contactable physician (patient). A 45-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142), via an unspecified route of administration in the left arm on 13Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included benign prostatic hyperplasia (BPH). Concomitant medication included alfuzosin. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) in the left arm on 23Dec2020 16:00 at the age of 44 years old for COVID-19 immunization. On 14Jan2021, the patient started having fever of 101 to 101.7, diffuse severe muscle aches, and tachycardia of 110 to 130. Thursday evening (14Jan2021) through Sunday (17Jan2021), the patient also had painful lymphadenopathy of the ipsilateral axilla and clavicular lymph node (LN). Thursday evening (14Jan2021), the patient had slight 1-2/10 substernal chest pain on/off. Friday evening around 23:30 (15Jan2021), the patient had chest pain substernal 7-8/10 that lasted for one hour. The burning sensation was worse with cold air. It resolved with paracetamol (TYLENOL) and ibuprofen. Monday early morning at 04:00 (18Jan2021), the patient experienced STEMI COVID vaccine induced wherein the patient woke up with 10/10 chest pain and shoulder pain which lasted for 30 to 40 minutes and resolved with paracetamol and ibuprofen. The patient also decided to check blood work Monday morning (18Jan2021) while in the hospital. Trop came back 16.28 ng/ml. This is the old trop not high sensitivity. Normal high is 0.30 ng/ml. The patient went to the hospital. ECG showed ST elevation inferior lead. Left heart catheterization was done. The patient have clean coronaries. No evidence of any atherosclerosis. Echocardiogram showed normal EF. No wall motion abnormality. It was concluded that the patient also had coronary spasm. The patient underwent other lab test and procedure which included nasal swab COVID test showed negative on 18Jan2021. Outcome of the lymphadenopathy was recovered on 17Jan2021, of the chest pain was recovered on Jan2021, of the coronary spasm and STEMI was recovering, while of the remaining events was unknown. The events coronary spasm and STEMI resulted in hospitalization and life threatening illness.; Sender's Comments: The reported coronary spasm with chest pain and suspected STEMI were likely related to the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) due to plausible temporal relationship, and no evidence of any atherosclerosis during left heart catheterization. The case will be reassessed should additional information become 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.
45 2021-01-27 pain in extremity The next morning I started to have some pain in my right calf which worsened throughout the day. Th... Read more
The next morning I started to have some pain in my right calf which worsened throughout the day. The following day I went to the ER with a DVT. I was given Xarelto for treatment.
45 2021-01-29 tenderness 15-36 hours after: headache, chills, injection site pain 9 days after: Hair follicle and or skin ... Read more
15-36 hours after: headache, chills, injection site pain 9 days after: Hair follicle and or skin tenderness concentrated to the back left lower quadrant of head.
45 2021-01-31 pain in extremity achiness in his legs and hands; Chills; Fatigue; injection site swelling and achiness; injection sit... Read more
achiness in his legs and hands; Chills; Fatigue; injection site swelling and achiness; injection site swelling and achiness; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored program. A 45-years-old male patient received bnt162b2 (BNT162B2; Batch/lot number: EK4176), via an unspecified route of administration at left arm on 13Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history reported as none. There were no concomitant medications. The patient experienced fatigue on 17Jan2021 with outcome of not recovered, achiness in his legs and hands on 18Jan2021 with outcome of not recovered, chills on 18Jan2021 with outcome of not recovered, injection site swelling and achiness on 13Jan2021 with outcome of recovered on 14Jan2021. The patient reported after he got the first COVID vaccine on 13Jan2021 he experienced fatigue, achiness, and injection site swelling. Patient wanted to know if this is normal after the first dose and this was discussed. Patient explained that the fatigue - this didn't start until 17Jan2021 and was ongoing. On 18Jan2021 he starting having achiness in his legs and hands and he also had a few chills today. The injection site swelling and achiness there, was gone after the 14Jan2021. Patient was really looking for an answer to his question on if it was normal or should he get a COVID test. He was on day 5 after getting the vaccine and from what he read most people have side effects within a 24 hours and gone within 48 hours. Some of his side effect didn't start until 4 days later. The Vaccination Facility Type was hospital. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Patient did not go to Emergency Room or Physician Office. There was no Prior Vaccinations (within 4 weeks).
45 2021-02-02 pain in extremity Currently experiencing bodyaches and soreness in the left arm
45 2021-02-03 pain in extremity arm soreness, fatigue Narrative: Developed arm soreness and fatigue following vaccine administratio... Read more
arm soreness, fatigue Narrative: Developed arm soreness and fatigue following vaccine administration. Resolved by 1/1/21.
45 2021-02-07 numbness, nerve injury Local nerve injury/significant numbness and weakness in his upper extremities specifically in his le... Read more
Local nerve injury/significant numbness and weakness in his upper extremities specifically in his left deltoid muscle, affects his ability to perform usual work; At the time of vaccination he experienced discomfort in left deltoid which was the injection site; Cannot lift his arm greater than 45 degrees; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle; Developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle; This is a spontaneous report from a contactable pharmacist. A 45-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), intramuscular n deltoid left on 09Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. At the time of vaccination he experienced discomfort in left deltoid which was the injection site, cannot lift his arm greater than 45 degrees, local nerve injury, systemic fatigue ,myalgia and other arthralgia for 24-36 hours, developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle, affects his ability to perform usual work or task, all in Jan2021 with outcome of unknown. He called the employee health on 17Jan2021 and 19Jan2021 he saw a neurosurgeon. The neurosurgeon didn't think it was a cervical spine injury rather a local nerve injury related to the injection itself and he was prescribed a steroids taper, unclear whether if it was a temporary or permanent issue. Because this was like 10 days after the vaccine and he didn't really describe how much this issue affected his ability to perform usual work or task but he was a surgeon. The outcome of the events were unknown.; Sender's Comments: Based on the compatible time association, the peripheral nerve injury is possibly related to the injection technique, not vaccine BNT162B2. 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.
45 2021-02-08 weakness felt dizzy and weak. Was diaphoretic. BP at time was 98/32 w P 64. chest clear, no SOB no oral swell... Read more
felt dizzy and weak. Was diaphoretic. BP at time was 98/32 w P 64. chest clear, no SOB no oral swelling. Rested supine for 30 minutes. Felt much better. BP 118/72, P 68
45 2021-02-08 feeling hot, pain in extremity 45-year-old male follow-up from the ER. He received a COVID-19 vaccine on 1/22/2021. This was his fi... Read more
45-year-old male follow-up from the ER. He received a COVID-19 vaccine on 1/22/2021. This was his first dose. He began having bilateral lower extremity pain the following evening. In addition to the pain, he has been dealing with headaches, dizziness, auditory hallucinations, and large areas of redness and warmth on the left upper extremity and bilateral lower extremities. He went to the ER on 1/27/2021. Upon review of those records, he had microscopic hematuria. The patient states that he passed some kidney stones this week. Other abnormal labs include very elevated liver enzymes which the patient has not had before. He does not drink any alcohol. No new medications. He also had thrombocytopenia. O) Gen: Patient is in a wheelchair during today's exam. This is the first time he ever been in the exam room in a wheelchair. He required assistance to stand up. He says the pain is what makes it so difficult to stand up. Skin: On the left forearm, there is a large area of redness and swelling. The redness is relatively faint. On the lateral aspect of the right thigh, there is a large area of redness and swelling which is more prominent. ASSESSMENT 1. Severe myalgias 2. Elevated liver enzymes 3. Thrombocytopenia PLAN 1. Check sed rate and CRP. 2. Recheck CMP along with viral hepatitis panel and lipase. 3. Recheck CBC with differential. 4. Further recommendations based on these results. ADDENDUM Patient called on 2/1/2021 and reports his pain is getting worse to such an extent that he has been unable to make it to the bathroom fast enough and has been having accidents.
45 2021-02-08 unresponsive to stimuli Patient presented in normal healthy condition. After describing side effects and precautions, patien... Read more
Patient presented in normal healthy condition. After describing side effects and precautions, patient was administered vaccine through intermuscular route. Patient appeared to have a normal response to the administration and showed no reaction. The patients wife was the administered the vaccine within 2-3 minutes in the same treatment room. After her administration, the patient was noted with his head positioned forward, pale skin color and no response to questioning. At that point an emergency response was called. The patient remained unresponsive. At the time he was seated. Within about 2 minutes, the patient was laid on the floor and quickly returned to normal consciousness. The emergency squad was called and responded in about 10 minutes. By the time the emergency arrived the patient was fully recovered; he did not require further medical intervention.
45 2021-02-09 weakness Headache; Mild fever; Lack of energy; This is a spontaneous report from a contactable consumer (pati... Read more
Headache; Mild fever; Lack of energy; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248; Expiration date was not reported) on 19Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. Medical history included Celiac disease and gluten allergy. Concomitant medication included fexofenadine hydrochloride (ALLEGRA). On 20Jan2021, the patient had headache, mild fever and lack of energy. The patient did not receive any treatment for the reported events. The outcome of the events, headache, mild fever and lack of energy, was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested post-vaccination. No follow-up attempts are possible. No further information is expected.
45 2021-02-09 weakness 1. Moderate Pain Site of the Injection (started 12 hours after injection) lasted (4 days) 2. Painful... Read more
1. Moderate Pain Site of the Injection (started 12 hours after injection) lasted (4 days) 2. Painful Lymph-nodes : Location Right cervical , Right side supra clavicular and infra clavicular , lasted for 1 week 3. Light headed lasted 2 days 4.nauseas lasted 3 days 5 diarrhea mild lasted 2 days 6. Chills , lasted for 3 days 7 weakness , lasted 10+ days
45 2021-02-10 numbness Profuse sweating followed by headache and numbness to my head. After a few minutes my tongue began ... Read more
Profuse sweating followed by headache and numbness to my head. After a few minutes my tongue began to swell followed by my lips and face. Was given 50mg PO Benadryl five minutes later a shot from an EpiPen. Trip to ED via ambulance IV Benadryl and Solu-Medrol was administered. After 3 hrs all swelling was gone and was discharged.
45 2021-02-16 tingling Left arm began tingling immediately after shot 12/31/2020. Within a short time entire arm was tingl... Read more
Left arm began tingling immediately after shot 12/31/2020. Within a short time entire arm was tingling all the way to fingertips of left hand. Felt similar to when a limb "falls asleep". Continued for 2 days. Thereafter tingling sensation reduced but has not disappeared. Slight tingling still present at fingertips of left hand as of 2/17/2021. Second dose received in right arm 1/21/21. Symptom did not occur in right arm.
45 2021-02-17 tingling, cold sweat fainted; nausea; left arm began to tingle; dizziness; Broke out in a cold sweat; chills; Lost contro... Read more
fainted; nausea; left arm began to tingle; dizziness; Broke out in a cold sweat; chills; Lost control of my bladder.; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL6269), via an unspecified route of administration in Left arm on 04Feb2021 15:00 (at the age of 45-years-old) at SINGLE DOSE for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. 51 hours after receiving the vaccine, the patient was sitting down watching a film. His left arm began to tingle, and he felt a wave of dizziness and nausea come over him. He stood up, walked a few steps and sat back down. He broke out in a cold sweat, chills, and saw stars. He leaned forward with his head in his hands, and apparently fainted for a moment and lost control of his bladder. All events started on 06Feb2021 06:00 PM. No treatment received for the events. The outcome of the events was recovered in Feb2021. No covid prior vaccination, no Covid tested post vaccination, no known allergies.
45 2021-02-18 numbness Injection site soreness (mild) and mild muscle soreness during first 24 hours after 2nd dose of vacc... Read more
Injection site soreness (mild) and mild muscle soreness during first 24 hours after 2nd dose of vaccination. At about 29-30 hours, noticed mild numb feeling along right jawline from middle of mouth to right ear, and around the right ear. By morning (about 48 hours post vaccination), numb feeling appears gone on right jawline, but seems to have moved to left jawline (still mild). No trouble breathing or eating at all. Consulted primary care doctor out of concern over odd sensation, but not treatments at this time. Considering taking a benadryl tablet just to see if it has any effect.
45 2021-02-19 slurring, facial paralysis Patient suffered ICH within 24 hours of receiving COVID vaccine. Symptoms include facial droop and m... Read more
Patient suffered ICH within 24 hours of receiving COVID vaccine. Symptoms include facial droop and mild dysarthria. Admitted to Neuro ICU for monitoring.
45 2021-02-23 weakness Roughly 30 minutes after administration of vaccine patient endorsed weakness, dizziness and shortnes... Read more
Roughly 30 minutes after administration of vaccine patient endorsed weakness, dizziness and shortness of breath. His blood pressure and heart rate increased during the event. He was treated with epinephrine 0.3mg IM due to concern for anaphylaxis and transferred to the ER via EMS. In the ER his vitals were stable and he was observed in the ER for 3 hours, with improvement in his symptoms. During the course of his stay he was treated with Benadryl, dexamethasone and albuterol. He presented with no hives, pharyngeal edema, wheezing, hypoxia or nausea/vomiting/diarrhea.
45 2021-02-28 burning sensation Hives and rash covering about 80% of body. Itching and burning sensation. Raised welts on torso, arm... Read more
Hives and rash covering about 80% of body. Itching and burning sensation. Raised welts on torso, arms, legs, back. No reaction on face or genitals. Occurred when I woke up on Saturday morning with only hives on arms. It spread throughout the day to cover the entire body. On Sunday body was covered in more hives. Took benedryl and Claritin starting day 1 of symptoms but it didn?t help. Continued to take. On Sunday evening took Pepcid AC. Starting to resolve as of Monday morning (now).
45 2021-02-28 cold extremities 1. Diaphoretic 10 minutes after vaccine administration 2. Tongue swelling 3. Right arm cold and left... Read more
1. Diaphoretic 10 minutes after vaccine administration 2. Tongue swelling 3. Right arm cold and left arm hot 4. Throat tightening Was treated with Bendryl and EpiPen then sent to the ER
45 2021-03-03 discomfort Went into anaphylactic shock with 5 minutes. Throat started to itch, ears were popping and the left... Read more
Went into anaphylactic shock with 5 minutes. Throat started to itch, ears were popping and the left side of my face began to feel pressure. My wife injected me with my EpiPen. Within 10-15 minutes, the symptoms began to recede.
45 2021-03-04 pain in extremity Reported bruising and left upper arm pain which started on 3/3/2021 after receiving 2nd COVID-19 vac... Read more
Reported bruising and left upper arm pain which started on 3/3/2021 after receiving 2nd COVID-19 vaccine and persisted until 3/4/2021. Pain improved on 3/4/2021 but not resolved. Left upper arm/shoulder pain w/full ROM. Reported no side effects after 1st COVID-19 vaccine.
45 2021-03-04 tingling Complaint of "tingling" and "feeling" of edema in lips. Patient subsequently went to the bathroom t... Read more
Complaint of "tingling" and "feeling" of edema in lips. Patient subsequently went to the bathroom to see if his lips were swollen and they were not. Paramedic reported that the patient expressed anxiety about injections/needles and this may have contributed to perceived adverse effects. Patient asked for Benadryl and was given 25 mg po x 1.
45 2021-03-05 numbness I experienced numbness in the tip of my right pinky finger that I hadn?t noticed prior to the vaccin... Read more
I experienced numbness in the tip of my right pinky finger that I hadn?t noticed prior to the vaccine shot. I still have the numbness to this day. I don?t notice it unless I flick the right pinky fingertip with my right thumb. It seems to be the same amount of numbness during all these days, without change.
45 2021-03-09 bell's palsy Bell's palsy; This is a spontaneous report from a contactable consumer (patient's wife). A 45-year-o... Read more
Bell's palsy; This is a spontaneous report from a contactable consumer (patient's wife). A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on 02Feb2021 at 11:00 at a single dose on left arm for COVID-19 immunisation. Medical history included ongoing systemic lupus erythematosus (Lupus), ongoing hypertension (High Blood Pressure), ongoing gout and hip arthroplasty from Dec2020 to an unknown date; all diagnosed about 20 years ago. Concomitant medications included allopurinol, atorvastatin, benzonatate, chlorthalidone, apixaban (ELIQUIS), hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN), hydroxychloroquine, iron, loratadine, losartan potassium, mycophenolate mofetil, omeprazole, paricalcitol, prednisone, spironolactone and valacyclovir [valaciclovir] and vitamin D NOS. The reporter's husband had a reaction to the vaccine. She was wondering if it is ok to have the second dose. He got paralysis, Bell's Palsy on 14Feb2021. She clarified vaccine as COVID19 Vaccine. She would like any information available about second dose after having Bell's Palsy with the first dose. The outcome of the event was not recovered.
45 2021-03-10 cold sweat, tremor Recipient reports feeling bad all over started immediately, shaking but waited in his car in the par... Read more
Recipient reports feeling bad all over started immediately, shaking but waited in his car in the parking lot after the 15 minute waiting period. Reported back into the vaccination site approx 45 minutes after his injection. Elevated BP 150/105, few minutes later was 170/110 hr 125 rr 20 skin clammy at intervals. Glucose 148 per his report from his insulin pump. No hypertension history or meds per his report.
45 2021-03-10 numbness Acute right index finger digital ischemia after initial complete numbness from PIP joint distally ab... Read more
Acute right index finger digital ischemia after initial complete numbness from PIP joint distally absent any previous symptoms ever. Recurrence Jan 20 of same symptoms. Suspect antibody complex clot blocking terminal branches of digital arteries.
45 2021-03-10 tremor, cold sweat Recipient stated began feel bad almost immediately after his injection, stayed 15 minutes and left v... Read more
Recipient stated began feel bad almost immediately after his injection, stayed 15 minutes and left vaccination area but waited in the parking lot and reported back into the vaccination clinic approx 45 minutes. Reported feeling very bad all over, trembling, glucose per his report of 148. skin was somewhat clammy to touch, bp 150/105 and 5 minutes later 170/110, hr 120s, rr 20, referred to PCP
45 2021-03-12 pain in extremity, numbness soreness to r arm that grew in intensity - while in pcp office, blood pressure was 154/106, hr was 1... Read more
soreness to r arm that grew in intensity - while in pcp office, blood pressure was 154/106, hr was 112 - at that time, on 3/8/21, I began to have numbness in my left thumb that went up my arm and into my face on the left side. At this time, they transported me to the ER, which is right across the street for evaluation and treatment. Mercy ER physician ran bloodwork, an ekg, and a shoulder xray. All tests had good results and I was later released with some medication.
45 2021-03-12 pain in extremity NEXT DAY STARTED GETTING COUGH, CONGESTION, DYSPNEA, MALAISE, LOSS OF TASTE, LEFT ARM PAIN. GRADUALL... Read more
NEXT DAY STARTED GETTING COUGH, CONGESTION, DYSPNEA, MALAISE, LOSS OF TASTE, LEFT ARM PAIN. GRADUALLY WORSENED, PERSISTING.
45 2021-03-15 cold extremities Left injection soreness (3/12/21) Right knee pain where replacement is (3/14/21). Right hip pain whe... Read more
Left injection soreness (3/12/21) Right knee pain where replacement is (3/14/21). Right hip pain where replacement is(3/14/21). Right scapular pain (3/14/21). Bilateral hand coldness (3/14/21. Taking Naproxen 220mg 1 tablet daily since 3/14/21.
45 2021-03-16 tingling Pt started to feel slightly lightheaded about 10 minutes after vaccination, then started to have som... Read more
Pt started to feel slightly lightheaded about 10 minutes after vaccination, then started to have some tingling in his face. He received 25 mg of oral diphenhydramine with good results within 30 minutes. Pt has a h/o anaphylaxis to allergy shots as a child one time, but then never had a reaction again.
45 2021-03-16 tenderness Tenderness in eft hand, mainly pink and index fingers.
45 2021-03-18 nerve pain Beginning 6 days after 2nd vaccine dose, had one day of low grade fever (first day only), 2 days of ... Read more
Beginning 6 days after 2nd vaccine dose, had one day of low grade fever (first day only), 2 days of arthralgia of MCP and IP joints of hands, knees, ankles, MTP joints of feet; 4 days of peripheral worse than central neuralgia (mild on anterior torso and thighs, increased over both forearms and legs, and extreme/severe of hands & feet, with even light touch, clothes, bedsheets causing burning pain. Neuralgia responsive to Gabapentin, but not acetaminophen or ibuprofen. After 4 days of neuralgia resolved, then still had altered heat and cold sensation/perception for hands and feet (palms & soles more than dorsa) for 3-4 more days, but no pain.
45 2021-03-18 numbness and pain in extremities, nerve pain 3 days after vaccination severe nerve pain and neuropathy; 3 days after vaccination severe nerve pai... Read more
3 days after vaccination severe nerve pain and neuropathy; 3 days after vaccination severe nerve pain and neuropathy; Low grade fever, under 100; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202), via an unspecified route of administration, administered in left arm on 27Feb2021 at 12:00 PM (at age of 45 years old) at a single dose for COVID-19 immunization. Medical history included hereditary spastic paraplegia. No known allergies. The patient did not have COVID prior vaccination, also not tested COVID post vaccination. No other vaccine in four weeks. Concomitant medications included dextromethorphan hydrobromide, quinidine sulfate (NUEDEXTA), pregabalin (LYRICA), cetirizine hydrochloride (ZYRTEC), venlafaxine. On 02Mar2021 at 09:15 AM (3 days after vaccination), severe nerve pain and neuropathy occurred. Sensation common with my disorder, but never this severe. Affected arms and legs. Lasted about 18 after onset. Typical incident will last no more than an hour. Low grade fever, under 100. No treatment received. The outcome of the events was recovering.
45 2021-03-20 muscle spasms, pain in extremity This was the first shot of the Covid vaccination, brand Pfizer. The nurse administered the shot in... Read more
This was the first shot of the Covid vaccination, brand Pfizer. The nurse administered the shot in the wrong place entering my rotor cuff tendon of my left arm. The evening of February 19th, the same day as the shot, I could not lift my arm. The pain continued throughout the weekend. My doctor was called on 2/22/21 and the nurse stated that it was SIRVA (shoulder injury related to vaccination). She said to apply ice to the area and call in two weeks if it didn't feel better. Went to a chiropractor on 3-5-21 and he did range of motion and said it looks liked an injury however he would recommend a Physical Therapist to examine it further. He did light shoulder manipulation. 3-8-21, went to Physical Therapist and he confirmed through range of motion that the injury occurred to a tendon located in the rotor cuff area. He diagnosed it as tendonitis (possible tear) with possible bursitis. 3-10 and 3-11 PT appointments. 3-12-21 second COVID shot in the correct deltoid muscle. No issues. 3-16 PT appointment. 3-19 -21. From favoring my right arm, my lower back went into spasms. Dr. appt with Doctor over the phone consolation. Prescription administered. At this time, therapy will continue. Previous to the first 2-19-21 shot, I was in perfect health with an A+ doctor physical, worked out weekly, and took no medication. Since this time, I have been unable to continue to work out, it has effected my lifestyle, and caused continued financial expenses to manage. This is the 3rd event I have heard of throughout State of the same sort. The local PT doctor is treating someone for the same thing and a local teacher experienced the same thing at another site. The training is obviously not in place.
45 2021-03-21 weakness After 2nd dose, I did not have a high fever but been fatigue and lightheaded/energy drained for 3 da... Read more
After 2nd dose, I did not have a high fever but been fatigue and lightheaded/energy drained for 3 days with heart palpitations like If I had OD on energy drinks. The symptoms disappeared on 4th and 5th but returned the 6th day morning ... feeling like I woke up after 2 tablets of Bynadril
45 2021-03-25 tingling After vaccine vaccination, patient has vasovagal syncope. Patient states swelling of tongue, blurry ... Read more
After vaccine vaccination, patient has vasovagal syncope. Patient states swelling of tongue, blurry vision, nauseous hands tingling, dizzy and lightheaded. Called code green, paramedics arrived. Laid patient down flat down on cot. Patient is stable. BP 106/67 98% o2sat HR 65 RR 16
45 2021-03-26 facial pain, facial paralysis, bell's palsy Right ear pain started on the Wednesday afternoon, two days after Vaccine shot. By Friday evening th... Read more
Right ear pain started on the Wednesday afternoon, two days after Vaccine shot. By Friday evening the ear pain was intense and it had moved below the ear to lymphnode area. Saturday, his ear was really swollen and red. He went to the Urgent Care and they prescribed an antibiotic Cephalexin thinking it could be some sort of ear infection or insect bite. Sunday morning he woke up with his face droopy. We tried to get an appt. with Urgent Care, but they sent us to the ER. The ER did a physical assessment and concluded he had an ear infection and Bells Palsy. The prescribed another antibiotic Doxycycline, an antiviral Famciclovir and a steroid of prednisone. By Monday he was extremely nauseas and had started having vertigo. We went to Urgent Care and they prescribed him Ondansetron for nausea and made the assessment that he had Shingles in his ear. We saw PCP on Wednesday and he assessed that this was a zoster ear infection causing facial paralysis and vertigo, also known as a rare condition called Ramsay Hunt Syndrome and that it was most likely attributed to his Covid vaccine shot and not to get the second vaccine shot. The Dr. took him off the antibiotics and put him on a higher dose of prednisone, a different antiviral (valacyclovir) and Meclizine for vertigo symptoms. He sent referrals for Neurology, ENT and Eye Dr. He saw the Neurologist that Friday and he concurred Ramsay Hunt Syndrome, most likley from Covid Vaccine and do not get the second vaccine shot. The neurologist referred him to Physical Therapy to treat his vestibular issues. He ordered an MRI and some blood work. We are still waiting for the results. We saw an ENT an he had him have a hearing test which showed moderate high frequency hearing loss. The ENT prescribed Gabapentin for the ear and face pain. He started to see a physical therapist this week, he had his MRI on Wednesday and we see the ENT again on Monday. He has no improvement yet, other than the nausea has subsided.
45 2021-03-26 flushing Flushing; BP 147/97 (pulse 100), 97% O2 sat. Water and crackers given.
45 2021-03-27 bell's palsy, slurring, numbness Bells palsy- pain and pressure on rear left side of head and ear. Numbness on the left side of face ... Read more
Bells palsy- pain and pressure on rear left side of head and ear. Numbness on the left side of face ,jaw and tongue. Left eye does not blink so constantly tears, slurred speach and no taste. Symptoms started on 3/21/21 and got worse. Meds prescribed acyclovir 800mgs , prednisone 10mg and Diclofenac sod dr 75 mg for pain.
45 2021-03-27 feeling hot 0950 pt reported feeling "hot and sweaty and dizzy " 10 minutes after receiving vaccine dose. Instru... Read more
0950 pt reported feeling "hot and sweaty and dizzy " 10 minutes after receiving vaccine dose. Instructed to lay down on floor as also reported "feeling like I am going to pass out". Pt placed on gurney via backboard and placed in Trendelenburg position. transported to medical observation area. vs taken upon arrival to medical observation BP 116/79 P 93 pox 95%, strong pulse, pallor noted. Pt stated "feeling better" and color improved to pink , strong pulse noted. Pt placed in supine position on gurney. 0958 Pt continued to improve with HOB elevated to 45 degrees and pt given graham crackers and 4 0z apple juice . BP 133/89 P 90 pox 95%. 1010 Pt reports feeling much better, drank 4 oz water and ate more graham crackers. Pt reported that he had not eaten breakfast and only drank a cup of caffeinated coffee prior to receiving vaccine. Reports "feeling much better" with the water , juice and crackers. BP 124/84 P 89 pox 97%. 1025pt sitting in chair and reportins feeling "back to normal" BP 125/84 P 83 pox 96%. Pt discharged with instructions to f/u with pcp if any other symptoms today. instructed to remain hydrated today and to eat healthy lunch and dinner.
45 2021-03-28 muscle spasms About 2 weeks after the first dose I started having muscle spasms in the left side of my face. Frequ... Read more
About 2 weeks after the first dose I started having muscle spasms in the left side of my face. Frequency has increased after the second dose.. Second dose was on: March 18 2021 Pfizer Lot: en6207 administered by injection in left arm no treatment or outcome has been pursued yet
45 2021-03-30 feeling hot, tingling I fainted about 5 minutes after the injection. When I awoke, my fingers tingled, I was hot, and my b... Read more
I fainted about 5 minutes after the injection. When I awoke, my fingers tingled, I was hot, and my breathing was labored.
45 2021-03-30 pain in extremity Within the first few day - typical AEs (low grade fever, sore arm, fatigue). However, the atypical ... Read more
Within the first few day - typical AEs (low grade fever, sore arm, fatigue). However, the atypical AEs included daily and persistent dizziness, "brain fog", fatigue, difficulty going up the stairs without getting winded (difficulty with physical exertion). These symptoms are still present on March 31st (11 days post injection). GI / diarrhea symptoms are also present. Of note, I did have COVID in the past (January 2021) - and had similar symptoms that had resolved at the time of the vaccine. These symptoms are severe enough that it may prevent the second shot (due to concerns of worsening AEs or prolonged events). Of note, the fatigue was worse with the actual disease vs. the vaccine.
45 2021-03-30 pain in extremity headache; left arm pain; chills; body aches; This is a spontaneous report from a contactable consume... Read more
headache; left arm pain; chills; body aches; This is a spontaneous report from a contactable consumer. A 45-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 17Feb2021 11:30 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation. Medical history included irritable bowel syndrome and GERD (gastrooesophageal reflux disease) from an unknown date and unknown if ongoing. Concomitant medication(s) included probiotics taken for an unspecified indication, start and stop date were not reported; clotrimazole taken for an unspecified indication, start and stop date were not reported; diphenhydramine taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported. The patient previously administered first of BNT162B2 (lot number :EL3247) on 27Jan2021 11:30 AM administered in Left arm for covid-19 immunisation. The patient experienced headache, left arm pain, chills and body aches on 17Feb2021 11:45. The patient did not received prior vaccination and covid tested post vaccination and also reported known allergies as no. Therapeutic measures were taken as a result of headache, left arm pain, chills and body aches and included treatment with acetaminophen 500 mg x 2 tablets. The outcome of the events was reported as not recovered.
45 2021-03-31 feeling cold, pain in extremity There were chills (like I was having a fever) at mid-night of the shot (shot was given in the mornin... Read more
There were chills (like I was having a fever) at mid-night of the shot (shot was given in the morning), to the extent that I was shivering. I had a low grade fever for most of the day. I measured it once and it came to 99F. I felt like I had a bad cold or mild flu. Symptoms prompted me to take the day easy (took off work and stayed in bed). Symptoms completely resolved by the next morning. I did not take any medication. I had no reaction to the first shot at all (besides a sore arm which was common for both shots)
45 2021-03-31 pain in extremity Chills, Fever starting 12-13 hours after injection, lasting 8 hours. Sore arm.
45 2021-04-01 weakness 10-12 hours after getting the shot I started to experience body aches, chills, and fever. These sym... Read more
10-12 hours after getting the shot I started to experience body aches, chills, and fever. These symptoms lasted through the night. The following day I felt better but had no energy. It was a one day thing. I've felt fine since then.
45 2021-04-01 discomfort, pain in extremity On the first dose I was very tired. On the second dose I had right arm pain for a day. Very heavy... Read more
On the first dose I was very tired. On the second dose I had right arm pain for a day. Very heavy.
45 2021-04-01 pain in extremity sore arm, brain fog, headache, swollen lymph nodes, pain in brain stem, sore neck, lethargy, diarrhe... Read more
sore arm, brain fog, headache, swollen lymph nodes, pain in brain stem, sore neck, lethargy, diarrhea, bowel discomfort, arthritis flare-up
45 2021-04-03 numbness, pain in extremity Within 3 minutes of receiving vaccine I had Instant fever, nausea, arm pain, face and lips numb, diz... Read more
Within 3 minutes of receiving vaccine I had Instant fever, nausea, arm pain, face and lips numb, dizziness, blood pressure low, chills. The pharmacy had to call 911 for a paramedic. I'm still feeling symptoms almost 24hrs later. I chose not to go to hospital in ambulance.
45 2021-04-05 numbness Throat closure,, ears and face swelling, arm and leg numbness
45 2021-04-07 nerve pain Acquired shingles including nerve pain and rash. Treating with antiviral (acyclovir) and gabapentin
45 2021-04-09 weakness Patient had generalized weakness, dizziness, fatigue, confusion, blurry vision, lethargy, neck pain ... Read more
Patient had generalized weakness, dizziness, fatigue, confusion, blurry vision, lethargy, neck pain 5 minutes after the first dose of Pfizer coronavirus disease vaccine. MRI C spine negative for COVID related transverse myelitis. CT head negative. His glucose was also low that was treated. He felt better the next day and was discharged.
45 2021-04-09 weakness Went to get up to get ready for work and instantly collapsed-scraping up knee. Became extremely naus... Read more
Went to get up to get ready for work and instantly collapsed-scraping up knee. Became extremely nauseous, weak, excruciating headache and dizzy. Unable to stand, had to crawl to nearby chair and call for wife. Thought might be dehydrated, extremely pale, tried to drink water, but began vomiting. BP was elevated, but no temperature. Tried to eat crackers and drink more water, but continued to violently vomit. Never felt so badly in entire life. No strength to stand or get up the stairs to be taken to ER, so had to call paramedics. When they arrived, BP had come down, but they felt needed to be transported to ER, so they took to healthcare facility at about 1:30 pm.
45 2021-04-10 feeling cold, slurring On initial assessment, client found sliding downwards from the chair, skin pale, diaphoretic, cool ... Read more
On initial assessment, client found sliding downwards from the chair, skin pale, diaphoretic, cool to touch, speech slurred. Client aroused to verbal stimuli. Client transferred to cot after ~ 15 seconds. Able to ambulate to observation with assistance.
45 2021-04-10 grand mal seizure I received the vaccine on 3/21. On 4/1 I had a breakthrough grand mal seizure walking down the stre... Read more
I received the vaccine on 3/21. On 4/1 I had a breakthrough grand mal seizure walking down the street after being seizure free for almost 5 years. The seizure resulted in a fractured vertebra (T12). On 4/5, while resting at home I woke up and had another seizure sitting in a relax the back chair. I had a mri on my brain that I understand came back normal. The doctors aren?t sure what caused the seizures but increased my dosage by 500 mgs per day despite my previous dosage controlling my seizures for about 5 years prior to my vaccine. No doctor has definitively stated the seizures were caused by the vaccine. However, the timing has prompted me to notify you of these events.
45 2021-04-10 muscle twitching One week after first dose, I began to experience slight muscle twitching in legs, arms, and torso. ... Read more
One week after first dose, I began to experience slight muscle twitching in legs, arms, and torso. The symptoms are not severe and I typically only feel them when at rest. I'm submitting in an effort to continue tracking data. Unless I hear otherwise, I plan to receive second dose next week.
45 2021-04-11 numbness The first night after the shot extreme stifles walk me up, It started at the upper sides of my calve... Read more
The first night after the shot extreme stifles walk me up, It started at the upper sides of my calves and quickly moved across the body, I would compare it after death rigor mortis, it went away but complete numbness in my right hand and arm stayed for the night. The next morning I got up with stiff legs but I was able to warm up and walk as normal. Right-hand numbness persisted for another 3 days. Now after a 6th it's getting to normal with occasional numbness in my right hand.
45 2021-04-12 flushing Light headedness and flush feeling to the face and left arm. Client seen and assessed by EMT and vi... Read more
Light headedness and flush feeling to the face and left arm. Client seen and assessed by EMT and vital signs are: BP 165/113, HR 98, O2 99. Client denies any other symptom and voiced that his BP is usually high and that there is no need for concern. Client advised to contact his PCP if symptoms worsen or go to ER. Client verbalized understanding and was cleared to go home by EMT once he stated he felt a decrease in sensation.
45 2021-04-12 pain in extremity first, 2 days arm soreness, the 4th 5th 6th continued, nausea throwing up, chills, chest and body pa... Read more
first, 2 days arm soreness, the 4th 5th 6th continued, nausea throwing up, chills, chest and body pain when coughing, headache, light shortness of breath.
45 2021-04-13 feeling hot I have been experiencing the subjective sensation internally of heat on the top of my ears and scalp... Read more
I have been experiencing the subjective sensation internally of heat on the top of my ears and scalp. My ears also feel warm to the touch compared to my fingers. Sometimes it makes me feel like the room is hot when I know it is not. This has been happening on and off for 6 weeks since shortly after my first shot.
45 2021-04-13 numbness, tingling Tingling mild numbness in my right cheek started 30 minutes after receiving the shot. Tingling subs... Read more
Tingling mild numbness in my right cheek started 30 minutes after receiving the shot. Tingling subsided/went away by 8pm that evening.
45 2021-04-13 tingling After receiving her vaccine client states she has tingling in both hands and nausea. Vital signs BP... Read more
After receiving her vaccine client states she has tingling in both hands and nausea. Vital signs BP 100/67, HR 67 O2Sat 96%. Client states she feels better. Client d/c home by EMS.
45 2021-04-14 numbness Pt felt SOB, c/o hand/lip numbness Vitals: 1400, HR 82, BP 198/118, O2 99, @1406 HR 80, BP 174/111... Read more
Pt felt SOB, c/o hand/lip numbness Vitals: 1400, HR 82, BP 198/118, O2 99, @1406 HR 80, BP 174/111, O2 100, @1419 HR 77, BP 166/97, O2 100 Pt discharged to home with others at 1432
45 2021-04-15 cold extremities, pain in extremity - In the early morning of 4/14/21 Pt called Kaiser help line complaining of cold hands/ feet, restle... Read more
- In the early morning of 4/14/21 Pt called Kaiser help line complaining of cold hands/ feet, restlessness, pallor, R arm pain. - Telephone visit 4/14/21 complained of chills, nausea, vomiting, abdominal cramping, diarrhea. Fluids and rest recommended. - 4/15/21 presented to Kaiser with chest pain, shortness of breath, abdominal pain. Diagnosed with late presentation of acute coronary syndrome / anterior ST elevation MI. Echo with low EF < 25%, LV apical thrombus - 4/16/21 heart catheterization showed 100% occlusion of LAD treated with PCI / DES x 2, IABP. Endotracheal intubation for respiratory failure.
45 2021-04-15 tenderness Swollen lump and itching at injection site. Tender to the touch.
45 2021-04-16 pain in extremity Blood clots developed in the 3 arteries in my lower right leg, cutting off all blood flow below my a... Read more
Blood clots developed in the 3 arteries in my lower right leg, cutting off all blood flow below my ankle. Extreme pain in my calf, my foot immediately lost its color and no pulses could be detected in my ankle or foot. Rushed to ER by ambulance. Vascular surgeon diagnosed it as simultaneous arterial thrombosis in the posterior tibial artery, anterior tibial artery, and fibular artery of the lower right leg. Admitted to the ICU, treatment was heparin drip for 3 days until all 3 clots cleared and all foot pulses were detectable.
45 2021-04-17 pain in extremity sore arm; muscle soreness; general fatigue; This is a spontaneous report from a non-contactable cons... Read more
sore arm; muscle soreness; general fatigue; This is a spontaneous report from a non-contactable consumer. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 22Mar2021 as single dose for COVID-19 immunization. Medical history included high blood pressure and cholesterol. Prior to vaccination, the patient did not diagnose with COVID-19. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He experienced sore arm and muscle soreness and general fatigue on 22Mar2021. Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the events was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
45 2021-04-17 tingling, feeling hot passed out; fingers were tingling on both hands; very hot and sweating; breathing was labored; very ... Read more
passed out; fingers were tingling on both hands; very hot and sweating; breathing was labored; very hot and sweating; This is a spontaneous report received from a contactable consumer (patient) . A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 (Batch/Lot Number: EP7533) as single dose (at the age of 45 years old) for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included magnesium citrate taken for an unspecified indication, start and stop date were not reported. It was reported that about five minutes after the shot, the patient passed out in the observation area. When he awoke, his fingers were tingling on both hands, a was very hot and sweating, and his breathing was labored. Events onset date was 27Mar2021. The patient received lactated ringers as treatment. The outcome of the reported events was recovered. Since the vaccination, the patient has not been tested for COVID-19.
45 2021-04-18 weakness, feeling cold Around 09.50 at night, I started to feel chills and a feeling of cold for no apparent reason, and I ... Read more
Around 09.50 at night, I started to feel chills and a feeling of cold for no apparent reason, and I had to go to bed because I could barely stand. Once in bed, I began to feel severe back pain, headache, and a progressive increase in fever to 103.5. I was taking Tylenol during the night and trying to hydrate myself, since I perceived that due to the fever, I was sweating frequently. The next day I also had a fever and a severe headache, but I was able to rest well, and today, Monday, I am already without apparent symptoms, beyond a feeling of moderate weakness.
45 2021-04-18 tremor metallic taste, hand tremor, slight throat tightness
45 2021-04-19 weakness Pt reports he felt weak and diaphoretic shortly after receiving vaccine. Denies dizziness or lighthe... Read more
Pt reports he felt weak and diaphoretic shortly after receiving vaccine. Denies dizziness or lightheadedness. Given water and crackers and transported to med obs #1 via wheelchair. Pt prefers to sit on side of bed, rather than lying down in stretcher. No s/s of distress noted. Pt reports resolution of symptoms. Registration called to bedside to schedule pt for second dose per his request, prior to d/c to home. VS are as follows: 1300: BP 145/95, HR 85, RR 17, O2 sat 96% on RA. 1305: BP 127/87, HR 79, RR 16, O2 sat 97% on RA; 1310: BP 137/94, HR 77, RR 17, O2 sat 97% on RA.
45 2021-04-19 cold sweat clammy, feels like passing out, dizzy. Evaluated by EMS-Refusal to transport.
45 2021-04-19 discomfort SWOLLEN MOUTH, EVERY 4-6 HOUR LEFT SIDE LUNG DISCOMFORT BELOW THE RIB BUT ABOVE THE STOMACH. ULCER ... Read more
SWOLLEN MOUTH, EVERY 4-6 HOUR LEFT SIDE LUNG DISCOMFORT BELOW THE RIB BUT ABOVE THE STOMACH. ULCER LIKE PAIN AND DISCOMFORT EVERY 4-6 HOURS, LESS SLEEP LIKE 5 HOURS DAILY.
45 2021-04-19 migraine I suffer from Meniere's disease and have had 2 episodes over the past 6 months. Since the vaccine I... Read more
I suffer from Meniere's disease and have had 2 episodes over the past 6 months. Since the vaccine I've had several small episodes and two big episodes in the span of 2 weeks and ongoing. A big episode will knock me out for hours even up to a day. See symptoms below. Small episodes: Dizziness-feel tipsy Nausea Headaches Vomiting Big episodes: (includes small) Full vertigo, feels like I'm drunk and have trouble walking. Feels like room is spinning Migraines Pressure in my head makes me feel like a bobble head and wobbly This has affected my work. My doctor told me to report this to you. I got the 1st vaccine shot on 04/05/21. I suffer from Meniere's disease and have had 2 episodes over the past 6 months. Since the vaccine I've had several small episodes and two big episodes n the span of 2 weeks and ongoing. . A big episode will knock me out for hours even up to a day. See symptoms below. Small episodes: Dizziness Nausea Headaches Vomiting Big episodes: (includes small) Full vertigo, feels like I'm drunk and have trouble walking. Feels like room is spinning Migraines Pressure in my head makes me feel like a bobble head and wobbly My second does is scheduled for 04/26/21, should I take it?
45 2021-04-19 pain in extremity Chills no matter how much clothing I had on. Also a strong stomach ache. Also a soar arm.
45 2021-04-20 numbness ~2230 chest tightness/pain (unlike asthma) that radiated to neck and left arm with left arm numbness... Read more
~2230 chest tightness/pain (unlike asthma) that radiated to neck and left arm with left arm numbness, anxiety He had taken 325mg of ASA 4x that day d/t right shoulder pain from previous injury
45 2021-04-20 night sweats Day after shot, progressively felt sicker and more sore throught the day. Had a slight fever at 4 pm... Read more
Day after shot, progressively felt sicker and more sore throught the day. Had a slight fever at 4 pm. By 630 pm at a 102 fever. Very high blood sugars that I couldn't manage for the day. Night sweats and fever over night but fever broke by morning. Felt off on the third day. On the fourth day woke up with a locked neck which never happens and felt ill, tired, sore, had a cough and mild vertigo for next 4-5 days.
45 2021-04-20 pain in extremity Extreme pain at the injection site and upper arm. The injection site has hard knot and is a little ... Read more
Extreme pain at the injection site and upper arm. The injection site has hard knot and is a little swollen.
45 2021-04-20 pain in extremity Intense nausea, fatigue, right arm pain and rash on both forearms
45 2021-04-21 pain in extremity arm soreness and stiff neck 11 days after vaccination.
45 2021-04-23 hot flush Headache. Body aches. Hot/cold/freezing. Boiling eyeballs. Not able to sleep. Perfuse sweating. Dizz... Read more
Headache. Body aches. Hot/cold/freezing. Boiling eyeballs. Not able to sleep. Perfuse sweating. Dizzy. Nausea. Like bad flu symptoms, like the worst flu I have ever felt.
45 2021-04-24 pain in extremity #1 ...extreme fatigue, sleepiness, drowsiness. (several days) #2 mild low grain headache (3 hrs) #3 ... Read more
#1 ...extreme fatigue, sleepiness, drowsiness. (several days) #2 mild low grain headache (3 hrs) #3 mild nausea (short period) #4 sniffles... runny nose. #5 soreness on right arm I have a general negative disposition to the Pfizer vaccine, overall I felt much better before taking the vaccine then after. There are well defined 'side effects' that are notable. Overall feeling after the vaccine is unwell. (Nothing like the side effects for say the flu virus) The side effects are much more pronounced. The side effect that is/was most notable is fatigue and drowsiness. I've felt unusually fatigued and sleepy over the past few days with the severest fatigue occurring the day after taking the vaccine. (I've felt fatigue like symptoms over the past few days since taking the vaccine on 4/22.)
45 2021-04-25 pain in extremity Outbreak of 3 cold sores on upper lip. Substantially sore arm.
45 2021-04-25 cold extremities No symptoms on day of vaccination. Day 1 following vaccination, tired. Day 2 following vaccination, ... Read more
No symptoms on day of vaccination. Day 1 following vaccination, tired. Day 2 following vaccination, diffuse rash on face, neck and chest. Day 3 following vaccination, rash worsening and spreading to arms; also cold feet, especially toes. Day 3, met with telehealth physician who prescribed prednisone 40 mg once daily for 5 days and diphenhydramine 50 mg TID.
45 2021-04-25 tremor Fever; muscular pain; joint pain; fatigue; headache; pain in the eyes, shaking; sweetness;
45 2021-04-26 flushing, numbness numbness in the extremities. Dizziness and mild vertigo. Flushing about 5 minutes after vaccination.... Read more
numbness in the extremities. Dizziness and mild vertigo. Flushing about 5 minutes after vaccination. symptoms resolved quickly and on there own . negative orthostatic Vitals- BP: 122/73 - HR:76 - RESP:14 - sp02: 98%
45 2021-04-27 discomfort Dull pain in injection shoulder two weeks after injection. Major discomfort. Unable to sleep comfort... Read more
Dull pain in injection shoulder two weeks after injection. Major discomfort. Unable to sleep comfortably. Advil doesn?t help. Ice has helped some.
45 2021-04-27 limb paralysis Dizziness, left arm/leg loss of movement. Confirmed stroke
45 2021-04-27 pain in extremity Splitting headaches, chills, fever, nausea, vomiting, soreness in left arm
45 2021-04-28 cold sweat After being seated for monitoring period after 2nd dose, patient was witness to loose consciousness.... Read more
After being seated for monitoring period after 2nd dose, patient was witness to loose consciousness. When nurse arrived to assist patient, patient took a deep, snoring breath and regained consciousness. After being placed on monitor, patient noted to be bradycardic with HR as low as 36. Pulse palpable. O2 sats remained stable. BP noted to be 80 palp. Blood glucose level noted to be 91. Patient coloring noted to be very dusky originally and patient noted to be clammy. Patient oriented when regaining consciousness. O2 applied via nasal canula and HR returned to low 70's. Patient given Gatorade and monitored by EMS. Patient declined transport to hospital and left ambulatory without any lasting symptoms.
45 2021-04-28 hot flush, migraine, pain in extremity When I woke up the day after (Day #2) being given the vaccine I was extremely tired exhausted, I had... Read more
When I woke up the day after (Day #2) being given the vaccine I was extremely tired exhausted, I had intense chills and hot flashes. Never a fever. I felt nauseated. Completely lethargic. Muscle aches all over my body, was hard to move. I couldn't stay awake. My eyes hurt. I had intense migraines. And no appetite. My right arm hurt, but not as bad as many others' reported. I took ibuprofen to help, it didn't. I drank lots of water and gatorade zero for the electrolytes. It didn't help either. On day #3, this was when it got scary. The previous symptoms carried over, minus the nausea and I was able to be mobile (less lethargic). But something new started to happen. I took my dog out for a short walk, a slow pace, I am very athletic, and I had shortness of breath. I was winded from just walking slowly. Then the brain fog started to set in. This I hated the most. I wasn't able to comprehend things. I tried to assemble an item I bought from Amazon and it was extremely hard to follow simple instructions. I wasn't able to see clearly for some reason. And even comprehending emails that I was receiving was troublesome. I kept drinking water, and was able to eat a little. Had two more bottles of Gatorade Zero. On day 3, most of all the symptoms subsided except that I still got winded from movement. On day 4, I was fine.
45 2021-04-28 pain in extremity Upon awakening the morning of April 18, the day after the 2nd dose, I had severe muscle pain between... Read more
Upon awakening the morning of April 18, the day after the 2nd dose, I had severe muscle pain between my left shoulder blade and spine. The pain occasionally went away but always came back. Around April 22 or 23 the pain moved down to the underneath side of my left tricep just above the elbow, but still would occur at the original site on my back. By the 25th or 26th the pain had started occuring as well in my left pectoral muscle right at the breastbone. Now the pain migrates around all 3 areas and can occupy one or all sites simultaneously. The pain has subsided somewhat by the time I saw my primary. He prescribed icing the back 3 times a day and referred me to phys therapy. Phys therapist gave me stretching exercises
45 2021-04-29 seizure Seizure brought in by adverse reaction to my seizure medication.
45 2021-04-30 feeling of body temperature change, pain in extremity, hot flush, weakness so nauseated; hot flashes and chills; hot flashes and chills; Caller reports one minute feels hot, n... Read more
so nauseated; hot flashes and chills; hot flashes and chills; Caller reports one minute feels hot, next minute feels cold; started having abdominal pains in stomach; has absolutely no energy and no strength; Arm was sore; so fatigued and so tired/extremely exhausted; This is a spontaneous report from a contactable consumer (patient). A 45 years old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0150) in left shoulder (arm) on 08Apr2021 14:45 at age of 45 years old at single dose for COVID-19 immunization. No medical history (including any illness at time of vaccination) reported. There were no prior vaccinations within 4 weeks. There was no adverse event (AEs) following prior vaccinations, this is the first he can ever recall. There was no family Medical History patient can think of. Patient knew his Dad got the Covid-19 second dose about the same time patient got his first shot Pfizer Covid-19 vaccine and his Dad was not doing so well. There were no additional vaccines administered on same date of the Pfizer suspect. Concomitant medications were not reported. Patient was a consumer reporting he received the first dose Pfizer BioNTech Covid-19 vaccine last Thursday in his left shoulder was calling about his side effects. Patient stated his arm was sore for a couple of days. Patient confirmed it was his left arm that was sore. Reports this arm soreness was still ongoing. Stated his arm is still sore if patient touches his arm. The pain in the arm has faded but it is still there, if patient bumps his arm, he noticed. By starting Saturday, patient was so fatigued and so tired, reported he could not stay awake. Then yesterday the patient was so tired and went for a walk for a few hours. Patient was still extremely exhausted. Reports tiredness is ongoing today. Patient still felt exhausted and did not get out of bed until 14:00, just seems ongoing. Last night (11Apr2021) after patient went to bed, started having abdominal pains in stomach, not able to sleep all night because of the pain. Reported the abdominal pain in stomach was touch and go. By morning (12Apr2021), patient was so nauseated, had to call out of work, patient did not get out of bed until 45 minutes ago. Had absolutely no energy and no strength, ongoing. Patient reported the only other side effect had today (12Apr2021) was hot flashes and chills, took hot bath to get rid of chills. Began about 0900 or 1000 this morning. After patient started getting really nauseated this morning, tried throwing up to empty out stomach and nothing there. A little while later patient noticed hot flashes real bad, later on had to take hot bath to get rid of chills. It was still going on but it was minor, not as strong as what it was, seems to be improved but still having hot flashes and chills. Patient reported one minute feels hot, next minute feels cold. Patient wondering if they should try to go to work tomorrow or if patient should let his body rest more. He was not sure what to do. The adverse events were not required a visit to Emergency room or Physician office, but a friend of the patient's says he should go. Outcome of event arm was sore and hot flashes and chills, one minute feels hot, next minute feels cold was recovering, for event so fatigued and so tired/extremely exhausted, no energy and no strength was not recovered, for abdominal pains in stomach was recovered, for so nauseated was unknown. No follow-up attempts are needed. No further information is expected.
45 2021-04-30 tingling, tremor, speech disorder, muscle twitching, inability to speak stroke/mini stroke; he couldn't move/loss of motor function/movements were off; Loss of motor functi... Read more
stroke/mini stroke; he couldn't move/loss of motor function/movements were off; Loss of motor function including movement and speech/couldn't speak; head was very tingly; speech was not slurred but more like there was an impediment; he couldn't move his mouth properly, his tongue and the bottom of his jaw wasn't moving like he wanted it to; Caller states he thought he was going to die, his body was shutting down; behavior change; his legs are shaky; eyes feel a little dry; thumbs weren't working right; rule out MS or Parkinson's; rule out MS or Parkinson's; I have had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head; he was a little dry thought he may be dehydrated; very tired; pounding headache in the back of his head constantly; he was twitching; really off-feeling; digestive issues/digestive problems; eyes were real mucusy/First week mucous in my eyes/could be allergy; eyes were real mucusy/First week mucous in my eyes/could be allergy; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 25Mar2021 as single dose for COVID-19 immunization on an unspecified facility. There were no medical history. No known allergy. The patient had no health issues with any severity, he is pretty athletic, pretty healthy. The patient's concomitant medications were not reported. No COVID-19 prior to vaccination. On 26Mar2021, the patient had digestive issues/digestive problems, eyes were real mucus, first week mucous in my eyes which could be allergy which resolved on 01Apr2021. On 06Apr2021 08:00 the patient reported that he couldn't move/loss of motor function and movements were off but his cognitive functions were fine, loss of motor function including movement and speech/couldn't speak, had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head, suffered a stroke or mini stroke and was sent to the emergency room. On 06Apr2021 at unspecified time the patent couldn't move his mouth properly, his tongue and the bottom of his jaw wasn't moving like he wanted it to, head was very tingly, speech was not slurred but more like there was an impediment, very tired, pounding headache in the back of his head constantly, he was a little dry thought he may be dehydrated, he was twitching, really off-feeling, and states he thought he was going to die, his body was shutting down. On an unspecified date, the patient had eyes feel a little dry, thumbs weren't working right, his legs are shaky, and noticed behavior change. The patient was hospitalized for 3 days from 06Apr2021 to 09Apr2021 due to thought he was going to die, his body was shutting down, stroke/mini stroke, couldn't move his mouth properly, his tongue and the bottom of his jaw wasn't moving like he wanted it to, couldn't move/loss of motor function/movements were off, head was very tingly, speech was not slurred but more like there was an impediment, loss of motor function including movement and speech/couldn't speak. The patient underwent lab tests and procedures which included IGG antibody test: positive and IGM antibody test: negative both on 19Apr2021, computerised tomogram: showed nothing on 06Apr2021, echocardiogram: unknown result on unspecified date, magnetic resonance imaging brain: showed nothing both on an unspecified date in Apr2021 (not sure if 15Apr2021 or 16Apr2021) and on 07Apr2021, COVID-19 test: negative on 06Apr2021, repeat COVID-19 test: negative on 07Apr2021. Therapeutic measures were taken as a result of stroke/mini stroke, loss of motor function including movement and speech/couldn't speak have had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head which includes TPA and digestive issues/digestive problems were treated with high fiber diet. The outcome of the event he was going to die, his body was shutting down, stroke/mini stroke, he couldn't move/loss of motor function/movements were off, head was very tingly, speech was not slurred but more like there was an impediment, loss of motor function including movement and speech/couldn't speak, have had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head, very tired, pounding headache in the back of his head constantly was not recovered, for the events digestive issues/digestive problems, eyes were real mucusy/first week mucous in my eyes/could be allergy was recovered on 01Apr2021, while for the rest of the events was unknown. Caller states he has an appointment with a neurologist and he's trying to get it moved up. Caller states his doctor wants to do a lumbar puncture to rule out MS or Parkinson's that sort of thing. Caller states but at this point they are trying to rule things out. Caller states he doesn't have a family history of really either them. Caller states there was no diagnosis. Caller states the doctor said he was pretty sure its a stroke, mini stroke, but his general practitioner doesn't think its a mini stroke. Caller states the effects are so long going and they will improve and fall back and then the doctor also said at the fact that has been cognitively aware the whole time, so there's been no official diagnosis yet.
45 2021-04-30 seizure Patient suffered a seizure and pulmonary edema four days after receiving second Pfizer shot. He was ... Read more
Patient suffered a seizure and pulmonary edema four days after receiving second Pfizer shot. He was pronounced dead several hours later. Patient had no health issues and was 45 years old.
45 2021-05-01 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
45 2021-05-02 burning sensation, tingling 12/10/20 - 12/25/2202 COVID with mild symptoms 3/10/2021 1st Shot Pfiizer 2pm 3/13/2021 Brief Vert... Read more
12/10/20 - 12/25/2202 COVID with mild symptoms 3/10/2021 1st Shot Pfiizer 2pm 3/13/2021 Brief Vertigo 3/31/21 2nd Shot Pfizer 4pm 4/4/21 running and throwing all day with kids 4/3/21-4/4/21 Tingling in shins like sunburn Week of 4/4/21- 4/11 progressive burning lower legs and arms as well as instability standing and sensitivity to light . Weakness in peronials right lower leg. Dizziness as well as wobbly gait, like I was stepping over a curb. Neck soreness and stiffness as well as a burning in the spine when I laid down. Weakness in right and left arm consistent with a pinched nerve. (history of trauma and nerve damage in right arm from an accident) TMJ jaw soreness and eye focal issues. -During this time i could still balance on on leg and passed several basic neurological exams -Balance on toes and heals 4/11-4/13 Symptoms dissipated by 30% Chiropractic helped some. Still had neurological instability like I had cold or Woozy head feeling with stiff neck 4//14 Primary Care Doc . Prescribed me Predizon 10 mg - 4pills 3 days, 3Pills 3days, 2Pills 3 days, 1 pill 3 days. Took at least 6 days but physical symptoms were about 85-90% gone I was left with Bilateral burning ( intermittent ) in hamstrings, feet lower, legs left and left glute. And tingling in Scrotum. I have L5 bulge. I also still had a ?woozy or unstable feeling intermittent as well as a intermittent visual focal issues I also have/had a light sunburn like tingling intermittent in outer arms, abdomen and legs. intermittent tmj bilateral tension.. 4/26 - Ophthalmologist looked at my eyes and said everything was perfectly fine I may need reading glasses and that the symptoms I was experiencing were not related to anything he found 4/27 - Spoke to a Rheumatoid Arthritis Doctor ( I had elevated levels on blood work) He said nothing that suggests RA at all. I told him my story and he said he has heard of this and it is most likely some reaction to the shot and may take a couple of months to work itself out. Referred me to a neurologist to be sure I have nothing else going on. He put me on 5mg of Prednisone daily for 30 days as well ad 200 mg of Celebrex for 30 days with a follow up call in 30 days Helping all physical symptoms almost immediately 4/29 - I currently have Intermittent visual focus issues, sensitivity to light and sore neck and slight instability. Like my body is recovering from a virus. My cognition and energy are improving and I finally slept for more than 4 hours straight.
45 2021-05-04 weakness 14 days after the vaccine I am feeling a bit better but still unusually tired. At first I was weak, ... Read more
14 days after the vaccine I am feeling a bit better but still unusually tired. At first I was weak, wobbly and tired, every day got a bit better, but I'm still feeling it as of today; 14 days after the vaccine I am feeling a bit better but still unusually tired. At first I was weak, wobbly and tired, every day got a bit better, but I'm still feeling it as of today; 7 days after my first Pfizer Covid vaccine I developed severe fatigue and moderate headache,14 days after the vaccine I am feeling a bit better but still unusually tired; 7 days after my first Pfizer Covid vaccine I developed severe fatigue and moderate headache; This is a spontaneous report from a contactable consumer (Patient). A 45-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was unknown), dose 1 via an unspecified route of administration, in left arm (shoulder) on 16Jan2021 09:15 (at 45-years age) as single dose for covid-19 immunisation. Medical history was and concomitant medications were not reported. Patient was not allergic to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021 06:00 7 days after first Pfizer Covid vaccine patient developed severe fatigue and moderate headache. 14 days after the vaccine he was feeling a bit better but still unusually tired. At first, he was weak, wobbly and tired, every day got a bit better, but he was still feeling it as of today. On 24Jan2021 patient underwent laboratory test that include post vaccination COVID-19 nasal swab test which results negative. The patient did not receive any treatment for the events. The event outcome was reported as resolving. Information on the lot/batch number has been requested. Follow-up (15-Apr-2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
45 2021-05-04 cold sweat, muscle spasms cold sweat; headache; cramping/spasm; bumps on the side of neck; body aches; Bumps on his head that ... Read more
cold sweat; headache; cramping/spasm; bumps on the side of neck; body aches; Bumps on his head that were also painful; stomach cramps; diarrhea; he threw up several times; nauseous; disorientated; just not feeling good at all; tired; neck pain; felt weird; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; /Lot Number: ER2613), via an unspecified route of administration, administered in right arm on 04Apr2021 (at the age of 45-years-old) at 14:00 as single dose for covid-19 immunisation. Medical history included COVID: he had gotten diagnosed with COVID back in December or January and twice tested positive for covid and his body had fought it off (as reported). Medical history included also back pain Concomitant medication included diphenhydramine hydrochloride (BENADRYL) taken to sleep, start and stop date were not reported. The patient reported that around the night of vaccination he experienced cold sweat, headache, and cramping for several hours then subside and come back later. Patient had some bumps appear on the side of his neck. He stated that he could not say that's from the shot, something may have bit him. The patient did bump his head a chandelier and went to the ER. He received Ibuprofen for the symptoms. Patient stated that the reported events occurred the same day as his COVID Vaccine and began a couple of hours later and wakes up every night in a cold sweat; stated he was in and out of the emergency room in about an hour and they gave him Ibuprofen 400mg and a of nights had to take two Ibuprofen because his head and body was hurting so bad and he had to take some kind of relief and he does not like taking stuff like that and pain pills make his stomach hurt. Patient stated he did a whole Ibuprofen and did not feel good after that and can't take the Ibuprofen anymore and then took 1-2 Aleve after that and does not like taking pain medication. He stated he was healing with the bumps but had this every day since the Pfizer Vaccine and he was starting to heal but the bumps were still there on the side of his neck and were improving and healing and he had the bumps on his head that were also painful; states the bumps occurred the same day as his Pfizer COVID Vaccine; states he was up in his attic and could have gotten into a spider nest and might have poison in him from the spiders and then went to the hospital emergency room with these issues. States he told the emergency room about the bites and bumps and that he had the Pfizer COVID Vaccine and they gave him the Ibuprofen and sent him home. The patient stated that this was a real concern for him due to the blood clots stuff coming out about how people have different reactions after a vaccine. States he felt like the hospital did not even do anything; he could have hit his head a couple of times on a chandelier; states the emergency took an image of his head and they did not address the bumps or anything else and said his head was not bleeding and gave him Ibuprofen and he did not think you should take Ibuprofen like when you have COVID and they sent him home and nothing was done. Caller states he does not know but when he received the Pfizer COVID vaccine he noticed a patch of bumps in his neck, and his neck got really tight and his neck still hurts on the left side; states he could have gotten bitten by something. The patient reported that after he had the Pfizer COVID vaccine, he was waking up every night with cold sweats, and recently last night had extreme cramps in his stomach area like was crawling around the floor getting away from the pain and is still having abdominal cramps. He ate a burger and had extreme cramps and diarrhea for days and this was after his Pfizer COVID vaccine and he is doing this again with stomach cramps and diarrhea; he can't distinguish what the cramps and diarrhea were from and maybe he ate something bad and is confused about his body; states the cramps are way worse and the diarrhea began after the burger. States the diarrhea is a lot and this time is less diarrhea but more abdominal cramps and he threw up several times last night and did not throw up a lot but was so nauseous and threw up twice a little bit. Patient stated that the reported events were just like when he had covid and after waking up at 12:00 he had body pains and was not able to go back to sleep until 4:00; states he had pretty bad headaches which are ongoing and had had headaches ever since he was diagnosed with COVID, stated it is the same thing also as when he had covid; states with covid he got sick and was up from 12:00 4:00 and had fatigue, had body pain, had headaches and nausea and then it got better and he started sleeping through the night. States the Pfizer COVID shot and it was like the same all over again where he was up from 12:00 4:00, had pain and was disorientated, just not feeling good at all which has gone on since the shot; states there were two nights where he slept through the night and was up in a cold sweat which wakes him up and drenches him head to toe and he has to get out of bed to change clothes and sit there til he is tired again and sometimes goes to sleep in the chair and then sleeps ok. Patient stated he took Benadryl just to sleep through the night and did not and got up once and then went back to sleep. He stated on the left side where the headaches were and he had neck pain and it was kind of the left side and felt weird. The patient stated also that in the emergency room he was given Valium in his arm and also has a knot on the back of his neck and tried to address it with the emergency room and they said it was a spasm and did not seem concerned and it felt hard and not a bump under his skin in his neck and it just felt like maybe a pea sized hard knot and noticed this after his Pfizer COVID Vaccine. Caller stated he actually felt pretty good and was sleeping through the night after he had COVID and felt back to normal and then after his Pfizer COVID vaccine everything went downhill. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.
45 2021-05-04 migraine Chills, fever, vomiting, migraine
45 2021-05-05 numbness Reports left sided numbness that comes and goes, perhaps 20 minute episodes over the last several we... Read more
Reports left sided numbness that comes and goes, perhaps 20 minute episodes over the last several weeks. First reported these symptoms three weeks after vaccination. Has been evaluated several times with no neuro deficit. Continues to be evaluated periodically by physician and APP with no observable deficits.
45 2021-05-05 tingling Was diagnosed today with shingles- rash on chest, back and under arm on one side. Stabbing pains and... Read more
Was diagnosed today with shingles- rash on chest, back and under arm on one side. Stabbing pains and tingling. Have had chicken pox but this is first time with shingles
45 2021-05-06 myelitis transverse Transverse myelitis in the thoracic cord. Symptom onset 1 week after 2nd vaccine dose. Sensory chang... Read more
Transverse myelitis in the thoracic cord. Symptom onset 1 week after 2nd vaccine dose. Sensory change in the left leg and increased reflexes/clonus
45 2021-05-07 muscle spasms, cold sweat nearly fainted twice; I've been having weird pains in several spots inside my muscles all over the p... Read more
nearly fainted twice; I've been having weird pains in several spots inside my muscles all over the place in my legs, feet, arms, neck, chest, face and even my left hand ring finger tip. It's pain that is in spots, it feels; I've been having weird pains in several spots inside my muscles all over the place in my legs, feet, arms, neck, chest, face and even my left hand ring finger tip. It's pain that is in spots, it feels; pains in chest; catching my breath; very cold and clammy; This is a spontaneous report from a contactable consumer (the patient). A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EW0169), via an unspecified route of administration, on 14Apr2021 at 11:30 (at the age of 45-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included cardiac disorder from an unknown date and unknown if ongoing, irregular heart beat and depression from an unknown date and unknown if ongoing. Concomitant medication included metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported. The patient did not have any other vaccines within four weeks prior to the vaccination. The patient stated that when he first got the shot he actually nearly fainted twice and had to lay on the floor for a while. It was very scary, he thought he was going to die. He got very cold and clammy and had pains in chest and had a hard time catching his breath. They checked his vital signs a couple times and said they looked good. But he still felt sick and they said if he did not feel better soon they may have to call for an ambulance for him. Eventually he felt better enough to where he was able to get up off the floor and on handicap cart to drive out of there. Also, he's been having weird pains in several spots inside his muscles all over the place in his legs, feet, arms, neck, chest, face and even his left hand ring finger tip. It's pain that is in spots, it feels like mini-charley-horses that lasts anywhere from 20 something to 30 something seconds. Now it's mostly continuous pains in his thigh muscles between his legs. And a pain in one spot in his left arm bicep. This has been happening for days." The patient experienced "nearly fainted twice" on 15Apr2021 with outcome of not recovered, chest pain, got very cold and clammy and had a hard time catching his breath on 15Apr2021 with outcome of not recovered. He also reported that he has been having weird pains in several spots inside his muscles all over the place in his legs, feet, arms, neck, chest, face and even his left hand ring finger tip. it's pain that is in spots, it feels starting on 15Apr2021 with outcome of not recovered. The patient underwent lab tests and procedures which included unspecified investigation: myalgias on an unspecified date . Therapeutic measures (unspecified) were taken as a result of the events.
45 2021-05-09 pain in extremity Deep vein thrombosis (DVT). Woke up on 4th day after vaccine (May 5, 2021) with pain in calf. Swelli... Read more
Deep vein thrombosis (DVT). Woke up on 4th day after vaccine (May 5, 2021) with pain in calf. Swelling continued to get worse. Went to an emergency room just over one week after vaccine (May 8, 2021) and was diagnosed with DVT in the lower left calf (after D Dimer test and ultrasound). No family history of clotting issues. And no personal history of clotting issues. Currently on Rivaroxaban (Xarelto), 15 mg twice per day. Will be on for at least 3 months (moving to 20 mg once per day after the first 21 days).
45 2021-05-09 seizure Syncopal Episode with seizure episode then syncope again. EMS at vehicle. Close to refused transport... Read more
Syncopal Episode with seizure episode then syncope again. EMS at vehicle. Close to refused transport to hospital. Called emergency contact after EMS checked client out.
45 2021-05-09 tenderness My shoulder began hurting around 2 weeks after my first COVID vaccination and has not stopped hurtin... Read more
My shoulder began hurting around 2 weeks after my first COVID vaccination and has not stopped hurting. First vaccination was on April 8th. Shoulder began hurting extremely on or around April 18th. Still had my follow up pfizer vaccination on April 29th. It's May 10th and my should is still extremely sore/tender. Tylenol and Advil doesn't relieve the pain. Ice helps temporarily.
45 2021-05-10 weakness Fever, cough, body ache, headache weakness
45 2021-05-11 bell's palsy Bells Palsy; This is a spontaneous report from a contactable consumer. A 45-year-old male patient re... Read more
Bells Palsy; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on 19Apr2021 at 14:30 (Batch/Lot Number: EW0161) as SINGLE DOSE for covid-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and the patient has not been tested for Covid-19 since the vaccination. Medical history included Anxiety, depression and known allergies: Tree nuts. Concomitant medication included duloxetine (DULOXETINE), mirtazapine (MIRTAZAPINE), lamotrigine (LAMICTAL) and gabapentin (GABAPENTIN) all taken for unspecified indications, start and stop dates were not reported. The patient experienced bells palsy on 24Apr2021 at 19:00. Therapeutic measures were taken as a result of bell's palsy which included Prednisone and Valyacyclovir. The patient received first dose of BNT162B2 on 29Mar2021 (lot ER8730) at 15:30 administered to right arm. Outcome of the event was recovering. Follow up attempts needed. Further information is expected
45 2021-05-11 pain in extremity Having issue with my arm. It is painful to lift/raise. From my shoulder to my elbow. I never had any... Read more
Having issue with my arm. It is painful to lift/raise. From my shoulder to my elbow. I never had any issues with my arm prior to the vaccine shot. (Pain is in the same arm shot was done on)
45 2021-05-12 tingling, weakness about 10 minutes after the shot his fingers felt "strange". Soon after his chest felt tight and he ... Read more
about 10 minutes after the shot his fingers felt "strange". Soon after his chest felt tight and he felt weak. No SOB. No tongue or month swelling. He felt faint, but did not have a syncope episode. Vitals were taken x 2 )201/106 pulse 117 pulse ox 97%. Patient was A&Ox3 and laid down on a cot. He was sent to hospital via ambulance. EMS called at 1202 and arrived at 1215. left facility at 1220.
45 2021-05-13 cold sweat Sweats, cold sweats, nausea, headache, dizziness
45 2021-05-13 pain in extremity By next morning arm sore injection site arm. The 21st of January, I had exposure to a patient who te... Read more
By next morning arm sore injection site arm. The 21st of January, I had exposure to a patient who tested positive to COVID. Wednesday, 13th, is when I developed high fever, shortness of breath, cough, body aches. My SATS were 93/94. I had those symptoms for about a week. Treatment: Z Pak and support supplements Tylenol/ Advil/ OTC Nyquil; Tessalon Pearls for cough suppressant. In between I was due for my second vaccine I still had a fever when I had my second vaccine 1/18/2021. After that second vaccine, my fever spiked and my fever was worse. Since I've been sick I've been having weird abdominal pains that come and go and I have more irritable and down since I've been sick.
45 2021-05-14 bell's palsy Diagnosed with Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A ... Read more
Diagnosed with Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 13Apr2021 15:00 (Lot Number: ER8737) as single dose for covid-19 immunisation. Medical history included ongoing high blood pressure. There were no known allergies. Concomitant medications included omeprazole; tizanidine; meloxicam and metoprolol all taken for an unspecified indication, start and stop date were not reported. 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 has not been tested for COVID-19. The patient was diagnosed with bells palsy on 26Apr2021 08:00 with outcome of recovering. The event resulted in Doctor or other healthcare professional office/clinic visit.
45 2021-05-17 tremor Nervous reaction where I can't stop my arms and head from shaking.; This is a spontaneous report fro... Read more
Nervous reaction where I can't stop my arms and head from shaking.; This is a spontaneous report from a contactable consumer (patient). This 45-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on 12Feb2021 12:00 (Lot Number: EN5318) as single dose (at 45 years old) for COVID-19 immunisation. Medical history included high blood pressure and high cholesterol. Concomitant medications included atorvastatin, ramipril, venlafaxine, vitamin D nos, all taken for an unspecified indication, start and stop date were not reported. Previously the patient received the first dose of BNT162B2 (Lot Number: EL1283) on 22Jan2021 in the left arm for COVID-19 immunisation. On 12Feb2021 23:30 , the patient experienced nervous reaction where I can't stop my arms and head from shaking. with outcome of not recovered. No treatment was received. The vaccine was administered at Public clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Follow-up attempts completed. No further information expected.
45 2021-05-19 pain in extremity pain in his leg that felt like a clot; pain in his leg; This is a spontaneous report from a contacta... Read more
pain in his leg that felt like a clot; pain in his leg; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on Mar2021 at 11:15 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing venous insufficiency since 2019. Concomitant medications were none. The patient did not receive any other vaccinations within 4 weeks of the vaccine. The patient stated that he received his first dose on 30Mar2021 or 31Mar2021. On an unspecified date, the next day after the first vaccination, the patient experienced pain in his leg that felt like a clot for the first week and a half to two weeks. Then, the patient got a little bit better, even though he had almost gone to the emergency room, but he got better after a couple weeks. The clinical outcome of "pain in his leg that felt like a clot " was resolved on Apr2021. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021507016 Same patient/drug, different dose/event
45 2021-05-20 feeling hot, cold sweat Shortly after receiving the vaccine the patient fainted and bumped his head from the fall. He was ve... Read more
Shortly after receiving the vaccine the patient fainted and bumped his head from the fall. He was very pale, clammy, hot and somewhat disoriented from the reaction. After some water, food, and sitting patient recovered almost fully. He does report having similar reactions to other vaccines/blood draws. He was checked on by phone that same night and about 36 hours later and overall was doing ok.
45 2021-05-21 pain in extremity, tenderness Patient reported that he woke up the day after vaccination with a slightly swollen, tender area abo... Read more
Patient reported that he woke up the day after vaccination with a slightly swollen, tender area about 1 inch X 1/2 inch on the inner aspect of his left leg below the knee (lateral calf muscle). Fearing he had a deep vein thrombosis, he called the ER. I took the call and agreed with the need for evaluation. At the ER he was examined by a physician. No radiology or laboratory tests were performed. He was released with a prescription for Motrin, PO, prn. Follow up call to the patient today (36 hours after discovery of painful area and 56 hours after vaccination) the patient reports no improvement and no worsening of the painful area.
45 2021-05-25 muscle spasms From hospital discharge summary: "45 y.o. right-hand-dominant male who presents with few hours of i... Read more
From hospital discharge summary: "45 y.o. right-hand-dominant male who presents with few hours of improving left arm heaviness/left hand cramping in the setting of getting his second Pfizer COVID-19 vaccination in his right arm 3 days ago and 3 weeks of mildly increased exercise/intermittent fasting. The patient reports getting his first Pfizer COVID-19 vaccination on April 7, 2021. Reports some mild symptoms afterwards. Around that same time, the patient reports having a checkup with his primary care doctor that was notable for a cholesterol elevation to 200. This prompted him to try and lose weight including intermittent fasting and increase in exercise, especially for exercises and cardio. The patient reports approximately 20 pound weight loss over the past 3 weeks. 3 days ago, the patient reports getting his second Pfizer COVID-19 vaccination in his right arm. Reports fever (maximum 103 Fahrenheit) and mild headache the subsequent 2 days after the vaccine. Last night, the patient went to sleep on his left side at around 8 PM. He woke up at 4 AM with significant left arm heaviness and left hand cramping. He tried to massage his hand with some slight improvement of the symptoms but otherwise the symptoms persisted. Hence, this morning, he called his PCP, who told him to come into the ER for further evaluation. Here, the patient reports improving left arm heaviness/left hand cramping. He also does report family history of heart attack and an uncle at a similar age and massive heart attack of his grandfather in their 60s. He denies fever, anorexia, unexpected weight change, headache, blurry vision, sinus pressure, cough, hemoptysis, orthopnea, PND, SOB, DOE, chest pain, pleurisy, changes in taste/smell, N/V/D, abdominal pain, flank pain, urinary sxs, genital sxs, black stools, incontinence, absence of flatus, calf pain, leg swelling, numbness/tingling, streaking redness/rash/skin changes, easy bruising. Also, deny history of HTN, DM, smoking, prior MI, prior PCI, prior CABG, prior TIA/CVA, or history of PAD. Further, denies recent trauma/fall, history of cancer, blood thinner use, recent drug use, recent travel, sick contacts, family history of connective tissue disease/congenital aortic anomaly, or family history of similar sxs. --- Hospital Course by Problem # Troponinemia (Likely myopericarditis) The patient has a family history notable for MI and CABG in relatives aged 50-70 on his mother's side. The patient notes that most of these family members were heavy smokers and drinkers, which he is not (never-smoker, rare EtOH, never illicit drugs). His symptoms are notable for L arm heaviness/cramping that began around 8pm on 4/30/21 at 9/10 severity and subsequently was 3-4/10 severity on presentation to ED and is 0-1/10 severity at time of admission to the floor; he has no associated numbness, weakness, coolness, or pallor. His symptoms are non-exertional. He denies CP, SOB, lightheadedness, nausea, jaw pain, abdominal pain, fatigue. He noes that he recently got the second COVID shot in the R arm, and had a post-vaccine course notable for Tmax 103 ~3d ago and 101 as recently as yesterday. His EKG was notable for ST-elevation in II/III/aVF and his troponins were elevated 305 -- > 298 -- > 328. Of note, his CRP was elevated at 69. The patients symptoms and findings could certainly be compatible with atypical ACS and, given the low risk of bleeding associated with heparin, he was treated conservatively upon admission with heparin infusion, metoprolol tartrate 6.25mg q6h, atorvastatin 80mg (he received ASA 325mg in the ED). However, given his recent covid vaccination and elevated CRP and reported fevers, this could also be compatible with myocarditis or other inflammatory etiology. TTE on 5/3 demonstrated preserved EF 55% with no WMA. Given reassuring TTE, a cMRI was ordered to assess for myocarditis vs scar tissue from recent ischemic event. Cardiac MRI on 5/5 was notable for finding consistent with myopericarditis (see below). Aspirin and atorvastatin was stopped on discharge. Patient was discharged with metoprolol 25 mg daily."
45 2021-05-25 nerve pain Significant increase in neuropathic pain lasting over 45 days. Breathing difficulties, daily nausea... Read more
Significant increase in neuropathic pain lasting over 45 days. Breathing difficulties, daily nausea episodes, upper right abdominal pain, muscle weakness, increased pain to all areas below T6, inability to breath without pain. Fatigue. Lasted acutely for over 30 days. Symptoms including breathing difficulty, nausea, and increased peripheral nerve pain continue to linger.
45 2021-05-25 pain in extremity Sore arm, Fever, fatigue, headache, treated with Advil/Tylenol, ok by next morning.
45 2021-05-25 pain in extremity Sore Arm; This is a spontaneous report from a contactable consumer. (patient) A 45-year-old male pat... Read more
Sore Arm; This is a spontaneous report from a contactable consumer. (patient) A 45-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 via an unspecified route of administration in the left arm on 19Feb2021 11:15 A.M (Batch/Lot Number: En6200) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with Covid-19 prior to vaccination. The patient has no known allergies. The patient received 1st dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) at vaccination age of 45-year-old on 29Jan2021 (lot number: En5318) at 11:00 AM for covid-19 immunisation. The patient did not receive other vaccine in four weeks. On 19Feb2021 04:00 PM, the patient had a sore arm. No treatment was received for the adverse event. The patient has not been covid tested post vaccination. The outcome of the event was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.
45 2021-05-25 cold extremities, seizure A little more than 5 minutes after receiving shot had a seizure. Told me his wife he didn't feel rig... Read more
A little more than 5 minutes after receiving shot had a seizure. Told me his wife he didn't feel right and hands were very sweaty cold his eyes rolled back in head. Lost his color loss control of bodily functions( urine). Throwing up hard. EMT were called vitals were alright. Once we were home vomiting subsided and he slept hard.
45 2021-05-26 numbness, weakness, tingling, speech disorder cannot talk properly; his body and mind are responding slow; It affected him and he didn't know a ca... Read more
cannot talk properly; his body and mind are responding slow; It affected him and he didn't know a car was coming and didn't even see them; Not able to make good decision/made the wrong decision; weak when he walks and knees are bending; left side very slow and weak, unable to use left side; weak; could not stand up or be on his feet/ left side weak an unable to stand or walk; cannot type on the keyboard; fell on the floor; numbness on his left hand/numbness and tingling in hand; tingling in hand/numbness and tingling in hand; This is a spontaneous report from a contactable consumer (Patient, self-reported) via medical information team. A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER729; Expiration Date: 31Jul2021), dose 2 via an unspecified route of administration, administered in Hand Left (shoulder) on 10Apr2021 12:00, as 2ND DOSE, 0.3 ML SINGLE; for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes dose 1 (Batch/Lot Number: EP75334, Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Hand Left (shoulder) on 20Mar2021 02:30PM, as 1ST DOSE, SINGLE. It was reported that patient received the second dose of the Pfizer Covid-19 vaccine on 10Apr2021 and he started experiencing numbness on his left hand and next morning he could no feel anything on the left side of his body, it was so weak that he could no lift his hand, walk on stand on his feet. He went to the ER, they made some tests, but primary care doctor did not provide a diagnosis. He started feeling better but today he could not stand up or be on his feet, he cannot talk properly, cannot type on a keyboard and the left side of his body is very slow and weak. Reportedly, the primary care provider was not able to provide him with any diagnosis. He was feeling better, but today, he noticed that he was not able to stand up on his feet again. He cannot talk properly due to weakness. He cannot type on the keyboard. The left side is very slow and very weak. It has been several weeks and he is not feeling better. Stated that he is 46 and was 46 when he experienced these events. Last week, patient went to the neurologist and no one had helped him. The only thing was about the side effects and were not telling him how that can be fixed. Numbness in hand has been more than 2 weeks. He doesn't feel numbness now but is very weak. The left side of his body has less strength. The numbness was minutes after the shot and the tingling was immediately after. The numbness and tingling lasted 30 to 40 minutes after the shot. The emergency doctor gave him some medicine but he does not remember what medicine. They also gave him fluids and then he got some strength. Woke up the next day and was unable to stand. He tried to go to the restroom and was so weak, he fell on the floor. They did all the tests and could not find anything. He is still not feeling normal. His right hand is fine. The left side, where they did the shot had less strength. He can't even move his finger properly and can't type on the keyboard, from the left hand side. if there are any cases like this and how that person got better and what was the root cause. So many weeks, this has been affecting his day to day life. He can not work. He is a software programmer. He needs to use his hands. He can't use his hands. Is feeling like his body and mind are responding slow. When he drives, he is not able to make good decisions. One time he really made the wrong decision. It affected him and he didn't know a car was coming and didn't even see them. States that he spoke to medical information, they could not provide any medical advice. Everyone is making this hard. They could not find another person with similar symptoms. Patient did not receive other vaccine in four weeks of vaccination. On an unspecified date, the patient experienced cannot talk properly, on 10Apr2021 12:05, numbness on his left hand/numbness and tingling in hand, 12:01 tingling in hand/numbness and tingling in hand, on 11Apr2021 weak, could not stand up or be on his feet/ left side weak an unable to stand or walk (was reported as worsened), fell on the floor, cannot type on the keyboard, weak when he walks and knees are bending, left side very slow and weak, unable to use left side, on an unspecified date his body and mind are responding slow, it affected him and he didn't know a car was coming and didn't even see them, not able to make good decision/made the wrong decision. Patient went emergency room on 11Apr2021 they made some tests, but primary care doctor did not provide a diagnosis. Patient was sent home to recover at home. wife was with him and brought him home. They gave him medicines and fluids. He was able to walk and stand up and somehow was recovering well. The patient underwent lab tests and procedures which included blood test: didn't find anything, nothing significant, electrocardiogram: didn't find anything, nothing significant, laboratory test: didn't find anything, nothing significant on an unspecified date. Therapeutic measures were taken as a result of left side very slow and weak, unable to use left side (asthenia). Outcome of the events numbness on his left hand/numbness and tingling in hand and tingling in hand/numbness and tingling in hand was recovered on 10Apr2021 12:45; left side very slow and weak, unable to use left side was not recovered and other events outcome was unknown. Follow-up attempts are needed. Further information is expected.
45 2021-05-27 unresponsive to stimuli, seizure Approximately 5 minutes after administering the vaccine, he was waiting in his car with a friend, He... Read more
Approximately 5 minutes after administering the vaccine, he was waiting in his car with a friend, He became unresponsive and appeared to have lost consciousness. Upon arrival to the vehicle he looked to be having a seizure. Did not respond to verbal commands but did respond to sternal rub. EMS called. BP 118/58 and pulse 60. He was diaphoretic and pale. EMS arrived and during their interview he had another more intense and longer seizure. Transported to the Emergency Room.
45 2021-05-30 weakness Bowel discomfort and stuffed right ear, partial hearing loss, vertigo, nausea, shingle like rash on ... Read more
Bowel discomfort and stuffed right ear, partial hearing loss, vertigo, nausea, shingle like rash on right side of the body. Treated with antibiotic and beclomethasone , seems to help with vertigo. vertigo came back one week later after finishing the antibiotics round. now on 30 days round of doxycycline, no vertigo , very little dizziness and nausea. 2 weeks back started a high dose of vitamin C that it seems to help with the dizziness and nausea. Right ear still stuffed and feeling weakness from time to time.
45 2021-05-31 pain in extremity On April 7, I received the first Pfizer vaccine, on April 9 my left knee started to hurt, on April 1... Read more
On April 7, I received the first Pfizer vaccine, on April 9 my left knee started to hurt, on April 10 I had to go to an urgent care because my left knee hurt and I was limping, on April 11 In April I went to the emergency room because I had a very strong pain in both legs, I could not walk and a severe headache, I also had a fever. On Monday the 11th they operated on my left knee because there was a lot of inflammation, that same day the second knee became inflamed, I was hospitalized from April 11 to 17 with a lot of pain in both legs. On April 21 I continued with a lot of pain and swelling in both legs and even in the ankles there was swelling. A rheumatologist doctor, because of the laboratory tests she conducted, did come to the conclusion that it was reactive arthritis caused by the Pfizer vaccine. Today June 1, 2021, I still have pain in both knees and ankles, especially the right one, both knees and the right ankle are a little swollen, until May 24 I walked with a walker and I did it with too much pain.
45 2021-06-01 weakness dizziness, nausea, weakness, fatigue, cough, headache
45 2021-06-01 pain in extremity, numbness Shortness of breath when physically active. Chest pains, pain / numbness in arms. Elevated Blood Pre... Read more
Shortness of breath when physically active. Chest pains, pain / numbness in arms. Elevated Blood Pressure, sweating, light headedness, dizziness, nasuea.
45 2021-06-01 pain in extremity Pt called call center reporting left arm pain after he got Ist dose covid vaccine started since 04/2... Read more
Pt called call center reporting left arm pain after he got Ist dose covid vaccine started since 04/28 not getting better. Denies left arm swelling,redness or loss of sensation. Pt stated he got swollen roof of mouth at vaccination site after he got first dose covid vaccine,MD evaluated him at site and took bendaryl as per onsite MD recommendation wiith relief. Still slight swelling of palate there but much better than before, pt speech clear,denies sob or any emergency sx. MD appt scheduled for patient and ED precautions provided to patient
45 2021-06-03 weakness, pain in extremity Arm soreness; Low grade fever; Headache; Body fatigue; Weakness; Dizziness; Chills; This is a sponta... Read more
Arm soreness; Low grade fever; Headache; Body fatigue; Weakness; Dizziness; Chills; This is a spontaneous report from a non-contactable physician, the patient. A 45-year-old male patient 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 on 17Mar2021 at 15:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. The patients medical history was not reported. The patient did not receive any concomitant medications within two weeks prior to the second dose of vaccination. The patient previously 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 14:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. 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 four weeks prior to the COVID vaccine. On 18Mar2021 at 05:00, the patient experienced weakness, dizziness, arm soreness, low grade fever, headache, body fatigue and chills. The patient did not receive any treatment for the events. The clinical outcome of the events weakness, dizziness, pain in arm, low grade fever, headache, fatigue and chills were recovering. Information about lot/batch number cannot be obtained. No further information is expected.
45 2021-06-03 pain in extremity Sore arm; Fever; body aches; chills; This is a spontaneous report from a contactable consumer or non... Read more
Sore arm; Fever; body aches; chills; This is a spontaneous report from a contactable consumer or non-health care professional (patient). A 45-year-old male patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6203) via an unspecified route of administration and administered in Left arm on 05Mar2021 at 09:00 am as single dose for COVID-19 immunization. The patient experienced COVID-19 prior to vaccination and not tested post vaccination. The patient didn't receive any other vaccine in four weeks. The patient medical history and concomitant medications were not reported. On 06Mar2021, at 03:00 am the patient experienced Sore Arm, Fever, body aches and chills. The patient did not receive any treatment for events. The outcome of events was not resolved. No follow-up attempts are possible. No further information is expected.
45 2021-06-03 pain in extremity muscle pain; joint pain; headache; fever; injection site swelling; nausea; diarrhea; vomiting; arm p... Read more
muscle pain; joint pain; headache; fever; injection site swelling; nausea; diarrhea; vomiting; arm pain; This is a spontaneous report from a contactable consumer reported for himself. A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 19May2021 (at age of 45 years old) 09:00AM (Lot Number: EW0179) as 1st dose, single for covid-19 immunisation. Medical history included covid-19, No known allergies. The patient's concomitant medications received within 2 weeks of vaccination were none. The patient experienced muscle pain, joint pain, headache, fever, injection site swelling, nausea, diarrhea, vomiting and arm pain, all on 19May2021 11:00 PM, no treatment received for events, and patient was not recovered from events. Adverse events result in Congenital anomaly or birth defect and Seriousness criteria reported as Congenital anomaly/birth defect (pending clarification). Prior to vaccination, the patient was 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. No follow-up attempts possible. No further information expected.
45 2021-06-06 brain damage Fever, headache, confusion, encephalopathy, hospitalized 5/28/21-6/1/21.
45 2021-06-07 speech disorder, coordination abnormal 1 day after receiving vaccine I experienced "brain fog". Approximately 10 days afterwards (around 2... Read more
1 day after receiving vaccine I experienced "brain fog". Approximately 10 days afterwards (around 2/25), I experienced symptoms of a minor stroke - I experienced lack of coordination in typing and later that evening experienced difficulty with speaking and comprehension, but only for a few minutes. A few days later, that weekend, I had some issues playing songs on the piano I had played before, making a lot of mistakes. About another 2 weeks afterwards, on 3/9/2021, I experienced more symptoms of stroke. For most of the day I had issues with typing, and later that evening I had some coordination issues with closing a soda bottle. On the morning of 3/10/2021, I continued to experience issues with typing and also had difficulty speaking and understanding my wife. At this point I went to the emergency room and was found/diagnosed to have experienced multiple TIA strokes.
45 2021-06-08 pain in extremity mild headache; Sore arm 11 hours post-vaccine; more tired than normal that evening; This is a sponta... Read more
mild headache; Sore arm 11 hours post-vaccine; more tired than normal that evening; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN 6199) via an unspecified route of administration administered in right arm on 09Mar2021 09:45 (at 45 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included high blood pressure, acid reflux, fatty liver, and overweight; all from unspecified date and unknown if ongoing. Concomitant medications included unspecified blood pressure and acid reflux medicines. The patient did not have COVID prior vaccination and no COVID tests done post vaccination. The patient experienced sore arm 11 hours post-vaccine and more tired than normal that evening on 09Mar2021. The patient also experienced mild headache the next morning on 10Mar2021. All were non-serious. No treatment was given due to the events. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
45 2021-06-09 numbness Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Numbness (sp... Read more
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: numbness on left side from neck to toes. did not go away for days
45 2021-06-10 cold sweat I almost got fainted or black out; My blood pressure and heart rate dropped to 76/55/42 respectively... Read more
I almost got fainted or black out; My blood pressure and heart rate dropped to 76/55/42 respectively; My blood pressure and heart rate dropped to 76/55/42 respectively; Sweaty; Clammy; This is a spontaneous report from a contactable consumer. This 45-year-old male consumer (patient) received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration administered in arm right on 27May2021 12:26 (Batch/Lot Number: EW0180) as single dose for covid-19 immunisation. There was no medical history or concomitant medications. 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. The patient received first Pfizer dose in his right arm at 12:26 PM on 27May2021. even minutes after vaccination, at 12:33 PM, he almost got fainted or black out. His blood pressure and heart rate dropped to 76/55/42 respectively. The patient was sweaty and clammy for about 3 minutes. At 12:40 PM, his blood pressure and heart rate elevated to 103/69/65. At 1:05PM, his blood pressure and heart rate came back to normal 120/84/67. The patient drove home afterwards without further reaction. He was a heathy male with no underline health condition. The patient have been testing for COVID-19 once a week since 07May2021 and all test results came back negatives (on 28May2021). The events result Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The outcome of blood pressure and heart rate dropped was recovered on 27May2021 1:05PM, of other events was recovered in May2021. No treatment was received for the events.
45 2021-06-10 numbness, feeling hot, tingling 15 - 20 min post vaccine, patient complained of bilateral hand/feet tingling/numbness. Vague heavine... Read more
15 - 20 min post vaccine, patient complained of bilateral hand/feet tingling/numbness. Vague heaviness across chest and throat. Feels warm and anxious. Treated with diphenhydramine 25 mg po x 1, diphenhydramine 25 mg IV x 1, Diphenhydramine 50 mg IV x 1 (had developed angioedema/throat swelling). Admitted to hospital and then transferred to another facility.
45 2021-06-15 migraine, pain in extremity Severe migraine severe dizziness vertigo brain fog it?s relentless nonstop 24 seven from the time I ... Read more
Severe migraine severe dizziness vertigo brain fog it?s relentless nonstop 24 seven from the time I wake up until the time I go to sleep severe pain in every single droid back arms legs feet it doesn?t matter I literally can?t function thank you I really appreciate the vaccine and went along way to help give me Covid symptoms is what I did I?m beyond frustrated every single day I can?t go to work I can?t do anything I can?t live I can?t function I?m in chronic pain. Let?s not forget the increased heart rate where I feel like I?m going to die Please get this poison out of me help me The pain is relentless in all my joints I can?t function why did I take this my push something. Everywhere I?ve ever had a problem from concussion two herniated disc it seems like the pain is exacerbated in all these areas even my notes wrist arms. I was perfectly fine until I got the shot. Oh I also can?t look at a cell phone I can?t look at screens that makes the migraines worse. 2 months of daily suffering thanks
45 2021-06-16 weakness, feeling cold felt cold; sweaty repeatedly; felt weak; This is a spontaneous report received from a contactable co... Read more
felt cold; sweaty repeatedly; felt weak; This is a spontaneous report received from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration on left arm on 16Mar2021 at 11:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. Concomitant medications not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The past drug history includes the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9266), via an unspecified route of administration on left arm on 23Feb2021 at 11:15 as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 at 23:45 evening the patient experienced cold. On an unknown date in Mar2021 the patient experienced sweaty repeatedly through the night. On an unknown date in Mar2021 morning following second dose the patient experienced felt weak all day. No treatments for the adverse event taken. The clinical outcome of the events feeling cold, sweaty repeatedly and felt week was recovered on an unknown date in Mar2021. No follow-up attempts are possible. No further information is expected
45 2021-06-16 weakness Swelling of lymph nodes for two months, First time treated with Predisone and Naproxin to combat sev... Read more
Swelling of lymph nodes for two months, First time treated with Predisone and Naproxin to combat severe pain in back and knee. Recently within the last month Ultrasound performed and I experienced full body pain and weakness. Treated with Augmenton and narco.
45 2021-06-16 bell's palsy Bells palsy
45 2021-06-16 pain in extremity pain in my left arm lasting for about 24 hours; After Vaccine #2 also experienced flu/cold-like symp... Read more
pain in my left arm lasting for about 24 hours; After Vaccine #2 also experienced flu/cold-like symptoms; Body aches/pain; sneezing; running/stuffy nose; running/stuffy nose; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in arm left on 10May2021 11:30 (Lot Number: EW0173) at age of 45-year-old at single dose for COVID-19 immunization at facility of Health Clinic. Medical history included multiple Chemical Sensitivities, polyneuropathy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or any other medications the patient received within 2 weeks of vaccination. The patient previously took first dose of bnt162b2 (Lot number: EW0161) on 19Apr2021 18:30 in left arm and experienced pain in left arm and lasting for about 24 hours. After second dose, the patient experienced pain in his left arm, flu/cold-like symptoms , body aches/pain, sneezing, running/stuffy nose, all on 10May2021 23:00. The events were serious for disability. There was no treatment for the events. Body aches slowly started to disappear on 11May2021. Other symptoms lessened over the course of next 10 days but never really gone away. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the body aches/pain was resolved on 11May2021, the rest events was resolving.
45 2021-06-16 pain in extremity pain in left arm lasting for about 24 hours; This is a spontaneous report from a contactable consume... Read more
pain in left arm lasting for about 24 hours; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 19Apr2021 18:30 (Lot Number: EW0161), at the age of 45-year-old, as single dose for COVID-19 immunisation. The medical history included multiple chemical sensitivities and polyneuropathy. The concomitant medication was not reported. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. After Vaccine #1 the patient experienced pain in his left arm lasting for about 24 hours in Apr2021. The outcome of the event was recovered in Apr2021.
45 2021-06-17 weakness, numbness - Chest pain after 1.5 months from the second shot - Left arm numbness - Shortness of breadth - Har... Read more
- Chest pain after 1.5 months from the second shot - Left arm numbness - Shortness of breadth - Hard to stay asleep - Lack of energy
45 2021-06-25 cold sweat No side effects after the 1st vaccine. No noticeable side effects until 58 hours after the 2nd vacci... Read more
No side effects after the 1st vaccine. No noticeable side effects until 58 hours after the 2nd vaccine. Fatigue most likely started until 48 hours after the shot. At hour 58 post-vaccine and for the next 36 hours: fever up to 102F, chills, cold sweat, muscle pain. Headache (pain level 4). At hour 96 post-vaccine and for the next 36 hours: urinary incontinence, cluster headaches (pain level 8, which required a tele visit and a Diclofenac prescription). An easy exercise outdoor (a walk) was attempted on day 6 after vaccine; abandoned after 0.25 of a mile due to chest tightness and a discomfort in the heart area. Slow return to easy exercises attempted again on day 8 after the vaccine. Max athletic output at 50% of capabilities prior to the vaccine. As of June 10th chest tightness and dull pain in the center/right side of the chest still experienced, which was reported to the primary physician during the annual checkup. As of June 21th chest tightness and dull pain in the center/right side of the chest still experienced; in addition ? a dull pain in the shoulder blade area when air was inhaled and held. As of June 25th max athletic output at 80% of capabilities prior to the vaccine.
45 2021-06-29 night sweats night sweats; Headache; chills; This is a spontaneous report received from a contactable consumer. A... Read more
night sweats; Headache; chills; This is a spontaneous report received from a contactable consumer. A 45-years-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route of administration on 17Mar2021(at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included COVID-19, gout and fatty liver. The concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021, the patient experienced headache, night sweats and chills for 3 days which was reported as ongoing. The patient did not receive any treatment for the reported 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 events headache, night sweats and chills were not recovered at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
45 2021-06-29 pain in extremity, night sweats Bilateral lower extremity pain; pain 9/10 ankle swelling w pain; pain 9/10 ankle swelling w pain/Kne... Read more
Bilateral lower extremity pain; pain 9/10 ankle swelling w pain; pain 9/10 ankle swelling w pain/Knee pain; Unable to difficulty to ambulate; Night sweats; Chills w/o fever; Nausea; This is a spontaneous report from a contactable other hcp. A 45-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in right arm on 19Jan2021 14:30 (at the age of 45-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included none. The patient concomitant medications were not reported. AE treatment was given at physicians office visit. The patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. On 24Jan2021 the patient experienced bilateral lower extremity pain, pain 9/10 ankle swelling w pain, knee pain, unable to difficulty to ambulate. Night sweats, chills w/o fever and nausea. On 24Jan2021 the patient underwent lab tests and procedures which included pain assessment: 9/10. Therapeutic measures were taken as a result of bilateral lower extremity pain, pain 9/10 ankle swelling w pain, knee pain, unable to difficulty to ambulate, night sweats, chills w/o fever and nausea. The outcome of the events was unknown. Information about lot/batch number has been requested. Follow-up (11May2021): Follow-up attempts completed. No further information expected
45 2021-06-29 pain in extremity under his eyes felt swollen and painful; under his eyes felt swollen and painful; intense all around... Read more
under his eyes felt swollen and painful; under his eyes felt swollen and painful; intense all around headache that was pretty much circling his whole head and his sinuses were feeling pressured; sore throat; dark red streaks down the back of his throat; intense all around headache that was pretty much circling his whole head and his sinuses were feeling pressured; sore throat; intense all around headache that was pretty much circling his whole head and his sinuses were feeling pressured; sore throat; his arm was hot to the touch around the area where the COVID vaccine was; soreness in his arm/but then on the second day he had soreness but for the second COVID vaccine it was the worst on the first day; little bit of dizziness right after the vaccine; flash fevers where he would get hot almost to the point of him sweating; flash fevers where he would get hot almost to the point of him sweating; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0162, age at vaccination 45 years), dose 2 via an unspecified route of administration, administered in arm left on 20Apr2021 as single for COVID-19 immunisation. Medical history included thyroid condition (he thinks it is hypothyroid, it is a new condition to him he was only diagnosed a couple months ago), kidney stones and asthma. Concomitant medications included spironolactone, potassium citrate, both taken for kidney stones and thyroid medication taken for thyroid condition (he thinks it is hypothyroid). The patient previously took the first dose of BNT162B2 (Lot number: ER8733) as single for COVID-19 immunization and experienced his arm didn't feel too bad when he got it but then on the second day he had soreness. On 20Apr2021, the patient has had soreness in his arm and on-and-off fevers for the last two days. For the second COVID vaccine they happened that day which was the worst day for the arm soreness. He also had a little bit of dizziness right after the vaccine when he was sitting there. And a couple times throughout the day he had like flash fevers where he would get hot almost to the point of him sweating with some and then it would go away and that happened throughout the night. On 21Apr2021, the soreness had let up on his arm a little and he had more movement, but his arm was hot to the touch around the area where the COVID vaccine was and it was a little hard. Also, he had some headaches on and off but they would last only a few minutes and then they would go away. On 22Apr2021, his arm was still sore and hot but he had some more movement but that was about all that he had noticed so he thought that he was getting better. On 23Apr2021 night, he woke up at around 04:30 in the morning with an intense all around headache that was pretty much circling his whole head and his sinuses were feeling pressured too/ face pressure. As he started going through the day, he realized that his throat was sore. He looked in the mirror noticed that he has dark red streaks down the back of his throat and he knew that he can get a sore throat and headaches after the COVID vaccine but was it normal for him to get the redness in the back of his throat or was that something that he should talk to someone about. The patient further reported that his arm was still tender to the touch and if he rolls or bumps into it or his arm was just hanging for a while, it would get achy. He was feeling it but he can move it without much pain, but it was still painful. It got better with each day a little bit. With his first COVID vaccine it was kind of opposite, his arm didn't feel too bad when he got it but then on the second day, he had soreness but for the second COVID vaccine it was the worst on the first day. Caller confirmed that his dizziness was only after the COVID vaccine on 20Apr2021 and he says that the flash fevers were from 20Apr2021 to 21Apr2021. He confirmed that the intense all around headache, his sinuses feeling pressured and the sore throat began today, 23Apr2021 at around 04:30 when he had woken up. He confirmed that he was still experiencing this to now and when probed for outcome he reported that the headache has gotten a little better. He has been trying to not drink any caffeine to try and open things up a little and he knew that part of this was in his sinus area, so he has tried using steam to get it to open a little bit. He can still feel it on his temples and it was still there. It was not as intense but it was a discomfort. Later in the call, he confirmed that the arm soreness that began the day after his first COVID vaccine began on 31Mar2021. The patient thought it was the 3rd day that it had gotten pretty decent. Still, again, there was a little bit of pain but it wasn't very noticeable and it didn't limit anything he was doing. The patient assessed the events as non-serious. The outcome of events pain in eyes, eyes swollen, rash and vaccination site warmth was unknown, dizziness was resolved on 20Apr2021, fever and sweating was resolved on 21Apr2021, and was resolving for the rest of the events. No follow-up attempts are possible. No further information is expected
45 2021-06-29 tingling Having tingling sensation in fingertips, fingernails; general weakness in the arms; This is a sponta... Read more
Having tingling sensation in fingertips, fingernails; general weakness in the arms; This is a spontaneous report from a contactable other healthcare professional (patient). A 45-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in the left arm on 27Jan2021 (at the age of 45-year-old) as single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient's concomitant medications were not reported. On 28Jan2021, the patient experienced having tingling sensation in fingertips, fingernails and general weakness in the arms starting second day of initial dose. It has been almost 2 weeks since and symptoms not going away. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was reported as not resolved. Follow-up attempts completed. No further information expected.
45 2021-07-01 seizure, flushing, tremor, unresponsive to stimuli Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Severe, Systemic: Seizure-Medium, Systemic: Shakiness-Medium
45 2021-07-02 weakness, pain in extremity sleepy; Back and knee are a little sore; feeling weak; a little headache; Back and knee are a little... Read more
sleepy; Back and knee are a little sore; feeling weak; a little headache; Back and knee are a little sore; Arm a little sore from the shot; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old male patient received an unknown dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; EP6955) via an unspecified route of administration in the left arm on 23Mar2021 at 08:15 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medication, food or other products. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On an unknown date in Mar2021, the patient experienced little soreness in the arm from the shot, felt weak and sleepy. The patient also had little headache, little sore in back and knee. The clinical outcome of the events pain in arm, weakness, sleepy, headache, sore back and pain knee were unknown at the time of reporting. No follow-up attempts are needed. No further information is expected.
45 2021-07-03 flushing, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Mild
45 2021-07-07 weakness First dose, I only had a sore arm, second dose, I had fever beginning ~12 hours after injection and ... Read more
First dose, I only had a sore arm, second dose, I had fever beginning ~12 hours after injection and lasting until ~36 hours after. The subsequent illness I reported in V-safe seems unrelated to my vaccination. I experienced fever (up to 102 degrees) and general malaise for three successive nights starting on June 4th, 2021 (2+ months after second dose). The fever only came at night and broke in the early morning each night. I had two COVID screenings on June 7th, both came back negative. The final fever occurred the night of June 6th. I continued experiencing malaise and general weakness and had some bloodwork done. My bloodwork came back indicating Fe deficiency anemia, and I have been experiencing this condition since. The cause is suspected to be due to overuse of NSAIDs in dealing with a bulging disc in my cervical spine from early March onward. I am scheduled for endoscopy to further investigate whether I am having bleeding issues causing the anemia. as previously mentioned, seems unrelated to vaccination.
45 2021-07-07 numbness, weakness Sometimes has numbness in right foot. No strength when walking and weakness. Can?t extend toes espec... Read more
Sometimes has numbness in right foot. No strength when walking and weakness. Can?t extend toes especially big toe after pushing them down.
45 2021-07-08 pain in extremity pain and swelling in arm where hadinjection; pain and swelling in arm where hadinjection; Feeling ti... Read more
pain and swelling in arm where hadinjection; pain and swelling in arm where hadinjection; Feeling tired; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown), via an unspecified route of administration in the left arm on 22Mar2021 at 14:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient did not have 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 COVID-19 vaccine. The patient did not receive any medications within two weeks of COVID-19 vaccine. On 22Mar2021 at 14:00, the patient had experienced pain and swelling in arm where the patient had injection and was feeling tired. The patient did not receive any treatment for the adverse events. Adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events pain and swelling in arm where had injection and feeling tired was resolved on an unspecified date in Mar2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
45 2021-07-12 numbness Numbness in left arm from elbow to 4th and 5th digits. The numbness largely went away but persists ... Read more
Numbness in left arm from elbow to 4th and 5th digits. The numbness largely went away but persists to this day with the sides of the ring finger and pinky finger remaining numb. I fear at this point is is permanently damaged nerves
45 2021-07-12 pain in extremity, weakness Weakness and extreme soreness in left arm from shoulder down to wrist
45 2021-07-15 muscle twitching, tremor tremor or twitch of right thumb
45 2021-07-15 muscle twitching Experienced twitching in right ear in or around ear drum at night after my second dose in the aftern... Read more
Experienced twitching in right ear in or around ear drum at night after my second dose in the afternoon. The twitching produced a sensation of throbbing sound and was very frequent and constant, occurring almost every other second. The next day was even worse with constant twitching throbbing sensation and I my sleep was hugely affected. I would stay up and walk at night. Got an appointment on May 11 with my Dr. who said basically I have ringing ears, Tinnitus, which might be due to hearing loss from childhood etc. He checked hearing which was still fine. I did mention it all started happening right after 2nd dose of COVID vaccine but he didn't think there was any connection with that. He did say he will keep this in mind and see if any link between vaccine and Tinnitus is found as cases are reported. He said there is not much that can be done for Tinnitus other than reducing noise levels.
45 2021-07-15 tingling Red spots over entire body. Feeling like joints being hammered on by an ice pick. Tingling in hand... Read more
Red spots over entire body. Feeling like joints being hammered on by an ice pick. Tingling in hands and legs. Side effects lasted roughly 24 hours then stopped completely.
45 2021-07-15 tingling Chest pain (heart area), waves of extreme fatigue, occassional tingling in legs, three instances of ... Read more
Chest pain (heart area), waves of extreme fatigue, occassional tingling in legs, three instances of pre-syncope.
45 2021-07-21 weakness Severe headache, muscleache, high fever (38.7 'C under arm), dizziness, overall weakness.
45 2021-07-21 tremor, pain in extremity Terrible pain in left arm; Sore throat; Runny nose; Grogginess; Lethargy; Fogginess; Wobbliness; Mil... Read more
Terrible pain in left arm; Sore throat; Runny nose; Grogginess; Lethargy; Fogginess; Wobbliness; Mild general achiness; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 17:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as no chronic health conditions. The patient did not have any known allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of COVID-19 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 patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 01Apr2021, the patient experienced terrible pain in left arm, sore throat, runny nose, grogginess, lethargy, fogginess, wobbliness and mild general achiness. The patient did not receive any treatment for the reported 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 terrible pain in left arm, sore throat, runny nose, grogginess, lethargy, fogginess, wobbliness and mild general achiness was not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
45 2021-07-22 discomfort Some lumps have shown up in veins noticeable in hand veins; Swelling of lymph nodes near throat.; Bo... Read more
Some lumps have shown up in veins noticeable in hand veins; Swelling of lymph nodes near throat.; Bothering of lymph nodes near throat; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 18Mar2021 at 16:15 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to medications, food or other products. The patient did not receive any medications within two weeks prior to the vaccination. The patient did not received any other vaccines within 4 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. On 21Mar2021, the patient had some lumps which had shown up in veins noticeable in hand veins and swelling of lymph nodes near throat which was bothering. The patient did not receive any treatment for the events. The clinical outcome of the events some lumps which had shown up in veins noticeable in hand veins and swelling of lymph nodes near throat which was bothering were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
45 2021-07-23 pain in extremity Pain and soreness in all 4 extremities. Thankfully, It is not a sharp or stabbing type though. It ... Read more
Pain and soreness in all 4 extremities. Thankfully, It is not a sharp or stabbing type though. It is more like I've been holding on something as tightly as I could while swinging it around for hours . While I've never done this activity, I imagine it would be the same feeling if I had just spent the day having to swing a sledgehammer to break down boulders or concrete.
45 2021-07-23 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: After adminstration during obeservation ... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: After adminstration during obeservation period, patient briefly fainted fell from chair and scraped head slightly. Patient sat up on own back into chair, gave some water and did some deep breathes to help relax. Continued to observe no further symptoms, patient was anxious before adminstration.
45 2021-07-27 feeling hot, muscle spasms Vomiting; Body Chills; abdominal pains; body aches,; sharp pains in knees,; back spasms; and violent... Read more
Vomiting; Body Chills; abdominal pains; body aches,; sharp pains in knees,; back spasms; and violent headaches,; warmth throughout the body,; severe exhaustion.; 100F; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male 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 30Apr2021 at 14:45 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included asthmatic and mushroom allergy (Food allergy). The patient did not receive any medications within two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, it was unknown that the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 06:00 the patient experienced vomiting, body chills, 100 degrees Fahrenheit, abdominal pains, body aches, sharp pains in knees, back spasms, violent headaches, warmth throughout the body, severe exhaustion. The clinical outcome of the events vomiting, body chills, abdominal pains, body aches, sharp pains in knees, back spasms, violent headaches, warmth throughout the body, severe exhaustion and 100 degrees Fahrenheit were recovering at the time of the report. No follow-up attempts are needed; information about the lot number cannot be obtained.
45 2021-07-27 muscle spasms Severe muscle spasms in the bicep of arm he got the vaccine/now it is (muscle spasms) spread to othe... Read more
Severe muscle spasms in the bicep of arm he got the vaccine/now it is (muscle spasms) spread to other muscle groups; He could not sleep; This is a spontaneous report from a contactable physician (patient's wife). A 45-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported) via an unspecified route of administration, administered in Arm Left on 03May2021 at 11:00 (at an age of 45-year-old) as dose 1, single dose for COVID-19 immunization. The patient medical history was not reported and had no problems with vaccines in past. Concomitant medications were not reported. The patient had no other vaccines given the same day or 4 weeks prior. On 03May2021, approximately 3-4 hours after the injection (dose 1), he developed a severe muscle spasm in the bicep of the same arm of the injection. Physician saw the contraction of the head of the bicep muscle. The first night was very frequent, overnight, and he could not sleep. He had not had that before the vaccine and did not do any exercises that could have caused it. After 5-6 days, it had improved but now spasms had spread in other muscle groups (at the time of report), like the quadriceps and on the back, but less severe compared to the arm. Spasms have continued, although improved and it was mainly at night now (at the time of report). The reporter was concerned if this could happen to anywhere in the body. Wonders if this could happen to any other part of body for the rest of his life. The reporter asked if patient should get his second dose if he has developed severe muscle spasms after the first dose. Physician did not feel that it was medically significant. On 03May2021, patient recovered from event could not sleep, the patient had not yet recovered from severe muscle spasm. Information on lot/batch number has been requested.
45 2021-07-27 pain in extremity Partial clot; has been experiencing pain and aching in his leg; didn't sleep at all that night; hear... Read more
Partial clot; has been experiencing pain and aching in his leg; didn't sleep at all that night; heart was feeling weird; having pain in the vein; Venous insufficiency; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date : unknown), dose 2 via an unspecified route of administration, administered in arm right on 27Apr2021 11:15 as dose 2, single for covid-19 immunisation. Medical history included peripheral venous disease from 2019 and ongoing. The patient's concomitant medications was not reported. Historical vaccine of BNT162B2 for COVID-19 immunization on Mar2021 at the age of 45-year-old as per first dose. Prior Vaccination (within 4 weeks prior): None. He has no family medical history, just his personal medical history. He already had venous insufficiency to some degree present but the COVID vaccine made it worse. He was diagnosed in 2019. Caller says that he got the Pfizer COVID vaccine and he is having some little adverse events. He has called a couple doctors today for an appointment to go in and be seen and they all suggested for him to call Pfizer as well. He clarifies that his adverse event is that he has a little bit of venous insufficiency already but it was relatively okay but with both doses of the COVID vaccines, immediately it was like a a switch. As soon as he got the COVID vaccines the situation got much worse for him. He had pain in his leg that felt like a clot for the first week and a half to two weeks after his first dose. Then he got a little bit better, even though he had almost went to the emergency room but he got better after a couple weeks. After his second COVID vaccine, starting that same night, last Tuesday, to now he has been experiencing pain and aching in his leg and he feels like his venous insufficiency went from a 5 to a 10 and it doesn't seem to be getting better so he is going to go see a doctor but they suggested for him to let Pfizer know about this. It was reported that first dose, his pain began the day after he had his COVID vaccine. His second dose was on 27Apr2021 and his 1st dose was 4 weeks before that, so his first dose was either on 30Mar2021 or 31Mar2021. His clarifies that his pain actually began the second day after his first dose. Second dose, the same day of his COVID vaccine, 27Apr2021, he felt pain in his legs and his whole body was flushed and he felt hot. He also didn't sleep at all that night and his heart was feeling weird. He had read that the racing feeling is part of the initial reaction so he had let it go. Then the next couple of days he had felt better and then he started having this feeling of stinging, burning pains in his leg where he knows that vein is, it's his superficial great saphenous vein. He has been having pain in the vein and it has been stinging, burning and aching and he can't sit for more than 20 minutes. He has been exercising every day, drinking water, elevating his leg on the wall to drain it but as soon as he sits again it starts hurting. He feels like it could be a partial blockage but he doesn't really know. He doesn't know if it is actually a partial clot or if it is just his venous insufficiency to such a degree that the fluid pressure inside is making it hurt. It has been this way everyday even though he has been exercising. Honestly, before the COVID vaccine he could exercise and his circulation would be fine that night and for about the next 3 days with no problems but since the COVID vaccine he has been exercising everyday and it doesn't seem to make a difference. He already had a situation but then the vaccine was like a switch and instantly made it worse both times. Probed for 2nd dose outcome and he says that when he is moving around, exercise is the only thing that provides relief, but after that he typically would of been okay for the next few days, but when he gets home from the gym tonight he knows his legs are going to start hurting as soon as he sits down. Even though he sits on his bed and elevates his legs on the wall he knows that as soon as he stands up his legs will start hurting. That's what has happened every day since last Tuesday. Therapy start date populated as Mar2021 since caller is unsure of the exact date of his first COVID vaccine and the therapy stop date populated as the date for his second COVID vaccine. History/ Investigations showed probed for test results, medical conditions or concomitant products and caller says no, there has been nothing out of the ordinary. Anatomical Location of Administration of Pfizer vaccine considered as suspect: right arm for both. No, but he is waiting for the doctor's office to call back him back to schedule for testing. He spoke with them and they said that if it gets worse or continues like it is for another day then he needs to go to the emergency room. The outcome of event pain and aching in his leg was recovered. The outcome of remaining events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
45 2021-07-28 flushing, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Was walking around and started to get dizzy, and blacked out fell. He woke up and thought he hit his head and yelled for help. Called an ambulance and they took to the ER. No trouble breathing.
45 2021-07-28 migraine migraine; slight burning in chest; body aches; warm/hot feeling on arm where the dose was administer... Read more
migraine; slight burning in chest; body aches; warm/hot feeling on arm where the dose was administered; nauteous feeling; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient 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 on 30Apr2021 at 16:45 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Apr2021 at 17:30 (at the age of 45-year-old) as a single dose for COVID-19 immunisation and Buckwheat. 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 01May2021 at 06:00 the patient experienced migraine, slight burning in chest, body aches, warm/hot feeling on arm where the dose was administered, nauseous feeling which lasted most of the day, until around 19:00. The clinical outcome of the events migraine, slight burning in chest, body aches, warm/hot feeling on arm where the dose was administered and nauseous feeling was recovered on 01May2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
46 2021-01-03 tingling, numbness He stated he was fine for 20 minutes after the administration, but noticed driving home that the lef... Read more
He stated he was fine for 20 minutes after the administration, but noticed driving home that the left side of his face felt funny/tingly. He says it progressed that evening to numbness and states his spouse noticed slight swelling to his face. He also complained of pain to his teeth and gums. He voiced concerns about bell's palsy, but stated he didn't notice any asymmetry or paralysis in his face and his symptoms have resolved entirely as of today 1/4. He was never seen or evaluated while he was having symptoms, unfortunately, and was able to continue working. Denied chest pain or difficulty breathing, no rash. He reports self-medicating with prednisone on sat/sun with improvement and as mentioned, is now asymptomatic.
46 2021-01-04 weakness, burning sensation Severe allergic reaction; BP of 170/104; felt like his whole body was on fire; chest tightness; HR e... Read more
Severe allergic reaction; BP of 170/104; felt like his whole body was on fire; chest tightness; HR elevated at 110bpm; Severe allergic reaction with symptoms that include/ rash all over his body including his throat, chest, and inner legs.; Right side of neck was swollen and sore; Right side of neck was swollen and sore; his neck was stiff to turn; he feels "really weak and tired"; he feels "really weak and tired"; This is a spontaneous report from a contactable other healthcare professional. A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date unknown) via an unspecified route of administration, on 29Dec2020, at a single dose, for COVID-19. The patient's medical history and concomitant medications were not reported. Patient is a 46y/o male certified nursing assistant (CNA). He received his first dose of Pfizer-Biontech Covid19 vaccine, yesterday 29Dec2020. On an unspecified date in Dec2020, patient experienced severe allergic reaction with symptoms that include: felt like his whole body was on fire, chest tightness, BP of 170/104, HR elevated at 110 bpm, rash all over his body including his throat, chest, and inner legs. Right side of neck was swollen and sore. Both sides are swollen, today, and his neck was stiff to turn, he feels "really weak and tired". Patient was taken by ambulance to the emergency room. Patient then asked if he should get the second dose of the vaccine. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of severe allergic reaction with multiple symptoms cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. 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.
46 2021-01-04 weakness No immediate reaction within 15 minutes of injection. Increasing injection site pain throughout the ... Read more
No immediate reaction within 15 minutes of injection. Increasing injection site pain throughout the day with mild chills and nausea starting around 7:00 pm (Approx 11 hrs after injection). Chills steadily intensified, with fever beginning, became severe over the next 2-3 hours, and persisted throughout the night. Along with the fever/chills & nausea, there was also moderate muscle/joint pain (mainly neck and back), moderate to severe fatigue and weakness, weird freaky dreams, restlessness, and moderate headache. Symptoms started to relent around 6:00 am the morning after injection, however fatigue/weakness, nausea, and mild fever/chills have persisted throughout the day with minimal improvement.
46 2021-01-07 feeling cold Chills, body aches, head aches,fever and felt dizzy
46 2021-01-07 tingling Following administration of COVID-19 vaccine, patient experienced "tingling in throat and lower legs... Read more
Following administration of COVID-19 vaccine, patient experienced "tingling in throat and lower legs" plus dizziness. After monitoring for 30 minutes, patient reported symptoms started to resolve. Upon follow-up, patient reported that tingling in lower legs had resolved after 3 days.
46 2021-01-08 cold sweat Headache, SkinRash & Rash Narrative: Had to go to the ER, started with a rash all over his body an... Read more
Headache, SkinRash & Rash Narrative: Had to go to the ER, started with a rash all over his body and itchiness, was given Prednisone and Benadryl, and today feels like he has a headache. Also feels clammy. Meds given in ER helped the rash some, less reddened today.
46 2021-01-08 tingling c/o tingling in both hands, light headed, profuse sweating and color pale. 120/68, 83, 28, 98%O2 sat... Read more
c/o tingling in both hands, light headed, profuse sweating and color pale. 120/68, 83, 28, 98%O2 sat. T 97.7 Narrative: c/o tingling to both hands, light headedness, profuse sweating, and color pale. 120/68, 83, 28, 98%O2 sat.; 122/62, 84, 24, 98% O2sat.; 119/60, 82, 20, 97% O2sat. ; at discharge 125/88, 78, 18, 98% O2 sat.. 09500: Recovered and "feeling better."
46 2021-01-08 tingling Patient received 2nd dose of Pfizer covid vaccine. Began to complain of dizziness and tingling in ex... Read more
Patient received 2nd dose of Pfizer covid vaccine. Began to complain of dizziness and tingling in extremities. 1234- 166/95 hr 72 98% 1239- 146/106; 1242- 180/103 1247- 160/98 1317- 168/96 1325- 142/97   1255- Called Dr. Patient given 25mg benadryl PO per MD orders.   Patient transported to ED by wheelchair
46 2021-01-09 cold sweat Headache, full body aches, fatigue, cold sweats/chills, increased urine output and frequency. Treate... Read more
Headache, full body aches, fatigue, cold sweats/chills, increased urine output and frequency. Treated with rest, acetaminophen for pain, fluid replenishment.
46 2021-01-10 feeling hot HEAVY WARMTH FEELING IN EXTREAMITIES
46 2021-01-10 pain in extremity, cold sweat Saturday all day my arm hurt. Sunday I woke up with no arm pain. Then after eating lunch I had diarr... Read more
Saturday all day my arm hurt. Sunday I woke up with no arm pain. Then after eating lunch I had diarrhea consistently and increased. Woke up in the middle of the night with more diarrhea and cold sweats. Temp 93.4. Sugar 112 in the middle of the night. I feel completely like trash, feel sick all over. Stomach hurts and lots of gas and diarrhea consistently.
46 2021-01-11 bell's palsy, facial paralysis Sun 10pm change in taste. Taste continued all day Tuesday. Had COVID test done. It was negative. Tha... Read more
Sun 10pm change in taste. Taste continued all day Tuesday. Had COVID test done. It was negative. That evening his eye started blinking.... Bells Palsey. Difficulty with face movement. Today still persisting. Now taking a steroid. He is a MD.
46 2021-01-11 facial pain, facial paralysis patient developed acute onset of right-sided facial palsy and pain; patient developed acute onset of... Read more
patient developed acute onset of right-sided facial palsy and pain; patient developed acute onset of right-sided facial palsy and pain; Brain MRI done showing T2 hyperintensity in the brainstem and basal ganglia, suspicious for inflammation; This is a spontaneous report from a contactable physician. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 18Dec2020 at SINGLE DOSE for COVID-19 immunization. Medical history included psoriasis. No COVID prior vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine.No known allergies. Concomitant medications (received within 2 weeks of vaccination) included fluoxetine. days following vaccination,on 23Dec2020,the patient developed acute onset of right-sided facial palsy and pain. Brain MRI done showing T2 hyperintensity in the brainstem and basal ganglia, suspicious for inflammation. Work-up is ongoing. AE Resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage].It was unknown if the event was treated. The event was assessed as serious for Disabling/Incapacitating. The patient had been tested for COVID post vaccination (covid test result-Negative). The outcome of the events werenot recovered Information about lot/batch number has been requested.; Sender's Comments: A possible causal relationship between acute onset of right-sided facial palsy and pain with MRI findings suspicious for brain inflammation and BNT162B2 cannot be completely ruled out considering the 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.
46 2021-01-11 cold extremities Cold extremity below injection site
46 2021-01-12 facial paralysis, facial pain Within 5 days of vaccination, he developed severe right-sided facial pain, and about two days later ... Read more
Within 5 days of vaccination, he developed severe right-sided facial pain, and about two days later developed complete right-sided facial paralysis. In the following days he also developed balance problems and nausea/vomiting. His facial pain has begun to improve with high-dose prednisone.
46 2021-01-14 pain in extremity feeling "not quite right"; nausea; headache; arm was sore/ it felt like someone shot him in the arm;... Read more
feeling "not quite right"; nausea; headache; arm was sore/ it felt like someone shot him in the arm; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0140), via an unspecified route of administration on 24Dec2020 10:00 at SINGLE DOSE at left arm for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. On 31Dec2020, the patient experienced headache, "lungs felt uber clean and clear," and nausea. The patient stated about a week afterward he started feeling "not quite right" He stated his arm was sore for about 12 hours after the shot, but this has resolved. He has already seen his PCP, lungs are clear, and Covid test was negative. He said that a week ago, he started to feel not quite right. He said that his lungs felt uber clean, but stated that he had a headache and nausea every now and then. He was wondering if it is related to the vaccination. He said that he went to the doctor and his O2 sat was 99% and she did not even think he needed a Covid test, but the rapid test was Covid negative. He stated that on the website that it says that up to 7 days after vaccination 77% of people reported fever, chills, headache and other symptoms. He said that he did not know that you could experience side effects a week after getting a vaccine. He said that his eases his mind a little bit. He wanted to know if it could be because of the vaccine? He stated that sometimes he feels fine and other times he feels strange. He stated that sometime he just feels different. He said that he received the vaccine on 24Dec2020. Caller said that sometimes he is perfectly fine and then he will get the headache or nausea for a few moments and then it would go away. Caller said that at the doctor's office his blood pressure was 118/78 and his O2 sat was 99% He stated that he does work around Covid patients and takes all precautions when he is around them. He said that exactly 12 hours later after receiving the vaccine at 2200 24Dec2020, he said that it felt like someone shot him in the arm. 2-3 hours after he got up on 25Dec2020 it was gone. Caller said that he rarely gets sick and has not had the flu vaccine. The outcome of the events nausea, and headache was not recovered, and arm was sore was recovered on 25Dec2020, while unknown for the event feeling abnormal.
46 2021-01-14 tremor woke up in the middle of the night; shivering; shaking; feverish, general malaise; muscle aches and ... Read more
woke up in the middle of the night; shivering; shaking; feverish, general malaise; muscle aches and pains; headache. Lasted about 36 hours. Patient took ibuprofen; acetaminophen.
46 2021-01-15 feeling of insects crawling on skin Low grade headache/dizziness/cobwebs still 10 days after vaccine - always there but sometimes barely... Read more
Low grade headache/dizziness/cobwebs still 10 days after vaccine - always there but sometimes barely feel, sometimes stonger
46 2021-01-20 weakness fever; chills; fatigue; weakness; pain in the arm (injection site)/sore arm; joint pain; Headache; T... Read more
fever; chills; fatigue; weakness; pain in the arm (injection site)/sore arm; joint pain; Headache; This is a spontaneous report from a contactable other HCP. This 46-Year-old male Other HCP (patient) reported that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at 1 DF single dose at right upper arm for covid-19 immunisation on 11Jan2021 around 10 AM. Relevant history included ongoing asthma, environmental and food allergies (ongoing). The patient was also allergic to a few medications, both had his entire life. Relevant concomitant drugs were unknown. The subject previously received the first dose BNT162B2 (Batch/lot number: EK4176, Lot number: EJ1685) at the right upper arm on 21Dec2020 for covid-19 immunisation. The patient was tested for COVID Virus before his vaccination either on 07Jan2021 or 08Jan2021. The patient experienced fever last night (11Jan2021), this symptom was gone but he described it as if fever went and came back but it seemed to be gone, he had also experiencing waking up with chills, fatigue, weakness, pain in the arm (injection site) and joint pain since the evening/night of 11Jan2021. He went and saw his primary care doctor. He had been using Tylenol and Antihistamines. He took Tylenol for joint pain. The patient stated it was not bad to start. Experienced fever, headache, fatigue, weakness, joint pain, waking up with chills, and a sore arm, which was to be expected. In general he was just really fatigued. Fever: Had come and gone. It was hopefully gone for good. He had a low grade fever last night, but he checked his temperature an hour ago and it was 98.6 Fahrenheit on 14Jan2021. The outcome of fever was recovered on 13Jan2021, the outcome of headache was recovering, the outcome of event pain in the arm (injection site)/sore arm was unknown. The outcome of other events was not recovered. on the 3rd day. He did a test for the virus and it came back negative. Information about lot/batch number has been requested.
46 2021-01-20 bell's palsy Pfizer-BioNTech COVID- 19 Vaccine EUA Received communication that patient experienced a Bell's Palsy... Read more
Pfizer-BioNTech COVID- 19 Vaccine EUA Received communication that patient experienced a Bell's Palsy symptoms on 1/16/2021. Patient received vaccine dose #1 on December 18, 2020 and dose #2 on January 8, 2021.
46 2021-01-22 facial paralysis, bell's palsy Left side of face started drooping on Thursday afternoon. Was diagnosed with Bells Palsy on Thursday... Read more
Left side of face started drooping on Thursday afternoon. Was diagnosed with Bells Palsy on Thursday evening.
46 2021-01-23 weakness The next morning after the vaccine I began feeling light-headed and weak. Over the next few hours s... Read more
The next morning after the vaccine I began feeling light-headed and weak. Over the next few hours symptoms worsened to include fever of 102.3, chills, body-aches and extreme fatigue. I was coughing more as well. Heart rate elevated to 110 bpm. These symptoms lasted about 12 hours. By the next morning, approx 24hrs after symptoms started, I was back to normal.
46 2021-01-24 migraine Sunday, Jan 24th 2:22 am - woke to violent, uncontrollable chills/shivers - lasted for 8 minutes bef... Read more
Sunday, Jan 24th 2:22 am - woke to violent, uncontrollable chills/shivers - lasted for 8 minutes before stopping. Severe migraine-level headache. 6:30 am - thoracic muscle pain/soreness, occasional chills continued, axillary temp 100.4 F. 17:35 pm - repeat episode of violent chills/shivering - lasted for 5 minutes, severe headache continued, axillary temp 101.8 F. Monday, Jan 25th 3:30 - woke with continued severe headache and mild chills. Axillary temp 100 F.
46 2021-01-26 burning sensation Began on the 21st of December, sores on the tip of the tongue and progressed to canker like sores on... Read more
Began on the 21st of December, sores on the tip of the tongue and progressed to canker like sores on the inside of the bottom and top lips , burning sensation that covered the facial area. Doctor instructed to keep taking Valtrex and prescribed a Z pack , I was already taking the Valtrex with little to worsening effect BUT after administering the Z pack condition quickly deminished and went completely away within 2 days.
46 2021-01-27 difficulty speaking subject developed hives/itchy bullae over trunk and extremities. over the next few days, despite usi... Read more
subject developed hives/itchy bullae over trunk and extremities. over the next few days, despite using diphenhydramine, also had swelling of lips and sensation that his throat was closing. Voice was slightly hoarse. Was seen in clinic and ER. was given steroids.
46 2021-01-28 tenderness Difficult to determine if this event was related to vaccination. 46 y.o. male with a pertinent inte... Read more
Difficult to determine if this event was related to vaccination. 46 y.o. male with a pertinent interval and past history of HTN, sponge kidney, ckd, gerd and HLD. Presents to ED with worsening redness and tenderness of his right upper mid thigh. Patient states that he got the Pfizer vaccination yesterday second shot evening and then developed some subjective fevers sweats and chills. Also had myalgias this all lasted approximately 2 hours but he was able to get to bed and fall asleep. Woke up this morning feeling better but still with some chills but noticed some tenderness and redness in his right upper mid thigh. This got progressively worse. Continues to have chills but improving.   ED work-up including CBC unremarkable, CMP with mild hyponatremia and hypokalemia of 134 and 3.4 respectively. ED drew blood cultures and then started vancomycin. Vitals normal and stable in ED. Admitted to hospital. Provider notes on 2nd day of admission as follows. Cellulitis and abscess of the right medial thigh likely secondary to a skin tag tear which introduced infection. Patient currently is on broad-spectrum antibiotics in the form of doxycycline and vancomycin. Unfortunately, the patient has been eating just ate lunch and also has been getting Lovenox. He is not going to tolerate a bedside incision and drainage. We will plan on proceeding to the operating room tomorrow for quick I&D and cultures. Procedures been explained. The wound will need to be packed afterwards and ultimately healed in. Patient seems understand plan and we will proceed accordingly
46 2021-02-01 tremor, feeling cold Approximately 10 hours after receiving my second COVID shot and right before I went to bed at 10pm I... Read more
Approximately 10 hours after receiving my second COVID shot and right before I went to bed at 10pm I started getting chills. My symptoms worsened as the night went on, I was shaking and could not get warm. I also had a very bad headache and I had trouble lifting myself up. At about 3am I started sweating and feeling feverish. I got out of bed to take Tylenol and drink water, and had trouble walking and I was breathing heavy. At 6am I decided to take a hot bath with Epsom salts to help with my aches and headache. When I got out of the bath I felt very dizzy and fatigued and need assistance from my wife to get back in bed. At about 9am I started feeling better. I sat myself up and ate apples and salty tortilla chips and drank lots of water. By 1pm I was able to walk without difficulty and I felt better with only a mild headache.
46 2021-02-03 cold extremities Fever, Chills, Fatigue, Body aches, cold hands / feet even with the heater blasting. Duration of eve... Read more
Fever, Chills, Fatigue, Body aches, cold hands / feet even with the heater blasting. Duration of events: ~2 days.
46 2021-02-03 seizure, feeling cold I have never had a seizure in my life before or since, but that morning I had five partial focal sei... Read more
I have never had a seizure in my life before or since, but that morning I had five partial focal seizures in y right arm, over the course of six minutes. As I was on the phone (to report the first one to my caregiver) when the second hit, I inadvertently punched myself rapidly and repeatedly in the right side of my head, with the phone handset functioning as an impromptu bludgeon, leaving bruises reminiscent of the victim of a fist fight. Also at the time I had a strong headache, cold chills, a 102 degree Fahrenheit fever and body aches. None of which persisted beyond noon.
46 2021-02-03 tremor Elevated BP 176/108 , shakiness, didn?t ?feel right?, several episodes of vomiting.
46 2021-02-04 tenderness Reported that he was under dosed. Noted injector did not give full dose. Reported had slight stiff n... Read more
Reported that he was under dosed. Noted injector did not give full dose. Reported had slight stiff neck over L side of neck x 1 minute within 15 minutes and subsided. Overnight had L side of neck tenderness and subsided the day after.
46 2021-02-07 weakness, feeling hot tightness on the chest; chest was hurting and felt like it has been compressed; congested; body ache... Read more
tightness on the chest; chest was hurting and felt like it has been compressed; congested; body aches/ his body is still aching/ body was aching/ achy; headaches; fever/ he has a temperature at 100; tired; felt weak; feeling kind of hot and achy; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL9261, expiry date unknown) via an unspecified route of administration on 20Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient had no medical history and no known allergies. There were no concomitant medications. The patient did not receive medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient received the first dose of BNT162B2 (lot number: EL1284, expiry date unknown) on 29Dec2020, 11:00AM at a single dose on the left arm for COVID-19 immunization. The patient reported he is probably 160 pounds, 5ft 6 inches; he received the second dose of the COVID-19 vaccine on 20Jan2021, while being due for it on 19Jan2021. He explained having body aches, headaches, fever, tired, and felt weak the following morning (21Jan2021, 04:30 AM) and therefore went to the ER. He had blood works and an X-ray done on 21Jan2021 (results unknown) and they said he had no COVID. Today, 22Jan2021, he has a temperature at 100, his body is still aching, the headaches are there along with a tightness on the chest that concerns him. He also described it as his chest was hurting and felt like it has been compressed. Patient asked what to do. He then mentioned that the nearby urgent care had refused to take him because the vaccine is still 'under investigation' and the ER is far away. Patient also reported that he was feeling kind of hot and achy, body was aching on 21Jan2021.Today, 22Jan2021, he was still the same. He got a fever, was congested, and his body is aching. Patient did not received treatment for the events. Outcome of the events 'body aches/ his body is still aching/ body was aching/ achy,' headaches, 'fever/ he has a temperature at 100,' tired, felt weak, 'feeling kind of hot and achy,' and congested was not recovered. Outcome of the other events was unknown. The events body aches/ his body is still aching/ body was aching/ achy,' headaches, 'fever/ he has a temperature at 100,' tired, and felt weak required Emergency room visit and were reported as medically significant.
46 2021-02-07 numbness At 1700 01/10/2021, he began to feel numbness in his left lip, like he was given a numbing shot at t... Read more
At 1700 01/10/2021, he began to feel numbness in his left lip, like he was given a numbing shot at the dentist. Over the next hour, it traveled superiorly up to his left cheek and to the inferior ear. He had a steroid and antihistamine sent in to the pharmacy and took this once he got home about 1930. Shortly thereafter, he started developing tongue numbness. He woke up in the middle of the night to use the restroom and reports he nearly fell into the bathroom wall due to the intensity of vertigo he was experiencing. The vertigo worsened throughout the day and he is very unsteady on his feet, requiring assistance and support from his wife to ambulate. He is unable to drive and reports exacerbation of dizziness when moving his head side to side. His wife reports he had a fever throughout the night 01/10/2021-01/11/2021. He feels the left eye is dryer and a bit weaker than usual and he has had to administer drops to help keep it moist.
46 2021-02-08 tremor, feeling cold, pain in extremity The first dose of Pfizer vaccine was on 1/17/2021. I did not feel anything except a severe pain over... Read more
The first dose of Pfizer vaccine was on 1/17/2021. I did not feel anything except a severe pain over my left arm only. But the second dose of this vaccine (on 2/7/2021) was different. In addition to the severe pain on my left arm, I had (and still) a severe headache, pains all over my body and bones, high fever (102), dizziness, shaking, fatigue, cold at all times, and a little bit taste loss (as of right now, 24 hours after the vaccine). It looks like a hard flu symptoms exactly.
46 2021-02-09 discomfort, numbness Approx. 1-2 minutes after vaccine patient reported numb left arm and gradual numbing/heavy feeling o... Read more
Approx. 1-2 minutes after vaccine patient reported numb left arm and gradual numbing/heavy feeling of entire left side. ( face, leg, arm) I was made aware about 15 minutes post vaccine ( 1;30pm). NO SOB, itching, rash. BP 136/102. I I suggested getting medical attention. Nurse at facility continued to observe patient for total 30-40 minutes. Patient said feeling better. AT 2;15pm and 2;45 pm I checked on patient both times he was felling "better" than the last time I checked on him. Numbing was subsiding. Both times I urged him get medical attention. He did call his PCP> He would not go to ER, considered urgent care. ***patient told me before his 2nd dose that he had a numb arm post 1st dose, he did not report this to clinic staff day of 1st clinic** I plan to follow up with patient in 24 hours.
46 2021-02-09 pain in extremity, numbness nausea coughing sneezing sore and numb arm
46 2021-02-11 tingling, numbness 12/15 vaccination 1/1 4:30 started having tingling and numbness in face, L side. Felt 'off'. My le... Read more
12/15 vaccination 1/1 4:30 started having tingling and numbness in face, L side. Felt 'off'. My left arm started to tingle and numb. Didn't last very long. Would come and go. Laid down. Ate some dinner; queasy. 1/2 Still felt 'off' 1/3 Symptoms occurred again with the numbness; face down to arm. HR was high for resting; 130's. BP 200/100. ED - CTA head/neck EKG, blood panel Symptoms resolved in ED; vitals normal 1/7 Neurology. Normal exam. MRI of brain; normal. Referral to cardiologist. Echocardiogram; normal Heart Monitor - waiting on results COVID - negative *DR/MGR of vaccine clinic
46 2021-02-12 tremor, feeling cold At 10:30pm (received vaccine shot #2 at 8:18am), i stood up and immediately felt chilled to the bone... Read more
At 10:30pm (received vaccine shot #2 at 8:18am), i stood up and immediately felt chilled to the bones and started shaking/shivering uncontrollably for 5min. Took temp, no fever. No other issues
46 2021-02-13 cold extremities On December 17, 2020, my husband, received his first BioNTech BNT162b2 COVID-19 vaccination. On Thur... Read more
On December 17, 2020, my husband, received his first BioNTech BNT162b2 COVID-19 vaccination. On Thursday January 7, 2021, he received this second COVID-19 vaccination. The following three days after his second vaccination, he felt fine. The fourth day, on Sunday January 10, my husband felt extremely fatigued. On Monday the 11th and Tuesday the 12th, he worked a full shift but complained of extreme fatigue and extreme chills to the point that his teeth were chattering while on the phone with me. He decided to work through it. When he got home on Monday night, he started vomiting. On Wednesday January 13, he woke up and had swollen eyes. Once again, he felt extremely fatigued, even after a full nights rest. He had the day off but had an early meeting. After his meeting, he was still tired so he went back to sleep. I left to get lunch, and drop off our kids, and upon my return, I found him on the walk in closet floor, face up, having passed away. He felt as cold as ice. The rapid test done after they called the paramedics resulted in a negative COVID-19 test for him.
46 2021-02-15 hot flush, night sweats Lingering headache for 6 days. Hot flashes/night sweats and on-going chills. Tiny mouth sores. No... Read more
Lingering headache for 6 days. Hot flashes/night sweats and on-going chills. Tiny mouth sores. No appetite. No libido. All symptoms have lasted for 6 days.
46 2021-02-15 pain in extremity Chest pain, shortness of breath, LEFT arm pain
46 2021-02-15 sciatica Got First Pfizer Covid vaccine on 06JAN2021. About 4 days after that I started noticing allergy symp... Read more
Got First Pfizer Covid vaccine on 06JAN2021. About 4 days after that I started noticing allergy symptoms and mild intermittent wheezing. Then on about the 5th day after, my lower back pain increased, causing significant sciatic pain worse than ever before. On 22JAN21 I ended up going to urgent care for increased breathing problems, and also had to have pain management appointment within days as sciatic pain was debilitating and also significantly interfered with my sleep. After steroid injection (In spine)on FEB 3rd for sciatica/back pain, and steroids/inhaler treatment for the breathing stuff, I would say I was pretty good to go . I didn't think too much of these unusual events for me both in timing and severity. On 12FEB2021, I got my second pfizer covid dose. I 14FEB I started noticing allergy symptoms again, and slight shortness of breath, used inhaler I had from before to help as breathing in seemed to not give me full breaths. Then, on 15FEB2021, in the evening out of nowhere while walking, my lower back/sciatica pain came back in full force, as if my leg were a lighting rod like before. So it almost seems as if the covid vaccine triggered an inflammatory reaction in my body. I am not certain, but because the series of events seem the same and in timing after my first covid vaccine, I figured I would at least report it.
46 2021-02-16 pain in extremity LEFT ARM PAIN, OVER ALL MUSCLE WEAKNESS AND PAIN, & FATIGUE.
46 2021-02-17 numbness 1/10/2021-Approximatley 34 hours after vaccination developed left facial numbness followed by severe... Read more
1/10/2021-Approximatley 34 hours after vaccination developed left facial numbness followed by severe dysequilibrium 5 hours later. 1/11/2021-left facial numbness and dysequilbrium significantly worse along with severe rotary nystagmus in the left eye. Had appointment with primary care and then ENT , who started me on prednisone 30 mg and antivert. ENT refered me to Neurology. Neurology ordered MRI/MRA that night and increased my prednisone to 60mg/day for 5 days followed by a taper over next five days. Currently, Symptoms of dysequilibrium and numbness have not subsided, on a second course of prednisone 60 mg/day for 3 days followed by taper. MD , Neurologist, provided Diagnosis of vaccine induced polyneuropathy affecting cranial nerves 5 and 8. Since the onset on January 10, Cannot work(physician/anesthesiologist) , drive, or perform minor tasks due to the severity of the symptoms. Symptoms during 1/10/21-1/17-21, bed-ridden, slept 18-20 hours/day, could not walk without assistance-would fall to the left, could not read, nystagmus of left eye, had to keep eyes closed due to severe vertigo/dysequilibrium, nausea. 1/18/21-1/24/21 slight improvement in disequilibrium/able to walk, no change in facial numbness severity , started on 100 mg gabapentin at night, and low dose valium 1.25 mg to 2.5 mg to help with dysequilibrium 1/25/21-1/29/21 50% improvement in facial numbness, began vestibular PT, slow improvement in dysequilibrium and ability to walk and read 1/30/21 Symptoms worsened again, facial numbness returned, dysequilibrium returned to its original severity, difficulty reading/focusing 2/1/21 Followed up with Dr, started another prednisone 60mg/day for 3 days, followed by taper over the next 5 days 2/4/21 Left Facial numbness not improved, dysequilibrium still severe, having difficulty focusing and reading
46 2021-02-23 discomfort, pain in extremity "I had an uncomfortable night and bad dreams, left arm soreness more painful than flu soreness. 1/4... Read more
"I had an uncomfortable night and bad dreams, left arm soreness more painful than flu soreness. 1/4/21 5am fever 100.5, and took Tylenol at 5am." Reported feeling better now at 10:30 am
46 2021-02-23 discomfort 1. Minor headache 2. Moderate pain in left underarm. Minor swelling of lymph node in the same area. ... Read more
1. Minor headache 2. Moderate pain in left underarm. Minor swelling of lymph node in the same area. I feel discomfort when trying to place my arm against my body. I have to keep arm extended to avoid discomfort.
46 2021-02-25 facial pain started with slight pain in left cheek and then had swelling with no pain. started approximately 3 h... Read more
started with slight pain in left cheek and then had swelling with no pain. started approximately 3 hours after injection.
46 2021-02-27 feeling cold Pale, SOB, cold/chills, nausea, emesis, feels like I am drunk the patient stated. EMS evaluated. Ref... Read more
Pale, SOB, cold/chills, nausea, emesis, feels like I am drunk the patient stated. EMS evaluated. Refused transport.
46 2021-02-28 facial paralysis, bell's palsy On 2/22/2021, started to feel numbing sensation in mouth. On 2/26/2021, left side of face started to... Read more
On 2/22/2021, started to feel numbing sensation in mouth. On 2/26/2021, left side of face started to become paralyzed. On 2/28/2021, left side of face became totally paralyzed and went to ER because worried it was a sign of a stroke.
46 2021-02-28 tenderness I woke up on 1/9/2021 with my lower left leg swollen and red and DR said it could be a superficial b... Read more
I woke up on 1/9/2021 with my lower left leg swollen and red and DR said it could be a superficial blood clot. January 9 - ER - Diagnosed cellulitis - round of Ceflex for a week - things got worse. Since January 9, I've had two other separate ER visits and three rounds of CEFLEX. Was referred to Dermatology - Arrhythmia Nodusem - so now I'm off Ceflex and on a steroid regimen now. I just started it today. It hurts to even touch my skin and it hurts to walk.I'm in a lot of pain. I have no open wounds so no reason for this to happen.
46 2021-03-02 tingling Rash on neck, tingling, throat swelling. BP 148/86 (pulse 75), O2 sat 96%. Benadryl 50 mg IM x 1. Re... Read more
Rash on neck, tingling, throat swelling. BP 148/86 (pulse 75), O2 sat 96%. Benadryl 50 mg IM x 1. Resolved. BP 137/83 (pulse 80).
46 2021-03-03 numbness lightheaded, numbness in fingers. Evaluated by EMS-Cleared
46 2021-03-04 grand mal seizure Approximately 3 minutes post-vaccination, the patient suffered a witnessed tonic-clonic seizure, whi... Read more
Approximately 3 minutes post-vaccination, the patient suffered a witnessed tonic-clonic seizure, which lasted less than a minute.
46 2021-03-04 tingling, feeling hot 11:42am Patient complaint of feeling "tingling and warm" throughout body. RN present and took patie... Read more
11:42am Patient complaint of feeling "tingling and warm" throughout body. RN present and took patient to treatment area. Vital signs BP 142/91, HR 68, RR 18, O2 sat 98% on room air. Patient reports NKA, no past medical history, and takes vitamins at home. Patient observed and noted to be diaphoretic. Post vital signs patient states feeling better. Vital signs recheck BP 138/84, HR 66, RR 18, O2 sat 97% on room air. Education on sign/symptoms to monitor and adverse reactions provided by RN. Patient escorted to car accompanied by patients wife and RN at 12:10pm.
46 2021-03-05 flushing Immediate metallic taste, flushing, sweating, itchiness. Patient progressed to itching in throat an... Read more
Immediate metallic taste, flushing, sweating, itchiness. Patient progressed to itching in throat and mouth, mild SOB, tachycardia, nausea, and rash over chest, abdomen, upper arms, and back over the next 30-60 minutes. Treatment: Benadryl 50 mg PO, Zofran 4 mg PO, Loratidine 10 mg PO, ranitidine 150 mg PO. Repeat doses of Benadryl, Zofran, and Loratidine given later that day. Patient stated improved symptoms within a few hours. The facial redness and rash on chest persisted until the next morning.
46 2021-03-10 sciatica Felt mild sciatica pain Thu morning following 1st vaccine shot that Monday. Through the day (I was j... Read more
Felt mild sciatica pain Thu morning following 1st vaccine shot that Monday. Through the day (I was just working at home like every other day) Sciatica began to get worse deteriorating to probably the worst pain I've ever experienced. As I mentioned, my Sciatica has been well controlled for 10+ years. I would have occasional mild sciatica pain following hard falls wakeboarding or snowboarding, but haven't done either in weeks nor had any hard falls.
46 2021-03-12 pain in extremity Starting about 5-6 hours after the shot I developed severe bloating, cramping and gassy-ness, litera... Read more
Starting about 5-6 hours after the shot I developed severe bloating, cramping and gassy-ness, literally constant burping. My stomach has been in constant pain. I?ve also had a slight fever and a very sore arm. Tylenol and rest has worked for the fever and arm, and I've had some addition body aches. Not sure how much is due to being in bed for an extended period. Also on Friday (about 24 hrs after getting the shot I was pretty fatigued. I just woke up from 13 hours of sleeping. But the stomach cramps/pains was severe and prompted me to try to find a way to report it, especially since it doesn't seem to be too common. It's been really bad.
46 2021-03-16 muscle spasms Headache within an hour of the shot, left work. Muscle spasms in my upper back and neck within 4 hou... Read more
Headache within an hour of the shot, left work. Muscle spasms in my upper back and neck within 4 hours. Major spasm that prevented me from turning my head or laying down at around 6-8 hours. Upper back, neck, and muscle pain in my head and jaw continue today (3/17/21) but symptoms are slowly decreasing in severity.
46 2021-03-17 feeling hot pt had adverse rxn after his covid vac. he told me he felt hot, and his heart was racing. had him pu... Read more
pt had adverse rxn after his covid vac. he told me he felt hot, and his heart was racing. had him put his feet up, and take off his coat. we took bp @1pm=156/98, 1:08=150/96, 1:16 158/109, 1:30 139/92, 142Pm 134/91. We gave him benadryl 15 mls at 1:05pm.I gave him 3 benadryl 25mg for tonight if needed same with 3 ibuprofen 400 mg tablets. I called him at 2:20 pm to see if he got home okay. he did and was feeling better. he takes diabetic medication but doesn't know the names of the medications. he had eaten breakfast before his vaccine. dx syncope.
46 2021-03-18 pain in extremity Had fatigue and myalgias and low-grade fever, so stayed in bed most of the next day. Developed calf ... Read more
Had fatigue and myalgias and low-grade fever, so stayed in bed most of the next day. Developed calf pain 2 daysafter that. Was diagnosed with DVT via Doppler ultrasound on Monday, March 8, 2021.
46 2021-03-18 tingling, numbness Numb/ tingling tongue, lips, fingers, & toes. Lasted 3, 4, & 5 March- subsided. Reoccured 16 Mar- on... Read more
Numb/ tingling tongue, lips, fingers, & toes. Lasted 3, 4, & 5 March- subsided. Reoccured 16 Mar- ongoing.
46 2021-03-19 seizure like phenomena, unresponsive to stimuli After receiving first dose of pfizer covid vaccine, patient alerted EMS he didn't fell well. When EM... Read more
After receiving first dose of pfizer covid vaccine, patient alerted EMS he didn't fell well. When EMS responded to the patient the patient went unresponsive slumped over in his chair with seizure like activity. Patient was being moved when he regained consciousness. Patient was moved to EMS area. Patient was pale, lightheaded and nauseous. Blood pressure was taken as well as oxygen and heart rate. Blood sugar was checked and an IV was started. Patient was stable and transported.
46 2021-03-20 tremor Chills and Shakes started at time indicated, 2 hours later vomiting. Vomiting only lasted 20 minut... Read more
Chills and Shakes started at time indicated, 2 hours later vomiting. Vomiting only lasted 20 minutes. Second night, extreme sweating. Sunday still have some sweating and nausea but feel 90% better than Friday night.
46 2021-03-22 flushing Chills, BP drop, and flush after Covid-19 vaccine
46 2021-03-22 pain in extremity Lost consciousness; fell face first onto floor; Arm pain; Chills shivering; This is a spontaneous re... Read more
Lost consciousness; fell face first onto floor; Arm pain; Chills shivering; This is a spontaneous report from a contactable other health professional (patient). A 46-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6202), via an unspecified route of administration, administered in right arm on 05Mar2021 08:45 as single dose for COVID-19 immunization at a hospital. The patient has no medical history. Concomitant medications were not reported. Patient has no known allergies. The patient previously received the first dose of bnt162b2 (lot number: EL9264) on 12Feb2021 14:30 (2:30 pm) for COVID-19 immunization. The patient did not received other vaccines in four weeks. No COVID-19 test post vaccination was done. On 06Mar2021 at 13:45 (1:45 pm), the patient lost consciousness and fell face first onto floor. The patient also experienced arm pain and chills shivering. No treatment was received. The event required doctor's office visit. The outcome of the events was recovering.; 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.
46 2021-03-22 pain in extremity Within hours of second dose(3/10/2021) in the right arm on 3/11/2021 I started feeling pain on the ... Read more
Within hours of second dose(3/10/2021) in the right arm on 3/11/2021 I started feeling pain on the underside of my left arm. As the days have gone on it?s gotten a little worse. Left under arm pain, armpit area, left chest (pectoral) pain. Just lingering pain. Very sensitive to the touch. I also developed a rash on the left side of my spine between the shoulder blades. It showed up this past weekend or the end of last week. It?s more of a painful rash than itchy. It?s very uncomfortable to lean against or lay on. This is all 13 days after the second shot. I have just been taking ibuprofen for the pain. Going to see my doctor today.
46 2021-03-23 bell's palsy Bell's palsy predniSONE 20MG vaiACYclovir HCL 1GM Artifitial Tears Erythomycin
46 2021-03-23 facial paralysis, numbness, tingling, weakness facial paralysis; dizziness; weakness; palpitations; tingling; extremities numbness; panic; anxiety;... Read more
facial paralysis; dizziness; weakness; palpitations; tingling; extremities numbness; panic; anxiety; chills; This is a spontaneous report from a contactable consumer(patient) reported for himself. A 46-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 06Mar2021 12:00 at single dose for covid-19 immunisation. Medical history included left kidney missing. Patient had allergies to Ambroxol, levofloxacino, cefalosporina, hidrocortizona. The patient's concomitant medications were not reported. First symptom took place 5 minutes after receiving the vaccine, it started with a severe dizziness followed by body weakness, quite accelerated and uncontrolled palpitations, tingling and extremities numbness, mild right-sided facial paralysis, panic feeling and anxiety. Finally, severe chills. Full recovery after 40 minutes with a mild lightheadedness for a few hours. Vital signs kept stable at all times according to paramedics' diagnosis. Patient received treatment for these events. Outcome of events was recovered. Information on the lot/batch number has been requested.
46 2021-03-23 pain in extremity Sudden and significant lower back pain in lubar region and localized without radiation to the legs. ... Read more
Sudden and significant lower back pain in lubar region and localized without radiation to the legs. Pain persisted 7/10 for first 12 hours from onset, gradually lowering to level of 2/10 over 48 hours and then 1/10 after 72 hours. Onset of pain occurred without physical stress to the region (was quietly sitting in a chair). Pain similar to when I herniated L5-S1 years ago (requiring hospital transport). Pain was controlled to tolerable levels by immobilization (lie on floor with knees elevated, application of heat, and ibuprofen. I did not associate this with the vaccine initially, but after consulting with my doctor, he recommended I report, as he stated there were some earlier reports about back pain with the similar Moderna vaccine, and there isn't a physical explanation otherwise as to why the sudden pain.
46 2021-03-24 mild one side paralysis left pontine stroke patient had right sided weakness of upper and lower extremity 3 days after vacc... Read more
left pontine stroke patient had right sided weakness of upper and lower extremity 3 days after vaccination and presented to the emergency department on day 6 when he was found to have a stroke on MRI
46 2021-03-25 numbness After a couple hours my face and head went numb.
46 2021-03-28 pain in extremity Left arm lymph nodes are swollen and painful. My entire arm hurts down to my fingers. Diarrhea, body... Read more
Left arm lymph nodes are swollen and painful. My entire arm hurts down to my fingers. Diarrhea, body pain and fatigue.
46 2021-03-30 electric shock sensation On or about 0845 am, RN administered Covid vaccine (2nd one for patient). Attempted administration w... Read more
On or about 0845 am, RN administered Covid vaccine (2nd one for patient). Attempted administration with syringe (a Haiou, 1ml, 23g, 1'', Lot 20JC2, Exp: 10-17-25) resulted in needle going into patient's arm, but the 2 piece retractable distal needle and hub separated from the proximal tube part of the syringe resulting in COVID vaccine dose being lost. None of the 1st dose entered patient's arm. With needle and distal hub still fully immersed in patient's arm, RN removed it and held pressure on bleeding. RN informed patient that needle failed, to which pt stated he was "shocked," and felt an "electric" sensation when needle was inserted. Patient tolerated well. Bleeding abated. RN administered a 2nd dose of vaccine to the patient with no problems on the same LUE, more medial by about 2 inches than the first attempt. Bandage applied to both sites due to scant bleeding. Patient tolerated well, but showed no emotion. Pt complied with all instructions, and RN thanked patient for coming in.
46 2021-03-30 pain in extremity Here are my side effects: 1. Low grade Fever 2. Arm so sore that you dont want to move it 3. Body A... Read more
Here are my side effects: 1. Low grade Fever 2. Arm so sore that you dont want to move it 3. Body Aches 4. Fatigue 5. Headache 6. Metallic Taste in my mouth. Nothing tasted good yesterday. 7. Nasal Drip with Nausea
46 2021-03-31 facial pain Pain in the 2 sides of the face (under ears) close to the temporal bone
46 2021-04-02 flushing Patient developed flushing and rash on his neck. Improved with benadryl. Was monitored for several h... Read more
Patient developed flushing and rash on his neck. Improved with benadryl. Was monitored for several hours, remained stable, discharged home.
46 2021-04-02 tremor, weakness Body has been weak and shaky since I got the vaccine. I have had 2 episodes where I am short of brea... Read more
Body has been weak and shaky since I got the vaccine. I have had 2 episodes where I am short of breath and my blood pressure has gone up. The doctor has put me on anxiety medication but I still feel no difference. I have not been able to work for the past 3 weeks.
46 2021-04-03 migraine Appointment with family doctor next week
46 2021-04-06 pain in extremity, muscle spasms Sore arm; Muscle cramps all over the body; Sugar was very high; Dehydrated; This is a spontaneous re... Read more
Sore arm; Muscle cramps all over the body; Sugar was very high; Dehydrated; This is a spontaneous report from a contactable consumer (patient's mother). A 46-year-old male 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 27Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history included heart attack (at the age of 39) and had couple of stents (and the things done) later after that, and Lyme disease (past this Summer). The patient was taking several concomitant medications (unspecified). The patient's mother was calling for her son (patient) as he works out on the road, but he has had a heart attack at 39 years old and has had some other problems. The patient got his first Pfizer shot and about 2 to 3 days later while he was working, he first just had the sore arm on 03Mar2021. The patient worked in fiber glass repair on pools and it was very warm, and he started having muscle cramps all over the body on 03Mar2021. The patient ended up in the hospital on 03Mar2021 and his sugar was very high, and he was dehydrated. As treatment taken for the events, they gave him fluids through an IV and they gave him metformin medication 500 mg. The patient underwent laboratory tests and procedures (his doctor did the laboratory work), and they did laboratory work at the hospital where he went. It was clarified that they just did blood work on 03Mar2021, but the patient's mother didn't know what it was. The patient was just held for observation and was out the next day (04Mar2021). That was only the first shot, so the patient was really afraid to get the second shot one. The patient's mother told him she will try to find out something about it. patient's mother looked up the side effects and she did not see that as a side effect. At the time of reporting, the patient still had cramps once in a while. The patient had not recovered from "Muscle cramps all over the body". The outcome of the other events was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
46 2021-04-06 pain in extremity Patient received COVID immunization #1 on 3/17/2021, then on 4/1/2021 he started having right calf p... Read more
Patient received COVID immunization #1 on 3/17/2021, then on 4/1/2021 he started having right calf pain and swelling. Got worse over the following 3 days so he presented to Urgent care. DVT was identified in UC on bedside ultrasound, started on Eliquis that day.
46 2021-04-07 numbness Patient reported numbness of the right side of face and right arm weakness 2 hours after receiving v... Read more
Patient reported numbness of the right side of face and right arm weakness 2 hours after receiving vaccine. Patient didn't take any medication for this occurrence. Symptoms went away after 45 minutes and then returned again on 4/8/2021. Pharmacist on duty recommended patient see a doctor on 4/8/2021
46 2021-04-07 numbness numbness in arm and shoulder, radiates down to fingers. pain in whole arm, not just localized to inj... Read more
numbness in arm and shoulder, radiates down to fingers. pain in whole arm, not just localized to injection site. injection site is worse though. have tried ice and tylonol
46 2021-04-07 pain in extremity arm pain; malaise; This is a spontaneous report from a contactable consumer. A 46-year-old male pati... Read more
arm pain; malaise; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, on 11Feb2021, as single dose for COVID-19 immunisation, at Workplace clinic. Patient's medical history and concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive Other medications in two weeks of vaccination. On 12Feb2021, the patient experienced arm pain and malaise. No treatment was received for the events. Patient was not diagnosed with COVID prior vaccination. Patient has not been tested for COVID post vaccination. Outcome of the events was reported as not recovered. Information on Lot/Batch number has been requested.
46 2021-04-07 unresponsive to stimuli, flushing Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventil... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Medium
46 2021-04-07 unresponsive to stimuli, flushing Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium
46 2021-04-08 flushing, unresponsive to stimuli Site: Pain at Injection Site-Medium, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: ... Read more
Site: Pain at Injection Site-Medium, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Tachycardia-Medium, Additional Details: PT HAD FLUSHING AT 9 PM HEADACHE AND PASSED OUT FRACTURING HIS MANDIBLE IN PROCESS. PT HAD ATRIAL FIBRILLATION PT IS IN STABLE CONDITION ON DILTIAZEM HAD NO HX OF HEART DISORDERS PRIOR TO VACCINE
46 2021-04-08 flushing Flushed and Tachycardic
46 2021-04-08 tingling patient admits to vagal response and passing out in past. few mins after vaccine became diaphoretic ... Read more
patient admits to vagal response and passing out in past. few mins after vaccine became diaphoretic and near syncopal. arrived to obs and placed in tredelenberg, bp 119/80 hr 58 rr 18 sats 98% on ra. offered snack and water, refused snack. few mins later, diaphoresis resolved. stretcher sat up, bp 123/78 hr 50 rr 18 sats 98% on ra; states baseline is bradycardic around 50's. sat up to side of bed with feet dangling, bp 116/81 hr 52, then 112/80 hr 58, then standing bp 104/70 hr 63, patient started to feel dizzy and needed to lie back down, once laying down bp returned to 123/81 hr 50. 5 mins later, sitting bp 118/81 hr 53, standing 111/75 hr 58, few mins of standing had bp 90/63 hr 57, tingling in fingers and dizziness, causing patient to need to lay back down. few mins later lying bp 109/69 hr 59 sitting bp 113/70, 114/79, 121/86. standing bp checks 121/87, 114/82, and stabilized with final bp at 117/83. no further s/s of issues or orthostatic hotn. escorted with spouse, who was driving, to exit with no issues.
46 2021-04-10 seizure, feeling cold After sitting in waiting room at 10:00, at 10:03 a.m. began to feel strange with a sort of coldness ... Read more
After sitting in waiting room at 10:00, at 10:03 a.m. began to feel strange with a sort of coldness and dizziness. Woke up on the floor with nurses around. Was told by nurses, I was convulsing and was placed on the floor by nurse. After several minutes paramedics arrived and checked all vitals and blood pressure.
46 2021-04-11 weakness, pain in extremity The day of the vaccine patient started feeling tired, and weak with arm pain . As the days went by ... Read more
The day of the vaccine patient started feeling tired, and weak with arm pain . As the days went by the patient started deteriorating and was feeling more tired and and weak and abdominal pain 4 days later patient decided to go to urgent care (March 4,2021) Patient was declined because he had Covid symptoms such as chills and fever. Patient instead got Covid tested, results came back negative. Abdominal pain that patient had was getting worse and fever and chills had not improved. On Monday March 8,2021 patient was admitted into hospital and underwent 2 surgeries. He also had 6-8 inches of his colon cut and was left with and Ostomy bag and will be needing a 3rd surgery in June. patient was released from the hospital Wednesday 24th, 2021
46 2021-04-11 pain in extremity Sore Arm and sore neck muscles starting at 1 o?clock am
46 2021-04-11 tenderness 11:55 p.m. day of vaccine woke up with severe chills, muscle aches heavy breathing. Under my left ar... Read more
11:55 p.m. day of vaccine woke up with severe chills, muscle aches heavy breathing. Under my left arm there is swelling and tender to the touch at that location. 22 hours after vaccination chills subsided, however fatigue, achiness, headaches, chills and swelling under left arm still remain. 38 hours after vaccination headache still persists, chills still come and go, swelling under left arm visible along with headaches
46 2021-04-12 flushing, feeling hot Patient began experiencing feeling hot and flushed approximately 10 minutes after injection. He fel... Read more
Patient began experiencing feeling hot and flushed approximately 10 minutes after injection. He felt it was similar to his anxiety attacks he had in past. He had multiple "waves" where he said he would feel anxious, his heart rate would increase. His vital signs remained stable. At 09:26 am, he had a tightness in chest and states he normally gets that with his anxiety. Site captain consulted and continued to monitor patient and vitals. At )9; 33 a.m. he had chest pressure, and tightness. Described the pressure was 'different' than his usual. EMS was called and recommended follow up at hospital since his father died of heart attack at age 38, and he has had no follow up with heart since he was in high school. Patient refused EMS transport but his wife said she would drive him to be evaluated. EMS loaded patient into private vehicle.
46 2021-04-13 weakness Symptoms: lethargic, exhausted, tired, sleepy, low energy, short of breath while talking, short of b... Read more
Symptoms: lethargic, exhausted, tired, sleepy, low energy, short of breath while talking, short of breath even with minimal physical activity , it's been 7 days since vaccine, unable to finish 8 hr shift at work
46 2021-04-14 pain in extremity Fever, aches, general malaise
46 2021-04-14 tingling Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Error: Shoulder Joint Injury (prol... Read more
Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.), Additional Details: Patient called to let the pharmacy knows that he has been feeling a lot of pain especially at the shoulder area since his shot on 4/5. He has been taking ibuprofen 800mg and it did not help with thre pain. He has a hard time putting his arm against the balcony at home. He reported that his symptoms are not getting better. I advise the patient to seek medical help from his primary doctor to assess his shoulder pain.
46 2021-04-14 unresponsive to stimuli, weakness Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhau... Read more
Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: difficulty walking had to call 911-Severe, Systemic: Nausea-Severe, Systemic: Weakness-Severe, Additional Details: per Nurse, pt developed severe vertigo and pt had developed weakness and lead to difficulty walking
46 2021-04-15 feeling hot hot, sweaty, room swirling. 1610 pulse 49, p ox 96%. No issues breathing. He was grey, felt faint, r... Read more
hot, sweaty, room swirling. 1610 pulse 49, p ox 96%. No issues breathing. He was grey, felt faint, room swirling; stated felt like would pass out. Leaning back in chair. Rapid response called; BP 98/60. 1615 Treatment/intervention : given epi 0.3 mg in R thigh. BP 100/70; feeling better; pulse up to 64, p ox 96%. Still grey, sweating. Able to drink water. 1630 Pulse 68; p ox 93-94%, with mask off 96%. Patient reports past history of reaction to flu vaccine; no allergies noted. Agreeable to be monitored in ED; got in wheelchair without dizziness; still grey.
46 2021-04-15 tingling Facial/mouth tingling of left mandibular area that started approximately 10 minutes after injection.... Read more
Facial/mouth tingling of left mandibular area that started approximately 10 minutes after injection. Client given Benadryl 50mg po x1 approximately 5 minutes after symptoms began. Client reported increased in facial/mouth tingling and complained of nausea. No vomiting. Client continued to report increasing symptoms of facial/mouth tingling which resulted in transport to the local ER. No notable external edema observed in facial area or otherwise.
46 2021-04-16 numbness, tingling, muscle spasms A 46 y.o. male who presents today with numbness in both legs, difficulty concentrating and forgetful... Read more
A 46 y.o. male who presents today with numbness in both legs, difficulty concentrating and forgetfulness, and cough with chest tightness. Covid symptomatic in November. Received Covid Pfizer vaccine on 4.13.21 at 1pm. Felt fine headed into the vaccine. He completed the observation period and felt chest tightness after about 5 minutes similar to Covid in November. He felt slightly better and went to work. At work his cough and chest tightness worsened. Very tired, unable to eat with no appetite. Extreme fatigue Wednesday sleeping most of the day. Cough and chest tightness and feeling he cannot catch breath like being submerged in a pool. On 4.15.21 his feet became numb and tingling bilaterally. He felt more confusion, forgetting what he was doing, left frozen food in the sink and unable to recall why. He is also having headache posteriorly 7-8/10 which began on 4.14.21. He reports headache is not common, now 3-4/10 and feels very similar to Covid in November. Does have some mild neck stiffness associated. Chest tightness almost identical to Covid in November. Reports numbness and tingling in the feet has been ascending in nature. He felt unsteady on his feet yesterday morning. He is having tingling and cramping in the bilateral calf muscles today. His cough continues with no phlegm. Comes in coughing spells with chest tightness. He also noted cough is worse with exertion. Fever 99.8 yesterday. No diarrhea. No loss of smell or taste. In ED noted to have right LE weakness. Wife reports that he seemed unsteady while walking Kept for observation. difficulty concentrating - back to baseline 4/17/21 at 3:26 pm assessment SOB: CTA thorax 4/16/21 unremarkable CT angiogram thorax Symptoms began approximately 5 minutes after his Pfizer. Reports that his cough and shortness of breath now seems to be improving. Continues to have some mild chest tightness, intermittent cough. Robitussin significantly helped. Extensive workup including CT angiogram of the thorax reveals no evidence for pulmonary embolism or infiltrate. COVID-19 PCR testing is negative x2, severe respiratory isolation has been discontinued. Patient has a negative D-dimer, LDH, ferritin, CRP. Cardiac troponin has been negative x2. Patient does have some wheeze, after cough, suggesting some bronchospasm. Will trial albuterol inhaler q.i.d.. Patient does report a history of what sounds like an environmental triggers asthma like event in the past, though reports that he has undergone evaluation for asthma and was told that he does not carry a diagnosis of asthma. Patient is currently on room air. I have reviewed the reported adverse reactions from the Pfizer vaccine and coughing shortness of breath are not listed. Continue supportive care, with Tessalon and Robitussin, IS
46 2021-04-16 pain in extremity Woke up on the second day with pain In right shoulder and right wrist and right hand areas. I origi... Read more
Woke up on the second day with pain In right shoulder and right wrist and right hand areas. I originally thought I slept on the shoulder wrong. The pain in the right wrist lasted for about 5 days. It has lessened through today but can still be achy. Shoulder pain persists. It is acute pain if I raise the shoulder while keeping elbow and hand parallel to the ground above shoulder height. I read today these symptoms could result from vaccination and the timing fits.
46 2021-04-16 tingling, burning sensation On 4/14/21 in afternoon I started to feel tingling in my feet and hands. The tingling in my feet pro... Read more
On 4/14/21 in afternoon I started to feel tingling in my feet and hands. The tingling in my feet progressed to intermittent burning and pain. Pain kept me awake Thursday and Friday nights. It appears to have started in just the tips of my toes and now I am having sensation up to my calves. I went to ER on Saturday morning where lumbar CT ruled out nerve impingement and lab tests for Lyme disease are still pending.
46 2021-04-16 tingling, pain in extremity Pfizer shot administered on 03/30 at vaccination center. Day 1 sore left Arm, Day 2 sore left Arm. D... Read more
Pfizer shot administered on 03/30 at vaccination center. Day 1 sore left Arm, Day 2 sore left Arm. Day 2 on 04/13 weeks after 1st shot headaches, joint and muscle pain. Sore throat and Covid Rapid Antigen Abbot Testing ministered on 04/16 . Results negative. Constantly joint tingling and some leg muscles felling sores.
46 2021-04-18 pain in extremity Patient received #2 of Pfizer COVID vaccine on 2/12/2021, reports that 2-2.5 weeks later he had bila... Read more
Patient received #2 of Pfizer COVID vaccine on 2/12/2021, reports that 2-2.5 weeks later he had bilateral leg pain + swelling. He was seen in hospital ER on 3/8/2021 and diagnosed with non occlusive dvt in distal fem vein of Right lower extremity
46 2021-04-18 trigeminal neuralgia, weakness On March 25, 8 days after the vaccine shot in my left arm, I began experiencing intense pain on the ... Read more
On March 25, 8 days after the vaccine shot in my left arm, I began experiencing intense pain on the left side of my neck and head. By March 28 the pain had become so excruciating I went to an Urgent Care facility and they sent me to the Emergency Room. While in the ER I had blood tests and a CT scan which all came back negative. I was given Oxycodone-Acetaminophen for the pain and prescribed Cephalexin in case there was some type of infection. They also ruled out Shingles. I continued to have pain and contacted my Primary Care Physicians Office and spoke with one of the Physician Assistants two times the next week. She prescribed Baclofen 10 mg and took me off the Cephalexin and put me on Amoxycillin because we thought the problem might have been an ear infection. The next week I spoke with my Primary Care Physician, and he believed I was suffering from Trigeminal Neuralgia, so he put me on Carbamazepine 200 mg twice a day. That same week, on April 9, I was finally able to meet with the Physician Assistant at the Neurologists office and she also believed I was suffering from Trigeminal Neuralgia. I continued to take the Carbamazepine daily and the Baclofen and Oxycodone-Acetaminophen as needed. On Monday April 12 I informed the nurses at the Neurologist office that I was experiencing several symptoms/side effects that included dizziness, weakness, difficulty swallowing and a pounding heartbeat. The nurses talked with the PA and the PA took me off the Carbamazepine and put me on Oxcarbazepine 150 mg twice a day and she prescribed Methylprednisolone 4 mg. On Thursday April 15 I began to have intense prolonged pain behind my left ear down to the neck and in the Trigeminal nerves in the forehead and top of the head on the left side. I was in so much pain I slept for less than 2 hours. The next morning, I vomited and went to the Emergency Room again. At the ER they treated my pain with a headache IV cocktail that included Ibuprofen, Benadryl, an anti-nausea medication, Fentanyl, and a steroid. Within an hour my pain level dropped from a 9 to a 3 and I was released. The ER prescribed Gabapentin 300 mg (3 times a day) which I started the evening of April 16. I have had less constant pain since leaving the ER and starting the Gabapentin, but I continue to have pain in the Trigeminal nerve areas and neck with some flare ups that reach a 7 out of 10 in pain. I am scheduled for an MRI on April 23 and a visit with the Neurologist on May 10.
46 2021-04-19 weakness fever, body aches, lack of energy
46 2021-04-19 bell's palsy Bell's Palsy
46 2021-04-19 flushing "Administered - 12:02 Adverse event started - 12:05 Patient had flushing/sweating, lightheadedness. ... Read more
"Administered - 12:02 Adverse event started - 12:05 Patient had flushing/sweating, lightheadedness. Worked night shift per patient. BP 90/48 (57) -- > 101/65 (73), HR 71 -- >73, RR 16 -- > 16, O2 99% -- > 100%. Provided VSS, water, crackers. Patient stable, released from vaccination site."
46 2021-04-19 pain in extremity Developed left arm pain and swelling after 1st vaccine in left shoulder. Persisted longer than previ... Read more
Developed left arm pain and swelling after 1st vaccine in left shoulder. Persisted longer than previous reactions. Found to have blood clot in left brachial vein on 4/15/21 on ultrasound after evaluation by me
46 2021-04-19 tingling, pain in extremity, numbness Diarrhea came two days after for four days. Sore arm. Head felt numb-ish, tingly on right side and s... Read more
Diarrhea came two days after for four days. Sore arm. Head felt numb-ish, tingly on right side and sore shoulder/arm. Then, small bumps on head and headache. Then, five days or later large bumps formed on head. Top of head, then moved to right side of head, lymph nodes and right side of neck swelling. Very severe head ache 7 days later. Emergency call to doctor and doctor visit. Bumps moving and forming in different areas side of vaccine. Face swelling. Throat swelling...all on right side.
46 2021-04-20 inability to speak Pt recieved 2nd dose of pfizer vaccine on 4/14. on 4/15 pt had fever up to 103. Pt has had ongoing ... Read more
Pt recieved 2nd dose of pfizer vaccine on 4/14. on 4/15 pt had fever up to 103. Pt has had ongoing fevers since. On 4/20 pt became confused and displayed s/s of stroke. Brought to hospital by EMS and evaluated for stroke like sx. Pt was treated for stroke- given TPA and placed in ICU. CT showed show evolving subacute infarct. Pt has word difficulty, confusion, diaphoresis. Currently still in ICU.
46 2021-04-20 numbness, tingling Shingles -- onset began with headache on 3/19, blister outbreak on 3/20, nerve tingling and numbness... Read more
Shingles -- onset began with headache on 3/19, blister outbreak on 3/20, nerve tingling and numbness on 3/23. Diagnosed per Dr. on 3/23 with shingles and prescribed VALACYCLOVIR HCL (1GM) and PREDNISONE (30MG) for symptoms.
46 2021-04-20 tingling THE PATIENT STARTED TO HAVE BLURRY VISION AT ABOUT 10 MINUTES AFTER VACCINE, THEN TONGUE IN ONE SPOT... Read more
THE PATIENT STARTED TO HAVE BLURRY VISION AT ABOUT 10 MINUTES AFTER VACCINE, THEN TONGUE IN ONE SPOT ON FRONT TINGLING, STARTED TO GET TINGLING ARM. BP TAKEN AND AT 151/111 AT 10:45 AM. CALLED 911, SQUAD TOOK PATIENT AT AMBULANCE AND LEFT PROPERTY
46 2021-04-21 weakness Pt was nervous before getting shot. After receiving shot he was in a monitor area. He raised hand ... Read more
Pt was nervous before getting shot. After receiving shot he was in a monitor area. He raised hand and stated he felt weak. He was pale and diaphoretic. Helped him to ground and allowed to rest. Felt better. Pt evaluated by paramedics. VS @ 1107 HR 68, OxSat 99%, BP 96/47. @1115 Sit in chair. BP 104/56, HR 70, OxSat 100%. @ 11:45 Pt ambulated w/o difficulty. Taking bus home. Told to call nurse when he arrives home.
46 2021-04-21 tenderness In my left armpit I experienced soreness and swelling. I first experienced this on Sunday, April 19,... Read more
In my left armpit I experienced soreness and swelling. I first experienced this on Sunday, April 19, 2021 around 8am. As of April 22, 2021 I still have the swelling. My lymph node in my left armpit is still tender to the touch.
46 2021-04-22 pain in extremity After two hours of putting the first dose, I experienced headache, pain in the joints of the feet an... Read more
After two hours of putting the first dose, I experienced headache, pain in the joints of the feet and hands, abdominal pain in the lower part of the back. A little fever at night and nausea. I took acetaminophen for the fever and the pain subsided quite a bit in my symptoms.
46 2021-04-22 tremor Body aches, joint pain, shaking, chills, cough, fatigue, shortness of breath on exertion
46 2021-04-23 weakness, feeling of body temperature change, burning sensation Pt became nauseated, c/o burning hot/cold, diaphoretic, head spinning, feeling weak. PB 170/100 lef... Read more
Pt became nauseated, c/o burning hot/cold, diaphoretic, head spinning, feeling weak. PB 170/100 left arm. Pt still symptomatic and was taken to Emergency Department.
46 2021-04-24 numbness Loss of hearing in left ear; tinnitus/echoing; numbness around area of left ear; This is a spontaneo... Read more
Loss of hearing in left ear; tinnitus/echoing; numbness around area of left ear; This is a spontaneous report from a contactable health care professional (patient). A 46-year-old male patient received the second dose BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: El3248), via an unspecified route of administration, administered in the left arm on 18Jan2021 as a single dose for COVID-19 immunization. Medical history included Hashimoto's disease, high cholesterol and is prediabetic all from an unknown date and unknown if ongoing. The patient has no known allergies. The patient did not have COVID prior to vaccintion and has not been tested for COVID post vaccination. Concomitant medications included empagliflozin (JARDIANCE); levothyroxine (manufacturer unknown); metoprolol (manufacturer unknown); rosuvastatin (manufacturer unknown) and fish oil (OMEGA 3 [FISH OIL]), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (lot number: Es1685) on 28Dec2020 at 12:00 PM via intramuscular route on the right arm for COVID-19 immunization. The patient experienced loss of hearing in left ear, tinnitus/echoing and numbness around area of left ear all on 22Mar2021 at 12:00. The ENT prescribed prednisone 10mg as treatment for the events. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a causal association between the reported events and BNT162B2 cannot 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 RAs, Ethics Committees, and investigators, as appropriate.
46 2021-04-26 flushing Client reported receiving Pfizer COVID 19 vaccine on 4/22/2021 in right arm. On 4/23/2021 starting h... Read more
Client reported receiving Pfizer COVID 19 vaccine on 4/22/2021 in right arm. On 4/23/2021 starting having body aches, dizziness, headache and filling flushed. On 4/24/2021 lip swelling started and now both lips, sides of mouth with clear blisters. Per Client, allergic to shellfish and no other known past medical history. Per Client has taken Benadryl and Ibuprofen, but symptoms are still presenting. PHN recommended that Client follow up with PCP, be seen at urgent care, ER and to call 911 with any respiratory concern or medical emergency. Client verbalized understanding information provided by PHN and plans to follow up and seek medical attention.
46 2021-04-26 pain in extremity Itching and discharge from right eye Pain in left calf (next day)
46 2021-04-26 pain in extremity Pain began this morning in groin on left leg. It now feels like I have severe (or at least what I as... Read more
Pain began this morning in groin on left leg. It now feels like I have severe (or at least what I assume it feels like) arthritis in my left hip. Hard to walk.
46 2021-04-27 feeling jittery After both shots. About 1-2 minutes after I started feeling nauseous, shaky, dizzy and then my heart... Read more
After both shots. About 1-2 minutes after I started feeling nauseous, shaky, dizzy and then my heart pounding out of my check for 30-40 seconds. My heart settled down and I was shaky and jittery the rest of the day.
46 2021-04-27 mild one side paralysis I started to have weakness on my left side around 9 hours after receiving the vaccine. I went to the... Read more
I started to have weakness on my left side around 9 hours after receiving the vaccine. I went to the hospital and was told I had a stroke in the right side of my brain from a clot in my brain, which they took the clot out using a catheter through my leg. I am currently undergoing rehabilitation at a rehab hospital.
46 2021-04-27 numbness Patient received his second COVID shot and waited the 15 minutes with no issues. He went out to his... Read more
Patient received his second COVID shot and waited the 15 minutes with no issues. He went out to his car and was about to drive off when he informed his wife that the side of his face felt a little numb. He had no other symptoms. His wife suggested he come back inside and ask what to do. Based on his symptoms, I asked him to have a seat for another 15 minutes to see how he felt. He was completely coherent. After checking on him again, he reported no change in symptoms. A few minutes later, around 12;45 pm, his wife said they would contact his doctor from the car. He left and I tried calling him around 4pm to ask how he was doing. I had informed him to contact his doctor, go to the ER if his symptoms worsened or stayed the same after a little while.
46 2021-04-27 tremor, migraine I received my second Pfizer COVID vaccine shot at 11:00 am. The first 12 hours after everything was... Read more
I received my second Pfizer COVID vaccine shot at 11:00 am. The first 12 hours after everything was normal and fine. I ate dinner and got ready for bed. But then, starting 12 hours after my shot, starting at 11:00 pm, I began to have severe chills and total body shakes. I was curled up into a ball under blanket, both freezing cold and profusely sweating. My breathing was very fast and I couldn't slow it down. My stomach was very upset and I was unable to eat anything. At 3:30 am, I got a severe Migraine which lasted until 6:00 am. I continued to feel very ill the whole rest of the day. Finally, around 9:00 am some 34 hours after syptoms began, they left me.
46 2021-04-28 weakness Patient received first dose of Pfizer vaccine and started to feel dizzy, weak, nauseous, and have sl... Read more
Patient received first dose of Pfizer vaccine and started to feel dizzy, weak, nauseous, and have slight chills about 5 minutes after receiving vaccine. Patient's symptoms were on and off. Blood pressure was taken and fluctuating. Paramedics were called per patient's request. Patient did not leave with paramedics and signed waiver. BP 1: 90/60 Pulse 1:104 BP 2: 124/86 Pulse 2:74 BP 3: 114/74 Pulse 3: 61 BP 4: 109/75 Pulse 4: 84
46 2021-04-28 discomfort, pain in extremity 46 year old male with history of depression, polio, HTN/HLD, chronic lung disease 2/2 remote PNA, a... Read more
46 year old male with history of depression, polio, HTN/HLD, chronic lung disease 2/2 remote PNA, and cirrhosis suspected 2/2 schistosomiasis, who presents with 1wk of dyspnea, w/ waxing waning subjective fevers. Per ED Note: Endorses chronic fatigue until 4/16 when he received first dose of Covid vaccine (Pfizer). Since then, pt reports persistent dyspnea, worsening fatigue. Reports 2 days of left-sided chest pain w/ periumbilical abd pain and enlarging abdomen. Pt believes these are 2/2 covid vaccination. Chest pain is described as constant generalized discomfort under left breast that worsens with pressure. Also worse with deep inspiration. No radiation or migration since onset. Pt describes abdominal pain as periumbilical tightness, "pain". Describes subjective, unmeasured fevers that "come and go" over last week. When asked to repeat the story of what happened on arrival to the unit, wife speaks for the patient since he is slightly dyspnic. States this morning, went to small clinic, husband had a headache and slight fever. Clinic said to come in to the big hospital. Fever and pain in legs and head, started a few days after he got the covid vaccine. The fever came and went. Didn't measure the fever. Also has some problems with Abdominal pain - doesn't know how to describe it. Feels like stomach ache. Stomach pain is getting better. Has since gone away since arriving to the hospital. He denies any cough, denies chills, denies nausea or vomiting. States he took some medications at home for constipation because he felt like he couldn't go. From the conversation it appears he does not take lactulose for HE, more for constipation. ED workup included an Xray, CT C/A/P with multifocal lung lesions suspicious for multifocal pneumonia. Lactate of 16. Na of 124. Noted to be anemic and thrombocytopenic. UA cloudy, pyuric, w/protien >100. Chest and abdominal pain resolved by the time pt was examined on the floor. Still tachypnic and tachycardic. Stated most bothersome was feeling anxious. Has anxiety at a baseline. Not complaining of any pain at the moment. Cannot describe chest pain in more detail, put his hand over the right side of his chest and presses on it but does not say if it hurt more when he would press on it, does not say it was reproducible. Not painful when he touches or presses on it now. Per chart, patient recently re-established care after long-time from follow up during pandemic. At visits last month c/o gingival bleeding, fatiguem & found to have Hgb drop from 13 in 2018-> 9.7 on 3/2/21. Referred for EGD but cancelled due to anxiety. I am the Infectious Diseases attending asked to see him for septic shock. He developed septic shock and respiratory failure requiring mechanical ventilation and 3 vasopressors. He has evidence of DAH, DIC, acute renal failure, progressive liver failure and he has Klebsiella pneumoniae bacteremia.
46 2021-04-28 face paralysis, bell's palsy Right side of face muscle nerve weakening. Got diagnosed with Bell?s Pallsey
46 2021-04-28 pain in extremity Regular pain feeling; Headache; Muscle pain; Calf feels tight, stiff, it feels like dead weight; Cal... Read more
Regular pain feeling; Headache; Muscle pain; Calf feels tight, stiff, it feels like dead weight; Calf feels tight, stiff, it feels like dead weight; Pain running up the right arm up to the shoulder/Calf pain; He asked if someone can tell him if it is a blood clot in the back of his calf; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm (shoulder) on 12Mar2021 10:07 (Lot Number: EN6202) as single dose for covid-19 immunization. There were no medical history and concomitant medications. The patient has no prior vaccinations within 4 weeks. The patient was not sick at time of vaccination. The patient reported that on 12Mar2021, he has been feeling the regular pain feeling, a headache, muscle pain before, it comes and goes. However, he said that the last few days (2021), there had been, by his calf muscle in the back there, they've been tightening, like stiffening up on him when he's sleeping. His calf feels tight, stiff, it feels like dead weight. It wakes him up at times. He also reported pain running up the right arm up to the shoulder on unknown date in 2021. He was just curious in terms of what that might be. He asked if someone can tell him if it is a blood clot in the back of his calf. The headache went away after 2-3 days. He also reported that his eyes also hurt a little bit and was the same time frame as the headache (onset date reported as 12Apr2021: after the second dose, pending clarification). He stated that those things were just mild, nothing major. He did not take anything for these. He confirmed he no longer had muscle pain. He just has pain behind the calf and right arm up to his shoulder. His calf pain, started to feel tight, started within the last 2- 3 weeks (2021). The arm pain in right arm up to shoulder started maybe within 2 days. The patient received the second dose on 02Apr2021. Outcome of the events muscle pain and headache was recovered in Mar2021, events pain running up the right arm up to the shoulder/Calf pain was not recovered, and outcome of other events was unknown.
46 2021-04-29 migraine Fever, chills, migraine
46 2021-04-29 pain in extremity Fever - 99 degrees F for about day and a half. Chills - about day and a half. Accelerated heart rate... Read more
Fever - 99 degrees F for about day and a half. Chills - about day and a half. Accelerated heart rate & skipped heart beats, i.e. arrhythmia - for about 7 days but improving each day. Terrible, splitting, constant headache - 2 days. Stuffy nose - 1 day. muscle pain, chest, both shoulders, arms - 4 days. Joints pain - 2 days. Pain in the lymph nodes - 2 days. Pain in the lower back around kidneys - 1.5 days. Fatigue - 3 days Nausea and stomach ache - could not eat protein of any kind, only bread and cheese for 4 days.
46 2021-04-29 unresponsive to stimuli, feeling hot I experienced mild fatigue and chills about 12 hours after the shot. No treatment necessary. I wok... Read more
I experienced mild fatigue and chills about 12 hours after the shot. No treatment necessary. I woke up at approx. 1:30 am feeling very warm. I got out of bed. While in the bathroom, I began to feel very lightheaded and passed out while I was washing my hands. My wife heard me crash to the floor. I returned to consciousness but passed out again while trying to stand, unresponsive to my wife. I returned to consciousness after about 1 minute. I stayed sitting for several minutes while my wife brought me some water. I felt thirsty and it's possible I was dehydrated, but I had been drinking fluids (water) the day before as normal. Due to the two fainting spells and a possible head injury, I went to the Emergency Room for treatment at approx. 2 am.
46 2021-04-30 numbness, tingling Numbness and Paresthesia bilateral feet and shins; Numbness and Paresthesia bilateral feet and shins... Read more
Numbness and Paresthesia bilateral feet and shins; Numbness and Paresthesia bilateral feet and shins; right lower extremity weakness; cough; shortness of breath; chest tightness; confusion; This is a spontaneous report from a contactable physician reporting for a patient. A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 13Apr2021 13:00 (Batch/Lot Number: EW0162) as SINGLE DOSE for covid-19 immunisation at 46 years old. Medical history included DJD cervical spine and Raynaud's Phenomenon from an unknown date. Concomitant medications included amlodipine taken for an unspecified indication, start and stop date were not reported. The patient experienced numbness and paresthesia bilateral feet and shins; right lower extremity weakness, cough, shortness of breath, chest tightness, confusion on 13Apr2021 13:15. Treatment included albuterol. The patient was hospitalized for the events on an unspecified date for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 antibody test (Nasal Swab): negative on 16Apr2021 and 17Apr2021, and blood test (SARS-CoV-2 antibody test) negative on 16Apr2021.Outcome of the events was recovered with sequelae (Recovered with lasting effects) on an unspecified date in 2021.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Based on the available information and the temporal association of BNT162B2 administration to the events, a possible contribution of the drug to the events 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
46 2021-04-30 pain in extremity calf feels tight, stiff, it feels like dead weight/started within the last 2- 3 weeks; calf feels ti... Read more
calf feels tight, stiff, it feels like dead weight/started within the last 2- 3 weeks; calf feels tight,; pain running up the right arm up to the shoulder; pain running up the right arm up to the shoulder/his calf pain, started to feel tight, started within the last 2- 3 weeks; He asks if someone can tell him if it is a blood clot in the back of his calf; his eyes also hurt a little bit; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 46-years-old via an unspecified route of administration, administered in arm left on 02Apr2021 (Batch/Lot Number: ER8734) as single dose for covid-19 immunisation. There was no medical history reported. There were no concomitant medications. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Mar2021 (lot number: EN6202) at the age of 46-years-old for covid-19 immunisation and experienced If it is a blood clot in the back of his calf, Regular pain feeling, Headache, Muscle pain, Calf feels tight, stiff, it feels like dead weight, Pain running up the right arm up to the shoulder and Calf pain, started to feel tight. The patient reported that he has been feeling the regular pain feeling, a headache, muscle pain before, it comes and goes on 12Mar2021. However, he says that the last few days there had been, by his calf muscle in the back there, they've been tightening, like stiffening up on him when he's sleeping on an unspecified date. It wakes him up at times. He also reports pain running up the right arm up to the shoulder on an unspecified date. He says he is just curious in terms of what that might be. He asks if someone can tell him if it is a blood clot in the back of his calf on an unspecified date. The headache went away after 2-3 days. He says his eyes also hurt a little bit on 12Apr2021 and was the same time frame as the headache. He says those things were just mild, nothing major. He did not take anything for it. He confirmed he no longer has muscle pain. He just has pain behind the calf and right arm up to his shoulder. He says his calf pain, started to feel tight, started within the last 2- 3 weeks. The arm pain in right arm up to shoulder started maybe within the last 2 days. The outcome of the events was unknown. Follow-up attempts completed. No further information expected.
46 2021-04-30 pain in extremity Low grade Fever; Arm so sore that you dont want to move it; Body Aches; Fatigue; Headache; Metallic ... Read more
Low grade Fever; Arm so sore that you dont want to move it; Body Aches; Fatigue; Headache; Metallic Taste in my mouth; Nasal Drip; Nasal Drip with Nausea; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8727) via an unspecified route of administration in the right arm on 30Mar2021 at 08:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included sarcoidosis from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in the 4-weeks prior to the COVID vaccine. Concomitant medications included atorvastatin, pantoprazole, fluticasone propionate (FLONASE), and cetirizine hydrochloride (ZYRTEC) all from unknown dates for unknown indications. The patient previously received morphine on an unknown date for an unknown indication and experienced drug allergy, and the first dose of BNT162B2 (lot number EN6208) on 09Mar2021 at 13:15 (at the age of 45-years-old) for COVID-19 immunisation. On 30Mar2021 at 08:45 the patient experienced low grade fever, arm so sore that you don't want to move it, body aches, fatigue, headache, metallic taste in their mouth, further reported as nothing tasted good yesterday (as of 31Mar2021), and nasal drip with nausea. No treatment was provided for the events. The outcomes of low-grade fever, arm so sore that you don't want to move it, body aches, fatigue, headache, metallic taste in their mouth, and nasal drip with nausea were not recovered. It was also reported the patient had not been tested for COVID since vaccination. No follow-up attempts are needed. No further information is expected.
46 2021-05-01 muscle spasms, pain in extremity Patient presented to the emergency department on 4/10 with a complaint of left leg pain. Patient re... Read more
Patient presented to the emergency department on 4/10 with a complaint of left leg pain. Patient reports onset of symptoms on Wednesday (4/7). He states that initially it just felt like a cramp in his calf. He states that over the past couple days, the pain has gotten significantly worse. He states the pain is now sharp and severe in nature. He states that he is having due to the severity of the pain. He states the pain is now moving up into his medial thigh. Patient states that around noon on 4/10, he began having chest pain and shortness of breath. Patient describes a tightness across his chest and states that he cannot breathe associated with this. Patient does have a history of asthma and states that he has had a couple of episodes like this in the past. Patient also reports a history of diabetes, hypertension. Patient does report a family history of coronary artery disease as well as a family history of blood clots. He received his Pfizer Covid vaccine 2nd dose on 4/9/2021 (Lot # ER8729) and 1st dose (Lot # EN6204) given on 3/12/2021 at an outside facility He does report arm soreness but is otherwise doing well. No recent travel. No recent immobilization. Upon evaluation in the ED, he was noted to have positive US for DVT in the LLE. Follow up CTA Chest was positive for bilateral lobar and segmental PE with right heart strain. CVM was consulted for possible PE intervention evaluation. Patient started on therapeutic Lovenox, but discharged home on 4/11 with Eliquis. . The next day 4/12/21 he returned to ED for SOB/Wheezing and LLE pain. On 4/15/21 he underwent EKOS, IVCF and iliac stent placement per Vascular surgery and subsequently sent home on Eliquis 4/16/21. Pt returned to the ER again 4/21/21 for recurrent SOB. CTA chest with no significant change in clot burden, no associated hypoxia.
46 2021-05-01 muscle spasms Red rash, tongue swelling, nausea, vomiting, diarrhea, muscle cramps, dizziness, fever, chills. Too... Read more
Red rash, tongue swelling, nausea, vomiting, diarrhea, muscle cramps, dizziness, fever, chills. Took Benadryl tablets about an hour after receiving the vaccine. Took Tylenol for the fever. Took some nausea medication during the night about 6 hours after receiving the vaccine to stop the vomiting.
46 2021-05-01 tremor Fever, body aches, shakes, body sweats, sore arm at the injection site
46 2021-05-02 tingling, myelitis transverse transverse myelitis - potentially related to immunosuppression from Humira, the herpes simplex virus... Read more
transverse myelitis - potentially related to immunosuppression from Humira, the herpes simplex virus or the vaccine (or combination of all 3). Sx included areflexia, bilateral paresthesia (legs and feet), double vision, cord damage from cervical region to conus of the cord. Also developed urinary retention.
46 2021-05-03 pain in extremity Within 5 minutes after receiving the shot, patient started having headache & heartache on and off fo... Read more
Within 5 minutes after receiving the shot, patient started having headache & heartache on and off for about 10 minutes. Patient also complaint about his throat/mouth was dry. 15 minutes after he started to have numbness around his mouth and on tip/ middle part of his tongue. Numbness lasted for about half an hour. That night he vomited and has chills. Next day he had very mild fever, pain in the right lung when he sneezed / coughed. He didn't have much symptoms on the 3rd day except for an sore arm and tireness.
46 2021-05-03 speech disorder I had a Stroke; Blood clot travelled to my brain; effected left side of my body; ability to speak; T... Read more
I had a Stroke; Blood clot travelled to my brain; effected left side of my body; ability to speak; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: ER 8729), via an unspecified route of administration in left arm on 10Apr2021 (at the age of 46-years-old) as single dose for covid-19 immunisation. The vaccination facility type was a pharmacy/drug store. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not have covid prior vaccination. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient had a stroke. Blood clot travelled to his brain and effected left side of his body and ability to speak on 15Apr2021 at 17:30. The events resulted to emergency room/department or urgent care, hospitalization for 3 days, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient received unspecified treatments for the event. Covid test post vaccination on 15Apr2021 with result of negative. The outcome of the events was recovering.
46 2021-05-04 night sweats This is a spontaneous report from a contactable consumer (patient's fiance). A 46-year-old male pati... Read more
This is a spontaneous report from a contactable consumer (patient's fiance). A 46-year-old male patient received the first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 18Apr2021 11:20 (Lot Number: EW0162) (received at the age of 46-years-old) as SINGLE DOSE for COVID-19 immunisation. Medical history included right knee pain. Concomitant medications were not reported. The patient received the Pfizer 1st shot 18Apr2021 11:20 am. On 19Apr2021, at midnight, he had low grade fever then swelling right leg. On the day of the report, 20Apr2021, he had swelling to both legs. The patient had taken ibuprofen as treatment beside propping legs up. The reporter wanted more information on the swelling and if it's related to taking ibuprofen. It was further reported that the patient experienced severe swelling from the knees down to the calves on both legs on 19Apr2021. He also experienced night sweats, fever, lightheadedness and dizziness on 19Apr2021. They want to know if there are any reports regarding the swelling side effects and if it is from the vaccine. The first dose of the vaccine was given 2 days ago (18Apr2021) and the second dose is due on 09May2021. The patient got his first shot on 18Apr2021 about 11:20am. After about 15 hours he developed swelling in one leg, she later clarified this to be his right leg, and now reports that both of his legs are swollen at the time of report (20Apr2021). She noted that patient told her his legs are not painful. She doesn't know if it's a blood clot or if they needed to go to the hospital. She also wanted to know if there is information about this as a side effects or if other people are having this too. She then reported that the patient started experiencing a fever, profuse sweating, and was spacey about 12 hours after the vaccine, a little after midnight 19Apr2021. She doesn't know if the dehydration made it worse. His fever was low-grade 99.8 degrees and lasted 4 and a half to 5 hours and has now resolved. When asked if patient received any treatment for fever, caller said it was so recent, and that was listed as a common side effect that goes away. Reported the patient drank fluids and she kept an eye on him. Leg swelling was about 15 hours after the vaccine, early morning 19Apr2021. She noted that the swelling in the right leg got bigger and didn't go down, but the left leg did. But today the left was more swollen and more prominent today. She further clarified that the patient takes ibuprofen for pre-existing right knee pain. Caller also reported that the patient propped his legs to alleviate the swelling, it has improved some but the swelling did not go away. The adverse events did not require a visit to the physician office or emergency room. Outcome of the event fever was resolved on 19Apr2021 (lasted 4 and a half to 5 hours); outcome of the event "severe swelling from the knees down to the calves on both legs" was not resolved; outcome of the remaining events was unknown.
46 2021-05-05 tingling Dizziness after 2nd shot. Also arms tingling after 1st dose 4/13/21 still not gone away.
46 2021-05-06 feeling hot SO I took the second dose on Tue around noon. Wed around noon I started feeling slight chills and sl... Read more
SO I took the second dose on Tue around noon. Wed around noon I started feeling slight chills and slight body ache. Slept it off until 7 pm . Thu around noon - more body ache about similar chills. Rest for a couple hours, slept it off for a couple of hours. Fri again around noon - similar body ache but significant uncontrollable chills. Body felt warm on and off through these periods noon to 7 pm. Treated with Tylenol (300) + advil (600). Some comfort, but that comfort seems to be lessening over the period. For example the uncontrollable chills today started concerning me. Tylenol took more than an hour to slightly lessen the chills. Had advil to see if that helps. As I write this chills seems to have subsided. But that feeling of warmth especially in the face has returned. Feel like placing a cold towel on the face. Weirdly enough its this noon to 7 pm time frame when the symptoms are at their worst and in any combination really any given day. Outside of that I function pretty well, almost normal! Its past 48 hours so thought I'd report.
46 2021-05-06 tenderness Baseball size lump in left arm pit. Very sore to the touch
46 2021-05-07 nerve pain, tingling On 4/14, had a series of rashes on left side of face - eye lid, eye brow, forehead and well into the... Read more
On 4/14, had a series of rashes on left side of face - eye lid, eye brow, forehead and well into the scalp. Following a visit to Dr, He confirmed this to be Shingles and referred me to the Ophthalmologist as the Shingles had affected eye surroundings. I have been prescribed and taking Valacyclovir, Gabapentin, and Prednisolone eye drops to treat the Shingles. Into week 3, Shingles rashes have all healed, blisters have all crusted out and cleared, however nerve pain continues in the head and around the eyes. The ophthalmologist suspects this to be post-Shingles effect, i.e., Postherpetic Neuralgia. My current condition results in Insomnia during various nights, and itchiness/tingling sensations, for which I have to apply cold/wet compress and Calamine Lotion to provide temporary relief. As a result of above following the 1st COVID vaccine, I have postponed my 2nd COVID-19 (Pfizer) vaccine to 5/22. However, my confidence level to proceed and get this 2nd vaccine on 5/22 is low at this time, until CDC is able to let me know whether there is a link between the COVID-19 vaccine and this causing Shingles in rare cases, to help me avoid a repeat of the stressful experience after the 1st COVID-19 shot. I would greatly appreciate a callback or an email.
46 2021-05-07 seizure, unresponsive to stimuli Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic:... Read more
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Additional Details: Pt apeared to have HTN crisis / seizure like aftivity 3 min after injection. Airway and then consiousness was lost with no breathing. EMS was called pt was assisted to floor and after opening airway and stimulation regained consiousness.
46 2021-05-08 bell's palsy I developed Bell's Palsy after receiving covid vaccine. No history of Bell's Palsy.
46 2021-05-09 difficulty speaking, weakness 4/6/21 called PCP office stating ?Patient called stating since his first COVID 19 vaccine he has had... Read more
4/6/21 called PCP office stating ?Patient called stating since his first COVID 19 vaccine he has had wheezing in his lungs, short of breath on exertion and productive cough. Voice also sounds "harsh" per patient. He has used his inhaler and it is not helping.? Nurse recommended Urgent care tonight. Patient agreed. 4/6/21 went to urgent care. CXR no acute airspace process. COVID-19 PCR: neg. Given Prednisone. Sent home 4/13 allergy appointment cancelled. 2nd vaccine 4/20/21 received. Reports difficulty breathing, dizziness and weakness and headache on survey. Calls Nurse triage 4/20/21 and reports extreme fatigue, headache, nausea, vomiting, and chills. Calls Nurse triage phone on 5/6/21 reporting shortness of breath, phlegm and cough. Recommended to go to ED. Went to ED.
46 2021-05-10 weakness diaphoresis, fevers, sinus congestion, body aches, headache, scratchy throat, cough, lack of energy
46 2021-05-10 bell's palsy classic right sided Bell's palsy with right sided weakness; This is a spontaneous report from a cont... Read more
classic right sided Bell's palsy with right sided weakness; This is a spontaneous report from a contactable Physician reporting for a patient (reporter's son.) A 46-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular, administered in the left arm on 04Apr2021 14:45 (Lot Number: ER8732) as a single dose (at the age of 46-years-old) for COVID-19 immunisation. Medical history included ongoing gout (controlled), and Bell's palsy from an unknown date (patient had Bell's palsy 13 years before). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included allopurinol (300 mg) at 300 mg from an unknown date for gout. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 12Apr2021 the patient experienced Bell's palsy. The patient started symptoms on 12Apr2021 and progressed to facial paralysis on 23Apr2021 which was finally diagnosed as Bell's Palsy. The Bell's Palsy is stable and has not improved much yet. Clinical course is as follows: on Monday, 12Apr2021 one and a half weeks after the vaccine the patient's symptoms began, he had minimal symptoms on 10Apr2021 and on 23Apr2021 he had facial paralysis and on that day he started treatment. On Friday (date not specified) the patient had facial weakness. The reporter considered the event non-serious. The reporter would like to know the post-marketing incidence of Bell's palsy and the reporter was trying to decide whether the patient (reporter's son) gets second dose of Pfizer Covid BioNTech Vaccine or forgoes it. Therapeutic measures were taken as a result Bell's palsy included treatment with high-dose prednisone and valicyclovir (VALTREX). The clinical outcome of the Bell's palsy was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The reporter stated that this (Bell's palsy) may be a random event or a related event. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between event Bell's Palsy 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.
46 2021-05-10 seizure, flushing, unresponsive to stimuli Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Medium
46 2021-05-11 facial pain, bell's palsy, numbness Right submandibular lymph node swelling, facial/ear pain (ongoing but getting better-antibiotics giv... Read more
Right submandibular lymph node swelling, facial/ear pain (ongoing but getting better-antibiotics given) Right facial numbness/droop diagnosed as Bell?s Palsy right side (ongoing)
46 2021-05-13 feeling hot, flushing Pt complain of feeling flushed and hot. A/Ox3. No acute distress noted. Given water w/gatorade pack... Read more
Pt complain of feeling flushed and hot. A/Ox3. No acute distress noted. Given water w/gatorade packect. Cold compress applied. Within 5 min pt stated he felt better. A/Ox3. Ambulated to lobby w/o difficulty.
46 2021-05-13 pain in extremity Red rash and itching on left arm went away after two days then 2 days later came back bigger and red... Read more
Red rash and itching on left arm went away after two days then 2 days later came back bigger and redder than before and lasted about 4 days. Has cleared up since. 1st day was very painful also.
46 2021-05-14 bell's palsy Diagnosed with Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 46... Read more
Diagnosed with Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on 23Apr2021 18:00 (at the age of 46-year-old) (Lot Number: EW0170) as single dose for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No 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 had not been tested for COVID-19. The patient was diagnosed with bells palsy on 04May2021 08:00. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of diagnosed with bells palsy, medication steroid and antiviral were used. Event outcome was not recovered.
46 2021-05-14 discomfort mental dullness; Severe fatigue; muscle aches; body heaviness; This is a spontaneous report received... Read more
mental dullness; Severe fatigue; muscle aches; body heaviness; This is a spontaneous report received from a contactable consumer reported for himself and a other healthcare professional. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EW0170) at left arm on 26Apr2021 13:00 at single dose for COVID-19 immunization in Hospital. Medical history and Concomitant medications were none. No Known Allergies. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. the patient did not receive within 2 weeks of vaccination. It was reported nothing that made him feel in danger. Severe fatigue, mental dullness, body heaviness, muscle aches, all on 27Apr2021, 06:00 AM. Received shot at 1pm. Bicycle ride that late afternoon. No side effects until next morning. Major effects lasted until about 2pm the next day. All was back to normal the following morning after a normal night's sleep. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has note been tested for COVID-19. No treatment received for the events. Outcome of the events was recovered on 28Apr2021. Batch/Lot number has been obtained. further information has been requested.
46 2021-05-16 mild one side paralysis Headache Muscle ache Fatigue Fever Left sided hemiparesis
46 2021-05-20 bell's palsy 10 days post vaccine patient was diagnosed with Bells Palsy at the local ER. No hospitalization req... Read more
10 days post vaccine patient was diagnosed with Bells Palsy at the local ER. No hospitalization required.
46 2021-05-20 night sweats A week after night sweats began. Persistent for 8 weeks. 6 weeks after the first symptoms of acute p... Read more
A week after night sweats began. Persistent for 8 weeks. 6 weeks after the first symptoms of acute pancreatitis began. I don't smoke or drink and meet none of the usual indicators for pancreatitis.
46 2021-05-20 tenderness, numbness I didn't get sick or tired, only sweating. Today I went to the bathroom and have a rash on my hip, i... Read more
I didn't get sick or tired, only sweating. Today I went to the bathroom and have a rash on my hip, its hard like with a bunch of spots on it and it hurts to touch. It feels like I got a shot in my hip and it's about the size of a 50cent piece and my leg feels a little bit numb under the skin. Its weird and hard to explain.
46 2021-05-21 weakness Flu like symptoms: Weakness, achy joints, fever of 102*F, chills, headache. Cough, and difficulty ta... Read more
Flu like symptoms: Weakness, achy joints, fever of 102*F, chills, headache. Cough, and difficulty taking deep breath. Sleepiness. Dizziness. Could not stand for long periods. Fever finally broke around 9pm. Chills turned to sweats. By 10:30pm, felling better, but still weak and joint aches. Went to bed, sweat most of the night.
46 2021-05-21 muscle spasms Almost fainting 3 minutes/Almost fainted/Really close to blacking out; Almost passed out; Nauseated/... Read more
Almost fainting 3 minutes/Almost fainted/Really close to blacking out; Almost passed out; Nauseated/Swirling strong nausea through the body up to the chest; Rapid heart rate; Hyperventilation; Labored breathing; 5-10 minutes before able to uncramp his hands; Waves of the feelings came throughout the day; This is spontaneous report received from a contactable consumer (patient). A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: ER8733), via an unspecified route of administration, administered in Arm Left on 15Apr2021 11:00 as single dose for covid-19 immunization. Medical history included sensitivities to ephedrine from an unknown date and unknown if ongoing. The patient had no concomitant medications. The patient experienced almost fainting 3 minutes/almost fainted/really close to blacking out, nauseated/swirling strong nausea through the body up to the chest, rapid heart rate, hyperventilation, labored breathing, 5-10 minutes before able to uncramp his hands, waves of the feelings came throughout the day, almost passed out/ really close to blacking out; all on 15Apr2021. The events were not required a visit to emergency room, nor physician office. Caller is a 47 years old patient who received the 1st dose of the Pfizer Covid vaccine on 15Apr2021. He complained of feeling nauseated, and rapid heart rate, with hyperventilation, and almost fainting 3 minutes after the 1st dose of the Pfizer Covid vaccine. This lasted approximately 15 minutes. 3 minutes after receiving a vaccine. He started to complaint about feeling nauseated. He started rapid heart rate which caused him to have hyperventilation and almost fainted. The episode last for 15 minutes and he just want to go and report it. Consumer confirmed it was the Pfizer Covid19 vaccine. The consumer wasn't still experiencing the side effects. They lasted to 5pm. I got my shot at 11am. The event was no longer persisting but he was wanting to understand the effect of the second shot, the consumer wasn't took any treatment for adverse event. Caller states that he is calling about the Covid Vaccine. Says with the first round of the vaccine he had an adverse event. He is looking to Pfizer and his doctor for some feedback to understand whether or not he should get the second dose. Says that about three minutes after the vaccine he felt a swirling, strong nausea throughout his body up to his chest. He had labored breathing and a really fast uncontrolled heart rate for about 5 minutes. States he was hyperventilating and almost passed out. He had to sit on the ground of the parking garage where he had gotten his vaccine. About 5-10 minutes later he was finally able to uncramp his hands. States that before the vaccine he was calm and not at all in an elevated state. States he is wondering about the second dose being stronger. He almost blacked out after the first dose. States it was close to the limit of what he could tolerate. States he needs further details. He was reading about clinical trials and some doctors. States that he did not have all the symptoms of anaphylaxis that they described. Says his symptoms lasted about 5 minutes or so. About 10-15 minutes later he was recovered. Says waves of these feelings came over him throughout the day. Says they decreased each time and ended that evening around 1700. Caller says he did not go to the Emergency Room when it happened. The nurses at the vaccination site attended him. At the end of the call the caller mentions that he has a sensitivities to ephedrine. States he does not take any Sudafed or Dayquil or anything like that. States he didn't know if that was relevant to mention or if anything like that is in the vaccine to make him have the response that he did. History of all previous immunizations with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. No prior Vaccinations (within 4 weeks). No family medical history relevant to events. No Relevant Tests. The outcome of events was resolved on 15Apr2021.
46 2021-05-22 facial paralysis, numbness Patient arrived to the Emergency Department today with facial droop and left sided facial/mouth numb... Read more
Patient arrived to the Emergency Department today with facial droop and left sided facial/mouth numbness and headache.
46 2021-05-22 flushing, pain in extremity Approx 27hrs after 2nd dose I felt my heart suddenly started irregular beats, arrhythmia with dizzy ... Read more
Approx 27hrs after 2nd dose I felt my heart suddenly started irregular beats, arrhythmia with dizzy feeling, flush on face which lasted a minute or 2 followed by very rapid / hard beating of my heart (I could see my shirt move on my chest from the beating). This lasted for almost 10 minutes. Very scary. Paramedics were called about 5 minutes into the episode. (I had a similar reaction of dizzy, flush with rapid and hard heart beat reaction after 1st dose about 5 minutes after it was given which lasted couple minutes then subsided). When the paramedics arrived, I was laying down in my bed trying to relax and breath. By then the rapid and very hard beating of heart was calming down but was still elevated pulse for a resting position...~128bpm. My BP was measured at 154/87. They connected the 12point electrodes and the reading came back normal...only elevated pulse. Paramedics ran 3 more scans during the 20 minutes they were there for...all came back normal. My O2 was 100%. I elected to no go to ER since we live only 2 miles from the local hospital and I was feeling much better by then...but would go if I had another heart episode. I have had none since. Only other strange side effects was sore arm for 2 day and I notice is constant ringing in my ears all the time...strange. I hope that will go away soon...very annoying.
46 2021-05-23 weakness A week after second shot: Intermittent 2 degree fever, lower back pain, tiredness, headache, weaknes... Read more
A week after second shot: Intermittent 2 degree fever, lower back pain, tiredness, headache, weakness, brain fog.
46 2021-05-23 numbness Facial numbness on and off for 10 days. Hands and Feet numbness approximately 9 days after injection... Read more
Facial numbness on and off for 10 days. Hands and Feet numbness approximately 9 days after injection. Chest pressure, including pressure into my back directly behind the heart and my left shoulder 9 days after injection. Went to the Emergency Room and had 3 EKGs, a chest x-ray, and blood work. Chest, Back, and Shoulder pressure continues on and off to this day - over one month since the injection.
46 2021-05-24 weakness Shortness of breath, heavy weight on my chest, feeling weak, needed to sit or lay down.
46 2021-05-24 pain in extremity PT GOT THE VACCINE ELSEWHERE: PT ALSO STATES, THIS IS HIS 2ND DOSE OF pziefer HE STATES HE HAD PAIN ... Read more
PT GOT THE VACCINE ELSEWHERE: PT ALSO STATES, THIS IS HIS 2ND DOSE OF pziefer HE STATES HE HAD PAIN ON BOTH LEGS AFTER A COUPLE OF HOURS OF THE VACCINE TODAY HE COMES IN WITH BOTH FEET SWOLLEN AND PAIN
46 2021-05-28 weakness, fibromyalgia Full Fibromyalgia flare up. Extreme Pain over 10 on 1-10 scale. Incapacitated. I feel this should ... Read more
Full Fibromyalgia flare up. Extreme Pain over 10 on 1-10 scale. Incapacitated. I feel this should have be told. Especially for other people with the condition.
46 2021-05-28 pain in extremity I only slept 1 hour; My arm, head and back hurt.; My arm, head and back hurt.; My arm, head and back... Read more
I only slept 1 hour; My arm, head and back hurt.; My arm, head and back hurt.; My arm, head and back hurt.; Dry mouth; coughing; random thoughts; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 15May2021 12:00 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 15May2021 12:15, the patient only slept 1 hour, his arm, head and back hurt. Dry mouth, coughing, random thoughts. He felt like he was dying over here. Events were considered serious, disability. No treatment was received for the events. 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. There were no other medications the patient received within 2 weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
46 2021-05-30 feeling cold, pain in extremity Dizziness....tired....soar arm......chills.......low grade fever
46 2021-05-31 migraine Headaches, Migraines, Chills
46 2021-05-31 pain in extremity everything hurts; Ache; her husband said this morning he had a bad headache; her husband said his sk... Read more
everything hurts; Ache; her husband said this morning he had a bad headache; her husband said his skin was feeling tight this morning; injection site pain after receiving the COVID-19 Vaccine yesterday; Her husband developed an itchy, red, rash on his abdomen & shins about 2 hours after receiving his 2nd COVID-19 Vaccine. She said the rash is red, raised bumps. was reported as worsened; he has a charley horse-type pain in his left arm; he has a charley horse-type pain in his left arm; her husband said he got itchy immediately after receiving his COVID-19 Vaccine yesterday; Her husband developed an itchy, red, rash on his abdomen & shins about 2 hours after receiving his 2nd COVID-19 Vaccine. She said the rash is red, raised bumps; Her husband developed an itchy, red, rash on his abdomen & shins about 2 hours after receiving his 2nd COVID-19 Vaccine. She said the rash is red, raised bumps; her husband had red, raised hives on both sides of his abdomen, and both his shins; She said her husband said his skin burned really bad; her husband said he got itchy immediately after receiving his COVID-19 Vaccine yesterday was reported as worsened; This is a spontaneous report from a contactable consumer. This consumer reported for a 46-years-old male patient (husband) received Second dose (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: EN5318) on 12Jan2021 at 1:00PM (at the age of 46 years) on unspecified route in the left arm as a 2nd dose, single for COVID-19 Immunization. Medical history included ongoing Psoriasis, her husband doesn't have any allergies, except for Penicillin. Concomitant medications were not reported. The patient previously took her first dose on 12Jan2021 between 1:00-2:00PM (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: EL3302) on unspecified route in the left arm as a 1st dose, single for COVID-19 Immunization and also experienced Injection site pain, got itchy immediately, a week after her husband received his first COVID-19 Vaccine dose, he said he felt so bad, her husband said he felt run down a week after he received his first COVID-19 Vaccine dose, Rash. On 02Feb2021 patient experienced her husband said he got itchy immediately after receiving his COVID-19 Vaccine yesterday was reported as worsened, Her husband developed an itchy, red, rash on his abdomen & shins about 2 hours after receiving his 2nd COVID-19 Vaccine. She said the rash is red, raised bumps, her husband had red, raised hives on both sides of his abdomen, and both his shins, he has a charley horse-type pain in his left arm, her husband said his skin was feeling tight this morning, on 03Feb2021 her husband said this morning he had a bad headache, everything hurts, Ache, her husband said his skin was feeling tight this morning. On Feb2021 she said her husband said his skin burned really bad. Reported her husband had the same experience after he received his first COVID-19 Vaccine dose on 12Jan2021, clarifying her husband said he got itchy immediately after receiving the COVID-19 Vaccine. She said her husband has had psoriasis for a long time. She said her husband has had psoriasis outbreaks before, but not in that area of his body. She said her husband usually has a psoriasis outbreak at his waist where his belt buckle is located, as well as, his elbows, and knees. And her husband didn't think anything of his itchiness and rash after he received his first dose of the COVID-19 Vaccine because he has a history of psoriasis. She said the rash he developed after his first COVID-19 Vaccine dose went away. Reported her husband used (Name) soap and Calamine lotion for the hives and rash on his abdomen and both his shins. She said the rash went away after 2-1/2 weeks. She clarified her husband bathed with Ivory soap, Clean Body Wash (Lot Number: 90845395GC, Expiration Date: Unknown) and applied Calamine lotion to his rash. She said he used the Calamine Plus Itch Relief pink-colored Calamine lotion (Lot Number: A49014, Expiration Date: 2023) only one day and then switched to the clear Calamine lotion with Pramoxine HCL 1% and Zinc Acetate 0.1% (Lot Number: A60023, Expiration Date: Sep2024), so he wouldn't stain his work clothes. Reported her husband told her when the itchiness and rash came back after he received his second COVID-19 Vaccine yesterday that he thinks he is allergic to the COVID-19 Vaccine and also her husband's rash is on both sides of his left and right upper abdomen, between his ribs and hips, and on both his left and right shins. Reported a week after her husband received his first COVID-19 Vaccine dose, he said he felt so bad, and felt run down. She said he was told at that time what to expect after receiving the COVID-19 Vaccine, and after a couple days he was OK. Reported today her husband said he can't move, and that everything hurts, and that he is achy. She said her husband's breathing is OK, so he is not having an anaphylactic reaction. She said her husband said his left arm was so painful with the first COVID-19 Vaccine dose, that he said couldn't put on his shirt. Reported her husband told her he doesn't want to go to the doctor. She said she told him he needs to see the doctor so he can have an allergy panel done. her husband has the bad rash at his waist, so his pant's are touching his waist, and it is uncomfortable. She said her husband said his skin is itching and burning at the same time. She said it wasn't until after receiving his second COVID-19 Vaccine dose that he made the connection with the itchiness and rash he had after receiving his first COVID-19 Vaccine dose. Reported they changed the filter for their showerhead in the bathroom to make sure it wasn't their public water causing the itchiness and rash and looked online for the Pfizer COVID-19 Vaccine ingredients and were confident in taking the COVID-19 Vaccine. She said the CDC had listed that a person can have hives and reactions like the itching and rash. The clinical outcome of the events her husband said this morning he had a bad headache, injection site pain after receiving the COVID-19 Vaccine yesterday, he has a charley horse-type pain in his left arm, her husband said his skin was feeling tight this morning, her husband said he got itchy immediately after receiving his COVID-19 Vaccine yesterday was reported as worsened, Her husband developed an itchy, red, rash on his abdomen & shins about 2 hours after receiving his 2nd COVID-19 Vaccine. She said the rash is red, raised bumps. was reported as worsened, She said her husband said his skin burned really bad were unknown. However, the outcome of the rest all events were not recovered.
46 2021-06-01 tremor, numbness, muscle spasms, tingling Spasms in hands and feet/spasms in his feet was a weird sensation like little explosions going off, ... Read more
Spasms in hands and feet/spasms in his feet was a weird sensation like little explosions going off, like a nerve issue, around feet, toes, and ankles; Both hands went numb; Both hands went numb and were tingling quite a bit and the next day when he woke up it was worse; He is having the tremors around ankles and feet; It is very uncomfortable and has not been able to sleep well because of it.; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0183), via intramuscular route administered in left arm (left shoulder as reported) on 17May2021 (age 46-year-old at time of vaccination) (in noon as reported) as single dose for preventative/COVID-19 immunisation. Medical history included had an allergy to penicillin and that was when he was a child, he thinks he had a rash. He does not know if he was still allergic. Prior Vaccinations (within 4 weeks) were none. Concomitant medications were none. It was reported that the evening after getting the first shot on 17May2021, both hands went numb and were tingling quite a bit and the next day when he woke up it was worse. On the third day after getting the shot he started getting and was still have spasms in hands and feet on 20May2021. The spasms in feet was a weird sensation like little explosions going off, like a nerve issue, around feet, toes, and ankles, stated it was also in his hands but not quite as much in hands. He still has numbness and tingling in hands and fingers. It was worrisome since he was an artist and paints. It is hard to paint with numbness and tingling. The numbness and tingling has stayed the same but there are periods of it getting intense from time to time, it has not subsided. He was hoping it would only last 2 or 3 days. As he was talking, he was having the tremors around ankles and feet in 2021. It was very uncomfortable and had not been able to sleep well because of it in 2021. The spasms are still the same, if anything they have worsened. No treatment received for events. The outcome of events tremor and insomnia was unknown and for remaining events was not recovered. Follow up needed, further information has been requested.
46 2021-06-02 weakness Initial discomfort subsided within 24hr (Sx pain, fever and fatigue). Tx was ibuprofen 800 and hydra... Read more
Initial discomfort subsided within 24hr (Sx pain, fever and fatigue). Tx was ibuprofen 800 and hydration. Lingering side effects, 1. I am an avid jogger/runner (5k and 10k and 13.1 miles). Since the vaccine was taken, I have not been able to run at the previous rate. Cannot complete a single mile without having to stop and massage legs muscles and stretch the joints. The week prior to the second dose I was running 4 miles every other day and a long distance run weekly. Also have not been able to complete my normal weight training routine. Arm, chest and back muscles shot in pain doing a previous dominate routine. example, from doing a 100 repetitions with 25pounds dumber, I cannot do 20 repetitions with 15 pounds dumber without having to stop in pain. To be able to run, take pain killers and rub muscles with pain relieving creams before a run. 2. Fatigue, without changing diet or sleep habits, raising from the bed is hard. Feel weak and struggle to get out of bed. Not mental health issues, just physical weakness.
46 2021-06-03 night sweats Night sweats; chills; Tired; This is a spontaneous report from a contactable consumer (Patient). A 4... Read more
Night sweats; chills; Tired; This is a spontaneous report from a contactable consumer (Patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Brand: Pfizer), dose 1 via an unspecified route of administration, administered in Left Arm on 03Mar2021 12:45 PM (Batch/Lot Number: EN6205, Lot unknown: False) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included High blood pressure, High heart beat rate. Facility type vaccine: Other, Facility type vaccine other: Vaccination Center. Known allergies: No, Other medical history: High blood pressure, high heart beat rate. There were no concomitant medications. If other vaccine in four weeks: No. The patient experienced night sweats (non-serious) on 05Mar2021 02:00 am, chills (non-serious) on 05Mar2021 02:00 am, tired (non-serious) on 05Mar2021 02:00 am. Adverse event: Night sweats and chills 36 hours after taking the vaccine. Tired up to 48 hours after taking the vaccine. Adverse event country: US. If patient recovered: Recovered. If treatment ae: No. If covid prior vaccination: No. If covid tested post vaccination: No. Explicit consent: Yes. For all events, outcome was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.
46 2021-06-03 tingling stiff joints, jaw pain, arms tingling,
46 2021-06-04 tingling facial tingling on the right side of face, largely cheek bone to jaw bone and only to right side of ... Read more
facial tingling on the right side of face, largely cheek bone to jaw bone and only to right side of face and to this day still with this sensation; This is a spontaneous report received from a contactable consumer (patient him-self). A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection and Lot Number: ER8729) via an unspecified route of administration in Arm Left on 13Apr2021 (at the age of 46-year-old) as single dose for COVID-19 immunization. The patient medical history was reported as none. The patient's concomitant medications were not reported. It was reported as patient received his only dose on 13Apr2021 and about an hour after dose started facial tingling on the right side of face, largely cheek bone to jawbone and only to right side of face and to this day still with this sensation. Patient stated that some days pretty mild and some pretty severe. Not numbness but he has a feeling and has sensation and it hasn't left but states it is on his right side. He says some days are mild and other days more pronounced and it moves around face. Sometimes in cheek bone and other is jaw and always on the right side. Patient visited physician office. Lab data includes on 04May2021 he had tests and he was told that he didn't have any allergies. On 26May2021 he had MRI and he pretty much ruled out anything neurological. On an unspecified date he went through some tests a cause hasn't been identified as to why he is having symptoms. Outcome of event was not recovered.
46 2021-06-06 muscle twitching, tingling, numbness tingling hands, went numb, nerve twitches hands and feet,
46 2021-06-07 facial paralysis, bell's palsy Bell?s Palsy, right side of face is paralyzed, severe pain around and behind right ear.
46 2021-06-07 pain in extremity He started having chest pain and shortness of breath. Arm was sore and felt lightheaded. Blood press... Read more
He started having chest pain and shortness of breath. Arm was sore and felt lightheaded. Blood pressure increased. So he went to the hospital. They did chest x-rays and lab work. Monitored for about four hours for blood pressure. Gave him an IV.
46 2021-06-08 feeling hot Passed out; Warm sensation; Sweating; This is a spontaneous report from a contactable consumer, the ... Read more
Passed out; Warm sensation; Sweating; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 01Apr2021 (at the age of 46-year-old) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. On 01Apr2021 (10 mins after receiving the vaccine), the patient passed out, had warm sensation and sweating. Patient was later transported to medical centre. Outcome of the events was unknown. Information on the lot/batch number has been requested.
46 2021-06-08 pain in extremity blood clot in his leg; swelling in his leg; sore arm; his muscle aches; didn't dilute it and he's re... Read more
blood clot in his leg; swelling in his leg; sore arm; his muscle aches; didn't dilute it and he's received 6 times over the amount; didn't dilute it and he's received 6 times over the amount; Diarrhea; real tired; his blood pressure was real high; breathing problems; This is a spontaneous report received via a Pfizer-sponsored program. A contactable consumer reported that a 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) via an unspecified route of administration on 20Apr2021 (at the age of 46-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Apr2021, patient experienced diarrhea, was real tired and his blood pressure was real high. It was also reported that the vaccine wasn't diluted and the patient received 6 times over the amount on 20Apr2021. On an unspecified date, patient had sore arm and his muscles ached. On Apr2021, patient had breathing problems and was treated with breathing treatments three times a day and was put on steriods and inhalers. On May2021, patient had a lab work that confirmed that he had a blood clot in his leg, which has worsened because he has some swelling in his leg, the same leg that they found the blood clot in. The patient was hospitalized for the event blood clot in his leg and was given blood thinners. The patient underwent lab tests and procedures which included CAT scan of head and lungs both with unknown results on May2021. Outcome of the events blood clot in his leg, swelling in his leg and breathing problems was not recovered while outcome of all other events was unknown. Information on the lot/batch number has been requested.
46 2021-06-09 weakness fever; chills; vomiting; weakness; headache; cough; trace- pleural effusion; who received the entire... Read more
fever; chills; vomiting; weakness; headache; cough; trace- pleural effusion; who received the entire vial of the undiluted Pfizer COVID vaccine; received the entire vial of the undiluted Pfizer COVID vaccine/The entire vial was administered all 6 doses in the right deltoid; This is a spontaneous report from a contactable nurse and a physician. The nurse reported similar events for two patients. This is one of the two reports. Only this case is serious. A 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 46 years old, administered in right deltoid on 12May2021 (Lot Number: EW0168; Expiration Date: Aug2021) at single dose for COVID-19 immunization. Medical history included ongoing CRD on hemodialysis since 25Sep2017, ongoing Polycystic kidney, ongoing HTN, ongoing Brain aneurysm, ongoing GERD, ongoing Seizure disorder; Fever, nausea, vomiting, sepsis, Secondary hyperparathyroidism. Family history included Polycystic kidney disease- brother/father/uncles. Concomitant medications included ongoing allopurinol, ongoing paracetamol (TYLENOL), ongoing amlodipine, ongoing cholecalciferol, hydralazine, metoprolol, vitamins nos (MVI), phenytoin. Historical Vaccine included first dose of BNT162B2 on 21Apr2021 (Lot number ER8736, Expiration date Jul2021) at the age of 46 years old, administered in right deltoid for COVID-19 immunization. The nurse reported a medication error for two patients who received the entire vial of the undiluted Pfizer COVID vaccine on 12May2021. The entire vial was administered all 6 doses in the right deltoid. The reporter did not provide specific signs and symptoms. They were in their care after the vaccine was given for an hour and was sent home. They were instructed for any signs and symptoms to report to ER immediately. The patient also experienced fever/chills, vomiting, weakness, headache and cough, all on 12May2021 which were caused emergency room visit and hospitalization from 13May2021 to 15May2021 with treatment unknown. Lab data included CXR on 13May2021 with result: trace- pleural effusion. The outcome of the events were unknown. Follow-up (25May2021): new information received from a contactable physician included: new reporter-physician added, medical history and concomitant medications added, lab data added, vaccination on 12May2021 is updated as second dose and Historical Vaccine with first dose of BNT162B2 added, new events "fever/chills, vomiting, weakness, headache and cough, trace- pleural effusion" added and case upgrade to serious. No follow-up attempts are needed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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) : US-PFIZER INC-2021540031 Same reporter/product, similar events, different patient
46 2021-06-10 numbness, tingling Bad headache on Left side of head where ear is toward the back. Confusion, Dizziness, , Light headed... Read more
Bad headache on Left side of head where ear is toward the back. Confusion, Dizziness, , Light headed, Tingling and numbness from left eye to jaw. Drooping of left eye and lips. Memory and processing information issues. One month later still some head pain off and on and numbness around left eye. Still have memory and processing issues. I've never had any other prior issues with the head or face. No falls or activities such as boxing
46 2021-06-11 tremor The patient began shaking and had trouble standing. Had shortness of breath and was very pale.
46 2021-06-12 nerve injury, numbness Mr arm And injection site hurt for a few days and then from that spot my arm got numb and the pain s... Read more
Mr arm And injection site hurt for a few days and then from that spot my arm got numb and the pain spread to my chest on the left side. It felt like nerve damage and felt like when an arm falls asleep And starts to awake. My family worried I was having chest issues and went to Urgent Care for a ekg which was fine. I knew it was from the shoe because the pin spread from the injection site and my left arm and chest felt numb and like nerve issues. It?s not a month later and I still can feel the nerve issues but not as bad. Went to doctors and waiting on blood work . Maybe an autoimmune Response since I have an auto immune condition?
46 2021-06-12 numbness and pain in extremities Peripheral neuropathy on right Indra finger and right elbow
46 2021-06-13 cold sweat Patient was waiting in our observation area when he began to experience dizziness, cold sweats and t... Read more
Patient was waiting in our observation area when he began to experience dizziness, cold sweats and tunnel vision. He lay down on the floor, and our technician asked him if he was OK. I immediately went out to him, and he told me he was already feeling better. I had him put his feet up on the chair, and he told me that he thought this reaction was due to anxiety. He was talking and breathing normally. I offered to check his blood pressure and get him some water, but he declined. He rested on the floor for approximately 5 minutes and then said he was feeling well enough to go.
46 2021-06-13 facial paralysis, tingling Patient is a 46 year old male who admitted to hospital for Facial nerve palsy. Patient felt with lef... Read more
Patient is a 46 year old male who admitted to hospital for Facial nerve palsy. Patient felt with left sided facial droop and tingling sensation for 2 days. He reported symptoms onset at 1330 on 6/10/2021 while driving a truck. He also had left sided occipital headache and rested for 1 hour. His symptoms improved after the nap but never resolved completely. He got into a location and rested there for 1 night. In the morning after waking up he was having difficulty chewing food on his left side. He called EMS and was brought to hospital. While in the ED, he received workup including CT Head W/O, CTA Head/Neck with perfusion scan that were all negative. Other labs obtained included BMP, CBC, Troponin x1, Coag studies & CXR which were largely unremarkable. Neurology were called for stroke alert and given ASA 325mg and ordered MRI. Patient's MRI was unremarkable for stroke or masses. He was started on Prednisone 40mg once daily for Facial Nerve Palsy. He was seen by physical therapy and occupational therapy, they recommended him go home to family. His symptoms improved after therapies were initiated but are not completely resolved. Patient will continue taking his home medications per his primary care doctor. He will complete a 7 day steroid course, has 3 days remaining. He will take Acyclovir 5 times per day for 10 days. We also gave him lubricating eye drops since he continues to have difficulty closing his left eye. He spends a lot of time outdoors and works with horses. He reports getting tick bites before in his body but never noticed a rashes. He has never received treatment for Lyme Disease. He is a long-haul truck driver and has driven all around. He reports walking in wooded areas when he stops in the rest area. We obtained Lyme Titers, which were eqivocal for IgM and negative for IgG. Western blot was ordered to rule out Lyme disease. He should followup with PCP for treatment if he is positive. We will call him with results when available. Of note he received Pfizer 2nd COVID vaccine on 6/9/21 (LOT #EW0178). He reported fever and diarrhea that night and next morning. He then reports having presenting symptoms after 7 hours of driving. We also believe the cause of his facial nerve paralysis could have been a side effect of his vaccination.
46 2021-06-13 numbness, burning sensation, discomfort, tingling Slight pins and needles feeling on left side of body from neck to top of left knee a few hours after... Read more
Slight pins and needles feeling on left side of body from neck to top of left knee a few hours after 2nd dose of vaccination. Over the course of days, the discomfort only occurs in left hand thumb, index and middle finger. 3 weeks later, the numbness is only on index finger tip of left hand. About 4.5 weeks later(June 14th), the burning sensation still persist only on left hand index finger tip. Have no history of carpal tunnel.
46 2021-06-23 numbness Facial Numbness, partial swelling to nose, upper lip, cheeks ( Dr. Visit Tested for Herpes - Negativ... Read more
Facial Numbness, partial swelling to nose, upper lip, cheeks ( Dr. Visit Tested for Herpes - Negative Possible Lupus)
46 2021-06-24 weakness her husband said he got itchy immediately after receiving his first COVID-19 Vaccine; She clarified ... Read more
her husband said he got itchy immediately after receiving his first COVID-19 Vaccine; She clarified her husband's rash is on both sides of his left and right upper abdomen, between his ribs and hips, and on both his left and right shins; a week after her husband received his first COVID-19 Vaccine dose, he said he felt so bad; her husband said he felt run down a week after he received his first COVID-19 Vaccine dose; Injection site pain; This is a spontaneous report from a contactable consumer (patient's wife). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302, Expiration date: Not reported) via an intramuscular route of administration, administered in Arm Left on 12Jan2021 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included ongoing psoriasis, Allergic to penicillin. The patient's concomitant medications were not reported. It was reported that her husband had the same experience after he received his first COVID-19 Vaccine dose on 12Jan2021, clarifying her husband said he got itchy immediately after receiving the COVID-19 Vaccine. She said her husband has had psoriasis for a long time. She said her husband has had psoriasis outbreaks before, but not in that area of his body. She said her husband usually has a psoriasis outbreak at his waist where his belt buckle is located, as well as, his elbows, and knees. She said her husband doesn't have any allergies, except for Penicillin. She said her husband didn't think anything of his itchiness and rash after he received his first dose of the COVID-19 Vaccine because he has a history of psoriasis. She said the rash he developed after his first COVID-19 Vaccine dose went away. She clarified her husband's rash is on both sides of his left and right upper abdomen, between his ribs and hips, and on both his left and right shins. She said a week after her husband received his first COVID-19 Vaccine dose, he said he felt so bad, and felt run down. She said he was told at that time what to expect after receiving the COVID-19 Vaccine, and after a couple days he was OK. She said her husband said his left arm was so painful with the first COVID-19 Vaccine dose, that he said couldn't put on his shirt. The outcome of the events was recovered on Jan2021. Follow-up attempts are completed. No further information is expected.
46 2021-06-24 feeling of insects crawling on skin PATIENT CLAIMED HE WAS ITCHY, HAD METALLIC TASTE, SKIN CRAWLING, NAUSEA AND SWEATING INSTANTLY AFTER... Read more
PATIENT CLAIMED HE WAS ITCHY, HAD METALLIC TASTE, SKIN CRAWLING, NAUSEA AND SWEATING INSTANTLY AFTER RECEIVING VACCINE. AMBULANCE WAS CALLED BUT HE REFUSED TO BE TREATED AND LEFT UNDER HIS OWN POWER.
46 2021-06-24 numbness Pt also had the TDap vaccine on 4/19/2021 Pt started to have abd pain on 4/22/2021. Pt pain became ... Read more
Pt also had the TDap vaccine on 4/19/2021 Pt started to have abd pain on 4/22/2021. Pt pain became worse despite treatment and then started to have lower ext wkness and numbess and unable to walk. Pt also had loss of hearing Diagnosed with Guillain Barre syndrome while in the hospital by a neurologist
46 2021-06-26 flushing Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Patient reported extreme dizziness and light headedness; found on floor in waiting error. Remained conscious the entire time. Improved with water and cold compress. Called 911 but by the end of conversation patient was up and moving, no need for them to respond.
46 2021-06-26 unresponsive to stimuli Systemic: Fainting / Unresponsive-Severe
46 2021-06-27 pain in extremity pain in arm and muscles since date of injection until current date. unable to walk properly. unable ... Read more
pain in arm and muscles since date of injection until current date. unable to walk properly. unable to use arms properly.
46 2021-06-28 tremor chills and uncontrollable shakes, no fever initially; within a few hours temp was 101.6; cultures an... Read more
chills and uncontrollable shakes, no fever initially; within a few hours temp was 101.6; cultures and labs showed urinary tract infection; sensitivities showed resistant to rocephin and ceftin; bactrim didn't prove strong enough; improvement finally began with levaquin; fever persisted 8 days; ibuprofen was required around the clock
46 2021-06-30 numbness numb; This is a spontaneous report from a contactable consumer(patient) or other non-health care pro... Read more
numb; This is a spontaneous report from a contactable consumer(patient) or other non-health care professional. A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 07Jun2021(Age at vaccination 46) (Batch/Lot Number: EW0196) as dose 1, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. It was reported that morning after the vaccine at night. He got it at 8:30 pm that night and then at 11:30 the next morning at 11am the patient experienced Numb on 08Jun2021, He had been at work a couple of hours and it felt like Novocain for a filling. It went away just after a week it was much better and then four to five days it was very much there. He is concerned about dose number two and he read about Bell's Palsy and he is worried about extreme side effects. It would be nice if someone from Pfizer to get back to him about if people had this type of side effect after the first dose. It is not listed on the four-page thing with the vaccine. Attempted to clarify with caller the date it went away It was like the moustache area, and nose then the bottom and lips. Mostly the moustache area and nose were the focus. Treatment included reported as he saw a doctor. He pushed on it and wasn't totally numb. It was a little bit on the sides by the TMJ joint and the temples had the same weird type of numbness. He was not taken second dose. The patient underwent lab test included herpes test and result was negative. The outcome for the event recovered on 16Jun2021. Additional Information has been requested. Further information is expected
46 2021-07-01 pain in extremity Approximately 1-2 days after my second dosage i developed progessivly severe pain in what i can best... Read more
Approximately 1-2 days after my second dosage i developed progessivly severe pain in what i can best describe as my rotator cuff. Over a couple days I then developed severe pain in both rotator cuffs, both knees throughout my back and in both thumbs at the bases between my thumb and wrists. This pain has persisted in all areas to this day and continues at varying levels and has at times severely affects my mobility/activity. I wore at times two or alternated knee braces and took lots of advil, ice, heat and self therapy with a vibrating muscle massager. I honestly feel that although the vaccine may not have caused all these issues it somehow attacked or targeted previous injuries or weak points in my body. I have had injuries or pain in these areas before but most not for 5-15 years and they all became almost unbearable within days for no reason. The severe lower groin pain that I felt very shortly after the first dosage had lessened substantially over the month. After the second shot it abruptly came back and has not left. It changes in severity but is now continually present and i will be seeking medical attention for it.
46 2021-07-01 pain in extremity Left under arm pain; chest (pectoral) pain; Lymphadenothopy.; Developed rash on left side of spine b... Read more
Left under arm pain; chest (pectoral) pain; Lymphadenothopy.; Developed rash on left side of spine between shoulder blades.; This is a spontaneous report received from a contactable consumer, the patient. A 46-years-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264) via an unspecified route of administration in right arm on 10Mar2021 at 16:00 (at the age of 46 years old) hours as single dose, for COVID-19 immunisation. No known Medical history. The patient did not have any allergies to food, medications, or other products. The patient previously took of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9262) via an unspecified route of administration in left arm on 10Feb2021 at 16:00 hours as single dose, for COVID-19 immunisation and the events were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. No Concomitant medication. The patient did not receive any other medications or vaccines within 4 weeks prior to the vaccination. On 11Mar2021 at 5:00 hours, the patient experienced Left under arm pain and chest (pectoral) pain, Lymphadenothopy. Developed rash on left side of spine between shoulder blades. It was a painful bumpy rash about the size of a silver dollar. The lymph node issues began within hours of second shot and had not improved in 2 weeks. The 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 events. The clinical outcome of events painful left arm, chest pain, lymphadenopathy and rash were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
46 2021-07-02 weakness, pain in extremity Arm pain at injection site location, followed by radiating pain into bicep and elbow, occasionally i... Read more
Arm pain at injection site location, followed by radiating pain into bicep and elbow, occasionally into the forearm, causing reduced strength and hand weakness. Pain is intensified during exercise.
46 2021-07-04 seizure Patient had seizure and was rushed to hospital. He stayed in the hospital over night for high blood ... Read more
Patient had seizure and was rushed to hospital. He stayed in the hospital over night for high blood pressure after seizure.
46 2021-07-05 bell's palsy, numbness, tingling Patient received his first dose of the Pfizer Covid-19 vaccine on 7/2/21. Later that day the tip of ... Read more
Patient received his first dose of the Pfizer Covid-19 vaccine on 7/2/21. Later that day the tip of his tongue had no taste. About 72 hours later, patient experienced numbness/tingling down the side of his face. He went into the emergency room and had workup/CT scan. Patient was diagnosed with Bell's Palsy.
46 2021-07-07 bell's palsy, face paralysis, nerve pain I had swelling in my right armpit lymph node and a mild rash that developed on the 4th day. I also d... Read more
I had swelling in my right armpit lymph node and a mild rash that developed on the 4th day. I also developed Bell?s palsy in the right side of my face. I went to the ER where I was prescribed prednisone and valacyclovir. These medications both helped a little. On June 25th the rash got worse, and the doctor prescribed a steroid cream which has helped. The rash has gone away from under my arm, but my lymph node is still swollen. On June 25th the doctor also said my face was more symmetrical, but I still have weakness and pain on my jawline and lip area. The pain is like a nerve pain and still comes and goes but it is not as bad as it was initially.
46 2021-07-07 slurring, weakness, muscle spasms Vertigo, Dizziness, Nausea, Headaches, Weakness, Shortness of Breath, Chills, Fever, Muscle Cramps, ... Read more
Vertigo, Dizziness, Nausea, Headaches, Weakness, Shortness of Breath, Chills, Fever, Muscle Cramps, Joint Pain, Slurring Speech, cannot drive or work. Has been occuring since injection.
46 2021-07-07 pain in extremity Arms hurt, requested BP check. Evaluated by EMS-Refusal to transport
46 2021-07-09 pain in extremity Rash eczema/psoriasis behind left knee and by right knee. Knee pain including significant swelling b... Read more
Rash eczema/psoriasis behind left knee and by right knee. Knee pain including significant swelling behind left knee which has resolved. Rash behind left knee resolved but right knee rash (burning/itching) has persisted but improved and using topical steroid. Severe diffuse headache, difficulty concentrating, slow performance, tachycardia to 120's mainly and some shortness of breath and left sided chest pressure for 48 hours along with fatigue. June 01, had tinnitus for a day. June 07, general intense feeling of not feeling well and headache. June 15, developed severe left leg pain and malaise. June 23, 8-9/10 pain behind left thigh and difficulty walking. Later developed exacerbation of prior mild right knee pain of recent onset to point could not walk.
46 2021-07-09 speech disorder Patient received the first COVID Pfizer vaccine, left the immunization room, walked to a chair, and ... Read more
Patient received the first COVID Pfizer vaccine, left the immunization room, walked to a chair, and sat down. Less than a minute later, patient lost consciousness (not sure if just passed out or had seizure), lips turned blue, was gurgling, pupils were dilated, and went limp. His companion helped me get him to the floor, where he was breathing. He remained unconscious for less than a minute longer. We called 911, who instructed us to leave him on the floor until help arrived. His blood pressure was normal when they arrived and patient refused to be further evaluated in the ambulance and refused to go to the hospital. Patient walked out of the store.
46 2021-07-12 pain in extremity Shingles; severe pain in back; severe pain in leg; This is a spontaneous report from a contactable c... Read more
Shingles; severe pain in back; severe pain in leg; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: UNKNOWN), via an unspecified route of administration in left arm on 05Mar2021, 16:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient had not received any other medications within 2 weeks of vaccination. The patient did not report any allergies to food or other medicinal products. 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 four weeks prior to the COVID-19 vaccination. On 21Mar2021, the patient experienced shingles, severe pain in back and leg. Therapeutic measures were taken as result of events reported and included treatment with anti-viral and pain medication (unspecified). The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events shingles, severe pain in back and leg were resolving at the time of this report. No follow up attempts are needed; information about lot/batch number cannot be obtained.
46 2021-07-12 tingling 12/18/20- Left arm pain at site of injection-treated with rest, pain continues from 12/20-4/21 was h... Read more
12/18/20- Left arm pain at site of injection-treated with rest, pain continues from 12/20-4/21 was hopeful that pain was temporary and would go away. 04/08/21- saw MD for check up, had complaints of left arm aching, told to start capsaicin cream 3x daily, take NSAIDs and home exercises as discussed 07/01/21- saw Dr. for check up and continued left arm pain -has complaints of intermittent tingling of left upper extremity, instructed to stop Capsaicin cream due to it not helping. MD made referral for Physical Therapy for left upper extremity pain
46 2021-07-13 seizure Received first covid vaccine on 3-26-21, had my first ever seizure on 4-5-21, second covid vaccine ... Read more
Received first covid vaccine on 3-26-21, had my first ever seizure on 4-5-21, second covid vaccine was given on 4-17-21, second seizure occurred 5-1-21.
46 2021-07-14 unresponsive to stimuli Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsiv... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Severe, Additional Details: After giving the vaccine to the patient he fainted and fell off the chair hitting his head on the floor. This was a few minutes after the vaccine was administered. After fainting the pt was a little out of it and was bleeding on his nose/forehead. I gave him a water and ice pack for his head. I had him stay sitting on the floor and after 20 mins we decided to the ambulance because his family was not coming. He was checked out and decided not to go to the hospital.
46 2021-07-16 burning sensation After then 2nd vaccination, patient had a burning sensation for at least 6 hour after the injection.... Read more
After then 2nd vaccination, patient had a burning sensation for at least 6 hour after the injection. Patient put some ice on the injection site. Patient claims that the burning sensation went away after 6 hours but a discoloration of the skin is noticeable on the vaccinated arm. Patient claims it occurred after the burning sensation went away. The discoloration is till present on day 22 after the vaccination. Patient is not in pain currently.
46 2021-07-17 feeling hot, burning sensation High fever; He was having a fever and he ended up sweating it out on the bed, he was not even making... Read more
High fever; He was having a fever and he ended up sweating it out on the bed, he was not even making the signs; Actually woke up in a furrow of water that came out of his body with a 102 degree fever; Sore throat; Teeth hurt; Teeth ache; Teeth all hurting; Pain on my teeth; Body ache; High fever; He was having a fever and he ended up sweating it out on the bed, he was not even making the signs; Actually woke up in a furrow of water that came out of his body with a 102 degree fever; Fatigue all over body; Sweaty sweat all over body, dripping sweat; I broke out with sweat and sweaty palms and forehead; Really sweaty; Woke up super-hot like the whole bed was wet; Got sick; Feeling tired all over, Very tired; We were really hot at night, it is like burning inside; Extremely very hot, very thirsty, and dizzy, kind of tired, fatigue; Extremely very hot, very thirsty, and dizzy, kind of tired, fatigue; Extremely very hot, very thirsty, and dizzy, kind of tired, fatigue; This is a spontaneous report from a contactable consumer. There were 2 reporters on the call reporting for themselves. This is the second case out of the two cases where reporter handed over the phone to her Fiancée (Consumer) and he is reporting for himself. This consumer (patient) reported for himself that a 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0191), via an unspecified route of administration on 19Jun2021 at 16:15 (at the age of 46-year-old), as dose 1, single in deltoid left, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no family medical history. On an unspecified date, the patient experienced high fever; he was having a fever and he ended up sweating it out on the bed, he was not even making the signs; actually woke up in a furrow of water that came out of his body with a 102 degree fever; sore throat; teeth hurt; teeth ache; teeth all hurting; pain on my teeth; body ache; fatigue all over body; sweaty sweat all over body, dripping sweat; I broke out with sweat and sweaty palms and forehead; really sweaty; woke up super-hot like the whole bed was wet; got sick; feeling tired all over, very tired. Patient was really hot at night, it was like burning inside; and extremely very hot, very thirsty, and dizzy, kind of tired, fatigue. Patient received treatment for the events. Treatment medications included Tylenol 500mg and Advil 200mg and Naproxen 500mg, once every 12 hours, twice a day. Patient had to take Nyquil and half a Benadryl to help fall asleep because of the pain on his teeth, and sore throat. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The clinical outcome of all events was reported as unknown. Follow-up attempts are completed. No further information is expected.
46 2021-07-17 pain in extremity, discomfort Next day left arm soreness lasted 2 days. Also 2nd day started feeling tired, exhausted for 1 week a... Read more
Next day left arm soreness lasted 2 days. Also 2nd day started feeling tired, exhausted for 1 week and nauseous for about 4-5 days. I fely hung over, achey, had slight fever and chills for 5 days. I am feeling 95% better now going on 9 days. I'm scared 2nd shot will be worse?
46 2021-07-17 pain in extremity Sore upperarm; This is a spontaneous report from a contactable consumer (patient). A 46-year-old mal... Read more
Sore upperarm; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in shoulder on 22Jan2021 09:45 (Lot Number: EK9231) as a single dose at the age of 46-year-old for covid-19 immunisation from doctor's office/ urgent care, hospital. Patient's medical history, concomitant medications and prior vaccinations were none. The patient experienced sore upper arm after the first dose. The outcome of event was unknown.
46 2021-07-19 seizure This pt called stating he needed vaccine information for his first Covid shot. The patient experien... Read more
This pt called stating he needed vaccine information for his first Covid shot. The patient experienced a seizure the next day that resulted in a motor vehicle accident in which him and 4 passengers were airlifted to hospital where they sought care for their injuries (patient's service dog also passed away). He stated he has no history of epilepsy and this was an isolated seizure event. He also claims that his toxicology report came back negative. The State Police are currently investigating the nature of this crash. It was also verbalized to the patient to report this incident using V-Safe.
46 2021-07-20 bell's palsy Bells Palsey in the left side of the face. Lasted approximately 2 weeks and still have numbness in m... Read more
Bells Palsey in the left side of the face. Lasted approximately 2 weeks and still have numbness in my tongue. Prescribed prednisone 60mg for 7 days. Also experienced extremely swollen lymph nodes in my left neck for approximately 4 days.
46 2021-07-20 numbness PATIENT STATED THAT SEVERAL DAYS AFTER 2ND COVID SHOT HE EXPERIENCED WHAT FELT LIKE A SUNBURN ON FAC... Read more
PATIENT STATED THAT SEVERAL DAYS AFTER 2ND COVID SHOT HE EXPERIENCED WHAT FELT LIKE A SUNBURN ON FACE AND NUMBNESS IN HANDS BILATERALLY LASTING AT LEAST 12 HOURS THAT WAS NOT RELIEVED WITH ICE AND ALOE VERA HE WAS OUTDOORS AT THE TIME AND TAKING IBUPROFEN WHICH BOTH HE DOES ON A DAILY BASIS. HE HAD PREVIOUSLY RECEIVED A STEROID INJECTION FOR HIS EAR. HE INFORMED ME OF THIS 7/21/21 AND STATED IT REOCCURED TO A MUCH LESSER EXTENT YESTERDAY AND WAS DOING FINE AND THE REDNESS HAD DIMINISHED HE STATED HE CHECKED HIS TEMP THE FIRST OCCURENCE AND HAD A NORMAL TEMP
46 2021-07-25 tremor PATIENT RECEIVED FIRST DOSE OF FIZER VACCINE. PATIENT FELT HIS PALM SWEAT AFTER 30 SECONDS. HE CAME... Read more
PATIENT RECEIVED FIRST DOSE OF FIZER VACCINE. PATIENT FELT HIS PALM SWEAT AFTER 30 SECONDS. HE CAME IN TO THE WAITING ROOM. THE PATIENT'S WIFE NOTICED THAT HE BECAME YELLOW, AND HIS HEAD WENT TO THE SIDE. HE STARTED TO SHAKE HIS HEADS FOR 10 SECONDS, AND THEN STOPPED SHAKING. PATIENT ALERTED THE PHARMACY TEAM. PHARMACY TEAM GAVE PATIENT SOME WATER AND GATORADE AS WIFE TOLD US THAT PATIENT HAS LOW BLOOD SUGAR. I CALLED 911 IN CASE IT BECAME WORSE. THE PATIENT THEN WENT INTO THE RESTROOM. PARAMEDIC ARRIVED AND MONITORED PATIENT BLOOD PRESSURE AND HEART RATE. HE WAS FINE, BUT PARAMEDICS RECOMMENDED HE GO IN THE AMBULANCE RIDE. THE PARAMEDICS SAID IT COULD JUST BE A SYNCOPE EPISODE AS PATIENT IS AFRAID OF NEEDLES. HOWEVER, THE PATIENT DECLINED THE RIDE. WIFE TOLD US SHE MIGHT TAKE HIM TO ER.
46 2021-07-26 weakness I feel weak and dizzy with achy bones and soreness around the injection site
46 2021-07-27 weakness Increase of Atrial Fibrillation (Afib) events and severity. For the 20 years preceding the Covid sho... Read more
Increase of Atrial Fibrillation (Afib) events and severity. For the 20 years preceding the Covid shot, I had 1-2 Afib events in low severity about every 8 months and only one severe event in 2008. Since getting the Covid shot, I've had 1 event every week with 2 severe events and 2 emergency room visits. Three cardiologists have confirmed my condition and verified my event history and the increase in frequency. My workouts have been relatively the same for 3 years. Now, after any workout that I push to failure, onset of Afib occurs approximately 4-6 hours later with a medium to high severity. Afib Severity: Low; occasional light headed when exerting. Medium; weakness, need to sit. Severe; semi/or unconscious.
46 2021-07-28 sciatica extreme pain in his stomach with swelling and bloating; painful to breath because his abdomen was sw... Read more
extreme pain in his stomach with swelling and bloating; painful to breath because his abdomen was swollen/ extreme pain in his stomach with swelling and bloating; Dry heaves; painful to breath because his abdomen was swollen; sciatica to hurt and aggravated his lower back pain; sciatica to hurt and aggravated his lower back pain; hip pain; The pain was high up under his rib cage; Stomach discomfort; tenderness at the injection site; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6204; Expiration date: unknown), via an unspecified route of administration, administered in arm left on 13Mar2021 at 11:00 (at the age of 46-years-old) as dose 1, single for COVID-19 immunisation at hospital. Medical history included systemic herpes zoster infection (disseminated varicella zoster virus infection), ongoing HIV infection (he has been positive for HIV for 30 years) and previously had hip injury. Concomitant medications included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY) taken for HIV infection from an unspecified start date and ongoing (taking for 3 years); aciclovir sodium (ACYCLOVIR [ACICLOVIR SODIUM]) taken for disseminated varicella zoster virus infection from an unspecified start date and ongoing (taking for 6 years). There was no history of any previous immunization with the Pfizer vaccine considered as suspect and no prior vaccinations within 4 weeks. The patient did not receive any additional vaccines on same date of the Pfizer suspect. There was no family history. The patient experienced tenderness at the injection site on 13Mar2021, diarrhea, stomach discomfort on 13Mar2021 at 18:00, extreme pain in his stomach with swelling and bloating, dry heaves, painful to breath because his abdomen was swollen, sciatica to hurt and aggravated his lower back pain, hip pain, the pain was high up under his rib cage on 14Mar2021. Patient stated recently had the Pfizer COVID 19 vaccine on Saturday and had some side effects that he had not read about. The patient clarified that he received the first dose of the Pfizer COVID 19 vaccine 13Mar2021 at 11:00 AM in the left arm. He reported that there was a little tenderness at the injection site, but it was no big deal. Then at 18:00 he noticed some stomach discomfort and had one episode of diarrhea. Then at midnight he woke up with extreme pain in his stomach with swelling and bloating. He couldn't stand up with the pain, it was at his limit. He added that his roommate wanted him to go to the emergency room, but he didn't want to go to a rinky dink hospital in the middle of the night, so he stayed home. Stated that he started to have dry heaves and brought up some fluid then it was just violent dry heaves then finally he was able to bring up air. It was painful to breath because his abdomen was so swollen, and he felt like he was exhaling forcefully. The pain was high up under his rib cage. This all continued until around noon on Sunday when air finally came up. He laid on his stomach on a heating pad and by afternoon he was better; by Sunday evening the swelling had mostly subsided. Patient stated that when he had the swelling and bloating it felt hard up under his rib cage. It pushed his ribcage out of position and caused his sciatica to hurt and aggravated his lower back pain. Mentioned he had a previous hip injury and the swelling that caused his back to be out and also caused hip pain. He further stated that his stomach was still irregular and making noises. And then at the time of this report, stated that he could do his usual stretches. Mentioned he got an email from the hospital and he reported his symptoms to them, but this was the first time to call Pfizer. He was scheduled to receive the second dose on 05Apr2021. He asked what to do to prepare for the second dose. The adverse events did not require a visit to physician or emergency room. The patient did not undergo relevant test. The outcome of the events tenderness at the injection site, diarrhea was resolved on 13Mar2021; events of extreme pain in his stomach with swelling and bloating, dry heaves, painful to breath because his abdomen was swollen was resolved on 14Mar2021 and outcome of rest of the events was resolving. No follow-up attempts are possible. No further information is expected.
47 2021-01-03 numbness NUMBNESS TO BOTH ARMS AND LEGS
47 2021-01-04 numbness, facial pain Developed right sided facial numbness; numbness of right side of anterior tongue; numbness progresse... Read more
Developed right sided facial numbness; numbness of right side of anterior tongue; numbness progressed to some facial pain as well; This is a spontaneous report from a contactable Other Health Professional (patient). A 47-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, intramuscular in the right arm, first dose given on 23Dec2020 12:30 at a single dose for COVID vaccination. Medical history included asthma, seasonal allergic rhinitis and Bell's Palsy affecting that side of the face. Concomitant medication included loratadine, pseudoephedrine sulfate (CLARITIN-D) and montelukast sodium (SINGULAIR). The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. He was not diagnosed with COVID-19 prior to and post vaccination. The patient previously took and had allergies to Keflex, Vicodin and Motrin. It was reported that the patient developed right-sided facial numbness and numbness of right side of anterior tongue. These occurred within 10- 15 minutes of vaccine administration on 23Dec2020 at 12:45 PM. It was mentioned that the patient has history of Bell's Palsy that was affecting that side of the face. The patient had numbness progressed to some facial pain as well. Symptoms lasted for 6 days and slowly abated with prednisone treatment which was given at 20 mg BID (twice a day) x 5 days. The events were reported as non-serious. The outcome of the events patient developed right-sided facial numbness and numbness of right side of anterior tongue and numbness progressed to some facial pain as well was recovering.
47 2021-01-06 tingling Monday morning I woke up with itchy red hives in several parts of my body, Tuesday morning since the... Read more
Monday morning I woke up with itchy red hives in several parts of my body, Tuesday morning since the symptoms were not any better (legs, torso) I decided to go to the walk in clinic at work and they suggested me to take some OTC Benadryl and it did work the same day and the rest of the day. The next day around lunch time the hives came back again I had a very red and tingling area around my neck and in my head. I returned to the walk in clinic and they gave me shot of Benadryl and prednisone and another drug I do not remember.
47 2021-01-06 throat numbness Numbness noted in tongue and back of mouth/throat starting morning after injection. No other associa... Read more
Numbness noted in tongue and back of mouth/throat starting morning after injection. No other associated symptoms noted
47 2021-01-07 pain in extremity sore arm, swelling/"knot" at injection stie; this has resolved. But still experiencing pain/limited ... Read more
sore arm, swelling/"knot" at injection stie; this has resolved. But still experiencing pain/limited range of motion 3 weeks post vaccine Narrative: pain and limited ROM of arm; she is seeking care through her pcp; xray of her arm has been ordered by her pcp
47 2021-01-08 seizure, cold sweat Dizziness, Seizures, Syncope, Bradycardia, cold, clammy Narrative: 10 mins after administration, Emp... Read more
Dizziness, Seizures, Syncope, Bradycardia, cold, clammy Narrative: 10 mins after administration, Employee began expressing lightheadedness, Employee assessed, employee was cold and clammy. Employee then began to have a seizure which last approx 30 sec. Vital signs assessed BP 110/80 HR 87 then dropped to 50 which is unusual for employee. o2 sat 94% on room. Employee regained consciousness and was able to state name, time and place. Reported no previous history of seizures. Employee handed off to ER staff for further eval.
47 2021-01-10 muscle spasms fever >100 , body aches/whole body muscle spasms, chills, nausea (no vomiting), headaches, physical ... Read more
fever >100 , body aches/whole body muscle spasms, chills, nausea (no vomiting), headaches, physical exhaustion, all symptoms resolved approx 1.5 days of vaccine administered, symptoms began approx 12 after vaccine received.
47 2021-01-10 pain in extremity 1. Onset roughly 12 hours after injection lasting until approximately 32 hours after injection: feve... Read more
1. Onset roughly 12 hours after injection lasting until approximately 32 hours after injection: fever, chills, body aches, nausea, sore left arm. Treated with 600 mg Ibuprofen every four hours. Fever would break and then come back. 2. Onset roughly 51 hours after injection lasting until approximately 55 hours after injection: fever, chills. Treated with 600 mg Ibuprofen. No symptoms since.
47 2021-01-11 pain in extremity Very minor light headedness the day after injection; typical sore arm; This is a spontaneous report ... Read more
Very minor light headedness the day after injection; typical sore arm; This is a spontaneous report from a contactable other HCP (patient). A 47-year-old male patient received the first dose of BNT162B2 (Lot number: EL1284), via an unspecified route of administration on Jan2021 09:30 at single dose in the left arm for COVID-19 immunization. Medical history included high BP and Pre-diabetic, both from unknown dates. The patient's concomitant medications were not reported. The patient previously took codeine and experienced allergies. The patient experienced very minor light headedness the day after injection on Jan2021. It lasted throughout the day. Also reported typical sore arm on Jan2021. Neither of which required any medical attention. The patient did not receive any treatment for the events. 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 recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
47 2021-01-12 concussion Approximately 13 hours after receiving the vaccine I became overwhelmingly tired. Went to get ready ... Read more
Approximately 13 hours after receiving the vaccine I became overwhelmingly tired. Went to get ready for bed by first going into the bathroom. While getting ready I passed out (micturation syncope). Hit my head on the floor and sustained a concussion. I am still experiencing post concussive symptoms but this is to be expected as it has been less than a week.
47 2021-01-12 numbness, bell's palsy Reported facial and lip numbness x 3 days following covid vaccination (Bells Palsy) . By 5pm it had ... Read more
Reported facial and lip numbness x 3 days following covid vaccination (Bells Palsy) . By 5pm it had creep to the face, right cheek was not responding fully. Described the numbness like having a Novocain at the dentist. Symptoms lasted 3 days
47 2021-01-14 cold sweat Pulse dropped to 30. Low pressure too. Brachycardia. Lost consciousness. Did not seem to be Vasovag... Read more
Pulse dropped to 30. Low pressure too. Brachycardia. Lost consciousness. Did not seem to be Vasovagal. Saline IV. Blurred vision. Very. Strange. Girl friend said I seemed catatonic for about 5-10 seconds. Cold sweat. Dizziness. Immediate Symptoms lasted about an hour. Injection site very sore 10 hours later. Body pains.
47 2021-01-14 muscle spasms 2 days after vaccine, left neck spasms and pain. Now developed sternoclavicular synovitis on the lef... Read more
2 days after vaccine, left neck spasms and pain. Now developed sternoclavicular synovitis on the left side
47 2021-01-14 pain in extremity, flushing, muscle twitching 1/13/21 0740 Received second dose of COVID-19 vaccine, which was scheduled for that morning. Did not... Read more
1/13/21 0740 Received second dose of COVID-19 vaccine, which was scheduled for that morning. Did not experience anaphylaxis or other symptoms of vaccine injury. I took 1gram of Tylenol PO when I got back to my motel by 0830. By 0924 I noted that my left deltoid (injection site) and arm were very sore/achy. I fell asleep until 1740. I noted that I was experiencing more body aches at this time (joint and muscle, especially in my bilateral shoulders, lower back, knees and pelvis). Calf muscles were quite sore. I made pasta with red sauce and made a pot of blueberry tea, ate and went back to bed. 2327 I woke again with weird fever dreams and my right bicep was intermittently twitching. I think I was starting to run a low grade fever at this time (my ears felt hot, and my stomach was queasy but was not nauseous), no diaphoresis, shortness of breath or airway constriction. I remained awake until 0200, 1/14/21. By 0400 I was experiencing mild chills, face was flushed, headache on the right, with pressure behind my right eye, parietal and occipital areas of my skull. The pain extended into the right muscles of my neck (trapezius, levator scapulae and sternocleidomastoid muscles). Bilateral upper arm muscles and joints were 5:10 pain. I was also experiencing mild photophobia, but not migraine related, and a mild non-productive cough and pressure behind my facial and ethmoid sinuses with scant viscous secretions at the back of my throat. 0433 I forced myself to get out of bed and head to the bathroom. My temp was 101. I took a very hot shower and am back in bed. Experiencing a lot of malaise and lethargy. 1/15/21 0830 temp is currently 99.1, headache is present, 3:10. Joint aches have mostly subsided. Injection site is warm and tender, but no erythema is present.
47 2021-01-14 seizure Day of the vaccination, patient went home and developed a bilateral nosebleed and had a seizure. Pat... Read more
Day of the vaccination, patient went home and developed a bilateral nosebleed and had a seizure. Patient continues to feel poorly as of 1/15/2021 but has returned part time to work.
47 2021-01-18 tingling New Sporadic Tingling sensation to the upper spine.
47 2021-01-20 pain in extremity Tennis ball size swelling of lymph notes in Right armpit. Discovered 36 hours after shot. Only oth... Read more
Tennis ball size swelling of lymph notes in Right armpit. Discovered 36 hours after shot. Only other symptom is pain in right arm that required OTC ibuprofen.
47 2021-01-20 pain in extremity nausea; vomiting; Mild headache; arm was hurting/Left arm soreness; This is a spontaneous report fro... Read more
nausea; vomiting; Mild headache; arm was hurting/Left arm soreness; This is a spontaneous report from a contactable physician reporting for himself. A 47-years-old male patient received the second dose of bnt162b2 (BNT162B2; Lot # EJ1686) vaccine , intramuscular in the left deltoid on 07Jan2021 11:00 at single dose for Covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. Previously on 17Dec2020 the patient received the first dose of BNT162B2 vaccine. The patient experienced nausea and vomiting on 10Jan2021 23:59 with outcome of recovered , mild headache on 07Jan2021 20:30 with outcome of recovered , arm was hurting/left arm soreness on 07Jan2021 20:30 with outcome of recovered. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 20Nov2020. Nausea and vomiting were considered Important Medical Events.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events nausea and vomiting cannot be excluded. The information available in this report is limited and does not allow a medically meaningful 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.
47 2021-01-21 pain in extremity About 4 am the night after the vaccination, I developed significant left arm pain. Hurt; throbbed ... Read more
About 4 am the night after the vaccination, I developed significant left arm pain. Hurt; throbbed and didn't want to use it. Went to work but about 7:00 am- I noticed my right arm began to work as well - almost in the the same severity. Spell- lose consciousness alost- had bad headache; - it abated and it happened again - almost lost consciousness. It left. And it happened again a third time and went to a stretcher - nurse took my BP 220/110 - blood pressure - very high for me and laid on the stretcher and had nurses hook me up ot monitors; No change on cardiogram and my oxygen saturation level never altered and never dropped; My BL remained elevated - significantly. 180/90 before I went home. Continued to check my BP when I went home - queasy; nauseated - upset stomach and then fever the following day - remained for 4-5 days. Fever was one day and got 100.5 and then was gone after that day. BP continued to check regularly through next few days - it did improve a bit but was still elevated - 180/150 (systolic) and 110/95 (Diastolic) - Slowly got back to normal by day 7 after vaccination. Went to work the 30th the day before New Year's Eve, finally and had dizziness never got quite as severe - 50% but left arm pain very very painful - almost numb; right arm hurt some, too. Blood 190/110 .Oxygen Saturation remained good. Arm pain very bad - ordered EKG - was normal Admitted my self to ER - Had a full work up - repeated EKG - negative; two sets of troponins - negative; chest x-ray - nothing - BMP - elevation in my creatine which I've never had before. CBC - normal; They treated me with fluid hydration; Tylenol; fentanyl and hours later I felt a bit better. Things calmed down and I was released. BP remained elevated for next two days. I got better after two days _ enough to work - but still would get a little disequilibrium not enough to pass out but just like an odd feeling and then it would go away after a few seconds. And that is only recently disappeared - within the last week or so. I feel better now but my BP remains elevated - 160/140 (systolic) over 105/95 (dystolic) - that's al new for me. I have declined the second vaccination. Have sort of recovered but it did come back after time and so it may come back again - don't know. I may have been exposed to COVID the week before my vaccination. About 4 days after the severe symptoms that lead to my leading to take off work; I took test for COVID - PCR at CVS (returned positive) and COVID test PCR and rapid antigen (returned negative) at Public Health -
47 2021-01-24 migraine Approximately 48 hrs after my second Pfizer vaccination for covid I experienced chills, migraine, le... Read more
Approximately 48 hrs after my second Pfizer vaccination for covid I experienced chills, migraine, lethargy, loss of appetite, and general digestive discomfort. Treated with plenty of fluids, naproxen, and rest. Experienced mild fever but never > 100 degrees that I know of.
47 2021-01-25 tremor Uncontrollable shivering shaking almost like a seizure type. Severe headache, pain muscles, close th... Read more
Uncontrollable shivering shaking almost like a seizure type. Severe headache, pain muscles, close throat dry throat. Tiredness fatigue.
47 2021-01-26 flushing, feeling hot Systemic: Headache-Medium, Systemic: Warm, flush feeling at forehead; symptoms lasted 1 day
47 2021-01-26 numbness, tingling Pfizer-BioNTech Covid 19 Vaccine Description 1.26.2021: It first started with swelling hands then ... Read more
Pfizer-BioNTech Covid 19 Vaccine Description 1.26.2021: It first started with swelling hands then tingling in bilateral fingers and hands. That progressed to tingling in feet and toes. The nerves coming into my arm pits were very painful and I couldn't put my arms against my body. Petechia rash on my torso. Numb left lower lip and jaw area, numb right shoulder, numb shins and calfs. when the numb lip began my PCP had me go to the ED for evaluation. All blood work and Electrolytes came back normal. All this lasted over a week and the petechia spots are still on my torso, but seem to be going away.
47 2021-01-27 tingling, feeling hot I experienced headaches, severe abdominal pain, change in bowel movements, ribs felt like they were ... Read more
I experienced headaches, severe abdominal pain, change in bowel movements, ribs felt like they were being ripped apart, tired/fatigue, blurry vision, dizziness, my body felt hot from the inside out, tingling sensation in feet and hands.
47 2021-01-31 night sweats soreness, fatigue, congestion, night sweats, itchy, rash, difficulty breathing
47 2021-01-31 tingling tingling to face, redness to face, headache, throat swelling
47 2021-02-01 hot flush, flushing 0825 flushed, nausea , slightly SOB, O2 sat 96%, RR24 HR 77 BP 137/97. Pepcid 40mg, Benadryl 50mg... Read more
0825 flushed, nausea , slightly SOB, O2 sat 96%, RR24 HR 77 BP 137/97. Pepcid 40mg, Benadryl 50mg 0830 Dizzy, flushed, SOB 0835 Dizzy, not flushed feeling, slightly SOB. O2 sat 95% 0840 Throat scratchy - slight difficulty to swallow O2 sat 93-94% HR 90 RR 28 0850 Epi pen injection, Throat tight and scratchy, hard to catch breath after coughing 911 called 0900 Ambulance transported to ER 0909 Ambulance arrived to ER still somewhat SOB and scratchy throat and nauseated, Dizziness improved. No stridor or wheezing, no hives or itching, no swelling of tongue or lips or facial swelling Received IV Benadryl, IV Decadron, IV Pepcid and albuterol nebulizer treatment and observed for an extended amount of time. SOB cleared, throat issue resolved and was discharged with just a slight residual tiny scratchy throat. He was discharged on Benadryl every 6hours until symptoms are completely resolved and Prednisone for 3 days starting on 1/26 if any residual symptoms are felt. Also given Albuterol inhaler if develop any recurrent SOB. Released home at 1413 on 1/25. Follow up on 1/27 and he stated he had fully recovered
47 2021-02-01 tenderness Staff experienced left shoulder tenderness and general malaise after vaccination. The malaise was de... Read more
Staff experienced left shoulder tenderness and general malaise after vaccination. The malaise was determined to be enough for the staff to miss work to stay home and rest.
47 2021-02-02 pain in extremity After the vaccine, within about an hour after, I started feeling a headache, diarrhea, and extreme f... Read more
After the vaccine, within about an hour after, I started feeling a headache, diarrhea, and extreme fatigue. The next day I still had a headache, fatigue and arm soreness. On the 31st, the symptoms kinda went away. I did notice some SOB when walking. I did see my Pulmonologists and was prescribed a medicine.
47 2021-02-03 numbness, feeling cold Muscle aches, fever of 102, got/cold feeling, loss of appetite, dry heaving, lethargic and sleepy, n... Read more
Muscle aches, fever of 102, got/cold feeling, loss of appetite, dry heaving, lethargic and sleepy, numnous in hands
47 2021-02-03 pain in extremity Upper arm pain, mild; muscular discomfort, mild; This is a spontaneous report from a contactable con... Read more
Upper arm pain, mild; muscular discomfort, mild; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL3247) solution for injection intramuscular in the left arm on 20Jan2021 at 13:45 (at the age of 47-years-old) as a single dose for COVID-19 vaccination. There was no medical history. There were no concomitant medications. There were no allergies to medications, food, or other products. 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. On 21Jan2021 at 13:45, the patient experienced upper arm pain, mild with associated muscular discomfort, mild. No treatment was provided for the events upper arm pain and muscular discomfort. The outcome of the events upper arm pain and muscular discomfort was recovering. Since the vaccination, the patient has not been tested for COVID-19.
47 2021-02-06 weakness I 'had Covid' beginning Saturday before Thanksgiving. During that period, I had two tests, both fro... Read more
I 'had Covid' beginning Saturday before Thanksgiving. During that period, I had two tests, both from facility, and both tests came back negative. Symptoms included fever 102-103 for 12 days. No appetite (didn't eat for that duration). Headache. Excessive sweating. Extreme shallow breath. Hyperventilation. Body ache. No loss of smell or taste. No nausea. No mucus response. Since that time, I have experienced extreme fatigue, weakness, shortness of breath, headache. After the first shot, those three symptoms increased. With the second shot, I had fever 99.5-101 from Tuesday though Saturday. Nausea, headache, body ache, weakness, shortness of breath. It felt 85% similar in symptom and intensity as when I 'had Covid'. The greatest difference is the nausea. When I 'had Covid' there was no nausea and I did not throw up. This time, I had persistent nausea and threw up multiple times in the first three days.
47 2021-02-07 tingling, numbness After injection, left side finger tips and face tingled. Finger tips resolved, face felt numb afterw... Read more
After injection, left side finger tips and face tingled. Finger tips resolved, face felt numb afterwards including head and neck. Feels like patient had dental work and the numbing is wearing off.; After face felt numb afterwards including head and neck. Feels like patient had dental work and the numbing is wearing off.; This is a spontaneous report from a contactable consumer reporting for himself. A 47-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number EL3249, via an unspecified route of administration on 22Jan2021 10:00 (at the age of 47-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included acromegaly (surgery done to remove tumor) from an unknown date and unknown. The patient's concomitant medications were not reported. The patient previously took doxycycline and experienced drug allergy. The facility where the most recent COVID-19 vaccine was administered was at a hospital.On 22Jan2021 10:00AM, the patient experienced after injection, left side finger tips and face tingled. Finger tips re-solved, face felt numb afterwards including head and neck. Feels like patient had dental work and the numbing is wearing off. The events after injection, left side finger tips and face tingled. Finger tips re-solved, face felt numb afterwards including head and neck. Feels like patient had dental work and the numbing is wearing off were reported as non-serious and did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events. The clinical outcomes of the "after injection, left side finger tips and face tingled. Finger tips resolved, face felt numb afterwards including head and neck. Feels like patient had dental work and the numbing is wearing off" was not recovered. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.
47 2021-02-07 cold extremities, numbness, tingling At time of the vaccine: I experienced a tingling/numbing sensation down my left arm into my left han... Read more
At time of the vaccine: I experienced a tingling/numbing sensation down my left arm into my left hand and fingers. Approximately 18 hours after the vaccine: I experienced chills, elevated temperature (99 to 100 degrees F), headaches, fatigue. Approximately 42 hours after the vaccine: the chills, elevated temp, headaches, and fatigue were gone, but I had a armpit aching on the left side. The armpit ache faded over the next 24 hours. Today is 7 days post vaccine and I still have periodic tingling/numbing/cool sensation on the pinky and ring fingers on my left hand.
47 2021-02-09 pain in extremity Shortness of breath; palpitations/increased heart rate; palpitations/increased heart rate; Immediate... Read more
Shortness of breath; palpitations/increased heart rate; palpitations/increased heart rate; Immediate left arm/chest pain; Immediate left arm/chest pain; fatigue; body aches; This is a spontaneous report from a contactable physician. A 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3246), via intramuscular, on 18Jan2021 at single dose on the left arm for COVID-19 immunisation, administered at Hospital. The patient did not have a relevant medical history. No known allergies. No relevant concomitant medications were provided. No other vaccine was received in four weeks. The patient developed immediate left arm/chest pain, and fatigue/body aches. On 23Jan2021 (5 days later), he developed shortness of breath and palpitations/increased heart rate. Post-vaccination COVID test was not performed. The patient was not treated for the events. The patient was recovering from the events.
47 2021-02-11 pain in extremity Local arm soreness and generalized muscle aches. Approximately 6/10. Took Tylenol, resolved after ab... Read more
Local arm soreness and generalized muscle aches. Approximately 6/10. Took Tylenol, resolved after about 30 hours.
47 2021-02-14 migraine Migraine Headaches; chills; body aches; sore arm; This is a spontaneous report received from a conta... Read more
Migraine Headaches; chills; body aches; sore arm; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261, expiry date: unknown), intramuscular in the left arm, on 26Jan2021 14:00, at single dose, for COVID-19 immunization, at the hospital. Medical history included migraine and diabetes mellitus (diabetic). The patient has no allergies to medications, food or other products. Concomitant medication included metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-10 post vaccination. The patient experienced migraine headaches, chills, body aches and sore arm on 26Jan2021 at 14:00. No treatment was given for the events. The outcome of the events was unknown. The events were assessed as non-serious.
47 2021-02-15 pain in extremity Had daily headaches after first dose of vaccine. For 3 weeks. Decided to skip the second dose becaus... Read more
Had daily headaches after first dose of vaccine. For 3 weeks. Decided to skip the second dose because of that. Then had leg pain after nearly a month of the vaccine. Thought it was muscle pain but landed up in ER with shortness of breath and was diagnosed with DVT and large PE.
47 2021-02-17 weakness onset of dizziness and fatigue 24 hours after vaccine (1/30/2021). 48 hours after vaccine (1/31/20... Read more
onset of dizziness and fatigue 24 hours after vaccine (1/30/2021). 48 hours after vaccine (1/31/2021), developed cough and low grade fever. Symptoms continued to progress with continued cough, fatigue, and generalized weakness with shortness of breath. Had O2 sat of 88% with activity on 2/9/2021 and went to emergency department and was diagnosed with pneumonia. Treatment started for community acquired pneumonia with Amoxicillin and Azithromycin. Patient discharge home from emergency department
47 2021-02-17 migraine I was dizzy all along and almost fainted; I was dizzy all along and almost fainted; migraine; This i... Read more
I was dizzy all along and almost fainted; I was dizzy all along and almost fainted; migraine; This is a spontaneous report from a contactable consumer (patient). This 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 20Jan2021 for COVID-19 immunization. Medical history included sleep apnea; high blood pressure; high cholesterol; borderline diabetes. Concomitant medications included losartan; alirocumab (PRALUENT, injection) on 20Jan2021. Since 23Jan2021, patient was dizzy all along and almost fainted and was still having symptoms of mild migraine and he don't know like some light sensitivity. Doctor believed it was from vaccine. Patient was wondering how long was this going to be last as he had second shot coming out. He didn't think it was an adverse reaction and he thought he should get the second shot. But this was continuing to me and it had already been two weeks and patient still having symptoms of mild migraine. Patient was worried about taking the second shot as a result. He had never had a migraine before and was told it was probably from the vaccine and that was not something he wanted to hear. Patient wanted to know if this was normal to still be having this side effect for this long. Patient was taking acetaminophen (for migraine), it was not a TYLENOL, it was from a different brand. Patient did liver and cholesterol test and blood test in Jan2021 at Cardiologist and they came back fine, nothing was found there. The outcome of event migraine was not resolved. The outcome of rest events was unknown. Information on the lot/batch number has been requested.
47 2021-02-18 weakness Within a half hour, I felt dizzy and light headed. in 45 minutes - I could barely stay awake. I had ... Read more
Within a half hour, I felt dizzy and light headed. in 45 minutes - I could barely stay awake. I had to stop driving. Within two hours, I had a bad headache. I became slightly agitated that day. The headache lasted throughout the day - I took Ibuprofen but that didn't help much. Sunday, the headache was still there. It wasn't a migraine; but intense. I was agitated. My agitation level grew and my irritability grew and the headache I had the whole day. Sunday evening about 7 pm the agitation and irritability got very intense - I was having impulse control issues with it. I don't have anger issues but I wanted to yell at TV or throw my phone. From 8- midnight, I was lethargic and fatigued - I didn't have the energy to roll over;: had extreme anxiety I was sweating and having weird thoughts like harming my animals and harming myself; my mind was racing and then I would get really depressed. Until about midnight, I have had past struggles with anxiety and depression - there had been a past feeling like this - but it was really extreme - it was worse night of my life. Lasted four hours, and finally I slept for about one hour. I remember thinking, I finally can take a breath. My racing thoughts were gone and sweating was gone. The irritability had subsided enough that I could try to gain control of my thoughts again. I had really bad nightmares the rest of that night; I was confused _ I didn't know where I was - confused about that - occurred about three different times until I got up at 5:30 am for work. To summarize, for the next week, I had moments of anxiety and depression. I had mental fog. I played pro football - and I had post concussion syndrome. It was very identifiable to what I had had. So this was occurring in moments - forgetful; depressed; and random moments of anxiety - like I was going to go play football again. 7-10 days - it got a little better each day. Ten days it took to subside. I still exercised and taking extra fluids to get back to my normal. Exercised help. No fever occurred. With COVID - I had had a sense of anxiety and depression and some mental fog when I had COVID I didn't have it to this extreme. Did not get the second dose.
47 2021-02-23 pain in extremity Vaccine given 2/17/2021. Client developed soreness in arm and shoulder area and chills post vaccin... Read more
Vaccine given 2/17/2021. Client developed soreness in arm and shoulder area and chills post vaccine, joint achiness on day 2 post vaccine. On 2/21, client developed lower back and flank pain bilaterally which progressively got worse and continues yet on 2/24. Client rates pain a 6 or 7. Pain is constant. Pain will decrease to a 2 or 3 following Aleve. Denies blood in urine, urgency, burning with urination or difficulty starting urine stream. States bowel movements have been normal. States discomfort is not like a pulled muscle sensation. Has had temperature in the 99 degree range. Client started Potassium supplement on 2/22 thinking it may help but has had no relief. Pain continues as of time of report.
47 2021-03-02 weakness Patient received 1st dose of his Covid vaccine; after~10 min, during observation period, he was not... Read more
Patient received 1st dose of his Covid vaccine; after~10 min, during observation period, he was noticed to become pale ,diaphoretic and with decreased level of responsiveness; was put on the stretcher. Physician who was monitoring the vaccination area reported: "BP 110/64 HR 76 Sat 95% Patient was feeling better upon being placed supine and was verbalizing as well. Denied chest pain and shortness of breath. Just felt dizzy and weak." Patient was taken to ER; CBC,CMP,ECG- all normal and he was discharged after 2 hrs of observation with diagnosis of Vasovagal Syncope. Today, patient is well and went to work as per his spouse. Patient has history of similar syncope or near syncope events in the past during stressful situations, like seen blood .
47 2021-03-10 pain in extremity Sore arm; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male pa... Read more
Sore arm; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EL3302, via an unspecified route of administration in left arm on 05Feb2021 10:15 at a single dose for covid-19 immunization in a military base at age 47 years old. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore arm on 05Feb2021 10:15. The event was reported as non-serious. No treatment was received from the adverse event. The patient recovered from the event on an unspecified date in Feb2021. No follow-up attempts are possible. No further information is expected.
47 2021-03-12 weakness I have had multiple issues, back pain, chills, uncontrollably fall asleep, feel feverish with no fev... Read more
I have had multiple issues, back pain, chills, uncontrollably fall asleep, feel feverish with no fever, exhaustion, joint pain, weakness.
47 2021-03-16 facial paralysis, slurring, bell's palsy Swollen face, tongue feels fat, headache behind R ear, facial dropping, slurring words, eye doesn't... Read more
Swollen face, tongue feels fat, headache behind R ear, facial dropping, slurring words, eye doesn't close all the way. Started Sunday night to the morning went to ER. Did blood test for Lymes. Diagnosed with Right sided BELLS PALSY Gave prednisone and Valtrex in ER and discharged on those meds too.
47 2021-03-17 weakness Fever body aches and weakness Narrative:
47 2021-03-17 facial paralysis, bell's palsy, numbness Patient presented tot he hospital Emergency Department with right side facial numbness and drooping.... Read more
Patient presented tot he hospital Emergency Department with right side facial numbness and drooping. Patient was initially screened as a stroke patient but it was ultimately diagnosed as Bell's Palsy. Patient was treated and discharged home.
47 2021-03-18 feeling hot The pt received the vaccine and after approximately 5-10 minutes while waiting, informed the staff h... Read more
The pt received the vaccine and after approximately 5-10 minutes while waiting, informed the staff he was experiencing some anxiety and added he gets this when he only drinks coffee and not having eaten anything. His vital signs were done by the nurse and the PA spoke with him, too. He was given 6 8oz water bottles, a few pkgs of graham crackers and a banana while he waited in the rear of the pod. When he mentioned "chest" breathing the PA decided he should be brought to the E.D. The pt was going to walk but the staff requested he be wheeled down. He went to the E.D> with an RN and the Pod Mgr. ED: 47 yo m no pmhx p/w lightheadedness after receiving his covid vaccine. AFVSS, well-appearing, nad. Feeling better after eating, no cp or sob. Do not suspect acs. No signs of allergic reaction. Possible vasovagal vs anxiety related to vaccine. Reassurance provided, Plan for dc
47 2021-03-18 flushing Mild to moderate headaches, chills and flush feeling Ibuprofen 600 mg @ 2 times/day
47 2021-03-19 tremor Patient felt like something was in his throat, tongue felt thick, dizziness/lightheadness, and tremo... Read more
Patient felt like something was in his throat, tongue felt thick, dizziness/lightheadness, and tremors
47 2021-03-21 feeling hot, pain in extremity Notes: APRN (Nurse Practitioner), Cosigned by: MD at 3/19/2021 9:22 AM, COVID VACCINE CLINIC 3/18/20... Read more
Notes: APRN (Nurse Practitioner), Cosigned by: MD at 3/19/2021 9:22 AM, COVID VACCINE CLINIC 3/18/2021 Patient/Date: 3/18/2021 Subjective: a 47 y.o. male who was seen at SVH COVID Vaccine Clinic today for his first dose of the COVID Pt is a 47 y.o. male who was seen at COVID Vaccine Clinic for his first does of COVID 19 vaccination. He was given the Pfizer vaccination in the left deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience lightheadedness and dizziness. He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. Pt received shot and complained of being hot and sweaty. He was laid on the floor in injection room 5, with his feet elevated, some water was given and once pt was feeling better he was transferred to the ER bay for observation. He refused a wheelchair and walked to the bay with help. After sitting for awhile we cooled down and he was allowed to leave. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness, and hot and sweaty: CONT negative, HENT negative, Eyes negative, Respiratory negative, Skin negative, GI negative, Musculo negative, Previous Reactions: None, Objective: Vitals - There were no vitals filed for this visit. Physical Exam - Constitutional: Appearance - He is well-developed. HENT: Head -Normocephalic and atraumatic. Right Ear- External ear normal. Left Ear: External ear normal. Nose - Nose normal. Eyes - Conjunctiva/sclera: Conjunctivae normal. Pupils - Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm - Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort - Pulmonary effort is normal. Breath sounds: Normal breath sounds. Musculoskeletal: General -Normal range of motion. Cervical backN -normal range of motion and neck supple. Skin: Coloration: Skin is pale. Neurological: Mental Status - He is alert and oriented to person, place, and time. Assessment/Plan: Treatment include - water and snacks. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash). Pt was released at 3:26, he was accompanied by his wife. APRN Electronically Signed 3/18/2021 3:19 PM
47 2021-03-21 flushing, cold sweat Pt appeared dizzy, cold and clammy, pale, and flushed. Paramedics accessed pt, found out he was hypo... Read more
Pt appeared dizzy, cold and clammy, pale, and flushed. Paramedics accessed pt, found out he was hypotensive. MD on site examined pt and called management. Pt was transported to Hospital via ambulance, accompanied by wife. Pt was alert and oriented x3, EKG done on sinus rhythm .
47 2021-03-22 cold sweat, seizure Patient stated prior to vaccine he has a history of fainting after vaccination. About 1 minute after... Read more
Patient stated prior to vaccine he has a history of fainting after vaccination. About 1 minute after vaccination he became pale, clammy, and lightheaded. Spoke with patient while someone else retrieved an ice pack and water. About 2 minutes after vaccination patient became unconscious and upper body had seizure like activity. Patient was moved to the floor immediately regained consciousness. Event lasted approximately 15-20 seconds. After regaining consciousness, stated he felt better. Remained on the floor for about 5 minutes, EMS was called as precaution. EMS stated vital signs and blood sugar were stable. Patient refused transport to hospital. Instructed to follow up with PCP.
47 2021-03-23 numbness Numbness of right side of face. No treatment sought at this time. Still some numbness 5 hours after ... Read more
Numbness of right side of face. No treatment sought at this time. Still some numbness 5 hours after shot.
47 2021-03-23 numbness Patient reports receiving first dose of COVID-19 from Hospital (was not given vaccine card as their ... Read more
Patient reports receiving first dose of COVID-19 from Hospital (was not given vaccine card as their policy is to wait until after second dose). The day after vaccination, patient was complaining of fatigue with subjective fevers and rigors with associated headache and neck stiffness and on the day of presentation he complained of increased fatigue and general malaise for which he left work early and was ultimately found poorly responsive in his private vehicle with concern for possible seizure activity. He was brought to ER by ambulance. He reported numbness in hands and legs, rigidity, and an episode of urinary incontinence. He was started on empiric antibiotics for possible CNS infection, lumbar puncture completed. Found to have acellular CSF and antibiotics were discontinued. Patient remains in hospital at this time with course complicated by post-LP headache.
47 2021-03-25 facial paralysis, inability to speak 47 year old Gynecologist with PMH of severe MDD, GERD, asthma, referred to the ED by his PCP, after ... Read more
47 year old Gynecologist with PMH of severe MDD, GERD, asthma, referred to the ED by his PCP, after 5 days of gait instability, and about 4 weeks of altered mental status, confusion, short term memory deficits and malaise. ADEM suspected and extensive infectious, inflammatory and neoplastic workup was initiated. CT brain - reported NAD MRI brain consistent with Acute Diffused Encephalomyelitis and suspected ADEM. MRI cervical spine with evidence of demyelination involving posterior cord. ICU course complicated by new onset of aphasia, partial left frontotemporal seizures, LGIB due to proximal rectal laceration and central diabetes insipidus. Admitted 3/15/21. On 3/17 he developed aphasia with right sided facial droop and stroke alert was called. Later on 3/17 he developed GI bleeding and was taken for emergent colonoscopy, from which no significant conclusions could be made due to lack of preparation and subsequent poor visualization. No foreign body was reported. After he continued to have ongoing bleeding, the patient had a sigmoidoscopy, during which the migrated clip could be removed and two new hemostatic clips were placed. He subsequently developed large volume urine output and nephrology was consulted; the patient was diagnosed with likely diabetes insipidus. On 3/20 acyclovir was discontinued after HSV PCR was negative. High dose solumedrol for ADEM completed 5 day course 3/21. VDRL was non reactive. There were no oligoclonal bands. Solumedrol 1g daily was started 3/24/21: MRI showed L>R patchy enhancement and diffusion abnormalities consistent with ADEM. Repeat MRI showed new restricted diffusion of the left superior cortex, bilateral medial temporal lobes and hippocampi, genu of the corpus collosum, and pericallosal white matter, with ddx including status epilepticus, autoimmune encephalitis and infectious encephalitis including herpes simplex. Completed 5 day course of high dose steroids, 6 days of IVIG and on ongoing PLEX. Neurological improvement noted 3/25
47 2021-03-28 burning sensation, migraine, numbness Swollen lymph nodes Migraine headaches Burning in back of left thigh continuously Numbness in left... Read more
Swollen lymph nodes Migraine headaches Burning in back of left thigh continuously Numbness in left foot
47 2021-03-28 seizure Patient called into clinic to report about two hours after receiving vaccine he passed out and the p... Read more
Patient called into clinic to report about two hours after receiving vaccine he passed out and the person that was with him said he had a seizure. Patient reported feeling fine after about an hour, but was very tired and had a headache.
47 2021-03-30 weakness Chills, fever, muscle aches, joints pain for the first 4 days. On 5th day cough, generalized weaknes... Read more
Chills, fever, muscle aches, joints pain for the first 4 days. On 5th day cough, generalized weakness. I took Ibuprofen, vitamins, Airborne pills, Tylenol, antihistamines with some improvement. On 5th day due to caught and low grade temperature I started Augmentin 500mg po TID.
47 2021-03-30 bell's palsy Pt's MD reports Pt developed Bells Palsy after 1st dose, 4 days later.
47 2021-03-31 pain in extremity sore arm; This is a spontaneous report received from a contactable physician, the patient, reporting... Read more
sore arm; This is a spontaneous report received from a contactable physician, the patient, reporting on himself. A 47-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EJ1685), via an intramuscular route of administration in the left arm on 17Dec2020 11:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced clinically significant adverse events and sore arm on an unspecified date. The outcome of event, clinically significant adverse events and sore arm, was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021021539 second dose
47 2021-03-31 seizure Pt received Pfizer vaccine dose 1 at 12:05pm, immediately experienced seizure for aproximately one m... Read more
Pt received Pfizer vaccine dose 1 at 12:05pm, immediately experienced seizure for aproximately one minute. Postictal state symptoms include agitation and confusion. At 12:20 pt is AOx4, BP 188/118, HR 116, O2sat 99% 8 LPM NRB. Pt transported via EMS to hospital to receive further care.
47 2021-04-01 pain in extremity Severe Chills, Fever 102.2 on Tylenol, Body Aches, Headache, Arm soreness. Began about 10 hours aft... Read more
Severe Chills, Fever 102.2 on Tylenol, Body Aches, Headache, Arm soreness. Began about 10 hours after shot. Next day, fever down to 99 on Tylenol, still body aches. During severe chills was having hallucinations (I'm sure related to the fever).
47 2021-04-01 pain in extremity Soreness on the left arm, Fatigué, Fever with chills remained for 2 days; readings ranged from 99.9... Read more
Soreness on the left arm, Fatigué, Fever with chills remained for 2 days; readings ranged from 99.9F - 101F
47 2021-04-01 tenderness, migraine starting on 2nd day after the shot, right side of torso become soar and the skin in that area became... Read more
starting on 2nd day after the shot, right side of torso become soar and the skin in that area became somewhat tender as if there was a rash. Then on the 3rd day, a few small pimples showed up in that area, near the belt line. Then on the 4th day, the pimples started to look more like a rash. Then on the 4th day the rash became raised and looked more like boils. On the 6th day, I went to the doctor and they believe it is shingles. Started antiviral treatment for shingles on the sixth day. This entry is being made on the 7th day, one day into the shingles antiviral treatment. Never had shingles before. Also, migraine headache started on the 7th day, but this is not uncommon for me.
47 2021-04-03 tenderness tenderness at left side around waist and below, pea size lumps
47 2021-04-05 cold sweat Pfizer-BioNTech COVID- 19 Vaccine EUA: Paramedic noticed vaccine recipient's eyes roll back, and mil... Read more
Pfizer-BioNTech COVID- 19 Vaccine EUA: Paramedic noticed vaccine recipient's eyes roll back, and mild brief tonic (arms) preceding syncopal x1 activity, patient was pale, clammy. Paramedic held patient up in chair to avoid fall. Patient taken to OBS medic tent for observation for syncopal event. Observed, water offered, orthostatic positioning, rest. Patient walked out after recovery.
47 2021-04-05 facial paralysis, bell's palsy Around 3/19/21 shortly after patient started taking the (flonase), He had what felt like earache/inf... Read more
Around 3/19/21 shortly after patient started taking the (flonase), He had what felt like earache/infection. that went away in a day or so, but started having issues with the left sided drooping of my face. My PCP diagnosed it Bells Palsy, some nerve got swollen up/aggravated.
47 2021-04-05 pain in extremity tinnitus: high-frequency hissing/ringing non-stopping, volume - low, more on right ear. wakes me up ... Read more
tinnitus: high-frequency hissing/ringing non-stopping, volume - low, more on right ear. wakes me up at night. learned to train my brain to ignore. two weeks after the 1st vaccine shot, hearing another high-frequency ringing on right ear, louder, on and off, needing more effort to handle. other reactions: right after the 1st shot, felt face swelling. these symptoms disappeared 4 hours later. left arm sore for rest of the day, back to normal next day.
47 2021-04-05 pain in extremity arm pain, dizziness, passed out x2. Evaluated by EMS-Refusal to transport.
47 2021-04-06 pain in extremity Delayed cutaneous hypersensitivity (started within 24 hours but has continued intermittently for now... Read more
Delayed cutaneous hypersensitivity (started within 24 hours but has continued intermittently for now up to 9 days after injection. Sore arm, mild pain and redness and itchy rash on forearm of the arm where the vaccine was administered.
47 2021-04-06 pain in extremity Huge lump on right underarm. Used pain medication and cold/hot compress for the pain and sensitivit... Read more
Huge lump on right underarm. Used pain medication and cold/hot compress for the pain and sensitivity. Fully recovered after one week.
47 2021-04-07 pain in extremity Soreness in arm (worse than the first shot). Fatigue Fever chills
47 2021-04-08 tremor Patient was sitting in a chair drinking a soda being observed for 15 minutes after his first shot. ... Read more
Patient was sitting in a chair drinking a soda being observed for 15 minutes after his first shot. Ten minutes into his observation time, he started feeling sweaty, dropped his soda, started shaking and fell out of is chair face down. He gained cosciousness, turned onto his back and put his knees up. His blood pressure was 132/108. The ambulance was called. The patients vitals were normal whe the emt evaluated the patient. The patient refused treatment and called his wife to come pick him up and agreed to follow up with his primary care physician Monday.
47 2021-04-08 unresponsive to stimuli Client was in the observation area with his spouse post vaccination. Wife reported client dropped hi... Read more
Client was in the observation area with his spouse post vaccination. Wife reported client dropped his paperwork and became pale, diaphoretic and unresponsive. EMS responded immediately at which time the client was responsive, awake, alert and oriented. Client assessed and found to have vital signs within normal limits. 12 lead EKG performed and normal. Residual leg weakness improved quickly and patient was counseled regarding transfer to Emergency Department which was declined.
47 2021-04-09 weakness Severe chills; pain at injection site began at night and lasted until morning. All of the next day, ... Read more
Severe chills; pain at injection site began at night and lasted until morning. All of the next day, fatigue and weakness. Following evening, fever of 100.9
47 2021-04-09 weakness Extreme fatigue, lack of stamina, runny nose and headache
47 2021-04-09 numbness Beginning on day 13-14 after injection, mild numbness from injection point to finger tips. Lasting t... Read more
Beginning on day 13-14 after injection, mild numbness from injection point to finger tips. Lasting to present.
47 2021-04-09 pain in extremity, flushing Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Sys... Read more
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Vision changes-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient presented with sweating, and pale face. Chest pressure/pain and left arm pain. Face was pale. Pt reported nausea and vision bluring in and out. Reported unable to stand and verbalized the desire to call an ambulance to evaluate. 911 was called and all advice followed until EMS arrived. Rph remained with patient until EMS arrival. Pt had NO swelling of lips/eyes or difficulty breathing. No hives. Unable to reach patient to assess curent status
47 2021-04-10 fibromyalgia feeling of swelling in tongue and lower lip. Scratchy feeling also in same areas. Started about 25 m... Read more
feeling of swelling in tongue and lower lip. Scratchy feeling also in same areas. Started about 25 minutes after shot on drive home. Took allegra and it went away in 30-60 minutes. Tongue was sore the next day. I also suffered a mild anxiety attack at the same time. Treatment for that was meditation and cessation of throat swelling symptoms. Lastly, I also had a severe flare up of my fibromyalgia symptoms in my forearms starting 3 days after the injection. I don't know if this was a primary effect from the vaccine, or secondary from the additional nociceptive input from the joint and muscle pain I was experiencing in my forearms. I increased my lyrica to compensate. Two weeks out from the shot I'm almost back to baseline.
47 2021-04-11 weakness Patient reported he had SOB and trouble breathing while sleeping and his tongue felt "heavy" while e... Read more
Patient reported he had SOB and trouble breathing while sleeping and his tongue felt "heavy" while eating. Patient went to the ER at 1634 on 4/8/2021. ER report- positive for swollen tongue, weakness, negative for respiratory distress, Respirations were normal with mild scattered bronchial sounds
47 2021-04-11 numbness Dizziness, vertigo, confusion, numbness in legs, loss of balance
47 2021-04-11 pain in extremity Same night as shot: right arm soreness lasting 24 hours 2 Days after shot: really bad diarrhea lasti... Read more
Same night as shot: right arm soreness lasting 24 hours 2 Days after shot: really bad diarrhea lasting 12 hours Both cleared up on their own
47 2021-04-12 weakness Pain from injection. Lasted 2 days. Bad dreams 12 hours after injection. Very low energy 30 hours a... Read more
Pain from injection. Lasted 2 days. Bad dreams 12 hours after injection. Very low energy 30 hours after injection with a metallic taste in my mouth, Aches and pains, diarrhea, nausea, racing heart, confusion, exhaustion, 5 days after injection energy is better. All other symptoms are slowly subsiding.
47 2021-04-12 cold sweat 1430 PT SITTING IN POST VACCINE WAITING AREA AND HAD SYNCOPAL EPISODE. FALL TO FLOOR FROM CHAIR SITT... Read more
1430 PT SITTING IN POST VACCINE WAITING AREA AND HAD SYNCOPAL EPISODE. FALL TO FLOOR FROM CHAIR SITTING POSITION. PT TURNED TO BACK WITH ASSISTANCE FROM STAFF. PT QUICKLY REGAINED CONSCIOUSNESS AND NOTED TO BE WITH DILATED PUPILS AND TRYING TO FOCUS. NOTED CLAMMY SKIN. VS WITH HEART RATE IN 40'S WEAK RADIAL. BP 122/76. NOTED APPROX 1/2 INCH ABRASION TO RT TEMPORAL AREA FOREHEAD. PT ORIENTED TO SURROUNDINGS AND SITUATION. STATES "I TRIED TO RAISE MY HAND TO TELL NURSE I FELT FUNNY, THEN I FELT LIKE I WAS IN A DREAM AND WOKE UP WITH YOU ALL AROUND ME" EMS NOTIFIED IMMEDIATELY. PT DENIES ANY MEDICAL HX. VS MONITORED WITH BP 90/36 ON 2ND CHECK. EMS HERE AND TOOK POSSESSION OF PT
47 2021-04-12 pain in extremity Arm pain, fatigue, trouble sleeping
47 2021-04-13 tingling, weakness Mild tingling in the right foot, tachycardia during the first 15 minutes after getting vaccinated. S... Read more
Mild tingling in the right foot, tachycardia during the first 15 minutes after getting vaccinated. Severe pain and swelling of the left shoulder, tachycardia or change in heart rate, mild swelling of the hands, mild headache, weakness and tiredness for 48 hours after the first 5 hours of getting the vaccine.
47 2021-04-13 sensory loss tongue and jaw swelling, numbness post vaccination similar to first vaccine. BP 132/99, o2 98%. Give... Read more
tongue and jaw swelling, numbness post vaccination similar to first vaccine. BP 132/99, o2 98%. Given zyrtec PO, symptoms improved. Doctor and EMT on site and released to go home.
47 2021-04-14 feeling hot, cold sweat Patient received his first dose of Pfizer vaccine on 4/14/21 around 4pm and the next day on 4/15/202... Read more
Patient received his first dose of Pfizer vaccine on 4/14/21 around 4pm and the next day on 4/15/2021 woke up with left deltoid soreness at the site of injection which pt. expected but otherwise felt well until around 11am when he developed lightheadedness, became clammy and diaphoretic and felt feverish. His temp was 98.0 (oral) during evaluation and Blood pressure slightly elevated 140/80s (did not take his BP meds yet) but otherwise unremarkable vitals with no orthostatic hypotension. Random finger stick glucose was 142. Pt. given Tylenol 2 tabs PO in clinic and a hydration pack with water and allowed to lay down in clinic. Pt. monitored for 1.5 hours and Vitals remained stable, lightheadedness resolved. Pt. still felt warm but no longer diaphoretic and remained afebrile and d/c home in stable condition. Symptoms reported via V-safe app by patient.
47 2021-04-14 flushing Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: complained of heart burn and blood pressure rose
47 2021-04-14 numbness Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / ... Read more
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Joint Pain-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium
47 2021-04-14 tingling Tingling in upper & lower extremities
47 2021-04-15 feeling cold, tremor Fever. Headache. Muscle pain. Chills. Shakes.
47 2021-04-15 pain in extremity Headache, chills, soreness in legs, tired. Starting the morning after the injection and lasting all... Read more
Headache, chills, soreness in legs, tired. Starting the morning after the injection and lasting all day.
47 2021-04-15 pain in extremity Lower left leg pain, swelling and redness 3 days after 2nd dose of Pfizer Covid vaccine. Ultrasound... Read more
Lower left leg pain, swelling and redness 3 days after 2nd dose of Pfizer Covid vaccine. Ultrasound confirmed superficial blood clot from ankle to knee.
47 2021-04-17 pain in extremity, tenderness Purple or blue toes, cold to the touch, tender and sore. Three smallest toes on foot on same side as... Read more
Purple or blue toes, cold to the touch, tender and sore. Three smallest toes on foot on same side as receiving shot. Started about 4 days after receiving first shot of Pfizer. Worsened over about a day. Felt almost like bruising. Would no longer blanch when pressed or rubbed. Elevation helped. Seemed to stop progressing in severity by day 7.
47 2021-04-18 weakness Severe shivering. Fever. Aching. Headache. No energy. Lasted all weekend.
47 2021-04-18 feeling cold, migraine Eye redness and puffy, migraines, fever cold chills, muscle pain and joint pain, it?s been five days... Read more
Eye redness and puffy, migraines, fever cold chills, muscle pain and joint pain, it?s been five days and eye almost closed completely. Wanted to report the blood shot eyes and puffy ness around left eye
47 2021-04-18 flushing Systemic: After patient was directed to sit down for 15 min to be observed. A few min after patient ... Read more
Systemic: After patient was directed to sit down for 15 min to be observed. A few min after patient sat down in chair he passed out and fell off his chair. Nurse gave epipen called 911. Had scrape on R front scalp and some blood on nostril.-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: Patient reported that he had a phobia of needles prior to vaccination. Vaccine was given at approximately 2:50pm. After he fell, the nurse noted he was face down. The nurse asked him to roll on his back and he responded after a few moments. His skin was red, blotchy, and sweaty. Patient said that he was ok and didn't want to get sent to ER. Epipen was administered at 3:02pm on 3/17/21 and ambulance arrived 3:07pm. The nurse noted some improvement but pt was complaining of hand and arm pain.
47 2021-04-18 hypersensitivity of all senses @ 2 HOURS AFTER RECEIVING VACCINE, ELBOW STARTED TO BECOME SWOLLEN, RED, VERY PAINFUL AND HOT TO THE... Read more
@ 2 HOURS AFTER RECEIVING VACCINE, ELBOW STARTED TO BECOME SWOLLEN, RED, VERY PAINFUL AND HOT TO THE TOUCH. SYMPTOMS DO NOT APPEAR TO BE EASING. PAIN AND SENSITIVTY IS RESTRICTING MOVEMENT AND INTERFERING WITH NORMAL DAILY ACTIVITY. ALSO DAY OF VACCINCE - VERY ITCHY, NO RASH OR HIVES PRESENT.
47 2021-04-20 weakness Chills. Aching muscles and joints. Tired and weak. Lasted 36 hours. Slept 13 hours and treated... Read more
Chills. Aching muscles and joints. Tired and weak. Lasted 36 hours. Slept 13 hours and treated with ibuprofen.
47 2021-04-21 numbness, tingling acute severe low back pain radiating to both legs, with bilateral leg numbness/tingling
47 2021-04-21 pain in extremity I got this second shot a month ago. My arm still hurts. It's not as bad as it was the night I got ... Read more
I got this second shot a month ago. My arm still hurts. It's not as bad as it was the night I got the shot but I have a constant pain in my left arm. A constant nagging dull pain.
47 2021-04-22 weakness 5:41 patient mentioned feeling dizzy, weak and lightheaded. He sat down in a chair and began monitor... Read more
5:41 patient mentioned feeling dizzy, weak and lightheaded. He sat down in a chair and began monitoring symptoms. He said he has a history of seizures. At 5:45 after making sure he could take deep breaths and his airway was cleared, he took a sip of water. At 5:47 he mentioned having an increased heart rate. At 5:49, he willingly laid on the floor. At 5:51 he said his chest hurt and had a headache. At 5:53 he then sat up and took a few more sips of water. He felt comfortable enough to stand back and go home. He and his fiancé left the building. He vocalized that his fiancé will be driving him home.
47 2021-04-22 hot flush Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-M... Read more
Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Additional Details: Patient reported that he had difficulty hearing. Patient sat in the chair and then lost conciousness. He was laid down on the ground, vitals were checked, and water was given. Noted high blood pressure. Patient regained conciousness within 3-5 minutes. Vitals were rechecked and returned to normal.
47 2021-04-22 numbness Numbness radiating down left arm, numbness moving up neck and left side of ear and scalp. Multiple... Read more
Numbness radiating down left arm, numbness moving up neck and left side of ear and scalp. Multiple Hives on arms , chest, and back.
47 2021-04-22 tingling I myself a healthy physician with no prior medical illnesses received Pfizer COVID19 vaccine first ... Read more
I myself a healthy physician with no prior medical illnesses received Pfizer COVID19 vaccine first on 12/18/20 and second dose on 1/8/21 both doses at Hospital , ( they have the information of the lots)- Then on March 19th I started to develop an acute ascending sensory symptoms first in feet and then arms ; also involved torso . Sensory symptoms consisted of pins and needles and paresthesias . They persists on even today but less intense . Also had temperature dysregulation of the feet when shoes worn. There seem to have also some changes in my sweat gland activity. Saw my PCP and neurologist with working diagnosis of acute sensory neuropathy of unclear etiology. Though this could be idiopathic but like to check out if any association with COVID19 vaccine as this only association i could think about in healthy patient ie myself with no medial issues or any acute illness recently nor any systemic disorders to account for symptoms ; wanted to report so that you are aware and I personally wanted to see if this is being recognized in other vaccine recipients and might help me to arrive at a diagnosis.
47 2021-04-25 pain in extremity, numbness SORE ARM, NUMB ARM, HEADACHE, NAUSER, TIRED, VOMIT.
47 2021-04-25 pain in extremity Moderate pain in the left arm. First injection was in the left arm and the second was in the right a... Read more
Moderate pain in the left arm. First injection was in the left arm and the second was in the right arm.
47 2021-04-25 pain in extremity On Saturday, April 24, around noon, I heard a ringing in my right ear, then it clogged up. The clogg... Read more
On Saturday, April 24, around noon, I heard a ringing in my right ear, then it clogged up. The clogged sensation changes depending on how much I move around, but it has not gone away. I can clear my eustachian tubes, so whatever it is seems to be further in the ear. I can still hear, it's just muffled in the right ear. The only other adverse reaction I've had was on Monday, April 19, where I had very sore hips/back around 8pm and around 11pm when I went to bed, I had chills as if I had a fever. Those symptoms were gone by the morning of Tuesday, April 20.
47 2021-04-25 tingling client complained of left hand tingling after receiving 2nd Pfizer. Client informed EMTs of new ons... Read more
client complained of left hand tingling after receiving 2nd Pfizer. Client informed EMTs of new onset of symptoms. PHN joined team shortly after. Per client had been in waiting area 20mins and new onset 8 mins ago. First vitals 1303: blood pressure: 130/90, pulse 74, oxygen 97%. Per client sensation to left hand as if "hand had fallen asleep". Sensory and motor intact on left hand. Client received vaccine in left deltoid. Client denied pain or radiation past wrist. Per client no reactions to first dose. Vitals 1308: blood pressure 120/80, pulse 71, oxygen 98%. Per client tingling sensation lessened. Medical history of diabetes, takes metformin. No history of allergies. at 1313 client ready to leave. Per client felt fine. EMT advised client to seek medical care of worsened symptom. Last vitals: blood pressure: 120/80, pulse 72, oxygen 98%. Client left facility with steady gait at 1315.
47 2021-04-26 feeling hot Patient complained of getting hot. While sitting in the chair, he fell to ground, hitting head on th... Read more
Patient complained of getting hot. While sitting in the chair, he fell to ground, hitting head on the back of the chair. This patient was evaluated by EMT and Nurse. Patient denies double or blurred vision, nor nausea or vomiting, nor headache, nor dizziness, but some soreness at back of head. No noted swelling at this site. At 3:44 pm, vitals were: O2 sat 97%, B/P 110/60, HR 86, R 20. Offered water and tolerated well. Patient's family accompanied him to this event. At 4:07pm, vitals , O2 sat 99%, B/P 112/68, HR 86, R 20. At 4:26 pm, paramedics were called, and arrived, and evaluated patient. Vitals now, O2 sat 100%, B/P 125/73, HR 76, R 20. Paramedics deemed patient stable to go home. At 4:35 pm, patient released to go home with family.
47 2021-04-26 numbness Rapid heart rate, slight nausea, slight numbness to front right cheek and lips. Onset within 1 minu... Read more
Rapid heart rate, slight nausea, slight numbness to front right cheek and lips. Onset within 1 minute of injection. No treatment given. Heart rate started to decrease after 10 minutes and returned to normal within 30-40 minutes. Numb areas returned to normal within 45-60 minutes. Slight feeling of anxiety for several hours, but this could have been simply from stress from the initial reaction. I also occasionally have random panic attacks and could have potentially had a small one at the onset of my face going numb which could have contributed to the length of unease.
47 2021-04-26 tingling, tremor, involuntary muscle movements, inability to speak At 1118 patient fainted, had fixed shaking, pale, loss of speech. Once patient reactted he was able ... Read more
At 1118 patient fainted, had fixed shaking, pale, loss of speech. Once patient reactted he was able to speak and gave Past medical history of Asperger syndrome and no fainting spells before. Patient complained of stomach pain. numb lip, tingling sensation on fingers. Hands began to flexion and tense up. Vital signs were with in normal range. clinet began to show normalized sign and symptoms. Ems was still called and was taken to hospital for furhter observation at 1153.
47 2021-04-27 pain in extremity pt start to feel leg pain 10 days after the injection and then shortness of breath a week later pt ... Read more
pt start to feel leg pain 10 days after the injection and then shortness of breath a week later pt was found with DVT and PE
47 2021-04-27 tingling Severe, Acute Inflammatory Demyelinating Polyneuropathy (Guillain-Barré syndrome), with no other an... Read more
Severe, Acute Inflammatory Demyelinating Polyneuropathy (Guillain-Barré syndrome), with no other antecedent upper respiratory illness or GI illness. First developed extremity paresthesias, followed by rapid onset and progression proximal > distal, upper >lower extremity weakness on 4/6/2021, reaching peak on 2nd day of IVIG (4/13) initially with subtle improvements on his 3rd dose of IVIG (4/14; received total 2g/kg over 5 days) and then rapid worsening since 4/21/2021 to quadriplegia and bulbar weakness, requiring intubation on 4/26. Now on plasmapheresis and still hospitalized.
47 2021-04-27 tremor Patient with history of throat constriction, lip tingling, headache, fecal urgency and chills/tremul... Read more
Patient with history of throat constriction, lip tingling, headache, fecal urgency and chills/tremulousness about 15-20 mins after Pfizer COVID-19 vaccination.
47 2021-04-28 speech disorder, difficulty speaking 11:30 Shot administered at drive thru site 11:40-50 Feeling mild tingling on lips, back of throat fe... Read more
11:30 Shot administered at drive thru site 11:40-50 Feeling mild tingling on lips, back of throat feels dry, getting the urge to pass stool. In the mirror I see the arches around the uvula swollen and red 11:50 Inform the nurse. Body starts shivering, talking and breathing is labored- according to my wife my voice sounded very different. Nurse checks lungs through stethoscope and SPO2+ heart rate- All normal, does not detect any constriction of lung air passages. But I am panting while talking. 11:55 I decide to wait and monitor. Shivering slowly stops, breathing slowly starts to return to normal (in about 20 mins). The urge to pass stool stopped. 12:22 No change either way- Breathing is ok, but mild tingling around lips, and feeling of tightness at back of throat. I take 5mg Cetrizine HCl. [Note: My mouth and throat felt like I have felt in the past with a reaction to shellfish.] 1:15 Redness at back of throat is less, and I feel normal. I drive off the parking lot of the vaccination site Next day Throat feels sore, but otherwise ok
47 2021-04-30 bell's palsy Bell's Palsy. Currently managing ok with a steroid and antiviral.
47 2021-05-01 feeling cold, feeling hot i was sick with flu like symptoms; i was sick with flu like symptoms; chills; hot; cold flashes; ach... Read more
i was sick with flu like symptoms; i was sick with flu like symptoms; chills; hot; cold flashes; achy; i am extremely tired; This is a spontaneous report from a contactable consumer (reported for himself). This 47-year-old male patient received second dose of BNT162B2 (Pfizer covid-19 vaccine, solution for injection, Batch/Lot number: EP6955) via an unspecified route of administration at left Arm on 17Apr2021 09:00, as a single dose for covid-19 immunization. The patient did not have any medical history or allergy to medications, food or other products. Concomitant medications were not reported. He received first dose of BNT162B2 (Pfizer covid-19 vaccine, solution for injection, Batch/Lot number: EP6955) via an unspecified route of administration at left Arm on 27Mar2021 09:00, as a single dose for covid-19 immunization. On 18Apr2021 07:00, he was sick with flu like symptoms, chills, hot, cold flashes, achy and felt extremely tired. He did not receive any treatment events. He did not visit doctor or other healthcare professional office/clinic or emergency room/department or urgent care. He did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was recovering from the events of sick with flu like symptoms, chills, hot, cold flashes, achy and felt extremely tired. He was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. No follow-up attempts are needed. No further information is expected.
47 2021-05-01 numbness, muscle spasms, numbness and pain in extremities Flared up peripheral neuropathy symptoms within 30 minutes including numbness tingling in toes, hand... Read more
Flared up peripheral neuropathy symptoms within 30 minutes including numbness tingling in toes, hands, feet, legs, face/head, and back. Included muscle pains and spasms and ear pain. Pain from pressure on almost any part of body. Worst the first week but symptoms have continued 3 weeks afterwards. Still muscle pains, numbness and tingling:
47 2021-05-04 numbness numbness on the fingers of the arm in which I received the injection; This is a spontaneous report f... Read more
numbness on the fingers of the arm in which I received the injection; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 07Apr2021 17:15 (Lot Number: EP7533) (at the age of 47) as single dose for covid-19 immunisation. Medical history included fruit allergy (kiwi) from an unknown date and unknown if ongoing. The patient's concomitant medications were none (no other medication in 2 weeks). No other vaccine was received in four weeks. No covid tested post vaccination. No covid prior vaccination. The patient experienced 'numbness on the fingers of the arm in which i received the injection' on 11Apr2021 07:30. No treatment received. The outcome was not recovered (it was reported: '9 days later I still have this numbness in my fingers (though it has not gotten any better or worse since I first noticed the numbness))'. No follow-up attempts are possible. No further information is expected
47 2021-05-04 pain in extremity, muscle twitching arm twitching; arm is kind of hurting; This is a spontaneous report from a contactable consumer (pat... Read more
arm twitching; arm is kind of hurting; This is a spontaneous report from a contactable consumer (patient's wife). A 47-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in left arm at the age of 47-year-old on 12Apr2021 11:45 (Lot Number: EW0158) as single dose for COVID-19 immunisation. Medical history included none. Family Medical History reported Diabetes, heart disease, high cholesterol. There were no concomitant medications. The patient previously took first dose bnt162b2 (Lot Number: EN6199, Route IM, Anatomical Location: Left)) at the age of 47-year-old on 22Mar2021 for COVID-19 immunisation. Caller reporting side effects from Pfizer COVID vaccine that her husband is experiencing. Caller states that her husband had 2nd dose on Monday 12Apr2021 and he is generally ok, his arm is kind of hurting in Apr2021. Caller states her husband arm started twitching today 15Apr2021 (twitching started today around 11AM this morning) and would like to know have other people been reporting this, what this is. Caller states that he caller her about 10:50am this morning so it seems like it has been 72 hours, that the arm twitching started, after the Pfizer COVID vaccine that her husband had on Monday 12Apr2021. Caller states that she is feeling guilty because she had no reaction to the vaccine but her husband is having problems and she made the appointment and made him go get the Pfizer COVID vaccine. No any AEs require a visit to Emergency Room or Physician Office. The outcome of event arm twitching was not recovered. The outcome of event arm is kind of hurting was unknown. No follow up attempts are needed. No further information is expected.
47 2021-05-04 pain in extremity Slight headache; Right arm was sore where shot was; Little tiredness; Arm swelling after first dose;... Read more
Slight headache; Right arm was sore where shot was; Little tiredness; Arm swelling after first dose; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17Mar2021 10:15 (Batch/Lot Number: EN6198) at the age of 47-years-old as single dose for covid-19 immunization (reported as 'protection for self and others'). Medical history included ongoing Fibroneuropathy, he had it in his feet, started after low back surgery 30 years before in 1991, L5 fractured, had 2 rods and 4 screws into low back, ongoing tremors both arms and hands, mainly left started in high school when first he first noticed, ongoing high blood pressure started in early 2000s, ongoing high cholesterol started in early 2000s, and patient had been on social security disability since 2014 and ongoing. The patient's concomitant medications were not reported. The patient experienced slight headache, right arm was sore where shot was, little tiredness, arm swelling after first dose on 17Mar2021. The outcome of the event headache was recovered on 17Mar2021 with duration of 15 minutes, the outcome of the other events was recovered on 19Mar2021. No follow-up attempts are needed. No further information is expected.
47 2021-05-06 facial paralysis I thank I got Bell?s Palsy. I got the shot at about 9:00am on May 3 2021, in my left arm. Who I woke... Read more
I thank I got Bell?s Palsy. I got the shot at about 9:00am on May 3 2021, in my left arm. Who I woke up the next morning and tried to drank water it came back out on the left side of my face. I went to look in the mirror and tried to smile and only the right side of my mouth would go up. The rest of my left side is fine it?s just the left side of my face.
47 2021-05-06 numbness Vertigo, Vomiting, Dizziness, face numbness, double vision, left arm is difficult to use, went t... Read more
Vertigo, Vomiting, Dizziness, face numbness, double vision, left arm is difficult to use, went to the emergency, given Meclizine, baby aspirin, Atorvastatin Calcium I still have difficulty walking, double vision comes and goes my balance is still off
47 2021-05-08 weakness Fever chills body ache no energy head ache
47 2021-05-10 muscle spasms Medical history included ongoing hypersensitivity , ongoing asthma. The patient concomitant medicati... Read more
Medical history included ongoing hypersensitivity , ongoing asthma. The patient concomitant medications included products for allergy. The patient experienced debilitating back, spinal and muscular pain in his back on an unspecified date with outcome of recovering , not really able to move at all on an unspecified date with outcome of unknown , he has cramps on an unspecified date with outcome of unknown. The clinical course was as follows 24 hours after the vaccine, he developed debilitating back, spinal and muscular pain in his back for at least 72 hours. He was not really able to move at all. It got better to the point he can function now, but he is still getting it. He has cramps, back aches, spinal aches, muscles aches from it still. They have Improved but not resolved. He didn't receive treatment for them. The only thing he did take is Advil it kind of helped. He knows it is contraindicated for 6 weeks after the vaccine , so he tried not to take it. He only took it for the debilitating pain. The events were assessed as non-serious. No follow-up attempts are needed. No further information is expected.
47 2021-05-10 seizure generalized convulsion/second seizure witnessed by medical staff; elevated CSF protein to 79, CSF Gl... Read more
generalized convulsion/second seizure witnessed by medical staff; elevated CSF protein to 79, CSF Glucose 73; elevated CSF protein to 79, CSF Glucose 73; severe headache; confused; This is a spontaneous report from a contactable physician. A 47-years-old male patient received the first dose of BNT162B2 (PFIZER COVID 19 VACCINE), intramuscular on 22Apr2021 09:30 (Batch/Lot number was not reported) at age of 47 years as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had been tested for COVID-19. On Friday 23Apr2021, patient woke up with severe headache, per wife was confused. Then had a generalized convulsion. Presented to the ED, had a second seizure witnessed by medical staff. Workup with MRI, CTA and LP were notable for an elevated CSF protein to 79, CSF Glucose 73, otherwise no structural abnormality was identifed. Patient was clinically improving after being treated with seizure medications as of 26Apr2021. The adverse event result in Emergency room/department or urgent care, hospitalization. Covid 19 pcr nasal swab on 24Apr2021 was negative. Outcome of events was unknown. Follow-up needed. Information about batch/lot number has been requested.; Sender's Comments: Considering a plausible temporal relationship , a possible contributory role of suspect product BNT162B2 to the reported event seizures, CSF glucose increased, CSF protein increased, headache, confusional state cannot be completely 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.
47 2021-05-12 impaired body coordination, numbness and pain in extremities neuropathy; ataxia; neurological deficits with headache; Headache; This is a spontaneous report from... Read more
neuropathy; ataxia; neurological deficits with headache; Headache; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm left on 16Mar2021 (Lot Number: En6208) (at age of 47-year-old) as single dose for covid-19 immunization. Medical history included high blood pressure, there was no known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 23Feb2021 (Lot number: En6198) for covid-19 immunization. There was no other vaccine in four weeks. Adverse event: Headache occurred 10-15 mins after second vaccination. Persistent headache after 3 weeks of 2 COVID vaccination. After the 3 weeks (also reported as on 26Mar2021) started experiencing neurological deficits with headache. Symptoms include: motor sensory weakness, ataxia and neuropathy. Admitted to hospital for neuropathy and ataxia on 21Apr2021. AE results in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 21Apr2021.There was no COVID prior vaccination. The outcome of the events was not recovered.
47 2021-05-23 weakness, tremor, cold extremities Patient had become extremely paleness, sweating, coldness of the hands, light headed, dizziness, wea... Read more
Patient had become extremely paleness, sweating, coldness of the hands, light headed, dizziness, weakness, shaky like trembling sign of minor seizures.
47 2021-05-25 weakness fever keeps going up; 1st it was 99, then 100 and then 101; headache; body aches; Not feeling well; ... Read more
fever keeps going up; 1st it was 99, then 100 and then 101; headache; body aches; Not feeling well; weak; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number and expiration date were not reported), via an unspecified route of administration on 13May2021 at 15:00, (at the age of 47-years-old) at 1ST DOSE single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever and it kept going up, 99 at first, then 100 and then 101, had headache, body aches, not feeling well and weak in May2021 after the first dose. He stated he just took two pills of Tylenol Extra Strength. Treatment was given for the events. Patient wanted to know if it was normal to have a fever and other symptoms and how long it would lasts. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
47 2021-05-28 feeling cold, pain in extremity I have diarrhea; intense body aches all over accompanied with fever; intense body aches all over acc... Read more
I have diarrhea; intense body aches all over accompanied with fever; intense body aches all over accompanied with fever; didn't have an appetite; I had a splitting headache; arm felt heavy like it was falling asleep; pain at the injection site that I expected and radiated down to my wrist.; pain at the injection site that I expected and radiated down to my wrist.; he had pain in his shoulder, arm and forearm down to his wrist; he had pain in his shoulder, arm and forearm down to his wrist; His hand on the left side (on the injection site arm) felt very cold; He is tired and exhausted too; This is a spontaneous report from a contactable consumer reporting for himself. This is one of the two report from same reporter. A 47-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Solution for injection), via an unspecified route of administration, administered in Arm Left on 28Apr2021 (Batch/Lot Number: EW0179; Expiration Date: Aug2021) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 28Apr2021, within a half hour after vaccination the patient arm felt heavy like it was falling asleep and recovered on the same day (reported as His arm felt heavy for 3 hours). Eventually that turned into pain at the injection site that he expected, and the pain radiated down to his wrist. On 30Apr2021, he had a splitting headache for a couple days. On 02May2021, reported as the next couple days he experienced intense body aches all over accompanied with fever. Also, he didn't have an appetite. The outcome of the event splitting headache was recovered on 02May2021. Reported as "today he still doesn't feel 100%". On 03May2021, he had diarrhea (reported as Yesterday and today). He did not have a prescribing doctor. He went to the clinic from the local health department. The body aches were starting to go away. He kept himself informed and up with the science, but he was just mostly concerned the effects have lasted this long. On an unknown date in 2021, he had pain in his shoulder, arm and forearm down to his wrist. His hand on the left side (on the injection site arm) felt very cold. It felt as though it was not having the circulation it should. As that went away, he could feel the pain in the injection site. He had a splitting headache that lasted Friday, Saturday, and Sunday. He recovered completely. He didn't normally get headaches. He was tired and exhausted too on unknown date in 2021. It was reported that, he didn't typically take naps, but he took a nap yesterday. His stomach feels a little better, but yesterday and today he did have diarrhea. He was a very healthy person. The injection site pain has gone away on unknown date in 2021. The body aches are starting to go away (recovering). On an unknown date in 2021, the events wrist pain recovered. On an unknown date in May2021, the patient recovered from the event fever. The outcome of the event diarrhea was recovering. The outcome of the events decreased appetite, pain in his shoulder, arm, and forearm down, felt very cold, and tired and exhausted was unknown. No follow-up attempts are needed. No further information is expected.
47 2021-05-28 seizure getting lightheaded and dizzy all the time; Seizure; This is a spontaneous report from a contactable... Read more
getting lightheaded and dizzy all the time; Seizure; This is a spontaneous report from a contactable consumer (patient) and a consumer (patient's ex-wife/ roommate) A 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER2613 and expiration date not provided), via an unspecified route of administration, on 01May2021 (at the age of 47-year-old), at single dose, for COVID-19 immunization. Medical history included blood cholesterol, high blood pressure, ongoing seizures from 1991; patient was being hit in the head with a steel baseball bat 13 times, and had a lot of brain damage; and ongoing sleep. Prior Vaccinations (within 4 weeks) provided as no. Concomitant medications included ongoing topiramate (TROKENDI XR) for seizure, ongoing allopurinol (ELAVIL) for sleep, and medication for cholesterol and one for high blood pressure. Patient had been on topiramate a couple of months. They were working with him to get him better than he was because he was having a lot of the little ones. He got the pill packs. He tried the little compartment things and they weren't working. Roommate suggested they try the pill packs to make it easier. There was the time on the packs. The patient experienced seizures on 13May2021; getting lightheaded and dizzy all the time on unknown date. Patient's second dose was scheduled 22May2021. Due to symptoms that he experienced he was afraid to take second dose. Patient had petite mal seizure last night on 13May2021, he got ahold of the doctor and got an appointment with his family doctor. They don't know about the seizure yet. Patient was feeling ok until he got the shot. Now, he was back to getting lightheaded and dizzy all the time. Patient got social security and had a hard time remembering his phone number. Patient's ex-wife clarified that patient called the doctor and got an appointment. He had upcoming appointment. The doctor wanted him to go to the emergency room. She had known him since 2005. When he had a mild seizure the ER doesn't do anything for him. They just leave him in the bed and wait until he comes to his senses. She just told patient to go in his room and lay down and offered him paracetamol (TYLENOL) and all that stuff. She couldn't move him when he was having one of the worse seizures because he turns into a board. She tried to get him aware. They didn't last long. Patient had grand-mal seizures since the age of 18 after being hit in the head with a steel baseball bat 13 times. He had a lot of brain damage. The brain can't fix itself. She was the only one that knows how to handle him. Patient's ex-wife listed at the doctor office because patient had a hard time explaining things and stutters a lot, he can't answer right away. The seizure patient had yesterday was a petite mal seizure. It wasn't a full blown grand mal seizure. He had three different phases of seizures. He had the staring one where he was looking out in space. Then he had the next one that happened in the car. He sat down and put his head back to relax. She thought he was taking a break, but it was a seizure. She touches him to focus and get him back. At night was when he has the worst ones where he looses control of his bladder, foams at the mouth, and turns into a board. He can't bend. He has only had 3 of those in the time she had known him. The other ones he had quite often. The quicker he comes out of it the less headache he has after it. If they let it run its course he has a bad headache and nausea. She tries to open his eyes because he comes out better. One time when he had grand mal seizure she couldn't get him rolled over and had to get help. Even though it was saliva and he was foaming at the mouth she was afraid he would choke on it. He had one starring seizure shortly before the COVID vaccine. He had them a lot. If they take blood or run scan it won't show patient had a seizure. For a little while patient and his roommate weren't together. If he did have seizure during that time he got himself out of it. He has only had 3 bad ones since 2005. Patient told his doctor that he thought it was related to the COVID shot. Patient's ex-wife didn't believe that was what caused the seizure (She thought if it was related it would have happened within 20 minutes of getting the vaccine). She thought he just had one. It played in his mind that he had the shot. Patient's brain stopped growing when he was 18 due to damage. The outcome of the events was unknown.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Seizures, Dizziness and the suspect BNT162B2.
47 2021-05-31 weakness This is a spontaneous report from a contactable consumer (patient). This 47-year-old male patient r... Read more
This is a spontaneous report from a contactable consumer (patient). This 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unknown route in the right arm, on 23Feb2021 12:45 (at the age of 47-year-old) at single dose for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included COVID-19 from Dec2020. The patient did not have concomitant medications. On 01Mar2021, the patient developed runny nose, congestion, a little bit of weakness and tired. He said he felt like he did when he had the COVID-19 virus in Dec2020. He said when he had the COVID-19 Virus in Dec2020, he had the virus for a few days, and the virus was not bad. He clarified he had the COVID-19 Virus for like 10 days total. He clarified he had a runny nose, congestion, a little bit of weakness, and was tired. He said today (on 02Mar2021) his symptoms were not as strong as yesterday, clarifying his symptoms were down by maybe 20% from yesterday. He took some liquid dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL) for his symptoms. The events did not require emergency room visit/physician office visit. The patient was recovering from the events. No follow-up attempts are possible; information about Lot/Batch number cannot be requested.
47 2021-06-01 cold sweat Extreme body and joint aches; joint aches; extreme fatigue/ very tired; cold sweats; This is a spont... Read more
Extreme body and joint aches; joint aches; extreme fatigue/ very tired; cold sweats; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 23Feb2021 09:00 (Batch/Lot number was not reported), age at vaccination of 43-years-old, as single dose, for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. The patient previously took nitric oxide and experienced hypersensitivity, received BNT162B2 dose 1 administered in Arm Left on 03Feb2021 01:00 PM (Batch/Lot number was not reported) for covid-19 immunisation. Concomitant medications included metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported; simvastatin (SIMVASTATIN) taken for an unspecified indication, start and stop date were not reported; bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extreme body and joint aches, extreme fatigue, cold sweats and was very tired, all on 24Feb2021. No treatments were given for the events. 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 recovered from the events on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
47 2021-06-01 pain in extremity Right shoulder and elbow pain with inflammation of tendons. Left knee pain with inflammation of the... Read more
Right shoulder and elbow pain with inflammation of tendons. Left knee pain with inflammation of the adductor tendons around the knee, enthesopathy of the right index extensor tendon
47 2021-06-03 muscle twitching I am suffering from facial spasm; Muscle underneath the eye keep pumping for couple of minutes; This... Read more
I am suffering from facial spasm; Muscle underneath the eye keep pumping for couple of minutes; This is a spontaneous report from a contactable consumer. A 47-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8732), via intramuscular route of administration in the left arm, on 29Mar2021 as a 2nd dose, single for COVID-19 immunisation. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6199), via unspecified route of administration in the left arm, on 08Mar2021 as a 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient underwent annual lab check up and the results were unspecified. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient experienced facial spasm and her muscle underneath the eye was pumping for couple of minutes. It was reported that it was became more serious on 09May2021. The patient wanted to find out how many people got the same symptoms like her. The patient did not received any treatment. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
47 2021-06-06 weakness Severe exhaustion. After 3 weeks I got a B12 shot at recommendation of doctor. Benefit has worn of... Read more
Severe exhaustion. After 3 weeks I got a B12 shot at recommendation of doctor. Benefit has worn off and I need to get another B12 shot. I went from running for an hour after work every day to having to take an hour nap after work if I want to make it through dinner.
47 2021-06-06 pain in extremity DVT in left leg, painful swelling still today
47 2021-06-07 bell's palsy, facial paralysis Systemic: Bell's Palsy-Medium, Systemic: Ear pain as well-Mild, Additional Details: States issue sta... Read more
Systemic: Bell's Palsy-Medium, Systemic: Ear pain as well-Mild, Additional Details: States issue started 24 hours after vaccine. Right side of face is drooping and states has ear pain. He also stated same issue happen to him when he was younger and lasted for about 6 weeks. Stated he remembers being treated with steriods that which helped. I advised patient to seek medical attention from hospital/urgent care to see if they can help.
47 2021-06-07 pain in extremity pain in the arm is getting worse every week, throbbing pain 0 to 8 number in the arm.; pain at the i... Read more
pain in the arm is getting worse every week, throbbing pain 0 to 8 number in the arm.; pain at the injection site; This is a spontaneous report received from a contactable consumer (Patient). A 47-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left in Mid-afternoon on 30Apr2021 (Batch/Lot Number: EW0176) as 2nd dose, single dose for covid-19 immunisation. The patient medical history was reported as none. Concomitant medication was not reported. Patient family Medical History Relevant to AE was reported as none. Patient historic vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunization on 31Mar2021. Adverse event following prior vaccination was reported as none. Patient did not receive any other vaccine within 4 weeks prior to the first administration date of the Pfizer vaccine. On 30Apr2021, had a little bit of pain, normal, where the shot was. From that time, about 1-2 times per week he had pain in that left arm. Pain had been progressively constant on 0-8 pain scale for the site where the shot was put in his arm. He called the CDC, just came from his doctor's office. He was following CDC protocols implemented on this. He had to get bloodwork-clarified he had bloodwork drawn today; doctor wanted him to get an ultrasound done on his arm and start steroids as prescribed. As soon as he got the shot, he felt some...what he thinks was an indication of he got a shot-his body protecting itself from foreign body. About a week later he started to develop more pain in that area and then it progressively got worse, throbbing. He just had an appointment with his doctor's PA at 08:30 this morning on 01Jun2021. He just had bloodwork drawn but had no information for that or any other relevant testing/investigations done to provide for report. He received second dose of Covid-19 Vaccine, which he verified as being Pfizer-BioNTech product from CDC vaccine record card, on 30Apr2021. He reported pain starting that day and progressively worsening. He asked how long this side effect is going to take, who is going to pay for this process because supposedly he has to pay for this; but this is basically a clinical trial and when in a clinical trial the company pays for this, right? He also mentioned that his first dose of Covid-19 Vaccine was on 31Mar2021, and second dose of Covid-19 Vaccine was on 30Apr2021; so, second dose administered 30 days after first dose. He reported that kept him within the 6-week window. The outcome wof the events was not recovered.
47 2021-06-08 pain in extremity tendon inflammation; red dots all over my legs; I could not just walk; on my left leg down I have a ... Read more
tendon inflammation; red dots all over my legs; I could not just walk; on my left leg down I have a bump and it's painful; on my left leg down I have a bump and it's painful; This is a spontaneous report from a contactable consumer or other non hcp. A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 14May2021 (at the age of 47 years old) as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No relevant medical history. The patient reported that he got first dose of PFIZER-BIONTECH COVID-19 VACCINE on 14May2021 and was scheduled to get his second dose on 04Jun2021. The patient looking for guidance if he should get a second dose today as he experienced adverse reactions after first dose. On 30May2021, when he woke up in the morning he could not just walk, stated never happened before. His right thigh, right leg completely painful, he got crutches and started to walk. On 31May2021, he went to emergency room, where they did an X- ray and blood tests for blood clots but they did not see any blood clots. They gave him some gel and some muscle relaxants and told him that maybe he had tendon inflammation, but he did not run or he did not even exercise. Now after 4-5 days (Jun2021), cannot walk and now he started walking a little bit, but pain was still there. His thigh was swollen, and he had red dots all over his legs and on his left leg down he had a bump, and it was painful. He also had this red and red dots everywhere. The patient underwent lab tests and procedures which included X- ray and blood tests: did not see any blood clots on 31May2021. The outcome of the events red dots all over my leg, tendon inflammation was unknown, i could not just walk was recovering, on my left leg down i have a bump and it's painful was not recovered.
47 2021-06-09 pain in extremity My left arm has been sore for the last 5 weeks since the shot; This is a spontaneous report from a c... Read more
My left arm has been sore for the last 5 weeks since the shot; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Em 9808) via an unspecified route of administration administered in arm left on 07Feb2021 09:00 AM as first dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Facility type vaccine was reported as other. The patient was not tested with Covid infection prior to Covid vaccination. The patient was not on any other vaccine four weeks prior to Covid vaccine. The patient was not on any other medications two weeks prior to Covid vaccine. On 07Feb2021 at 10:00 AM, the patient experienced left arm had been sore and was there for the last 5 weeks since the shot. The patient had not received any treatment medication for the resulted events. The patient received Pfizer other vaccine (unspecified) on 26Feb2021 on left arm. The outcome of the event was not recovered. No follow-up attempts are possible. No further information was expected.
47 2021-06-09 pain in extremity Blood pressure and it was 179/91/still 150 over 70 over 69 which is quite high for me; I felt feveri... Read more
Blood pressure and it was 179/91/still 150 over 70 over 69 which is quite high for me; I felt feverish; Rash with bumps on my forehead/Broken out rash, turned red; Face was red; Heart rate has also been high; Head hurt; My arm was a little sore; I was a little tired; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 47-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER8736), via an unspecified route of administration on 30Apr2021 (at the age of 47 years) as a 2nd dose, single dose for COVID-19 immunisation. The patient medical history included over active autoimmune disease, Rheumatoid arthritis. The patient concomitant medication included adalimumab (HUMIRA, Lot number and expiration date was unknown) 0.4 ml, once a week, a shot in his belly or leg all around for rheumatoid arthritis and Methotrexate (Lot number and expiration date was unknown) 2.5mg, took 6 of them once a week for rheumatoid arthritis and autoimmune. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER8731), via an unspecified route of administration on 09Apr2021 as a 1st dose, single dose for COVID-19 immunisation. On 30Apr2021, the patient at first experienced arm was a little sore and little tired. On 04May2021, patient felt bad, felt feverish. On Wednesday, he got a rash with bumps on his forehead. The BP was 179/91. Heart rate has also been high and this morning BP was 150/71. Patient was send home from work and he was feeling that from two days after he got the shot but it's been couple of days ago. The patient went in upstairs and then was sent to medical to that they said his face was red, "I didn't look like, look good" and took blood pressure and it was 179/91 and patient was sent home and told to stay home today (06May2021). Patient called his doctor and he said 'it would be risky' for a couple of days. This morning my blood pressure has come down some but it was still high, it wasn't near high as it was, run like 129, 130 over 58 or some like that and this morning it was still 150 over 70 over 69 which is quite high. But it has still come down a lot that's the reason patient called the doctor and he said take it easy, stay out of sun don't work stay at home and her said if you want to call Pfizer call them. The events have improved since yesterday, patient kept thinking he was running fever because his head hurt. But it started on Tuesday and it was Wednesday when someone sent me when the second time patient had broken out rash again and it has turned red. But yesterday (05May2021) it was 170 and 150 is way better today (06May2021. Patient informed that as directed he did not to take his medications, the Methotrexate and Humira. He did not take it within 7 days of taking the shot because he was told not to take it within 7 days of taking the shot, so he got off the medicine for the shot. The patient went for one actually two weeks ago or three weeks ago for his heart checkup and all that stuff, everything was fine, cholesterol was fine, everything was good. The outcome of the events was recovering. Follow up (06May2021 and 06May2021): This is a follow up spontaneous report from a contactable consumer (patient): Added product details (Expiry date, lot details), Concomitant drug details, events (face was red, broken out rash, turned red, blood pressure was 179/91/ run like 129, 130 over 58 or some like that and this morning I was still 150 over 70 over 69 which is quite high for him, fever, head hurt), reporter's comments and clinical course and narrative was amended accordingly. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
47 2021-06-10 difficulty speaking Within 20 minutes my throat felt tight and I had trouble swallowing. My voice sounded froggy; Within... Read more
Within 20 minutes my throat felt tight and I had trouble swallowing. My voice sounded froggy; Within 20 minutes my throat felt tight and I had trouble swallowing. My voice sounded froggy; Within 20 minutes my throat felt tight and I had trouble swallowing. My voice sounded froggy; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in arm left on 28Feb2021 18:00 as single dose for COVID-19 immunization. Medical history included reaction to flu shot many years ago and known allergies from clams. Concomitant medications included tocopherol (VITAMIN E [TOCOPHEROL]); lisinopril; amitriptyline hydrochloride (AMITRIPTYLIN); rosuvastatin. No COVID prior to vaccination. The patient had not been tested for COVID post vaccination. On 28Feb2021 18:15, the patient experienced within 20 minutes my throat felt tight and he had trouble swallowing, his voice sounded froggy. The patient visited the emergency room/department or urgent care for the events. Treatment medications included Epipen, Benadryl and steroids. Outcome of the events were reported as recovered with sequel. No follow-up attempts are needed. No further information is expected.
47 2021-06-11 numbness Headache 3 weeks, severe fatigue 3 weeks. Immediate reaction numbness in extremities, bulging veins... Read more
Headache 3 weeks, severe fatigue 3 weeks. Immediate reaction numbness in extremities, bulging veins in hands, increased heart rate.
47 2021-06-15 pain in extremity Patient experienced usual arm soreness from the shot, but as the days wore on, the soreness progress... Read more
Patient experienced usual arm soreness from the shot, but as the days wore on, the soreness progressed into pain. Within a few days, patient realized the pain was more than a usual vaccination soreness. Within 7 days, Patient's shoulder was making loud popping sounds, and he kept feeling like it was falling out of socket. Basic movements like combing hair, teeth brushing, driving, and typing were painful and difficult with his left arm. Patient visited a physical therapist, and he said it isn't rotator cuff, but it could be a laberal tear. An MRI would better diagnose the issue. The physical therapist recommended 6 weeks of immobility on his shoulder. Patient purchased a brace and is wearing that to prevent mobility. Patient had not done anything else to injure his shoulder and was perfectly healthy when he presented himself to be vaccinated.
47 2021-06-16 weakness difficulty walking; headache; chills; aching of bones; tiredness and weakness; tiredness and weaknes... Read more
difficulty walking; headache; chills; aching of bones; tiredness and weakness; tiredness and weakness; loss of weight; loss of appetite; my joints got pain; it's the pain at the injection site; Muscle pain; Fever; Nausea; Feeling unwell; Restless; congestion; dizzy; swollen; constantly using the bathroom, having bowel movements; peeing a lot; can't stand up; I can't get out of the bed; my legs are so weak; I can't even stand now; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0191), via intramuscular route of administration in right arm on 01Jun2021 at 01:00PM as single dose for covid-19 immunisation. The patients medical history included large prostate, gold stones in 2014, high blood pressure, operation on Gall Bladder (gall stones that were in gall bladder in 2014). Concomitant medication included lisinopril (20 mg, 1xday) for blood pressure measurement. Patient had the Pfizer covid vaccine on 01Jun2021. Patient went to get the Moderna but he got the Pfizer. Nurse told him that everybody was different, and it work in different kind of ways and she said that once he got the vaccination to fight the COVID, it just maintains that. On 03jan2021, Patient did not get out of the bed, he became dizzy, weak, his legs were so weak, lost massive weight (dropped to 145kg/2 pound) and the pain at the injection site, feeling tired, had a headache, got muscle pain, had the chills, joints got pain, bone aches. He had a fever, nausea, congestion, feeling unwell, swollen, was restless and pain to walk. He did not stand up. Took tylenol (spoonful, once a day, orally) for the headache and the fever. Had also been using the bathroom a lot. his most recent weight was 135 after he took the shot at 1:00pm on 01Jun2021. On 22Jun2021 to patient has get the second one but did not feel like taking it. Patient did not had any prior vaccinations within 4 weeks. The outcome of the event cannot stand was unknown and other event was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
47 2021-06-16 numbness, tingling horriblemuscle pull from hip down.; PeriodicNumbness; tingling in right footand calf.; Very cloudy u... Read more
horriblemuscle pull from hip down.; PeriodicNumbness; tingling in right footand calf.; Very cloudy urine at firsturination of the day.; This is a spontaneous report received from a contactable consumer, the patient. A 47-year-old-male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534,) via an unspecified route of administration in the left arm on 17Mar2021 at 12:30 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203,) via an unspecified route of administration into left arm on 24Feb2021 at 12:30 for COVID-19 immunisation. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient did not receive any medications within 2 weeks of vaccination. Prior to vaccination the patient had not tested positive for COVID-19. No concomitant medications were reported. Since the vaccination, the patient had not diagnosed with COVID-19. On 17Mar2021 at 14:30, the patient had experienced horrible muscle pull in right leg from hip, periodic numbness and tingling in right foot and calf, very cloudy urine at first day of vaccination. The patient did not receive any treatment for the reported events. The clinical outcome of the events horrible muscle pull from hip down, periodic numbness, cloudy urine, tingling in right foot and calf was not resolved. No follow-up attempts are possible, no further information is expected.
47 2021-06-16 numbness, tingling This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient recei... Read more
This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: ERB 730), via an unspecified route of administration in left arm on 24Apr2021 at 10:45 (at the age of 47-years-old) as 1st dose single dose for COVID-19 immunization. The medical history of patient was reported as no. The patient had no known allergies. The patient concomitant medications were not reported. Patient did not received any other vaccine in four weeks and no other medications in two weeks.. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested with COVID-19. It was reported that since vaccination the patient was feeling pain in the arm that had been escalating and the arm gets numb and with tingles like it was no circulation on 24Apr2021 at 11:00. The patient reported that he left it over because according to given information, any adverse symptom should disappear in a few days, but up until today it was not, it really worries him since before vaccination he did not have anomalies in his arm, the patient scheduled an appointment at the clinic for next Wednesday to get his arm revised because this was happening for almost a month. It was reported that no treatment was taken as a result of adverse events. The outcome of events was not recovered.
47 2021-06-16 tingling, sensory loss, burning sensation, numbness tingling in his right pinky/tingling in certain parts of my legs saying "it'll flash then stop/Tingl... Read more
tingling in his right pinky/tingling in certain parts of my legs saying "it'll flash then stop/Tingling in my fingers; My arm felt stiff; A loss of sensation stating "I really haven't had any sense of sharp pain; He states that the sensation is more warm or burning; that it was a "swelling/numbing effect".Swell little bit; I could feel things were swelling; He reports that immediately after he received the dose (in his right arm) he "could feel it throughout my body" and that it was a "swelling/numbing effect".; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 47-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection,Batch/Lot Number: ER8735), via an unspecified route of administration, administered in Arm Right on 12May2021 (Age at time of vaccination 47-years-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Patient stated that I took the Ibuprofen because when I first got the shot I could feel things were swelling (further details unknown), I could feel some like, I took pills at the time like a it was swelling like some pain initially and then I heard from other that to prevent the headaches and to prevent the soreness of the arm, to took Ibuprofen, so that I took it as a preventive measure that, I would not get sore but I didn't have any of those, my arm felt stiff but I never felt the pain, and I never feel any headache at the time, like I said, I kind of lost sense of acuteness, loratadine taken for hypersensitivity, start and stop date were not reported. Patient reports that immediately after he received the dose (12May2021) (in his right arm) he "could feel it throughout my body" and that it was a "swelling/numbing effect". He has since been experiencing neurologic symptoms that include: tingling in his right pinky, a loss of sensation stating "I really haven't had any sense of sharp pain. I can feel pressure but can't determine actual point of pressure." He also reports "tingling down [his] left arm while laying down last night" and tingling in certain parts of my legs saying "it'll flash then stop" and is most notable in the calf/shin of his right leg. He states that the sensation is more warm or burning, "not sharp pain" and that it will be a "small burst in a certain area, then go away". On an unknown date Patient also experienced that ,I kind of noticed that I can't feel thing I will say go numb as if kind of feeling through my body,Swell little bit; I could feel things were swelling,I don't have like feeling like touch like when I touch something I feel pressure but I don't have that huge sense of feeling,Tingling in my fingers, its practically I lost my left arm The outcome of events was unknown. Information on the lot/ batch number has been requested.
47 2021-06-16 seizure, burning sensation, muscle twitching, pain in extremity, tremor Body felt like it was on fire. Pain everywhere but also very focused in areas of previous injuries,... Read more
Body felt like it was on fire. Pain everywhere but also very focused in areas of previous injuries, rotator cuff, knee, hand. Muscle twitches that turned to convulsions and unstoppable shaking.
47 2021-06-18 tingling Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Tingling in legs, ... Read more
Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Tingling in legs, hands and tongue
47 2021-06-20 numbness, tingling At 19:24 client received dose 1 of the COVID19 Pfizer vaccine (Lot #EW0187 Exp 08/31/21). Client?s ... Read more
At 19:24 client received dose 1 of the COVID19 Pfizer vaccine (Lot #EW0187 Exp 08/31/21). Client?s adult daughter was accompanying him. After receiving the vaccine, client and his daughter walked to the observation room and sat down. At 19:57 client communicated to EMT1 that 2 of the fingers on his right hand (pointer & middle fingers) were tingling and felt a little numb. EMT1 radioed Lead RN for notification purposes. Lead RN arrived in the observation room at 19:59. Client informed Lead RN that he was not experiencing shortness of breath, chest pain, or trouble breathing, but his fingers were numb, and he felt a little dizzy. AT 20:02, EMT2 took client?s vitals (BP: 148/102, HR: 88, RR: 14 SPO2 Sat: 99%) and confirmed that he was alert and oriented to person, place, time, and self. Client stated to Lead RN that he has no known allergies, and his underlying conditions consist of diabetes and high blood pressure. He also stated that he takes Metformin and another medication for his diabetes that he could not remember the name of. Client could not provide the name of the high blood pressure medication he has previously taken. Client also stated that since the COVID19 pandemic started, he hasn?t taken much of his blood pressure medication because he has not been able to see his doctor. Client implied that if he still has high blood pressure, it is not being managed. Client stated he was starting to gain feeling back and his fingers and that maybe his hand fell asleep because of the way he was sitting. Lead RN asked client when he had last eaten and/or drank something. Client stated he had not consumed anything since 12:00. EMT1 gave client a granola bar and a bottle of water. After eating the granola bar and drinking the water, client stated he was starting to feel better and was feeling very little, if any, dizziness. At 20:18, EMT2 took client?s vitals (BP: 140/102, HR: 83, RR: 14, SPO2 Sat: 98%). Client stated he felt totally fine and was ready to go. At 20:20 Lead RN educated client on high blood pressure signs and symptoms, the importance of blood pressure management, and recommended client contact his medical provider for follow-up. Lead RN also educated client on the side effects and adverse effects of the COVID19 Pfizer vaccine. Lead RN instructed client to go to urgent care if he started to experience extreme side effects and/or dizziness again and to call 911 if he started to experience any difficulties breathing, shortness of breath, or chest pain. Client stated he understood. Client left with his daughter at 20:23 walking with a steady gait.
47 2021-06-22 discomfort, pain in extremity I experienced chest and arm pain and pressure, irregular heart beats, and myocarditis. I had the Pf... Read more
I experienced chest and arm pain and pressure, irregular heart beats, and myocarditis. I had the Pfizer dose.
47 2021-06-23 burning sensation Heart Attack. A feeling of burning in my arms and mouth of the stomach, in addition to fatigue when ... Read more
Heart Attack. A feeling of burning in my arms and mouth of the stomach, in addition to fatigue when walking, started on June 12, 2021. I never had such pain before and thought it's just a stomach virus or so. As the pain continues, I called my primary-care Dr. early morning of June 17 and scheduled appointment for a week later. But around 9:30 pm that day, June 17, the pain became so severe, in addition to nausea and shortness of breath. I went to emergency room and have been told that there is acute heart attack in progress and was moved to the Critical Care Unit in the Heart and Vascular Center. A blockage has been removed and a stent was installed in morning of June 18, through heart catheterization procedure. As there was damage to the heart muscle due to the heart attack, I am supposed to go back later, in 4-6 weeks, to remove couple more blockages and install stents.
47 2021-06-24 muscle spasms, seizure like phenomena Patient came in to receive his first Pfizer vaccination. The patient was signed up and vaccinated li... Read more
Patient came in to receive his first Pfizer vaccination. The patient was signed up and vaccinated like normal. About 5 minutes after administering the vaccine to the patient, he stood up and came to the window to tell the technician on duty that he was not feeling well. He appeared sweaty and pale. The technician immediately advised the patient to sit down and called for the pharmacist on duty. The pharmacist went into the vaccine area and when she reached him, he went into a seizure-like state. He was foaming at the mouth, his hands were spasming, and he went stiff. The technician immediately called 911 and advised them of the situation. The employees stayed with the patient until the emergency services arrived approximately 7 minutes later.
47 2021-06-27 pain in extremity, numbness Patient's (mom) caregiver reported patient was experiencing right arm numbness within 10 to 15 minu... Read more
Patient's (mom) caregiver reported patient was experiencing right arm numbness within 10 to 15 minutes of his 2nd covid-19 immunization. In addition, pain in the right arm was initially reported. Over the next few minutes, while discussing the arm pain, patient reported worsening of symptoms extending to right leg and right side of mouth. Emergency services (EMT) was called and patient was taken to Emergency Departemnt.
47 2021-06-29 muscle twitching Twitching in upper left arm where the shot was administered, the muscle started twitching as soon as... Read more
Twitching in upper left arm where the shot was administered, the muscle started twitching as soon as the needle was removed; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old-male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 08Mar2021 at 13:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. 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. On 08Mar2021 at 13:15, the patient experienced twitching in upper left arm where the shot was administered. The muscle started twitching as soon as the needle was removed and had continued since then. The twitching was not constant but had been persistent since 08Mar2021. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was reported that the patient did not receive any treatment for the event. The clinical outcome of the event muscle twitching was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
47 2021-06-29 pain in extremity Chills all day; Headache; injection site pain over 24 hours plus; pain under arm when lifting; Muscl... Read more
Chills all day; Headache; injection site pain over 24 hours plus; pain under arm when lifting; Muscle pain; Joint pain; tiredness; This is a spontaneous report received from a contactable consumer, the patient. A 47years-old-male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number ER 8727) via an unspecified route of administration in right arm on 20Mar2021 at 10:00 (at the age of 47 years) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had unspecified allergies to medication, food or other products. The patient had received unspecified medications within 2 weeks of vaccination. The patient did not have symptoms associated with COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021 at 11:00, the patient experienced chills all day, headache which was gone with 3 hours, vaccination site pain over 24 hours plus, pain under arm when lifting, muscle pain, joint pain, tiredness. The patient was not treated with any medication for the events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of chills, Vaccination site pain, pain in arm, muscle pain, joint pain and tiredness was recovering and for headache it was recovered on the same day. No follow-up attempts are needed. No further information is expected.
47 2021-06-29 tingling, sciatica, burning sensation On the 29th after a walk, my hamstrings felt tight and I had burning in my calves and I took it eas... Read more
On the 29th after a walk, my hamstrings felt tight and I had burning in my calves and I took it easy for a few days and Saturday Jan 2, I started having bilateral upper gluteal pain, and kept progressing On the night of the 6th I had increasing bilateral joint pain, on 8th I had a med clinic visit, pain constant increasing of bilateral gluteal pain and it kept progressing and I started feeling bilateral sciatica pain tingling in my feet, I was advised not to receive the 2nd dose. As it constantly progressed and pain focused on SI Joint and bilaterally , I saw a NP on the 12th they ordered an MRI of lumbar spine with and without contrast. They did see irregularities in sacral joints. NP prescribed methyl prednisone, I started taking that Feb 3-Feb 8. I also was having fasciculations and both of my legs.
47 2021-06-29 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
47 2021-06-30 pain in extremity He experienced typical arm soreness in the left arm; shooting pain in shoulder; Experiencing loud po... Read more
He experienced typical arm soreness in the left arm; shooting pain in shoulder; Experiencing loud popping sounds and feeling like his shoulder was dislocated; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 47-year old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 11May2021 16:00 (Batch/Lot Number: EW0182) as dose 1, single for covid-19 immunisation. Medical history was not reported. The patient had a no allergies. Concomitant medication(s) included multivitamins [vitamins nos] (MULTIVITAMINS [VITAMINS NOS]) taken for an unspecified indication, start and stop date were not reported; omega-3 nos (OMEGA-3 NOS) taken for an unspecified indication, start and stop date were not reported. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient not had any other vaccine in four weeks. The patient not had a covid prior and post vaccination. On 12May2021 16:00, the patient experienced typical arm soreness in the left arm, where the shot was administered, within 24 hours of the shot. Within 48 hours, however, the soreness turned into shooting pain in his left shoulder. Within 7 days, He was experiencing loud popping sounds and feeling like his shoulder was dislocating with simple movements, like brushing teeth, typing or driving. The patient visited a teledoc on 31May2021 prior to his second dose on 01Jun2021, and the doctor encouraged him to continue with his 2nd shot, but do the right arm as a case study. He experienced no lasting issues from the 2nd shot. On 07Jun2021, withheld visited a physical therapist, and he did a physical exam. He knew it was not a rotator cuff issue, but was thinking it could be a laberal tear. And MRI would be required to diagnose. The MRI has not been ordered due to expense for the patient. The events seriousness was reported as disabling/incapacitating. The patient not received any treatment for the events. The clinical outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
47 2021-07-01 pain in extremity eye with the new cornea turned bright red; Sore arm; This is a spontaneous report from a non-contact... Read more
eye with the new cornea turned bright red; Sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6205) via unspecified route of administration in the left arm on 15Mar2021 at 12:30 PM (age at vaccination 47-years-old), as a single dose for COVID-19 immunisation. Medical history included keratoconus, cornea transplant, epilepsy, depression. Past drug included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot no: EN6209) via unspecified route of administration in the left arm on 22Jan2021 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Concomitant medication included levetiracetam (KEPPRA), venlafaxine (EFFEXOR), ibuprofen (UNKNOWN MANFACTURER), for unknown indications from unknown date. The patient did not have allergies to medications, food, or other products. 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 reported that recently had a cornea transplant. My eye with the new cornea turned bright red after the vaccinations and also sore arm. On 15Mar2021 16:00 the patient experienced bright red eye, sore arm. Therapeutic measures included as Steroid eyedrops for the events bright red eye. The clinical outcome of the events bright red eye and sore arm was recovering. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: patient name added in general tab, 47 years added as age/units for Historical Vaccine since DOB and 1ST DOSE date provided, Start Date/Time and Stop Date/Time of 2nd dose updated to 15Mar2021 12:30, Vaccine Facility Information added, Keppra, Effexor, ibuprofen added as Concomitant drug, Onset Date/Time of events updated to 15MAR2021 16:00.
47 2021-07-02 feeling hot Blood pressure was elevated; having daily mild chest pain; mild left neck tension/warm sensations; m... Read more
Blood pressure was elevated; having daily mild chest pain; mild left neck tension/warm sensations; mild left neck tension/warm sensations; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 12:00 (at the age of 47-years-old) (Batch/Lot Number: ER8737) as single dose for COVID-19 immunisation. Medical history included Allergies to medications, food, or other products: Yeast intolerance. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications 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. 10 days after 1st dose vaccination, on 10Apr2021, the patient started having daily mild chest pain and mild left neck tension/warm sensations. This was still continuing at this date. Blood pressure was elevated and saw physician and had blood work. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event was Unknown. Outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
47 2021-07-07 tension headache Horrible tinnitus with very bad neck pain; Horrible tinnitus with very bad neck pain; Tension headac... Read more
Horrible tinnitus with very bad neck pain; Horrible tinnitus with very bad neck pain; Tension headaches; vision issues; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6202 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 07Mar2021 at 14:45 hours as dose 2, single (at the age of 47-years-old) for covid-19 immunization. Medical history included known allergy to penicillin from an unknown date and unknown if ongoing and had no other medical history. Patient previously received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: ELG9266 and Expiration date was not reported), via an unspecified route of administration, in left arm on 14Feb2021 at 14:00 hours as dose 1, single (at the age of 47-years-old) for covid-19 immunization. Patient did not receive any other medications the patient received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Patient had not been tested for COVID-19, since the vaccination. On 21Mar2021 at 19:00 hours, patient experienced horrible tinnitus with very bad neck pain, tension headaches and vision issues. Patient had doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit for the events. Patient had various ongoing treatments for all the events. The events were reported as non-serious as per the reporter. The outcome of all the events was not recovered.
47 2021-07-09 nerve pain, muscle spasms, seizure Received first Covid shot April 6 (same location as the data entered for this one, Pfizer Lot EW0153... Read more
Received first Covid shot April 6 (same location as the data entered for this one, Pfizer Lot EW0153). April 10 had uncontrollable muscle spasms in both legs for 5 minutes. Did not seek treatment. Received second Covid shot April 27. April 30 had muscle spasms increasing throughout day and anxiety. Did not seek treatment. Anxiety increased through May 5 when I went to the hospital around 2AM due to muscle spasms, muscle pain, anxiety. In hospital I experienced over 1 hour of constant full body muscle spasms/seizures where all my muscles would tense up uncontrollably over and over. This eventually subsided and I was released. Diagnosis absent any other cause was anxiety. From May 5 through ~June 11, experienced frequent random muscle spasms and tics mostly in left leg but also encompassing abdominal, lower back, chest and rib pain. Experienced feeling of left arm heaviness through July 3. Arm pain in shot area recurred since the time of the second shot at least six separate times (last July 3). Was stared on Gabapentin for nerve pain, muscle spasms, anxiety, which eased symptoms. As of July 10 feeling mostly normal, no longer experiencing muscle spasms with any frequency.
47 2021-07-10 discomfort Patient c/o dry cough, left sided headache, since returing in may. was seen in ER on 5/17. COVID te... Read more
Patient c/o dry cough, left sided headache, since returing in may. was seen in ER on 5/17. COVID test neg. symptoms improved and patient received I dose of COVID vaccine on 6/4 21. since then c/o constant left sided headache, left eye pain, on/off blurring of vision, severe dry cough. c/o loss of vision in left eye, headaches and feeling "a lot of pressure" for about 3 weeks since receiving the vaccine, sees 2 spots in the left eye that got larger than before. Had 4 episodes of vision in left eye only going black for several seconds, then when vision comes back it is "no good" for 20-30 minutes, last occurrence was 10 days ago. Pt also felt dizzy. patient has a history of stroke. After multiple provider and specialist visits patient was diagnosed with iritis and transient vision loss. Patient received second dose of vaccine on 06/27/21 (both at pharmacy) and reported return of symptoms which resolved as reported on their 06/30/21 follow up with PCP and vision specialist.
47 2021-07-12 pain in extremity fever; an ugly bruise on my arm; Severe arm pain; achiness; exhaustion; it's a little stiffness stil... Read more
fever; an ugly bruise on my arm; Severe arm pain; achiness; exhaustion; it's a little stiffness still; it was much more painful than first shot /excruciating pain in his arm; body aches; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male consumer received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date was not reported), via left arm on 19May2020 as single dose for COVID-19 immunization. The patient medical history included arm pain, fever, achiness, and exhaustion. The patient concomitant medication was not reported. The patient previously took first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was EW0191, and expiration date was Sep2021), via left arm on 28Apr2021as single dose for COVID-19 immunization. After his 1st dose of the Pfizer COVID 19 vaccination, he called and reported his side effects and now he had received his second dose and he had some questions regarding his side effects. On 19May2021 patient experienced Severe arm pain. It felt as if someone was stabbing him with a large dagger that night and on 20May2021 he had an ugly bruise on his arm, and it was not going away. It been a week and it was still there and on same day had Fever as Persisting. On an unspecified date 2021 patient experienced pain, fatigue, little stiffness, body aches, and He was feeling the excruciating pain in his arm, so he did not want to look, and did not look until the next day, and took a look, removed the band-aid and was surprised, he had some arm pain with the first, but there was no sign of it on his arm with anything. The outcome of event (fever and body aches) was recovered, event of stiffness was not resolved and event of arm pain was recovering rest of all events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
47 2021-07-15 discomfort, pain in extremity The pain & soreness that many people including myself experience the day after returned about 5 or 6... Read more
The pain & soreness that many people including myself experience the day after returned about 5 or 6 weeks later after feeling perfectly fine for over a month. Since I first started experiencing the discomfort it has progressively gotten worse - this week especially. I am unable to put much weight on the arm or move it in certain directions. I tried massaging the sore area last night and it seemed to irritate it more. I have been periodically keeping ice on it the past few days. I took some ibuprofen last night to try to ease the pain. as well. The ice packs seem to help a little, but the pain is still there when I move my arm in certain directions.
47 2021-07-17 feeling hot lightheadedness and dizziness; Hot; Sweaty; This is a spontaneous report from a non-contactable othe... Read more
lightheadedness and dizziness; Hot; Sweaty; This is a spontaneous report from a non-contactable other hcp. A 47-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 18Mar2021 (Batch/Lot Number: EN6205) (at the age of 47yearsold) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported Patient previously received bnt162b2 (BNT162B2), via an unspecified route of administration on unspecified date (Batch/Lot Number: not reported) as DOSE 1, SINGLE for covid-19 immunisation. on 18Mar2021 the patient experienced light headedness and dizziness, hot, sweaty. The patient didn't had symptoms of rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, light-headedness/dizziness, facial swelling, lip swelling and tongue swelling. Therapeutic measures were taken as a result of light headedness and dizziness, hot, sweaty patient was laid on the floor and water and snacks were given patient was transferred to Emergency room for observation patient was stable to go home and was asked to follow up with PCP. The outcome of the event was recovered and the outcome of the events dizziness, hyperhidrosis was recovering. No follow-up attempts are possible. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Patient's Country captured as, For event light headedness and dizziness Coding updated from Light headedness to PT Dizziness, For event Hot Outcome updated from Unknown to Recovered/Resolved with Stop Date Mar2021 per verbatim After sitting for a while we cooled down, For other two events light headedness and dizziness and Sweaty Please review if need update the Outcome from Unknown to Recovering per verbatim Stable to go home and follow up with PCP.Leading sentence was This is a spontaneous report from a contactable Health care professional. updated as This is a spontaneous report from a non-contactable Other Health Professional. Final sentence No follow-up attempts are needed. No further information is expected. updated as No follow-up attempts are possible. No further information is expected. since reporter was non-contactable. Initial information need review Reported Event. During his 15 minutes waiting period after the injection, the patient began to experience light headedness and dizziness. He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, light headedness, dizziness, facial swelling, lip swelling and tongue swelling. Pt received shot and complained of being hot and sweaty. He was laid on the floor in injection room 5, with his feet elevated, some water was given, and once patient was feeling better, he was transferred to the Emergency room bay for observation. He refused a wheelchair and walked to the bay with help. After sitting for a while, we cooled down and he was allowed to leave. Assessment Plan Treatment included water and snacks. Follow up response to treatment was excellent. Patient discharge reported as Stable to go home and follow up with PCP.
47 2021-07-17 feeling of insects crawling on skin Several redness and rashes and itch all body every day; Several redness and rashes and itch all body... Read more
Several redness and rashes and itch all body every day; Several redness and rashes and itch all body every day; Several redness and rashes and itch all body every day; A lot of thread veins are visible.; It's like an insect crawling inside the skin; Daily life is difficult and very stressful; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24Apr2021 15:15 (Batch/Lot Number: EW0150) as DOSE 2, SINGLE for covid-19 immunisation, age at vaccination 47 years old. The patient medical history and concomitant medications were not reported. 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 received the first dose of BNT162B2 (Lot/batch no: EW0165) on 03Apr2021, 15:00 at Arm Left for covid-19 immunization. Patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and had no other medications the patient received within 2 weeks of vaccination. Patient had been getting several redness, rashes and itch all body every day even 2 months have passed. It's like an insect crawling inside the skin. Also, a lot of thread veins are visible. Patient mentioned that It's been two months and he was not the only one who still has these symptoms. Because of this, daily life is difficult and very stressful (He didn't have any allergies to food or vaccines). Patient had antihistamine injections, took antihistamine pills and medicine for several weeks. However, when he stopped taking the medicine, the symptoms recurred. Physician office was visited. Outcome of the events was not recovered. Information on batch/lot number was available. Additional information has been requested.
47 2021-07-17 pain in extremity Arm pain after vaccination #1; This is a spontaneous report from a contactable consumer. A 47-year-o... Read more
Arm pain after vaccination #1; This is a spontaneous report from a contactable consumer. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown if the patient was diagnosed with COVID-19, prior to the vaccination. It was unknown if the patient had been tested for COVID-19, since the vaccination. It was unknown if the patient had received any other vaccines within four weeks prior to the COVID vaccine. On an unknown date, the patient experienced arm pain after vaccination #1. It was unknown if the patient had received any treatment for the event arm pain after vaccination #1. The clinical outcome of the event arm pain after vaccination #1 was unknown at the time of the report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
47 2021-07-19 burning sensation Burning to the touch sensation in leftleg. From upper groin to bottom of feet; This is a spontaneous... Read more
Burning to the touch sensation in leftleg. From upper groin to bottom of feet; This is a spontaneous report received from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8730) via an unspecified route of administration in the left arm on 28Mar2021 at 01:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included graves' disease. Concomitant medications included thiamazole (METHIMAZOLE) for an unknown indication and from an unknown date. 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. On 29Mar2021 at 04:00, the patient experienced burning to touch sensation in left leg, from upper groin to bottom of feet. 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. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event burning sensation in left leg from upper groin to bottom of feet was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
47 2021-07-20 night sweats At Midnight I was going to sleep, I was sweating profusely and could not feel my pulse. When I asked... Read more
At Midnight I was going to sleep, I was sweating profusely and could not feel my pulse. When I asked my wife to call 911, I went into the bathroom to change into clothes to get ready to go. I do not remember going to get dressed, I passed out and 911 had arrived and they believed I was in cardiac arrest. I went to the ER, there was a right artery blockage and put in a stint. They also found out I had 8 facial facial fractures due to the fall I had. I was all swelled up in my face so in May I went back for surgery on my face to fix the multiple facial fractures. And now I am back to normal, except I am on blood thinners. The DR could not find anything wrong after follow up, so no one knows why the cardiac happens.
47 2021-07-22 weakness his liver panel showed issues; Graves' disease; white blood cells came down; loss of appetite; weak;... Read more
his liver panel showed issues; Graves' disease; white blood cells came down; loss of appetite; weak; Diarrhea; he would get tired very quickly.; spiking fevers; Increased blood pressure; high resting heart rate; baseline heart rate was over 105/his heart rate from 60 to about 80 in the month of April.; his pulse is starting to slow; They did the TSI test on the patient and noticed an extreme increase; having thyroid issues; blood sugar was dropping; The caller's symptoms went from being mild to very acute.; The caller's T3 and T4 were extremely high and his TSH was extremely low.; The caller's T3 and T4 were extremely high and his TSH was extremely low.; The caller's T3 and T4 were extremely high and his TSH was extremely low.; Palpitations/extreme palpitation in his chest and aorta that would pulsate; Weight loss; Sinus pain; Eye irritation; restlessness at night; extreme nausea; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8733), via an unspecified route of administration, administered in left arm on 27Mar2021 as dose 2, single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, he was diagnosed from 4 years (in 2017). The patient no other products taken. Prior to March the patient had no problem (before vaccination). About 2 weeks after the second dose of the vaccine on 11Apr2021, the patient had extreme nausea, palpitations, baseline heart rate was over 105 and lost 40 pounds. Patient also started having sinus pain and eye irritation, and restlessness at night and started waking up very early. The caller had a weight loss of 8 pounds for the month of April without changing his lifestyle. Patient had a slow increase in his heart rate from 60 to about 80 in the month of April. Towards the beginning of May the patient had loss of appetite and he would get tired very quickly. When it all hit the patient at once it was around May202, he started spiking fevers, nausea, extreme palpitation in his chest and aorta that would pulsate, and increased blood pressure. The patient went and saw his doctor and checked his thyroid levels that were normal nearly 6 months prior. The patient's T3 and T4 were extremely high and his TSH was extremely low. They did the TSI test on the patient and noticed an extreme increase and then diagnosed him with Grave's disease. The patient did all of the scans. The patient was hospitalized for nearly 6 days because they put him on methylprednisolone and had a toxic effect on his system. The caller's white blood cells came down, it attacked his bone marrow, his liver panel showed issues. The caller was hospitalized on 27Jun2021 to 02Jul2021 for this. The patient had never had any indications of having thyroid issues or Grave's disease prior to this event. The patient's symptoms went from being mild to very acute. The patient was weak right now (at the time of report) because of the weight loss, his pulse was starting to slow and still has palpitations and his nausea was still there and lots of diarrhea. Everything had worsened until now that he had sought treatment (at the time of report). The patient's blood sugar was dropping during this time and had an A1C of 6. The patient underwent lab tests and procedures which included blood sugar was dropping during this time and had an A1C of 6: positive on 07Jul2021, TSH (thyroid stimulating hormone): .008 on 07Jul2021, radioactive iodine uptake assays: show diffuse uptakes of the radioactive tracers and is consistent with Grace's disease on 07Jul2021, 08Jul2021 and 09Jul2021, free thyroxine: >30 on 07Jul2021, T3 (tri-iodothyronine): >8 on 07Jul2021, Free T3 (tri-iodothyronine free): > 32.6 on 07Jul2021, patient's CBC and platelets were in the normal range. Outcome of the event grave's disease was resolving; weak, diarrhea and pulse was starting to slow was unknown and outcome of rest of the events was not resolved. Follow-up attempts are needed. further information is expected.
47 2021-07-22 numbness, muscle spasms, pain in extremity I started feeling a numbing of my feet and lower legs (calves). On the morning of May 31s, I awoke ... Read more
I started feeling a numbing of my feet and lower legs (calves). On the morning of May 31s, I awoke to an excruciating painful calf cramp. In the past, whenever I've had these, they would fade in pain within one or two hours. The pain from this cramp lingered for several days. I soon noticed my feet afterwards becoming swollen and feeling even more numb and for entire days. On June 11, I couldn't fit my feet into my shoes. I put on some loose-fitting sneakers and took myself to the Emergency Room.
47 2021-07-23 facial paralysis Noticed crooked mouth and paralyzed on right side of face in the morning; Major headaches; Blistered... Read more
Noticed crooked mouth and paralyzed on right side of face in the morning; Major headaches; Blistered tongue and blistered inside and outside of right ear (very painful).; Blistered tongue and blistered inside and outside of right ear (very painful).; This is a spontaneous report received from contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 05Jun2021 10:00 AM (Batch/Lot Number: ER8735) at the age of 47 years as single dose for covid-19 immunisation. Patient had no medical history and no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Major headaches started 05Jul2021. Noticed crooked mouth and paralyzed on right side of face in the morning. Blistered tongue and blistered inside and outside of right ear (very painful). Admitted to Emergency room on 08Jul2021. Date of start of reaction/event was 05Jul2021 9:00. Treatment received included valacyclovir hcl and prednisone. Adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Outcome of events were not recovered.
47 2021-07-25 weakness, numbness, muscle twitching, speech disorder, tingling 1st event, 3 weeks after vaccine major muscle twitch exceeding 24 hrs continuous in left bicep, sto... Read more
1st event, 3 weeks after vaccine major muscle twitch exceeding 24 hrs continuous in left bicep, stopped after 36 hrs. 2 nd event major muscle twitch in left thigh lasted 2 hrs. 3rd event major muscle twitch in left thumb >24 hrs., stopped 28 hrs. End of month/June & July, minor muscle twitch, throughout body, visible, random , every 5 sec to 60 sec., legs, arm, stomach, back, all feet, issues with leg, arm weakness, dropping items and speech, including fatigue, numb tingling hand and feet off on. Symptoms align with ALS, MS, or other neurological disease
47 2021-07-27 bell's palsy, numbness Half of head became very numb; Drooping eye lid; Earache; Sharp pain in head on right side; Pressure... Read more
Half of head became very numb; Drooping eye lid; Earache; Sharp pain in head on right side; Pressure behind eye; Tongue weakness in back of tongue on right side; bell's palsy; This is a spontaneous report from two contactable other health care professionals one of the (patient). A 47-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EW0183), via intramuscular, administered in Deltoid Left on 20May2021 10:20 (age at the vaccination 47-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included been dealing with tinnitus for over a year and hypertension from 12Jul2017 and ongoing. There were no concomitant medications. The patient previously took flush from alcohol and experienced known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications 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. Patient experienced bell's palsy on 20May2021 13:00, half of head became very numb, drooping eye lid, earache, sharp pain in head on right side, pressure behind eye, tongue weakness in back of tongue on right side on 20May2021 03:30 PM. Patient received treatment of Prednisone for the event Bell's palsy. Patient visit physician office for this event. Patient did not receive treatment for other events. The outcome of the event bell's palsy was recovering and not recovered for another events. Follow up attempts are needed; further information has been requested.; Sender's Comments: Based on available information, a possible contributory role of the suspect product, BNT162B2 vaccine, cannot be excluded for the reported event Bell's palsy due to close temporal relationship. The case will be reassessed once additional information is 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.
47 2021-07-27 pain in extremity Right foot pain and swollen. Unable to bear weight. Started to swell 24 hours after vaccine.
47 2021-07-28 pain in extremity Difficult to sleep; Both feet hurt; Feet were slightly swollen, but not discolored; This is a sponta... Read more
Difficult to sleep; Both feet hurt; Feet were slightly swollen, but not discolored; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 24Apr2021 at 09:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient previously did not receive any medications. Concomitant medications included simvastatin (STATIN) taken for an unknown indication from an unknown date. 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 24Apr2021, Saturday morning, the patient received the shot. On 26Apr2021, Monday night, the patient noticed both his feet hurt. The patient's pain increased on Tuesday and Wednesday (28Apr2021) making it difficult to sleep on Wednesday. On Thursday and Friday, they hurt less but the patient still experienced a little hurt. The patient never had foot pain for any reason in the past, except after a long hike or other extreme exertion. The patient did not do anything unusual to make his feet hurt. On an unknown date in Apr2021, the patient's feet were slightly swollen, but not discolored and they were not sore to the touch. The clinical outcome of the events both feet hurt, making it difficult to sleep and feet were slightly swollen, but not discolored was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
48 2021-01-03 facial paralysis I had right sided headache for the first two days, then resolved. The right sided headaches recurre... Read more
I had right sided headache for the first two days, then resolved. The right sided headaches recurred along with right tongue numbness initially on 12/29/2020. The symptoms worsen on 12/31/2020 and severe on 1/1/2021. I was initially started on Valtrex thinking it maybe due to shingles but soon with the right sided facial paralysis, it was obvious it was Bell's Palsy and was started on steriods on 1/1/21 and also received acupuncture treatment on 1/2/21 which significant help improve the symptoms. I still have some residual weakness of the right eye with some tearing and mouth weakness.
48 2021-01-04 cold sweat, pain in extremity, weakness weak from lack of nutrition; weak from lack of nutrition; Tired; stomach cramps; felt out of breath;... Read more
weak from lack of nutrition; weak from lack of nutrition; Tired; stomach cramps; felt out of breath; nausea; vomiting when exercised; headache; Sore arm; chills; no appetite; clammy hands/clammy hands and feet; very sore at injection site; This is a spontaneous report from a contactable other HCP (patient) reported for himself. A 48-years-old male patient received first dose of BNT162B2, via intramuscular in left arm on 21Dec2020 10:15 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included known allergies: Shellfish, Corn, Whitefish. The patient's concomitant medications were none. No other vaccine was received within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination and patient was not tested for COVID-19 since the vaccination. The patient experienced no appetite, clammy hands, very sore at injection site on 21Dec2020 (reported as day 1), sore arm, no appetite, clammy hands and feet, chills on 22Dec2020 (reported as day 2), no appetite, nausea, vomiting when exercised, headache, clammy, chills on 23Dec2020 (reported as day 3), no appetite, nausea, stomach cramps, headache, felt out of breath, clammy, chills on 24Dec2020 (reported as day 4), tired, clammy, headache on 25Dec2020 (reported as day 5) and symptoms resolved but weak from lack of nutrition on 26Dec2020 (reported as day 6). No treatment was received for all the events. The outcome of the events was recovered in Dec2020. The information on the Lot/batch number has been requested.
48 2021-01-04 numbness Hypertensive crisis; Numbness to my left ear; progressively it went down to my mandible, my face and... Read more
Hypertensive crisis; Numbness to my left ear; progressively it went down to my mandible, my face and my left shoulder numbness; Radial blood pressure cough; This is a spontaneous report from a contactable nurse reporting for himself. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunization. Medical history reported as none. There were no concomitant medications. During the administration the patient did experience some types of reaction where it wanted medical supervision. So, basically when he did got the injection he was waiting for his 15 minute prolapse. But within probably he would say 7 to 8 minutes he started to experiencing some numbness to his left ear and usually he thought it was secondary to the that he had (not clarified) but progressively it went down to his mandible, his face and his left shoulder numbness and he was experiencing some numbness that radiate towards his fingertips only to the left side. At that time he waived to the Nurse to supervise and at that time he wait again and a Physician came over. He checked his pulse and noted that he had normal rhythm during the pulse check and at that time and he had Emergency medical technician (EMT) come over. The EMT checked his blood pressure he thought multiple times through the left and to the right brachial. He was having what they would consider a hypertensive crisis where systolic were in 170's, 180's, diastolic numbers were between like 120's and 130's and his heart rate was in 70's. So, initially it was not anxiety induced. But he do not have no blood pressure. They wanted he to go to the hospital to treat the hypertensive crisis that was in. The patient opted not to. So he went home in a quieter environment he did have a radial blood pressure cough that he had been checking his blood pressure rigorously, tried different techniques and now he was back to normal state to 120-130 systolic and his diastolic was 70-80. This instance was weird that he did not see as a part of one of the side effects listed with Pfizer BioNTech Vaccine. No treatment received for the events, because he had no history of hypertension it was just more of decreasing the ambient around he. At that time he wanted to go to a quiet environment, took a shower and check his blood pressure. He did orthostatic while laying down sitting up, standing up and he was not hypertensive. For the causality, the nurse stated, "I think it did. This is a fact I mean I was doing fine prior to administration and then this event is slowly subsiding." The outcome of the events was recovering.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported hypertensive crisis 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.
48 2021-01-05 pain in extremity Arm soreness, headache for a day
48 2021-01-06 numbness, muscle twitching woke up this morning feeling slight numbness on my left cheek. The sensation is very similar to whe... Read more
woke up this morning feeling slight numbness on my left cheek. The sensation is very similar to when I receive a numbing shot from my dentist for dental work. The feeling of numbness comes and goes with varying levels of intensity. Sometimes twitching my cheek can make it go away; but it keeps occurring.
48 2021-01-07 night sweats Chills, fever, night sweats, nausea, bad headaches
48 2021-01-07 tingling all joints hurt, right arm swollen from elbow down to fingers, tingle sensation in lower right arm a... Read more
all joints hurt, right arm swollen from elbow down to fingers, tingle sensation in lower right arm and fingers
48 2021-01-09 pain in extremity Arm soreness, chills, fatigue, headache lasted 24 hours. Had same reaction to the first dose, almost... Read more
Arm soreness, chills, fatigue, headache lasted 24 hours. Had same reaction to the first dose, almost identical.
48 2021-01-10 coordination abnormal three hours after administration felt fatigued (drunk) and uncoordinated. slept for four hours woke ... Read more
three hours after administration felt fatigued (drunk) and uncoordinated. slept for four hours woke up with no affects
48 2021-01-10 feeling hot, tingling Within 10 minutes felt a rush of heat down right arm and tingling in fingers. Then I felt it in the... Read more
Within 10 minutes felt a rush of heat down right arm and tingling in fingers. Then I felt it in the left arm, however the left arm stopped tingling within 24 hours, but my right arm still has the tingling , feels bloated in my hand and my arm feels restless.
48 2021-01-12 flushing This patient is a 48 y.o. male presenting to the emergency department with a chief complaint of alle... Read more
This patient is a 48 y.o. male presenting to the emergency department with a chief complaint of allergic reaction s/p 1st COVID vaccine at 1330 this afternoon. Patient states he became very flushed to his face/chest 2-3 minutes after receiving the vaccine. EMS was on scene and evaluated the patient. He was found to be a little confused/disoriented upon questioning which quickly resolved. Patient was also having mild difficulty swallowing, however states he was not gasping for air. He had an IV placed for precautions, however no medications were given. Patient was transferred here for evaluation. He currently feels asymptomatic aside from a dry throat. Patient denies having any hives, shortness of breath, or syncopal episodes. He also denies having prior episodes of anaphylaxis requiring epinephrine.
48 2021-01-14 numbness and pain in extremities Fatigue starting at 22:00 Impaired night vision starting at 0500 1/9/22 Rigors starting at 0500 1/9/... Read more
Fatigue starting at 22:00 Impaired night vision starting at 0500 1/9/22 Rigors starting at 0500 1/9/21 Neuropathy in the hands starting at 0500 1/9/21
48 2021-01-14 pain in extremity Dark purple bruise on injection site about 2 in in size discovered the night of inject 10Sep2020. Pa... Read more
Dark purple bruise on injection site about 2 in in size discovered the night of inject 10Sep2020. Painful to the touch.; Dark purple bruise on injection site about 2 in in size discovered the night of inject 10Sep2020. Painful to the touch.; Dark purple bruise on injection site about 2 in in size discovered the night of inject 10Sep2020. Painful to the touch.; Left shoulder and arm pain; arm pain; This is a spontaneous report from a contactable pharmacist (patient). A 48-year-old male patient received the second dose of BNT162B2 (Lot number: EL1283), via an unspecified route of administration from 09Jan2021 08:30 at single dose in the left arm for COVID-19 immunization. Historical vaccine included BNT162B2 (Lot number: EH9899), received first dose via an unspecified route of administration on 19Dec2020 10:45 at single dose in the left arm for COVID-19 immunization. There were no medical history. Concomitant medication included ibuprofen on 11Sep2020 11:00. On 09Jan2021 09:00, the patient experienced dark purple bruise on injection site about 2 in in size discovered the night of inject 10Sep2020. Painful to the touch. Left shoulder and arm pain. Did not alleviate as of 10Nov2020 when report submitted. No treatment received for the events. 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 not recovered.
48 2021-01-14 cold extremities Headache, Cold Feet and Hands, Chills, body aches.
48 2021-01-17 weakness During 15 minute observation period post vaccine individual became slightly diaphoretic and felt wea... Read more
During 15 minute observation period post vaccine individual became slightly diaphoretic and felt weak. He does comment that he has not had much to eat or drink. Was offered juice and a snack which he tolerated and improve his symptoms. Vital signs were taken stable with slight tachycardia that improved at second set of vitals. Seen by provider on site and physical exam was benign. No medication intervention was needed. Left observation on own recognizance
48 2021-01-17 pain in extremity, tremor After the injection my arm got really sore. I began to feel really tired and begin to have chills a... Read more
After the injection my arm got really sore. I began to feel really tired and begin to have chills and shakes. I started having diarreah and began throwing up. I had a sever headache and body aches which all symptoms lasted for about 3 days and I felt so bad so on Wed 12/30 I went to Urgent Care and was given fluids which did make me begin to feel a little better. On Monday I was sent for a COVID test which was negative. On Friday 1/1 i was finally able to return back to work.
48 2021-01-17 tingling Herpes Zoster, L3 dermatome developed 14 days after first dose of vaccine
48 2021-01-18 feeling of body temperature change Patient reports fatigue, soreness and swelling to the injection site, hot and cold flashes, joint pa... Read more
Patient reports fatigue, soreness and swelling to the injection site, hot and cold flashes, joint pain and muscle soreness and lethargy
48 2021-01-18 muscle spasms 6 hours after receiving vaccine I developed frequent loose stools. This continued for two days, on t... Read more
6 hours after receiving vaccine I developed frequent loose stools. This continued for two days, on the 3rd day I developed cramping with loose stools. This continues today. I am using pedialyte to keep my hydration, immodium AD and probiotics for the diarrhea. No fever; mild chills
48 2021-01-18 pain in extremity Fatigue, Headache, Sore arm, Achy muscles
48 2021-01-18 tingling, numbness After the administration, I was monitored for 15 minutes and I was fine. I left the hospital, start ... Read more
After the administration, I was monitored for 15 minutes and I was fine. I left the hospital, start driving, and suddenly felt that my right arm was heavy, numb, with a tingling sensation. I stopped the car and called the nurse and I was told that it will go away, and I can take a tylenol/motrin. It improved over the next hour and I felt it resolved a few days later but then it returned on 1/18 but not to the same extent, and I also felt intermittent tingling and numbing in my right foot. I also experienced intermittent episodes of fast heartbeats and missing heartbeats since the vaccine almost daily. I was fatigued and extremely thirsty for 3 days but that resolved completely.
48 2021-01-19 weakness Severe side effects - Swollen facial features especially evident in lips; began approximately 0730, ... Read more
Severe side effects - Swollen facial features especially evident in lips; began approximately 0730, 14JAN21 - 17JAN14; used diphenhydramine (50 mg ) at night to control swelling - weakness - fast heartbeat Side effects (each of the side effects lasted around the same time period, 13JAN21-17JAN21; alternated acetaminophen and ibuprofen to try and relieve symptoms -injection site pain (began about 1 hour after injection) -headache (severe) -muscle pain -chills - joint pain (severe), began during sleep and I first felt it in my hands - fever (even while taking acetaminophen and ibuprofen, I still had a fever of 100.6 degrees) -injection site swelling (13JAN21-19JAN21) -injection site redness
48 2021-01-20 migraine Body aches Migraine Cough High fever Massive Dizziness Runny nose Fatigue
48 2021-01-21 weakness, tingling, feeling jittery, feeling hot Hot and tingling face and hands, slight dizziness and weakness, pulse 130-140, high level of anxiety... Read more
Hot and tingling face and hands, slight dizziness and weakness, pulse 130-140, high level of anxiety. Symptoms came on suddenly, after about 30 minutes they began to subside slightly. Returned to 90% of normal after approximately 2 hours. Remained jittery for another 6 hours after that.
48 2021-01-21 pain in extremity Some background: I normally react badly to flu/respiratory vaccines in that I generally get sicker a... Read more
Some background: I normally react badly to flu/respiratory vaccines in that I generally get sicker after the vaccine than I do when I get the virus. So this isn't entirely unexpected. However, the timing is really strange and Now I wonder if I should get COVID tested. Here is the chronology of events. Day of shot (Friday) - pain in arm lasted about 2 days but wasn't too intense. As the pain in the arm began to fade, I started getting really sleepy. I slept probably 48 hours over the next three days but did not experience any pain except maybe slight muscle aches and a little of the accompanying eye burn that is associated muscle aches and sleepiness. By Tuesday, the sleepiness had passed. Thursday night (last night), I started to experience ALL general symptoms of a respiratory flu/COVID. I developed an intense cough and associated phlem (though it is very sporadic rather than persistent) and the precursors to intense muscle pain. I woke up at around 3am Friday with a fever, the muscle pain, burning eyes (associated with flu-muscle pain and fever), and extreme chills (though my windows was open... a normal practice as my computer makes it hot in my room). I felt oddly rested however, as though the getting sick, while making me tired, was also helping me sleep better. My body is definitely reacting to something. If it wasn't 6 days afterward, I would say it was my normal reaction to virus shots. However, the timing is alarming. I have not knowingly been exposed to anyone with COVID. This morning the chills are gone, the fever is down (though not entirely gone), but I still feel "down for the count." Like I said... it is my normal reaction to virus vaccine except that it is about 6 days late (usually sets in within 24 hours). This morning is the week "anniversary" of the shot.
48 2021-01-21 pain in extremity I received the first dose of Pfizer EK5730 at 18:07 on 12-30-2020. For the first day my arm was a b... Read more
I received the first dose of Pfizer EK5730 at 18:07 on 12-30-2020. For the first day my arm was a bit sore but nothing to bad. The next few days 48-72 hours later I started to have many more symptoms, some minor to sever including joint pain, headache, fatigue, and dizziness. lesser included some nauseas. The joint pain was so bad at one point i had to pull over while driving. on 1-2-21. as of writing this now 14 days out I still have some joint pain especially in my arms. No other symptoms of note. I would add that I tested positive for COVID -19 on 10-18-2020 and was not released from quarantine until 11-5-20 I did seek treatment during this time through by calling my Dr. did not require any hospitalization.
48 2021-01-21 tingling, numbness 8 minutes after the vaccine i satrt to experience some tingling to my left earlobe. It then radiated... Read more
8 minutes after the vaccine i satrt to experience some tingling to my left earlobe. It then radiated to my left jaw line where i felt an onset of numbness. the numbness hten radited to my left shoulder all the way down to my left extrremity digits. atthat time i waived over a nurse who waived a physician who check my radial pulse, pulse was noted in the 70's. At that time the physician asked a EMT perofrmed four evalautions of my BP and my BP was reading syttolically between was 140-150 and my datolics was reading 110-115. Throughout that time the numbness was still to my left side of my face and shoulder and arm and to myfingers. This was only localized to those two areas. At that time it was requested for me to go to the hospital to seek medical attention. I deferrred to going home to check my BP and at that time i was running 150/100. The numbness was still present and mu thought process my body was stressed out. I then took a nice cold shower with breathing techniques. I did orthastatics on myself. I then followed with my PCP the next day and she ordered bunch of labs, CRP, triponents, CBC, bubble study and chest x-ray and EKG. ALl the testes were deemed to be negative. My systolics were 120/80 when i saw my PCP, however i was recommedned to take the whole week off and was recommended to go back to work after the new year. After five days the numbness went away to my digits went away but not to my face. My grips were equal. I had no Bal palsy nor stroke. The numbness sill persisted up till day 9 and the umbness to the face went away.
48 2021-01-23 numbness Reported numbness in left side of face and left arm , improved after 1 day,
48 2021-01-24 pain in extremity Arm is very painful. The day after achy, muscle pain, head ache fatigue and chills. Just lasted 4 to... Read more
Arm is very painful. The day after achy, muscle pain, head ache fatigue and chills. Just lasted 4 to 5 hours.
48 2021-01-25 muscle spasms Patient called on 1/25/21 and reported to the pharmacist that he was having severe pain in the shoul... Read more
Patient called on 1/25/21 and reported to the pharmacist that he was having severe pain in the shoulder that was radiating up to his neck and causing muscle spasms. He reported to his doctor who told him to report to the pharmacy as we administered the vaccination. Patient stated he has tried ice, heating pad, Tylenol, ibuprofen, and has seen a chiropractor with no relief.
48 2021-01-25 muscle spasms Patient called on 1/25/21 and spoke with pharmacist. He reported that he is still having pain at inj... Read more
Patient called on 1/25/21 and spoke with pharmacist. He reported that he is still having pain at injection site including muscle pain that is radiating into his neck and causing muscle spasms. He reported it to his doctor who told him to contact us at the pharmacy who administered the immunization. Patient reported using ice, heating pad, Tylenol, Ibuprofen, and has seen a chiropractor and still has no relief.
48 2021-01-27 tingling 1/20/21 vaccinated. 1/21 afternoon-itchy feeling on top of buttocks, tingling sensation consistent w... Read more
1/20/21 vaccinated. 1/21 afternoon-itchy feeling on top of buttocks, tingling sensation consistent with herpes II/Zoster, nerve down right leg tingling, testing for all venereal diseases June 18, 2015, July 2015-Present married to wife no sexual activity outside of marriage, hyper sensitive to venereal disease. Wife is negative, PT is negative for IGA and IGE, PT received vacc and is now showing symptoms positive for herpes 2, PT is waiting for results as to if he is POSTIVE, blister on right side of penis-clear fluid filled, right sores/blisters crusty on buttocks, right inner thigh leg blister on scrotum with red dots in the middle, nothing on glands penis/urethra or anus. Thursday night, pt had intimacy and it was dryer than normal, uncomfortable on the right side with penetration-skin is compromised. Saturday, PT was not feeling great, shaft not showing, in a rush to urinate, scrapped scrotum and now has lesions. Sunday, fatigue, outbreak/whelp on legs, PT wore gauze/bandages to prevent chafing. Monday, shaft not showing, patient went to urgent care. PT was told it presented as Zoster. Nothing on penis at this point in time. Penis issues did not show until 1/26/2021. EX wife had herpes II. PT again was tested after in 2015 and was negative for IGE and IGA. Tuesday, patient started meds from urgent care. Wednesday morning, chest pain/pleurisy like-pain across chest. Arm vaccination site sore, bruised to this day. Herpes Zoster not typically going to end up on shaft, its unusual, PT is probable he has cross contaminated by itching his buttocks and then going to the restroom and touching right side of penis.
48 2021-01-29 numbness, nerve pain numbness and pain along the ulnar nerve distribution of left arm c/w brachial neuritis
48 2021-01-31 bell's palsy Bells Palsy
48 2021-02-03 weakness, sensory loss Ulnar nerve swelling causing entrapment at left elbow and wrist. Loss of sensation left ulnar nerve ... Read more
Ulnar nerve swelling causing entrapment at left elbow and wrist. Loss of sensation left ulnar nerve distribution 2 days after first vaccine. EMG demonstrated demyelinated neve with conduction velocity of 17 m/s. Loss of sensation. Motor weakness.
48 2021-02-05 tingling Patient complains of tingling and swelling of fingers and toes starting day after vaccine.
48 2021-02-07 cold sweat Chills, fever, cold sweats, nausea, diarrhea, headache. All lasting @ 48 hours.
48 2021-02-07 tingling, numbness Hands and feet turned pale blue and were numb to touch 3 days after vaccine. Hands and feet swelled... Read more
Hands and feet turned pale blue and were numb to touch 3 days after vaccine. Hands and feet swelled 5 days after vaccine and alternate between normal and swollen (cannot wear rings). Day 7 noticed nerve tingling sensations at random sites (arms, legs, back, hips). Random 'pop-up' welts that subside after 20-30 minutes. Tingling and random swelling inside lips.
48 2021-02-08 tingling Shortness of breath, tight lungs, tingling of face, tight lips, very dizzy, and extremely fatigued.
48 2021-02-08 tingling tight lungs, shortness of breath, tingling face, tight lips, extreme fatigue, dizziness
48 2021-02-10 pain in extremity bakers cyst behind my right Knee; pain and swelling in my right knee/ calf and ankle/in the right le... Read more
bakers cyst behind my right Knee; pain and swelling in my right knee/ calf and ankle/in the right leg/in left hand; pain and swelling in my right knee/ calf and ankle/in the right leg/in left hand; pain and swelling in my right knee/ calf and ankle/in the right leg/in left hand; pain and swelling in my right knee/ calf and ankle/in the right leg/in left hand; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, lot number EH9899, via an unspecified route of administration in left arm on 06Jan2021 at 09:00 at single dose for COVID-19 immunization. The patient received vaccination in Doctor's office/urgent care. Medical history included bladder cancer from an unknown date, cancer treatment with tumor vaccine therapy BCG (Bacillus Calmette Guerin) on 23Dec2020, bone spur in right thumb from an unknown date, COVID-19 from an unknown date and drug allergy to amoxicillin/clavulanate potassium (AUGMENTIN). The patient has not been tested for COVID-19 since the vaccination. Concomitant medication included doxycycline. On 08Jan2021 (also reported 3 days after the vaccine) at 05:45 the patient experienced pain and swelling in his right knee/calf and ankle. Pain and swelling in the right knee, calf and ankle continued until 14Jan2021 when the patient went to the urgent care. He was sent to the emergency room with a suspected blood clot and ultrasound proved no clot was in the leg. On 15Jan2021 the patient went to a hematologist and had an additional ultrasound which found a bakers cyst behind his right knee. He continued to have pain and swelling in the right leg and left hand which had already arthritis and he suspected it was an immune response to the vaccine. Rest, ice, compression and elevation were suggested as therapeutic measures to treat the events. The reported events had not resolved yet at the time of the report.
48 2021-02-11 feeling cold, cold sweat, pain in extremity, weakness Within 30 seconds pain on my arm and it increased slightly. I was able to do my work. But every time... Read more
Within 30 seconds pain on my arm and it increased slightly. I was able to do my work. But every time I was stable and tried to use it again I felt pain again. Pain was always there - it was tolerable. I was told to take Ibuprofen about three hours later. Second day, I could feel it but I didn't take medication. It slowly went away. No swelling, nothing. On January 4th started having symptoms nose bleeding; diarrhea; cold sweats; had a fever - but I didn't take it to know what it was. I very tired/ extremely sleepy; my eyes started feeling warm- these symptoms creeped up on me. It started around 10:00 am and within an hour an a half I had to tell my boss and they told me to leave work - but I couldn't drive. I stayed in my car and just slept and I was extremely tired. I had a coworker keep an eye on my because I looked really bad. I slept two or three hours in my car. I was still tired and I couldn't drive yet. So I stayed in my car a little longer until I felt stronger and drove home. I had started coughing and knocked out - but I was beginning to coughing a lot on drive home- the first hour I couldn't sleep because I was coughing so much - lasted an hour. Chest coldness for a couple of days - cold chest. It wasn't tight. Next day, January 5, 2021 - went to doctor and they ordered COVID test. Dr thought I had a stomach virus. Diarrhea continued for two days. Weak and fatigue for 5 days. My Fever - temperature was on the first day was one day only. Second day, I did have a lot of fatigue and I was coughing a lot. The fatigue lasted 10 days.
48 2021-02-11 feeling hot low grade fever headache eyes were warm breath is warm lethargic
48 2021-02-16 numbness left Lower jaw and neck Numb, Pain in shoulder (not at inection site), headache
48 2021-02-16 tremor, feeling cold, weakness I awoke from sleep freezing cold. Colder than I have ever felt. violent shakes. So much that I wa... Read more
I awoke from sleep freezing cold. Colder than I have ever felt. violent shakes. So much that I was worried my muscles would begin to sieze up and cramp. I had warm clothes and 5 blankets and could not get warm for over 2 hours. Elevated heart rate and breathing. Nothing warmed me. Eventually (and with ibuprofen) the incident subsided. I felt weak and just "off" with slight body aces and fatigue for the next day and a half.
48 2021-02-19 tremor, feeling hot Difficulty breathing, swelling of throat, cough, warmth in chest, dry mouth, chills, violent shaking
48 2021-02-24 flushing Facial flushing, diaphoresis, nausea, patient refused to be seen by EMS
48 2021-02-25 inability to speak throat tightness, difficulty speaking and breathing
48 2021-02-27 migraine, pain in extremity Dose Given 1/20/21, sore arm after 1/20/21. Migraine headache developed evening 1/21 Intermittent ti... Read more
Dose Given 1/20/21, sore arm after 1/20/21. Migraine headache developed evening 1/21 Intermittent tinnitus developed 1/21/21. Woke up with subjective hearing loss/fullness Left ear and mild vertigo with nystagmus on morning of 1/23/21.
48 2021-02-27 seizure like phenomena Aural symptoms and seizure like symptoms. Patient has been seizure free for eight years with Zonegr... Read more
Aural symptoms and seizure like symptoms. Patient has been seizure free for eight years with Zonegran controlling tonic/clonic seizures. The patient experienced persistent seizure like aural symptoms, ringing in ears for four to five hours post onset and post dictal tiredness.
48 2021-03-03 numbness I had numbness in fingers in left arm. I still exp it now it's not as bad. I'm scheduled to have a E... Read more
I had numbness in fingers in left arm. I still exp it now it's not as bad. I'm scheduled to have a EEG later this month with the Neurologist.
48 2021-03-03 seizure Patient had two witnessed seizure like episodes with nystagmus and unresponsive each episode lasted ... Read more
Patient had two witnessed seizure like episodes with nystagmus and unresponsive each episode lasted less than 20 seconds. Patient had prodrome prior to both events but no memory or either event. Both event happened within 15 minutes of vaccine administration. Patient was transported to the emegency department for further testing and care.
48 2021-03-06 weakness 2/05/2021 @ 5pm: Received first dose (no adverse reaction) 2/26 @ 6:20pm: Second dose (no immediate ... Read more
2/05/2021 @ 5pm: Received first dose (no adverse reaction) 2/26 @ 6:20pm: Second dose (no immediate adverse reaction) 2/27 @ 6am: woke up and felt fine 2/27 @ 7am: feeling of being hungover (dizziness, slight nausea, slight headache, mild chills) 2/27 @ 10am: low-grade fever of 99.5F, general ashiness, moderate headache 2/27 @ 1pm: fever of 100.4F, severe headache, general weakness/achiness 2/27 @ 4pm: fever of 101.4F, severe headache, general weakness/achiness 2/27 @ 7pm: fever of 102.0F, extreme headache, general weakness/achiness 2/27 @ 10pm: fever down to 99.0F (without any medications), extreme headache, loud ringing in the ears -- took 1 dose of ibuprofen 2/28 @ 7am: normal body temp, mild headache, slight dizziness 2/28 @ 11am: mild headache, fever returned to 99.6F -- took 1 dose of acetaminophen 3/01 @ 8am: normal body temp, slight headache (especially when standing up or bending over), slight weakness 3/02 @ 8am: slight headache when standing or bending suddenly, mild episodes of dizziness 3/03: No noticed symptoms
48 2021-03-07 flushing Flushing/sweating, racing heart, and warmth over entire body. Initial BP 158/89 (pulse 80), 99% O2 s... Read more
Flushing/sweating, racing heart, and warmth over entire body. Initial BP 158/89 (pulse 80), 99% O2 sat. Final BP 135/80 (pulse 76), O2 sat 100%.
48 2021-03-08 pain in extremity swelling in left hand, first knuckles of index, middle and ring fingers also swelling in right index... Read more
swelling in left hand, first knuckles of index, middle and ring fingers also swelling in right index finger pain when making a fist in left hand itching in both hands especially between fingers duration: 36 hours before swelling started to subside took one Loratadine 3/9/21 7pm
48 2021-03-12 numbness Pt reported left periorbital headache and left arm numbness. Vitals signs were stable. Pt was observ... Read more
Pt reported left periorbital headache and left arm numbness. Vitals signs were stable. Pt was observed in car for 30 mins. Pt endorsed similar reaction to initial vaccine
48 2021-03-14 difficulty speaking, flushing hoarse voice, throat tightness Narrative: Patient received his 1st COVID shot 3/11/21. Ten minutes ... Read more
hoarse voice, throat tightness Narrative: Patient received his 1st COVID shot 3/11/21. Ten minutes later he developed intense itching, a horse voice, and felt itching in his throat stating " I feel like my throat was getting tight". Spoke in full sentences without difficulty, O2 sat 98% on RA, denied chest pain or shortness of breath. Denied throat or facial swelling or n/v. Denied any prior similar reaction except for pruritus from opiates. Admitted to ER. IV Diphenhydramine and dexamethasone were administered with 1L of normal saline. Observed for 2 hours and discharged as symptoms resolved, no longer flushed, and voice returned to normal. Advised not to have second COVID vaccine administered due to concerns of increased reaction with second dose.
48 2021-03-14 pain in extremity Was given shot in top of right shoulder straight into joint. Had infectious cellulitis in elbow tur... Read more
Was given shot in top of right shoulder straight into joint. Had infectious cellulitis in elbow turn into gangrene. Was hospitalised for 4days and had to have surgery to remove dead tissue and clean out infection!
48 2021-03-16 pain in extremity, tenderness Pain and tenderness in legs quads and lower leg
48 2021-03-17 pain in extremity As per patient reporting : Sx: Sorearm; 10pm : Shivers ; Next day (1/12/21). 12pm : Nausea ; exhaust... Read more
As per patient reporting : Sx: Sorearm; 10pm : Shivers ; Next day (1/12/21). 12pm : Nausea ; exhaustion, feelings i was going to die ; unable to sleep at night for 2 nights. As per my evaluation : Patient presented with worsening of psychosis and manic sx.
48 2021-03-18 pain in extremity Sore arm on day one then day 3 fever chills and aches muscle aches and just for the night day 4 okay
48 2021-03-18 tremor Chills and body shaking for 3-4 hours
48 2021-03-19 numbness FACE FEELS NUMB
48 2021-03-19 tingling, numbness * All of skin feels warm sensation to burning in left arm; sensation not crawling, not tingling, no... Read more
* All of skin feels warm sensation to burning in left arm; sensation not crawling, not tingling, not numb, not shooting pain, not pricking of pins and needles. * Upper body muscles tingling. * Muscles relaxed to weakness or numbness. * Feeling tired, sleepy, fatigue. * Forehead pressure; not congestion, headache, or fever. * Eyes tired and burning.
48 2021-03-20 seizure Seizures
48 2021-03-22 pain in extremity, tremor I received my first Pfizer/BioNTech vaccination at 1:00 PM on March 21, 2021. I was fine all day, b... Read more
I received my first Pfizer/BioNTech vaccination at 1:00 PM on March 21, 2021. I was fine all day, but near bedtime felt like something was beginning to happen. My upper left arm was also sore from the injection. I fell asleep at 11:30 PM and awoke at 1:00 AM with body aches and chills. I was never able to get back asleep the entire night. The following morning, March 22, I had body aches, chills, shaking and a terrible headache all day. All of these symptoms continued throughout the day and evening. I stayed hydrated with Gatorade and Sprite and ate very light foods. By the next morning, March 23, the headache was gone, but still have a little remaining of the body aches. No more chills or shaking. Moving slow still, but getting better.
48 2021-03-22 tenderness Weakness in muscles, joint pain, muscle pain and aches affecting movement, injection site pain, tire... Read more
Weakness in muscles, joint pain, muscle pain and aches affecting movement, injection site pain, tiredness/fatigue
48 2021-03-26 muscle spasms On 3/24/2021 about 1 hour, after I received the shot I started to have lower stomach cramps, they go... Read more
On 3/24/2021 about 1 hour, after I received the shot I started to have lower stomach cramps, they got more server as the night progressed. I could not sleep with the pain. Then on 3/25/2021 at about 2 am in the morning I started getting a headache while still having stomach cramps. At about 7:00 am I had a fever of about 99.5 degrees then at about 11:00 am I had a fever of about 100.2 degrees and the stomach cramps were still there. I drank lots of water and Pedialyte to stay hydrated but had a very difficult time urinating. it was very little. At about 10 pm the cramps started to subsided but were still lightly present. my appetite went to almost nothing but soup for 2 days, I have had leg and arm cramps off and on during this process as well. I did not want to eat. today 3/27/2021 is the first day I have started to feel normal.
48 2021-03-28 slurring, pain in extremity At around 10:00pm person stated that he began with swelling in mouth, "delirious", slurring of speec... Read more
At around 10:00pm person stated that he began with swelling in mouth, "delirious", slurring of speech, right arm pain, trouble breathing. These symptoms continued until 8:00am on 3/27/2021. No meds were taken at this time. Person did not go to ER for a visit and did not phone Dr.
48 2021-03-28 feeling hot After receiving the 1st dose of Pfizer COVID-19 vaccine, the patient moved to the observation area. ... Read more
After receiving the 1st dose of Pfizer COVID-19 vaccine, the patient moved to the observation area. After 5 min, patient reported feeling light-headed and tried to stand up. The patient sat down on the floor and leaned against the wall. Patient was able to stand and walk to the provider room for closer observation. Patient felt hot and looked pale. The provider placed a blood pressure cuff on the patient, at which point the patient slumped forward and stopped breathing. A carotid pulse was not able to be appreciated. The patient was pulled to the floor, positioned airway open and was given oxygen. BP was 96/40. Blood sugar was checked (104) and the AED pads were placed. EMS was called. AED advised no shock, patient had a pulse and was breathing. Patient gradually became alert, though reported not feeling well. Patient was disoriented and was not aware of passing out nor the current event. Repeat BP 115/50. Patient began vomiting (~300-400 mL). Patient left with EMS to be evaluated at local Emergency Department. Of note, patient reports history of vasovagal syncope events 2/2 to various situations.
48 2021-03-29 bell's palsy 10 days following the second dosage of the Pfizer vaccine, patient developed Bell's Palsy. While we ... Read more
10 days following the second dosage of the Pfizer vaccine, patient developed Bell's Palsy. While we are unsure if it was related to the vaccine, we wanted to report the condition in hopes of helping others in the future.
48 2021-03-29 numbness patient complaining of tingling to tongue and numbness to upper back area. He was given 2 doses of b... Read more
patient complaining of tingling to tongue and numbness to upper back area. He was given 2 doses of bendaryl 12. mg/5ml. patient still wasn't feeling better after the Benadryl and was sent to the ER
48 2021-03-29 tremor PT was administered vaccine at 1025 and shortly there after started to shake, felt sweaty and just f... Read more
PT was administered vaccine at 1025 and shortly there after started to shake, felt sweaty and just felt weird. Then passed out. PT was quickly assisted by vaccination staff at car side and then medical staff was notified. Upon arrival PT was very pail and lacked color, but was awake and stated that he has never had that happen before. Denies any history of having adverse effects to medications. NKDA. Ambulance was called. 1045 Vitals BP: 80/60 Pul: 68 Sp02: 97 1045 Ambulance arrived 1050 BP: 92/58 PT was taken to local ER for further observation.
48 2021-03-31 cold sweat Patient reports sensation of heart racing as well as feeling clammy. He states that he is not light ... Read more
Patient reports sensation of heart racing as well as feeling clammy. He states that he is not light headed and does report history of anxiety, stating that he takes Xanax as needed. Symptoms come in waves and are short lasting. Patient was given juice and crackers and was monitored in medical observation. Reports feeling a "twinge" in vaccinated arm. BP 122/74
48 2021-04-01 feeling hot Headache, hot feeling body
48 2021-04-03 tingling Tinnitus. Moderate fuzzy tingly pitch. No treatments.
48 2021-04-05 numbness C?O numbness in legs, became confused, disoriented. Transferred to Emergency Department. Diagnosed ... Read more
C?O numbness in legs, became confused, disoriented. Transferred to Emergency Department. Diagnosed with CVA event. Still being treated at this time.
48 2021-04-05 pain in extremity, tingling Swollen/painful left arm, tingling in left finger tips, fever, chills, pain in left collar bone, ran... Read more
Swollen/painful left arm, tingling in left finger tips, fever, chills, pain in left collar bone, random abdominal pains, muscle aches
48 2021-04-06 weakness Anxiety, Panic, Weakness, unable to stand, generalized weakness. 98/60 68. Pt. observed with gene... Read more
Anxiety, Panic, Weakness, unable to stand, generalized weakness. 98/60 68. Pt. observed with generalized weakness. unable to keep eye open. Emergency personnel notified and pt. was transported to Hospital for further evaluation.
48 2021-04-06 pain in extremity, hypersensitivity of all senses, tingling, nerve pain DURING VACCINE, PATIENT FELT A SHARP TINGLING/SHOOTING PAIN DOWN HIS ARM. PAIN WENT AWAY, BUT HE WAS... Read more
DURING VACCINE, PATIENT FELT A SHARP TINGLING/SHOOTING PAIN DOWN HIS ARM. PAIN WENT AWAY, BUT HE WAS AWOKEN FROM SLEEP THAT NIGHT FROM THE PAIN. ARM WAS SORE AGAIN IN THE MORNING BUT THAT EVENING FELT AS THOUGH IT WAS SHOOTING AGAIN. PATIENTS WRIST STILL HAS TEMPERATURE SENSITIVITY AND CONSTANT NERVE PAIN, AND PATIENTS ARM IS SWOLLEN TO THE ELBOW.
48 2021-04-06 unresponsive to stimuli 48 year old man recieved pfizer vaccine at 9:45am and began experiencing symptoms at 9:48am. Pt pres... Read more
48 year old man recieved pfizer vaccine at 9:45am and began experiencing symptoms at 9:48am. Pt presented diaphoretic with drool dribbling from his mouth with eyes rolling back, staring straight up with beats of horizontal nystagmus slumping in his chair. Pt did not respond to verbal or tactile stimuli. This episode lasted ~20 seconds. After this episode pt was AOx3 with eyes open. Pulse remained regular throughout the entire encounter. Denies: SOB, CP / dyspnea, HA, N/V, trauma, numbness, tingling, erythema. EMS was called to monitor vitals. Pt was transported via EMS to hospital (as per patients request), pt agreed to be transported. EKG was unable to be obtained due to chest hair. PMH: HTN, hyperlipidemia PMH: HTN, hyperlipidemia, Anxiety Meds: amlodipine, metoprolol, simvastatin, remapril, pepcid, lexapro Allergies: Penicillin (rash) Patient was advised for second dose of Pfizer to request to be laying down while getting the vaccine in case of a repeat episode or vasovagal risk.
48 2021-04-07 pain in extremity Extreme soreness and pain at the injection site and throughout upper right arm and shoulder.
48 2021-04-08 tingling, nerve pain, mild one side paralysis, numbness Swollen lymph nodes under left armpit were severely inflamed when I woke up on Saturday 2/06/2021. 1... Read more
Swollen lymph nodes under left armpit were severely inflamed when I woke up on Saturday 2/06/2021. 1-2 days later I had severe pain on my Left back- ended up being my brachial plexus nerve. Few days after that I developed numbness and weakness on my left side and pins and needles in my Left index finger. I saw my primary care doctor twice that week. He started me on low dose Prednisone and gabapentin for the pain while sleeping. When the nerve pain/numbness did not subside, I asked for a neurology referral. Two doctors saw me for brachial plexus neuritis. I have had 2 ultrasound guided and one fluoro guided cortisone shots along the nerve. I have also been going to PT 2-3 x/week to regain my strength on the Left side & calm nerve.
48 2021-04-09 cold sweat Patient stated he was sitting in the chair and he started feeling clammy tunnel vision and blacked o... Read more
Patient stated he was sitting in the chair and he started feeling clammy tunnel vision and blacked out. he doesnt remember being brought over to the observation room. He was encouraged to drink fluids, patient stated he was feeling better and reported no further tunnel vision, he was escorted out with his son accompanying him. vital signs @ 1024 HR 62, BO 98/60 RR 18, pulse ox 96%, at 1027, HR 81, BO 111/65, RR 18 and pulse ox 95% on RA, at 1044 HR 62, BP 111/ 69, RR 18 and Pox 97%. He was released at 1045 by himself to the exit of the facility.
48 2021-04-09 pain in extremity Sore arm, similar to a tetnus shot. Lasted around 36 hours.
48 2021-04-09 pain in extremity Patient was inadvertently given a COVID19 vaccine as the second dose after receiving a COVID19 vacci... Read more
Patient was inadvertently given a COVID19 vaccine as the second dose after receiving a COVID19 vaccine. Patient was given one manufacturer on 3/28/21 at another pharmacy and incorrectly thought he had missed his second dose. He came to our pharmacy to get the second dose, and it was not realized he had already received different manufacturer just 12 days before. Patient is not experiencing any unusual adverse effects, just a sore arm and drowsiness as would be expected after theCOVID19 vaccine.
48 2021-04-09 tingling patient stated he was sitting after receiving the vaccine he start feeling a tingling feeling on his... Read more
patient stated he was sitting after receiving the vaccine he start feeling a tingling feeling on his forehead then he started feeling light headed then bust into a feverish sweat patient was assessed vitals are as follows 5:27p b/p 154/96 p 89 r 18 sat 100% 5:45p b/p 148/93 p 87 r 18 sat 99% 6:00p b/p 152/93 p 81 r 18 sat 99% patient stated he is feeling better patient will be wheeled out to the front entrance where patient will be released to go home.
48 2021-04-09 tingling shortness of breath; tight chest/lungs; tingling in face; tight lips; dizziness; fatigue; This is a ... Read more
shortness of breath; tight chest/lungs; tingling in face; tight lips; dizziness; fatigue; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6201), via an unspecified route of administration in right arm on 06Feb2021 at 05:30 PM at single dose for COVID-19 immunisation. Medical history included allergies to macadamia and brazil nuts, and was on medication for a few health issues. Concomitant medications included unspecified medication (medications in two weeks). No other vaccine received in four weeks. Patient has not tested COVID prior vaccination. The patient experienced shortness of breath, tight chest/lungs, tingling in face, tight lips, dizziness, fatigue on 06Feb2021 at 06:15 P.M. Events resulted in visit to doctor or other healthcare professional office/clinic. No treatment was given for events. Patient has not tested COVID post vaccination. The outcome of events was recovered with sequel. No follow-up attempts are possible. No further information is expected.
48 2021-04-11 weakness Today on 12 April, 2021 I woke up feeling dizzy. I am also having nausea, feeling light headed, and ... Read more
Today on 12 April, 2021 I woke up feeling dizzy. I am also having nausea, feeling light headed, and a feeling of wanting to faint. Energy level feels down. Feeling slight confusion and disorientation.
48 2021-04-12 seizure Seizure lasting 2 minutes. Taken to er. Hospitalized for 3 days and all tests negative. Started on a... Read more
Seizure lasting 2 minutes. Taken to er. Hospitalized for 3 days and all tests negative. Started on anticonvulsants
48 2021-04-13 feeling hot, seizure like phenomena, unresponsive to stimuli Five minutes after receiving dose, stated he started to feel warm and light headed, so he sat down. ... Read more
Five minutes after receiving dose, stated he started to feel warm and light headed, so he sat down. He then lost consciousness, falling out of his chair and hitting his head. Staff at his side immediately; pale and extremely diaphoretic; started to come to after 10-20 seconds. He sat up immediately on his own. He was oriented to self, place, date. After about 30 seconds, stated he thinks he should lay down again. Lowered his head to the floor, blanket placed under his head and feet elevated using a chair nearby. BP 120/52 Sats 100%, HR 72. Cool packs applied to his neck and forehead. After 2-3 minutes requested to move him to the medical area. Got up to wheelchair, but lost consciousness again; head fell forward, appeared as if upper extremities stiffened and contracted, like sz activity. When in medical evaluation area, client was conscious, but starring blankly and not responding verbally. At 3:02, with assist of 2, moved to the cot to elevate his feet, but again, not responding to requests, such as lay down or elevate your feet, so assisted client to this position. Continues to be diaphoretic, pale and ashen. 911 called at 3:07. Informed him of this and the plan. Friend is by his side. Client denies allergies, states he takes meds for hypertension. 3:15 BP 100/56, HR 52, Sats 92%, hands cool to the touch. EMS here at 3:23; report given and client transferred to Hospital via ambulance.
48 2021-04-13 tingling 48 yo healthy male no PMH - recent L leg fracture 10 months ago and has had surgeries for this -- n... Read more
48 yo healthy male no PMH - recent L leg fracture 10 months ago and has had surgeries for this -- no known allergies or other medical issues After 5 minutes --had swelling L ankle and then subsequently had paresthesias to L upper thigh and L arm and L chest No CP or SOB No fever or chills VItals normal 133/89 T 97.6 PO 97% P 68 Neuro exam: CN 2-XII intact Strength 5/5 + and symm bilat UE/LE Ambulatory No sensory difference No airway compromise Observed for 1 hour and feels slightly better --no worsening symptoms - L arm /chest tingling is gone, mild symptoms L ankle
48 2021-04-14 tremor, night sweats High fever onset 04/03/2021, chill and shakes, night sweats nightly until 04/13/2021; headaches cont... Read more
High fever onset 04/03/2021, chill and shakes, night sweats nightly until 04/13/2021; headaches continue Ibuprofen and Acetamenophen to reduce fever.
48 2021-04-15 feeling hot Feeling hot/chills about 10 hours after administration Fatigue and headache for 3 days , gradually i... Read more
Feeling hot/chills about 10 hours after administration Fatigue and headache for 3 days , gradually improving
48 2021-04-16 bell's palsy Development of Bells Palsy. At approximately 11 pm on 4/14/2021 noticed limited lip movement left s... Read more
Development of Bells Palsy. At approximately 11 pm on 4/14/2021 noticed limited lip movement left side. By next morning, left side of face paralyzed. Evaluated at ER approximately 8:30 am on 4/15/2021 who diagnosed episode of Bells Palsy. Advised to follow up with Primary first of next week and also follow up with Nuerologist in approximately 3 weeks.
48 2021-04-16 night sweats Extreme fatigue, constant headache that Tylenol and Ibuprofen would not help. Chills, fever, nig... Read more
Extreme fatigue, constant headache that Tylenol and Ibuprofen would not help. Chills, fever, night sweats.... from 6:00 p.m. to noon the following day.
48 2021-04-17 weakness, tremor Extreme dizziness and nausea resulting in fainting twice and hitting chin on furniture. Diarrhea al... Read more
Extreme dizziness and nausea resulting in fainting twice and hitting chin on furniture. Diarrhea all night at least once per hour. Chills and shaking. Sweats, very fatigued, no appetite, no sleep. Rested all Sunday, no more chills but still nauseous, diarrhea all day. No energy or appetite.
48 2021-04-17 weakness I started shivering around 1am. It got so bad that my teeth were chattering, too. I slept poorly a... Read more
I started shivering around 1am. It got so bad that my teeth were chattering, too. I slept poorly and at 6am took my temperature. It was 101.4. I used a digital thermometer under the tongue. I took 2 acetaminophen at 8am. At around 10am my fever broke. My temperature stayed around 99 throughout the day. I felt "whoozy" and weak for the rest of the day. Today, April 18th at 10am I don't have any symptoms.
48 2021-04-17 pain in extremity Pfizer 1st Shot gave me loud Tinnitus and hasn't stopped.; headache; Had fever for a few days; fatig... Read more
Pfizer 1st Shot gave me loud Tinnitus and hasn't stopped.; headache; Had fever for a few days; fatigued; arm soreness; he was scared; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 17Mar2021 11:30 (Batch/Lot Number: EN6204) as SINGLE DOSE for covid-19 immunisation, age of vaccination 48 years old at workplace clinic. Medical history included Heart Disease and Covid-19 from an unknown date. No other vaccines in four weeks. Concomitant medication included losartan taken for an unspecified indication, start and stop date were not reported. The patient experienced loud tinnitus and hasn't stopped. Described as screaming High Pitch Ringing. Patient stated he was praying it will go away. Patient had headache, had fever for a few days, fatigued, and arm soreness on 19Mar2021 20:30 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): negative on 20Mar2021. Treatment was not received for tinnitus, headache, had fever for a few days, fatigued, and arm soreness. Physician office visit was made for tinnitus, headache, had fever for a few days, fatigued, and arm soreness. The patient stated "This is really scary stuff. Please stop blaming it on Covid". Patient further stated, "Since day 2 of shot which I got on St Patty's Day 17Mar2021. I am on Day 13 of this new hell with no end in sight". He filed a VAERS report and notified his Primary care Dr and ENT. Patient won't get the 2nd shot, as he was scared (Mar2021)." Outcome of the event scared was unknown while not recovered for the other events. The patient considered the tinnitus as serious (very serious and others have experienced this). No follow-up attempts are possible. No further information is expected. Lot number has been obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366081 Same reporter/drug/AE, different patient;US-PFIZER INC-2021366082 Same reporter/drug/AE, different patient
48 2021-04-17 tremor, weakness Upset stomach starting about 36 hours after injection. Stomach issues continued for 5 days; nausea; ... Read more
Upset stomach starting about 36 hours after injection. Stomach issues continued for 5 days; nausea; body shakes; weakness; fatigue; chills; This is a spontaneous report received from a non-contactable consumer reported for self. This 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 24Mar2021 11:30 AM Left arm as single dose (lot: EP7533) for COVID-19 immunisation. No pregnant at the time of vaccination. Medical history included Eosinophilic Esophagitis. Prior to vaccination, the patient did not diagnose with COVID-19. No allergies to medications, food, or other products. Concomitant medication included Omeprazole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He experienced Upset stomach on 26Mar2021 02:00 AM. Stomach issues continued for 5 days culminating in an episode of nausea, chills, body shakes, weakness, and fatigue. This episode passed fairly quickly in about an hour. Since the day after this episode have felt fine (approximately 48 hours). Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the event Upset stomach was recovered on 31Mar2021 02:00. Outcome of the events nausea, chills, body shakes, weakness, and fatigue were recovered on 28Mar2021 02:00. No follow-up attempts are needed. No further information is expected.
48 2021-04-18 pain in extremity 1). Fever (100.1) 2). Body ache 3). Lower left Leg moderate pain 4). Right under Arm pit swelling a... Read more
1). Fever (100.1) 2). Body ache 3). Lower left Leg moderate pain 4). Right under Arm pit swelling and moderate pain
48 2021-04-20 feeling hot VS: 106/67, SPO2 98%, HR 75, RR 18, Pt altered observational nurse, he was feeling hot and lighthead... Read more
VS: 106/67, SPO2 98%, HR 75, RR 18, Pt altered observational nurse, he was feeling hot and lightheaded. Pt fell to the ground, states he has a history of passing out with needles. Small laceration to forehead and small abrasion to nose. Within 10 minutes in observation hall pt states he felt much better. A&Ox3, with slight HA. Pt wife at bedside. Educated on s/s of when to seek medical attention. Ambulated with steady gait. Denies PMH, meds or allergies. Offered to call EMS to take to hospital, patients wife at bedside stating she feels comfortable taking the pt home. Educated on when to seek medical care if needed.
48 2021-04-20 tingling About 5 minutes after vaccination patient reported tingling feeling feeling all over his body. He a... Read more
About 5 minutes after vaccination patient reported tingling feeling feeling all over his body. He also said his throat "felt funny" but that symptom went away within 1 hour.
48 2021-04-21 flushing Syncope, flushing/sweating, dizziness. Patient fainted. BPs 99/57 (pulse 64), 103/61 (pulse 67). Giv... Read more
Syncope, flushing/sweating, dizziness. Patient fainted. BPs 99/57 (pulse 64), 103/61 (pulse 67). Given water, juice, crackers.
48 2021-04-21 throat numbness Approximatley5 minutes after the first vaccine dose, I experienced a slight numbing of the throat an... Read more
Approximatley5 minutes after the first vaccine dose, I experienced a slight numbing of the throat and minor difficulty swollwing. Breathing never seemed to be compromised. Symptoms last for about 1 hour.
48 2021-04-22 facial paralysis, bell's palsy, numbness Red patch on arm for about 10 days, he in size to 4"x6". Tingling on tongue. Pain on back of head fo... Read more
Red patch on arm for about 10 days, he in size to 4"x6". Tingling on tongue. Pain on back of head for several days, still continuing. Numbness in left jaw, Loss of muscle use on left side of face. Went to ER where they indicated Bell's palsy.
48 2021-04-22 facial paralysis right facial paralysis
48 2021-04-23 numbness This was my first injection of Pfizer COVID vaccination in my left arm. I woke up next morning with... Read more
This was my first injection of Pfizer COVID vaccination in my left arm. I woke up next morning with my left hand partially numb. The thumb and right pointer finger feeling most of the numbness. The last three fingers had partial to no numbness. Today (04/24/2021), the numbness is still present. No pain is present, just the numb feeling.
48 2021-04-23 numbness 4 weeks after 2nd dose, suffered minor head ?cloudiness? and numbness in right hand. Lasted about 1 ... Read more
4 weeks after 2nd dose, suffered minor head ?cloudiness? and numbness in right hand. Lasted about 1 hour
48 2021-04-23 muscle spasms, discomfort 102° fever, extreme muscle aches (sharp pain, pressures, cramps), chills, lethargic and soreness a... Read more
102° fever, extreme muscle aches (sharp pain, pressures, cramps), chills, lethargic and soreness at injection area. Most symptoms began approximately 12 hours after the shot and lasted approximately 18 hours. Took Tylenol for fever and pain.
48 2021-04-24 discomfort swollen/inflamed gallbladder; swollen/inflamed gallbladder; discomfort; very sharp pain in my upper ... Read more
swollen/inflamed gallbladder; swollen/inflamed gallbladder; discomfort; very sharp pain in my upper right abdomen; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 (Batch/Lot Number: EN6208) as SINGLE DOSE, 48 years old. Medical history included none from an unknown date. The patient's concomitant medications were not reported. No known allergies. No COVID prior vaccination. Not tested for COVID post vaccination. No other vaccine in four weeks. There were no other medications in two weeks. On unspecified date after first dose patient suddenly experienced very sharp pain in her upper right abdomen. Patient went to hospital. They could not pinpoint anything. The doctor believes it is a swollen/inflamed gallbladder. The pain lessened due to the new diet. I still have pain and discomfort. Scheduled for a gallbladder scan. Treatment includes change to low fat diet. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Outcome of the events were reported as not recovered. The second dose was administered in Arm Left on 01Apr2021 (Batch/Lot Number: EP7533) as SINGLE DOSE for covid-19 immunisation.
48 2021-04-24 pain in extremity Sore Arm; Sore Throat/Scratchy Throat; Sore Throat/Scratchy Throat; Headache; Chills; This is a spon... Read more
Sore Arm; Sore Throat/Scratchy Throat; Sore Throat/Scratchy Throat; Headache; Chills; This is a spontaneous report received from a contactable consumer (Patient) reported for himself. A 48-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK5730 and expiration date was not provided) and (lot number: EK5730 and expiration date was not provided), via an unspecified route of administration, in Arm left, on 25Mar2021 at 01:30 PM (at the age of 48-years-old) at a single dose for COVID-19 immunisation, at workplace clinic. Medical history and concomitant medications were not reported. Allergies to medications, food, or other products included: gluten, penicillin, ciprofloxacin, differin, tessalon pearls. The patient previously took first dose of BNT162B2 (lot number: EJ1685) on 04Mar2021 at 03:30 PM (at the age of 48-years-old) in Left arm for COVID-19 immunisation and experienced headache /sore arm started after first dose, headache started within 1 hour of receiving vaccine. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive other medications in two weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. It was reported that on 26Mar2021 at 01:00, the symptoms started after receiving second dose at around 1 am after 2nd dose, dose time was 1:30 pm day before sore arm sore throat/scratchy throat, headache, chills. The events were reported as non-serious. No treatment was received for the events. Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
48 2021-04-24 pain in extremity Headache; sore arm; This is a spontaneous report received from a contactable consumer (patient himse... Read more
Headache; sore arm; This is a spontaneous report received from a contactable consumer (patient himself). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection and Lot Number: EJ1685) via an unspecified route of administration in left arm on 04Mar2021 at 15:30 (at the age of 48-year-old) for COVID-19 immunisation. Medical history included allergies to tartrazine, gluten and penicillin. Concomitant medications were not reported. Patient previously took ciprofloxacin, differin and tessalon perle and experienced with allergy for all. On 04Mar2021 (stated within 1 hour of receiving vaccine) patient had headache and on an unknown date in Mar2021 (after first dose), patient had sore arm. Treatment was not received for the adverse events. Outcome for the event headache was not recovered and was unknown for sore arm.
48 2021-04-24 pain in extremity Regular - Arm pain. Adverse - Abdominal pain / pressure, green stools, dizziness, fast heartbeat, a... Read more
Regular - Arm pain. Adverse - Abdominal pain / pressure, green stools, dizziness, fast heartbeat, anxiousness, irritation, body hyper alert, triggered.
48 2021-04-25 cold sweat Within 10 minutes of COVID #2 Pfizer vaccine at about 10:18am, patient developed lightheadedness, co... Read more
Within 10 minutes of COVID #2 Pfizer vaccine at about 10:18am, patient developed lightheadedness, cold sweats, and throat swelling sensation. Patient's temperature was low at 95.8 to 96.2.
48 2021-04-26 numbness Leg weakness and numbness, bladder dysfunction. Diagnosed with Gullian Barre after hospitalization 3... Read more
Leg weakness and numbness, bladder dysfunction. Diagnosed with Gullian Barre after hospitalization 3/17/21.
48 2021-04-27 speech disorder At approximately 1:30 on 4/28/2021, my throat started tingling on the left and right near my glands,... Read more
At approximately 1:30 on 4/28/2021, my throat started tingling on the left and right near my glands, and I had trouble speaking. I took three benedryl and then went to the ER at 2pm. They gave me a steroid in the ER, and also a prescription for prednisone. I returned home at 6pm
48 2021-04-28 weakness Client fainted after receiving the COVID-19 vaccine as per the vaccinating nurse. Attending nurse a... Read more
Client fainted after receiving the COVID-19 vaccine as per the vaccinating nurse. Attending nurse administered an ammonia inhalant. The client woke up, Fire Rescue arrived to evaluate client. Showed symptoms of weakness, diaphoresis and paleness. Client presented hypotension and bradycardia. Client needed to be transported to a hospital as per Fire Rescue. Client was transferred to Clinic by Fire Rescue at 3:27pm.
48 2021-04-29 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
48 2021-04-30 weakness, pain in extremity syncope; Soreness overnight in left arm; expanding pain to left shoulder; Strong Fever/low fever; bo... Read more
syncope; Soreness overnight in left arm; expanding pain to left shoulder; Strong Fever/low fever; body pain; headache; felt uneasy; nausea/Felt like throwing up; dizzy/lightheaded; Profuse sweating; EKG showed low heart rate, blood pressure; EKG showed low heart rate, blood pressure; feeling weak; could not stand; Feeling worse; This is a spontaneous report from a contactable consumer. A 48-year-old male patient received second dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 14Apr2021 at 16:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included Cholesterol (blood cholesterol abnormal) from an unknown date. There were no concomitant medications. The patient previously received first dose of BNT162B2 for covid-19 immunisation on 24Mar2021. The patient also previously received naproxen and experienced allergies. The patient experienced syncope, soreness overnight in left arm, expanding pain to left shoulder, strong fever/low fever, body pain, headache, felt uneasy, nausea/felt like throwing up, dizzy/lightheaded, profuse sweating, ekg showed low heart rate, blood pressure, feeling weak, could not stand and feeling worse all on 15Apr2021 at 13:00. All the reported events caused hospitalization for 1 day. It was reported that After receiving Pfizer vaccine at 4pm developed Soreness overnight in left arm, expanding pain to left shoulder. Strong Fever and body pain in morning. Feeling worse throughout morning after breakfast of tea and fruits. While having lunch at 1.30 pm felt uneasy and nausea and could not complete lunch. Felt like throwing up and got up feeling dizzy and lightheaded. Experienced syncope and had to lie down on kitchen floor. Tried to get up with help from family members but could not stand and had to lie down again on floor. Profuse sweating. Wife called 911 and ambulance who arrived and checked pulse, EKG showed low heart rate, blood pressure. Taken by ambulance and paramedics to hospital Emergency where IV fluids were given to stabilize and discharged after 4 hours of observation. Still feeling weak, headache, low fever. Taking Tylenol and fluids while recovering. Adverse event start date: 15Apr2021. Adverse event start time: 01:00 PM. The patient underwent lab tests and procedures which included blood pressure (blood pressure measurement): low on 15Apr2021, EKG (electrocardiogram): showed low heart rate, blood pressure on 15Apr2021 and pulse/heart rate (heart rate): low on 15Apr2021. Therapeutic measures were taken as a result of all the events which includes IV fluids and Tylenol. Outcome of all the events was recovering Information on batch/lot number was requested.
48 2021-05-02 cold sweat Post vaccine pt became lightheaded and clammy. Pt transferred to med obs via wc. Pt reported feeling... Read more
Post vaccine pt became lightheaded and clammy. Pt transferred to med obs via wc. Pt reported feeling better after sitting on stretcher. Vitals obtained and monitored. Pt released at 12:51 PM. Vitals as follows: 1205 LYING BP 138/90 HR 77 RR 16 SpO2 100% 1210 SITTING BP 138/87 HR 72 RR 16 SpO2 100% 1215 SITTING BP 130/86 HR 70 RR 16 SpO2 100% 1245 SITTING BP 134/84 HR 69 RR 16 SpO2 100% 1250 STANDING BP 132/93 HR 71 RR 16 SpO2 100%
48 2021-05-02 numbness, burning sensation, tingling Insomnia, being "jolted" awake or just waking up at random times and unable to go back to sleep. Ver... Read more
Insomnia, being "jolted" awake or just waking up at random times and unable to go back to sleep. Very tired and groggy most days. Hard to concentrate at work. Depression, excessive anxiety. Always worried about there not being a cute for this. Tingling, burning back, shoulder, and neck pain. Never too severe, but there a lot. Painful to sleep after a few hours. Nausea over half the time. Loss of appetite. Eating significantly less. Lost 15 lbs in two months. Fatigue, brain fog, dizziness, lightheadedness. Extremely tired. Originally neck pain in the front, now teeth/jaw hurt in the mornings. Random sensitivity to cold/hot foods. Unpredictable desire to have a bowel movement or to urinate. Usually unproductive. Sweaty hands/feet. Elevated heart rate randomly. Skin tingling/burning on the tops of arms and cheeks. Numbness in fingers. Originally ring/pinky, now thumb/index/middle finders. Mostly left side. Tinnitus, ear pain. Has gotten slightly louder and more noticeable. Symptoms appeared starting a few days after vaccine #1 and are still ongoing as of date of VAERS report.
48 2021-05-03 weakness Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Swelling at Inje... Read more
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: PE and DVT more prominent in/on the right side of body than left-Severe, Systemic: Vomiting-Medium, Systemic: Weakness-Severe, Additional Details: patient was diagnosed with COVID-19 in October 2020, but asymptomatic with underlying cough
48 2021-05-03 pain in extremity Developed constant pain originating in right shoulder blade area, wrapping around right under arm to... Read more
Developed constant pain originating in right shoulder blade area, wrapping around right under arm to right pectoral on Monday, April 19, 2021. Diagnosed with shingles on Saturday, April 24, 2021 at after hours clinic and prescribed seven day course of Valtrex to treat shingles. Still experiencing same pain today, Tuesday, May 4, 2021.
48 2021-05-06 feeling hot, discomfort pt states he developed symptoms of covid. His body is itchy feeling all over his body on the inside... Read more
pt states he developed symptoms of covid. His body is itchy feeling all over his body on the inside. His muscles felt heavy, he felt hot and was sweating with no fever. His heart beating about 125 bpm. On 4/30/21 he went to ER. EKG was normal. Blood test results showed TSH low and T3 is high. He repeated test 4 days later and had the same results. These test were normal before taking the vax. He was discharged to see a endocrinologist on 5/26/2021. Pt still has the itchy sensation, his eyes burn, still feeling extremely tired and feels like he dying.
48 2021-05-06 numbness, bell's palsy 48 yo male received first dose of his Pfizer COVID-19 vaccination on 3/20/21. On 4/5, he calls this ... Read more
48 yo male received first dose of his Pfizer COVID-19 vaccination on 3/20/21. On 4/5, he calls this institution to report right sided facial and tongue numbness that started the day prior. The numbness resolved the next day, however he was still unable to smile normally or close his right eyelid all the way. He has a family history of Bell's Palsy (mother and sister), with similar symptoms. Pt then presents to the clinic that same day (4/5) for an acute visit. Pt diagnosed with Bell's Palsy and given prednisone and artificial tears for treatment. Unknown if patient received dose 2 of COVID-19 vaccination.
48 2021-05-06 speech disorder Starting on the day after my shot I was completely fatigued and unmotivated. This continued for four... Read more
Starting on the day after my shot I was completely fatigued and unmotivated. This continued for four full days afterwards before easing off on the fifth day, and gone by the sixth. During this time I also had some confusion and difficulty comprehending reading and verbal explanations. Unsure what day it was. I found myself misspeaking words with the wrong meanings. I also was confused if I had completed tasks such as going for a scheduled unrelated blood test, taking my car in for maintenance, etc, and could not recall if I had done these things or if they still needed done. I would stay awake no more than a few hours, 5 at most, then sleep for 8-10 hours. This went on until the fifth day.
48 2021-05-07 pain in extremity Left arm sore improved after first shot as well as after second shot; He had 101.1 degree fever; Exh... Read more
Left arm sore improved after first shot as well as after second shot; He had 101.1 degree fever; Exhaustion and extremely tired; His stomach was hurting a lot; lungs felt like someone reach inside inside and punched him in the lungs; Achiness in joint in any place he had problems in the past in his body; nauseated; came right up on Pulmonary oil micro embolism or POEM; This is a spontaneous report from a contactable consumer, reporting for himself. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscular, administered in the left arm on 15Apr2021 at 12:00 (Batch/Lot Number: EN6204) as 2ND DOSE, SINGLE (at the age of 48 years old) for covid-19 immunisation; and testosterone cipionate (Perrigio manufacturer), via an unspecified route of administration from 2018 (Batch/Lot Number: 2005126.1; Expiration Date: Jul2023), at 200mg/ml. 100mg injected weekly for secondary hypogonadism . Medical history included hypogonadism from 2018, diagnosed allergies from an unknown date, compromised immune status from an unknown date, respiratory illness from an unknown date, genetic /chromosomal abnormalities from an unknown date, endocrine abnormalities from an unknown date, diabetes from an unknown date, and obesity from an unknown date. The patient's concomitant medications were not reported. Historical vaccine included flu vaccine over a year ago, and the first dose of BNT162B2 on 24Mar2021 at 12:30 injected intramuscularly in left arm for which he had a mild sore left arm. The patient experienced came right up on pulmonary oil micro embolism or poem on 16Apr2021 with outcome of unknown, left arm sore improved after first shot as well as after second shot on 16Apr2021 at 13:30 with outcome of unknown, exhaustion and extremely tired on 16Apr2021 at 00:30 with outcome of recovering, his stomach was hurting a lot on 16Apr2021 with outcome of recovering, lungs felt like someone reach inside inside and punched him in the lungs on 16Apr2021 with outcome of recovering, he had 101.1 degree fever on 16Apr2021 at 01:00 with outcome of recovering, achiness in joint in any place he had problems in the past in his body on 16Apr2021 with outcome of recovering, and nauseated on 16Apr2021 with outcome of recovered on 18Apr2021. Details were reported as follows: 16Apr2021 at 8-9 am he gave himself the testosterone injection and he felt that tickling, rough feeling in his wind pipe like he just had to cough hard. Caller states, "yesterday, 22Apr21, I gave myself the testosterone injection like I have always done, my wind pipe started feeling like I had to cough, it tickled and felt just like it did on 16Apr21 following the 2nd vaccine dose. I looked my symptoms up on line and found pome-(pulmonary oil micro embolism)." The patient underwent lab tests and procedures which included pyrexia: 101.1 fahrenheit on 16Apr2021. The action taken in response to the event(s) for bnt162b2 was not applicable, and for testosterone cipionate was unknown.
48 2021-05-07 tenderness Fri. Apr. 23, 2021: Within 12 hours of vaccine administration, and in addition to injection site sor... Read more
Fri. Apr. 23, 2021: Within 12 hours of vaccine administration, and in addition to injection site soreness and discomfort, began to notice tenderness above left clavicle, and could feel slight lump or swelling there. Sat. Apr. 24, 2021: -7am-8am. Lump on upper surface and tucked behind left clavicle more noticeable and tender, painful if pressed. Was often irritated and pressed on by seatbelt when driving. -8pm: Lump above and on clavicle a noticeably swollen, firm mass approximately 2cm across, painful to pressure or touch. Apparently a swollen lymph node. Injection site deltoid sore, like ?punch? to arm. From this point on I will not document that further, other than to say the soreness peaked the following day, and lessened to non-issue rapidly after. Sun. Apr. 25, 2021: -8am: Swollen lymph node above left clavicle swollen even more, 2-2.5cm across, constantly sore. Painful when touched or pressed. -12pm: Pain associated with swollen lymph node above left clavicle spread laterally to lateral end of clavicle, and slight swelling to discomfort below lateral end of clavicle, in hollow between pectoral and deltoid muscles. Remained through night. Mon. Apr. 26, 2021: -8am: Lymph node over left clavicle still enlarged and tender, painful to touch or pressure, but not quite as bad as previous day. Irritated by seatbelt when driving. -8pm: Lymph node over left clavicle reduced in size to around 1.5cm across, still firm to touch and painful when pressed. Tue. Apr. 27, 2021: -8am: Lymph node still swollen, about 1-1.5cm across, firm, and painful if pressed. -8pm: Lymph node approximately 1cm across, but still firm, and painful if pressed. Wed. Apr. 28, 2021: -8am: Lymph node above left clavicle remains approximately 1cm in size, firm to touch, but not painful, only some tenderness if pressed. -8pm: Same condition as earlier in day. Thurs. Apr. 29, 2021 through Fri. May 7, 2021: The lymph node above the left clavicle was pain free. It stayed the same size, around 1cm, and is still firm enough to feel and locate by touch. May 7 marked 2 weeks since vaccination dose 1. Please note, patient was diagnosed as Covid-19 positive on Dec. 27 or 28th, 2020, but had a nearly symptom-free run of the disease (slight and short-lived cough, some joint pain 1 day, no fever, no other symptoms).
48 2021-05-09 cold sweat, flushing Patient felt nauseous immediately after vaccination. Nausea resolved fairly quickly afterwards. Pt a... Read more
Patient felt nauseous immediately after vaccination. Nausea resolved fairly quickly afterwards. Pt also felt flushed and clammy. These symptoms lasted about 1 hour before he was back to normal. Pt asked and was given water, which he says helped him get better.
48 2021-05-10 feeling of body temperature change Hot and cold flash fever off and on Cough Muscle or body aches Headache Acute hypoxemic respirator... Read more
Hot and cold flash fever off and on Cough Muscle or body aches Headache Acute hypoxemic respiratory failure Pneumonia due to COVID-19 virus Received plasma therapy remdesivir dexamethasone?changed to oral Decadron upon discharge
48 2021-05-10 migraine A male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for in... Read more
A male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Apr2021 12:30 or 12:35 (Batch/Lot Number: ER8731) as single dose for covid-19 immunisation. Medical history included migraine from 2000 to an unknown date, ongoing hepatitis c. Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE) taken for migraine. The patient previously took atropine and experienced hypersensitivity. Caller states that he got the vaccine at 12:30 in the morning and he got a headache at 5 or 6 o'clock in the evening. He read also, in his country, that with other vaccines, not Pfizer, that after each shot they had a mild headache. He states that he read on line that it is normal to get a headache after getting the vaccine and that it can last up to three days. He states that the headache can come on again and off again. He states that once you get a migraine it doesn't go away until you take medication. He states that he has been taking medication for years so he knows that this is a migraine headache and not related to the vaccine. He states the next day after getting the vaccine the headache was gone. From Friday until Sunday he was fine, for 3 days he had nothing. Now he states its a migraine. He woke up and felt like he has motion and wants throw up. He states that if you are hungry and you go to sleep and then you wake up that feeling will come back after sleep. So when he goes to sleep, and wakes up with a migraine, he takes medication and it goes away. He states that he read online that within 24 hours don't take any medication because it can lessen the effect the vaccine. He states he knew that getting a headache was normal, now he know it is not Pfizer's vaccine effect, he knows it's a migraine. He was just wondering if he can take his medication. He states that he read that you can have a headache for two or three days after the vaccine. He is calling because has been sick with a migraine for a long time. He has been taking Excedrin migraine medication for migraines because it saves him all the time. He wants to know if he can take medication now or should he avoid it. He states that he read somewhere that it is normal to have a headache for up to three days after getting the vaccine so he was ready for it. He also read some where that he should not to take and medication with in 24 hours of getting the vaccine and he wants to know if he can take the medication now. The outcome of the event headache was recovered The outcome for the events migraine and he has a motion and wants to throw up was unknown. No follow-up attempts are needed. No further information is expected.
48 2021-05-10 pain in extremity, tenderness, numbness Patient is a 48-year-old male with patient history significant for CAD, CHF, ICD, HTN, hyperlipidemi... Read more
Patient is a 48-year-old male with patient history significant for CAD, CHF, ICD, HTN, hyperlipidemia, and smoking who presented to the ED yesterday morning with 1 day history of chest pain. Patient described the CP as moderate aching in the substernal area that did not radiate. The pain was intermittent, with each episode lasting 1-2 minutes. The CP was associated with LUE numbness and SOB on exertion. The chest pain and LUE numbness have now resolved. Patient also reports a three week history of RUE swelling. The swelling gradually worsened and is now associated with pain and proximal RUE bruising. RUE pain is rated 5/10. In the ED, patient was found to have NSTEMI and small right lower lobe segmental pulmonary artery embolus. Venous Doppler was positive for occlusive thrombosis in the R subclavian, basilic, and cephalic veins. Patient was started on IV heparin. Patient is scheduled for cardiac cath today. Hematology is consulted regarding PE and RUE DVT. Patient denies personal or family history of blood clots or recent travel. Reports receiving COVID vaccine in LUE approximately three weeks ago. Also admits to being more sedentary recently due to being unemployed. Denies nausea, vomiting, bleeding, bowel changes, fever, or chills. Significant PE findings: RUE edema, firm and tender to palpation, ecchymosis on proximal RUE, distal sensation and active ROM intact
48 2021-05-11 tingling, inability to speak TIA with aphasia/right hand weakness- fully recovered. On 5/7/21, took a nap after work, when he wo... Read more
TIA with aphasia/right hand weakness- fully recovered. On 5/7/21, took a nap after work, when he woke at 6:45PM, realized he couldn't read - knew it was words, but seemed jumbled, so went to talk to his wife but he was speaking jumbled words. He could understand her speaking and hear himself, just couldn't respond in words. Wife called 911, by the time EMS arrived sx were resolving. When EMS arrived, he was evaluated and found that his right hand was slightly tingly/tired. ABCD2 score of 5 for HTN BP>140/90, speech disturbance , weakness, sx <60 min.
48 2021-05-11 tingling, muscle twitching Muscle twitching and tingling. First started in the right hand, but now it is also happening in both... Read more
Muscle twitching and tingling. First started in the right hand, but now it is also happening in both legs. Almost constant twitching. No pain.
48 2021-05-12 pain in extremity Became sore, achey, flueish and tired that night. Sore arm. Next 10 days was extremely tired altho... Read more
Became sore, achey, flueish and tired that night. Sore arm. Next 10 days was extremely tired although other initial symptoms cleared up in 36 hours after shot.
48 2021-05-12 trigeminal neuralgia G50.0 - Trigeminal neuralgia
48 2021-05-13 muscle twitching Facial twitching on the left side of his face; This is a spontaneous report from a contactable consu... Read more
Facial twitching on the left side of his face; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: ER8735; NDC number: unknown, Expiration Date: 31Jul2021), via an unspecified route of administration, administered in left arm on 21Apr2021 09:00 as single dose for COVID-19 immunisation (Because he travels internationally for work once that opens up and for safety purposes). There was no patient medical history (no diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity). There was no family medical history relevant to AE, they all were pretty healthy. The patient did not take concomitant medications (no other products). There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). There were no additional vaccines administered on same date of the Pfizer suspect. There was no prior vaccinations (within 4 weeks). There was no AE following prior vaccinations. On 22Apr2021 he noticed facial twitching on the left side of his face, which is same side that he was administered the Pfizer Covid Vaccine injection given in his left arm. He does not have any droopiness, just the facial twitching on the left side of his face. He asked for further information regarding this event relative to the Pfizer Covid Vaccine. Facial twitching on the left side of his face: outcome persistent, about the same, just annoying. Onset time is unknown, just sometime on 22Apr2021. He mentioned that he read some clinical reports where people you know ended up getting the bell's palsy on the second one, so if he is already getting twitching he does not want to get the second dose of the Pfizer Covid Vaccine and end up with this for 6 months or bell's palsy. His second dose was going to be 13May2021, but he has permanently stopped product in response to this event. There was no emergency room or physician office visit. There was no relevant test. Seriousness for event was unspecified. The patient was not hospitalized. There was no investigation assessment. The outcome of the event was not recovered. No follow-up attempts are needed. No further information is expected.
48 2021-05-14 mild one side paralysis Mini Stroke; Weakness on left side; memory loss; This is a spontaneous report from a contactable con... Read more
Mini Stroke; Weakness on left side; memory loss; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EW0153) via an unspecified route of administration, administered on the left arm on 20Apr2021 10:30 1st dose, single for COVID-19 immunisation. Medical history included COVID (prior to vaccination), pre-diabetic, anxiety, chest tubes and chest pain. The patient's concomitant medications were not reported. On 29Apr2021 22:00, the patient had a Mini Stroke. Also have weakness on left side and memory loss. The events resulted in Emergency room/department or urgent care visit/hospitalization. The patient was hospitalized for 2 days. Treatment was received for the events which included bloodwork, MRI, CT scan. Since the vaccination, the patient has not been tested for COVID-19. The facility where the vaccine was administered was in a pharmacy or drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was not recovered.
48 2021-05-14 muscle spasms, migraine, discomfort I felt fine after the shot, but two hours later, my throat felt like it was closing and it hurt in a... Read more
I felt fine after the shot, but two hours later, my throat felt like it was closing and it hurt in a way I've never felt before. I had a bad migraine and my whole body was sore. My blood pressure was high for me at 143/94 with a heart rate of 94. I trend at 120/80 with a heart rate around 90. I take my blood pressure regularly to help manage Type II Diabetes. I was concerned with my throat, as the other symptoms seemed normal for the vaccine. It was very uncomfortable. I phoned the nurse line and was told to have someone bring me to the ER to check me out and take a Benadryl. I took the Benadryl and packed for the ER with meds and ID and my friend drove me. I was still uncomfortable enough to warrant wanting to go and had become very dizzy. When we got to the ER there was a wait and I went to my friend's car until called. After about 30 minutes (about 45 minutes after the Benadryl) my throat released and felt much better. My vitals were taken and seemed normal. The normal aches of the vaccine didn't concern me enough to stay, so I returned home. My symptoms remain what seem to be normal reactions to the vaccine: sore joints, slight headache, slightly sore throat, Charlie horse feeling at the injection site. Nothing of major concern. My largest worry was with the throat feeling closed, but it appears the Benadryl took care of it.
48 2021-05-16 bell's palsy, facial paralysis This is a Healthcare employee working at a facility, divested this center and it is under new manage... Read more
This is a Healthcare employee working at a facility, divested this center and it is under new management. Previously on 12/1/2020 PT was diagnosed as COVID-19 positive, remained asymptomatic and returned to work on 12/11/2020. On 12/28 administered the vaccine at a workplace clinic . 4 days post-immunization on 12/31/2020 PT reported feeling "unwell' to his direct supervisor and was sent home. On 1/4/2021 PT reported to his supervisor that he had gone to the hospital due to having a fever and shortness of breath, he was tested for COVID at that time and was negative. PT returned home. On 1/13/2021 the center received a call from PT mother reporting that her son had returned to the hospital on the evening of 1/12/2021. Per his mother, PT was attempting to drink from a straw, but was unable to and had noted a facial droop. When he arrived at the hospital he was diagnosed with "suspected Bell's Palsy". Due to the immunization being administered on 12/28/2020 and suspected diagnosis of Bell's Palsy on 1/13/2021 it is unclear if the two events are related.
48 2021-05-17 facial pain, burning sensation Starting approximately a week after the vaccine was administered, cranial pressure / burning sensat... Read more
Starting approximately a week after the vaccine was administered, cranial pressure / burning sensation started particularly in the forehead area. This has been accompanied by headaches / pain experienced in the forehead areas and sometimes spreading to other areas of the head. This has been constant now for over 11 weeks with varying degrees of intensity. Nothing else changed (diet / lifestyle / etc.) that seems to be able to account for these symptoms, never experienced before that appeared all of a sudden, other than the administration of the vaccine.
48 2021-05-17 muscle spasms Headache, body aches, fever, chills, Hand Cramps. Started about 10 to 12 hours after shot and last... Read more
Headache, body aches, fever, chills, Hand Cramps. Started about 10 to 12 hours after shot and lasted for around 16 hours after starting.
48 2021-05-17 pain in extremity On the first night at around 11pm started to experience left sided chest/muscle pain. The next day 4... Read more
On the first night at around 11pm started to experience left sided chest/muscle pain. The next day 4/30, I noticed my veins in my hands were bulging and others around noticed as well. Both hands affected, very uncomfortable and this continued until the 3rd or 4th day and then slowly over the next couple weeks were lessening, still experiencing the swollen veins as of today 5/18/21. On Day 2 I also started experiencing left upper leg pain as well as the chest pain. All left sided, even though my shot was in my right arm.
48 2021-05-17 tingling, feeling cold Pt states he passed out & not feeling good. Diaphoretic. BP 102/67 Via w/c taken to Observation are... Read more
Pt states he passed out & not feeling good. Diaphoretic. BP 102/67 Via w/c taken to Observation area to lie down. Feeling cold, tingly all over & "wiped out". 3:25PM Taking juice & crackers. Still dizzy when tried to stand up. BP 127/92 3:40PM Left w/o assistance. Feeling much better
48 2021-05-18 tremor Immediately tired Chills Shaking Sweating Fever 101 Lymph swelling Sight injection swelling
48 2021-05-19 pain in extremity Pt Complaints of left arm pain - Took Blood pressure and it was 168/120-Code Assist called.
48 2021-05-26 difficulty speaking voice had been messed up; hardly walk; Mild fever; Body aches; Muscle pain and joint pain in his hip... Read more
voice had been messed up; hardly walk; Mild fever; Body aches; Muscle pain and joint pain in his hips, shoulders, knees, and back of neck; Muscle pain and joint pain in his hips, shoulders, knees, and back of neck; This is a spontaneous report received from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EP7533), via an unspecified route of administration in the left arm on 30Mar2021 at 11:00 (at the age of 48-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN6204) on 09Mar2021 (at the age of 48-years-old) in the left arm for COVID-19 immunization and had no events following the first dose. The patient did not receive any other vaccinations within 4 weeks of the vaccine. On 30Mar2021, the patient experienced body aches, muscle pain and joint pain in his hips, shoulders, knees, and back of neck. On Apr2021, the patient experienced a mild fever and could hardly walk. On an unspecified date, the patient's voice had been messed up. The course of events was follows: On 30Mar2021 at around 20:00-21:00, the patient had full body aches (further described as muscle pain and joint pain in his hips, shoulders, knees, and back of neck ) and then it got a little better for a couple of days. The patient woke up on 31Mar2021 and it was really bad. He tried to work through it. However, he finally went to the doctor and then the Emergency Room (ER) for the first time. He was put on meloxicam 15mg for 4 days and it didn't do anything, although it was reported he didn't take them all. On Apr2021, the first week after the second vaccine (also reported as a few days later, even up to 5 days), the patient had a mild fever, for one or two days it got up to 100.3 degrees F. The patient had not had respiratory problems or breathing problems. When the meloxicam didn't work, the patient went back to the ER. He received a steroid shot while there. He received 5 days of 60mg daily of prednisone. The patient felt fine when he was taking it, but when it wore off, he crashed real hard and was right back to where he could hardly move. After the prednisone wore off, he went back to the ER for the third time, on approximately 23Apr2021, because he could hardly walk. He was told to take ibuprofen and paracetamol (TYLENOL) until he could get into see his primary care. That was probably for about a week. The patient saw his new primary care and was so bad he had to use a wheelchair. The patient had regular blood panels completed with unknown results. The provider put him on the second round of prednisone, but he was told he couldn't keep taking it because it could really screw him up. He was prescribed prednisone 10 mg tablets to take 6 tablets for 3 days (for a total of 60mg), then 4 tablets for 3days, then 2 tablets for 3 days, then 1 tablet for 3 days and stop. He felt good at the beginning, but as the dosage went down, the medication wore off, his pain came back real bad. He was hurting really bad because he was tapering off the steroid, prednisone. He went in "last Friday" and they put him on duloxetine (CYMBALTA) 30mg by mouth once a day. He was also taking over-the-counter naproxen sodium (ALEVE) 220 mg about every 8 hours for pain. The patient was checked for "rheumatoid stuff" with unknown results. The patient was put on duloxetine because he was normally a very active person, but this had been debilitating, some days he cannot even get off the couch because of the pain and not being able to walk. He just started a new job and now he's not been able to work. For example, "today", the patient can hardly lift his arms above his head because his shoulders hurt so bad. The patient reported that the muscle and joint pain persisted, but some days the pain got real bad. "Yesterday" he couldn't even get up hardly to go use the restroom, he had to use a cane. This morning, he has been able to get up better today. The pain is just always there since this all happened. He can't move very good, it hurt so bad. The patient also added that his voice had been messed up since all of this. The patient underwent the following lab tests on 27Mar2021 COVID-19 rapid test: negative, on 09Apr2021 COVID-19 test: negative, on 10Apr2021 COVID-19 rapid test: negative. The clinical outcome of mild fever, voice had been messed up and hardly walk was unknown, of body aches and muscle pain and joint pain in his hips, shoulders, knees, and back of neck was not resolved. No follow-up attempts are needed; no further information expected.
48 2021-05-26 pain in extremity Starting 04Feb2021 I began having a headache; And then my left arm had pain radiating from my should... Read more
Starting 04Feb2021 I began having a headache; And then my left arm had pain radiating from my shoulder blade to my pinky; This is a spontaneous report from a contactable Other HCP (patient). A 48-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EL1284) via an unspecified route of administration in Right arm on 12Jan2021 (at the age of 48-years-old) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient's medical history included Herpes, eczema and concomitant medications included Truvada, escitalopram. Historical vaccine included first dose of COVID 19 (lot number= EH9899) via an unspecified route of administration in Right arm on 21Dec2020 at 07:00 AM. Patient had known allergies to Gluten/Wheat. The patient did not received any other vaccines within 4 weeks. The patient had no covid prior vaccination. Post vaccination, the patient was not tested covid. On 04Feb2021 at 08:00 AM, the patient reported that I began having a headache and then my left arm had pain radiating from my shoulder blade to my pinky. It has persisted for two days now and has made it difficult to hold heavy objects (10 lbs+). Though, it felt slightly better on day 2 than day 1. Treatment was not received. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.
48 2021-05-27 facial pain 5 days post second pfizer covid vacine, ~4/25 developed pain over right maxillary teeth and right si... Read more
5 days post second pfizer covid vacine, ~4/25 developed pain over right maxillary teeth and right sided red facial rash consistent with herpes zoster opthalmicus V1. Also developed zoster keratitis. Admitted to hospital where he received IV acylcovir x 4 days before transition to PO valtrex. Zoster rash resolved over time but then developed in mid May new diplopia and right pupilary dilation. Saw Opthomology who were concerned for CN3 defect. Represented and admitted to hospital where MRI was notable for right ocular motor nerve with questionable enhancement of right V1 nerve likely refelctive of post viral neuritis. Resumed IV acyclovir course x 10 days and started on PO prednisone taper.
48 2021-05-31 pain in extremity Swelling and pain to left arm from deltoid to fingertips; Swelling and pain to left arm from deltoid... Read more
Swelling and pain to left arm from deltoid to fingertips; Swelling and pain to left arm from deltoid to fingertips; This is a spontaneous report from a contactable nurse (patient also). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL3248) via Intramuscular route of administration, administered in left arm on 03Feb2021 at 08:45 AM as 1st dose single for covid-19 immunisation in hospital. The patient medical history included hypertension. The patient had allergies with eggs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient not been tested for COVID-19. The patient's concomitant medications included lisinopril, HCTZ and fexofenadine (within 2 weeks). On 03Feb2021, 09:00 AM, the patient experienced swelling and pain to left arm from deltoid to fingertips. The patient did not receive treatment for the adverse event. At the time of this report events outcome was not recovered. Follow-up attempts are completed. No further information is expected.
48 2021-06-01 weakness, pain in extremity I felt like 8-10 hours after the vaccine around 8:00PM, I experienced the general tiredness and weak... Read more
I felt like 8-10 hours after the vaccine around 8:00PM, I experienced the general tiredness and weakness and malaise. I had a low grade fever and body aches. 1-2 days after that around 01/06/2021 I felt like my legs were sore like I had done a leg work out. The fatigue and weakness lasted about 24 hours and the muscle aches lasted a couple weeks.
48 2021-06-01 bell's palsy Bell's palsy; This is a spontaneous report from a contactable consumer (patient) reported for himsel... Read more
Bell's palsy; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 28Apr2021 16:45 (Batch/Lot Number: EWO172) as 1st dose, single for covid-19 immunisation in Pharmacy or Drug Store. Medical history included myocardial ischaemia/Ischemic heart disease. Concomitant medication included acetylsalicylic acid (ASPIRINE) received within 2 weeks of vaccination. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No Past drug event. The patient experienced bell's palsy on 13May2021 13:00. Hospitalization Prolonged was No. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 included RT PCR SARS COV 2 on 09May2021: negative with Nasal Swab. treatment received for the adverse event included Corticosteroids, naproxen. Outcome of the event was recovering. Follow up needed, further information has been requested.
48 2021-06-02 burning sensation, pain in extremity cranial pressure; has a burning pressure sensation in his head/ cranial pressure/ burning sensation ... Read more
cranial pressure; has a burning pressure sensation in his head/ cranial pressure/ burning sensation in forehead; the pain can move from one place on his head to another; has a burning pressure sensation in his head; fever; elevated heart rate; headache after second dose; experienced arm pain; arm soreness; This is a spontaneous report from a contactable consumer. A 48-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 20Feb2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included eczema, psoriasis, neuropathy peripheral feet. The patient's concomitant medications were not reported. The patient previously took amoxicillin, bnt162b2, 1st dose, Batch/lot number: EL9264 for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received various vitamins within 2 weeks of vaccination. Caller reported adverse events following his second dose of the Pfizer COVID-19 vaccine. He had the second dose of the vaccine on 20Feb2021. He said that he has a burning pressure sensation in his head and it is still ongoing. He said the pain can move from one place on his head to another. He wanted to know if that has been reported as an adverse event for the Pfizer COVID-19 vaccine (immediate and long term). He added that he never experienced anything like it. He said that he did not have any lifestyle change, no diet change, and no change in supplements. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. The patient experienced cranial pressure/ burning sensation in forehead accompanied by headache pain in forehead and other areas of head with varying degrees of intensity starting approximately a week after the second vaccination. For the past 11 weeks the symptoms have been constant with varying levels of intensity. The adverse event result in doctor or other healthcare professional office/clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced cranial pressure on 27Feb2021 with outcome of not recovered, has a burning pressure sensation in his head/ cranial pressure/ burning sensation in forehead on 27Feb2021 with outcome of not recovered, the pain can move from one place on his head to another on 27Feb2021 with outcome of not recovered, has a burning pressure sensation in his head on 27Feb2021 with outcome of not recovered, experienced arm pain on 20Feb2021 with outcome of recovered, fever on 21Feb2021 with outcome of recovered, elevated heart rate on 21Feb2021 with outcome of recovered, arm soreness on 30Jan2021 with outcome of recovered, bad headache after second dose on 20Feb2021 with outcome of recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14May2021. Information on Lot/Batch number was available. Additional information has been requested.
48 2021-06-02 cold sweat prolific cold sweats; Muscle pain; restlessness; severe chills; This is a spontaneous report from a ... Read more
prolific cold sweats; Muscle pain; restlessness; severe chills; This is a spontaneous report from a contactable Consumer. A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EP6955) via an unspecified route of administration, administered in left arm on 06Mar2021 at 12.45 PM (at the age of 48-year-old) as single dose for COVID-19 immunization. The did not have allergies to medications, food, or other products. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to and since vaccination, the patient was not diagnosed with COVID-19. On 07Mar2021 (next day of vaccination) It was in the middle of the night (probably after midnight), the patient experienced muscle pain, restlessness, severe chills, prolific cold sweats. Did not received treatment for the adverse event. The outcome of events was recovering. No follow-up attempts are needed. No further information is expected.
48 2021-06-05 involuntary muscle movements This is a follow up to a previously filed report.... Conditions continue to worsen. Swollen gland in... Read more
This is a follow up to a previously filed report.... Conditions continue to worsen. Swollen gland in neck continues, I've begun having fevers (days 16-17 after second vaccine shot), loss of appetite, difficulty opening mouth because something is now going on on my right jaw/ear area. Also, I'm not developing small skin infections on both hands and those are being treated by a dermatologist with topical antibiotic.
48 2021-06-07 numbness Numbness left foot
48 2021-06-07 numbness Severe pain in right lower back; Severe pain in right lower back; traveled to lower right abdomen; I... Read more
Severe pain in right lower back; Severe pain in right lower back; traveled to lower right abdomen; It left a numb feeling behind; The caller thinks he has a rare case of shingles happening; Slight swelling on right side; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 48-year-old, via an unspecified route of administration, administered in left deltoid on 23Apr2021 (Lot Number: EW0171; Expiration Date: 31Aug2021) as 1st dose, single dose for COVID-19 immunisation. Medical history included chronic lymphocytic leukaemia from 2021 and ongoing (states he was diagnosed about 2 months ago) and had shingles once already when he was 20 years old. The patient's concomitant medications were not reported. The patient stated that he had the first dose of the vaccine on 23Apr2021. The patient experienced severe pain in his right lower back on 23Apr2021. He spent 24Apr2021, 25Apr2021, and 26Apr2021 at the hospital in the Emergency Room getting treated for severe pain in his right lower back. He states they ran all kinds of tests, but they could not figure out what was going on. States he was not admitted to the hospital during that time; he was treated for severe pain in his right lower back in the Emergency Room. The patient mentions that his wife also had the vaccine and she had a sore arm and some body soreness, but she wasn't sick or anything like that. He states he was still recovering from severe pain in his right lower back. The pain migrated from his back around to the lower right side of his abdomen on Apr2021. States that it left a numb feeling behind on Apr2021. The patient stated that after reading and after seeing 5 doctors; the patient told his oncologist that he thinks he has a rare case of shingles happening on Apr2021. He thinks it was the very rare kind where you don't have a rash appear. He had shingles once already when he was 20 years old. This time he thinks that was what it was again with no rash, just pain and discomfort. The severe pain in his right lower back was much better than it was. Says his skin looks normal. There was some slight swelling on his right side on Apr2021. The patient states that when it was time for his second dose of the vaccine, he hadn't recovered from the first dose. He did not go get his second dose; states his doctor agreed with that decision. Severe pain in right lower back, traveled to lower right abdomen resulted in emergency room and physician office visit. The patient underwent lab tests and procedures on Apr2021 which included CT scan (they were checking his lymphatic system), MRI and Ultrasound were done at the Emergency Room. The patient stated they found nothing on these tests. The outcome of the event low back pain was recovering and for the rest of the events was unknown.
48 2021-06-09 cold sweat Heart attack in right carotid artery. Severe chest pain, shortness of breath, clammy, sweat for abou... Read more
Heart attack in right carotid artery. Severe chest pain, shortness of breath, clammy, sweat for about 45 minutes. Then irregular heart beat and significantly high blood pressure (over 190). Stent put in.
48 2021-06-09 pain in extremity Swollen inner checks; Extreme arm pain; Fatigue; This is a spontaneous report from a contactable con... Read more
Swollen inner checks; Extreme arm pain; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on 11Mar2021 13:00 (at the age of 48-years-old) at 1st dose, single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. The patient has no allergies to medications, foods, or other products. On 11Mar2021 23:00, the patient experienced swollen inner cheeks, extreme arm pain, and fatigue. The patient did not receive any treatment for the events. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, did not receive any other medications within 2 weeks of vaccination, has not been diagnosed with COVID-19 prior to vaccination, and has not been tested for COVID-19 since the vaccination. Outcome of all the events was reported as recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
48 2021-06-10 bell's palsy, facial paralysis, numbness I experienced facial numbness and paralysis. As per Doctor it's Bell's Palsy; I experienced facial n... Read more
I experienced facial numbness and paralysis. As per Doctor it's Bell's Palsy; I experienced facial numbness and paralysis. As per Doctor it's Bell's Palsy; I experienced facial numbness and paralysis. As per Doctor it's Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0176), via an unspecified route on 03May2021 at 14:30 (at the age of 48-years) as 2nd dose, single dose in the left arm for covid-19 immunisation. The patient medical history included chronic lymphocytic leukaemia. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was unknown 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 rivaroxaban (XARELTO). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0151), via an unspecified route on Apr2021 at 14:30 as 1st dose, single dose in the left arm for covid-19 immunisation. On 28May2021, the patient experienced facial numbness and Paralysis. As per doctor it's bell's Palsy. The patient received treatment for events with prednisone and valacyclovir. The patient visited physician office. The outcome of the events was not recovered. Follow-up attempts are needed. Further information is requested.
48 2021-06-10 seizure Patient passed out, fell over out of chair, hit his head, then had a seizure. 911 was called. Patien... Read more
Patient passed out, fell over out of chair, hit his head, then had a seizure. 911 was called. Patient refused to go to the hospital. Incident happened about 5 minutes after vaccine was given.
48 2021-06-13 pain in extremity, weakness, tingling, tremor - presents with a cc of chest and shoulder pain - he had the 2nd dose of covid vaccine pfizer May 7t... Read more
- presents with a cc of chest and shoulder pain - he had the 2nd dose of covid vaccine pfizer May 7th and then soon after started having chest pain into his back, both shoulders, and down both arms; also into his neck and head and jaw; pain is constant and worsening - pain is achy; it is worse with sitting and walking around/standing makes it better - denies numbness but has has tingling in his arms - sometimes his heart is beating fast, has palpitations - feels overall weak - reports lower back pain for a while prior to the vaccine, sometimes this goes down his legs bilaterally, he is not worried about - HA is hard to describe, he has never had headaches before the vaccine; sometimes his head feels light, other times it feels heavy; hurts all over his head and into his neck; turning his head makes his head worse; pain is constant - sometimes he has blurry vision, not currently - sometimes he feels presyncopal but has not actually passed out; he sits down and feels better; its a fleeting sensation - symptoms are worse with sitting, moving around makes all his symptoms better - has intermittent room spinning sensation - has general overall fatigue and weakness, nonfocal - denies dyspnea on my exam - denies rash - feels intermittent diaphoresis and chills/rigor like shaking - reports he was evaluated by an ER since the symptoms started (5/28) and also has seen his pcp who is working him up for fibromyalgia - reports brain fog and feels slower and harder time with his memory
48 2021-06-13 unresponsive to stimuli Patient had no reaction at time of vaccination; was monitored for 15 minutes prior to leaving clinic... Read more
Patient had no reaction at time of vaccination; was monitored for 15 minutes prior to leaving clinic. This nurse was notified today by ER Physician that the patient came into the ER around 8pm (on the night of the same day that he received his vaccine in the early morning hours) with c/o shortness of breath. It was reported that the patient had taken nebulizer treatments at home with no relief. Symptoms began around 5:30pm. Patient ambulated into ER at time of visit but during the visit became unresponsive. Patient was intubated and coded with time of death called at 9:52pm. Patient has history of asthma.
48 2021-06-14 pain in extremity, numbness Approx 2 weeks after second the injection i developed significant pain in shoulder and intermittent ... Read more
Approx 2 weeks after second the injection i developed significant pain in shoulder and intermittent numbness and nerve type pain in my left should, forearm, hand, thumb and fingers.
48 2021-06-14 tenderness Tea-cup size rash on left side of neck. Postules are grouped, itchy, and sore to the touch.
48 2021-06-15 weakness 48 y/o M presented to receive first dose of Pfizer vaccine. Pt received vaccine at 0915 to LD, pt pr... Read more
48 y/o M presented to receive first dose of Pfizer vaccine. Pt received vaccine at 0915 to LD, pt presented with symptoms shortly after vaccine at 0918. Symptoms included pallor, weakness, nausea, and diaphoresis. RN attended to patient immediately- ice pack applied to back of neck, pt asked to take off mask to allow increased tissue perfusion, ice water offered and pt only able to take a few sips due to nausea. Vital signs were obtained (while patient was sitting up in chair) as the following 76/49 BP, HR 53, SpO2 at 97% at 0923. Vital signs were repeated at 0930 while patient was laying on gurney. Vital signs recorded as the following 101/54 BP, 53 HR, 94% SpO2. RN stat called at 0925, staff arrived to assist patient. Pt taken to treatment room for further observation. Upon arrival to treatment room, vital signs obtained and recorded as the following at 0935 BP 102/70, HR 61, SpO2 96%, RR 20. Pt stated symptoms has improved significantly.
48 2021-06-16 bell's palsy Bell's palsy. Treated with steroid and antiflammatory. Seems to be a mild case, and I am improving, ... Read more
Bell's palsy. Treated with steroid and antiflammatory. Seems to be a mild case, and I am improving, but am not fully recovered.
48 2021-06-19 restless legs syndrome My first symptoms from COVID developed in Apr 2020 after having been presumed positive with COVID. I... Read more
My first symptoms from COVID developed in Apr 2020 after having been presumed positive with COVID. I had never had problems with nausea before, but have needed nausea meds ever since for every meal since that time. No change since then. Vaccine dose 1 given Mar 18. On Mar 24 began having body temperature regulation issues. For example my feet would be freezing and buzzing, similar to restless leg/body, but my upper body would be so hot I couldn't rest my hands on my chest. This happened every time I would lay down. Walking around or sitting up made it netter, but laying down the symptoms would begin quickly. This made it impossible to sleep without taking some type of strong medicine that would relax my body enough to even it out. Luckily I was taking morphine for back pain and that seemed to help. Normal OTC pain killers would not make any effect. This still occurs nightly, or even daily if I'm trying to nap during the day. Without morphine or something similar in my system at the time my body temperature and buzzing / restless body feeling continues. On Mar 27 I began experiencing a worse inability to stay asleep than I have ever experienced. This continues to this day. I awake every hour to an hour and a half regardless of how exhausted I am. Without a significant sleeping pill, which I am not currently prescribed, I cannot remain asleep through the night. Xanax has helped but does not always keep me asleep. I am still searching for a sleep doctor to assist to help address this sleep issue which was largely controlled by my CPAP once I finally was diagnosed and treated with sleep apnea. But now I am having nightly issues of awakeness, what appears to be called "coronasomnia" in some places, which makes me exhausted during the day. Finally, I ended up in the ER for kidney stones on Apr 8, the day I was scheduled for my second vaccination shot. I have never had kidneybstones before. Though I understand they would not develop so quickly, I understand there have been many reports of kidney stones making themselves known shortly following COVID vaccinations. I have not received my second vaccination and do not plan to do so given the effects I've had so far.
48 2021-06-20 hot flush, numbness Facial numbness, hot flash, Sweating, increased heart rate, palpitations, shortness of breath, Dizz... Read more
Facial numbness, hot flash, Sweating, increased heart rate, palpitations, shortness of breath, Dizziness, faintness, nausea, headache, fullness in the ears, lightheadedness, stomach pain.
48 2021-06-23 numbness, muscle twitching Phase 1. Injury (6 APR) Pain during Injection (tip of needle) and immediate flinch/twitch in heart ... Read more
Phase 1. Injury (6 APR) Pain during Injection (tip of needle) and immediate flinch/twitch in heart area. Racing heart, Intensity of beat, Severe tinnitus left ear only, adrenaline, Can?t sleep; Symptoms worst when I get into bed Phase 2. (10 APR) Urgent Care Visit: Chest very weak, each day gets worse; inflammation left side of body (chest, hand, face), felt like hole in heart, shortness of breath, numb hand, easy to excite, pain when lean forward; heart out of rhythm; Phase 3: (13 APR) Nighttime rushed by wife to ER due to symptoms of a heart attack couldn?t breathe, numb hands, shivering, heart going berserk, dizzy, aggressive, heart out of rhythm. Did EKG and diagnosed with Arrhythmia and Palpitations Phase 4: 14 APR Condition Stabilizes with bed rest; heart speed and intensity reduces slightly, heart still out of rhythm; ringing in left ear continues; noticed left hand, face, chest all swollen, out of breath walking to mailbox; can?t breathe deeply; Chest begins to bubble, gargle, fizzle when I lay down. Palpitations in throat, legs, need to drink a lot water; can?t sleep due to heart racing then sore and breast bone enlarged; chest tenses up often. Phase 5: Visit to Cardiologist (26 APR) He mentions potential Nerve damage with injection and prescribes Ultrasound. Days later I have second ?ER like? Scare and confirm in my mind this also nerve related. Phase 6: Mid May Start Recovery: Chest still tenses up doing emails, phone, late at work; easily excited; Each night total relaxation; start to feel nerves twitching like electric pulses in left chest; Feels like Electric Pulses/Pain from injection site to location of original twitch in heart area. Lean forward pain/discomfort; Still very weak chest muscles that get painful and sore easily Phase 7: Early June: Ultrasound at Heart Dr. (2 JUN) looks better /normal size. Heartbeat steadier and quiet but palpitations persist (extra heart beats felt in my throat); Overall body feeling stronger but chest muscles still weak and sore after ultrasound experience. Ringing in the left ear is better and milder twitches in chest at night. Teeth sensitive to cold liquids and Numb hands while walking esp 4 June; tense chest at work/home and need to step away and breath; Heart faster; long time to calm after warm/hot bath Currently late June still suffer from muscle weakness especially left chest, left arm where shot went in. Hands are still numb and Heart races when in bed.. Chest also still freezes up during work. Have to focus on breathing calmly. Overall though my condition continues to improve.
48 2021-06-23 numbness, tingling Within 15 minutes of 2nd shot had significant pins and needles (and some numbness) in right leg most... Read more
Within 15 minutes of 2nd shot had significant pins and needles (and some numbness) in right leg most significantly below knee in calf to foot area - this persisted for approximately 24 hours. Typical flu like symptoms (aches)/fever along with slight cough with phlegm occurred from 18-48 hours as these resolved patient was left with significant and persistent pain in chest on day 3 post vaccination. This pain persisted and spread to neck, back, jaw. Ultimately due to persistent pain patient went to a hospital emergency room for evaluation. Nuclear stress came back abnormal and patient was admitted for further evaluation but eventually released to follow up with cardiologist. Patient currently following up with medical professionals for continuing care for suspected myocarditis.
48 2021-06-25 weakness Muscle pain; weakness; joint pain; fatigue; This is a spontaneous report from a contactable consumer... Read more
Muscle pain; weakness; joint pain; fatigue; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 administered in Arm Left on 14Jan2021 12:00 (Batch/Lot Number: EL1283) at age of 48-year-old as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included atorvastatin calcium; venlafaxine hcl; capsaicin, menthol (ALLEVESS). No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. The patient experienced muscle pain and weakness, joint pain, fatigue on 15Jan2021 12:00. The outcome was not recovered. The events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Treatment received included Blood tests, neurological tests, x-rays. Follow up attempts needed. Further information is expected.
48 2021-06-28 muscle twitching, muscle spasms Crohn's Flare Up; Brain Fog; fever; cramps and major abdominal pain; cramps and major abdominal pain... Read more
Crohn's Flare Up; Brain Fog; fever; cramps and major abdominal pain; cramps and major abdominal pain; heart rate increased; neck area twitching and in face; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 05Jun2021 15:00 (Batch/Lot number was not reported) at the age of 48 years old as dose number unknown, single for COVID-19 immunization. Medical history included ongoing Crohn's. The patient's concomitant medications were not reported. The patient previously took fexofenadine (ALLEGRA) and fluoxetine (PROZAC), with known allergies to both. No other vaccine was received in four weeks. No other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 05Jun2021 19:00, the patient experienced Crohn's flare up, brain fog, fever, cramps and major abdominal pain, heart rate increased, and neck area twitching and in face. Adverse events (AE) resulted in doctor or other healthcare professional office/clinic visit. No treatment received for AE. Outcome of events was recovering. Information about batch/lot number has been requested.
48 2021-07-01 pain in extremity Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male ... Read more
Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: ER3727), via unspecified route of administration in left arm on 23Mar2021 at 08:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and no known allergies were reported. The patient was not taking any concomitant medications within 2 weeks of vaccination. The patient had not taken any other vaccine within four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021, after the vaccination, the patient experienced sore arm. The event did not result in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse event. The clinical outcome of the event sore arm was recovering. No follow-up attempts needed. No further information is expected.
48 2021-07-04 numbness Three weeks after the first Vaccine, I developed numbness in both feet between the big toe and the n... Read more
Three weeks after the first Vaccine, I developed numbness in both feet between the big toe and the next one. This numbness/Cold feeling/Tingling slowly started spreading up my legs and seemed to settle the thigh area for a short time which even caused my clothes that touched it to generate a strange sensation (Almost like a hyper sensitivity) and it was a constant feeling. Then the feeling/numbness started affecting my calves and shin areas to a greater degree where they both feel like I have some fatigue and after walking or using them for a short time I feel like I have been running a marathon. At this point the skin around my ankle would come and go with becoming numb to the touch. As the numbness continued to spread further up to my waist area It eventually started to affect my abs, back and around the right and left outside edges of my chest. They have strange sensations and occasionally I can feel them as numb or some sort of sensory deprivation with the exception of my chest area which was sensitive to the touch (Pain). Continuing further I now have the same tingling/cold issues with both of my arms and there have been instances where both of my shoulders feel weak along with the numb behavior. This has all been going on over the past 6 months and is still continuing. I have been to multiple Urgent Care facilities, Doctor Visits, Whole barrage of tests: MRI's, Cat Scans, EMG's, Blood Work, Spinal Tap, etc. And so far all tests have come back normal. Jan 14 -- Trip to Urgent Care for numbness -- They said that I got too cold / did an X-Ray of my back.. Everything looked fine they said. Jan 25th -- Trip back to Urgent Care, numbness getting worse. Around Jan 28th -- MRI of lower Lumbar area. Nothing found Feb 17 -- Initial Consult Dr. Neurologist -- Orders Complete Bloodwork and does basic nerve tests Feb 12th -- Bloodwork done Health -- All normal Feb 22 -- Office Visit Dr. Neurologist -- Electromyogram of both legs. All normal Feb 24 -- MRI Lumbar Spine -- nothing that could cause the issues noted. March 10 -- Office Visit March 22 -- MRI Brain with and without contrast -- nothing that could cause the issues noted. April 16 -- Office Visit May 3 -- MRI - Neck area --nothing that could cause the issues noted. May 17 -- Office Visit -- Electromyogram (EMG) of arms and hands -- all Normal. May 21 -- ER visit -- Bowel issues, tiredness, fatigue ? Cat Scan performed.. All tests normal and released May 26 -- Gastro visit to make sure the numbness had not affected bowel control May 28 -- Dr. -- Changed Neurologists --- Scheduled Spinal Tap (Suspected MS even though nothing was showing up in all tests) June 3 -- Spinal Tap -- Everything normal not showing any signs of MS or any other disease. June 10 -- Spinal Headaches (received Blood Patch) June 18 -- Office Visit -- Doctor suggested could be Covid Vaccine related but sending to Medical Center and giving medicine in case it is Lyme disease
48 2021-07-08 bell's palsy two bouts of Bell's palsy; patient received the first dose on 29Apr2021 on left arm as dose 1, singl... Read more
two bouts of Bell's palsy; patient received the first dose on 29Apr2021 on left arm as dose 1, single and second on 29Apr2021 on left arm as dose 2; A 48-years-old male patient received the first dose on 29Apr2021 on left arm as dose 1, single and second on 29Apr2021 on left arm as dose 2; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EWO151) via an unspecified route of administration on 29Apr2021 on left arm as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EWO170) via an unspecified route of administration on 29Apr2021 (at age 48-year-old) on left arm as dose 2, single for COVID-19 immunization. Medical history included several previous incidents of Bell's palsy and allergy to penicillin (start data and ongoing status unknown). The patient's concomitant medications were not reported. It was mentioned that patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. It was reported that, a 48-year-old male patient received the first dose on 29Apr2021 on left arm as dose 1, single and second on 29Apr2021 on left arm as dose 2 (inappropriate schedule of vaccine administered, overdose) and the patient experienced two bouts of bell's palsy on 25May2021. One 4 weeks after vaccination on the right side and now a second one on the left about four weeks after the first incident. Therapeutic measures were taken with valtrex and prednisone as a result of two bouts of bell's palsy. The outcome of event two bouts of Bell's palsy was recovering. No follow-up attempts are possible. No further information is expected.
48 2021-07-08 severe one side paralysis Two months after receiving my second dose of the Pfizer COVID19 vaccine, I suffered a stroke. Sympt... Read more
Two months after receiving my second dose of the Pfizer COVID19 vaccine, I suffered a stroke. Symptoms included vision loss, complete left-side paralysis, loss of cognition, and loss of consciousness. Within ~15 minutes of the event, I was transported by ambulance to the nearest hospital and provided care. Within 3 hours of the event, I received tPA (Tissue Plasminogen Activator), and recovered fully.
48 2021-07-08 pain in extremity I took the first dose of the vaccine (EW0196) on 06/16/2021, And I took the second dose (FA6780) on ... Read more
I took the first dose of the vaccine (EW0196) on 06/16/2021, And I took the second dose (FA6780) on 07/07/2021. The injection site started to swell and be very painful , I also had tiredness and a headache, and I don't really get headaches. The whole left arm was also very painful. I also had a fever. And my back and joints started hurting.
48 2021-07-12 cold sweat Cold sweats; chills; muscle fatigue; headache; This is a spontaneous report from a non-contactable c... Read more
Cold sweats; chills; muscle fatigue; headache; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 26Mar2021 at 11:30 (at the age of 48-years-old) for COVID-19 immunisation. The patient had known allergy to guaifenesin. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248) via an unspecified route of administration in the left arm on 05Mar2021 at 13:00 (at the age of 48-years-old) for COVID-19 immunisation. 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 had not been tested for COVID-19. Concomitant medications received within two weeks of vaccination included vitamin D (MANUFACTURER UNKNOWN) and famotidine 20mg acid reducer (MANUFACTURER UNKNOWN). The patient experienced cold sweats, chills, muscle fatigue and headache on 27Mar2021 at 03:00. 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 cold sweats, chills, muscle fatigue and headache were resolving at the time of this report. No follow-up attempts are possible. No further information is expected.
48 2021-07-12 numbness @1045 Nurse was called to the hallway because pt was feeling tachycardic. C/O dizziness, SOB, tachyc... Read more
@1045 Nurse was called to the hallway because pt was feeling tachycardic. C/O dizziness, SOB, tachycardia with rate of 100s+ Upon seeing pt, he reported that the HR is better. C/O feeling hot, dizzy, numbness and weakness to bilat hands, SOB. Resp even and unlabored. RR22. VS 170/95 (110) 59 98%. Team alert was initially called but pt refused to go to the ED. Team alert cancelled. Pt wants to rest and wait it out. Assisted back to room. Pt ambulated with supervision and support of RN. Pt refused to use the wheelchair. Water provided. Pt was able to ambulate towards to room without any difficulties. Able to speak in full sentences. @VS 1117 VS 150/89 59. Pt's symptoms are starting to get better. Dizziness is really mild. Denies SOB. Slightly better numbness and weakness to hands. Instructed to increase fluid intake. @1125 VS 140/92 (107) 60 97%RA. Pt is feeling better. Denies dizziness, tingling to hands. C/O mild weakness to hands but able to move it better than initial encounter. Pt stated that he wishes to leave, go to cafeteria and eat. Pt is confident of going home. Pt has a ride home, mother will drive him home. Checked with the Dr. Per MD, okay to go home. Encourage pt to follow up with PMD and to go to the ED for new symptoms or worsening symptoms. Pt verbalized understanding. @1142 VS 151/82 (109) 61 Pt stood up. Feeling better. Gait stable. Denies any dizziness. Mild weakness to bilat hands. No sob noted. No s/sx of distress noted. Resp even and unlabored.
48 2021-07-13 migraine, numbness, muscle twitching I started with being sensitive to bright lights and then anything could bring migraines on - 1, 2 to... Read more
I started with being sensitive to bright lights and then anything could bring migraines on - 1, 2 to 4 or 5 a week. They mimicked that of a TIA (the migraines).Doctor has prescribed A medicine injectable (Emgality)- I have to take it once a month. (My insurance doesn't want to pay for the meds that the doctor has prescribed but luckily there is a company where I can get coupon cards to help with the costs of the meds) I'm still getting them now - so My nose will still go numb and twinge and I still have vision at most times - before the injectable medication I couldn't feel my arms, blurred vision, numbness in face (that numbness came first before the left side of my body) and it was almost like I was getting a stroke. Sometimes it felt like bright light brought the migraine on and sometimes it would come on out of nowhere. I used to have an issue of these years and years ago but it wasn't the amount of having these like I was having every day - at most I'd get one or two a year - the ones after the vaccine may be slightly worse than what I got years ago but they were still very debilitating. I still get pain in the Right back side of my head - pain -and that is controlled by Tylenol - so it still happens one or two times a week but it's tolerable compared to what it was doing.
48 2021-07-18 pain in extremity A few days later his arm hurts. States his arm still hurts when he moves his arm. He is able to mov... Read more
A few days later his arm hurts. States his arm still hurts when he moves his arm. He is able to move his arm fine. He feels he can?t move his L arm as well as the r arm now since receiving vaccination.
48 2021-07-18 tingling Acute tachycardia, rate up to 105 bpm accompanied with a rise in blood pressure with a maximum readi... Read more
Acute tachycardia, rate up to 105 bpm accompanied with a rise in blood pressure with a maximum reading of 155/98. My normal blood pressure reading is 130/80 with a pulse rate of 70 bpm. Accompanied with a body wide tingling sensation like an adrenal release.
48 2021-07-19 numbness, pain in extremity numbness of half left face; numbness of tongue; headache; pain on left arm; This is a spontaneous re... Read more
numbness of half left face; numbness of tongue; headache; pain on left arm; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male 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 31Mar2021 at 12:00(at the age of 48-year-old), as a single dose for COVID-19 immunisation. Medical history included gout and high cholesterol. Concomitant medications included pyridoxine hydrochloride, biotin, folic acid, cholecalciferol, cyanocobalamin, phytomenadione, nicotinamide, sodium ascorbate, calcium pantothenate, thiamine mononitrate, zinc oxide, potassium iodide, manganese sulfate, chromic chloride, dl-alpha tocopherol acetate, sodium selenate, sodium molybdate dihydrate (CENTRUM VITAMINTS). No known allergies were reported. 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 31Mar2021 at 12:30 the patient experienced numbness of tongue, headache, pain on left arm and numbness of half left face. Therapeutic measures were taken as a result of adverse events and included treatment with TYLENOL 500 MG. The 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 numbness of half left face, numbness of tongue, headache, pain on left arm were unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
48 2021-07-20 numbness, bell's palsy Started with metallic taste in my mouth when eating food, then progressed to any liquid tasting salt... Read more
Started with metallic taste in my mouth when eating food, then progressed to any liquid tasting salty. Two days after Metallic taste left side of face and moth went numb. Diagnosis was Bells Palsy.
48 2021-07-21 pain in extremity Experienced sore arm pain after first dose for a few days. Then no pain normally except when I trie... Read more
Experienced sore arm pain after first dose for a few days. Then no pain normally except when I tried to lift my left arm above 90 degrees. When I try to lift my arm above 90 degrees I experience pain in my left arm in the injection area. This has persisted since the first dose of the vaccine. I did not have any additional pain after the 2nd dose and had no other Covid symptoms that others have shared after either vaccine shot. This is the only problem I have had. I am only reporting this because it has persisted now for 4 months. No change. Not better not worse. It does not hurt accept when I try to lift my arm.
48 2021-07-22 numbness PATIENT REPORTS PAIN UPON NEEDLE ENTERING ARM AND THE VACCINE ACTUALLY ENTERING HIS MUSCLE. OVER TH... Read more
PATIENT REPORTS PAIN UPON NEEDLE ENTERING ARM AND THE VACCINE ACTUALLY ENTERING HIS MUSCLE. OVER THE COURSE OF THE NEXT FEW MONTHS, HIS PAIN RANGED FROM 1-8 ON THE PAIN SCALE. THE PAIN WAS SOMETIMES ACCOMPANIED WITH LOSS OF FEELING, NUMBNESS, DOWN THE ARM AND OVER THE SHOULDER INTO THE BACK. SEVERAL TIMES HE THOUGHT HE MIGHT HAVE BEEN HAVING A HEART ATTACK. RANGE OF MOTION WAS DECREASED AT TIMES BUT HAS NOW RETURNED TO SOMEWHAT NORMAL ALTHOUGH THE PAIN IS STILL PRESENT. PATIENT HAS USED SEVERAL OTC OPTIONS FOR PAIN, INCLUDING ACETAMINOPHEN, PAIN PATCHES, AND SUPPLEMENTAL CREAMS. THESE HAVE PROVIDE SOME BENEFIT BUT THE UNDERLYING PAIN, WHILE SOMEWHAT BETTER, REMAINS.
48 2021-07-25 feeling hot Patient reported that he waited 30 minutes at the Health Center as suggested due to his allergies. A... Read more
Patient reported that he waited 30 minutes at the Health Center as suggested due to his allergies. Around 6:30pm the same day, about 7 hours after receiving his second vaccine his Right Arm, not the arm he received his Covid vaccine in became itchy and red and then broke out in hives from his shoulder half way down his forearm. patient did not take anything for the hives, he stated this lasted about 30 minutes and then resolved on it's own. On Saturday night he experienced some right knee pain behind his knee, if stretched he can feel some pain, but as of today 7/26 reports it is 80% resolved. Patient also stated that last night (7/25) he experienced warm sensations three times on his right thumb
48 2021-07-25 pain in extremity After receiving the vaccine I had the occasional sore arm and pain at the vaccination site. The seco... Read more
After receiving the vaccine I had the occasional sore arm and pain at the vaccination site. The second day after I started to feel my chest started to burn, which was accompanied by trouble breathing. It was a pain that I have never experienced before in my chest it felt tight and was burning very bad. I started to feel light headed as if I was going to faint while doing my normal daily activities. I decided to stop doing anything that caused my heart to beat too fast. So later on that night i decided to go to the ER, where they did an ekg and some blood work. They also did a scan of my chest where the doctor said everything came back and looked normal. Over time the pain and everything I was experiencing started to get better. I still have a hard time breathing every now and then. Also after the vaccine I experienced a slight cough and runny nose.
48 2021-07-27 migraine This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient re... Read more
This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 18Mar2021 at 15:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure, cholesterol, fusion surgery on c6/c7, known allergy to cantaloupe and known seasonal allergies. Concomitant medications included lisinopril 10mg (MANUFACTURER UNKNOWN), rosuvastatin 5mg (MANUFACTURER UNKNOWN), and cyclobenzaprine (MANUFACTURER UNKNOWN); all for unknown indication from unknown dates. The patient previously took azithromycin (MANUFACTURER UNKNOWN) for unknown indication from unknown date and experienced drug allergy. 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 has not been tested for COVID-19. On 18Mar2021 the patient experienced mild headache for the first 2 days. On 21Mar2021, on the third day, the patient experienced severe migraine. On an unknown date in 2021 the patient experienced vertigo periodically. The patient reported to have had hazy and mild headache lasting since the vaccine. The headache "comes and goes" as reported. The patient had no fever. 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 the events headache, migraine, and vertigo were unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
48 2021-07-28 weakness, unresponsive to stimuli, flushing Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainti... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe, Additional Details: EMS arrived on scene, gave patient o2 and monitored vitals until stable
48 2021-07-28 pain in extremity, weakness heart rate went from the 50s to the 120s; Heart racing; His heart rate went from 120 beats to in the... Read more
heart rate went from the 50s to the 120s; Heart racing; His heart rate went from 120 beats to in the 70s and 50s; blood pressure and it was 138/90 which is high for me lately; Dizzy; whole body is weak; my legs were kind of weak; my arm was a little tender, little sore; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received dose 1 of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in the left arm on 13Jul2021 at 12:05 PM (Batch/Lot number reported as EW0181 or FW0181) single, for COVID-19 immunization (also reported as to be precautionary and his wife is a teacher). Medical history included blood pressure high from 2018 to an unknown date (the caller has been on the lisinopril since 2018 and started at 40 mg and went down to 5mg), high cholesterol from 2018 to an unknown date, back pain from 03Jul2021 to an unknown date, rib fracture from an unknown date and unknown if ongoing, and fall from 03Jul2021 to an unknown date. Concomitant medications included lisinopril taken for hypertension from 2018 and ongoing; and ibuprofen taken for pain from 03Jul2021 to an unspecified stop date. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect, did not have additional vaccines administered on the same date of the Pfizer vaccine, and did not have prior vaccinations (within 4 weeks). The patient had whooping cough vaccine 6 years ago and had a sore arm for 3 days. The patient experienced 'muscular weakness' and 'pain in extremity' on 13Jul2021; and 'heart rate increased', 'palpitations', 'heart rate decreased', 'hypertension aggravated', 'dizziness', and 'asthenia' on 14Jul2021. The patient inquired about additional information regarding side effects of the Pfizer COVID-19 vaccine. He received his first dose on 13Jul2021 and reported that this morning, while taking a shower, his heart rate went from the 50's to the 120's. The patient stated that yesterday (13Jul2021) about 12 in the afternoon, he got his first dose of the vaccine. He sat in the place for 30 minutes after the fact, the only thing was his legs were kind of weak but the tech said that was normal so he walked out and continued his day. He drank an electrolyte drink and around about a gallon of water. The patient didn't have a fever, sweats, or chills. He did cardio (stationary bike ride) for about 30 mins, but he'd been taking it easy because on 03Jul2021, he injured his ribs from a fall down a flight of stairs. There were no fractures and he has been taking ibuprofen 600mg twice a day for pain. The pain wasn't bad enough to take that, so he discontinued taking it 5 days ago. He had nothing in his system except for lisinopril that he takes for high blood pressure. The patient further stated that about 8 hours after the vaccine, he had a few glasses of wine last between 6pm-7pm and his arm was a little tender, little sore, but everything else was fine. He was inquiring if there were other reports of this happening. The patient didn't have any rapid pulse when he got the vaccine. His legs feeling weak was improved but after that episode with his heart his whole body was weak, he hasn't felt right since that happened. According to the patient, he did his normal routine this morning. The patient woke up this morning at 7:00am and felt okay. He went to take a shower and his heart rate went from his average of 50-55 beats per minute and started racing. The patient checked his pulse it was about 125 and rapidly getting faster. Also stated that when he was turning the shower on this morning and was washing his hair and face, he could feel his neck pulsating where his pulse was. The caller felt weak and dizzy and then his heart rate went from 120 beats to in the 70s and 50s. Stated that he doesn't drink coffee, but drinks herbal tea. As soon as he got in the shower, he was washing his face and hair and he felt his neck (where you take a pulse), it felt like it was beating fast. He checked it and it was 115, 120. He has a monitor that he wears. It was just out of the blue. He had no stress and no anxiety. It happened all of a sudden, it was strange. The patient didn't know if it was a combination of the few glasses of wine or what. This reaction was so long after the fact and he took his blood pressure medicine at 5:30 last night. Stated that he has been on lisinopril since 2018 and started at 40 mg and went down to 5mg. He tried to calm down, he took the electrolyte drink, a Xanax, and drank water and then in 15-20 minutes, it calmed his heart rate down. The patient's heart rate was back down in the 50s but he didn't feel 100%. The caller's blood pressure was okay. He thought he would go to the ER so he started driving and saw his heart rate going down so he drove home and checked his blood pressure and it was 138/90 which was high for him lately. But his pulse started coming down so he rechecked his blood pressure and it was 130-135/75 with a pulse around 55-65. It's been like that since and stated that he's fine. He was asking why it took almost 24 hours for these to happen. The events did not require a visit to the Emergency Room or Physician's Office. The patient's heart rate and blood pressure had been fine since the episode. The patient underwent laboratory tests and procedures which included blood pressure measurement: 130-135/75 and 138/90 on 14Jul2021, heart rate: 115, 120, 55-65, his heart rate went from the 50s to the 120s on 14Jul2021. The patient stated that he was scheduled for an ECHO and stress test on Friday, but wanted to call Pfizer too. Outcome of the events heart rate increased was recovered on an unspecified date, for hypertension was recovered in Jul2021, for palpitations was not recovered, for muscular weakness was recovering (also reported as ongoing), while for the other events was unknown. Information regarding the batch/lot number has been requested.
48 2021-07-28 pain in extremity Pain in half of his head, like a headache, after first vaccine; Pain in left arm, after first vacci... Read more
Pain in half of his head, like a headache, after first vaccine; Pain in left arm, after first vaccine; This is a spontaneous report received from a contactable consumer(patients wife). A 48-year-old male patient received the first dose of BNT162B2 (PFIZER VACCINE FOR COVID 19) via an unspecified route of administration on the left arm on 21Jul2021 at 17:00 (Batch/lot number:FA6780; Expiration Date: Unknown) at the age of 48-year-old as single dose for COVID-19 immunization. Medical history and concomitant medication were none. Investigation Assessment was none. Family Medical History Relevant to AEs was not provided. Because it was requested at the patient workplace thus the patient taking Pfizer vaccine for COVID-19. The patient was not related to a study or programme. Prior vaccination (within 4 weeks), the patient didn't received any other vaccinations. Relevant Test was none. History of all previous immunization with the Pfizer vaccine considered as suspect was none. AEs following prior vaccinations was none. On 22Jul2021 morning, the patient experienced pain in half of head, like a headache and pain in left arm. The events were ongoing. The reporter stated she needs some information because her husband went to work, and he experienced side effect. The reporter stated her husband didn't saw any one doctor at the clinic. The reporter wanted to known whether it would be better to call his doctor and whether this was normal and whether they could prescribe medication. The reporter stated that her husband was calling her asking for some medication for the pain, and she confirmed, that her husband hadn't taken any medication. The events didn't resulted in emergency room and physician office. The outcome of events was not recovered.
48 2021-07-29 weakness Flu like symptoms; Headache; Was having pain, headaches, mostly in the eye areas.; having very low e... Read more
Flu like symptoms; Headache; Was having pain, headaches, mostly in the eye areas.; having very low energy/feeling weak; nasal congestion; dizziness; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in arm right on 17May2021 (at a age of 48 years-old) as dose 2, single for COVID-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing. High blood pressure runs in his family. Takes high blood pressure medicine once a day. Ongoing Amlodipine taken for high blood pressure frequency: once a day. Medicines for a year and a half. Concomitant medications were not reported. Historical vaccine included bnt162b2 (First dose: three weeks before last Monday) administered in left shoulder at administration time: 5:00 or 6:00 PM on an unknown date 2021 (at a age of 48 years-old) for COVID-19 immunisation. On an unknown date May2021, experiencing nasal congestion, dizziness, feeling weak, and having very low energy and asked would it be something to do with the vaccine, or something else. On an unknown date May2021, experienced feeling weak, was having pain, headaches, mostly in the eye areas. On 18May2021, the second day he had flu like symptoms and was starting to feel better on the third day. He is now congested, feeling dizzy and back to being weak again and has low energy. Towards the end of the week, he had lack of energy again and head was so congested, and wondering was this anything he could be dealing with or if it something else and was mostly lack of energy. Height was between 5.9 and 5.10, weight was about 240 to 245. The symptoms started over the weekend and end of last week, he had no get up and go like he used to have before he took this last shot. Flu like symptoms started the first day after, he was having flu like symptoms big time and had to go home early from work. Wednesday, he had started improving a little. Towards the end of the week, Friday or Saturday, he had a lack of energy and was congested. Was having pain, headaches, mostly in the eye areas. It may not be the shot, he is just trying to see if he could still be having symptoms. He says the lack of energy, feeling congested, headache in his eye area all began Friday or Saturday, like into the weekend. Sometimes he tried to work on Sunday, but yesterday it was just not happening because of his lack of energy and today he was starting out the same way. It was a little worse Friday and Saturday now, was not quite as bad as it was. He did not take anything for the treatment. He took 2 water pills with the blood pressure medicine and does not remember the name of the 2 water pills. The dosage wasalso unknown. He took all of these once a day. Has had blood work 3 or 4 months ago but nothing recently. The patient underwent lab tests and procedures which included blood work resulted as unknown results on an unknown date 2021. The clinical outcome of the event dizziness was unknown, and rest of the events was resolving. Information related to batch/Lot no. was requested.
49 2021-01-03 tingling Approximately 4 days after vaccine I started experiencing sharp lower back and left hip pain. Also m... Read more
Approximately 4 days after vaccine I started experiencing sharp lower back and left hip pain. Also my left foot feels like pins and needles.
49 2021-01-05 discomfort The body aches started in his shoulder and now are all over his neck, back and whole body aches; The... Read more
The body aches started in his shoulder and now are all over his neck, back and whole body aches; The body aches started in his shoulder and now are all over his neck, back and whole body aches/ feeling like he has 1,000 pounds on his back; The body aches started in his shoulder and now are all over his neck, back and whole body aches; Body aches/The body aches started in his shoulder and now are all over his neck, back and whole body aches; Headache; Chills; Feel like crap; Low grade temperature; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old male patient received BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL0142) intramuscularly at right shoulder approximately at 17:30 on 29Dec2020 for Covid-19 immunization. The patient's medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity (a little over weight but he is fit). The patient had COVID in the end of Apr2020. The patient had no family medical history and had no prior vaccinations within four weeks. The patient had no concomitant medication. The second day of the vaccination, the patient called to report body aches, headache, chills, low grade temperature. As he reported, he just woke up and was walking around feeling like he had 1000 pounds on his back and felt like crap. The body aches started in his shoulder and currently all over his neck, back and whole body aches. Chills started last night (vaccination night). He was just trying to get to sleep and had to put an extra sweatshirt on last night. He did not check his temperature until he got up and it was 99.2 degrees Fahrenheit. He was not able to provide a start date for the temperature. "Body aches, headache between, chills between, low grade temperature (unspecified start date), feels like crap" were considered developing between 24:00-01:00. He stated that they were all medically significant and he needs a day to recover hopefully. He just felt like he was hit by a truck. The patient had not visited physician or went to ER yet. The outcome of low grade temperature was unknown, chills was resolving and all other events did not resolve at the time of reporting.; Sender's Comments: There is a reasonable possibility that the events vaccination site pain, headache, chills, and pyrexia were related to BNT162b2 based on known drug safety profile. The association between the other reported events with BNT162b2 can not be completely excluded based on 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.
49 2021-01-05 flushing Fever, feeling flushed, tunnel vision, light headedness, headache/pressure, chills, elevated pulse r... Read more
Fever, feeling flushed, tunnel vision, light headedness, headache/pressure, chills, elevated pulse rate, elevated blood pressure. Took migraine medication for headache, outcome unknown
49 2021-01-05 numbness after 5 minutes states her fingers felt weird -numb and felt like her hear was racing, very anxious ... Read more
after 5 minutes states her fingers felt weird -numb and felt like her hear was racing, very anxious started to hyperventilate. Took her to ER via WC . During transfer stated her fingers were twisting (noticed definite contractures in both hands. States her heart was beating very fast. Denies any allergies but did states she has history of low potassium and has had issues with medications nad vaccines in the past. However no sx like this but does get "a little loopy" even when taking motrin. Instructed her to notify any provider prior to any vaccinations of the above sx. If I would have know any off this I would have highly recommended her to get authorization from her PCP prior
49 2021-01-05 pain in extremity SkinRash Sore arm Narrative: Redness about the size of a quarter on left hand, sore arm day after i... Read more
SkinRash Sore arm Narrative: Redness about the size of a quarter on left hand, sore arm day after injection
49 2021-01-06 difficulty speaking moderate injection site pain and swelling, fatigue after 1 day from vaccination, day 2 from vaccinat... Read more
moderate injection site pain and swelling, fatigue after 1 day from vaccination, day 2 from vaccination developed unwell feeling and congestion, scratchy voice, and worsening fatigue
49 2021-01-06 tremor Had a slight headache a few hours after the injection, three hours later felt tired and headache wor... Read more
Had a slight headache a few hours after the injection, three hours later felt tired and headache worsened but improved with 500mg Tylenol. That night fatigue got worse but headache improved. Went to bed at 9pm and had severe chills and shaking, heart was beating fast. Chills lasted for several hours. Increased heart rate all night and could not sleep at all. Fitful night sleep and started to sweat in the Early morning. Woke up for work at 5:30 am and had headache, dizziness, and flu-like symptoms with joint and muscle aches. Had sweats all day today. Went home early from work and slept from 9:30 am to 4:30 pm. Most symptoms improved now but feel like I still have a fever and sweats.
49 2021-01-07 pain in extremity, flushing, tremor approximately 5" after receiving injection, headache developed. Progressively got worse within 30",... Read more
approximately 5" after receiving injection, headache developed. Progressively got worse within 30", rated 6/10. described as "felt like the Hulk was squeezing the back of my neck". Returned back to CVCU and coworkers commented on how red he looked- "face and arms were red like he had just ran a marathon, but not blotchy or rash". HIs entire arm began hurting and has been hurting and waking him up every night and needing repositioned several times throughout the night. L arm shakes/tremors, constantly - described incident where he was holding a plate at home a few days after injection and his left arm involuntary shook, uncrontrollably.
49 2021-01-08 tingling, numbness Headache tingling and numbness in R side down to toe's then whole body, HA on R side, felt better af... Read more
Headache tingling and numbness in R side down to toe's then whole body, HA on R side, felt better after standing up. stayed 30 minutes. Felt better and left. Narrative:
49 2021-01-09 tremor RECEIVED DOSE AT 1;17 pm 1/7/2021. At 9pm 1/7/2021, muscle aches, fatigue, fever (100.4F) and shakin... Read more
RECEIVED DOSE AT 1;17 pm 1/7/2021. At 9pm 1/7/2021, muscle aches, fatigue, fever (100.4F) and shaking chills began. waxed and waned throughout 01/08/2021 and finally ended approximately 05:00 Saturday 01/09/2021. I have felt totally fine since then. I received the first dose 12/17/2020 in my left arm at 1230pm. I had no side effects except for paining some swelling in the deltoid muscle that lasted a day or so. I get the full vaccine every year and never have any sort of reaction, even a mild one. I am a physician and understand the purpose of the vaccine and how it works.
49 2021-01-10 tingling Vaccine given at 07:50 (AM), with no immediate concerns. Within 4-6 hours, soreness at injection sit... Read more
Vaccine given at 07:50 (AM), with no immediate concerns. Within 4-6 hours, soreness at injection site was noted (soreness took 12-18 hours to start after first dose) By 8 hours after vaccination, had generalized "tingling" like a flu prodrome. By 12 hours after vaccination, experienced generalized aches, chills, mild headache and ipsilateral axillary lymphadenitis All symptoms persisted for 48 hours before resolution, except for axillary lymph node pain. Axillary lymphadenitis persisting , but resolving, by 72 hours after vaccination.
49 2021-01-11 pain in extremity, numbness Approximately 24 hours post shot I experienced severe joint pain in most all joints. Shortly after ... Read more
Approximately 24 hours post shot I experienced severe joint pain in most all joints. Shortly after onset of joint pain experienced severe chills. Those symptoms persisted for approximately 12 hours after which I continued to experience injection site pain, but began to experience pain with some numbness that radiated from the injection site distally down my arm and into my pinky and ring fingers on my left hand. No other symptoms. As of today the injection site pain persists as does the pain and numbness in my pinky and ring fingers, but I get the feeling that it is getting slightly worse. The pain and slight numbness is present when I awake, but gets worse throughout the day. Some evenings there is considerable discomfort.
49 2021-01-11 pain in extremity Arm soreness; This is a spontaneous report from a contactable physician. A 49-year-old male patient ... Read more
Arm soreness; This is a spontaneous report from a contactable physician. A 49-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number EK9231), via an unspecified route of administration on 19Dec2020 08:00 at single dose at right arm for COVID-19 immunization. Medical history included asthma. Concomitant medications included budesonide (PULMICORT), mometasone furoate (NASONEX), ibuprofen, and paracetamol (TYLENOL). On 20Dec2020, the patient experienced arm soreness. The patient did not receive treatment for the event. The outcome of the event was recovered.
49 2021-01-12 numbness Systemic: LLE numbness
49 2021-01-13 bell's palsy Was working on a shower door and i got dizzy, called my wife (She's a RN) because i didn't feel good... Read more
Was working on a shower door and i got dizzy, called my wife (She's a RN) because i didn't feel good. She came in and said it looked like i had a stroke. She called 911 and i was taken to ER
49 2021-01-14 pain in extremity, weakness prominent lower axillary swelling same side as shoulder injection site; Flu-like symptoms; soreness ... Read more
prominent lower axillary swelling same side as shoulder injection site; Flu-like symptoms; soreness (other than injection areas including thighs); soreness (other than injection areas including thighs); more severe soreness/generalized soreness (other than injection areas including thighs); more severe soreness including back of shoulder; generalized weakness; This is a spontaneous report from a contactable physician (patient himself). A 49-year-old male patient received a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) via an unspecified route of administration (right arm), on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received chlorhexidine and propylene glycol and experienced allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) in the left arm on 17Dec2020 at 17:30 for COVID-19 immunization. On 08Jan2021, the patient experienced more severe soreness including back of shoulder, generalized weakness, and generalized soreness (other than injection areas including thighs) beginning at 13:00 following day lasting the rest of the day. On an unspecified date, the patient also had prominent lower axillary swelling same side as shoulder injection site, flu-like symptoms, and focal soreness. The patient received over the counter (OTC) Motrin as treatment for the events. The patient recovered from flu-like symptoms, but has not yet recovered from the remaining events.
49 2021-01-14 pain in extremity Arm pain; Injection site pain; Fever; Chills; Nausea; Headache; Body aches; General malaise; This is... Read more
Arm pain; Injection site pain; Fever; Chills; Nausea; Headache; Body aches; General malaise; This is a spontaneous report from a contactable nurse, the patient. This 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9231 ), dose 2 , single dose via an unspecified route of administration in the left arm on 07Jan2021 at 07:30 AM (at the age of 49 years-old) for COVID-19 vaccination. Relevant medical history included high cholesterol. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL0140,), single dose, dose 1 in the left arm on 18Dec2020 at 09:30 AM. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included aspirin, rosuvastatin (CRESTOR), D3, zinc and multivitamin. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 07Jan2021 at 10:00 PM, the patient experienced arm pain, injection site pain, fever, chills, nausea, headache, body aches and general malaise. The report was reported as non-serious. The patient was not treated for arm pain, injection site pain, fever, chills, nausea, headache, body aches and general malaise. The clinical outcome of arm pain, injection site pain, fever, chills, nausea, headache, body aches and general malaise was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
49 2021-01-15 muscle spasms Muscle Spas; Weakness in both limbs. Pressured speech
49 2021-01-15 pain in extremity 12 hours after injection, noticed l mild right arm soreness, along with fatigue and chills. 18 hour... Read more
12 hours after injection, noticed l mild right arm soreness, along with fatigue and chills. 18 hours after injections, body aches, joint (back and hips mostly) pain, and severe chills. Low grade 100.4 F fever and malaise / fatigue. Symptoms all resolved, except mild fatigue, after 24 hours
49 2021-01-17 cold sweat Chest tightness, Chills, Dizziness, 'cold sweats'
49 2021-01-18 burning sensation Vasculitis of hands and feet. Symptoms first noted in hands on 1/17/2021 - intermittent - adverse re... Read more
Vasculitis of hands and feet. Symptoms first noted in hands on 1/17/2021 - intermittent - adverse reaction on 1/18/2021 at 11:08 pm - hands became bright red as well as feet. Burning sensation (similar to taking Niacin) Color changed in feet from bright red to dark red with some purple in digits 2 and 3 of both feet. Appears swollen. I was informed on 1/12 (4 days after being vaccinated) that my daughter had been exposed to COVID. We family quarantined. The adverse reaction led me to go to an urgent care clinic to be tested for COVID. I had the POC test performed and came back positive. My temperature was recorded at 99.3 F.
49 2021-01-18 migraine slight headache and muscle ache, during the evening it progressed to extreme chills, achiness, heada... Read more
slight headache and muscle ache, during the evening it progressed to extreme chills, achiness, headache off the charts; slight headache and muscle ache, during the evening it progressed to extreme chills, achiness, headache off the charts; slight headache and muscle ache, during the evening it progressed to extreme chills, achiness, headache off the charts; joint pain in elbows; extreme chills; migraine was at a level of intractable pain; maybe a low grade fever of 99F; This is a spontaneous report from a contactable other hcp (Anesthesiology, patient). A 49-years-old male patient received second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 07Jan2021 08:30 at SINGLE DOSE for covid-19 immunisation. Medical history included migraines headaches. This was migraine plus; extreme pain which he took migraine pain medicine. The patient's concomitant medications were not reported. The patient previous received 1st dose of bnt162b2.The other HCP reported: On Thursday 07Jan2021, he received the 2nd shot at 8:30am, then about 3-4pm he had symptoms of slight headache and muscle ache, during the evening it progressed to extreme chills, achiness, headache off the charts. Throughout the evening into the next day, he suffered chills that went away, joint pain in elbows; headache pain, which he had to do migraine medicine again. Saturday morning he felt better, he don't have a headache, but for a good 36 hours, migraine was at a level of intractable pain since Jan2021. He never had a fever, well maybe a low grade fever of 99F in Jan2021. The even outcome of chills was recovered Jan2021, headache was recvoered on 09Jan2021; outcome of other events were unknown. Information on the lot/batch number has been requested.
49 2021-01-19 feeling of body temperature change Exhausted and cold then hot.
49 2021-01-19 pain in extremity Achy left arm and left armpit resulting in me taking Ibuprofen. (Took 3 -400mg pills over 12hrs)
49 2021-01-21 pain in extremity First injection in left arm, Head ache lasting for 4 Days, arm sore for 5 Days. Second injection a... Read more
First injection in left arm, Head ache lasting for 4 Days, arm sore for 5 Days. Second injection after an hour tingling in left side of lip and pain in the left jaw joint. Head ache still persistant. Tingling went away after 6 HR and pain in jaw joint stopped.
49 2021-01-22 tremor Monday, 1/18: Extremely tired., shaky, diarrhea 4 times, legs very week and heavy feeling like I was... Read more
Monday, 1/18: Extremely tired., shaky, diarrhea 4 times, legs very week and heavy feeling like I was walking with cinder blocks on my feet. Tuesday 1/19 : Very tired, no bowel movement (took imodium AD 1/18) ,legs very painful after sitting and the pain was generally from knee to hip. Movement helped alleviate the pain. Tired/shaky feeling increased throughout the day. Wednesday 1/20: Same symptoms as 1/18 AND a sensation of pins and needles all over my body. It would randomly come and go from literally every area of my body and this was so pronounced it was hard to fall asleep that night. Thur 1/21. Leg pain gone but still week and tired. Pins and needles sensation better but not gone. Friday 1/22 same as 1/21 Saturday 1/21 same as 1/21. Tried to do a little work around the house and was exhausted. Pins and needle sensation remains the same.
49 2021-01-24 pain in extremity On 1/18/2021, at approximately 02:00 AM, I woke up with extreme pain in my right arm. The pain radia... Read more
On 1/18/2021, at approximately 02:00 AM, I woke up with extreme pain in my right arm. The pain radiates from the shoulder/bicep down to the forearm. The pain did not subside until later in the evening. I continued to have discomfort and pain on and off throughout the week. On 1/25/2021, I again woke up with extreme pain in my right arm. I have tried ibuprofen and different arm positions to reduce the pain and discomfort without any luck. The arm is tender/sore. I am not sure if this is a reaction to the vaccine or if the needle protruded too far when administered. I have an MRI scheduled to rule out any type of injury.
49 2021-01-25 tension headache 2nd dose had fatigue; mild fever; body ache; tension headache; This is a spontaneous report from a c... Read more
2nd dose had fatigue; mild fever; body ache; tension headache; This is a spontaneous report from a contactable nurse reported for himself. A 49-year-old male patient received second dose of bnt162b2 (BNT162B2, Lot#: EJ1686), via an unspecified route of administration on 11Jan2021 on Right Arm at single dose for covid-19 immunisation. Medical history included Ulcerative Colitis. No allergies to medications, food, or other products. Concomitant medications included the patient received within 2 weeks of vaccination: Mesalamine. The patient previously took first dose of bnt162b2 (Lot#: EH9899) via Intramuscular on 21Dec2020 09:30 AM on Left arm at single dose for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced 2nd dose had fatigue, mild fever, body ache and tension headache from 12Jan2021 06:00 AM. The outcome of the events was recovered. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Location of injection information is available for all vaccines received on the same date.
49 2021-01-26 feeling hot Raised, hot, red rash at right knee, bilateral elbows, and midback. Itchiness was 8/10 itchy per pa... Read more
Raised, hot, red rash at right knee, bilateral elbows, and midback. Itchiness was 8/10 itchy per patient.
49 2021-01-26 muscle spasms, tremor, weakness Pressured Speech; Weakness and tremors to both limbs; Weakness and tremors to both limbs; muscle spa... Read more
Pressured Speech; Weakness and tremors to both limbs; Weakness and tremors to both limbs; muscle spasm; This is a spontaneous report from a contactable Other HCP (patient). This 49-year-old male patient received his first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec202 at 17:30 in left arm at single dose for COVID-19 immunisation at the age of 49-year-old. Lot number was EK9231. Medical history included gout. Concomitant medications were unknown. On 10Jan2021, the patient experienced Pressured Speech, weakness and tremors to both limbs and muscle spasm. The events resulted in Emergency room/ department or urgent care and Hospitalization for one day. The patient was not treated for the events. COVID was tested post vaccination on 13Jan2021, Nasal Swab, polymerase chain reaction (PCR) and it resulted negative. The patient did not recover from the events.; Sender's Comments: The events pressured speech, weakness and tremors to both limbs ,muscle spasm are less likely related to suspect BNT162B2 administration given the weak time association. The available examination results would be helpful for further assessment. 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.
49 2021-01-27 pain in extremity sore arm
49 2021-01-28 pain in extremity Mild arm tenderness; This is a spontaneous report from a contactable pharmacist reported that a 49-y... Read more
Mild arm tenderness; This is a spontaneous report from a contactable pharmacist reported that a 49-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on the left arm on 17Dec2020 09:00 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced mild arm tenderness on an unspecified date with outcome of recovered. No treatment received for the reported event.
49 2021-02-01 facial paralysis Diagnosis of Bell's palsy/ getting peripheral nerve palsy/Left side partial facial paralysis/droopy ... Read more
Diagnosis of Bell's palsy/ getting peripheral nerve palsy/Left side partial facial paralysis/droopy face; difficulty with blinking; This is a spontaneous report from a non-contactable consumer. A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL3246), via an unspecified route of administration on 09Jan2021 14:30 at left arm at single dose for covid-19 immunisation. Medical history included type 2 diabetes, Hep B carrier. Concomitant medication included metformin, entecavir. On 17Jan2021 04:30 PM, the patient experienced left side partial facial paralysis, droopy face, difficulty with blinking...went to ER to rule out stroke, MRI and CAT scan normal. Diagnosis of Bell's palsy. First time getting peripheral nerve palsy. AE treatment: Prednisone, Valtrex, eye drops...IV steroids. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. No known allergies. The patient underwent lab tests and procedures which included computerised tomogram: normal, magnetic resonance imaging: normal. The outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected.
49 2021-02-02 tenderness Bump and red rash around it. Started night after second shot. Still theren48 hours later. Painful... Read more
Bump and red rash around it. Started night after second shot. Still theren48 hours later. Painful to touch.
49 2021-02-03 pain in extremity arm pain; fatigue; This is a spontaneous report from a contactable consumer (patient himself). A 49-... Read more
arm pain; fatigue; This is a spontaneous report from a contactable consumer (patient himself). A 49-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date not reported), via an unspecified route of administration on 21Dec2020 07:30 at single dose for COVID-19 immunization. Medical history included seasonal allergy and mild jackfruit allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included finasteride and testosterone. The patient experienced arm pain and fatigue on an unspecified date. Clinical outcome of the events was unknown.
49 2021-02-04 pain in extremity Extreme fatigue; Heavy and achy legs; Heavy and achy legs; Headache; No appetite; Nausea; Lethargic;... Read more
Extreme fatigue; Heavy and achy legs; Heavy and achy legs; Headache; No appetite; Nausea; Lethargic; Injection site pain; This is a spontaneous report received from a contactable consumer (patient). A 49-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration in the left arm, on 16Jan2021 17:15, at single dose, for COVID-19 immunization, at the hospital. There were no medical history and no known allergies. The patient did not have COVID-19 prior to vaccination. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient did not receive other vaccines in four weeks. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date unknown), via an unspecified route of administration in the left arm, on 28Dec2020 16:45, for COVID-19 immunization. The patient did not test for COVID-19 post vaccination. On 17Jan2021 at 08:00, the patient experienced extreme fatigue, heavy and achy legs, headache, no appetite, nausea, lethargic and injection site pain. No treatment was provided for the events. The outcome of the events was resolved on an unspecified date.
49 2021-02-04 pain in extremity arm pain; fatigue; beginning 1/13 a constant high pitch whine in whole head; probably tinnitus; This... Read more
arm pain; fatigue; beginning 1/13 a constant high pitch whine in whole head; probably tinnitus; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246; expiry date: unknown) via an unspecified route of administration in the left arm, on 11Jan2021 at 07:30, at a single dose, for COVID-19 immunization. Medical history included seasonal allergies and mild jackfruit allergy. Concomitant medications included testosterone, finasteride, and unspecified vitamins. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown) on 21Dec2020, at 07:30 AM, in the left arm, for COVID-19 immunization and experienced arm pain and fatigue. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. On an unspecified date, the patient had arm pain and fatigue from second dose but milder. On 13Jan2021, at 07:00 AM, the patient experienced a constant high pitch whine in whole head, probably tinnitus. The patient has not sought medical attention yet. The events were considered non-serious. Outcome of the events "beginning 1/13 a constant high pitch whine in whole head" and tinnitus was not recovered, while outcome of the other events was unknown. The patient has not been tested for COVID-19 since vaccination.
49 2021-02-04 tingling Mild Tingling, Shortness of Breath and stuttering
49 2021-02-07 facial paralysis Peripheral facial paralysis (Bell's Palsy) left side 8 days after vaccination; This is a spontaneous... Read more
Peripheral facial paralysis (Bell's Palsy) left side 8 days after vaccination; This is a spontaneous report from a contactable 49-year-old male other healthcare professional (HCP) (patient) reported for himself received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via unspecified route on left arm single dose for COVID-19 immunization on 09Jan2021, 02:30 PM, at 49-year-old. Medical history included: Borderline Type 2 diabetes; Hepatitis B carrier. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: metformin, entecavir. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2. The patient had peripheral facial paralysis (Bell's Palsy) left side 8 days after vaccination (17Jan2021) and was reported as non-serious. Treatment was received as steroids and antiviral. Emergency room/department or urgent care visited. Since the vaccination, the patient had not been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the event was not resolved.; Sender's Comments: Based on currently known drug safety profile, a causal association between the reported event peripheral facial paralysis and BNT162B2 cannot be fully excluded. The event facial paralysis can also be caused by other virus infection. Case will be reassessed when additional information is available including viral testing. 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.
49 2021-02-11 feeling cold, feeling hot Got the does on the 6th of January around 3:00pm Around 9a on the 7th my skin started to hurt the... Read more
Got the does on the 6th of January around 3:00pm Around 9a on the 7th my skin started to hurt then about about 9:00PM I developed chills Around 2 am the next day I woke up really hot also with chills 5AM 8th I noticed a 10cm soft lump on the left arm pit 22nd Completely resolved
49 2021-02-13 pain in extremity I am a physician who received the second Pfizer COVID-19 vaccine in my right arm on 1-13-21. On 1-14... Read more
I am a physician who received the second Pfizer COVID-19 vaccine in my right arm on 1-13-21. On 1-14-21 I developed deep aching right sided neck pain distinct from the injection site pain, and this progressed to right cervical radiculopathy, with 12-15 hours of radicular pain radiating from my right neck through my right hand. The best way to describe this is it felt like a tooth ache from my neck to my hand. That is not why I'm writing. I'm writing because around 2-9-2021 I developed a pruritic rash near my right wrist that I originally thought was contact dermatitis, but I could not recall the initial contact. The rash persisted, and 2-13-21 it spread, began to crust, and started burning, consistent with shingles in the C8 distribution. I'm a 49 year old quacks-like-a-duck doctor, and wanted to share my story due to the possible connection between the Pfizer mRNA vaccine and herpes zoster.
49 2021-02-15 tremor, pain in extremity 1/6/2021 vaccination; Later that afternoon, I started to go into a 'fog', tired, HA. I could functi... Read more
1/6/2021 vaccination; Later that afternoon, I started to go into a 'fog', tired, HA. I could function but nothing seemed 'clear' or 'sharp', 1/7/2021 fatigue, arm sore. The 'fog' was worse; 1/8 fog was really bad; forgetting conversations. 1/9 2:45 in morning. Went to bathroom. Walking, about 1/2 way there, felt like a 'spike' and instant HA. I went to bathroom, door closed, I got sick/vomiting. The shiver, shakes, and fever spiked. I bent down to throw up and I cant relieve. I fell into the wall, pushed self to stand up. Was back in bedroom, laying on floor and passed out. Wife woke me, I was bleeding. Don't know how long I was on the floor. BP144/78, 133 blood sugar, O2 was 98%, temp 98.1. 3:45 I decided to go to hospital, EKG, CT scan, Xray, etc. 'Just fainted' *PCP stated it was due to shot / vaccine. **busted lip, ER bill ***2nd vaccine; minor side affects (slight HA, )
49 2021-02-16 weakness FEVER, DIARRHEA, HEADACHE, WEAKENESS, MILS ABDOMINAL DISCONFORT
49 2021-02-22 bell's palsy Patient developed R sided Bell's Palsy approximately 10 days after vaccination
49 2021-02-25 muscle spasms 1/22 ? Received second dose of vaccine 1/23-1/25 ? started having LLQ abdominal, flank, and back pai... Read more
1/22 ? Received second dose of vaccine 1/23-1/25 ? started having LLQ abdominal, flank, and back pain. The pain was isolated, sharp in nature and rated 7/10. No rash or blistering in the area. 1/25 ? Contacted primary care physician and referred to medical facility for work up. Ruled out kidney stone. Abdominal CT scan negative. Treated with Torodal and Dilaudid with minimal relief. Discharged dx of muscle spasm and rx for muscle relaxants. 1/26 ? Follow up appointment with primary care physician. Added NSAIDS for ongoing pain. 1/27 ? Represented to ETC for ongoing LLQ abdominal, flank, and back pain. Noted constipation. KUB(kidney, ureter, and bladder) showed ileus. 1/28 ? Follow up appointment with primary care physician. Started on gabapentin 100mg TID for ongoing pain. 2/3 ? LL abdominal bulge noted (16cm x 10cm). Contacted primary care physician and referred back to hospital. Repeat KUB(kidney, ureter, and bladder) and CT scan are negative. 2/4 ? Follow up appointment with primary care physician. MRI of lumbar spine ordered. 2/10 ? Appointment with colorectal surgeon. Appreciated continued bulge. Recommended follow up appointment with hernia surgeon. 2/11 ? Appointment with hernia surgeon. Noted that the bulge decompresses when laying flat. Abdominal ultrasound ordered to rule out spigelian hernia. 2/12 ? Ultrasound negative for any kind of defect. Lumbar MRI performed. 2/17 ? follow up appointment with hernia surgeon. Based upon everything they believe that this is a pseudohernia likely caused by the COVID vaccine and possible irritation of HZ virus. Continued to not show any rash or blistering. Continue with gabapentin and added acyclovir."
49 2021-02-26 numbness, tingling Reaction started approximately 10 hours post-vaccination and included loss of vision in left eye, nu... Read more
Reaction started approximately 10 hours post-vaccination and included loss of vision in left eye, numbness and tingling on right side (arm, legs), numbness of tongue, pain in all joints including knees, shoulders, neck, ankles and arms/elbows.
49 2021-02-28 weakness Injection site pain-minimal Tiredness- 3days, low energy Headache-severe for over 3 days Nausea- mil... Read more
Injection site pain-minimal Tiredness- 3days, low energy Headache-severe for over 3 days Nausea- mild, 2 days Difficulty breathing- on two separate occasions after minimal activity
49 2021-02-28 numbness, bell's palsy Feb 15, 2021 Monday, I started feeling pain on the right portion of my neck; Feb 16, 2021 Tuesday, I... Read more
Feb 15, 2021 Monday, I started feeling pain on the right portion of my neck; Feb 16, 2021 Tuesday, I felt the pain radiating inside my right ear and had a mild headache. Tuesday evening, my wife noticed that I am not fully blinking/closing my right eye; Feb 17, 2021 Wednesday, I didn't have the same pain but there's numbness on my right cheek extending to my right lips. Wednesday afternoon around 2pm, I went to my dentist thinking it was due to my Invisalign which I started on Jan 25, 2021. The dentist told me it is most likely Bell's palsy so I decided to go to Emergency.
49 2021-03-01 pain in extremity Early Wednesday morning (2/24) around 5:00AM, I woke up to extreme pain in my left arm, primarily al... Read more
Early Wednesday morning (2/24) around 5:00AM, I woke up to extreme pain in my left arm, primarily along the upper forearm, inside of my elbow, and lower bicep. There was no trauma or unusual behavior prior to onset of pain. It came on suddenly and worsened with extension of the arm. Symptoms worsened over the next few days, with pain intensifying and extending down into my hand and up into my armpit and shoulder. I tried ice, Ibuprofen, Acetaminophen, and Vicodin for pain relief, but nothing really helped other than the ice. On Saturday morning (2/27), I visited Urgent Care and was diagnosed as brachial plexis neuritis, aka Parsonage-Turner Syndrome by Dr and prescribed Prednisone and rest. On Sunday evening (2/28), I went to the ER seeking pain relief and second opinion. On Monday (3/1) morning, I was seen by ED doctors, and then three different neurologists. After doing an ultrasound which ruled out vein/artery thrombosis, the neuro team diagnosed Parsonage-Turner Syndrome. They've prescribed Gabapentin, Acetaminophen, and Ibuprofen for pain relief, a follow-up neuro consult, an MRI for next Friday, and an EMG in a few weeks. Last night while sitting and reading, the same pain began in my right arm, similarly to how it presented in my left arm last week. The right arm pain is less than the left arm pain, but at this point seven days later, I am experiencing neuropathic pain in both arms.
49 2021-03-01 sensory loss, mild one side paralysis, weakness Decreased sensation from chest/abdomen through lower extremities, diminished strength and mobility ... Read more
Decreased sensation from chest/abdomen through lower extremities, diminished strength and mobility of left side. Symptoms started approximately 24 hours after receiving the vaccine starting with decreased sensation in the lower extremities . 02/14/2021 I started experiencing weakness on the left side. 02/16/2021 symptoms progressed to limited movement on the left side preventing ability perform normal daily functions and digestion was effected.
49 2021-03-04 pain in extremity Bitter metallic taste in my mouth; fatigue; arm soreness; lip tingling; headache; This is a spontane... Read more
Bitter metallic taste in my mouth; fatigue; arm soreness; lip tingling; headache; This is a spontaneous report from a contactable consumer (patient). This 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9262) via an unspecified route of administration in the left arm on 02Feb2021 at 09:30 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Medical history included kidney cancer from 2009 and unknown if ongoing; costochondritis from an unknown date and unknown if ongoing; non-alcoholic fatty liver disease (NAFLD) from an unknown date and unknown if ongoing; gastroesophageal reflux disease (GERD) from an unknown date and unknown if ongoing; irritable bowel syndrome (GERD) from an unknown date and unknown if ongoing; migraines from an unknown date and unknown if ongoing, low immunoglobulin A (IgA) from an unknown date and unknown if ongoing; and steri strip allergy from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included rosuvastatin calcium (CRESTOR) from an unknown date for an unknown indication; vitamin D from an unknown date for an unknown indication; and vitamin B12 from an unknown date for an unknown indication. The patient previously received a dose of BNT162B2 (lot number EK5730) in the left arm on 12Jan2021 for COVID-19 immunization. On an unspecified date in 2021 (reported as 02Jan2021 at 15:00) the patient experienced bitter metallic taste in his mouth, fatigue, arm soreness, lip tingling and headache. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. Lab tests and procedures included polymerase chain reaction via nasal swab on 31Jan2021 with negative results. The clinical outcomes of bitter metallic taste in his mouth, fatigue, arm soreness, lip tingling and headache were not recovered. It was also reported that since vaccination the patient was tested for COVID-19.
49 2021-03-04 tingling Left arm tingling after vaccination that did not go away after 30min. Evaluated by EMS. ST elevation... Read more
Left arm tingling after vaccination that did not go away after 30min. Evaluated by EMS. ST elevation in screening lead 2, 12 lead performed but revealed only enlarged QRS, no ST change. No resp distress, no chest pain, given aspiring by EMS and transferred to hospital for continued monitoring and observation.
49 2021-03-06 tingling Developed prickly feeling and slight rash...perhaps some mild hives about 11 hours after the vaccine... Read more
Developed prickly feeling and slight rash...perhaps some mild hives about 11 hours after the vaccine. I also felt like I had a bit of a lump in my throat. I called the Doctor's office and spoke with a nurse who suggested I take Benadryl. I did so at around midnight and that seemed to take care of things. Went to bed and woke up the next morning feeling ok (though groggy from the Benadryl).
49 2021-03-07 depressed level of consciousness, slow speech Patient was administered COVID vaccine while in ER for monitoring of possible reaction. Per ER repor... Read more
Patient was administered COVID vaccine while in ER for monitoring of possible reaction. Per ER report: "Pt noted to be having reaction, pt with decreasing level of consciousness (groggy), did answer questions. Epi/Benadryl given from bedside. VSS at that time. Currently speech is slow but does answer appropriately." Patient was discharged home.
49 2021-03-07 numbness and pain in extremities, numbness Peripheral, digital neuropathy: Dysaethesia in fingers Dig 4 and 3, first occurence in the left Hand... Read more
Peripheral, digital neuropathy: Dysaethesia in fingers Dig 4 and 3, first occurence in the left Hand. The dysaesthesia was self limting (at least to date and lasted ca 5 days), now I have it on the right hand on Dig 4. No motor function issues observed, purely dysaethetic in nature. Tactililty altered and reduced. Whole finger is affected, albeit distal lateral portion most. No other issues, left hand , Dig 4 is almost back to normal sensation (80%). No neurological history personal or in the family- ever. No treatment attempted, resp what would help anyway?
49 2021-03-10 bell's palsy Bell's palsy(Left face)
49 2021-03-12 flushing, tingling Pfizer-BioNTech COVID-19 Vaccine EUA: 10 minutes after vaccination patient reported flushing, dizzin... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: 10 minutes after vaccination patient reported flushing, dizziness, lightheadedness, and tingling. Vital signs all within normal ranges. Transported to emergency department where physical exam was normal; neurological exam reported no focal deficits. Patient denied chills, blurred vision, shortness of breath, nausea, pain (including chest pain), rash, and headaches. Patient observed, symptoms resolved, and discharged to home stable.
49 2021-03-14 weakness, pain in extremity On the day of the shot I had a little soreness in my arm but on day 2 I couldn't lay down on that ar... Read more
On the day of the shot I had a little soreness in my arm but on day 2 I couldn't lay down on that arm because it hurt. For 4 days I had to have a nap during the day because I ran out of energy. However, since that shot I feel like I have been living in a "brain fog" because I can tell I'm processing things slower and it's not getting better.
49 2021-03-15 tingling Received first dose vaccine at approximately 1045 began feeling tingling in hands and lips about 20 ... Read more
Received first dose vaccine at approximately 1045 began feeling tingling in hands and lips about 20 minutes later. Vitals were taken and remained stable. Patient was given citirizine 10mg orally and symptoms began improving at approximately 1115. Symptoms resolved completely by 1200.
49 2021-03-17 flushing, unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium, Systemic: loss of color, unresponsive, sweating. epipen gi... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: loss of color, unresponsive, sweating. epipen given. ems evaluated and determined stress rxn and sent home. -Medium, Systemic: Flushed / Sweating-Medium
49 2021-03-18 pain in extremity bleeding; my skin on my hands and the bottom of my feet started to peel off; very painful in the fin... Read more
bleeding; my skin on my hands and the bottom of my feet started to peel off; very painful in the fingers and the feet; This is a spontaneous report from a contactable other healthcare professional (patient). A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3249, expiration date not reported) via unspecified route of administration in the arm right on 21Jan2021 at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. The patient previously took iodine and experienced drug allergy; also received first dose of bnt162b2 (Lot number: EJ1685) via unspecified route of administration in right arm on 30Dec2020 14:00 for COVID-19 immunization. Facility type vaccine: clinic. It was reported that on 23Jan2021, couple of days after the second shot, patient experienced skin on hands and the bottom of my feet started to peel off and bleeding and very painful in the fingers and the feet. The events resulted in both: Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. It was unknown if treatment received for the events. Outcome of all events was recovering.; Sender's Comments: Based on plausible temporal relationship and known drug profile, a contributory role of the suspect BNT162B2 cannot be excluded in the development of bleeding, skin exfoliation and pain in extremity. 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.
49 2021-03-22 numbness Felt swelling in arm, third fourth and fifth finger on right arm became numb, tiny pinpoint red bump... Read more
Felt swelling in arm, third fourth and fifth finger on right arm became numb, tiny pinpoint red bumps appeared on arms and legs. Right eyebrow and extending down to the right cheekbone feels "puffy"
49 2021-03-22 tingling, numbness and pain in extremities Peripheral neuropathy and/or paresthesia in hands, feet and (occasionally) face.
49 2021-03-23 tremor, feeling cold joint and muscle ache and fatigue, fever, chills, sweating, headache, shaking, cycling between feeli... Read more
joint and muscle ache and fatigue, fever, chills, sweating, headache, shaking, cycling between feeling cold and shaking to hot and sweating. I was positive for COVID-19 in April of 2020, the reaction to the first shot of the vaccine was worse than the virus itself (with the exception of chest congestion and cough). it is nearly 48 hours from receiving the vaccine and I feel slight improvement, but still have body and muscle aches, slight fever, chills.
49 2021-03-24 inability to speak Approximately 5 minutes after vaccination was administered, patient was diaphoretic, pale in color, ... Read more
Approximately 5 minutes after vaccination was administered, patient was diaphoretic, pale in color, and unable to speak. Blood pressure was taken (48/28) with a pulse of 24. Patient stated that he had not eaten anything that day prior to coming to get his vaccination.
49 2021-03-25 night sweats, pain in extremity Had a very strong erection through night most of the morning; Very horrible side effects; very unusu... Read more
Had a very strong erection through night most of the morning; Very horrible side effects; very unusual side effects, Was pretty crippling; Lost my voice; Left groin is terribly painful; I go urinate and it would come back; was very really weird; Groin is so tender; Leg is uncomfortable; couldn't walk/Balance was off; I was on the floor; couldn't even make me anything to eat; Lethargic; I pee pretty frequently; Head, the base of head is very uncomfortable; Had sweats last night really strong; Couldn't sleep; Left buttock and all the way down to my toes was extremely painful; Body aches and chills; Glands swollen; Headache; Sick most of the day; This is a spontaneous report from a contactable consumer. A 49-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 19Feb2021 15:00 (Batch/Lot number was not reported) at singe dose for covid-19 immunisation. Medical history included genital herpes, TBI (Traumatic brain injury), chronic laryngitis, low blood pressure, seasonal allergy, appendix taken out, sinus surgeries, no sense of smell, tonsils removed, allergy. It was reported that he got her vaccine (unspecified Vaccine) Friday afternoon at 3 o'clock pm mountain standard time. He was fine on Friday and Saturday, he was horrible, very horrible side effects, that's why he thought he need to call, very unusual side effects he had typical, he was really struggling to talk today. On on 19Feb2021 23:00 he lost my voice, my glands were swollen, body aches he experienced. He got my shot in my left arm, my left buttock and all the way down, all the way to my toes was extremely painful and it cuts through my groin area. My left groin which is terribly painful. patient left buttock, all the way down to the toes extremely painful and that continued into my groin. And he had erection, he had a very strong erection through night, most of the morning. He go urinate and it would come back that was very really weird. That was when he knew it was really weird. And he knew that Pfizer was the one that makes Viagra. And my groin is so tender. When he pee, he pee pretty frequently. He think that was the most unusual side effects. His head, the base of my head was very uncomfortable. He had sweats last night really strong. Today, he woke up, he could not sleep, he went to the bed early. He had no energy today, he was doing a lot (not clarified over the call). He do have a headache today and obviously my voice hasn't come back completely and my leg is uncomfortable, he couldn't walk he was like if he was drunk yesterday, he couldn't, my balance was off. He was on the floor. He couldn't even make me anything to eat. It was pretty crippling that it made me feel like. He was very lethargic and he was sick most of the day. he was just hoping to give you information. He waited for long time on the phone to share experience. I hope this information helps you, I mean the other people if having the same problems or maybe not. Consumer also stated, he cannot locate the card that was given to me. He could not locate today. He was doing my laundry today maybe it is in my pocket. he dig into my pocket, he guess could not find it. They gave me card but he was not sure if he had it. Date when started experiencing the events: Consumer stated, I would say the date of the vaccine 19Feb2021. It probably towards the evening, I would say late at about 11 o'clock. Still experiencing Consumer stated, I am experiencing mild headache. I am experiencing dull pain at the base of my neck. I am experiencing the tenderness in my left groin. I am experiencing a little pain when I pee. I am experiencing a little bit of body aches, chills. I haven't fully gotten my voice back. I feel so sick. The erection has subsided but my penis is painful, it is uncomfortable. For treatment Consumer stated he did today he took this afternoon about maybe 3 pm, he took 4 Ibuprofen. Outcome of the event had a very strong erection through night most of the morning was recovering, outcome of the events lost my voice, left groin is terribly painful, groin is so tender, left buttock and all the way down to my toes was extremely painful, body aches and chills, headache not recovered. Outcome of the other events unknown. Information about lot/batch number has been requested.
49 2021-03-26 weakness Extremely ill,weak and somewhat flu like but tested negative for both
49 2021-03-26 pain in extremity Joints pain - hands, elbow, knee, wrist, ankle pain in the back - pain on my clavicle Pains are no... Read more
Joints pain - hands, elbow, knee, wrist, ankle pain in the back - pain on my clavicle Pains are not constantly, come and go every two or three days.
49 2021-03-28 tremor 3/25: Approx 5 mins after injection, started breathing quickly and became lightheaded. Moments later... Read more
3/25: Approx 5 mins after injection, started breathing quickly and became lightheaded. Moments later, heart rate elevated north of 190 bpm and blood pressure went up to approx 180/100. Developed dry mouth (was very thirsty) and shaking/chills. Took about 60 minutes to stabilize. Went to ER for evaluation and tests around 2:30P. Received a liter of fluid. Both EKG and Bloodwork was indicated as normal. Released from hospital around 6P. Slept through most of the night. 3/26: heart rate was erratic all day. Would race and then stabilize throughout the day/night. Extremely lethargic. No trouble breathing (was able to breathe and take deep breathes) but took effort to breathe. 3/27: 1:40A woke up heart began racing at close to 200 bpm. Dry mouth, shakes. Similar to what I experienced immediately following the vaccine shot. Went to ER out of precaution. Symptoms stabilized after about an hour. Hospital did EKG, blood work and chest X-ray. all were normal, lungs were clear. However, glucose and bilirubin were both slightly elevated. 3/29: Still feeling lethargic. Heart rate has stabilized some but is still erratic. It easily increases from simply walking around the house (much more than usual). 3/30: Scheduled appointment with primary care physician 3/31: Scheduled appointment with cardialogist
49 2021-03-29 flushing Fever, stiff neck, pain in low back, full body aches, flushed face.
49 2021-03-30 cold extremities, numbness pt. c/o of pain in the chest. heavy chest like someone is standing on my chest- pt. said. lt. hand... Read more
pt. c/o of pain in the chest. heavy chest like someone is standing on my chest- pt. said. lt. hand cold and numbness dizziness, blur vision. His leg numbness.
49 2021-03-31 burning sensation, numbness 1 hour after receiving the vaccine, my face and neck on the side of the shot started to burn like a... Read more
1 hour after receiving the vaccine, my face and neck on the side of the shot started to burn like a nerve issue and then went numb. My arm where I received the shot went cold and burned. A friend came over and took the temperature of my hand because it was cold and it was 15 degrees colder than my other hand. I took 1 Benadryl of 25mg and laid down for a few hours. At around 4 hours after the vaccine my neck went stiff as well as my upper back. I am reporting this because I don't believe the neck and face going numb is a normal thing and it was concerning and had it continued I would have went to the ER. I am not sure if the Benadryl helped but maybe.
49 2021-03-31 tingling, numbness, slurring Patient received 2nd dose of vaccine at 1120 today . He had 2 petite mall seizures, tingling, numbne... Read more
Patient received 2nd dose of vaccine at 1120 today . He had 2 petite mall seizures, tingling, numbness to right hand, glazed stare, slurred voice within 30 min of receipt of vaccine. Patient transported to emergency room via wheelchair.
49 2021-03-31 tremor uncontrollable shivering/shaking multiple times during the evening and night
49 2021-04-01 feeling cold 1800 hrs at work(same day as shot 1), started feeling nausea, vomited several times from 1815-1830. ... Read more
1800 hrs at work(same day as shot 1), started feeling nausea, vomited several times from 1815-1830. started with chills and sweating then and extreme fatigue. 1845 started vomiting again until about 1900 when it ended with violent vomiting and retching. Left work early, freezing the whole way home. fell asleep on the couch in clothes, sweatshirt and two blankets due to chills. Slept for 2 1/2 hours, woke up feeling much better. next day had slight headache and slight lethargy.
49 2021-04-01 pain in extremity persistent left shoulder pain
49 2021-04-01 pain in extremity Fatigue Chills Runny nose Sore arm
49 2021-04-01 tremor Loss of taste, smell Achy Fever and shakes Loss of appetite Irritability Lethargy
49 2021-04-03 coordination abnormal Fever, loss of equalibrium (fall), loss of coordination.
49 2021-04-03 discomfort Shortness of breath when exercising or active. Slight fluid in lungs...lungs feel heavy. Must stop a... Read more
Shortness of breath when exercising or active. Slight fluid in lungs...lungs feel heavy. Must stop and catch breath, cough and rest. Has happened 7-10 times since vaccine. No fever. Some fatigue
49 2021-04-03 numbness, tingling Tingling and partial numbness on the left side of my face; from my left cheekbone down to just under... Read more
Tingling and partial numbness on the left side of my face; from my left cheekbone down to just under my chin.
49 2021-04-03 nerve pain adverse event: shingles; symptoms include itch, nerve pain, muscle pain, rash/sores; onset at 3 days... Read more
adverse event: shingles; symptoms include itch, nerve pain, muscle pain, rash/sores; onset at 3 days following covid vaccination treatment: Valacyclovir hcl 1 gram tablets (3 daily for 7 days); ibuprofen as needed; administered at 1 week following covid vaccination outcome: ongoing recovery
49 2021-04-04 tenderness Swelling and mild tenderness of lower left axilla; possible lymph node; developed the day after the ... Read more
Swelling and mild tenderness of lower left axilla; possible lymph node; developed the day after the vaccine which patient states was "injected roughly". Pt describes swelling into left chest; was seen in the ER on 4/3-4/3/21, and seen via video visit with me on 4/5/21.
49 2021-04-05 numbness, tingling patient started day after vaccine with rt hand numbness and tingling and left hand trigger finger.
49 2021-04-06 feeling hot Minutes after vaccination patient began feeling hot, was diaphoretic, hypotensive, and was placed in... Read more
Minutes after vaccination patient began feeling hot, was diaphoretic, hypotensive, and was placed in trendelburg position
49 2021-04-06 flushing Flushing/sweating, dizziness, chills. Initial BP 151/80 (pulse 80). Glucose 285. F/u BP 112/74 (puls... Read more
Flushing/sweating, dizziness, chills. Initial BP 151/80 (pulse 80). Glucose 285. F/u BP 112/74 (pulse 72). O2 sats 93% and 95%.
49 2021-04-06 nerve injury, facial paralysis, numbness Numbness on side of face and cheek/numbness went from his cheek up on to the temple area and jaw are... Read more
Numbness on side of face and cheek/numbness went from his cheek up on to the temple area and jaw area; Mouth pulls weird; Previous nerve damage in his neck that hadn't been acting up in about a year but it was acting up now; Previous nerve damage in his neck that hadn't been acting up in about a year but it was acting up now; Felt loopy; Some weird palsy going on in his face/mild palsy in the left side of the face/Felt like face was heavy on left side or drooping/left side of his face was sagging; This is a spontaneous report from a contactable consumer reporting for himself. A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6203), via an unspecified route of administration on 23Mar2021 14:40 at single dose for COVID-19 immunization. Medical history included he had some previous nerve damage in his neck that had not been acting up in about a year. Concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 (Lot Number: EL9269) on 02Mar2021 for COVID-19 immunization. On 24Mar2021, patient had some facial numbness and mild palsy in the left side of the face. He stated he had some previous nerve damage in his neck that had not been acting up in about a year, but it was acting up then. He stated it was the feeling like when you go to sleep on something, and it felt heavier. He asked what he should do, if he should seek medical attention and for information on this. After providing information from the Prescribing information, he asked if the Bell's Palsy went away in these individuals in the clinical trials? He stated his wife just said that the left side of his face was sagging. He stated he did not think it was a stroke though because he could move that side of his face and can articulate everything. He felt loopy but did not feel like it was a stroke. Patient reported that basically he felt numbness on the side of his face and cheek. There were reactions when he smiled, it seemed a little bit off. There was a weird feeling and numbness in his face. The numbness went from his cheek up on to the temple area and jaw area, the numbness was primarily on the left side of his face. Patient had nerve damage in his neck already. Patient wanted to know if he should go somewhere with it, was it ok, what was going on with the numbness in his face. Patient thought the numbness in his face and cheek had worsened. Felt like face was heavy on that side or drooping: Caller reported that looking in mirror, the left side of his face did not react the same. Patient's face felt like it was heavy or drooping on the left side, but that it pulls up higher. Patient reported that his face looked ok. Mouth pulls weird: Patient reported that this could be from his prior nerve damage, it was like he had got some weird palsy going on in his face. Patient stated that he just wanted someone to tell him dude wait it out, go to the emergency room, go to the doctor. Patient inquired if the facial numbness was because he had prior nerve condition and if the Covid-19 vaccine had exacerbated his existing nerve condition. The outcome of the events were unknown.
49 2021-04-06 pain in extremity Very sore arm. Unable to move
49 2021-04-07 seizure He got the vaccine, 15 minutes later he got very fatigued, could not walk in his house and could bar... Read more
He got the vaccine, 15 minutes later he got very fatigued, could not walk in his house and could barely make it to the bed and had to lie down. He had headache, nausea, disoriented. Then he went to bed, woke up at 9:00 AM and had a seizure, which he has had in the past but it had been over a year. He rested after the seizure and knew what to do and it took 2-3 days to recover from that due to the weakness in the legs, disoriented. He has gotten stronger and is pretty much back to his normal self. He has not had any additional seizures since then. He had his FU physical today and she is aware of the seizure and told them to report the incident.
49 2021-04-08 burning sensation Rash all over my body that looks like chicken pox, which started in my hair. I have a bad patch betw... Read more
Rash all over my body that looks like chicken pox, which started in my hair. I have a bad patch between my breasts. It itches horribly. Severely tired. My body, especially my ears and face, have this feeling of being on fire occasionally. Stomach upset with diarrhea that hits suddenly. Horrible headache. Skin is extremely itchy and dry. I cannot think. Memory loss.
49 2021-04-08 unresponsive to stimuli I went with my wife, whom we were more concerned about possible reactions to the vaccine given her h... Read more
I went with my wife, whom we were more concerned about possible reactions to the vaccine given her history of anaphylaxis reactions to bee and wasp stings, has had to carry a Epi-pen always, so we stayed an additional 15 minutes for 30 minutes total before we left. She was completely fine throughout, I however as we were walking out I began to feel a little ?Off?, not necessarily nauseous or dizzy, just a bit Off. Told my wife that and that I wasn?t sure I should drive us home (I drove us there), so she drove. About 15-20 minutes into the drive, it got worse and I passed out. My wife says my eyes rolled in the back of my head with my eyes open but no responsive. She says she kept hitting my chest but I didn?t respond. I came to about 2 minutes after passing out. She asked me if I felt like I needed to goto the hospital, I told her I needed to eat, that I felt like what I needed was food, then we go from there. I did eat breakfast, an English muffin at about 8am that morning, it was almost 12:30 by that point. When I finally got food in me I felt much better and have had no adverse reactions since.
49 2021-04-09 flushing 3/30/21 at 1:30 am until 4/1/21 approximately noon: 103 F fever, chills, joint aches, extreme fatigu... Read more
3/30/21 at 1:30 am until 4/1/21 approximately noon: 103 F fever, chills, joint aches, extreme fatigue, loss of appetite, difficulty sleeping, headache, brain fog. 4/1/21 until present: tachycardia / racing heart rate as high as 125 bpm, feeling flushed as though I have sunburn but without any sun exposure, forgetfulness / trouble focusing / brain fog , Insomnia and frequent awakenings from sleep, feeling dehydrated and head achy or thirsty frequently, more frequent than normal urination, urine clear or pale yellow.
49 2021-04-10 feeling of body temperature change Had extreme soarness throughout entire body. Bad headache Chills Hot and cold episodes
49 2021-04-10 numbness I noticed numbness and blood withdrawal from my left toes when exposed to cold weather a few days af... Read more
I noticed numbness and blood withdrawal from my left toes when exposed to cold weather a few days after receiving the first shot. It started with my big left toe and has now spread to four other toes on my Left foot. Right foot is perfectly normal. I've never had raynauds like symptoms after living in alaska for almost 20 years.
49 2021-04-11 weakness Chills and body ache for 18 hours since symptoms started. Low energy and fatigue since the day aft... Read more
Chills and body ache for 18 hours since symptoms started. Low energy and fatigue since the day after the second dose of vaccine. Dizziness, stomach ache 10 days after the vaccine. A mont later after the vaccine (3/30) I had headache, body ache and chills for 6 days. COVID test was negative Palpitations started on 4/4. Dizziness, chills, dry eyes, weakness and fatigue until today.
49 2021-04-11 cold sweat Both the following are being experienced 1) Vertigo (sensation of movement, whirling or feeling off... Read more
Both the following are being experienced 1) Vertigo (sensation of movement, whirling or feeling off-balance) 2) Disequilibrium (feeling of unsteadiness or impending fall). They are worse in the early morning and brought on my rapid head movement while in bed. Symptoms remain throughout the day and are triggered by rapid movement (standing quickly). Severe enough that upon onset I am unable to stand and must come to the ground to seek stability. Also experiencing mild cold sweats during these attacks. Minor injection site pain was experienced but subsided after 48 hours.
49 2021-04-11 pain in extremity Sore arm, lasted 2 days. Swollen lymph node in collar bone area on right side. Still ongoing. Bac... Read more
Sore arm, lasted 2 days. Swollen lymph node in collar bone area on right side. Still ongoing. Back and joint pain lasted 36 hours. Mild chills lasted 48 hours.
49 2021-04-11 unresponsive to stimuli I counselled the patient prior to giving him the Pfizer Covid19 vaccine. He received the vaccine at... Read more
I counselled the patient prior to giving him the Pfizer Covid19 vaccine. He received the vaccine at 10:10am. During the 15 minute observation period, one of my technicians was standing next to him talking to another patient. She saw some papers slip out of patient's hand and noticed he was unresponsive when she tried to talk to him. She yelled out for help and I ran out and saw his head rolled back, eyes open, and he sounded like he was snoring. He never left the chair--just his head rolled back. We tried to rouse him awake and I had my other technician call 911. I also called for a store manager. The patient came to about 15-30 seconds later. I asked him his name, what day it was, and if he knew where he was. He answered all questions correctly. He told me that he's fainted before after vaccines, however he never disclosed this to me prior to the vaccine and had answered "no" under the question if you've ever had a serious reaction to the vaccine. We gave him some water and a cold paper towel. The paramedics came and evaluated him. He declined to go to the hospital and his wife came and picked him up.
49 2021-04-12 mild one side paralysis Had subarachnoid hemorrhage 1 hour after getting shot. Ended up in hospital for 13 days. Had drain ... Read more
Had subarachnoid hemorrhage 1 hour after getting shot. Ended up in hospital for 13 days. Had drain placed in head and multiple CT scans and MRI exams while there. Discharged with home PT and neurologist follow ups. Experiencing left side weakness and head fogginess still.
49 2021-04-13 tingling tingling in lower L arm Treatment: vitals, monitored Received 2ND dose 1/26/21 - No adveRse reaction
49 2021-04-14 weakness Severe lower back pain at site of herniated disk, fever, diarrhea, weakness.
49 2021-04-14 feeling hot Started experiencing some dizziness on March 8th that lasted for approximately 3 weeks. Did get the ... Read more
Started experiencing some dizziness on March 8th that lasted for approximately 3 weeks. Did get the second dose of the Pfizer vaccine and a week later felt a sort of hot feeling in my head similar to that ballon sensation when first coming down with the flu but nowhere near as intense. The dizziness was worst on March 10th then slowly resolved itself over the next few weeks. It was mild to moderate in intensity, I could feel a continuation of movement after turning my head sideways, it felt like the head was still going. Strange. I was still able to go to work but the effect was noticable. The only variables in my life recently were beginning Humira on Feb 2nd 2021 and getting the series of Pfizer Covid vaccines on Feb 19 and March 12. I did notify my gasteroenterologist because at first I assumed it was the Humira. He said that is not a side effect. On further research I have seen a lot of people reporting vertigo several weeks out after the Covid shots as if the antibody formation produces and inflammatory response in the ear in some patients. Unknown the symptoms are related to the shot or not. I had one outbreak of Meniere's Disease in 2006 and has not recurred. Perhaps the vaccine can cause a recurrance?
49 2021-04-14 unresponsive to stimuli, muscle spasms Patient was in observation for 15 minutes, before releasing patient nurse noticed that patient looke... Read more
Patient was in observation for 15 minutes, before releasing patient nurse noticed that patient looked as if they were going to pass out. Nurse pulled patient aside and shortly after patient's eyes began to roll back and started to have muscle spasms an became unresponsive. Nurse layed patient back and gave sternal rub in attempt to awaken the patient. Patient remained unresponsive and nurse administered epi pen 0.3mg to left thigh. Patient awoken after 3 minutes and became alert. EMS arrived and transported patient to emergency room.
49 2021-04-15 numbness Jaw locking up, numbness across face from mouth back to ears, severe pain in posterior neck radiatio... Read more
Jaw locking up, numbness across face from mouth back to ears, severe pain in posterior neck radiation to jaw, feels like jaw is in a vise.
49 2021-04-15 muscle spasms stomach ache and diarrhea about 7-9 hours after shot that lasted about 24 hours leg cramps about 18 ... Read more
stomach ache and diarrhea about 7-9 hours after shot that lasted about 24 hours leg cramps about 18 hours after shot while sleeping (only an issue the first night) general malaise for 72 hours after shot massive headache that started 48 hours after shot and lasted ~24 hours before turning into a milder but continuous headache for about 4 days. Around the time the headache turned milder I developed a case of tinnitus which has still not gone away. Tinnitus is ever present in both ears
49 2021-04-17 night sweats, tremor Shaking, chills, and night sweats.
49 2021-04-17 tingling Metallic taste hour about an hour after shot that lasted about an hour. Severe headache that lasted... Read more
Metallic taste hour about an hour after shot that lasted about an hour. Severe headache that lasted about 4 days, mild headache another 3 days Most concerning was a super sensitive, tingly lower back. A ?rash? developed Monday (4/12). I went urgent care on 4/17 and was diagnosed with shingles.
49 2021-04-18 bell's palsy Bell's Palsy on Right side of face
49 2021-04-18 hot flush, weakness The evening of the shot my body basically turned on itself and began an all out mission to rid the v... Read more
The evening of the shot my body basically turned on itself and began an all out mission to rid the vaccine. Of course, that couldn't happen, but my body was going to proceed until I was dead or recovering. I began having severe chills, roasting heat flashes, headache, and body ache. Every sweat gland turned on full blast and did not turn off. I began to vomit in outrageous fashion. As violent as I've ever experienced. I had "sessions" of vomiting at least thirty times from Thurs night to Monday afternoon. When I could get out of the bathroom, I would collapse back into my sweat soaked bed. I would have an awful time trying to catch my breath. It would be up to ten minutes of hyperventilating and racing pulse, until it would suddenly normalize. And then I'd be utterly exhausted and slip into some kind of semi-sleep coma. This would not last even an hour before I'd be racing to the bathroom again. This was the first sixty hours. Vomit. Hyperventilate. Wish for death. Sleep coma. Repeat. About 24 hrs in I added severe diarrhea that was a part of every bathroom journey from then on. Ate nothing. Couldn't take normal meds. Sipped some pedialite. Late Sunday I turned a corner and felt like I wouldn't die. Took a full seven days for me to get any energy back and feel human again.- Every single symptom besides headache, was the worst I've ever experienced.
49 2021-04-20 weakness Extended period of lethargy after second injection, from day 7 (post injection) to at least day 18. ... Read more
Extended period of lethargy after second injection, from day 7 (post injection) to at least day 18. Afternoon and evenings are mentally cloudy, low energy, and sleepy, requiring afternoon naps, and loss of work every day. Symptoms were worst at about day 10 to day 14, post second injection, and gradually reducing in severity through day 18 (though still existing at this time of reporting).
49 2021-04-20 pain in extremity Starting night of 2nd vaccine, started having low grade fever, fatigue, arm pain. Continued for an a... Read more
Starting night of 2nd vaccine, started having low grade fever, fatigue, arm pain. Continued for an additional day. Started experiencing lupus flare symptoms 3 weeks after 2nd vaccine - rash, hair loss (alopecia), joint pain/swelling, low grade fever, worsening kidney function (elevated proteinuria). Continued to have symptoms for 2 months - led to change in medications with rheumatologist.
49 2021-04-22 pain in extremity Severe pain in foot 1 day after injection. Pain increased about 4 hours after running. Doctor repo... Read more
Severe pain in foot 1 day after injection. Pain increased about 4 hours after running. Doctor reported bursitis in the left foot heel.
49 2021-04-22 unresponsive to stimuli, seizure Two 10 second convulsions followed by paleness and sweating. Patient was anxious prior to shot and w... Read more
Two 10 second convulsions followed by paleness and sweating. Patient was anxious prior to shot and was not responsive during convulsions. Wife stated that he "always has this reaction". Nurse Practioner that administered the vaccine stated that it was congruent with classic vasovagal symptoms after immunization. EMS arrived but patient did not want to go with them.
49 2021-04-24 numbness and pain in extremities Existing light neuropathy in feet and hands increased about 4-5 days after first dose. Feet more pro... Read more
Existing light neuropathy in feet and hands increased about 4-5 days after first dose. Feet more pronounced than hands. Seems to be progressing vs receding. Have not had second dose yet. The neuropathy is not extremely painful or debilitating but is probably 25-50% more pronounced in my feet post vaccine and doesn't seem to be subsiding may be getting worse, but hard to tell. Definitely some sort of reaction.
49 2021-04-24 pain in extremity continued arm pain after 12 days. goes from my shoulder down to my forearm.; The is a spontaneous r... Read more
continued arm pain after 12 days. goes from my shoulder down to my forearm.; The is a spontaneous report from contactable consumer. A consumer (patient) reported for self that the 49-year-old male patient received first dose of bnt162b2 (BNT162B2, COVID19, Pfizer), via an unspecified route of administration on 24Mar2021 16:00 at single dose for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced "continued arm pain after 12 days. goes from my shoulder down to my forearm" on 25Mar2021 with outcome of not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. Reporter wanted to discuss a possible side effect that he is experiencing after he received the firs dose of the vaccine. He did not elaborate further. No Follow-up attempts are needed. No further information is expected.
49 2021-04-25 tremor, hot flush The night of the second vaccine, I experienced severe chills, sweating and uncontrollable shivering/... Read more
The night of the second vaccine, I experienced severe chills, sweating and uncontrollable shivering/shaking. The next day I began experiencing headaches, body aches, nausea and continued hot flashes and waves of fever. This has now persisted for over 48 hours.
49 2021-04-27 tremor Flared- Autoimmune Disorder; Flared- Autoimmune Disorder; Extreme Fatigue; Fever; Headache; Body Ach... Read more
Flared- Autoimmune Disorder; Flared- Autoimmune Disorder; Extreme Fatigue; Fever; Headache; Body Aches; Muscle Tremors; Rash on Tongue and Lips; Rash on Tongue and Lips; This is a spontaneous report from a contactable consumer. This 49-year-old male consumer (patient) reported for himself that he received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported) via an unspecified route of administration in right arm on 01Apr2021 12:00PM (at the age of 49-year-old) at single dose for COVID-19 immunisation. Relevant medical history included known allergies to mushrooms, latex and adhesive; mystenias Gravis (preliminary diagnosis) and autoimmune disorder (still in research). The patient had not COVID prior to vaccination. Concomitant medications were not reported. On 01Apr2021 12:00PM the patient experienced extreme fatigue, fever, headache, body aches, muscle tremors, rash on tongue and lips flared- autoimmune disorder (diagnosis still pending research - as reported) symptoms lasted for more than 4 days. The patient was tested for COVID post vaccination - no results reported. The events were resolving at the time of report. Information on the lot/batch number has been requested.
49 2021-04-28 discomfort Increased resting heart rate. Noticed that my heart started to pump harder, first during an afterno... Read more
Increased resting heart rate. Noticed that my heart started to pump harder, first during an afternoon while sitting, no stress or agitation. The next morning, I woke up in the middle of the night due to some discomfort. I was at 100 BPm (normally at 60).
49 2021-04-28 slurring, facial paralysis 4/23/21- Experienced lip numbness 4/24/21- current - Eyes, cheek, mouth droopy and slurred speech.
49 2021-04-28 feeling hot, flushing Flushing - feeling of warmth, anxiety. Received water. BP 144/61 (pulse 89), 160/78 (pulse 82).
49 2021-04-28 night sweats, tingling Chills, night sweats, fever, arm tingling, muscle aches
49 2021-04-28 pain in extremity Arm/Shoulder are extremely sore. Mainly at night or when arm is at rest for period of time. Been... Read more
Arm/Shoulder are extremely sore. Mainly at night or when arm is at rest for period of time. Been going on for a week and its not getting better.
49 2021-04-28 tingling, pain in extremity Muscle aches, intense arm pain, left arm tingle
49 2021-04-28 tingling Hypertension spike since 1st dose of vaccine (averaging 150/100) since getting vaccine. Lightheaded... Read more
Hypertension spike since 1st dose of vaccine (averaging 150/100) since getting vaccine. Lightheaded, shortness of breath. No history of Hypertension (though always on the borderline (averaging 120/80).
49 2021-04-29 bell's palsy 3 days of intractable headache beginning 4/11. Right sided facial symptoms beginning 4/14 - diagnosi... Read more
3 days of intractable headache beginning 4/11. Right sided facial symptoms beginning 4/14 - diagnosis of Bell?s palsy. Later diagnosis of cluster headaches. Treatment: prescribed 7 days of Prednisone (60mg) and Valtrex. Currently acupuncture 2x weekly, oral B12 (2500mcg), TCM herbal supplements. Prescribed Sumatriptan for h/a but not used as they have subsided. Headaches currently subsided to jaw only. 15 days after diagnosis, Bell?s palsy symptoms show very minor improvement (R eyelid more functional now).
49 2021-04-29 cold sweat, unresponsive to stimuli Client received COVID vaccine @ 3:45pm. Client in observation area, reported having "cold sweats" t... Read more
Client received COVID vaccine @ 3:45pm. Client in observation area, reported having "cold sweats" to EMT staff @ 3:55pm. EMT staff provided client with water, attempted to assist client to zero-gravity chair. Client became unresponsive @3:58pm. Client became responsive @4:01pm, transferred over to cot with assistance, with legs raised. Client able to speak, denies shortness of breath, reports "anxiety with injections and anything going in to my body". Vital signs @ 4:06pm, BP 102/58, P 87, RR 12, O2 sat 97%. Client continued with observation, provided with water. Vital signs @ 4:14, BP 104/60, Pulse 82, RR 12. Client reports he feels much beter, able to sit up in chair. Client advised to follow up with primary care, client reports he will call parents for ride home. Client left observation area @ 4:30pm, walking with steady gait.
49 2021-04-29 feeling hot 1st shot: No adverse reactions after the shot. 2nd shot: 3 minutes after the second shot, felt warm ... Read more
1st shot: No adverse reactions after the shot. 2nd shot: 3 minutes after the second shot, felt warm wave in my body and became dizzy. Did not have additional side effects and left in 20 minutes. During driving back and 1 hr after the vaccination became even more dizzier and fatigued, with walking balance issues. Second day dizziness disappeared, but I had a pain in the area of the shot, headache, body aches, and fatigue, balance issues. 3rd day started recovering. 3-8 day side effects gradually disappeared but started having panic attacks and generalized anxiety which I suffered years ago.
49 2021-04-29 tingling, numbness Experienced tingling, numbness and weakness in my left arm shortly after receiving injection. The nu... Read more
Experienced tingling, numbness and weakness in my left arm shortly after receiving injection. The numbness was throughout my entire arm but was especially pronounced along the outside down to the pinky finger. Within about 2hours the numbness also affected my left leg along the outside of the leg to the pinky toe and all around the lower thigh. Symptoms still present 8 hours after injection at time of writing this description.
49 2021-05-02 coordination abnormal I'm being diagnosed with Parsonage Turner Syndrome and have been in severe pain for over a week. I'v... Read more
I'm being diagnosed with Parsonage Turner Syndrome and have been in severe pain for over a week. I've also lost control of 3 fingers on my left hand making it difficult to perform normal tasks.
49 2021-05-05 muscle spasms, pain in extremity, cold sweat, cold extremities, weakness Cramps on leg, cold sweats on hand and feet, heart beat faster than usual and dizzy when that happe... Read more
Cramps on leg, cold sweats on hand and feet, heart beat faster than usual and dizzy when that happens, discomfort in the stomach, symptoms of insomnia, weakness in the whole body, pain in the thighs, knees, and calves
49 2021-05-05 muscle spasms 4:40pm: Patient complained of arms cramping, back of head pounding, coughing blood, tachycardia; 1... Read more
4:40pm: Patient complained of arms cramping, back of head pounding, coughing blood, tachycardia; 16:48pm EMS called. 17:08 EMS Arrived; Vitals: 16:50pm 148/90 101 18 O2 100%; 1700pm 144/100 100 20 O2 100%; 1730pm EMS departed to hospital. Pt. status when transported to hospital: Stable, no longer vomiting.
49 2021-05-05 muscle spasms Systemic inflammation. Deep in my hip, the iliacus muscle is completely inflamed and spasmed after ... Read more
Systemic inflammation. Deep in my hip, the iliacus muscle is completely inflamed and spasmed after the second shot. This also affects my psoas to a lesser degree and 2 adductor muscles to a greater degree - the brevis and pectineus. I have not been able to sit down for more than 10 minutes since the shot, if I do my leg and hip go into spasm, lock up, I can't move and literally will fall out of a chair.
49 2021-05-06 pain in extremity 36 hours after vaccination, I woke up at 3am with ringing in both ears for the first time in my life... Read more
36 hours after vaccination, I woke up at 3am with ringing in both ears for the first time in my life. I've seen two ENTs and a chiropractor. My hearing test was normal and showed no loss of hearing. The ENT said the pressure test was normal. I have had periods of ear pressure, clogging and the feeling of water in the ears. Over the past 10 weeks, those specific symptoms have diminished and only now happen a few times a week, but the ringing in the ears persists. It is constant. I have gotten more used to it, and there are times when it's louder and times when it's less loud, but I cannot say that it is "disappearing". The ringing is definitively not resolved. I have tried prescription nasal spray and allegra, which possibly help. In addition, 13 days after vaccination, I started experience chest tightness, sternum pain, aches and pains throughout my upper body: both arms, back. The tightness in the chest is exacerbated by exercise. Those symptoms have diminished over time but have not resolved. I have not gone back to exercise. Chest xray was negative and stress test was normal. Transthoracic Echo showed some abnormalities. Blood pressure became elevated post vaccination and remains elevated.
49 2021-05-07 numbness, tingling Numbness and pins & needles tingling in left arm.
49 2021-05-09 unresponsive to stimuli He felt very bad the night he received the 2nd shot of Pfizer covid-19 vaccine on April 27. He even ... Read more
He felt very bad the night he received the 2nd shot of Pfizer covid-19 vaccine on April 27. He even joked he probably would die that night. He also complained that despite his protest, the person who administered the shot insisted to inject on his shoulder joint. He developed a bigger-than-quarter-size bruise on his right inner arm the next day. He was feeling tired the following days. On May 4 around 3:30, I heard he was making loud noises. I came to his side immediately. At the time I thought he was making louder than usual snores. I nudged him gently but he didn't respond. After about 15 seconds, the sound stopped, and he had no breath. I then called 911 within 10 seconds, tried to do CPR on him. It took EMS 6 minutes to arrive even though we live very close to a fire station in a well-accessed urban area. EMS worked on him for about 30 minutes before transported him to hospital. They continued to work on him for a while. He never regained breath.
49 2021-05-10 numbness, tingling Pt has experienced a numb and tingling sensation to his left index finger and part of his thumb exte... Read more
Pt has experienced a numb and tingling sensation to his left index finger and part of his thumb extending up into his forearm. This started a couple days after his second covid-19 vaccine and has not resolved.
49 2021-05-11 sensory loss, numbness and pain in extremities, pain in extremity have some clots; Neuropathy; autoimmune disorder; Fell and hit elbow and 3 ribs on left side; lost 6... Read more
have some clots; Neuropathy; autoimmune disorder; Fell and hit elbow and 3 ribs on left side; lost 6 (lbs) pounds/Within 2 months, he has lost 47 lbs and eats all the time and is still losing weight; falling; felt super strong; dizziness; failed all the tests for motor skills for his arms and legs; Fell and hit elbow and 3 ribs on left side; Fell and hit head; Sensory nerves are all gone; Fatigue; scabs; delusional; tore tendons in between ribs; They are tender(ribs); hurting all over; Cannot walk or lift anything; chest pain; his arm was sore a little; Left arm injection site pain; Disoriented; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in left arm on 03Feb2021 (batch/lot number and expiration date not reported) at the age of 49 years old, as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included COVID-19 from Dec2020 to an unknown date, vascular disease, bilateral stents placement, cataracts since he was born. Concomitant medication included gabapentin taken for an unspecified indication from an unspecified start date and ongoing. On 04Feb2021, the patient experienced left arm injection site pain. The patient experienced dizziness, falling, and couldn't go to work on unspecified date. He was treated by his (MD) physician, was given a CT scan, echocardiogram, and found to have some clots. He stated he has a history of vascular disease and had bilateral stents placed a year ago. He was placed back on an aspirin/Plavix regimen and referred to a neurologist because he has no motor skills anymore. He stated he failed all the tests for motor skills for his arms and legs. He was advised not to take the second dose of the vaccine and was diagnosed with neuropathy and autoimmune disorder (caller does not specify which disorder). He reported being positive for Covid-19 in Dec2020. He wanted to know what else he can do for his symptoms and is offering to be tested by Pfizer for treatment. The symptoms come in really hard seven days later. He actually had to go to the (ER) emergency and they worked on him and a whole string of doctors. He went to the emergency room and something was going on and wanted him to go to a family practitioner. They sent him to vascular, neurological and now they want to send him to a research center. It was a whole week after receiving vaccine before he began having symptoms. With the neuropathy and autoimmune, he cannot work like he did. He can hardly walk. Unspecified autoimmune was diagnosed last week. He can't remember the name of it. They told him not to take second one because the first one did what it did to him. It hurt a little and it was quick. The next day (04Feb2021), he said his arm was sore a little. He is only taking 4 medications and they looked it up. He did not think they were relevant. He was disoriented and fell and hit his head a couple of times. They ran an MRI on his head trying to figure that part out. That was done last week. He doesn't know the date and said it may have been on Friday. Results were good. The date he was disoriented was Wednesday 03Feb2021, when he took the shot. He has been disoriented and has been that way ever since. They kept him for 15 minutes to make sure no one passed out. He has been disoriented since then. He could not think clearly, and he could not do his job. He tore tendons in between ribs. He first thought he actually broke his ribs, but did not. There were two different falls. He cannot feel feet or anything. His motor skills are OK but when they did neuropathy test, they put needles in and shocked him to make his motor fire. His reflexes were really bad. He fell and hit elbow to keep from falling on face and twisted going down hitting 3-4 ribs on left side. It has been over 3 weeks now for his ribs. They are tender but they are not like the initial blow. It feels like they are healing. He fell and hit head a week ago. He was unsure of the exact date. He did not go to the emergency room with this one because the bed caught him. He fell and hit his head. All he has left is scabs. He cannot walk or lift anything (11Feb2021). That next Wednesday, he got ready to go to work and was so delusional and could not go in. He slept from 5:30 all that day and all that night. Then Thursday, he gets up and goes to work and goes slower, just to see what happened on Wednesday. He had fatigue and was disoriented. He did not provide start date or outcome for fatigue. He walked in and said either call an ambulance or he would go home. He went home and that was the last day of work. He then stated he laid in the car for 30 minutes and he said he is going to the emergency room. He went straight there that day. He had stents put in lower part of his body a year before. The neuropathy and the autoimmune kicked in 7 days later after the shot. The reason he went to the ER is because he thought it was his stent. He had bilateral, 4 of them. He was having chest pain and hurting all over on 11Feb2021. He thought he was having a heart attack. He was seen in the emergency room and released. It depends on how far he goes, how the chest pain worsens. Right now, he is ok, but when he gets up and moves around, it does the same thing. Within 2 months, he has lost 47 lbs and eats all the time and is still losing weight. He was about 200 something and was kind of built and now is skin and bones. He lost 6 (lbs) pounds within a week and is eating like crazy. Sensory nerves are all gone. If hit with a baseball bat and he would not feel it. It came on slowly almost that he did not know it was happening. That is why they want to send him to Privacy for a research center and he does not want to go. He never had this happen before. ER or physician's office required: 1st date was on Thursday, 11Feb2021, when he went to Privacy. He was having chest pain and hurting all over. He thought he was having a heart attack. He was released. The patient stated he wanted to change the information he had provided since he was not in his right mind since he had taken the wrong medication dose than the doctor had given him. He stated the medication dosage he wanted to change was for Amiripyin. He stated he wanted to say he told the representative the symptoms he had experienced was enhanced which they were yesterday because he was trying to fight everything and stay awake. COVID 19 vaccine: he stated the doctor did not want him to take the second dose of the vaccine. He stated one of the symptoms he had experienced after the vaccine that he wanted to change the outcome for is the neuropathy. He stated he is back to where he used to be and yesterday it was bad he could hardly walk or talk. He stated also the other symptoms he wanted to change the outcome for is the autoimmune. The patient has not recovered from neuropathy, autoimmune disorder, disoriented, can't walk or lift anything, chest pain, and sensory nerves all gone; while outcome of the remaining events was unknown. Information on the lot/batch number has been requested.
49 2021-05-12 numbness Intense shoulder pain, reduced motion, numbness in fingers and arm, sharp pain when lying face down... Read more
Intense shoulder pain, reduced motion, numbness in fingers and arm, sharp pain when lying face down, tightness and knots in shoulder, back, and neck muscles.
49 2021-05-14 numbness, bell's palsy Bells Palsy; Facial numbness and drooping left side. Eye, cheek, lips.; This is a spontaneous report... Read more
Bells Palsy; Facial numbness and drooping left side. Eye, cheek, lips.; This is a spontaneous report from a contactable nurse. A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 11Jan2021 15:00 (Batch/Lot Number: EK4176) as 2nd dose, single for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Dec2020 15:30 in the left arm (lot number: EH9899). The patient did not receive any other vaccines within 4 weeks prior the COVID vaccine. The patient experienced Facial numbness and drooping left side. Eye, cheek, lips; had Bells Palsy on 30Apr2021 11:00 which resulted a visit in the emergency room or urgent care. Steroids and acyclovir were taken as treatment for the events. The patient was not diagnosed with COVID prior vaccination and has not been tested after vaccination. The outcome of the event was unknown. The event Bells Palsy was assessed as serious- medically significant.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported serious event cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. 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 the Authorities, Ethics Committees and Investigators, as appropriate.
49 2021-05-16 flushing Patient complained of Flushing/sweating, Nausea, and dizziness. BP 143/97, HR 76, RR 18 -- > 137/91... Read more
Patient complained of Flushing/sweating, Nausea, and dizziness. BP 143/97, HR 76, RR 18 -- > 137/91, 75, 18. Pt A&O x4, VSS, no Resp distress. Water/juice given. Pt states symptoms resolved and released from vaccination site.
49 2021-05-17 pain in extremity Patient had vaccine on the 12th. Leg pain three days later. Diagnosed with DVT six days later. No ri... Read more
Patient had vaccine on the 12th. Leg pain three days later. Diagnosed with DVT six days later. No risk factors for DVT. Unknown lot number for vaccine. Not done at my faciluty
49 2021-05-17 tingling I had a skin reaction that started on my torso It felt prickly and itchy over the past week has mo... Read more
I had a skin reaction that started on my torso It felt prickly and itchy over the past week has moved to include my extremities. I have taken Benadryl a couple of times because of the itching. I also have a constant tinnitus in my life ears. I have had tinnitus before but not for going on a week.
49 2021-05-18 cold sweat, pain in extremity, tingling Zero arm pain until around 8PM. Then came on and intensified for next two hours. Became very tired. ... Read more
Zero arm pain until around 8PM. Then came on and intensified for next two hours. Became very tired. Went to bed at 10PM. Woke up at 12;30AM with a 101 degree fever and intense pain in lower back/upper buttocks. Fever/pain persisted and worsened throughout the night. Aches spread to other areas of my body but still centralized to back/buttocks. Headache introduced in the AM. Fever bounced all day between 102 and 104.2 degrees all day until about 8:30PM on Sunday. Tried ibuprofen to manage pain and temperature but had minimal effect. General tingly and buzzy feel after 8:30PM and into Monday. Headeache reappeared on Monday evening with cold sweats. Strange calf ache in right leg Monday night into Tuesday AM that consistently woke me up. Tried massage, stretching, to no avail. Tuesday AM most everything dissipated with just a bit of fogginess throughout Tuesday (though less than Monday).
49 2021-05-19 pain in extremity Arm pain; aches; tiredness; This is a spontaneous report from a non-contactable consumer (patient). ... Read more
Arm pain; aches; tiredness; This is a spontaneous report from a non-contactable consumer (patient). A 49-year old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 17Feb2021 12:30 (Lot Number: EL3247) as single dose (at age of 49-year-old) for covid-19 immunisation. Medical history included asthma. Patient received first dose of bnt162b2 (BNT162B2) on 26Jan2021 at 12:00 PM in Left arm (at age of 49-year-old) for covid-19 immunisation, lot number: EL3247. Concomitant medications in two weeks included ubidecarenone (COQ10), ergocalciferol (VIT D), glucosamine (GLUCOSAMINE). Patient did not receive any other vaccine in four weeks. On 18Feb2021 patient experienced arm pain, aches, tiredness. Patient was able to perform work but at a reduced pace. No treatment was received for the events. Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. Patient had not recovered from the events, at the time of the report. No follow-up attempts are possible. No further information is expected.
49 2021-05-20 flushing, weakness Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotensi... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Weakness-Severe, Additional Details: Shortly after receiving his first shot the patient started to feel severely light headed while being observed. He was not able to walk over to the bench from his seat, so I had to help him from his seat onto the floor to lay down. After laying down and drinking water, he started to regain color to his face. After laying down for roughly 30 minutes he felt strong enough to stand up and walk to the bench where he then sat for an additional 20 minutes.
49 2021-05-20 flushing Pt c/o flushing/sweating and dizziness. BP 131/84, HR 71, RR 14. Pt stable and released from the v... Read more
Pt c/o flushing/sweating and dizziness. BP 131/84, HR 71, RR 14. Pt stable and released from the vaccination site.
49 2021-05-20 muscle twitching dizziness. Had syncope episode, was snoring and twitching. Very diaphoretic. Less than 1 minute rega... Read more
dizziness. Had syncope episode, was snoring and twitching. Very diaphoretic. Less than 1 minute regained consciousness. Patient was assisted to floor on his side. Patient able to answer questions.
49 2021-05-20 night sweats Patient readmitted on 5/19 who was just discharged on 5/15. Patient initially presented with fever, ... Read more
Patient readmitted on 5/19 who was just discharged on 5/15. Patient initially presented with fever, SOB, lymphadenopathy, diffuse maculopapular rash. He had his first dose of COVID vaccine (Pfizer) on 4/23, and his symptoms began on 4/29. He was itchy all over, but when he developed fever and SOB he came to the ER on 5/2 and was discharged on prednisone. His symptoms continued and so he came back to the ER and was admitted. He had a lymph node biopsy to rule out lymphoma (pathology returned negative for lymphoma). He was treated empirically with ceftriaxone and doxycycline. He tested + for EBV IGG but not IGM. EBV PCR was pending upon discharge. He had a borderline positive lyme serology. He was discharged on doxycycline and steroids with improved symptoms. He returned to the ER with again worsening SOB, night sweats, worsening rash, recurrence of fever. He denies sore throat or any sick contacts. He reports a normal appetite. He was found to be hypotensive and in AKI.
49 2021-05-23 feeling hot Patient received dose 2 of the Pfizer COVID vaccine (lot EW0179, exp 8/2021) at 1300. At 1318, patie... Read more
Patient received dose 2 of the Pfizer COVID vaccine (lot EW0179, exp 8/2021) at 1300. At 1318, patient was sitting in the observation area when he informed EMT that he felt dizzy, warm, and had blurry vision. EMT informed PHN who came over to assess. At 1320, vital signs: blood pressure 130/86, O2 97%, pulse 93, respirations 18. Patient reported blurry vision had resolved. EMT r offered to have patient lay down in the zero-gravity recliner but patient declined. Patient denied allergies, medical conditions, or taking medication. Patient reported eating breakfast and that he experienced no adverse reaction to dose 1. PHN encouraged patient to follow up with provider and when to contact 911. PHN offered Benadryl but patient declined. At 1326, vital signs: blood pressure 124/82, pulse 97, O2 98%, respirations 18. Patient reported all symptoms had resolved. Patient stood up, reporting no dizziness or remaining symptoms. PHN encouraged patient to wait for 30min since onset of symptoms, patient stated he was leaving. Patient left AMA, walking with steady gait at 1330.
49 2021-05-25 weakness Dizziness and weakness, injection site pain, tiredness, headache, muscle pain, chills, fever, nausea... Read more
Dizziness and weakness, injection site pain, tiredness, headache, muscle pain, chills, fever, nausea, diarrhea
49 2021-05-25 bell's palsy I developed Bell's Palsy
49 2021-05-25 muscle twitching, tingling had twitching and tingling sensations all over his body, mostly in his legs, thighs, calves, ankles,... Read more
had twitching and tingling sensations all over his body, mostly in his legs, thighs, calves, ankles, and occasionally in his lower and upper arm as well as his fingers; big finger twitch/had twitching and tingling sensations all over patient body, mostly in his legs, thighs, calves, ankles, and occasionally in his lower and upper arm as well as his fingers; This is a spontaneous report from a non-contactable consumer (patients wife) via medical information team. A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date were not reported) via unspecified route of administration on 23Mar2021 (at the age of 49-year-old) as 2nd dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reportedly, patient received historical vaccine first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date were not reported) via unspecified route of administration on 02Mar2021 as 1st dose, single for COVID-19 immunization. Reportedly, on an unspecified date in Mar2021 (48 hours after the second dose) patient experienced very big finger twitch. On an unknown date (Within last 2 or 3 days) patient had twitching and tingling sensations all over patient body, mostly in his legs, thighs, calves, ankles, and occasionally in his lower and upper arm as well as his fingers. Reporter wanted to know if it was related to the vaccine. Reporter stated that while they were researching about it, they saw that bells palsy has also been reported with the use of the vaccine. Reporter also said that there were some people who had the same reaction as patient after receiving the vaccine. Reporter mentioned that patient was from (place name withheld), and they said that they heard about an existence of a Bells Palsy-like symptoms there. With that, reporter wanted to know if there was any information about neurological side effects or something similar to Bells Palsy that may be associated with the vaccine. Reporter also wanted to know what they should tell the doctor once they meet up with him or if there was any additional information from Pfizer that she could tell their doctor to help rule out what patient had. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
49 2021-05-27 pain in extremity I have a broken shoulder and my humerus bone broke; I have a broken shoulder and my humerus bone bro... Read more
I have a broken shoulder and my humerus bone broke; I have a broken shoulder and my humerus bone broke; May be just felt a little bit of a sore arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 49-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported) via an unknown route of administration on 05May2021 as 2 nd dose, single for Covid-19 immunization. The patient received co suspect Ibuprofen (IBUPROFEN) 800 mg in the morning (Batch/Lot number: not reported), Paracetamol (TYLENOL) 1000 mg (around 12 took Tylenol 1000 mg) (Batch/Lot number was not reported) via an unknown route of administration on an unknown date for an unknown indication. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 on an unknown date as SINGLE for Covid-19 immunization and experienced no adverse event. On an unknown date, the patient experienced to have a broken shoulder and humerus bone broke and may be just felt a little bit of a sore arm. It was reported that patient had been hearing multiple news conferences about aspirin and ibuprofen when receive Pfizer vaccinations as it lowers the dose of vaccination. It was reported that patient was informed not to take Ibuprofen and Tylenol whatsoever and patient had been taking it all long like Ibuprofen 800 mg in the morning and then Tylenol 1000 mg around 12 and patient did not felt the first vaccine even the second vaccine patient did not feel nothing. May be just felt a little bit of a sore arm other than that nothing and patient do not feel protected. The outcome of the events was unknown. No follow-up attempts were possible; information about lot/batch number cannot be obtained.
49 2021-05-28 pain in extremity Upon waking up the morning following the injection, a ~2 inch diameter erythema was present on the p... Read more
Upon waking up the morning following the injection, a ~2 inch diameter erythema was present on the patient's upper arm at the injection site. In the center was a ~1 inch raised bump, painful and hot to the touch. Later in the day, corresponding to ~24 hours post injection, the patient developed 101 degree fever, an unusually strong headache, chills and myalgias. The symptoms peaked ~28 hours post injection. The patient took 1,000 mg of acetominophen which didn't appear to have an impact. Before going to bed that day, the patient took a full dose of Nyquil liquid. The fever, headache, myalgias and chills resolved overnight. The arm was painful and the myalgia/bump persisted for 4 additional days.
49 2021-05-31 numbness, sensory loss Patient reports to the pharmacy 3 days after receiving the 2nd dose of his Pfizer vaccine, complaini... Read more
Patient reports to the pharmacy 3 days after receiving the 2nd dose of his Pfizer vaccine, complaining of complete numbness and loss of sensation in both hands along with swelling of right hand. Vaccine was received on the afternoon of 5/29 and patient reports a loss of sensation in both hands beginning that evening. This has continued for 3 days up to today morning (06/01) where patient reports some improvement in degree of swelling of right hand and a return of some feeling in both hands.
49 2021-05-31 sciatica 4/21: Felt "explosion in head," lightheaded, poor focus, vision off, felt like concussion, fatigue, ... Read more
4/21: Felt "explosion in head," lightheaded, poor focus, vision off, felt like concussion, fatigue, "my computer short circuit", spinning, dizzy, anxiety, "eyes darting", racing thoughts at night while trying to sleep. 4/26: light sensitivity, new onset sciatica, hypersensitivity, inability to focus, spinning. 2nd phase: right posterior occipital pain (neuralgia). 3rd phase: moving eyes, felt crunching noise. Vertigo treated with vestibular therapy. Anxiety/insomnia treated with Xanax.
49 2021-06-01 bell's palsy I developed Bell's Palsy, paralysis on my left side of my face. This occur 3 weeks after I receive m... Read more
I developed Bell's Palsy, paralysis on my left side of my face. This occur 3 weeks after I receive my first dose of the Pfizer vaccine. I could not close my left eye, inability of smile, drooling, facial distoration, difficulties in eating.
49 2021-06-01 burning sensation Pharmacy reported to patient that he was given a full vial of the vaccine instead of one dose. They ... Read more
Pharmacy reported to patient that he was given a full vial of the vaccine instead of one dose. They indicated the error was not diluting it before giving him what they thought was one dose. He reported that it burned when he was injected with the vaccine.
49 2021-06-01 hot flush, tingling Headache; hurt right below my chest and in stomach; skin became extremely prickly; Low grade fever l... Read more
Headache; hurt right below my chest and in stomach; skin became extremely prickly; Low grade fever like 99; Dimer test showed kind of high levels with mainly blood clot; some fiber or Fibrogen which was for thickening of blood/ supposed to be between 400 and 420, his was 879; have COVID, it was positive COVID antigen test; have COVID, it was positive COVID antigen test; felt pressure in his back almost like pneumonia; Chills; sweat; Hot flashes; Stomach was cramping/ hurt right below my chest and in stomach; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on right shoulder single dose for COVID-19 immunization; second dose with lot number: EV10161 on 22Apr2021, first dose with lot number: EP7533 on 01Apr2021, at 49-year-old. Medical history and concomitant medication were not reported. The patient was non-smoker, non-drinker. The patient had a little headache with the second shot but 2 weeks later on 03May2021 started having chills every night and would sweat. He was having chills and hot flashes and stomach was cramping and when inhaled like taking a deep breath, felt pressure in his back almost like pneumonia like lungs were filling with fluid or clotting. On the 07May2021, he took a little flu medication Theraflu over the counter (treatment) thinking that'd clear it up. Every time he took a deep breath, it'd just hurt right below my chest and in stomach and skin became extremely prickly. He'd have like a low-grade fever like 99. This was 2 weeks after the second shot, so he went to the ER on 07May2021 and was given a COVID test, a fluid test and lab work trying and figure what he was having. One of his blood test - Dimer test showed kind of high levels with mainly blood clot so they gave him a CT scan, scan showed no blood clots, no kidneys stones or anything like that should had any sweating. ER doctor gave him an antibiotic (ciprofloxacin) for infection like diverticulitis or diverticulosis. The doctor said the patient did not have a stomach infection, his tests showing such high levels for clots so the doctor did more lab work a PRC, CRT, TRP or CPR, a CRT lab work and some fiber or Fibrogen which was for thickening of blood. Those numbers are supposed to be between 400 and 420, his was 879 today (17May2021). The patient did have COVID, it was positive COVID antigen test, I got those results today (17May2021). Outcome of the events was unknown.
49 2021-06-01 migraine Client (received the COVID vaccine (Pfizer dose 2, lot # EW0187, expiration 6/28/2021) at 1800. At 1... Read more
Client (received the COVID vaccine (Pfizer dose 2, lot # EW0187, expiration 6/28/2021) at 1800. At 1829, the client reported itching on his skin and in his throat. EMT, EMT #2, PHN, and RN responded at this time. The client was sitting comfortably in his chair, alert and oriented x4. The client's vital signs were as follows: heart rate 57, O2 97, respiratory rate 14, blood pressure 150/92. The client's skin was pink, warm, and dry. The client denied any shortness of breath or chest discomfort. The client was able to speak in full sentences and had no visible swelling on his face or tongue. The client declined Benadryl at this time. The client stated he has environmental allergies and has had an anaphylactic reaction to trees in the past. The client stated he has a medical history of anxiety, acid reflux, migraines, and hay fever; he takes antacids, sumatriptan, and allegra. The client stated that he took 1 allegra at 1816, but stated he didn't know the exact dosage and did not have the medication bottle with him. The client was able to speak in full sentences. At 1835, the client identified a small, red, erethematous area approximately 1 centimeter in length on the left medial area of his elbow, which he stated itched. He also stated his eyes were itching; neither eye or eyelid appeared red. The client stated his throat was dry and was offered and accepted water. The client declined Benadryl again at this time. The client was transferred to the zero gravity chair at this time, denied any dizziness during ambulation or transfer. At 1839 the client's vital signs were as follows: blood pressure 142/84, heart rate 74, O2 97%. The client stated "I had an itchy throat this morning" and said that he had a migraine that morning but did not remember if he had taken any medication for the migraine. At 1849, the client's vital signs were as follows: blood pressure 122/84, heart rate 73, respiratory rate 16, O2 99%. At 1853, the client stated "I feel less itchy." At 1900, the client initially requested Benadryl, but then refused both the medication and vital signs when offered. The client stated that his arm "still itched" but denied that it was getting worse. The client stated "I wanted a Benadryl for the road but now I think I'm going to wait." The client denied shortness of breath, chest tightness or pain, or any difficulty breathing. The client did not appear to be in any distress and had no swelling visible on his face or tongue. The client continued to chat with staff and spoke with a pleasant demeanor. Education provided by PHN, EMT, and RN regarding primary care follow up and when to seek medical care. At 1915, the client requested Benadryl and stated "I think my rash is growing." The client's vital signs at that time were as follows: blood pressure 138/92, heart rate 88, O2 99%, respiratory rate 12. At 1922, the client was given 50mg Benadryl orally. At 1927, the client stated "my wife is here, it's time for me to go." RN reiterated the importance of staying for a 30 minute observation time, but the client continued to leave the building. EMT accompanied the client outside, where he ambulated with a steady gait. He walked to the outdoor observation area and then sat down, requesting to be evaluated by EMS. EMS was called by RN at 1933. The client was sitting comfortably and denied any shortness of breath or chest pain. EMS arrived on scene at 1936. At 1938, the client's vital signs were as follows: blood pressure 140/90, heart rate 60, and O2 100%. The client stated at that time that he "felt better" and declined transport to the hospital. The client signed AMA paperwork at 1945 and ambulated to his car with a steady gait, accompanied by his wife, who he stated was going to drive him to an urgent care.
49 2021-06-01 pain in extremity Disseminated, non-traumatic bruising, Pain and swelling in the leg.
49 2021-06-01 unresponsive to stimuli Patient was given the second dose of Pfizer Covid 19 vaccine on 6/2/21 at 12:29pm and was asked to w... Read more
Patient was given the second dose of Pfizer Covid 19 vaccine on 6/2/21 at 12:29pm and was asked to wait for 15 minutes to watch how the patient reacts with the vaccine. He didn't have any side effect on his first dose. After 3 minutes of getting the vaccine, his wife notified me that she needs assistance. He was sweating profusely and was about to lose consciousness. His wife and I kept saying his name to check his response. He could not response or was about to faint. His pulse is slow, and his face is red. Since there was other customers waiting for shots in the clinic, I asked the technician to ask for pharmacy manager assistance. He came in the clinic, and checked patient's pulse and blood pressure. The blood pressure was high (170/89). We checked his blood pressure again, and it was lower after couple minutes. Patient started to have consciousness and understand what we are talking. He told us that he always had the same reaction after getting his blood drawn. We asked him to sit down and was monitored by us in the clinic. After 30 minutes, he said that he was feeling fine without any problems and decided to leave. He can breathe ok and didn't have any adverse reactions such as swelling of throat and lip or hives. His wife and he didn't eat anything before getting the vaccine. I checked his blood pressure again, and it was 130/80. Will follow up on him this evening and tomorrow.
49 2021-06-02 pain in extremity Anaphylactic reaction; skin was on fire; sweating; stomach cramps; throwing up; his arms and saw the... Read more
Anaphylactic reaction; skin was on fire; sweating; stomach cramps; throwing up; his arms and saw they were solid red; inflamed; hands swelled up; itchy; sore; sore where injected the Testosterone into left arm.; sore where injected the Testosterone into left arm.; This is a spontaneous report from a contactable consumer (patient). An 49-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 11May2021 16:45 (Lot Number: EW0182; Expiration Date: 31Aug2021) as 1st 0.3 ml single dose at the age of 49-years-old for covid-19 immunisation; testosterone cipionate, via an unspecified route of administration from 2020 (Lot Number: 88945; Expiration Date: 30Sep2021) and ongoing, at 150 mg, 2x/week (150 mg injection bi weekly ) for gonads, low testosterone. The patient medical history included low testosterone, gastrooesophageal reflux disease, COVID in the past (He did not know initially he had it, he had lost of taste and smell). Concomitant medication included dexlansoprazole (DEXILANT) taken for gastrooesophageal reflux disease from an unspecified start date and ongoing. None prior vaccinations (within 4 weeks). No family medical history relevant to AEs. No additional vaccines administered on same date of the pfizer suspect. The patient experienced anaphylactic reaction (medically significant) on 17May2021. Time of onset (24-hour clock): Roughly 18:00. Usually he took the testosterone in the morning, but he forgot. He was wrapping up the day, took the testosterone and by 18:02 he was on the ground, cold. The patient got his vaccination last Tuesday (11May2021). He was also on testosterone for gonadism. He usually administered the vaccine in his shoulders. He took the testosterone bi-weekly. On Monday he administered it his left shoulder and on Thursday it is in his right shoulder. After getting the vaccine he administered testosterone in his right shoulder on Thursday and had no issues. The patient mentioned everyone else who got the COVID Vaccine he knows had sore arm, nausea, but he did not have any of that. On Monday (17May2021) he injected his testosterone into the same arm/location, left arm, where he got the COVID vaccine and had an anaphylactic reaction. He contacted his doctor and went to the emergency room. The patient confirmed he felt like he had recovered completely from the anaphylactic reaction. Caller clarified the anaphylactic reaction. He did the testosterone injection in the same spot he had the COVID injection. Within 5 minutes it was like his skin was on fire. He was sweating, had stomach cramps, and was throwing up. Once he stopped throwing up he looked at his arms and saw they were solid red. They were all inflamed. His legs were inflamed. His hands swelled up. They were red. He had to take his wedding ring off. He was itchy. It was like he was on fire. He was sore, and sore where injected the Testosterone into left arm. He confirmed he had no problems swallowing or breathing. Based on the symptoms he was experiencing he realized these were things listed to be aware of when getting the COVID shot and to seek medical attention for. He went to the ER and they verified it was an anaphylactic reaction. Treatment included: He was given an Epi-Pen. It made him feel like off, like he had too much coffee or something. he was also given Benadryl and some Anti-Inflammatory to calm his body down. Investigations: He had blood drawn at the ER. However, he does not know if was actually tested. He was informed when the nurse drew blood it would be up to the doctor, but he has no knowledge if anything was done. Action taken of testosterone cypionate was dose not changed. Outcome of the events was recovered on 17May2021.
49 2021-06-02 seizure seizure (one time)
49 2021-06-05 pain in extremity Arm alittle sore for less than a day. During the time dated on this report. Personality changed. Bec... Read more
Arm alittle sore for less than a day. During the time dated on this report. Personality changed. Became extremely agitated, paranoid, showed symptoms of a Mood Disorder such as Bipolar 1 or 2. Family noticed a significant change in personality and mood. Also some hallucinations mostly at nights. This all occurred suddenly with no explanation
49 2021-06-07 tingling per Spanish interpreter, pt had Pfizer vaccine, the 2nd dose on the 29th foot swollen and has hand ... Read more
per Spanish interpreter, pt had Pfizer vaccine, the 2nd dose on the 29th foot swollen and has hand tingling sx started on the 31rst, sx still present but improved vaccine given at marlin stadium lot number ew0153 first vaccine on may 8th no reaction
49 2021-06-09 sensory loss, feeling cold, tingling, numbness, burning sensation, weakness Paresthesia starting in left arm especially along the outside of arm to the outside of hand and litt... Read more
Paresthesia starting in left arm especially along the outside of arm to the outside of hand and little finger. Progressed to affect both arms within several hours. Numbness, cold, burning sensations, tingling. Also feeling of weakness and slight loss of motor control. Symptoms continued to occur intermittently for around 6 days affecting the arms and legs along the outer part of the limbs. At one point I had almost no feeling in my lower legs. I still have numbness/loss of feeling in the outside portion of my left thigh which became worse after the second does of the vaccine, but has persisted since my first does of the same vaccine. I also experienced severe stiffness and strong pain in my spine. The pain affected different parts of my spine but the worst of it was concentrated in my lower back, which lasted several days.
49 2021-06-10 feeling hot, weakness, discomfort, burning sensation wife is reporting that his right arm felt like it was on fire and like he had hot fingers. About 30... Read more
wife is reporting that his right arm felt like it was on fire and like he had hot fingers. About 30 hours after taking the vax he felt hot at the core and felt like his breath was hot when he was breathing out. He went to PCP. had blood work with normal results. He has not developed chest pains and a feeling of heaviness on the left side of this body. He is feeling weak, tired and BP is elevated. He went to medical facility. He had a CTA. He was discharged to go home and FU w/ PCP where the test results were sent.
49 2021-06-14 numbness Heart flutters, chest discomfort, and numbness left side of face
49 2021-06-14 pain in extremity Patient describes right arm pain that started after injection and continues for several months. Pat... Read more
Patient describes right arm pain that started after injection and continues for several months. Patient is following up with his PCP.
49 2021-06-16 pain in extremity His arm was slightly sore after the injection on the day he got it; could not move nor lift his arm;... Read more
His arm was slightly sore after the injection on the day he got it; could not move nor lift his arm; muscles ached so bad; not been able to sleep since then; He is upset; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 49-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: not reported), via an unspecified route of administration on an un-specified date (at the age of 49-year-old) at a 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced his arm was slightly sore after the injection on the day he got it, could not move nor lift his arm, muscles ached so bad, not been able to sleep since then, he is upset. Reporter is a 49 year old male patient who has received his 1st dose of the Pfizer COVID Vaccine on Tuesday last week. He mentioned that he has a side effect that has been on going for 6 days, with the 7th day being tomorrow. His arm was slightly sore after the injection on the day he got it. By the next day, he could not move nor lift his arm. His muscles ached so bad and he has not been able to sleep since then. He mentioned that he has never had anything like this before the vaccination. He thought he was doing the right thing but now he is in a very bad situation. He is upset because he can't even work. He and his family is very concerned because of this. He mentioned that there is absolutely no way in heck he is getting the 2nd shot. Outcome of the events was unknown. Follow up (PRD14Jun2021/SRD15Jun2021): This is a follow up spontaneous report from a contactable consumer. This 49-year-old male consumer (patient) reported that: When consumer was again informed about the role of Pfizer Drug Safety and requested to probe, consumer stated, consumer really just want to know, consumer really concerned about what happened. Consumer want to know whether he is going to be okay or consumer need to go to the hospital. Consumer don't want to file nothing for no safety or no stuff like that, consumer want to know whether he is okay. Because consumer thought consumer was doing the right thing by getting this and now consumer can't even move my arm for 6 days, so consumer am very concerned about it. Information regarding the Lot/Batch number has been requested.
49 2021-06-18 facial paralysis Patient experienced facial drooping on the right side of his face starting on 6/17/21 and worsening ... Read more
Patient experienced facial drooping on the right side of his face starting on 6/17/21 and worsening over the next two days. He experienced tearing in his right eye. Patient denies any additional symptoms. Recommended patient be seen by provider asap to rule out potential stroke. Patient denies any additional symptoms.
49 2021-06-23 numbness and pain in extremities, speech disorder On 04/06/2021 Patient got his first Pfizer COVID-19 vaccination. Within 24 hours, he got sharp pain... Read more
On 04/06/2021 Patient got his first Pfizer COVID-19 vaccination. Within 24 hours, he got sharp pain in the injection site and shoulders with an increase in brain fog type issues. He thought it was due to induced immune response depleting energy from the body. However, a week or so in his usual daily activities started slowing down (e.g., going from daily showers to 3 times a week, not getting chores done in a timely manner). On 04/27/21, he got his second shot, resulting in complete mental shutdown. Patient was not showering or shaving and only ate when forced. All internal sense of motivation and intuition was gone. He experienced memory issues, trouble speaking, and suffered from a ?complete state of nothingness which I?ve never experienced before? also known as abulia. He rarely took part in activities he did daily before the vaccine such as spending time on PC and reading the news. On 5/16/21, his condition started to improve and his precious feelings of "nothingness" turned to anger. He got intense neuropathy escalation in fingertips at this time which lasted about a week and half. His reaction lasted two months and now he is currently able to shower, shave, and exercise daily but still has memory and executive functioning issues.
49 2021-06-24 flushing, tingling, pain in extremity "Pt w/ allergy to Penicillin (hives). PMH Psoriasis, HTN, HLD, GERD, CAD (NSTEMI 1/20), anxiety, car... Read more
"Pt w/ allergy to Penicillin (hives). PMH Psoriasis, HTN, HLD, GERD, CAD (NSTEMI 1/20), anxiety, carpal tunnel. PSH Nerve repair Left index finger, Cardiac Cath. 1/2020 hospitalization for NSTEMI: s/p cardiac cath on 1/30/2020, which showed dominant RCA with proximal 70% lesion followed by 99% mid RCA lesion (LM/LAD/LCx without significant CAD) now s/p PCI of mid RCA with 3.0 x 15 mm Onyx DES and PCI of proximal RCA with 3.5 x 22 mm Onyx DES. Today, via Spanish interpreter) , he reports that he has localized right chest discomfort 2/2 right arm tingling and pain when he received the vaccine today. Pt also has flushing/sweating. He is alert and oriented x 4. He was very ""anxious"" and tears in his eyes. He states that he has ""panic attacks"" in the past and he feels very ""anxious"" after getting the shot. C/o tingling and pain right arm. Pt given 2L O2 via NC. Slowly sx of chest discomfort resolved after 5 min. Pt stable and released from the vaccination site. Pt verbalized ""he feels fine now"". VSS. His is back to baseline. Right arm pain resolved, tingling improved. Denies CP, dizziness, HA, or palpitations. His son is driving him home. Instructed patient to rest at home. He has NTG prn for CP. ED precautions discussed. If CP recurs, he agrees to call 911. FU with PCP if right arm numbness and tingling are worsening or persist after 3 days or CP/pain/palpitations/HAs/syncope. Current medications: acetaminophen (TYLENOL) 500 MG tablet Take 1 tablet by mouth every 6 (six) hours as needed for Pain. adalimumab (HUMIRA) 40 mg/0.8 mL subcutaneous injection pen kit Inject 0.8 mLs into the skin every 14 (fourteen) days. aspirin 81 MG EC tablet Take 1 tablet by mouth daily. atorvastatin (LIPITOR) 40 MG tablet Take 1 tablet by mouth at bedtime. carvedilol (COREG) 6.25 MG tablet Take 2 pills by mouth in the morning and 1 pill in the evening famotidine (PEPCID) 20 MG tablet Take 1 tablet by mouth 2 (two) times daily. gabapentin (NEURONTIN) 300 MG capsule Take 1 capsule by mouth 3 (three) times daily. For hand numbness hydrocortisone 2.5 % cream Apply to affected areas 2 (two) times daily. lisinopril (PRINIVIL,ZESTRIL) 10 MG tablet Take 1 tablet by mouth daily. loratadine (CLARITIN) 10 mg tablet Take 1 tablet by mouth daily. nitroglycerin (NITROSTAT) 0.4 MG SL tablet Dissolve 1 tablet under tongue every 5 minutes as needed for chest pain, max 3 tablets. If pain continues 5 minutes from first dose call 911 "
49 2021-06-24 pain in extremity Arm soreness; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer r... Read more
Arm soreness; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported (patient) that a 49-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: un EWO185) via an unspecified route of administration on 25May2021 14:48 (age at vaccination 49years old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm soreness on an unspecified date. The clinical outcome of the event was unknown. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021716077 similar report from same reporter
49 2021-06-25 muscle twitching, tingling, muscle spasms, numbness Migrating numbness and tingling in both arms and legs, (4 months, still present). Insomnia (4 months... Read more
Migrating numbness and tingling in both arms and legs, (4 months, still present). Insomnia (4 months, still present). Muscle twitching all around my body. (4 months, still present). Fasciculations especially in both calves, constant (3 months, still present). Acid reflux (without heartburn, but reflux in my esophagus, 1 month, still present). Difficulty swallowing (1 month). Cramping or discoordination in hands (4 months, still present). Anxiety (4 months, still present).
49 2021-06-26 pain in extremity MYOCARDITIS shortness of breath, brain Fog, chest Pain pain left shoulder and Arm i gave blood and a... Read more
MYOCARDITIS shortness of breath, brain Fog, chest Pain pain left shoulder and Arm i gave blood and alot of chest pain has decreased.
49 2021-06-27 tremor About a week after shot 1 I started to feel very fatigued and run down. I was able to function but ... Read more
About a week after shot 1 I started to feel very fatigued and run down. I was able to function but got tired easily. On May15, I received shot 2 and my fatigue got worse. I started to get tremors and shakes in my hands and arms. Legs felt weak, its difficult to hold my arms up at times. I felt hyper, yet weak. Unable to stay asleep. On June 6 I took a hot shower and barely made it out before collapsing. I went to the emergency room .
49 2021-06-28 pain in extremity Painful severe swelling right calf/lower leg.
49 2021-06-29 numbness Tightness that traveled from the shoulder (site of the vaccine) to the wrist; numbness that travele... Read more
Tightness that traveled from the shoulder (site of the vaccine) to the wrist; numbness that traveledfrom the shoulder (site of the vaccine)to the wrist.; This is a spontaneous report from a contactable consumer. A 49 -year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EP6955,) via an unspecified route of administration in the left arm on 22Mar2021 at 11.00 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. Medical history included overweight and hemochromatosis. The patient did not have any allergies to medications, food or other products. Concomitant medication included ADDERALL, for unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021 at 12:00, the patient experienced tightness and numbness that travelled from the shoulder (site of the vaccine) to the wrist which subsided completely after about three hours. The patient did not receive any treatment for the events. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of tightness and numbness was resolved at the time of reporting. No follow-up attempts are needed. No further information is expected.
49 2021-06-30 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Head... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Additional Details: Patient recieved covid shot, and fainted within 8-15 minutes. He bumped his head while falling and had redness at the site. We called the ambulance to make sure patient will be okay. Paramedics mentioned that his blood pressure was low.
49 2021-07-01 grand mal seizure, cold sweat 49yom with PMH HTN presents with CP and SOB. Ddx includes but is not limited to: ACS, PE, PNA, aorti... Read more
49yom with PMH HTN presents with CP and SOB. Ddx includes but is not limited to: ACS, PE, PNA, aortic dissection, pericarditis, myocarditis. On arrival, patient appeared critically ill with cool, clammy skin, diaphoretic, complaining of chest pain. Patient initially able to answer simple questions, however quickly became unconscious, witnessed having tonic colonic seizure activity. Patient given 2 mg of lorazepam which aborted the seizure, however he remained unresponsive. IV fluids were started, and patient remained hypotensive after 3 L of fluids. Bedside cardiac ultrasound was performed which showed a large pericardial effusion with tamponade physiology. We continued fluid resuscitation and patient was intubated, while stat Cardiology consult was called. Patient suffered a cardiac arrest shortly after intubation. Cardiology performed emergent pericardiocentesis at the bedside which showed hemopericardium with output of greater than 500 mL of blood. ROSC was achieved following pericardiocentesis, and we continued resuscitative measures. Emergent arterial line and central venous lines were placed. Patient began to have profuse bleeding from all orifices, and massive transfusion protocol was initiated. Patient was stabilized enough to be taken to CT scanner which showed an extensive aortic dissection extending into the RCA, abdominal aorta, brachiocephalic artery, common carotids, and into the abdominopelvic vasculature. Cardiac and vascular surgery were consulted stat, and the decision was made to take the patient emergently to the OR. We were informed shortly after that the patient had expired en route to the operating room and they were unable to obtain ROSC. Final impression: type A aortic dissection, cardiac tamponade. Second dose of mRNA vaccine (unknown if Pfizer or Moderna) received two days prior to event.
49 2021-07-01 numbness Pt presented for 2nd dose on 6/28. Pt noted that ~24hrs after receiving the first dose, he developed... Read more
Pt presented for 2nd dose on 6/28. Pt noted that ~24hrs after receiving the first dose, he developed left sided hives and numbness that lasted a few days. Unknown if any rescue medication was used during that time. 2nd dose held.
49 2021-07-04 pain in extremity Extreme pain when moving my arm at and above shoulder's high and when moving arm past the chest plan... Read more
Extreme pain when moving my arm at and above shoulder's high and when moving arm past the chest plane towards the back of my body. I had taken Naproxen (440mg) every 12 hrs. for several days but it doesn't seem to help. This started about a month or so after the first dose of the vaccine and it felt like a minor discomfort but it gotten worse over time to the point of not being able to use my arm normally; for instance, I cannot lay on that side when in bed.
49 2021-07-04 tremor While getting my hair cut the following day I was sitting in my chair and started to feel intoxicate... Read more
While getting my hair cut the following day I was sitting in my chair and started to feel intoxicated for about 2 minutes and then started to sweat, I then passed out and started to shake as if I were having a seizure. This went on for about a minute I was told.
49 2021-07-04 tremor Headache began at 3:00pm. Woke up at 11:00 pm violently shaking all over. I was not hot or cold. ... Read more
Headache began at 3:00pm. Woke up at 11:00 pm violently shaking all over. I was not hot or cold. Woke up several times after the 11:00 pm also violently shaking. Seemed to have stopped by 3:00 am.
49 2021-07-08 pain in extremity I had swelling of my shoulder and left arm. I also had pain down my neck and fingers in my left arm.... Read more
I had swelling of my shoulder and left arm. I also had pain down my neck and fingers in my left arm. This went away in about 4 days. The only remaining symptom was pain in my index finger on my left hand.
49 2021-07-08 pain in extremity That night I had chills and fevers which lasted all night. The next day I was tired and got a rash o... Read more
That night I had chills and fevers which lasted all night. The next day I was tired and got a rash on my leg. By Thursday, I had little red dots all over the bottom half of my legs. That cleared up a couple days later. Since then, I have had spots on my leg that itch all the time. About 2-3 weeks ago I began experiencing pain in my pinky finger. Also, my index finger began getting stiff with pain. I went to see a doctor, where they did some blood work and Xrays. Both were normal. I am scheduled to get an ENG done next.
49 2021-07-17 weakness redness; feeling very weak; he couldn't, his speech was because he was shivering so much that he cou... Read more
redness; feeling very weak; he couldn't, his speech was because he was shivering so much that he couldn't fully speak; dry cough; his pupils dilate; gets bit of a blurred vision; Fever; sweats; chills; throbbing headaches; rash that looks like bruising spread over the body; fatigue; shortness of breath, he wasn't breathing fully; kind of look like bruises; This is a spontaneous report from a contactable consumer. A 49-year-old male patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 intramuscular, administered in Arm Right on 15Jun2021 17:30 (Batch/Lot Number: EW0161) as DOSE 1, SINGLE for covid-19 immunisation. The patient's Medical history was not reported. The patient's Concomitant medication included collagen (COLLAGEN) taken for an unspecified indication, start and stop date were not reported. On 16Jun2021 17:30 patient experienced fever, sweats, chills, throbbing headaches, rash that looks like bruising spread over the body, fatigue, shortness of breath, he wasn't breathing fully, kind of look like bruises and On an unknown date patient experienced redness, feeling very weak, he couldn't, his speech was because he was shivering so much that he couldn't fully speak, dry cough, his pupils dilate, gets bit of a blurred vision. The patient underwent lab tests and procedures which included blood test: unknown result on 23Jun2021 "He underwent taking blood test on June 23". Patient was treated with "Antibiotics, tylenol, motrin" for the events fever, sweats, chills, throbbing headaches, rash that looks like bruising spread over the body, fatigue, shortness of breath, he wasn't breathing fully, kind of look like bruises, redness, feeling very weak, he couldn't, his speech was because he was shivering so much that he couldn't fully speak, dry cough, his pupils dilate, gets bit of a blurred vision. Patient experienced Fever, sweats, chills, throbbing headaches, rash that looks like bruising spread over the body, fatigue, difficulty breathing for 8 days, and some of the symptoms still ongoing past 8 days. Currently on 10th day. Symptoms started day after vaccine. Reporter stated, "If you are asking, is he suffering from medical condition, he did after taking the vaccine but before that he did not have any other medical condition". Reporter stated, "A week later, on June 23rd (not clarified) he went to see a doctor and he prescribed him antibiotics and before that he was taking Ibuprofen, he was taking Advil and then they told him not to take Ibuprofen but to take Tylenol and Motrin. So, since June 23 (not clarified) he has been taking Antibiotics, Tylenol and Motrin." (later clarified that patient was taking Antibiotics, Tylenol and Motrin as treatment). Reporter stated, "He underwent taking blood test on 23Jun." (not clarified further). Reporter stated, "So, he was taking Advil and then since 23Jun, he has been taking Antibiotics, Tylenol and Motrin". Reporter further stated, "He had severe headache and even when he took Advil sometimes it would not go away and it would get worse when he was just lying down and he would get headache that would come and go. He would wake up in the middle of the night sweating. He would have to (voice breaking) many times and then after that he would get chills and get very cold and he would shake, he was very cold. He had shortness of breath, he wasn't breathing fully and then on June 23rd (not clarified) which was a week later, he started having this rash all over the body and on his face specifically, they kind of look like bruises. So, when it was like pressed too long like when he had contact and it was pressed too long, it did developed redness and the redness is starting to go away, now it has gone away and he was feeling very weak and then he couldn't, his speech was because he was shivering so much that he couldn't fully speak and he was getting a little bit of dry cough. But mostly, it was the headache that would not stop and then yesterday, he is getting better and now, he is now able to breathe fully, he is able to walk around with more energy, he has less of a temperature fluctuations and but he still sweats at night but not as much and then sometimes he gets like his pupils dilate and he gets bit of a blurred vision but the shivers have gone away now". The outcome for the events "fever, sweats, chills, throbbing headaches, rash that looks like bruising spread over the body, fatigue, shortness of breath, he wasn't breathing fully, kind of look like bruises" was recovering and outcome for the events "redness, feeling very weak, he couldn't, his speech was because he was shivering so much that he couldn't fully speak, dry cough, his pupils dilate, gets bit of a blurred vision" was Unknown. No follow up attempts are possible. No further information is expected.
49 2021-07-17 discomfort 12 hours after receiving my second dose I became very ill.; skin hurt; I became to shiver uncontroll... Read more
12 hours after receiving my second dose I became very ill.; skin hurt; I became to shiver uncontrollably and could not get warm enough; I developed a fever of 101.4; My muscles ache. Instead of feeling "sick"this was more painful than "ill".; it is difficult tosleep.; I'm in somuch discomfort; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 29Mar2021 at 12:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, sleep apnea and pre-diabetes. Concomitant medications included propranolol 120 mg (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN) and armodafinil (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates. The patient previously 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 08Mar2021 at 15:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation and morphine on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination the patient had not been 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 COVID vaccine. On 30Mar2021 at 00:30 after 12 hours of second dose, the patient experienced illness, skin hurt, shivered uncontrollably and was not getting warmed enough, fever - 101.4 (unspecified unit), muscle ache, hurt to move, discomfort and difficulty sleeping. The patient did not receive any treatment for the event. The 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 illness, skin pain, shivers, fever, muscle ache, sleep difficult and discomfort were not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
49 2021-07-17 numbness, tingling, pain in extremity Achy left arm; fingers (left) feel tingly and almost numb; finger almost numb; This is a spontaneous... Read more
Achy left arm; fingers (left) feel tingly and almost numb; finger almost numb; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: PFIZEREP7534); via an unspecified route of administration in the left arm on 15Mar2021 at 08:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other medications within two weeks prior to the COVID vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID 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 18Mar2021 at 07:00, the patient experienced achy left arm very painful to sit, to lay in bed or drive (pain felt like it hit his funny bone). The patient experienced fingers (left) tingly and almost numb. The arm pain started 3 days after the first dose. The adverse event resulted in doctor or other healthcare professional office/clinic visit/ emergency visit/ department or urgent care. Therapeutic measures were taken as a result of pain in arm, tingling and numbness and included ibuprofen, cyclobenzaprine and naproxen. The clinical outcome of the events pain in arm, tingling and numbness were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
49 2021-07-17 numbness Constant numbing sensation on right big toe, ball of big to and top of left hand.
49 2021-07-17 tremor Significant fatigue; Extremely Lethargic; Erratic heart rate; No appetite; Chills; Glucose and bilir... Read more
Significant fatigue; Extremely Lethargic; Erratic heart rate; No appetite; Chills; Glucose and bilirubin slightly elevated; Glucose and bilirubin slightly elevated; Extremely rapid heart rate; Elevated blood pressure; Dry mouth; Lightheaded; Shakes; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received first dose of BNT162B2 via an unspecified route of administration at arm left on 25Mar2021 13:15 (age at 49 years old, Batch/Lot Number: EP6955) as single dose for COVID-19 immunisation. Medical history reported as none. The patient was not diagnosed with COVID-19 prior to vaccination and the patient did not test for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included cetirizine hydrochloride (ZYRTEC); vitamins nos (MULTIVITAMIN); fish oil; all as supplement. About 5 mins after injection (25Mar2021 13:30), the patient developed extremely rapid heart rate and elevated blood pressure, dry mouth, lightheaded and shakes. The patient went to emergency room (ER), heart rate stabilized after about 60 mins. Blood work and EKG were normal on 25Mar2021. Next day on 26Mar2021, the patient developed extremely lethargic, erratic heart rate, no appetite. The following evening, the patient had another the same episode as post injection, rapid heart rate, chills, elevated blood pressure. The patient went to ER, EKG/Chest x-ray/blood tests all normal (glucose and bilirubin slightly elevated) on 26Mar2021. 4 days post injection (29Mar2021), heart rate still erratic and significant fatigue, heart rate spiked with little effort. The events required Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received iv fluids as treatment. All events were not recovered.
49 2021-07-18 pain in extremity It started with just extreme exhaustion. Within about an hour I had extreme pain in both legs, star... Read more
It started with just extreme exhaustion. Within about an hour I had extreme pain in both legs, starting from my waist all the way down to my toes. It was not a "coming and going" type of pain. It was constant, and severe. It was so painful that I could not walk. The pain was not relieved by lying down and elevating my feet. It was so painful that I could not really rest or sleep. It lasted about 48 hours before it started getting a little better. It has been nearly 72 hours now, and I'm starting to feel a bit normal again. I did not seek treatment because I did not think there was anything a doctor could do to help me.
49 2021-07-19 discomfort chest pain; uncomfortable; This is a spontaneous report from a contactable consumer (patient). A 49-... Read more
chest pain; uncomfortable; This is a spontaneous report from a contactable consumer (patient). A 49-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0162; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in left upper arm on 20Apr2021 09:30 as dose 1, single and dose 2 via an unspecified route of administration, administered in arm left on 19May2021 09:30 (Batch/Lot Number: EW0183; Expiration Date: 31Aug2021) (at the age of 49-years-old) as dose 2, single for COVID-19 immunization (He discussed it with his 21 year old daughter and wife). Caller wanted to get back and do some things. He felt that if he got Covid after the vaccine, he would not get as many side effects. He did get his flu shot and the experience had always been positive. His daughter also got flu shot and had positive experience. Caller thought that most people who didn't get shots was because they were afraid of needles. He thought maybe there was a different way to administer it so more people were taking it. Medical history included ongoing hypertension (About 14 years). He did not have high blood pressure if he was exercising. It was in good control. When caller was asked if he had a family history related to reactions to any vaccines, he stated that both his mother and father got the vaccinations. They were the first ones in the elderly group. His dad got sick and got a little lethargic and out of it for a day or so. He was not feeling well. His Mom just had a sore arm. Caller declined to do report on his parents. Concomitant medication included olmesartan medoxomil (BENICAR) taken for hypertension from an unspecified start date and ongoing, he said he really didn't needed to take it anymore, but he still took it and had been taking it for about 14 years. The patient experienced chest pain on 30May2021 around 22:00 and was uncomfortable on an unspecified date with outcome of unknown. Caller stated his first dose was on 20Apr2021 and his second dose was 19May2021. Caller stated on 30May he started having chest pain, so he went to the ER and was at the hospital for a day and a half for observation. Caller stated he now had a cardiologist appointment on 05Aug2021 and even though all of the tests came back negative, they put him on low dose aspirin. Caller stated he had seen the studies about 19-39-year-olds having chest pain and inflamed hearts and would like to know if there was information based on his age. Caller asked if there was anything he could do or take for the chest pain. Caller stated that it had been going on for a while and he was very uncomfortable. Stated that Pfizer cannot make treatment recommendations. Stated that caller got both doses of the Pfizer Covid vaccine. He experienced lots of chest pain. It was a dull achy pain near his heart in his chest. It occurred a week later after his second shot. Caller wanted to know if Pfizer offered assistance. He said that he was going to accrue a great deal of expenses. He had an appointment with a cardiologist on 05Aug2021. His appointment was so far out as that was what he could schedule. Caller also said that he was at the ER for a day and a half as they wanted to remove all life threatening possibilities such as the risk of a heart attack. They could not find a heart attack. He's never had a heart attack, but from what people described to him, that feeling in his chest.ck. When caller was asked if he was a healthcare provider, he said that he had done First aid, but he was not a healthcare provider. Caller did not want to provide email address. Caller clarifies that he had chest pain on Sunday night, around 22:00. He was sitting on his couch watching TV. Outcome: States it is persisting, then states he felt that there was a slight improvement at this time. He did not feel it around the clock like he did the first week when it was constant pain. It was coming and going very frequently. Caller stated that the only thing they told him to do was take a baby Aspirin 81mg. They told him he could resume activities. He walked and hiked a lot. He was hesitant to hike with altitude. He did outdoor activities like cutting the grass. There was no difference in the feeling of the chest pain whether he was doing activity or resting. It didn't make it better or worse. Caller stated that they did several tests on his heart when he was at the ER. His heart was strong. They could not find anything. They wanted him to go to the cardiologist to get an EKG and sonogram. He would have those done 05Aug2021 before his meeting with the cardiologist. His blood pressure in the ER when he arrived was 133/89 approximately. It lowered as they kept taking it. Caller stated that he knew probably 10 to 15 black males who took shot. None of them had this problem. They had normal side effects such as sore arm and lethargic feeling after the second dose. He was talking to them to see if anyone had anything like this. None of them had chest pain. Some of them were big men like 270 to 280 pounds. Caller declined to do reports on these men. No further information provided. It was a park that had everything there. He had to schedule the appointment. It was a very legitimate site. Caller provided the address as (address withheld). When caller was asked if he had any adverse reactions to any other shots, he said he had the flu shot and was fine. He had been getting that done forever and he had a sore arm only. Caller stated that the purpose of his call was two-fold. First, he wanted to know about assistance with his expenses. Second he wanted to provide information. He did not know about inflammation in the heart. He heard about CDC report of inflammation in the heart in age group 18 to 39 but not in his age group. Blood pressure of patient was 133/89 approximately. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
49 2021-07-20 pain in extremity Diffuse Right shoulder and upper arm pain starting 2 weeks and 3 days after second dose of Pfizer va... Read more
Diffuse Right shoulder and upper arm pain starting 2 weeks and 3 days after second dose of Pfizer vaccine; in addition to Rt axillary lymphadenopathy 2in x 2in, painful, starting 2 weeks and 1 days after second dose of Pfizer vaccine, symptoms are still present, recommended OTC Tylenol as needed and follow up with primary care provider for further evaluation and treatment
49 2021-07-22 facial paralysis, bell's palsy 7/7 - about 9am or 10 am in morning, his face on the right side began to droop. He felt as though... Read more
7/7 - about 9am or 10 am in morning, his face on the right side began to droop. He felt as though he may be having stroke, as known from prior event. Yet, he drove himself to the ER. A stroke event was ruled out. He was diagnosed with Bell's Palsy syndrome with numbness and paralysis on the right side of his face. Treatment include high dose steroid Prednisone for 5 days. Adjustment with increase in this blood pressure medication, as his blood pressure was running in the 210s/110s. (extremely high). Prior to this event - pt traveled under the false security that he was okay to mingle since he had been vaccinated. (Currently, the place he traveled to is showing a COVID surge). Now today on 7/22 -patient still is suffering from the Bell's Palsy side effect. Slowly he is regaining feelings and very slight movement of his face.
49 2021-07-25 pain in extremity, numbness arm pain from the moment he received tie injection. Hands and fingers went numb. was told arthritis ... Read more
arm pain from the moment he received tie injection. Hands and fingers went numb. was told arthritis in shoulder. Went to Er on the 20th of july and a CT scan was done . Had stroke on the 21st . two blood clots were found
49 2021-07-26 tingling about 2-3 hours after vaccination, i began to get a tingling sensation in both my upper and lower li... Read more
about 2-3 hours after vaccination, i began to get a tingling sensation in both my upper and lower lip. It progressed to prickly feelings that continued for approximately 18 hours after vaccination. I have never had this happen before.
50 2021-01-01 pain in extremity Had chills, body aches, and low grade fever starting approximately 14 hours after vaccination. Sym... Read more
Had chills, body aches, and low grade fever starting approximately 14 hours after vaccination. Symptoms continued off/on for approx. 16 hours. Treated with Tylenol and Ibuprofen without any further issues. Arm was quite sore also for a day and a half.
50 2021-01-04 flushing 2 min after shot became dizzy, flushed, sweaty. Lasted 6-7 min. Arm soreness and extreme tiredness b... Read more
2 min after shot became dizzy, flushed, sweaty. Lasted 6-7 min. Arm soreness and extreme tiredness both for two days. Next day developed itching that progressed over several days. Rash/hives to upper chest, arms, and back started on day 3 after injection. Had to take Benadryl and vistaril initially then Doctor prescribed Prednisone on day six.
50 2021-01-04 tingling Patient reported tingling in her fingers but reported she was fine by 3:06pm
50 2021-01-05 weakness Cough; Flu like symptoms; It hurts to walk; I have a stuffed up nose, I did not have it yesterday; P... Read more
Cough; Flu like symptoms; It hurts to walk; I have a stuffed up nose, I did not have it yesterday; Pale; I felt weak; Bones ache; Have not been feeling good; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 28Dec2020 at single dose on arm for suppress the COVID-19 (COVID-19 immunization). The patient's medical history included blood pressure, stomach ulcer and psoriatic arthritis. The concomitant drug was reported as colecalciferol (VITAMIN D), potassium citrate, multivitamin, etanercept (ENBREL) at once a week, pen shot in stomach, omeprazole (PROTONIX) at once a day for stomach ulcer and blood pressure medications. The patient was a correction officer, patient work at the prisons in (state name) and were given vaccination of Pfizer on Monday and he did that on Monday and have been getting sick and it's getting worse everyday, so yesterday at work everything was fine and he went home at 8 'O' clock at night because he was getting pale, felt weak, bones ache and have not been feeling good and today he called it in because he woke up with the cough, flu like symptoms. And it's worse today than it was yesterday. Consumer stated today, bones ache was worsening of like weaker, it hurts to walk and bone ache was really, today was worse than yesterday for the bone. Today flu like symptoms was worse, today patient have more heavier cough, was coughing more today and have a stuffed up nose, I did not have it yesterday. Wanted to know if this was a side effect or is that normal with that vaccine. Start date of events was on 28Dec2020. When patient started feeling some symptoms that started getting progressively worse on 29Dec2020. Treatment included Tylenol for bone pain and hurts to walk. Lab test blood work done in Dec2020, once a month through psoriatic arthritis doctor. The outcome of events, weak, Bone pain, Cough, Flu like symptoms, was not recovered. The outcome of other events was unknown. Information on Lot/batch number has been requested.
50 2021-01-05 flushing, tingling 1011-2nd Dose of Pfizer administered; 1025 pt began feeling a quivering in his stomach about where h... Read more
1011-2nd Dose of Pfizer administered; 1025 pt began feeling a quivering in his stomach about where his diaphragm is located. the feeling went away and pt went back to his office. 1045-Symptoms began again flushed/faintness accomapanied the initial quivering. Pt bean feeling tingling his fingers and toes and felt like a lump was in his throat, his neck felt tight. 1052-Reported back to COVID pop up vaccine clinic reporting symptoms to staff in the clinic. 1100-BP 200s/90s HR 110s SPO2 96%. pt interviewed by lead FNP and evaluated. PT given water and granola bar as he reported he did not eat that morning, only took Excedrin. 1115-BP 165/86 HR 92 SPO2 98%RA. pt reports symptoms starting to resolve. 1120-HR 84 SPO2 98%RA. 1122-Pt dc'd to work. pt asked to not leave the hospital for 4-6 hours, not even to work offsite. pt agrees to report to ED if symptoms return.
50 2021-01-05 flushing Neck and Face flushing. Tachycardia with rate of 120 for 1.5 hours.
50 2021-01-06 weakness Headache, Fever, fatigue, weakness, sore throat Narrative: 12/29 - received vaccine. 12/30 - woke up... Read more
Headache, Fever, fatigue, weakness, sore throat Narrative: 12/29 - received vaccine. 12/30 - woke up with a fever and scratchy throat and headache. Since then the symptoms have lingered. Jan 2- 3 he developed more fatigue. Jan 4 - fever to 101 and headache. He also feels weak and has intermittent scratchy throat. Also had injection site soreness. He has Rheumatoid Arthritis for which he's taking actimira, and methotrexate (immunesupressants). Will test him today (1/4) for COVID-19. 1/5 - COVID-19 test is negative. Employee reports resolution of all symptoms.
50 2021-01-06 tingling Patient received Pfizer Covid 19 vaccine at 1400. He felt fine initially. At 1600 developed lighthea... Read more
Patient received Pfizer Covid 19 vaccine at 1400. He felt fine initially. At 1600 developed lightheadedness, slight headache and intermittent tingling to his left fingers. He reports itching to his extremities. He has not noticed a rash. He denies syncope, nausea, vomiting, sore throat, congestion, chest pain, SOB, palpitations, weakness, slurred speech, abdominal pain, diarrhea. He denies history of prior allergic reactions. No new medications. he is not anxious. Denies rash likely related to vaccine administration at 1400; seen in the urgent care at 1600 and discharged after treatment and evaluation at 1858. Inventions: ekg no acute findings; methylPrednisonolone 125 mg IV; diphenhydramine 25 mg IV; famotidine 20mg po; odansetron 4mg IV home with Benadryl 25 mg Q6 hours for 5 days.
50 2021-01-07 flushing he dust that landed on his face caused hives; feeling flushed; started feeling itchy about 2 hours p... Read more
he dust that landed on his face caused hives; feeling flushed; started feeling itchy about 2 hours post vaccine; This is a spontaneous report from a contactable nurse. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK5730, intramuscular from 23Dec2020 11:00 at a single dose for COVID-19 immunization. Medical history included patient's known allergies: Only grass, pollen, dust mites; and hives all from unspecified dates. Concomitant medication included naproxen sodium (ALEVE) for " itchy", ibuprofen (MOTRIN) and paracetamol (TYLENOL 8 HOUR). The patient got the COVID vaccine on 23Dec2020 at 11:00. He stayed at vaccination location for 30 minutes and then drove to his destination. Upon arrival at 12:00, he started feeling flushed. No shortness of breath or breathing difficulties. He then started feeling itchy about 2 hours post vaccine. He took an Aleve. At home in the evening, took Benadryl with improvement of symptoms. The following day he also took Benadryl. On 25Dec2020 & 26Dec2020, he still had some itching, but not bothersome enough to take medications. On 27Dec2020 he was working cutting tile and wearing protective eye wear, but the dust that landed on his face caused hives. He has been taking Benadryl since. He said that this has occurred in the past when his body was hypersensitive, the hives. He has seasonal allergies but no allergies to food/medications/vaccines. Patient was not diagnosed with COVID-19 and since the vaccination, he has not been tested for COVID-19.
50 2021-01-07 pain in extremity Sore arm for day and a half; onset of chills, body aches, low grade fever.; onset of chills, body ac... Read more
Sore arm for day and a half; onset of chills, body aches, low grade fever.; onset of chills, body aches, low grade fever.; onset of chills, body aches, low grade fever.; This is a spontaneous report from a contactable nurse (patient). A 50-year-old male patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL0142), via an unspecified route of administration on the right arm on 31Dec2020 07:45 at SINGLE DOSE for COVID-19 immunization at the hospital. There were no concomitant medications. It was reported that the patient was the patient diagnosed with COVID-19 prior to vaccination on 12Dec2020 (pending clarification). On 31Dec2020 22:00 (approximately 14 hours after vaccination), the patient had a sore arm for day and a half and onset of chills, body aches, low grade fever were noted. It was mentioned that the symptoms were treated with acetaminophen (TYLENOL) and ibuprofen. The patient was not tested for COVID-19 since the vaccination. The patient recovered from sore arm on 02Jan2021 10:00 (day and a half) and from the remaining events on 01Jan2021 14:00 (lasted for approx. 16 hours off/on).
50 2021-01-08 flushing 12 minutes after receiving the 2nd covid vaccination, I felt flushed and became diaphoretic. I felt ... Read more
12 minutes after receiving the 2nd covid vaccination, I felt flushed and became diaphoretic. I felt heart palpitations and checked my heart rate which was 117, increasing to a max of 123. I was placed on a pulse ox monitor, which showed 93%, BP was elevated at 146/85. I was not given any medical treatment, and was placed on a monitor for one hour. Once my hr and 02 stas were at my baseline, I was allowed to be discharged. I went back to my department and decided to go home, as I felt tired and was mildly nauseous.
50 2021-01-08 numbness Left sided facial numbness 36 hours Dizzy spells 36 hours Fatigue 58 hours and counting body aches 4... Read more
Left sided facial numbness 36 hours Dizzy spells 36 hours Fatigue 58 hours and counting body aches 48 hours headache 36 hours stabbing pain 36 hours
50 2021-01-10 flushing Patient experienced lip swelling, tachycardia and flushing after vaccine administration. Patient was... Read more
Patient experienced lip swelling, tachycardia and flushing after vaccine administration. Patient was evaluated and treated in the ER and has been discharged at this time.
50 2021-01-11 weakness, tingling Shortness of breath on exertion; weakness; fatigue; chills; tingling sensation of extremities that c... Read more
Shortness of breath on exertion; weakness; fatigue; chills; tingling sensation of extremities that continues on; This is a spontaneous report from a contactable healthcare professional, the patient. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK9231) solution for injection intramuscular on 21Dec2020 (at the age of 50-years-old) as a single dose for COVID-19 vaccination. Medical history included neuropathy. Concomitant medication included gabapentin. Past drug history included known allergies: TOPAMAX. 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. On 27Dec2020, the patient experienced fatigue, chills, tingling sensation of extremities that continues on. Treatment for the events fatigue, chills, tingling sensation of extremities included ibuprofen (MOTRIN) and acetaminophen (TYLENOL) taken with minimal or short temporary relief. On 30Dec2020, the patient experienced shortness of breath on exertion and weakness and tried to go to Urgent care clinic for Covid test but no available test so the doctor prescribed ZITHROMAX in case it was Covid. On 30Dec2020, MRI, XRAY, LABS were taken and all came back negative and normal except having all these symptoms. On 02Jan2021, Covid test done and result was negative, tested for antibody and it was positive. The outcome of the event fatigue was unknown. The outcome of the events chills and tingling sensation of extremities was recovered in Jan2021. The outcome of the events shortness of breath on exertion and weakness was not recovered. The events fatigue, chills, tingling sensation of extremities that continues on, shortness of breath on exertion and weakness required a physician office visit.
50 2021-01-11 feeling hot, flushing, hot flush Patient hot and flushed in the head, face, neck, and back area. It was disappears after 10 minutes.... Read more
Patient hot and flushed in the head, face, neck, and back area. It was disappears after 10 minutes. The patient was given Benadryl 25mg as a precaution.
50 2021-01-11 flushing 0811 - pt c/o lightheaded and flushing. Pt reports I feel like I am going to pass out. Pt assisted... Read more
0811 - pt c/o lightheaded and flushing. Pt reports I feel like I am going to pass out. Pt assisted to stretcher. BP - 131/83, hr 87, rr 22, sats 100. Pt given water. 0813 - Pt reports "I am feeling normal.: 0814 - 120/79, p 74, rr 20, sats 99 0818 - Pt clearing throat. Pt states this happened with first vaccine. Pt states "I feel a tickle in my throat." Pt unable to take Benadryl pills. 0820 - Pt given 25 mg liquid Benadryl 0828 - bp 137/85, hr 67, rr 18, sats 98.. Pt reports I feel better. Pt assisted to chair. 0835 - Walked in hallway with patient. Pt reports I feel normal. 0840 - Pt walked to door. Denies throat tickle, being lightheaded or flushed.
50 2021-01-12 pain in extremity, weakness Dizziness, Headache, numbness of tongue, then fogginess in head, then at 1pm started with headache,... Read more
Dizziness, Headache, numbness of tongue, then fogginess in head, then at 1pm started with headache, the arm soreness; transient 1/6/2021 light headeness and weakness; all resolved Narrative:
50 2021-01-13 weakness Feverish feeling and chills with myalgias and weakness at 4am on 12/18/2020. Took 800mg advil and 10... Read more
Feverish feeling and chills with myalgias and weakness at 4am on 12/18/2020. Took 800mg advil and 1000mg tylenol. Felt perfect by 7 am. Despite this, fearing covid, I did not go to work, was rapid trsted covid negative that day and pcr tested that day retirning negative 2 days later. Days later I began to have vague nagging chest pain with occasional sharp chest pain over my heart. I had what I would describe as chest tightness in addition in which it felt hard for me to expand my chest fully like pressure without being short of breath. This would last at most several minutes and perhaps occurred three or four times over a seven day period. Throughout this. I could exercise with no chest pain no increasing shortness of breath, including a PR on Peloton and two hours of tennis without cardiac symptoms. Yesterday, my smart internist heard a split S2 heart sound as I lay on my left side and held my breath; the EKG showed a depressed PR interval ad some ST elevstions consistent with pericarditis, which I am treating with motrin. I assume this is a viral pericarditis. I had two types of Covid tests during that time period. My second dose of the vaccine was January 8. The feverish feeling occurred before dose 2, as did some of the chest oains and tightness.
50 2021-01-13 flushing, tenderness Anaphylactic reaction - swollen lips, dizziness, flushing, rapid heart rate
50 2021-01-13 muscle spasms Moderate severe headache, chills, muscle aches and muscle spasms/cramps. Severe enough to keep me i... Read more
Moderate severe headache, chills, muscle aches and muscle spasms/cramps. Severe enough to keep me in bed the following day.
50 2021-01-14 weakness, night sweats 1/12/2021 @ 2200hrs - Muscle/body aches, injection site tenderness 1/12/2021 @ 2300hrs - Muscle/body... Read more
1/12/2021 @ 2200hrs - Muscle/body aches, injection site tenderness 1/12/2021 @ 2300hrs - Muscle/body aches, chills 1/13/2021 @ 0300hrs - Muscle/body aches, chills, fever of 99.0, general malaise 1/13/2021 @ 0600hrs - Muscle/body aches, chills, tired, no energy, difficult to get out of bed. Did not go to work. 1/13/2021 @ 1000hrs - Symptoms continued. Advil 600mg PO taken. Allowed sleep from 1030-1230hrs. 1/13/2021 @ 1230hrs - Woke up feeling damp as if having had night sweats. Rested the entire day. 1/14 to 1/15/2021 - Left arm site tenderness with raised hard area at site of injection. Left armpit raised/swollen, appears as lymphadenopathy.
50 2021-01-18 flushing facial and eye flushing, hot breath
50 2021-01-18 tingling, numbness C/O felling numbness in the back of his head and some tingling in left arm. Seen By EMT. BP-131/91,7... Read more
C/O felling numbness in the back of his head and some tingling in left arm. Seen By EMT. BP-131/91,76. O2 Sat 98%. TEl./EKG SR.
50 2021-01-19 pain in extremity on the night of 1/5/2021, headache and right arm pain. starting in the pm on 1/16/21 vomiting starte... Read more
on the night of 1/5/2021, headache and right arm pain. starting in the pm on 1/16/21 vomiting started and lasted through Tuesday 1/19/21. As of today lasting symptom is fatigue.
50 2021-01-19 pain in extremity the night of the vaccine, headache and arm pain started. On Saturday 1/16/21 vomited started and las... Read more
the night of the vaccine, headache and arm pain started. On Saturday 1/16/21 vomited started and lasted until Tuesday 1/19/21. Continues to feel fatigue today on 1/20/21.
50 2021-01-20 muscle spasms I expeirienced Body aches and cramoing. It was not sharp pains like cramping but a dull pain and was... Read more
I expeirienced Body aches and cramoing. It was not sharp pains like cramping but a dull pain and was very stift/sore till next day, approx 18 hours. Mild headache
50 2021-01-25 numbness numbness in his right hand; This is a spontaneous report from a contactable pharmacist (patient hims... Read more
numbness in his right hand; This is a spontaneous report from a contactable pharmacist (patient himself). A 50-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EH9899, expiration date was unknown), intramuscularly on the right arm on 18Dec2020 at 12:00 at a single dose for COVID-19 immunization administered at the hospital. The patient had no medical history. He had no known allergies. There were no concomitant medications. The patient had no other vaccine in four weeks and had no other medications in two weeks. The patient had no Covid prior to vaccination. He was not tested for Covid post vaccination. On an unspecified date, following the first vaccine, the patient had numbness in his right hand for two (x2) days. The patient did not receive any treatment for the event. The patient recovered from the event "numbness in his right hand" on an unspecified date.
50 2021-01-26 weakness, muscle spasms Malaise, weakness, muscle cramps fatigue.
50 2021-01-27 numbness Numbness right side of face and gums. Rash on arms.
50 2021-01-27 pain in extremity, burning sensation Date these symptoms started was 1/27/2021: About 12 hours after injection, developed fatigue and sl... Read more
Date these symptoms started was 1/27/2021: About 12 hours after injection, developed fatigue and slight nausea as expected. Oral temperature 98.0. Commuted to work without issue. ~ 1400: As day progressed, nausea subsided, but fatigue grew more profound and developed pain in the right subscapular area with exertional shortness of breath walking any length of time. (Injection of initial and second doses were both in right deltoid). 1540 - 1800: Fatigue increased, developed a burning/tearing pain with every yawn and deep breath from the top of my trachea into both left and right mainstem bronchi and radiated to right arm. It literally felt like someone was trying to tear out my bronchial tree with each breath. 1800: Arrived home and medicated self-medicated with Motrin 400mg. 1800 -2030: rested at home with still some breathing pain, no shortness of breath, but incredibly tired. 2045: Went to bed and slept for the next 12.5 hours without any issued during the night. 0800: Woke up nearly all symptoms were gone, only some minor residual fatigue. No breathing pain, no nausea, no subscapular pain. I did not seek medical attention for symptoms, nor did I contact my provider. I experienced fatigue and a headache with the first dose, but no other symptoms. I never experienced fever or chills
50 2021-01-27 pain in extremity Red sore arm, body aches, and head ache
50 2021-01-28 numbness, facial pain fever; my lighter weight facial fillers swelled and were painful (around the eyes - not my lip fille... Read more
fever; my lighter weight facial fillers swelled and were painful (around the eyes - not my lip fillers); my lighter weight facial fillers swelled and were painful (around the eyes - not my lip fillers); numbness in both hands; This is a spontaneous report from a contactable pharmacist (patient). A 50-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK4176, expiration date not reported), intramuscular on the left arm, on 07Jan2021, at 11:30 at a single dose for Covid-19 immunization. The patient has no medical history and no known allergies . There were no concomitant medications. The patient previously took the first vaccine of bnt162b2 on 18Dec2020, at 12:00 PM, Intramuscular, on the Right arm for Covid-19 immunization, he had numbness in his right hand x2 days. On 09Jan2021, following second dose, he has had numbness in both hands x2 days and on 10Jan2021, day 2, he ran a fever and his lighter weight facial fillers swelled and were painful (around the eyes - not my lip fillers). His eyes have a mix of Juvaderm products. It spontaneously resolved after 1 day with a subjective loss in overall volume. Density of the product used seemed to be a factor in the response. He knows this has been reported with the Moderna product, but he does not believe is has been reported with our product. It appears the response may not be product specific, but more specific to the type of vaccine. The patient has no Covid prior vaccination and not covid tested post vaccination. No treatment was received for the events. Outcome of the events was recovered in Jan2020.
50 2021-02-01 flushing Patient felt flushed and nauseous.
50 2021-02-02 pain in extremity 6 hours after shot, arm was in pain where i could hardly move, by morning felt like i had flu, by mo... Read more
6 hours after shot, arm was in pain where i could hardly move, by morning felt like i had flu, by mon afternoon temperature went up to 101.8 before dropping tues evening.
50 2021-02-02 seizure Seizure unilateral right side, less than 2 mins. 2 times post injection.
50 2021-02-04 numbness Numbness in the cheeks, lips and the tongue; Numbness in the cheeks, lips and the tongue; Numbness i... Read more
Numbness in the cheeks, lips and the tongue; Numbness in the cheeks, lips and the tongue; Numbness in the cheeks, lips and the tongue; This is a spontaneous report from a contactable consumer (patient). This 50-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# SL3247), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. The patient's medical history included ongoing thyroid. The patient's concomitant medications included thyroid (ARMOUR THYROID) for thyroid. Patient had a COVID 19 vaccine on 22Jan2021 and had couple of side effects with the numbness in the cheeks, lips and the tongue in Jan2021. No treatment received. Outcome of the events was unknown. No investigation assessment.
50 2021-02-08 pain in extremity left hand swelling. entire hand and fingers. not arm or lymph nodes. just hand. painful and difficul... Read more
left hand swelling. entire hand and fingers. not arm or lymph nodes. just hand. painful and difficult to make a fist and bend fingers
50 2021-02-09 pain in extremity, weakness sore arm; lack of energy; Headaches on occasion.; This is a spontaneous report from a contactable co... Read more
sore arm; lack of energy; Headaches on occasion.; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: El1283), via an unspecified route of administration in the left arm on 18Jan2021 14:00 at a single dose for covid-19 immunization. The patient has no medical history and concomitant medications. On 19Jan2021 06:00, the patient reported sore arm, noticeable lack of energy and headaches on occasion. The patient does not have covid prior vaccination and had not tested positive post vaccination. The patient did not receive treatment for the events. The outcome of the events was not recovered.
50 2021-02-09 pain in extremity arm was sore; This is a spontaneous report based on the information received by Pfizer. (Case Number... Read more
arm was sore; This is a spontaneous report based on the information received by Pfizer. (Case Number: 01845505). A non-contactable consumer (Wife) reported 50-year-old male patient that: Description: Voicemail left on PIR line on 14Jan2021 at 10:29 PM. She learned of from her husband, on the Pfizer COVID-19 vaccine. He had his first vaccine on 13Jan2021 and on 14Jan2021 reported that his arm was sore, "really really sore like he had been punched in the arm". There is not permission to contact the patient about this report. No PQC reported. Physical information: Product: Pfizer Covid-19 vaccine Product circular#: N/A Lot number: EL3249 Expiration date: Unknown by reporter Dose/ frequency: single dose No follow-up attempts are possible. No further information expected.
50 2021-02-14 discomfort body aches/chills/headache/lymphadenopathy L sided (side of injection) - all resolved except of sign... Read more
body aches/chills/headache/lymphadenopathy L sided (side of injection) - all resolved except of significant Left axillary lymphadenopathy - swelling was the size of small melon, non-tender, rather uncomfortable. Next day, it got a bit smaller - about size of large fist, but still present, day 4. Post auricular and posterior cervical Left lymph nodes were also enlarged and tender, but not to the same extend.
50 2021-02-14 tingling Pfizer-BioNTech COVID-19 Vaccine: About 15 minutes after vaccination, patient started to feel that ... Read more
Pfizer-BioNTech COVID-19 Vaccine: About 15 minutes after vaccination, patient started to feel that there is a lump in his throat and both hands had tingling. Paramedic was on site and put patient on EKG monitor and observed patient for 20 minutes. The patient left the site independently and stated no further issues.
50 2021-02-17 flushing delirium; Fever of 100.8; chills; flushed; overall soreness; deltoid pain; This is a spontaneous rep... Read more
delirium; Fever of 100.8; chills; flushed; overall soreness; deltoid pain; This is a spontaneous report from a non-contactable consumer. A 50-year-old male patient received BNT162B2 (lot# unknown) on 03Feb2021 01:30 PM at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Patient experienced Fever of 100.8, chills, flushed, overall soreness, delirium, and deltoid pain on 04Feb2021 04:00 AM with outcome was Recovering. No covid prior vaccination. No covid tested post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
50 2021-02-22 flushing Flushed, pale, diaphoretic, bradycardic. Epi administered and RRT called. Admitted to hospital with ... Read more
Flushed, pale, diaphoretic, bradycardic. Epi administered and RRT called. Admitted to hospital with cardiac cath - likely unrelated.
50 2021-02-23 numbness and pain in extremities B12 deficiency, identified via neuropathy.
50 2021-02-25 pain in extremity Little back problems, lower back; hurts(Back); My arm is hurting; my arm was killing me; my arm hurt... Read more
Little back problems, lower back; hurts(Back); My arm is hurting; my arm was killing me; my arm hurts; I throw up twice yesterday; I got a little sick; I just got a little chill; I got chills on the lower part of my back; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL3247), via an unspecified route of administration at the age of 50 years, on 25Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient stated, "Yesterday I took my second vaccine shot and my side effects this morning was a little back problems, lower back, my arm is hurting, and I throw up twice yesterday, I got a little sick. So, I just wanted to call and let somebody know." It was also stated, "Yesterday when I got home after the shot, I just got a little chill and then I laid down, I throw up twice and I just laid down and laid down. And when I woke up I was calling you all since 1 in the morning because my arm was killing me." It was stated, "Yes, my arm hurts and my back, I am in my house and I got the back thing on for, the heating pad (treatment), just for my back." The consumer stated, "I took aspirin because I throw up twice yesterday so I just took aspirin. And then I was laid down and I woke up this morning and I took one in the morning. I have been trying to call you all morning, all morning I just got, just to let you know that my arm is hurting and I got a chills on the lower part of my back." Therapeutic measures were taken as a result of little back problems, lower back; hurts(back) (back pain), i throw up twice yesterday (vomiting). The outcome of the events was not recovered.
50 2021-02-26 bell's palsy I received 2nd dose of vaccine on Jan 11. On the date above I developed eye irritation. The next... Read more
I received 2nd dose of vaccine on Jan 11. On the date above I developed eye irritation. The next day I couldn?t blink that eye and was diagnosed with Bells Palsy.
50 2021-02-28 numbness About twenty minutes after the injection, I was walking to the transit and my legs felt a little bit... Read more
About twenty minutes after the injection, I was walking to the transit and my legs felt a little bit numb (but not tingly) I thought maybe it was nerves. About 25 minutes after the injection, I was concerned (possibly too anxious) and I decided to return to the site. I crossed the bridge and sat down at the bridge gate. The personnel there called an EMT, and about 15 minutes later the EMT came to talk to me and take my blood pressure and pulse Oxygen. Blood pressure was 137 - 87. Pulse Ox was 100%. By that time I had calmed down the sensation in my legs had eased. Approximately 2 hours after the injection I began to feel soreness in my joints (and this did not pre-occupy me, since I knew that feeling the beginning of aches and pains a couple hours after injection is normal). It is now 6 hours and 32 minutes after the injection, and I am feeling ok. It was quite probably anxiety on my end. The folks in city were very nice to me at the pedestrian bridge gate. I have noted talking the EMT below as health professional visit, I also plan to go see Dr. prior to the 2nd shot.
50 2021-03-03 numbness The evening of the 2nd vaccine started having numbness in left shoulder and progressed to hand. The... Read more
The evening of the 2nd vaccine started having numbness in left shoulder and progressed to hand. Then numbness also affected left side of face and neck and left anterior chest wall. Intermittent pain in chest wall with intermittent resolve of numbness. The worst of it lasted a week. After a week, numbness started to resolve, but still have residual numbness in left hand. Did have headaches as well for that week and then headaches resolved after a week.
50 2021-03-03 tingling I have experienced low-level numbness/tingling in my left hand; primarily in my thumb and index fing... Read more
I have experienced low-level numbness/tingling in my left hand; primarily in my thumb and index finger. Range of motion has been normal. No pain either. Strangely it began 1 week after my first injection. It was intermittent in the time after that and before the 2nd injection. On the day of the second injection I experienced renewed symptoms in the same hand immediately after receiving my 2nd dose. I spoke with the attending physician at the time and was told that she had heard about some instances of numbness but it would probably fade with time. Unfortunately I am now over 2 weeks since the second dose was administered and my symptoms have been nearly constant and do not appear to be waning.
50 2021-03-04 tingling About an hour after the shot, I felt some tingling in my face; that was followed by a few odd sensat... Read more
About an hour after the shot, I felt some tingling in my face; that was followed by a few odd sensations, all of which are basically the same as when I have a flu shot. Eight hours after the shot, I noticed that I was smelling smoke; my sense of smell started to do weird things an hour before (for example, smelling rotten food in the fridge), but this became clear when the smoke smell started. Over the first 48 hours, my left arm was sore (sore to touch at 24 hours, gone at 48), and I had some mild flu symptoms (sore throat, stuffy nose, fatigue), plus some chest "tightness" which I have been feeling from time to time since March 2020. The flu-like symptoms were all basically gone except the stuffy nose. I still have a slight stuffy nose, and the strange smell issue. I have been able to smell things fine all along, it's just overlaid with a smell that started as smoke or BBQ, and varies in strength; it's a bit like smelling dirt now. It's always possible this is coincidental, but I wasn't exposed to smoke or anything that I think could cause my nose to go haywire.
50 2021-03-06 tingling, slurring Initial confusion upon waking at 7AM. Uncomfortable but unable to determine why. Tried to re-arrange... Read more
Initial confusion upon waking at 7AM. Uncomfortable but unable to determine why. Tried to re-arrange pillows but could not get arms to complete the process even though fully mobile. A minor amount of weakness in arms/legs and tingling across the lower face, particularly on the right side. Once up, had an inability to form words even though thoughts were coherent. Minor difficulty swallowing water. Speech slurred badly enough to be incomprehensible to my wife. By 7:30 we arrived at the hospital where symptoms were improving.
50 2021-03-06 tenderness Testicular pain and tenderness in the left testicle. There is no redness and only slight swelling. T... Read more
Testicular pain and tenderness in the left testicle. There is no redness and only slight swelling. The pain was focused on the back side of the left testicle and radiated up the inguinal canal into the abdomen. It was present on palpation and intermittently without palpation. Pain came on quickly and subsided over 24 hours. No penile discharge, fever, or other signs were present.
50 2021-03-08 seizure Friday at 1:30 (3/5 my husband received the first shot. That evening he wasn't feeling well at all. ... Read more
Friday at 1:30 (3/5 my husband received the first shot. That evening he wasn't feeling well at all. Went to sleep in the morning on 3/6 he still was feeling horrible. Looked gray in color- thought he was getting the flu. At 2AM I woke to him having a seizure. Followed by another seizure at 10AM ( 3/7) followed by another seizure at 3PM (3/7) followed by another seizure at 3AM (3/8) and another seizure at 6:30 AM on (3/8).
50 2021-03-09 pain in extremity Pain at injection site. Achy body. **Severe pain in my left hip and down my left leg. Unable to walk... Read more
Pain at injection site. Achy body. **Severe pain in my left hip and down my left leg. Unable to walk without severe limp and pain.**
50 2021-03-10 numbness Within 5 hours of receiving the shot my entire right arm was numb and tingly and my pinky finger fel... Read more
Within 5 hours of receiving the shot my entire right arm was numb and tingly and my pinky finger felt like it wasn?t there. I also has the worst headache of my life, ibuprofen didn?t help it. The next morning (Friday) I felt somewhat better but by noon, I felt just as bad as the night before and the horrible headache was back. Saturday and Sunday were exactly like Friday. Monday morning, my arm was back to normal and the horrible headache was gone. Since them I?ve had headaches on and off, but not as horrible as Thursday thru Sunday. This afternoon marks 1 week since my first of 2 doses. I?m not sure at this point if I want to get the 2nd dose or not when it?s due.
50 2021-03-11 feeling hot Pt states he felt a flush of warmth through his body for 10 minutes. Had a drink water, take off hi... Read more
Pt states he felt a flush of warmth through his body for 10 minutes. Had a drink water, take off his jacket and wait. Seen by NP, symptoms resolved. VSS @ 1400 BP 170/98, Pt has history of High blood pressure but did not take medications. HR 88, O2Sat 98%, T: 97.5F. VSS @ 1420 Discharge, T: 97.5, HR 86, OSat 99%
50 2021-03-11 tingling Swelling and tightness of right side of face (cheek), right leg paresthesia.
50 2021-03-12 seizure Had seizure in car when leaving the facility, about 1/2 hour after the vaccination.
50 2021-03-15 burning sensation, tingling Approximately 3 days after the injection I had a bad breakout of acne on my scalp and on my temples.... Read more
Approximately 3 days after the injection I had a bad breakout of acne on my scalp and on my temples. I went to the dermatologist and this was treated with Doxycycline Hyclate. The bad breakout of acne cleared up in about 1-1.5 weeks. At the two week mark I started to have a burning sensation near my left eye that felt like a sunburn or some nerve tingling. I interpreted this to potentially be the early signals of shingles so I started taking Valtrex. I will take a 1,000 mg dosage of Valtrex twice a day for 7 days to treat this. I had the Shingrex vaccine on 12/19/19 and 4/29/20. I feel like both of these issues were potential side effects from the Covid vaccine.
50 2021-03-16 weakness Client had syncopal episode, diaphoretic, n/v assessed by Lead RN & EMS , EMStransported client for... Read more
Client had syncopal episode, diaphoretic, n/v assessed by Lead RN & EMS , EMStransported client for hypotension and weakness.
50 2021-03-16 tremor, tingling, flushing Tingling up left shoulder, neck and head approximately 1 minute post injection. Followed by flushi... Read more
Tingling up left shoulder, neck and head approximately 1 minute post injection. Followed by flushing, nausea and trembling. Approximately 5-7 minutes post injection experienced onset of difficulty swallowing and rapid heartbeat. 10-12 minutes post injection sensation of throat closing with some difficulty breathing, difficulty swallowing increased. 15-17 minutes post injection, paramedics arrived. Blood pressure was 169/113. Dizzy upon standing. 20 minutes post injection paramedics administered 50mg Benadryl due to difficulty swallowing and sensation of throat closing however it wasn?t worsening. Paramedic asked me to rate the swallowing difficulty (1-10) which was a 5-6 but never exceeded that. Transported to Emergency Room.
50 2021-03-17 pain in extremity A lot pain in my arms Stomach discomfort
50 2021-03-18 flushing, weakness Flushed, sweating, ?fever feeling?, altered vision, weakness
50 2021-03-18 numbness 3-17-21 6:30PM 'A LITTLE NUMBNESS TO RT FOREARM'. PTP INDICATES ANTERIOR ASPECT. MOTOR AND SENSORY I... Read more
3-17-21 6:30PM 'A LITTLE NUMBNESS TO RT FOREARM'. PTP INDICATES ANTERIOR ASPECT. MOTOR AND SENSORY INTACT; NO DEFICIT NOTED. CAP REFILL GOOD. BOTH ARMS PINK, W/D. EQUAL STRENGTH AND GRIP NOTED. NO ACUTE OR OBVIOUS DISTRESS NOTED.
50 2021-03-19 pain in extremity Started with sore arm 10 hrs after shot, then body aches, headache, chills started around 11pm(12 ... Read more
Started with sore arm 10 hrs after shot, then body aches, headache, chills started around 11pm(12 hrs after) My normal temp us about 97.8 it was up to 99 at 1am Nausea started around then. Dry mouth, by 3am temp was 99.9, vomited 3 times by 4am and temp went to 100.3 20 min later it was 99.6 at 8am i still had massive headache, temp iup to 101, still chills and sweats, nauseous Well it was 101, now 99 in just 20 min Nausea subsided enough to take Acetaminophen Temp around 100 till mid afternoon. Headache continued. Was able to eat dinner. Around then most symptoms stopped except headache and itchy skin Btw i had covid 7/2020
50 2021-03-19 pain in extremity right arm pain
50 2021-03-19 tremor Light headed Stomach upset Headache Passed out and shook on the ground Called paramedics
50 2021-03-21 bell's palsy, tingling, numbness left side of face just under cheek bone feels slightly numb and tingly, left side of mouth appears v... Read more
left side of face just under cheek bone feels slightly numb and tingly, left side of mouth appears very, very, very, slightly "drooped" like it does not match the right side of my mouth; left side of face just under cheek bone feels slightly numb and tingly, left side of mouth appears very, very, very, slightly "drooped" like it does not match the right side of my mouth; left side of face just under cheek bone feels slightly numb and tingly, left side of mouth appears very, very, very, slightly "drooped" like it does not match the right side of my mouth; This is a spontaneous report from a contactable consumer (patient himself). A 50-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 06Mar2021 15:45 (at age of 50-year-old) (Lot Number: EN6206) as single dose for COVID-19 immunization. Medical history included high blood pressure, high cholesterol, obesity. There was known allergies: bee stings and sulfa drugs. Concomitant medications included atorvastatin (LIPITOR); hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ); and emtricitabine, tenofovir disoproxil fumarate (TRUVADA). The patient reported "left side of face just under cheek bone feels slightly numb and tingly, left side of mouth appears very, very, very, slightly 'drooped' like it does not match the right side of my mouth but you have to stare and look really close to notice it. Should I hold off on getting my second dose in the next 3 or 4 weeks to see how this goes?" The adverse events start time was 06Mar2021 20:45. The events did not result in emergency room visit or physician office visit. It was unknown if treatment received for the events. There was no COVID prior vaccination or COVID tested post vaccination. The outcome of events was not resolved.
50 2021-03-21 pain in extremity I got my first Pfizer covid shot around 3:30 PM on March 16, 2021. Around 10:00 PM, my arm started ... Read more
I got my first Pfizer covid shot around 3:30 PM on March 16, 2021. Around 10:00 PM, my arm started to get some soreness. I also noticed that I started feeling really sluggish with some muscle pains. Approximately 11:30 PM, I attempted to go to sleep and noticed that I started having a minor respiratory distress where I could hear myself wheezing. The wheezing only lasted about one hour. All the symptoms disappeared after 36 hours without any treatments or medications. At this point, I'm not sure If I should get my second vaccine shot.
50 2021-03-22 numbness Numbness from ring to pinky finger of left arm travelling up to shoulder. Heaviness in lower left ar... Read more
Numbness from ring to pinky finger of left arm travelling up to shoulder. Heaviness in lower left arm. These symptoms started 1 day after vaccination on 01/15/2021 and have persisted until now. Patient reports worsening symptoms in the last 1-2 days.
50 2021-03-23 feeling hot Patient received his first dose of Pfizer COVID-19 vaccine on 3/15/21, administered by store. He had... Read more
Patient received his first dose of Pfizer COVID-19 vaccine on 3/15/21, administered by store. He had the following reaction within minutes of receiving the vaccine. States he was still under the watch of the clinical team who administered it: Turned red, and got really hot. He tried to stand up, he felt fine but was sweating terribly. He developed a rash on the middle of his back 6-7 inches red rash, it did not itch. Reactions resolved within that same day. However, had a severe headache for about 24 hours.
50 2021-03-23 pain in extremity Dizziness, Myalgia, Fever, Diarrhea, FEVER 100.1, ARM PAIN, DIARRHEA,BODY ACHES, FATIGUE, DIZZINESS ... Read more
Dizziness, Myalgia, Fever, Diarrhea, FEVER 100.1, ARM PAIN, DIARRHEA,BODY ACHES, FATIGUE, DIZZINESS Narrative: FEVER 100.1, ARM PAIN, DIARRHEA,BODY ACHES, FATIGUE, DIZZINESS following 2nd Pfizer COVID Vaccine. Other Relevant History:
50 2021-03-23 cold extremities Extreme sweating, especially under the armpits. I've never had this before. Both armpits have what l... Read more
Extreme sweating, especially under the armpits. I've never had this before. Both armpits have what looks like a red skin rash. Also, my toes are extremely cold.
50 2021-03-24 weakness Severe sweating; fever; weakness; Worst headache of my life/daily headaches; searing eye pain; fatig... Read more
Severe sweating; fever; weakness; Worst headache of my life/daily headaches; searing eye pain; fatigue; This is a spontaneous report from a contactable physician (patient). A 50-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1284), via an unspecified route of administration in left arm on 05Jan2021 16:00 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730) in the right arm on 16Dec2020 12:00 PM. The patient had no other vaccine in four weeks. The patient had not been diagnosed with COVID prior vaccination. The patient experienced severe sweating, fever, weakness, "worst headache of my life," searing eye pain for the last 2 months, daily headaches and fatigue on 06Jan2021 12:00 AM (also reported as first 48 hours). The events resulted in disability or permanent damage. Treatment was administered for the reported events. Outcome of events was unknown. The patient underwent Covid nasal swab test post vaccination on 27Jan2021 with negative result.; Sender's Comments: Based on temporal association and known drug profile a contributory role of BNT162B2 to the reported events cannot be excluded. Case will be reassessed if additional information is received. 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.
50 2021-03-24 tingling Back of left arm tingled after injection. No shortness of breath /dizziness/lightheadedness A&O Cl... Read more
Back of left arm tingled after injection. No shortness of breath /dizziness/lightheadedness A&O Client left at 4:45pm arm no longer tingling. No shortness of breath
50 2021-03-25 flushing 30 minutes after receiving Pfizer COVID vaccine #1 pt reports he became very flushed and hot and fat... Read more
30 minutes after receiving Pfizer COVID vaccine #1 pt reports he became very flushed and hot and fatigued. Itching started later that night. Face felt swollen but no difficulty breathing, swallowing. I saw him the following day via telehealth and he reported generalized redness was improving but not resolved and pruritis persisted but was improving but the hour.
50 2021-03-25 pain in extremity Sore arm, body aches, nausea, severe headache
50 2021-03-27 pain in extremity, numbness 1. Around March 20th, 7 days after the vaccination, felt mild pain between left ear and temple. Pain... Read more
1. Around March 20th, 7 days after the vaccination, felt mild pain between left ear and temple. Pain was more if the head is shaken or if I jump. This pain disappeared on 27th March. 2. On March 26th both the feet are swollen , left foot more than the right. I still feel slight numbness in the feet today on March 28th. 3. On March 27th , around noon, a blood clott showed up on my left palm , it caused intense pain in the arm for 10 minutes before starting to subside itself. I felt a lump in my palm , it was visible in dark color ,about 1 cm in size. I still feel it in my palm today on 28th March.
50 2021-03-27 tingling Paresthesia In injection arm and face
50 2021-03-27 tenderness Swelling in Left Underarm area, slightly painful to touch. Tiredness
50 2021-03-28 bell's palsy Part of the face started to clench a little, don't know if that's part of Bell's palsy or that was j... Read more
Part of the face started to clench a little, don't know if that's part of Bell's palsy or that was just; Heart palpitations; Chills; This is a spontaneous report from a contactable consumer, who reported for himself. A 50-years-old male consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EN6206), via an unspecified route of administration, on 03Mar2021 at 3:15 pm (at the age of 50-years-old) as a single dose for COVID-19 immunization, in left arm. Relevant medical history included cholesterol. Concomitant medications included: Rosuvastatin 20mg, once a day for cholesterol, started a year ago and Vitamin C. On 03Mar2021, the patient had heart palpitations that lasted multiple days. I went to a cardiologist and he wasn't sure whether I should do a second vaccine dose, given that was one of the side effect. He gave me metoprolol which took down the heart rate. But I had the chills, I had part of the face started to clench a little. I don't know if that's part of Bell's palsy or that was just, I just don't know. It wasn't strong, it went away relatively quickly, within 4 hours. Treatment for heart palpitation: Metoprolol Tartrate, 25 mg, one. No treatment received for chills. The clinical outcome of the events Heart palpitations and chills was recovered on 11Mar2021, the outcome of the event face started to clench a little was recovered on 03Mar2021.
50 2021-03-28 numbness, tingling Numbness/tingling in lips then spread to cheek and nose on right side of face. Then right thumb and... Read more
Numbness/tingling in lips then spread to cheek and nose on right side of face. Then right thumb and index finger and back of right hand numbness and tingling. Has lasted for close to 24 hours.
50 2021-03-28 tingling, numbness, pain in extremity one day after: sore arm two days after: numbness and tingling in hand and elbow of left arm (my sh... Read more
one day after: sore arm two days after: numbness and tingling in hand and elbow of left arm (my shot was in the left upper biceps)
50 2021-03-28 tingling, pain in extremity Sore arm with tingling down to hand. Very present while running. Tingling not completely gone nearly... Read more
Sore arm with tingling down to hand. Very present while running. Tingling not completely gone nearly three weeks later.
50 2021-03-28 tingling Patient felt pressure in the chest, tingling in the right leg and watery eyes after receiving the va... Read more
Patient felt pressure in the chest, tingling in the right leg and watery eyes after receiving the vaccine. After drinking water the patient felt better. Heart rate and breathing were fine
50 2021-03-29 feeling hot Reported being hot and having a headache. No sign or symptoms of distress. Client monitored then R... Read more
Reported being hot and having a headache. No sign or symptoms of distress. Client monitored then Released.
50 2021-03-29 flushing Flushing/sweating, dizziness. BP 106/60 (pulse 63). Final BP 120/82 (pulse 75).
50 2021-03-29 tingling hands tingling. Evaluated by EMS-Cleared
50 2021-03-30 facial paralysis, bell's palsy HISTORY OF PRESENT ILLNESS: HPI Patient is a male presenting to the emergency department with conce... Read more
HISTORY OF PRESENT ILLNESS: HPI Patient is a male presenting to the emergency department with concerns regarding left-sided facial droop. The patient tells me that he received a COVID-19 vaccine (1st dose) 10 days ago. Patient states that he went to sleep around 23:00 last night. He woke up this morning with left-sided facial droop and inability to close his eye completely on the left. Patient presented to the emergency department for evaluation. He denies any symptoms otherwise. He denies any facial numbness, but states that her rather feels like it is ?paralyzed.? Patient denies any numbness or tingling in his arms or legs. He denies any unilateral arm or leg weakness. He denies any visual changes. No blurry or double vision. He denies any difficulty with speech or finding words. He denies any headache or dizziness. No chest or abdominal pain. No nausea or vomiting. No fevers or chills. No flu-like symptoms. He denies any loss of taste. He denies any numbness or tingling in his tongue or lips. He has no symptoms otherwise. There is no problem list on file for this patient. No past medical history on file. Reviewed and negative. He denies any personal medical history. Denies any family history of strokes or personal history of strokes. Vital signs reviewed. Patient evaluated. Based on exam and history, it is consistent with left-sided Bell's palsy. He has no other neurological symptoms and his neurological exam aside from the facial droop is otherwise unremarkable. I have low concern for stroke based on evaluation today. He has involvement of the forehead muscles. At this point, I did discuss with him that this is Bell's palsy and he will be treated with prednisone and valacyclovir . I do not feel additional workup indicated. He was agreeable. He was given an eye shield that he was given eye lubricant to help avoid dry eye. I did discuss with him that this also may be related to the vaccine given recent administration. I discussed that he should talk to his doctor about this prior to his 2nd dose. Patient instructed to monitor symptoms and all questions were addressed. He was discharged in stable condition Follow-up Information No Results Physician, MD. BLOOD PRESSURE SCREENING: HTN (>/=140/90), recommend follow up with PCP within 1 month. Orders Placed This Encounter Medications ? hypromellose (GENTEAL) 0.3 % GEL ophthalmic gel Sig: Apply 1 Application to left eye if needed for Dry Eyes. Dispense: 10 g Refill: 0 ? valACYclovir (VALTREX) 500 MG tablet Sig: Take 2 tablets by mouth 2 times daily for 7 days. Dispense: 28 tablet Refill: 0 ? predniSONE (DELTASONE) 20 MG tablet Sig: Take 3 tablets by mouth daily for 7 days. Dispense: 21 tablet Refill: 0 ? predniSONE (DELTASONE) tablet 60 mg ? valACYclovir (VALTREX) tablet 1,000 mg
50 2021-03-30 numbness My right foot is numb. I can move the foot but I don?t have any feeling on the bottom of it.
50 2021-03-30 muscle spasms Chills, muscle cramping
50 2021-03-31 numbness 30 minutes after shot administered in left arm, pain in left shoulder blade along with pain on left ... Read more
30 minutes after shot administered in left arm, pain in left shoulder blade along with pain on left side of neck. After 2 days, pain in neck subsided as pain in left shoulder blade and left shoulder increased and after a week left index finger and thumb became numb. Pain remains in left shoulder, however pain in shoulder blade after 2 weeks moves from left should blade to neck and sometimes both. Loss of sleep due to pain and on a scale of 1-10 pain is an 8-9 constantly. Went to a Chiropractor on Monday, March 29, 2021 for an adjustment and assessment, nerve test reveled nerves in that area not firing properly. Followed with a massage with no avail or reduction in pain or numbness. Have an appointment with DO my doctor on Thursday, April 8, 2021 or if she can get me in sooner.
50 2021-03-31 numbness NUMBNESS FINGER AND TOES
50 2021-03-31 muscle spasms I experienced muscle soreness at the injection site (upper-left arm) around 9P followed by cramping ... Read more
I experienced muscle soreness at the injection site (upper-left arm) around 9P followed by cramping of my left calf. I went to bed and work up at 2A with body aches, stiffness, and joint throughout my body. The next day I continued experiencing the cramp in my leg and body aches, stiffness, and joint pain throughout my body, and general fatigue. The symptoms were mostly gone after my second night's sleep. I am still feeling lingering (mild) soreness and fatigue today, 4/2/2021.
50 2021-03-31 pain in extremity Intense pain in upper arm and shoulder, staying about an hour after injection and laying for approx... Read more
Intense pain in upper arm and shoulder, staying about an hour after injection and laying for approximately 36 hours. Also fatigue that continues to now.
50 2021-03-31 unresponsive to stimuli Responded to Nurse Alert in Covid vaccine clinic Department. Interventions: IV NS 0.9% started ... Read more
Responded to Nurse Alert in Covid vaccine clinic Department. Interventions: IV NS 0.9% started @ rate: Bolus , time: NA, per instruction (Verbal Order) by Dr. Blood Sugar Reading (per accucheck): 106 mg/dl; Nourishment offered: no Baseline and succeeding Vital Signs: Time Taken 1945 Temperature na Pulse Rate 42 Respiration Rate 16 Blood Pressure 96/62 O2 Saturation 72 Quick Nursing Assessment at the Scene: Pt was dysphoretic, A&Ox3 gray in color. Cold and clammy. Pt reports feeling dizzy and almost falling in the bathroom. During assessment Pt want unresponsive. Pt never lost his pulse. Nurses alert was called than 911. Pt was A&Ox3 when EMS arrived. 2L of O2 NC was placed on Pt and SPO2 increased to 100%. 20G IV was started in the left AC and NS bolus was rendered. EMS ALS took Pt to the nearest hospital. Pt did receive 0.3 second dose of Pfizer vaccine. Patient Disposition: 911 called.
50 2021-04-01 tingling Starting 3/30/21 head and whole body paresthesias with mild chest tightness. Still present 4/2/21 a... Read more
Starting 3/30/21 head and whole body paresthesias with mild chest tightness. Still present 4/2/21 and symptoms about the same. No weakness, change in mental status, shortness of breath or loss of any function.
50 2021-04-02 feeling cold Major (extreme) chills (almost uncontrollable chills and coldness, teeth rattling, slight delirium);... Read more
Major (extreme) chills (almost uncontrollable chills and coldness, teeth rattling, slight delirium); body aches, major headache. Couldn't get warm despite spouse providing me with multiple blankets that night. Took tylenol to help with headache through the night. Woke up the next day with major body aches throughout my body. Continued headache and fatigue like symptoms along with the pain. Used tylenol PM the second night to combat continued headache but no chills the second night. Started to feel better today, April 3rd, which is 48 hours since my 2nd Pfizer vaccination.
50 2021-04-02 pain in extremity Sore arm for a day after; This is a spontaneous report from a Contactable Consumer (patient's wife).... Read more
Sore arm for a day after; This is a spontaneous report from a Contactable Consumer (patient's wife). A 50-year-old male patient received first dose of bnt162b2 (BNT162B2; Solution for injection) via unspecified route of administration on 27Jan2021 at single dose for covid-19 immunization. Her husband takes no medications. He has no medical history or conditions. He has no allergies at all. It was reported that She thought she would report some side effects after one shot of the Pfizer COVID19 Vaccine. It is strange. She didn't read the symptoms until seven days out. Then she saw some have reported a lot less. After the shot, that night she had swelling in her upper chest. She thinks it was lymph nodes in the breast and chest area on the side she got the shot. The next day her arm that she got the vaccine in got very large. Then, she doesn't know if it was related, two days later she had itching on both of her feet. It was the tops of her feet and only for a couple of days. She is not counting that. Day five after the shot has been the main problem. Her arm pits started itching like crazy. It was severe itching and swelling in her arm pits. The itching lasted for three to four days. The lymph nodes in her arm are still swollen. It was five days after the shot. It is both arm pits. The night of the shot she had a lot of neck pain and she thinks it was probably the lymph nodes in the back of her neck. That has lasted and is slowly diminishing. Height six-foot one inch or six foot two inches. Weight 225 to 230 pounds. He is not obese, but a big guy. There was an agency for assisted living for people that need help. They were giving it and had extra doses. This guy in charge at the assisted living house offered it to caller and caller's husband because her and her husband run a behavior health counseling. He offered it to them as healthcare professionals. Her husband got it at the same time and didn't even have a sore arm. Caller clarified that he did have a sore arm for a day after. It didn't swell up. The outcome of the event was "Unknown". Information on the lot/ batch number has been requested.
50 2021-04-02 tremor Headaches Bodyaches Vomiting Fever Shakiness Heart racing
50 2021-04-04 pain in extremity Two days after receiving vaccine, left side neck, left arm, and back began to hurt as if a nerve was... Read more
Two days after receiving vaccine, left side neck, left arm, and back began to hurt as if a nerve was pinched. It is still happening.
50 2021-04-05 hot flush, numbness 4-Apr, 20:00 - pain at injection site, numbness in right ring and pinkie fingers. Numbness cleared ... Read more
4-Apr, 20:00 - pain at injection site, numbness in right ring and pinkie fingers. Numbness cleared after vigorous flexing of hand. Repeated symptom and solution throughout night. Treatment: see above 5-Apr, 02:30 - pronounced pain at injection site and right hip (site of existing injury) radiating to groin, nausea (without vomiting), alternating hot flashes and chills, generalized muscular discomfort. Treatment: OTC painkiller (Tylenol) 5-Apr, 04:00 - Headache, sound of rushing blood in right ear. Treatment: none
50 2021-04-06 flushing Flushing, headache, and hypertension Treated with intravenous ketorolac and famotidine Flushing, hea... Read more
Flushing, headache, and hypertension Treated with intravenous ketorolac and famotidine Flushing, headache, and hypertension improving
50 2021-04-07 feeling cold Fever and chills beginning approximately 14 hours after second shot. Insomnia and racing heart all ... Read more
Fever and chills beginning approximately 14 hours after second shot. Insomnia and racing heart all night. Body felt extremely cold, and I had to add three layers of sweatpants/sweatshirts/socks to stay warm. Headache and fatigue lasted approximately 48 hours. Took 72 hours to feel back to 100%
50 2021-04-07 pain in extremity, night sweats First dose, next morning. Slight body aches low fever (below 100), lethargy and foggy headedness. ... Read more
First dose, next morning. Slight body aches low fever (below 100), lethargy and foggy headedness. Arm hurt at injection site and pain spread slightly. All symptoms seemed worse day 2 post shot (3/17/2021). Persisted for about 4 days, gradually getting better. Went to work but was pretty miserable. Took Tylenol and Ibuprofin alternating every 2 hours for fever. Second dose next morning. Higher fever (topped at about 101 and change), severe fatigue, slept 18 hrs and took off work. Alternated tylenol and ibuprofin every 2 hours. Also chills, heavy night sweat body aches.. Next day, sub 100 fever that "rollercoastered" all day. Alternated tylenol and ibuprofin every 2 hours. Body aches, arm ached at injection site. Worked from home. Day 3 post injection (4/8/21) felt better, went to work, fine in the am, slight fatigue towards shift's end.
50 2021-04-07 pain in extremity In evening severe left arm and neck soreness, very tired, followed by prolonged diarrhea which cont... Read more
In evening severe left arm and neck soreness, very tired, followed by prolonged diarrhea which continued until next day.
50 2021-04-08 bell's palsy, facial paralysis Two to three hours after injected, I bit my inner lip several time while eating. My wife said left... Read more
Two to three hours after injected, I bit my inner lip several time while eating. My wife said left side of face seem swelling. The next morning has symptoms of Bell's Palsy. Left side of face seem paralysis. As days progress, the symptoms was more obvious. Text doctor on Sunday and Doctor office called on Monday and recommend i go to ER to confirm .
50 2021-04-08 pain in extremity Pain in right big toe. Pain got worse throughout the night, pain on touch and in joint of toe. Una... Read more
Pain in right big toe. Pain got worse throughout the night, pain on touch and in joint of toe. Unable to put pressure on it, unable to sleep. Pain subsided~12 hours after start. After 24 hrs no pain at all. No other adverse effects.
50 2021-04-08 tremor, tingling Site: Swelling at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mi... Read more
Site: Swelling at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: patient described as an almost panic attatck reaction - shakiness, dizziness, blurry vision, nausea. Blood pressure and heart rate not elevated. SAt for 20 minutes and started feeling better then got the chills and more shakiness
50 2021-04-09 flushing Face Flushing. About 2 hours later face became red but no other symptoms and patient was counseled t... Read more
Face Flushing. About 2 hours later face became red but no other symptoms and patient was counseled to go to ER if any other symptoms develop.
50 2021-04-09 hot flush I am dizzy and can't hardly stand up, having severe hot flashes, throwing up, gagging, fatigue , out... Read more
I am dizzy and can't hardly stand up, having severe hot flashes, throwing up, gagging, fatigue , out of it and dry mouth. I need help. The room keeps spinning!
50 2021-04-09 hot flush fatigue; chills; hot flashes; headache; insomnia; This is a spontaneous report from a contactable 50... Read more
fatigue; chills; hot flashes; headache; insomnia; This is a spontaneous report from a contactable 50-year-old male consumer reported that a 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Age at vaccination: 50 Years), dose 2 via an unspecified route of administration, administered in Arm Right on 11Feb2021 13:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included hypertension. Concomitant medications included amlodipine besilate (NORVASC); telmisartan (MICARDIS); zinc; VITAMIN C [ASCORBIC ACID]; vitamin d nos. The patient previously received first single dose of bnt162b2 on Right arm on 21Jan2021,11:00 single (Age at vaccination: 50 Years) for Covid-19 immunization. the patient not receive any other vaccines within 4 weeks prior to the COVID vaccine; List of any other medications the patient received within 2 weeks of vaccination: Norvasc, Micardis, multivitamin, vitamin C+D+zinc. On 11Feb2021 21:15, patient had fatigue, chills, hot flashes, headache, insomnia. Patient received treatment with Advil. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. The outcome of the events was recovering. Information on the lot/batch number has been requested.
50 2021-04-10 bell's palsy Pfizer-BioNTech COVID-19 Vaccine EUA Diagnosed with Bell?s palsy.
50 2021-04-10 tenderness Vaccine administered 9.20am. Fatigue shortly after vaccine was administered - slept most of afternoo... Read more
Vaccine administered 9.20am. Fatigue shortly after vaccine was administered - slept most of afternoon. Injection site pain - feels like been punched in arm. Headache in the evening. Night chills and complained of "tight" (not acute) chest pain... but no breathing problems. Morning fever of 101F. Headache, Dizzy, Fatigue, Muscle Pain (esp in legs, asif he had "run a marathon"). He spent most of the day "resting". Evening on day two, we noticed a large bump under his vaccinated arm. Radius about 5cm - larger than what I know swollen lymph nodes to look like - almost looks like a bicep between his armpit and nipple. Tender to touch. Morning of day three (48 hours after vaccine) bump under his arm remains and all other symptoms seem milder.
50 2021-04-11 weakness After dose 1 on 3/18/21, extreme fatigue for two weeks and arm hurt for a couple days at shot site.... Read more
After dose 1 on 3/18/21, extreme fatigue for two weeks and arm hurt for a couple days at shot site. After dose 2 on 4/8/21, weak, chills and body aches all over for one day on 4/9, and arm hurt for a couple days at shot site.
50 2021-04-11 numbness 3 days after shot I developed a rash on my neck, torso ,arms and hands. My thumbs where swollen and ... Read more
3 days after shot I developed a rash on my neck, torso ,arms and hands. My thumbs where swollen and numb. I developed a fever ranging from 101 to 104.4 for 48 hours. intense body achs.
50 2021-04-11 nerve pain Approximately 36 hrs after the injection I started feeling severe nerve and muscle pain to the left ... Read more
Approximately 36 hrs after the injection I started feeling severe nerve and muscle pain to the left deltoid (the injection site). there are no other signs or symptoms noted. It is a debilitating pain especially after even the most mundane of tasks. OTC pain relief is ineffective.
50 2021-04-12 weakness Weakness, headache, nausea, exhausted, wanting to sleep constantly, trouble breathing when sleeping(... Read more
Weakness, headache, nausea, exhausted, wanting to sleep constantly, trouble breathing when sleeping(wife noticed this). These symptoms although getting better have lasted six days.
50 2021-04-12 difficulty speaking About 6.5 hours after vaccination my throat got a bit dry and feeling like a start of a cold /raspy ... Read more
About 6.5 hours after vaccination my throat got a bit dry and feeling like a start of a cold /raspy feeling and I felt two spots on the front of my neck itching. I looked in mirror and saw two pimple size type spots itchy. over the neck 30 mins another itchy pimple grew and neck got a bit red and under an ear got red and itchy. over the next hour my breathing felt a little more difficult, though oxygen level oximeter reading still good. 8.5 hours after vaccination both sides of my upper back/shoulders were covered in hives. I felt a bit foggy also. I administered epinephrine pen to my thigh. Over next few minutes the hives disappeared (except for a few pimple size spots though they basically disappeared)and the itch was gone. My breathing felt fine. I monitored signs and symptoms with no noticeable issues for the next day+. This was the 1st time I ever used an epi pen.
50 2021-04-12 tingling, numbness 20 - 25 Mins after shot, Left side of face from ear down to jaw and chin started to go numb and ting... Read more
20 - 25 Mins after shot, Left side of face from ear down to jaw and chin started to go numb and tingly. tingling continued down on left side of neck from ear to adams apple. Felt consistent with novocaine wearing off and my ear/jaw was numb. Went to ER @ the Hospital, I had an EKG done and they checked physically for stroke. I was in Hospital for approx. 1.25 hours and the feeling started to go away.
50 2021-04-12 tremor, flushing Roughly 30 mins (10:30am) after I received my 2nd Pfizer vaccine shot, I was about 5 mins from my ho... Read more
Roughly 30 mins (10:30am) after I received my 2nd Pfizer vaccine shot, I was about 5 mins from my home and began to feel tingling/numbing in my mouth and tongue. I got in my house and told my wife I was not feeling right and started to notice a dizziness coming on. I was to call the pharmacy to find out what I should do, but noticed my heart rate was up, I looked at my Apple watch monitor and my BPM was 164. I felt flush and told my wife to call 911. Ambulance arrived and took my vitals and ( I do not recall the blood pressure, but it was high for me) when they put me into the ambulance I began to shake uncontrollably and then began to sweat profusely. They took me to the emergency room, but did not administer any drugs. The Dr. came in and said he did not think it was related to the vaccine, but my personal Dr. agreed with me based on my medical history that it had to be related to the vaccine. My resting heart rate (I monitor this daily) is between 45 - 60 and my last blood pressure reading at my yearly physical on April 2nd, 2021 was 100/70.
50 2021-04-13 pain in extremity He began to develop a rash on his left arm about three hours after having the vaccine. At first ther... Read more
He began to develop a rash on his left arm about three hours after having the vaccine. At first there were lumps, then the appearance of blisters, draining clear liquid eventually. The rash continues to itch. His left arm hurts. At the time of evaluation 4/13/2021, the lumps were discrete, some excoriated, scabbing, not in a linear pattern, located on his left upper arm and lower arm.
50 2021-04-14 flushing Approx. 30 min after receiving 2nd dose of COVID vaccine pt stated feeling "dizzy and flushed." Pt t... Read more
Approx. 30 min after receiving 2nd dose of COVID vaccine pt stated feeling "dizzy and flushed." Pt taken by wheelchair to private observation area and VS assessed by RN. Pt noted to have an elevated BP outside of normal parameters. Pt aox4, denies any pain, sob, chest pain or difficulty breathing. Pt continued to monitored and assessed by RN over a period of approx. 30 min. and BP remained elevated outside normal parameters. Pt agreeable to be treated in Emergency Room. Pt taken by wheelchair to ED by charge nurse and another ED staff member. Pt able to follow commands and able to ambulate on his own to wheelchair. Pt denies any dizziness, blurred vision, nausea, sob, head/chest pain or difficulty breathing.
50 2021-04-15 muscle spasms Severe allergic reaction anaphylactic shock Hives, rash,swelling, headache, stomach ache, body aches... Read more
Severe allergic reaction anaphylactic shock Hives, rash,swelling, headache, stomach ache, body aches, elevated heart rate, uncontrollable body spasms, loss of appetite
50 2021-04-16 muscle spasms, muscle twitching Had soreness and tenderness at injection within one hour of vaccination. Approximately 13-15 hours a... Read more
Had soreness and tenderness at injection within one hour of vaccination. Approximately 13-15 hours after Vaccination, woke from sleep with fever and chills. Fever was 100 as measured using oral digital thermometer. Experienced mild body muscle aches and stiffness, especially in the upper back, shoulders and neck. Had mild to moderate fatigue and persistent headache at base of skull. Also experienced muscle twitching within 2 hours of vaccination through the lower limbs and torso, with more activity concentrated in the legs and feet. Was not painful, but strange. Some of this muscle fluttering and twitching preceded muscle cramping in the feet. Frequency was almost continuous with short, 60 second pauses between twitches. The moved and we?re not in the same exact location. We?re especially active when when lying flat, relaxed in bed. All symptoms aside from the twitching subsided fully by the following Morning (April 15th 2021). Took body temp that morning and had returned to 98.7 f. Muscle twitches have continued five days beyond vaccination, although they have grown milder and less frequent.
50 2021-04-16 night sweats Shot was received at 6:15pm and symptoms started at 7:30am. I had a soar arm at injection site. Se... Read more
Shot was received at 6:15pm and symptoms started at 7:30am. I had a soar arm at injection site. Severe dizziness to the point I could not walk, headache and joints pains started around 10am while at work. I left work at 1:30pm When I got home around 2:00pm, I felt tremendous amount of fatigue. I slept from 2pm until 5:00pm. I went back to bed at 6:30pm. During the night I had cold chills and sweated all night until my sheets were drenched. I slept until 9:30am. I felt much better after taking a shower. I would not have the second dose!!
50 2021-04-17 bell's palsy patient developed Bell's palsy, left sided facial nerve palsy 2 days after getting first Pfizer vacc... Read more
patient developed Bell's palsy, left sided facial nerve palsy 2 days after getting first Pfizer vaccine. he is being treated with oral prednisone/Valtrex for bell's palsy now. no fevers or bodyaches. mild left deltoid soreness after injection.
50 2021-04-18 weakness Shortness of Breath with cough , generalized weakness, left rib pain radiating to upper back pain (s... Read more
Shortness of Breath with cough , generalized weakness, left rib pain radiating to upper back pain (sharp in nature)
50 2021-04-18 numbness, facial paralysis I have facial numbness on left side of my face. I cannot move my left eye freely, and left side of ... Read more
I have facial numbness on left side of my face. I cannot move my left eye freely, and left side of my lips freely. I cannot close or open my left eye, and left side of my lips are droopy.
50 2021-04-19 tenderness Given at . Patient presents to office 4/20/2021. Rash which is similar to others noted in A reacti... Read more
Given at . Patient presents to office 4/20/2021. Rash which is similar to others noted in A reactivation of shingles over the upper chest arm and back. Started five days after vaccine, with five small patches of raise clusters of small blisters. Has spread to neck , top of shoulder and back. Symptoms include pain to touch and itching.
50 2021-04-20 slurring Pt felt "strange and uneasy" right after the vaccine. Sunday (3 days post shot) pt had very dry mo... Read more
Pt felt "strange and uneasy" right after the vaccine. Sunday (3 days post shot) pt had very dry mouth, numb tongue, and sore inside his mouth. Patient's wife reports slurred speech. Symptoms have been slowly getting worse since Sunday.
50 2021-04-20 tingling, numbness, feeling cold left hand numb, left arm cold sensation and tingling, resolved, pt. left site.
50 2021-04-21 discomfort, numbness Consistent numbing discomfort that develops into pain daily. Affected area is from the elbow to the... Read more
Consistent numbing discomfort that develops into pain daily. Affected area is from the elbow to the shoulder. Feels as if there is inflammation in the center area of the arm. Responds to ibuprofen or rest/sleep bur reoccurs in the same cycle daily.
50 2021-04-22 weakness 4 hours shivering, joint and muscle pain, 24 hours weakness
50 2021-04-22 numbness Shortness of breath, heart palpitations, vertigo/dizziness, phantom body pains appearing and disappe... Read more
Shortness of breath, heart palpitations, vertigo/dizziness, phantom body pains appearing and disappearing in various places, occasional itching sensation, numbness, brain fog, double-vision, extreme tiredness. Symptoms tapered off over 3-5 days. Similar experience with 2nd vaccine but less pronounced with a shorter timeframe, tapering off after 2-3 days. Strongest side effects after first vaccine, symptoms did not become noticeable until a couple of hours after it was administered, increasing next 24 hours before lessening over time. Basically identical to long covid symptoms but lasting only for a few days after vaccinations and not before.
50 2021-04-22 nerve pain, burning sensation Headache 2-3 days; Day 3 the rash began on both legs with blisters, itching, pain, burning sensation... Read more
Headache 2-3 days; Day 3 the rash began on both legs with blisters, itching, pain, burning sensation appeared to be shingles (I have had shingles previously but no shingles vaccine) Lasted a total of 2.5 weeks until most symptoms were gone. Still have occasional nerve pain and burning.
50 2021-04-22 pain in extremity Patient is here with complaints of left calf pain. Started after returning from city on 4/12. Drove ... Read more
Patient is here with complaints of left calf pain. Started after returning from city on 4/12. Drove home. Was very sore, treated with aspirin. Helped at first but now pain and swelling have persisted. Did go jogging while on vacation and thought this may have attributed, now more concerned about DVT. Brother with history of blood clots but is a smoker.
50 2021-04-23 weakness 2 weeks from the day I received the shot I developed a half dollar sized round rash on the opposite ... Read more
2 weeks from the day I received the shot I developed a half dollar sized round rash on the opposite arm that the shot was administered. The rash was red in color, raised skin and was located near my right bicep, inside elbow area. This rash subsided for most part the day after. Also had the chills for over 48 hours, slight headaches on and off and was extremely tired with low energy. It felt like I was in a fog for a couple of days.
50 2021-04-23 unresponsive to stimuli, flushing Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Additional Details: anxious before the shot. started sweating and felt dizzy 2-3 minutes after the shot. gave water to patient and asked them to take deep breaths. patient then started to become unresponsive,pale with no blood flow to face. no improvement was seen and then epinephrine shot (adult) was administered. patient started to regain consciousness and became slightly responsive after a couple minutes. had the patient sit down and put theit legs up on a chair. EMT arrived and out of caution took them to ER.
50 2021-04-24 weakness Flu like , muscle ackes everywhere, no energy, and no hunger only for one day.
50 2021-04-24 bell's palsy Bell's Palsy that affects the right side of his face; This is a spontaneous report from a contactabl... Read more
Bell's Palsy that affects the right side of his face; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955), via an unspecified route of administration on 28Mar2021 at 16:45 (at the age of 50 years) at a single dose in the right arm for COVID-19 immunization. Medical history included overweight and high blood pressure. The patient's concomitant medication included an unspecified multivitamins. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 29Mar2021 at 17:00, the patient was diagnosed with a case of Bell's Palsy that affects the right side of his face. The event resulted in emergency room/department or urgent care. Prescription medications were given as treatment for the event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.
50 2021-04-24 pain in extremity headache; unable to maintain an erection/ some issues with maintaining an erection; soreness in his ... Read more
headache; unable to maintain an erection/ some issues with maintaining an erection; soreness in his arms/ soreness was on both shoulders; real soreness" in his arm where he got the injection/ injection site had pain; developed a "large lymph node under that arm", which he "feels internally"/ lymph node he could feel internally/ internal bone like pain; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE at the arm right (reported as right shoulder) for covid-19 immunisation (reported as he is trying to avoid serious illness). The patient medical history includes sleep from unknown date and if ongoing. Concomitant medication included zolpidem (reported as generic ambien) taken for sleep, start and stop date were not reported and added that he has been taking it for years but he hasn't taking it since he got the vaccine but thinks he took it the day before. The patient previously took bnt162b2 first dose on 10Mar2021 (roughly two weeks before the second dose) at the left shoulder for covid-19 immunisation. It was reported that the patient had no reaction to the first dose of the Pfizer-BioNTech COVID-19 vaccine, and he received the second dose on 31Mar2021. He explained following the second dose, his first issue was a "headache", then he had "real soreness" in his arm where he got the injection. He added he developed a "large lymph node under that arm", which he "feels internally". He specified he still feels it a week later. He also explained he is "unable to maintain an erection". He described himself as "athletic" and specified not having erectile problem in the past. He asked if his current symptoms have been reported as side effect to the vaccine. It was also added that after the second dose he appeared to have some issues with maintaining an erection on 04Apr2021. It was stated he is fairly active with a muscular build and could be a result after an exercise injury but this did happen after his second shot. Caller states he also had soreness in his arms and an enlarged lymph node under his arm that he could feel with his hand but that went away yesterday (from 01Apr2021 to 07Apr20210). The soreness was on both shoulders but he thinks the soreness on the other shoulder is from lifting weights and the shoulder from the injection site had pain, internal bone like pain (from 01Apr2021 to 07Apr20210). It was stated that the lymph node he could feel internally but didn't protrude through skin and went away yesterday and lasted 6-7 days. It was also reported that the soreness and lymph node went away yesterday and believes everything will get back to normal, he expected soreness to last a couple of days and it lasted a week. The patient stated he took some sleep medication after the second injection. He doesn't remember if it was the night before the injection. He took Ambien, a higher dosage. States maybe issues with maintaining an erection are beginning to improve. It was also stated the soreness and lymph node he noticed it the day after the injection, by the evening of 01Apr2021 and as of yesterday 07Apr2021 evening it feels like its completely back to normal. It was noted for the treatment that he didn't take anything but bought a gripper where he squeezes it and builds strength in his hands to give him some relief. The patient added that he's pretty active, he works out 4-5 days a week, including running. The outcome of the event some issues with maintaining an erection/ unable to maintain an erection was recovering; for the event headache was unknown, for all other events was recovered on 07Apr2021. Information about the Lot/batch number has been requested.
50 2021-04-24 seizure Generalized seizures without ever having a seizure before; This is a spontaneous report from a conta... Read more
Generalized seizures without ever having a seizure before; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not available), via an unspecified route of administration, Left arm on 08Apr2021 at 09:00 AM (at the age of 50-years-old) at a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient had no known allergies. Concomitant medication included celecoxib (CELEXA). The patient was vaccinated at a hospital. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced generalized seizures without ever having a seizure before on 10Apr2021 at 15:00. The event caused hospitalization in Apr2021 and was also reported as life-threatening. The patient underwent lab tests and procedures which included nasal swab test: negative on 10Apr2021. Therapeutic measures taken as a result of the event included hospitalization and med flight, as reported. The outcome of the event was not recovered. Information about lot/batch number has been requested.
50 2021-04-26 weakness, muscle spasms, discomfort 42-43 hours after receiving the first dose of the Pfizer vaccine, patient starting projectile vomit... Read more
42-43 hours after receiving the first dose of the Pfizer vaccine, patient starting projectile vomiting, approx. or 10 times, every hour from 10am Sunday, 4/25 until approx. 2pm 4/25. Patient also had extreme abdominal pain (score of 10 on a 10 point scale) , showed signs of extreme agitation, discomfort , weakness, mild disorientation. no fever at this time nor diarrhea . Due to extreme abdominal pain and vomiting, patient was taken to Emergency Room where he was given medications to stop the vomiting, cramping . Tests run: EKG, CAT scan and blood work. Blood was normal, and EKG. CAT scan showed extreme swelling and inflammation to the entire abdominal cavity. Patient was discharged after pain was brought under control . Within hours of coming home the patient started to experience sever diarrhea, (watery discharge every hour for about 6 hours - patient estimates at least a gallon or more of liquid loss). Patient was on Gatorade, water intake , as much as he could take , continuously. No vomiting was experienced, but at this point patient was on the medications to control symptoms given at ER discharge. Patient experienced intermittent sharp pain despite medications to stop cramping and coat stomach and nausea continued despite nausea medication . on Monday, April 26th, around 3pm the abdominal pain increased, and by 10pm a high fever was present: 102.8 without ibuprofen, 101.4 with ibuprofen, and at this writing, Tue 4/27/21 at 2:30pm, the fever continues at 101.4 with continuous ibuprofen. The patient has not eaten solid foods and is now on Pedialyte, He has vomitted twice since 7am and is currently experiencing diarrhea .
50 2021-04-26 pain in extremity Pain on left arm for 1 day, Headaches 6 days, bodyache 6 days ,chills ,soft stool for 2 days and Ti... Read more
Pain on left arm for 1 day, Headaches 6 days, bodyache 6 days ,chills ,soft stool for 2 days and Tiredness 6 days.
50 2021-04-26 pain in extremity Lower back pain (continuous as of today however less than before), fatigue (7 days), mid-chest pain ... Read more
Lower back pain (continuous as of today however less than before), fatigue (7 days), mid-chest pain (1.5 days), intermittent dull pulse pain?right leg calf (continuous)
50 2021-04-27 facial paralysis Patient presented to the emergency room with right sided facial droop including foreheady, +bells si... Read more
Patient presented to the emergency room with right sided facial droop including foreheady, +bells sign, no sensation deficits, no other focal numbness or weakness. Patient also reports dry eye which cannot close. In rhe ER he received 60mg prednisone and, 1000mg valtrex. He received prescription for prednisone (60mg/day for 5 days), valtrex (3 grams/day for 7 days) and hypromellose artifical tear drops). He as instructed to with PCP and neurology.
50 2021-04-27 cold extremities, muscle spasms Awoke to uncontrollable spasmatic shivering, ice cold feet, increased heart rate of 110, increased b... Read more
Awoke to uncontrollable spasmatic shivering, ice cold feet, increased heart rate of 110, increased blood pressure 151/84. Worst of it lasting over 1 and a half hours before extreme shivering subsided with continued stress.
50 2021-04-28 weakness, flushing Systemic: Dizziness/Lightheadedness-Mild, Systemic: Flushed/Sweating-Mild, Systemic: Visual Changes/... Read more
Systemic: Dizziness/Lightheadedness-Mild, Systemic: Flushed/Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: Patient reported feeling dizzy and was found on floor after the vaccine. He was asked to wait for about 30 minutes for extra monitoring. Called patient after he arrived home and reported feeling okay.
50 2021-04-28 tremor, flushing During 15 minute observation period, patient complained of dizziness, lightheadedness and minor stom... Read more
During 15 minute observation period, patient complained of dizziness, lightheadedness and minor stomach upset. Patient was instructed to sit down, his feet were elevated, a cold compress was applied. Patient's blood pressure, heart rate and pulse ox were taken. First blood pressure reading was 168/54 mmHg, first pulse was 71 bpm and pulse ox was 98-99%. Patient was shaky, anxious, and flushed. No complaints of shortness of breath, itching, or swelling of the face/mouth. Repeat vitals after 10 minutes were 185/105 mmHg, pulse was 76 bpm, and pulse ox was 100%. Patient was still dizzy and shaky. Administered 50 mg of diphenhydramine orally and contacted transport to emergency room. While waiting for transport, patient complained of forehead and forearm itching. Still no complaints of shortness of breath, no coughing or lip swelling. Noted red hives starting to appear. EMT arrived and took over care.
50 2021-04-29 pain in extremity Pain in arm muscles pain drowsy headache
50 2021-04-30 weakness Severe 'chicken-pox' like rash began on arms; face pustules; eruct; infection; scarring result; Low ... Read more
Severe 'chicken-pox' like rash began on arms; face pustules; eruct; infection; scarring result; Low energy; digestive symptoms; skin problems; This is a spontaneous report from a contactable consumer (patient himself). A 50-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the right arm on 05Feb2021 at 12:00 (Batch/Lot Number: EL3249) as a single dose for COVID-19 immunization. The vaccination facility type was reported as the hospital. Relevant medical history included asthma and known allergies to sulfur and intravenous (IV) contrast; all from an unknown date and unknown if ongoing. Concomitant medications included lisinopril; atenolol; and omeprazole (PROTONIX); all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 at 12:00 PM (lot number: EK9231) at the age of 49 years, administered on the right arm for COVID-19 immunization. The patient had no other vaccine in four weeks. The patient had no prior vaccination. On an unspecified date in Mar2021 at 12:00 PM, the patient experienced severe 'chicken-pox' like rash began on arms; face pustules, eruct, infection; scarring result; low energy; and digestive symptoms in correlation with skin problems. All the adverse events (AE) resulted in a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care; and had also led to disability or permanent damage. The patient underwent lab tests and procedures, which included COVID-19 test via nasal swab: inconclusive on 20Mar2021 (post vaccination). Therapeutic measures were taken as a result of all the events, which included topical corticosteroids, oral steroids, and oral antibiotic (antib). The patient was not recovered from all the events.
50 2021-04-30 pain in extremity Fatigue/tiredness; cough; head cold; congestion; arm pain; This is a spontaneous report from a conta... Read more
Fatigue/tiredness; cough; head cold; congestion; arm pain; This is a spontaneous report from a contactable consumer reported for himself. A 50-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on 01Apr2021 11:45 as single dose for COVID-19 immunisation. Medical history included diabetes mellitus. No known allergies. Concomitant medications included metformin 500 mg, amlodipine besilate (NORVASC) 2.5 mg. The patient experienced fatigue, cough, head cold, congestion, tiredness, arm pain on 08Apr2021 (also reported that on the 4Apr2021 was when the symptoms started), that lasted 24 hours, no treatment received for the adverse events. The events were reported as non-serious. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovering. The patient became aware that it may have to do with the vaccine and not with his seasonal allergies on the 11Apr2021. No follow-up attempts are needed. No further information is expected.
50 2021-05-02 weakness High fever for two days. First day could not get out of bed to get water to drink. Followed by half ... Read more
High fever for two days. First day could not get out of bed to get water to drink. Followed by half day of moderate fever. One week later very itchy rash appeared on left armpit, left groin and left hand. This was accompanied with slight fever and general weakness. Rah eventually resolved a week after four days of Valacyclovir therapy. The Valacyclovir helped with to reduce the itching. Viral cause of the rash suspected.
50 2021-05-03 bell's palsy Bell's Palsy, Left side of face
50 2021-05-03 slurring, speech disorder Pt says that he has had "fuzzy thinking," having trouble recalling words and was off balance. He ha... Read more
Pt says that he has had "fuzzy thinking," having trouble recalling words and was off balance. He had slurred speech. He also had left side chest pain and trouble breathing.
50 2021-05-03 pain in extremity Localized swelling at injection area a couple of days afterwards and continued pain in the entire ar... Read more
Localized swelling at injection area a couple of days afterwards and continued pain in the entire arm up to 2 weeks after second dose. Left arm felt as if there was a torn muscle and 10 days after second dose, a large bruise appeared running lengthwise from armpit to below the interior elbow. the torn muscle feeling is subsiding though and seems to be getting better day by day.
50 2021-05-03 pain in extremity About 4 hours after receiving the 2nd dose, my left arm started to become sore (where the shot was g... Read more
About 4 hours after receiving the 2nd dose, my left arm started to become sore (where the shot was given) About 10 hours after receiving the 2nd dose, I started feeling "fluish" (achy, feverish, nauseous) All throughout that evening, the symptoms became worse and worse where I repeatedly took my temperature thinking I had a very high temperature only for it to read "below" normal at 97.3. The symptoms continued to get worse, without much sleep throughout the night and into the next day and evening. I almost scheduled an appointment with my primary care physician on 4/24 because I felt so horrible. It wasn't until about 11 am on the 2nd day after receiving the shot (4/25) that I felt somewhat better and by that evening around 6pm, felt normal again. The 2nd dose was absolutely, without a doubt, MUCH worse of symptoms than the first dose. I hope this helps and please contact me with any questions or to help further.
50 2021-05-04 inability to speak, involuntary muscle movements, weakness Was feeling fine and health when prior to the shot. We were directed (wife and I) to sit down for 1... Read more
Was feeling fine and health when prior to the shot. We were directed (wife and I) to sit down for 15 minutes before leaving. For the first 13 minutes I was talking to my wife, joking, etc. I felt fine. However, after 13 minutes or so, I started to felt light heading and week. Then started to sweat and then I couldn't speak. I felt like passing out. My wife told me that the a man was trying to told we up and prevent me from falling. I could hear what others were saying. My wife states I turned pale, eyes looked stright ahead, and my mouth was distorted. This came all at once and within a minute experienced all these symptoms. The pharmacy staff gave me an eppy shot to get me back, then I was told to lay down on the floor. I came to withing a minute or two and felt much better. They had called 911 for an ambulence to come out. The responders checked me out (vitals) and all looked fine, but I was highly advised to go with them to the ER to get checked out.
50 2021-05-04 cold sweat Symptoms started about 8 days after receiving first vaccine. The first symptom to present was Tinni... Read more
Symptoms started about 8 days after receiving first vaccine. The first symptom to present was Tinnitus started light then went to SEVERE. About 6 days after onset of tinnitus I started with cold sweats, chills, BAD vertigo, Nausea, headaches around my head (not just in one spot) and no appetite. In the following days symptoms have not subside .....going on 2 weeks now.
50 2021-05-08 pain in extremity I felt well for the 8-9 hours after the shot, around 8pm that evening, a headache and mild fever st... Read more
I felt well for the 8-9 hours after the shot, around 8pm that evening, a headache and mild fever started. By 1am, fever, chills, increased headache, severe joint pain were in full swing, muscle almost felt like they were on fire. Even rolling over in bed HURT. Fever got as high as 101.8 (I usually am around 97.6 or so). Symptoms started to abate by mid morning, but I was essentially useless until that evening. By May 6, I felt like I had a really bad hangover all day, then was mostly recovered by that evening. It is now May 9. I have a long history of knee/arthritis pain, and am generally a rather active person, but since the second dose, my knee pain as well as my hands to a large degree, have been extraordinarily sore and painful. My knees in particular, while the symptoms were really peaking, I experienced some very acute,atypical pains a couple times in both knees that seem to keep recurring 2-3 times per day, as well as exacerbated, continual soreness and general pain when I am active.
50 2021-05-09 seizure CEREBROVASCULAR ACCIDENT R56.9 - Seizure (CMS/HCC)
50 2021-05-11 pain in extremity, weakness He got his vaccine, he felt tiredness but nothing major. The next day he started feeling nauseous a... Read more
He got his vaccine, he felt tiredness but nothing major. The next day he started feeling nauseous and really out of strength. His muscles were tired, and he got a strange bump under his right armpit, and had a mild fever. He also had little bumps around the vaccine site. The arm is red, but not itchy but does hurt upon touching the arm. It's beginning to get better. He did run fever, and had fever blisters in his mouth that are still there, and he has a lot of pain on the right arm, and on the shoulder blade area. He has taken Ibuprofen for these symptoms. He did not call his doctor.
50 2021-05-11 seizure Brain inflammation; Stroke like event/seizure; Stroke like event/seizure; This is a spontaneous repo... Read more
Brain inflammation; Stroke like event/seizure; Stroke like event/seizure; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), via an unspecified route of administration, administered in left arm on 19Apr2021 16:00 (Lot Number: ER8731) 2ND DOSE, single for COVID-19 immunization. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received 1st dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, lot number: EP6955) on 29Mar2021 01:00 PM in the left arm for COVID-19 immunization and experienced stroke like event/seizure. The patient had stroke like event/seizure following first and second injections. The patient also had brain inflammation. Events onset date reported as 22Apr2021 11:00. The events were reported as serious due to hospitalization in Apr2021 for 5 days. Events resulted in doctor or other healthcare professional office/clinic visit and a visit to emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient been tested for COVID-19 since the vaccination. Outcome of events was unknown. The patient underwent lab tests and procedures which included Nasal Swab: negative on 22Apr2021. No treatment received for the events. Further information has been requested.
50 2021-05-12 seizure seizure; Stroke like event; This is a spontaneous report received from a contactable consumer (Patie... Read more
seizure; Stroke like event; This is a spontaneous report received from a contactable consumer (Patient) reporting for himself. A 50-year-old male patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on 29Mar2021 01:00 (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunization. Medical history included rheumatoid arthritis from an unknown date. The patient's concomitant medications were not reported. The patient experienced seizure and stroke like event on 22Apr2021 at 11:00. The patient was hospitalized for seizure and stroke like event for 5 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Apr2021. Outcome of the events was unknown Information on Lot/Batch number was available. Additional information has been requested.
50 2021-05-14 cold sweat severe fatigue and body pain. chill, cold sweats. no fever.
50 2021-05-14 muscle twitching Severe headache, Swollen throat. Twitching.
50 2021-05-16 tenderness An enlargement showed up on my lower right neck below the Adam's apple. It was painful when chewing ... Read more
An enlargement showed up on my lower right neck below the Adam's apple. It was painful when chewing or sneezing or pressing it. I put cold compress every night and drank lots of water. It disappeared on the 3rd day.
50 2021-05-18 bell's palsy Bell's Palsy - Left Side of Face; This is a spontaneous report from a contactable consumer (patient)... Read more
Bell's Palsy - Left Side of Face; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 28Apr2021 (Batch/Lot Number: EW0171) as 2nd dose, single for covid-19 immunisation. The first dose was received on 03Apr2021 (lot number: ER8733). There were no medical history. Concomitant medications included metformin, diazepam and lisinopril. No other vaccine were received within 4 weeks. The patient experienced bell's palsy - left side of face on 03May2021 10:00. Event resulted in physician's clinic visit. Outcome of the event was not recovered. Patient was not diagnosed with covid-19 prior to vaccination and had not been tested post vaccination.
50 2021-05-19 weakness Chills started evening of. Progressed into fever (101), shivering while sweating, extreme loss of en... Read more
Chills started evening of. Progressed into fever (101), shivering while sweating, extreme loss of energy, dizziness, and lack of cognition
50 2021-05-19 bell's palsy Bell's palsy affecting left facial nerve
50 2021-05-19 bell's palsy Bellls Palsey and headaches developed 21 days after administration
50 2021-05-19 pain in extremity, tingling Immediate pain associated with tingling down to elbow and upper arm weakness
50 2021-05-20 pain in extremity Patient had sharp pain in shoulder during what he describes a deep injection, and subsequently has h... Read more
Patient had sharp pain in shoulder during what he describes a deep injection, and subsequently has had right elbow pain which radiates to the right hand as well as hand and forearm muscle weakness intermittently. These all developed in the 24-48 hour period post-vaccine after the shoulder pain subsided.
50 2021-05-21 speech disorder nurse stated it could possibly be blood clots; Patient is afraid he is going to have a stroke or sca... Read more
nurse stated it could possibly be blood clots; Patient is afraid he is going to have a stroke or scared he had one after the COVID-19 Vaccines; blurred vision in right eye that comes and goes; ringing in his left ear; Very fatigued throughout the day, sleeping a lot/tired and sleeps a lot; Very fatigued throughout the day, sleeping a lot/tired and sleeps a lot; Date received First dose: Third Friday in Feb2021/Received second dose on 12Apr2021, six weeks after first dose; Date received First dose: Third Friday in Feb2021/Received second dose on 12Apr2021, six weeks after first dose; Fullness in face; Body aches; Brain fog: At times he can't do the simplest things. He will look at the clock on the wall and says he knows what it is, but can't find the words to say. Cannot carry on a conversation intelligently; Brain fog: At times he can't do the simplest things. He will look at the clock on the wall and says he knows what it is, but can't find the words to say. Cannot carry on a conversation intelligently; Brain fog: At times he can't do the simplest things. He will look at the clock on the wall and says he knows what it is, but can't find the words to say. Cannot carry on a conversation intelligently; headache all over the back of his head/Affecting his balance. In back of head, moves around, sometimes the front; headache all over the back of his head/Affecting his balance. In back of head, moves around, sometimes the front; feeling dizziness/had to stop driving; This is a spontaneous report from a contactable consumer (patient's wife). A 50-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 12Apr2021 (may have been in morning) (Batch/Lot Number: Unknown; Pfizer COVID-19 vaccine) as 2ND DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 50 years old. The patient's medical history and concomitant medications were not reported. History and Investigations: Doesn't take any medications. Has no medical conditions, unless age was considered a medical condition. Historical vaccine included first dose of COVID-19 Vaccine reported as on Third Friday in Feb2021 (First dose: between 1430-1530), and experienced AEs: Brain fog; Headache: Thinks in the back of the head, but moved around too, sometimes in the front. Has affected his balance. Dizziness: Had to stop a couple times while driving home from vaccine facility. Aches and pains. All symptoms from the first dose went away within 3-4 days. Caller would say patient recovered completely from symptoms associated with first dose. The patient experienced nurse stated it could possibly be blood clots on an unspecified date with outcome of unknown, patient is afraid he is going to have a stroke or scared he had one after the covid-19 vaccines on an unspecified date with outcome of unknown, brain fog: at times he can't do the simplest things. he will look at the clock on the wall and says he knows what it is, but can't find the words to say. cannot carry on a conversation intelligently on 12Apr2021 with outcome of not recovered, headache all over the back of his head/affecting his balance. in back of head, moves around, sometimes the front on 12Apr2021 with outcome of not recovered, feeling dizziness/had to stop driving on 12Apr2021 with outcome of not recovered, blurred vision in right eye that comes and goes on an unspecified date with outcome of not recovered, ringing in his left ear on an unspecified date with outcome of not recovered, fullness in face on 12Apr2021 with outcome of not recovered, body aches on 12Apr2021 with outcome of not recovered, very fatigued throughout the day, sleeping a lot/tired and sleeps a lot on an unspecified date with outcome of not recovered, date received first dose: third friday in feb2021/received second dose on 12apr2021, six weeks after first dose on an unspecified date with outcome of unknown. Patient was caller's husband. Had both doses and had the same problem. His experience is very bad with the second dose and has had it for a month. Within a day after the first dose, had brain fog, headache, and dizziness where he had to stop driving a couple times. This went away within a few days. Patient and caller were concerned about the second dose. They spoke with patient's doctor and the local Health Department, both said it couldn't be from the vaccine. Patient was advised to get the second dose. Had the same symptoms with second dose, but occurred within an hour of received second dose. Symptoms have continued. Also experiencing blurred vision in right eye that comes and goes. Patient had an appointment with his doctor this week, but the doctor basically didn't look at him. Doctor advised patient to see a neurologist. Another nurse stated it could possibly be blood clots. Caller is trying to find help. Caller wanted to add with the second dose, patient experienced ringing in his left ear, fullness in his face, and headache all over the back of his head. Was feeling dizziness after second dose and had to stop driving. Patient is afraid he is going to have a stroke or scared he had one after the COVID-19 Vaccines. If the COVID-19 Vaccines woke up some other health issues, patient wants to get it taken care of. Received second dose on 12Apr2021, six weeks after first dose. Got second dose at a different location. Second dose COVID-19 Vaccine AEs: Started experiencing symptoms within an hour. Headache: Affecting his balance. In back of head, moves around, sometimes the front. Comes and goes. Brain fog: At times he can't do the simplest things. He will look at the clock on the wall and says he knows what it is, but can't find the words to say. Cannot carry on a conversation intelligently. Dizziness. Blurred vision in right eye: Doesn't know if this started on 12Apr2021 or a couple days after. States as the day goes on and he gets tired, it will worsen. It comes and goes. Ringing in left ear: Began on 12Apr2021 or a few days after. Fullness in face: Stated this comes and goes, but has stayed the same. Documented as provided. Body aches: Comes and goes. Seems to worsen as the day goes on. Very fatigued throughout the day, sleeping a lot: He's tired and sleeps a lot. It was hard for him to get out of bed. Caller stated patient's symptoms worse as the days goes on. Patient never experienced pain at the injection site. Guesses patient received COVID-19 vaccines in his left arm because the county was doing a dive-thru clinic. Since he didn't get out of his car, she believed patient would have received the vaccines in the left arm. The events REQUIRE A VISIT TO Physician office: Doctor doesn't think anything is wrong. ER: Not yet. Is considering going to the ER today. PRIOR VACCINCATIONS WTIHIN 4 WEEKS was None. RELEVANT TESTS: None. Events Clot blood and stroke considered medically significant. Follow up attempts are needed. Information of Lot/Batch number has been requested.
50 2021-05-22 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypo... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium
50 2021-05-24 pain in extremity Headache, Chills, Fever, Nausea, Left Hallux Pain for 2 days (Gout)
50 2021-05-25 feeling cold body felt cold; Tiredness; This is a spontaneous report from a contactable consumer, a patient and o... Read more
body felt cold; Tiredness; This is a spontaneous report from a contactable consumer, a patient and other healthcare professional. A 50-year-old Male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the right arm on 11Mar2021 at 1300 hours (at the age of 50-years-old), as a first single dose for COVID-19 immunisation. Concomitant medications included Zyrtec and multi vitamins (manufacturer unknown), for an unspecified indication. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021 the patient experienced tiredness and on 16MAR2021, the patient's body felt cold, however patient did not have any fever and was able to maintain his normal schedule of work and exercise. The clinical outcome of the event tiredness was recovering. The clinical outcome of the event felt cold was unknown. No follow-up attempts are possible. No further information is expected.
50 2021-05-25 pain in extremity chills; Nausea; Extreme body pain; Fever; This is a spontaneous case from a contactable consumer, th... Read more
chills; Nausea; Extreme body pain; Fever; This is a spontaneous case from a contactable consumer, the patient. A 50-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL9266) as a first dose in the left arm on 15Feb2021 at 10:30 am and (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6206) as a second dose in the right arm on 08Mar2021 at 13:30 pm via an unspecified route of administration for COVID-19 immunization(age at the vaccination: 50 years). Medical history and concomitant medications are not reported. Prior to the vaccination the patient was not diagnosed with COVOD-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was at a Clinic. On 15Feb2021, the patient experienced Fever, chills, extreme body aches, nausea for first dose and no side effects for second dose. No therapeutic measures were taken for the events fever, chills, extreme body aches and nausea. The clinical outcome for the events fever, chills, extreme body aches, nausea are recovered on an unknown date. The patient feels like he didn't get a second dose or something was wrong with the second dose as he did not experience with any events. No follow-up attempts are needed. No further information is expected.
50 2021-05-25 tingling, numbness Left side numbness and tingling, arm, face, back, leg. Also occurred on 4-19 and 5-6, with ER visit... Read more
Left side numbness and tingling, arm, face, back, leg. Also occurred on 4-19 and 5-6, with ER visits and hospitalization detailed below
50 2021-05-25 speech disorder, bell's palsy On 04/25/21, my face felt like I was having an allergic reaction, but wife couldn't understand my sp... Read more
On 04/25/21, my face felt like I was having an allergic reaction, but wife couldn't understand my speech. So, we rushed to hospital (emergency room) and Dr diagnosed Bell's Palsy. Recommended I see a neurologist. Neurologist confirmed the diagnosis.
50 2021-05-26 pain in extremity Throwing up, very sore arm happened 20 mins after getting it
50 2021-05-26 pain in extremity I received the first dose of the Pfizer-BioNTech COVID-19 Vaccine EUA on 3/31/21. My arm soreness n... Read more
I received the first dose of the Pfizer-BioNTech COVID-19 Vaccine EUA on 3/31/21. My arm soreness never subsided by the day of my second dose, which was on 4/24/21 at 12:00 p.m. Here we are on 5/27 & the soreness still has not gone away. It's been 8 weeks and it's actually gotten worse the last 2-3 days. I can't find information on this particular situation anywhere. My arm is not swollen or red and there are no hard bumps or anything like that in the area. It's just sore whenever I move it. This is not right. Please let me know what to do.
50 2021-05-26 tremor High fever 103.5 for about 15 hours then low grade fever 100+ for the next 24 hours with chills and ... Read more
High fever 103.5 for about 15 hours then low grade fever 100+ for the next 24 hours with chills and shakes. Headache for 5 days and fatigue for 4 days.
50 2021-05-26 tremor Site: Pain at Injection Site-Mild, Systemic: Arm Shaking after-Mild, Additional Details: Arm shaking... Read more
Site: Pain at Injection Site-Mild, Systemic: Arm Shaking after-Mild, Additional Details: Arm shaking told patient to do cold compress
50 2021-05-29 pain in extremity Fever up to 101.4, left arm soreness, fatigue, drowsiness
50 2021-06-01 muscle twitching twitching in the muscle in his right arm, which is the arm he got the shot in; positive COVID-19 tes... Read more
twitching in the muscle in his right arm, which is the arm he got the shot in; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for different doses. This is the first of two reports. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm right on 02Apr2021 reported as at 1600 or 1700 (Batch/Lot Number: ER8732) at the age of 50 years old as 1st dose, single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient received the 1st and 2nd dose of PFIZER-BIONTECH COVID-19 VACCINE. He experienced twitching in the muscle on Apr2021. It has not gone away. He received both doses of the vaccine. With the first dose, the patient experienced positive covid-19 test with symptoms. He had headache and diarrhea on Apr2021, fever and tired/fatigue on 05Apr2021, muscle aches and pains on 06Apr2021. He had the first dose on 02Apr2021 (Friday). He tested positive for COVID on 09Apr2021. One of the side effects that he has been getting and still has is twitching in the muscle in his right arm, which is the arm he got the shot in. He was asking if this has been reported in anyone else and wanted to know what the timeframe is before it wears off. Headache started Monday or Tuesday and recovered by Friday (Apr2021). Diarrhea started Thursday or Wednesday and recovered by Friday (Apr2021). Fever started Monday night (05Apr2021) and recovered by Friday (09Apr2021). The twitching in his right arm started two weeks after the first shot (Apr2021) and has been more steady the last couple of days - it had worsened. He recovered completely from COVID about a week after symptoms started. No additional vaccines administered on same date. No visit to Emergency Room not Physician Office required. Prior Vaccinations (within 4 weeks) was none. Outcome of event positive covid-19 test with symptoms was recovered on Apr2021, while other event was not recovered. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021503563 same patient, similar event; different dose
50 2021-06-02 tremor Patient started shaking a lot 5 minutes after vaccination. Checked Vitals and his BP was 241/212,SpO... Read more
Patient started shaking a lot 5 minutes after vaccination. Checked Vitals and his BP was 241/212,SpO2 was 98. Called 911 and patient was taken to the hospital. BP dropped to 171/117 when EMS came in and checked.
50 2021-06-03 bell's palsy G51.0 - Bell's palsy
50 2021-06-03 pain in extremity Continue with pain in left arm since April 20, I am taking 2 Advil Avery day to control the pain wai... Read more
Continue with pain in left arm since April 20, I am taking 2 Advil Avery day to control the pain waiting to the pain let go, but not happening, and I and starting to worry
50 2021-06-05 night sweats I had experienced several Adverse Events after getting the Covid 19 Vaccine. I had Pain at the Inje... Read more
I had experienced several Adverse Events after getting the Covid 19 Vaccine. I had Pain at the Injection site on my Left arm a few hours after receiving the vaccine at 11:00 am on 6/5/21. Initially I did not feel anything. However the Pain got worse thruout the day until I went to bed at night. The Injection site also was a little swollen after a few hours of getting the vaccine. I had experienced some fatigue and tiredness on 6/5/21 after getting the vaccine. When waking up in the morning on 6-6-21 I must of had fever at night because in the morning I was sweaty. I also felt tired and fatigued when waking up. The pain at the injection site seems to have gotten a little better. Also there is no fever or sweating after i woke up.
50 2021-06-07 bell's palsy Bells Palsy
50 2021-06-07 burning sensation BPPV; burning sensation; partial loss of hearing; fullness and burning sensation in ears; tinnitus; ... Read more
BPPV; burning sensation; partial loss of hearing; fullness and burning sensation in ears; tinnitus; brain fog; pressure in the back of my head; severe vomiting; shortness of breath; Pyrexia; Mental status changes; This is spontaneous report from contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 14:30 (Batch/Lot Number: EWO161), at the age of 50 years, as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 on 30Mar2021, at the age of 50 years, Time: 03:45 PM, Lot no. EW8730, anatomical location: Left arm. 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 not been tested for COVID-19. On 30Apr2021 19:30 the patient experienced Benign Paroxysmal Positional Vertigo (BPPV) (hospitalization, life threatening). On 30Apr2021 19:30 the patient experienced fullness and burning sensation in ears, tinnitus, brain fog, pressure in the back of head, severe vomiting, shortness of breath, pyrexia, mental status changes. On 12May2021 the patient experienced partial loss of hearing. On 28May2021 the patient experienced burning sensation. Clinical course: Nine days after taking a second dose of the Pfizer vaccine it started with multiple episodes of vertigo for 2 days, followed by severe vomiting, non-stop vertigo, shortness of breath. Taken into Emergency Room (ER) by ambulance on 02May2021, multiple tests performed (CT scan, blood, EKG) diagnosed with BPPV. Discharged the same night. The symptoms escalated into fullness and burning sensation in ears, partial loss of hearing, tinnitus, brain fog, pressure in the back of my head. Went to primary care physician on 05Jun2021, again multiple tests (blood, urine, EKG). Referred to ENT. Visited ENT on 12May2021, audiology test confirmed partial hearing loss. On 28May2021 the patient was still suffering with burning sensation and fullness in the right ear, as well as loss of hearing (high frequencies) and tinnitus. Periodic episodes of brain fog and severe vertigo. The patient underwent lab tests and procedures which included blood test: diagnosed with BPPV on 02May2021, blood test: unknown results on 06May2021, CT scan: diagnosed with BPPV on 02May2021, electrocardiogram: diagnosed with BPPV on 02May2021, electrocardiogram: unknown results on 06May2021, audiology test: partial hearing loss on 12May2021, urine output: unknown results on 06May2021. The patient received treatments due to the events: Diazepam, Meclizine, Potassium Chloride, Metoclop. The outcome of the events was not recovered.
50 2021-06-07 numbness Severe worsening of tinnitus. I don't remember exactly when but it was it was very noticeable the fo... Read more
Severe worsening of tinnitus. I don't remember exactly when but it was it was very noticeable the following day after receiving the first shot (and very possibly that night) and continued to worsen for the next few days. I've have very mild tinnitus most of my life, however this is *far* worse than anything I have ever experienced (can hear it very clearly over day-time background noise, conversations, etc. whereas before could only hear it when it was relatively quiet.) It has been 3 weeks and has not abated, and in fact is probably continuing to grow worse. It is probably noteworthy that within minutes of receiving the shot, a got quite light headed and my face felt slightly numb for a period of an hour or two. These symptoms went away, however the tinnitus has not.
50 2021-06-09 tingling, numbness When I first got the shot, my left arm and leg went numb and was tingling. About a day later, my who... Read more
When I first got the shot, my left arm and leg went numb and was tingling. About a day later, my whole body started feeling stiff like I could not move. On Feb. 23, I went to the ER. They drug test (negative), blood work, and some x-rays. They could not find out what is causing this.
50 2021-06-10 tingling Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild
50 2021-06-12 tremor, numbness Cryptogenic Ischemic Stoke. At approximately 11am on the morning of the incident I felt the blood le... Read more
Cryptogenic Ischemic Stoke. At approximately 11am on the morning of the incident I felt the blood leaving my arms and legs, began to feel feint. Laid down on ground with legs elevated. Began shaking. Called 911. Was taken to the hospital by ambulance. Once at hospital, felt arms and legs were numb. After a period of time going through testing at the ER, feeling returned to all but left leg. Stayed overnight, went home on 5/6/2021. Strength returned to left left over the next several days. Since 5/6/2021. Have been dealing with increasing debilitating anxiety, as well as photosensitivity, insomnia, and other related issues since returning home.
50 2021-06-14 flushing Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Medium, Systemic: Hypotension-Medium, Sy... Read more
Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Medium, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: at 5:15 pt was sweating through shirt, put on fan took bp1:80/60 pulse 70, had pt elevate legs, also had visual changes bp2: at 5:25pm 195/126 pulse 73, bp3: 185/124 pulse 79, pt has history of high bp, told pt to follow up with md if bp is elvated later today and tomorrow
50 2021-06-15 pain in extremity Joint pain limited to hands that started approximately 1 week after injection. Started in one finger... Read more
Joint pain limited to hands that started approximately 1 week after injection. Started in one finger and progressed to entire hand, then both hands after each vaccination.
50 2021-06-16 weakness general malaise; general weakness; fever; chills; body ache; This is a spontaneous report from a con... Read more
general malaise; general weakness; fever; chills; body ache; This is a spontaneous report from a contactable consumer. A 50-year-old male patient received his second dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported), unspecified route of administration on 01May2021 as 2nd dose, single dose (at the age of 50 years old) for COVID-19 immunization. The patient's medical history includes hypertension but it is under control with medication (not mentioned). Concomitant medications included unspecified hypertension medication. Historical vaccine includes first dose of Pfizer COVID vaccine on 08Apr2021 (at the age of 50 years old), for COVID-19 immunization and no reported issues. On an unspecified date, while the reporter was playing cricket with his teammates against another team, he overheard the patient talking about general malaise and weakness. The patient also mentioned how he feels exactly how he felt after the 2nd shot of vaccine, which was the Pfizer COVID vaccine. The patient had body ache that night (01May2021) but took paracetamol (TYLENOL) and even played cricket the next day. On 03May2021, the patient had chills and fever, took paracetamol again and then no issues afterwards. On 12May2021, the patient had chills and general weakness but no fever and continued until 14May2021. On 15May2021, the patient was starting to feel better, no fever or chills but slight weakness. On an unspecified date, the patient experienced malaise. The reporter was not sure if the most recent malaise was vaccine related, but he figured he should err on the side of too much information. The outcome for general weakness was recovering; outcome for body ache, fever and chills was recovered on an unspecified date; outcome for malaise was unknown. No follow-up attempts are needed. Information about lot/batch number can not be obtained.
50 2021-06-16 numbness kidney issues/ Is that possibly his kidney?; cold; numbness of left upper arm/He also had numbness i... Read more
kidney issues/ Is that possibly his kidney?; cold; numbness of left upper arm/He also had numbness in his arm.; lower back pain/but started hurting again.; difficulty walking/He was also unable to walk the first week.; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 13May2021 at 14:00 (Lot Number: EW0176) (at the age of 50-year-old) as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 administered in left arm on 21Apr2021 (lot number: ER8731) for COVID-19 Immunization. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Vaccines administered on same date with the Pfizer vaccine considered as suspect was reported as none. Illness at time of vaccination was reported as none. On 13May2021, the patient complaints of lower back pain, difficulty walking, and numbness of left upper arm. The patient was wondering how the pain can be resolved. The patient was asking and wanted to know if he was having kidney issues due to his lower back pain. On reply Pfizer did not provide any recommendations regarding the management or treatment of potential adverse events. The patient was advised healthcare provider was in the best position to provide appropriate action to take as healthcare provider was most familiar with medical condition, clinical history and treatment and any relevant information to specific case. He had lower back pain. He didn't know that this was a side effect at the time. The pain was in in his left lower back, and he was also unable to walk the first week. After receiving the second dose the patient started to feel something but didn't know exactly what it was. A few days ago, he found that it was cold be a side effect. He also had numbness in his arm. For that he requested that he receive the vaccine in his left arm. He had numbness for 2-3 days that he remembered. It did not bother him after 7 days. He took Advil or Ibuprofen. He has not gone for treatment. He thought it was something else. He went back to where he received the vaccine. They were unable to tell him anything. Outcome of the event for difficulty walking/He was also unable to walk the first week was recovered on 15May2021, for numbness of left upper arm/He also had numbness in his arm was recovered on an unknown date in 2021, for lower back pain/but started hurting again was not recovered, while unknown for rest of the events.
50 2021-06-16 pain in extremity PT called call center on 5/18/21 states he has pain on the right shoulder/arm 8/10 and sometimes ra... Read more
PT called call center on 5/18/21 states he has pain on the right shoulder/arm 8/10 and sometimes radiates to the chest area for a month after vaccine. Pt states right shoulder/arm pain goes away with lotion and exercise but would come back. Advised pt to go to ED immediately for evaluation and explained the importance of going for evaluation and pt verbalized understanding but states he will go tomorrow morning. Received vaccine from outside pharmacy
50 2021-06-20 feeling cold Pt received his 1st Pfizer vaccine on 3/31/21 and presented to the emergency room with chest pain on... Read more
Pt received his 1st Pfizer vaccine on 3/31/21 and presented to the emergency room with chest pain on 4/16/21 that was ongoing x 1 week. he also reported some shortness of breath. he reported a cold feeling on the side of his chest as well. he also was feeling his heart racing at times. he denied any recent illness, fever or chills or hx of covid 19 infection, he was evaluated and sent home to follow up with his primary care and cardiology if his chest pain returned. He then received his 2nd pfizer COVID-19 vaccine on 4/21/21 and called the hospital on 6/18/21 reporting that since the second vaccine he was experiencing a weird feeling of coldness to his ears, vertigo and dizziness and has suddenly developed a fixed, hard, kidney bean sized lymph node to the r side of his neck. he now has to have imaging and work up with possible biopsy of the lymph node. He reported he has not felt right since his vaccines were given .
50 2021-06-21 feeling of body temperature change, night sweats Persistent dry throat , feeling the need to clear my throat but little to no phlegm is produced. ... Read more
Persistent dry throat , feeling the need to clear my throat but little to no phlegm is produced. Night sweats, difficulty regulating body temperature (Example: Feeling the need for air conditioning but feel cold after shortly after) I normally work outdoors (over 30 yrs) and some of these symptoms are close to seasonal allergies but this has been a constant since over 30 days since 2nd vaccine shot
50 2021-06-22 inability to speak After first shot an uptick in paranoia as every day got worse. Before second shot I was having the ... Read more
After first shot an uptick in paranoia as every day got worse. Before second shot I was having the vivid dreams. I was also hearing, seeing, smelling, tasting things that weren't there. The second shot put me over the edge immediately. I felt as if I was being poisoned, the vial with medicine inside turned amber color and I shut down as paranoia turned into an orchestrated conspiracy against me. for the next 3- 4 weeks I hallucinated daily, I believed reality was a dream and fiction was my reality. My wife tried multiple times to make me understand that what I was going through was not real, yet because my paranoia and psychosis I remained shut down and basically sleeping for two weeks. I could not speak about what was going on b/c I could not formulate a tangible and coherent thought. During this time I believed everyone was against me, which now I know is not true. It was a nightmare that lasted months. On June 4th I saw Dr., whom recommended a psychologist. I was able to book the first appointment on June 15th and have been going to Dr. on a weekly basis. The internal hysteria, paranoia, hallucinations kept me mute for about a month. About a month after my second shot I began to speak about it although it was disjointed. It was on May 13th. It took weeks of trying to formulate thoughts to go to a doctor. I am still having issues remembering words. Psychologist suggests I see a neurologist. That is why it has taken me so long to report.
50 2021-06-24 slurring, numbness swelling of tongue; difficulty breathing; headache (bad one); numbness in right side; confusion; swe... Read more
swelling of tongue; difficulty breathing; headache (bad one); numbness in right side; confusion; swelling of face; slurry words; This is a spontaneous report from a contactable other healthcare professional. A 50-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EM9810, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 10Feb2021 at 09:00 am (age at vaccination was 50 years) as 1st dose, single for COVID-19 immunization. Medical history included asthma. The patient had known allergies to iodine, shrimp and iodide (like the CATSCAN contrast fluid). Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) and One-A-Day Mens over 50 vitamin. The patient previously received first dose of flu shot in upper right arm on 12Jan2021. The facility where the most recent COVID-19 vaccine was administered was Hospital. On 10Feb2021 at 15:00 pm, the patient experienced swelling of tongue, face, confusion, slurry words, difficulty breathing, no pains though, headache (bad one) and numbness in right side. The patient received treatment with DECADRON (steroid) and Diphenhydramine (Benadryl). Since the vaccination, the patient has been tested for COVID-19. The patient underwent Nasal Swab COVID test (COVID Nasal/Nasopharynx COVID test) on 28Feb2021 and the result was negative. The outcome of the events was resolved on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. 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.
50 2021-06-26 seizure, tremor First: I had the coronavirus infection at the end of December/beginning of January. Second: I recei... Read more
First: I had the coronavirus infection at the end of December/beginning of January. Second: I received my First dose of the Pfizer shot on May 24th. Got a fever and body aches for about 24 hours. Thursday June 24th: T-0: Received PFIZER-BIONTECH COVID-19 VACCINE (Link is to the Pfizer Factsheet) T-11.5: Began having fever of 100°F and chills. Took a dose of Nyquil. T-14: Woke up in a daze and was half sleep walking around the room. While walking around in the room I passed out and fell to the floor. Was out for about 10 seconds. My wife woke me. I then passed out a second time and experienced a mild incontinence for about 15 seconds, came out of it and then went to the bathroom. When in the bathroom I passed out on the toilet for about 30 seconds, I experienced incontinence of everything left in me, bowel and bladder, I experienced convulsions and altered state(thousand yard stare). When I came too I began vomiting and had extreme body shakes. Some of this information was relayed to me by my wife obviously. T-15.3: Arrived at hospital and during check in I had another episode. (15 seconds) T-25: In hospital bed I had another episode duration unknown, no one saw me go out but I recall regaining consciousness. T-29: In hospital bed I had another episode duration unknown, no one saw me go out but I recall regaining consciousness. I passed out a total of 6 times.
50 2021-06-27 weakness The morning after the vaccination I began feeling fuzzy headed. As the day progressed I developed a... Read more
The morning after the vaccination I began feeling fuzzy headed. As the day progressed I developed a mild fever, chills and muscle aches similar to a severe flu throughout my body (arms, legs, back). This lasted through the night and into the next day, slowly subsiding from mid-day of the second day fading to only general weakness the second evening (48 hours after the vaccination).
50 2021-06-27 burning sensation, breast pain I have been experiencing sharp needle like pain in my right breast area, including burning sensation... Read more
I have been experiencing sharp needle like pain in my right breast area, including burning sensations in the same area on my my back in multiple areas. The pain and burning sensation has increasing gotten worse. It now has been going on 3-4 weeks.
50 2021-06-27 feeling cold Initially I had a more severe pain than i had with the first dose. Swelling and Soreness at the inj... Read more
Initially I had a more severe pain than i had with the first dose. Swelling and Soreness at the injection site was worse than the first dose. Later at night when trying to go to sleep I felt a SUDDEN Onset of CHILLS. I then had Muscular Pain thruout various parts of my body. I had Headache. I felt cold thruout the first night after I got the vaccine. I felt tired and unable to do day to day tasks the following day.
50 2021-06-28 weakness Pt.'s friend stating 06/11/2021 after receiving vaccination difficulty breathing, swelling of the fa... Read more
Pt.'s friend stating 06/11/2021 after receiving vaccination difficulty breathing, swelling of the face, dizziness/weakness, on/off fever, chills. Edema of both legs (Left more swollen), no seeping. No physician seen.
50 2021-06-28 seizure Extreme Convulsions (uncontrollable shaking); Fever spiked from no fever to 102 w/in 30 minutes and ... Read more
Extreme Convulsions (uncontrollable shaking); Fever spiked from no fever to 102 w/in 30 minutes and lasted for about 8 hours; extreme pain in the hips to where he could not move; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 10Jun2021 17:00 (Batch/Lot Number: EW0187) (at age 50 years old) as dose 2, single for COVID-19 immunization. The patient's medical history. No known allergies. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient previously received the first dose BNT162B2 on 19May2021 16:00 (lot number: EW167) (at age 50 years old) in left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. On 11Jun2021 21:30, the patient experienced extreme convulsions (uncontrollable shaking), fever spiked from no fever to 102 w/in 30 minutes and lasted for about 8 hours, extreme pain in the hips to where he could not move, and shortness of breath. The events were reported as non-serious. Treatment was not given. The patient was recovering from the events.
50 2021-06-29 pain in extremity Lump or swollen left breast; Lump or swollen left breast; Nipple is sore to the touch or pushing in ... Read more
Lump or swollen left breast; Lump or swollen left breast; Nipple is sore to the touch or pushing in on it is sore.; Feel some aching in left hand like arthritis; Feel some stiffness; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via unspecified route of administration in left arm on 25Feb2021 at 19:00 (at the age of 50 years) as a single dose for COVID-19 immunisation. Medical history included human immunodeficiency virus (HIV) and back pain. Concomitant medications within two weeks of vaccination included BIKTARVY, meloxicam (MANUFACTURER UNKNOWN), SEROQUEL, gabapentin (MANUFACTURER UNKNOWN) and vit D (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID 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. The patient did not have allergies to medications, food, or other products. On 03Mar2021 at 00:00, the patient experienced lump or swollen left breast, the nipple was sore to the touch or pushing in on it was sore, felt some aching in left hand like arthritis, stiffness and typical left arm soreness. Visual swelling compared to right breast was noticeable and swelling was right under the nipple size of quarter. It was unknown if any therapeutic measures were taken for the reported events. The clinical outcome for the events breast lump, breast swelling, sore nipple, hand pain and stiffness was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.
50 2021-06-29 tingling, burning sensation acne breakout on my scalp and on my temples; potential shingles flare up; burning/tingling sensation... Read more
acne breakout on my scalp and on my temples; potential shingles flare up; burning/tingling sensation on the left side of my face; burning/tingling sensation on the left side of my face; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration in the right arm on 01Mar2021 at 11:30 (at the age of 50-year-old), as a single dose for COVID-19 immunisation. Medical history included allergies to phenergan drug and strawberries. Concomitant medications taken within two weeks included PROPECIA, losartan pot (MANUFACTURER UNKNOWN), probiotic (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN) and vitamin C (MANUFACTURER UNKNOWN) all for unknown indications from unknown dates. 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 four weeks prior to the COVID-19 vaccine. On 02Mar2021, a day after vaccination, the patient had a bad acne breakout on his scalp and temples. On an unknown date in Mar2021 (two-week mark), the patient experienced burning/tingling sensation on the left side of his face (near to left eye) which the patient interpreted as a potential shingles flare up. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a results of event acne and shingles flare up included treatment with doxycycline (on dermatologist visit) on 03Mar2021 and Valtrex for 7 days, respectively. The clinical outcome of events acne, potential shingles, burning sensation and tingling was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
50 2021-07-05 numbness Right hand numbness
50 2021-07-09 tingling Tingling/needle/itchy feeling in hands, feet, scalp, inner thighs
50 2021-07-10 migraine Arm felt dead with pain at injection site; Low grade fever; Chills; Body aches; Migraine pain on lef... Read more
Arm felt dead with pain at injection site; Low grade fever; Chills; Body aches; Migraine pain on left side of head and neck; General malaise; Lingering headaches; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in the left arm on 19Mar2021 at 13:00 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included kidney stone and liver issues. The patient did not had allergies to any medications, food, or other products. The patient did not receive other medications within 2 weeks of vaccination. 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 had not been tested for COVID-19. On 19Mar2021 at 18:00, the patient experienced dead arm pain at injection site (for 3 days), low grade fever with chills and body aches, migraine with pain on left side of head and neck (for 3 days), general malaise. The patient experienced lingering headaches. The patient was definitely not looking forward to another shot. 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 the events vaccination site pain, low grade fever, chills, general body pain, migraine, general malaise and headache were resolved with sequelae (recovered with lasting effects) on an unknown date of Mar2021. No follow up attempts are needed. No further information is expected.
50 2021-07-12 numbness, tingling the patient reported that after he received his second done he stated experiencing numbness and ting... Read more
the patient reported that after he received his second done he stated experiencing numbness and tingling in his face and his legs feel "funny" and get swollen from time to time
50 2021-07-12 pain in extremity Five days later pains in leg, three weeks later diagnosed with with DVT and PE
50 2021-07-12 pain in extremity Dose 1 at 11Mar2021 and Dose 2 at 25Mar2021; Chills; Fever; Aching legs; sore arm where shot was giv... Read more
Dose 1 at 11Mar2021 and Dose 2 at 25Mar2021; Chills; Fever; Aching legs; sore arm where shot was given; sweating; This is a spontaneous report from a contactable consumer. A-50-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: er8727) via unspecified route of administration in the left arm on 25Mar2021 at 10:45hrs (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient had no known allergies to medications, food or other products. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: en6205) via unspecified route of administration in the left arm on 11Mar2021 at 10:30hrs(at the age of 50-years-old) as a single dose for COVID -19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since having the vaccine. The patient received first dose on 11Mar2021 and second dose on 25Mar2021 (inappropriate schedule of vaccine administered). On 26Mar2021, at 02:00, the patient experienced chills, fever, aching legs, sweating and sore arm where shot was given. The patient underwent lab tests and procedures, which included body temperature and the temperature was 99.2 F. Therapeutic measures were taken and included treatment himself with Tylenols . 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 chills, fever, aching legs, sore arm and sweating was recovered on unknown date and of the inappropriate schedule of vaccine administered was unknown. No follow-up attempts are needed. No further information is expected.
50 2021-07-15 numbness Pt received first Pfizer covid vaccine and subsequently developed large rash within 15 minutes of re... Read more
Pt received first Pfizer covid vaccine and subsequently developed large rash within 15 minutes of receipt of the vaccine. Due to prior reactions to vaccines, the patient was taken to the emergency department. Patient reported tunnel vision, burning feeling on skin with itching, numb lips, tongue and hands. Patient had rash across neck, chest, arms, and back as well as tongue swelling. Patient had taken benadryl 50mg prior to immunization and an additional 50mg of benadryl upon feeling reaction.
50 2021-07-15 numbness and pain in extremities Ongoing neuropathy that began after my flu shot in 2017 became significantly worse about 36 hours af... Read more
Ongoing neuropathy that began after my flu shot in 2017 became significantly worse about 36 hours after the COVID vaccine. This neuropathy had no physical cause when it began in 2017 other than it began about 36 hours after my flu shot. Over the course of 3 years while taking Lyrica the pain decreased substantially. It is now approaching it highest levels from 3 years ago 8 days after the COVID vaccine.
50 2021-07-18 weakness, pain in extremity First aches in prior injury sites: Right Rotator Cuff ( surgery 1989) Lumbar spine ( strains off/on)... Read more
First aches in prior injury sites: Right Rotator Cuff ( surgery 1989) Lumbar spine ( strains off/on) left 5th MTP ( fracture 2014) Progressed to general malaise with increased pain at left midfoot and 5th MTP along with lateral ankle pain. No recent trauma to any areas noted. Currently still suffer from lack of energy and intermittent left foot pain.
50 2021-07-18 numbness, tingling, pain in extremity Approximately 18 hours post 1st injection of Pfizer vaccine, patient developed 103.5 fever with the ... Read more
Approximately 18 hours post 1st injection of Pfizer vaccine, patient developed 103.5 fever with the following additional symptoms which lasted approximately 24 hours: numbness tingling in toes teeth and gums hurt blood vessels in eyes felt like they were spasming felt brief momentary pains up through legs and in chest
50 2021-07-19 discomfort experiencing moderate pain and discomfort in kidneys and bladder.; experiencing moderate pain and di... Read more
experiencing moderate pain and discomfort in kidneys and bladder.; experiencing moderate pain and discomfort in kidneys and bladder.; experiencing moderate pain and discomfort in kidneys and bladder; experiencing moderate pain and discomfort in kidneys and bladder; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male 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 13:15 hours (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not have relevant medical history. The patient was allergic to opiates. The patient did not receive concomitant medications. 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 19:30 hours the patient experienced experienced moderate pain and discomfort in kidneys and bladder within 6 hours of vaccination. The 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 patient did not receive any treatment for the event. The clinical outcome of the event moderate pain and discomfort in kidneys and bladder was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
50 2021-07-19 numbness, tingling Ongoing Dizziness Ongoing lightheadedness Ongoing face numbness Ongoing face tingling Ongoing fatigu... Read more
Ongoing Dizziness Ongoing lightheadedness Ongoing face numbness Ongoing face tingling Ongoing fatigue
50 2021-07-19 tingling, numbness Numbness, tingling and loss of dexterity in both hands Numbness, tingling and mild burning sensation... Read more
Numbness, tingling and loss of dexterity in both hands Numbness, tingling and mild burning sensation in both arms Numbness and tingling in both legs.
50 2021-07-20 tremor, muscle twitching 1st shot 3/25/21 2nd shot 4/15/21 Within a couple minutes of shot, sharp pain in center chest to the... Read more
1st shot 3/25/21 2nd shot 4/15/21 Within a couple minutes of shot, sharp pain in center chest to the left. A strange confusion and unknown stress/anxiety within 15 minutes, couldn't find the door easy to exit the convention center. Within 1-7 days, a internal trembling or pulsating of inner tissue, muscles and organs. Within 2 months, twitching of muscles when put under strain or exercise Within 2-3 months, visible shaking when fingers extended for instance onto a cell phone Within 3-4 months, symptoms seem to be getting worse or evolving into other related inner and very subtly outer shaking or trembling Within 4-5 months, overall feeling of body shaking getting worse. Please contact so that I can get help.
50 2021-07-21 electric shock sensation, tingling The night of my second Pfizer shot I developed very bad paresthesia. Very intense "electrical shock... Read more
The night of my second Pfizer shot I developed very bad paresthesia. Very intense "electrical shocks" in my shins. Strong enough to wake me from sleep. These seemed to pass away for a few weeks but then returned about 3 weeks later and have continued as of this date (7/22/2021). I feel shocks and pin pricks globally all over my body several times a minute. Sometimes more than once within ten seconds. This has been my daily experience since early June 2021. The intensity of the sensation is less, but the frequency is extreme.
50 2021-07-22 weakness He is currently 203 pounds; it is starting to work on him mentally; He has not felt well; His energy... Read more
He is currently 203 pounds; it is starting to work on him mentally; He has not felt well; His energy levels are terrible; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 50-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0180; Expiration Date: 30Sep2021, NDC: unknown) via an unspecified route of administration, administered in arm right on 07Jun2021 14:00 (at the age of 50-year-old) at dose 2, 0.3 ml single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0182; Expiration Date: 31Aug2021, NDC: Unknown) via an unspecified route of administration, administered in right upper arm on 07May2021 14:00 (at the age of 50-year-old) at dose 1, 0.3mL single for covid-19 immunisation. On an unspecified date the patient experienced he is currently 203 pounds, it is starting to work on him mentally and on 10Jun2021 he has not felt well, his energy levels are terrible. Patient is calling about the Pfizer covid vaccine. He received the second dose of the covid vaccine on the afternoon of 07Jun2021. He has not felt well since 10Jun2021. He is going to see a doctor on Tuesday. He has not seen his doctor recently because of covid. He had to find a new doctor. His energy levels are terrible. He wishes he did not take the covid vaccine. He drives for a living. He feels terrible. He did not get a fever. He has not felt this way in years. He is currently 203 pounds. He is normally 215 pounds. He has lost 12 pounds. He does not know how common this is. He really does not want to make conversation with people, because people will be scared to take the covid vaccine. He started to feel terrible three days after the covid vaccine, and it is starting to work on him mentally. This has been going on for a month now. His energy levels are terrible: Whenever he eats something, he feels a little better. He does not feel terrible whenever he wakes up. He goes through the stresses of the day and started to not feel well around noon. He will eat lunch and fell and little better. Then start to feel bad again, and then eat again and feel better. Indication: He lives with his elderly mother and has two older sisters. He has to be as healthy as possible to be around his 84-year-old mother. Outcome of the events he has not felt well, his energy levels are terrible was not resolved and he is currently 203 pounds, it is starting to work on him mentally was unknown.
50 2021-07-23 muscle twitching, pain in extremity, tingling Starting 1 week after second dose; ear ringing, just getting better Starting from 3 weeks after sec... Read more
Starting 1 week after second dose; ear ringing, just getting better Starting from 3 weeks after second dose to now: swollen hands, feet, ankles, tingling pain along tibia bones, brain fog, joint pain whole body, nuscle weakness and twitching
50 2021-07-23 tremor, electric shock sensation, inability to speak 5/24 got second covid vaccine, symtpoms sated 30 hours after. he laid on the floor , couldn't talk, ... Read more
5/24 got second covid vaccine, symtpoms sated 30 hours after. he laid on the floor , couldn't talk, was having shaking. ER visit. nl labs he felt a little better the next day 1 week later got up off of the couch, severe pain in achilles. given shots, pain med, x ray. 1 week after that, he had pain in the right (other ) achilles. given muscle relaxer, motrin. he got a splint. last night started getting "electrical shocks" arms, legs. he started having confusion, couldn't talk. he was shaking. h got second covid vaccine he feels his symptoms have been exacerbated
50 2021-07-27 tingling Tingle/needle feeling in hands, feet, legs; Itchy scalp; This is a spontaneous report from a contact... Read more
Tingle/needle feeling in hands, feet, legs; Itchy scalp; This is a spontaneous report from a contactable consumer (patient). A 50-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/batch no: EW0162) via unspecified route in the left arm on 23Jun2021 at 16:30 (at the age of 50-years) as dose 1, single for COVID-19 immunization.Medical history was none. There were no known allergies. Patient received balance of nature within 2 weeks of vaccination. 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 had not been tested for COVID-19.On 25Jun2021at 07:00, patient experienced tingle/needle feeling in hands, feet, legs, itchy scalp, patient would be making a doctor appointment. The patient did not receive any treatment for events. The patient had not yet recovered from the events. Follow-up attempts are completed. No further information is expected.
50 2021-07-28 muscle spasms Immediately after receiving the injection, I felt pain/sore that traveled from the injection site, w... Read more
Immediately after receiving the injection, I felt pain/sore that traveled from the injection site, went through and across my left pectoral and ended at center of my chest/heart area. I waited 15 minutes in the observation area to see if symptoms would get worse, but they did not; and so I left the facility and drove home. On my way home, about 45 minutes after receiving the shot, I felt my throat tightening up a bit, and my left hand and eyelids began to cramp up. I stopped at a pharmacy and bought some Benadryl. After 30 minutes, the pain in my chest began to feel better, and the cramping had disappeared. At about 6 pm that same day, my chest pain returned; and so I took one more Benadryl. The pain/soreness began to disappear after about 30 minutes. I felt fine for exactly two weeks. On Thursday, April 1st, I woke up with severe abdominal pain, diarrhea, and constant vomiting for about 12 hours. Went to urgent care and received an anti-nausea shot. The vomiting stopped, but the abdominal pain continued until the next morning. The weekend of April 10th, I experienced the chest pain again. This time it was very concerning because I felt very lightheaded, short of breath and faint. I checked myself into ER two days after.
51 2021-01-02 tremor Dizziness, shortness of breath, swollen hands and fingers, shaky blurred vision. all occurred 2 hour... Read more
Dizziness, shortness of breath, swollen hands and fingers, shaky blurred vision. all occurred 2 hours after giving the shot. Patient was given benadryl and felt better in about 1 hour, he went home and the next day came back to work normal
51 2021-01-04 burning sensation I felt as if I had blow torches during the 2 hour mark on the lateral thighs, femur bone pain and hi... Read more
I felt as if I had blow torches during the 2 hour mark on the lateral thighs, femur bone pain and hip pain.
51 2021-01-04 face paralysis, facial paralysis Patient developed tingling on the tongue 7 days after vaccine and developed unilateral facial weakn... Read more
Patient developed tingling on the tongue 7 days after vaccine and developed unilateral facial weakness 9 days later diagnosed as bell's palsy and started on Prednisone, Valcyclovir and ophthalmic Lubricants.
51 2021-01-05 pain in extremity Myalgia Pain at injection site and arm
51 2021-01-09 weakness Fever close to 102, rigors, aches, fatigue, overwhelming weakness
51 2021-01-09 pain in extremity 3 hours after 2nd dose almost fainted when exercising. 4 hours after injection started to feel ache... Read more
3 hours after 2nd dose almost fainted when exercising. 4 hours after injection started to feel achey, headache, and stiff neck. 12 hours after injection started shivering and increased heart rate. Took advil which helped, but shivering resumed 18 hours later. Took more advil. Body aches, sore arm, and headache continued for 48 hours. I still don't feel great 48 hours later but much better
51 2021-01-10 flushing, feeling hot Very hot, flush, stomach upset, sweating, increased respiratory rate, slouched in chair, chills over... Read more
Very hot, flush, stomach upset, sweating, increased respiratory rate, slouched in chair, chills over face/neck
51 2021-01-11 pain in extremity got home from the shot at 1145a. Fell asleep until 930pm. During sleep was told by family that i was... Read more
got home from the shot at 1145a. Fell asleep until 930pm. During sleep was told by family that i was angry, cursing and yelling in my sleep. I don't remember any of it , i felt delirious and out of co; got home from the shot at 1145a. Fell asleep until 930pm. During sleep was told by family that i was angry, cursing and yelling in my sleep. I don't remember any of it , i felt delirious and out of co; got home from the shot at 1145a. Fell asleep until 930pm. During sleep was told by family that i was angry, cursing and yelling in my sleep. I don't remember any of it , i felt delirious and out of co; got home from the shot at 1145a. Fell asleep until 930pm. During sleep was told by family that i was angry, cursing and yelling in my sleep. I don't remember any of it , i felt delirious and out of co; Left arm was extremely painful; This is a spontaneous report from a contactable Other-HCP. A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number # EL1284) on 02Jan2021 at 10:00 AM at single dose via intramuscular on left arm for COVID-19 immunization. Medical history included allergy to codeine hypertension and asymptomatic HIV infection. Concomitant medications were not reported. Patient got home from the shot on 02Jan2021 at 11: 45 am. Fell asleep until 930p:m. During sleep was told by family that He was angry, cursing and yelling in his sleep. He didn't remember any of it, He felt delirious and out of control. Left arm was extremely painful. At the time of the reporting had recovered from the events without any treatment.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event delirious 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.
51 2021-01-11 tingling, numbness 30 min after injection, right arm and hand suddenly felt tingly and a bit numb (like it was "asleep"... Read more
30 min after injection, right arm and hand suddenly felt tingly and a bit numb (like it was "asleep"). The sensation moved to shoulder, traps, and face after about 30-45 minutes; 30 min after injection, right arm and hand suddenly felt tingly and a bit numb (like it was "asleep"). The sensation moved to shoulder, traps, and face after about 30-45 minutes.; numbness/tingling mostly right side (arm, shoulder, face); This is a spontaneous report from a contactable consumer, the patient. A 51 -year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, 0.3 mL, lot number: EL0140), via an unspecified route of administration on 05Jan2021 at 05:30 PM, (at the age of 51 years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included Hashimoto's thyroiditis, hypertension and asthma. The patient was allergic to gadolinium MRI contrast, morphine (plus standard environmental allergies). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included allergy shots weekly, vitamin C, vitamin D3 and zinc quercetin. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 05Jan2021 at 06:15 PM, (also reported as 30 min after injection), the patient's right arm and hand suddenly felt tingly and a bit numb (like it was "asleep"). The sensation moved to the shoulder, traps, and face after about 30-45 minutes. The sensation started to subside after about 3-4 hours. There was never ever any weakness or sensation of throat, hives or rash, breathing issues or pain at injection site. Just a numbness/tingling mostly right side (arm, shoulder, face). The lower extremities or left side was not affected. The events were reported as non-serious. Laboratory data included a COVID-19 test (nasal swab) on 15Oct2020 which was negative. The patient was not treated for right arm and hand suddenly felt tingly and a bit numb (like it was "asleep"), the sensation moved to the shoulder, traps, and face. right arm and hand suddenly felt tingly and a bit numb (like it was "asleep"), sensation moved to the shoulder, traps, and face. The clinical outcome of right arm and hand suddenly felt tingly and a bit numb (like it was "asleep"), sensation moved to the shoulder, traps, and face was recovering. It was also reported that since the vaccination, the patient has been tested for COVID-19 (nasal swab) on 15Oct2020 .
51 2021-01-12 pain in extremity tachycardia (HR110-120); left arm soreness; This is a spontaneous report from a contactable physicia... Read more
tachycardia (HR110-120); left arm soreness; This is a spontaneous report from a contactable physician (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at the left arm on 16Dec2020 14:00 (lot number: EH9899) at a single dose, then intramuscular at the left arm on 05Jan2021 16:00 (lot number: EK9231) at a single dose for COVID-19 immunization in the hospital. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient medical history was not reported. The patient has no allergies to medications, food, or other products. Concomitant medications included allopurinol and atorvastatin. The patient experienced left arm soreness and tachycardia with hr of 110-120 on 06Jan2021 16:30. No treatment was given in response to the events. The patient assessed the events as non-serious. The outcome of the events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination.
51 2021-01-14 flushing Whole body aches from head to toes, chills , flushing, diarrhea, low grade fever
51 2021-01-14 pain in extremity fluctuating Temperatures up to 103.7 Painful Body aches throughout all joints Chills Symptoms laste... Read more
fluctuating Temperatures up to 103.7 Painful Body aches throughout all joints Chills Symptoms lasted 36 hours Right leg fluctuating tissue/faccia pain lasting 2+weeks, MD states related to virus/vaccine
51 2021-01-18 weakness headaches; Right deltoid is very tender to touch at injection site; A little weak feeling running to... Read more
headaches; Right deltoid is very tender to touch at injection site; A little weak feeling running to right shoulder blade; This is a spontaneous report from a contactable pharmacist reporting for himself. A 51-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL1284), intramuscular (right arm) on 08Jan2021 07:15 at SINGLE DOSE for COVID-19 immunization. The patient's other medical history was not reported. The vaccine was given at hospital. No other vaccines in four weeks. Patient did not have COVID-19 prior vaccination and was not tested for COVID-19 after vaccination. Patient has no known allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot: EJ1685) on 21Dec2020 07:15, left arm at single dose and experienced headaches, general malaise, moderate soreness at left deltoid running down thru left shoulder and mid back on 21Dec2020 18:00, with no treatment given. Concomitant medication included krill oil and an unspecified multivitamin; unspecified dates and indication. On the second vaccine, patient experienced same headaches starting the evening of after getting second vaccine on 08Jan2021. Patient also experienced headaches feel exactly the same as before, seemingly in the middle, top half of head, right deltoid is very tender to touch at injection site, and a little weak feeling running to right shoulder blade all on unspecified date in Jan2021. No treatment was given. Outcome of the events was unknown. The reporter assessed the events as non-serious.
51 2021-01-18 seizure APPROXIMATELY 5 MIN AFTER RECEIVING VACCINE, IN OBSERVATION, BEGAN TO HAVE A SEIZURE. FELL ONTO STA... Read more
APPROXIMATELY 5 MIN AFTER RECEIVING VACCINE, IN OBSERVATION, BEGAN TO HAVE A SEIZURE. FELL ONTO STAIRS IN THEATER-LIKE SEATING. CARE WAS IMMEDIATELY REDERED BY RNS, A CODE BLUE WAS CALLED. CODE TEAM ATTENDED TO PATIENT AND SUBSEQUENTLY TOOK TO THE EMERGENCY DEPARTMENT.
51 2021-01-18 seizure ABOUT 5 MINUTES AFTER RECEIVING VACCINE, PATIENT BEGAN SEIZURE. PATIENT FELL TO FLOOR FROM CHAIR. ... Read more
ABOUT 5 MINUTES AFTER RECEIVING VACCINE, PATIENT BEGAN SEIZURE. PATIENT FELL TO FLOOR FROM CHAIR. OBSERVING RN'S PROVIDED IMMEDIATE CARE. A CODE WAS CALLED. CODE TEAM TREATED PATIENT, THEN TOOK TO EMERENCY DEPARTMENT.
51 2021-01-19 tingling, weakness, numbness 2 days after 1st dose: severe headache and body aches. Severe tinnitus. Insomnia, constipation. Afte... Read more
2 days after 1st dose: severe headache and body aches. Severe tinnitus. Insomnia, constipation. After 3 days tingling numbness and weekends in extremities. Loss of appetite. Weight loss. Symptoms persisting for 3 weeks.
51 2021-01-20 weakness Uncontrollable rigors; profound fatigue; weakness; achiness; nausea; fever (up to about 102).; This ... Read more
Uncontrollable rigors; profound fatigue; weakness; achiness; nausea; fever (up to about 102).; This is a spontaneous report from a contactable physician reporting for himself. A 51-year-old male patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL3246, expiry date not reported) on 09Jan2021 at 08:30 via an unspecified route of administration in the left arm for COVID-19 immunization. The patient's medical history included penicillin allergy. No other medical history. The patient had not had COVID prior to the vaccination and had not been tested post the vaccination. The patient had received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685, expiry date not reported) on 19Dec2020 at 16:30 via an unspecified route of administration in the left arm for COVID-19 immunization. No other vaccine received in four weeks. Concomitant medication included paracetamol (TYLENOL). On 09Jan2021 at 23:30, the patient experienced uncontrollable rigors, profound fatigue, weakness, achiness, nausea, fever (up to about 102). The events were non-serious. The patient took over the counter paracetamol (TYLENOL) and ibuprofen for the events, and was recovering from the events.
51 2021-01-21 slurring, impaired body coordination pt had severe, non-hospitalized covid infection late August: fever, loss of taste/smell, fatigue, dy... Read more
pt had severe, non-hospitalized covid infection late August: fever, loss of taste/smell, fatigue, dyspnea, cough; recovered all except smell /taste loss has improved but not normal; covid Ab positive in November; After the injection he began with chills that night around 3 am. The next day he felt ataxic, hit a curb twice while driving, was slurring speech; those sx's resolved over the next few hours; fatigue persisted for the next 48 hours.
51 2021-01-22 pain in extremity fever, chills, arm pain, fatigue but mainly swollen lymph nodes continuing to swell for two days
51 2021-01-24 pain in extremity, muscle spasms I had a sore arm for about two days after receiving my second shot with mild tiredness. On the 22nd ... Read more
I had a sore arm for about two days after receiving my second shot with mild tiredness. On the 22nd of January I work up around 2:30 with severe cramp and joint. I could even close my hands because my nuckles were so sore. I hand a temperature of 101 degrees. On the 25 I?m moving around but very sore but is getting better everyday. I spent the entire day though resting in bed.
51 2021-01-25 facial paralysis 14th of jan i had a pain around my jaw got up the next day i started having water eyes, the right si... Read more
14th of jan i had a pain around my jaw got up the next day i started having water eyes, the right side of face started to droop. went to ER and was diagnosed with Belspaulsy. after that did a follow up appointment with neurology
51 2021-01-25 muscle twitching, pain in extremity, feeling hot, flushing, feeling cold, tingling Dose 1 -Muscle twitched on injection into R deltoid. Immediately after injection experienced warm a... Read more
Dose 1 -Muscle twitched on injection into R deltoid. Immediately after injection experienced warm and cold sensations through right arm, intermittent pains along arm. Was asked to be observed 30 mins post injection. Sent home. Paresthesias (intermittent warm, cold, tingling sensations) continued with radiation into right axillary, and into neck. Experienced intermittent facial tingling. On day 3 post injection, started with burning eye discomfort in right eye. Went to eye doctor to rule out eye infection. No eye infection, Instructed to use Refresh drops. In 4 days subsided. Day 7 experienced ear flushing and warmth that last 3 days and subsided. Saw a neurologist to rule out nerve damage. EMG was normal. ANA titer was 1:40 with speckled and cytoplasma pattern. My last ANA was negative when tested for inflammation due to back pain few years prior. Neurologist did not think this was an allergic reaction and since symptoms were gradually improving recommended second dose. Symptoms fully resolved after 2 weeks Dose 2 - Jan 19 , 2021 (21 days post) - Decided to inject left deltoid to avoid trauma to right arm. Was observed 30 mins and released. No symptoms. Moderate arm soreness x 4 days. Day 3 post injection developed burning eye discomfort, intermittent tingling sensation in arm, warm/cold sensations. Pain radiating to shoulder and neck. Day 6 started very mild tingling and warm sensations in in cheek and chin area. Also experienced intermittent prickly sensations in throat and sensation of throat tightness predominantly on left side. (but no actual swelling). Today (Jan 26, 2021) is Day 7 and these intermittent sensations are persisting. Arm soreness has resolved. Right eye burning discomfort improving.
51 2021-01-26 discomfort, pain in extremity he had 102.1 temp; he started not feeling well; chills; ringing in ears/ The ringing was in both ear... Read more
he had 102.1 temp; he started not feeling well; chills; ringing in ears/ The ringing was in both ears; body aches; joint aches; fatigue; lymphadenopathy/had swollen lymph nodes like the size of an apple; he was uncomfortable; His eyes were also hurting; The light bothered his eyes; This is a spontaneous report from a contactable Other HCP (patient) and a contactable Nurse (patient's wife). A 51-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Batch/lot # EL3246, Expiry Date Apr2021) at single dose at left arm on 11Jan2021 18:00 for Covid-19 immunisation, administered at hospital as being a certified registered nurse anesthetist (CRNA). The patient medical history was none. There were no concomitant medications. The patient received the 1st dose of bnt162b2 (BNT162B2, lot # EK5730, expiry: 31Mar2021) at single dose at left arm on 23Dec2020 for Covid-19 immunisation and he has been fine, no adverse effect occurred. No additional vaccines administered on same date of BNT162B2. The patient experienced lymphadenopathy which is a size of tennis ball under my left armpit /had swollen lymph nodes like the size of an apple in his left arm in the axillary area, where he received the vaccine on 12Jan2021, he started not feeling well on 12Jan2021 around 9.00, he had 102.1 temp Fahrenheit on 12Jan2021 17:00, chills on 12Jan2021, ringing in ears/ the ringing was in both ears on 12Jan2021, body aches on 12Jan2021, joint aches on 12Jan2021, fatigue on 12Jan2021, his eyes were also hurting on an unspecified date in Jan2021, the light bothered his eyes on an unspecified date in Jan2021. The patient underwent lab tests and procedures which included body temperature: 102.1 fahrenheit on 12Jan2021, he was uncomfortable on 12Jan2021, body temperature: 100 and something fahrenheit on 13Jan2021. The outcome of lymphadenopathy/had swollen lymph nodes like the size of an apple was worsened, of he had 102.1 temp, ringing in ears/ the ringing was in both ears was not recovered, he started not feeling well, his eyes were also hurting, light bothered his eyes was unknown, chills, body aches, joint aches, fatigue was recovered on 13Jan2021. Course of events: Around 9AM on 12Jan2021 he started not feeling well. By the time he got home from work he had 102.1 temp Fahrenheit around 5PM. Temp was ongoing. His eyes were also hurting. The light bothered his eyes. He can't put his arm down. His left arm in the axillary area, where he received the vaccine, had swollen lymph nodes like the size of an apple. He had chills, ringing in ears, body aches and joint aches, and fatigue 12Jan2021. He was uncomfortable. The ringing was in both ears. On 13Jan2021 his temp was one hundred and something. What is concerning was the swelling in the armpit in the arm he received the vaccine in. It was very painful. It was starting to radiate up his arm. He did not go to the doctor, since he was relatively healthy. No event required a visit to Emergency Room or Physician Office. The reporting Nurse assessed the events he had 102.1 temp, His left arm in the axillary area, where he received the vaccine, had swollen lymph nodes like the size of an apple as serious as medically significant. The reporting Nurse assessed the events he had 102.1 temp, His left arm in the axillary area, where he received the vaccine, had swollen lymph nodes like the size of an apple, chills, Ringing in ears, body aches and joint aches, and Fatigue as related to BNT162B2.; Sender's Comments: Based on a compatible temporal association and known product safety profile, causality between events lymphadenopathy and fever and BNT162B2 COVID-19 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.
51 2021-01-28 tingling sharp pain in shoulder blades that radiates, tingling in right hip
51 2021-01-29 pain in extremity, feeling cold Began with a slight headache that eventually got worse. Started, when treated, at a 5 of 10. Left ... Read more
Began with a slight headache that eventually got worse. Started, when treated, at a 5 of 10. Left facility with a 7 of 10 headache. Then I had a weird taste in my mouth (metallic like). My tongue started to tingle and was a bit numb. Eventually after Doctor at facility took me in, I was given benedryl 50 mg and an antacid. After a few minutes the right side of my mouth became itchy but the tingling stopped. The itch was not unbearable but it was getting there. I was already having a slight difficulty breathing but that was from the morning even with inhalers. As an instrument player a doctor said I have super lungs so my results would be skewed due to how much air I take in. But any loss of air, although in the safe range for others, is like breathing through a straw for me. My blood pressure was 139/90 at the time. My normal blood pressure is 117/70. I went home feeling cold and just not feeling well, relatable to flu symptoms. This is the next day after taking benedryl every 6 hours at 50mg/dose. My breathing is slightly labored. I feel ok but my arm hurts, I have been moving it around a lot just to get it mobile. My chest feels like there is a slight weight on it which is weird for me. At the moment my pulse is 81bpm and my oxygen is at around 96. My norm is around 70bpm and oxygen at 99. No temperature is consistent at 97.3. I feel a little weird today. I am stiff all over as well. Little aches here and there but that is a norm. Doing my stretches and exercise is not a go today. Can't breathe as normal.
51 2021-01-31 bell's palsy, facial paralysis I am a pediatric critical medicine physician and received my COVID-19 vaccine at my workplace. 1st ... Read more
I am a pediatric critical medicine physician and received my COVID-19 vaccine at my workplace. 1st Pfizer EH9899 (on Dec 18, 2020) and 2nd Pfiszer EL1283 (on Jan 9, 2021). Both IM through my left arm. Directly for about less 48H post vaccination I had muscle pain that were self-resolved. On Jan 18, 2021, I started having funny sensation (like having a foreign body) over my left eye medial /innercantus area. The next 2 days I started to have pain over my left external ear canal, then it progressed into pain over my left lower jaw, left vertex of my head, inner side of left eye. My SS progressed on 1/30/21 at around 3:30 PM to numbness over my left sided tongue and left sided lip. Then on 1/31/21 at around 5 AM, I started having left facial paralysis. I have left BELL's PALSY which was confirmed. following a negative non-contrast brain MRI to rule out stroke and negative SARS-CoV2 PCR test. I start taking Prednisone 60 mg daily and Acyclovir 1 g TID on Jan 31, 2021. To this date I still have left facial paralysis but not worsening.
51 2021-02-06 bell's palsy Left Bell's palsy (unable to close eyelid all the away, tearing, left facial drooping)
51 2021-02-08 cold sweat Approx 14 minutes after receiving the vaccine, client felt like his heart was racing and his blood p... Read more
Approx 14 minutes after receiving the vaccine, client felt like his heart was racing and his blood pressure elevated, and dizzy. vital signs monitored, his BP was 150/108. He was clammy and shaky He was taken behind the white curtain and took his mask off, which he said helped tremendously. He was monitored. BP down to 140/100. He recently started BP medication. Told to discuss this episode with his PCP.
51 2021-02-08 pain in extremity Sore arm
51 2021-02-20 flushing, feeling hot Systemic: Chills-Mild, Systemic: Ringing in ears, chills,then feeling flushes. No obvious signs of ... Read more
Systemic: Chills-Mild, Systemic: Ringing in ears, chills,then feeling flushes. No obvious signs of diaphoresis-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Hypertension-Medium, Systemic: Tinnitus-Mild, Additional Details: Report. 20 min post admin, Aid ckd BP and reported 204/134. Rpt ringing in ears, chills, then warm sensation all over. BP 5-10 min later in other arm, reported 213/162. Gave Pt water. COO at facility to call paramedics to assess. Lied pt down for 5 min, rck BP 180/117. Pt reported feeling fine w/ occasional chill. Waiting on Paramedics. Approx 5 min, pt sat up complaining of headache. Paramedic arrived about 5 minutes later, assessed pt, bp 232/120?. To Hospital
51 2021-02-22 tingling Itchy and tingly hands/arms in morning of 2/22/21. Rash broke out on body in the evening (face, leg... Read more
Itchy and tingly hands/arms in morning of 2/22/21. Rash broke out on body in the evening (face, legs, shoulders, waist, thighs/groin). Took a Benadryl and ibuprofen. Symptoms improved by morning, but still evidence of the rash. Took normal allegry meds in AM. Will monitor symptoms moving forward.
51 2021-02-23 pain in extremity Started being more fatigue and right arm stays sore everyday in the bend shoulder on right side stay... Read more
Started being more fatigue and right arm stays sore everyday in the bend shoulder on right side stays sore
51 2021-02-25 tingling swollen lymph node under his left arm; I feel tingling in my arm; I turn my neck to the right side, ... Read more
swollen lymph node under his left arm; I feel tingling in my arm; I turn my neck to the right side, I feel like little pain on the neck side; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231) via an unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunization. Medical history included blood pressure (abnormal) and diabetes. Concomitant medication included lisinopril for blood pressure, amlodipine, atorvastatin and metformin for diabetes. The patient previously received first dose of BNT162B2 on 02Jan2021 for COVID-19 immunization. The patient had his second shot of his COVID 19 vaccine and then the first day was okay but the second day (24Jan2021) was, he had like swollen lymph node under his left arm. And also, he felt tingling in his arm. And when he turned his neck to the right side, he felt like little pain on the neck side. "I don't know if this will go away or what. This is the third day I had the vaccine." Consumer stated, "I took Ibuprofen." The patient underwent lab tests and procedures which included lab on an unspecified date with unknown results (the patient don't have it, his primary care have it). Outcome of the events was not recovered.
51 2021-02-25 seizure At about 2am on 2/10/21, Patient got up from bed and fell down a flight of stairs. He was initially ... Read more
At about 2am on 2/10/21, Patient got up from bed and fell down a flight of stairs. He was initially bleeding and unconscious and was brought by EMS to the hospital. Upon arrival at the hospital he had a temperature of 40 C. He was found to have 2 small left temporal hemmorhagic contusions on CT scan. He had a seizure during the hospitalization. He was initially treated for HSV encephalitis but it is not clear if that was confirmed. The hospital team may not have known of the recent vaccination. He improved during the hospitalization, but remained with a very unsteady gait. He could not return to the group home. He was transferred to a rehab facility to receive PT on 02/16/2021. He remains at rehab. Prior to the fall, on the 3rd day after vaccination, on 2/8/21 at about 10 am, the patient coughed and had a small blood on the inside of his face mask while at his day program. He was seen by his PCP and had no abnormal findings. He had a CBC, BMP and CXR and all were unremarkable.
51 2021-02-28 tingling Patient noted tingling to LUE and tongue swelling, no other symptoms.
51 2021-03-02 bell's palsy Bell's Palsy
51 2021-03-03 weakness Patient felt weak and lightheaded immediately after receiving vaccine Heart Rate increased to 122 BP... Read more
Patient felt weak and lightheaded immediately after receiving vaccine Heart Rate increased to 122 BPM. BP 180/80. Other vital signs normal After 45m obs v/s HR 96 O2 98% room air, PB 110/60. Patient stated she felt she felt too sick for discharge home and requested EMS be called. EMS responded and xported to hosp
51 2021-03-03 weakness Dizziness/felt woozy/light headed; Weakness; vision changed; increased heart rate/heart rate went up... Read more
Dizziness/felt woozy/light headed; Weakness; vision changed; increased heart rate/heart rate went up slightly; had pressure in his head; pressure in his hands and feet like he could not move his feet; pressure in his hands and feet like he could not move his feet; headache; muscle tightness/muscles tightened in his back and in his calf muscles/tightness in his neck; he felt like he was just not himself; lethargic; lump in his throat; lymph nodes got tight on the same side as the vaccine/lymph node on his left side was tight throughout his neck; cringing in his stomach muscles; kind of like a muscle spasm in his stomach; didn't sleep that well last night; wobbly; back was hurting; muscle pain; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EZ9261, expiry date: unknown), via an unspecified route of administration, from 01Feb2021, at single dose, for COVID-19 immunization. Medical history included anemia (anemic), inflammation, acid reflux (esophageal), pain, on blood thinner, high cholesterol, sinus disorder (sinuses), overactive bladder/bladder control, acid reflux, stools hard (to soften stool), nerves, blood pressure high (high bp), car accident, and costochondritis in chest. Concomitant medication included atorvastatin calcium for high cholesterol from an unspecified date and ongoing; docusate sodium to soften stool; famotidine to soften stool from an unspecified date and ongoing; garlic [allium sativum] as blood thinner from Nov2020 (3 months ago) and ongoing, gabapentin for nerves from an unspecified date to an unspecified date and from Nov2020 (got back on this 3 months ago) and ongoing; hydrocodone for pain; iron for anemia from Nov2020 (been taking this for the last 3 months) and ongoing; meloxicam for inflammation, omeprazole (PROTONIX) for acid reflux from an unspecified date and ongoing; tadalafil for overactive bladder/bladder control from an unspecified date and ongoing; vitamin c (ascorbic acid), colecalciferol (VITAMIN D), vitamin b for trying to build up his immune system; ranitidine hydrochloride (ZANTAC) for sinuses; "One a Day Men's" from 2016 and "50+" (as reported, pending clarification). On 01Feb2021, after the shot, the patient experienced dizziness/felt dizzy and had weakness. When he walked to the desk to check out he felt his vision changed and his heart rate went up slightly but it did go down once he sat down but he felt woozy and had pressure in his head and pressure in his hands and feet like he could not move his feet. He was kind of like dizzy and light headed. He walked somewhere to sit down, he stayed 30 minutes and left after and sat 30 minutes in the car and he got a headache and his muscles tightened in his back and in his calf muscles and he felt like he was just not himself. He felt lethargic and felt like his lymph node on his left side was tight throughout his neck. He felt like his lymph node was getting tight and he just sat until he felt like his symptoms had dissipated. He also had lump on his throat. He had stuff going on with his stomach like cringing in his stomach muscles, it was kind of like a muscle spasm in his stomach. He didn't sleep that well last night (01Feb2021) as he felt some symptoms come on again, the tightness in his neck again and when he sat up, he got dizzy and wobbly, his back was hurting, his calf muscle was tight. He felt more muscle pain. He checked his blood pressure and it was good, but he just felt a little dizzy on 02Feb2021. The patient stated that all his symptoms have improved since 01Feb2021. The patient also mentioned that the girl looked really young (referring to the person who administered the vaccine), "maybe she jacked it up, he knows it supposed to be a very little bit, maybe she put more in him than she was supposed to". He went back to his doctor as he wants to come off of some of his medications because he is supposed to have another shot and he want to take the second shot. He wanted to stop taking all the medications around the second shot in case it was his medications that caused it. The patient asked since he had complications with the fist dose, should he still take the second dose. The patient was recovering from the events.
51 2021-03-03 numbness, tingling Numb and tingly face; Numb and tingly face; Fatigued; lethargic; This is a spontaneous report from a... Read more
Numb and tingly face; Numb and tingly face; Fatigued; lethargic; This is a spontaneous report from a contactable consumer (patient). A 51-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN 5318), via an unspecified route of administration left arm single dose on 02Feb2021 14:30 (at the age of 51) for covid-19 immunisation. The patient medical history included covid 19 with mild symptoms on 29Dec2020. The patient's concomitant medications were not reported. No other vaccine was received in four weeks. The patient experienced numb and tingly face, both on 02Feb2021 18:00, fatigued and lethargic on 02Feb2021 8-36 hrs after vaccination. The events outcome was recovered.
51 2021-03-07 pain in extremity Fever started 2 days after vaccination, followed by shortness of breath, dyspnea, weakness and pain ... Read more
Fever started 2 days after vaccination, followed by shortness of breath, dyspnea, weakness and pain and edema in both legs. edema was traveling up and reached umbilicus. Weakness in both legs. Started to improve with steroids. When steroids were starting to taper, symptoms worsened again. Patient was seen in ED.
51 2021-03-07 pain in extremity Mild Fatigue, pain in right aram and foreign body sensation
51 2021-03-07 pain in extremity Sore right arm, foreign body sensation, mild fatigue
51 2021-03-08 numbness Several hours after receiving the injection, patient developed numbness in his 4th and 5th fingers, ... Read more
Several hours after receiving the injection, patient developed numbness in his 4th and 5th fingers, left hand.
51 2021-03-09 seizure like phenomena 3 hours post vaccine, patient passed out and lost consciousness, demonstrating seizure like activity
51 2021-03-11 pain in extremity I got my shot, 18 hours later I woke up with a mild headache and it go worse. I went into work and h... Read more
I got my shot, 18 hours later I woke up with a mild headache and it go worse. I went into work and had to have my wife come get me because it was so bad. It lasted 3 days. I had some arm soreness.
51 2021-03-14 tingling Warm left arm at the injection site after 4 hours. Both shoulder joints and hip joints were painful... Read more
Warm left arm at the injection site after 4 hours. Both shoulder joints and hip joints were painful about 8 hours after injection. Took Tylenol. Light headache and tingling under hairline on the back of the neck. 8 hours after injection. 2:30am chills until 3:00am. Fell back to sleep. 8:00 am - 9:30 am. Sore muscles and bones from head to toe. 9:45am took Motrin and Tylenol seems to work. I feel better.
51 2021-03-16 muscle spasms Extreme headache, fever, nausea, leg cramps
51 2021-03-16 cold extremities 1st Shot on 2/22/21, no adverse reaction aside from injection side muscle pain. 2nd Shot on 3/15/21,... Read more
1st Shot on 2/22/21, no adverse reaction aside from injection side muscle pain. 2nd Shot on 3/15/21, vaccine administered at 15:15EST, after going home, became very tired around 17:30, took nap, woke up at 21:30 with pounding headache and the "chills." Went to bed at that time, took ibuprofen for headache, Slept through morning alarm on TUE 3/16 at 05:15, woke up at 08:45, in to work by 10:30. Left work at 13:30 due to continued headache & body aches, chills, (had to turn a space heart on in my office), hands were cold. Took nap from 16:00 - 19:00. Still had headache, body aches, and chills. Went to bed around 21:15. Woke up on WED 3/17 at 01:30, had the chills, and was shivering, still had head ache. Turned up the thermostat from 70 to 75. Put an extra blanket on the bed. Woke up at 03:30, t-shirt and blanket soaked in sweat. Woke up for day at 05:45. Right underarm swollen, (lymph gland/nodes). Experiencing runny nose, body aches, headache continues.
51 2021-03-17 tingling, burning sensation After immunization, patient immediately felt nausea and complaint of tingling down (r) arm. Patient... Read more
After immunization, patient immediately felt nausea and complaint of tingling down (r) arm. Patient was very anxious, also complaint of (r) arm burning. Patient takes Gabapetin, Flexaril, ibuprofen. Patiet felt light headedness. Smoker, anxiety, hiatal hernia, chronic neck pain, history of shoulder surgery.
51 2021-03-18 cold sweat, tremor PATIENT BEGAN TO FEEL NAUSEAS, CLAMMY, AND HAD TREMORS. LASTED FOR ABOUT 30-40 MINUTES. CHECKED VITA... Read more
PATIENT BEGAN TO FEEL NAUSEAS, CLAMMY, AND HAD TREMORS. LASTED FOR ABOUT 30-40 MINUTES. CHECKED VITALS - SUGAR WAS 117 AND BLOOD PRESSURE 126/84. PULSE 64.
51 2021-03-19 flushing Systemic: Flushed / Sweating-Medium, Additional Details: patient became flush approximately 5 minute... Read more
Systemic: Flushed / Sweating-Medium, Additional Details: patient became flush approximately 5 minutes into his 15 minute observation period. Placed patient on floor and elevated legs. Patient was able to return to a sitting position in a chair approximately 8 minutes later. BP during epidose was 130/88 and pulse was 60 per automatic blood pressure cuff machine. Patient also stated he was light-headed as well. Patient was doing much better when he left the observation area.
51 2021-03-20 feeling hot, cold sweat About 10 minutes after the shot I started feeling hot, started sweating, clammy hands, dizzy and the... Read more
About 10 minutes after the shot I started feeling hot, started sweating, clammy hands, dizzy and then I passed out walking to get help. I hit my head on a chair when I was falling and cut my head. I stayed laying down because I was still dizzy and hot. They called the squad and did vitals and I was fine. I sat there for about another half an hour and I went home. I have felt fine ever since. Only thing that hurt was my head from the fall.
51 2021-03-20 tingling Patient first reported feeling a tingly/"prickly" feeling down his left arm and left shoulder, we ad... Read more
Patient first reported feeling a tingly/"prickly" feeling down his left arm and left shoulder, we advised patient to stay an extra 30 minutes for closer monitoring. About 15 minutes later his left knuckle began to swell with some redness, patient reported no difficulty breathing and no itching of the throat. Pharmacist decided to give Diphenhydramine 50mg IM after patient consented. The swelling and redness began to subside within 10 minutes. Patient received a ride home from family due to drowsiness from the Diphenhydramine
51 2021-03-22 numbness Patient was found in the bathroom , urinating , walked to the wheelchair complaining of numbness ove... Read more
Patient was found in the bathroom , urinating , walked to the wheelchair complaining of numbness over his whole right side denies any chest pain no tingling no trauma no incontinenc
51 2021-03-23 tingling Progress Notes 3/24/2021 Date: 3/24/2021 ... Read more
Progress Notes 3/24/2021 Date: 3/24/2021 Subjective Patient is a 51 y.o. male who was seen at COVID Vaccine Clinic today for his first dose of the COVID 19 vaccination. He was given the Pfizer vaccination in the right deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience "funny feeling in his face" and difficulties breathing. He denied rash, difficulty swallowing, wheezing, throat tightness, dizziness and facial swelling. This provider was notified of patient reaction and he 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 and skin changes. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, facial swelling, cough, chest tightness, shortness of breath, wheezing, dizziness and headaches Previous Reactions: Denies. Objective Vitals Vitals: 03/24/21 0825 BP: (!) 132/90 Pulse: 89 SpO2: 100% Physical Exam Vitals reviewed. 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: He is alert and oriented to person, place, and time. Assessment/Plan Treatment included: antihistamines, water and snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Systemic reaction (hypoglycemia, hypotension, generalized rash) 3/24/2021 9:12 AM
51 2021-03-24 weakness After covid second shot I had fever i took Tylenol, fever gone. 01/08/2021 I went to work. Next morn... Read more
After covid second shot I had fever i took Tylenol, fever gone. 01/08/2021 I went to work. Next morning 01/09/2021 . I was stroked out taken to er. Still I have weakness on left , hearing loss, loss taste, even I drink water taste bitter. Loss smell. I am doing physical and speech therapy. Still not recovered.
51 2021-03-24 weakness The patient is a 51 yo old reservist with a history of hypercholesterolemia with an onset of illn... Read more
The patient is a 51 yo old reservist with a history of hypercholesterolemia with an onset of illness 10 days after Pfizer vaccine (lot #2 ELI283) on 6 JAN 2021, where he was on 87 day active duty orders with Medical Task Force - COVID mission. He denies any AE after dose #1 (Dec 17 lot #ELD140). He denies any immediate symptoms suggesting IgE event(pruritis, urticaria, SOB, wheezing, oral, facial throat, tongue swelling etc.) and denies any local site reaction. He reports about 10 days later he experienced severe nausea vomiting and diarrhea, CP and SOB. He was seen in ER 3 times where he was found to have Acute Kidney injury, and treated with IVF, odansetron meclizine dicyclimine. After the third ER visit he was admitted where he subsequently developed GI pain. He has continued to have significant health issues, but no unifying diagnosis has been identified. He would like to know if this was related to his Covid vaccine receipt. He reports no one else in his group will ill and they were otherwise isolated for travel related Covid quarantine. Per review of records he presented to ER 17 JAN 2021 (day 11) with complaints of nausea global weakness, watery diarrhea, and shortness of breath . He had a acute kidney injury with cr 1.4. A non contrast ABD CT was normal. He was diagnosed with viral gastroenteritis, treated with hydration, Zofran and Bentyl. He returned to ER 19 JAN (day 13) with a complaint of same with severe dizziness. A noncontrast head CT was normal He had a positive Dix-Hallpike and he was diagnosed with benign positional vertigo. On 1/20/21 (day 23) he continued symptoms with tachypnea on minimal exertion noted in ER. CXR demonstrated lateral RLL opacity and he was treated with Rocephin and azithromycin. He developed vague abdominal pain and was transferred to MTF. 26 JAN 21 GASTROENTEROLOGY: EGD - 'marked chronic active gastritis' - blood, stool sample and gastric biopsies are negative for H pylori infection - Protonix 40mg BID CT of kidney showed cyst on the left and nonobstructive 3mm stone and creatinine on is 0.9 (0.7-1.2).
51 2021-03-24 flushing I was given the first shot and sent to an observation room. I felt slightly flushed, it went away. B... Read more
I was given the first shot and sent to an observation room. I felt slightly flushed, it went away. By the evening, I started to feel flushed again. I commented to my wife that I felt like my blood pressure was up. (I don't have high blood pressure). That is the best way I can describe it. I can't recall if the ringing in my ears was noticeable at that time. My the next day I could still feel the flushed feeling and the ringing was clearly noticeable and increased over time, until it can overcome TV or someone speaking to me. I also had a feeling of persistent light headedness. About Feb 3 I had pain in my ear and went to a clinic. I was diagnosed with a minor ear infection (right). I was given and took a course of anti-biotics. The infection went away but the ringing never did, sometimes it would lessen, but always louder than prior to the shot. I went ahead and took the second shot on Feb 11, thinking my problem was probably and ear infection. I the ringing could get so loud it would wake me up and keep me awake. On Feb20 I woke up to very loud ringing, nausea, and general feeling of unease. I went to a clinic the next day. I was told there was probably some inflammation and was given a steroid shot. After about 4 hrs the ringing lessened and I felt better, the first relief I had from the start. On Feb 23, I saw my ENT Dr. He gave me a course of steroids and ordered a brain MRI. The MRI came back with negative results...no abnormal indications. The ringing is starting to increase again as of the last several days.
51 2021-03-27 bell's palsy Bell's Palsy; Arm sorness; This is a spontaneous report from a contactable consumer (wife) from a Pf... Read more
Bell's Palsy; Arm sorness; This is a spontaneous report from a contactable consumer (wife) from a Pfizer Sponsored Program. A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, at the age of 51-year-old, administered in Arm Right on 01Mar2021 13:00 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced arm soreness in Mar2021 (after vaccination). The patient experienced bell's palsy/experienced no mobility in the left side of the face and was diagnosed with bells palsy on 08Mar2021. The patient went to the ER in response to bell's palsy. Outcome of the events was unknown. Information about lot/batch number has been requested.
51 2021-03-27 night sweats, tremor Very Lethargic late in the night. Went to bed and had really bad chills, shakes, and ultimately nigh... Read more
Very Lethargic late in the night. Went to bed and had really bad chills, shakes, and ultimately night sweats. This lasted essentially through the night, into the late morning, and early afternoon. Started to fell normal late afternoon, 24-26 hours after the shot.
51 2021-03-27 tenderness Several days following 2nd dose, middle/upper back rash size of a softball, with several pimples (?)... Read more
Several days following 2nd dose, middle/upper back rash size of a softball, with several pimples (?) and muscle pain in that area developed suddenly. Smaller size of quarter rash with no pimples on lower edge of front right rib cage with similar pain and sensitivity. OTC tylenol and 1% hydrocortisone used. Day 5 presently since rash appeared, seems getting better although still tender but redness has subsided. Temperature normal.
51 2021-03-28 weakness, nerve pain, numbness, cold sweat chills, shivers, cold sweats, dizziness, headache, joint and nerve pain above baseline, hands and fe... Read more
chills, shivers, cold sweats, dizziness, headache, joint and nerve pain above baseline, hands and feet completely numb more than baseline, chest (rib cage) pain when breathing, weakness, fell several times, LOC x 1, gas, crawled instead of walked at times, bloating, abdominal cramps, diarrhea every 1-3 hours, slept the rest of the time, was able to drink Gatorade, pedialyte, water, ginger ale for hydration, no vomiting,
51 2021-03-28 pain in extremity Arm pain within 24 hours. However, the arm pain in my left should really start hurting on the ninth ... Read more
Arm pain within 24 hours. However, the arm pain in my left should really start hurting on the ninth or tenth day after the 2nd dose. By the time I made it to urgent care, I was in serious pain to the point I had to raise both of my arms to help tolerate the pain. After the EKG was done to comfirm I wasn't having a heart attack, the Nurse Practitioner ordered a pain relief injection in my right hip and a prescription of ibuprofen 800 mg along with ice compression on my left arm where I received the 2nd dose.
51 2021-03-28 tingling Developed paresthesias in right arm, into axilla, nex and right side of face; burning irritation of ... Read more
Developed paresthesias in right arm, into axilla, nex and right side of face; burning irritation of right eye; This is a spontaneous report from a contactable nurse (the patient). A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL0142), via an unspecified route of administration, in the right arm on 29Dec2020 at 15:00 PM (at the age of 51 years) as a single dose for COVID-19 immunization. Medical history included sciatica. There was no known allergies. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Dec2020, within 4 hours of vaccination, the patient developed paresthesia's in right arm, into axilla, neck and right side of face, burning irritation of right eye. The patient was evaluated by neurologist. No treatment given. Symptoms resolved in 10 days. The clinical outcome of the events paresthesia's in right arm, into axilla, neck and right side of face, burning irritation of right eye was recovered on 08Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. 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.
51 2021-03-28 tremor, pain in extremity, muscle spasms C/O dizzy, blurred vision, SOB, Right arm severe pain and tremors with Rt sided neck pain/spasms. B... Read more
C/O dizzy, blurred vision, SOB, Right arm severe pain and tremors with Rt sided neck pain/spasms. Brought to Medical Tent by W/C. Verbalized had a Rt sides stroke 10 years ago, hx of pain/spasms in Rt arm if irritated. Had not eaten or drank fluids. Given OJ and Gatorade. Ice applied to neck & upper arm. No redness, rash/hives at injection site. Vitals stable. Home with wife after observation of 30 minutes. Advised to f/u with primary care physician if further adverse reactions. Advised not to have vaccinations in Rt arm.
51 2021-03-29 feeling hot Per pt c/o intermittent feeling of feeling hot lasted 5 minutes and lasted for 2 days. Only occurred... Read more
Per pt c/o intermittent feeling of feeling hot lasted 5 minutes and lasted for 2 days. Only occurred 2 times. 1 episode 3/10/21 the other episode 3/11/21 then subsided.
51 2021-03-29 muscle twitching 2.8kg 51 yo M with hx of hypothyroidism and allergy to pencillin was given his first Pfizer vaccine ... Read more
2.8kg 51 yo M with hx of hypothyroidism and allergy to pencillin was given his first Pfizer vaccine around 0915 3/27 at Medical Center (lot # not reported). Within 5 minutes he states he felt a "jolt" throughout his body and became very nervous and had sweaty hands. Patient reported symptoms at the vaccination location. Blood pressure was reportedly "low" and patient was told he could leave if he felt better. After about 30 minutes from the injection, patient decided to go home but continued to feel nervous and was twitching all over and decided to come to urgent care. He presents with chest pressure (4/10), muscle tremors, mouth dryness and mild dizziness. Denied any history of Covid.Denied any previous reactions to any vaccines. Denied any shortness of breath/trouble breathing, lightheadedness, nausea, or vomiting. No history of high blood pressure or high cholesterol. Denies any history of anxiety or nervousness. States he felt fine prior to the vaccine. Patient did drink his coffee and have a flour tortilla along with a breakfast bar today. HR 82 but BP elevated 199/122.at 1125. BP treated with SL nitroglycerin and four 81mg aspirin. Chest pain improved 1/10. EKG showed inverted T waves V4-V6 with no ST elevation or depression. Sent to ED where EKG was repeated. Incomplete right BBB. BP 128/73 and pulse 47. CXR negative. Unknown if patient was admitted. ED was at Medical Center.
51 2021-03-29 pain in extremity Soreness in arm, aches, vomiting (though this could have been from food poisoning, we are not sure)
51 2021-03-29 tingling, numbness, feeling cold, burning sensation Shortly after receiving the injection my arm went ice cold all the way to my fingers and warmed up a... Read more
Shortly after receiving the injection my arm went ice cold all the way to my fingers and warmed up again quickly. On the way home (about an hour later) I noticed numbness and tingling in my hand and that has continued since (11 days as of this report). My upper arm muscle was sore later that evening and by the next day the pain in my upper arm was extreme. I couldn't move my arm without extreme pain. I took some tylenol late in the day and that did help cut down on some of the pain. I also put an ice pack on my upper arm but it didn't help. The pain wasn't as bad the next (3rd) day but it's still significant enough for me to restrict activity with it. There is also a burning sensation off and on as well as itching deep in my arm. My upper arm has also felt like there is a tight band around it (since day 2) although the muscles themselves don't feel like there's any tightness or knots. I took ibuprofen on day 10 and it helped a little but not a whole lot. At this point I also have what feels like swelling or tenderness under my arm near the armpit area. The pain, burning and itching in my upper arm continues as well as the numbness, tingling and pins all up and down my arm to my hand and fingers.
51 2021-03-30 feeling cold Pain at injection site; fatigue; headache; chills
51 2021-03-30 numbness, tingling I had a tingling/numbness feeling in my face similar to Novacaine. It was only in the areas of my f... Read more
I had a tingling/numbness feeling in my face similar to Novacaine. It was only in the areas of my face where my beard and mustache were. It dissipated in about 30 minutes. Then I had chills at about 1.5 hours.
51 2021-03-30 pain in extremity Sore arm; Diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (patie... Read more
Sore arm; Diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN5318, batch and expiration date not reported), via an unspecified route of administration, administered on the left arm on 26Jan2021 07:00 (at the age of 51-years-old) at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered to the patient was at the Workplace Clinic. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient experienced sore arm and diarrhea on 26Jan2021. Events were assessed as non-serious. Treatment was not received for the events. The outcome of the events reported was unknown.
51 2021-03-31 difficulty speaking Developed hoarseness and then loss of voice.
51 2021-03-31 pain in extremity Dehydration; Pain in kidney area; Soreness in left arm; Costochondritis flare up; This is a spontane... Read more
Dehydration; Pain in kidney area; Soreness in left arm; Costochondritis flare up; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6206), via an unspecified route of administration administered in left arm on 06Mar2021 at 10:30 AM as SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was not COVID tested post vaccination. Medical history included heart attack 3 years prior and a prior kidney stone event. The patient had no known allergies. Concomitant medication included atorvastatin. On 06Mar2021 at 12:30 PM, the patient experienced soreness in left arm starting about 2 hours after administration of the vaccine. On 06Mar2021 at 18:30, the patient experienced dehydration and pain in kidney area on left side starting about 8 hours after vaccination, lasting through the next day. Felt similar (though not as intense) to a prior kidney stone event, but slightly higher and in front left side. Costochondritis flare up overnight after the vaccine on 06Mar2021. There was no treatment given for the events. The patient was recovering from all events.
51 2021-04-01 bell's palsy Myasthenia gravis; double vision, cannot focus; left eye droop/right eye droop; Bell's Palsy came ba... Read more
Myasthenia gravis; double vision, cannot focus; left eye droop/right eye droop; Bell's Palsy came back with left eye droop/right eye droop; Bell's Palsy came back with left eye droop/right eye droop; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), via an unspecified route of administration in the left arm on 09Mar2021 08:48 am (lot number: EN6199) as a single dose for covid-19 immunisation. Medical history included facial paralysis from 20Jan2021 to an unknown date diagnosed initially as bell's palsy but now is diagnosed as myasthenia gravis and gastric reflux. Concomitant medication included unspecified gastric reflux medication and unspecified vitamins. The patient did not receive other vaccines within 4 weeks prior and did not receive other vaccine on the same day. The patient previously he was put on prednisone 60 mg tablets by mouth times 7 days, then 10 mg tablets for an additional 7 days. The patient mentioned he received the vaccine in a vaccination center. The patient reported that prior to his first shot towards the end of Jan2021, his doctor thought he had Bell's Palsy. On 20Jan2021, he stated that he was put on a high dose of steroids to clear it up. He stated that on 09Mar2021, he had his first Covid vaccine with no issues. On 12Mar2021 between 5-6 pm, he mentioned that it came back (the Bell's Palsy) with a vengeance, near his eye and with eye droop. He specifies left eye droop. He added that the Monday after (15Mar2021) over the weekend, it got worse. He mentioned that he talked with his neurologist who told him to speak with his ophthalmologist who the patient spoke to on Tuesday. The patient mentioned that both doctors came up with the diagnosis of Myasthenia Gravis. He inquired since one of his doctor's is concerned about him taking the second vaccine and the other doctor was ok with it. He mentioned that one doctor had a feeling of some bias, and the other doctor. He did some research in an association with people diagnosed with it. One of his doctors said that he is immunocompromised, so he looked at autoimmune information, and the information says it is ok. He reached out to the local medical center that is doing the vaccination and they are unwilling to talk with him over the phone. He has read on the association site and they seem to recommend to take it. He did not want to rebel against his doctor, so he wants to be sure. He inquired if it was safe for him to take his second dose and wanted to get good factual information that can give him a good starting point that is related. He mentioned that his second dose schedule was on 30Mar2021. He also stated that initial onset of Bell's Palsy with left eye droop, he was on a high dose steroid regimen and that seem to help which he finished up early Feb2021. It was mentioned that the event initial onset was not after the vaccine. The Ophthalmologist checked him on Tuesday and his left eye which he could barely open, and his doctor also noticed right eye droop. He stated without medication, it is worsening but with his medication, it is definitely helping to transmit between nerves. He stated before the medication this time of day he could not lift his left eye longer throughout the day, the more difficult it is for the muscles as they become weaker. There was noticeably drooping of the right eye. The ophthalmologist exam on his right eye was drooping which was ongoing. It is still there, his wife and he were comparing their eyes and how much he could open it, and it surprised them how little he could open it. It was different and strange. The time reported for the drooping of the right eye was 2:30 pm and persisting but the left eye was worse. He hasn't noticed a difference about the same, medication has been helping. It was also mentioned that myasthenia gravis reported that it started on the 16Mar2021 2:30 pm (talked to the Neurologist to compare notes, so maybe 3:30 - 4:00) when they made the initial diagnosis and started testing the next day. He is waiting for blood work to come back, but all the tests have pointed in that direction. Myasthenia gravis was ongoing, but the condition has worsened and the medications at a therapeutic level, it keeps it at bay. He further added that his eye became so hard to see, so he pyridostigmine bromide on 17Mar2021 since he couldn't open or focus, he thought he would give it a try. It works when he can't focus and if he doesn't take, it he will go back to where he was before. He will not be able to open his eye and the double vision will come back. The events required physician's office visit but did not require emergency room visit. He mentioned that there were 3 test and one more scheduled. The first one was a common test; the first initial test diagnose Myasthenia gravis. The second test was the ice test since they went on the assumption in their initial thinking it was Bell's Palsy and in his, doctor's, opinion it didn't look right. The test sounds goofy and it is one of the tests, they did to predict how it was going to go. He reported that they placed an ice cube in a cloth on the eye and let cool for 2-3 minutes. The eye lid is raised more than it was before the test and it went back down. This test was done on 16Mar2021. He reported that the did a chest x-ray on 17Mar2021 and looked for enlarge thalamus, he states it was normal. He has a CT scheduled next Wednesday (24Mar2021) to check his thalamus and lungs. The patient underwent lab tests and procedures which included blood test with unknown results on 17Mar2021, he reported that he is waiting for the results to look for antibodies for Myasthenia gravis; chest x-ray was normal on 17Mar2021, he reported that they did a chest x-ray and looked for enlarge thalamus, he states it was normal; endoscopy with results of no finding on Mar2021, his GI doctor wanted to do an upper and lower endoscopy, so 2 weeks prior to the vaccine he had an upper and lower endoscopy with no finding; and ice test with results of bell's palsy on 16Mar2021 and in his doctor's opinion, it didn't look right. The outcome of the events was not recovered.
51 2021-04-01 feeling cold Ringing in ears head cold feel. Throbbing and slight pain in ear. Mainly left ear. Have contacted ... Read more
Ringing in ears head cold feel. Throbbing and slight pain in ear. Mainly left ear. Have contacted nurse and tele doctor and I am taking antibiotics now. About 4 days now.
51 2021-04-01 numbness About 3-4 days after the shot I was walking in food city and my left foot felt like it was asleep li... Read more
About 3-4 days after the shot I was walking in food city and my left foot felt like it was asleep like it wouldn?t wake up later that day it kept getting stiffer and stiffer and eventually went all the way up the whole left side of my body went kind of numb it The next day I woke up it was completely stiff hard to walk so I went to my doctor he thought it was something to do with the spinal cord I told him it could possibly be from the shot I thought maybe went through many thousands of dollars of tests they tested me for MRIs I?ll kinds of stuff they have yet to find anything wrong with me I?ve been in and out of the doctors I still have left sided numbness at times left side of my head feels numb left chest left but area and all way down to my toes At this point after going to the neurologist only thing they?re all just could find was I was low on vitamin B 12 I have started injections on vitamin B 12 I still have no notice no change
51 2021-04-01 night sweats Unusual impotence; Extreme night sweats; Elevated heart rate resting rate of 100. My normal is 74 BP... Read more
Unusual impotence; Extreme night sweats; Elevated heart rate resting rate of 100. My normal is 74 BPM; Shortness of breath; This is a spontaneous report from a contactable other health care professional. A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in Arm Left on 02Mar2021 16:00 (at the age of 51-years-old) (Batch/Lot Number: EN6201; Expiration Date: 30Jun2021) as SINGLE DOSE for covid-19 immunisation. The patient's medical history was reported as none. The patient's concomitant medications were not reported. The patient previously took tylenol and experienced allergies. The patient did not receive other vaccines in four weeks, and other medications in two weeks. On 12Mar2021 16:00, the patient experienced Elevated heart rate resting rate of 100. My normal is 74 BPM. Shortness of breath. Extreme night sweats. Unusual impotence. All started 10 day after injection. The outcome of the events was not recovered.; Sender's Comments: The company does not attribute the unusual impotence (PT: Erectile dysfunction) to BNT162b2, considering the event being an intercurrent disorder. 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.
51 2021-04-01 pain in extremity has a constant severe headache; tinnitus in right ear/Tinnitus continues to persist/Right Ear ringin... Read more
has a constant severe headache; tinnitus in right ear/Tinnitus continues to persist/Right Ear ringing; stomach pain; high BP; sore arm; tinging in in throat and right side of face,; irritated right eye; Right Ear ringing worsened culminated in 8 days of insomnia from severe ringing; mesenteric inflammation; This is a spontaneous report from a contactable nurse (patient) and a consumer. A 51-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 29Jan2021 (Batch/Lot Number: EL3247) at single dose for COVID-19 immunization. Medical history included sciatica (resolved), and the patient took the first dose of BNT162B2 (lot/batch number: EL0142) at 15:00 on 29Dec2020 administered in arm right for COVID-19 immunization and developed paresthesias in right arm, into axilla, nex and right side of face and burning irritation of right eye, both on 24Jan2021. The patient's concomitant medications were not reported. Clinical course: 3 days after vaccination, patient developed sore arm, tinging in in throat and right side of face, irritated right eye. 6 days after vaccination, patient woke up with tinnitus in right ear, stomach pain and high BP. On 30Jan2021 (as reported), patient went to Emergency Room. CT scan showed mesenteric inflammation. Right Ear ringing worsened which culminated in 8 days of insomnia from severe ringing. Tinnitus continues to persist. He also had a constant severe headache. All events were reported as serious and seriousness criteria were disability. No allergies to medications, food, or other products. 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 outcome of events was not recovered.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
51 2021-04-01 pain in extremity Sore arm for two days, mild general fatigue, but at -37 hours post-vaccine, upper lip itched and sw... Read more
Sore arm for two days, mild general fatigue, but at -37 hours post-vaccine, upper lip itched and swelled slightly. Went down after taking a Benadryl.
51 2021-04-01 pain in extremity Pain in left arm. Fever (102.7). Chills. Fatigue. Headache. Dizziness. Light-headedness. ... All las... Read more
Pain in left arm. Fever (102.7). Chills. Fatigue. Headache. Dizziness. Light-headedness. ... All lasting at least 15 hours. Cleared upby the next morning.
51 2021-04-02 pain in extremity, tremor, cold sweat, feeling cold after 4 hours - sore arm - this was expected. After 10 hours - body cold - skin dry - severe shaking... Read more
after 4 hours - sore arm - this was expected. After 10 hours - body cold - skin dry - severe shaking / teeth chattering - uncontrollable - then sweating / cycle hot & cold. Cannot stop shaking. Severe lower body aches - from hips down - bones aches. After 30 hours - fever of 102.1 for around 2 hours. seems like a sever flu. After 48 hours - feeling much better - low fever - 100 all day Friday April 2nd. Good nights sleep - feel great Saturday April 3rd - temp at 99.
51 2021-04-02 tremor Severe pain in shoulder, to where I could not lift arm, Felt like 20 hornets stung me, 100.4 tempera... Read more
Severe pain in shoulder, to where I could not lift arm, Felt like 20 hornets stung me, 100.4 temperature, fatigue, and had the shakes. This was from Wednesday night through Thursday. Felt better on Friday.
51 2021-04-04 tenderness The morning after his vaccination, his left elbow swelled up and was tender. The elbow gradually de... Read more
The morning after his vaccination, his left elbow swelled up and was tender. The elbow gradually decreased in size. Patient wants to get his next dose in his right arm.
51 2021-04-05 pain in extremity About 4 hours after the shot (on Monday), I developed pain in my left leg--particularly the left but... Read more
About 4 hours after the shot (on Monday), I developed pain in my left leg--particularly the left buttock and left shin. The pain rapidly became worse. Walking became quite difficult. Tuesday, I received a steroid injection from my doctor. The pain got slightly better over the next few days. Saturday, I started a course of oral steroids: 20mg prednisone, three times per day. Symptoms have been improving significantly, although as of today (Tuesday) there is still some pain. The pain was specific to my leg. I didn't get any other aches.
51 2021-04-06 feeling hot pt c/o feeling hot. Denies SOB pain, itch or diziness. appears diaphoretic. said he feels anxiety. ... Read more
pt c/o feeling hot. Denies SOB pain, itch or diziness. appears diaphoretic. said he feels anxiety. Used interpreter. 140/92 HR 128 O2 sat 97 BS 196
51 2021-04-06 numbness and pain in extremities, numbness, tingling General muscle soreness 2 days after vaccine, then peripheral neuropathy started day 3 after vaccine... Read more
General muscle soreness 2 days after vaccine, then peripheral neuropathy started day 3 after vaccine. Signs progressed to dizziness, numbness of feet and hands, prickly sensations over arms and legs. Unable to resume normal daily functions. Symptoms still present as of today
51 2021-04-06 pain in extremity Sore arm that developed into very painful area on left side of ribs as well, fever for 3 days up to ... Read more
Sore arm that developed into very painful area on left side of ribs as well, fever for 3 days up to 101 degrees
51 2021-04-06 pain in extremity patient stated his arm swelled and hurt the next day. His lips swelled but he could not take Benadry... Read more
patient stated his arm swelled and hurt the next day. His lips swelled but he could not take Benadryl. He took a Claritin instead
51 2021-04-07 weakness First symptom was weakness and fatigue approximately 8 hours after injection. Onset of fever of 101... Read more
First symptom was weakness and fatigue approximately 8 hours after injection. Onset of fever of 101? F approximately 12 hours after injection, 24 hours after onset still had 100? F temperature, gone by beginning of day 3. Headache and body aches that lasted about 3 days. After fever was gone the weakness/fatigue/headache/body aches lasted an additional 12 hours or so. Approximately a day after all these symptoms disappeared I got a very minor sore throat and some congestion that has lasted a couple of days. Treatment was Alleve every 8 hrs, lots of fluids and rest.
51 2021-04-07 facial paralysis, bell's palsy pt states on 4/1/2021 when he woke up his mouth was crooked and face was dropping. He thought he wa... Read more
pt states on 4/1/2021 when he woke up his mouth was crooked and face was dropping. He thought he was having a stroke Pt went to Hospital ER. They gave him a CT, Blood test, X-RAYS. pt was transported to another hospital to have the MRI which showed no sign of stroke. He was brought back to hospital where he was admitted for observation. He was released after 3 days. His DX was Bells Palsy. He was prescribed valacyclovir 1mg bds and prednisone. He has to wear a patch of his left since he cant close it and he has no control of the tear ducts in this eye. The left side of this face is still drooping and he cant use the left side of his mouth and he bites his tongue when he is eating. He wishes he had not taken the shot.
51 2021-04-08 numbness Sensation of numbness/tingling washing over B arms and legs and nose
51 2021-04-09 pain in extremity, tremor About 2 and a half hours after the vaccination, I started to have pain in the body, I was shaking, h... Read more
About 2 and a half hours after the vaccination, I started to have pain in the body, I was shaking, headache, tired, chills. During the course of about 4-5 hours after the vaccination, I had other symptoms such as an urge to urinate, accompanied by pain and burning. Pain in the ribs, back, left arm, diarrhea, felt like inflamed lungs and shortness of breath. Today and 3 days later I still have diarrhea, headache, fatigue and pain when urinating.
51 2021-04-10 pain in extremity I had the usual sore arm, fatigue, and body aches. But the one side effect I had was insomnia for tw... Read more
I had the usual sore arm, fatigue, and body aches. But the one side effect I had was insomnia for two days. I missed work the day after receiving the shot (Wednesday). Went to work on Thursday with no sleep. Missed on Friday due to not being able to sleep.
51 2021-04-11 weakness From 4pm Saturday including all day Sunday I had fever and chills, low energy, and headache. I alter... Read more
From 4pm Saturday including all day Sunday I had fever and chills, low energy, and headache. I alternated between Tylenol and Advil to treat fever symptoms.
51 2021-04-11 pain in extremity, tremor It started feeling current in the posterior part of the body, then it started pain in the whole body... Read more
It started feeling current in the posterior part of the body, then it started pain in the whole body that continued to increase and burning sensation in the skin, chills, felt like was burning, marked respiratory difficulty, sensation of asphyxia, pain in the ribs, urinary retention, hematuria, liquid diarrheas, trembles, pain in the ribs and pain in the left arm (contrary to the one injected). Took Tylenol 500 mg 2 tabs q 4 hrs
51 2021-04-11 pain in extremity SORE ARM, EXHAUSTED ON SATURDAY. SUNDAY MORNING TEMP OF 102, NAUSEA, CHILLS, JOINT PAIN ITCHING LEFT... Read more
SORE ARM, EXHAUSTED ON SATURDAY. SUNDAY MORNING TEMP OF 102, NAUSEA, CHILLS, JOINT PAIN ITCHING LEFT NECK AND LEFT FACE FAST HEART RATE (102 AT REST NORMAL IS 60 AT REST) CONTINUED TO MONDAY MORNING.
51 2021-04-11 pain in extremity approximately 2-3 hours after injection, unusual discomfort in the front left pelvic area. 8.5 hours... Read more
approximately 2-3 hours after injection, unusual discomfort in the front left pelvic area. 8.5 hours after injection, left ear ringing and arm left deltoid soreness began. Woke up in the middle of the night with dizzyness. The next morning, dizzyness has subsided, left arm soreness and left ear ringing continues. Took 2x200mg ibuprofen.
51 2021-04-14 bell's palsy, facial paralysis DEVELOPED BELL?S PALSY - DIAGNOSED 4/14/2021 COLD SYMPTOMS DEVELOPED 8 DAYS AFTER SECOND SHOT (4/3/... Read more
DEVELOPED BELL?S PALSY - DIAGNOSED 4/14/2021 COLD SYMPTOMS DEVELOPED 8 DAYS AFTER SECOND SHOT (4/3//2021), AND THEN FACIAL PARALYSIS WITH BELL?S DIAGNOSED ON 4/14
51 2021-04-14 bell's palsy Bells palsy diagnosis. Given Prednisone. Started to recover then received second dose on 04/06/2021 ... Read more
Bells palsy diagnosis. Given Prednisone. Started to recover then received second dose on 04/06/2021 and symptoms of bells palsy returned to level prior to medication.
51 2021-04-14 pain in extremity Arm hurt for 3 days, nausea and stomach/intestinal cramping started 24 hours later, vomited once /2... Read more
Arm hurt for 3 days, nausea and stomach/intestinal cramping started 24 hours later, vomited once /24 hours after vaccine and spent the rest of the day in bed. Felt better 48 hours after vaccine.
51 2021-04-14 tremor fever and chills with severe shaking that lasted for about three hours
51 2021-04-15 slurring Cryptogenic stroke. Experienced garbled speech for a period of less than one minute. Symptoms resolv... Read more
Cryptogenic stroke. Experienced garbled speech for a period of less than one minute. Symptoms resolved on their own. Went to ER and had an MRI showing three spots for affected tissue.
51 2021-04-15 muscle twitching The day after my vaccination I felt like I had mild to moderate flu symptoms, achy, stuffy with head... Read more
The day after my vaccination I felt like I had mild to moderate flu symptoms, achy, stuffy with headache. The day after that the flu like symptoms abated, but then were replaced with muscular and joint soreness, especially in the lower legs. It felt like my calf muscles were going to charlie horse at any moment. Also, I experienced random muscle twitches throughout my body, but mostly in the calf region. This muscular twitching has continued for two weeks now, though it has abated to some degree in terms of frequency and intensity. The muscle twitching is the reason that I'm writing this report. I expected that I might have flu like symptoms, but not twitching muscles all day and night.
51 2021-04-16 bell's palsy Bell?s palsy- prednisone and anti-viral drugs
51 2021-04-17 bell's palsy Left facial Bell's Palsy; BNT162B2 subcutaneous; This is spontaneous case report from a contactable ... Read more
Left facial Bell's Palsy; BNT162B2 subcutaneous; This is spontaneous case report from a contactable physician (patient himself). A 51-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL1283), subcutaneous, at Arm Left on 09Jan2021 (at age of 51 years old) at single dose for COVID-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EH9899) Subcutaneous at Left Arm on 18Dec2020 18:00 (at 51 years old) at single dose for COVID-19 immunisation. The patient didn't 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. Test Name: SARS-CoV2 RT PCR. Allergies to medications, food, or other products was None. The patient experienced Left facial Bell's Palsy on 30Jan2021. The patient underwent lab tests and procedures which included Nasal Swab: negative on 31Jan2021. The adverse event Left facial Bell's Palsy result in Emergency room/department or urgent care. Treatment (Prednisone, Acyclovir) received for the adverse event. The outcome of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of Left facial Bell's Palsydue to temporal relationship and current known drug 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. 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.
51 2021-04-18 weakness Fatigue, weakness, achiness- especially in legs Now is in the hospital due to severe optic nerve sw... Read more
Fatigue, weakness, achiness- especially in legs Now is in the hospital due to severe optic nerve swelling behind both eyes
51 2021-04-18 pain in extremity Blood Clot/The Blood clot was in the legs and went to his lungs; Blood Clot/The Blood clot was in th... Read more
Blood Clot/The Blood clot was in the legs and went to his lungs; Blood Clot/The Blood clot was in the legs and went to his lungs; fell; Leg pain; This is a spontaneous report from a contactable consumer. A 51-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 27Mar2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included thrombosis from 2020 to an unknown date, it was Months ago in 2020, He was prescribed a medicine for blood clots, but since then he has had no issues, anxiety from an unknown date and unknown if ongoing. Her brother in law had anxiety about even getting the vaccine. The patient experienced leg pain on Mar2021 , pulmonary thrombosis, leg thrombosis and fall on an unspecified date. The patient died on 02Apr2021. An autopsy was not performed. The clinical course was the following: The Blood clot was in the legs and went to his lungs, his leg never got red or anything and it was a blood clot. He was having such bad leg pain, it's too bad, had there been some sort of warning, he would have thought to wait till next year. There was nothing the day he got vaccine, but that night his leg started hurting, his girlfriend said let me go get a cold wrap and she wrapped it, he's a farmer. He wakes up the next day and his leg is still hurting, the 3rd day it goes on, his leg still hurting and no one is thinking it a blood clot, he calls the doctor and tells the doctor his leg is hurting, they suggest ibuprofen for inflammation, the next day thought maybe it's better, by Friday he was making breakfast, fell and died. With his girlfriend she said what's going on, and he went straight to hospital, they said the clot in his leg went to the lung. The Blood clot when it was in the leg it never got hot, red, or anything like that. He had the vaccine in the morning and on that same day the leg pain started later that night. It Started out with Leg Pain, she does not know if it was right or left but it was just one leg.; Reported Cause(s) of Death: Thrombosis pulmonary; Thrombosis leg; Fall; Leg pain
51 2021-04-18 tingling, numbness, pain in extremity Tingling and numbness in both arms and hands, but mainly in the left arm. The tingling and numbness... Read more
Tingling and numbness in both arms and hands, but mainly in the left arm. The tingling and numbness began about a day after the shot and I thought at first that it had to do with yardwork, but it has continued for about nine days so far. It goes away for a few hours a day and some nights are not as bad as others, but it's painful - like your hand/arm falling asleep for an extended period of time - and interferes with sleep as well as concentration during the day.
51 2021-04-19 feeling cold Ringing in both ears. Both ears feel clogged. Hard to hear. Vertigo Chills and aches (which I ex... Read more
Ringing in both ears. Both ears feel clogged. Hard to hear. Vertigo Chills and aches (which I expected)
51 2021-04-19 pain in extremity sore left arm, for 36 hours post shot. joint pain 12 hours post shot approximately 9 days later, br... Read more
sore left arm, for 36 hours post shot. joint pain 12 hours post shot approximately 9 days later, broke out in Hives, abdominal cramps, constipation. lasted approx 4 days. no changes in diet
51 2021-04-20 weakness Severe muscle pain and weakness in entire body, crippling-unable to walk or even stand with the assi... Read more
Severe muscle pain and weakness in entire body, crippling-unable to walk or even stand with the assistance of a walker device. lasted 3 days
51 2021-04-20 weakness Severe muscle pain and weakness in entire body, crippling-unable to walk or even stand with the assi... Read more
Severe muscle pain and weakness in entire body, crippling-unable to walk or even stand with the assistance of a walker device. lasted 3 days - Same side effect as after 1st dose.
51 2021-04-20 pain in extremity Become so forgetful since I had the injection that it feels like I have Alzheimer's; brain fog; Brai... Read more
Become so forgetful since I had the injection that it feels like I have Alzheimer's; brain fog; Brain fog and fatigue is unreal/fatigue; chilling pain; it feels like I have Alzheimer's; Arm is till really hurting; Hematoma; This is a spontaneous report from a contactable consumer. A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in Arm Left on 28Mar2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included ongoing hypertension, anxiety, blood cholesterol increased, hypertriglyceridaemia, covid-19 from Sep2020 ("My wife was tested positive, I had it back in September, my wife was tested positive in January and that's when I started experiencing loss of smell and taste). Concomitant medications included lisinopril taken for hypertension, propranolol taken for hypertension, alprazolam (XANAX) taken for anxiety, atorvastatin calcium (LIPITOR) taken for blood cholesterol abnormal, bacopa monnieri, eleutherococcus senticosus root, rosmarinus officinalis essential oil, schisandra chinensis fruit (BACOPA COMPLEX) taken for hypertriglyceridaemia. On unknown date patient experienced "become so forgetful since i had the injection that it feels like I have Alzheimer's", fatigue, brain fog, chilling pain and on 01Apr2021, arm is till really hurting and hematoma (described as I went to ER last night and he said that the pharmacist might have punctured a vain or a capillary). Patient had no temperature, blood pressure is normal, patient stated he never had anything like that from other vaccines.
51 2021-04-20 pain in extremity Really sore arm all the way to my hand, around my neck and shoulder where the shot was given. Tired... Read more
Really sore arm all the way to my hand, around my neck and shoulder where the shot was given. Tired and fatigued really bad. Barely get moving every day since shot.
51 2021-04-20 tremor Severe body aches. Pain in the injection site. Extreme body shakes. Headaches and back pains.
51 2021-04-21 burning sensation diarrhea. one the day after vaccine Stomach gurgling when eating or drinking day 2...worse when lyin... Read more
diarrhea. one the day after vaccine Stomach gurgling when eating or drinking day 2...worse when lying down Day 4 upper Stomach discomfort/Pain minor Day 5 increased pain burning sensation Day 14 still persistent
51 2021-04-21 cold sweat i experienced cold sweats and an unwell feeling shortly after injection. I passed out at the vaccina... Read more
i experienced cold sweats and an unwell feeling shortly after injection. I passed out at the vaccination site and was taken by ambulance to the medical center yesterday, april 21st around 356pm.
51 2021-04-21 pain in extremity Severe fatigue. Arm soreness. Light nausea. Flu-like symptoms
51 2021-04-22 pain in extremity 102 degree F Fever - 4 hours reduced with Advil Mild 99 - 100 degree F fever for 1.5 days, reduced w... Read more
102 degree F Fever - 4 hours reduced with Advil Mild 99 - 100 degree F fever for 1.5 days, reduced with Advil Severe headache for 4 hours followed by mild headache for 3 days reduced with Advil Sore achy muscles in arms and legs - 2 days Sore joints, knees, elbows shoulders - 2 days Tired and lethargic for 2 days.
51 2021-04-24 muscle spasms Patient had first dose on 4/1/21 he developed fatigue and muscle cramps lasting about 36 hours Pati... Read more
Patient had first dose on 4/1/21 he developed fatigue and muscle cramps lasting about 36 hours Patient had second dose 4/22/21 and once again developed muscle cramps. He also started to have vision changes, increase thirst, and blood sugar spikes between 400-500. He is not a diabetic
51 2021-04-25 feeling hot, numbness, weakness patient having reaction to pfizer shot given on april 11th. patient states symptoms from numbness to... Read more
patient having reaction to pfizer shot given on april 11th. patient states symptoms from numbness to extremities, shortness of breath, sores on lip, headache, yellow eyes, weakness. on 4/25 Overnight he felt very "hot", like he was breaking a fever, but was not febrile per vital signs. He sweated and then noticed bubbling of his skin on both hands and feet and then those bubbles popped and his skin is peeling now.
51 2021-04-25 migraine, cold sweat Migraine headache that persisted the entire day. Took a Bayer Back & Body Extra Strength (500mg) to ... Read more
Migraine headache that persisted the entire day. Took a Bayer Back & Body Extra Strength (500mg) to attempt to get rid of itarround noon. Headache only lessened slightly but persisted. Cold chills began in the late afternoon and persisted into the evening. No fever was detected when checked. Took a second Bayer Back & Body Extra Strength around 8pm before bed. Fell asleep about 10pm. Woke up with alarm at 2am. Clothes had a feeling of having absorbed a cold sweet while asleep. Cold chills no longer present, migraine headache no longer present.
51 2021-04-25 migraine syncope, followed by profuse sweating, patient fainted twice., very low blood pressure, severe migr... Read more
syncope, followed by profuse sweating, patient fainted twice., very low blood pressure, severe migraine and vomiting EMS called after prolong time of syncope and vomiting. Patient refused travel to ER. I followed up a call to the patient later in the day and patient was tired but had fully recovered.
51 2021-04-25 pain in extremity Left are was painful and stiff for 2-4 days.
51 2021-04-25 cold extremities, pain in extremity, muscle spasms, weakness Extreme joint pain tiredness fingers felt cold and ached to touch anything sore neck in lymphnode ar... Read more
Extreme joint pain tiredness fingers felt cold and ached to touch anything sore neck in lymphnode area then the headaches started a few days later like 5 days i felt very tired weak not sick to stomach but felt like blood was dirty hard to explain right kidney hurt then weeks of headaches felt like head was bleeding it hurt so bad chest felt like just got over a chest cold or bronchitis or ran out in cold weather and also very cramped feet some of this still happening but most has subsided . The scariest part was the feeling of my headache terrible .i never went to a er or doctor but almost did.
51 2021-04-26 tingling Client received vaccine and began to feel a tingling sensation on his left hand and believed it look... Read more
Client received vaccine and began to feel a tingling sensation on his left hand and believed it looked blue. Assessed client. Vitals all wnl. no further evaluation needed. Client released at 1:15pm.
51 2021-04-26 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: nurse instructed pt to call for ride hom... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: nurse instructed pt to call for ride home pt declined and said he did not feel the need. he hais he feel better and pt discharged
51 2021-04-27 flushing Reports after the vaccine his arm has become swollen and hard. It will go away, but then it comes ba... Read more
Reports after the vaccine his arm has become swollen and hard. It will go away, but then it comes back. Today in office it was indurated slightly. Reports on and off flushing and body aches that are new- feels like a toothache
51 2021-04-27 tremor Swollen glands in neck at collarbone, arm pit and groin area upon awaking on day three. All swollen... Read more
Swollen glands in neck at collarbone, arm pit and groin area upon awaking on day three. All swollen glands were on the side the injection was given, and are visible to the naked eye. Physician advise taking Benadryl and consult them in 24 hours if effects continue. First dose side effects were shaking, rapid heart rate, and lethargic, lasting 2 weeks. These side effects were not present with second vaccine at this time.
51 2021-04-28 mild one side paralysis, slurring, facial paralysis, speech disorder Within 30-minutes of vaccination, the patient reported a headache, slurred speech, and right side we... Read more
Within 30-minutes of vaccination, the patient reported a headache, slurred speech, and right side weakness. EMS evaluated the patient on-site. The patient was hypertensive (197/129) with a FSBG of 95mg/dL. During stroke assessment, the patient had new onset facial palsy/droop and need speech abnormality which signaled a stroke alert. 12-lead EKG was unremarkable. EMS transported the patient to Emergency Department. In the ED, the patient presented with a headache, chest heaviness, and slurred speech, but no aphasia. NIH stroke scale was 0. Patient remained hypertensive (170/109). Labs, tests, and imaging did not indicate rtPA administration. ED physician administered 0.4mg SL Nitroglycerin, 10mg IV Hydralazine, and 325mg PO Aspirin prior to admission for suspected Transient Ischemic Attack. Upon admission, differential was TIA vs. CVA vs. ACS. Admitting physician ordered HbA1C, lipid panel, MRI brain, CTA head/neck, 2D echo, and neurology consult. Throughout course of admission, patient had recurring midsternal chest pain that was relieved with Nitroglycerin. Imaging ruled out CVA. Given elevated TGs and Cholesterol, patient was started on Atorvastatin 40mg PO. Suspected TIA and ACS. Neurology consult reviewed the labs and imaging, and stated the episodes of stuttering are most commonly associated with anxiety or stress reaction. Neuro did not recommend any further workup unless this happened again unprovoked. Patient was discharged after a 3-day admission with diagnosis of cerebrovascular disease, unspecified. The patient was prescribed 81mg PO Aspirin, 20mg PO Lisinopril, and 40mg PO Atorvastatin.
51 2021-04-28 muscle twitching Frequent facial twitching and on less frequently on the arm
51 2021-04-28 pain in extremity, cold extremities he reports discoloration resolved but developed worsening bilateral lower extremity edema; lower ext... Read more
he reports discoloration resolved but developed worsening bilateral lower extremity edema; lower extremity pain and swelling; lower extremity pain and swelling; blue toes on both feet; extensive deep vein thrombosis in left lower extremity requiring treatment and thrombectomy; legs were cool to touch; This is a spontaneous report from a contactable physician reporting for a patient. A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 02Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, at 51 years old. Medical history included triplegia, neurogenic bladder, hyperlipidaemia, chronic abdominal pain, type 2 diabetes mellitus, chronic opioid use, known allergies: Latex from an unknown date and unknown if ongoing. No other vaccine in four weeks. No COVID prior vaccination and was not tested for COVID post vaccination. The patient's concomitant medications were not reported. The patient previously took sulfamethoxazole;trimethoprim and experienced allergies to Sulfamethoxazole-trimethoprim. The patient experienced lower extremity pain and swelling, lower extremity pain and swelling, blue toes on both feet, extensive deep vein thrombosis in left lower extremity requiring treatment and thrombectomy, legs were cool to touch on 02Apr2021; and he reported discoloration resolved but developed worsening bilateral lower extremity edema on an unspecified date. Clinical course was reported as follows: The patient presented to the hospital on "4/7" (as reported) with lower extremity pain and swelling. Patient reports received 1st dose on pfizer vaccine on 4/2 (as reported) and immediately noticed blue toes on both feet and legs were cool to touch. He reports discoloration resolved but developed worsening bilateral lower extremity edema. Imaging revealed extensive deep vein thrombosis in left lower extremity requiring treatment and thrombectomy. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 07Apr2021, and sars-cov-2 antibody test (nasal swab): negative on 13Apr2021. Treatment was received for the events. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (Apr2021). Outcome of the events was recovering. Information on the lot number has been requested.
51 2021-04-28 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: Fainted five minutes after receving 2nd ... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Fainted five minutes after receving 2nd dose. Hx of fainting due to needles. Reported not eating or drinking prior. Fainted from the chair and broke small fragment of glasses. Did not injure his head. Interventions: bottle of orange juice and water, lifting legs and having him laydown/ sit up for 15 minutes. Walked him to car with his partner ensuring safety. First set of vital signs taken at 1800 (3pm): 96 degrees F, 55 bpm, 102/62, 14 RR. 1815 vitals: 66bpm, 16 RR, 96.8F, 118/84 BP.
51 2021-04-29 weakness Patient reports swollen glands, blisters inside nose and mouth, achy body, and pain similar to his p... Read more
Patient reports swollen glands, blisters inside nose and mouth, achy body, and pain similar to his past shingle infections. Patient believes he is now having an outbreak of shingles. Patient also reports feeling overall very weak 48 hours after the vaccine.
51 2021-04-29 pain in extremity Within a day of 2nd Pfizer dose (intramuscular, left shoulder) had flu-like symptoms (aching joints,... Read more
Within a day of 2nd Pfizer dose (intramuscular, left shoulder) had flu-like symptoms (aching joints, tired, chills, swelling under jawline, metallic taste in mouth) but they disappeared by third day from date of vaccination. By the 10th day after vaccination had developed intense shoulder pain radiating from shoulder to mid-arm (left arm) and upper back (trapezius/neck). Went to local Urgent Care next day and was X-rayed and given the following: Methylprednisolone - 4MG (tapered dosage) ? Shoulder/trapezius muscle pain/inflammation Cyclobenzaprine - 10MG ? Muscle relaxant for shoulder/trapezius muscle pain/inflammation. By end of tapered does still feeling intense ache/throb and pain in same areas.
51 2021-04-30 pain in extremity Received the shot around 10:15 am on 30 April 2021 at a public vaccination clinic at a community cen... Read more
Received the shot around 10:15 am on 30 April 2021 at a public vaccination clinic at a community center. I didn't expect any side effects as no one I know has had any from the first shot. However, within about 2-3 hours started to feel mild body aches similar to when you have the flu coming on and minor fatigue. Nothing debilitating. Ended up taking a few long naps during the day and not getting much work done. By the evening I had a very slight headache at the base of my neck which was probably related to the sore muscles. Also noticed that the soles of my feet were a little sore which seemed unusual. Went to bed around 11:30 pm on 30 April. Woke up around 3 am on 1 May and just felt "off." I could still feel body soreness but also had developed a strong metallic taste at the back of my mouth and into my throat. Drank a lot of water to try to see if that changed anything but it didn't. Woke up around 7 am on 1 May. Body was very sore (like from a major workout), bottoms of feet still tender, minor headache and strong metallic taste. Tried to work on some things but ended up going back to bed around 8 am for a few hours. Woke up around 10 am and feel much better. Minor body aches (including the sore feet, which is weird) and just a minimal metallic taste.
51 2021-05-01 weakness At 7:30 p.m. on the day of the vaccine, I started to feel chills, which steadily increased throughou... Read more
At 7:30 p.m. on the day of the vaccine, I started to feel chills, which steadily increased throughout the evening. My temperature increased from 97 to 104.4 over the next 6 to 7 hours and stayed above 100.4 until about 24 hours after initial symptom onset. The chills subsided as my temperature declined. I felt drained, had no appetite, and had a low grade headache that intensified on movement, particularly bending over. The headache, lack of appetite and energy, lingered after the chills and fever had subsided into the following day (5/1). On 5/2, I felt much better and was up and about at 80% of normal activity. I expect to be fully back to normal tomorrow.
51 2021-05-03 pain in extremity Had a sore arm immediately after the shot. didn't think much of it, of course, I just had a shot. ... Read more
Had a sore arm immediately after the shot. didn't think much of it, of course, I just had a shot. I was already on some prednisone for Gout from the first shot, After this shot, the Gout really kicked up even higher, so my Dr. increased the steroid, pain in arm/shoulder was there, but again, just thought was normal shot kind of thing. (saw dr. a week after shot for Gout pain increase). Pain in arm stayed steady, now pain is just worse and worse each day, and it's been well over a month, so I know this is NOT normal. I went to Dr. on 4/26. He was unfamiliar with SIRVA. He said see how it goes, and we can do a shot in the arm (I'm AFRAID Of a SHOT in the ARM) , an MRI, to see what is happening. We decided to give another week. Well, this week was HORRIBLE! I cannot sleep, the pain at night is unbearable, and taking aleve, tylenol, etc do nothing. The pain during the day is getting more each day, I've been doing exercises I've found online with no relief.
51 2021-05-03 seizure, flushing, unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium, Systemic: Anixety-Mild, Systemic: Flushed / Sweating-Mediu... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Anixety-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Medium, Additional Details: Patient discussed vaccination with immunizer for a few minutes before injection was given. After the injection was given, patient experienced brief syncope episode with brief 2-3 seconds of "seizure-like" activity. Patient woke back up and was pale and diaphoretic. EMS services were activated and patient rested, given water and orange juice. Maintained a slow, steady heart rate of 48 bpm while awaiting EMS. EMS evaluated patient and transported to hospital
51 2021-05-04 inability to speak The next day I noticed a measles like red spotty rash all over my arms legs and torso. This rash at... Read more
The next day I noticed a measles like red spotty rash all over my arms legs and torso. This rash at first did not itch but later itched mildly and intermittently this rash continues today, May 5th 2021. Furthermore I've suffered what I can only describe as brain fog that has left me discombobulated, absent mind, stumbling for words. Also my mood is significantly altered as I am suffering from anxiety and a short temper.
51 2021-05-04 pain in extremity High fever, chills, nausea, headache, during 12-24 hrs after injection. Treated with (1) Acetaminoph... Read more
High fever, chills, nausea, headache, during 12-24 hrs after injection. Treated with (1) Acetaminophen (500mg) every 6 hrs (2x total) . Periodic sharp pains in legs (calves) about 25-27hrs causing awakening from sleep. Took 320 mg aspirin, symptoms alleviated.
51 2021-05-04 pain in extremity on same day: headache a 10 hours after application small left arm pain... Read more
on same day: headache a 10 hours after application small left arm pain next day: morning ok after 34 hours heavy headache, nausea, strong left arm pain two days later: morning ok 60 hours mild headache, mild left arm pain three days after: tiredness at the end of the day Fourth day: back to normal
51 2021-05-05 weakness Since my 2nd Pfizer vaccination, I have been experiencing consistent fatigue, weakness, body aches, ... Read more
Since my 2nd Pfizer vaccination, I have been experiencing consistent fatigue, weakness, body aches, chills, headaches, brain fog, and an itchy cough.
51 2021-05-05 flushing Flushed face, "felt like I had a glass of wine." Felt dazed.
51 2021-05-06 burning sensation Within 48 hours, small itchy spots on feet and legs. Within one week large eczema-type spots on fron... Read more
Within 48 hours, small itchy spots on feet and legs. Within one week large eczema-type spots on front of both legs. Tx: triamcinalone cream, no difference. Rash ithcy burning and open sores. Rash began to creep up legs and invasive to sides of torso.
51 2021-05-06 night sweats Post nasal drip, sore throat, cough, sinus pressure, nasal irritation, fatigue, night sweats, burnin... Read more
Post nasal drip, sore throat, cough, sinus pressure, nasal irritation, fatigue, night sweats, burning in chest stay well-hydrated and well-nourished while resting appropriately For cough: honey 1 to 2 teaspoons every 4 hours can help to quiet a cough buPROPion SR (WELLBUTRIN SR)
51 2021-05-06 tingling, numbness, impaired body coordination Tingling in hands and feet; numbness in toes , lose control of legs and arms not being able to walk ... Read more
Tingling in hands and feet; numbness in toes , lose control of legs and arms not being able to walk and a lot of pain. I was treated with plasma IVIG , and steroids. Still in rehab
51 2021-05-07 muscle spasms, weakness Symptoms: Headache: stabbing pain headache especially right temple Tinnitus: ringing in right ear Sk... Read more
Symptoms: Headache: stabbing pain headache especially right temple Tinnitus: ringing in right ear Skin: rt ear red, swollen & bumpy. hair / scalp pain sensitivity Dizziness / Vertigo: Equilibrium and balance are off, walking like a drunk. Vision swims on head turn, phone appears to rotate in dark. Slight associated nausea. Occasional dry cough causing headache to explode. Progression SUNDAY 4/18/21 Second shot pfizer COVID-19 vaccine Gradual onset starting Thursday 4/22/21 (Day 4 since vax) or Friday (day 5 since vax.). SATURDAY 4/24/21- day 6 (since vax) , 0 (since full onset) - sharp stabs of headache every once in a while, noticed at game & really set in in evening. Feverish at night. SUNDAY - day 7,1 - low energy, body aches, difficult to get out of bed, 3 hour nap, severe headache. MONDAY - day 8,3 - Dr 9:45. 185 lbs, 97.8. Flu, strep, COVID negative. 5 day course of steroids, Start Flonase, Still fairly dizzy TUESDAY - day 9,4: Significant headache still but manageable with acetaminophen. Balance issues, vertigo? WEDNESDAY day 10,5 - 5:30am - Awakened by splitting headache. feverish. 1 acetaminophen, 1 chlorphenirmine @ 6am. By 10 AM, headache is back, high sensitivity to loud noise. Difficulty walking straight. THURSDAY day 11,6- 5:30am - awakened by splitting headache, 99.9 deg. 2 x acetaminophen. FRIDAY- calls back, Will call in a prescription for anabiotic, meclizine. SATURDAY 4:30am 2 x Acetaminophen 4am. first antibiotic @ noon , Diarrhea & cramping 7pm. Probiotic. 11 PM: 2X acetaminophen, anabiotic. SUNDAY- antibiotic 8, probiotic 10, Meclizine noon. TUESDAY- day 11 - Didn?t sleep well; 1x acetaminophen @ 5am. Headache pulse WEDNESDAY- Day 12 - 1x acetaminophen @ 1am, Headache seems just enough to prevent sleeping well without meds. Dizziness continues at same level. Meclizine doesn?t work. THURSDAY - Second visit with Dr : might be shingles based on lesions on ear, will prescribe anti-viral. Less likely: Ménière?s, something else. Call on for MRI Monday if symptoms not resolved. SATURDAY 5/8/21 - Day 15-still on antibiotic and antiviral, neither seems to be doing anything. Headache mostly gone, but dizziness /vertigo persist. Can not successfully walk heel to toe without falling over.
51 2021-05-07 pain in extremity I had an ultrasound done on my leg where a blood clot was found. I had a chest CT performed where se... Read more
I had an ultrasound done on my leg where a blood clot was found. I had a chest CT performed where several clots were found; Two days after my vaccine I began having severe pain in my right leg in the calf area and pain in my chest when I took a deep breath or coughed. Over the weekend it got worse and worse, on Tuesday th; Pain in my chest; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 14Apr2021 13:00 (Batch/Lot Number: Ew0153) (at the age of 51 years old) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included duloxetine; trazodone; pregabalin (LYRICA); oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]); and meloxicam, all taken for an unspecified indication, start and stop date were not reported. The patient previously took vancomycin and daptomycin and experienced drug allergy to these medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Apr2021 09:00, two days after the vaccine, the patient began having severe pain in his right leg in the calf area and pain in his chest when he took a deep breath or coughed. Over the weekend, it got worse and worse, on Tuesday 20Apr2021, the patient had an ultrasound done on his leg where a blood clot was found. He had a chest computerized tomography (CT) performed where several clots were found. The event resulted in doctor or other healthcare professional office/clinic visit. The treatment included blood thinners. No COVID prior vaccination and not COVID tested post vaccination. The case was assessed as non-serious by the reporter. The outcome of the event was not recovered.
51 2021-05-10 migraine, night sweats dehydration; low blood sugar; fatigued; Appetite; Pneumonia; Night sweats; Headache; Couldn't eat an... Read more
dehydration; low blood sugar; fatigued; Appetite; Pneumonia; Night sweats; Headache; Couldn't eat anything; Wheezing; migraine; Light, hacking cough; Fever/ 103.9 degrees; Chills; No more than 2-3 hours of sleep per night for 5 nights; Short of breath; This is a spontaneous report from a contactable consumer (patient). A 51-years-old male patient received the second dose of BNT162B2 (COVID-19 VACCINE), via an unspecified route of administration, administered on left arm on 14Apr2021 10:45 (Batch/Lot number was not reported) at age of 51 years as single dose. The patient medical history and concomitant medications was reported as none. Historical v for covid-19 immunisation accine included the first dose of BNT162B2 administered on left arm on 24Mar2021 at age of 51 years for covid-19 immunisation and experienced no issues. Patient reported that after the second dose of the Covid-19 vaccine, he had a fever for 8 days and was diagnosed with pneumonia on 21Apr2021. Patient reported that he was tested for both Covid-19, Influenza A, and Influenza B twice on 19Apr2021 and 21Apr2021 and tested negative for Covid-19 and influenza both times. Patient reported that he had no pre-conditions and that he was feeling great the night before he received the second dose of the Covid-19 vaccine, 13Apr2021. Patient reported that he was planning to go to work following the second dose of the Covid-19 vaccine on 14Apr2021. He began running a low-grade fever (102 degrees) on 14Apr2021 after receiving the Covid-19 vaccine and then his temperature flared up to 103.5 degrees on 15Apr2021. Fever: He received the second dose of the Covid-19 vaccine at 10:45 on 14Apr2021 and about 2:00 in afternoon on 14Apr2021 was the first fever that was significant. The last fever he had on 21Apr2021, his temperature was 103.9. He was put on antibiotics for pneumonia. He contacted the on-call nurse for his company. The on-call nurse advised him to see a doctor on Saturday, 17Apr2021.He went to the doctor on Monday, 19Apr2021. The doctor only ran a Covid-19 swab for testing and a flu swab. His doctor did not do blood work and stated that the patientwas experiencing an ill effect of the Covid-19 vaccine and sent the patient home. He went back to the doctor on Wednesday, 21Apr2021. When he went back to the doctor, the staff performed a chest X-ray and ran 4 different blood works to see what the patient had. The second Covid-19 test that he received on 22Apr2021 was performed with both the rapid test and the test that was sent off. Both Covid-19 tests came back negative. SARS test on 22Apr2021 was negative. 508-3 High Sensitivity CRP: One of his numbers that was parts per liter, 3 is considered to be high risk and he had 300 (300+) of whatever it was on 21Apr2021. He went back to the physician and was given another steroid shot an additional prescription. He had been back to the doctor 3 times since then. Fever: His fever was 103 consistently after 15Apr2021. 508-3 High sensitivity CRP: This value showed abnormal. The results said that relative risk was greater than 1 mg/liter and high was greater than 3. 1000 CBC with auto differential on 21Apr2021: The abnormal results were red blood cells measured at 4.38; hematocrit measured at 13.82; MCHC measured at 36.4; Neutrophils measured at 84; Lymphocytes measured at 12; and absolute Lymphocytes measured at 0.57. He wore a Garmin and that it recorded that he received no more than 2-3 hours of sleep per night for 5 nights. He didn't know anything about pneumonia previously and that he had specifically told his physician's office everything about what he was experiencing. He told his physician about the wheezing in his chest (on 17Apr2021), cough (on 16Apr2021), fever, and chills (on 14Apr2021). His physician told him it was a normal reaction to the Covid-19 vaccine and sent him home on 19Apr2021. He then consulted Google and started to realize that his side effect were very atypical. Wheezing: When he breathed really light, the crackling would continue. If he breathed shallow, the wheezing was audible but if he breathed deeply, it was not. The pneumonia was in the left side of his chest. He was still being treated for the pneumonia. He has his last dose of medication tomorrow, 27Apr2021, and that he was also being released to go back to work tomorrow. Cough: He had a little cough that would then go away. The cough began late Friday, 16Apr2021. It was interesting because it wasn't a main part of the illness. The cough was just kind of a hacking cough every once in awhile. The cough was not continuous like go and go and go and stop. The cough came, went away for awhile, then came again.The cough being worse was relative. He was coughing more than he did on Wednesday 21Apr2021, Thursday 22Apr2021, and Friday 23Apr2021. The cough was consistent more so at night when he laid down. He would probably say that it was a different feel towards the cough but it was still a cough. The cough was still the same volume but not the same effect. Headache (on 18Apr2021): He had been waking up with headaches in the morning and going to bed with them at night. On Wednesday, 21Apr2021, the headache was due to dehydration from the fever and night sweats. Once he got away from the dehydration headaches, the headache got better but he had woken up with a headache the last few days and had a headache at bedtime a few nights in a row. The headache was usually a frontal headache and this morning, 26Apr2021, the headache was toward the back of his head. The headaches last a few hours until he started moving around. On Saturday, 17Apr2021 he experienced a migraine that would not go away. He didn't usually get migraines. The migraine lasted hours if not for a day and that the headache was something furious. Sunday 18Apr2021 was pretty much the same thing with the headache. Because of the massive fever, he couldn't eat anything at all (17Apr2021). The headache was mostly due to low blood sugar and dehydration. Appetite: His appetite improved after his second doctor's appointment on 21Apr2021. The second provider was a lot more straightforward and advised the patient that he needed to start taking care of himself and trying to force himself to eat. He forced himself to eat on 21Apr2021 and by Thursday 22Apr2021, he had a full appetite and was craving food again. Shortness of breath (Apr2021): Patient reported that the shortness of breath was just from being fatigued. Patient reported that he got out of breath from going up and down the stairs. He was unsure when the shortness of breath began because he was moving very little, but that he noticed the shortness of breath on Monday, 19Apr2021 when he got up to go to the doctor.On Friday 16Apr2021 and Saturday 17Apr2021, he had a really good break.On Friday 16Apr2021 from 9 AM to 1 PM, he had no fever and it was like the sun was coming out, then the fever hit really hard. The same thing happened on Saturday, 17Apr2021, but the fever free period lasted maybe a little longer. His fever returned and that the afternoon of Saturday 17Apr2021 was the worst he had been the entire time. On 13Apr2021 to get away from arm soreness, he did a few laps in the pool. On 13Apr2021 he had a new best time on the 100 in freestyle in the pool and that he felt really strong going into 14Apr2021 to get his second dose of the Covid-19 vaccine. There was nothing that would have indicated that he had anything going on before getting the second dose of the Covid-19 vaccine. Up until Saturday, 17Apr2021, he had only been taking Motrin and just taking 2 tablets. He had no break in between fevers and chills and was not able to get ahead of the fever with the Motrin. There was a long stretch where the Motrin wasn't working and his temperature didn't get below 100 for several days. He tried to cycle acetaminophen in beginning Saturday 17Apr2021 to try to get the acetaminophen in between the Motrin doses. When he went back to the doctor on 21Apr2021, the provider told him that he could take 3 to 4 Motrin tablets at a time but not to exceed 4 doses per day. He never took more than 3 tablets. Motrin was generic ibuprofen. Night sweats (on 21Apr2021): The last couple of nights have been the same. He had a fan on to keep a little cooler and that it was 61 degrees outside and he felt the night sweats. He had a buckwheat mat that was cool that he put on the floor to stay cooler with the night sweats. Come Thursday, 22Apr2021, he said we're done with this and he couldn't sleep from it (Apr2021). Last night, 25Apr2021, he knew that he had night sweats because he was sweating at night and the temperature in the room was 64 degrees. AEs did not require a visit to Emergency Room. AEs required a visit to Physician Office for fever, wheezing, cough, shortness of breath, chills. Outcome of events was unknown.
51 2021-05-10 pain in extremity runny nose; Covid-19 vaccine cured allergies; Pain in arm; Little fatigue; This is a spontaneous rep... Read more
runny nose; Covid-19 vaccine cured allergies; Pain in arm; Little fatigue; This is a spontaneous report from a contactable consumer or other non-healthcare professional. Follow-up (PRD 23Apr2021) received from a contactable consumer was processed together with initial information. A 51-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EB8731), via an unspecified route of administration in left arm on 21Apr2021 at 12:00 as single dose for COVID-19 immunization. Medical history included ongoing allergic to dust, ongoing allergic to dust mites, ongoing allergic to cold air and ongoing allergic to pollen. Patient reported that he has been suffering from allergies every single year for many years. Patient reported that 10 years ago, he started having flu shots. Patient reported that they worked on his body for a few years then came back. Patient reported that flu shots made patient sick, ever since then, he had not gotten any vaccines at all. Patient reported that he doesn't get the flu. Patient also reported that his son has had the flu and he had been in close contact with his son when his son had the flu and the patient did not get the flu. Concomitant medication(s) included ongoing cetirizine hydrochloride (ZYRTEC ALLERGY) 10 mg, one pill every 2 days as needed for allergies. Patient did not take it for 2 days before getting vaccine. On 21Apr2021, patient experienced pain in arm (8 hours after the vaccination), patient reported that the place on his arm where the needle went in for the Covid-19 vaccine had pain. Patient reported that the pain was getting better and that if he pressed on the injection site there was not much pain and experienced little fatigue (at night). Patient reported that he played badminton on the night of 21Apr2021, (6 hours after the vaccination), played badminton for 2 hours and stopped. Patient reported that he thought that he might have been a little fatigued because he lost 2 badminton games. On 22Apr2021, patient experienced COVID-19 vaccine cured allergies. On an unspecified date, patient reported that when he woke up in the morning and came downstairs, he had a runny nose. Patient reported that he usually jogged daily and brang tissues with him because his nose would be running. Patient also reported that he really enjoyed walking outside with the sunlight and the air. Patient reported that yesterday on 22Apr2021, when he went jogging, he didn't have any runny nose at all. Patient reported that he was not having any problems with a runny nose at all, 23Apr2021.Patient mentioned that when he smells something or if he smells soap, later clarified as detergent or any fragrance, the runny nose will usually come right away. Patient also mentioned that he had not experienced this since getting the Covid-19 vaccine. Patient wanted to know the fundamental or principle behind Pfizer vaccine cured allergies. Patient also wanted to know if Pfizer had done any research on allergy cures or something that boosts the immune system. Patient reported that he told people on social media that the Covid-19 vaccine cured his allergies. Patient reported that he had so many friends that replied that had the same benefit from the Covid-19 vaccine. Patient reported that he was not a fan of taking medicine. Patient reported that even sometimes if he had a cold, he didn't take medication. Patient reported that instead of taking medication for a cold, he would eat spicy food to make himself sweat and drank lots of water. For LOT# Patient reported that the handwriting on his vaccine card was very bad, especially the second letter of the lot number. Patient reported that the letter looked like a B, but could be a P or an R (could be EB8731, ER8731 or EP8731). Patient reported that the lot number could be ER8731. Outcome of Covid-19 vaccine cured allergies was not recovered, pain in arm was recovering, little fatigue was recovered and runny nose was recovered on 22Apr2021. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021460544 same reporter, product and AE, different patient
51 2021-05-10 tremor, burning sensation, feeling hot, pain in extremity gums are sore and hurt; can hardly eat anything or hard foods; arm was sore; roof of his mouth and h... Read more
gums are sore and hurt; can hardly eat anything or hard foods; arm was sore; roof of his mouth and his gums hurt and had a burning sensation; got massive blisters all over his mouth inside and out, it was red and irritated bubbles on the roof of his mouth and blisters on his top and bottom lip.; mouth started itching and weirdness; fever 103-104; woke up shaking really bad; felt hot; This is a spontaneous report from a contactable consumer. This consumer reported that the 51-year-old male patient received first dose of bnt162b2 (BNT162B2, Pfizer Covid Vaccine, quantity 0.3 and RX7546, NDC number of Covid Vaccine: 59267-1000-01), via an unspecified route of administration, administered in Arm Right on 09Apr2021 15:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included dry age-related macular degeneration from an unknown date and unknown if ongoing, he had appendicitis as a kid and has never smoked and doesn't drink and he goes to the gym and he put on weight after his carpal tunnel surgery. States he body builds all his life and after the surgery he went 3-4 years and stopped working out. States he gained 70-80 pounds and he is back at the gym getting in better shape as he had gotten thicker. The patient's concomitant medications were not reported. The patient experienced arm was sore on an unspecified date with outcome of unknown, fever 103-104 on 10Apr2021 with outcome of recovered on 11Apr2021, got massive blisters all over his mouth inside and out, it was red and irritated bubbles on the roof of his mouth and blisters on his top and bottom lip on 11Apr2021 with outcome of unknown, gums are sore and hurt on an unspecified date with outcome of unknown, can hardly eat anything or hard foods on an unspecified date with outcome of unknown, woke up shaking really bad on 10Apr2021 with outcome of unknown, felt hot on 10Apr2021 with outcome of unknown , mouth started itching and weirdness on 11Apr2021 with outcome of unknown, roof of his mouth and his gums hurt and had a burning sensation on an unspecified date with outcome of unknown. The clinical course was reported as follows: Caller states he has a question, he had the shot on 9Apr2021 and didn't have problems, his arm was sore and that was a little worse Saturday and Sunday. States Friday into Saturday he got a fever 103-104 all day and it broke Sunday afternoon. States then he got massive blisters all over his mouth inside and out, it was red and irritated bubbles on the roof of his mouth and blisters on his top and bottom lip. States his gums are sore and hurt and he can hardly eat anything or hard foods. Caller is asking is this something normal that happens. Caller provides that he has gotten blisters with high fevers before but nothing like this before. Caller states he is scheduled for the 2nd dose 7May2021 and is wondering if he should take the 2nd part and if he will get a high fever. Caller relays he is prone to fevers since he was a kid. States at 4am into Saturday morning he woke up shaking really bad, his girlfriend took his temperature in his ear and said he had no fever it was 99 but he was shaking. States about an hour later he felt hot and had a fever 103-104, the highest was 104. States he was taking Extra Strength Tylenol and switched off with Ibuprofen until Sunday. States he took Ibuprofen last at 10pm Saturday into Sunday and the fever didn't come back Sunday. States his mouth started itching and weirdness and he figured he would get a blister, didn't get 1 it was the side, top lip, half the bottom lip, inside his mouth, around the edge of his mustache, and was feeling raw on top of his mouth and his gums started to hurt on 11Apr2021. States this is bad, he didn't get blisters really before and now it's a bunch everywhere and he doesn't know if it's from the 104 fever or if it is a combination of the vaccine and the fever he doesn't know. Caller relays that his doctor gave him cream for the inside of his mouth and has stuff for the outside of his mouth, states by Monday it was all over. States he got the cream yesterday, 14Arp2021 for inside his mouth. Provides that it is Triamcinolone 0.1% instructions say don't rub in, take cotton and slowly tap inside mouth where bubbles are. Caller states it creates a paste and doesn't hurt as bad to put something inside his mouth. Caller relays he also got Abreva for the blisters on the outside of his mouth. Caller relays they are getting better and are drying up and falling off. States when he brushes his teeth his says oh my God because the inside is sore so he brushes slow and rinses slow. States the Abreva works really well and the blisters are falling off slowly and he has raw spots on his lips that need to seal up because the skin comes off with the blisters and it's a little raw and he has to be careful with things like citrus. States he had a turkey wrap he had to throw out he couldn't eat it and had tried and his mouth was killing him, the roof of his mouth and his gums hurt and had a burning sensation. Caller relays that the outside of his mouth is getting better faster than the inside because that stays wet and is taking a little longer. Caller states he had coronavirus last Sep2020 and had a fever for 3 weeks straight and got maybe 1-2 blisters, not like now. States he had it for a month and a half. Caller states to prevent from catching it again, it was horrible and he has heard if it comes back it can be worse and kill you. States he had a heavy cough and lost 22 pound when he had it. Caller states he had appendicitis as a kid and has never smoked and doesn't drink and he goes to the gym and he put on weight after his carpal tunnel surgery. States he body builds all his life and after the surgery he went 3-4 years and stopped working out. States he gained 70-80 pounds and he is back at the gym getting in better shape as he had gotten thicker. Caller states he didn't see his healthcare provider, he was able to call in and explain what was happening and she prescribed the medication and how to apply it. History of all previous immunization with the Pfizer vaccine considered as suspect: 1st dose. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No AE(s) require a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks was none. AE(s) following prior vaccinations was none. Relevant Tests was none. Caller states he wants the other dose and he may be feeling better when it comes time but he is scared about taking it and maybe he should take half of it. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
51 2021-05-11 pain in extremity First week soreness of arm, patient can't lift up the arm without extreme pain and assistance of the... Read more
First week soreness of arm, patient can't lift up the arm without extreme pain and assistance of the other arm. Patient cannot lift anything with this arm. This has been a gradual decline per patient which is still continuing to occur 2 months after the vaccine.
51 2021-05-12 discomfort ED to Hosp-Admission Discharged 2/23/2021 - 2/25/2021 (2 days) Treatment team Costochondritis Princ... Read more
ED to Hosp-Admission Discharged 2/23/2021 - 2/25/2021 (2 days) Treatment team Costochondritis Principal problem Discharge Summary (Physician Assistant) ? ? Internal Medicine Cosigned by: MD at 2/27/2021 4:06 PM Discharge Summary Hospitalist Medicine Admission Date: 2/23/2021 Length of Stay: 0 Days Discharge Date: 2/25/2021 Admission Diagnosis Hospital Problems POA * (Principal) Costochondritis Yes COVID-19 Yes Problem List Resolved POA Resolved Problems Atypical chest pain 2/25/2021 Yes SIRS (systemic inflammatory response syndrome) (CMS/HCC) 2/25/2021 Yes Hyponatremia 2/25/2021 Yes Dehydration 2/25/2021 Yes Home Or Self Care CODE STATUS: Full Code Active Issues Requiring Follow-up Test Results Pending at Discharge Pending Labs Order Current Status Blood culture x 2 SETS Preliminary result Blood culture x 2 SETS Preliminary result Hospital Course Hospital Course: Please refer to the admitting providers H&P for full history. Patient is a 51-year-old male with a PMHx significant for hemochromatosis, sarcoidosis and morbid obesity who initially presented to the ED for evaluation of chest pain, cough and shortness of breath. On presentation, vitals were mostly unremarkable other than some mild tachycardia and tachypnea. Patient was able to maintain adequate oxygenation on room air but was placed on supplemental oxygen for comfort. Blood work was mostly unremarkable. ABG was not particularly concerning. Troponin was negative x3. Patient underwent chest CTA which showed basilar atelectasis bilaterally and scattered groundglass opacities and scattered borderline size hilar and mediastinal lymph nodes consistent with patient's known sarcoidosis. Patient was treated with supportive care and monitored overnight. He was able to maintain sufficient oxygen levels. On the time my evaluation, patient continues to complain of bilateral rib pain worse with deep breaths consistent with costochondritis. I discussed with the patient that he will need to continue to take NSAIDs on a scheduled basis to help with his discomfort. Additionally I offered to prescribe cough medicine. I discussed possibly discharging the patient on steroids however he states that he makes a point to avoid taking steroids due to his history of hemochromatosis. At this point, patient no longer requires care in the hospital and can be discharged home. Patient is agreeable with the plan and all questions have been answered appropriately.
51 2021-05-13 cold sweat Intense Headache 7-10 of 10; Low grade fever 100.4; Significant bodyaches; cold sweats; This is a sp... Read more
Intense Headache 7-10 of 10; Low grade fever 100.4; Significant bodyaches; cold sweats; This is a spontaneous report from a contactable other health care professional (Patient, self-reported). A 51-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration, administered in arm left on 27Jan2021 07:30AM, as second dose, single, dose 1, (Batch/Lot Number: EJ1686), via an unspecified route of administration, administered in Arm Left on 06Jan2021 07:30AM, as first dose, single for covid-19 immunization. Reportedly other medical history was none. Patient did not have allergies to medications, food, or other products/known allergies. Concomitant medication included paracetamol (TYLENOL) and ibuprofen (MOTRIN [IBUPROFEN]) received in two weeks of vaccinations. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19 prior vaccination. Patient has not been tested for COVID-19, post vaccination. On 28Jan2021 02:45AM, the patient experienced intense headache 7-10 of 10, low grade fever 100.4, significant body aches and cold sweats. The patient underwent lab tests and procedures which included pain assessment: 7-10 of 10 and pyrexia: 100.4 on 28Jan2021. Treatment was not received for adverse events. Outcome of the events was recovering. Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
51 2021-05-13 muscle spasms Shortly after getting the second dose, my legs started cramping the 3rd day after and then I came do... Read more
Shortly after getting the second dose, my legs started cramping the 3rd day after and then I came down with shingles. It started at my lower back and traveled down my left leg to the bottom of my left foot.
51 2021-05-14 bell's palsy, numbness Palsey on left side. Watering left eye. Numbness on left side around mouth and cheek.; Palsey on l... Read more
Palsey on left side. Watering left eye. Numbness on left side around mouth and cheek.; Palsey on left side. Watering left eye. Numbness on left side around mouth and cheek.; Palsey on left side. Watering left eye. Numbness on left side around mouth and cheek.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 29Mar2021 10:00 (Batch/Lot number was not reported) at the age of 51 years old, as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included mitral valve prolapse. Concomitant medication included warfarin taken for an unspecified indication, start and stop date were not reported. The patient previously took doxycycline hydrochloride (DOXYCYCLIN) and experienced allergy. The patient previously received first dose of bnt162b2 on 09Mar2021 09:00 AM at the age of 51 years old for COVID-19 immunization (vaccine location: right arm). No other vaccines received within 4 weeks prior to COVID vaccine. On 05Apr2021 07:00, the patient experienced Palsy (palsey) on left side, watering of left eye and numbness on left side around mouth and cheek. No treatment was received for the adverse events. The patient recovered from all the events on unspecified date. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.
51 2021-05-14 night sweats nausea; diarrhea; night sweats; This is a spontaneous report from a Pfizer-sponsored program receive... Read more
nausea; diarrhea; night sweats; This is a spontaneous report from a Pfizer-sponsored program received from a contactable other healthcare professional and a consumer. A 51-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), in Apr2021 (at 51-years-old) at unknown, single for COVID-19 immunisation and tofacitinib citrate (XELJANZ XR tablet 11 mg) on 16Feb2021 at 11 mg. Medical history and concomitant medications were not reported. The patient experienced nausea, diarrhea, night sweats and 8 missed doses of tofacitinib citrate when he had his COVID vaccine, in Apr2021. The action taken with tofacitinib citrate was temporarily withdrawn on 19Apr2021. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
51 2021-05-21 weakness General weakness; lightheaded; muscular pain; light headache.
51 2021-05-21 pain in extremity, tingling, numbness and pain in extremities allergic reaction to the Covid 19 vaccine; nerves in his right wrist are bothering him, feels the ne... Read more
allergic reaction to the Covid 19 vaccine; nerves in his right wrist are bothering him, feels the nerves moving up and down and his arms, and feeling like the nerves in his right arm were jumping; right hand won't relax, can't bend the fingers on his right hand, can't make a fist with his right hand; like he has no control of his arm; right wrist feels like needles and pins; right hand blew up with inflammation; His fingers on his right hand were swollen, right hand looked like it was going to explode; Like his right arm was agitated, right arm was still very uncomfortable; pain in his hand; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EW0164), at the age of 51 years old, in right arm at single dose on 23Apr2021 16:30 for covid-19 immunization. Medical history included sleep apnea, congestive heart failure, high blood pressure and type 2 diabetes, seasonal allergy and covid-19 in May2020. The patient reported he had symptoms of the covid-19 virus in May2020. He had a positive covid-19 virus test and did quarantine. The patient reported he's never been allergic to any kind of medication. Concomitant medications included atenolol 50-25 mg at one tablet a day. The patient didn't know the name of the other medication combined with the atenolol. The patient reported one was for the heart and one was for the blood. He also took medication for seasonal allergies but declined to provide the name. The patient previously received a flu vaccine (NDC/Lot/Expiry: unknown) on 2020 that made him feel bad with a head cold. The patient previously received the first dose of BNT162B2 (lot number: EP7534), at the age of 51 years old, in right arm at single dose on 02Apr2021 16:30 for covid-19 immunization. The patient started having some problems maybe a week after that. He started feeling like the nerves in his right arm were jumping. Like his right arm was agitated. His finger on his right hand were swollen. The patient did get his vaccine in the right arm. He thought his arm was going to bother him after he got the vaccine. The nerves in his right wrist are bothering him. Like he felt the nerves moving up and down and his arms, like he had no control of his arm. His right hand blew up with inflammation. His right hand looked like it was going to explode. His right hand won't relax. On 01May2021 was when he noticed his arm acting funny. He would say that the swelling had gone down from taking the antibiotics but his right arm was still very uncomfortable and he couldn't bend the fingers on his right hand and he couldn't make a fist with his right hand. His right wrist felt like needle and pins. The patient went to the emergency room at a hospital two nights in a row on 04May2021 and 05May2021. The first time he had x-rays done. The second time he had x-rays and a sonogram of his right arm to check for blood clots and he had some blood work done. All of that came back negative. The emergency room doctor asked him what arm did receive BNT162B2 in, he told the doctor his right arm, the doctor told him he's having an allergic reaction to BNT162B2. The emergency room doctor prescribed him an antibiotic to take. He'd already finished the antibiotic and didn't recall the name, the bottle had been thrown away. The patient followed up with his primary care doctor on 13May2021 and was given a prescription for a muscle relaxer and motrin 600 mg to help bring the swelling and pain down in his hand. In the emergency department he had a right arm and right wrist x-ray. The doctor was trying to figure out why his right hand looked like a balloon. The only conclusion the emergency room doctor came up with was that he was having a reaction to BNT162B2. The outcome of events nerve in wrist bothering, felt nerve moving, feeling nerves jumping, right arm agitated, no control of arm, right hand won't relax and couldn't bend fingers was not recovered. The outcome of events hand blew up with inflammation, fingers on right hand swollen, right hand explode and pain in hand was recovering. The outcome of events wrist felt like needles and pins and allergic reaction to vaccine was unknown. No follow-up attempts are needed. No further information is expected.
51 2021-05-22 feeling jittery recommended emergency room evaluation . which the caller has refused
51 2021-05-23 weakness Flu-like symptoms: weakness, fatigue, soreness, headache. Began 16 hours after vaccine and lasted ap... Read more
Flu-like symptoms: weakness, fatigue, soreness, headache. Began 16 hours after vaccine and lasted approximately 36 hours. Treated with bedrest. However, tiredness/fatigue still continue 12 days after vaccination, and have not subsided.
51 2021-05-24 flushing, tingling heart races a little; feels flushed; checked his pulse and it was a little elevated; eyes are tingly... Read more
heart races a little; feels flushed; checked his pulse and it was a little elevated; eyes are tingly; feeling feverish but no fever; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 51-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EL9262) via an unspecified route of administration administered in Arm Right on 25Jan2021 14:00 (at the age of 51-years-old) as single dose for covid-19 immunisation. The patient's medical history included blood pressure. The patient's concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ) ongoing at 12.5 of unknow units once daily for blood pressure and tamsulosin. The patient underwent lab tests and procedures which included heart rate: little elevated. He checked his pulse and it was a little elevated. It was reported as the patient received the first dose of the pfizer covid 19 vaccine on Monday 25Jan2021 but did not have any symptoms until Thursday 28Jan2021. The patient reported feeling feverish but no fever, heart races a little, eyes are tingly and feels flushed. The patient wants to know if what he is experiencing normal. The patient wanted to know if the rumor is true that the second dose has more side effects. He has had no allergic reactions to medicine. He takes a blood pressure medicine, anti-anxiety medicine, and cholesterol medicine. Starting yesterday he started to feel feverish but had no fever. His eyes started to feel tingly, like a feverish feeling. This started after lunch time. He took a nap for like an hour, slept fine, and then the feeling was gone and he was okay. Today, he woke up this morning around 6:30 AM and was fine. It was not until later this morning around 11 AM when he started to feel the same way again. It was like his heart raced a little. He checked his pulse and it was a little elevated, but nothing crazy. He felt flushed. His eyes were tingly. It is like something does not feel right. He was calling to see if these were side effects. Feeling like his heart was racing has subsided. It was worse earlier. The feeling flushed is minor now. The eyes tingly has almost subsided, but still there. The patient experienced feeling feverish but no fever, eyes are tingly on 28Jan2021, heart races a little, feels flushed and checked his pulse and it was a little elevated on an unspecified date. The outcome of the events heart races a little and eyes are tingly and feels flushed was recovering, while the outcome of remaining events was unknown. Follow-up attempts are completed. No further information is expected.
51 2021-05-24 numbness Around 6 AM March 24 about 30 hours after my first injection of the Pfizer vaccine I experience stro... Read more
Around 6 AM March 24 about 30 hours after my first injection of the Pfizer vaccine I experience stroke like symptoms. Numbness on the left side of my body. Including my face arm and leg. I went to hospital. Where I was first given a CAT scan. And a day later an MRI.
51 2021-05-26 involuntary muscle movements On 5/20/21 the patient was at home with his mother when he had acute nausea, light-headedness, and a... Read more
On 5/20/21 the patient was at home with his mother when he had acute nausea, light-headedness, and abdominal pain. He presented to the ED by ambulance. Excerpt from ED notes od MD follows: "Initial ED interventions: iv fluids, low dose iv ativan, iv toradol, iv zofran. ED course: patient arrives very anxious, writhing on bed, difficult to redirect. With chronic tonicity, not seizing. Mother arrives, and he recognizes her, seems to be consoled somewhat by her presence, but she is unable to direct him, and describes his behavior as irregular, and events acute this evening at her home. Patient rests, and then HR decrease to 50s on monitior and patient found to be pulseless - I immediately start chest compressions, and achieve ROSC after PEA arrest with administration of EPI/compressions. Patient intubated per procedure note without complication. L femoral central attained per procedure note without complication. CPR performed over ED course intermittently (always PEA arrest) with ROSC achieved with administration of EPI, EPI drip started in addition to sedation meds, and iv fluids. No obvious STEMI on ECG to administer lytics, with suspicion of dissection and AAA prominent. I am able to stabilze and accompany patient to CT suite, where I recognize B/L massive PE immediately. I discuss with Dr. of Cardiology, who agrees with admininstration of alteplase. I disucss risks with mother who consents verbally. Patient without response to alteplase, and with continued pattern of PEA arrest following bradycardia. I discuss etiology of presentation with mother,and that patient is with very poor prognosis of survival, and likely poorer prognosis of neurological status, and patient is made comfort care, and fentanyl drip increased, patient is taken off of ventilation and drips. Pronounced deceased at 22:00. MDM: Initial concern for but not limited to appendicitis, AAA, diverticulitis, renal stones, pyelonephritis, musculoskeletal pain, pancreatitis, toxic ingestion, ACS, obstruction, perforation, sepsis (2/2 PNA, UTI, meningitis, intra-abdominal infection), AAA, dissection, PE - as ED course progresses, differential narrows and consider more likely PEA arrest secondary to ACS, PE, dissection, AAA, necrotic pancreatitis, tension PNX (less likely). Considered but do not suspect seizures, stroke. Imaging studies reviewed - CXR with ETT in place, no acute pathology. CTA chest/A/P remarkable for massive proximal B/L PE. Labs reviewed. ECGs without STEMI, with sinus tach initially, LBBB after initial ROSC, and then AFib in RVR on subsequent ECG. Per above, patient suffered massive B/L PE, with subsequent cardiac arrest, despite heoric efforts including thrombolysis. Death called art 22:00. Diagnosis: massive B/L PEs, PEA arrest. Disposition: deceased."
51 2021-05-28 tingling Paresthesia-like effect experienced on finger, right hand thumb. Treatment ?Dermoplast? spray (benz... Read more
Paresthesia-like effect experienced on finger, right hand thumb. Treatment ?Dermoplast? spray (benzotgonium chloride/benzocaine) followed by ?Neosporin? (bacitracin/neomycin/polymyxin). Reason for for selected treatment was initial suspected cause of potential insect sting. No skin puncture was found or other signs of insect bite. This symptom has never been experienced by patient before. The symptom laster approximately 30 minutes.
51 2021-05-30 feeling cold Very sluggish,cold not chills no fever,out of sorts feeling,lasted only 1 day,feeling better on 2nd... Read more
Very sluggish,cold not chills no fever,out of sorts feeling,lasted only 1 day,feeling better on 2nd day
51 2021-05-31 pain in extremity constant headache; had body pain & aches; extreme fatigue; pain in entire upper arm; This is a spont... Read more
constant headache; had body pain & aches; extreme fatigue; pain in entire upper arm; This is a spontaneous report from a contactable other hcp (patient). A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: en6202; Expiration Date: unknown), dose 2 via an unspecified route of administration, administered in left arm on 24Feb2021 15:00 (at the age of 51-year-old) as 2nd dose, single dose for COVID-19 immunization. The patient received the historical vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: el9269; Expiration Date: unknown) via an unspecified route of administration, administered in left arm on 03Feb2021 17:00 (at the age of 51-year-old) as 1st dose, single dose for COVID-19 immunization. The patient had no other medical history. Concomitant medications in two weeks included acetylsalicylic acid (ASPIRIN 81) at a dose of 81 mg, atorvastatin (ATORVASTATIN), multi vitamin. There was no other vaccine on same date or in four weeks of product. The patient did not had COVID prior to vaccination. The patient has not been tested for COVID post vaccination. On 25Feb2021 12:00, the patient experienced constant headache, body pain and aches, extreme fatigue, pain in entire upper arm. Reportedly, constant headache, started 25Feb2021 12pm still present (26feb2021), had body pain & aches, extreme fatigue, pain in entire upper arm until 26Feb2021 06:00, headache still present 26Feb2021 at 20:00. No treatment was given for adverse event. The clinical outcome of the events was not recovered. Follow-up attempts completed. No further information expected.
51 2021-06-01 pain in extremity Dose 2. Sore arm; Headache; Fatigue; Vertigo; This is a spontaneous report received from a contactab... Read more
Dose 2. Sore arm; Headache; Fatigue; Vertigo; This is a spontaneous report received from a contactable consumer (reporting on himself). A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Ew0167 and Expiration Date was not reported) via an unspecified route of administration in Arm Right on 19May2021 18:30, as 2nd dose, single dose for COVID-19 immunization. Medical history included, vertigo from 2019 to an unknown date. The patient's concomitant medications were not reported. Patient did not have known allergies. Previously patient took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Ek8735 or ER8735 and Expiration Date was not reported) via an unspecified route of administration in Arm Right on 24APR2021 04:00, as 1st dose, single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20May2021 08:00, patient experienced dose 2. sore arm, headache and fatigue first 48 hours; vertigo and significant fatigue began at 48 hour point has continued for two days. Has a bout of vertigo around 2019 that lasted weeks. Patient did not received any treatment for adverse events. Since the vaccination, the patient has tested for COVID-19. The outcome of the events was not recovered.
51 2021-06-03 weakness Rapid heart rate. Resting rate of 120 to 130 beats per minute for at least 2 days. Then 100 to 110 f... Read more
Rapid heart rate. Resting rate of 120 to 130 beats per minute for at least 2 days. Then 100 to 110 for another 2 days. After 2 weeks still having trouble with normal activities. Heart beat feels different and I get weak whenever moving quickly for example doing laundry or cleaning the house.
51 2021-06-03 weakness Fatigue; muscle pain; low grade fever; chills; excessive sweating; headache; back pain; generalized ... Read more
Fatigue; muscle pain; low grade fever; chills; excessive sweating; headache; back pain; generalized weakness; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route and administrated in the left arm on 16Mar2021 at 16:45 hours (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension which was controlled. Patient was not allergic to medications, food, or other products. Concomitant medication included amlodipine besylate 10mg (MANUFACTURER UNKNOWN) and hydrochlorothiazide 25mg (MANUFACTURER UNKNOWN) for an unknown indication. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 17March2021 at 14:00 hours, patient experienced fatigue, muscle pain, low grade fever, chills, excessive sweating, headache, back pain and generalized weakness. Patient did not receive any treatment for the reported events. On an unknown date in Mar2021, the patient was recovered from the events fatigue, muscle pain, low grade fever, chills, excessive sweating, headache, back pain and generalized weakness. No follow-up attempts are needed. No further information is expected.
51 2021-06-03 migraine Vomiting; Massive Migraine; Pain in neck; Dizziness; Headache; Nausea; Made me sick; This is a spont... Read more
Vomiting; Massive Migraine; Pain in neck; Dizziness; Headache; Nausea; Made me sick; This is a spontaneous report from a contactable consumer (Patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EW0167; Expiration Date: 31Aug2021), via an unspecified route of administration on 20May2021 at 16:30 (at the age of 51-year-old) as 1st dose, single dose in right arm for COVID-19 immunisation at Public Health Department. The patient's medical history included arthritis and gout. The patient had known allergies to amoxicillin. Concomitant medications within 2 weeks of vaccination included allopurinol (ALLOPURINOL) taken for gout, celecoxib (CELEBREX) taken for arthritis, gabapentin (GABAPENTIN), and buprenorphine (BUPRENORPHINE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20May2021 at 22:30, after the first shot of vaccine, the patient experienced massive migraine, pain in neck, dizziness, vomiting, headache, and nausea. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment medication included Sumatriptan Succinate 50mg and then 100 mg (Manufacturer: Aurobindo). On an unspecified date in May2021, the patient reported that the Pfizer shot had made her sick. The patient underwent lab tests and procedures on Apr2021 which included blood test: unknown results and patient had several blood test over the last month. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the event made me sick was unknown and clinical outcome of all other events was not resolved.
51 2021-06-03 tenderness Left armpit is swollen and tender; Left armpit is swollen and tender; Is the same side as the inject... Read more
Left armpit is swollen and tender; Left armpit is swollen and tender; Is the same side as the injection; Typical soreness where the shot was; This is a spontaneous report received from a contactable consumer or other non hcp. A 51-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch number: ER8731 and Expiry date: Unknown), via an unspecified route of administration, on 24May2021 13:00 as 1st dose, single dose on left arm for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had the shot on typical soreness where the shot and Is the same side as the injection has not really had any side effects until this morning. On the same date he got the shot he had some tenderness at the site. The patient experienced left armpit is swollen and tender and is the same side as the injection on 27May2021. The events assessed as non-serious. The patient initially stated this was subsided, but clarified it was still ongoing even though he initially said he had no side effects until today as well. If he touches it, it was still tender. Outcome of the events Is the same side as the injection and Typical soreness where the shot was resolving while outcome of the remaining events was unknown. Information on Lot/Batch number is available; Further information has been requested
51 2021-06-06 muscle twitching I began having a constant eye twitching in my left eye approximately two weeks after my second shot.... Read more
I began having a constant eye twitching in my left eye approximately two weeks after my second shot. It has been twitching since then and it is now June 7th. I am unsure of this is a reaction to the vaccine.
51 2021-06-07 pain in extremity axillary lymphadenopathy/Lymphadenopathy was evident in the left axilla/large lymph nodes; full blow... Read more
axillary lymphadenopathy/Lymphadenopathy was evident in the left axilla/large lymph nodes; full blown flu like syndrome with headache, body ache and flu like chills, nasal drainage and eyes watery/ congested, nose running like a faucet non stop; sore throat; severe right deltoid pain; arm very tender and swollen; fees like crap and is hard to get out of bed every morning; rhinitic, congested, draining like a faucet; severe pain in left foot and right hand; Has been fatigued and his body aches and he is exhausted.; He couldn't even walk, it was completely painful.; This is a spontaneous report from a contactable physician (patient). A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 04May2021 (at age of 51 years old) (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included flu, has gotten the flu before but has never gone on this long. The patient's concomitant medications were not reported. Clinical course as reported: He is a practicing physician who has been providing vaccinations to patients all of his life. He ended up with severe right deltoid pain. It is usually not a problem, he has dealt with this with other shots. By the second or third day, it was very tender and swollen and had axillary lymphadenopathy on the same side he re-ceived the vaccination. It persisted the next day until day 5 or 6. He then started to get worried. He went to the hospital. They did a CT scan which noted there was notable lymphadenopathy. They thought it was a reaction to the Covid vaccination. 2 days later, he went home and he kept taking Motrin and Tylenol on board. Lymphadenopathy was evident in the left axilla, inguinal nodes, and is still there now. On day 7, he went into full blown flu syndrome, had a headache, body aches and flu like chills, the whole thing. Is still a little bit rhinitic and is very congested, and is draining like a faucet. It has all been happening since he got vaccinated. He was told he was either exposed to covid or it is from the vaccination. He went to urgent care yesterday (20May2021) and they did a Covid test which was negative. He hates to point fingers but this fatigue has been overwhelming and is never ending. He called withheld where he got the vaccination. He said the pharmacist has been hearing this from a lot of patients. He reported for 7 days straight the clinical events as they were happening. Nobody has contacted him, they said some-one would be contacting him the next day and he has not heard from anyone. This laid him up for 5 days. The last 4 days, he had severe pain in the left foot, and the right hand. It was out of the blue like someone whacked him with a hammer. He couldn't even walk, it was completely painful. He hasn't worked out since he got the damn shot. In 15 days, he has not gone to the gym. They did an X-ray which didn't say anything. He was in immense pain. They gave him prescription for Prednisone 50mg and he hasn't been able to get to the pharmacy to get it yet but will head over shortly. Has been taking Motrin and Tylenol around the clock. Has been taking antihistamines because his nose has been running like a faucet non stop and he has a sore throat. Sore throat has gotten better in the last 5 days. The pain was really bad. The sore throat has subsided. The nasal drain-age and his eyes are watery are still there. Has been fatigued and his body aches and he is exhausted. The second vaccination is due 25May2021 and he is absolutely not getting the second one. When having other viral syndromes, he has never felt this sick. Has gotten the flu before but has never gone on this long. He is just feeling like crap. Can barely even get out of bed every morning. It is unbelievable. He hasn't had any true positive exposure. Has not been exposed to other family members with Covid/ coronavirus. Have practices strict isolation in their home. They have 5 kids and they did not go near anyone or go to any public places. For this to happen, it has to be because of the vaccine. Nothing else could have caused this. No one else around him has been sick. Is not sure if they are getting a lot of reports. When going on line to the Pfizer vaccine reporting, it took him a while to get a number to contact Pfizer directly. He called (Withheld) and they gave him 2 wrong numbers. It took 4 people to get the number to report this to Pfizer. He thinks there is a lot of under reporting. If he has a deductible, he would like Pfizer to take care of the cost for his ER visit. On 21May2021, reported that Beginning 05/04 when received vaccine, experienced Very large lymph nodes and Flu syndrome. Outcome for events sore throat was recovered on May2021, for other events was unknown. The lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer drug 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.
51 2021-06-07 pain in extremity Slight dizziness; a slight breathing difference; heart palpitations; soreness in arm and shoulders; ... Read more
Slight dizziness; a slight breathing difference; heart palpitations; soreness in arm and shoulders; soreness in arm and shoulders; tiredness; This is a spontaneous report from a non-contactable consumer (patient). A 51-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration: not reported), via an unspecified route of administration, administered in arm right on 06Mar2021 10:45 as single dose for covid-19 immunisation (at the age of 51-year-old). The patient's medical history was none. Concomitant medication(s) included nortriptyline (as other medications in two weeks) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks, no covid tested post vaccination, no covid prior vaccination and no known allergies. Previously, the patient received first dose of PFIZER-BIONTECH COVID-19 VACCINE (Batch/Lot number and expiration was not reported), via an unspecified route of administration, administered in arm right on 13Feb2021 10:45 as single dose for Covid-19 immunisation (at the age of 51-year-old). On 06Mar2021 11:30, the patient experienced slight dizziness, a slight breathing difference and heart palpitations, and soreness in arm and shoulders, with tiredness. Not major issues but the patient thought should report them. No treatment taken. The outcome of all events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
51 2021-06-09 muscle spasms Extreme fatigue; Lower back pain is now moderate but currently ongoing; I had severe back spasms (lu... Read more
Extreme fatigue; Lower back pain is now moderate but currently ongoing; I had severe back spasms (lumbar region); Tightness in upper back; Hamstrings; This is a spontaneous report from a contactable (Patient). A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN 6203 and Expiration Date not reported) via an unspecified route of administration, administered in left arm on 05Mar2021 at 01:45 PM as single dose for COVID-19 immunisation. The patient medical history included suspected allergy of penicillin and allergic to wasps. The patient not received other vaccine in four weeks. The patient concomitant medications included loratadine (CLARITIN) and omeprazole. The patient did not have COVID prior vaccination. On 06Mar2021 at 08:00 AM (18-hours after the vaccination), patient had severe back spasms (lumbar region) along with tightness in upper back and hamstrings, followed by extreme fatigue after 48 hour (morning of 07Mar2021) lasting until Tuesday (09Mar2021). Lower back pain was now moderate but currently ongoing. The patient visited doctor or other healthcare professional office/clinic as a result of events. The patient received treatment with Ibuprofen and Acetaminophen and electrolytes. The patient not tested for COVID post vaccination. On 09Mar2021, the extreme fatigue was resolved. The outcome of all other events was recovering. No follow-up attempts are possible. information about lot/batch number cannot been obtained.
51 2021-06-10 pain in extremity Pain in shoulders and elbows have persisted for over 2 months now. Range of motion of the right arm... Read more
Pain in shoulders and elbows have persisted for over 2 months now. Range of motion of the right arm in particular is limited significantly die to pain. There is dull to throbbing pain during certain times of the day even when arms are not being used. Pain becomes more intense if arms are moved in certain ways like reaching back or quick movements. Pain emanates from joints but seem to affect muscles of the upper arm as well.
51 2021-06-16 weakness, numbness violently ill; nausea; sick; very dizzy with flu symptoms; grogginess and extreme exhaustion; arm go... Read more
violently ill; nausea; sick; very dizzy with flu symptoms; grogginess and extreme exhaustion; arm got numb; grogginess and extreme exhaustion; arms were getting weaker and weaker; weak; sweat; dizzy, weak, sweats; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Apr2021 (at 51-year-old) (Batch/Lot number was not reported) as 1st dose, single in arm left for COVID-19 immunisation. Medical history included ongoing chronic back pain (diagnosed for years), and ongoing type 1 diabetes mellitus. The patient's concomitant medication was not reported. After the first dose, date unknown, he got violently ill, stated literally he got ill at the center where he got the vaccine, he was weak, started to sweat, the medical people there were a little concerned they held him there for an additional amount of time for observation after the first vaccine. He was very dizzy. (event weak, sweat and dizzy onset 24Apr2021 03:00 as reported) He went home and he was very nausea and sick, at 23:00 he laid down and slept all day until the next day. He woke up on the third day very dizzy with flu symptoms, but was able to get up and get moving and was getting better, after about a week during the four weeks between the two doses started calling doctor telling them something was wrong, got over the first three days and then the grogginess came back extreme exhaustion, noticed every night in bed if he curled up in bed or brought arms up or like now if he has arm up to his ear on the phone his arm got numb immediately. Arms went within a minute. The doctor and nurse practitioner doubted this was lingering side effects, progressively his arms were getting weaker and weaker, he was getting weaker and weaker as a person. MRI and rheumatology (lymes, MS, lupus) showed negative. The outcome of the events violently ill and arm numb was not resolved; of events weak, sweat, dizzy, nausea, sickness, flu symptoms, exhaustion, groggy and weakness of arms was unknown. The events under second dose referred to case 2021648178. Information on the lot/batch number has been requested.
51 2021-06-17 weakness, tremor rash around the body/rash all around body was reported as worsened.; sore throat/sore throat was rep... Read more
rash around the body/rash all around body was reported as worsened.; sore throat/sore throat was reported as worsened; sweating; shaking; weakness; pain around the kidney; Pain around back; muscle pain in his back; a little scared.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 29May2021 (Batch/Lot Number: FW0187) as 1st dose, single for COVID-19 immunization. No medical history and concomitant medication were reported. The patient experienced the following symptoms: weakness on 29May2021, pain around the kidney on 29May2021, muscle pain in his back in 2021, sweating on 29May2021, shaking on 29May2021, rash around the body on 30May2021/rash all around body was reported as worsened and sore throat on 30May2021/sore throat was reported as worsened, a little scared in 2021, pain around back on 29May2021. Clinical course: A couple hours after the first vaccination, he started to feel weakness and pain around his kidney and back part. Also, some symptoms that are very common. He felt sweating and shaking and stuff like that. That night he noticed he started to have a rash all around his body and day by day it has been getting worse. On 01Jun2021, he went to the hospital emergency room and they gave him some medicine. He received a shot of diphenhydramine hydrochloride (BENADRYL) in the hospital. They also gave him an IV to flush out his body. Then the doctor gave him three prescriptions. He was released from the emergency room yesterday as well. 1. Aluminium hydroxide gel, dried, magnesium carbonate (PEPCID) 20 mg Expiration- Nov2022 in a pharmacy bottle, No lot number; 2. diphenhydramine hydrochloride (generic one) 25mg Expiration- Nov2023 in a pharmacy bottle, no Lot number; 3. Methylprednisolone tablet 4mg (NDC: 68001-005-01; Lot number: 20P0432, Brand: Bluepoint). Dose details: 6 days- First day to take 6 together, second day to take 5 together, fourth day to take 4 and so on for 6 days. So far, he has just taken the first dose which is 6 together. When he woke up today, he noticed that his rash was even worse. He didn't know how far the rash will go. The rash was like a burn and watery. The rash was all around his body. It started on his head; under his head and all around his face, then stomach, back and legs. His primary doctor and the emergency doctor suggested for him to not get the second dose because the second dose of BNT162B2 was going to have a stronger reaction. Some event details described as follows: weakness: Experienced 5 hours after receiving the shot. Considering how it has worsened his daily activities, from zero to 10, was like a 4. Pain around kidney: Like a muscle pain around kidneys that started about 8-10 hours after the shot. That pain came and went. It's not that much pain but still with him. Zero to 10 is like a 4 or 5 on pain level. Pain around back: pain was like a muscle pain. He experienced this 10 hour after vaccine. The pain has sort of improved. It was almost resolved. Sweating: He experienced on first night. 12 hours after. It came and went, but still ongoing. It was not that much, but still he still had it. Shaking: He experienced this on same night as the sweating. 12 hours after. It was almost recovered. It has happened one or two times over the past two days. Rash all around body: He noticed this a day after his shot. It was a couple of them around his body. It started from his head and spread all around body, but it was not that much at first. Day by day it has been getting worse and today is the worst day so far. The emergency room doctor checked his kidneys just in case. They told him everything was fine with the kidneys. It seems like it is a problem with the muscle. Also, he had a sore throat. It started 3 days ago. When he drinks or eat something, he felt burning. He noticed it the first time at nighttime. The emergency room doctor is assuming he had a vaccine reaction. Reporter seriousness for events weakness, pain around kidney, pain around back, sweating, shaking, rash all around body and sore throat was provided as unspecified. The outcome of event muscle pain in his back and a little scared was unknown; of event shaking and pain around back was recovering; of rest events was not recovered.
51 2021-06-17 numbness, tremor, muscle twitching He also reports his right leg and foot started swelling; He also reports his right leg and foot star... Read more
He also reports his right leg and foot started swelling; He also reports his right leg and foot started swelling; Sweating; feels weird; Shaking; Later that day he states his left arm (injection arm) started twitching; he vomited; and his left pinky and ring fingers were numb; right leg blew up; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0181), via an unspecified route of administration in left arm on 28May2021 as single dose for covid-19 immunization. The patient's medical history included alcohol use stated that all he does was drink some liquor and beer. No medications or surgeries. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient stated that after he received his first Pfizer COVID-19 vaccine dose on 28May2021, later that day he states his left arm (injection arm) started twitching, he vomited, and his left pinky and ring fingers were numb, and the patient felt nervous like he was shaking. On 14Jun2021, the patient also stated that he got the shot and the band aid that they cover the injection area with, it was branded in his arm and he got the shot 3 weeks ago and it looks like a band aid is on his arm. He thought it would be gone and it stayed. On an unknown date, the patient reported that his right leg and foot started swelling. The patient's right leg blew up. He reports the band aid to his injection site looks like it "burned" into his arm. He states his right/foot leg swelling and left arm twitching have continued and wants to know if this is a reported side effect. Now after he got the shot his arm has been twitching, he's sweating and vomiting all morning. His right leg blew up and he feels weird. He just doesn't feel like himself. Right after the shot, the patient felt like there's a bunch of fluid. It's ongoing, it has gone down a little bit. It's improved a little, very irritating when it does happen. He can't eat. It won't stay in his stomach and he can't hold water. It has improved but when it happens, he feels terrible. There was no emergency or physician room visit for the events. The clinical outcome for the events was unknown, the other events muscle twitching, and shaking was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
51 2021-06-18 pain in extremity Slight malaise went getting ready for bed at 11pm Ache in legs Woke at 12:50am with the worse case o... Read more
Slight malaise went getting ready for bed at 11pm Ache in legs Woke at 12:50am with the worse case of the chills I can remember. Room was 75F, I went into another room to get a blanket. Woke at 3:00am with slightly less chills; took my temperature, it was 100F (digital thermometer runs a little cool on me, normal is ~98F) Felt better by 10am (fever gone)
51 2021-06-21 bell's palsy PATIENT STATES THAT ABOUT 20 DAYS AFTER GETTING HIS FIRST COVID VACCINE HE WAS DIAGNOSED WITH AND TR... Read more
PATIENT STATES THAT ABOUT 20 DAYS AFTER GETTING HIS FIRST COVID VACCINE HE WAS DIAGNOSED WITH AND TREATED FOR BELLS PALSY
51 2021-06-21 tingling, numbness, pain in extremity Started out with back pain and within 6 weeks was in a wheelchair unable to move my legs, pain, musc... Read more
Started out with back pain and within 6 weeks was in a wheelchair unable to move my legs, pain, muscle weakness, numbness, pain and tingling in fingers and toes.
51 2021-06-22 burning sensation Within an hour or two of receiving my second shot, I noticed a burning sensation along my shoulders.... Read more
Within an hour or two of receiving my second shot, I noticed a burning sensation along my shoulders. A day or two later, there was a rash on both my forearms. This rash is till there and persists, despite taking Benadryl or anti-histamine cream.
51 2021-06-22 feeling cold Have been experiencing a strong coldness in my feet,hands, head and penis since receiving the second... Read more
Have been experiencing a strong coldness in my feet,hands, head and penis since receiving the second vaccine
51 2021-06-23 tingling, numbness and pain in extremities, burning sensation Three weeks after receiving the second dose of the Pfizer/BioNTech COVID19 vaccine, I started to exp... Read more
Three weeks after receiving the second dose of the Pfizer/BioNTech COVID19 vaccine, I started to experience a marked increase in neuropathy symptoms including burning, parasthesias, fasciculation and pins and needles. I have a pre-existing peripheral neuropathy, but it had been stable prior to vaccination for a number of years. The flare up in symptoms was the worst of the 27 years that I have had the neuropathy and continues unabated to this day (roughly four months later). I do not know if this increase in symptoms is permanent or not at this stage.
51 2021-06-24 burning sensation his hands and feet and legs were just itching and burning all day almost; little pain; his hands and... Read more
his hands and feet and legs were just itching and burning all day almost; little pain; his hands and feet and legs were just itching and burning all day almost; little pain; his hands and feet and legs were just itching and burning all day almost; little pain; his hands and feet and legs were just itching and burning all day almost; little pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 51-years-old male patient received bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration, administered in Arm Left on 05Jun2021 09:41 (Batch/Lot Number: ER8731) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation (51-years-old at the time of vaccination). The patient medical history was not reported. Concomitant medication included ubidecarenone (COQ-10) taken for an unspecified indication. Patient had no prior vaccination. No family history of itchy hands and legs. The patient previously took first dose of BNT162B2 on 15May2021 (Age-51-year-old) (Batch/Lot Number: ER8733) for covid-19 immunisation with no reaction (No events reported). Consumer stated, he had second shot Pfizer Covid vaccine on 05Jun2021 and when he woke up that morning his hands and feet and legs were just itching and burning all day almost in jun2021 (About two days, 14Jun2021 (not clarified)).Consumer was informed about Pfizer Medical Information department. Patient did not receive any treatment for the events. The clinical outcome of the events was not recovered. Information on lot/batch number was available. Additional information has been requested.
51 2021-06-27 discomfort After both the 1st & 2nd dose my lower back was extremely stiff and panful. For the week after each... Read more
After both the 1st & 2nd dose my lower back was extremely stiff and panful. For the week after each dose it was very painful to bend or in general move at the waste, activities like sitting down, standing up, getting in/out of bed were quite uncomfortable. The pain gradually declined over the week but my lower back remains a bit stiff and sore. Prior to the vaccinations I never had any similar issues with my back.
51 2021-06-29 numbness left face numbness; moderate pain up the left side of neck 8 hours after injection,; This is a spont... Read more
left face numbness; moderate pain up the left side of neck 8 hours after injection,; This is a spontaneous report received from a contactable consumer, the patient. A 51-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via unspecified route of administration on right arm on 18Mar2021 at 09:45 (at the age of 51 year) as a single dose for COVID-19 immunisation. Past medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Concomitant medication included olmesartan (MANUFACTURER UNKNOWN) from an unspecified date for an unknown indication and CENTRUM MEN 50+ MULTIVITAMIN from an unspecified date for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 at 17:45 the patient experienced moderate pain up the left side of neck. On 18Mar2021 at 21:45 the patient experience face numbness. The patient visited doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit for the event occurred. No no treatment was taken in response to the event. It was reported that on the day of vaccination, the patient experienced moderate pain up the left side of neck, the patient took a nap and woke with left face numbness approximately 12 hours after the injection. the patient. The clinical outcome of the event neck pain and facial numbness was not recovered. No follow-up attempts are needed. No further information is expected
51 2021-06-29 pain in extremity Hands Hurt; Swollen Hands/Arms itching, swollen, and red; hives are under his chest, groin, and all ... Read more
Hands Hurt; Swollen Hands/Arms itching, swollen, and red; hives are under his chest, groin, and all over now, but not on his face; itching on his hands like crazy, like he wanted to take his skin off; Arms itching, swollen, and red; This is a spontaneous report from a contactable consumer. A 51-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number and expiry date was not reported) via an unspecified route of administration on 23Apr2021 as a single dose for covid-19 immunisation. Medical history included ongoing splenectomy which was continuing. The patient's concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection) on 02APR2021 for covid-19 immunisation. On 29Apr2021 20:00 patient experienced swollen hands with, hives are under his chest, groin, and all over now, but not on his face, itching on his hands like crazy, like he wanted to take his skin off, hands hurt, arms itching, swollen, and red, arms itching, swollen, and red, arms itching, swollen, and red. Therapeutic measures were taken(Benadryl three times a day) as a result of swollen hands, hives are under his chest, groin, and all over now, but not on his face, itching on his hands like crazy, like he wanted to take his skin off, hands hurt, arms itching, swollen, and red, arms itching, swollen, and red , arms itching, swollen, and red. Patient did not visited emergency room/physician office due to events. Outcome of the events was recovering. Information on the lot/batch number has been requested. Follow-up (21Jun2021): Follow-up attempts completed. No further information expected.
51 2021-06-30 weakness June 15 - Right side lower rear rib cage pain. June 17 - Lightheaded. June 20 - shortness of breat... Read more
June 15 - Right side lower rear rib cage pain. June 17 - Lightheaded. June 20 - shortness of breath and weakness. Symptoms progressively get worse and increase in intensity. June 26 - go to Emergency Room. CT scan with contrast revealed a blood clot in each lung of moderate size and several small clots. Diagnosis was pulmonary embolism. Put on Heparin and admitted to hospital. Administered Heparin for 2 and 1/2 days. Upon discharge (June 29) was prescribed Eliquis.
51 2021-06-30 burning sensation stinging sensation on my legs, also had similar sensations on my torso and back; pain; This is a spo... Read more
stinging sensation on my legs, also had similar sensations on my torso and back; pain; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727); via unspecified route of administration in the left arm on 20Mar2021 at 12:00(at the age 51-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no allergy to any medications, food, or other products. Concomitant medications included low dose of acetylsalicylic acid (ASPIRIN) and amitriptyline (MANUFACTURER UNKNOWN); both from unknown dates for unknown indications. The patient did not receive any other vaccine within four weeks of 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. On 21Mar2021 at 13:15, approximately 24 hours after the vaccination, the patient experienced stinging sensation on her legs. This had repeated the following two days as well, all at random times during the day, but not after he go to bed. he also had similar sensations on my torso and back. There had been no visible signs at all. The sensations last from 10-60 minutes. The pain is similar, but slightly less than a fire ant bite. 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 outcome of stinging sensation of legs, torso, back and pain was not recovered. No follow-up attempts are needed. No further information is expected.
51 2021-06-30 tingling, numbness After 2 weeks of getting second Pfizer covid-19 vaccine patient started having numbness and tingling... Read more
After 2 weeks of getting second Pfizer covid-19 vaccine patient started having numbness and tingling on the left side of his face, dizziness, and his existing tinnitus became worse.
51 2021-07-01 weakness, flushing Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemi... Read more
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Weakness-Severe, Additional Details: Fully recovered
51 2021-07-01 difficulty speaking, pain in extremity fever; sore arm in the location of the injection.; hoarse throat & raspyvoice; aches all over my bod... Read more
fever; sore arm in the location of the injection.; hoarse throat & raspyvoice; aches all over my body.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: ER2613) via an unspecified route of administration in the left arm on 20Mar2021 at 10:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and suspected COVID-19 on 22Dec2020. The patient was non-allergic to medication, food or other products. Concomitant medications included Flovent diskus of 250 microgram (mcg) and albuterol (MANUFACTURER UNKNOWN) both for an unknown indication from an unknown date. The patient had not received 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 had not tested for COVID-19. On 20Mar2021 at 19:00, the patient experienced sore arm in the location of the injection, very sore/aches all over body and fever/aches had lasted approximately up to 36 hours. The patient experienced hoarse throat raspy voice, which patient had assumed due to it. The patient had not received any treatment for the events. On an 22Dec2020, the patient had tested for COVID-19 which resulted in positive and on 21Mar2021, the patient had tested for body temperature which resulted in 100.3-degree Fahrenheit. 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 the events fever and general body pain were resolved with sequelae on 23Mar2021 at 07:00 whereas that of the events sore arm in the location of the injection, hoarse throat & raspy were resolved with sequelae on an unknown date. No follow-up attempts are possible; No further information is expected.
51 2021-07-01 pain in extremity I tried to think maybe I am infected with covid, see if I got it or; I got sourness in my arms.; I g... Read more
I tried to think maybe I am infected with covid, see if I got it or; I got sourness in my arms.; I got soreness and I am sick ever since; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 51-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0191), via an unspecified route of administration on 10Jun2021 (at the age of 51-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient included hypersensitivity from an unknown date and unknown if ongoing. The concomitant medications of the patient included paracetamol, pseudoephedrine hydrochloride, triprolidine hydrochloride (SUDAFED SINUS PAIN & ALLERGY RELIEF) taken for hypersensitivity, start and stop date were not reported, dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL) taken for an unspecified indication, start and stop date were not reported and mesna (MESNEX) taken for an unspecified indication, start and stop date were not reported. It was reported that patient had been taking some allergy medicines (unspecified medication), It never worked it never working, he was taking over the counter cold medicines like Sudafed, NyQuil, mesnex and he took two pills every four hours, 10 mg (unspecified pills) he donot know it was confusing. On 13Jun2021 the patient reported i tried to think maybe i am infected with covid, see if i got it or, i got sourness in my arms, i got soreness and i am sick ever since and just have been taking some allergy medicines. The patient stated he donot know what the shot did to him but he was sick that he wanted to report what kind of medical guidance can he get, do his event and asked to inform him if is there anything else he can visit to hospital. Therapeutic measures were taken as a result of AE. The outcome of the events was reported as unknown. Follow up attempts are needed; Additional information has been requested.
51 2021-07-03 pain in extremity, sciatica Sciatica, severe pain down right leg, unable to sleep/walk normally for several weeks
51 2021-07-05 tingling, muscle spasms Within an hour of the second dose, I was so tired that I fell asleep and slept over 24 hours. When ... Read more
Within an hour of the second dose, I was so tired that I fell asleep and slept over 24 hours. When I awoke, I had soreness in my muscles and cramps. The cramps migrated to my chest area and I have had severe chest pains, soreness in the back of my neck on the left side and in my left chest with occasional tingling in my right arm. The pains have slowly subsided and went away for about 5 days and returned fiercely last Friday in the middle of the night. It hurt so bad I couldn't sleep, so I took an Advil and after 30-45 minutes, the pain subsided. When the Advil wore off, the pains returned, so I attempted to contact a walk in clinic, they referred me to an urgent care facility. The urgent care facility took my vitals, asked about my symptoms and then hooked me up to an EKG. They told me I have an abnormal T-wave and sent me to the emergency room. The emergency room triaged me, took blood samples, reviewed my EKG and took chest X-rays. After several hours, they ruled out heart conditions and sent me home with a prescription for heartburn medicine. I do not have heartburn, I have symptoms that mirror Myocarditis/Pericarditis.
51 2021-07-06 weakness, night sweats weakness, body aches, headaches, increased BPs (checked by wife at home), chills, sweats at night, y... Read more
weakness, body aches, headaches, increased BPs (checked by wife at home), chills, sweats at night, yellowing of eyes, nausea, intermittent cough
51 2021-07-08 pain in extremity, weakness sore left arm; severe itch whole body; headache; slightly elevated temperature; low energy; This is ... Read more
sore left arm; severe itch whole body; headache; slightly elevated temperature; low energy; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK5730), via an unspecified route of administration in the left arm on 24Mar2021 at 09:45 (at the age of 51-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: EJ1685), via an unspecified route in the left arm on 03Mar2021, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 20:00, the patient experienced sore left arm, severe itch whole body, headache, slightly elevated temperature, and low energy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient took ibuprofen as a treatment for the reported events. The clinical outcomes of the events sore left arm, severe itch whole body, headache, slightly elevated temperature, and low energy were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
51 2021-07-09 feeling of body temperature change Took shot early that morning and by 9:30-9:45pm the same day, very tired , exhausted. Went to bed an... Read more
Took shot early that morning and by 9:30-9:45pm the same day, very tired , exhausted. Went to bed and fell asleep . Woke up in 1/2hr with: Fever , chills , hot /cold, body aches , head aches
51 2021-07-10 tingling right hand finger tingling; Headache, Right sided.; body muscle aches; overall feeling of being sick... Read more
right hand finger tingling; Headache, Right sided.; body muscle aches; overall feeling of being sick; This is a spontaneous report from a contactable other healthcare professional. A 52-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Right on 25Feb2021 09:00 am (at the age of 51-year-old) as dose 2, single for covid-19 immunisation. Medical history included high cholesterol, heart disease, diabetes from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported; carvedilol (COREG) taken for an unspecified indication, start and stop date were not reported; olmesartan medoxomil (BENICAR) taken for an unspecified indication, start and stop date were not reported. The patient had no allergies to medications, food, or other products. 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 Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Right on 04Feb2021 09:00 am (at the age of 51-year-old) as dose 1, single for covid-19 immunisation. On 25Feb2021 16:00, the patient experienced right hand finger tingling, headache, right sided, body muscle aches, overall feeling of being sick. No treatment was taken as a result of events. The outcome of the events were recovered on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.
51 2021-07-12 pain in extremity Excruciating pain in both souls of my feet Especially in my heels.
51 2021-07-12 tingling Body stiffness to the point where other people have noticed it. Knee pain. Sleep disturbance problem... Read more
Body stiffness to the point where other people have noticed it. Knee pain. Sleep disturbance problems. Tingling sensation on my back. I will be seeing a doctor soon regarding these issues.
51 2021-07-13 tingling, tremor Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Medium, Systemic: Shakiness-Medium,... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient compained of shakiness immediately after receiving immunization. Had patient sit for 10 minutes. CHecked blood pressure and was elevated (156/80) and patient reports usual BP around 110/80. Had patient sit for awhile longer and symptoms continued to worsen. After another 15 minutes BP was up to 158/84 with a pulse of 98. Adminstered benadryl 25mg and had patient sit for additional 20 minutes. No change in blood pressure and pateint continued to have shakiness, but no worsening symptoms.
51 2021-07-14 feeling hot 5 minutes after the shot, dizziness, sweating underarms, hot, nausea. Rested for 30 minutes at the ... Read more
5 minutes after the shot, dizziness, sweating underarms, hot, nausea. Rested for 30 minutes at the pharmacy. 4 hours later. 9:30 PM. Fatigue EXTREME, dizziness when turning head quickly.
51 2021-07-15 muscle spasms Shortly after receiving the second Pfizer shot I developed extremely severe spasms and cramping thro... Read more
Shortly after receiving the second Pfizer shot I developed extremely severe spasms and cramping throughout my chest and back. The pain level is profound and unrelenting and has not changed in two months. Pain free time is rare, 50% of every day is spent trying to survive the pain, but I am frequently at the hospital. I cannot eat or sleep or work and dropping weight dangerously fast. I am completely incapacitated and now have a caretaker
51 2021-07-17 numbness, tingling numbness and tingling on left side of face, around left eye, forehead, skull, and left cheek/ear.; n... Read more
numbness and tingling on left side of face, around left eye, forehead, skull, and left cheek/ear.; numbness and tingling on left side of face, around left eye; numbness and tingling on left side of face, around left eye, forehead, skull, and left cheek/ear.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 30Mar2021 at 08:55(at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as no chronic illness. The patient did not take any concomitant medications. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have 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. On 30Mar2021 at 9:00, the patient experienced numbness and tingling on left side of face, around left eye, forehead, skull, and left cheek/ear. Within about 10 minutes of symptom onset, intensity subsided, but still felt lingering slight numbness. The patient had no dizziness and balance was fine. The patient still felt slight/lasting numbness in affected area at the time of this report(11:15).On 30Mar2021, the blood pressure and oxygen saturation was reported as normal. The patient did not receive treatment for the reported events. 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 numbness in face, eye numbness and tingling was recovered with sequelae at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
51 2021-07-17 numbness, sensory loss I lost the feeling in my left finger tip all 4 fingers except the thumb went numb; I lost sensation ... Read more
I lost the feeling in my left finger tip all 4 fingers except the thumb went numb; I lost sensation in my right hand and my right arm is very very weak and it really started getting scary; my right arm is very very weak; He noticed visible blanching in my fingers; my pulse is extremely weak on my right side; Treatment for the rashes; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0178, expiration date: unknown), via intramuscular, administered in left arm on 26May2021 13:30 (at the age of 51-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown, expiration date: unknown) on an unspecified date. The patient's medical history includes hypertension and Lyme disease. Concomitant medications include BENAZEPRIL HYDROCHLORIDE 10 mg once daily and AMLODIPINE BESILATE 5mg once daily, both for hypertension and unspecified antidepressants. No other vaccines prior to 4 weeks. On 28May2021, 1 day 10 hours after the vaccination, the patient experienced loss of feeling in left fingertip, all 4 fingers except the thumb went numb, later, on an unknown date, patient experienced loss of sensation in right hand and right arm is very weak, patient's doctor noticed visible blanching in fingers, extremely weak pulse on right side and rashes. Patient visited her doctor and his doctor marked it as adverse COVID 19 vaccine reaction and patient was waiting for the specialist to watch in. The outcome of the events was not recovered. No follow-up attempts are possible. No further information was expected.
51 2021-07-17 numbness, speech disorder I can't speak or eat; I can't speak or eat; his whole entire face went numb; he had a viral infectio... Read more
I can't speak or eat; I can't speak or eat; his whole entire face went numb; he had a viral infection in the nerve ; 7th nerve; Ear ache; he had a viral infection in the nerve ; 7th nerve; This is spontaneous report from a Pfizer sponsored program. A contactable 51-year-old male consumer reported for himself. A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8729), via an unspecified route of administration on 20Apr2021 (at the age of 51-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included type 2 diabetes mellitus. Concomitant medication(s) included dapagliflozin propanediol monohydrate (FORXIGA) 10 mg taken for type 2 diabetes. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8727), via an unspecified route of administration on 30Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient reported that he had ear ache on 23Apr2021. He went to his ear and throat specialist. He got an MRI done and his whole entire face went numb. It turned out he had a viral infection in the nerve (7 th nerve) and he just wanted to report this. He also stated that his whole face is grooving numb, and he cannot speak or eat. When asked about the treatment, consumer stated, he was currently not taking because any medication cause glucose level increase. Caller also stated that he received the second Pfizer vaccine on 20Apr2021, and he would like some financial assistance with medical issues due to facial numbness as a reaction. Reporter seriousness for I can't speak or eat was unspecified. The patient underwent lab tests and procedures which included magnetic resonance imaging: viral problem (viral something like that in my seventh nerve) on 06May2021. The outcome of ear ache and had a viral infection in the nerve: 7th nerve was not recovered, for I cannot speak or eat outcome was unknown and for Hypoaesthesia outcome was unknown. No follow-up attempts are possible. No further information is expected.
51 2021-07-17 pain in extremity, muscle spasms This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient re... Read more
This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8733) via an unspecified route of administration in the left arm in Mar2021 at 13:30 (at the age of 51-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 6206) via an unspecified route of administration in the left arm on 29Mar2021 (at the age of 51-years-old) as single doses for COVID-19 immunisation. Medical history included asthma. The patient did not have any allergies to food, medications, or other products. The patient did not receive any concomitant medications. 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 13Mar2021 at 09:00, about week after the first dose, the patient had cramping and a lot pain up and down the legs. For example, when the patient sat, it was hard to stand and legs were almost petrified. When the patient walked it was sore and painful. This lasted for about 4 to 5 days. After the second dose, the morning after it started again and was actually worst than previous time. The adverse events did not result in a visit to the 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 cramp legs, leg pain, difficulty in standing and difficulty in walking. The clinical outcomes of the events cramp legs, leg pain, difficulty in standing and difficulty in walking were unknown at the time of the report. No follow-up attempts are needed. No further information is expected.
51 2021-07-17 pain in extremity Sore arm; Headache; Tiredness; This is a spontaneous report received from a contactable consumer, th... Read more
Sore arm; Headache; Tiredness; This is a spontaneous report received from a contactable consumer, the patient. A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: unknown) via an unspecified route of administration in the right arm on 19Mar2021 at 09:30 (at the age of 51 years) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021, at 15:00 hours, the patient experienced events sore arm, headache and tiredness. The patient did not receive any treatment for the events. 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 events sore arm, headache and tiredness were recovering at the time of reporting. No follow-up attempts are needed; Information about lot/batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: Age and age at vaccination updated from 52 years to 51 years per DOB and event onset time. Final sentence updated as no follow-up attempts are needed; Information about lot/batch number cannot be obtained.
51 2021-07-17 pain in extremity Intense Headache; Mild Nausea; Pain in Arm; This is a spontaneous report from a contactable consumer... Read more
Intense Headache; Mild Nausea; Pain in Arm; This is a spontaneous report from a contactable consumer, the patient. A 51-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6204), via an unspecified route of administration in the left arm on 09Mar2021 at 10:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to guaifenesin (MANUFACTURER UNKNOWN) and BENEDRYL. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included lansoprazole (PREVACID 30 mg), cetirizine hydrochloride (ZYRTEC) 10 mg and fluticasone propionate (FOLNASE) spray received on unspecified dates for an unknown indication. On 09Mar2021 at 17:45, the patient experienced, mild nausea, pain in arm and intense headache while driving home from office. The headache on left side to left temple was painful, different type of pain which was consistent, pain emitted from the inside out and lasted for more than six hours. The patient did not receive any treatment for the events. The clinical outcome of the events intense headache was resolved on 09Mar2021, however mild nausea and pain in arm were resolved on unspecified date in Mar2021. No follow-up attempts are needed. No further information is expected.
51 2021-07-18 weakness, muscle spasms Two days of severe body aches, chills, mild fever. Five additional days of severe leg cramps, loss o... Read more
Two days of severe body aches, chills, mild fever. Five additional days of severe leg cramps, loss of strength, headaches, disorientation, extreme fatigue.
51 2021-07-18 numbness, tingling, feeling hot At 6:03 PM, Client stated that he felt a warm feeling in both feet. He stated that numbness and ti... Read more
At 6:03 PM, Client stated that he felt a warm feeling in both feet. He stated that numbness and tingling he had in his feet was not new. Reported that this is a S/E from the medication Mitazopine that he takes at night. Client stated that his feet feel better after he removed his socks and lifted up his feet. Client instructed to go to ER if he felt worse. He said he would if the symptoms of warming feeling returned.
51 2021-07-18 numbness Since the second shot of the vaccine I have been experiencing numbness in my feet and hands like the... Read more
Since the second shot of the vaccine I have been experiencing numbness in my feet and hands like they are falling asleep. Also thought it was weird that everybody complained about getting a little sick after the second shot and with me I did not get any side affects. Of course arm hurt where the shot was but only for a few hours. Other then that no side effects except for the feet and hand thing which might not even be related to the vaccine. Just thought I would let you know just in case others have had the same thing happen. Thanks
51 2021-07-19 night sweats Night/sleep sweats; Fever; headache; This is a spontaneous report from a contactable consumer, the p... Read more
Night/sleep sweats; Fever; headache; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male 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 (also reported as left shoulder) on 28Mar2021 at 15:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not have any allergies to food, medications, or other products. The patient did not receive any concomitant medications. Prior to the 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 prior to the vaccination. On 30Mar2021 at 09:00, within 48 hours of the vaccine, the patient experienced fever that went away on 31Mar2021 (reported as next day). The patient also experienced night/sleep sweats and headache within the 48 hours which were still present. The adverse events did not result in a visit to the 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 fever, night/sleep sweats and headache. The clinical outcome of the event fever was resolved on 31Mar2021 while that of night/sleep sweats and headache was not resolved at the time of the report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
51 2021-07-21 facial pain, migraine, hypersensitivity of all senses Left eye/cheek/ear/jaw/forehead pain began evening of May 5th; progressively worsened and became mor... Read more
Left eye/cheek/ear/jaw/forehead pain began evening of May 5th; progressively worsened and became more frequent; May 19 started 7-day course of antibiotics prescribed by dentist to rule out sinus infection; at that point, pain behind left eye was 24hrs/day, 7 days a week; saw ENT May 26 who ruled out sinus infection and ordered CT scan of head and prescribed 5 day course of prednisone (seemed to have little/no effect on left eye pain); before CT scan could be scheduled, noticed left pupil significantly contracted; saw ophthalmologist urgently June 3rd, who instructed me to go immediately to ER for suspected Horner Syndrome; admitted to hospital and underwent several CT and MRI scans to rule out tumor/carotid artery dissection/etc. for cause of pressure on trigeminal nerve--none were found; all parasitic lab tests returned negative; during hospital stay continued to have pain in left eye and left side of face, migraines, and left scalp and chest sensitive to touch, migraines; migraine medication would ease migraine pain, but had no effect on pain and symptoms on left side of face and head; ultimate diagnosis: neurologist and other attending physicians unsure, with best guess partial Horner Syndrome/Raeder Syndrome combined with migraines/cluster headaches, with no apparent cause discernible.
51 2021-07-21 muscle twitching, pain in extremity Site: Pain at Injection Site-Severe, Systemic: eye twitching-Severe, Additional Details: injection s... Read more
Site: Pain at Injection Site-Severe, Systemic: eye twitching-Severe, Additional Details: injection site pain started day of vaccination (4/20/21) and continued to increase in severity over the next 7 days. patient is experiencing chronic arm pain and decreased range of motion (can not reach at all behind in and can only raise arm 3/4 of the way in front of him). also experiencing severe eye twitching that is affecting vision
51 2021-07-22 migraine, pain in extremity left eye has blurry vision; A very large floater in the middle of the eye.; Throbbing migraine; Arm ... Read more
left eye has blurry vision; A very large floater in the middle of the eye.; Throbbing migraine; Arm soreness; This is a spontaneous report from a contactable other healthcare professional, the patient. A 51-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via an unspecified route of administration in the left arm on 29Mar2021 at 10:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included a heart attack 11 years ago due to Kawasaki virus. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication. The patient previously received aspirin-based products and experienced sensitivity (but not bad as reported). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the left arm on 08Mar2021 at 13:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID -19 vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021, the patient experienced throbbing migraine and arm soreness a day after he received the vaccine. On 31Mar2021 at 06:00, the patient experienced blurry vision in left eye and a very large floater in the middle of his eye, two days after he received the vaccine. The events resulted in a doctor or other health care professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the event throbbing migraine, arm soreness, floaters in eye and blurry vision was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
51 2021-07-22 speech disorder, difficulty speaking sweaty hands and feet/his hands and feet were sweating and really clammy; tingling in tongue; brain ... Read more
sweaty hands and feet/his hands and feet were sweating and really clammy; tingling in tongue; brain fog for two months; losing weight/States he was 220 pounds. States not he is around 160-170 pounds; Was walking 5-10 miles a day, has not been; Caller states the she feels her husband is handicapped from this; now introverted where previously he was the life of the party; he's not speaking much; The patient states he feels like he's dying on the inside/She says some doctors say he is depressed but he has never had any kind of mental health disorders; Says his mentality is not right; Abdominal Pain; Says his voice went from being vibrant to low and monotone; flat affect; irregular bowel movements; double vision; Caller says her husband has a small appetite, but he had always previously been an avid eater; This is a spontaneous report from a contactable nurse (patient's wife) and consumer (patient's sister). A 51-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 19Feb2021 (Batch/Lot Number: EQ3249) and dose 1 administered in Arm Right on 29Jan2021 (Batch/Lot Number: E19263) as single dose for covid-19 immunisation at the age of 51-year-old. Medical history included ongoing type 2 diabetes mellitus which was diagnosed 2-3 years ago, the patient was not on insulin or anything, unspecified Allergy, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, obesity. There were no concomitant medications. The patient experienced losing weight in Feb2021, flat affect in 2021, sweaty hands and feet on 20Feb2021, tingling in tongue in Feb2021, brain fog for two months in Feb2021, irregular bowel movements in 2021, double vision in 2021, small appetite in 2021, was walking 5-10 miles a day, has not been in Feb2021, handicapped from this in 2021, now introverted where previously he was the life of the party in 2021, not speaking much in 2021, feels like he's dying on the inside/she says some doctors say he is depressed but he has never had any kind of mental health disorders in 2021, his mentality is not right in 2021, abdominal pain in 2021, his voice went from being vibrant to low and monotone in 2021.The patient was hospitalized from 07May2021 to 09May2021.The patient underwent lab tests and procedures in 2021 which included colonoscopy: normal, computerised tomogram: normal, echocardiogram: normal, endoscopy gastrointestinal: normal, magnetic resonance imaging: normal, weight: 160-170 pounds, blood test: normal. The outcome of the events was not resolved. The nurse reported that her husband received his second dose of the Pfizer BioNtech covid 19 vaccine on 19Feb2021. The next day he woke up with the following symptoms: sweaty hands and feet, tingling in tongue, brain fog for 2 months, irregular bowel movements, double vision, and flat affect. The nurse reports he was now introverted where previously he was the life of the party, he's not speaking much, not doing things he previously enjoyed such as previously doing yard work, driving, and walking 5-10 miles every morning. He is losing weight without trying 220 lbs to 160-170 lbs now. The nurse reported they have been in and out of the emergency room and sought medical care from many different people including a psychiatrist. The nurse reported they have had labs and bloodwork drawn that all resulted normal. The patient states he feels like he's dying on the inside. The nurse was seeking treatment recommendations as one doctor suggested that these reported symptoms could be caused from the Pfizer BioNtech covid 19 vaccines. He has been losing weight and his affect and demeanor are different since he got the second vaccine. They have been to every doctor and specialists. His blood work is perfect, and they cannot find out what is wrong with him. The nurse says that her husband was happy and jovial. he was 220 pounds and now is around 160-170 pounds. his mentality is not right; he has no affect. he used to be cutting grass and gardening. Now he is not speaking to family and friends; he is not even speaking to her as much. no one knows what is wrong. The nurse states that several doctors believe it to be from the vaccine because nothing happened until after the second dose of the vaccine. The nurse is uncertain about this. He has lost weight quickly. On 20Feb2021: He woke up and his hands and feet were sweating and really clammy. States she could touch them and feel the moisture. He went to the (privacy) and they gave him a roll-on for his hands. The following week he kept saying that his tongue was tingling; like as if he had bit it. He started seeing the dentist about it and they prescribed medications. A week after the tongue tingling he started experiencing brain fog. She states this brain fog lasted for 2 months. Along with the brain fog, he started to lose weight and complain of intense abdominal discomfort, Abdominal pain. He said that his bowel movements were not regular. He went to a gastroenterologist and they did a colonoscopy and EGD and found nothing on these tests. He kept the gastrointestinal issues for a long time. he has been wearing glasses because he is nearsighted. After the vaccine he complained of double vision. He saw his optometrist who said everything was fine. He has been in and out of the emergency room. Everyone says that he is fine. All of his labs are within normal limits; blood work, urine tests, and stool. He is steadily losing weight; he was 220 pounds, now he is 160-170 pounds. He was bright and affectionate. And he loves the outdoors and would walk 5-10 miles a day. But he has not been walking since Feb2021. He has a small appetite, but he had always previously been an avid eater. He was admitted into the hospital around 07May2021-09May2021. She had to push for that admission. her husband would wake up every morning saying he felt like he was about to die. she has been taking him to the emergency room about twice a week since February. While hospitalized he had CT Scans, MRI, Echocardiogram, and nothing was found on these tests. she feels her husband is handicapped from this. Their daughter is getting married, they are about to be grandparents, and her husband's affect is just flat. She says some doctors say he is depressed but he has never had any kind of mental health disorders. she has not seen her husband smile since February or March. his voice went from being vibrant to low and monotone. Patient's sister reported Her brother was fine, he had the first one then he got the second one and after the second one he is now having these foggy brain, mental kind of stuff happen. He got it in February and it started right there after, this is still going on and she wants to know how long it may last. No follow-up attempts are needed. No further information expected.; Sender's Comments: Based on close temporal association there is reasonable possibility of causal association between the reported serious events and the suspect drug Comirnaty. 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
51 2021-07-23 migraine On the next day I experienced a very severe migraine headache with nausea and vomiting. I had to thr... Read more
On the next day I experienced a very severe migraine headache with nausea and vomiting. I had to throw up almost every 30 minutes. After calling urgent care, I was advised to visit the nearest emergency room where I was given an IV with pain and anti-nausea medication.
51 2021-07-24 nerve pain Expected symptoms ended within about 24 hours from the shot. But 48 hours after the shot there was m... Read more
Expected symptoms ended within about 24 hours from the shot. But 48 hours after the shot there was massive nerve pain in the (left) shoulder of the shot, the pain radiated throughout deltoid, chest, shoulder, neck on the left side. This nerve pain lasted for about 36 hours and then dissipated (I know it was nerve pain because years ago i experienced something similar in the other shoulder for unrelated reasons). But the shoulder was very sore and weak for 2 full weeks, during which i saw an orthopedist who diagnosed bursitis caused by SIRVA. For weeks afterwards the shoulder felt like it returned to normal . However in the first 2 weeks of June my whole left arm began getting sore and tired. In midjune i noticed that my shoulder was atrophying and the front deltoid was not activating (my biceps was doing all the work). Orthopedist ordered an EMG (June 29), which confirmed axillary nerve damage to anterior deltoid. I?ve been doing physical therapy since mid June and as of today July 25th it is beginning to recover but it could take months to a year and may never fully recover.
51 2021-07-26 pain in extremity Herpes zoster-appearing skin rash localized to deltoid area on opposite arm (vaccination in left arm... Read more
Herpes zoster-appearing skin rash localized to deltoid area on opposite arm (vaccination in left arm, skin rash on right arm in same dermatome). Symptoms included itch and mild localized pain with no apparent systemic symptoms. Rash was a cluster of 4-5 elevated erythematous 1mm lesions with mild surrounding erythema. Lesions blistered during the course of a few days. After almost 4 weeks post-injection the blisters slowly resolved, leaving a red mark at each site.
51 2021-07-27 numbness Numbness to thumb and index finger and arm
51 2021-07-27 tingling chills; tiredness; joint aches; left side of face tingle; This is a spontaneous report from a contac... Read more
chills; tiredness; joint aches; left side of face tingle; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 01Apr2021 at 16:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had intermittent shellfish allergies and only certain shellfish trigger allergic reactions but it's very rare. Concomitant medications included famotidine (MANUFACTURER UNKNOWN) 20 mg taken once daily from an unknown date for an unknown indication. 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. On 02Apr2021 at 10:00 the patient experienced chills, tiredness, joint aches and left side of face tingle. The events did not result in doctor or other health care professional office/clinic visits, and the emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events chills, tiredness, joint aches and left side of face tingle were recovered on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.
51 2021-07-29 feeling hot, feeling of body temperature change Threw up; started chilling; Started burning up late in night or early morning on 5/4.; Hot and cold ... Read more
Threw up; started chilling; Started burning up late in night or early morning on 5/4.; Hot and cold through out the morning; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 03May2021 at 11:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included covid-19 on an unspecified date. Concomitant medications included ramipril (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 12Apr2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 the patient experienced started burning up late in night or early morning. On the same day around 06:45 started chilling and on the same day around 09:15 threw up. On the same day hot and cold through-out the morning. The clinical outcome of the events feeling hot, chills, vomiting, feeling hot and cold was not recovered. No follow-up attempts are needed. No further information is expected.
52 2021-01-03 tremor, weakness Patient experienced shaking, nausea, vomiting, and diarrhea beginning the night of the immunization ... Read more
Patient experienced shaking, nausea, vomiting, and diarrhea beginning the night of the immunization (12.17.20). Patient had "extreme" fatigue and weakness for 2 weeks. Went to urgent care on 12.28.2020, no medications or treatment given. Resolved as of 1.4.21 with continued "slight" weakness. Patient also reports to have lost a considerable amount of weight.
52 2021-01-04 pain in extremity DEVELOPED PAIN IN ARM AND NAUSEA
52 2021-01-05 muscle spasms Moderate ankle pain left x 1.5 days Hamstring cramping moderate x 1 day Fatigue - moderate x 1 day
52 2021-01-05 pain in extremity Long bone aching pain, involving bilateral humeral bones and left femur. Pain began on day two and... Read more
Long bone aching pain, involving bilateral humeral bones and left femur. Pain began on day two and resolved on day five. I required two doses of ibuprofen to sleep on days three and four.
52 2021-01-06 discomfort Swollen under left armpit that irradiates to my arm, L+ right side of my chest and L+ neck side. It ... Read more
Swollen under left armpit that irradiates to my arm, L+ right side of my chest and L+ neck side. It caused pain and discomfort since last night.
52 2021-01-06 facial paralysis Patient developed Bell's Palsy on 1/1/2021 and was seen in the Emergency department and started on o... Read more
Patient developed Bell's Palsy on 1/1/2021 and was seen in the Emergency department and started on oral steroids. I saw him 1/6/2021 and he continued to have left sided facial nerve palsy/paralysis.
52 2021-01-06 facial paralysis Patient developed left side Bell's Palsy 8 days after receiving vaccine. He was seen in the Emergenc... Read more
Patient developed left side Bell's Palsy 8 days after receiving vaccine. He was seen in the Emergency Department and started on Prednisone
52 2021-01-06 numbness BlurredVision, UrticariaPruritus, numness face and tongue
52 2021-01-06 numbness Date and time of vaccination: 12/17/21 19:30 Age at vaccination 52Y 10M Adverse symptoms: - Visual m... Read more
Date and time of vaccination: 12/17/21 19:30 Age at vaccination 52Y 10M Adverse symptoms: - Visual migraines 12/19,12/20,12/21 with loss of vision/aura for about 30m-1h, mild headache followed. -numbness, intermittent in left ring and pinky finger 12/19,12/20,12/21
52 2021-01-07 discomfort Dizziness & HYPERtension Narrative: Patient reports light headedness, dizziness, "heavy" feeling to ... Read more
Dizziness & HYPERtension Narrative: Patient reports light headedness, dizziness, "heavy" feeling to monitoring staff. Patient given some water and monitored for 30 minutes by monitoring staff. BP 139/111 HR 75, recheck BP 141/99 HR 80 reported to this RN. Event reported to this RN at 1350, patient returned to workstation.
52 2021-01-07 difficulty speaking The Patient present Sore throat , cough ,hoarseness . the doctor gave him Benadryl 50 mg IM now
52 2021-01-07 muscle twitching Patient spoke to me this morning regarding some symptoms he had after his Pfizer COVID 19 vaccinatio... Read more
Patient spoke to me this morning regarding some symptoms he had after his Pfizer COVID 19 vaccination yesterday. He said he had some pain at the injection site and mild headache in the afternoon; however, around 12 to 1 am in the morning, he was feeling heart palpitation and he felt his muscle twitching from his upper torso which went down to his thigh and no loss of consciousness. He said he checked his heart rate and it was 70 and he did not have any problems breathing. He said his heart palpitation felt better after taking some deep breaths. He said he no longer had heart palpitations or muscle twitching any more. He denied any other symptoms. Generally, he appeared well, no facial drooping, awake, alert, oriented, speech clear, and normal gait. (Today)
52 2021-01-07 pain in extremity covid 19 test result came up positive; covid 19 test result came up positive; severe left arm pain; ... Read more
covid 19 test result came up positive; covid 19 test result came up positive; severe left arm pain; This is a spontaneous report from a contactable unspecified Healthcare professional reporting for himself. This 52-year-old male patient received on 20Dec2020 02:30 PM first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730) at single dose intramuscular in the left arm for COVID-19 immunization. No allergies to medications, food, or other products. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID 19. Concomitant medications (all started on an unknown date and received within 2 weeks of vaccination) included buspirone hydrochloride (BUSPIRON), atorvastatin (manufacturer unknown) and acetylsalicylic acid (BABY ASPIRIN). On 21Dec2020, 10 hours after getting vaccine the patient had body aches, cold and severe left arm pain. 4 days after getting vaccine again the patient had cold, body aches and sore throat for couple of days. On 28Dec2020, covid 19 test (nasal swab) result came up positive. The patient went to Emergency room. Outcome was recovered on an unknown date. It was unknown if a treatment was performed.; Sender's Comments: The association between the event lack of effect (COVID 19 nasal swab test result came up positive) with BNT162b2 can not be fully excluded.
52 2021-01-08 tremor Headache tremors, fatigue Narrative:
52 2021-01-09 weakness General body aches, lost of appetite, general weakness, painful vaccination site
52 2021-01-11 pain in extremity body ache; Headache; soreness in his arm; This is a spontaneous report from a Pfizer-sponsored progr... Read more
body ache; Headache; soreness in his arm; This is a spontaneous report from a Pfizer-sponsored program from a contactable physician reported for himself. A 52-year-old male patient intramuscularly received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK5730), first dose on 15Dec2020 21:00 and second dose on 05Jan2021 09:00 at single dose at deltoid left for preventative. Medical history and concomitant medications were reported as none. The patient experienced body ache on 06Jan2021 with outcome of unknown, soreness in his arm on 05Jan2021 with outcome of recovering, headache on 06Jan2021 with outcome of not recovered. He was asking if he can take paracetamol (TYLENOL) for body ache and soreness in his arm following administration.
52 2021-01-12 tingling About 10minutes post vaccine, he started c/o tingling to the right side of his neck and radiating do... Read more
About 10minutes post vaccine, he started c/o tingling to the right side of his neck and radiating down to his fingers. Vital signs were stable: BP 129/87, 97% RA, temp 97, HR 75, respirations 20, denies pain. Also c/o sweating palms, nausea but no emesis, mild dizziness, no SOB/difficulty breathing. Stated he did not eat anything this morning. Provided with crackers and water. At 0839, re-evaluated, nausea improved VS 132/88, hr 73, 98% RA, denies pain, continues to have tingling but not worsening, sweaty palms improving. At 0905 tingling and nausea have improved no longer c/o dizziness, vs 130/95, hr 81, 98% RA, RR 18, denies pain. Felt good to go home. Total time of about 30 minutes wait.
52 2021-01-13 pain in extremity soreness in my arm; This is a spontaneous report from a contactable nurse (patient). A 52-year-old m... Read more
soreness in my arm; This is a spontaneous report from a contactable nurse (patient). A 52-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EH9899; expiration date: not known), via an unspecified route of administration on left arm on 15Dec2020 at single dose for covid-19 immunization, administered at hospital. Medical history included idiopathic epilepsy. The patient's concomitant medications were not reported. With first dose, the patient experienced soreness in his arm with no other symptoms on an unspecified date. The outcome of the reported event soreness in his arm was unknown. On 06Jan2021 10:45, the patient received second dose of vaccine. On 06Jan2021 at 17:00, the patient had fatigue two days after as well lymph node swelling in armpit of arm where second dose administered.
52 2021-01-14 tremor fever went up 99.9; woke up covered in sweat; shaking so bad; shivering; had trouble keeping balance... Read more
fever went up 99.9; woke up covered in sweat; shaking so bad; shivering; had trouble keeping balance; swaying when walking; felt like crap; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Dec2020 at a single dose SINGLE DOSE for COVID-19 immunization. Medical history included COVID-19 in Apr2020. The patient's concomitant medications included celecoxib (CELEBREX). After receiving the vaccine fever went up 99.9, woke up covered in sweat, shaking so bad, shivering, had trouble keeping balance, was swaying when he was walking on an unspecified date. The patient also stated he felt ill for 3-4 days. The outcome of the events was unknown. Information about lot/batch number has been requested.
52 2021-01-15 flushing Flushing, possible rash/hives, vision changes. Allergy medication given at test site. Transported ... Read more
Flushing, possible rash/hives, vision changes. Allergy medication given at test site. Transported to ER for observation. Given Decadron and Pepcid. Observed and discharged.
52 2021-01-18 flushing EE woke up on 12/22/2020 experiencing diarrhea, facial flushing and swelling, lip/brow swelling, han... Read more
EE woke up on 12/22/2020 experiencing diarrhea, facial flushing and swelling, lip/brow swelling, hands started swelling, edema, redness/rash. Patient was evaluated at local EC and was found to have low BP. EE was treated with Solumedrol, Benadryl, and Pepcid. Patient was discharged home from EC after 2 hours with PO steroids x4 days.
52 2021-01-18 pain in extremity Pain and weakness to left leg, causing drop foot.
52 2021-01-19 pain in extremity Soreness in arm about 8 hours later; December 26 I started to have congestion, and headache and litt... Read more
Soreness in arm about 8 hours later; December 26 I started to have congestion, and headache and little bit of a cough. Some body aches, loss of taste and smell, as well. 27th - Covid test - Pos-tive (notified on 28th). Symptoms lasted for about 7 days except loss of taste and smell was only 5 days and it resolved. Took Tylenol and Mucinex D. Went to Urgent Care. Still having lingering congestion and fatigue.
52 2021-01-19 tenderness Approximately 4-5 hours after the injection, my right elbow began hurting. There is no swelling o... Read more
Approximately 4-5 hours after the injection, my right elbow began hurting. There is no swelling or injury. The elbow is a burning pain. It hurts to even touch my elbow!
52 2021-01-20 cold sweat, tremor Cold sweats, shaking, headache, congestion., joint soreness, muscle soreness
52 2021-01-20 feeling hot, tingling approximately 5 mins after vaccine administration patient felt itching, tickling feeling, and warmth... Read more
approximately 5 mins after vaccine administration patient felt itching, tickling feeling, and warmth on her abdomen around her naval area. Patient monitored for full 30 mins. Redness decreasing, itching & tickling resolved by discharge at 1140. MD discussed OTC Benadryl use.
52 2021-01-20 pain in extremity, numbness, cold extremities Patient states he had mild to moderate discomfort in my L arm (injection location), it has continued... Read more
Patient states he had mild to moderate discomfort in my L arm (injection location), it has continued for approximately 12hrs, along with my hands feeling numb and cold, patient also felt a bit lightheaded.
52 2021-01-24 feeling hot, hot flush sick; With the first dose he got tired and had malaise, and body aches for two days; With the first ... Read more
sick; With the first dose he got tired and had malaise, and body aches for two days; With the first dose he got tired and had malaise, and body aches for two days; With the first dose he got tired and had malaise, and body aches for two days; felt warmth in the arm; hot flash; just got really hot; This is a spontaneous report from a contactable consumer (patient himself). This 52-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ELO140), via an unknown route, on 23Dec2020 (at 06:00 AM), at single dose in the left upper arm on 23Dec2020 for COVID-19 immunization, administered at hospital. The patient had COVID-19 from 17Jul2020 to 14Aug2020 for which he was not hospitalized but he was pretty sick and had circulations issues; he had a little of numbing and tingling in his left three fingers after COVID virus. The patient clarified left three fingers as his middle finger, index finger, and ring finger. He had numbing and tingling in his toes as well. Relevant concomitant medications included ubidecarenone (COQ-10), rosuvastatin calcium (CRESTOR OD), monascus purpureus (RED YEAST RICE PLUS), and acetylsalicylic acid (BABY ASPIRIN). With the first dose he got tired and had malaise, and body aches for two days: He got the vaccine after working that night (He works in the intensive care unit). He got it at 6:00 AM. He felt warmth in the arm. It went all the way down the left arm. He got a hot flash. He stayed there for 15 minutes and was fine, but just got really hot. He finished his shift and didn't have any other reactions. He went to sleep and woke up in the afternoon on the 23Dec2020 and went to work. He didn't feel anything at that time. He was working six or seven days in a row. When he was working that night was when he started feeling body aches and fatigue. He didn't even put two and two together that it was from the vaccine. He felt like he needed to take something. His body temp was normally 97 and when he checked it was 98. He took a little ibuprofen (MOTRIN) and felt a lot better after taking it. He slept when he got home and had body aches and fatigue for a couple of days. He cancelled going away for a couple of days. By noon on 25Dec2020 he was feeling like he was getting back to normal. He continued to lay around all day and didn't do much. He was sick with the first and was expecting to be more sick with this one. He wanted to give himself an extra day before he had to go back to work. The patient had recovered from the event 'with the first dose he got tired and had malaise, and body aches for two days' on 25Dec2020 while the outcome of the remaining events was unknown.
52 2021-01-24 pain in extremity received shot in left arm, the next day my left arm, neck and upper back were sore, the next day I h... Read more
received shot in left arm, the next day my left arm, neck and upper back were sore, the next day I had aching pain radiating through my right shoulder and down my right arm. and getting worse. Seems my neck/upper back pain may have pinched nerve and is causing this.
52 2021-01-25 weakness his brain was still a little cloudy; tested positive for covid; tested positive for covid; lost 10 p... Read more
his brain was still a little cloudy; tested positive for covid; tested positive for covid; lost 10 pounds; energy level changed drastically; weak; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EH9899, via an unspecified route of administration in left arm on 21Dec2020 09:00 at a single dose for COVID-19 immunization in a hospital. Medical history included hypertensive and diabetic, both ongoing. Concomitant medication included metformin for diabetic and olmesartan medoxomil (BENICAR) for hypertensive. There were no prior vaccinations within 4 weeks. The patient received the covid vaccine first dose on 21Dec2020 and started developing covid symptoms on the 27Dec2020. He was tested positive for covid on the 28Dec2020. The patient wanted to know what is next. He patient stated that it has been 10 days and he wanted to know if he is still contagious. He is scheduled to get the second dose on 11Jan2021. He wonders if he can get the second dose or does have to start the process over again. He works in a doctor's office. He is a technician. While providing height and weight he commented it has changed drastically. He later clarified it was his weight that changed drastically. He lost ten pounds. His weight and energy level changed drastically, and this was after getting the COVID Vaccine. His symptoms started the weekend after taking the vaccine. He had COVID symptoms. He later clarified and stated they all started on 27Dec2020. He clarified his symptoms as: body aches and fever. The body aches and fever started the night of 27Dec2020 and recovered from 08Jan2021. He was unable to provide an exact time of onset. These have resolved, but at the time of report he was just weak. He had a COVID test done on 28Dec2020 he tested positive. He confirmed he has not had a follow-up COVID test done afterwards. The patient also mentioned that his brain was still a little cloudy since an unspecified date. The patient had not recovered from the event weak; while outcome of "lost ten pounds", "his brain was little cloudy" and "tested positive for covid" was unknown.
52 2021-01-26 tingling 4hrs after vaccine mild right arm hand Parasthesias in a radial distribution. These have persisted.... Read more
4hrs after vaccine mild right arm hand Parasthesias in a radial distribution. These have persisted. Same eve mild facial Parasthesias. This has progressed Now primarily left sided and have objective fasiculations and tongue deviation. Also mostly left lower leg Parasthesias. Some right.
52 2021-01-26 tremor he got real cold and shaky and couldn't get warm; he got real cold and shaky and couldn't get warm; ... Read more
he got real cold and shaky and couldn't get warm; he got real cold and shaky and couldn't get warm; temperature was low at 96 degrees Fahrenheit; He got nauseous with it; He had severe fatigue; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO140) via an unspecified route of administration on left arm on 11Jan2021 at 9:15 at single dose for COVID-19 immunization. The relevant medical history included Covid-19 from 17Jul2020 to 14Aug2020, he didn't get hospitalized but was pretty sick. He had circulation issues with it. He had numbing and tingling in his left three fingers (clarified left three fingers as his middle finger, index finger, and ring finger) and numbing and tingling in his toes as well. Concomitant medications included ubidecarenone (COQ-10), acetylsalicylic acid (BABY ASPIRIN), rosuvastatin and monascus purpureus (RED YEAST RICE). The patient previously received the first dose of BNT162B2 at the age of 52 years old on 23Dec2020 at single dose for COVID-19 immunization. With second dose the patient thought he would be better, but about 12 hours later he got real cold and shaky and couldn't get warm. He checked his body temperature and he didn't have a temp. His temperature was low at 96 degrees Fahrenheit. He tried to keep himself warm. He got nauseous with it. Basically he looked on line and was having them. Today he started to feel better, but still a little nauseous. He had severe fatigue. He didn't realize he could go fill out something on the website for CDC. He knew he had wanted the vaccine because he had some severe symptoms when he had COVID. He didn't want to get COVID again. His hospital frustrates him sometimes. They didn't put the date on there when he was to come back for the second dose. They didn't tell him to come back on the 13th. He had to figure the dates from the website and emails. He talked it over with his wife. He came in contact with it every night. He was taking care of people that were critical. He worked in the intensive care unit. Even the people he took care of that didn't have it, ended up with it. He wore a mask. He used hand sanitizer. He didn't want to get it again. People were shocked when he got it the first time. He did verify that he got the second dose one day sooner, instead of the three day window. He was sick with the first and was expecting to be more sick with this one. He wanted to give himself an extra day before he had to go back to work. He had a couple of emails where they discussed increasing the window to do it a day sooner. He was going to have to go an hour an half a way to get the second dose and he didn't want to do that. The patient underwent lab test included height was approximately six two, weight was about 194 lbs on an unspecified date, and body temperature showed 96 degrees Fahrenheit in Jan2021. The outcome of the event he got real cold and shaky and couldn't get warm, temperature was low at 96 degrees Fahrenheit was recovering, for the events he got nauseous with it and he had severe fatigue were not recovered.
52 2021-01-27 weakness generalized itching, maculopapular rash, lips, face, neck, tongue swelling, difficulty of swallowin... Read more
generalized itching, maculopapular rash, lips, face, neck, tongue swelling, difficulty of swallowing, left wrist swelling, generalized weakness, fatigue. 2nd dose of vaccine received on 01/11/21, first was on 12/22/20. Symptoms started on 01/16/21 between 1 and 2 am. First day symptoms were mild resolved after taking allegra and benadryl. On 01/17/21 between 2 and 3 am started again, and got worse, did not improve after taking allerga and zyrtec. Later in the day started on prednisone daily, allegra daily and one dose of benadryl. Symptoms lasted for few more days
52 2021-01-29 hot flush Mild nausea, muscle/body aches, and hot flashes for 12 hours
52 2021-02-01 bell's palsy Bells Palsy after 2nd dose given on Jan 27th. Onset that Friday night with full effects of BP that S... Read more
Bells Palsy after 2nd dose given on Jan 27th. Onset that Friday night with full effects of BP that Saturday
52 2021-02-05 bell's palsy, facial paralysis Loss of muscle control on one side of my face, diagnosed as Bell's Palsy.
52 2021-02-06 sensory loss 2 weeks after my second shot, I had a CVA causing complete loss of sensation in my left arm. I am i... Read more
2 weeks after my second shot, I had a CVA causing complete loss of sensation in my left arm. I am in good health and do not have multiple risk factors for CVA. While the scans showed evidence of a CVA, no underlying cause has yet to be determined.
52 2021-02-07 weakness Severe insomnia over the past 8 weeks, unrelenting. Start exactly at 24 to 48 hours after vaccine. H... Read more
Severe insomnia over the past 8 weeks, unrelenting. Start exactly at 24 to 48 hours after vaccine. Had no previous illnesses before that. No history of Covid infection. Has done all sorts of CBT modifications with no improvement. Was previously a super high functioning Interventional Cardiologist with no prior history of anxiety, depression or sleep problems. This was very acute and worsened after second dose. Labs are all normal. Now unable to work as this insomnia is quite debilitating.
52 2021-02-07 seizure Vaccine administered on 1/19/21 at 2:15pm and patient began having seizure activity on 1/20/21 at ap... Read more
Vaccine administered on 1/19/21 at 2:15pm and patient began having seizure activity on 1/20/21 at approximately 4pm Patient sent to ER for evaluation. Temperature of 102 was noted at ER. Seizure eventually resolved and he returned to his residence. He has a prior history of seizures.
52 2021-02-09 weakness energy level was throught the roof; energy level was throught the roof; no energy and was unable to ... Read more
energy level was throught the roof; energy level was throught the roof; no energy and was unable to get out of bed; felt really weak; Appetite lost; Pain; left shoulder felt heavy with first dose; This is a spontaneous report from a contactable consumer. A 52-years-old male patient started to receive bnt162b2 (BNT162B2) Lot# EL1686 via an unspecified route of administration on 03Jan2021 16:00 1 dose at SINGLE DOSE for covid-19 immunisation. Vaccination Facility Type: Nursing Home. Anatomical Location of vaccine left arm. Medical history included diabetes mellitus from Nov2020 and ongoing. Concomitant medication included glipizide (GLIPIZIDE), metformin (METFORMIN). The patient experienced left shoulder felt heavy with first dose on 03Jan2021 with outcome of recovered, pain on 06Jan2021 with outcome of recovered felt really weak on 07Jan2021 with outcome of recovered, appetite lost on 07Jan2021 with outcome of recovered, no energy and was unable to get out of bed on 08Jan2021 with outcome of recovered, energy level was through the roof on 15Jan2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24Jan2021. The reporter stated "Following the first dose his left shoulder felt heavy. On 06Jan2021 he had pain. It was in his waist. It was constant and was on both sides of his waist. On 07Jan2021 the pain moved from his waist to between his shoulder blades. It was like that for the whole day. He also felt really weak. He was unable to keep his upper body up. He struggled all day while at work. He thought he had Covid but was tested and the result was negative. The pain became worse and moved from his spinal cord to his head. This caused him to miss work. He did not have any energy and was unable to get out of bed. He also lost his appetite. Then on 15Jan2021 his energy level was through the roof like he was on steroids" The action taken was not applicable.
52 2021-02-10 weakness Severe lip swelling; Body rash; Chills, rigors; Muscle aches; Nausea; Generalized weakness; This is ... Read more
Severe lip swelling; Body rash; Chills, rigors; Muscle aches; Nausea; Generalized weakness; This is a spontaneous report from a contactable physician (patient). A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration Arm Left on 11Jan2021 at 01:00 PM as a single dose for COVID-19 immunisation, lot number: EK5730. Medical history and concomitant medications were not provided. Patient had no known allergies. Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 at Left arm for COVID-19 immunisation, lot number: ELO142. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 14Jan2021 at 04:00 PM patient experienced severe lip swelling, body rash, chills, rigors, muscle aches, nausea, generalized weakness. The events were treated with fexofenadine hydrochloride (ALLEGRA), diphenhydramine hydrochloride (BENADRYL) and presnosone. Events resulted in Doctor or other healthcare professional office/clinic visit. Patient had not tested for COVID-19 since having the vaccine. Patient was recovering from the events, at the time of the report.
52 2021-02-10 nerve pain, pain in extremity Symptoms - ?Patient reports immediately after injection really bad arm pain and described as ?nerve ... Read more
Symptoms - ?Patient reports immediately after injection really bad arm pain and described as ?nerve pain, stinging in nature.? Patient verbalizing concerns with injection technique by vaccine administrator. Patient reports he didn?t think anything of it and worked night shift (7p-7a) on 1/10, 1/11, 1/12 without improvement. Patient reports he worked on 1/19, 1/20, 1/21 and Patient reports pain to R scapula. Patient reports he used Acetaminophen; Ibuprofen and muscle rub without relief. Patient notified EH and had appointment with PA on 2/1. Patient reports he has been receiving PT at TCH twice/weekly. Patient reports he was prescribed Gabapentin and reports significant relief. Patient had f/u appointment today (2/11) with PA and was notified to contact us to report adverse reaction. EE reports he was told by PA to contact ?occupational health? for more assistance. Patient notified vaccine support line is for adverse reactions to vaccine and Patient verbalized he was unsure who he was supposed to contact. Patient notified to contact PA directly as he is under his care and ask for the contact phone number/email of who he needs to contact next. patient reports next f/u appointment scheduled with EH on March 4th. Patient verbalized back understanding and denied further questions at this time. Last day of work and shift - unknown, Patient did not disclose. Home remedies? - see ?symptoms? for detailed account Any improvement? - yes Recommendation? Patient educated to continue to follow instructions provided by PA at EH as he is under his medical care. Patienteducated to contact PA at EH with further questions or concerns regarding management of care.
52 2021-02-11 feeling hot Warm risk throughout body, similar to contrast in a CT scan. Lasted 3 minutes. Had mild body aches n... Read more
Warm risk throughout body, similar to contrast in a CT scan. Lasted 3 minutes. Had mild body aches next day.
52 2021-02-11 seizure like phenomena *Please note it is not known if event was related to vaccine* On 2/10/2021, at approximately 5:30 A... Read more
*Please note it is not known if event was related to vaccine* On 2/10/2021, at approximately 5:30 AM, patient began to experience dizziness and shortness of breath. Per witnesses, he then began to have seizure activity followed by cardiac arrest. He was treated with CPR and 1 shock from the AED, which resulted in spontaneous return of circulation. He was awake and confused after return of pulse and sent to Hospital Emergency Room. This event occurred 19 days post first vaccine. He was scheduled to get his second dose on 2/12/2021, but did not receive it due to event.
52 2021-02-16 night sweats On 1/18 developed fever 102.5, upon waking, around 8am. Fever climbed to 103.5 in the afternoon. Ac... Read more
On 1/18 developed fever 102.5, upon waking, around 8am. Fever climbed to 103.5 in the afternoon. Acetaminophen 1000mg taken and fever dropped to 102.5 in evening of 1/18. Severe night sweats and chills at night of 1/18 and 1/19, 1/20. Was advised by employer to go to ED due to elevated fever >12hrs. Pt declined due to cost of ED visit.
52 2021-02-17 migraine with aura This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient recei... Read more
This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received his second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL3248; expiration date: unknown), via an unspecified route of administration right arm on 04Feb2021 07:45 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no allergies to medications, food, or other products. The patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL3248; expiration date: unknown) at the vaccination age of 52-year-old via an unspecified route of administration left arm on 14Jan2021 08:45 AM at a single dose for covid-19 immunization. On 04Feb2021 04:45 PM, the patient reported that he believed he experienced an ocular migraine in his left eye approximately 9 hours after getting the second shot. He took 2 acetaminophen 500 mg tablets and the symptoms cleared up in 20-30 minutes. He has never experienced this sort of sensation before so he figures it could possibly be related. He woke up with a mild headache at the start of this second day (05Feb2021), as well. The events were non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event ophthalmic migraine was recovered on 04Feb2021 while headache was recovered on Feb2021.
52 2021-02-18 nerve pain, burning sensation 1. during the administration, it burned really bad 2. progressive more pain, (muscle) soreness sta... Read more
1. during the administration, it burned really bad 2. progressive more pain, (muscle) soreness starting about 10 days after shot--steadily increasing shoulder, trapzius, neck pain/stiffness 3. after conventional at home treatment for sore muscles for 2 weeks, I saw PA at employee health (25 days after injection) 4. at the time of visit, (Feb 01) I was in the most pain
52 2021-02-18 nerve pain Around noon on 1/29/21 (less than 24 hours after the shot) i felt a weird nerve sensation throughout... Read more
Around noon on 1/29/21 (less than 24 hours after the shot) i felt a weird nerve sensation throughout my entire body. The only way to describe it is the nerve pain you feel when you hit your funny bone. That was the sensation I was feeling throughout the body. There was also intense bone pain and lower back pain. These were also the same symptoms I had when I had a mild case of covid 3/2020 and didn?t know I had it. In June 2020 I tested positive for antibodies.
52 2021-02-19 pain in extremity muscle and arm soreness for 4 days
52 2021-02-19 unresponsive to stimuli, seizure, tremor, flushing Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Seizure-Medium, Systemic: Shakiness-Severe, Additional Details: About 5 minutes after receiving vaccine, patient was seated in observation area and notified facility staff member who was in charge of observing patients that he felt faint. Staff member reported patient quickly turned extremely red and was showing seizure-like activity, unconscios. She alerted the pharmacists to come over I came over and patient appeared bright red, pupils extremely dilated and was not conscious, grabbed pt arm he woke up and then showed typical vasovagal symptoms thereafter.
52 2021-02-21 pain in extremity, weakness Slightly sore arm for a day. Starting ten hours and lasting maybe thirty hours was a series of inten... Read more
Slightly sore arm for a day. Starting ten hours and lasting maybe thirty hours was a series of intense chills and strong, flu=like weakness. From about 24 hours for maybe the next 4 days, significant aggravation of legacy rashes from my chronic skin conditions. After 4 days, they reverted to normal.
52 2021-02-25 bell's palsy reoccurrence of left bell's palsy
52 2021-02-25 numbness NUMBNESS ON LEFT SIDE OF BODY, CRYING, "LOOKS" DIFFERENT
52 2021-02-26 bell's palsy Pt states he developed Bell's palsy two weeks after his first Covid vaccine. He states he saw his P... Read more
Pt states he developed Bell's palsy two weeks after his first Covid vaccine. He states he saw his PCP. His PCP recommended he still get the second injection-but to put it off as long as possible. Pt said the symptoms from Bell's Palsy have entirely resolved.
52 2021-02-26 hot flush Left jaw pain & soreness near left ear (difficult to open mouth, chew food) from 7 am day after inje... Read more
Left jaw pain & soreness near left ear (difficult to open mouth, chew food) from 7 am day after injection (current as of 10pm, same day), mild nasal congestion (starting around 6pm day after injection, current as of 10pm), chills (lasted about an hour 6-7pm day after injection), flush (about an hour after chills ended). AM temp 97.7 (9 AM), PM temp 101.1 (10 PM).
52 2021-02-28 facial pain Fever; Chills; Body Ache; Pain in face; Pain in back; pain in hip; Headache for 2 days; Vivid nightm... Read more
Fever; Chills; Body Ache; Pain in face; Pain in back; pain in hip; Headache for 2 days; Vivid nightmares; Sweats; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162B2 (BNT162B2, Solution for injection, lot number: EL3249, expiry date: not reported), via an unspecified route of administration, on 25Jan2021 03:00 PM at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. Medical history was none. The patient was not diagnosed with covid prior to vaccination. He had no known allergies. Concomitant medications were not reported. On 26Jan2021 01:15 AM, the patient experienced fever, chills, sweats, body ache, pain in face, pain in back, pain in hip, headache for 2 days, vivid nightmares. 2 days later (at the time of report, 27Jan2021), the patient still had low grade fever, sweating, body ache and headache. No treatment was received for the reported adverse events. Outcome of the events was reported to be recovering. The patient was not tested for covid post vaccination.
52 2021-02-28 tingling Patient noted tingling to throat, mouth and nose, he was monitored in parking lot for 30 mins but st... Read more
Patient noted tingling to throat, mouth and nose, he was monitored in parking lot for 30 mins but still had some tingling in nose. Advised Benadryl, he was agreeable,. He was monitored thereafter for 15 mins. Insisted on going home, he was alone, risks discussed. Noted he was going straight home, where wife and mother could monitor him.
52 2021-03-02 difficulty speaking 35 Minutes after receiving vaccine, itching on head, then body and face, including welt on chest, hi... Read more
35 Minutes after receiving vaccine, itching on head, then body and face, including welt on chest, hives. 50 minutes later eye itchiness and swelling in left eye, throat felt weird (swelling), dizziness, change in voice, wheezing (not severe, but could tell breathing was more restricted than before shot). Almost went to ER, but symptoms subsided without any medication in 2 hours. Did not go to hospital or ER.
52 2021-03-05 numbness Heart fluttering/skipping beats shortly after receiving and periodically continuing up to this date.... Read more
Heart fluttering/skipping beats shortly after receiving and periodically continuing up to this date. Numbness feeling in face and jaw several hours after receiving that continues today. Feel pressure on forehead and nostril area.
52 2021-03-07 weakness Goosebumps tingly sensation in head; Blood pressure and palpitation/heart rate/heartbeat is getting ... Read more
Goosebumps tingly sensation in head; Blood pressure and palpitation/heart rate/heartbeat is getting higher and higher.; Blood pressure and palpitation/heart rate/heartbeat is getting higher and higher.; feeling weak; Heaviness in the head; Feeling anxiousness in the brain; Localized soreness and pain; This is a spontaneous report from a contactable consumer reported for himself. A 52-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Jan2021 18:00 (Lot number: EL9263) via unspecified route of administration in the left upper arm at SINGLE DOSE for COVID-19 Immunization. The patient's medical history included ongoing diabetes (Due to diabetes has low testosterone), High cholesterol both from 2005, Colitis ulcerative from 1999, Glaucoma from 2010, Enlarged prostate gland from 2018 and Chronic sinus infection, Acid reflux and GERD from an unknown date and unknown if ongoing. The concomitant medication included Janumet (Metformin hydrochloride/sitagliptin) ongoing for diabetes mellitus at (50/1000 one tablet twice daily), amoxil (amoxicillin) for low testosterone via topical route at 4 pumps, azelastine at two sprays twice a day for chronic sinus infection, crestor (rosuvastatin calcium) ongoing at 5 mg once a day blood cholesterol increased, tamsulosin ongoing at 0.4mg once a day for enlarged prostate gland, dexilant (dexlansoprazole) at 30 mg once a day for acid reflux and GERD, lialda (mesalazine) ongoing at 4.8 mg, once a day (1.2gram 4 tablets once a day) for colitis ulcerative, canasa (mesalazine) ongoing 1 g once a day (at night time) for colitis ulcerative, timolol ongoing at one drop both eyes at once a day for glaucoma, lumigan (bimatoprost) ongoing for at one drop both eyes once a day for glaucoma, melatonin ongoing at 5mg once a day for insomnia, zyrtec (cetirizine hydrochloride) ongoing at 10 mg (on of them) for insomnia, xanax (alprazolam) 1 mg at 1mg at night time and 1 mg as needed for generalized anxiety and blood pressure, 5-hydroxytryptophan ongoing at 100mg for anxiety, carvedilol ongoing at 25 mg, once a day (12.5mg in the morning 12.5 at night) for blood pressure measurement, valsartan ongoing at 160 mg, once a day (160mg one tablet once day in the morning) for blood pressure measurement, hydrochlorothiazide tablet ongoing at 12.5 mg, once a day for blood pressure measurement, Vitamin E at 400 international units; one capsule once a day, ongoing ambozil for low testeterone, clonidine ongoing at 0.1 mg as needed for blood pressure measurement. History of all previous immunization with the Pfizer vaccine considered as suspect: None, this was the first dose. No other vaccine administered on the same date. The patient had no events prior vaccination within 4 weeks. In all his life. He had vaccines that received and had no adverse event or side effect whatsoever. He had had the regular flu vaccine early November. The patient experienced feeling anxiousness in the brain, Heaviness in the head, feeling weak in Feb2021, Localized soreness and pain in Jan2021, Goosebumps tingly sensation in head, Blood pressure and palpitation/heart rate/heartbeat is getting higher and higher on 04Feb2021. The patient could not take Benadryl as he cannot tolerate Benadryl. With Zyterc he does not have secondary effects like he does with Benadryl. The first week after getting the vaccine he only had kind of had localized soreness and pain in the area. He later clarified it was in the area where got the injection, vaccine. He just had pain soreness in that area. Other than that he had no side effects at that time. The third week, initially stated as, about 5-7 days ago he started to have a feeling of anxiousness in the brain. He could feel anxiousness and sensation in his brain that he did not feel before. It was like he had the flu kind of thing, but he did not have a temperature. However, the feeling is in his head. It is like heaviness feeling from the flu in his head. He has been having the heaviness in the head feeling for 4-5 days. He later further clarified and initially clarified the localized pain and soreness was noticed the second day, the day after getting the vaccine. This only lasted a few days. He does not remember exactly when this ended. He did not take anything for the localized pain and soreness in the same area as the injection. He confirmed he has recovered completely from this event. Caller further clarified the feeling of anxiousness started Thursday or Friday of last week, maybe 05Feb2021. Stated it was like this feeling is getting worse and worse. Stated it was hard to explain, but he started to feel a goosebumps tingly sensation in his brain in head, in scalp Thursday of last week first. It started with that and slowly over the past few days it has changed and transformed into this heaviness feeling that one would feel from the flu, but he has no fever or anything; it is just in his head. Also, along with that feeling at the same time his blood pressure and palpitation/heart rate/heartbeat was getting higher and higher. His regular blood pressure medications won't work anymore to bring it down. His blood pressure typically ranges in the 130/85 or less range with all the blood pressure medications he was taking. Once he started having this tingling sensation in his head he had the higher blood pressure and higher heart rate. Now his blood pressure would average being about 170/110 to 180/115. This was like the upper and lower range. His heart rate was typically around 70-75 and now it goes about 80-85. Later during call, he also added, every six months or so his blood pressure may be elevated on these medications. Sometimes his blood pressure was not maintained by the three different blood pressure medications he takes. He was also prescribed two other medications for emergent use Clonidine and Xanax. Usually every six months he would have to take Clonidine and Xanax and typically in an hour to two hours the blood pressure would come down and it's good. However, this time, he took two Clonidine and Xanax starting last Thursday when had the high blood pressure episode and they were failing to bring the blood pressure down. He further explained it would bring it down for some time, but then it would go back high. The Clonidine is no longer working for the last six days. When probed for labs/testing he sated he could not work anymore due to the events reported. He was feeling weak. He could not really walk. He took time off from work. He went to see his primary care provider on Monday. On Monday the doctor doubled the dose of Carvedilol. Since then instead of taking 12.5 twice a day, he is now taking 25mg twice a day. On Tuesday, yesterday, he went to get blood work done. Blood was drawn but has no results yet. Localized pain and soreness time of onset didn't remember, stated he may have had a little pain right after getting the vaccine, but it was around 21:00 25Jan2021 he really noticed the soreness and pain. The following morning around 9 AM it woke him from his sleep and he could feel it more compared to the first day. Anxiousness in the brain around 16:00. The patient had no emergency visit. Stated he almost felt like going when his blood pressure was 182/116 on Saturday night of last week. He was about to go to the ER but decided not to. He ended up taking two Clonidine and one Xanax, laid down, and eventually his blood pressure came down a little. Therefore, he did not go. The patient had physicians office visit. After getting the vaccine he mentioned started to have a feeling of anxiousness in the brain that was getting worse. He could feel anxiousness and sensation in his brain that he did not feel before. Also, his blood pressure and palpitation/heart rate/heartbeat was getting higher and higher. His regular blood pressure medications won't work anymore to bring it down. Later during call, he also added, every six months or so his blood pressure may be elevated on these medications. Sometimes his blood pressure was not maintained by the three different blood pressure medications he takes. He was also prescribed two other medications for emergent use Clonidine and Xanax. Clonidine: 0.1mg only during times he has episodes of high blood pressure. Usually every six months he would have to take Clonidine and Xanax and typically in an hour to two hours the blood pressure would come down and it's good. However, this time, he took two Clonidine and Xanax starting last Thursday when had the high blood pressure episode and they were failing to bring the blood pressure down. It would bring it down for some time, but then it would go back high. The Clonidine was no longer working. The patient experienced side effects on the 3rd week after getting vaccinated and had already made a report. The patient's second dose was scheduled for 21Feb2021 which was 28 days after the first dose. The outcome of the event Feeling anxiousness in the brain was not recovered, Localized soreness and pain recovered in 2021 and outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.;
52 2021-03-07 weakness light fever, aches, muscles sore, loss of energy
52 2021-03-07 pain in extremity, tenderness Extreme Muscle Soreness in both thighs, tenderness to the touch, next morning extremely stiff and pa... Read more
Extreme Muscle Soreness in both thighs, tenderness to the touch, next morning extremely stiff and painful, movement seems to loosen them up a bit, but still painful and sore. Sore all day Sunday so you walk with a limp especially after sitting, up and down stairs hurts the most, still sore on Monday, 3/8/2021
52 2021-03-09 hypersensitivity of all senses, tingling paresthesias and hyperesthesia from hips up to scalp. slowly improved over next week, no treatment p... Read more
paresthesias and hyperesthesia from hips up to scalp. slowly improved over next week, no treatment provided
52 2021-03-09 numbness Twelve hours after first vaccine dose, experienced mild facial swelling, numbness. Resolved 6 hours ... Read more
Twelve hours after first vaccine dose, experienced mild facial swelling, numbness. Resolved 6 hours later without intervention.
52 2021-03-10 tingling, numbness Bilateral upper and lower extremity paresthesias, left facial paresthesias and numbness, fasciculati... Read more
Bilateral upper and lower extremity paresthesias, left facial paresthesias and numbness, fasciculations in abdomen and face
52 2021-03-10 tremor, feeling hot Tremor in right am, Injection site swelling and redness, Dizziness and Patient said very hot, Ad... Read more
Tremor in right am, Injection site swelling and redness, Dizziness and Patient said very hot, Adverse reaction lasted 15 to 20 mins. Treated with Ice packs, gave water and observed for 20 mins.
52 2021-03-16 burning sensation Sudden pain and rash appeared, took a single Zyrtec pill and rash and burning sensation went away. N... Read more
Sudden pain and rash appeared, took a single Zyrtec pill and rash and burning sensation went away. No other medications or change in diet at the time of the reaction were present.
52 2021-03-16 pain in extremity Sore arm
52 2021-03-18 feeling hot 3-16-21 2:11PM PT STATES 'CHEST DISCOMFORT AND FELT HOT FOR 1 MIN AFTER GETTING SHOT'. STATES 'NO P... Read more
3-16-21 2:11PM PT STATES 'CHEST DISCOMFORT AND FELT HOT FOR 1 MIN AFTER GETTING SHOT'. STATES 'NO PAIN OR DISCOMFORT NOW'. A/O, PINK, W/D, RESP REG WITH EASE. AMBULATORY TO EXIT - GAIT BRISK AND STEADY. HOME WITH WIFE. NO ACUTE OR OBVIOUS DISTRESS. 3-17-21 1:28: PT STATES HE 'WENT TO THE ER WITH CHEST TIGHTNESS AND LIGHTHEADED. WAS THERE 5 HR AND WAS CHECKED OUT - EVERYTHING WAS OK'.
52 2021-03-18 tingling, burning sensation Redness, prickly/itching sensation over face, arms, legs, chest/abdomen, burning sensation on lips a... Read more
Redness, prickly/itching sensation over face, arms, legs, chest/abdomen, burning sensation on lips and around eyes, pressure/fullness in back of throat, pain in infections site, fatigue, muscle aches.
52 2021-03-19 weakness Delayed reaction with sore throat, nasal congestion, feeling run down, headache. Also the well known... Read more
Delayed reaction with sore throat, nasal congestion, feeling run down, headache. Also the well known soreness of the injection site in right arm.
52 2021-03-19 pain in extremity On 1/27/2021, after having received Dose #2 of Pfizer Covid-19 vaccine on 01/07/21, I experienced se... Read more
On 1/27/2021, after having received Dose #2 of Pfizer Covid-19 vaccine on 01/07/21, I experienced severe calf pain while playing soccer. Over the next 2 weeks I experienced vascular claudication in that leg and was eventually diagnosed with arterial thrombus in Left tibioperoneal, anterior tibial/dorsalis pedis and posterior tibial arteries. I do not have any known predisposing conditions for arterial thrombus and no history of thromboembolic disease.
52 2021-03-20 weakness 24-48 he's post vaccine— Acute Insomnia with severe anxiety component; 24-48 he's post vaccine— Ac... Read more
24-48 he's post vaccine— Acute Insomnia with severe anxiety component; 24-48 he's post vaccine— Acute Insomnia with severe anxiety component/Anxiety worsening; Completely out of character with no preceding symptoms; very debilitated; This is a spontaneous report from a contactable physician (patient). A 52-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EH9899), via an unspecified route of administration, administered in left arm on 17Dec2020 8:00 as single dose, second dose via an unspecified route of administration, administered in left arm on 07Jan2021 (Batch/Lot Number: EL3246) as single dose for covid-19 immunisation. Medical history included hypertension and Increased cholesterol. Concomitant medication included atorvastatin (LIPITOR); lisinopril. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. other medications the patient received within 2 weeks of vaccination were Lipitor and Lisinopril. It was reported 24-48 hours post vaccine (18Dec2020 22:00) patient had Acute Insomnia with severe anxiety component. Completely out of character with no preceding symptoms. No prior history of any recent event to explain acute change in personality and character. Insomnia has now persisted for seven weeks. Was better two weeks after 1st dose then worsened again after the 2nd dose was given. Same timeline. Anxiety worsening. Never suffered form any psych issues. Highly functional Interventional Cardiologist now very debilitated. the adverse event result in doctor or other healthcare professional office/clinic visit; The patient received treatment with Psych therapy, Benzos, Ambien, Trazadone, Melatoni. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. The reported seriousness was non serious. The outcome of the events was not recovered.
52 2021-03-23 bell's palsy Left sided Bells palsy. Notably pt with remote hx of Bells palsy on the same side. occurred approx 1... Read more
Left sided Bells palsy. Notably pt with remote hx of Bells palsy on the same side. occurred approx 12 hours after injection.
52 2021-03-23 muscle twitching My right eye felt like there was something in it and it still seems to be twitching
52 2021-03-23 tingling, numbness Pain at injection site expanded to joints and muscles in all parts of the body. Mild sense of swelli... Read more
Pain at injection site expanded to joints and muscles in all parts of the body. Mild sense of swelling in arms and legs and face, numbness and tingling in extremities. Slight tightness in chest.
52 2021-03-24 facial paralysis, bell's palsy On 03/24/2021 @ 0730 am, I experienced drooping and weakness of right side of face and mouth. Diagno... Read more
On 03/24/2021 @ 0730 am, I experienced drooping and weakness of right side of face and mouth. Diagnosed with Bells Palsy at emergency room. CT was negative for mass. Prescribed Prednisone 20 mg 3 tab daily for 7 days, & Acyclovir 800mg 5 tablets daily for 10 days..
52 2021-03-25 bell's palsy New onset bells palsy, 2 days after first vaccine dose, no prior history of bells palsy. treating wi... Read more
New onset bells palsy, 2 days after first vaccine dose, no prior history of bells palsy. treating with pred/valtrex
52 2021-03-25 feeling jittery Patient had pallor, reported lightheadedness, felt jittery. Patient reports not having breakfast. Ju... Read more
Patient had pallor, reported lightheadedness, felt jittery. Patient reports not having breakfast. Juice given and calming techniques provided, did not resolve symptoms. Denies throat swelling or difficulty breathing. Blood pressure elevated, denies history of hypertension. Other vital signs stable.
52 2021-03-25 pain in extremity Patient complains of arm soreness, decreased range of motion which started the next day after gettin... Read more
Patient complains of arm soreness, decreased range of motion which started the next day after getting the shot. Still has the arm soreness, but states that is seems to be a little better than before. Has not tried taking anything for it like ibuprofen or Tylenol. Has not tried a cold pack on it. No swelling, warmth, or redness at site.
52 2021-03-25 sensory loss, facial paralysis, bell's palsy Patient was diagnosed with Bells Palsy. On 3/15/21, patient noticed loss of taste and a sensation in... Read more
Patient was diagnosed with Bells Palsy. On 3/15/21, patient noticed loss of taste and a sensation in his tongue. On 3/16/21, patient had right sided facial paralysis with some right ear discomfort, right eyelid drooping, right upper temple headache, sensitivity to sounds, and right eye only able to be open halfway. Patient also states that his right eye was watery. He denies a mouth droop. Patient went to urgent care on 3/16 and he was prescribed Prednisone. On 3/18, patient went to see his primary care physician and was prescribed an antiviral. He has not had any new or worsening symptoms since 3/18 pm, but he has not seen much improvement in symptoms either. He describes a small improvement in taste.
52 2021-03-25 unresponsive to stimuli, tremor Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive... Read more
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: purfuse sweating, lose of sight left eye, dizziness, nausea-Severe, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient began to fell better about 5 minutes after epinephrine was administered. EMS was called but did not transport.
52 2021-03-26 weakness Achey, chills, fever, general feeling poorly approx 22 hrs after vaccination
52 2021-03-26 tremor, cold sweat 1. Headache within 1 hour after shot. Severe after 12 hours. Still light at 48 hours. 2. Muscle ... Read more
1. Headache within 1 hour after shot. Severe after 12 hours. Still light at 48 hours. 2. Muscle aches within 8 hours. Still light at 48 hours. Peaked at 24 hours after shot. 3. "Glans/local ache' (lower back/kidneys and testicles) within 8 hours. Testicle ache stopped with 36 hours after shot. Kidney/lower back ache still lightly present at 48 hours. 4. Shaking/Chills. Started 12 hours after shot. Went from light to extreme within 30 minutes. Shaking and shivering uncontrollably. To the point I would not have been able to dial 911 for help if I had needed. No matter what I did I could not get warm or stop shaking. Extreme shaking lasting about 2 hours. In about 2 more hours shaking subsided and stopped. So shaking stopped around 16 hours after shot. Chills continued until around 36 hours after shot. 5. Cold sweat/Fever. Sweating starting 11 hours after shot. Lasting until about 36 hours after shot. For fever, Unknown how high it was as I was too busy uncontrollably shaking to take my temperature. Fever remained for about 48 hours in low grade form EXCEPT for hours 11 through 18 after shot - I am sure it was very high due to headache, chills, shaking, etc at that time. Basically, for most of the 2 days, it felt like the flu. But for 6 hours, (hours 11 through 17 after receiving the shot), it was the sickest I can recall beings in decades. Will 'click' I have recovered below in item 20. But not 100% back to normal yet. 90% back to normal would be a good current 'level'. Expect to feel 100% again tomorrow or the next day based on recovery rate.
52 2021-03-27 cold sweat, feeling hot About 15-20 minutes after receiving the shot, he reported feeling warm and clammy. He mentioned that... Read more
About 15-20 minutes after receiving the shot, he reported feeling warm and clammy. He mentioned that was similiar to the beginning of his other reaction. Because he has had a reaction to epinephrine in the past, an ambulance was offered to be called for him, however, he declined. He was offered a 25mg dose of Benadryl with some cold water, and upon afterwards he felt better. It was noted that he had only ate a piece of toast that morning (it was now around 1pm). His wife was called so she would be able to drive him home. Patient stayed for another 30 minutes after before his wife came to pick him up.
52 2021-03-27 muscle twitching Severe Muscle aches in back and neck lasted for 9 days Muscle twitch in legs came on after 10 days a... Read more
Severe Muscle aches in back and neck lasted for 9 days Muscle twitch in legs came on after 10 days and ongoing
52 2021-03-27 tingling, numbness High Blood Pressure: 135-91, numbness and tingling in my left hand, and itchiness in my right foot. ... Read more
High Blood Pressure: 135-91, numbness and tingling in my left hand, and itchiness in my right foot. I also experienced pain and swelling in the injection site.
52 2021-03-29 muscle spasms, tingling, feeling of insects crawling on skin After 1st dose - stomach began churning constantly within a week, scalp and side of face tingling oc... Read more
After 1st dose - stomach began churning constantly within a week, scalp and side of face tingling occasionally, After 2nd dose - stomach churning increased, scalp and face tingling more pronounced within 1st week, occasional nausea and tingling in pinky fingers and lack of appetite 2nd week, occasional tingling in pinky toe and sides of ankles as well as more nausea and chest discomfort during 3rd week when resting (1st ER visit), pronounced tingling in fingers and feet as well as farther up legs 4th week when experienced difficulty walking after one night where entire legs had formication and calf cramping (2nd ER visit). Symptoms then dissipated on their own approx 8 weeks after first appearing
52 2021-03-29 muscle spasms Severe back muscular and intestinal cramping lasting for about 8 hours. Abdomen distention was pron... Read more
Severe back muscular and intestinal cramping lasting for about 8 hours. Abdomen distention was pronounced. Also very fatigued and lethargic for over 24 hours.
52 2021-03-30 weakness In the 1-2 weeks after vaccination pt reports generalized weakness, polyuria, polydipsia, weight lo... Read more
In the 1-2 weeks after vaccination pt reports generalized weakness, polyuria, polydipsia, weight loss, vision changes. Presented to ED on 3/30/2021 and found to have DM2 with A1c of 12.4. Previously had well controlled DM2 on metformin 500mg. Most recent prior A1c was 7.0 on 11/12/2020
52 2021-03-30 tingling, numbness, face paralysis Paresthesias in upper and lower extremities; left facial numbness and paresthesias; left facial weak... Read more
Paresthesias in upper and lower extremities; left facial numbness and paresthesias; left facial weakness; fasciculations in abdomen and face; This is a spontaneous report from a contactable physician. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 52-year-old intramuscular on 21Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. There were no covid prior vaccination and covid tested post vaccination. The patient experienced Paresthesias in upper and lower extremities, left facial numbness and paresthesias, left facial weakness, fasciculations in abdomen and face on 21Jan2021, resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment was received including Prednisone. The outcome of events was recovering. Information on batch/lot number was requested.
52 2021-03-30 tingling After leaving the location I got tingling at the base of my neck, soon after it moved to the left si... Read more
After leaving the location I got tingling at the base of my neck, soon after it moved to the left side of left side of my the back of my head around my ear, then I started to get ringing in my ear which is progressively getting louder. I am rather concerned.
52 2021-03-31 pain in extremity, tenderness arm pain; Also reports joint stiffness around neck and shoulder; Lymphadenopathy-Lymph Node Pain/te... Read more
arm pain; Also reports joint stiffness around neck and shoulder; Lymphadenopathy-Lymph Node Pain/tenderness on right side- near the axilla, underneath the arm next to the chest; Lymphadenopathy-Lymph node pain around left clavicle; Lymphadenopathy-Lymph node pain around left clavicle; This is a spontaneous report received from a contactable pharmacist (patient himself). A 52-year-old male patient received first dose of BNT162B2 (Solution for injection, Lot Number: EN6205, Expiry date: Jun2021), via intramuscularly to the left arm on 26Feb2021 at single dose for COVID-19 immunization. The patient medical history included Hypertriglyceridaemia ongoing. Concomitant medication included Fenofibrate. The patient previous vaccination included Shingrix used for shingles and experienced with sore arm. The patient lab test included Sar-cov-2 which was negative. Patient reported that he received his first dose of the Pfizer BioNTech covid vaccine on 26Feb2021. He is due for his second dose this Friday 19Mar2021. He is calling because he experienced lymphadenopathy- explains he experienced Lymph node pain/tenderness around his left clavicle. Caller clarified that the injection was on his left side. The pain/tenderness occurred the next day, 27Feb2021 and it was self limiting and it lasted about 5-7 days. He didn't think anything of it, everything else was ok, the arm pain resolved after one day. On 12Mar2021, he developed similar pain on the right side, but it was a more intense pain/tenderness and lasted maybe 4 days. He still experiences it, but less frequently. He is not sure if he is describing it correctly. During the afternoon, it gets a bit more tender. He doesn't feel it in the morning, but by the afternoon he notices the pain/tenderness. He did not know if there were any reports of contralateral lymphadenopathy (lymph node pain). He clarified that there is no redness or lump- he doesn't feel anything, even if he touches it there's no pain, but periodically there will be a shooting tenderness. He feels like it's getting better, but it is still persisting. He clarified that on the right side- he is experiencing pain near the axilla, underneath the arm next to the chest. He is waiting to see if it is improving and doesn't know how long he should wait. He stated that it wasn't that painful on the left side, it was just a little tender; he knew something was different. The pain wasn't always there. Sometimes there's a little pain on the left side still, but not as intense as the right side. The pain is there, it's not worsening but it is not improving. The patient also reports joint stiffness around neck and shoulder and describes discomfort as ongoing intermittent tenderness. The reporter reported events Lymphadenopathy-Lymph node pain around left clavicle, Lymphadenopathy-Lymph Node Pain/tenderness on right side- near the axilla, underneath the arm next to the chest to be serious due to Medically significant. The outcome of events was not recovered. No follow-up attempts needed. No further information expected.; Sender's Comments: Based on the available information, temporal association and known product profile, a possible causal relationship cannot be excluded between the suspect product BNT162B2 and the reported events Lymphadenopathy, Lymph node pain and Tenderness. 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.
52 2021-03-31 pain in extremity Swelling, pain in arm, joint pain, chills, slight fever, congestion, headache.
52 2021-03-31 pain in extremity Mild symptoms including chills, headache, fatigue, arm soreness more intense than first shot (but no... Read more
Mild symptoms including chills, headache, fatigue, arm soreness more intense than first shot (but no problems with mobility).
52 2021-04-01 pain in extremity heart attacks; bad immune system; lethargic; mild headache; feeling not well; soreness in the arm in... Read more
heart attacks; bad immune system; lethargic; mild headache; feeling not well; soreness in the arm initially; may be dehydrated; This is a spontaneous report received from contactable consumer (patient) via medical information team. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration at the age of 52-years, on 20Mar2021 at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that on 20Mar2021, he had the Pfizer covid vaccine and experienced lethargic, mild headache, feeling not well, soreness in the arm initially on an unspecified date. The patient also stated that he had heart attacks, has a bad immune system on an unspecified date and may be dehydrated. The outcome of the events was unknown. Information on the lot/batch number has been requested.
52 2021-04-03 flushing Flushing/sweating, dizzy. History of fainting with shots. BPs 154/92, 121/74 (pulse 52). O2 sats 97%... Read more
Flushing/sweating, dizzy. History of fainting with shots. BPs 154/92, 121/74 (pulse 52). O2 sats 97%, 100%.
52 2021-04-04 burning sensation, numbness and pain in extremities I developed cipro toxicity in 2017 due to a dose of cipro combined with steroids. Symptoms include n... Read more
I developed cipro toxicity in 2017 due to a dose of cipro combined with steroids. Symptoms include neuropathy, tendon damage, vision and hearing issues, muscle aches and burning sensations throughout the body. These symptoms flare. I have been pain free for four months before getting the Pfizer vaccine. All of my symptoms came back 2 hours after the shot.
52 2021-04-04 night sweats Night sweats starting 5 or 6 nights after vaccine and lasting through at least last night.
52 2021-04-06 weakness Dizziness, weakness, feeling faint, disoriented, headache, some shortness of breath
52 2021-04-06 tremor, weakness, pain in extremity anaphylactic shock Began with neck pain on left side, heavy dry mouth, profuse sweating, saw odd co... Read more
anaphylactic shock Began with neck pain on left side, heavy dry mouth, profuse sweating, saw odd colors and dashboard of car coming at me in design, very cold and light headed, trouble breathing, throat felt swelled, bowels and bladder felt they were going to let loose. went unconscious, - after recovery I had tremors for a few hours such that I could not hold a glass of water, legs felt hot to the touch and ached for several days. Still feel weak and tired.
52 2021-04-07 tingling, numbness Shortly after receiving the first shot, I started getting numbness and tingling in my left hand. I r... Read more
Shortly after receiving the first shot, I started getting numbness and tingling in my left hand. I received the shot in my left arm. The numbness / tingling still continues today.
52 2021-04-08 weakness Severe vertigo with onset approximately 8 hours after injection. Mild fever symptoms but temperature... Read more
Severe vertigo with onset approximately 8 hours after injection. Mild fever symptoms but temperature wasn't measured. Lethargy and weakness accompanied other symptoms. Symptoms cleared after 48 hours.
52 2021-04-08 flushing Syncope, Diaphoretic, Flush, arrhythmia
52 2021-04-08 tingling Patient reports a sensation of tingling at the site of his vaccine. He reported a sensation of swel... Read more
Patient reports a sensation of tingling at the site of his vaccine. He reported a sensation of swelling, but no swelling was noted on examination. The symptoms lasted about 15 minutes.
52 2021-04-11 tingling, numbness Numbness and tingling from, and including, tips of left thumb, index, and middle finger (ring and li... Read more
Numbness and tingling from, and including, tips of left thumb, index, and middle finger (ring and little finger unaffected) and extending up top of arm to elbow and tightness in the entire shoulder area. Has been ongoing since onset, and is affected by arm position. Symptoms never fully alleviate, as there is always residual mild numbness in my fingers/hand. Have not sought treatment yet, as I am uninsured and have no idea what my options are. Symptoms are ongoing.
52 2021-04-12 weakness, tremor, pain in extremity, feeling hot, feeling cold tremors; legs felt hot; legs felt hot to the touch and ached; weak; tired; anaphylactic shock; went ... Read more
tremors; legs felt hot; legs felt hot to the touch and ached; weak; tired; anaphylactic shock; went unconscious; neck pain; heavy dry mouth; profuse sweating; saw odd colors and dashboard of car coming at me in design; very cold; light headed; trouble breathing; throat felt swelled; bowels and bladder felt they were going to let loose; bowels and bladder felt they were going to let loose; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 02Apr2021 at 14:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies (sometimes seafood and some fresh fruits) from an unknown date and unknown if ongoing. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), lisinopril and lamotrigine (LAMICTAL), all taken for an unspecified indication, start and stop dates were not reported. The patient experienced anaphylactic shock which began with neck pain on left side, heavy dry mouth, profuse sweating, saw odd colors and dashboard of car coming at him in design, very cold and light headed, trouble breathing, throat felt swelled, bowels and bladder felt they were going to let loose. The patient then went unconscious. After recovery, the patient had tremors for a few hours such that he could not hold a glass of water, legs felt hot to the touch and ached for several days. Still feel weak and tired. Reaction began about 18 minutes (also reported as 14:15) after the shot. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering. The events were assessed as serious and life-threatening by the regulatory authority. Information on the lot/batch number has been requested.
52 2021-04-12 pain in extremity Within moments of injection experienced metallic taste in mouth that lasted several days. Day after ... Read more
Within moments of injection experienced metallic taste in mouth that lasted several days. Day after vaccine experienced fever up to 100.5 (even with 400 mg ibuprofen every 6 hours) that lasted 18 hours. Substantial pain that traveled from shoulder down the left arm. Very large swelling of the lymph node in left arm pit three days after injection. (not recovered from this yet)
52 2021-04-12 sciatica Sciatica, muscle pain, back pain. Difficulty walking, sleeping, due to pain. 2 weeks duration (so fa... Read more
Sciatica, muscle pain, back pain. Difficulty walking, sleeping, due to pain. 2 weeks duration (so far).
52 2021-04-13 difficulty speaking Patient received his second vaccination 2 days prior to presentation. States he woke yesterday feel... Read more
Patient received his second vaccination 2 days prior to presentation. States he woke yesterday feeling tired with associated chills, nausea, decreased appetite and hoarse voice. He was able to go to work as usual. He came home and ate some fish and clam chowder for dinner. Around 7pm that evening, his voice became muffled. Symptoms progressed to difficulty swallowing and sensation of throat swelling so he came to the emergency department for evaluation. On arrival to the ED, he was noted to have water bag edema of the uvula. O2 sats 98% on room air, no respiratory distress. He was treated with diphenhydramine, famotidine, and methylprednisolone and observed. No progression of symptoms noted.
52 2021-04-13 tremor, muscle spasms Diarrhea since 04/06/2021 everyday two times per day. On April 8th developed heavy abdominal pains ... Read more
Diarrhea since 04/06/2021 everyday two times per day. On April 8th developed heavy abdominal pains and fainted became rigid, clenched fists, and shook like a seizure. My wife stood by my side and witness me waking up pale and confused after about 10 seconds of episode. I continue to have diarrhea.
52 2021-04-14 night sweats Received a Janssen product 3 weeks earlier. His wife had received the Pfizer and she had a 2nd appt... Read more
Received a Janssen product 3 weeks earlier. His wife had received the Pfizer and she had a 2nd appt and he thought he needed one as well. Cough, generalized soreness, lethargy, shortness of breath, joint pain, watery diarrhea, night sweats.
52 2021-04-14 tingling Tingling sensation all over my shoulders radiating to both hands.
52 2021-04-14 tingling Tingling intermittently throughout body
52 2021-04-16 cold extremities, weakness I work 3rd shift Started with chills about 11pm same day as shot, then by 3am my heart rate dropped ... Read more
I work 3rd shift Started with chills about 11pm same day as shot, then by 3am my heart rate dropped to 48 bpm and extreme shivering. (My normal resting rate is about 80 bpm). Heart rate came back up shortly but still below my normal bpm. When I got home at 7am was very weak and chilled, and on both hands my fingers turned completely white like they wasn?t getting circulation and were very cold.. I went to bed feeling horrible hoping it wasn?t serious and after I slept more than normal, I feel good now. Can?t say my heart rate going that low wasn?t kinda scary.
52 2021-04-17 bell's palsy Came down with Bell's palsy symptoms 5 days after injection on the Right side of my face.; This is a... Read more
Came down with Bell's palsy symptoms 5 days after injection on the Right side of my face.; This is a spontaneous report from a contactable consumer reported for himself. A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 27Mar2021 (Lot Number: ER8732) as single dose for covid-19 immunisation. The patient previously took the first dose bnt162b2 on 06Mar2021 for covid-19 immunization. The patient medical history included allergies to penicillin. The patient's concomitant medications were not reported. The patient came down with bell's palsy symptoms 5 days after injection on the right side of face on 01Apr2021 06:00. Facial paralysis resulted in emergency room visit. Therapeutic measures were taken as a result of facial paralysis included Steroid and Viral scripts. The outcome of event was unknown. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.
52 2021-04-18 numbness, tingling, pain in extremity Numbness, pain and tingling in lower left leg and foot. Started 5-7 days after 1st shot and acceler... Read more
Numbness, pain and tingling in lower left leg and foot. Started 5-7 days after 1st shot and accelerated after 2nd shot
52 2021-04-18 unresponsive to stimuli 4 episodes of nausea/vomiting/diarrhea, then found by spouse with altered mental status and nonrespo... Read more
4 episodes of nausea/vomiting/diarrhea, then found by spouse with altered mental status and nonresponsive/snoring. Taken to Emergency department for stroke evaluation. Ruled out for stroke, intubated for airway protection and cerebral edema with meningeal enhancement observed on CTA. Admitted to ICU.
52 2021-04-19 pain in extremity Systemic: Big toe swelling/pain day after immunization-Medium
52 2021-04-21 pain in extremity Pain and swelling in the elbow of the opposite arm of the shot. Some redness, stiffness and a lot o... Read more
Pain and swelling in the elbow of the opposite arm of the shot. Some redness, stiffness and a lot of swelling a little over 24 hours after the covid-19 shot.
52 2021-04-21 tremor 2:30pm - Vaccine administered. Some muscle soreness at the vaccination site, but otherwise no notic... Read more
2:30pm - Vaccine administered. Some muscle soreness at the vaccination site, but otherwise no noticeable side effects. 1am - 10 hours after vaccine. All over body shaking. Not unlike "chills" but didn't have the cold feeling with it. No accompanying fever at the time. Lasted until 5:30am. 6am - 15 hours after vaccine . Shortly after the shaking stopped, spiked a 101.5 degree fever. That continued until approximately 5am the following day. Took 500mg acetaminophen at 7am, and again at 4pm, and again at 12am. Throughout the following day - 15 hours to 36 hours after vaccine - general body aches (most noticeable in the back), lethargic - but that could have been a result of no sleep the night prior due to shaking. 5pm following day - 27 hours after vaccine - bad headache. That lasted until midnight 5am the next morning - most all side effects gone. Some lethargy but temperature at 98.6 degrees, body aches no longer apparent, headache gone.
52 2021-04-22 grand mal seizure, muscle twitching, tremor 52 yo male received first dose of Pfizer vaccine on 3/20 at outside institution. The next morning, p... Read more
52 yo male received first dose of Pfizer vaccine on 3/20 at outside institution. The next morning, pt experienced uncontrollable tremors and twitching and presented to the ED. In the ED, patient had generalized tonic-clonic seizure that lasted for about 1-3 minutes. CT head scan was unremarkable. Neurology started pt on Keppra 500 mg BID and plan for MRI and routine EEG. The next morning, pt felt back to baseline and was alert and oriented. Patient has a history of HIV and stroke with residual right-sided weakness. He has no history of seizure nor reactions to vaccines. Physician advised patient that he should not receive second dose of vaccine.
52 2021-04-22 muscle spasms Muscle spasm, twitching of the tongue, soreness in teeth/jaw.
52 2021-04-22 pain in extremity, numbness 4/15 immediate post-injection reaction: "Patient evaluated for chest pain after vaccine. Patient wit... Read more
4/15 immediate post-injection reaction: "Patient evaluated for chest pain after vaccine. Patient with L sided chest pain and back pain immediately after vaccine. Patient had identical reaction after first dose. When patient was laid in bed and given oral hydration, pain resolved. Patient felt confident that this was anxiety as with his first vaccine. VS and exam WNL. 2 lead EKG showed NSR with no clear ST changes. Patient was returned home with wife as driver. " 4/16 reaction: patient contacted PCP with complaints of "Nausea, stomach ache, headache, injection site discomfort, fatigue, some diarrhea." Patient requested something for nausea. Provider prescribed ondansetron. 4/22: patient contacted PCP with complaints that since 2nd dose, he has felt "Fatigue and feet pain with swelling and intermittent numbness . Also since then has not been able to control CBG, in AMs >200, using medications as prescribed." PCP monitoring; no medication treatments.
52 2021-04-22 pain in extremity SIRVA. Patient developed severe left shoulder/arm pain and weakness 48 hours after receiving Pfizer ... Read more
SIRVA. Patient developed severe left shoulder/arm pain and weakness 48 hours after receiving Pfizer vaccine.
52 2021-04-23 feeling cold 4/5 - Trip to emergency room, fever 104 to 104.3, headache, backache, neckache (right side), chills,... Read more
4/5 - Trip to emergency room, fever 104 to 104.3, headache, backache, neckache (right side), chills, muscle aches, diarrhea, lethargic - first 3 days, then next 4 days - intermittent fever - low grade, muscle aches, very lethargic, and diarrhea. (7 or a few more in total) 4/20/21 - 2nd shot - 36 hours of low grade fever, 100 or less, headache, chills, muscle aches and diarrhea.
52 2021-04-24 numbness and pain in extremities, feeling cold Significant mental impacts: Depression (to the point of suicidal ideation); Neuropathy in Face, Arms... Read more
Significant mental impacts: Depression (to the point of suicidal ideation); Neuropathy in Face, Arms, Legs; Sensation of coldness in bones; Extreme sudden fatigue; Significant mental impacts: Depression (to the point of suicidal ideation); Inability to concentrate; Light sensitivity; low grade headache in center of brain; This is a spontaneous report from a non-contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 03Apr2021 10:30 (Batch/Lot Number: ER8732) as single dose for COVID-19 immunization, in the hospital. Medical history included nonalcoholic fatty liver disease (NAFLD), now almost gone, from an unknown date. The patient has no history of COVID prior vaccination. The patient was not COVID tested post vaccination. There were no concomitant medications. The patient experienced neuropathy in face, arms, legs, sensation of coldness in bones, extreme sudden fatigue, significant mental impacts: depression (to the point of suicidal ideation), inability to concentrate, light sensitivity, and low grade headache in center of brain, all experienced on 04Apr2021 12:00 AM. No treatment was given for the events. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
52 2021-04-24 pain in extremity Side effects: light chills, strong headache (3 days, after now 9 days still coming back briefly), fe... Read more
Side effects: light chills, strong headache (3 days, after now 9 days still coming back briefly), fever (37.8C), muscle pain, body joint pain for 3 days, left arm pain (3 days), sweating (2nd night), fatigue for ~2days, and most importantly: for over 9 days/nights swollen nymph knot under left arm, was as big as a full hand full (like a full bar of soap), has meanwhile improved daily, but I can still sense a small (wallnut size) under the arm now, 9 days after the shot. It's important to inform because the media and the doctors are not reporting how bad and lasting the side effects are and it is important to be transparent to patients what to expect, otherwise trust is eroded and people stop getting vaccinated.
52 2021-04-25 throat numbness 09:53 tingling / numbness to back of throat no sob or tongue swelling wctm. Recheck 10:10 vs. tingl... Read more
09:53 tingling / numbness to back of throat no sob or tongue swelling wctm. Recheck 10:10 vs. tingling decrease pt going. instructions for calling EMS should allergy symp. increase. pt stable decreasing symptoms no sign of allergic reactions
52 2021-04-26 numbness, pain in extremity, tingling Vaccine April 24th 9:15 am, by afternoon was feeling tingling and numbness in left side of face. Apr... Read more
Vaccine April 24th 9:15 am, by afternoon was feeling tingling and numbness in left side of face. April 25th, arm hurt, headache (typical), but tingling and numbness was increasing. It felt like I had a novocaine shot. April 25th Doctor said to got to ER. At ER they had me take an EKG, Full Blood Work, CT Scan and CTA Scan. MRI to be determined in a couple days.
52 2021-04-27 pain in extremity serious pain on his left leg; This is a spontaneous report received from a contactable consumer, the... Read more
serious pain on his left leg; This is a spontaneous report received from a contactable consumer, the patient. A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as a single dose (at the age of 52 years-old) for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) for COVID-19 immunisation. The patient experienced serious pain on his left leg on an unknown date in Mar2021 after the second dose of bnt162b2. The patient underwent lab tests and procedures which included x-ray on an unknown date: which showed x-ray hasn't had any improvement. The clinical outcome of the event serious pain on his left leg was unknown. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
52 2021-04-28 weakness First vaccine was 3/1/21. 3/2/21 had muscle & joint aches, weakness, low grade temp, swollen lymphoi... Read more
First vaccine was 3/1/21. 3/2/21 had muscle & joint aches, weakness, low grade temp, swollen lymphoid under arm until 3/3/21. Second vaccine was 3/22/21. Had same symptoms only more severe & higher temp. This time I was sick 4 days & unable to work. I was not better until 3/26/21
52 2021-04-28 numbness, slurring Ringing of ears intensified; Face was numb; Slurred speech; Slight swelling of tongue; Slight troubl... Read more
Ringing of ears intensified; Face was numb; Slurred speech; Slight swelling of tongue; Slight trouble breathing; Wheezing; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Er8735), via an unspecified route of administration, administered in left arm on 12Apr2021 as single dose for COVID-19 immunisation. Medical history included known allergies on certain beta blockers and macadamia nuts from an unknown date and unknown if ongoing. The patient has no history of COVID prior vaccination and was not COVID tested post vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number= Er6204) on 22Mar2021 11:30 AM, on left arm, for COVID-19 immunisation, and experienced ringing in both ears. Upon receipt of the second shot, ringing of ears intensified and has continued to present. Additionally, approximately 25 minutes after the second shot on 12Apr2021, the patient's face was numb, had slurred speech and slight swelling of tongue, slight trouble breathing with wheezing. Face numbness subsided after 10 hours. The events resulted in disability or permanent damage. No treatment for the events was received. The patient has not recovered from the reported events.
52 2021-04-28 unresponsive to stimuli Pt received vaccine, wife was receiving her vaccine and pt became unresponsive, diaphoretic. 1150: C... Read more
Pt received vaccine, wife was receiving her vaccine and pt became unresponsive, diaphoretic. 1150: Code Medical called immediately. Car seat reclined.. BP 92/50, HR 40, RR18. Pt pale and diaphoretic. 1152: Pt arousing but unable to communicate clearly. BP 98/48, HR 40, RR1. Able to drink OJ, small sips. 911 activated. 1154: Pt removed from car and placed on cot awaiting EMS. 1156: Pt answering questions, remains pale and diaphoretic. BP 102/62, HR 54. Alert & Oriented X3. 1202: EMS arrived and walked pt to ambulance. BS 102, BP 114/68, HR 51. Skin warm and dry. Alert & Oriented. Pt to be transported to ED secondary to decreased Heart Rate.
52 2021-04-29 weakness soon after shot, pain in muscle area ...around 11 hrs later,very bad chills, body aches started.. t... Read more
soon after shot, pain in muscle area ...around 11 hrs later,very bad chills, body aches started.. then as time went on nausea, weakness and running low grade fevers..symptoms getting better and worse over a period of time thru late Sunday morning when started to feel like myself..by the end of the day, felt better..
52 2021-04-29 numbness, tingling Tingling and numbness in both arms (below the elbow to hands) & legs (below the knees to the feet). ... Read more
Tingling and numbness in both arms (below the elbow to hands) & legs (below the knees to the feet). Started in right arm and progress to the other extremities within a few hours. Neurologist has seem me and is conduction further tests including an EMG. Test is being taken 4/30/21. At this time the tingling and numbness has climbed above the knee and has stayed the same in the arms.
52 2021-04-30 numbness, bell's palsy 3/31: earache, headache 4/1 ? 4/4: earache, headache, sore throat, vertigo, vomiting, brain fog. On... Read more
3/31: earache, headache 4/1 ? 4/4: earache, headache, sore throat, vertigo, vomiting, brain fog. On 4/4, doctor prescribed Amoxicillin 125 MG 2x/day 4/5 ? 4/7: sharp earache with pressure, loss of hearing in left ear, sore throat, brain fog, headache 4/8 ? 4/11: noticed Ptosis, numbness left side of face, persistent headache. Went to Emergency Room, performed CT scan, blood test, confirmed there is no stroke, DIAGNOSED FOR BELLS PALSY. Prescribed Prednisone and Valacyclovir for 7 days. 4/12 ? 4/22: Treated by NP for Bells Palsy, referred for rehab/therapy. 4/23: symptoms clear, Bells Palsy 95% return to normal 4/30 : received 2nd Pfizer vaccine dose Lot # ER8737
52 2021-04-30 night sweats fever, chills, joint and muscle aches, night sweats, fatigue, lightheadedness, foggy headedness, - 3... Read more
fever, chills, joint and muscle aches, night sweats, fatigue, lightheadedness, foggy headedness, - 3 days in a row starting April 8 then subsided and started again a few days later
52 2021-05-01 burning sensation Within a week of vaccine started to have intense itching on back. A week later it progressed to the ... Read more
Within a week of vaccine started to have intense itching on back. A week later it progressed to the torso - both on the right side. Was diagnosed with shingles on April 18th and began a round of antiviral which reduced itching/burning sensation and reduced rash. Rash is now nearly gone although still feeling very fatigued.
52 2021-05-01 tremor, feeling cold, pain in extremity, seizure Upper arm soreness started at about 8:30 pm, about 10 h after injection. Went to be like normal and ... Read more
Upper arm soreness started at about 8:30 pm, about 10 h after injection. Went to be like normal and arm was just sore, but nothing else at that time. At 1:10 am, patient woke up with horrible shakes, verging on convulsions, and the feeling of freezing to death. Uncontrollable shivers/shaking. At around 1:40 am, patient was able to move enough to get out of bed to find a second blanket and extra strength Tylenol and took the Tylenol with some seltzer water and hid under blankets to get warmer. After about an hour, around 2:30 - 2:40 am, the shaking was reduced enough that the patient was able to relax and try to get to sleep. At 5;30 am, the patient woke up with much the same symptoms, but with the addition of the worst headache he had had since he stopped having migraines in his mid 20s and also his whole body ached like he had been hit by a truck (that [getting hit by a truck] had happened to him once about 15 years ago, so he has the actual reference to compare against). This experience was worst overall body aches/pains ever experienced by the patient. He took additional Tylenol at 6 am and about 30 minutes later, the chills subsided and the pain was reduced enough that he could go to sleep again. Shortly before 10 am the symptoms started to get worse again and he took ibuprofen (400 mg) at 10 am, after the shakes started to come back. He has traded off every 4 hours taking tylenol and ibuprofen, which keeps the temperature perception swings to a minimum and overall body aches lower, but the headache does not go away. He feels exhausted, and has slept for spurts of 15 - 30 minutes on and off all day. He was able to each crackers at around noon and some homemade chicken vegetable soup at about 1 pm as the nausea had subsided. Prior to that, he could only drink water and Gatorade. He is hoping that within 24 - 48 h he will feel much better, without having to take Tylenol or Ibuprofen.
52 2021-05-02 migraine, muscle spasms, tenderness Blood clotting in the left leg, Use ultrasound to identify and confirm clotting locations in the le... Read more
Blood clotting in the left leg, Use ultrasound to identify and confirm clotting locations in the left calf leg. Cramp like pain in the left calf with blue-ish/purple color in the ankle and left foot. Foot and leg was cold to the touch with extraordinarily strong migraines. Person leads healthy lifestyle and is physically and athletically fit. I was given Gemtesa to treat the clots, 150mg x2 a day for 7 days then to 75mgx2 a day for an unknown period. First dose on 3/24/ 2021 Pfizer Lot#EN6205 Second Dose ON 04/14/2021 LOT#EW0161 10:30AM.
52 2021-05-02 pain in extremity, cold extremities, migraine Blood clotting in the left leg, Use ultrasound to identify and confirm clotting locations in the le... Read more
Blood clotting in the left leg, Use ultrasound to identify and confirm clotting locations in the left calf leg. Cramp like pain in the left calf with blue-ish/purple color in the ankle and left foot. Foot and leg was cold to the touch with extraordinarily strong migraines. Person leads healthy lifestyle and is physically and athletically fit. I was given Gemtesa to treat the clots, 150mg x2 a day for 7 days then to 75mgx2 a day for an unknown period. First dose on 3/24/ 2021 Pfizer Lot#EN6205 Second Dose ON 04/14/2021 LOT#EW0161 10:30AM
52 2021-05-03 muscle twitching The first 2 days had fever chills fatigue teeth hurt headache tiredness. 4 days after shot have dev... Read more
The first 2 days had fever chills fatigue teeth hurt headache tiredness. 4 days after shot have developed a cough left side chest pain at times twitching in left shoulder area headaches and now have a difficult time doing anything physical like simple walking feel out of breath.
52 2021-05-03 tingling Tingling sensation on Right fingertips BP:148/101 first reading BP: 169/110 Second reading Pulse 8... Read more
Tingling sensation on Right fingertips BP:148/101 first reading BP: 169/110 Second reading Pulse 82 BP: 164/106 third reading Rapid response team activated and team assesed patient Patient is advised to go to the ER for further evaluation BP: is going up after 15 minutes. Patient refused to go to ER. Patient stated he will consult his primary care physician he feels better. No more tingling sensations. RN witness patient completed statement. "I am doing ok - I am ok thanks all good care greatful to Hospital.
52 2021-05-04 muscle spasms Evening symptoms, injection site pain, mild headache, sleeplessness caused by mild limb spasms till ... Read more
Evening symptoms, injection site pain, mild headache, sleeplessness caused by mild limb spasms till 1:00 am. Spasm symptoms seem to have subsided, headache remained mild. able to fall asleep. Awoke at 5:30 (normal time) seemed good other than arm soreness. By 8 am I developed Vertigo like symptoms. 48hrs after injection this morning, the headache is gone but vertigo symptoms remain however lesser than the previous day.
52 2021-05-06 bell's palsy, facial paralysis patient developed left facial paralysis consistent with Bell's Palsy 7 days after receiving the COVI... Read more
patient developed left facial paralysis consistent with Bell's Palsy 7 days after receiving the COVID19 Pfizer vaccine #1
52 2021-05-06 feeling hot Pt was administered second dose of pfizer after assessment by PA. Pt reported that he felt "hot" wit... Read more
Pt was administered second dose of pfizer after assessment by PA. Pt reported that he felt "hot" within min of administration. Vs stable and pt skin was warm and dry. Pt tolerated po water w/o difficulty. Pt bp and pulse monitored after 30 min watch over at 1335 as pt aroused and still c/o feeling warm. Sandwich and juice offered and refused, cold pack offered and pt placed behind his head. Pt then noted to sleep with easy rr, skin remained warm and dry, no c/o nausea, no redness, itching or hives noted. After 1 hr watch, 1405, pt aroused and was ambulated in the hall with continuous pulse ox which remained above 93% on ra with ambulation 40 feet. Pt c/o "not feeling well', c/o still feeling hot and has a cough that leads to sob. Pt noted to have slight audible wheezing as reported by PA. O2 sats at this time are still maintained above 93% which is pt baseline. Pt was slightly unsteady on his feet while ambulating. Pt to take rescue inhaler but did not bring it with him. Medical response called and pt taken to ED across the hall via WC with this writer. Report given to RN in ED. 1310 152/87 93% 18 1344 147/87 69 96% 97.9 18 1354 130/87 77 94% 18 1404 89 95% 20
52 2021-05-07 migraine Migraine, chills, body aches, very tired feel, strong body pain all over
52 2021-05-07 pain in extremity 3 weeks after second shot arm started feeling sore like it was after the first shot.
52 2021-05-09 bell's palsy Developed Bell's Palsy, now being referred to neurologist.
52 2021-05-10 numbness blurry eyes; Headache; numb face and arms; Felt dizzy; Had to call out of work to rest and sleep all... Read more
blurry eyes; Headache; numb face and arms; Felt dizzy; Had to call out of work to rest and sleep all day; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A 52-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on 19Apr2021 16:00 as single dose for COVID-19 immunization. The patient's medical history included diabetes. Concomitant medication was not reported. The patient received second dose of Pfizer BioNTech Covid 19 vaccine on Monday 19Apr2021 around 4pm. The next day the patient experienced numb face and arms, felt dizzy, and had to call out of work to rest and sleep all day. Today he felt okay but started feeling dizzy with a headache and blurry eyes. He has diabetes but has been taking his blood sugar in the morning and they have been okay. He has been taking tylenol for the headaches. The patient said he was driving to work next day and face and arm went numb. Had to turn around and go back home. Next day tried going to work again, face and arm went numb also was dizzy and slight headache. Wants to know if this side effect has been reported and what do we suggest. It was reported that the patient went to see his animals and I (sentence incomplete). I am calling you because of the side effects that I am having from the vaccine. Also, I want to know if this was the part of the side effects that was going on with me. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
52 2021-05-10 numbness eyes kind of cloudy; dizzy and off balance; Headache; dizzy and off balance; whole right arm and fac... Read more
eyes kind of cloudy; dizzy and off balance; Headache; dizzy and off balance; whole right arm and face numb; Drowsiness; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER8734, on 19Apr2021 16:00 at single dose in left arm for COVID-19 immunization. Medical history included ongoing Diabetes mellitus since 2011. Concomitant medication was none. The patient previously received first dose of BNT162B2, Lot: GR8735, on 28Mar2021. The patient received his second dose of the Pfizer Covid-19 vaccine at 1600 on Monday (19Apr2021). Yesterday (20Apr2021), he went to work to feed his horses and he couldn't work. He was drowsy, his whole face and right arm was numb, he rested all day. Today (21Apr2021) as he was driving to work he pulled over. He had a headache and was drowsy and his eyes were kind of cloudy. The patient was drowsy early this morning again, it came back like yesterday morning. He laid down in his truck and rested and he got better. His arm and face being numb started yesterday around 9am and stopped between 1800 to 1900. At the jobsite, it was lunchtime and he drove the employees, reported his eyes bring kind of cloudy was better now. This morning he was drowsy and dizzy, off balance. He stayed in his truck. His balance was getting back to normal again. He had been taking Tylenol for his headache. The outcome of Drowsiness, eyes kind of cloudy, dizzy and off balance was resolving. The outcome of whole right arm and face numb was resolved on 20Apr2021. The outcome of Headache was unknown. No follow-up attempts are needed. No further information is expected.
52 2021-05-10 pain in extremity pt woke up Friday morning (after having had vaccine on Wednesday evening) with R calf pain and swell... Read more
pt woke up Friday morning (after having had vaccine on Wednesday evening) with R calf pain and swelling. He was sent to ER, where he was diagnosed with DVT
52 2021-05-11 numbness Sharp pain at injection site. Arm completely numb the following day.
52 2021-05-12 pain in extremity, weakness A lingering and recurring soreness in left shoulder and arm. Occasionally, it was almost to a debil... Read more
A lingering and recurring soreness in left shoulder and arm. Occasionally, it was almost to a debilitating extent. The past few days my left chest or pectoral area is feeling odd. I have inquired with several different nurses from several different agencies/offices and the consensus is possible nerve damage from the injection. It is because it is recurring that I am reporting this.
52 2021-05-14 pain in extremity Blood Clot in right leg; Severe pain in leg; cry; This is a spontaneous legal report (Marketing Prog... Read more
Blood Clot in right leg; Severe pain in leg; cry; This is a spontaneous legal report (Marketing Program) from a contactable consumer (patient himself). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection) dose 2 (Batch/Lot Number: EW0770) via an unspecified route of administration, on 21Apr2021 11:30, as single dose for covid-19 immunization. Medical history included Asthma ongoing, Diabetes had been on and off since 2018, Covid-19 in an unspecified date in Jan2021. The patient received dose 1 (Batch no/Lot Number: ER8732) via an unspecified route of administration, on 29 Mar 2021, as single dose for covid-19 immunization. The patient's concomitant medications were not reported. On 21Apr2021 around 11:30-12:00 in the night the patient experienced Blood clot in his right leg, had a severe pain and cannot walk, feels like he's being stabbed in the leg every time he gets up. He had to keep his legs up all the time and not put them down. He stated that his life was going to be upside down for 6 months because of the Covid vaccination. Stated that was unacceptable. Reporter also said that if the blood clot breaks off it could be dangerous. Said it was substantial; it was all the way up to his groin, not its down almost to his knee and goes all the way down to his ankle. Patient went to the hospital last Saturday due to pain in the back of his leg. The pain started 12 hours after the second Covid vaccine. He wanted to cry he was in so much pain. He could not take anything for it. Patient stated that if the clot breaks off, he was dead. So, he had to put everything on hold because he did the right thing which ended up being the wrong thing. Patient stated that the pain in his leg was a 13 or 14 on a scale of 1-10. Patient took Tylenol and Pain patches did not work on a blood clot. Patient stated that when he was in the hospital, 4 different doctors, told him the event was at least 50 if not 100 percent caused by the Covid dose of vaccine. Patient stated that after the first dose of vaccine he was sick as a dog and he said that the clot may have started with the first dose of vaccine, stated that he had a 102 degree fever a few minutes after the vaccination, felt dizzy and thought he was going to fall over. Patient stated that he got the vaccination dose to get his life back and now he could not, that what about in 6 months if he had to get a booster vaccine and probably go through it all over again; or to be on quarantine. Patient stated that he went with his 84-year-old mother to get the vaccine. Patient said that the only reason she didn't get a blood clot was because she was already on blood thinners and said that he is the one who takes care of his mom and now he cannot walk barely, he had Covid in January and that people who had Covid shouldn't be taking these vaccinations because they have immunity, he talked to a doctor and a woman yesterday who still have their antibodies a year after having Covid. He said that the vaccine was injuring people. He was hospitalized related to his leg pain and diagnosed with the blood clot from 24 Apr 2021 to 27 Apr 2021. In the hospital he was told to him take Oxycontin or Morphine. He said that he did not want to take those and end up addicted. He said after a motor vehicle accident he had in 2002 he took Naprosyn and it helped, he said could not take that now because he was on a blood thinner. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had tested COVID-19 positive prior to vaccination. This is to notify that potential legal action from a reporter in the attached source document booked into AER 2021506757 and 2021506972. The outcome of the event Blood Clot in right leg and Severe pain in leg was not recovered, feels like he's being stabbed in the leg was recovered and cry was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
52 2021-05-16 weakness Fatigue, weakness, general ill-feeling, fever measured at 101.5 on Saturday, May 8. Fatigue continu... Read more
Fatigue, weakness, general ill-feeling, fever measured at 101.5 on Saturday, May 8. Fatigue continued until May 13.
52 2021-05-16 pain in extremity Loss of use of right arm from shoulder to wrist
52 2021-05-16 tenderness, tingling - fever and chills during overnight hours the past 2 nights after shot, unable to sleep for more tha... Read more
- fever and chills during overnight hours the past 2 nights after shot, unable to sleep for more than an hour at a time. - headache most of the day on Sunday, headache area more so on top of head and some tingling in head at times. - worse chills overnight the 2nd night, had to change pajamas due to chills and sweating 2nd night. - 2nd shot given in left arm, 2 mornings later (Monday), excessive swelling in left armpit and pec muscle, swelling almost size of baseball and protruding, no bruising or pain, just very tender and uncomfortable, feels tight and can certainly feel skin stretched due to swelling.
52 2021-05-17 weakness, flushing On 11/08/20 the client had symptoms of fever up to 103.5 F, chills tachycardia 117 bpm, O2Sat nadir ... Read more
On 11/08/20 the client had symptoms of fever up to 103.5 F, chills tachycardia 117 bpm, O2Sat nadir of 85%, respiratory rate 22, development of hypotension with BP 85/55 bpm with weakness, drowsiness, chills, flushed skin, bilateral edema both lower extremities with wheezing and rhonchi throughout both lungs and was sent to a local medical hospital for treatment where he tested positive for COVID and was returned to the psychiatric hospital after a 3 day stay and 2 administrations of remdesivir on 11/09/20 and 11/10/20 improved. The client subsequently received the Pfizer COVID19 vaccinations on 12/29/20 and 01/19/21 from different lot numbers noted above. On 5/16/21 the client began to have respiratory symptoms including temp of 99.5, pulse 103 O2 Sat of 85% with rhonchi responsive to albuterol inhalation and subsequently albuterol nebulizer treatment; however the following day symptoms progressed with weakness, wheezing, cough, shortness of breath, pallor and O2 saturation 77% unresponsive to albuterol nebulizer treatment. He was was transferred to a local medical hospital for treatment of severe respiratory symptoms and tested positive for COVID a second time and after the complete Pfizer COVID19 vaccination series approximately 4 months prior. He is still hospitalized at the medical hospital at the time of this report (2 days).
52 2021-05-17 migraine He got his vaccine, he felt fine after it for the rest of the day. The next morning he woke up with... Read more
He got his vaccine, he felt fine after it for the rest of the day. The next morning he woke up with dizziness, headache and vision/near sighedness was impaired. He has some emotional issues that have been corrected but they seemed to have returned. Also had fatigue that was fairly mild at first, and over the next 3 days got worse, and has remained the same since that time to present. About a week some of the dizziness and headaches are not as often, but the headaches have become more severe. Before it was a low grade migraine that was constant, but other times it is horrific and others not too bad. No predictability. No fever, no chills, no sore injection site. He has notified his doctor who tested his electrolytes which came back normal. He ended up falling getting out of the shower and hurt his back and shoulder and prescribed him Hydrocodone which did not help the headache.
52 2021-05-19 weakness Clinical Support 3/31/2021. Exposure to SARS-associated coronavirus +1 more. Dx Labs Only. Reason fo... Read more
Clinical Support 3/31/2021. Exposure to SARS-associated coronavirus +1 more. Dx Labs Only. Reason for Visit ED Discharged 4/30/2021 (2 hours) Treatment team. Providers COVID-19 Clinical impression, Fever, Generalized Body, Aches, Chills. Chief Complaint Patient presents with Fever, Generalized Body Aches, Chills. HPI: 52-year-old male with history of diabetes, hypertension, obesity presents the emergency department with gradual onset of moderately severe generalized nasal congestion with associated cough unproductive of sputum and fever, T-max 103.8 at home the patient states began approximately 1 week prior to arrival. The fever worsened today and he decided to be seen at that time. He states he had his first dose of Pfizer COVID-19 vaccine 3 weeks ago. Denies sick contacts, chest pain, shortness of breath, syncope, dizziness, lightheadedness, numbness, focal weakness, abdominal pain, nausea, vomiting or diarrhea, changes in bowel or bladder habits or other complaint. No other signs or symptoms and no treatment prior to arrival. ED Discharged 5/1/2021 - 5/2/2021 (5 hours). Last attending Treatment team COVID-19 +1 more. Clinical impression, Chest Discomfort, Chief complaint. ED Provider Notes. Expand AllCollapse All. HPI. Chief Complaint Patient presents with. Chest Discomfort. Patient History. 52-year-old male with history of asthma, diabetes, heart murmur, hypertension, obesity, sleep apnea and was seen in the emergency department yesterday complaining of generalized nasal congestion, fever and cough and was discharge with a diagnoses of COVID-19 4/30/2021 presents to the emergency department with complaint of chest tightness. The patient states that tonight he developed chest pain which woke him from sleep. He describes the pain as burning. He states the pain is similar to the pain he had when he had a gallbladder attack. He also states the pain is well localized and does not radiate. Initially the pain was 10/10 initially and is currently a 4/10. He took his temperature and states he had a fever of 101.6 and took 1,000 mg of tylenol just prior to arrival. His O2 saturation today has not gone under 90%. Medical History. Past Medical History: Diagnosis Date Asthma 5/29/2017, Diabetes mellitus, Heart murmur, Hypertension, Obesity, Sleep apnea, obstructive. APAP 8-20CM WME AIRVIEW. Surgical History. Past Surgical History: Procedure Laterality Date CARDIAC CATHETERIZATION 03/2004. OTHER SURGICAL HISTORY ear surgery as a baby. STRABISMUS SURGERY repair of congenital strabismus-childhood. Family History. Problem Relation Age of Onset. Hypertension Mother. Diabetes Father. Hypertension Father. Hearing loss Other. Kidney disease Other. Social History. Tobacco Use. Smoking status: Never Smoker. Smokeless tobacco: Never Used Vaping Use. Vaping Use: Never used. Substance Use Topics. Alcohol use: No. Drug use: No. Review of Systems. Constitutional: Positive for fever. Respiratory: Positive for chest tightness. Cardiovascular: Positive for chest pain. All other systems reviewed and are negative. ED to Hosp-Admission. Discharged 5/4/2021 - 5/6/2021 (2 days) Hospital. Last attending Treatment team Acute hypoxemic respiratory failure due to COVID-19. Principal problem. Presenting Problem/History of Present Illness/Reason for Admission. Acute hypoxemic respiratory failure due to COVID-19. Hospital Course. Patient is 52 yo BMI around 40, presents to the hospital with severe sepsis secondary to COVID-19 pneumonia. He was first positive on 04/30, had progressive shortness of breath with weakness and worsening cough. He presented to the hospital originally on 05/04, and desaturated to 85% on room air. He admitted to the medicine service, pulmonology was consulted. Severe sepsis (tachycardia, tachypnea, and fevers with acute hypoxemic respiratory failure) secondary to COVID-19 pneumonia. He was started on dexamethasone IV, and transition to oral dexamethasone. He will continue 7 more days at home to complete 10-day therapy. He was started on remdesivir therapy and received 3-day treatment. Pulmonary consulted, as he was a possible candidate for Actemra, however his inflammatory markers including D-dimer, ferritin, CRP improved, and his oxygen requirements also improved. On discharge, he will continue with oxygen supplementation 2 L with rest, 4 L with activity, 2 L with sleep to be infused into his CPAP therapy. Hyperlipidemia. Continue rosuvastatin 10 mg Monday, Wednesday Friday. Benign essential hypertension. Holding hydrochlorothiazide Continue lisinopril and metoprolol.
52 2021-05-19 coordination abnormal Brain fog, fatigue, loss of coordination, mood swings. Symptoms have persisted for 16 days. It cont... Read more
Brain fog, fatigue, loss of coordination, mood swings. Symptoms have persisted for 16 days. It continues to affect my ability to perform daily work/home activities. I have not sought treatment yet
52 2021-05-19 cold extremities I passed out or fainted; I passed out or fainted; Hand and feet were extremely cold; This is a spont... Read more
I passed out or fainted; I passed out or fainted; Hand and feet were extremely cold; This is a spontaneous report from a contactable consumer. A 52-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Right arm on 04May2021 (Batch/Lot Number: EW0164; Expiration Date: Aug2021) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 05May2021, 1 day after the administration of vaccine the patient experienced I passed out or fainted and Hand and feet were extremely cold. Clinical course reported as I passed out or fainted and my hand and feet were extremely cold before fainting. Patient stated, that he had been trying to report an adverse reaction to the Pfizer COVID 19 Vaccine, the second shot through the 'portfolio' on the website and he tried 3 times and for whatever reasons it just won't transmit the information. So he was wondering, it is possible to report that with a live agent today. The outcome was not recovered for Hand and feet were extremely cold and unknown for rest of the events.
52 2021-05-20 inability to speak The patient had Covid 19 from approximately January 28, 2021 through early February 2021. He receive... Read more
The patient had Covid 19 from approximately January 28, 2021 through early February 2021. He received the first dose of the Pfizer Vaccine on March 26, 2021. On March 27, 2021 at approximately 7:30 PM, the patient suddenly became unable to speak clearly and walk normally. The ambulance was called at approximately 7:45 PM. The patient was evaluated and placed in the ambulance by approximately 8:15 PM. He stopped breathing in the ambulance. He was resuscitated and placed on a ventilator at some point. After evaluation at the hospital, it was found that he had suffered a pontine hemorrhage. He was kept alive until his heart stopped on March 29, 2021.
52 2021-05-21 cold sweat Woke up in the middle of the night with 100.5 fever, cold sweats, aching all over and blurry vision
52 2021-05-22 tenderness, numbness I had the shot on the 8th, The first 24 hours I was tired and had some injection site soreness. Da... Read more
I had the shot on the 8th, The first 24 hours I was tired and had some injection site soreness. Day 2 until now I have had numbness in legs and feet. A huge lump appeared a few inches from injection site. My whole body feels swollen and tender. My eyes are swollen and my vision is blurry. It feels like someone is poking my internal organs. I am tired all the time and I have pain in back. I am scheduled for second shot in a week and now I am very afraid that the side effects will be worst after the second shot or possibly permanent.
52 2021-05-23 muscle spasms Severe Cramping in Legs and Left Side of Stomach
52 2021-05-24 breast pain Left of my breast, almost in the armpit region, it is swelled up, and a bit tender and sore; Left of... Read more
Left of my breast, almost in the armpit region, it is swelled up, and a bit tender and sore; Left of my breast, almost in the armpit region, it is swelled up, and a bit tender and sore; Left of my breast, almost in the armpit region, it is swelled up, and a bit tender and sore; This is a spontaneous report from a contactable other HCP reported for himself. A 52-years-old male patient received second dose of BNT162B2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL9261; Expiration date: Unknown) via intramuscular route of administration, in left arm on 25Jan2021 at 06:45am as single dose for COVID-19 immunization. No Medical history was reported. There were no known allergies to medications, food, or other products. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and other medications within 2 weeks of vaccination. Prior to vaccination, the patient did not diagnose with COVID-19. No other medications the patient received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (solution for injection, Batch/Lot number: unknown) on an unknown date for COVID-19 immunization and experienced no adverse event. On 27Jan2021, the patient experienced left of my breast, almost in the armpit region, it is swelled up, and a bit tender and sore. It was reported that the events were four days after patient 2nd dose. No treatment was received for the adverse event. The most recent COVID-19 vaccine was administered in hospital. Since the vaccination, the patient has not tested for COVID-19. Events were reported as non-serious. The outcome of the events was not recovered. Follow-up attempts were completed. No further information was expected.
52 2021-05-24 hot flush Received fax on Thursday. Had ?normal? fatigue next day. On Saturday woke up feeling better. Saturda... Read more
Received fax on Thursday. Had ?normal? fatigue next day. On Saturday woke up feeling better. Saturday evening aroun 7:30pm felt hot flash and had sweats and my back started to ache. Pain continued and also radiated from center abdomin and left side and intensified. No sleep as I has fairly severe pain all night. Sunday consulted with nurse and was advised Togo to the ER. Went to ER at Hospital around 5:07pm. Had several tests conducted including CT SCAN which revealed bloackage in the splenic vein. Admitted and started me on morphine and also started Heparin blood thinner. Many many blood tests and additional CT scan conducted. Released on Tuesday around 12:30pm. Still have painful spasms as a result of the damage done to spleen. According to Dr, it may take 2-3 weeks before spleen is healed and spasms are gone. Follow up visit TBD in 2 weeks.
52 2021-05-25 pain in extremity Patient had his 2nd dose of the pfizer vaccine 05/25/2021. Patient is c/o left arm pain and chest pa... Read more
Patient had his 2nd dose of the pfizer vaccine 05/25/2021. Patient is c/o left arm pain and chest pain with pressure that started since last night, 05/24/2021. He denies any SOB, fevers, abdominal pain, or swelling, redness, or tenderness at injection site on the left upper arm. Told the patient to please go to the nearest ER for evaluation of the chest pain; patient verbalized understanding and states that someone will take him to the ER
52 2021-05-27 weakness, bell's palsy, severe one side paralysis signs of a transient ischemic attack; lost control of the left side of the face and possibly of the ... Read more
signs of a transient ischemic attack; lost control of the left side of the face and possibly of the left side of his body; lost control of the left side of the face and possibly of the left side of his body; elevated blood pressure 180/100 and came down to 140/100 after the one-hour long episode; weakness; This is a spontaneous report from a contactable consumer (patient's son) via Medical Information team. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08May2021 at 15:30 (at the age of 52 years old) (Batch/Lot number: EW0176, Expiration date was unknown) as the 2nd dose, single for COVID-19 immunization. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number: ER8730, Expiration date was unknown) on 17Apr2021 at 2:30 PM (at the age of 52 years old) for COVID-19 immunization. The vaccine was not administered at the military facility. Relevant medical history included ongoing high cholesterol, ongoing high low density lipoproteins (LDLs), ongoing high triglycerides, and patient might have borderline diabetes, possibly prediabetic, but the reporter was not quite sure. The patient had family history of heart problems. The patient was taking unspecified concomitant medications, but the reporter did not know the medications that the patient was taking. It was also reported that the patient was not completely compliant with his medications. The patient had no additional vaccines administered on the same date of the Pfizer suspect. Prior to vaccinations (within 4 weeks), the patient had no other vaccinations and there were no adverse events (AEs) following prior vaccinations. The reporter stated that in the morning at the time of the report on 13May2021, about 5 days after the second COVID-19 vaccine, the patient had signs of a transient ischemic attack; he lost control of the left side of the face and possibly of the left side of his body; he had elevated blood pressure 180/100 and came down to 140/100 after the one-hour long episode; and he experienced weakness, but was able to move around. At the time of the report, the patient was on his way to the emergency room (ER). The event "loss of control of left side of face" did require a visit to the emergency room. It was further reported that the patient had signs of a transient ischemic attack and loss of control of the left side of his face and maybe the left side of his body, but the reporter was not sure; he also had some weakness and this episode lasted about an hour during which time the patient's blood pressure was 180/100. After the hour, his blood pressure came down to about 140/100. The patient was able to move around and on the way to the emergency department. No further information was available regarding the patient's visit to the emergency room at the time of the report. The reporter was asking for information on transient ischemic attacks and the Covid 19 vaccine and if there were reports of strokes as well. The reporter stated his family called several doctor friends and doctor relatives and based on the patient's symptoms, it seemed likely that he had a transient ischemic attack. The outcome of the events was unknown.
52 2021-05-27 bell's palsy right sided Bell's Palsy that started 5 days after second vaccine
52 2021-05-28 pain in extremity Full blown flu symptoms; Severe headache; Random sharp muscle pain; Fatigue; Joint pain; Chills; Fev... Read more
Full blown flu symptoms; Severe headache; Random sharp muscle pain; Fatigue; Joint pain; Chills; Feverish; Sore arm; This is a spontaneous report received from a contactable consumer. A 52-years-old male patient received first dose of bnt162b2 (BNT162B2,Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration (at the age of 52-year-old), administered in right arm on 02Mar2021 10:15 at a single dose (1ST DOSE, SINGLE) for covid-19 immunisation. Medical history included hypertension and gerd. Concomitant medications included daily multivitamin, atenolol, chlortalidone and lansoprazole (PREVACID). The patient had known allergies chantix and prozac. Patient not diagnosed with COVID-19, prior to vaccination. Patient not tested for COVID-19, since the vaccination. The patient experienced severe headache, random sharp muscle pain, fatigue, joint pain, chills and feverish on 03Mar2021 10:30. On 02Mar2021, the patient had sore arm. On 04Mar2021, patient had full blown flu symptoms. No other vaccines within 4 weeks prior to the COVID vaccine. He returned to work on 05Mar2021 with just minor fatigue. The outcome of the events was recovered with sequelae while sore arm and full blown flu symptoms were unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
52 2021-05-28 tingling, numbness Numbness/tingling right arm since vaccine. Sweaty palms since vaccine. Chest pain starting 18MAY, sh... Read more
Numbness/tingling right arm since vaccine. Sweaty palms since vaccine. Chest pain starting 18MAY, shortness of breath associated with it 20MAY, continued chest pain with relief when leaning forward- concern for pericarditis
52 2021-05-30 flushing, unresponsive to stimuli, seizure, muscle spasms Received the vaccine and then sat in waiting area with no immediate issues. After about 10 minutes ... Read more
Received the vaccine and then sat in waiting area with no immediate issues. After about 10 minutes started to feel flushed and a couple seconds later blacked out. When coming around, felt disoriented and nurse was asking me questions as I was still sitting in chair. My wife reported that I was having a seizure and stiff against the wall with eyes rolled back and unresponsive for about a minute. My right arm was cramping, BP 220/180 and pulse 44. The clinic staff laid me on the floor and call an ambulance that took me to the ER for observation and testing.
52 2021-06-01 muscle spasms, feeling cold, tingling, pain in extremity, numbness feels like there are little tiny baby hands pinching his internal organs throughout his abdomen; Eye... Read more
feels like there are little tiny baby hands pinching his internal organs throughout his abdomen; Eyes swollen and his vision was diminished; Eyes swollen and his vision was diminished; On his injection arm- 2 inches away from the injection site appeared a size of a gigantic golf ball/A huge lump appeared a few inches from injection site; Numbness from his ankle to his feet and from his knees to his feet/numbness in legs and feet; feels like it's cold and tingly; feels like it's cold and tingly; ringing ears; pressure in his neck to his injection site; back pain/pain in back; vision is blurry; throat was swollen.; Toes locking up; Really dizzy and really lightheaded; Mind has been foggy; Glands were swollen; Arm soreness; Nose is bone dry; tiredness/tired; injection site pain/injection site soreness; This is a spontaneous report from a contactable consumer (patient, self-reported). A 52-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0173 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 08May2021 at 02:38 PM, as a single dose for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. The patient's medical history included Bug bite (happened 5 days prior to 30Apr2021 and regimen of an antibiotic). He was completely done with the rotation for a least 8 days before he got the vaccine. It might have something to do with this. concomitant medication included dicloxacillin (started it on 30Apr2021 and it was for 5 days. He did not know what it did was). The patient reported that on 08May2021, day one, he experienced, tiredness and injection site pain. On day 2, until now side effects which had not gone away. It hadn't gotten worse, but it was not any better. The patient felt like congestion, but his nose was bone dry, like crusty dry. It hurts a little bit because it was so dry and he had arm soreness, nothing out of the ordinary. The arm soreness was just normal injection stuff. At first it was a little tender on the injection spot. It went away after about a day. On 10May2021, the patient felt like there were little, tiny baby hands pinching his internal organs randomly throughout his abdomen. It was not a sharp pain, more like a little squeeze all through his abdomen. It felt like his whole throat was swollen. It was not visually swollen, it more felt like a football in his neck. Stretching it was helping. His toes have been locking up like a pre-clamping. He had numbness from his ankles to his feet for 8 days, and now he has numbness from his knees to his feet. It was not completely numb, but it was not normal. The feeling of baby hands pinching his internal organs started the second day after the vaccine and has stayed consistent. The patient's eyes swollen, and his vision was diminished. Day 2 through today, it felt like his eyes were swollen, his vision was seriously diminished, he had a golf ball sized welt on his arm not at the injection site but 2 inches from it, and he was really dizzy and really lightheaded and almost fainted at the corner store. The feeling like his eyes were swollen started on day 3 after the vaccine. The crease of his eye be-low the eyebrow and on top of the socket got red and puffy and looked like sunburnt skin does. It was at the point that now it feels swollen all the time almost like he had pink eye and his vision has been diminished about 30%. He had a test done yesterday and his vision was 20/25. Some-times he could not even read a text and had to stare at his phone for 10 minutes to make out words. He did not have these issues before. The feeling of his eyes being swollen was a little better in the mornings and about 1300 it gets worse when he gets lightheaded to where was when it started. His vision became diminished about day 3 after the vaccine. It was a little better in the morning, but in the afternoon, it goes to exactly the same as when it started. He noticed the golf ball sized welt on his arm about 3 days ago. The doctor seemed to think a drop of the injection might had travelled from the injection site and his body was creating a defense to it. It was scary to take a shower and then see that. It didn't hurt. It was not painful, but it was a weird foreign entity. The cramping in his toes started probably day 3 and was consistent. The numbness started on day 2 after the vaccine, and up until 3 days ago it was just his ankles and feet. 3 days ago, it got to the point where it was from his knees to his feet. It has gotten worse since it was now travelling up his legs. On his injection arm- 2 inches away from the injection site appeared a size of a gigantic golf ball - when asked with his doctor he said that he thinks that a drop of the vaccine travelled and his body building a reaction to it and it was very abnormal. The patient also had numbness from his ankle to his feet worsened and from his knees to his feet- almost feels like it was cold and tingly. The patient also had dizziness and lightheaded about day 2 after the vaccine and it was the same. It came in waves but was consistent throughout the day. He would be fine then had a wave of dizziness. He has been laying down so much because he was so tired, ringing ears, felt like his glands were swollen, pressure in his neck to his injection site, and back pains. The patient stated that his doctor was only form urgent care. The patient Felt like whole throat was swollen, toes locking up, really lightheaded, mind has been foggy, and arm soreness. The patient had bizarre side effects from the Covid Vaccine for 11 days now. He thought it was the smart thing to report them to Pfizer. He didn't like to give personal information. He declined to give his mailing address or his email address. He hated when asked for race, but he guessed it might be important. He did not have a mailing address, phone number, or email address handy for his physician. He went to Urgent Care yesterday to have it checked and they did an EKG and said he had to be sent by ambulance to the ER. The doctor did bloodwork, and she said everything looked alright and to rest a few more days and keep hydrated. The patient underwent the lab work and procedures which included chest X-ray with unspecified result. He thinks it was on 18May2021. His mind has been foggy with all of that. It was yesterday or the day before. He could not be sure. He has been sleeping so much and was in a complete daze. The fogginess he had the whole time as his other symptoms, and it was the same. He has been eating well and hydrating and taking a multivitamin and Gatorade, all the things' people say to do. He asked if Pfizer has heard of this before. He was panicked it might be chronic, and he worries about the safety of the second shot for him. He was sure many people haven't reacted, but these are freaky side effects. He asked for advice and if Pfizer had heard of this before or if he was some weird anomaly. On his way to get the vaccine he asked 2 people at the city health line if they had taken it and they both said no. He asked 3 other patients and they said they took the Pfizer. One woman said she will take it when they make her. The guy who gave him the shot lied and said he wasn't eligible. It might have been his way of not having to discuss it. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not diagnosed with Covid prior vaccination. The patient was tested for Covid post vaccination with Nasal Swab on 18May2021. The outcome of the events was not recovered. Device Date: 23May2021,Additional information has been requested.
52 2021-06-02 coordination abnormal, weakness dizziness; nausea; He did not feel well at all and was not able to feel well enough to stand up.; de... Read more
dizziness; nausea; He did not feel well at all and was not able to feel well enough to stand up.; definite lack of coordination; he vomited on himself; his cholesterol was high at 208.; had very little strength; started feeling like something was wrong; just had sort of a feeling like being really drunk; passed out (fainted) in his car 3 times; He was told he had a vasovagal reaction; This is a spontaneous report from a contactable consumer (patient). A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15May2021 10:50 (Lot Number: EW0173; Expiration Date: 31Aug2021) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included vasovagal reactions in high school. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient's concomitant medications were not reported. Within 2 minutes of receiving the Covid 19 vaccine he started feeling like something was wrong. He pulled to the side in the parking garage and as soon as he stopped the car he passed out. He woke back up and was able to put the car in park and he passed out a second time. He woke up again and his foot was on the gas pedal and he tried to roll down the window. He was able to roll down the window but he wasn't able to get anyone's attention. He passed out a third time. When he woke up again he wasn't able to get the door open and he was nauseated. He basically had nausea, dizziness, and a definite lack of coordination. He just had sort of a feeling like being really drunk. He doesn't drink. He had very little strength but he was able to push his car horn. He was out of it. He could see someone in his car mirror a little ways behind his car and the horn didn't get the person's attention so he honked a second time and someone came to help him, maybe from the fire department and maybe some emergency medical technicians. He was placed on a golf cart or ATV to be transported downstairs to a waiting ambulance and while on the ride he vomited himself. He mentioned that the EMTs called it a vasovagal reaction. He was brought to the hospital in which he had a lot of tests done. He did not feel well at all and was not able to feel well enough to stand up. He had tests done at the hospital, a chest x-ray and his blood was drawn. He had a cardiac ultrasound later in the afternoon the next day on 16May2021. The doctor's didn't find anything wrong other than his cholesterol was high at 208. He was admitted to the hospital on 15May2021. He continued to have his blood drawn through the night and the next morning, on 16May2021, he had a CAT scan. For his cholesterol he was told to eat better and maybe follow up with a doctor in a couple months to check his cholesterol again. No one had any answers to the effect of what happened to him. Everything was fine, his tests were normal. He was told he had a vasovagal reaction. He's had vasovagal reactions before and he can tell this was much different than the vasovagal reactions he's had before. In the past when he's had vasovagal reactions the world went black like looking through a small circle, his vision got blacker and blacker and then he'd pass out. He did not have this feeling with the Covid 19 vaccine. He can only describe this feeling that he had like an occasion in his past when he's drank to much and he's stumbling around. He may have passed out briefly to someone helping him move to a bed and his arms are weighted and he can't lift them and he's disoriented but still has a sense of what's going on but he feels like he could vomit at any second. He's comparing his experience to the Covid 19 vaccine to drinking to much alcohol and then falling asleep or passing out. He was pretty much out of it for 5 hours. Between the fourth and fifth hours after receiving the Covid 19 vaccine he was comfortable enough to stand on his own for brief moments. He was feeling better and was able to use the restroom. By the next day, around the 24 hour period after the vaccine he was feeling almost normal. He was released from the hospital the next day, 16May2021 at around 4:00PM. He was maybe in the hospital for about 27 to 28 hours. At the hospital he had all these tests and he was found to be healthy with no problems. He also had a Covid 19 virus test, he never asked what the results were but he's going under the assumption that if he was Covid 19 virus positive the hospital staff would have told him. Passing out, nausea, dizziness required a visit to Emergency Room. The outcome was unknown.
52 2021-06-03 numbness Patient presented symptoms of high blood pressure three days after receiving the vaccine (05/31/21).... Read more
Patient presented symptoms of high blood pressure three days after receiving the vaccine (05/31/21). Seven days later, the wife tells the pharmacy that she has a headache in the left back, has a droopy eyelid on the left side and numbness in the left area of ??the face. He was advised to visit his doctor, and his wife indicated that the patient was going to go that same day (04/06/2021).
52 2021-06-06 tremor -Dizziness -Mental fogginess -Tremors
52 2021-06-08 muscle spasms Severe headache; Whole body pain; All day Vomiting; Nausea; Muscle Spasms; Intense Chills; fever cyc... Read more
Severe headache; Whole body pain; All day Vomiting; Nausea; Muscle Spasms; Intense Chills; fever cycle; Very High blood pressure; This is a spontaneous report from a contactable patient. A 52- year-old male patient received first dose of BNT162B2 (Pfizer BioNTech covid 19 vaccine) (Lot no.: EN6207) via an unspecified route of administration in right arm on 12Mar2021 at 12:00 PM (at the age of 52-years-old) as a single dose for COVID-19 vaccination. Medical history included high blood pressure and thyroid disorder. He also thought he had a false negative covid test in Jul2020, and actually did have covid in Jul2020. The patient did not have any allergies to medications, food and other products. Concomitant medication lexapro, losartan, DIM (as reported, unspecified), retinol (vitamin A), vitamin d and phytomenadione (VITAMIN K), trazadone within 2 weeks of vaccination for an unknown indication. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, patient was not tested positive for COVID-19. On 13Mar2021, patient trip to the emergency room (ER) for severe headache, whole body pain, muscle spasms, intense chills and fever cycle, very high blood pressure, all-day vomiting and nausea. Nothing they tried eased any of the symptoms. There is no amount of ibuprofen or acetaminophen. He threw up nausea medicine. Two doses of morphine at the ER took the pain from a 10 to a 7. He had never, ever felt this badly. The clinical outcome of the events severe headache, body pain, muscle spasms, intense chills, fever, very high blood pressure, vomiting and nausea was not resolved. No follow-up attempts are possible. No further information is expected
52 2021-06-09 weakness, pain in extremity weakness; fatigue; body aches; headache; sore throat; chills; fever; slight arm pain; chest cold; co... Read more
weakness; fatigue; body aches; headache; sore throat; chills; fever; slight arm pain; chest cold; cough; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0183), via an unspecified route of administration in left arm on 20May2021 at 00:45 (at the age of 52-years-old) at 1st dose, single dose for COVID-19 immunization. The patient's medical history was not reported. He has no known allergies and was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included sertraline hydrochloride (SERTRALINE). He did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at an urgent care center. On 21May2021, the patient experienced slight arm pain for the first 2 days after the shot. On 23May2021, 3 days after the shot, he experienced weakness, fatigue, body aches, headache, sore throat, chills, and slight fever. On May2021, 4 to 5 days after the shot, cough and sore throat became more severe. He still had some fever, but it was reduced by ibuprofen. On 25May2021, 5 days after the shot, he still has cough like he has a chest cold. He also reported that all symptoms started to decrease. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measure was taken as a result of fever and included treatment with ibuprofen. He did not receive any treatment for all other events. The outcome of the event "slight arm pain" was recovered on 23May2021 and recovering for all other events.
52 2021-06-10 hot flush Caller stated he got the second shot two days ago and that next day he had a rash.; when he is in a ... Read more
Caller stated he got the second shot two days ago and that next day he had a rash.; when he is in a hot room like 78 degrees with the window open he can not take the heat like he used to; Hot flashes; rash got bright pink, patient stated within that second day of getting the first dose it was pink, then it came back again after the second dose and now the rash was healing; Scrapes in hands little dots now and skin peeled away got worse. Still a little pink on pinky but have little scabs. Last time felt tight but not it is stinging; felt like he was drugged; pulse rate has been a little elevated; Palpitations: Caller stated this started the same day 10 to 12 hours after getting the first shot. Caller stated it was getting somewhat better but after the second shot it got worse.; getting out of breath was reported as worsened; felt like there was pressure in his skull; he felt like he was going sideways and had to grab onto rail for 30 seconds to a minute so would not fall ove; Blood pressure went down to 124/78 and so his blood pressure has been better since the vaccine; This is a spontaneous report from a contactable consumer (patient, self-reported). A 52-year-old patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0183; expiry date: 31Aug2021) via unspecified route of administration in left arm on 01Jun2021 as single dose of COVID-19 immunization. The patient's medical history and concomitant medications was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0173; expiry date: 31Aug2021) via unspecified route of administration in left arm on 11May2021 as single dose of COVID-19 immunization and experienced palpitations, felt like he was drugged, felt like there was pressure in his skull, getting out of breath, rash got bright pink, respiratory rate was somewhere around 16, blood pressure went down to 124/78 and so his blood pressure has been better since the vaccine, pulse rate has been a little elevated, on his first finger, the thumb, there was a rash that started bubbling up below the middle knuckle. On an unspecified date in Jun2021, after second dose of vaccination, the patient experienced palpitations, getting out of breath like when he was walking up and down the stairs especially when carrying laundry or a garbage can and he never had this problem doing that unless he had an upper respiratory infection and prior to the vaccine he was perfectly fine, palpitations was reported as worsened, getting out of breath was reported as worsened, rash on his left side where he got the shot on his hand, specifically the top of hand and on his first, second, third, fourth, and fifth finger was reported as worsened, on his first finger, the thumb, there was a rash that started bubbling up below the middle knuckle was reported as worsened, crack in the knuckle area on the second finger was reported as worsened, rash got bright pink was reported as worsened, felt like he was drugged, Blood pressure went down to 124/78 and so his blood pressure has been better since the vaccine, pulse rate has been a little elevated, felt like there was pressure in his skull, felt like he was going sideways, and on 01Jun2021 experienced hot flashes. On 02Jun2021, he was in a hot room like 78 degrees with the window open he cannot take the heat like he used to. On an unspecified date in Jun2021, patient stated that palpitations got worse after the second shot it was started on the same day of first shot of vaccination, 10 to 12 hours after getting the first shot. The patient stated it was getting somewhat better but after the second shot it got worse. On 03Jun2021, that next day of vaccination, patient had a rash and explained that on his first finger, the thumb, there was a rash that started bubbling up below the middle knuckle, this stopped a week to ten days after the first dose and then it came back after the second. Patient had a crack in the knuckle area on the second finger: patient stated he was scheduled for the dose around 12:20 and they had to get more vaccines and so he had to get it around 3:00pm. The patient stated this started to feel bad in the first two hours. For the event of rash got bright pink, patient stated within that second day of getting the first dose it was pink, then it came back again after the second dose and now the rash was healing. Scrapes in hands little dots now and skin peeled away got worse. Still a little pink on pinky but have little scabs. Last time felt tight but not it is stinging. For the event "felt like he was drugged" patient stated this started within 4 hours of first dose, he started to feel better in 5 days and then 10 days after he was completely better and stated he got this again from the second shot and it was getting better but the more he exerts himself the slower he feels but he does not feel like he is on anesthesia. The patient stated that his pulse rate has been a little elevated, stated on the following day after first dose his pulse rate was 114 and 120 was the highest. He stated after the first dose it was between 116 to 120 and after the second dose it was slightly elevated like 90 or something. The patient stated but his pulse rate has been 86, 87, 90 so the pulse rate has been a little elevated. The patient reported he also had hot flashes. He felt like there was pressure in his skull, 10 to 12 day after the first vaccine and this got better, then within 7 to 10 days after the second shot he got it again and he anticipates that for 7 to 10 days he will have to deal with the same crap. The patient felt like he was going sideways, this stopped within two days after the first dose and then it happened within one day or a day in half after the second shot. The patient stated that hot flashes lasted a day or day in a half. The other problem he had noticed is when he is in a hot room like 78 degrees with the window open, he cannot take the heat like he used to. Reportedly, after the second shot they had the patient sit for 15 minutes and so he went to the hospital main area after to get a pass to eat and he felt like he was going sideways and had to grab onto rail for 30 seconds to a minute so would not fall over. He stated the first hour or so after the vaccine he felt like he was drug and he even had caffeine and got his car cleaned, but he felt like his body was behind him like woozy to stomach like in slow motion with exertion and it felt like he was drugged. The patient stated he just wished the vaccine dosage had a high of like if it was 0.3 maybe should be 0.2. The patient stated there should be a different regimen based on height and weight. The outcome of the event "hot flush" was resolved on 01Jun2021, for the event "Palpitations: The patient stated this started the same day 10 to 12 hours after getting the first shot. The patient stated it was getting somewhat better but after the second shot it got worse", "getting out of breath was reported as worsened", "The patient stated he got the second shot two days ago and that next day he had a rash", "he felt like he was going sideways and had to grab onto rail for 30 seconds to a minute so would not fall over", "felt like there was pressure in his skull", "Blood pressure went down to 124/78 and so his blood pressure has been better since the vaccine", "felt like he was drugged", "pulse rate has been a little elevated", "when he is in a hot room like 78 degrees with the window open he cannot take the heat like he used to" was not resolved and for the event "Scrapes in hands little dots now and skin peeled away got worse. Still a little pink on pinky but have little scabs. Last time felt tight but not it is stinging" was unknown, for the event "rash got bright pink, the patient stated within that second day of getting the first dose it was pink, then it came back again after the second dose and now the rash was healing" was recovering.
52 2021-06-15 pain in extremity After receiving the vaccine I had the soreness in my arm and a small fever of 99. Over the course o... Read more
After receiving the vaccine I had the soreness in my arm and a small fever of 99. Over the course of the next few weeks I was experiencing severe eye pain which caused me to start losing site in my right eye and also microclots in my eyes, my eye doctor stated that the vaccine was not the cause of my conditions with my eye. But other than the soreness of my arm where the vaccine was administered and a slight fever I really didn't have any other problems.
52 2021-06-16 burning sensation Chest pain in the upper right chest; Restlessness; Upper right shoulder pain; burning sensation; Thi... Read more
Chest pain in the upper right chest; Restlessness; Upper right shoulder pain; burning sensation; This is a spontaneous report from a contactable consumer (patient). This is Report 1 of 2. A 52-years-old male patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot number: EW0179, expiration date: unknown), via an unspecified route of administration, administered in right upper arm on 20May2021 as 2nd dose, single dose; and previously took first dose of BNT162B2(Lot number: EW0172), via an unspecified route of administration, administered in left upper arm on 29Apr2021 as 1st dose, single dose for COVID-19 immunization. Medical history included Depression diagnosed at 4 years old as he was adopted and everything, and had Previously heart attack on 23Oct2003, high cholesterol, and a finger cut off. Patient states it was work related and accidental, he put his hand in the wrong spot, the actuator came down, and took his finger off. States that was years ago, they were able to stitch it back on. Patient reported him and his wife are allergic to cottonwood and he don't know what treatment to take. Patient also reported after forty there is two things that happen, one you start losing your memory, and second you can not remember the other one, and that is exactly what happened to him. Concomitant medications included FLUOXETINE, 40 mg, 2 capsules once a day, every morning, he thinks he takes for cholesterol; ATORVASTATIN, 20 mg daily, he thinks he takes for depression; AMITRIPTYLINE HCL, 25 mg. Takes 3 at night which helps him sleep; LISINOPRIL, 20 mg tablet once daily, taken for an unspecified indication; since 1.5 years and start and stop date of all concomitant medications were not reported. No prior Vaccinations within 4 weeks of vaccination. The patient on an unknown date in May2021, woke up in the middle of the night, he was experiencing restlessness, and not really chest pain, almost like a shoulder pain, up in the shoulder, not like a heart attack or anything and chest pain in the upper right chest which is bearable, but annoying. Patient stated pain comes and goes. Chest pain is still persisting, and started about 2-3 days of second vaccination and has not improved, it is still steady, a burning sensation, and always in the upper right shoulder, above the male breast, up above that, up in the clavicle. The patient underwent lab tests and procedures which included blood cholesterol: only two points up. No investigation assessment. No Emergency Room or Physician Office visits. The outcome of chest pain in the upper right chest was not recovered, upper right shoulder pain was recovering; restlessness and burning sensation was unknown. Information on Lot/Batch number was available. Additional information has been requested.
52 2021-06-24 numbness Went to hospital with elevated blood pressure, chest pain, pulse in left finger tips and numbness in... Read more
Went to hospital with elevated blood pressure, chest pain, pulse in left finger tips and numbness in left arm. Heart / troponin levels were normal but kept for additional testing. Echocardiogram was performed and diagnosed with severe hypertrophic cardiomyopathy.
52 2021-06-26 cold sweat cold sweat, shivering, tiredness long term effect: Mucus build up in throat
52 2021-06-28 numbness About 10 minutes after getting the Pfizer vaccine my Jaw started hurting and lips tingling, then my... Read more
About 10 minutes after getting the Pfizer vaccine my Jaw started hurting and lips tingling, then my face starting getting numb. After I woke up this morning my face is still numb.
52 2021-06-29 migraine My body started shivering uncontrollably/feel extremely chilled; I had trouble sleeping and was up m... Read more
My body started shivering uncontrollably/feel extremely chilled; I had trouble sleeping and was up most of the night; high fever/I checked my temperature last night ranged from 101.8 to a high of 103.7; I woke up soaked in sweat; severe migraine; I felt dizzy all through the night; This is a spontaneous report from a contactable other health care professional. A 52-years-old male patient received bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3248, age at vaccination 52 years), dose 2 via an unspecified route of administration, administered in Arm Left on 04Feb2021 10:00 as dose 2, single for covid-19 immunisation. Medical history included irritable bowel syndrome (IBS), asthma, Low lung input and output, covid-19 covid prior vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient previously took BNT162B2, dose1, single (lot number EL3248) for covid 19- immunization on 14Jan2021, 11:00. The patient's concomitant medications were not reported. On 04Feb2021 22:30, the patient started to feel extremely chilled. He went to bed and covered up with 2 blankets. patient body started shivering uncontrollably. Patient normal temperature fluctuates from 94-95 degrees. He checked temperature last night ranged from 101.8 to a high of 103.7. patient had trouble sleeping and was up most of the night due to the high fever. He woke up soaked in sweat. He also had a severe migraine and he felt dizzy all through the night and into 05Feb2021. The patient underwent lab tests and procedures which included body temperature: ranged from 101.8 to a high of 103.7 on 04Feb2021. Seriousness was not serious. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Non-Allergies to medications, food, or other products. No treatment was received for the adverse events. The outcome of events was recovering. Follow-up attempts are completed. No further information is expected.
52 2021-06-29 pain in extremity, tremor, depressed level of consciousness, weakness Fever, second vaccine; Thirsty, second vaccine; spitting up green phlegm; Felt weird, felt bad, felt... Read more
Fever, second vaccine; Thirsty, second vaccine; spitting up green phlegm; Felt weird, felt bad, felt horrible, second vaccine; left side of his body was very sweaty; Chills, second vaccine; sneezing; headache; stuffy nose; loss of smell; Felt knocked out; fatigue, Tiredness; Sleepy, sleepiness, slept for very long hours, second vaccine; Nose running; Sinuses, stopped up, second vaccine; Aches, second vaccine; Did not eat much; he was shaking; coughing; weakness; pain to his left arm; dizziness; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in arm left on 26Mar2021 at 10:00 AM to 10:30 AM as a dose 2, single for COVID-19 immunisation. No family medical history relevant to ae(s). The patient's medical history included prostate and bronchitis, the caller stated that, he had a history of Bronchitis since he was small. The Bronchitis was worrisome with bad weather and a month prior there was bad weather and he had the chills. Past drug event included Tamsulosin for prostate, started about a year and a half ago for his prostate 0.4mg capsule, once a day and Finasteride for prostate, started about a year and a half ago for his prostate 5mg tablet, once a day. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via unspecified route of administration in the left upper shoulder on 05Mar2021 at 11:00 AM to 11:30 AM as a dose 1, single for COVID-19 immunisation. The patient's concomitant medications were not reported. Prior vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as no. Age at time of vaccination was 52 years. Enquired, the caller was a 53 y/o male. The patient received his first Pfizer Covid dose on 05Mar2021 and his second dose on Friday, 26Mar2021. The first and second vaccine both were given in the left upper shoulder. Stated that, his job offered to schedule his vaccines. After his second dose he developed pain to his left arm, which resolved on 28Mar2021. Stated that, on 26Mar2021, he sat down for 10 minutes after the dose and then drove home. Stated that, he drove the home on streets instead of the highway in case he started feeling bad so he wouldn't have to leave his vehicle on the highway. He kind of resisted being dizzy and sleepy, he was not that dizzy. The patient started feeling dizziness, fatigue, weakness a few hours after receiving the vaccine. Stated that, the second dose knocked him out. Stated that, he had a swift reaction about an hour after receiving his second dose, he was very tired, sleepy and sweating a lot and shakiness. The night he received the vacccine, he woke up at 3 AM and stated that, his left side of his body was very sweaty and he was shaking, coughing and sneezing. The patient reported that, a headache, stuffy nose and loss of smell. The patient wanted to know whether these were expected side effects. Response included referred to healthcare professional for further discussion and treatment recommendations. Informed the caller that, Pfizer cannot make treatment recommendations. It was reported that, the caller wanted to know whether the symptoms were immediate or took longer to effect someone after their second vaccine dose. Stated that, he knew everyone's reactions were different, he just wanted to know. Stated that, the patient was drinking a lot of water mixed with sprite to keep hydrated. The patient was sneezing a lot, had a stuffy nose, aches, fever but he could not find his thermometer. Stated that, he felt weird, bad, horrible and it hit him hard. Stated that, he did start to feel a lot better and on Saturday 27Mar2021, the patient thought he had improved. That morning he was ok to eat breakfast and able to smell his breakfast. In between 02:00 PM to 03:00 PM on Saturday, he was sleepy, slept very long hours, sweating on his left side a lot and some on right side of his body. On Friday and Saturday evening, the patient felt the same things, he was thirsty, sweating had chills all through night, was knocked out, had headaches, felt like the room was moving like in hyperspace, anytime he walked he felt like a guy on moon, like the ground was soggy underneath his feet. He stated he was not lethargic and kept his balance but like he was stepping on something soggy underneath him, he was dizzy. He had pain on his left side, his head, his arm as well and the left side of his face. The pain in his arm on Friday was so bad that he felt the pain in his face as well. The caller stated that, he had much less pain in his arm the next day on Saturday. Stated that, he heard the symptoms would start the next day after the shot. His nose was still stuffy. Stated that, the caller did not provide a healthcare professional for the report. Stated that, he had not seen a doctor for 10 years. The caller stated that, he was fine whether safety needed to clarify any documentation from the report. Stated that, his card does not have the Lot or Expiry date of the first dose and second dose. Stated that, with his first vaccine on 05Mar2021, he only had intense pain on his left side of shoulder, it was still there on Saturday and by Sunday the pain was much better. By Monday he was back to normal, only felt a little tired but not too much and he was able to do things. By Tuesday/Wednesday the patient was fine. The adverse events did not require a visit to emergency room and physician office. The reporter seriousness for other events was unspecified. Treatment received for the events was not provided. The relevant tests were reported as no. The outcome of the events pain to his left side was recovered on 28Mar2021 while for the other events was unknown. No follow-up attempts are needed, information about lot/batch number cannot be obtained.
52 2021-06-29 pain in extremity Severe soreness in left arm; This is a spontaneous report from a non-contactable consumer, the patie... Read more
Severe soreness in left arm; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 19Mar2021 at 10:45 (at the age of 52-years old) as a single dose for COVID-19 immunisation. Medical history included soreness. The patient was not allergic to any food, medications, or other products. The patient received unspecified medications within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Past drug history included unspecified injection for which patient experienced soreness. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested positive for COVID-19. On 19Mar2021 at 10:45, the patient experienced severe soreness in left arm to the point where it was hurting to use it and was painful. The patient stated that, it was not like the other unspecified injection soreness which she had experienced in the past. The patient did not receive treatment for the adverse event. The clinical outcome for the event severe soreness in left arm was resolving. Information about lot/batch number cannot be obtained. No further information is expected.
52 2021-06-29 tingling, burning sensation Mild Facial Burning; Tingling to bilat hands; This is a spontaneous report from a contactable Nurse ... Read more
Mild Facial Burning; Tingling to bilat hands; This is a spontaneous report from a contactable Nurse (Patient). A 52-years-old male patient received second doe second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EJ1686) via intramuscular route of administration in right arm on 08Jan2021 09:15 as single dose for COVID-19 immunization Hospital. The patient medical history and concomitant medications were not reported. Patient previously took first dose BNT162B2, Batch/Lot Number: EJ1685) via intramuscular route of administration in right arm on 18Dec2020 for COVID-19 immunization patient had extreme itching, burning over entire body, awoke 08:00 with body ache, headache. On 08Jan2021 11:30 the patient experienced mild facial burning, tingling to bilat hands on 08Jan2021 11:30. Patient had a visit to Emergency room and physician office for the events. Therapeutic measures were taken as a result of mild facial burning, tingling to bilat hands Benadryl, hydroxyzine, Loratadine, Pepsin. The outcome of the events mild facial burning, tingling to bilat hands was recovered on unspecified date. Follow-up (07MAY2021): Follow-up attempts completed. No further information expected.
52 2021-06-30 cold sweat, tingling BP shot up to 197/130; Throbbing headache; Nausea; Tingling in both arms and fingers; Itchy tongue; ... Read more
BP shot up to 197/130; Throbbing headache; Nausea; Tingling in both arms and fingers; Itchy tongue; Iitching all over body; Clamminess; Fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 52-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EP6955), via an unspecified route of administration, administered in left arm on 18Mar2021, 15:30 (age at vaccination was 52-year-old) as single dose for covid-19 immunization at hospital. Medical history included hypertension. The patient concomitant medication included Hydrochlorothiazide. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient did not diagnose with COVID-19. The patient had not been tested for COVID-19 since the vaccination. The patient had no known allergies to medications, food, or other products. On 18Mar2021 at 15:45 Within 60 seconds of vaccine, I got an immediate throbbing headache, nausea, tingling in both arms and fingers, itchy tongue, itching all over body, BP shot up to 197/130, clamminess, and fatigue. Patient received a treatment with Antihistamine given during episode for the events. The patient underwent lab test and procedures which included blood pressure measurement: 197/130 on unspecified date in Mar2021. The outcome of the events was not recovered. Additional information is excepted. Follow up is requested.
52 2021-07-01 weakness Patient complained of body aches starting after receiving his vaccine on that day. Throughout the we... Read more
Patient complained of body aches starting after receiving his vaccine on that day. Throughout the weak worsening joint and body pain and after 5 days began form oral lesions. He eventually presented to the ED on 6/11/21 HPI taken from ED Documentation: 52 yo male with no chronic medical problems presents to ED with complaints of body aches, weakness, and mouth sores. Also presents with fever (101.7) Denies any shortness of breath, chest pain, abdominal pain, nausea or vomiting.
52 2021-07-01 numbness, sensory loss Severe lower back pain. Went to ER almost two weeks later. MRI results showed two herniated discs in... Read more
Severe lower back pain. Went to ER almost two weeks later. MRI results showed two herniated discs in lumbar region. Lost sensation in left leg and foot. Could not get out of bed for one week. Needed aid of a walker and cane for three weeks. Prescribed prednisone, Flexeril, and 600 mg ibuprofen. Pain has subsided, but is still there. Top of the foot is still numb. Able to walk on his own now, but residual pain in lower pain limits physical activity.
52 2021-07-02 pain in extremity Almost a complete lack of sleep due to ache all over body; Almost a complete lack of sleep due to ac... Read more
Almost a complete lack of sleep due to ache all over body; Almost a complete lack of sleep due to ache all over body; felt exhausted; arm where the shot was is sore and very tender; This is a spontaneous report from a non contactable consumer, the patient. A 52-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Unknown) via an unspecified route in the left arm on 23Mar2021 at 15:00(at the age of 52 years old) as a single dose for COVID-19 immunisation. The patient had no medical history and did not have any allergies to medications, food, or other products. The patient did not take any concomitant medication and did not receive any vaccination within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 23Mar2021 at 22:00, the patient experienced complete lack of sleep due to ache all over body, felt exhausted, arm where the shot was is sore and very tender, though there are no swelling or shot location issues. 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 treatment for the reported event. The clinical outcome of the lack of sleep, ache all over body, exhausted, pain in arm and tenderness was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
52 2021-07-06 bell's palsy Bells Palsy
52 2021-07-06 pain in extremity, weakness, feeling cold I had positive COVID infection 12/13/2019 and was in the ICU and hospitalized multiple times. I had... Read more
I had positive COVID infection 12/13/2019 and was in the ICU and hospitalized multiple times. I had no adverse events or symptoms with the 1st dose (lot ER732 IM RA). The 2nd vaccine 5/24/2021 (lot EW0187 IMLA), the next day my arm was sore. I felt extremely tired all day. The 2nd day, I had extreme fatigue and could not go to work. My arm was still sore and I had flu like symptoms. These symptoms lasted for 5 days. I started to feel better for a couple days and go to bed and wake up still completely exhausted. I just wanted to sleep all the time. Since the 2nd vaccine, I have lost sense of smell and appetite and don't have the energy to do anything else. I have lost a total 25 pounds since getting the vaccine. My initial weight was 175 lb, my weight now is 149 lbs. My other symptoms include: difficulty regulating my body temperature, cold sensitivity, muscle pains in my hands, shoulders, chest and top of legs thighs. "I feel like my body is eating myself away." I also have confusion, depression, difficulty focusing and brain fog.
52 2021-07-06 tremor Patient presented with fevers, chills, then developed generalized tremors which were of unexplained ... Read more
Patient presented with fevers, chills, then developed generalized tremors which were of unexplained etiology, extensive neurological testing included MRI brain, EEG, CSF testing which were unrevealing. a serum autoimmune panel was sent which demonstrated elevated Acetylcholine ganglion Receptor Antibodies but patient's symptoms did not correlate with this finding, and was felt to be a false positive test. his INR values were also significantly deranged on arrival, despite him being on coumadin long term prior to this with stable INR values previously. Further workup revealed evidence of positive cardiolipid IgM and IgG antibodies, which confirmed findings of antiphospholipid syndrome. a follow up MRI also revealed a punctate cerebellar infarct which was not thought to be responsible for his diffuse tremors. His tremors were felt to be related to cardiolipiin antibody positivity (there are case reports/series describing above). The positive anti-cardiolipin antibodies were felt to be related to recent vaccination and potential molecular mimicry. he was treated wit steroids with a tapering dose, with eventual resolution of symptoms. repeat cardiolipin antibody testing has shown normalization of values.
52 2021-07-07 feeling of body temperature change Reports hot/cold shivering started 6/25 then started with nausea, vomiting & Diarrhea. Chest pain/pr... Read more
Reports hot/cold shivering started 6/25 then started with nausea, vomiting & Diarrhea. Chest pain/pressure started 6/29 and went to hospital. MD reports increasing Troponin so admitted to hospital for ECHO & Cardiac Cath. Discharged on 6/30. Still reports Fatigue
52 2021-07-07 muscle spasms, burning sensation I have severe pain in my leg muscles and bi-ceps in both arms, I'm extremely lethargic at all time... Read more
I have severe pain in my leg muscles and bi-ceps in both arms, I'm extremely lethargic at all times of day. I also have burning sensation in my leg calf nerves and forearms. I have also slight pain in my chest. I also have finger cramping when I wake up in the morning. slight lost in memory.
52 2021-07-07 night sweats That night I got night threats, no fever. The next day I started coughing, wheezing, short of breath... Read more
That night I got night threats, no fever. The next day I started coughing, wheezing, short of breath. The next day I saw my Dr., she listened to my chest, and checked my blood pressure and it was 160/100. I have never had high blood pressure before. She prescribed losartan potassium 60 mg tablet. I take 1 every morning now. And cough medication: benzonatate 200 mg tablets 1 every 8 hour now. The cough and the blood pressure is still ongoing. There is no pneumonia. I had a Bilateral hip replacement, total hip replacement on both legs, it has become very sensitive and painful after the vaccine. I take the 4 Advils for the pain in my hips. The doctor is trying to determine if I'm a long-hauler of COVID related. I have never had Covid-19 virus, not to my knowledge.
52 2021-07-08 night sweats Night sweats.; Extreme sweating during the night to the point of sheets being wet; This is a spontan... Read more
Night sweats.; Extreme sweating during the night to the point of sheets being wet; This is a spontaneous report from a contactable other health care professional, the patient. A 52-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 23Mar2021 at 14:00 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to penicillin (PCN). The patient did not receive any other medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 02Mar2021 at 13:45 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 24Mar2021 at 00:00, the patient experienced night sweats, extreme sweating during the night to the point of sheets being wet. The adverse 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 event night sweats and extreme (excessive) sweating during the night to the point of sheets being wet was recovered on 24Mar2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
52 2021-07-15 unresponsive to stimuli, seizure like phenomena Patient reported deceased to public health today. Date of death: 7/15/2021. Sister of patient repo... Read more
Patient reported deceased to public health today. Date of death: 7/15/2021. Sister of patient reports that case reported chest pain while at home walking on his treadmill, he then had to lie down and sister asked him if he was having pain and wanted ambulance called. Reports that patient declined 911 call. Sister then reports that patient had what looked like a seizure, but then went completely unresponsive, so she initiated CPR and called 911. Reports that CPR and 911 response was not successful and patient passed away.
52 2021-07-17 weakness Fever up to 104.4 times 4 days; uncontrolled chills; Weakness; body/ joint aches; body/ joint aches;... Read more
Fever up to 104.4 times 4 days; uncontrolled chills; Weakness; body/ joint aches; body/ joint aches; This is a spontaneous report from a contactable consumer (patient). A 52-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 16Mar2021 16:00 (at the age of 52-years-old) (Batch/Lot Number: EN6208) as single dose for COVID-19 immunisation. Medical history included Pulmonary embolism, Heartburn. The patient had no allergies to medications, food, or other products. Concomitant medication(s) included apixaban (ELIQUIS); dexlansoprazole (DEXILANT), both taken for an unspecified indication, start and stop date were not reported. 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 18Mar2021 16:00, the patient experienced fever up to 104.4 times 4 days, uncontrolled chills, Weakness, body/ joint aches. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. The reporter assessed the events as non-serious. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovered with sequelae (Recovered with lasting effects). Follow-up attempts are completed. No further information is expected.
52 2021-07-18 nerve injury, numbness, weakness, pain in extremity The immediate reaction was severe pain in neck, knees, hand, ankles, nausea and fatigue. This occurr... Read more
The immediate reaction was severe pain in neck, knees, hand, ankles, nausea and fatigue. This occurred for 3 days then on Sunday I was admitted to the hospital. I was given pain medication discharged still exp tiredness and fatigue. The nausea was gradually going away started to loose all functions in hands. As of today my energy level is at at 75% my left hand is better and right hand still experiencing some numbness. I have seen a Neurologist, Rheumatologist and Cardiologist.
52 2021-07-19 numbness Vaccinated 7/16, 7/17 developed mild chest pain, fever and body aches. 7/19 developed dizziness in a... Read more
Vaccinated 7/16, 7/17 developed mild chest pain, fever and body aches. 7/19 developed dizziness in addition to previously reported symptoms. 7/20 developed right leg numbness and reported symptoms to this clinic. Was escorted to ED
52 2021-07-23 numbness Starting at about 14:00 on the day of receiving the first dose of the Pfizer-BioNTech COVID-19 I be... Read more
Starting at about 14:00 on the day of receiving the first dose of the Pfizer-BioNTech COVID-19 I began to feel soreness at the vaccine injection point. After about another hour, I started to feel fatigue; about another hour or two later, headache; about another hour later numbness in my head; and about another hour later achiness in other parts of my body. I am submitting this report on July 24, 2021 at 06:53, about 23 hours after receiving the vaccine, and the numbness in my head has subsided, the headache and body aches have mostly subsided but are still present; and the soreness at the injection point has not yet subsided. I am noticing a little shortness of breath that I did not notice yesterday.
52 2021-07-24 pain in extremity It's been six months since my shots, suddenly I'm getting soreness in my arm muscles and joints. No... Read more
It's been six months since my shots, suddenly I'm getting soreness in my arm muscles and joints. Nothing has changed in my daily routines. so this constant soreness and pains seem totally not normal. I'm just curious is others are experiencing delayed reactions also?
52 2021-07-25 pain in extremity the second shot, I experienced pain on my right arm and it kind of when away a few days and it comes... Read more
the second shot, I experienced pain on my right arm and it kind of when away a few days and it comes back and at times the pain is extreme that I have difficulties moving my arm
52 2021-07-27 weakness, tremor, speech disorder Had 4 strokes/My girlfriend took me to the hospital to find out I suffered 4 strokes. 2 were 2 weeks... Read more
Had 4 strokes/My girlfriend took me to the hospital to find out I suffered 4 strokes. 2 were 2 weeks old.; few hours after 1st shot severe headache and vomiting/Didn't feel well for 2 weeks till I got the severe vomiting and headache again; few hours after 1st shot severe headache and vomiting/Didn't feel well for 2 weeks till I got the severe vomiting and headache again; Didn't feel well for 2 weeks; the next day didn't know anything, couldn't speak, shaking, weakness; the next day didn't know anything, couldn't speak, shaking, weakness; the next day didn't know anything, couldn't speak, shaking, weakness.; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received bnt162b2 (Pfizer, Batch/Lot Number: ER8736), via an unspecified route of administration, administered in arm left on 01May2021 as dose 1, single for covid-19 immunization. Other medical history was none before the covid shot, was healthy and now he lost his business and no income. Not known allergies. There were no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't receive any other medications within 2 weeks of vaccination. The patient experienced had 4 strokes/my girlfriend took me to the hospital to find out i suffered 4 strokes. 2 were 2 weeks old, few hours after 1st shot severe headache and vomiting/didn't feel well for 2 weeks till i got the severe vomiting and headache again, didn't feel well for 2 weeks, the next day didn't know anything, couldn't speak, shaking, weakness all on 01May2021. The events were serious per hospitalization, disability. The patient was hospitalized for these events. Had 4 strokes, few hours after 1st shot severe headache and vomiting. Didn't think too much about it since they said 50 + men don't get reactions. Didn't feel well for 2 weeks till he got the severe vomiting and headache again, and the next day didn't know anything, couldn't speak, shaking, weakness. His girlfriend took him to the hospital to find out he suffered 4 strokes. 2 were 2 weeks old. Backing it up till 01May2021 when he has the first covid shot. Therapeutic measures were taken as a result of events (Treatment for strokes). The adverse event result in doctor or other healthcare professional office/clinic visit and a visit to Emergency room/department or urgent care. Duration of Hospitalization was 5 days. Hospitalization was not Prolonged. Facility where the most recent COVID-19 vaccine was administered was hospital. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of events was resolved with sequelae.
52 2021-07-27 feeling hot Back in June I noticed I wasn't feeling well in the morning when I woke up, I was hot. General not f... Read more
Back in June I noticed I wasn't feeling well in the morning when I woke up, I was hot. General not feeling well. My blood pressure was really high 179/about 100 and pulse rate was about 110. I let it go on for a couple of days to make sure it wasn't something> I went to see my Cardiologist and he started me on blood pressure medications. It's gone down. But I've had blood pressure issues before so it's kind of out of the blue. Blood pressure seems to be controlled now.
52 2021-07-27 pain in extremity Hurt in his arm; The hair is falling out on the arm; He doesn't feel like his arm is normal; Before ... Read more
Hurt in his arm; The hair is falling out on the arm; He doesn't feel like his arm is normal; Before the skin was soft and thin/ it feels thick and rough only on the arm; They are red dots and there is some yellow in the middle; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EW0158), dose 2 via an unspecified route of administration on 09May2021 as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient had the reaction from the first vaccination. He had the first vaccination on 18Apr2021 and the second vaccine was on 09May2021. He had a lot of little dots. They are not pimples. They are dots on the whole arm. They are red dots and there is some yellow in the middle. He mentioned it to the person that gave him the second injection and they said it was normal. He wanted to mention that. He has hurt in his arm and the hair is falling out on the arm. He doesn't feel like his arm is normal. He doesn't feel it as before. Before the skin was soft and thin. Now when he feels it, it feels thick and rough only on the arm. He had the reaction on the first day he had the vaccination. HCP Information: He doesn't have any doctor. He would love anyone to see his arms. He doesn't have medical. Dots on the whole arm: They are going away. Some of them are going away. They are appearing again. He would not say that it has been worse or improving. For example, he can feel a new one there that was going away. They are just coming and going. They appear and disappear. He can feel that his skin is rough and thick. It is not like the arm looks horrible, but it is not either worse or improving. It is both arms.
52 2021-07-27 pain in extremity Rash at injection site; Soreness at injection site; Arm was sore; This is a spontaneous report from ... Read more
Rash at injection site; Soreness at injection site; Arm was sore; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 15Mar2021 at 09:45 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no 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 21Mar2021 at 12:00, 6 days after the vaccination, the patient experienced rash and soreness at the injection site. On an unknown date in Mar2021, the patient reported that initially arm was sore for two days, then the patient felt ok until day 6. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events rash and soreness at the injection site and sore arm were resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.
52 2021-07-28 pain in extremity, numbness, limb paralysis He can move and use his hand now,but it was like paralyzed; Gave him autoimmune response/ him hyper-... Read more
He can move and use his hand now,but it was like paralyzed; Gave him autoimmune response/ him hyper-rized his body; felt sick; Had complaints of nausea, felt as if he was beaten with a baseball bat from head to toe; felt as if he was beaten with a baseball bat from head to toe; Bone pain; Numbness in his hands to elbows with knots/Second dose: Has knots coming all over his hands/Second dose: Numbness; numbness in his hands to elbows with "knots" that appeared; Pain/it started in his hands and went up to his arm, to elbow, and had pain/The pain went from his elbows, down to his hands, and knuckles; Pain/it started in his hands and went up to his arm, to elbow, and had pain/The pain went from his elbows, down to his hands, and knuckles; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in right arm on Mar2021 14:45 (Batch/Lot number was not reported) (at the age of 52 years old) as dose 2, single for COVID-19 immunization. Medical history included diabetic, heart disorder, high triglycerides, high cholesterol, blood pressure high, anxiety and sleep problem, all were ongoing; and some kidney stones taken out so he knows pain/ 200 kidney stones and he knows pain (He does not take anything except that time when had kidney stone and took Morphine and it made so hyper) and back pain before the vaccine. Concomitant medications included insulin aspart (NOVOLOG) taken for diabetes, from an unspecified start date to unspecified date in 2021 (Have not used in last 3-4 weeks because diabetes is doing better); insulin glargine (LANTUS) taken for an unspecified indication from an unspecified start date and ongoing; atorvastatin taken to lower triglycerides and cholesterol from an unspecified start date and ongoing; dapagliflozin propanediol monohydrate (FARXIGA) taken as diabetic and heart pill from an unspecified start date and ongoing; lisinopril taken for blood pressure high from an unspecified start date and ongoing; carvedilol taken for high triglycerides from an unspecified start date and ongoing; lorazepam (ATIVAN) taken for anxiety from an unspecified start date and ongoing; and sertraline hydrochloride (ZOLOFT) taken as it helps with sleep or something, does not really know why taking (as reported) from an unspecified start date and ongoing. The patient previously had kidney stone and took Morphine and it him made so hyper and the patient said that he said he would never take it again. This was 18 years ago. No prior vaccinations (within 4 weeks). He got the Flu Vaccine back in September. He gets the flu vaccine and pneumonia each year and no reaction. The patient received the first dose of the Pfizer Covid-19 vaccine in in right arm back in Feb2021 15:00 and had complaints of a euphoric feeling that went away like initially sounded like stated 3 hours. After getting the second vaccine, two days after that everything changed and he and his body was never the same. After the second dose, it started in his hands and went up to his arm, to elbow, and had pain. It was so excruciating. The pain started two days after getting the second dose. The pain went from his elbows, down to his hands, and knuckles. He stated he no longer has any pain. It slowly went away . The pain started going away three weeks ago. He did not take any pain medicine. He does not take drugs or alcohol. The patient had the second dose of the Pfizer Covid-19 vaccine back in Mar2021 and felt sick, had complaints of nausea, felt as if he was "beaten with a baseball bat from head to toe", and afterwards he started developing bone pain and numbness in his hands to elbows with "knots" that appeared. He still has numbness and bone pain but the pain was getting better. Has been to rheumatologists and doctors for complaints he experienced after being administered the second dose of the Pfizer Covid-19 vaccine and HCP wants to put him on pain medication. He has had to see two rheumatologist so far and his family doctor. The knots on his hands started coming up slowly. It was not overnight. It was within 3-4 week time period it started to come up. He showed all of this to the doctor and told this is not right. He did not have anything until he got the Pfizer vaccine. The knots are almost gone, not 100% gone, but almost gone. The knots did not really hurt. However, the knots did move around with a little pain. The pain was not that bad. He stated he still cannot feel his hands. They were so freaking numb. He cannot feel his fingers. He started to feel numb three days after the second dose. It started and then got worse. He could not pick up his hammer. The pain was so excruciating. He reiterated he was very active, physical, exercised, ride bike each day. He worked hard all his life, and did not really have pain except back pain before the vaccine. After day two he started to have pain like never before. It's like the vaccine attacked something in his body. He later, confirmed the numbness is getting better at this time. The numbness use to be from his elbows down. The events did not require emergency room visit. The right one where got shot in was double as bad with the knots than the left. The pain was worse in the right arm than left a little bit. Mentioned he is right handed and uses his right hand more. He stated the vaccine has wrecked havoc on his life. He is a good church going guy. Whatever they put in him hyper-rized his body. Three doctors have told him it's an autoimmune vaccine and it attacked his body. Gave him autoimmune response. It's almost five months now into this and still having some effects. He can move and use his hand now, but it was like paralyzed. He was a very active guy and once his took this, it wrecked his life. He was a physical guy and has to use his arms and hands every day. This vaccine did not coincide with his body. It may with the other 1,000 people, but for him it did not at all. All these symptoms from a vaccine. He normally gets the flu vaccine and pneumonia vaccine each year and never had anything like this. He stated that with the Pfizer Covid-19 vaccine that he is the one guy it didn't work on. He stated that he has missed a lot of work and the vaccine has done a great thing by saving lives but not his life. The Pfizer Covid-19 vaccine was not free because it has caused him so much and he cannot do the physical activities that he was able to do before getting the Pfizer Covid-19 vaccine. His HCP told him not to get the Pfizer Covid-19 vaccine again. He stated that he was still frustrated as he was before this call. He doesn't believe no one else has not had his side effects and feels that there is more information about what he is experiencing. He got upset and stated this vaccine should have been studied more. He commented this vaccine is safe for like 99.99% of people, but it was not safe for him. It's not safe because one would not have these effects and then it slowly start to go away if it was safe. The patient has so much lab work done in the last 3-4 months. Has had enough lab work to last a life time. Now he has a paper to get it done again. He does not have any specific results to provide. Weight was reported as 157 pounds (also reported as 130 something pounds). The outcome of the event He can move and use his hand now,but it was like paralyzed was not recovered; event Numbness in his hands to elbows with knots/Second dose: Has knots coming all over his hands/Second dose: Numbness was recovering; event Pain/it started in his hands and went up to his arm, to elbow, and had pain/The pain went from his elbows, down to his hands, and knuckles recovered in Mar2021; and outcome of the other events was unknown. Information on lot/batch number has been requested.
52 2021-07-29 burning sensation Dizziness; Brain fog; Tinniutis; Unsure of balance; Disequilibrium almost to the point ofvertigo; He... Read more
Dizziness; Brain fog; Tinniutis; Unsure of balance; Disequilibrium almost to the point ofvertigo; Heart Racing; Bizarre nightmares; Benign hypertensive levels; Anxiety; Chills; Fatigue; Muscle Aches; Some burning in leg muscles; Severe joint inflammation in knees and ankles; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 23Mar2021 at 10:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included essential hypertension, benign. The patient has taken unspecified concomitant medications. It was unknown whether the patient had any known allergies. 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 26Mar2021, the patient experienced severe joint inflammation. On 31Mar2021, the patient experienced dizziness, foggy feeling in head, tinnitus, loss of balance, disequilibrium, heart racing, nightmares, benign hypertensive heart disease, anxiety, chills, fatigue, muscle aches and burning in leg muscles. It was reported that the patient experienced 3 days after vaccination, severe joint inflammation in knees and ankles, like a gout attack starting 7 days after vaccination dizziness, brain fog, tinniutis, unsure of balance, disequilibrium almost to the point of ,vertigo, for example at any time, with eyes closed and head up, my body will rock on his heels noticeably, heart racing, especially at night when trying to sleep or stay asleep, waking up numerous times, bizarre nightmares BP elevated above his essential benign hypertensive levels, anxiety starting 7 days after vaccine, but faded chills, fatigue required 2 days of rest muscle aches, some burning in leg muscles inflammation. 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. No therapeutic measures were taken as a result of the events. The clinical outcome of the event dizziness, foggy feeling in head, tinnitus, loss of balance, heart racing, nightmares benign hypertensive heart disease and anxiety was not resolved. The clinical outcome of the event chills, fatigue, muscle aches, burning in leg and joint inflammation was recovered at the time of this report. No follow-up attempts are possible. No further information is expected.
52 2021-07-29 muscle spasms Severe muscle spasms in injection arm; This is a spontaneous report from a contactable consumer, the... Read more
Severe muscle spasms in injection arm; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 28Mar2021 at 13:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included quadriplegia from an unknown date. The patient previously took sulfonamide for an unknown indication on an unknown date and experienced allergy. 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. The patient received unspecified medications within two weeks of vaccination. On 28Mar2021, the patient experienced severe muscle spasms in injection arm. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event of muscle spasms was recovering at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
52 2021-07-29 muscle twitching Right eyebrow twitch, twitch in bridge of my nose, brow and right ear.; This is a spontaneous report... Read more
Right eyebrow twitch, twitch in bridge of my nose, brow and right ear.; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 03Apr2021(at the age of 52-year-old) as a single dose for COVID-19 immunization. Medical history included psoriasis and high cholesterol. Concomitant medications included adalimumab (HUMIRA) for unknown indication from an unknown date. The patient's past drug history was reported as no. 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 COVID-19 vaccine. On 04Apr2021, the patient experienced right eyebrow twitch since the day after receiving vaccine. The patient sometimes felt the twitching in the bridge of the nose, brow and right ear. Twitching lasts just for few seconds and sometimes every five minutes or longer in between, but throughout the day for over 4 weeks. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event facial twitching was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
53 2021-01-05 feeling hot Fairly rapid onset of excess fatigue, difficulty keeping eyes open associated with oscillating visio... Read more
Fairly rapid onset of excess fatigue, difficulty keeping eyes open associated with oscillating vision, near simultaneous distortion of sound (at the time was watching a show using my phone, and the actors no longer sounded like themselves), sense of subtle disequilibrium, and a sense of intense heat involving my upper abdomen and lower chest, centered around my xiphoid process as if being pressed up against a space heater, the latter symptom was non-painful, perhaps the best example is the feeling one has after receiving intravenous contrast dye for CT imaging although more the "warmth" was more intense. Lasted 90-120 minutes before going to sleep, then gone by morning.
53 2021-01-05 pain in extremity Extreme Arm Soreness Painful axillary lymphadenopathy on side of injection Flu like symptoms (Fever... Read more
Extreme Arm Soreness Painful axillary lymphadenopathy on side of injection Flu like symptoms (Fever, HA, Muscle aches, malaise, chills) Abdominal cramping
53 2021-01-07 feeling hot within 10 minutes of receiving vaccine, patient reported having neck tightness and chest tightness; ... Read more
within 10 minutes of receiving vaccine, patient reported having neck tightness and chest tightness; patient was feeling warm and blood pressure was elevated; diphenhydramine 25mg was given and patient was taken to ER. ER reported it was a mix of a slight reaction and anxiety from receiving the vaccine. Patient was sent home from ER and is doing fine.
53 2021-01-07 migraine Server pain at the injection site to the point it is hard to move the arm, and it woke me up when I ... Read more
Server pain at the injection site to the point it is hard to move the arm, and it woke me up when I rolled onto it. Migraine headache with visual pain and nausea. I have taken Tylenol and ibuprofen for the pain and discomfort and I have also been icing the injection site. I missed work today because of the migraine
53 2021-01-08 tenderness, pain in extremity Headache, NauseaVomiting, swollen and painful left axilla and left arm; chills, strange taste in mo... Read more
Headache, NauseaVomiting, swollen and painful left axilla and left arm; chills, strange taste in mouth Narrative: 1/5 received vaccine. 1/6 woke up with left arm/axilla swollen and painful, severe headache, nausea, and chills. Also has a strange taste in his mouth. He stayed home from work. 1/7 employee reports fever overnight, chills, and lump under his left arm has enlarged. Advised to see his PCP. 1/8 left axillary lump has decreased from softball size to baseball size. It's still tender. His arm pain has improved. Headache, nausea, and chills have resolved.
53 2021-01-10 pain in extremity Sore Arm, Body Aches- resolved 24 hr
53 2021-01-12 cold sweat Received 2nd vaccination in series on 11 JAN 21. By next morning started to experience some muscle a... Read more
Received 2nd vaccination in series on 11 JAN 21. By next morning started to experience some muscle and joint symptoms. By afternoon of 12 JAN 21 experienced sudden onset loss of bladder control for first time in his life, followed a few hours later by blurry vision, vertigo, motion sickness, emesis and cold sweats that drenched his clothes. Taken to ER by paramedics, and admitted for further observation and evaluation for underlying neurologic vs. cardiogenic problems. Given positional treatments by PT for possible otoliths. Feels much improved on afternoon of 13 JAN 21, but symptoms not fully resolved. Will likely be discharged from hospital on 14 JAN 21 if problems continue to resolve.
53 2021-01-13 pain in extremity, feeling of body temperature change, tremor, migraine Headache; migraine; tenderness at injection site; Ten hours after injection he had shaking, sweats, ... Read more
Headache; migraine; tenderness at injection site; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Fatigue; This is a spontaneous report from a contactable physician (patient). A 53-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on right deltoid on 05Jan2021 07:45 at single dose for covid-19 immunization. Family history included migraine (other family members). Medical history included mild blood pressure and kidney stones, reactive airway disease. Concomitant medication included colecalciferol (VITAMIN D), potassium, allopurinol and hydrochlorothiazide/valsartan for mild blood pressure and kidney stones, fluticasone propionate, salmeterol xinafoate (ADVAIR) for reactive airway disease, atorvastatin, and multivitamins. The patient previously took fluticasone propionate, salmeterol xinafoate (ADVAIR) and experienced dry mouth and lost sense of taste. The patient also previously took Tdap booster on Aug2020, Shingrix on 10Aug2020, and influenza on 12Oct2020; all for immunization; and tetanus injections for immunization and experienced localized tenderness. The patient had the first dose of BNT162B2 (lot number: EH9899) for COVID-19 immunization on 15Dec2020 and experienced localized tenderness at injection point. The received his second dose of COVID vaccine on 05Jan2021. With the first dose he had increased localized tenderness at injection site on 15Dec2020, and he rated it mild to moderate. He would say it was 80% resolved in 24 hours. It had completely resolved in 36 hours. He would say that he has recovered completely form the localized tenderness with the first dose. Then he noted his second dose was yesterday, in the context of not having much sleep the night before. The actual injection was uncommonly eerily painless. The other folks in his department had similar experience. Maybe it was the nurse who gave the injection. Maybe it was because it was the same area and sensitivity was decreased. They had to check the Band-Aid to make sure blood was there. The administration was painless. He was relieved when the arm started getting sore to know he actually received it. He had increased arm tenderness at injection site which he rated as moderate which has now resolved. It got to moderate where lifting the arm up was sore. He definitely knew that he had been vaccinated. He got the vaccine at 7:45AM and now it is 16 to 17 hours later and he would say the pain is mild now. It did persist. The first vaccine hurt a little more. He expects this to go away. Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias. He had unrelenting headache over night that was moderate to severe. He said it kept him awake. It was exacerbated by lying down. Sitting up helped him. It became a migraine which is something he doesn't often experience. Migraines are pretty rare for him. He took 800mg of Advil at 6AM that helped for headache and migraine. The weight of the patient was 250 to 255 pounds. Shaking, sweats, hot and cold flashes, and augmentation of myalgias have resolved. Everything has resolved except for a little headache. In the background he literally had one or two hours of sleep. He thinks that likely precipitated a migraine was increased. Last night he slept literally an hour. He took 800mg of Advil and fell asleep. He is operating on 2 hours of sleep in 48 hours. Most of the stuff is gone except a little headache and expected fatigue. Headache Seriousness Criteria: he would say that it was relatively disabling. He would not have been able to carry on. He wouldn't have been able to operate last night. It would have interfered. It was dissimilar to others. He gets rare migraines. Everything was amplified with a migraine. He certainly felt that. It was fair to say the vaccine precipitated the migraine that was mild or severe. He doesn't want to falsely attribute these things to the vaccine. Causality Headache: precipitated by the vaccine. In the context that he had not slept the night before. He had a nasopharyngeal COVID test and it was negative. He has been in a COVID study where they are looking at combination. They developed a saliva test at (Name). There is a combination of saliva oropharyngeal and immunoglobins. He has been negative multiple times. The outcome of the events headache and fatigue was not recovered and recovered for the rest of the events.; Sender's Comments: A causal association between BNT162B2 and the reported event headache cannot be excluded based on a compatible temporal relation between vaccination and onset of events. 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.
53 2021-01-14 weakness 30 hours post injection mild weakness and fatigue; Onset began 18 hours after injection. 100.2 fever... Read more
30 hours post injection mild weakness and fatigue; Onset began 18 hours after injection. 100.2 fever; chills; body aches; extreme fatigue; Bedridden 8 hours; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1685, via an unspecified route of administration on 07Jan2021 at 15:00 (at the age of 53 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included high blood pressure from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination, but did receive the first dose of BNT162B2, lot number: EJ1685 on 19Dec2020 at 16:15 in the left arm. On 08Jan2021 at 09:00 (reported as onset began 18 hours after injection), the patient experienced 100.2 fever, chills, body aches, extreme fatigue, bedridden 8 hours. It was reported that 30 hours post injection (08Jan2021 at 21:00) he experienced mild weakness and fatigue. The patient did not receive treatment for the events. The clinical outcome of 100.2 fever, chills, body aches, extreme fatigue, bedridden 8 hours, mild weakness and fatigue was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
53 2021-01-15 pain in extremity, numbness Headache, Fever, Chills, L arm soreness and numbness Narrative:
53 2021-01-20 weakness I was sick all day fevers chills dry heaves no energy
53 2021-01-20 numbness, tingling mild SOB, facial tingling/numbness, flush, light headed all while eating lunch. Pt sats 100%. No res... Read more
mild SOB, facial tingling/numbness, flush, light headed all while eating lunch. Pt sats 100%. No resp distress noted. LS CTA. VSS. Denies chest pain or other symptoms
53 2021-01-23 flushing The injection site seemed inappropriately high in the shoulder/deltoid. No aspiration attempted. I ... Read more
The injection site seemed inappropriately high in the shoulder/deltoid. No aspiration attempted. I had a dripping sweat occur at the five to fifteen minute range. There was a flushing sensation during this. After a few minutes, it all abaited. The bandaid was saturated with blood. My arm was never sore and I had zero symptoms after the initial reaction. I believe this injection was given intravascularly. I have not been able to find ANY information to address the effectiveness of this route if administration and I seriously fear that I am not covered.
53 2021-01-25 numbness Numbness in the right thigh anterior and lateral aspects; This is a spontaneous report from a contac... Read more
Numbness in the right thigh anterior and lateral aspects; This is a spontaneous report from a contactable physician (patient). This 53-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 2nd dose (lot number:EJ1686) 06Jan2021 01:00 PM at left arm at single dose intramuscular for Covid-19 immunization. Facility type vaccine was hospital. Medical history was reported as "none". Patient had no known allergies. Concomitant drug in two weeks included finasteride (PROPECIA), acetylsalicylic acid (ASPRIN), atorvastatin, and multivitamin. Patient received 1st dose of BNT162B2 (lot number: EK5730) on 17Dec2020 01:30 PM at right arm for Covid-19 immunization. No other vaccine received in four weeks. It was unknown if covid prior vaccination. No covid tested post vaccination. Patient experienced numbness in the right thigh anterior and lateral aspects on 13Jan2021 starting on 09:00 PM. No treatment received. Outcome of the events was not resolved.
53 2021-01-27 tremor, weakness Extreme chills, shaking, shivering x 1 day, loss of appetite, diarrhea x 2 days, weakness, lighthead... Read more
Extreme chills, shaking, shivering x 1 day, loss of appetite, diarrhea x 2 days, weakness, lightheaded x 3 days, shortness of breath x 4 days
53 2021-01-28 pain in extremity After my second dose, I felt fin at around 10pm like the first dose my arm started to become achy. ... Read more
After my second dose, I felt fin at around 10pm like the first dose my arm started to become achy. I go to work around 230AM and when I was putting my contacts in my right eye had a huge busted vessel to the right side of my pupil.
53 2021-01-30 bell's palsy Bilateral facial nerve palsy started on 1/24/2021, left side worse than right.
53 2021-02-12 facial paralysis, bell's palsy Development of left sided facial Bells Palsy, initially started on Thursday 2/11/2021, symptoms wors... Read more
Development of left sided facial Bells Palsy, initially started on Thursday 2/11/2021, symptoms worsened until left mouth and eye droop on Saturday 2/13/21. Went to Urgent Care on 2/13/21 and received diagnosis of Bells Palsy. Prescribed Prednisone 60mg daily x 7 days. Will start today - 2/13/21
53 2021-02-13 weakness 12 hours after shot started chills, body aches, severe headache. 24 hours after shot, same condition... Read more
12 hours after shot started chills, body aches, severe headache. 24 hours after shot, same conditions, with nausea. 48 hours after shot same conditions, with vomitting. Unable to eat or drink and would just throw it up. 72 hours, severe headache, extreme light and sound sensitivity, nausea. 96 hours finally starting to feel better. Mild symptoms, such as slight headache, weakness.
53 2021-02-17 pain in extremity Pain in arm; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male ... Read more
Pain in arm; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 26Jan2021 08:00 AM at a single dose on the left arm for COVID-19 immunization. The most recent COVID-19 vaccine was administered at 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. Medical history was none. The patient had no known allergies to medications, food, or other products. The patient had no concomitant medications. On 26Jan2021 02:00 PM, the patient experienced pain in arm. No treatment was received for the event. Outcome of the event was recovering. Since the vaccination, the patient has not been tested for COVID-19. The reporter assessed the event as non-serious. Information on the lot/batch number has been requested.
53 2021-02-18 feeling hot hives (left arm, neck, upper legs, chest), itchiness, "feeling hot all over"
53 2021-02-22 tingling, numbness as I mentioned, he had a fever and aches one day prior to the first vaccine. following the vaccine ... Read more
as I mentioned, he had a fever and aches one day prior to the first vaccine. following the vaccine the fever spiked as high as 103 and fatigue continued. four days later a rash developed on his back, and a dry cough developed. He also is experiencing and continues to experience some numbness/tingling in his legs and arms. Two Saturdays following the vaccine he went to the ER and was diagnosed with pneumonia in both lungs. However, a fourth covid test was given and it was negative like the previous three tests.
53 2021-02-24 weakness Fatigue, body pain, weakness , headache.
53 2021-02-28 numbness, tingling After waiting 15 minutes in the observation room, I left as I was feeling fine. About 10 minutes la... Read more
After waiting 15 minutes in the observation room, I left as I was feeling fine. About 10 minutes later, as I was driving home, I had an odd taste in my mouth and my right cheek started to go numb. I arrived home and started looking for answers (Pfizer information page that lists side effects). The sensation lasted about an hour or so, then started to subside. By the time I went to bed, there was just a little tingle at the edge of my cheek bone. Other than being tired and a bit woozy, I feel better today.
53 2021-03-01 flushing Patient felt flushing across chest, sat down and symptoms resolved, patient then reported feeling sw... Read more
Patient felt flushing across chest, sat down and symptoms resolved, patient then reported feeling sweaty and wanting to lie down. Patient was assisted onto the floor by staff. No Loss of consciousness. Patient transferred to ED for evaluation. Patient received IV fluids and 0.25 mg alprazolam. Patient was discharged home from ED.
53 2021-03-04 numbness Progress Notes Expand AllCollapse All COVID VACCINE CLINIC 2/24/2021 Subjective Pt. is a 53 y.... Read more
Progress Notes Expand AllCollapse All COVID VACCINE CLINIC 2/24/2021 Subjective Pt. is a 53 y.o. male who was seen at COVID Vaccine Clinic today for his first dose of the COVID 19 vaccination. He was given the Pfizer vaccination in the right deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience numbness in right forearm and headache. He denied difficulty breathing, difficulty swallowing, itching and lightheadedness. This provider was notified of patient reaction and he was then assessed in the emergency area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms and skin changes. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, facial swelling, cough, chest tightness, shortness of breath, wheezing, dizziness and headaches Numbness right forearm.: Previous Reactions: None Objective Vitals Vitals: 02/24/21 1208 BP: 124/77 Pulse: 83 SpO2: 95% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic and atraumatic. Mouth/Throat: 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. Musculoskeletal: General: No swelling or deformity. Comments: No rashes noted on right arm where injection was given. Equal strength in bilateral upper extremities. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: He is alert and oriented to person, place, and time. Assessment/Plan Treatment included: Tylenol 1000mg and water. Follow up response to treatment: good. Sx completely resolved. Discussed that he may take Ibuprofen this evening if he experiences some numbness in the right forearm or fingers. He denied symptoms of headache and numbness resolved prior to discharge. I walked with patient to exit the facility. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Electronically Signed 2/24/2021 12:09 PM
53 2021-03-08 muscle twitching, pain in extremity following injection i had increased pain in back and into legs. it increased to point of week of Feb... Read more
following injection i had increased pain in back and into legs. it increased to point of week of February 1 I was having difficulty at work. on 2/5/2021 i started having fesiculations in both lower extremities at rate of 300-400 per minute. pain increased in lower back and thighs. These increased to point of inability to work related to inability to sit more than 15 seconds and need of walker to mobilize. I scheduled with back specialist and neurologist, ended up hospitalized on 2/18/2021 released on 2/21/21 with diagnosis of benign fesiculations meaning no testing identified cause. currently still unable to work.
53 2021-03-08 pain in extremity 1st symptom: Within 30 seconds, ache in arm from elbow to wrist. Got worse over next few minutes, f... Read more
1st symptom: Within 30 seconds, ache in arm from elbow to wrist. Got worse over next few minutes, fairly uncomfortable for about 45 minutes before subsiding slightly (tried to keep moving arm as recommended). Pain returned when I drove to work and while at my desk. Lasted for approx 4 more hours. Injection at 11:15am, pain mostly ended around 9:30pm (except when reaching or extending arm, pain in shoulder now mostly). 2nd symptom: Mild nausea starting about 5 min after injection, while in waiting room. Passed when laying down at home before work, approx 45 min later.. Started again while driving to work and lasted from about 4pm to 8pm. Subsided about 10pm. 3rd symptom - feel very fatigued.at typing of this report at 10pm - started about 5pm. So far nothing else - no headache or chills for example. No pain at all at the actual injection site - now the pain is mostly above it - from the shoulder joint to near the injection site (maybe a couple inches above.) as well as the forearm, all around. To make coping easier in case the symptoms (arm ache, fatigue, etc) are worse as commonly described from the 2nd dose I put in and was approved for PTO from work for scheduled 2nd date on March 30th. Will allow me to rest (avoid being effected at work with the fatigue and an even more achy arm as expected side effects of 2nd dose)
53 2021-03-09 facial paralysis, bell's palsy About 7pm the same day I got my vaccine. My right eye started watering profusely. I didn't think muc... Read more
About 7pm the same day I got my vaccine. My right eye started watering profusely. I didn't think much of it. at 10:30 I went outside to whistle for a dog and I could not whistle. The next morning I found that the right side of my face was completely drooped and I have no expression control.
53 2021-03-10 cold extremities visual disturbance/blurry, cold feet, dizzy, sob, dry throat. Evaluated by EMS-Cleared
53 2021-03-11 feeling hot Warm - No fever, just very warm with a red face Muscle fatigue and soreness General fatigue from usi... Read more
Warm - No fever, just very warm with a red face Muscle fatigue and soreness General fatigue from using any muscle... standing... walking...etc. I have no issues at all with performing any of these activities All symptoms were gone after approximately 36 - 48 hours
53 2021-03-12 numbness and pain in extremities, numbness, flushing Started with itching burning rashes neuropathy headaches fatigue and dizziness. Now have mouth sores... Read more
Started with itching burning rashes neuropathy headaches fatigue and dizziness. Now have mouth sores that won?t heal and debilitating malaise fatigue A few days later: Joint pain and air hunger A few days later: Numb extremities Two weeks to date: Body temp regulation issues , heart pounding, face flush. Sleep disturbance entire time. Extreme fatigue.
53 2021-03-16 pain in extremity Arm pain began evening of vaccine. About 48 hours after vaccine patient felt light headed and dizzy... Read more
Arm pain began evening of vaccine. About 48 hours after vaccine patient felt light headed and dizzy. He drank water and sat down. Then felt like he needed to lay down. About 1/2 hour later his heart rate was up and oxygen levels low. His blood pressure was also high. He was pale and pasty looking. No fever. This lasted about 1/2 hour but he still didn?t feel right. He felt fine about 2 hrs after the incident. Then he experienced chest pain In the middle of the night .
53 2021-03-16 speech disorder, flushing flushing and difficulty talking Narrative: Patient had similar reaction previously to tetanus immu... Read more
flushing and difficulty talking Narrative: Patient had similar reaction previously to tetanus immunization with flushing and difficulty talking/thick mouth
53 2021-03-18 tingling tingling in lips and sinuses 10 min. after vaccine -dizziness /lower lip slightly swollen /bp 124/84... Read more
tingling in lips and sinuses 10 min. after vaccine -dizziness /lower lip slightly swollen /bp 124/84 pulse 82 -c/o tightness in throat -swallowing -no respiratory issues
53 2021-03-20 feeling cold, burning sensation, pain in extremity, tremor Vaccine given at 10am. He worked all day, home at 11pm. He said the pain from the shot in his arm ha... Read more
Vaccine given at 10am. He worked all day, home at 11pm. He said the pain from the shot in his arm had traveled to his neck.At around 11:45 pm he got out of bed and became FREEZING, started shaking, teeth chattering, fever of 101. I gave him Tylenol pm to halt the fever. He was up all night shaking, teeth chattering, burning with fever. This morning the fever is 100. He had Covid over Thanksgiving which started the same way. He went to the ER with Covid and could not get out of bed for ten days. No additional medical treatment at this time
53 2021-03-21 feeling hot Patient feels hot, dizzy, lethargic
53 2021-03-23 tingling, pain in extremity Began approximately 17 days after injection Dull ache at the injection site with sharp pain radiatin... Read more
Began approximately 17 days after injection Dull ache at the injection site with sharp pain radiating down my left arm and up into my left trapezius muscle; tingling sensation in fingers of my left hand
53 2021-03-24 weakness No adverse effects initially. On second day after the vaccine, I woke up feeling like I had sustain... Read more
No adverse effects initially. On second day after the vaccine, I woke up feeling like I had sustained some kind of shoulder injury: significant reduction in motion, weakness, pain. So far it has lasted two days.
53 2021-03-24 tremor Rocking tremors back and forth in pelvis
53 2021-03-25 numbness, facial paralysis, bell's palsy About 30-45 minutes I began to feel tingling in my tongue and throat. A few hours later my face beca... Read more
About 30-45 minutes I began to feel tingling in my tongue and throat. A few hours later my face became numb - it was a circle around my face. The next day (3/7) the right side of my face was numb and showing symptoms of what doctors later decided was Bells Palsy. on 3/7 I had fatigue and general feeling bad like I had the flu. On Monday 3/8, I was feeling worse and I called the advice nurse who advised I go to the Emergency room due to right face partial paralysis, numbness, and face drooping. They diagnosed Bells Palsy and prescribed Valtrex and prednosone. From 3/9-12 the right side of my face was numb, droopy and I had ear pain and a lot of fatigue. By Saturday 3/13 I was feeling better and have gradually gotten better through today 3/26. I still have numbness in my right cheek. and occasional tingling in my lips. My doctor has advised me to go ahead and get the second dose of vaccine tomorrow 3/27. Also, during the week of 3/7 - 3/12 I had some dizziness and a general foggy feeling in my head.
53 2021-03-28 weakness, pain in extremity for one day only felt like had the Flu: body aches, low-energy, head ache and left arm sore. By morn... Read more
for one day only felt like had the Flu: body aches, low-energy, head ache and left arm sore. By morning of 29th felt better
53 2021-03-30 muscle spasms I received the first dose of the Pfizer vaccine on 3/16 and did not feel any adverse effects until o... Read more
I received the first dose of the Pfizer vaccine on 3/16 and did not feel any adverse effects until one week later. On 3/23 I started feeling a few twinges on my left side where my bra strap is normally, and then on 3/25 I noticed a rash in that same area. I thought it might be a reaction from the vaccine since it was on the same side as the injection site. But within a few days it was noticeably worse and painful. I went to urgent care on 3/27 and was diagnosed with shingles. I am now on antiviral medication and prednisone.
53 2021-03-30 seizure dizziness, sweat passed out, seizures
53 2021-03-31 feeling of body temperature change, pain in extremity, tremor Very sore arm within 12 hours of 2nd shot on Wednesday March 24th. Woke up the next day feeling "off... Read more
Very sore arm within 12 hours of 2nd shot on Wednesday March 24th. Woke up the next day feeling "off" and irritated. By 9pm Thursday my entire body ached severely as if I had a very bad flu. By 11pm I had very severe cold & hot shakes and felt extremely nauseous until the next morning. I checked my temp every couple hours and never was I above 98.5 but, I felt extremely sick until about 48 hours after the 2nd shot. On Friday, and for the next 2-3 days, I felt fatigued as if I was recovering from the flu. Only a flu that was without fever or any respiratory issues. By Monday I felt normal again.
53 2021-03-31 flushing 15 minutes after receiving vaccine, client began c/o headache, flushing, diaphoresis, and dizziness.... Read more
15 minutes after receiving vaccine, client began c/o headache, flushing, diaphoresis, and dizziness. Vital signs were obtained. BP was elevated. Client given oral Benadryl after c/o itching. No rash noted. Obtained VS every 15 minutes while monitoring for 45 minutes post Benadryl administration. VS stabilized. Client stated he was feeling better and was released home with spouse driving.
53 2021-03-31 pain in extremity Shortly after shot began to experience shoulder and elbow pain in left arm. Shoulder pain went away... Read more
Shortly after shot began to experience shoulder and elbow pain in left arm. Shoulder pain went away after 48 hours but the elbow pain has persisted for almost a week. The pain in on the back side of my elbow at the crux.
53 2021-04-01 tingling Last night, I was doing dishes and felt a brief, sharp pain at the injection site. Immediately afte... Read more
Last night, I was doing dishes and felt a brief, sharp pain at the injection site. Immediately afterwards, I got a tingling sensation that went from my left cheek to elbow. It lasted a bit but wasn't very bad , considering some of the side effects I had heard of. Then, on April 2nd, I found that touching the injection site caused the same reaction, albeit not as bad. This occurred twice today. When I looked the symptoms up on the web, I didn't find any mention of this. However, Google seems to have seen something because before I could get the entire search term in, it completed for arm tingling. At this point, I decided to report it. Again, the reaction is very mild, but very odd.
53 2021-04-04 flushing a few minutes after receiving the vaccine, the patient became flush and lightheaded. He was lowered... Read more
a few minutes after receiving the vaccine, the patient became flush and lightheaded. He was lowered to the floor where he never went unconscience, but did get very pale and sweaty. His blood pressure was low at 99/60. He reported he had not eaten. He was given glucose tabs and after 15 minutes began to feel better. he drank water and was observed for 30 minutes. He did not report this had happened previously, but did say he did not like needles or blood.
53 2021-04-05 numbness numbness to the left side of the face / tonque. pt denies any difficulty swallowing / breathing &/o... Read more
numbness to the left side of the face / tonque. pt denies any difficulty swallowing / breathing &/or other s/s. No visual swelling to the tongue. Medics present. pt. waiting another 30 mins to be monitored.
53 2021-04-05 tremor Extreme body tremors that wax and wane.
53 2021-04-06 weakness Whole body hurts and standing up is difficult for more than 10 minutes. Right side of body is in a l... Read more
Whole body hurts and standing up is difficult for more than 10 minutes. Right side of body is in a lot of pain and I can?t hold anything up
53 2021-04-06 pain in extremity, nerve pain, feeling hot Immediately after the shot , I felt arm get strangely itchy , then my left arm was very warm for a c... Read more
Immediately after the shot , I felt arm get strangely itchy , then my left arm was very warm for a couple hours. I told the Dr there , they released me after 20 min , as there was no serious pain . After couple of days with Sore Arm pain , my left ribs area became a little sore and starting to have what felt like nerve jolts from left side of my Neck down my left arm. The Neck pain and nerve feeling got steadily worse over the next 3-4 days , on the 5th or 6th day the pain was so bad I could not move out of bed in the morning for over 2.5 hours. With a sudden move there was lightening bolt type pain shooting down left arm and right leg. Pain subsided over the next 3-4 days. I would say now it's 90% .
53 2021-04-07 feeling hot Placed follow up called on 4/5/2021 at 1:25pm: Patient reported he is still feeling warm since rcvdi... Read more
Placed follow up called on 4/5/2021 at 1:25pm: Patient reported he is still feeling warm since rcvding 2nd dose on 4/1/2021. Patient also reported on 4/4/2021 there's a sore on the outside of his mouth, and this morning 4/5/2021 the tip of his tongue is red and there is a sore inside his mouth (reporting that there's discomfort inside his mouth when he consume something hard or drink hot beverages). Patient reported on 4/1/2021 in the evening he had high fever (temp 101.9 degree) that occured through Friday morning (4/2/2021), he reported taking Tylenol one time on 4/1/2021 evening and then continued to take Tylenol 3 more times on 4/2/2021. Patient reports that his left armpit is still swollen, and has been swollen for 3 days now, there is pain if pressure is applied to the swollen area. For the swelling in the left armpit patient reported taking Aleve one time on 4/3/2021 but that did seem to help with the swelling. Recommend patient to stay hydrated, and to take Tylenol as need for any fever or pain but not to exceed a dose of 4,000mg per day. Also recommend patient to contact PCP for further evaluation of symptoms. Patient reported will try to get in to see his PCP either 4/5/21 or 4/6/21. Advised will follow up on Wed 4/7/21 after 1pm. Follow up on 4/7/21. Spoke with patient he stated he's feeling a lot better. Fever subsided same day after taking the tylenol. Patient saw PCP on Tuesday 4/6/21 and he was prescribed a steroid. He stated the mouth sores and armpit swelling are 80% better. Patient is overall doing and feeling a lot better. Advised to continue with the medication pcp prescribed and to call if he has any questions or concerns.
53 2021-04-07 pain in extremity, feeling cold Tired, arm pain, cold, dizzy
53 2021-04-08 cold sweat Slight pain in shoulder several hours after injection. By 7:00 am it felt like I had Covid again. ... Read more
Slight pain in shoulder several hours after injection. By 7:00 am it felt like I had Covid again. I had a fever of 102.8 cold sweats, muscle aches throughout my body and bad headache. I took recommended dose of Tylenol drank tons of fluids and laid in bed the entire next day. what was mild discomfort in shoulder turned into large pain. after about 12 + hours of Tylenol and fluids the fever broke and was down to about 100.6. As of today (Friday) I am up and about with shortness of breath but no fever and minor aches.
53 2021-04-08 numbness Pain and numbness in the neck and back the day after the vaccination on the third day spread to the ... Read more
Pain and numbness in the neck and back the day after the vaccination on the third day spread to the shoulders
53 2021-04-08 nerve pain Patient reports new nerve type pain in shoulder. He cannot sleep on that side (left ) and has diffic... Read more
Patient reports new nerve type pain in shoulder. He cannot sleep on that side (left ) and has difficulty exerting pressure toward his inner body using that arm. Patient has not sought medical attention; he plans to see his chiropractor and possibly his primary medical doctor.
53 2021-04-09 difficulty speaking swollen lips; swollen tongue; hoarsness; difficulty swallowing; This is a spontaneous report receive... Read more
swollen lips; swollen tongue; hoarsness; difficulty swallowing; This is a spontaneous report received from a contactable consumer (Patient). A 53-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot# EL3247), via an unspecified route of administration in the right arm on 10Feb2021 at 3:00 PM (at the age of 53 years-of-old) at single dose for COVID-19 immunization. Medical history included hypertension, hypothyroidism, GERD and tree nuts allergy. Concomitant medication(s) included NEXIUM, PEPCID, QVAR and AMLODIPINE BESYLATE. On 11Feb2021, patient experienced swollen lips, swollen tongue, hoarseness and difficulty swallowing which resulted in emergency room visit. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3247), via an unspecified route of administration in the right arm on 20Jan2021 at 2:00 PM at single dose for COVID-19 immunization. Therapeutic measures were taken for events which include included Prednisone 50mg/5days and Benadryl. The patient took the most recent COVID-19 vaccine at Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The outcome of all the events was recovering.
53 2021-04-10 hot flush Fever (+2 degrees above normal); very strong headache, body aches, chills, fatigue, hot flashes, som... Read more
Fever (+2 degrees above normal); very strong headache, body aches, chills, fatigue, hot flashes, some chest congestion, could not sleep due to aforementioned. Symptoms began about 12 hours after second dose. Symptoms subsided about 24 hours after second dose.
53 2021-04-11 burning sensation shingles type rash on right hip about 12" in diameter. same on the middle lower back. took about 7 d... Read more
shingles type rash on right hip about 12" in diameter. same on the middle lower back. took about 7 days to start to go away, burning itching rashing
53 2021-04-11 muscle twitching After my second dose, I experienced muscle twitching exactly in the muscle where I got my shot. It h... Read more
After my second dose, I experienced muscle twitching exactly in the muscle where I got my shot. It hasn't stop since the then. the muscle twitching wakes me at night and happens almost every 5 minutes till I rubbed it hard. Please help, my insurance deductible is very high and I am out of work to pay for a visit to my doctor.
53 2021-04-11 pain in extremity 2 am sunday morning I woke up with pain in my left wrist and hand. A blood vessel traveling through ... Read more
2 am sunday morning I woke up with pain in my left wrist and hand. A blood vessel traveling through my hand and about 3 inches up my left arm felt like a rope to the touch with some swelling between my 3rd and 4th fingers. No redness or hot to the touch. Sunday morning at 9am the blood vessel returned to normal. However Sunday night at 830 pm the swelling and pain and rope like feeling of the same vein returned and the area is the same as of now [2pm Monday the 12th of April ].
53 2021-04-12 bell's palsy Facial paralysis/Bell's palsy/lip and tongue paralyzed; Lip and Tongue Paralyzed; reports neck, ear ... Read more
Facial paralysis/Bell's palsy/lip and tongue paralyzed; Lip and Tongue Paralyzed; reports neck, ear & head pain that started on 21Mar2021; reports neck, ear & head pain that started on 21Mar2021; reports neck, ear & head pain that started on 21Mar2021; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on 13Mar2021 between 15:00-16:00 as SINGLE DOSE for COVID-19 immunization. Medical history included diabetes mellitus from 2016 and ongoing States it started 5 years ago, and it is under control, hypertension from 2016 and ongoing States it started 5 years ago, and it is under control. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks. On 21mar2021, the patient experienced neck, ear & head pain on the left side. On 24Mar2021, the patient experienced facial paralysis, lip and tongue paralyzed the left side of the face, bell's palsy. The patient states that everything started before on sunday then on wednesday he started to get paralyzed on his face. The patient went to the ER on 24Mar2021 and they thought he was having a stroke, so they did a CT and MRI and his brain is fin and Stated that the Neurologist diagnosed him with Bells Palsy. He was admitted to the hospital on 24Mar2021 and discharge 25Mar2021 at 18:00. The patient enquired about getting second shot and he wants to know what is going to happen if he gets the second shot, was it recommended or not recommended. The patient underwent lab tests and procedures which included computerized tomogram: normal on 24Mar2021 brain is fine, magnetic resonance imaging: normal on 24Mar2021 brain is fine. Therapeutic measures were taken. The patient was treated with Acyclovir and Methylprednisolone. The outcome of the events facial paralysis, lip and tongue paralyzed were not recovered and for neck,ear and head pain was recovering Information on the lot/batch number has been requested.
53 2021-04-12 pain in extremity 4/1/2021: SEVERE LEG PAIN, PRESENTED TO HOSPITAL ER AND WAS FOUND TO HAVE ACUTE DEEP VENOUS THROMBOS... Read more
4/1/2021: SEVERE LEG PAIN, PRESENTED TO HOSPITAL ER AND WAS FOUND TO HAVE ACUTE DEEP VENOUS THROMBOSIS LEFT LOWER EXTREMITY. 4/4/2021: SEVERE SHORTNESS OF BREATH, SQUEAD WAS CALLED AND HE WAS TAKEN TO HOSPITAL ER WHERE HE WAS FOUND TO HAVE BILATERAL PULMONARY EMBOLISM
53 2021-04-12 tremor Shaking Chills Body Ache Rapid Heartbeat, my normal is 56-61, during reaction it was 81-88 checked ... Read more
Shaking Chills Body Ache Rapid Heartbeat, my normal is 56-61, during reaction it was 81-88 checked every hour Fever 99-100.1 Treatment: Fluids, Acetaminophen, Rest
53 2021-04-13 feeling cold Low fever, cold chills, sweats, headache
53 2021-04-13 muscle twitching, muscle spasms, pain in extremity I received 2nd Covid 19 vaccine on April 9th 20201 at 6pm PT. Then I started to have lower back pai... Read more
I received 2nd Covid 19 vaccine on April 9th 20201 at 6pm PT. Then I started to have lower back pain on Saturday (April 10), but I was still mobile, and was able to perform daily activities. However, on Sunday morning (April 11th), my lower back pain became better, but I started having very severe pain on my left thigh. The pain scale is 10 out 10, and I was unable to move around. I could feel the muscles around the nerve were twitching and cramping, and this gave me such an excruciating pain, and felt like the nerve was squeezed by the thigh muscles. Because of this severe pain, I was not able to mobilize at all on Sunday, then had to go see physician on Monday urgently. The physician was puzzled why I devel
53 2021-04-14 numbness Face numbness on right side. I started feeling numbness in the right corner of my mouth within minut... Read more
Face numbness on right side. I started feeling numbness in the right corner of my mouth within minutes of receiving the shot. Within a couple of hours it had spread to a larger area. From just below my eye to my chin including my lips on that side and inside my mouth and cheek. Symptoms were still there the next morning so I contacted my doctor. I was instructed to go to the emergency room. The ER doctor determined that it wasnt a stroke and said it was most likely a reaction to the covid shot. They also said it resembles a minor case of Bell Palsy but was most likely not Bell Palsy. It was probably an inflammation of the nerves in my face due to the shot. I was prescribed a steroid to use if the symptoms did not stop in a couple of days.
53 2021-04-14 numbness Client received the 1st Pfizer COVID vaccine (lot # EW0162 and expiration date: 4/18/21) at 10:11am... Read more
Client received the 1st Pfizer COVID vaccine (lot # EW0162 and expiration date: 4/18/21) at 10:11am. Client reported numbness in left arm at 10:26am to EMT. Vitals were taken at 10:28am oxygen: 100%, Blood pressure:120/80 and pulse:58. Both Nurses responded to find client alert and oriented x 4. Client reports numbness is localized from injection site to forearm of left arm where injection site is. Client has full mobility and sensation in left arm. Client had already waited 15 minutes, so advised waiting another 15 minutes and since vitals are WNL will get another set of vitals after 15 minutes. At 10:43am retake vitals: pulse: 65, blood pressure: 120/80 and oxygen: 100% and client reports that all symptoms completely resolved. Provided client with ER precautions and do advise primary care provider. At 10:44am client left facility with a steady gait.
53 2021-04-14 numbness and pain in extremities, numbness, tingling Numbness tingling internal vibrations in legs feet hands. Neuropathy symptoms in hands and feet star... Read more
Numbness tingling internal vibrations in legs feet hands. Neuropathy symptoms in hands and feet started after second dose and continues now after 2 1/2 months. Tried course of prednisone minimal improvement
53 2021-04-14 paralysis, pain in extremity After first dose, "normal" side effects of extremely sore arm, headache lasting one day. After seco... Read more
After first dose, "normal" side effects of extremely sore arm, headache lasting one day. After second dose, fever to 101.5 at 1:00am after receiving shot at 3:00pm previous day. Extreme arm and shoulder pain. Waking up again at 3:00am experienced FULL BODY paralysis. Estimate fever at 103+ but was unable to move to verify. Eyes were in pain and blurry vision. unable to reach phone to call 911. These symptoms lasted 1 hour and son called to check on me and rushed over. Fever was at 101 but immediate does of motrin and then later tylenol, broke fever. Arm remained immobile for full day. Now it is mobile but still painful to lift overhead. All other symptoms subsided.
53 2021-04-15 pain in extremity Left Arm Pain Approx 5 hrs post vaccination lasting 48 hrs. Headache, shoulder, neck and back muscle... Read more
Left Arm Pain Approx 5 hrs post vaccination lasting 48 hrs. Headache, shoulder, neck and back muscle aches developing overnight. Fatigue next day (approx 18 through 36 hrs post vaccination), ongoing muscle aches, low body temperature accompanied with chills (96.7-97.7°F) 30-36 hrs post vaccination.
53 2021-04-15 seizure like phenomena Patient experienced seizure like activity. EMS was on site to evaluate patient and transported him t... Read more
Patient experienced seizure like activity. EMS was on site to evaluate patient and transported him to emergency room. Spouse reports frequent seizure activity.
53 2021-04-16 migraine A fairly aggressive visual migraine, Episode lasted 15-30 minutes almost exactly 24 hours after inje... Read more
A fairly aggressive visual migraine, Episode lasted 15-30 minutes almost exactly 24 hours after injection. It would seem there was no mention of migraines as a side affect. So figured it best to report just in case it was a sign of something more. The floaters and flashes were similar to those I have gotten prior to migraine headaches. This was unusual as normally they normally do not interrupt my vision greatly and are simply in my vision and usually only in one eye. In this case it wasn't limited to one eye or one spot.. there were multiple and made it hard to focus and see. Usually when I get visual migraines, a headache comes shortly after. So far as of this writing, I only feel a tinge of a migraine coming on, but it is seeming to fade already. Should note, I do not get migraines often (maybe once every other year or so.. ) and when I do it is usually after extended exposure to the sun and not on a chilly morning when I first wake up. Thus this report.
53 2021-04-16 pain in extremity Tiredness, fatigue, sore in the arm, fever
53 2021-04-17 weakness I felt weak/drained within about an hour of vaccination on April 16. On April 17 I felt pain across ... Read more
I felt weak/drained within about an hour of vaccination on April 16. On April 17 I felt pain across my body at the level of the skin, including on my scalp. I was extremely cold without a fever, but later developed a fever with e a temperature of 100.7. The symptoms subsided at approximately 5:30 PM on the same day.
53 2021-04-17 feeling hot He was hungry all the time and when he ate, he noticed there was no taste at all; When he was tested... Read more
He was hungry all the time and when he ate, he noticed there was no taste at all; When he was tested for covid he thought he was feeling hot; lost sense of smell; He was hungry all the time and when he ate, he noticed there was no taste at all; Tested positive/tested for covid; fever; Headache; Symptoms in my throat ; This is a spontaneous report received from a contactable consumer. This 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6206), via an unspecified route of administration at the left arm on 12Mar2021 16:00 at single dose for COVID-19 immunization. The patient's medical history included high blood pressure (Diagnosed more than 5 years ago and is controlled) and diabetes (controlled). Concomitant medications were not reported. On 16Mar2021, the patient had fever, headache and some symptoms in throat. On 18Mar2021, patient was tested positive for Covid19. On 24Mar2021, the patient had lost sense of smell and lost sense of taste. It was reported that he was hungry all the time and when he ate, he noticed there was no taste at all. It was reported that when he tested positive for covid, the doctor gave him an antibiotic and cough syrup. The patient was taking regular medication for blood pressure and diabetes. He had been taking for years and does not fell it is relevant. Now he is taking a lowered dose of his diabetes medication. When he was tested for covid he thought he was feeling hot but had no temperature when verified. Outcome of fever, headache, symptoms in throat, lost sense of smell, lost sense of taste, covid19 was reported as recovered and outcome was unknown for feeling hot and hunger all the time.
53 2021-04-17 numbness, weakness 15 min after the vaccine patient was released from the pharmacy and exactly 20 min after the vaccine... Read more
15 min after the vaccine patient was released from the pharmacy and exactly 20 min after the vaccine patient began to experience numbness on the left side of his face and difficulty driving. When he came home he complained of numbness and loss of strength in his left arm and as the next hour progressed he began experiencing numbness in his left hip and decreasing strength in his left hand. I called a medical professional who told me to take him to call an ambulance or take him to the nearest hospital. We arrived at the hospital at 2:30pm and symptoms persisted. By the time we arrived his blood pressure had jumped to 185/114 (This morning before the shot he had self monitored his BP @ 128/80)
53 2021-04-21 cold sweat He felt nauseous, got up to go to kitchen sink and passed out for a few seconds. When I got to him,... Read more
He felt nauseous, got up to go to kitchen sink and passed out for a few seconds. When I got to him, he was on the ground, eyes open, but seriously disoriented. He got up to the couch. He was very, very clammy and his heart rate was 44 bpm. I held three fingers for him to identify, he correctly answered. He has a small gash on his forehead. His heart rate came up to 70, 20 minutes after episode. Refused to go to urgent care.
53 2021-04-21 pain in extremity Headache Sore arm Nausea Fatigue/Tired
53 2021-04-23 bell's palsy, facial paralysis In the late afternoon of April 23rd I started to experience the effects of Bell's Palsy. Droopiness... Read more
In the late afternoon of April 23rd I started to experience the effects of Bell's Palsy. Droopiness in my lip, eyelid not closing, difficulty in drinking and eating. We went to our local minor emergency center around 4pm and confirmed it was an episode of Bell's Palsy. The Dr prescribed Prednisone and Valtrex. I took the first dose around 6pm. All week long I'd been experiencing a mild headache and had seen the dr the day before. The diagnosis was muscle tension with arthritis in the neck and was assigned to physical therapy.
53 2021-04-24 weakness continued muscle pain; skin, hair was hurting, couldn't touch skin; muscular pain down to pelvis and... Read more
continued muscle pain; skin, hair was hurting, couldn't touch skin; muscular pain down to pelvis and knees aching; muscular pain down to pelvis and knees aching; diarrhea; chills; Fever; sweating; inner-skeletal pain; feeling of dry mouth; slight pain at left shoulder where the injection site was at; headache; Fatigue; weakness and dizziness; weakness and dizziness; sinus drainage; feels dehydrated; This is a spontaneous report received from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration administered in arm left (left shoulder) on 30Mar2021 09:00 (Lot Number: ER8733) at age of 53 years old as single dose for covid-19 immunisation. Patient's medical history (including any illness at time of vaccination) was none. Family medical history relevant to events: caller states he don't think so, his father had high blood pressure and diabetes. Concomitant medication included ibuprofen taken for tooth disorder at 600 mg every 8-12 hours, taking it probably a week before receiving the vaccine. No prior vaccinations (within 4 weeks). No events following prior vaccinations. No additional vaccines administered on same date of the Pfizer Suspect. The patient experienced slight pain at left shoulder where the injection site was at on 30Mar2021, chills on 02Apr2021, fever on 02Apr2021, sweating on 02Apr2021, continued muscle pain on 03Apr2021, skin, hair was hurting, couldn't touch skin on 03Apr2021, muscular pain down to pelvis and knees aching on 03Apr2021, diarrhea on 03Apr2021, fatigue in 2021, headache in 2021, weakness and dizziness in 2021, sinus drainage in 2021, feels dehydrated in 2021. The patient was calling to report some long term, severe side effects. He received the Pfizer covid-19 vaccine on 30Mar2021. He didn't have anything then muscle pain for the first two and a half days, no reaction until on Friday 02Apr2021 he had extreme chills, fever, sweating, then that continued on to be muscle pain, his skin and hair were hurting, couldn't touch skin through Sunday 04Apr2021. It dissipated into muscular and inner-skeletal pain. He had muscular pain down to pelvis and knees and things would start aching. Now it was kind of letting up. It was the 4th day now and no one he knows who had gotten it had such a long term reaction to this. Clarified that he had slight pain at left shoulder where the injection site was at and that dissipated on Thursday 01Apr2021 and he had no pain anymore and no other side effects. On Friday 02Apr2021 afternoon when it went haywire and thought he may have to go to the hospital on Sunday 04Apr2021. He had diarrhea and almost had everything on the list except redness at the site injection. He also did not have swollen lymph nodes. He didn't think he needed to go to the hospital, he normally didn't get sick and hadn't been ill for years and this was why he wanted to report it because it seemed that it was pulling for along time. He had been sleeping and drinking a lot of liquids. Headache, joint pain, and diarrhea continued all the way through Monday 05Apr2021 and started to dissipate Monday evening. He had no nausea and vomiting. The muscular pain down to pelvis started Saturday 03Apr2021. His knee would ache and then that would stop and then his other knee would ache then stop. It was like it would transfer around lower part of body, and that dissipated late Monday 05Apr2021 night into Tuesday (06Apr2021). Now he had fatigue was tired and had sinus drainage. He felt dehydrated and couldn't seem to drink enough liquids to get the feeling of dry mouth out. The diarrhea, fatigue and the sinus drainage was still continuing and the other symptoms seem to have dissipated. He still felt so fatigued and didn't feel the other symptoms are there. He hoped they didn't return. It had stayed the same for the diarrhea, fatigue and sinus drainage and he was still tired. Later added he did have weakness and dizziness, but assumed it was fever and chills. Caller states he did have weakness and dizziness and Saturday 03Apr2021 and Sunday 04Apr2021 were the worst two for all of the symptoms at the same time. It had dissipated as of Monday 05Apr2021 evening. Outcome of weakness and dizziness: Caller initially confirmed it had dissipated as of Monday 05Apr2021. However, he later stated he was still experiencing slightness there. He still feels some weakness, and feels about 60% right now. He thought it would be a good idea to get vaccinated because he had family members that had contracted covid-19 and be less weary of the virus. He was hesitant now to get the second shot. He was taking ibuprofen because he had issues with a tooth. He was taking Benadryl for the sinus and hadn't taken it in 36 hours and hadn't taking anything else. He was already taking Ibuprofen for the tooth issue, but was also using it to relieve some of the symptoms and if it was indeed that he may have contracted something after that. He hadn't been to the doctor but for checks ups in years and years. Time of Onset (24-hour clock): Caller stated it started about 1-2 pm in the afternoon on Friday 02Apr2021 and came on very quickly. The events did not require a visit to emergency room or physician office. The outcome of slight pain at left shoulder where the injection site was at was recovered on 01Apr2021. The outcome of diarrhea, fatigue, sinus drainage was not recovered. No follow-up attempts are needed. No further information is expected.
53 2021-04-25 weakness Upset stomach, weakness, tiredness, shivers, headache
53 2021-04-25 facial paralysis, bell's palsy, involuntary muscle movements reports symptoms of right eye tearing and tongue paresthesia with inabity to drink out of right side... Read more
reports symptoms of right eye tearing and tongue paresthesia with inabity to drink out of right side of mouth and or grasp straw. reported drooling with right side facial drooping noted on ER visit. Reports that symptoms started approx. on the 16 of Apr and was evaluated on the 23 of Apr for concerns of TIA which was ruled out. Pt was then treated for suspected Bells Palsy with Acyclovir and Prednisone
53 2021-04-25 migraine By 3pm a migraine occurred. Migraines continued to cycle for the whole week. Around 4pm-5pm the day ... Read more
By 3pm a migraine occurred. Migraines continued to cycle for the whole week. Around 4pm-5pm the day of the shot a minor panic attack occurred for about 30 min. No medications were taken for panic attack. Nurtec and Excedrin was taken to deal with migraine attacks along with sleep during course of the week. I was unable to maintain other routine doctor appointments that week as a result.
53 2021-04-25 pain in extremity swelling and pain in the arm, High blood pressue104/148
53 2021-04-26 flushing Client advised staff that he was feeling faint. Client was given cold water and was seen by EMT. C... Read more
Client advised staff that he was feeling faint. Client was given cold water and was seen by EMT. Client was red/flushed and seemed dizzy. Client also advised that he was very anxious and worried. Client seem to staff to be very agitated. Nurse suggested deep breathing to calm client. Client was kept in observation for another 10 min.
53 2021-04-27 tingling, numbness 2 days after vaccine developed parasthesia, numbness of left upper extremity. Persisting and seen to... Read more
2 days after vaccine developed parasthesia, numbness of left upper extremity. Persisting and seen today 6 days after vaccine.
53 2021-04-28 muscle twitching I now have a twitching face muscle in my chin. It is not constant but happens frequently every day.
53 2021-04-30 weakness 1. Felt flu-like symptoms (fatigue, weakness, muscle aches) starting around 8:00pm the day of the va... Read more
1. Felt flu-like symptoms (fatigue, weakness, muscle aches) starting around 8:00pm the day of the vaccination. The next morning, after waking and getting out of bed around 6:50am, continued to feel flu-like symptoms. Began feeling light headed and fainted. Fell on bathroom floor and was unconscious for approximately 1-2 minutes. 2. Two days after vaccination (4/23/21 around 7:00pm), developed rash on both feet. Rash improved by next morning and was gone by the day after (4/25).
53 2021-04-30 feeling cold Fatigue; Sleeping 10-12 hours most nights; felt cold (not chills); This is a spontaneous report from... Read more
Fatigue; Sleeping 10-12 hours most nights; felt cold (not chills); This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: ER8732), via an unspecified route of administration in the left arm, on 23Mar2021 at 14:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included hypogammaglobulinemia immunoglobulin A (IGA) (no IGA present in blood). The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ascorbic acid (VITAMIN C), vitamin D (MANUFACTURER UNKNOWN), cyanocobalamin (VITAMIN B12), and naproxen sodium (ALEVE). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced fatigue, sleeping 10-12 hours most nights, and felt cold (not chills) on 25Mar2021 at 09:30. The events were reported as non-serious. The events were described as: The fatigue set in about 36 hours (as reported) after the vaccine and the patient has been fatigued for 6 days. He has been sleeping 10-12 hours most nights and each day gets a little better. He has felt cold (not chills) and so has been wearing additional clothes, blankets at night and turned up heat in the house. The patient did not receive any treatment as a result of the events. The clinical outcome of fatigue, sleeping 10-12 hours most nights, and felt cold (not chills) was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
53 2021-05-03 weakness Immediate sharp, non-radiating neck pain after receiving second COVID-19 vaccination. Associated wit... Read more
Immediate sharp, non-radiating neck pain after receiving second COVID-19 vaccination. Associated with headache and weakness. No changes in vision, no chest pain, no syncope. Took ibuprofen 400 mg x1 which provided mild relief.
53 2021-05-03 pain in extremity It appears that I obtained gout as a result of the vaccination I received on May 2nd, 2021. I have n... Read more
It appears that I obtained gout as a result of the vaccination I received on May 2nd, 2021. I have no prior history of gout. Several hours after my vaccination my big toe on my left foot began to hurt. By Monday morning, May 3rd 2021, my big toe and the area surrounding it had swollen and was very painful, making it difficult to walk. I began putting my foot in cold water as well as hot water with epsom salt.to reduce the swelling and get rid of the pain. On Tuesday morning, May 4th, 2021, my toe felt better was still painful to walk and put pressure on it. There is still swelling on my foot in the area around my big toe as well. In googling my issue and feeling that this could only be due to receiving the Covid-19 vaccine, I decided to contact a podiatrist. I scheduled an appointment to see Dr. on Thursday, May 6th 2021 @ 11:30 a.m.
53 2021-05-04 pain in extremity Arm swollen, pain in arm, cold chills back pain arm pain right toes hurt fatigue could not sleep tir... Read more
Arm swollen, pain in arm, cold chills back pain arm pain right toes hurt fatigue could not sleep tired dehydrated sleepy shoulder pain bruising at injection site. Waiting for side affects to subsidize before seeking medical attention
53 2021-05-04 tingling, numbness I was having dinner and suddenly felt a strong numb/tingling sensation with a slight pain in the lit... Read more
I was having dinner and suddenly felt a strong numb/tingling sensation with a slight pain in the little toe at my left foot, as well as the bone connected to the toe. I tried stretching my toes for a while and gradually the sensation went away. However, when I remove my socks later in the evening, I noticed that symptom area is severely bruised, even though I never experience any external injury. Not sure if it's blood clot or blood vessel bursting.
53 2021-05-04 seizure, feeling cold Seizure; No recollection of anything that happened between 2000 and 2100 hours; Very foggy, not thin... Read more
Seizure; No recollection of anything that happened between 2000 and 2100 hours; Very foggy, not thinking properly, repetitive in what he was saying; Very foggy, not thinking properly, repetitive in what he was saying; Very foggy, not thinking properly, repetitive in what he was saying; Not comprehending; He was very cold; Very tired; Very Sweaty; Headache; This is a spontaneous report from a contactable consumer (Patient's wife). A 53-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 19Apr2021 12:30 (Lot Number: EW0164) as SINGLE DOSE (at age of 53 years old) for covid-19 immunisation. Medical history included ongoing epilepsy diagnosed with this when he was 15 years old, seizure from an unknown date and unknown if ongoing (then at 2015 he had a seizure). Concomitant medications included levetiracetam (KEPPRA) 1250 mg, daily (250mg; 5 pills a day) taken for epilepsy from an unspecified start date and ongoing; carbamazepine (CARBAMAZEPINE) 1000 mg, daily (200mg; 5 pills a day) taken for an unspecified indication from an unspecified start date and ongoing. Family Medical History Relevant to events was none. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 19Apr2021, the patient experienced seizure, Very foggy, not thinking properly, repetitive in what he was saying, very distant, like he was looking at his wife but not seeing her or hearing her, Headache, He was very cold, Very tired, Not comprehending, Very Sweaty, No recollection of anything that happened between 2000 and 2100 hours. The patient received his vaccine yesterday 19Apr2021 at 1230. On 19Apr2021 by 1500 he was very foggy, not thinking properly, and repetitive in what he was saying. He was very distant, like he was looking at the consumer but not seeing her or hearing what she was saying. He was very cold, very tired, and not comprehending. Then at 2015 he had a seizure. She called the paramedics, her husband was very sweaty on 19Apr2021 and that point and had no recollection of anything that happened between 2000 and 2100 hours. Patient was not taken to the Emergency Room or admitted to the hospital. Her husband is completely aware and recovered now. Consumer reported on 19Apr2021 he had a headache that is persisting since the seizure. The consumer reported that her husband is epileptic, but he hasn't had a seizure in over 10 years and hasn't missed any doses of his medication. Patient was evaluated by the Paramedics that came to his home but was not taken to the Emergency Room. Relevant Tests were none. Outcome of Seizure was Recovered/Resolved with Sequel on 19Apr2021. Outcome of Very foggy, not thinking properly, repetitive in what he was saying, He was very cold, Very tired, Not comprehending, Very Sweaty was recovered on 19Apr2021. Outcome of headache was not recovered. Outcome of No recollection of anything that happened between 2000 and 2100 hours was unknown.
53 2021-05-04 tremor, weakness Strong chest pressure; fluctuating heartbeat; slower breathing and respiratory response; slower brea... Read more
Strong chest pressure; fluctuating heartbeat; slower breathing and respiratory response; slower breathing and respiratory response; Extreme fatigue; very low energy; Loss of appetite; loss of weight; Abnormally wide fluctuation of blood pressure while not exerting myself; Difficulty relaxing and sleeping; Nausea; dizziness; Stomach pain; diarrhea; Headaches; low grade fever; shortness of breath; intense , powerful involuntary shaking of my body that comes in waves, and pressure and pain in the back of my head at the cerebellum.; intense , powerful involuntary shaking of my body that comes in waves, and pressure and pain in the back of my head at the cerebellum.; sudden increased heart rates and high blood pressures reading; spikes his heart rate/sudden increased heart rates; intestinal discomfort/strong stomach discomfort; intense chest pressure and some pain; This is a spontaneous report received from a contactable consumer (the patient). A 53-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0151) via an unspecified route of administration in right arm on 09Apr2021 12:30 at age of 53-year-old at single dose for COVID-19 immunisation. Medical history included high cholesterol, anxiety disorder, known allergies: Clonazepam (KLONOPIN), food allergies: sea bass and orange roughy. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included alprazolam (XANAX) taken for an unspecified indication from an unspecified date; lovastatin taken for an unspecified indication from an unspecified date; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication from an unspecified date; ibuprofen taken for an unspecified indication from an unspecified date; fluoxetine hydrochloride (PROZAC) taken for an unspecified indication from an unspecified date. The patient previously took the first dose of BNT162B2 (Pfizer Covid-19 Vaccine, lot number EP7534) via an unspecified route of administration in right arm on 18Mar2021 11:00 AM at age of 53-year-old for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was currently 11 days out from receiving his second COVID vaccine and he was still having very strong side effects. This included an emergency room visit on 16Apr2021. He was generally very good health and he exercised regularly including running so these were very abnormal effects for him. Beginning one day after receiving his second dose of the Pfizer vaccine for COVID-19: 1. Strong chest pressure and fluctuating heartbeat. 2. Slower breathing and respiratory response. 3. Extreme fatigue & very low energy (for example, walking up two flights of stairs made him very tired and spikes his heart rate, abnormal for him). 4. Loss of appetite and loss of weight. 5. Abnormally wide fluctuation of blood pressure while not exerting himself. For example, higher blood pressure readings (155/95) with a slower pulse (60) or the opposite scenario, (110/89) elevated pulse 98. 6. Difficulty relaxing and sleeping. 7. Nausea and some dizziness. 8. Stomach pain and diarrhea. 9. Headaches. 10. Low grade fever. As of 26Apr2021, it stated the day after the patient received his 2nd dose of the Pfizer Covid-19 vaccination (10Apr2021 12:00 PM), he began to have side effects which he expected to some extent. However, as of today, he has 17 days straight of side effects or perhaps an adverse event. His symptoms began mildly the day after but suddenly increased greatly within the next couple days and he had been dealing with this ever since. He had made two emergency room visits, seen his general practitioner, and as of today (26Apr2021) a cardiologist who ordered imaging. His symptoms range from, extreme fatigue, nausea, strong stomach and intestinal discomfort, weight loss, shortness of breath, sudden increased heart rates and high blood pressure readings, intense chest pressure and some pain, powerful involuntary shaking of my body that comes in waves, and pressure and pain in the back of his head at the cerebellum. His life was basically come to a screeching halt and he was searching for answers! The doctors he had spoken to were unclear as to what was wrong with him and why. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No treatment received for the events. COVID tested post vaccination on 17Apr2021 included PCR and Nasal Swab, both showed negative result. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
53 2021-05-04 unresponsive to stimuli, cold sweat Patient stated he felt dizzy after injection. Had the patient take slow deep breaths. Patient began ... Read more
Patient stated he felt dizzy after injection. Had the patient take slow deep breaths. Patient began to lightly shake, then patient was unresponsive with blank stare. Pt clammy, pale, and diaphoretic, Pt transferred via w/c and taken to medical monitoring.
53 2021-05-05 speech disorder 3/12/21 had few minutes of speaking incorrect words which led to eval for TIA 3/17/21 had dopplers o... Read more
3/12/21 had few minutes of speaking incorrect words which led to eval for TIA 3/17/21 had dopplers of carotid with unequal blood velocities 3/24/21 covid vaccine #1 4/15/21 covid vaccine #2 4/21/21 CTA chest to look for cause of carotid velocities being different and pulmonary emboli were found
53 2021-05-06 pain in extremity Experience extreme pain in shoulder and arm since 4/30/2021. No relief at all nothing has helped eas... Read more
Experience extreme pain in shoulder and arm since 4/30/2021. No relief at all nothing has helped ease the pain.
53 2021-05-07 bell's palsy Bell's Palsy symptoms
53 2021-05-10 numbness, tingling felt nauseous; face numb and tingling; face numb and tingling; This is a spontaneous report received... Read more
felt nauseous; face numb and tingling; face numb and tingling; This is a spontaneous report received from a contactable consumer (patient reported himself) via Medical Information Team. A 53-year-old male consumer received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 21Apr2021 as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, "E-transmitting possible duplicate AE (this report may contain additional information not shared prior to transfer to the Medical Information. Caller stated he had already reported this to the previous agent). First dose of Pfizer on 21Apr2021, side effects started, 5 minutes after shot, felt nauseous. 10 minutes later, face numb and tingling and did not last long. He was no longer having side effects, they were all gone that day. He saw his PCP before the second dose and would talk to him". Caller asked whether the small side effects were from the first Pfizer vaccine, should he get the second. Response received included: As noted in the Fact Sheet for Recipients, should not get the Pfizer-BioNTech COVID-19 Vaccine if he had a severe allergic reaction after a previous dose of the vaccine or if he had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason could not be made by Pfizer. He was referred to speak to his healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Healthcare provider would know his health situation and would have access to information that can better help inform this decision". No PQC present. Outcome of the events was recovered on 21Apr2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
53 2021-05-10 muscle spasms DVT causing Muscle cramps; DVT causing Muscle cramps; fever; chest pain; This is a spontaneous repor... Read more
DVT causing Muscle cramps; DVT causing Muscle cramps; fever; chest pain; This is a spontaneous report received from a contactable healthcare professional (patient). A 53-year-old male patient received the second dose of BNT162B2 (lot number: EL9261), intramuscularly in left arm on 03Feb2021 13:00 at single dose for COVID-19 immunisation. Medical history included gout. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: EL0142), intramuscularly in left arm on 06Jan2021 13:00 for COVID-19 immunisation. The patient experienced deep vein thrombosis (DVT) causing muscle cramps, chest pain, fever, etc 2-3 weeks after the second dose on 24Feb2021 12:00. Patient did not receive any treatment for the adverse events. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not resolved.; Sender's Comments: Considering a positive temporal association, a causal relationship between the event deep vein thrombosis 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
53 2021-05-10 muscle twitching I had Covid-19 back in December 2020. On the 10th day I ended up in the hospital for 3 days due to t... Read more
I had Covid-19 back in December 2020. On the 10th day I ended up in the hospital for 3 days due to the start of Covid pneumonia. It took me two months to finally feel 100%. I had my 2nd vaccination shot on Friday 5/7/21, I was sick Saturday with a fever of 101.5 and joint pain in fingers, hands and knees and slept all day. The adverse event happened on Sunday. I was still very tired during the day but no fever and felt like I was in a fog. Sunday evening went to bed at 9:30pm woke up at 11:30pm with uncontrollable body tremors. The tremors were muscular twitches from my neck to my feet. Everything was twitching at once. My fiance took my temperature and it was 97.5 so no fever when it started but after 45 minutes of tremors I started burning up, she took my temp again and it was 103.5. She wanted to call 911 or take me to the emergency room but I didn't want to go at that point. I took a baby aspirin thinking about possible blood clots and then 30 minutes later took 2 Tylenol to bring down the fever. The tremors finally stopped and the fever went down to 101. It took me a while to fall asleep and the next morning I woke up still tired and called out of work and slept all day again.
53 2021-05-10 pain in extremity Developed RLE pain and swelling on Friday. Progressed over the weekend. Evaluated on Tuesday. Found ... Read more
Developed RLE pain and swelling on Friday. Progressed over the weekend. Evaluated on Tuesday. Found to have distal DVT. Started on anticoagulation.
53 2021-05-10 tingling, weakness, flushing, numbness, muscle spasms, numbness and pain in extremities This is a spontaneous report from a contactable consumer. A 53-year-old male patient received bnt162... Read more
This is a spontaneous report from a contactable consumer. A 53-year-old male patient received bnt162b2 (COVID-19 VACCINE, lot number: EN6203; expiration date: Jun2021), dose 1 via an unspecified route of administration on 27Feb2021 18:00 as single dose for covid-19 immunisation. Medical history included ongoing lyme disease. There were no concomitant medications. The patient went through post- vaccination especially because he has Lyme disease. He has had this pre-existing autoimmune disease for 8, almost 9 years, he wants to add this information to the database. Caller states the first shot he would say was kind of catastrophic, the second shot, he will go into. Caller states the second shot, he showed up at the military vaccination place locally and they actually declined his ability to get it with them because of his first reaction even though he had the go ahead from his Lyme specialist and primary doctors. Caller states because of this, he went after four weeks instead of three and he went to a high risk clinic to protect him from anaphylaxis. He has received both doses, the first dose was horrendous and the second was quite easy. Caller states no reaction whatsoever with the second, though he still has remaining symptoms. Reporter Details: Caller states his legal name is (Name), he goes by (Name). Caller states he would prefer if company contacted him and also so that maybe they can warn people with autoimmune or Lyme that the first one is going to be kind of rough. Caller states he works with the public. Prescribing Healthcare Professional: Caller states unsure of email address. Caller states the only thing missing off the initial story is that all in all, the second shot was really good. Caller states he does have some very lingering issues still that he is going to be seeing the Lyme specialist about. Caller states the first dose, it's pretty intense. Caller states the second one, he had fatigue and neuropathy from the stupid autoimmune stuff. Caller states there is residual symptoms, but nothing like the initial ones. Caller states what he did was he just jotted some notes down about every third or fourth day up until the second shot just to detail each symptom. Caller states he only wrote about 5 days worth of little sentences. Caller states 27Feb2021, the first dose, it was a Saturday so by Monday 29Feb2021, it started with itching, burning rashes, so like a visible rash on his chest with raised bumps, neuropathy- shooting pains in his fingers and toes that feels like bugs are crawling all over him, headache, fatigue, and dizziness. Caller verifies all of these symptoms actually began on 01Mar2021. Itching, burning rashes: Caller states he would say they lasted about 2-3 weeks because he went to the walk-in to have them check and called his primary doctor and went into his primary and had him check. Caller states it ended sometime in Mar2021 and he has recovered completely. Neuropathy: Shooting pains in his fingers and toes: Caller verifies it began 01Mar2021. Caller states he would say he still has about 20% left. Caller states it is hard to sleep at night because he still gets itching and burning and stuff. Caller states it is persisting, but certainly not as bad. Headache: Caller verifies it started 01Mar2021. Caller states it ended Mar2021 and has recovered completely. Fatigue: Caller states began 01Mar2021. Caller states this is one of the bad ones he would say. Caller states he still, he would like to go for a walk or work out and he barely has the amount of energy to work let alone the others. Caller states he can't workout or walk. Caller states if he goes up and down stairs, he's exhausted. Caller states that's definitely a lasting one. Caller verifies it is ongoing, persisting. Dizziness: Caller verifies it began on 01Mar2021 and is ongoing. Caller states when he walks he literally cannot turn his head quickly or he feels like he's going to throw up or pass out. Caller verifies it is persisting. Caller states he would say about 4 or 5 days later from getting the first shot, this was really interestingly weird, he had mouth sores that wouldn't heal and debilitating malaise and fatigue. Caller states malaise so bad he couldn't get through work, he could barely work. Caller states the mouth sores were so weird. Caller states everything he is telling company he has read about online. Caller states he has had canker sores from low immunity, but this was on the tip of his tongue, either side of the tongue tip, it came and went three or four times through the entire month. Caller states it was like his immune system was on the edge of crashing, then he would sleep a lot more. Caller states he would do whatever he could do to make it come back. Caller verifies this debilitating fatigue is different than overall fatigue that began 01Mar2021. Caller states the debilitating malaise began 04Mar2021 or 05Mar2021. Debilitating Fatigue; Debilitating Malaise: Caller states the debilitating fatigue also began 04Mar2021 or 05Mar2021. Caller states it is acute. Caller states ended sometime in Mar2021. Caller states recovered completely but is still left with some fatigue. Caller states recovered with lasting effects maybe. Caller says the other one, he could barely get up, he could barely work, he literally couldn't function. Caller states the overall fatigue has not left, it's ongoing. Mouth sores that won't heal: Caller states began around 004Mar2021 or 05Mar2021 and stopped sometime in Apr2021, it took about a month. Caller states he recovered completely. Caller states he just wrote what happened down about every 2 days up until 14Mar2021. Joint Pain: Caller states literally every single joint in his body was killing him and felt inflamed. Caller states it began around 03Mar2021 or 04Mar2021. Caller states joint pain is ongoing, but has improved. Air Hunger, shortness of breath upon exertion: Caller states if he went up and down a few stairs, he would breathe almost as if he was having an asthma attack, it was shortness of breath upon exertion and started about four days after. Caller states it began around 05Mar2021. Caller states he actually had it this morning, felt like he just walked up a flight of stairs. Caller states he is very physically fit, so that should not happen. Caller states it's ongoing and has improved. Numb Extremities: Caller states a week later from 01Mar2021 he had numb extremities. Caller states he started being very aware of the fact that his fingers and toes were starting to lose feelings on 08Mar2021. Caller states it resolved within a week on 15Mar2021. Caller states it was a weird sensation that happened for a while but is completely resolved now. Body Temperature Regulation Issues: Caller states two days later, he had body temperature regulation issues. Caller states he was cold when he should have been hot and hot when he should have been cold. Caller states began around 03Mar2021/04Mar2021 and is ongoing, but not terrible, it's probably the least of the issues and has improved. Heart was pounding out of his chest; face was flushed: Caller states a day or two later, his heart was pounding out of his chest and his face was flushed to the point where people were asking if he was okay. Caller states he felt like he got a quick burst of a run and then stood still. His face was visibly red and very aware of his heart beating out of his chest and this is with no exertion. Caller states he was laying on the couch and he could feel his face flush while doing nothing basically. Caller states began 02 or 03Mar2021 and just stopped a week ago around 12Apr2021. He recovered completely, for now, it seems. Caller states he went to (Clinic name) on (Address), he doesn't have the doctors name, it was a walk-in. Caller states they literally said no big deal, it's all side effects of the vaccine, they just said he's fine. Caller states they simply recommended anti-inflammatories, Tylenol, which was smart and he wishes he thought about it. They also recommended Benadryl to stop the reaction. Caller states it was very helpful, the Benadryl really helped a lot. Caller states there was also a good amount of insomnia because of all the symptoms, it would be close to impossible to sleep. Insomnia: Caller states it seemed to get worse, started a week later because it was getting disconcerting to him so he couldn't sleep. Caller states it started 08Mar2021 and have had that on and off with Lyme. Caller states has struggled for years, is ongoing and is persisting. Caller states on 14Mar2021, he couldn't sleep, couldn't get out of bed, completely weak and dizzy, his left leg and quad was spasming like when he had Lyme's, left knee itches, tingles, and burns and that's where he got bit by the tick and that's when he had his symptoms when he was acute. Caller states it resolved within 3 weeks after the initial onset of the shot. Caller states when he had Lyme initially, that's what he experienced, his left knee swelled, burned and itched, his left knee cap. Caller states ended 17Apr2021. Caller states its a situation where some of those are still there because of Lyme and some are gone. Caller states the knee cap stuff and can't get out of bed was gone on 17Apr2021. Caller states he has recovered completely. Caller states he still is weak and dizzy and his left leg and quad are still spasming, but it's better and is improved. Caller states on 20Mar2021, his left knee cap hurt, was twitching and tight, his left toe was numb, felt like something is chewing on his toe with a sensation of worms under the skin and sleep disturbances. Caller verifies the sensation of worms under the skin and something chewing on his toe is all related to neuropathy, which is still there. Caller states he had written down that on 20Mar2021, he was supposed to get his second shot at 1800, but was denied due to side effects he was experiencing and was rescheduled for 31Mar2021 at a local high-risk clinic. Caller states on 22Mar2021, he slept good, but was fairly weak all day. caller states he took a shower mid-afternoon, and couldn't get off the couch. Caller states basically all he did was take a shower and threw himself on the cough the whole day. Caller states he has written that he has the sensation of ants crawling over the top of his back, no desires to go outside, and light sensitivity. Caller verifies the ants crawling over the top of his back was also neuropathy, and he recovered completely within 3 weeks. Light Sensitivity: Caller states throughout the whole thing, had it today and is still ongoing and persisting. Caller states began sometime in Mar2021, its been the whole time. Caller states 28Mar2021, he only slept 6 hours and woke up completely fatigued, could not get out of bed until 2:00 in the afternoon, has a complete loss of appetite, had a drink and 2 eggs and laid down, couldn't move until 1930. Caller states got up, had a nutrition shake, he wasn't desiring solid foods whatsoever, had 100% malaise, fatigue, no appetite, and was dizzy. Loss of appetite: Caller states he has lost 7 pounds since the first shot. Caller states he wasn't really interested in eating. Caller states he has a natural desire to eat and nothing sounded good. Caller states started Mar2021, is ongoing, and has improved. Caller states 31Mar2021, he got the second shot, he had a little bit of irritation, tingling and burning at site and definitely a flushed face throughout the day, almost like a sunburn. Caller states he was joking with clients and said the first shot killed him and the second shot cured him. caller states after the second shot, he is 80% better but can list the remaining symptoms. Caller states what he is left with is fatigue, he does not have any energy to do anything other than work, sleep issues, neuropathy, and dizziness. Dizziness: Caller states the dizziness has been consistent and goes with the sleeplessness, ongoing since Mar2021 and is persisting. Irritation, tingling, and burning at injection site: Caller verifies the irritation, tingling, and burning is at the injection site of the second dose. Caller states it happened within a few hours on 31Mar2021 and resolved within a week on or around 07Apr2021. Covid Vaccine: First Dose: Caller verifies he received the injection in his left arm around 1800. Caller unsure of NDC. Covid Vaccine: Second Dose: Caller verifies he received the second dose on 31 Mar2021. LOT: ER8730, Expiry Date: They didn't write that down so caller unsure. NDC: Caller unsure of NDC. Caller unsure of dosage given. Caller states was given via injection in his right arm around 1300 or 1330. Covid Vaccine: Indication: Caller states first off he owns a business, he did it to be responsible to the public. Caller states he wants his business to appear as safe and compliant as possible. Caller states he definitely was afraid because of the Lyme disease. Concomitant Products: Caller states he made sure he did nothing before purposefully. Test Results: Caller states after the first shot, he went to (Name) family physician, they did a lot of blood work trying to make sure his inflammatory markers weren't going up, to make sure he wouldn't have issues. Caller states the good news was he was great, everything looked normal, there was nothing crazy in the blood work. Caller states they though the shots would have triggered an autoimmune response of Lyme. Muscle/Joint: He reports a bit of muscular/joint pain in the area where the shot is, if he goes to reach The outcome of the event "itching, burning rashes, like a visible rash on his chest with raised bumps", "headache", "can't workout or walk", "exhausted", "immune system was on the edge of crashing", "immune system was on the edge of crashing", "face was visibly red" was resolved in Mar2021; the outcome of the event "debilitating malaise" was resolved with Sequel in Mar2021; the outcome of the event "Numb Extremities" was resolved in 15Mar2021; the outcome of the event "mouth sores" was resolved in Apr2021, the outcome of the event "face was flushed" was resolved in 12Apr2021; the outcome of the event "couldn't get out of bed" "left knee itches, tingles, and burns" was resolved in 17Apr2021, the outcome of the event Back disorder was unknown, the outcome of the event "complete loss of appetite", "Joint Pain", "Body Temperature Regulation Issues", "barely has the amount of energy to work let alone the others/Weak" was resolving, the outcome of the other events was not resolved.
53 2021-05-11 pain in extremity Arm pain for 1 day After 2 days I developed ringing in my ears (Tinnitus). It is constant & is a hi... Read more
Arm pain for 1 day After 2 days I developed ringing in my ears (Tinnitus). It is constant & is a high pitched tone. It is driving me crazy!
53 2021-05-11 seizure Hypo-osmolality and hyponatremia Acute kidney failure, unspecified Unspecified convulsions Hyponatre... Read more
Hypo-osmolality and hyponatremia Acute kidney failure, unspecified Unspecified convulsions Hyponatremia
53 2021-05-12 tremor CHILLS, VERY SHAKY, ANXIETY, VERY TIRED. All began within four hours of injection. Worse 10 hours... Read more
CHILLS, VERY SHAKY, ANXIETY, VERY TIRED. All began within four hours of injection. Worse 10 hours later Have been persistent the last 48 hours.
53 2021-05-13 numbness When I woke up the next morning, my left side of my face/eye was swollen and numb. I currently have... Read more
When I woke up the next morning, my left side of my face/eye was swollen and numb. I currently have Bells Palsy since October 2020 and it felt like it was giving me a reaction to the Bells Palsy. It lasted for three days.
53 2021-05-13 seizure seizure, possible stroke, transported to local hospital
53 2021-05-16 feeling hot He was waiting for 15 minutes after the vaccine. He was starting to feel warm and had a metallic ta... Read more
He was waiting for 15 minutes after the vaccine. He was starting to feel warm and had a metallic taste in his mouth. He also felt nauseous and lightheaded.
53 2021-05-16 numbness, tingling Numbness, decreased sensation, tingling, loss of mobility in hands and feet
53 2021-05-16 tremor 8 hours after shot I became nauseous. Was shaking, major chills, 2 large hives on face, accelerated ... Read more
8 hours after shot I became nauseous. Was shaking, major chills, 2 large hives on face, accelerated heart beat and had little bit issue breathing. Took benadryl. Started feel good after 20 minutes
53 2021-05-17 pain in extremity My lower extremities, from the knee down, are weak and sometimes it is hard to walk.; My lower extre... Read more
My lower extremities, from the knee down, are weak and sometimes it is hard to walk.; My lower extremities, from the knee down, are weak and sometimes it is hard to walk.; My knees also hurt; Dizziness; Skin was very pale and cold to the touch.; Profuse sweating.; Fatigue; Muscle Pain; Fainting 9 hours after administration; I had my first headache.; I had pins and needles in fingers 4 and 5 in the arm of vaccine administration; This is a spontaneous report from a contactable consumer (patient). A 53-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Apr2021 11:30 (Lot Number: EW0170), at age of 53 years old, at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took asparagus for Allergy. Reported Event: Immediately after the vaccine, I had pins and needles in fingers 4 and 5 in the arm of vaccine administration. 3 hours after vaccine, I had my first headache. Severe headache, dizziness, fainting 9 hours after administration. During fainting episode, skin was very pale and cold to the touch. Profuse sweating. This was on the same day as vaccine administration. For the next 3 days, I laid in bed with fatigue, severe headache, and muscle pain. After 10 days, I still feel weak, I get tired after walking half a mile, and I have episodes of dizziness during the day. My lower extremities, from the knee down, are weak and sometimes it is hard to walk. My knees also hurt. This is still present 10 days after the vaccine. Outcome for events was unknown. Prior to vaccination, whether the patient was diagnosed with COVID-19 Was Unknown, and 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. No follow-up attempts are needed. No further information is expected.
53 2021-05-17 unresponsive to stimuli, slurring, cold sweat Within 5 minutes of receiving vaccine patient complained to wife of feeling lightheaded, became awak... Read more
Within 5 minutes of receiving vaccine patient complained to wife of feeling lightheaded, became awake but not responsive for about 5 minutes, slurring words not getting any communication out, clammy/muggy, pale, refused to move onto the floor, was dead weight when trying to move. Blood pressure was 100/50 HR 60. Wife said he was not anxious walking in, later he said he has "white coat syndrome". Paramedics were called, was evaluated by paramedics and they attributed it as a vasovagal response. Patient finally after 10 minutes came around.
53 2021-05-19 bell's palsy Bell's palsy in left face
53 2021-05-19 pain in extremity, tenderness I had swelling and pain in the left armpit and swelling of the lymph nodes.. with both doses of th... Read more
I had swelling and pain in the left armpit and swelling of the lymph nodes.. with both doses of the vaccine. I felt faint about 30 minutes after the first dose as well. The second dose seemed to be going okay even though there was much more pain at the injection site. But the armpit and lymph node issue has become much worse after the second dose. Painful to touch today into the left pectoral region the sometimes travels into the rib cage. Soreness in the left elbow and left index finger. All of this has been occurring since April 29th and it is still happening May 20th.
53 2021-05-19 tingling About 7 hours after my shot I experienced tingling and radiating pain down my left arm from my shoul... Read more
About 7 hours after my shot I experienced tingling and radiating pain down my left arm from my shoulder to wrist. In the two weeks since my shot my symptoms are getting worse, not better. I used to be able to do two sets of 50 push-ups and I can no longer do one push up. I used to be able multiple sets of 15-20 pull ups for a total of 50 in a couple of minutes. I can no longer do one. I enjoy golf and can no longer play .
53 2021-05-21 feeling cold, flushing 4/22/21 about 1:55 pm I got the shot, 2:45 got a bad headache, dizzy, feeling flush and upset suma... Read more
4/22/21 about 1:55 pm I got the shot, 2:45 got a bad headache, dizzy, feeling flush and upset sumac I left work at 4 pm and when home. around 6 pm i started to get joint pain in my arms, legs and hip. by 730 pm I got the chills, shivers and got extremely tired. I when to bed around 8 pm and woke up around 730 am on 4/23/21. I felt like I was cold till Sunday (4/25/21), The headache remained till Wednesday (4/28/21). I don't know if this is related but I would like to provided the information. Prior to the shot my blood press was between 112 to 120/ 70 to 80. after the shot my blood pressure has been 140 to 150/ 80 to 93. am monitoring my blood pressure, adjusting my diet & trying to start a exercise regiment to address the blood pressure. I did have a epatch right before the shot from 4/19/21 to 4/22/21. .
53 2021-05-21 numbness, weakness Pt states that 10 days ago he had his 1st dose of the Pfizer COVID-19 vaccine. He states that 2 days... Read more
Pt states that 10 days ago he had his 1st dose of the Pfizer COVID-19 vaccine. He states that 2 days later he had HA, fever, myalgias, weakness, numbness of the hands and fingers, and abdominal pain that lasted a few days. He states the only sx that has persisted is the weakness and numbness of the hands and fingers. The pt states that his arms and legs are equally weak. Pt reports that today he had a fall due to the weakness today, and he denies any head strike or injuries from this fall. MRI of the brain with and without contrast was done showing no acute intercranial abnormality. MRI cervical spine showing no spinal cord abnormality. And MRI T-spine showing no spinal cord abnormality. Lumbar puncture was performed in the emergency room. Protein was found to be elevated at 109. Glucose was elevated at 134 CSF cell count within normal limits. CSF PCR panel within normal limits. Patient continues to complain of weakness. Lumbar puncture was completed showing a protein elevated at 109 likely representing GBS. MRI brain, cervical spine and thoracic spine showing no structural lesion. At this time we will start IVIG 0.4 g/kg daily for 5 days. Patient will be seen by physical therapy and Occupational Therapy. We will also consult inpatient rehab.
53 2021-05-21 numbness Arm has feelings of numbness, even after the second shot, at the same facility on April 28th . Stil... Read more
Arm has feelings of numbness, even after the second shot, at the same facility on April 28th . Still numb as date of this report
53 2021-05-21 seizure Patient said he had a seizure early in the morning the next day after the second dose.
53 2021-05-22 facial pain 1st day after vaccine. Chills, fever, fatigue, headache, 2nd day- stiff neck, headache. 3rd day afte... Read more
1st day after vaccine. Chills, fever, fatigue, headache, 2nd day- stiff neck, headache. 3rd day after vaccine - left side of face sore, headache, earache. 4thday -Chest pains,- very quick, sharp, very tired, had heart skip/ palpations went to ER @ 11:30pm. Had EKG, blood work, stress test from cardio dept. Followed up with Dr. with cardio dept. received Zio patch Heart Monitor and wore for 2 weeks. Currently waiting the results.
53 2021-05-23 pain in extremity Chest and back pain radiating into right arm
53 2021-05-25 burning sensation Heart Attack, burning from center of chest expanding to back like a dagger and outwards 1 stent plac... Read more
Heart Attack, burning from center of chest expanding to back like a dagger and outwards 1 stent placed to stop it 2 more stents the next day preventative Now attending cardiac rehab New meds prescribed
53 2021-05-25 numbness, tingling, bell's palsy Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips; Bell's palsy-like s... Read more
Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips; Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips; Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips/ Left shoulder, arm hand numbness and tingling/ Left leg numbness and tingling; Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips; Left eye pain and dryness; Left eye pain and dryness; Headache behind eye; Left shoulder, arm hand numbness and tingling/ Left leg numbness and tingling; Elevated blood pressure; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown) at the age of 53-years-old, intramuscular in left arm on 22Apr2021 at 14:00 at 2nd dose, single for COVID-19 immunization. Medical history was reported as none. The patient has no known allergies. It was unknown if the patient has COVID prior to vaccination. Concomitant medication included macrogol 3350 (MIRALAX). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) at the age of 53-years-old, via an unspecified route of administration on 26Mar2021 at 1st dose, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at a pharmacy/ drug store. On 25Apr2021, the patient experienced Bell's palsy-like symptoms: left eye lid drooping and numbness in left check and lips. He also experienced left eye pain and dryness; headache behind the eye; left shoulder, arm, hand, and left leg numbness and tingling; and elevated blood pressure. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was given in response to the events. The patient underwent lab tests and procedures which included PCR nasal swab for COVID: negative on 15Apr2021 and blood pressure: elevated on 25Apr2021. The outcome of the events was not recovered. Information on the lot/ batch number has been requested.; Sender's Comments: Based on temporal association a contributory role of BNT162B2 to the reported events cannot be totally 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.
53 2021-05-25 muscle spasms, pain in extremity Caller reports he had stool that was not fully formed/his stool was liquidy/close to diarrhea; pain ... Read more
Caller reports he had stool that was not fully formed/his stool was liquidy/close to diarrhea; pain in the arm; Double Vision , massive headaches; Double Vision , massive headaches; Achy and tired, like exhausted after the 2nd shot; Pain at the injection site.; achy/He was achy from joint pain; crampy; He was a little achy and had a headache after the second shot; double visions very disorienting; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Injection, Batch/lot number: EWO158, expiration date: Jul2021) at left deltoid, in his shoulder on 28Apr2021 15:00 PM at second dose, 0.3 ml single for COVID-19 immunization. Medical history included overweight. Concomitant medication was none. the patient not received other medications within 2 weeks of vaccination. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received first dose of covid vaccine (Lot number: EWO158) at Arm Left on 07Apr2021 15:00 PM for COVID-19 immunization and experienced diarrhea (since the first dose), worst headache of his life, Pain at the injection site, pain in the arm. Patient experienced double Vision and massive headaches, both on 05May2021 10:00 AM. patient had double vision about a week after the second dose of Pfizer COVID-19 vaccine (Also reported about 15 minutes after the 2nd COVID Vaccine, pending clarification), he read many times people saying it could be such neurological and/or blood clotting, reporter asked if people died from the vaccine. Caller stated he is overweight and afraid of this possible side effects affecting him even more than COVID-19 infection. He asked what about bowel movements or gastrointestinal side effects. He has had close to diarrhea for about 2 weeks now, since the first dose. Caller stated he does not have a Physician. Patient also reported the Headache after the 2nd vaccine was on 28Apr2021. patient reported he is getting a call. Never mind caller is letting it go to voicemail. Caller reports he was distracted but, he is better now. Caller reports he does not get headaches or neurological issues at all, usually. But after getting the 2nd shot, about a week ago from yesterday, he experienced double vision for about 15 minutes. When he got the 1st shot, the Monday after, he experienced the worst headache of his life worse than any hang over. He never had neurological issues and it terrified him because could not shake it right away, it lasted for about 15 minutes then it was gone. He asked if that is something that is a side effect that could be concern and should he be worried about it. Caller reports double vision for 15 minutes. He got the shot at about 10 am. This happened after the 2nd shot. He got the second shot on 28Apr2021. Caller confirms his first shot was on 07Apr2021. Double Vision: It lasted for about 15 minutes and he waited until it came back. It was scary. The double visions very disorienting, he couldn't see anything, he could not work, he could not do anything. For the double vision he just waited it out, by shutting his eyes and laying his head down, it did not work the first few moments but then it did. He was a little achy and had a headache after the second shot. He was achy from joint pain. He took Tylenol before he to went bed and the headache went away. After the first COVID vaccine he experienced the worst headache of his life: It was so bad it knocked him to knees he took Tylenol and it went away. Pain at the injections site, pain in his arm: Started right away after getting the 1st shot. He could not put weight on the arm or without feeling a little pain. After 09Apr2021 he did not notice much after that. Caller said he was achy all over after the first shot when mentioning the arm pain. He asked if this is all experimental right. He wants to find out as much as he can because he does not trust anything online or anyone that is why he called the source, which is Pfizer. Online there are reports from people against the vaccine and for the vaccine. Headache after the 2nd vaccine: He was achy, not as bad as the 12th. It went away on 29Apr2021 he took to some Tylenol before he went to sleep on 28Apr2021. and it went away in his sleep. The Tylenol took care of it. Achy and tired, like exhausted after the 2nd shot: Caller reports the event subsided on 01May2021. Gastro Issues: patient reports he had stool that was not fully formed, not diarrhea and not normal but, runny. It was not formed. He is feeling like he has to go after the second shot on 28Apr2021. It has not subsided yet, it is still kind of going right now. He is not rushing to the bathroom every 5 minutes, but its not comfortable, so its improved since the first time, he was very crampy and his stool was liquidy and now it is more solid, it is slightly improving. 1st Pfizer COVID vaccine Lot number: EW0158; zero maybe an O. he confirms both vaccines have the same Lot number as far as he knows. It is the same Lot on both cards he got. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for double Vision. Patient was recovered from double Vision on 05May2021, recovered from headache on 29Apr2021, recovered from Fatigue on 01May2021. Outcome of other events was unknown. It was reported as non-Serious, Seriousness criteria of Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect were all reported as No. Information on Lot/Batch number was available. Additional information has been requested.
53 2021-05-26 bell's palsy Bell paulsy left side of my face paralized
53 2021-05-27 seizure Seizures back to back to back/cause him to have more seizures; Wetting himself; This is a spontaneou... Read more
Seizures back to back to back/cause him to have more seizures; Wetting himself; This is a spontaneous report from a contactable consumer (patient's father). A 53-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 via an unspecified route of administration on 01May2021 (Lot Number: EW0161; Expiration Date: 31Jul2021) as 2nd dose, single for covid-19 immunization (keep him alive and healthy). Medical history included ongoing sugar (diabetes) that was diagnosed with sugar 15 years ago (2005), heavy (overweight) been heavy for years. (biggest at 250 and is down to 236-238 now. It was stated that he lost weight before the shot and they do not know why), ongoing seizure all his life (he has had seizures all life), cholesterol (blood cholesterol abnormal), son that is special needs and high functioning and on vagus nerve apparatus. The patient received the first dose bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) via unknown site on 10Apr2021 (Lot number: EW0158) for Covid-19 immunization. Concomitant medication included unspecified medications for seizures and has a VMS (unspecified). The reporter stated that has a son that is special needs and high functioning. The father stated that he has had seizures all life, so he wanted to know if the shot cause him to have more seizures. The father mentioned that he is having seizures back to back to back and wetting himself. The father does not think this has anything to do with the shot, but his mom does. The reporter mentioned that the patient's mom looked online and saw something that stated it causes seizures. The reporter inquired if there were any reports of having seizures for special needs or anybody. He added that the patient had four seizures back to back in his sleep on May2021. The reported further stated that he has an apparatus that was put in his chest that slows the vagus nerve to seizure activity which he has had it since 2004. It was mentioned that that two weeks ago (May2021) when he was with his mom and last night that the seizures started in his sleep. He also was wetting himself which started two weeks ago (May2021) when he was with his mom. The reporter mentioned that he has blood work every 90 days (unknown date) for seizure medications and cholesterol but does not wish to provide (unknown). The father mentioned that the treatment included the patient taking his medication for his seizures as for the wets himself, he got cleaned up and puts fresh clothes on. The outcome of the event convulsions aggravated was recovered on May2021 while the outcome of the other event was recovered on 12May2021.; Sender's Comments: Based on available information the reported seizures and urinary incontinence are unrelated to bnt162b2. These are due to the patient's underlying seizure disorder. Case will be reassessed if additional information is received.
53 2021-06-01 pain in extremity THE PATIENT SAID HIS ARM WAS SORE THE DAY HE GOT HIS SHOT. HE SAID 2 TO 3 DAYS LATER IT BECAME REAL... Read more
THE PATIENT SAID HIS ARM WAS SORE THE DAY HE GOT HIS SHOT. HE SAID 2 TO 3 DAYS LATER IT BECAME REALLY SORE TO THE POINT OF HURTING. HE SAID HE HAS A PHYSICAL JOB AND HE COULD HAVE EASILY INJURED HIS SHOULDER AT WORK THE DAY HE GOT HIS VACCINE, BUT DOES NOT REMBER INJURING ARM/SHOULDER. THE PATIENT PRESENTED TO THE PHARMACY FOR HIS SECOND VACCINE (OVER A MONTH LATER) AND HIS SHOULDER IS STILL HURTING. HE SAYS IT HURTS WHEN HE LIFTS IT UP, IF FEELS WEAK, AND HE HEARS/FILLS A 'POP'.
53 2021-06-02 pain in extremity Arm pain; fatigue; diarrhea; This is a spontaneous report from a contactable consumer (patient, self... Read more
Arm pain; fatigue; diarrhea; This is a spontaneous report from a contactable consumer (patient, self-reported). A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9766 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 25Feb2021 at 01:15 PM, as a single dose for COVID-19 immunization at hospital. The patient did not receive any other vaccine in four weeks. The patient's medical history included HIV, rheumatoid arthritis, asthma, and adrenal insufficiency. The patient did not have any known allergies. Concomitant medications were not reported. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 26Feb2021, he experienced arm pain, fatigue, and diarrhea. The patient did not receive any treatment for the events. Outcome of the events was recovered on an unknown date. No follow-up attempts are possible. No further information is expected.
53 2021-06-02 tingling, muscle spasms, discomfort, numbness He was tired; Felt discomfort; Feel numbness and swelling in his toes and hands/feel a numbness on f... Read more
He was tired; Felt discomfort; Feel numbness and swelling in his toes and hands/feel a numbness on fingers of hand and feet; Feel numbness and swelling in his toes and hands; Began to feel tingling in his back, a sensation that begins as if it were itching becomes a tingling sensation and transforms into a cramp; Began to feel tingling in his back, a sensation that begins as if it were itching becomes a tingling sensation and transforms into a cramp; Inflammation in the stomach; Abdominal pain; Sometimes his blood pressure increases; couldn't sleep with the symptoms; He was not feeling well; He woke up with inflammation in his fingers and toes; This is a spontaneous report from contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8731 and Expiration date not reported), via unknown route on his right arm on 16Apr2021, (at the age of 53 years) as a 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8733 and Expiration date not reported), via unknown route in left arm on 26March2021, (at the age of 53 years) as a 1ST DOSE, SINGLE DOSE for COVID-19 immunization. After the first dose patient had only pain in arm. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient experienced to feel numbness and swelling in his toes and hands, began to feel tingling in his back, a sensation that begins as if it were itching becomes a tingling sensa-tion and transforms into a cramp, he also presents inflammation in the stomach and abdominal pain for which it has already been prescribed with acetaminophen that calmed his symptoms a little, when he gets wet with hot or cold water feels all the discomfort described previously, he had never felt such symptoms, the patient is concerned that sometimes his blood pressure increases. The patient describes the experience as something similar to an allergy to some food that holds up for a long time and feels that its symptoms have increased, the symptoms diminish when performing his normal activities, today he was unable to work because he woke up with inflammation in his fingers and toes. The patient states, that the timing was normal, he just had the pain as normal, like everyone else getting the vaccine at that time, but with the second it became stronger, but still common with everyone else. Then he started to feel them with much more frequency. Numbness on fingers of hand and feet: the second dose he felt that, alongside the abdominal pain, he was generally not feeling good. He took Acetaminophen and it decreased, when the medication is active, then he goes back to normal, and it increases. Tingling in back started at the same time. At the time it was like itchiness on the back, at that point he wasn't able to scratch but it was fine, then it became tingling that he was not able to get rid of. Inflammation in stomach started with the second dose. The first dose was no issue, he was feeling the same, second dose he had those symptoms. It increases when he drinks milk and stuff so he would say it's getting worse. Blood pressure rises sometimes: He had felt his blood pressure rise since the second vaccine, but it's normal during the day, it was tested and normal, he gets to exercise, that's fine, he has no issues with blood pressure before the second, but for example, early this morning, 12 in the morning to 6 this morning, he felt it was increasing, and he was tired and stuff. outcome normal, his blood pressure fine during day, he exercises, but he felt it early this morning, felt discomfort, he was uncomfortable and tired and now, normally it's fine, regular pressure. reported. The patient describes the experience as something similar to an allergy to some food that holds up for a long time and feels that its symptoms have increased, the symptoms diminish when performing his normal activities, today he was unable to work because he woke up with inflammation in his fingers and toes. After receiving the second dose of vaccination patient felt all these symptoms, took some medication, Acetaminophen because he was not feeling well, yesterday he couldn't sleep with the symptoms. He would visit his doctor after making the report. Patient was working for a pharmacy for 3.5 years. When asked for consent to contact, the interpreter was no longer on the line. Primary care doctor's declined, caller states he doesn't have a PCP, states he is a tourist now. Card has on the back the date, where vaccine was done, states he didn't take any medication; he is very healthy. He took Acetaminophen, clarifies as he took Tylenol (UPC unknown. Lot: SPA084, expiry is Oct2024; strength is 500mg), verified, and he just appreciates the help. Details for Vaccine Supplemental Form not provided by caller. Patient was working in supermarket with friends, they said they would vaccinate people, so he took advantage. The outcome of the events, numbness localized, feel tingling in his back, stomach inflammation, abdominal pain was not recovered, the event blood pressure increases was recovered on unknown date in 2021, the event couldn't sleep, Feel numbness and swelling in his toes and hands, Began to feel tingling in his back, a sensation that begins as if it were itching becomes a tingling sensation and transforms into a cramp not feeling well, couldn't sleep with the symptoms, inflammation in his fingers and toes, he was tired, felt discomfort was unknown. Product complaint was filled: While providing and AE for the Pfizer COVID 19 vaccine, the caller states he had numbness on fingers of hand and feet: He takes Acetaminophen, later clarified as Tylenol, and it decreased, when the medication is active, then he goes back to normal and it increases. Follow up (26May2021): This is a follow up spontaneous report from contactable consumer. This 53-Year-old female consumer (patient) reported for herself new information included event detail, Batch/lot number was updated
53 2021-06-03 numbness Whole lip swollen and numb; Whole lip swollen and numb; Nose swollen and numb; Nose swollen and numb... Read more
Whole lip swollen and numb; Whole lip swollen and numb; Nose swollen and numb; Nose swollen and numb/ Some of his cheek under his left eye was numb; Face had swelled/ some of his cheek under his left eye was numb and swelled; Doesn't feel well, sickness like just don't feel well/ feels sick, kind of; This is spontaneous report received from a contactable consumer (patient himself). A 53-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0186), via an unspecified route of administration on 25May2021 at 14:10 (at the age of 53-year-old) as a single dose to protect him if he would get the coronavirus/ COVID-19 immunisation. The patient's medical history included has something like ALS (amyotrophic lateral sclerosis) (has not been actually diagnosed. Doesn't have anything to do with his lip swelling and nose going numb). No new meds, not anything new eaten, no new detergents. Noting was different other than he got the shot. Has medical conditions but doesn't have anything to do with swelling in lips or face. Patient states he has something like ALS or Lou Gehrig's disease, but has not been diagnosed. It has nothing to do with the swelling or lips turning numb. Concomitant medications were reported as none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0173), via an unspecified route of administration in left arm on 04May2021 (at the age of 53-year-old) as a single dose for COVID-19 immunization and experienced throwing up four days, sick for four days, slept for 17 hours straight and stayed in bed a total three to four days, tired. Family medical history relevant to adverse events was none. The patient did not administered additional vaccines on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks) within four weeks prior to the first administration date of the suspect vaccine. No adverse events following prior vaccinations. It was reported that, patient was calling about COVID, the Pfizer shot, the second Pfizer COVID shot. Had gotten the shot on Tuesday, 25May2021 at 14:10. Noticed yesterday (26May2021) around 2'clock half of his lip was swelled, and some of nose, and left side of face, cheek, under eye. As time went on it spread. He later clarified it was more around 14:30 after the 24hr period. He noticed his face had swelled, spread over time, and started with his upper left lip. His wife noticed that. Some of his nose was numb and swelled and some of his cheek under his left eye was numb and swelled. It went to other side of his lip, swelled and numb, and his nose was swollen and numb. Both lips are swelled and numb. He went to doctor yesterday, to walk in clinic that was in his doctor's office. They gave him a steroid shot yesterday (26May2021) and steroid pills today (27May2021). He had just taken his first steroid pill now. Confirmed dates and times, he stated the symptoms started after the 24-hour period. Whole lip swollen and numb: Big enough as of right now, that upper lip covers bottom lip, don't even see the bottom lip. Commented he has a sickness like does not feel well. He now feels sick, kind of, not throwing up. No investigation assessment. No relevant tests. No tests performed. Went to walk-in clinic downstairs from doctor's office. The doctor though his symptoms were from the shot and he got a steroid shot and steroid pills. The adverse events required a visit to physician office. The adverse events did not require a visit to emergency room. The outcome of the events was not recovered. Follow-up attempts needed. Additional information has been requested.
53 2021-06-03 night sweats, weakness high fever that continued to escalate from Friday night until the Following Wednesday. Intense night... Read more
high fever that continued to escalate from Friday night until the Following Wednesday. Intense night sweats, intense chills. So weak I couldn't even walk my own dog. Very frightening.
53 2021-06-03 pain in extremity Pain in arm; This is a spontaneous report from a contactable consumer (patient) reporting on himself... Read more
Pain in arm; This is a spontaneous report from a contactable consumer (patient) reporting on himself. A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8733 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient received the second dose of Pfizer COVID 19 vaccine on 16Apr2021. The patient medical history and concomitant medications were not reported. It was reported that, the patient experienced pain in arm on an unknown date in 2021. The outcome of the event was unknown.
53 2021-06-07 bell's palsy, numbness, facial paralysis Headache, facial drooping, numbing sensation, 7:30am
53 2021-06-07 facial paralysis, bell's palsy Diagnosed as Bells Palsy on right side of face. Started on 5/24/21 with headache in right side of f... Read more
Diagnosed as Bells Palsy on right side of face. Started on 5/24/21 with headache in right side of frontal lobe, neck pain slightly below right ear, and right side of tongue being numb. Tongue numbness spread to right, interior side of lips over next few days. On 5/28/2021 I noticed paralysis on right side of face (unable to smile on right side, unable to control direction of spit, unable to wink/close right eye (unless while closing both eyes), unable to furrow brow on right side, unable to keep right side of lips closed when trying to hold breath in mouth (air leakage).
53 2021-06-07 numbness, flushing, tingling Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Hypotension-Medium, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
53 2021-06-07 numbness, tingling THREE DAYS AFTER SHOT, HAVE TINGLING FINGERTIPS ON LEFT HAND, SENSATION ON AND OF FOR COUPLE OF DAYS... Read more
THREE DAYS AFTER SHOT, HAVE TINGLING FINGERTIPS ON LEFT HAND, SENSATION ON AND OF FOR COUPLE OF DAYS. WEEK AFTER THE SHOT, STABBING PAIN UNDER LEFT ARMPIT ACROSS MIDDLE OF LEFT CHEST. LEFT HAND FEELING NUMB
53 2021-06-09 numbness numbness in his fingers/right leg went numb; fog brain; aches and pains; This is a spontaneous repor... Read more
numbness in his fingers/right leg went numb; fog brain; aches and pains; This is a spontaneous report from a contactable consumer (patient's parent). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) (at the age of 53-years-old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included cardiac pacemaker insertion. The patient's concomitant medications were not reported. Patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date (at the age of 53-years-old) for COVID-19 immunisation. The patient said that his son felt no real results from the second dose of COVID-19 vaccine shot but in 2 weeks his son had numbness in his fingers and what his son called fog brain. He said his son also had aches and pains and went to the Emergency Room. The caller said while in the Emergency Room, they drew blood from his son and couldn't find anything. He said his son has been to doctors and his son can't seem to get any help from his symptoms. He said yesterday, his son's right leg went numb. The caller said he was worried for his son and would like some medical help for his son. The patient's mother said they wanted information so her son won't die. The patient's father said his son had read a lot of people who received the COVID-19 vaccine and experienced side effects 2 weeks after the COVID-19 vaccine shot. The patient's father said it was almost exactly 2 weeks after his son received his second COVID-19 vaccine shot that his son experienced his weird problems. Outcome of events was unknown. Information on the lot/batch number has been requested.
53 2021-06-10 pain in extremity SORE ARM, BIG RED SPOT SOUGHT CARE FROM DERMOTOLIOGIST
53 2021-06-11 numbness, tingling Seriousness: Does not really know what it is, it could be thrombosis; Caller has experienced redness... Read more
Seriousness: Does not really know what it is, it could be thrombosis; Caller has experienced redness/redness in thumb and finger tips; tingling/tingling in left hand; decrease sensation in his finger tips/numbness and decreased sensation in left hand; He is still experiencing all of these and has gotten worse; This is a spontaneous report from a contactable physician (patient). A 53-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 13May2021 (Batch/Lot Number: EW0183) in the morning between 10:00 and 11:00 am as single dose for covid-19 immunisation at the age of 53-year-old. Medical history included an open reduction internal fixation, surgery on his right clavicle 5 years ago, which is what made him want to get the vaccine. Concomitant drugs included Multivitamin, Vitamin A and Vitamin D. The patient had an exam in December and all of the test results were normal. On 16May or 17May2021, the patient has experienced redness in thumb and fingertips, numbness, and decreased sensation in left hand, tingling in left hand. Symptoms have been ongoing for 10 days; it has progressively gotten worse. It was reported that the symptoms started 2 days after getting the vaccine on 13May2021, was 16May2021 or 17May2021. He takes multi vitamins and minerals and thought it may be related to that. He takes high doses of Vitamin A and Vitamin D. He actually thought it was due to the Vitamin A and Vitamin D. He stopped the vitamins for a few days. Treatment included: Thought maybe, apart from the vitamins, it may be because he was washing his hands so much that it may be from that. He used Aveno lotion to try and lubricate them. The outcome of event Thrombosis was unknown, outcome of other events was not recovered. The reported considered the events were related to the vaccine as it was the left finger tips, especially the thumb, compared to the right. That's why he thinks it is related to the vaccine. The clinical course was reported as: The redness was first, then the tingling. He doesn't remember the exact day. The numbness and decreased sensation were afterward. He is still experiencing all of these and has gotten worse. The thumb on the left hand looks pink and wrinkled. When comparing the right see the difference tell they are different. Seriousness: Does not really know what it is, it could be thrombosis. The redness in the thumb and finger tips is in the right as well but is not as bad as in the left. Follow attempts needed. Further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported event of thrombosis. 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
53 2021-06-13 pain in extremity Initial adverse event was severe sickness the day after the vaccine. I was extremely ill for 3-4 da... Read more
Initial adverse event was severe sickness the day after the vaccine. I was extremely ill for 3-4 days after the vaccine with flu like symptoms. Fever, chills, body aches, head ache. 1-2 weeks after that I developed extreme joint pain in two specific areas. My left index finger knuckle, and my right knee. My index finger had extreme pain, was sensitive to touch, and would lock into position as I slept requiring me to gradually wiggle it (painfully) to gain function in the morning. My right knee became very sore to the point that it was hard to walk my dog, and the knee felt unstable and painful with any twisting or torquing moves. The two conditions persisted for 2 months before worsening. The specific pain moved from the middle knuckle of my index figure to the base knuckle, the pain in my knee also spread to a sharp pain in my ankle, and I developed a specific pain (exact location) in my head that would hurt when I coughed, bent over or clenched (like when peeing). At that point I went to the doctor to be checked out.
53 2021-06-16 weakness, muscle spasms Fever of 102.5, muscle cramps, loss of balance, weakness, tiredness and blurred vision
53 2021-06-19 weakness Starting on 6/6/21, the patient began to have low-grade fevers (usually ranging 100F to 100.4F), mya... Read more
Starting on 6/6/21, the patient began to have low-grade fevers (usually ranging 100F to 100.4F), myalgias, and weakness. This occurred daily for 2 weeks. It is slowly improving without interventions. His symptoms were improved with ibuprofen.
53 2021-06-19 pain in extremity After the vaccination, dull pain persisted at the injection site (right deltoid) until the onset of ... Read more
After the vaccination, dull pain persisted at the injection site (right deltoid) until the onset of the adverse affect. Several weeks after the vaccine was administered, a painful rash developed at the site of the injection and spread down my right arm and hand. I thought the rash was poison ivy or poison oak except the pain was excruciating. So I visited our GP and was diagnosed with shingles. He prescribed 10 days of Valacyclovir and Gabapentin. As of today 6/20 part of the rash has healed except some festering scabs on and near the vaccine injection site. I am currently experiencing severe pain / sensitivity in my entire right arm.
53 2021-06-21 sciatica Patient presented to the ED on 4/30/2021 for back pain with sciatica. Patient presented to the ED an... Read more
Patient presented to the ED on 4/30/2021 for back pain with sciatica. Patient presented to the ED and was subsequently hospitalized on 5/1/2021 for fever of unknown cause. These visits are within 6 weeks of receiving COVID vaccination.
53 2021-06-22 mild one side paralysis, weakness, facial paralysis, tingling, speech disorder The patient is a 53 yo previously healthy male who experienced GBS temporally associated with receip... Read more
The patient is a 53 yo previously healthy male who experienced GBS temporally associated with receipt of Pfizer BioNTech COVID vaccine (lot # EW0162 )13 APR 2021. He denies any illness symptoms such as fever, malaise, cough, URI symptoms, n/v/d in the preceding month. He denies any immediate reaction suggestive of IgE mediated event. He reports his initial only side effect was local site tenderness. Approximately 11 days after receipt he had been playing basketball with his kids during the. day and he noted unusual fatigue that evening, pain in his shoulders/neck, took ibuprofen and went to be early. In the morning (Day 14), his right leg slipped and he fell when standing after getting out of bed. He took a few steps and discovered he had no balance and fell again. Family brought him to ER. He was evaluated but no definitive diagnosis and discharged home. He reports on 29 APR 21 (day 16) he was brushing his teeth and couldn't retain water in his mouth. He noted facial drooping, his speech was affected and he returned to ER. ER eval was inconclusive but he was admitted for further evaluation. after multiple tests including LP he was diagnosed with atypical GBS. He received IVIG and was transferred to hospital. He states he improved dramatically after a few days. He was transferred back to hospital and then to rehab for one week and then discharged home. He reports currently he estimates strength at about 60%. He is continuing to improve but fatigues easily. . ER note 27 APR documents c/o body aches x2 days, cough, weakness, HA, perioral numbness and sinus pressure. Also states family member had URI symptoms. Diagnostics included ECG (1st degree block), CXR, CT head, CBC, Chem, LFT, Trop and COVID-19 which were are WNL. A UA showed 2+ ketones. Dx was viral syndrome or possible side effects from COVID vaccine and discharged home, but placed on isolation due to concern for COVID because of symptoms. ER note c/o oral and extremity paresthesias for this date. Triage diagnosis was vaccine reaction. ER note documents c/o facial droop, eye lid droop, left arm weakness. Neuro exam documents facial droop, unable to lift left arm above head. Diagnostics included plain films left femur and hip, ECG, CT/CTA head, MRI brain, MR venography were normal. Neuro consult did not think was CVA but he was admitted for further eval. Symptoms continued to progress to include increased weakness, DTR 1+ throughout, difficulty managing excretions. LP 01 MAY 2021 was positive for protein and neg for oligoclonal bands, or evidence of infection. He was diagnosed with atypical GBS, started on IVIG, and transferred to hospital. He was transferred back 06 MAY after completing IVIG and then transferred for rehab therapy x1 week followed by discharge home.
53 2021-06-22 pain in extremity shingles; rash spread down my arm; and was very painful on the surface and extended to deep tissue/ ... Read more
shingles; rash spread down my arm; and was very painful on the surface and extended to deep tissue/ joints; and was very painful on the surface and extended to deep tissue/ joints; arm was sore at the injection site; This is a spontaneous report from a contactable consumer. This contactable Consumer reported events for both doses of Comirnaty for this patient. This is regarding the 2nd dose. A 53-year-old male patient received (BNT162B2) (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP7533) dose 2, administered intramuscular in left deltoid on 08Apr2021 as 2nd dose, single dose for covid-19 immunization. Medical history was not available. Concomitant medications included valacyclovir and gabapentin. Historical vaccine received first dose BNT162B2 (COMIRNATY, Pfizer vaccine, Lot number: EN6204) on 18Mar2021 via intramuscular in right arm/deltoid for Covid-19 immunization and had vaccination site pain. It was reported that, arm was sore at the injection site from the date of the vaccination until the onset of the AE. A rush started forming at the injection site on an unspecified date in 2021. The rash spread down of his Right arm on 12May2021 and was very painful on the surface and extended to deep tissue /joints on an unspecified date in 2021. His physician diagnose shingles on 12May2021 and prescribe antiviral and pain medications. This could be unrelated to the vaccine but he thought they might find it interesting. The outcome of event arm was sore at the injection site was unknown, while with other events was recovering. No follow ups attempt needed. No further information was available.
53 2021-06-24 discomfort About 8 or 10 days after receiving the first Pfizer vaccine I developed a rash on my chest and abdom... Read more
About 8 or 10 days after receiving the first Pfizer vaccine I developed a rash on my chest and abdomen. It lasted for a couple weeks. After receiving the second Pfizer vaccine the rash went away after a couple days. Then, on approximately June 19th (75 days after the second vaccine dose) I noticed another rash on my back. This time it spread all across my back, neck, chest, abdomen and arms. It has been 6 days since the second rash began and it is still quite itchy and uncomfortable, although the rash severity does seem to be subsiding a bit.
53 2021-06-24 numbness left sided facial numbness; decreased movement of the facial muscles; This is a spontaneous report f... Read more
left sided facial numbness; decreased movement of the facial muscles; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on 15Mar2021 at 10:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and diabetes. The patient had no known drug allergies. Concomitant medications of included amlodipine (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), insulin (MANUFACTURER UNKNOWN), OZEMPIC and lisinopril (MANUFACTURER UNKNOWN); all for an 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 vaccination, the patient had not been tested positive for COVID-19. It was reported that within an hour or two patient experienced left sided facial numbness and decreased movement of the facial muscles and asymmetrical smile. It was reported that symptoms had improved slightly but still persists. On 15Mar2021, the patient experienced facial numbness and decreased movement of the facial muscles. The patient contacted doctor of medicine (MD), but instructed if symptoms worsened to seek emergency care. The patient did not receive any treatment for the reported events. The clinical outcome of the event facial numbness and decreased movement of the facial muscles was not recovered at the time of report; information about lot/ batch number cannot be obtained. No further information is expected.
53 2021-06-25 numbness Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Numbness along ri... Read more
Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Numbness along right arm for 1 day,k then numbness along right leg and foot for 2 weeks
53 2021-06-29 weakness very ill; Fever; no energy; nauseous; This is a spontaneous report from a contactable consumer, the ... Read more
very ill; Fever; no energy; nauseous; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route administration in the right arm on 16Mar2021 at 00:00, (at the age of 53-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have allergies to medications, food, or other products. On 16Mar2021 at 20:00, the patient experienced fever, no energy, nauseous and very ill. 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 treatment for the reported events. The clinical outcome of the events illness, fever, loss of energy and nauseous was not recovered at the time of this report. Information about lot number cannot be obtained. No further information is expected.
53 2021-06-30 numbness Experience slight numbness in feet and lower legs beginning 3/27/21 that progressed over time. Shing... Read more
Experience slight numbness in feet and lower legs beginning 3/27/21 that progressed over time. Shingles rash and diagnosis 6/1/21. Numbness in feet and lower legs persists as of this submission 7/1/21.
53 2021-07-05 weakness 2 days after the vaccine was given knot appeared on shoulder. after a week the knot moved to neck . ... Read more
2 days after the vaccine was given knot appeared on shoulder. after a week the knot moved to neck . went to doctor and was given antibiotics. a week later problem persist. was given steroids . Had no strength in left arm. problem has gotten better.
53 2021-07-05 hot flush, tremor The Second shot the next day my lymph nodes swole up as big a baseballs under my arms, hot flashes, ... Read more
The Second shot the next day my lymph nodes swole up as big a baseballs under my arms, hot flashes, uncontrollable shakes on lefts side. But now I am shaking on both sides, short of breath, and headache
53 2021-07-08 weakness Cough; Minor breath problems; No energy; This is a spontaneous report from a contactable consumer, t... Read more
Cough; Minor breath problems; No energy; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6207), via an unspecified route of administration in the right arm on 14Mar2021 at 09:30 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medication included montelukast sodium (SINGULAIR) from unknown date for unspecified indication. The patient previously received acetylsalicylic acid (ASPIRIN) on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021, the patient experienced cough, minor breath problems, no energy. The patient did not receive any treatment for the events. 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 cough, breathing difficult, loss of energy was recovered with sequelae. No follow-up attempts are needed. No further information is expected.
53 2021-07-11 weakness Within 12 hours, I felt tiredness, fatigue, body was weak. I had loss of appetite. Ran a low grade f... Read more
Within 12 hours, I felt tiredness, fatigue, body was weak. I had loss of appetite. Ran a low grade fever. The cough started 2 days after the vaccine was given. With each day, I felt worse, finally on 5/28/2021, I went to the walk in clinic. They took my vitals and wheeled me to the ER. I had a fever of 101.38, elevated heart rate, high BP. nausea with an upset stomach. Several test were run on me at this time. The ER Dr. said I would feel bad for a week or so, and was put off work for 1 week and a half. My cough got worse each day and I kept that cough for about 4 weeks. The ER Dr. said I should follow up with my regular Dr. I seen Dr. 2 different times during the next few weeks.
53 2021-07-11 pain in extremity, numbness Starting 2 day after vaccine I woke up with pain in my arm, it feels like both arms are falling off ... Read more
Starting 2 day after vaccine I woke up with pain in my arm, it feels like both arms are falling off my body, they felt just numb. The left arm was more sore than the other. My legs and knees are also hurting, I run 3 times/week. I can't feel the bottom of my feet so I am stumbling around. Less severe on the left leg. My arms are a little more numb than my legs. My neck is also hurting as of this morning, 07/12/2021. There is a sharp pain in my leg when water hits it in the shower, If I sneeze cough or swallow, pain goes down my neck. I cannot make my feet do what I want them to do. If I lift my neck, pain goes down the back of my neck; this has been every day since 2 days after vaccine. I have been taking all kinds of OTC pain medication. Has never received any other vaccines.
53 2021-07-12 pain in extremity I can feel a clot in arm making it very painful; My left arm has been in pain; I cannot use my left ... Read more
I can feel a clot in arm making it very painful; My left arm has been in pain; I cannot use my left arm.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 23Apr2021 11:00 (Lot Number: EW0172) as single dose for covid-19 immunisation at 53 years old. The patient medical history was not reported. Concomitant medication(s) included lisinopril (unknown manufacturer, 5 mg) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6955) on 27Mar2021 at 10:00 in left arm when 53 years old. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced can feel a clot in arm making it very painful (thrombosis) (medically significant), his left arm has been in pain (pain in extremity) (non-serious) and cannot use his left arm (mobility decreased) (non-serious) on 23Apr2021 with outcome of not recovered. The patient reported that his left arm has been in pain since the time of injection and now he can feel a clot in arm making it very painful and he cannot use his left arm. The patient was not treated for the events. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination. Information on Lot/Batch number was available. Additional information has been requested.
53 2021-07-14 weakness, pain in extremity Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Severe, Systemic: experience pai... Read more
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Severe, Systemic: experience pain on left side of neck down to arm and fingertips-Severe, Systemic: Weakness-Severe, Additional Details: pt. is experiencing pain from all day long , from left side of neck all the way to fingertips, radiating pain.pt. is unable to move arm readily.pt had seen physcian at urgent care, then came to pharmacy to report of effects. gathered information on his well being, and apologized for inconvenience and recommended to seek medical attention, and services
53 2021-07-17 numbness, tingling blurry vision; Could not stand or walk for more than 1-2 mins without discomfort; Could not stand or... Read more
blurry vision; Could not stand or walk for more than 1-2 mins without discomfort; Could not stand or walk for more than 1-2 mins without discomfort; Tingling sensation from the back ofboth knees, down to the feet & toes; numbing; Feels likes pins & needles; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 29Mar2021 at 09:00 as a single dose (at the age of 53-year-old) for COVID-19 immunisation. The medical history of the patient included type II diabetes mellitus. The patient reported no allergies to medications, food, or other products. Concomitant medications included metformin hydrochloride (METFORMIN), rosuvastatin calcium (CRESTOR), ascorbic acid (ESTER-C), colecalciferol (VITAMIN D3). 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 29Mar2021 at 14:00, the patient experienced tingling sensation from the back of both knees, down to the feet & toes, felt likes pins and needles and numbing and was not able to stand or walk for more than 1-2 mins without discomfort, even when sitting down, having both feet down on the ground. Had to be in a lying position or raised leg/feet position to feel relief. Also noticed blurry vision on 30Mar2021, the following day of administering the vaccine, even with his reading glasses on. No other unusual discomfort or adverse effect was noted that time. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events of tingling sensation, pins and needles, numbing, blurry vision. The clinical outcome of tingling sensation, pins and needles, numbing, blurry vision walking difficulty and difficulty in standing was not recovered. No follow-up attempts are needed. No further information is expected.
53 2021-07-17 pain in extremity Breathing Issue/problems breathing; Felt bad/crappy; Got Covid after receiving the Covid vaccine; As... Read more
Breathing Issue/problems breathing; Felt bad/crappy; Got Covid after receiving the Covid vaccine; Asthma; Cough; He got chills; hand is beginning hurt; Height shrank he thinks; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was EW0150 and expiration date was 31Jul2021) via an unspecified route of administration, administered in arm left on 07Apr2021 at 12:00 or 13:00 (at the age of 53-year-old) as dose 1, single for COVID-19 immunisation. Patient did not receive other vaccinations within 4 weeks prior to vaccination. Medical history included diagnosed allergies (allergy shots from 2019 to unknown date), according to the thing he was obese, and carpal tunnel. No family medical history reported. Concomitant medications included unspecified allergy shots for allergies (he had been taking for two years or a year and a half because they closed the offices for Covid and then his serum expired so he was going to have to restart again this year). The patient did not receive any vaccine prior vaccinations (within 4 weeks). The clinical course of the events was reported as: he got his first dose on 07Apr2021 and six days later he ended up getting Covid. His healthcare provider advised him to wait two months. He went to the clinic and they were going to give him a second dose, but he was wanting to know if that was ok or if he would have to start all over. He went to two locations and they did not want to give him the first vaccine. According to the CDC they were not allowed to give him three vaccines. He was not asking for three. He had to start over because this happened. They said they did not care and they would just give him the second. He said he told them no and that his doctor told him that he needs to start again. They told him they did not care what his doctor says and that they know more than him. He figured he would go directly to the manufacturer and see what Pfizer says. Pfizer would know the vaccine better than anyone else, his doctor or the pharmacist. Whatever Pfizer tells him to do, he would do. He clarified that he got Covid three days after the vaccine dose 1. He needed to take a picture with his phone because the sticker was so small. Then 10Apr2021 was when he got Covid. Height shrank he thought. But he felt crappy for still another week. For another week he was still coughing and having problems breathing which kind of still lingers, he still has it. He had asthma he guessed now. Asthma was what was diagnosed, but now they were saying it might be cardio. Stated he had recovered with lasting effects. He had never had asthma in his life until after the vaccine. Now they were saying it might not be asthma, it could be cardio. So he was going through tests right now (as reported). With physical activity he got out of breath and the only thing that did help was his inhaler. His inhaler did help him for now (as reported). He thought he missed his second dose in Apr2021. It was three weeks after his first one. Might be the 21Apr2021 or 28Apr2021. Cough came on the second week. It was the week of 12Apr2021. States it was still ongoing, but he had recovered with lasting effects: He stated he was definitely not recovered. It was not everything so he ok with the rest of the stuff. It was just the breathing that was still there. Breathing issue began on unspecified date (as reported). It was the first time he noticed it. He went for a bike ride and he felt it again maybe two weeks after and since then he had not done any physical activity. He was trying to avoid it. He stated he did tech support and R and D for a living and Pfizer was really thorough. It was good, but his hand was beginning hurt. He started feeling bad on the 10th. He got chills. Everything happened in April. He was feeling bad until 24Apr2021 or 25Apr2021. Might be even 01May2021. Asthma: He was feeling crappy for about a week and then he started to walk around his backyard and he was having trouble breathing, but he knew he had Covid. It started then, a week after his first effect. It was 15Apr2021 or 17aApr2021. They were possible cardio issue and they were testing but there was nothing concrete. The events were not resulted into emergency room visit and physician office visit, but he did have a tele visit. He did go get tested as well. The outcome of the events asthma, cough was recovered with sequel and the outcome of dyspnoea was not recovered and the outcome of the other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021807432 similar report from same reporter
53 2021-07-17 tingling Tingling in fingers; Headache for a week.; This is a spontaneous report from a contactable consumer.... Read more
Tingling in fingers; Headache for a week.; This is a spontaneous report from a contactable consumer. A 53-years old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in left arm on 19Mar2021 at 15:45 (at the age of 53-years old) as a single dose for COVID-19 immunisation. Medical history included diabetes. Allergies to medications, food, or other products was unknown. Concomitant medication included Metformin (MANUFACTURER UNKNOWN) within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. 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 was not tested for COVID-19. On 20Mar2021, the patient experienced tingling in fingers and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic treatment received for the events. The clinical outcome of the events tingling of extremities and headache was not recovered at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
53 2021-07-17 tingling slight tingling in my left cheek on my face; This is a spontaneous report from a contactable consume... Read more
slight tingling in my left cheek on my face; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male 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 24Feb2021 at 09:30 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included shellfish allergy and gluten intolerance. The patient did not receive any other medications within 2 weeks of vaccination. 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 had not been tested for COVID-19. On 24Feb2021 at 10:00 the patient experienced slight tingling in left cheek and on face which was reminiscent of allergic reaction to shellfish. The patient did not receive any treatment for the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of tingling was recovered on an unknown date. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
53 2021-07-19 numbness, tingling, mild one side paralysis Numbness, tingling and weakness in left arm, left hand, left leg and left foot within an hour of inj... Read more
Numbness, tingling and weakness in left arm, left hand, left leg and left foot within an hour of injection.
53 2021-07-20 numbness Extreme fatigue and sleepiness. Numbness in 3 right toes and part of foot.
53 2021-07-20 pain in extremity Pain and restricted movement in his left arm; Pain and restricted movement in his left arm; This is ... Read more
Pain and restricted movement in his left arm; Pain and restricted movement in his left arm; This is a spontaneous report from a contactable other hcp (patient). A 53-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 21Jan2021 12:00 as DOSE 1, SINGLE for covid-19 immunisation. Facility type vaccine was Workplace clinic. The patient medical history and concomitant medications were not reported. No other vaccine in four weeks. The patient experienced Pain and restricted movement in his left arm on 21Jan2021 at 12:00. AE resulted In Disability or permanent damage. The outcome was Not recovered. AE treatment included Pain medication. No covid prior vaccination. Covid tested post vaccination. Covid test post vaccination (Nasal Swab, name: Colo) on 02Feb2021 with unknown results. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of pain and restricted movement in his left arm due to temporal relationship. Case will be re-assessed upon the additional information provided. 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.
53 2021-07-21 numbness, tingling Right hand numbness; Right hand tingling; This is a spontaneous report from a contactable consumer, ... Read more
Right hand numbness; Right hand tingling; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male 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 01Apr2021 at 09:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus. The patient did not have any allergies to food, medications, 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. Concomitant medications included glipizide (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication. On 02Apr2021 at 03:00, the patient experienced right hand numbness and tingling. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events right hand numbness and tingling were not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
53 2021-07-25 discomfort Within several weeks, I started noticing what felt like heart palpitations that caused me to lose my... Read more
Within several weeks, I started noticing what felt like heart palpitations that caused me to lose my breath and wheeze/cough. I had called my primary care physician and saw them and said I wanted a visit with a cardiologist. Just one week later, during a work call, it the event happened so severely that I started passing out. Thus, I went immediately to the ER and checked myself in. It was not until mid-July that I got to see a cardiologist, and my symptoms were much less frequent or severe by that time. For several weeks though, it was very uncomfortable and unnerving.
53 2021-07-28 weakness initial flu like aches; gave way to extreme muscle weakness in lower extremities moving to upper bod... Read more
initial flu like aches; gave way to extreme muscle weakness in lower extremities moving to upper body weakness; gave way to extreme muscle weakness in lower extremities moving to upper body weakness; persistent low grade fever; loss of mobility; This is a spontaneous report from a contactable consumer. A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 05Jun2021 15:00 (at the age of 53 years) (Batch/Lot Number: EW0191) as a single dose for COVID-19 immunization. Medical history included COVID-19 prior to vaccination. Concomitant medication included ibuprofen (other medication in two weeks). On 06Jun2021 07:00, the patient experienced initial flu like aches which gave way to extreme muscle weakness in lower extremities moving to upper body weakness, persistent low grade fever, and loss of mobility. AE resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization for 2 days. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient has been tested for COVID-19 since the vaccination (nasal swab) with result negative both on 18Jun2021 and 19Jun2021. Patient has no known allergies. Therapeutic measures were taken as a result of the events. The patient has not recovered from the events.
53 2021-07-28 muscle spasms, muscle twitching Gout; on and off nauseated; twitching and cramps in hamstrings, feet and hands; twitching and cramps... Read more
Gout; on and off nauseated; twitching and cramps in hamstrings, feet and hands; twitching and cramps in hamstrings, feet and hands; This is a spontaneous report from a contactable consumer. This 53-year-old male consumer (patient) received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 11:00 (at the age of 53-years-old) (Batch/Lot Number: ER8737) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient previously took bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 (Batch/Lot Number: EN6200) as DOSE 1, SINGLE for covid-19 immunisation and experienced Hand swelling, Numbness and tingling in fingers/numbness and tingling in toes, Feet swelling, Ankle swelling, Cold chills without a fever, Fatigue and Gout. The patient was on and off nauseated and twitching and cramps in hamstrings, feet and hands on 02Apr2021, the patient states after the second shot that he got on 01Apr2021 this went on for a three-week period where he could not eat hardly, and he never threw up but always felt like it. He started getting better around 23Apr2021 or 24Apr2021. He still had it a little, but it was not as severe. Patient also had gout on 25May2021 and patient states last night at three in the morning he woke up with unbelievable pain and swelling in his left foot where he could not walk on it so he went to the emergency room and the doctor listened to all his symptoms and said they would treat his foot. Patient states they did not aspirate the joint in his foot he was just given a steroid injection and some pain meds and now the doctor wants him to see a podiatrist for the aspiration. Patient stated he was on pain meds and cannot walk because of it. He stated he did want to mention he had also been having twitching and cramps in hamstrings, feet and hands as well but not all the time as it comes randomly. Patient had not administered additional vaccines. Patient had no vaccination within 4 weeks and not prior also. Informed patient for medical advice to contact a doctor but if the patient was wondering if the symptoms, he had been experiencing had been reported side effects of the vaccine this DSU agent can transfer him to USMI. The outcome of event nauseated was recovering and all other events outcome was unknown. Information on Lot/Batch number was available. Additional information has been requested
53 2021-07-29 muscle spasms extreme cramping for two days after both covid vaccinations; severe pain where metal implants in my ... Read more
extreme cramping for two days after both covid vaccinations; severe pain where metal implants in my body (hip and neck); This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the left arm on 25Feb2021 (at the age of 53-year-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the right arm on 18Mar2021 for COVID-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing Prior to vaccination, spinal fusion surgery fused vertebrate in neck, hip arthroplasty artificial hip, medical device implantation (metal implants in my body (hip and neck), glucose tolerance impaired all are from an unknown date and unknown if ongoing. Concomitant medication included hepatitis a vaccine (HEPATITIS A) taken for an unspecified indication from 08Feb2021; hepatitis b vaccine (HEPATITIS B VACCINE) taken for an unspecified indication from 08Feb2021. The patient did not have allergies to medications, food, or other products. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced extreme cramping on 26Feb2021 at 05:00 for two days and severe pain in neck and hip where metal implants were present after both covid vaccines. It was reported that this was still occurring at the time of this report. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. It was reported that Adverse event: extreme cramping for two days after both covid vaccinations, followed by severe pain where I have metal implants in my body (hip and neck). This was still occurring.Prior to vaccination, was the patient diagnosed with COVID-19 was yes. No treatment was received. The clinical outcome of the events cramps and the implant site pain were not recovered. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: For suspect vaccine 2nd dose: "Anatomical Location" captured as "Arm Right" per source, 1st Dose "Hepatitis A" and 1st/2nd Dose "Hepatitis B Vaccine" captured as "Historical Vaccine", "metal implants in my body (hip and neck)" captured as History per verbatim, Suspect "HEPATITIS A" updated per event's onset, No Drug code for "Hepatitis b", coded in tab as "HEPATITIS B VACCINE"; And also updated from event's onset. Initial information need review.
54 2021-01-06 weakness I woke up the morning after the vaccine with a moderate headache. Felt very tired, no energy. Later ... Read more
I woke up the morning after the vaccine with a moderate headache. Felt very tired, no energy. Later in the day it seemed as though I had COVID again. Winded very easily, no strength, body aches.
54 2021-01-06 weakness Date of vaccine 12/7/2020-Patient had very sore painful left deltoid and had to take Tylenol pain le... Read more
Date of vaccine 12/7/2020-Patient had very sore painful left deltoid and had to take Tylenol pain level 7 out of 10 and interrupted sleeping. 2nd day-12/18/2020-Patient had left sided body weakness, pain at injection site, pain all on left side of body taking Motrin. On 3rd day symptoms all subsided and were gone. No fevers or chills during any symptoms.
54 2021-01-06 cold sweat Cold sweats, fever of 100, pain the my joints
54 2021-01-06 numbness localized swelling, hand/wrist numbness, anxious
54 2021-01-07 tingling RespDepression, Rash, paresthesia extremtiies (>24 hours post vaccine) Narrative: employee developed... Read more
RespDepression, Rash, paresthesia extremtiies (>24 hours post vaccine) Narrative: employee developed rash/hives 24 hours after vaccine; which progressed over time (initially arms, waist, then torso, face). She also began having shortness of breath. She took otc bendaryl day after vaccine but due to worsening of symptoms, she went to a community ER where she was treated with several doses of IV bendary, steroids, Pepcid, and zyrtec. Her symptoms have improved but she is still taking benadryl and steroid taper.
54 2021-01-07 tingling Subtle tingling left earlobe and left jaw Narrative: Patient complains of occasional tingling "pins... Read more
Subtle tingling left earlobe and left jaw Narrative: Patient complains of occasional tingling "pins and needles" sensation in left ear, left jaw starting 2 days after vaccination . No other complaints. Has not followed up with physician. States sometimes "it feels like its getting better"
54 2021-01-08 pain in extremity pain at injection site, tired, malaise, generalized pain, nausea, runny nose Narrative:
54 2021-01-10 unresponsive to stimuli he passed away; not responsive; mind just seemed like it was racing; body was hyper dried; Restless;... Read more
he passed away; not responsive; mind just seemed like it was racing; body was hyper dried; Restless; not feeling well; ate a bit but not much; kind of pale; Agitated; Vomiting; trouble in breathing; This is a spontaneous report from a contactable consumer (brother of the patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 04Jan2021 (at the age of 54-years-old) as a single dose for COVID-19 immunization. Medical history included diabetes and high blood pressure. Concomitant medications included metformin (MANUFACTURER UNKNOWN) taken for diabetes, glimepiride (MANUFACTURER UNKNOWN) taken for diabetes, lisinopril (MANUFACTURER UNKNOWN), and amlodipine (MANUFACTURER UNKNOWN). The patient experienced not feeling well, ate a bit but not much, kind of pale, vomiting, trouble in breathing, and agitated on 04Jan2021; body was hyper dried and restless on 05Jan2021; mind just seemed like it was racing on 06Jan2021; and not responsive and he passed away on 06Jan2021 at 10:15 (reported as: around 10:15 AM). The clinical course was reported as follows: The patient received the vaccine on 04Jan2021, after which he started not feeling well. He went right home and went to bed. He woke up and ate a bit but not much and then was kind of pale. The patient then started to vomit, which continued throughout the night. He was having trouble in breathing. Emergency services were called, and they took his vitals and said that everything was okay, but he was very agitated; reported as not like this prior to the vaccine. The patient was taken to urgent care where they gave him an unspecified steroid shot and unspecified medication for vomiting. The patient was told he was probably having a reaction to the vaccine, but he was just dried up. The patient continued to vomit throughout the day and then he was very agitated again and would fall asleep for may be 15-20 minutes. When the patient woke up, he was very restless (reported as: his body was just amped up and could not calm down). The patient calmed down just a little bit in the evening. When the patient was awoken at 6:00 AM in the morning, he was still agitated. The patient stated that he couldn't breathe, and his mind was racing. The patient's other brother went to him and he was not responsive, and he passed away on 06Jan2021 around 10:15 AM. It was reported that none of the symptoms occurred until the patient received the vaccine. Therapeutic measures were taken as a result of vomiting as aforementioned. The clinical outcome of all of the events was unknown; not responsive was not recovered, the patient died on 06Jan2021. The cause of death was unknown (reported as: not known by reporter). An autopsy was not performed. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Reported Cause(s) of Death: not responsive and he passed away
54 2021-01-11 feeling cold 12 hours after the injection. Developed "cold feeling" and muscle aches/join pain. no chills, no fe... Read more
12 hours after the injection. Developed "cold feeling" and muscle aches/join pain. no chills, no fever. no GI/Resp symptoms. lasting for about 30 hours and resolved completely
54 2021-01-12 pain in extremity Fever around 101, ache all over, cough and sore left arm. All symptoms were gone in 24 hours except... Read more
Fever around 101, ache all over, cough and sore left arm. All symptoms were gone in 24 hours except a cough which lingered until Monday 1/11/2021. Vaccine was given on 1/7/2021.
54 2021-01-16 hot flush, weakness 1. The first 24 hours (date of vaccination 12/29/2020: Minor Pain at the injection site, minor Hot ... Read more
1. The first 24 hours (date of vaccination 12/29/2020: Minor Pain at the injection site, minor Hot flashes, Moderate Headache (took Tylenol 1 gm po x 2 doses), lack of energy, anxiety. 2. 01/16/2021 @ 20:00: Swallen Lynph node in left armpit.
54 2021-01-18 unresponsive to stimuli Resident received 1st on 1/11/21 at 12:10am (1/12/21) resident was found unresponsive. Code Blue, 91... Read more
Resident received 1st on 1/11/21 at 12:10am (1/12/21) resident was found unresponsive. Code Blue, 911 called at 12:11am. FD and EMS arrived, resident pronounced at 12:51am.
54 2021-01-19 pain in extremity sore arm, stomach cramping and diarreah started at 5pm and got worse.
54 2021-01-20 bell's palsy, facial paralysis Injection @ 2:47 p.m. on 1/15/21. 1/15/21 around 8 p.m. Bottom lip was swollen. Staff noticed. 1/1... Read more
Injection @ 2:47 p.m. on 1/15/21. 1/15/21 around 8 p.m. Bottom lip was swollen. Staff noticed. 1/16/21 @ 8:15 a.m. staff viewed swollen lip. Patient reported no pain. 1/18/21 @ approximately 3:00 p.m. - Left eye watering, drooping and visibly swollen. Home health nurse called Dr. No pain reported. Blood sugar 128 and normal. Patient went to ER to be seen as face drooping was worse. ER @ 4:45 p.m. on 1/18/21 - Dr. evaluated and believes he has Bells Palsey. Ordered head CT & labs to verify. Head CT normal ruling out stroke & labs normal. Correlates 60 mg of prednisone daily for one week and 1,00 mg TID Valacyclovir for one week and artificial tears four times daily and cloth tape at night to hold eye lid shut. First doses given in ER at 7:20 p.m. on 1/18/21. 1/21/21 - continue to tape eye at night, all symptoms remain.
54 2021-01-21 weakness Weak, Dizzy, Dry Mouth & Very Thirsty
54 2021-01-21 flushing At time of injection slight chest pain under the arm pit, side of chest, hot flushed feeling shortne... Read more
At time of injection slight chest pain under the arm pit, side of chest, hot flushed feeling shortness of breath. Hours after injection moderate pain at injection site. Days after injection growing pain at injection site. Weeks after injection a blob of pain and discomfort rising up my left arm into my left shoulder joint and lower neck.
54 2021-01-24 numbness Caregiver received vaccine dose at 0900 and about 1100 he described feeling numb all over and dizzy.... Read more
Caregiver received vaccine dose at 0900 and about 1100 he described feeling numb all over and dizzy. Caregiver was taken to St Joseph Hospital via EMS.
54 2021-01-25 burning sensation Burn and itching throughout the entire body; Burn and itching throughout the entire body; This is a ... Read more
Burn and itching throughout the entire body; Burn and itching throughout the entire body; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302) via an unspecified route of administration in the left arm on 11Jan2021 10:30 AM at a single dose for COVID-19 immunisation. Medical history included diabetes and known allergies to peanuts. Concomitant medications were not reported. The patient previously had known allergies to amoxicillin. The patient experienced burn and itching throughout the entire body on 11Jan2021 which resulted to emergency room/department or urgent care. Treatment for the events included Benadryl. The patient had no COVID prior to vaccination. He did not have COVID tested post vaccination. The patient had no other vaccine in four weeks. The outcome of the events was recovering.
54 2021-01-29 tingling 9 days after the vaccination, I had fever 102-103 F with chill, malaise, paresthesia and body ache r... Read more
9 days after the vaccination, I had fever 102-103 F with chill, malaise, paresthesia and body ache requiring taking Tylenol alternate with Advil every three hours. I tested for COVID-19 (PCR) and it was negative. Fever continued. On day 6, I went to urgent care center and was tested again with PCR for SAR-CoV-2 virus. The result was again negative. On day 7, I started coughing so I went to Hospital ER and was admitted. Chest X-ray and CT scan of chests showed pneumonia. The COVID-19 PCR test was again done and was negative. Respiratory panel PCR was negative. Mycoplasma titer was negative. I was given steroid and fever improved. I continued to cough until now (1/30/2021)
54 2021-01-31 weakness ON THE THIRD DAY POST VACCINATION PT WOKE UP WITH HEAD ACHE, WEAKNESS, BODY ACHES, THE 4TH DAY START... Read more
ON THE THIRD DAY POST VACCINATION PT WOKE UP WITH HEAD ACHE, WEAKNESS, BODY ACHES, THE 4TH DAY STARTED DRY COUGHING , SORE THROAT, ON THE 5TH DAY BEGAN WITH COUGH AND YELLOW SPUTUM. BODY ACHES, FATIGUED
54 2021-01-31 tingling, muscle spasms Uncontrolled short rhythmic breathing; brief electric shock sensation; little sporadic back spasms; ... Read more
Uncontrolled short rhythmic breathing; brief electric shock sensation; little sporadic back spasms; strong head pressure sensation; depression symptoms; This is a spontaneous report from a contactable Other HCP reporting for self. A 54-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 09:00 at single dose for covid-19 immunisation. The patient medical history was not reported. Patient received first dose of bnt162b2 on 17Dec2020 09:00. The patient's concomitant medications were not reported. The patient experienced Uncontrolled short rhythmic breathing, brief electric shock sensation and little sporadic back spasms, strong head pressure sensation, depression symptoms currently persistent and decreasing gradually on 09Jan2021. Patient had Nasal Swab on 12Jan2021 with negative result. Outcome of events was recovering. Patient received treatment for all events.
54 2021-02-02 facial paralysis, weakness, mild one side paralysis, seizure Patient is noticed to have generalized weakness, holding his head towards right side, mild right fac... Read more
Patient is noticed to have generalized weakness, holding his head towards right side, mild right facial puffiness with mild left facial droop, and sent to ER, on 1/22/21. Patient also had mild fever for the last two days and was on Tylenol, blood pressure also remained elevated moderately than the usual readings. Patient was admitted through ER for 2 days and was discharged on 1/24/21, with a diagnosis of possible TIA, Todd's paresis post seizure. Patient's CT head and MRI of brain was negative for acute stroke. Patient's left facial droop and right side facial puffiness resolved over a week but noticed to have right sided pronounced weakness with moderate swelling on right arm. Patient used to eat by himself,but now not able to do so and not able to hold cup in the right hand. Patient was again sent to ER for repeat CAT scan of head, further evaluation and management. Not sure if patient had an adverse reaction to Covid-19 vaccination, but definitely these symptoms were developed after 2 weeks of receiving Pfizer vaccination, which may be coincidental. Patient was followed up by the neurologist a week after the discharge from hospital who couldn't rule out adverse reaction of vaccination. Patient is awaiting for an EEG, carotid ultrasound and Echo as an out patient.
54 2021-02-03 pain in extremity He had a secondary infection of bronchitis; positive COVID-19 test with symptoms; positive COVID-19 ... Read more
He had a secondary infection of bronchitis; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; sore arm; headache; This is a spontaneous report from a contactable consumer (patient). A 54-years-old male patient started to receive the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284), via an unspecified route of administration in the right arm on 30Dec2020 14:40 at single dose for COVID-19 immunisation. Medical history included hypothyroidism and blood cholesterol, both ongoing. The patient received the influenza vaccine on 04Nov2020. Concomitant medication included levothyroxine sodium (SYNTHROID), eicosapentaenoic acid ethyl ester (VASCEPA). On 31Dec2020 the patient experienced sore arm and headache with outcome of recovered on 01Jan2021. On 02Jan2021 and 03Jan2021 he felt fine. He had a scratchy throat on Monday 04Jan2021. Tuesday 05Jan2021 he felt like he was getting bronchitis which he got sometimes. Later that evening on 05Jan2021 he had a two degree temperature, chills, and achy muscles. He couldn't get in with the doctor on 05Jan2021, so he had to wait until 06Jan2021 when he went to the respiratory clinic. They did the COVID test on 06Jan2021, but the positive result didn't come back until 07Jan2021. He was just now recovering from it. He had a secondary infection of bronchitis and was given an inhaler.
54 2021-02-04 pain in extremity Sore arm; This is a spontaneous report from a contactable consumer. A 54-year-old male patient recei... Read more
Sore arm; This is a spontaneous report from a contactable consumer. A 54-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL9262), via an unspecified route of administration on 20Jan2021 19:00 at SINGLE DOSE at right arm for covid-19 immunisation. Medical history included Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included tamsulosin hydrochloride (FLOMAX), atorvastatin (LIPITOR), duloxetine hydrochloride (CYMBALTA), varicella zoster vaccine rge (cho) (SHINGRIX). On 21Jan2021 02:00, the patient experienced sore arm, normal effect with most shots. The patient did not receive treatment for the adverse event. The outcome of the event was recovering.
54 2021-02-09 feeling hot 3 days after the vaccination, started with shortness of breath, and dysphony. The shortness of breat... Read more
3 days after the vaccination, started with shortness of breath, and dysphony. The shortness of breath gets worse walking on stairs and the dysphony worsens when talk. I also noted a hotness sensation, but when used the thermometer the temperature was normal. When checked both lungs didn't have any abnormal sounds. On the absence of these symptoms, I started using Fluticasone with Salmeterol, that improved the shortness of breath, but it came back after 12-14 hours, requiring use of 2 inhalations mornings and nights, the dysphony was related to the hotness and light tiredness. I used the medicines from January the 16th to February 6, when noticed that the shortness of breath improved and didn't required the dose for the night, then stopped the dose for the morning. Regarding the hotness sensation, is still present but the dysphony disappeared.
54 2021-02-11 burning sensation Itchy, burning, hot rash over chest, clavicles, and neck. Spreading slowly and have had for over a ... Read more
Itchy, burning, hot rash over chest, clavicles, and neck. Spreading slowly and have had for over a week.
54 2021-02-11 feeling cold Patient woke up at 3:00 AM freezing and sweating with a bad headache. Chills and sweating stopped by... Read more
Patient woke up at 3:00 AM freezing and sweating with a bad headache. Chills and sweating stopped by 7:00 AM but slept for a majority of the day due to headache persisting.
54 2021-02-12 feeling hot Patient received his first COVID-19 vaccine on 2/12/2021 at approximately 11:30am at clinic. He is a... Read more
Patient received his first COVID-19 vaccine on 2/12/2021 at approximately 11:30am at clinic. He is a resident there. He was initially monitored for 30 minutes without incident. Approximately an hour later (12:30pm) he returned complaining of sweating, feeling warm (no fever, normal blood pressure) and blurry vision. He was monitored for an additional 30mins (approximately 1pm). Symptoms did not resolve. The facilities manager called EMS and patient was taken to Hospital. No further information available at this time.
54 2021-02-13 weakness Broke out in hives approximately 1 hour 30 minutes after injection. Severe weakness, body aches, fev... Read more
Broke out in hives approximately 1 hour 30 minutes after injection. Severe weakness, body aches, fever, and fatigue began approximately 20 hours after injection
54 2021-02-16 numbness and pain in extremities vagus nerve neuropathy - began one month after vaccine; dysphagia; vocal cord partial paralysis
54 2021-02-26 difficulty speaking Tightness in throat/chest; difficulty breathing; hoarse voice.
54 2021-02-26 pain in extremity Significant pain and lack of mobility in left arm. Much more pain and limited mobility than is "regu... Read more
Significant pain and lack of mobility in left arm. Much more pain and limited mobility than is "regular" post vaccine. Note that the injection site seems very high relative to "standard."
54 2021-02-27 weakness, tremor Headache 24 hours after injections Overall tired and weak 48 hours after injection Tremor in left t... Read more
Headache 24 hours after injections Overall tired and weak 48 hours after injection Tremor in left thumb at 48 hours and continues currently at about 72 hours post
54 2021-03-01 feeling hot, sensory loss tunnel vision; warm sensation travel from the left shoulder area to my chest/upper stomach; eyes bur... Read more
tunnel vision; warm sensation travel from the left shoulder area to my chest/upper stomach; eyes burned; could taste something; heart rate became rapid at a steadily increase amount (113 bpm)/pulse stayed at 92-94 BPM for approximately two hours; felt dizzy; lost speed sensation in the car I was driving; This is a spontaneous report from a contactable consumer (patient himself). A 54-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6201), via an unknown route, on 12Feb2021 (at 12:45) at a single dose in the left arm for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included atrial fibrillation from Jun2020, ablation surgery for atrial fibrillation on unknown date, ongoing atrial tachycardia, and ongoing premature ventricular contractions (PVCs). Past drug history included allergy to penicillin. Relevant concomitant medications included vitamin NOS, mineral NOS (MEGA MEN) and amino acids NOS, carotenoids NOS, herbal NOS, hyaluronic acid, methylsulfonylmethane, minerals NOS, vitamins NOS (GNC MEGA MEN SPORT). Within approximately two minutes of receiving the shot, he felt a warm sensation travel from the left shoulder area to his chest/upper stomach, his eyes burned, he could taste something, and his heart rate became rapid at a steadily increase amount. He watched his heart rate tick up on her watch to approximately 113 BPM. His normal resting heart rate was upper 60s. He felt dizzy and out of it for about 30 minutes. He felt like he had tunnel vision and lost speed sensation in the car he was driving. His pulse stayed at 92-94 BPM for approximately two hours. He wasn't anxious about getting the shot and had actually been looking forward to it. The patient was not treated for the events. The patient had recovered from 'felt dizzy' on 12Feb2021 while the remaining events resolved in Feb2021.
54 2021-03-02 tingling Pfizer-BioNTech COVID-19 Vaccine EUA Tingling on Left side of body, in the area between the top of s... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Tingling on Left side of body, in the area between the top of shoulder to left side neck area. Tingling occurs 4 to 5 times daily. No pain to report or server discomfort. Reported to my primary physician
54 2021-03-03 bell's palsy Diagnosed with Bell's Palsy on 19Feb2021; This is a spontaneous report from a contactable healthcare... Read more
Diagnosed with Bell's Palsy on 19Feb2021; This is a spontaneous report from a contactable healthcare professional (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration at the right arm on 06Jan2021 at a single dose for COVID-19 immunization. The vaccine was administered to the patient at a hospital. The patient had no COVID prior to vaccination. The patient's medical history was not reported. Concomitant medication included lisinopril and metoprolol. The patient had no other vaccine in four weeks. The patient was diagnosed with Bell's Palsy on 19Feb2021 (start of event was reported as 19Feb2021 at 06:15 AM). The event resulted in doctor or other healthcare professional office/clinic visit. The patient had COVID test post vaccination which was a nasal swab with unknown results on an unspecified date in 2021. Therapeutic measures were taken as a result of event Bell's Palsy which included unspecified medication. The outcome of the event was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: The possibility that suspect drug may have contributed to the reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
54 2021-03-05 flushing, feeling hot Heart started to race, face flushed, sweaty forehead and palms, felt hot. lasted approx 1 min, and... Read more
Heart started to race, face flushed, sweaty forehead and palms, felt hot. lasted approx 1 min, and slowly went away after 5min or so.... I did not notify anyone.
54 2021-03-07 pain in extremity Severe burning pain from neck down to wrist on injection arm. Pain started on 3/5, about 16 hours a... Read more
Severe burning pain from neck down to wrist on injection arm. Pain started on 3/5, about 16 hours after injection and is ongoing as of today (3/08).
54 2021-03-08 feeling hot Couple of episodes of feeling like i was getting sick. lasting a hour or so. (run down, warm). Had ... Read more
Couple of episodes of feeling like i was getting sick. lasting a hour or so. (run down, warm). Had a rash brake out. Mainly on torso, some on other body areas. Have been on for 6 days now.
54 2021-03-10 tremor Severe stomach cramps; Severe diarrhea; He felt like he was running a fever; Chills; Sweats; Shakes;... Read more
Severe stomach cramps; Severe diarrhea; He felt like he was running a fever; Chills; Sweats; Shakes; This is a spontaneous report from a contactable consumer (Patient) from a Pfizer-sponsored program. A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982), intramuscular on 02Feb2021 at around 10:00 (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was not reported. The patient had a family history of dementia. Concomitant medications were not reported. The patient did not receive other vaccines within 4 weeks prior to vaccination. About 36 hours after getting the vaccination (unknown date Feb2021), the patient experienced severe stomach cramps, severe diarrhea, felt like he was running a fever, chills, sweats, and shakes. The clinical outcome of the stomach cramps, diarrhea, fever, chills, sweats and shakes was recovered on an unknown date in Feb2021 (symptoms lasted about 18-24 hours).
54 2021-03-14 pain in extremity sore arm with both shots; Caller stated that he had an antibody test on 05Feb2021 and the test was n... Read more
sore arm with both shots; Caller stated that he had an antibody test on 05Feb2021 and the test was negative.; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable physician (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 (first dose, lot number: EK5730) and 19Jan2021 14:00 (second dose, lot number: EL3248) both in left shoulder at 0.3 mL, single for prevention. The patient medical history was not reported. There were no concomitant medications. He had 2 doses of covid vaccine with no side effect. 15 days later, he had antibody test on 05Feb2021 and the test of IgM and IgG basically were negative. He had no antibodies to the coronavirus. So he was not sure whether or not he got a vaccine that was too old, not taken care of properly, but he had no immune response 15 days after the second dose he should have developed a response, developed antibodies. He was inquiring if that was effective and wanted to know if he should get another antibody test and take another dose of the Pfizer vaccine or get the Moderna vaccine. The patient stated seriousness as it was serious, it did not require hospitalization, he was not ill at least and had been self-isolating very well, but he was thinking long term, he was feeling well, had no problems, no complications related to the vaccine, other than a sore arm with both shots, that's it, it went smoothly, it was serious, he hoped to have some protection, but was concerned he had none. The patient had sore arm with both shots. The outcome of event antibody test negative was not recovered and event sore arm was unknown.; Sender's Comments: It was noted that patient had antibody test and the test of IgM and IgG basically were negative. He had no antibodies to the coronavirus. 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.
54 2021-03-16 tingling Ten minutes after receiving his vaccination, he developed lightheadedness, vision changes (? vision... Read more
Ten minutes after receiving his vaccination, he developed lightheadedness, vision changes (? vision became cloudy?) , paresthesias in bilateral upper extremities. He was able to sit back down. No falls or trauma to his head or any part of his body. He was placed on a stretcher to a private section of the arena and monitored. Initially, his blood pressure was 103/69, and interval blood pressure 20 minutes later was 139/73. He was given water to drink, which he tolerated. He reports that he has similar reactions to needles in the past, but the current presentation is longer than usual (symptoms usually resolve in five minutes). He was able to recover from the symptoms after 25 minutes of monitoring.
54 2021-03-17 night sweats 36 hours after the vaccine, I don't know if it was the vaccine or what, but I had BODY PAIN CHILLS A... Read more
36 hours after the vaccine, I don't know if it was the vaccine or what, but I had BODY PAIN CHILLS AND FEVER OF 99.08 FOR A DAY OF FEVER. FROM MARCH 15 TO MARCH 16. AND FOR THREE NIGHTS IN A ROW I AM SWEATING A LOT OF WET MY T-SHIRTS AFTER SLEEPING 2 OR 3 HOURS I CHANGE THEM FROM 3 TO 4 TIMES AT NIGHT, IT IS ONLY AT NIGHT NOT IN THE DAY, I NEVER SLEEP IN THE DAY. I'M CONCERNED BECAUSE I HAVE AN APPOINTMENT FOR 03/04/2021
54 2021-03-18 cold sweat Received Vaccination @1030Am. PT felt faint and Clammy, 1037AM. Staff lied PT down. Pt was transf... Read more
Received Vaccination @1030Am. PT felt faint and Clammy, 1037AM. Staff lied PT down. Pt was transferred to wheelchair, given water. PT began to feel better. Left @ 1105AM.
54 2021-03-18 flushing Flushing erythematous macular rash over neck and upper torso, pt felt warm and flushed No treatment... Read more
Flushing erythematous macular rash over neck and upper torso, pt felt warm and flushed No treatment, 30min observation Rash was not improved or worsening after 30 min, pt was released with ER precaution
54 2021-03-18 pain in extremity Sore arm; headache; This is a spontaneous report from a contactable consumer (the patient). A 54-yea... Read more
Sore arm; headache; This is a spontaneous report from a contactable consumer (the patient). A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6200), via an unspecified route of administration in the left arm on 17Feb2021 15:30 (at the age of 54-years-old), as a single dose for COVID-19 immunization. The patient's medical history included: hypertension and high cholesterol. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications. The patient previously had allergies to topical iodine- produces rash. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Feb2021 16:00, the patient experienced sore arm and headache. No treatment was received for the events. The clinical outcome of sore arm and headache was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
54 2021-03-18 pain in extremity BODYACHES, ARM SORENESS, CHILLS
54 2021-03-19 tenderness Very soon after I left the parking lot after waiting 15 min for observation ( i was literally 15 sec... Read more
Very soon after I left the parking lot after waiting 15 min for observation ( i was literally 15 sec after ) I started to feel an slight painful tingling in the corner of my mouth on my lips I thought it was like a chapped lip it progressed to my full set of lips and it was tingling and slight painful to touch maybe slight swollen but not a lot I then started to clear my throat and felt like my mouth was very dry like a lump in the back of my throat i was slightly having little difficulty in feeling could not catch my breath and considered going to the closest hospital i was getting a little worried so that may have been the cause of resp issue It started to improve and i drove home and in about 10 to 15 mins all the symptoms were gone and i am symptom free now about 24 hours later
54 2021-03-21 numbness, sensory loss, weakness 3 days after receiving vaccine #1 I experienced: - Dizziness - Very unbalanced when trying to stand... Read more
3 days after receiving vaccine #1 I experienced: - Dizziness - Very unbalanced when trying to stand or walk - Right side extremities hand, arm, leg, foot were numb with loss of sensitivity and strength
54 2021-03-22 weakness It feels like I burnt my tongue. Because of that nothing tastes the same Still going on 3/23/21 1... Read more
It feels like I burnt my tongue. Because of that nothing tastes the same Still going on 3/23/21 10:54 AM Low fever 99.9 for a couple of days Headache, on going 3/23/21 10:54 AM Little dizzy and weak on going 3/23/21 10:54 AM Nothing horrible just uncomfortable
54 2021-03-22 muscle spasms, weakness chills, fatigue, weakness, diarrhea cramping swollen glands
54 2021-03-23 unresponsive to stimuli, pain in extremity Within minutes of patient receiving vaccine, patient began to feel lightheaded and skin color began ... Read more
Within minutes of patient receiving vaccine, patient began to feel lightheaded and skin color began to turn white. Patient parked by EMS in observation parking and became unresponsive. EMS began vital signs and tried to get him to wake up. Patient stayed unresponsive and vital signs continued to decline. EMS transported patient to hospital. Upon arrival to hospital, staff conducted EKG, chest x-ray, and blood work. All tests came back normal. Patient began to become coherent, and staff began to try and feed him and get him up. After patient was able to get self up and eat food, he was sent home. Patient is now at home recovering. He states he only feels a sore arm and is fatigued.
54 2021-03-24 feeling hot Pt c/o lip swelling and feeling warm, Ice pack given, and Benadryl 50 mg Orally given, Pt sent home
54 2021-03-25 inability to speak headache, nausea, vomiting 15 minutes after vaccine. Trouble speaking/remembering -- EMS transfer
54 2021-03-26 burning sensation Starting the following day after the vaccine a rash appeared on the whole body, arms legs feet. Rash... Read more
Starting the following day after the vaccine a rash appeared on the whole body, arms legs feet. Rash was treated with some medication throat started swelling, mild headache and burning sensation all over body.
54 2021-03-27 cold sweat, inability to speak Woke up with vertigo, nausea and cold sweats. Could not speak for about 10 minutes. Crawled to bath... Read more
Woke up with vertigo, nausea and cold sweats. Could not speak for about 10 minutes. Crawled to bathroom on stomach and vomited. After laying on floor, was able to speak and crawled back to bed. Vomited one more time around 10 am. Was in bed until 4:00 pm. Symptoms subsided by then, but I did not feel well until the next morning. The vertigo and nausea were the most severe I have ever had. At no point was I running a fever..
54 2021-03-29 weakness Adverse events experienced and are they still occurring now: Had chills, aches, fever of 101 and a ... Read more
Adverse events experienced and are they still occurring now: Had chills, aches, fever of 101 and a cough. She is still feeling weak and has a cough What happened as a result of the adverse event? (doctor visit, ED or urgent care visit, hospitalization, life threatening illness, disability/permanent damage, death, none of these): Home management and has been taking Tylenol once or twice a day
54 2021-03-29 tingling Pins and needles pain everywhere, even my eyelids
54 2021-03-29 tremor Pain on the side of the injection, chills, difficulty breathing, palpitations and severe dizziness a... Read more
Pain on the side of the injection, chills, difficulty breathing, palpitations and severe dizziness almost like fainting. Tremors in the hands and arms, these lasted approximately one hour and thirty minutes.
54 2021-03-31 muscle spasms received dose one of vaccine on Sunday around 6pm. On Monday evening I started to have some lower b... Read more
received dose one of vaccine on Sunday around 6pm. On Monday evening I started to have some lower bowel or intestine pain. It got worse through the night and had bad cramping in morning. I tried going BM and could not. After getting up and moving around a bit I was able to have a solid stool, but it did hurt a little. It also hurt when I went to urinate. Later that day I had 99 to 100 fever. For the next 2 days I was better but I did have some lower abdominal pain and tenderness.
54 2021-03-31 pain in extremity Sore arm, nighttime chills during sleep, headache, fever (99.7). Sore arm started 3 hours after sho... Read more
Sore arm, nighttime chills during sleep, headache, fever (99.7). Sore arm started 3 hours after shot and the others about 15 hours after shot.
54 2021-04-01 flushing Hypertensive Crisis, chest pain, facial flushing which is still occuring. Went to ER at 12:15 am on ... Read more
Hypertensive Crisis, chest pain, facial flushing which is still occuring. Went to ER at 12:15 am on 3/17/2021. Treated with Labetatol.
54 2021-04-01 pain in extremity, weakness Within approximately a couple of days from the first of two COVID19 Pfizer injections, I developed a... Read more
Within approximately a couple of days from the first of two COVID19 Pfizer injections, I developed a progressive, systemic, neuro/neuro-muscular inflammatory pain response. The inflammation and pain first manifested in my left wrist and hand, greatly worsening recent symptomology that may have been the start of a carpal tunnel syndrome. The inflammation and pain then progressed to my right wrist and hand and right shoulder. Then they progressed to my left shoulder, under my clavicles, my hips, and my upper lumbar/lower thoracic region of my spine. Muscle groups tightened and hurt, chief among them my hamstrings and upper back. All within days. The inflammation and pain were severe, especially from the early a.m. (3 or 4 in the a.m.) to waking hours. And the conditions left me nearly debilitated and incapable of sleeping well or performing many ADLs. Then, on Monday, March 29, 2021, I saw an orthopaedic for the pains in my wrists and hands, and he prescribed me a steroid for a preliminary diagnose of bilateral carpal tunnel. The inflammation and pain throughout my body decreased considerably after only two doses of the steroids. That led me to seek a consultation with the rheumatologist.
54 2021-04-03 numbness During early morning hours I awoke with pain and swelling at injection site, and hand and fingers we... Read more
During early morning hours I awoke with pain and swelling at injection site, and hand and fingers were numb util effectively exercised a few minutes. Shortly thereafter, I developed a sever headache along with fever, chills and lethargy. Sever body aches followed with joint pain throughout entire body. All symptoms lasted 24-36 hours. 48 hours later, still feeling stiff with aching back muscles and feeling tired. Large underarm lumps have developed 72 hours after injection. All of the aforementioned occurred after the second injection.
54 2021-04-04 bell's palsy Bell's Palsy (House-Brackmann grade IV) developed on 4/4/21, 17 days after administration of the fir... Read more
Bell's Palsy (House-Brackmann grade IV) developed on 4/4/21, 17 days after administration of the first Pfizer Covid=19 dose. Pt was started the next day (today) on prednisone and valacyclovir.
54 2021-04-04 pain in extremity I woke the morning after not feeling the best. About 10:00 am or so, I started getting achy all over... Read more
I woke the morning after not feeling the best. About 10:00 am or so, I started getting achy all over my back and shoulders. It got worse over next few hours and stayed with me all evening. Had a headache as well. The next morning I was 80% better and by the next morning I was fine. The pharmacist told me that most people only get sore arm and sometimes can hardly lift the arm. I had sore arm but nothing I couldn't deal with. He also said that second shot tends to make people sick. I guess I wanna be certain I should get second vaccine?! I tested positive for covid on 12/20/20 and negative on 1/8/21.
54 2021-04-04 tingling Recv'd first shot 4/3/21, was fine 4/4/21. Early in AM of 4/5/21 I had muscle aches, stomach crampin... Read more
Recv'd first shot 4/3/21, was fine 4/4/21. Early in AM of 4/5/21 I had muscle aches, stomach cramping, and chills. At 1 point I stopped working because I felt tingly, and started to sweat (only happened once). I'm feeling tired, like I have the flu.
54 2021-04-05 weakness Hives/rash on the whole body Fever on second day with headache and weakness
54 2021-04-05 tingling After receiving his vaccine, client stated he have headache, tingling sensation in L side of his fac... Read more
After receiving his vaccine, client stated he have headache, tingling sensation in L side of his face. No vital signs obtained by EMS. Client refuse vital signs as per EMT. Client states he is feeling better. Client discharge home.
54 2021-04-06 hot flush After 1st covid injection, Pt states felt shaken. Went to ER. Had hot & cold flashes, arm pain. Bega... Read more
After 1st covid injection, Pt states felt shaken. Went to ER. Had hot & cold flashes, arm pain. Began to feel better after waiting in ER. Saw Dr . Vitals ok and pt released home. Pt states ok now just tingling in hands.
54 2021-04-06 numbness, pain in extremity Extreme flair up of joint pain. Worst in one hip/leg on the level of pain of a kidney stone. Could n... Read more
Extreme flair up of joint pain. Worst in one hip/leg on the level of pain of a kidney stone. Could not walk without extreme pain or go down set of stairs. Has improved some but now also experiencing moderate pain in other leg and feet are numb
54 2021-04-06 pain in extremity Full body aches, arm pain, 100F fever, neck and headache and sinus pressure. All subsided after 16 ... Read more
Full body aches, arm pain, 100F fever, neck and headache and sinus pressure. All subsided after 16 hrs from onset.
54 2021-04-07 tremor Became cold and then violent shaking that lasted 2 1/2 hours
54 2021-04-08 weakness Headache; Body aches; Light headed; Loss of energy; This is a spontaneous report from a contactable ... Read more
Headache; Body aches; Light headed; Loss of energy; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient reported for himself that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Pfizer er8730, Expiration date: unknown) via an unspecified route of administration on 22Mar2021 at 13:00 on left arm at single dose for COVID-19 Immunization. Medical history included Chrones. The concomitant medication was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021 16:00 (24-hour clock), patient experienced headache, body aches, Lightheaded and Loss of energy. The patient did not receive any treatment for the events. The reporter assessed the event as non-serious. The events were not recovered. No follow-up attempts are possible. No further information is expected.
54 2021-04-08 electric shock sensation Dizziness, "brain zaps", body aches, lethargy.
54 2021-04-08 flushing Pt. Noticed rash on antecubital area of both arms - worse on Left (vaccine side) then he felt flushe... Read more
Pt. Noticed rash on antecubital area of both arms - worse on Left (vaccine side) then he felt flushes, his face turned slightly pink. Code called. Paramedics arrived. Waited extra 15 mins & walked out with no issues.
54 2021-04-08 pain in extremity, numbness Pt is reporting of arm pain and after stating that symptom is common pt reported having some numbnes... Read more
Pt is reporting of arm pain and after stating that symptom is common pt reported having some numbness in leg. Informed patient to contact their healthcare provider for exam
54 2021-04-09 pain in extremity Within an hour started feeling weird. over the course of the next 36 hours, my reaction to the vacc... Read more
Within an hour started feeling weird. over the course of the next 36 hours, my reaction to the vaccine is awful. Worse than my covid. At least I know my body is doing what it is supposed to be doing. But it is just miserable. Massive headache, soreness, weird shooting pains in my leg, sweats and chills and nausea, and now the racing heart and shortness of breath.
54 2021-04-13 tingling Nausea, diarrhea, fatigue, tingling in hands and arms. Lasted 4-5 days. Caused to miss work. Conta... Read more
Nausea, diarrhea, fatigue, tingling in hands and arms. Lasted 4-5 days. Caused to miss work. Contacted PCP but did not go in for visit.
54 2021-04-13 tremor Roughly six (6) hours after I received my second dose I became extremely agitated and angered what I... Read more
Roughly six (6) hours after I received my second dose I became extremely agitated and angered what I would call a homicidal rage that lasted for about an hour which then morphed into a visual hallucinations those lasted for about an hour and those turned into racing heart with heart palpitations and bilateral involuntary hand movements tremors
54 2021-04-14 weakness Fever of 102-105, headache, coughing, weaknesss
54 2021-04-15 inability to speak 14 hours after vaccination patient experienced signs and symptoms of a stroke: aphasia, left arm wea... Read more
14 hours after vaccination patient experienced signs and symptoms of a stroke: aphasia, left arm weakness, clumsy, could not text. Called 911
54 2021-04-15 weakness first evening very painful shoulder -- at point of injectcion. next morning: ZERO mobillity in my s... Read more
first evening very painful shoulder -- at point of injectcion. next morning: ZERO mobillity in my shoulder and could not move left arm. now, six days later: shoulder is still hurting and mobility is limiited in my left arm to 40 degrees of movement. but painful. and very very weak. the injection seemed to be very high on my shoulder/muscle area compared to first shot. first shot had no or limited shoulder pain. this time, I am in quite a bit of shoulder pain and again, have very very liimited arm movement. it is like a partial tear of my rotator cuff, which I had in the other shoulder a few years ago. very weak shoulder, very limited abilitiy to move my arm.
54 2021-04-15 numbness, weakness Pt. stated "I started feeling numbness on my face and weakness 10 minutes after getting vaccinated."... Read more
Pt. stated "I started feeling numbness on my face and weakness 10 minutes after getting vaccinated." Vital signs taken BP 100/70, HR 76, O2Sat 99%, R 18. At 12:37pm pt. is still having numbness of face. EKG was done. Normal sinus rhythm. At 12:50pm pt. stated he wants to go to the hospital. At 12:52pm pt. was transported to healthcare facility.
54 2021-04-15 muscle spasms, tremor Chills, shake, fever, headache. Shaking stopped by 6 AM. Fever was low stopped by 8 AM. Took Advil o... Read more
Chills, shake, fever, headache. Shaking stopped by 6 AM. Fever was low stopped by 8 AM. Took Advil once. Constipation 48 hours. Cramps on day 2. Headache continues after 48 hours. Shortness of breath on day 2. Advil taken morning of day 2. Dizziness at times.
54 2021-04-17 bell's palsy Right Sided Bell's Palsy; This is a spontaneous report from a contactable Other-HCP reporting for a ... Read more
Right Sided Bell's Palsy; This is a spontaneous report from a contactable Other-HCP reporting for a patient. A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 05Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Stargardt's Disease, Prediabetes, Low Testosterone, Chronic neck pain, and covid-19. Concomitant medication included testosterone (AXIRON). No other vaccine received in four weeks. The patient experienced right sided bell's palsy on 07Apr2021 06:00. The event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of right sided bell's palsy included Prednisone. Outcome of the event was not recovered. No Covid tested post vaccination. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported Bell's palsy cannot be excluded based on a 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.
54 2021-04-17 numbness Numbness in feet beginning 23 hours after 2nd vaccination. Toes white in color similar to what reyna... Read more
Numbness in feet beginning 23 hours after 2nd vaccination. Toes white in color similar to what reynauds syndrome looks like. Massaging to see if that helps, but it's been about an hour with no change. Heart rate and forehead temp normal. No other significant symptoms.
54 2021-04-17 pain in extremity, feeling of body temperature change This is a spontaneous report received from a contactable consumer (patient). A 54-year-old male pati... Read more
This is a spontaneous report received from a contactable consumer (patient). A 54-year-old male patient (height: 193cm, weight: 99.79kg) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN6207) via an unspecified route of administration at right upper arm on 18Mar2021 18:00 (54-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included blood pressure, teeth cleaned (Shortly before the shot, went to the dentist to have teeth cleaned. Directly from Dentist went to pharmacy. Went to pharmacy's Drive Thru to pick up a little antibiotic from the dentist. It was 4 capsules of Amoxicillin. He was supposed to take the Amoxicillin before the dentist office visit, but he forgot to do that. Therefore, soon as he left the dentist office he went to pharmacy to pick it up so he could take it. While he was there, was offered the COVID 19 vaccine and that it was the last shot). Concomitant medications included atenolol tablet from 2016 (been taking for 5 years) and ongoing for blood pressure, and ascorbic acid/ cyanocobalamin/ ergocalciferol/ nicotinamide/ pyridoxine hydrochloride/ retinol/ riboflavin/ thiamine mononitrate (ONE-A-DAY). No additional vaccines administered on same date. No history of all previously immunizations. No prior vaccincations wtihin 4 weeks. He got the shot Thursday and by Sunday, many different side effects were coming in. He has had side effects from the COVID VACCINE, but initially he does not want to file report, just thinks that everyone needs to get the shot. He does not have complaints. He is wondering how long the side effects will last, and when they go away. States that he is being treated as he has gone to the doctor's. Also states that he made an appointment with the doctor and almost went to the emergency room a couple of times. Right after the shot, he was getting in the car and his right leg started hurting (on 18Mar2021). It didn't go away for a couple of days. It went away but then noticed his shoes started feeling funny. He wasn't looking at his feet, put his shoes on they felt tight. Then he started to look at feet more. Below his knees, his legs are swollen. Swelling started within 2 to 3 days after the vaccine. The swelling is really severe when standing. Everybody at work has seen how sick he is and his legs. Swelling in the legs has him concerned, thinking maybe it's a blood clot. He was given medicine and would like to see it go away. He keeps his legs up. He has other side effects (all in Mar2021) and is having flu like symptoms. He basically has the flu. He has never had the flu shot. This is the first flu shot (He referred to the COVID vaccine as the flu shot as documented. However, confirmed suspect product as Pfizer covid vaccine) he has had that he knows of. He is questioning if he should get the second shot. He feels a little dizzy. Quick questions get him confused and that it comes and goes. Lungs felt full, gasping for air: not now but, since the doctor gave him antibiotics (unspecified injections, he was given 2 shots at the doctor's office, one in each arm), his lungs felt full. At times he was gasping for air. It went away but thought he was going to die. Now when he gets winded, it feels like he has a dry cough. Gets winded easily. The doctor ordered him an inhaler, Symbicort, but it was very expensive, so he did not get it at that time. He never picked it up because it was too much money. The fluid is not there anymore and he does not feel like he needs this as does not feel like it needs to be cleared. He is having wheezing. He can now take deeper breaths. Fatigue: initially, that he was feeling tired within 1 or 2 days, but he did not recall the next day feeling that way (later stated it was within 2-3 days he started to feel tired). He is still tired. Unable to clarify time frame of fatigue further. He feels bloated and full. Hasn't really eaten but feels real full and bloated. Hot and cold flashes started occurring about the same time as the other symptoms. He had these last evening. He does not get the flu very often and doesn't take the Flu shot. This is the closest thing he can remember having a pretty good episode with the flu. He was also given prescriptions for 2 new medications: Triamterene 37.5mg daily, for leg swelling; Clindamycin, 300mg, twice a day, an antibiotic. The odd thing is that it seems like his eyes are big, like really, really big, like they are really open. It is like big eye balls. States that he is just sick and his body is reacting to getting better. He has not been to work in the last 3 days. States that he is fine, just worried about work. Patient asked for personal advice about going back to work. The outcome of "his right leg started hurting" was recovered; outcome of "below his knees, his legs are swollen/ swelling in the legs/ put his shoes on they felt tight" and Fatigue/feeling tired was not recovered; outcome of other events was unknown.
54 2021-04-17 pain in extremity Muscular and joint pain in the knees, hands, and lower back.
54 2021-04-18 night sweats, numbness and pain in extremities chills, night sweats, chest pain, body aches, nausea, anorexia, back pain now, 16 lb weight loss, co... Read more
chills, night sweats, chest pain, body aches, nausea, anorexia, back pain now, 16 lb weight loss, cough when sitting up and moving, peripheral neuropathy, - chest pain resolved but other issues are persistently bad, adv some of the initial symptoms could have been related to the shot, such as initial body aches and chills, but persistent and worsening issues are NOT expected this far out. I adv HCF eval given likely unrelated persistent symptoms, consider ED if effects are severe and worsening. He will likely go in tonight but he isn't sure where he will go. I adv try not to drive yourself call back if issues. PCC will FU tomorrow with patient at home. 4/11-Patient positive for Covid per MD at hospital Follow up call - Patient feeling better today, went to ED at hospital , was prescribed Flexeril, Ibuprofen and ondestron. Second vaccination is next week.
54 2021-04-18 night sweats Persistent Increased heart 110-114bpm started 8-10 hours after the injection and continued roughly 3... Read more
Persistent Increased heart 110-114bpm started 8-10 hours after the injection and continued roughly 30-36 hours. My heart rate while sleeping was over 95+ bpm and 110-114bpm while awake In addition, I had severe joint aches, fatigue, night sweats, fever for 48-72 hours.
54 2021-04-18 pain in extremity About a week after my first shot i experienced the start of a rash on my lower back.Did not think mu... Read more
About a week after my first shot i experienced the start of a rash on my lower back.Did not think much of it at the time,assumed contact dermatitis. Rash started to spread slowly,used hydrocortosone daily as needed.Contacted my PCP on 4/09 virtually and he told me to keep an eye on it.After my 2nd shot I experienced the usual fatigue and arm.pain but my rash got worse.,Contacted local urgent care provider on 4/18/2021 @11:25 AM.My provider was Doctor. By this time my rash was all over my back and had travelled to my front.After full mock up she diagnosed me with a pityriays-rosea condition .She prescribed me kenalog 0.1% predisone cream and Benadryl for itching.
54 2021-04-20 burning sensation Patient presented to the vaccination observation area at 11:35. At 11:50 patient stated his tongue w... Read more
Patient presented to the vaccination observation area at 11:35. At 11:50 patient stated his tongue was numbness and whole body feeling burning and itches. No rash noted on the skin. He requested Diphenhydramine, he refused the Epi-pen and PO 50mg Diphenhydramine was administered. Site Lead came over speak with patient. Site Lead spent 20 minutes educating and encouraging patient to take Epi-pen and the need to call 911 ambulance due to his symptoms. Pt refused the Epi pen and calling 911 and stated that his condition is not getting worse. VS is BP 170/100, P 62, RR 20, O2 99% Pt stated that his BP 170/100 is his baseline on BP medications. Pt agreed to stay in observation for longer. At 12:50pm, pt stated that his tongue numbness is getting better only the back of tongue feeling numbness and the whole body feeling burning resolved, only the hands and back of ankles are itches. VS has not changed BP 170/100, O2 98%, RR 22, P 61. At 1:15pm, pt stated that hands itches resolved, back ankles itches are still itches. Only R side of back of the tongue still numbness.L side tongue numbness resolved. VS BP 170/100, RR 22, O2 100%, P 61. At 1:30pm, pt stated that L side back ankle itches resolved, only R side of back ankle still a little itches. R side tongue still numbness but less than 15min. VS BP 170/100, RR 20, P 61, O2 98%. At 1:30pm, pt left observation area. Advised pt to take public transportation to go back to work or home instead of self drive due to pt had Diphenhydramine 50mg, pt stated that he will consider the options of public transportation. Pt instructed s/sx when to reach out to PCP or ED.
54 2021-04-20 sensory loss Suspected Guillain Barre Syndrome. With bowel incontinence, urinary retention, motor and sensory we... Read more
Suspected Guillain Barre Syndrome. With bowel incontinence, urinary retention, motor and sensory weakness. Seems to all be involving S1-S5 nerves only. Had some mild foot drop on 3/25/2021 but then developed severe symptoms starting 4/15/2021 with rapid progression leading to hospitalization on 4/17
54 2021-04-20 tenderness, burning sensation, discomfort, tingling The pain that is felt is like many needle punctures on primarily the right lung, but has been felt o... Read more
The pain that is felt is like many needle punctures on primarily the right lung, but has been felt on the left lung at times. The pain is not constant but rather at random times throughout the day. This sudden, sharp, needle-like pain was felt mostly on the following dates: Tuesday, 04/13/2021 (both lungs felt pain twice early in the morning around 1:00 AM and a few more times in the afternoon), Sunday, 04/18/2021 (pain felt twice only on right lung around 2:00 PM), Monday, 04/19/2021 (pain felt on right lung around 10:00 AM and again around 4:00 PM), and on Tuesday, 04/20/2021 (pain felt on right lung around 1:30 PM). Since Monday, 04/19/2021, a constant feeling of discomfort, tenderness, and slight burning has been felt on the right lung.
54 2021-04-21 pain in extremity Joint swelling in hands three days after shot. Joint swelling and pain in big toe of right foot.
54 2021-04-21 tingling 11:39 am stated he was feeling sleepy , Vital sign were done 11:50 patient stated that his tongue f... Read more
11:39 am stated he was feeling sleepy , Vital sign were done 11:50 patient stated that his tongue felt different , experiencing nausea , clear emesis , Per Dr order , I gave patient benadryl 25 mg po. patient was alert . patient was left for further evaluation . 12:45 pm the patient began to complain about tightness off and on , nausea , emesis continue , whole body felt tingly. 12:47pm per Dr order , i administer the Epi Pen was administer . 911 was called . paramedics was transport to hospital .
54 2021-04-23 pain in extremity, tingling, nerve injury My arm in not longer sore from the injection , However I continue to have a tingling from the inject... Read more
My arm in not longer sore from the injection , However I continue to have a tingling from the injection spot down my left arm into my fingers . It feels like a nerve problem in my arm. It has been over a month and the problem has not gone away
54 2021-04-23 pain in extremity Flu-like symptoms, fever of 99.6, chills, nausea, headache, arm pain, for about 24 hours. Took Tyle... Read more
Flu-like symptoms, fever of 99.6, chills, nausea, headache, arm pain, for about 24 hours. Took Tylenol and Ibuprofen cold and sinus
54 2021-04-26 numbness, migraine, pain in extremity, cold extremities soreness in arm and elbow within 30 minutes, soreness and sharp pain on the whole upper body after 2... Read more
soreness in arm and elbow within 30 minutes, soreness and sharp pain on the whole upper body after 2hrs. severe pain in all joints and never seen before crippling arthritis within 4 days. numbness in my hands, severe neck, back, elbow and wrist joint pain. sores and infections all over my legs after 5 days. migraines. blood pressure and severe glucose spikes without substantial change in diet. now no feeling in hands other than ice-cold fingers that never warm and constant pain.
54 2021-04-26 pain in extremity Pain in arm - no longer occurring 3 days after pain in left side of testicle, pain is getting worse... Read more
Pain in arm - no longer occurring 3 days after pain in left side of testicle, pain is getting worse - still occurring Per poison specialist - Unknown if it is due to vaccine or not because it is not a usual/listed side-effect of the vaccine. Needs to get checked by PCP to run tests such as an ultrasound to check for any abnormalities and rule that out.
54 2021-04-27 muscle spasms continuous spasming across middle back to left kidney area, groin area, random spasming in abdomen a... Read more
continuous spasming across middle back to left kidney area, groin area, random spasming in abdomen area, lower chest; no treatment as of yet
54 2021-04-27 tingling, burning sensation I have symptoms of paresthesia. first dose was very mild (only pricking sensations for a few hours t... Read more
I have symptoms of paresthesia. first dose was very mild (only pricking sensations for a few hours the first day and limited to my extremities). Second dose the symptoms are pricking and burning sensations that are more intense and are quite frequent. They also happen almost everywhere on my body and are random in nature. Pfizer 2nd dose is lot # ER8729 given to me on April 15.
54 2021-04-27 unresponsive to stimuli Patient received the vaccine then reported to the observation area. After a few minutes in the obser... Read more
Patient received the vaccine then reported to the observation area. After a few minutes in the observation area the patient stated he was light headed and dizzy and might pass out. A few moments later the patient passed out. He passed out from his chair to the floor where he was assessed by pharmacists and a nurse. He was sweating and was coming in and out of responsiveness. Patient never stopped breathing. 911 was called and patient was taken away by EMS. Patient was still in and out of responsiveness when EMS arrived.
54 2021-04-28 discomfort I started feeling drugged about 2 hours after the shot. I then experienced extreme fatigue and felt ... Read more
I started feeling drugged about 2 hours after the shot. I then experienced extreme fatigue and felt unwell / sick for 6 days. My joints were extremely sore in my back, ankles and wrists. My body felt heavy and it was hard to stand and walk. It felt as if I was losing circulation in my feet. By 5PM each day I was in bed passing out for about 2 hours each day. Most of each day on couch sick. On day 5, I broke out in hives on my face. All symptoms began to clear on day 7. I was almost feeling normal Apr 28. Today, Apr 29 I feel OK.
54 2021-04-28 tingling Visual Snow Syndrome. Event started around 10pm last night. Lasted until 2:00am this morning. Also h... Read more
Visual Snow Syndrome. Event started around 10pm last night. Lasted until 2:00am this morning. Also had other symptoms such as "visual trailing" associated with Visual Snow Syndrome. I had previously reported Paresthesia as another side effect of Pfizer.
54 2021-04-30 bell's palsy, facial paralysis woke up in the morning to a droopy lip and the right side of my face didn't function properly. Went... Read more
woke up in the morning to a droopy lip and the right side of my face didn't function properly. Went to the hospital and was told i have Bell's Palsy. Was given anti viral meds and steroids.
54 2021-05-02 numbness, bell's palsy COVID 19 Pfizer vaccine dose#1 given 3/24/2021. COVID 19 Pfizer vaccine dose#2 given 4/16/2021. Deve... Read more
COVID 19 Pfizer vaccine dose#1 given 3/24/2021. COVID 19 Pfizer vaccine dose#2 given 4/16/2021. Developed puffiness and numbness on R side of face 4/29/2021. Evaluated on 5/2/2021 and diagnosed with Bell's Palsy. Will complete a four day course of steroid treatment.
54 2021-05-02 limb paralysis After 2nd. Vaccine my symptoms were fever, chills, body aches, headache, loss of right side arm and ... Read more
After 2nd. Vaccine my symptoms were fever, chills, body aches, headache, loss of right side arm and leg I?m a high risk and had previous stroke with minor paralysis on right side after shot loss of right side for 1 day slowly coming back
54 2021-05-03 cold sweat, weakness No effects for first 4 days. The evening of May 3rd around 7PM PDT I was stuck with severe nausea/ve... Read more
No effects for first 4 days. The evening of May 3rd around 7PM PDT I was stuck with severe nausea/vertigo. This lasted for several hours. Also experienced weakness for duration, cold sweat for first half hour. For first couple of hours any movement caused extreme nausea/vertigo, gradually fading. (my insomnia was not effected!). As I type this, May 4th at 742 AM I feel tired, very slightly nauseous. No other symptoms noted at this time.
54 2021-05-03 pain in extremity Received first dose on 1/4/21 and second dose on 1/25/21. 4/28/21 reported having leg pain and was ... Read more
Received first dose on 1/4/21 and second dose on 1/25/21. 4/28/21 reported having leg pain and was seen by primary care where it was determined he had a blood clot and was placed on blood thinners.
54 2021-05-03 pain in extremity Leukocytes in urine; urinating blood; Dark colored urine; couldn't sleep; anxiety; sweat; arm pain; ... Read more
Leukocytes in urine; urinating blood; Dark colored urine; couldn't sleep; anxiety; sweat; arm pain; lightheaded; Abdominal Discomfort; prostate infections; This is a spontaneous report from a contactable consumer reporting for himself. A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 24Mar2021 at 14:30 (at the age of 54 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included benign prostatic hyperplasia (BPH) and cholesterol. The patient was diagnosed with BPH a few years back 2016 or 2017 and had a uralist in 2019 and that resolved his issues. The patient had been on no BPH meds and back to normal since that procedure. Co-suspect medication included atorvastatin (LIPITOR) from an unknown date to 01Apr2021 at 40 mg, 1x/day for blood cholesterol. On an unspecified date in Mar2021, the patient experienced prostate infections, and abdominal discomfort. On 25Mar2021, the patient experienced arm pain, and was lightheaded. He described the arm pain as he had deltoid pain but he also had pain like he had been hit from his right pectoral down his arm to about 4-5 inches above his wrist. On 31Mar2021, the patient experienced couldn't sleep, anxiety, sweat, urinating blood, and dark colored urine. The patient was concerned with the dark urine so he stopped taking atorvastatin, and called his physician who said he didn't need it anyhow. The patient visited the urologist office and was prescribed ciprofloxacin (CIPRO) as treatment for dark colored urine, urinating blood and prostate infection. On 06Apr2021, the patient experienced leukocytes in urine. Relevant lab data on 06Apr2021 included a urinalysis which resulted in leukocytes and blood +3. The action taken in response to the event dark urine with atorvastatin was permanently withdrawn. The outcome of the events prostate infection, and abdominal discomfort was recovered on an unspecified date in 2021. The outcome of the events arm pain, and lightheaded was recovered in 26Mar2021. The outcome of the events couldn't sleep, anxiety, and sweat was recovered on 01Apr2021. The outcome of the events urinating blood and dark colored urine was recovered on 06Apr2021. The outcome of the event leukocytes in urine was unknown.; Sender's Comments: Based on the current available information, the serious events Prostate infection, Blood in urine, and Urine color abnormal are most likely related to an intercurrent or underlying condition which is not related to the suspected drugs. Relevant medical history of benign prostatic hyperplasia (BPH) may provide a plausible explanation for the events. 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) : US-PFIZER INC-2021450744 same patient/SD, different AE/dose
54 2021-05-04 weakness, muscle spasms Sudden onset of intense muscle spasms in back, down the legs to the knees. Intense pain for 3 days.... Read more
Sudden onset of intense muscle spasms in back, down the legs to the knees. Intense pain for 3 days. Moderate pain for 5 days. Ongoing soreness and weakness in back continues even after second shot. The doctor recommended taking the second shot, but prescribed muscle relaxants. Unsure of permanent damage.
54 2021-05-04 numbness, weakness 24 Hours after 2nd vaccination came down with fever of 103, shaking chills, and weakness all over. S... Read more
24 Hours after 2nd vaccination came down with fever of 103, shaking chills, and weakness all over. Slept 6 hours and symptoms subsided. 2 days after started having severe numbness in hands and feet. a few days later started having weakness in arms and legs, progressed over next week to the point I was unable to walk. Began steroid infusions on Mon 26 Apr. Admitted to hospital Wed 28 May for assessment and treatment. Released home on 30 Apr and returned 1 May for outpatient steroid.
54 2021-05-04 pain in extremity fever of 99.0; Pain at injections site; fatigue; arm pain; This is a spontaneous report from a non-c... Read more
fever of 99.0; Pain at injections site; fatigue; arm pain; This is a spontaneous report from a non-contactable consumer (Patient). A 54-years-old male patient received first dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 54-years-old, via an unspecified route of administration, administered in Arm Left on 14Apr2021 09:30 AM (Lot Number: EW0169) as single dose for covid-19 immunisation. Medical history included myocardial infarction, diabetes mellitus, asthma. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)); insulin aspart (NOVOLOG); carvedilol; atorvastatin; lisinopril; colecalciferol (VITAMIN D 3); vitamin E (VITAMIN E NOS); calcium and multivitamin, gummy vitamin. 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. Pain at injections site and fatigue on 14Apr2021. The injection site pain started the same day as the injection but the fatigue was more noticeable the day after the injection. Arm pain on 14Apr2021. Last night (15Apr2021) at approximately 9:00 pm symptoms of fatigue and arm pain continued. However, he started to run a fever of 99.0 given him two regular strength Tylenol and fluids. Today (16Apr2021) the fever was resolved in the morning. Event outcome of Pain at injections site and fatigue were not recovered, of fever was recovered on 16Apr2021, of the remaining was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
54 2021-05-04 tingling pt. c/o tingling sensation on left hand. Pt. advised to move left arm to help relieve symptoms. V/... Read more
pt. c/o tingling sensation on left hand. Pt. advised to move left arm to help relieve symptoms. V/S: 137/83, 87,18,97% RA, PS 0/10 #21 pt stable and went home
54 2021-05-04 tremor 15 minutes after patient left the clinic and was driving home, he developed a metallic taste in his ... Read more
15 minutes after patient left the clinic and was driving home, he developed a metallic taste in his mouth. He called his wife who told him he might pass out and should pull over. He stopped and put on his hazard lights. His vision started to tunnel and he did pass out for about 5 minutes. After coming to, he continued the drive home, about 2 more miles. He did feel shaky for several more hours but no further symptoms. He did not contact his provider.
54 2021-05-05 fibromyalgia A few days after receiving the first dose I started experiencing body aches, headache and minor back... Read more
A few days after receiving the first dose I started experiencing body aches, headache and minor back pain. The body aches only continued to get worse over time as well as the back pain. I did not have back problems or pain until the vaccine. I contacted my primary physician and explained that I received the vaccine and told her about my symptoms. She asked me to get a Covid-19 test. I did and the results was negative. At his point, May 6, 2021, the symptoms have only become worse. My back pain is so severe I can barely stand it. I have tried ice packs, a heating pad, over the counter pain medication and nothing has made it better. My physician does not know what to do. Another side effect is it has made my fibromyalgia pain much worse. I have had fibromyalgia for about fifteen years and my pain is tolerable but the past few weeks have been unbearable. I may have a weakened immune system due to the fibromyalgia so maybe that could be a explanation for my symptoms. I wanted to know if other people have experienced severe side effects. The only treatment is over the counter pain medication and ice packs and a heating pad. As of today, May 6, the back pain and body aches are still present and I would say severe. The headache is tolerable but still lingers and does not go away. The body aches, headache and back pain is twenty four hours a day and never get better.
54 2021-05-07 numbness, pain in extremity Nausea, fatigue, loss of taste, facial tingling and numbness, pain in elbows, pressure to front of h... Read more
Nausea, fatigue, loss of taste, facial tingling and numbness, pain in elbows, pressure to front of head and behind eyes, fogginess, memory loss, lack of concentration, muscle tingling in the middle of the night, numerous cysts in rt. arm, shooting pain in rt. thumb and hand, bone spurs and calciumafication of rt. elbow. No treatment. Schedule to neurologist and orthopedic doctor.
54 2021-05-08 tremor My body shakes on and off. I am really sensitive to sound and my Vision are really bright
54 2021-05-09 weakness, paralysis Weak when woke up. Fell 2 times was then paralyzed on that Sunday A. M. went to ER was Dx with GBS .... Read more
Weak when woke up. Fell 2 times was then paralyzed on that Sunday A. M. went to ER was Dx with GBS . Guillan Barre Syndrome. Hospitalized. Now in rehab hospital
54 2021-05-10 pain in extremity Client stated he felt he had a fever over the weekend but did not take his temperature. Swelling pre... Read more
Client stated he felt he had a fever over the weekend but did not take his temperature. Swelling present in R upper arm down elbow and complaints of pain in right arm. Stated he can feels discomfort in his neck on the right side. Complaint that he has difficulty swallowing. Client sent to ER by APRN. Client went to hospital.
54 2021-05-14 seizure convulsions; Fever (up to 103 F degrees); chills; confusion; dizziness for first 48 hours; body ache... Read more
convulsions; Fever (up to 103 F degrees); chills; confusion; dizziness for first 48 hours; body aches for 96 hours.; This is a spontaneous report from a non-contactable consumer who reported for himself. A 54-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0172), via an unspecified route of administration, in Arm Left on 20Apr2021 at 13:30 (at 54 years) at single dose for covid-19 immunisation . Medical history included known allergies penicillin. Previously, on 29Mar2021, patient took the first dose of the vaccine (lot Number: EQ0150) administered in Arm Left for covid-19 immunisation. The patient's concomitant medications were not reported. Patient had no COVID prior vaccination and was not covid tested post vaccination. On an unspecified date in 2021 patient experienced fever (up to 103 F degrees), chills, convulsions, confusion, dizziness for first 48 hours, body aches for 96 hours. No treatment given. Patient recovered from all the events on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.
54 2021-05-16 numbness pt states his head felt like it was 10 x the normal size. There was a lot of pressure on the left si... Read more
pt states his head felt like it was 10 x the normal size. There was a lot of pressure on the left side of the head and ear. The left side of his was face numb and he lost all hearing in left ear. He went to ER on 4/22/21. They removed ear wax and was prescribed amoxicillin and Mucinex. His symptoms did not improve so went to his PCP, on 4/29/21( he had to see his assistant ). They prescribed prednisone 40mg. He was referred to ENT. He saw her on 5/3/21. He was then prescribed 60mg prednisone and was given a hearing test. He had lost 20% of hearing at that point. He went back to ENT on 5/10/21 and had another hearing test. His hearing was better and almost back to normal but says he continues to have ringing in his head. He has a MRI scheduled on 5/24/21 further treatment.
54 2021-05-18 discomfort "Pfizer-BioNTech COVID-19 Vaccine EUA" I awoke on May 11th, '21 with sharp pains in my Right side... Read more
"Pfizer-BioNTech COVID-19 Vaccine EUA" I awoke on May 11th, '21 with sharp pains in my Right side Armpit area. The pain was very sharp and intermittent. When I looked under their I saw 6 red bumps in a V-shape .... the bumps appear almost like an insect sting,,, bumps are about 3 to 5 millimeters across, one of the bumps seems to have much smaller bumps clustered around it. I assumed that perhaps it was an insect, or spider bite, and hoped it would heal. It has now been 9 full days and the bumps still appear the same without fading, and the intermittent pain has intensified like something is pinching very hard in the area. On May 14th, '21 during my work day I begin to sense painful itching on my ...
54 2021-05-19 cold sweat After the 15 minute post shot waiting period patient said he felt "confused" with clammy hands. H... Read more
After the 15 minute post shot waiting period patient said he felt "confused" with clammy hands. He sat in the chair and was slow to talk. I asked him if he was diabetic, and he responded that he was, but he never feels this way and had eaten before coming in. After talking a while longer, I was going to ask him if he'd like us to check his sugar, he asked me if we had a blood pressure cuff. I said we did, but he wanted to use the machine in front of the store because he felt well enough to get up and wanted to walk. I walked to the machine with him. He sat and answered the many questions tapping on screen with no issues at all. The confusion was not evident. The maching reported 111/68 or very close, with a pulse of 48. He said, "that's the issue, my pulse is down. I need to walk around." I said he could stay back at the pharmacy where we could see him, or we could call someone for him. He said staying back here would not help his pulse. I told him there was no hurry, he'd been here for his 15 minutes, but we could keep an eye on him or help him and call whatever he needed. He said no, he'd be fine, he just needed to walk around. He now had pressure in his head, not really a headache just pressure, he said it was all related to his pulse. He said if he needed help later he could always go to an Urgent Care, I offered again to call anywhere for him or call for assistance, he was not interested.
54 2021-05-19 slurring, weakness Date 04/30/2021 Onset of symptom at approximately 1:30pm: developed slurred speech. Lost of strengt... Read more
Date 04/30/2021 Onset of symptom at approximately 1:30pm: developed slurred speech. Lost of strength started to left lower extremity and weakness and followed up to left upper extremity with lost of strength and weakness. Symptoms lasted approximately 3 minutes, and was taken to Hospital with an admitting diagnosis of Transit Ischemic Attack.
54 2021-05-19 flushing, weakness Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / ... Read more
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Mild, Additional Details: 5 minutes following second dose of pfizer pt with syncopal episode. LOC for 10 seconds, came to spontaneously without intervention. Pt placed in trendelenburg, regained consciousness. vital signs stable, blood sugar stable, no injury.
54 2021-05-19 pain in extremity Extremely Sore Left arm for 22 days. No treatments. Constipation for 6 days. Enema given. Light Feve... Read more
Extremely Sore Left arm for 22 days. No treatments. Constipation for 6 days. Enema given. Light Fever on days 3,4, and 6. No treatments. Severe coughing with lung pain from day 7- Present. Treatment is cough drops/Dextromethorphan HBr on Day 26. No male penis erections from Day 10-30. No treatments. Extreme Nausea from Day 14-Present. Feelings of vomiting but never did. 4-6 hours each day.
54 2021-05-21 pain in extremity The patient came to the pharmacy to get his "second shot" and informed the pharmacy he needed to pfi... Read more
The patient came to the pharmacy to get his "second shot" and informed the pharmacy he needed to pfizer vaccine. The information on his card was verified over the phone. He received a dose of the pfizer vaccine, only to realize 9 days later that his first dose was actually the moderna vaccine. The patient reported having a sore arm and fatigue.
54 2021-05-22 slurring Fever to T max 105.3, tachycardia to HR 135, altered mental status (lethargic, nonsensical speech)
54 2021-05-25 discomfort, weakness ED Discharged 5/5/2021 - 5/6/2021 (3 hours) Last attending ? Treatment team Acute nonintractable h... Read more
ED Discharged 5/5/2021 - 5/6/2021 (3 hours) Last attending ? Treatment team Acute nonintractable headache, unspecified headache type Clinical impression Headache Chief complaint Triage Note: To ED c/o severe HA behind R ear since being dx w COVID 4/30. Denies cough, dyspnea, fevers. Reporting he has had 1 round of COVID vaccines. Has taken "alieve, tylenol, and advil" w/o relief. Last doses all "early this morning." pt awake and alert in triage. History of Present Illness Patient is a 54 y.o. yo male presenting to the ED with severe headache behind the right ear since 4/30. Patient was diagnosed with Covid at that time and has taken 1 round of the Covid vaccine. He has tried Aleve, Tylenol and Advil without relief. He states that his last dose were all early this morning. Denies any numbness or tingling, visual disturbances, ataxia, photophobia. He has no history of strokes, MI or blood clots. He states that prior to his Covid diagnosis he is otherwise healthy. ED Discharged 5/8/2021 (4 hours) Last attending ? Treatment team COVID-19 Clinical impression Fever Chief complaint Medical Decision Making 54-year-old male who presents today due to uncontrolled fever, diagnosed with Covid on April 30. Symptomatic for about 2 weeks now. On exam appears to be uncomfortable, is febrile and tachycardic, however remaining vitals are stable. Physical exam is also reassuring. Patient not complaining of any chest pain, shortness of breath, lightheadedness. Will provide patient with symptomatic relief including fluids and ibuprofen, if able to improve patient's symptomatology will have him discharged home. His labs also show some slight hyponatremia, he will likely improve from fluids as I believe this is secondary to his diarrhea that he has been having over the last few days. CK also slightly elevated, would likely benefit from fluids. After a single liter of fluids, patient symptoms improved, fever and tachycardia also improved, continues to endorse some generalized weakness, will give second liter of fluid and Tylenol at this time as he is due for this. After receiving a second liter, the patient states that his symptoms have greatly improved at this time, comfortable returning home. I advised the patient that she should take ibuprofen and Tylenol on 6-hour cycles very regularly, he can take it in a pattern where he takes Tylenol followed by ibuprofen 3 hours later followed by Tylenol again 3 hours later, as long as he keeps 6 hours in between doses, explained to him that he should not take this any sooner than this however he should be sure to take these regularly as these will help control his fever. Also encouraged him to hydrate appropriately as this will likely prevent him from feeling poorly. He is agreeable with this plan, I provided him with appropriate return precautions.
54 2021-05-26 flushing Patient reported feeling "flushed" in the face, lightheadedness, and shortness of breath during 15 m... Read more
Patient reported feeling "flushed" in the face, lightheadedness, and shortness of breath during 15 minute post-vaccination observation period. States this felt like when he received contrast for imagining which resolved without intervention. Patient was given diphenhydramine 25 mg oral suspension. Patient reported that symptom were improving by time of discharge. MD discussed with patient that additional dose of diphenhydramine could be administered if symptoms persisted. Patient felt well enough to go home. Wife accompanied the patient.
54 2021-05-26 pain in extremity Extreme tired; Chills; Arm pain; This is a spontaneous report from a contactable consumer (patient) ... Read more
Extreme tired; Chills; Arm pain; This is a spontaneous report from a contactable consumer (patient) . A 54-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN5318) via an unspecified route of administration in left arm on 01Feb2021 at 07:30 (at 54 years) at single dose for covid-19 immunisation. Medical history included kidney donor.No known allergy. There were no concomitant medications. On 01Feb2021 at 10:00 the patient was extreme tired and experienced chills and arm pain.No treatment given and patient recovered from the events in Feb2021.No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021201495 same patient, different drug/AE
54 2021-05-27 hot flush, feeling hot, tingling Client received the 2nd COVID vaccine (Pfizer Lot # EW0185 and 06/19/2021) at 1906. At 1917 client w... Read more
Client received the 2nd COVID vaccine (Pfizer Lot # EW0185 and 06/19/2021) at 1906. At 1917 client was sitting in the observation area when he suddenly ran to one of the trash cans and started throwing up. PHN and EMT responded and assisted client into a chair and gave him an emesis bag. The client threw up one more time into the bag. Client stated that he ?suddenly felt nauseas, almost feels like a nervous reaction.? Client stated, ?I felt chills down my spine that traveled into my arms and my fingers tingled and my ears got hot. It felt like a hotflash.? Client was alert and oriented times four, and his skin was warm, and color was appropriate to race. Vital signs were taken at 1919 (blood pressure 110/78, heart rate 76, oxygen 96%). Client stated at 1921 ?I?m feeling better now,? and that the nausea had subsided. Vital signs were taken at 1924 (blood pressure 122/72, heart rate 73, oxygen 94%). Client was offered Benadryl by PHN and client refused. Client stated that he was feeling worried about receiving his second dose of the vaccine, ?we know someone who got their second dose a couple weeks ago and was paralyzed from it.? Client also stated that he was working outside in the sun all day. Vital signs taken at 1934 (blood pressure 122/80, heart rate 75, oxygen 96%). Client offered juice by PHN and he accepted and drank it. Client does not have any medical conditions, is not on any medications, and does not have any allergies. PHN advised client to follow up with his primary care provider, and education was provided to client on life threatening symptoms and to seek emergency services if he developed any. At 1947 client stated, ?I?m feeling fine,? and he left the facility unassisted with a steady gait.
54 2021-05-27 seizure SEIZURE MEMORY LOSS IN COHERENT
54 2021-06-01 pain in extremity 2 weeks after the first dose Awful pain and stiffness in both hands. went to DR on 4/12 did blood w... Read more
2 weeks after the first dose Awful pain and stiffness in both hands. went to DR on 4/12 did blood work diagnosed with RA. Did not think about the vaccine until two weeks after the second dose I struggle to walk with severe pain in my legs, arms, and hands. Life since has been pretty rough passed out from the pain on May 16th had to have 9 staples in my head. Now my life is trying to balance medication so I can sleep at night. And get through the days at work. I have had to miss days.
54 2021-06-01 unresponsive to stimuli Patient went swimming at a fitness center the day after he had his 2nd COVID-19 vaccine and was foun... Read more
Patient went swimming at a fitness center the day after he had his 2nd COVID-19 vaccine and was found unresponsive at the bottom of the shallow 4.5 deep pool while exercising. He was not able to be revived. The death certificate says that the immediate cause of death was Arrhythmia resulting from Hypertensive Atherosclerotic Cardiovascular Disease.
54 2021-06-02 sensory loss Feeling unwell, General body aches; he does every once in a while get an asthma episode; Fever; Feel... Read more
Feeling unwell, General body aches; he does every once in a while get an asthma episode; Fever; Feel a bit achy; Mild headache; vision is hard to focus; Not feeling right on and off; This is a spontaneous report from a contactable consumer or other non hcp (Patient himself). A 54-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: EW0150, expiry date: unknown), via an unspecified route of administration, administered in right arm on 02Apr2021 as 1st dose, single for covid-19 immunization. The patient's medical history included Type 2 Diabetes mellitus, patient reported that it was diagnosed at least 10 years ago, and his sugar levels had been in very good control, Covid-19 from unknown date in Nov2020 to unknown date in Dec2020. The patient's concomitant medications were not reported. On 03 Apr 2021maybe started Saturday after the vaccination the patient experienced with mild Headache and not feeling right on and off for 6 days. Patient reported that his head feels worse since he got the slight fever, he took Tylenol to deal with the fever in morning, like 11:00 AM then he did not feel quite right, probably feels worse to next day, sometimes his vision was Hard to focus he was to struggle a bit to focus or just worse because of the fever. since he got the vaccine, in the first couple days, he might have just felt like things were a little blurry and again it was very mild, but it seems worse than it had. on 08Apr2021 the patient feels little achy, and he took the Tylenol and only felt worse because of the fever and later felt better and had general body aches the patient did have COVID back in the end of November, then he recovered in the beginning of December, he got an asthma episode still that he believes was triggered by the COVID. The patient reported that he had a blood work on 03 MAR 2021, he saw his doctor on 10 MAR 2021 and his blood work was pretty normal. His blood sugar was very good, and he also has been very active, he walks every day. The patient enquired second dose was scheduled for 23 APR 2021, was it fine to have a second dose. The patient did not visit Emergency Room or No Physician Office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient took TYLENOL 500 mg for the treatment to the events (LOT: SJA014, scan code:30044439; NDC: 50580-449-36EXP: 06/2024). The outcome of the events headache, vision is hard to focus was not recovered, fever was recovering, feeling unwell, general body aches, feel a bit achy asthma episode and was unknown. No follow-up attempts are needed. No further information is expected.
54 2021-06-02 speech disorder Approximately 24 hours after second Pfizer vaccine dose, patient reported having severe vision and b... Read more
Approximately 24 hours after second Pfizer vaccine dose, patient reported having severe vision and balance problems, headache and severe fatigue and memory loss. Vision symptoms included hallucinations, tunnel vision and blurred. Unable to stand up without staggering. Confusion. Difficulty verbalizing thoughts. Treated with ivermectin, D3, Z, quercitin, aspirin and other supplements on advice of doctor. Symptoms persisted in severe form for 48 hours, then began to improve. At 6/3/2021, blurred vision while reading, higher than normal heart rate during exercise, fatigue and intermittent memory loss. Being treated by doctor and kinesiologist for brain injury from vaccine
54 2021-06-03 pain in extremity Right arm sore; Slight headache; This is a spontaneous report from a contactable consumer, the patie... Read more
Right arm sore; Slight headache; This is a spontaneous report from a contactable consumer, the patient. A 54-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201) via an unspecified route of administration in the right arm on 16Mar2021 at 08:30 (at the age 54-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol from an unknown 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 have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included simvastatin (ZOCOR) from an unknown date. On 17Mar2021, 22 hours post vaccination the patient experienced sore in right arm and had slight headache. The patient did not receive any treatment for the events. The clinical outcome of events sore in arm and headache were resolving at the time of reporting. No follow-up attempts are needed. No further information is expected.
54 2021-06-07 weakness Temperature ranging up to 102.6; body ache; headache; extreme weakness; cough; sleepiness; This is a... Read more
Temperature ranging up to 102.6; body ache; headache; extreme weakness; cough; sleepiness; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for Injection, Lot Number: EN6198) via an unspecified route of administration in arm left on 05Mar2021 at 15:15 (at the age of 54-year-old) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for Injection, Lot Number: EM9809) via an unspecified route of administration in arm left on 12Feb2021 (at the age of 54-year-old) at 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not have covid prior vaccination. Patient has not tested covid post vaccination. On 06Mar2021, the patient experienced Temperature ranging up to 102.6, body ache, headache, extreme weakness, cough, sleepiness. Patient did not receive treatment for the adverse events. The patient underwent lab tests and procedures which included body temperature: 102.6 on 06Mar2021. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
54 2021-06-07 muscle spasms Severe muscle cramping - upper back, neck, trapezoid
54 2021-06-09 fibromyalgia I began to feel the onset of the AE the next morning at around 3:00 AM after the vaccination. Genera... Read more
I began to feel the onset of the AE the next morning at around 3:00 AM after the vaccination. Generalize pain throughout my body, muscle aches, slight fever, muscular skeletal pain and general feeling of being extremely tired, and I feel like I have brain fog . Asthma and fibro maylagia are worse since I had the vaccination, sinuses I'm constantly congested. I feel more tired now than I did previously. I will never take this Pfizer vaccination again. My symptoms are not as bad as the week after the vaccination but I have not felt normal or as I did prior to the vaccination.
54 2021-06-09 nerve pain Patient had mild symptoms after the second dose, classic fever, body aches, etc. which resolved afte... Read more
Patient had mild symptoms after the second dose, classic fever, body aches, etc. which resolved after 1-2 days. Then 1 week later, he had more fevers and chills with worsening body aches, particularly right leg pain and worsening headaches and nausea. Rash developed on right lower extremity in an S1 dermatomal distribution, with severe neuropathic pain associated. PCR panel revealed Varicella Zoster Virus. Patient also presented with meningitis symptoms including headache, nuchal rigidity, and photophobia. PE positive for Kernig and Brudzinski signs.
54 2021-06-09 tingling, pain in extremity, numbness 3 days after receiving the 2nd Pfizer shot, the pt began experiencing numbness in both feet and toe... Read more
3 days after receiving the 2nd Pfizer shot, the pt began experiencing numbness in both feet and toes as well as R hand. A week later R thigh tingling followed by bilateral leg pain. Spread to calf region then knee caps toward the end of May. Then, balance became difficult, feeling like he was falling to the right. Was admitted to medicine service. Over course of week continued to decline and no longer can walk, needs bed lift to use the bathroom. Currently on day 1 of 5-day IVIG treatment. Due to possible tick exposure has also been receiving Abx for Lyme.
54 2021-06-10 bell's palsy I had Bells Palsey a few years ago and the symptoms came back very minor but hasn't gotten any bette... Read more
I had Bells Palsey a few years ago and the symptoms came back very minor but hasn't gotten any better. Not complete paralysis on my fight side of face but reduced strength by more than 50%; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration in right arm on 08Apr2021 at 14:15 as single dose for COVID-19 immunization. Medical history of the patient included Bell's palsy (a few years ago) and known allergies (nine patient is aware of). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included cetirizine hydrochloride (ZYRTEC) for an unspecified indication. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in right arm on 25Mar2021 at 14:15 as single dose for COVID-19 immunization. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 09Apr2021 at 05:00, 14 hours 45 min after receiving second dose of vaccination, the symptoms of Bell's palsy came back very minor but had not gotten any better, not complete paralysis on patient's right side of face but reduced strength by more than 50 per cent. Outcome of the event was not resolved. Information on the lot/batch number has been requested.
54 2021-06-12 feeling hot Approx 20 mins post vaccination pt felt dizzy, hot, not diaphoretic, skin w&d, AxO. No LOC. Was gi... Read more
Approx 20 mins post vaccination pt felt dizzy, hot, not diaphoretic, skin w&d, AxO. No LOC. Was given protein bar, water and ice pack applied to back of neck. pt rested in chair. Vitals, 3:50pm BP 180/90 P 120. 4:15pm BP 158/76 P 76 4:20pm pt feeling better, vss, Left for home with ride from co worker.
54 2021-06-12 pain in extremity Arm swelling with pain extending up my neck and culminating with a headache. More than a month after... Read more
Arm swelling with pain extending up my neck and culminating with a headache. More than a month after 1st shot I still have neck pain.
54 2021-06-13 tenderness I have an area around my collar bone on my left side close to the neck that is swollen and is tender... Read more
I have an area around my collar bone on my left side close to the neck that is swollen and is tender to the touch and is about 3 inches long.
54 2021-06-14 weakness Taken @ 7.30pm. By noon the next day, strong muscle aches over all body, a temperature of 102.00 (wi... Read more
Taken @ 7.30pm. By noon the next day, strong muscle aches over all body, a temperature of 102.00 (with Tylenol) and body weakness that lasted 24 hours, fatigue. Painful injection site that lasted several days.
54 2021-06-14 tingling 1) My face tingles regularly and it feels as if my tongue is numb 2) There have been more than 10 oc... Read more
1) My face tingles regularly and it feels as if my tongue is numb 2) There have been more than 10 occasions where my left arm has gotten very weak and it is difficult impossible to lift
54 2021-06-16 pain in extremity severe itching and pain also occurred at other locations such tongue, inside of cheeks, throat, and ... Read more
severe itching and pain also occurred at other locations such tongue, inside of cheeks, throat, and chest pain radiating into neck, left side of neck swelling and aching; severe itching and pain also occurred at other locations such tongue, inside of cheeks, throat, and chest pain radiating into neck, left side of neck swelling and aching; severe itching and pain also occurred at other locations such tongue, inside of cheeks, throat, and chest pain radiating into neck, left side of neck swelling and aching; severe itching and pain also occurred at other locations such tongue, inside of cheeks, throat, and chest pain radiating into neck, left side of neck swelling and aching; severe itching and pain also occurred at other locations such tongue, inside of cheeks, throat, and chest pain radiating into neck, left side of neck swelling and aching; severe itching and pain also occurred at other locations such tongue, inside of cheeks, throat, and chest pain radiating into neck, left side of neck swelling and aching; chest pain radiating into neck; chest pain radiating into neck/ left side of neck swelling and aching; both armpits swelling and itching extreme/ left side of neck swelling and aching; inside of right elbow were itching, swelling and medium pain; inside of right elbow were itching, swelling and medium pain/ severe pain in both shoulders which radiated down to hips; both wrists were itching and both hands were swelling with severe pain; wrist itching/ both heels were itching/ inside of right elbow were itching, swelling and medium pain/ both armpits swelling and itching extreme; hand swelling/ toes were swollen; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in left arm on 26Apr2021 08:45 (Batch/Lot Number: ER8736) (at the age of 54-years-old) as 2nd dose, single for COVID-19 immunization. Medical history was none. The patient had no known allergies. Concomitant medication included methylphenidate hydrochloride (RITALIN) 20mg ER. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in left arm on 29Mar2021 08:45 (Batch/Lot Number: EN6204) (at the age of 54-years-old) as 1st dose, single for COVID-19 immunization. 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. Since the vaccination, the patient had not been tested for COVID-19. On 27Apr2021 at 09:00 (day after injection) on the same arm, the patient experienced wrist itching and hand swelling (left). On the next evening on 28Apr2021, both wrists were itching and both hands were swelling with severe pain, lasted 3 hours then they went away completely. The next day on 29Apr2021 at 03:00, both heels were itching, toes were swollen mildly with almost no pain. The next day on 30Apr2021, inside of right elbow was itching, swelling and medium pain. The next day on 01May2021, there was nothing. The next day on 02May2021, both armpits swelling and itching extreme with severe pain in both shoulders which radiated down to hips after 1 hour started to go to emergency room (ER) but it all vanished completely. Sometimes the patient got a day break but otherwise, since 27Apr2021 this had happened to some part of his body (most commonly in hands) up to Friday 28May2021. The patient was put on second round of steroids and now antihistamines and he hadn't had any symptoms for 2 days. The severe itching and pain also occurred at other locations such tongue, inside of cheeks, throat, and chest pain radiating into neck, left side of neck swelling and aching. The patient had never had similar symptoms before. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment medications to lessen swelling and pain. The outcome of events was unknown.
54 2021-06-20 burning sensation Sunburn feeling on backs of hands, forearms, forehead, lips, tongue, top of feet, belly and calves. ... Read more
Sunburn feeling on backs of hands, forearms, forehead, lips, tongue, top of feet, belly and calves. No rash or redness present. Ongoing and unresolved after seven days.
54 2021-06-20 pain in extremity Blood clot R upper leg. 4/24 left lower leg deep tissue pain x 1 week. R lower leg pain 5/10 or 12... Read more
Blood clot R upper leg. 4/24 left lower leg deep tissue pain x 1 week. R lower leg pain 5/10 or 12 x 1 week. Then redness started 5/31 saw Urgent care 6/1 started abx Bactrim DS 6/2 though was lymph node 6/4 increased swelling saw doctor. Clinic sent for US + for blood clot started blood thinners on 6/5
54 2021-06-21 pain in extremity 18 days after receiving the first dose of the Pfizer COVID vaccine I began having pain in my left hi... Read more
18 days after receiving the first dose of the Pfizer COVID vaccine I began having pain in my left hip and thigh. The following day I began developing a painful rash on my left leg from my lower back, hip and thigh all the way to my toes which was diagnosed by two separate doctors as Shingles. I was prescribed 2 courses of Valacyclovir, 3 weeks of Prednisone and Gabapentin for pain. The Shingles infection is currently still ongoing (17 days now).
54 2021-06-21 tingling Feeling tingling in fingers and toes for about two weeks. Having a lot of leg cramps since first dos... Read more
Feeling tingling in fingers and toes for about two weeks. Having a lot of leg cramps since first dose.
54 2021-06-24 nerve pain High fever, pain in bones and muscles, lower back, virus associated with meningitis, nerve pains, ca... Read more
High fever, pain in bones and muscles, lower back, virus associated with meningitis, nerve pains, can't walk without assistance
54 2021-06-25 unresponsive to stimuli, cold sweat Wife present with pt and she stated before he received his vaccine that he has been known to pass ou... Read more
Wife present with pt and she stated before he received his vaccine that he has been known to pass out during a vaccine or after getting a vaccine. Pt's wife came and got me from exam room around 2:50p (about 10 mins after receiving vaccine and while pt was sitting in waiting room) stating that he didn't feel well. Pt's face was pale and skin was cool and clammy but alert when I asked him if he'd like to return to an exam room to lay down. He stated that he wanted to stay in waiting room sitting with his wife. I gave pt 2 small bottles of water but he declined them at that time. I started to check his BP and he became unreponsive but eyes still open. This episode last approximately 20-30 seconds and then color return to pt's face and he became responsive and answer questions appropriately. I asked pt again if he wanted to come into an exam room and lay down but he decline again. I advised pt and wife to stay in waiting room and asked his wife to watch for any other symptoms and advised them to stay an additional 15-20 mins. Both verbalized agreement and understanding. Pt's wife said he was feeling better at 3:15pm and after drinking the water I gave him and they left. Pt was alert and ambulatory upon leaving, steady gait.
54 2021-06-30 feeling hot Hot; itchy rash all across clavicles,chest and partial neck; This is a spontaneous report from a con... Read more
Hot; itchy rash all across clavicles,chest and partial neck; This is a spontaneous report from a contactable consumer (patient). A 54-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9261) via an unspecified route of administration on 26-JAN-2021 at 14:30 hours on right arm as dose 1, single (at the age of 54-years-old) for COVID-19 immunization at Health Clinic. The medical history and concomitant medications were not reported. It was mentioned patient did not have any allergies to medications, food, or other products and not received any medications within 2 weeks of vaccination. Prior to vaccination, patient did not receive any other vaccines within 4 weeks and was not diagnosed with COVID-19. On 04Feb2021 at 12:00 pm the patient experienced hot, itchy rash all across clavicles, chest and partial neck. Since the vaccination, patient has not been tested for COVID-19. The case was not considered serious and not resulted in death, and had no Life threatening, no Disabling/Incapacitating, not Caused/prolonged hospitalization and no Congenital anomaly/birth defect. No treatment was received for the events. The patient not recovered from events. Follow-up attempts were completed. No further information was expected.
54 2021-07-02 pain in extremity upper arm soreness; This is a spontaneous report from a contactable consumer (patient, self-reported... Read more
upper arm soreness; This is a spontaneous report from a contactable consumer (patient, self-reported). A 54-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EJ1685 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 03Mar2021 at 15:15 PM (age at vaccination: 54 Years), as a single dose for COVID-19 immunization at workplace clinic. The patient's medical history Meniere's disease and spring allergies from pollen and mold. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included Simvstatin, Lisinopril, and Tranmadol. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient reported that on 04Mar2021, he experienced upper arm soreness. The patient became aware of these symptoms the day after the injection. The patient did not receive treatment for the adverse event. Outcome of the event was recovering. Follow-up attempts are completed. No further information is expected.
54 2021-07-05 pain in extremity thought was lymph; redness; L leg pain x 1 week. r lower leg pain x 1 week; Blood Clot R upper leg; ... Read more
thought was lymph; redness; L leg pain x 1 week. r lower leg pain x 1 week; Blood Clot R upper leg; This is a spontaneous report from a contactable nurse. A 54-year-old male patient received bnt162b2 (brand: Pfizer), dose 2 intramuscular, administered in arm left on 27Mar2021 14:00 (Batch/Lot Number: EP6955) as dose 2, single at the age of 54-year-old for covid-19 immunisation. Patient received first dose (lot number: EN6199) intramuscular in left arm on 05Mar2021, 10:00 am for COVID-19 immunization. No known allergies or other medical history. No concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. 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 blood clot R (right) upper leg on 24Apr2021 17:00. L (left) leg pain x 1 week. R lower leg pain x 1 week about 10May2021 or 12May2021. Then redness started 31May2021 saw urgent care 01Jun2021 thought was lymph started abx bactrim then on 04Jun2021 to PMD (Withheld) clinic had us + blood clot r upper leg. The adverse event result in Doctor or other healthcare professional office/clinic visit. Event treatment included blood thinners. The outcome of event was recovering.; Sender's Comments: A causal relationship between BNT162B2 and the reported events cannot be excluded based on temporal association. 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 .
54 2021-07-07 numbness Systemic: Numbness (specify: facial area, extremities)-Mild
54 2021-07-08 pain in extremity I had some dull pain immediately following the vaccination that lasted three days. One the fourth d... Read more
I had some dull pain immediately following the vaccination that lasted three days. One the fourth day, I woke up with serious arm pain. By day five, I could barely move my arm. Raising my left arm above my waist would cause excruciating pain and I had to walk around with my arm at my side for over a week. Putting on or taking off a shirt was nearly impossible. I am not the type of person to complain about a little pain. I have undergone foot surgery with no anesthesia and don't need any local anesthetic when I get a cavity filled at the dentist, but this was really bad. I had some pain relievers left over from nose surgery years before and I had to take those just to get to sleep. It is now almost a month later, and my arm still hurts around the crease of my shoulder during physical activity. If I had a job that involved the muscle in my left shoulder, I would not have been able to do my work.
54 2021-07-09 tingling Rash shaped like band aid adhesive at injection site on 5/14/2021 after 1st injection days later. Ne... Read more
Rash shaped like band aid adhesive at injection site on 5/14/2021 after 1st injection days later. Nerve tingling sensations at the base of neck leading down to the right shoulder ten minutes after 2nd injection.
54 2021-07-11 pain in extremity Inflammation of left great toe consistent with gout. Treated with NSAIDs, Medrol dose pack. Pain pe... Read more
Inflammation of left great toe consistent with gout. Treated with NSAIDs, Medrol dose pack. Pain persisted for about 7 weeks.
54 2021-07-12 cold extremities For the first week, he had fever, body aches, and chills. After that, he had chest pain on both side... Read more
For the first week, he had fever, body aches, and chills. After that, he had chest pain on both sides. The pain was also between shoulder blades, stabbing in the chest in the middle of night. He had severe shortness of breath. His feet were cold and he could not sleep most of the nights. Today he said his breathing is okay, slowly getting back to normal.
54 2021-07-14 night sweats, tingling No immediate adverse reaction, however, began developing nightly fevers/profuse sweating on June 11.... Read more
No immediate adverse reaction, however, began developing nightly fevers/profuse sweating on June 11. This continued for two weeks with increasing symptoms of loss of appetite, nausea, abdominal pain, tingling sensation on scalp before going to ER. Visited urgent care on June 16 and bloodwork results indicated elevated white blood cell count and eosinophil count. There was a question as to whether patient had been subjected to a tick bite, so doxycycline was prescribed. After several days, patient returned to urgent care for follow-up bloodwork (June 20th). Results showed WBC and eosinophil count continued to escalate. He went to ER on June 25th and was admitted to the hospital for 5 days. During his visit at Hospital, he was seen by a team of specialists: cardiologist, pulmonologist, hematologist, infectious disease doctor. Multiple tests were run, as the doctors started broad to eliminate certain diagnoses - i.e., bone marrow biopsy, heart cath, CT scans, x-rays, thoracentesis, etc. Patient had fluid around his heart and lungs and was diagnosed with myocarditis. He had no previous heart issues nor family history of heart issues. Test results indicated no abnormal blockage or other issues, other than inflammation and his heart strength was at 27%. I am unable to access his account, as it was disabled after his death. An autopsy is being performed and results are pending; however, the question(s) at large: what was the condition of his heart at the time of his death and was this vaccine-related? Did his myocarditis get worse? Did his heart muscle weaken further and rupture? Please let me know if the autopsy results are needed and where to send them.
54 2021-07-18 bell's palsy Possible Bell's palsy To whom it may concern: I am an ED physician, I saw this patient for what app... Read more
Possible Bell's palsy To whom it may concern: I am an ED physician, I saw this patient for what appears to be Bell's palsy. He had his pfizer covid vaccine 1 week ago, and sx started a few days after that. He does not recall when he had the vaccine exactly and could only give estimate dates. He also did not recall the location he got the vaccine when I saw him in the ED. Further information should be obtained through him as I only know the limited information he had provided me.
54 2021-07-18 tremor Feeling of dizziness, lose of feeling and uncontrollable shaking in left leg.
54 2021-07-19 bell's palsy BELLS PALSY PER MD
54 2021-07-19 bell's palsy After 2 weeks and three days of the first shot developed systems of Bells Palsy. Did not recognize s... Read more
After 2 weeks and three days of the first shot developed systems of Bells Palsy. Did not recognize symptoms until after second shot.
54 2021-07-20 pain in extremity After taking the vaccine, I didn't have any symptoms. The next day, my arm got a little sore later o... Read more
After taking the vaccine, I didn't have any symptoms. The next day, my arm got a little sore later on in the day. That day at night, I started to feel a little headache. The next day after that, I started to get a little fever and a little headache. After that, everyday I was getting a headache and a fever for over a week. I went to the hospital and they said I had covid.
54 2021-07-21 difficulty speaking extremely tired; hoarse in my speech; A cold sore on my lip; This is a spontaneous report from a con... Read more
extremely tired; hoarse in my speech; A cold sore on my lip; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP 6955) via an unspecified route of administration in the left arm on 24Mar2021 at 15:15 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. Medical history included slightly high Blood Pressure (BP), slightly high low-density lipoprotein (LDL) cholesterol and cigarette smoker. The patient was not allergic to any medications, food, or other products. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), lisinopril dihydrate (LISINOPRIL) and zolpidem (MANUFACTURER UNKNOWN), all for an unspecified indications and from an unknown date. 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 07:00, day 6 after the vaccination, the patient felt extremely tired, had hoarse speech and developed a cold sore on lip. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcomes of the events extremely tired, hoarse speech and cold sore on lip were recovered on 31Mar2021 (day 7.75 after the vaccination). No follow-up attempts are needed. No further information is expected.
54 2021-07-24 inability to speak, severe one side paralysis Acute CHF with LV thrombus, multiple strokes involving MCA and left cerebellar stroke, aphasia, left... Read more
Acute CHF with LV thrombus, multiple strokes involving MCA and left cerebellar stroke, aphasia, left-sided paralysis, immobility. Patient was given tPA, clinical symptoms still progressed. In rehab facility now.
54 2021-07-25 pain in extremity, nerve pain About 1 hour after the first vaccine shot, I started to have typical symptoms -- achy body, tightnes... Read more
About 1 hour after the first vaccine shot, I started to have typical symptoms -- achy body, tightness of breath, basic flu like symptoms. About 3 hours after the vaccine I started having sharp pain (like 8 or 9 on a scale of 1-10) running down the insides of my legs. It felt like lightning was running through my body. I tried to sleep Friday as well as the weekend, and the pain was intense. I had to limit and stop all exercise, and to-date, I can only walk for limited times before I feel pain in my legs again. I have also long-term lethargy and tireness, and find I am sleeping 12-16 hours a day. Prior to Covid vaccine, I would only sleep 4-6 hours a night.
54 2021-07-27 feeling hot, flushing feeling hot; flushed with chills; strong stomach pain; Chills; This is a spontaneous report from a c... Read more
feeling hot; flushed with chills; strong stomach pain; Chills; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ep6955) via an unspecified route of administration in the left arm on 23Mar2021 at 13:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included bupropion hydrochloride (MANUFACTURER UNKNOWN) 150 of unspecified units and omeprazole (MANUFACTURER UNKNOWN) 20 of unspecified units, both from an unknown date for unknown indications. 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 24Mar2021 at 12:00, the patient experienced feeling hot, flushed, stomach pain and chills. Its reported that the patient felt hot and flushed with chills and strong stomach pain lasting all day (it was day 12 of it at the time of this report). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken for the reported events and included treatment with tylenol (MANUFACTURER UNKNOWN) and pepto bismol (MANUFACTURER UNKNOWN). The clinical outcome of the events of feeling hot, flushed, stomach pain and chills were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
54 2021-07-27 pain in extremity, unresponsive to stimuli pt developed fever later the day after getting his covid vax so he took ibuprofen and went to bed. ... Read more
pt developed fever later the day after getting his covid vax so he took ibuprofen and went to bed. Next day he went back to work. Pt showed no symptoms until the month of June when he started complaining about pain in both arms. He was using a heating pad on his shoulders to help with the pain. He was taking Aleve for the pain but it was not helping so he no longer wanted to take it. He had a vomiting episode on the afternoon of June 16th stating he thought he has eaten a bad lemon. He wasn't feeling well the morning of June 18th, 2021 but continued working. He only wanted something light to eat since he didn't feel well and was headed to bed. When his wife went to go to bed she found him collapsed on the bedroom floor with face forward in the bed. She turned him around and found him unresponsive. She contacted 911 and he was taken to Medical Center ER. They were not able to revive him. County conducted an autopsy where they found a blood clot in left artery.
54 2021-07-28 pain in extremity Arm pain Swelling at injection site Diarrhea Nausea Joint pain
54 2021-07-29 breast pain soreness in left breast; swelling of left breast; This is a spontaneous report from a contactable co... Read more
soreness in left breast; swelling of left breast; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 31Mar2021 at 09:00 (at the age of 54-year-old) as a single dose for COVID-19 immunisation and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 28Apr2021 at 08:45 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any concomitant medications. The patient had no past drug history. 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 an unknown date, the patient experienced soreness in left breast and swelling of left breast. The clinical outcome of the event soreness in left breast and swelling of left breast was not recovered. No follow-up attempts are needed. No further information is expected.
55 2021-01-05 pain in extremity top of left hand red; top of left hand pain; uncomfortable to open left hand; left wrist swollen; le... Read more
top of left hand red; top of left hand pain; uncomfortable to open left hand; left wrist swollen; left hand swollen/the top of his left hand was warm and red; regular shot pain in left shoulder; regular shot pain in left shoulder/ top left wrist pain; This is a spontaneous report from a contactable consumer(patient). A 55-year-old male patient received the first dose of BNT162B2 (lot number: EH9899), via an unspecified route of administration in left arm, on 22Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were none. The patient stated that he got his Pfizer Covid vaccination on Tuesday last week on 22Dec2020. The patient had few days regular shot pain in left shoulder. The patient stated that on Thursday(24Dec2020) that he was okay but got on his wrist on same arm and top of hand swollen was painful to movement. The patient stated that the top of his left hand was warm and red on Saturday(26Dec2020). The patient experienced top of left hand pain and top left wrist pain on 26Dec2020. The patient stated that he got the Covid vaccination in his left arm. The patient stated that on Sunday that he made a clinic appointment and they sent him anti-inflammatories. The patient stated that now he was getting better. The patient was uncomfortable to open left hand 25Dec2020. The patient stated that the pain in his left shoulder resolved Thursday or Friday. The patient stated that he can see his hand muscles more defined now. The patient stated that he can stretch his left hand better than before. The patient stated that he had blood work in doctor in Oct2020. The outcome of the events"regular shot pain in left shoulder" was recovered, of the event"top of left hand red" was not recovered and of the other events was recovering.
55 2021-01-06 pain in extremity Arthralgia right arm soreness; numbness & tingling upper lip 12/29 12:15 received the vaccine. 12/30... Read more
Arthralgia right arm soreness; numbness & tingling upper lip 12/29 12:15 received the vaccine. 12/30 0600 woke up with a sore arm and joint aches. 12/31 woke up with numbness and tingling across her enter upper lip. It is constantly present. Her sore arm and joint aches have improved. She denies all other symptoms. 12/31 later in the day her lip tingling resolved as did her sore arm and joint aches.
55 2021-01-08 cold sweat Sweaty/Clammy, vomiting Narrative:
55 2021-01-08 feeling hot Headache sweating, feeling hot Narrative:
55 2021-01-10 numbness A few days after first shot, noticed numbness in left little toe which progressed to 3,4,5 digits. A... Read more
A few days after first shot, noticed numbness in left little toe which progressed to 3,4,5 digits. After second dose (1-2days later) numbness extended to both feet, all digits, soles, and outside foot
55 2021-01-11 feeling hot Severe left knee pain and stiffness without trauma. No redness or swelling. Feeling of heat on ant... Read more
Severe left knee pain and stiffness without trauma. No redness or swelling. Feeling of heat on anterior of both lower extremities. Associated with chills and moderate fatigue.
55 2021-01-12 feeling cold Total body malaise, headache, chills
55 2021-01-12 pain in extremity Pain in right leg since evening of injection. Got rash 1 week after injection on right buttock . Fou... Read more
Pain in right leg since evening of injection. Got rash 1 week after injection on right buttock . Found to have shingles when saw pmd today
55 2021-01-14 numbness numbness to left little toe; This is a spontaneous report from a contactable physician. A 55-year-o... Read more
numbness to left little toe; This is a spontaneous report from a contactable physician. A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration, at the left arm on arm on 17Dec2020 10:15 at single dose for COVID-19 immunization at a hospital. Medical history included prostatitis. No known drug allergy. Concomitant medication included clindamycin hcl. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Dec2020 08:00, a few days after first shot patient noticed numbness to left little toe. This progressed slowly to 3rd and 4th digit. After second shot (day 2), patient noticed this now extended to both feet, digits 3-5, sole of feet, and outside edge of feet. No pain just numbness. The patient was not tested for it since the vaccination. The patient took the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), on 07Jan2021 at the left arn for COVID-19 immunization. The patient did not received any treatment for the event. The patient has not recovered from the event.
55 2021-01-14 night sweats mass in left brachial lymph nodes 11cmX8cmX5cm i also have fever chills and night sweats body aches
55 2021-01-15 pain in extremity fatigue arm pain, metallic taste, jaw pain, abdominal cramping, loose stool
55 2021-01-17 night sweats severe body aches; severe chills; night sweats; Fatigue; This is a spontaneous report from a contact... Read more
severe body aches; severe chills; night sweats; Fatigue; This is a spontaneous report from a contactable Physician (patient). A 55-year-old male patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at 12:00 at single dose in left arm for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose bnt162b2 in Dec2020 three weeks ago at 12:00 noon in the left arm for covid-19 immunization and experienced mild pain at the injection site which lasted two days and then was gone. The patient experienced severe body aches, severe chills, night sweats, and fatigue on 07Jan2021. Event details: The patient reported that he received the first dose of the Pfizer COVID 19 vaccine three weeks ago at 12:00 noon in the left arm. He did not know the exact date. After the first dose there was mild pain at the injection site which lasted two days and then was gone. He received the second dose of the Pfizer COVID 19 vaccine on 06Jan2021 at 12:00 noon in the left arm. He noticed 12 hours later severe body aches, severe chills, and night sweats. He also felt fatigue. Everything had mostly resolved except for the night sweats and they were still pretty severe. All events were reported as serious by reporter per medically significant. The outcome of event night sweats was not resolved, outcome of other events was resolved on 10Jan2021. Information about lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported severe body aches, severe chills, fatigue and night sweats, and the administration of the COVID 19 vaccine, bnt162b2, based on the reasonable temporal association. 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 RA, IEC, as appropriate.
55 2021-01-17 pain in extremity Slight fever. Severe left arm pain with arm pit swollen gland.
55 2021-01-21 pain in extremity had vaccine 12/30. About 1/1 had ill feeling, very tired, soreness in joints, extreme pain in arm/ ... Read more
had vaccine 12/30. About 1/1 had ill feeling, very tired, soreness in joints, extreme pain in arm/ legs. did not have breathing problem. pain and limited range motion lasted until 1/7/21. I called health clinic and they told me to call cdc number on vaccination card. That number sent me to reporting center, no help. Called family physician, they said they knew nothing about vaccine. Since i wasn?t having breathing problem i just dealt with pain and took Tylenlol couple times each day. Took second dose vaccine 1/20/21.
55 2021-01-22 numbness 12 hours after injection: 12 hours after injection and then resolved the next day: drenching night s... Read more
12 hours after injection: 12 hours after injection and then resolved the next day: drenching night sweats severe joint pain especially in hips and knees - even ribs hurt passed out and disoriented significant contracture of bilateral upper extremities from elbow to hands when I could not open them for over an hour rt ear tinnitus numbness in hands and feet tiredness
55 2021-01-24 pain in extremity On January 21,2021 developed headache and on January 22,2021, left arm pain, warm to touch, redness... Read more
On January 21,2021 developed headache and on January 22,2021, left arm pain, warm to touch, redness and contralateral hand swelling (right )
55 2021-01-26 weakness First episode 01-15-21, started 10am, i was at work, started feeling weak and brain fog so i sat dow... Read more
First episode 01-15-21, started 10am, i was at work, started feeling weak and brain fog so i sat down and another therapist came into the office and told her how i was feeling, they checked my BP 148/92, went to the ER. They took some blood work, CBC panel were negative, thyroid test, normal, anaiongap, normal, glucose reading, normal and an EKG normal. 2nd episode 01-21-2021 started 11;45am, that morning when i woke up i felt really strong feelings of sadness and despair. At 11;45a i was about to eat and i started to feel again brain fog, total body weakness, elevated BP, they took my BP again and it was 144/88 so i went to the ER again. I could not keep my eyes open. They did a EKG again with a CTA and a CT with perfusion both were normal. They gave me fluids, sodium fluids. Agian it was transient my BP slowly went down and went home. Third episode 01-25-2021 started about 9am, i was at home did not have access to a BP cup, symptoms were same but less intense, i could feel my heart pounding, brain fog and body aches and this lingered throughout the day. It felt like I had the flu. No elevated temperature on all three of my episodes.
55 2021-01-26 weakness It started abruptly, i experienced brain frog and super weak, globally with al muscles and was very ... Read more
It started abruptly, i experienced brain frog and super weak, globally with al muscles and was very fatigues and malaise. I had access to a blood pressure cup the reading was 148/92, usually my BP is 100/60. Once they took my BP, then i went to the ER. As time went on, I got more sleepy and tired. The first ER visit they did lab work, CBC panel which was normal, thyroid test which was normal, EKG and aniongap which were negative. They gave me no medications to take and was probably there in the ER for about 6 hours. which was on 01-15-2021. The second time, it was around 11:45am on 01-21-2021. While sitting at the edge of my bed, I felt a total sadness and despair and feeling of being alone. I then went to work felt normal in the morning and as i went to type some notes after a minute i felt the same symptoms happening again, my BP 140/88 and went to the ER. I was really tired and could of fallen asleep, felt oriented but took me a while to process things. I also had trouble moving my entire body. They placed an IV, gave me fluids, did an EKG again which was normal. They did a CT scan, CTA to my chest and neck and CT perfusion, had to inject contrast, exams were both normal. The doctor came in and told me if I was okay to drive home and I drove home. On the third episode. 01-25-2021 it occurred around 9am, the symptoms came back but with less intense. I lied down and rested., could feel my heart racing just like the other two episodes. This symptom lasted for about two hours and kind of lingered all day but i could still function. i felt like I had the flu, moderate malaise with brain fog.
55 2021-01-28 pain in extremity Within 16 hours, fever of 102, extreme fatigue, significant headache, body aches throughout, sore ar... Read more
Within 16 hours, fever of 102, extreme fatigue, significant headache, body aches throughout, sore arm, chills, lymph nodes under arm receiving vaccine swollen, temperature of 100.5 48 hours later.
55 2021-02-01 tingling patient complained of feeling "tingly and off". At 1610, BP 173/109, pulse 50, 100% on room air, E... Read more
patient complained of feeling "tingly and off". At 1610, BP 173/109, pulse 50, 100% on room air, EKG in the field WNL. Denied headache and chest pain. Rested for 30 min. BP 183/105 at 1637. Patient reported feeling normal and agreed to follow up with primary MD or go to ER if symptoms worsened.
55 2021-02-08 weakness, pain in extremity 99.7 low grade fever, extreme body aches including aches and pains in feet which made it painful to ... Read more
99.7 low grade fever, extreme body aches including aches and pains in feet which made it painful to walk, hand ached which made it hard to make a fist, all joints hurts especially hips and low back. Extremely low on energy causing me to have to sleep longer during the night and nap twice the next day.
55 2021-02-09 weakness 2/2/2021- seen in Ed with c/o intermittent fever following 2nd dose. Redness to bilateral upper ext... Read more
2/2/2021- seen in Ed with c/o intermittent fever following 2nd dose. Redness to bilateral upper extremities, c/o some pain with urination, weak. V/S stable, afebrile in ED. Assess for infection. No significant abnormal labs (see below), hydrated and discharged. 2/4/2021- arrived in ED with c/o vomiting, seen earlier by PCP that day labs drawn. Shortly after arriving in the ED copious amouts of emesis noted, the patient went into full cardiac arrest and CPR was started. -Please see HPI above, in addition after intubation the patient coded again. More epinephrine and lidocaine were given. CPR was resumed. We did obtain ROSC and targeted temperature management was pursued. He is placed on a lidocaine drip and a right femoral central line was placed by myself. At this time, norepinephrine drip was initiated given his continued hypotension. Post intubation chest x-ray suggests possible abdominal pathology and once the patient was stabilized further, he was sent to the CT scanner where CT head without IV contrast and CT chest, abdomen and pelvis with IV contrast was obtained. He did lose pulses once in the radiology suite. This was brief. IV fluids were initiated and he received over 2 L of crystalloid therapy. He continued to be hypotensive in the emergency department and vasopressin was added. He also had a single dose of Neo-Synephrine and IV push fashion to help bring his blood pressure up. CT scan reveals probable bilateral aspiration pneumonia/pneumonitis and dilated loops of small bowel without a transition point and pneumatosis involving loops in the left upper quadrant. I did try to initiate consult with critical care and possible transfer, however he continued to be unstable and coded requiring CPR multiple times. He was given IV bicarbonate given his prolonged CPR state and pH. Ultimately, the family decided to make the patient comfort measures only given his critical illness. Shortly after making this decision he did pass away in the emergency department. RADIOLOGY DIAGNOSTIC - CHEST PORTABLE 02/04 2051 *** Report Impression - Status: SIGNED Entered: 02/04/2021 2059 IMPRESSION: 1. Findings highly suspicious for portal venous gas which can be seen in the setting of bowel ischemia. Consider CT for further evaluation and/or surgical consultation. 2. Endotracheal tube 3.7 cm above the carina. 3. Low lung volumes with mild patchy perihilar opacities. Final Report Signed by: M.D., Sign Date/Time: 02/04/2021 8:55 PM Impression By: MD CT SCAN - CT HEAD WO 02/04 2140 *** Report Impression - Status: SIGNED Entered: 02/04/2021 2200 IMPRESSION: Negative for acute intracranial process. No evidence of mass effect, acute hemorrhage or definite acute cortical infarct. Final Report Signed by: M.D., Sign Date/Time: 02/04/2021 9:57 PM Impression By: - MD CT SCAN - CT CHEST/ABD/PELVIS W 02/04 2140 *** Report Impression - Status: SIGNED Entered: 02/04/2021 2214 IMPRESSION: 1. Ill-defined patchy opacities within the bilateral upper lobes, right middle lobe, in consolidative opacities within bilateral lower lobes which could represent aspiration, and/or multifocal pneumonia. 2. Small right trace left pleural effusions. 3. Diffusely dilated small bowel without a transition point and mucosal hyperenhancement involving the colon with areas of pneumatosis involving loops of small bowel within the left upper quadrant and portal venous air consistent with hypoperfusion complex. There is a small caliber appearance of the aorta and a flattened appearance of the IVC is well. 4. Intravascular air within the IVC and bilateral iliac veins could be secondary to right femoral central lying injection. 5. Somewhat abnormal enhancement pattern of the kidneys with hypoenhancement of the medullary pyramids which may suggest hypoperfusion injury as well. 6. Probable nondisplaced rib fractures on the right at ribs 2 through
55 2021-02-09 grand mal seizure gran mal seizure
55 2021-02-10 weakness This was my 2nd shot. (1st shot was 3 weeks prior). Four days after 2nd shot, I developed wheezi... Read more
This was my 2nd shot. (1st shot was 3 weeks prior). Four days after 2nd shot, I developed wheezing and congestion. On my 6th day, I had an asthma attack. I obtain an albuterol inhaler and used it occasionally for the next 3 days. Today, after 11 days, I still have a slight cough but feel like I'm getting my energy back.
55 2021-02-11 numbness Patient complained of burning sensation and achiness from left deltoid up to left side of neck and b... Read more
Patient complained of burning sensation and achiness from left deltoid up to left side of neck and behind left ear. Patient complained of left ear clogged, numbness, swelling, with swelling and tingling of lips. Patient took ibuprofen. Went UC and ED, was prescribed prednisolone.
55 2021-02-12 pain in extremity SORE LEFT ARM ON 2ND DOSE, FATIGUE, ITCHY LEFT & RIGHT ARMS AND HANDS, ITCHING NECK AND UPPER BACK. ... Read more
SORE LEFT ARM ON 2ND DOSE, FATIGUE, ITCHY LEFT & RIGHT ARMS AND HANDS, ITCHING NECK AND UPPER BACK. TOOK BENADRYL AND RESOLVED
55 2021-02-13 numbness Patient at appointed time for second dose and related this event. Patient reported that the vaccine ... Read more
Patient at appointed time for second dose and related this event. Patient reported that the vaccine site became progressively painful, swollen and bruised starting the day after the vaccination. The swelling progressed including his hand, numbness in the ulnar nerve area. By 3-4 days after vaccination he was unable to lift his shoulder so he saw his PCP who suspected a hematoma or thrombus but found neither. He then saw an orthopedist Feb 3 or 4 who was uncertain but sent him to Physical Therapy with a diagnosis of axillary nerve injury. See continuation page
55 2021-02-17 pain in extremity, night sweats sore arm; terrible chills; night sweats; This is a spontaneous report from a contactable consumer, t... Read more
sore arm; terrible chills; night sweats; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 22Jan2021 at 12:15 (at the age of 55 years-old) in the left arm as a single dose for COVID-19 immunisation. Medical history included Behcet's disease and penicillin allergy; from unknown dates and unknown if ongoing. Prior to the vaccination, the patient was diagnosed with COVID-19 from an unknown date and unknown if ongoing. Concomitant medications included adalimumab (HUMIRA), testosterone (MANUFACTURER UNKNOWN), citalopram hydrobromide (CELEXA), dexlansoprazole (DEXILANT), and paracetamol (TYLENOL); all taken for unknown indications from unknown dates and unknown if ongoing. It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine. The patient previously took sumatriptan (IMITREX) from an unknown date to an unknown date and experienced allergy. On 23Jan2021, the patient experienced sore arm, terrible chills, and night sweats. The patient did not receive any treatment for the events. The clinical outcomes sore arm, terrible chills, and night sweats was recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
55 2021-02-18 slurring syncope, headache, slurred speech 2 days
55 2021-02-18 slurring vision skewed, balance off, speech slurred, syncope,
55 2021-02-19 flushing high blood pressure: 188/110; patient felt flushed , unwell and experienced vertigo
55 2021-02-21 weakness Patient was tested for covid on 2/2/21 with positive resulted. Presented to Hospital ER on 2/10/21 w... Read more
Patient was tested for covid on 2/2/21 with positive resulted. Presented to Hospital ER on 2/10/21 with c/o of abdominal pain. Diagnosed with gastritis, prescribed metoclopromide and famotidine and dc home. Returned to ER on 2/13/21 with c/o of weakness, diarrhea, foot ulcer, and loss of appetite. Diagnosed: 1) Dyspnea and hypoxia secondary to Covid-19 2) Extensive bilateral lung infiltrates secondary to Covid-19 3) Increased Cr 4) Increased LFTs, ferritin, d-dimer, troponin secondary to Covid-19 5) Elevated procalcitonin placing the patient at high risk for sepsis 6) Chronic appearing Right foot wound without signs of secondary infection Patient transferred to a different hospital in another city.
55 2021-02-22 seizure Per H&P and physician notes, patient was admitted to hospital on 2/7/21 with status epilepticus from... Read more
Per H&P and physician notes, patient was admitted to hospital on 2/7/21 with status epilepticus from home. He had received his second dose of COVID19 vaccine on 2/6/21 per Emergency Department note. Patient was febrile on admission (40.7 Celsius) and was intubated. Patient had issues with hypotension, neurologic impairment, and metabolic issues. Received pressors, IV fluids, Keppra, IV antibiotics to cover for possible CNS infection. Lumbar puncture performed. Abnormal EEG on 2/9/21. Recurrent seizure on 2/10/21. Pt extubated on 2/12/21. Blood cultures, urine culture, and CSF culture all no growth. Sputum culture mixed oral flora. As of 2/22/2021, patient tolerating tube feeds, shakes head yes and no responding to questions.
55 2021-02-28 pain in extremity Patient had the first dose of the Pfizer COVID vaccine (LOT# EL9264) on 1/29/21 at the vaccination ... Read more
Patient had the first dose of the Pfizer COVID vaccine (LOT# EL9264) on 1/29/21 at the vaccination center at Medical Center (set up in Hotel). He had the second dose on 2/19/21 (LOT# EN6201) at 12:30pm, and reported leg pain and difficulty breathing on 2/26/21 as he was going to bed. He presented to the ER at Hospital that day, and was diagnosed with a deep venous thrombosis and pulmonary embolism. He is currently taking Xarelto, and will schedule an appointment with Hematology, as he has no family or personal history of clotting disorder.
55 2021-02-28 cold extremities 2 fingers on m left hand are cold to the touch. Taking a touchless thermometer reading the temperatu... Read more
2 fingers on m left hand are cold to the touch. Taking a touchless thermometer reading the temperature read 78°. There is no pain but the fingers are cold.
55 2021-03-03 tenderness, muscle spasms Within two hours Swelling on the left arm - upper part and it was painful. The first dose of the vac... Read more
Within two hours Swelling on the left arm - upper part and it was painful. The first dose of the vaccine, the pain started the second day and the injection site got swollen. But this second dose was within 2 hours of my vaccine even more and overwhelming fatigue. - aches, chills, muscle cramps, coughing, sweating - those lasted three days; headache - ever present and felt like head was in a vice; breathing was an issue - asthma was triggered on Sunday - I started prednisone - informal dr consultation with a friend - on Tuesday because of the asthma and by Friday I was feeling halfway better again and by the following Sunday about 75% better. 9 days later I was back at work. It took that week back at work though to get back out of the funk and by the following weekend I was close to 90%. Pain in the shoulder lasted about two weeks - it was quite tender for that long.
55 2021-03-04 pain in extremity pain in right arm redness swelling; pain in right arm redness swelling; pain in right arm redness sw... Read more
pain in right arm redness swelling; pain in right arm redness swelling; pain in right arm redness swelling; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9261), via an unspecified route of administration in the right arm, on 22Jan2021 at 17:00 (at the age of 55-years-old) at a single dose for COVID-19 immunization. The patient had no medical history or allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included atorvastatin calcium (LIPITOR). The patient experienced pain in right arm redness swelling on 23Jan2021. The events were reported as non-serious. The patient did not receive any treatment for the events. The clinical outcome of pain in right arm redness swelling was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
55 2021-03-06 pain in extremity I received my 2nd vaccine shot on Tues. 03-02-2021 and it has my right side from my neck down going ... Read more
I received my 2nd vaccine shot on Tues. 03-02-2021 and it has my right side from my neck down going into my fingers in severe pain, 6 days after receiving my 2nd dose. I have been taking Tylenol 500mg for pain and its not helping at all.
55 2021-03-07 cold sweat, tremor Extreme fatigue, loopiness, slight vomiting in first two days but not since, shaking hands (happened... Read more
Extreme fatigue, loopiness, slight vomiting in first two days but not since, shaking hands (happened on two days, was worse in the mornings but improved as day went on), cold sweats.
55 2021-03-08 pain in extremity Dizziness starting 20 minutes after vaccination. Slightly fast heartrate, sweating, anxiousness star... Read more
Dizziness starting 20 minutes after vaccination. Slightly fast heartrate, sweating, anxiousness starting within 1 hour of vaccination. All of the aforementioned symptoms went away by approximately 5.5 hours after vaccination. Left arm sore starting several hours after vaccination, increasing during the 24 hours after vaccine, then went away by roughly 48 hours after vaccination.
55 2021-03-10 flushing Facial flushing, lightheaded-Cleared by EMS
55 2021-03-10 night sweats Soreness in shoulder yesterday. The next day had headache and tiredness and fever with chills. Last ... Read more
Soreness in shoulder yesterday. The next day had headache and tiredness and fever with chills. Last night had sweats the whole night. Felt fine this morning, all symptoms had gone. Feels pretty good today.
55 2021-03-13 weakness injection site pain, minor, 36 hours duration, resolved no treatment tiredness, 10 hours duration, r... Read more
injection site pain, minor, 36 hours duration, resolved no treatment tiredness, 10 hours duration, resolved - sleep swollen lymph nodes, start within 30 minutes, duration 8 hours, resolved no treatment throat swelling, start within 1 hour, duration 6-8 hours, resolved no treatment dizziness and weakness, start within 2 hours, duration 6 hours, resolved - sleep
55 2021-03-13 unresponsive to stimuli, tremor, weakness Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Severe, Additional Details: note: pt stated no allergies on form and when asked verbally by immunizer. at the 7 minute mark he began to exhibit weakness and started falling off his chair. seemed like he was going to pass out. his breathing seemed labored. we position pt on floor, rph admin epipen to left outer thigh. 911 called. ems responded. pt felt better after epipen. bp, hr normal. pt taken to er by ems
55 2021-03-14 electric shock sensation STARTING AROUND 12:00pPM I EXPERIANCED TWO TIMES WHERE MY HEART STARTED TO RACE FOR ROUGHLY 5 SECOND... Read more
STARTING AROUND 12:00pPM I EXPERIANCED TWO TIMES WHERE MY HEART STARTED TO RACE FOR ROUGHLY 5 SECONDS. AFTERWARDS I EXPERIANCED SHOCK LIKE SENSATIONS AROUND CHEST, AND BACK. NOT SURE IF RELATED TO THE INJECTION BUT NEVER HAD PRIOR AND DIDN'T HAVE THE DAY AFTER OF SINCE
55 2021-03-14 pain in extremity 'Fuzzy brain' & forgetfulness lasting 24 hours. Sore arm lasting 48 hours
55 2021-03-14 pain in extremity ongoing left arm pain. No neck symptoms. Pain radiates to forearm. No numbness. No weakness. Last a... Read more
ongoing left arm pain. No neck symptoms. Pain radiates to forearm. No numbness. No weakness. Last advil was last night.
55 2021-03-18 bell's palsy Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male... Read more
Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 55-year-old, via an unspecified route of administration, administered in left arm on 16Feb2021 08:30 (Lot Number: EN6200) as single dose for COVID-19 immunisation. There were no medical history and concomitant medications. On 20Feb2021, the patient started developing some tingling and the right side of his face doesn't work anymore. The next day (21Feb2021) he went to the doctor and he was diagnosed with Bell's Palsy. He has got full blown, right side of his face was flop, bell's palsy. He went to the doctor and they put him on Prednisone, which he was still treating. The event required a visit to the physician office. The outcome of the event was unknown.
55 2021-03-19 weakness, discomfort, electric shock sensation 30 minutes after receiving vaccine, felt like electric shocks in the head (two to three times). It s... Read more
30 minutes after receiving vaccine, felt like electric shocks in the head (two to three times). It stopped in the evening but got constant low headaches afterwards. Around 5pm, felt like a change in taste (saltier taste) that was temporary. Has uncomfortable wrist pain like twisting a screwdriver too much. Started feeling itchy today after 9 am. Face was swollen after waking up today and has subsided greatly since. Had very low fever last night and now feels like no fever. Right now, feeling has a lot of saliva and then have to swallow and little uncomfortable in arms and knees, and weakness. Only took one Aleve pill last night. Around 4:30pm, felt a little blurry for 5 to 10 seconds.
55 2021-03-19 weakness I started having severe diarrhea the day after the shot , i am weak and exhausted, ight headed , its... Read more
I started having severe diarrhea the day after the shot , i am weak and exhausted, ight headed , its been going on now 6 days
55 2021-03-20 tingling syncopal episode, elevated HR, tingling in fingers, daughter states he's "afraid of needles," EMS ev... Read more
syncopal episode, elevated HR, tingling in fingers, daughter states he's "afraid of needles," EMS evaluated, patient refused transport.
55 2021-03-22 feeling hot Approximately 10 minutes after 1st dose of Pfizer vaccination. Pt. was fanning himself, appeared dia... Read more
Approximately 10 minutes after 1st dose of Pfizer vaccination. Pt. was fanning himself, appeared diaphoretic with mask down. He flagged down nurse and reported feeling hot/lightheaded. NP asked for BP machine, instructed patient to take slow deep breaths. Pt. reported he felt like he may lose consciousness. His eyes rolled and he became white/pale and appeared to stop breathing. Code assist called; didn't respond to sternal rub, but raspy breathing, weak/rapid pulse palpated; immediately transferred to the ground level without falling, 2 person assist. 9-1-1 called, BP machine didn't immediately work. As soon as his head was low, his face became bright red and he regained consciousness. He was disoriented briefly but then able to answer questions/oriented. BP elevated, HR 80s. BS 257. No s/s anaphylaxis. Hx of syncope r/t blood draw. Wife present and report hx of DM, HTN, Palpitations. He denied CP/SOB or palpitations. He had eaten and took regular medicine the morning. Paramedic arrived and patient was transported to the nearest ER. Pt. was later discharged.
55 2021-03-23 facial pain Face very sore and facial glands very swollen. ( hard to eat/ chew) Some lower back pain.
55 2021-03-23 feeling hot, flushing Patient was vaccinated on 3/1/2021 with 1st dose Pfizer, lot EN6205 expiration date 6/30/2021. Patie... Read more
Patient was vaccinated on 3/1/2021 with 1st dose Pfizer, lot EN6205 expiration date 6/30/2021. Patient informed RN that he had flushing, felt hot and dizzy approximately 2min after receiving 1st dose and symptoms resolved 2min afterwards. Patient denied allergies, medications, and medical conditions. Patient suffers from seasonal allergies. RN relayed information to PHN who texted the medical team. Per the medical team, patient is to wait until 28 days post 1st Pfizer dose before receiving Janssen vaccine, it is not recommended to receive Pfizer 2nd dose. Patient was advised to consult with his provider. VAERS report submitted 3/24/2021, confirmation number
55 2021-03-23 pain in extremity, numbness 24 hours post-vaccination, patient developed SEVERE arm pain, such that he has been unable to sleep ... Read more
24 hours post-vaccination, patient developed SEVERE arm pain, such that he has been unable to sleep thru the night and is in near constant pain. Now 6d post vaccination and still very severe pain. Otherwise healthy and fit 55yo. Only able to hold his arm in a couple of positions to get relief from the pain. Feeling numb in entire lower left arm.
55 2021-03-24 weakness, brain damage Within 5-minutes of vaccination, the patient reported weakness and confusion. EMS evaluated the pati... Read more
Within 5-minutes of vaccination, the patient reported weakness and confusion. EMS evaluated the patient on-site. No signs of stroke. EKG demonstrated NSR, rate 77bpm, no ST elevation. FSBG was 290mg/dl. EMS transported the patient to Hospital Emergency Department. Enroute, the patient became increasingly confused, forgetting their birthday and location. Patient was hypertensive (178/104) and reported a "crushing headache". EMS crew became concerned for stroke. In ED, the patient remained hypertensive (178/93). ED Physician had high suspicion of TIA versus acute reaction to COVID-19 vaccine. Administerd 650mg acetaminophen and 1mg Lorazepam. Admitted patient to critical care unit where patient stated they had developed a sudden-onset diffuse banding-like headache with associated nausea, diaphoresis, blurry vision, and confusion. MRI was negative and patient was transferred from ICU to hospital. Hospital physician believed the symptoms were likely a vagal mediated response or reaction to his COVID vaccination. Patient was discharged on 3/20 with diagnoses of TIA, Acute encephalopathy, Insulin-dependent type 2 diabetes, Essential hypertension, CAD, Unspecified mood disorder, Dyslipidemia, Obesity, and Mild neuro cognitive disorder
55 2021-03-24 nerve pain, paralysis, sensory loss Extreme exacerbation of CIDP symptoms. Weakness and paralysis of extremities, inability to walk, lo... Read more
Extreme exacerbation of CIDP symptoms. Weakness and paralysis of extremities, inability to walk, loss of sensation in hands and feet, marked increase in neuropathic pain
55 2021-03-24 pain in extremity Painful lump in my arm pit that came on the morning of 3/25/21.
55 2021-03-24 tingling, weakness Diarrhea , weakness, sharp pain on back left flank, needles in pelvis and extremities, cold extremit... Read more
Diarrhea , weakness, sharp pain on back left flank, needles in pelvis and extremities, cold extremities, headache, disoriented
55 2021-03-25 muscle spasms fatigue, flu-like symptoms, cramping in the legs and neck, severe back pain. Slept 18 hours a day ... Read more
fatigue, flu-like symptoms, cramping in the legs and neck, severe back pain. Slept 18 hours a day for three days
55 2021-03-27 numbness Numb face, forehead and right ear. Ringing in the ears
55 2021-03-27 numbness and pain in extremities, pain in extremity Intense pain around base of tailbone. Mild fever, fatigue, hand/wrist pain, sensitivity to cold. ... Read more
Intense pain around base of tailbone. Mild fever, fatigue, hand/wrist pain, sensitivity to cold. Intense bloating.
55 2021-03-28 weakness Symptoms started 3/19/21 and was diagnosed with COVID-19 on 3/21/21. Presented to ED with weakness, ... Read more
Symptoms started 3/19/21 and was diagnosed with COVID-19 on 3/21/21. Presented to ED with weakness, cough, confusion and fever on 3/27/21. He was started on supplemental oxygen, remdesivir, and dexamethasone and was admitted to hospital for 3 days.
55 2021-03-28 weakness Experienced all symptoms that occured for my actual covid disease. These include dizziness, aches i... Read more
Experienced all symptoms that occured for my actual covid disease. These include dizziness, aches in joints and muscles, extreme chills, injection site soreness(4-5 days), headache, complete lack of appetite and overall weakness. All symptoms lasted for approximately 36 hours.
55 2021-03-28 bell's palsy, numbness 3 days after dose 3/23, felt pain in back of head behind right ear. 3/25, felt right side of face sl... Read more
3 days after dose 3/23, felt pain in back of head behind right ear. 3/25, felt right side of face slightly numb. 3/27, visited ER , CT Scan taken. Diagnosed with Bell's Palsy.
55 2021-03-28 feeling hot started to lose his vision; he couldn't see anything; Shot was painful; he started to get hot with t... Read more
started to lose his vision; he couldn't see anything; Shot was painful; he started to get hot with the sweats; he started to get hot with the sweats; terrible headache; dizziness; nauseated; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 12Mar2021 00:30 (lot number: ENG6199) (at age 55 years old) as single dose for covid-19 immunization administered in a pharmacy or drug store. The patient had no relevant medical history. No known allergies. The patient had no covid prior to vaccination and was not tested post vaccination. Concomitant medication included tramadol taken for numbing shot for tooth, start and stop date were not reported. No other vaccines received in four weeks. The patient experienced the following with his first dose of the Pfizer vaccine. Shot was painful and in about 15 to 20 minutes later everything felt fine. But by the time he and his wife drove out of town, he started to get HOT with the sweats, terrible headache, dizziness and started to lose his vision. He pulled over to let his wife drive and by the time he got out of the car he could barely navigate to the passenger side. They turned around and headed for the hospital, 8 min away, at this time he couldn't see anything, he was nauseated but knew the hospital was pretty close. During this whole time his heart rate never raced just kept and even beat. His breathing was also just fine. By the time they got into the parking lot his vision was slowly getting better, so they sat in the parking lot for 30 minutes with the air conditioner on as high as it could go. His wife read through the side effects, he was experiencing many on the list. They left without going in. Onset of the events was reported as 12Mar2021 12:45 AM. Treatment was not given for the events. The patient recovered from the event "shot was painful" on 12Mar2021; while recovered from the rest of the events on an unspecified date in Mar2021.
55 2021-03-28 tingling tingling foot, gout
55 2021-03-29 flushing Arm started to swell around 3 PM. I had to quit work and go home. I was experiencing some moderate t... Read more
Arm started to swell around 3 PM. I had to quit work and go home. I was experiencing some moderate to severe pain in my left arm where the injection occurred. It is almost 9 PM and the arm still hurts, but not like before. On a scale of 1 to 10 the pain factor was about 5 to 7. I was experiencing some mild shock symptoms (flush face). I couldn't use my left arm for anything, the pain was too great.
55 2021-03-30 weakness Within hours, severe conjunctivitis, muscle pains, back pains, knees swelling. One knee required s... Read more
Within hours, severe conjunctivitis, muscle pains, back pains, knees swelling. One knee required swelling. Debilitation and difficult to walk. I've visited 5 different doctors in 3 weeks. Some symptoms subsided but then they returned following the second shot 3 weeks later.
55 2021-03-30 pain in extremity Right arm pain next morning; Unable to lift arm above shoulder height without sharp pain; This is a ... Read more
Right arm pain next morning; Unable to lift arm above shoulder height without sharp pain; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration, in the right arm on 03Feb2021 03:45 PM (at the age of 55-years-old) as single dose for COVID-19 immunisation. The patient had no medical history. The patient no allergies. 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 concomitant medications. 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: UNKNOWN), via an unspecified route of administration on an unspecified date for COVID-19 immunisation. It was reported that the patient expereinced right arm pain next morning on 04Feb2021. Unable to lift arm above shoulder height without sharp pain on 04Feb2021. No treatment was given to the events. Outcome of the events were recovered on 05Feb2021. Information about batch/lot number has been requested.
55 2021-03-31 night sweats I was woken up at about 1:15AM with major night sweats and vividly scary dreams of scary faces . I ... Read more
I was woken up at about 1:15AM with major night sweats and vividly scary dreams of scary faces . I opened my eyes and I was still seeing the scary faces that were scaring me and causing me to yell and move around in bed while asleep. I girlfriend said I was yelling and moving around a lot prior to waking up. Once awake, I was still seeing the visions for about 2 minutes until I turned on the light and my eyes adjusted to the brightness. When I turned the light off and tried to go back to sleep, the faces appeared again. I was not able to go back to sleep and ended up getting out of bed and going out on the couch to watch TV to avoid being in the darkness and closing my eyes. I'm not one to dream very often and this was certainly and vividly scary night.
55 2021-04-02 weakness, feeling of body temperature change The second day I only had a sore arm where I received the injection. Thereafter, and up until 4/2/21... Read more
The second day I only had a sore arm where I received the injection. Thereafter, and up until 4/2/21 PM when going to bed I had fluctuations of hot and cold sweats, difficulty sleeping, daily low grade fever, neck and shoulder pain, mild to medium headaches, and a much lower than usual energy levels.
55 2021-04-02 pain in extremity Extreme Fatigue; Achiness all over body, particularly back of arms; pain in joints, particularly an... Read more
Extreme Fatigue; Achiness all over body, particularly back of arms; pain in joints, particularly ankle joints, soreness in arm (expected this) and 102.9 temp
55 2021-04-03 weakness, pain in extremity No issues at/during injection, didn't even feel needle surprisingly. 1st 24 hrs, arm soreness as ty... Read more
No issues at/during injection, didn't even feel needle surprisingly. 1st 24 hrs, arm soreness as typical vax reaction 4 me. But that 2nd day after, G.I. issues began middle of nite. So fatigued & short-of-breath, barely made it to dialysis, where they put me on oxygen. All during treatment, BP fluctuated 90-170, temp 96-101, chills (shivering!), continued fatigue & weakness, even after leaving - they wanted to give me antibiotics & send me to e.r.!!! Staff did collect blood sample for culture (result in 24 hrs + neg). I refused antibiotics and e.r., convinced it was vax reaction, and I was right, all normal another day later. Anxious bout 2nd shot ??
55 2021-04-03 weakness On the night after my vaccination in bed I was very dizzy. Next morning dizzy and weak, and now when... Read more
On the night after my vaccination in bed I was very dizzy. Next morning dizzy and weak, and now whenever I put my head back I get dizzy and still when I go to bed dizzy when I?m laying down and when I move on my side. The dizziness does not stop. I?m also experiencing shortness of breath as a result from my daily walks, this never happened before.
55 2021-04-04 pain in extremity 4-5-21 11AM: PT STATES 'PAIN RT ARM (DESCRIBES DELTOID) WHEN HE PUTS HIS ARM ABOVE HIS HEAD.', SINCE... Read more
4-5-21 11AM: PT STATES 'PAIN RT ARM (DESCRIBES DELTOID) WHEN HE PUTS HIS ARM ABOVE HIS HEAD.', SINCE 3-28-21. DENIES ANY PAIN TO SHOULDER OR ELBOW. HAS NOT USED HEAT, COOL PACK OR ANY PAIN MED TO RELIEVE PAIN. HAS NOT SEEN PCP. NO CHANGE IN PAIN SINCE ONSET.
55 2021-04-04 pain in extremity Right foot pain worsening
55 2021-04-04 pain in extremity right foot pain starting less than 24 hours later
55 2021-04-04 tingling Client reported feeling "dizzy, nauseous, and tingly" in the observation area approx 5 mins. after r... Read more
Client reported feeling "dizzy, nauseous, and tingly" in the observation area approx 5 mins. after receiving 1st Pfizer dose. Client was led to wheelchair by EMT and placed in front of the area for closer observation. V/S taken at 2:30pm: HR 58, RR 22, BP 110/68, AOx3. V/S taken at 2:35pm: HR 66, RR 18, AOx3 BP 120/76 and client statement "feeling much better." At 2:45pm client walked away unassisted. No medication or treatment given.
55 2021-04-04 tremor chills and shakes followed by sweats.
55 2021-04-05 feeling cold Lots of pain at injection area. Severe chills lasting 3 hours, sharp pain in right hip. Afterward,... Read more
Lots of pain at injection area. Severe chills lasting 3 hours, sharp pain in right hip. Afterward, real tired and a little lethargic.
55 2021-04-05 pain in extremity Pain in upper arm and neck for close to a week. Got shot on Wednesday and felt sore throughout body... Read more
Pain in upper arm and neck for close to a week. Got shot on Wednesday and felt sore throughout body especially around upper arm and neck. By Friday had biting pain around neck. Could barely move it on Saturday and Sunday. Monday the biting pain left and neck pain started to let up. Tuesday seems like pain is getting better.
55 2021-04-06 feeling cold, weakness On 1/16/2021 I stated having ringing in my ears. I had chills, pain on the vaccine site, dizziness, ... Read more
On 1/16/2021 I stated having ringing in my ears. I had chills, pain on the vaccine site, dizziness, & weakness. I seen my doctor and they did a hearing test he diagnosed with tinnitus. Other symptoms were gone in 2-3 days except tinnitus that is getting worst.
55 2021-04-06 seizure Patient received 2nd dose of Pfizer at 10:14 am on left deltoid, lot # ER8729, expiration date on 07... Read more
Patient received 2nd dose of Pfizer at 10:14 am on left deltoid, lot # ER8729, expiration date on 07/2021. Patient reports no adverse reaction to first dose of Pfizer vaccine. Patient has history of epilepsy, stroke, hemiplegia left upper extremity. Patient takes medication daily for seizure, medication was last taken this morning. At 11:37 am, patient started to have a seizure in the chair. The three EMTs, and a RN responded immediately. No fall occurred, no clusters in observation room. At 11:38 am, EMS was activated. Patient remained in chair throughout seizure and was physically stabilized by EMT . His seizure lasted approximately 1 minute. At 11:38 am, patient was non-verbal, but breathing at a rate of 20 res/min. Patient nodded to respond to neurological assessment. Vital signs were taken every 5 minutes. At 11:38 am, BP 150/77 sitting, HR 103, SpO2 97% RA, RR 20 res/min labored. Patient was transferred to anti-gravity chair with assistance from EMTs. At 11:39 am, patient was able to verbally respond to questions. Patient was alert and oriented to person, place, time and situation. Patient states "I just had a seizure". At 11:42 am, BP 152/98, HR 104, Spo2 at 95%, RR 22 res/min, labored, patient stated "I feel palpitation". Staff approached patient calmly, encouraged deep breathing, provided quiet environment. Upon assessment, patient was alert, oriented X4, clear speech, communicated in Spanish and English. At 11:45 EMS arrived. patient stated "I feel a lot better". Patient was transferred into a gurney and transported to hospital. Emergency responders left with patient at 11:57 am. Patient was accompanied by his brother .
55 2021-04-07 numbness, burning sensation, feeling hot I received the vaccine about two - three inches from the center of the muscle and in back of center ... Read more
I received the vaccine about two - three inches from the center of the muscle and in back of center - it was more in back of deltoid than the front of my deltoid. When I first got the shot, I had a burning sensation from the site of needle to back of neck to behind my ear area. It felt like a burning aching feeling. My ear felt like it was clogged up and aching. I told the medical site about it and the doctor on site said that more likely they hit a nerve. My blood pressure was very elevated. They had me stay to be observed for 45 minutes. I went back to work. I still felt it at night. The next day, I started feeling up my neck and my collarbone and my left side of my face and my head - my face felt tight and my lip felt numb on the left side and I had a slight confusion too. I went to Emergency room. They did CAT Scan and exam. After that, I noticed it was going all the way down my arm, all the left side of my body to toes. It felt like numbness - like neuropathy type feeling. It felt like constant pain. I went to the Urgent Care and they gave me Prednisone steroid (5 days of it) 5 mg to help with inflammation. I took that for the five days. I started noticing a little black bruising on my body. After that, I went to the Urgent Care again and they gave me Naproxen and and Dr gave me more Naproxen to take. He took bloodwork, too. I went to the ER and I was still feeling sick and hot. They said it was anxiety. I am still going through it - I feel it on the spot where I got the shot - and on my neck and on my head and on my left eye and down on my legs a lot - some days are worse than others but not as bad as when I had the first symptoms.
55 2021-04-09 weakness Terrible congestion, runny nose that did not stop from Sunday 4/4/21-Saturday 4/10/21 8:00 am, chest... Read more
Terrible congestion, runny nose that did not stop from Sunday 4/4/21-Saturday 4/10/21 8:00 am, chest, lungs hurt, body aches earlier in week, had to stay in bed on and off all week, no energy, forced myself to eat, severe coughing by Wednesday 4/7/21 which has only stopped on 4/10/21. was most severe Thursday 4/8-Firday 4/9 Could not concentrate all week, even watching tv.
55 2021-04-09 pain in extremity, feeling cold, tremor was in the hospital trying to get his potassium up; extreme lower extremity weakness/my legs didn't ... Read more
was in the hospital trying to get his potassium up; extreme lower extremity weakness/my legs didn't want to work, I had to use a ladder to pull myself up out of the chair; checked his temperature and it was either 101 degree F or 100.1 degree F/running a fever now of 100.1 degrees Fahrenheit; he liked to froze to death in his house; his legs are so sore; chills; shaking; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6204), via an unspecified route of administration, administered in left arm on 23Mar2021 09:00 at single dose for COVID-19 immunization. The patient's medical history included ongoing high blood pressure (began years ago about 10 years ago, states he has no names or lot numbers of the blood pressure pill). The patient's concomitant medications were not reported. On 25Mar2021, the patient experienced chills and shaking. He stated he was probably running a fever but he don't know. On 26Mar2021, he woke up with extreme lower extremity weakness, stating his legs didn't want to work. He had to use a ladder to pull himself up out of the chair. He checked his temperature and it was either 101 degree F or 100.1 degree F. He was running a fever now of 100.1. Patient stated he had the 1st dose on 23Mar2021 and it was about three days ago and then yesterday (26Mar2021) he liked to froze to death in his house which was 80 degrees and he was covered up and had covers on him. He got ready for work today and when he got up his legs did not want to work and it would have been very easy to fall and when he came in, he fell in the door but his legs were so sore and he was running a fever now of 100.1 degrees Fahrenheit on 26Mar2021. Patient had the Pfizer COVID shot in his left arm and had no soreness or anything like that but stated he was in the hospital for three days trying to get his potassium up on an unspecified date and went through sixteen little bags of concentrated potassium and the first potassium bag was on a drip machine. The outcome of the events was unknown. Information on the lot/batch number has been requested.
55 2021-04-09 pain in extremity they had a ultrasound done and found out I had a number of clots in that position; a sore Leg, Upper... Read more
they had a ultrasound done and found out I had a number of clots in that position; a sore Leg, Upper part of the left calf 2 inches below the knee on the backside; This is a spontaneous report from a contactable consumer. A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 15:00 (Batch/Lot Number: En6207) as SINGLE DOSE for covid-19 immunisation. Medical history included Treatable Acid reflex, anxiety and mild depression. Concomitant medications included omeprazole, buspirone and alprazolam for unspecified indication. Patient had the Covid shot on 18Mar2021 at about 3 PM the next morning (on 19Mar2021 06:00) patient woke up with a sore Leg, Upper part of the left calf 2 inches below the knee on the backside. After it did not go away, he went to the doctor then they had a ultrasound done and found out he had a number of clots in that position. Treatment received for the adverse event includes they put patient on a blood thinner. Prior to vaccination, was the patient did not diagnose with COVID-19. Since the vaccination, the patient has been tested for COVID-19. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24Mar2021. Covid test post vaccination done via nasal Swab, They had the results in 15 minutes, covid test result Negative, ultrasound scan: clots in that position on 19Mar2021 found out, had a number of clots in that position. Outcome of the events was recovering.
55 2021-04-12 slurring, numbness Starting slurring speech, right arm went numb and right side of face was not responding. Went to ER... Read more
Starting slurring speech, right arm went numb and right side of face was not responding. Went to ER and they confirmed he was having a stroke. Continued to have multiple strokes at ER from 8:40pm last one was 1:30am (4 hours after clot buster given). Cause of stroke is still undetermined no clots found, no high blood pressure and no high chlorestrol.
55 2021-04-12 pain in extremity Ache leg muscles and lower back Ankle, knee and hip joints ache
55 2021-04-12 speech disorder On 4/8/21 patient reported increased difficulty speaking, increased dizziness, and vision changes. ... Read more
On 4/8/21 patient reported increased difficulty speaking, increased dizziness, and vision changes. Reports new headache rated 8/10 that started at 11am 4/8. Hx of stroke 2018 with residual right side symptoms. BP 162/104, HR 80, O2 sat 97% room air at 1740. Sent to a Medical Center ER and admitted with stroke symptoms and new onset diabetes.
55 2021-04-13 bell's palsy left side BELLS PALSY treated with PREDNISONE
55 2021-04-13 tingling Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-S... Read more
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.), Additional Details: patient called said pain from vaccine hurts badly had to go to doctor and now see physcial therapist; claims was given too high on arm
55 2021-04-14 weakness Fever, dizzy, loss of bladder control, killer head ache, weak.
55 2021-04-14 tingling Left arm pain at injection area and tip of shoulder. Also pins and needle feeling in left hand fing... Read more
Left arm pain at injection area and tip of shoulder. Also pins and needle feeling in left hand fingers.
55 2021-04-14 tremor Lower leg swelling from below knee to top of foot at ankle. Very angry red and swollen. Causing feve... Read more
Lower leg swelling from below knee to top of foot at ankle. Very angry red and swollen. Causing fever shakes and fatigue. Taking Amoxik Clav 875-125 tab. Nort. Began talking on Tuesday for 3 days with slight improvement.
55 2021-04-15 cold sweat few mins after vaccine, felt clammy, dizzy. staff notified, assisted patient to floor to put feet on... Read more
few mins after vaccine, felt clammy, dizzy. staff notified, assisted patient to floor to put feet on chair. few mins later assisted to stretcher and taken to obs. in trendelenberg. states was anxious about vaccine. bp 155/71 hr 86 rr 20 sats 95%. water and snacks provided, sat up, bp 172/68 hr 86, rr 18, sats 98% on ra; stated he hadnt taken his noon lisinopril yet and still pretty anxious. after resting, bp 167/81 hr 87, requesting to leave with spouse. escorted to exit with no further issues, instructed to take lisinopril once home.
55 2021-04-15 pain in extremity I received the first Pfizer injection Tuesday, April 13th. I had signed up for the 12:15 slot, but ... Read more
I received the first Pfizer injection Tuesday, April 13th. I had signed up for the 12:15 slot, but when I arrived it was like a cattle call. I arrived in time for what I thought was a 12:15 appointment but ended up standing in line for an hour before actually getting the shot. I was fine the rest of that day aside from developing soreness in the muscles of my right arm. The following morning, Wednesday, April 14th, I was awakened to very noticeable soreness in both arms and the back of my neck. As the morning progressed, I developed flu-like symptoms, complete body aches, chills, fever, slight nausea, blurred vision, mild diarrhea.
55 2021-04-15 pain in extremity Following day a sore arm and lethargic. 3 days after developed a very foggy mind unable to process ... Read more
Following day a sore arm and lethargic. 3 days after developed a very foggy mind unable to process information, headache severe at times. Severe joint pain throughout body. Nauseous minimal but there. Anxiety very severe at times . 7 days post symptoms remain and elevated anxiety, tired, lethargic, unable to focus, panic attacks, debilitating at times. Woken up from deep sleep still 7 days post of incredibly severe arm pain in arm hat was injected.
55 2021-04-15 tingling, numbness Pt c/o whole boy numbness and tingling.
55 2021-04-16 numbness Feeling pulses, whole arm is numb including fingers are numb
55 2021-04-16 muscle spasms On April 16 had absence seizure. I have not had one in over 7 months and felt no warning or precurs... Read more
On April 16 had absence seizure. I have not had one in over 7 months and felt no warning or precursors. That night fatigue, chills (freezing) headache, nausea, foggy thinking, tense shoulder neck muscles, foot cramps. Day of 17th (ongoing) fatigue, tense shoulders/neck/ lack of hunger, foggy thinking, headache went away with Ibuprofen and Tylenol. Have ate yet so unsure of nausea.
55 2021-04-16 muscle spasms Instant onset Sharp headache, spiked fever, cramping, nausea, with all adverse events intensifying o... Read more
Instant onset Sharp headache, spiked fever, cramping, nausea, with all adverse events intensifying over a 30 minute period
55 2021-04-16 pain in extremity -pain in left arm -dizziness starting on 4/10/21 to current date
55 2021-04-17 slurring, facial paralysis Facial paralysis on right side; Inability to see or focus and many more serious conditions sppeared ... Read more
Facial paralysis on right side; Inability to see or focus and many more serious conditions sppeared 20-30 approx; Inability to see or focus and many more serious conditions sppeared 20-30 approx; slurred speech; confusion; This is a spontaneous report from a contactable consumer reporting for himself. A 55-years-old male patient received the first dose BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, at School or Student Health Clinic, via an unspecified route of administration, administered in right arm on 29Mar2021, at 55 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included allergy to penicillin and sulfa since an unknown date. The patient was not diagnosed with COVID-19 prior to vaccination and he has not been tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. On 29Mar2021 at 12:00 the patient experienced facial paralysis on right side, inability to see or focus and "many more serious conditions appeared 20-30 approximately after injection", slurred speech and confusion, all assessed serious for disability. The patient visited his doctor and was prescribed with unspecified medications and a brain scan. The brain scan was performed on an unknown date and no result were provided. At the time of the report the reported events had not resolved yet. Information on the lot/batch number has been requested.
55 2021-04-17 facial paralysis, bell's palsy Bell's Palsy - face drooped, couldn't keep eye open, left nostril ran only
55 2021-04-17 pain in extremity, tremor, feeling hot cerebral palsy in my left hand and it seems to be a better; left hand started hurting; couldn't move... Read more
cerebral palsy in my left hand and it seems to be a better; left hand started hurting; couldn't move fingers; my whole hand swelled a little bit; hand had like a slight fever to it, it was warm; chills my whole hand like it's going down; little jerks in my hands; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP6955; Expiration Date: 30Jun2021), dose 1 via an unspecified route of administration, administered in Arm Right on 24Mar2021 (at the age of 55years) as single dose for Covid-19 immunization. Medical history included Chronic obstructive pulmonary disease (COPD), heterotaxia (Situs inversus), ankylosing spondylitis, back problem, and cerebral palsy; all from an unknown date and unknown if ongoing. Concomitant medications included diazepam, methocarbamol, meloxicam, salbutamol (ALBUTEROL), and unspecified muscle relaxant; all taken for an unspecified indication, start and stop date were not reported. The patient reported side effects that has official after taking the COVID shot (confirmed as Pfizer COVID Vaccine). The patient stated "I've got cerebral palsy in my left hand and it seems to be a better connection in my left hand, I can now, it's easier for me to pick up small objects and I used to have problems doing that. It is like, I am messenger pain is eating my nerve endings. But here's what happened, 2 days after taking the shot around 26th, I took the shot on 24thMarch, 2021; I took Diazepam, Meloxicam and muscle relaxer (captured as unspecified medication) for back problem. I don't even know if it had anything to do with it, might be just been all the shot, but methocarbamol too. I took those 3 drugs, 2 hours after that, my whole hand, my whole left hand, just my left hand started hurting (further clarification unknown hence captured as suspect conservatively). In my left-hand kind of after feeling and I couldn't move my fingers as well. And afterwards it was in March, it started hurting, my whole hand swelled a little bit. It had like a slight fever to it, it was warm, and it swelled up just slightly not up here, nothing big. I still can't put in my ring, but it was slightly bigger than what it is today, and this hurt. It felt like, I've chills my whole hand like it's going down. So, I work it out, I stretched it, that helped the pain so I could work with them during my fingers stopped working it out. And then afterwards I found out I could, my hands were moving better, it works better. Before I've like little jerks in my hands, you know my hand wouldn't do what I wanted it to do. What I wanted to do more, I can press button, I can pick up smaller objects. It's not 100 percent better, it's not as good as my right hand which had no cerebral palsy in it but it's a lot better than it was. So, I just wanted to report that." The outcome of events was unknown.
55 2021-04-18 pain in extremity Pain in left jaw bone / joint area 4 days after vaccine shot; pain / soreness in left arm & shoulder... Read more
Pain in left jaw bone / joint area 4 days after vaccine shot; pain / soreness in left arm & shoulder area; overall feeling of tired
55 2021-04-19 feeling hot, tingling, flushing Approximately 48 hours after shot I started feeling very warm flush and experiencing tingling in han... Read more
Approximately 48 hours after shot I started feeling very warm flush and experiencing tingling in hands and feet. No fever, headache or joint pain. Also just not feeling like myself. Lack of concentration, agitated, general fatigue. Hand and feet tingling has been worse and night and causing interrupted sleep. This feeling has not gone away and I'm now past two weeks since shot and Wondering if I should get second dose.
55 2021-04-19 muscle spasms, pain in extremity Patient was diagnosed with deep venous thrombosis 11 days after receiving Pfizer Covid-19 vaccine. ... Read more
Patient was diagnosed with deep venous thrombosis 11 days after receiving Pfizer Covid-19 vaccine. Patient developed L leg pain and swelling 3 days after vaccine. First notice pain with swimming when he felt a cramp. Over next few days leg became painful while walking on it. He had no shortness of breath or trouble breathing except for a brief time while he was swimming and felt as if he was slightly shorter of air than normal. He has had no injury to the leg that he can remember. He has not been immobilized or gone on long trips lately. Patient was diagnosed with DVT on 4/13. Patient was started on Xarelto
55 2021-04-19 pain in extremity, muscle spasms Patient developed pain and swelling in Left leg on 4/5/21. He first noticed it when he was swimming... Read more
Patient developed pain and swelling in Left leg on 4/5/21. He first noticed it when he was swimming and felt a cramp to his leg. Over time it began hurting when he walked on it. He has had no shortness of breath or trouble breathing except for a brief time while he was swimming and felt as if he was slightly shorter of air than normal. Patient was positive for DVT and started on Xarelto
55 2021-04-19 pain in extremity Fatigue, sore arm, muscle aches, low grade fever overnight
55 2021-04-21 weakness, pain in extremity, numbness Pain and numbness in right arm. Loss of strength. Been taking otc Tylenol, sometimes otc ibuprofen.... Read more
Pain and numbness in right arm. Loss of strength. Been taking otc Tylenol, sometimes otc ibuprofen. Recently prescribed 800mg ibuprofen but have not taken any at present time
55 2021-04-21 pain in extremity He got the vaccine, he had no issues at all. Then on Friday evening 4/16/21 around 6:00 PM he start... Read more
He got the vaccine, he had no issues at all. Then on Friday evening 4/16/21 around 6:00 PM he started having no appetite, he's having delusions/awareness of what's going on, headaches, light headedness. He still having soreness of the arm. He is having difficulty walking due to the dizziness. He is also having some coughing and congestion issues. He has a history of alcoholism and smoking. Has not taken anything for these symptoms, no insurance and trying to deal with it on his own to see if it would go away.
55 2021-04-21 tingling Patient received vaccination at 10:32 am. Patient stated he began feeling tingly sensation to eyes a... Read more
Patient received vaccination at 10:32 am. Patient stated he began feeling tingly sensation to eyes after 10:42 am. Vital signs taken. BP 118/88, pulse 67, RR 16, oxygen saturation 97. No signs of distress noted. Patient offered water, but declined and continued drinking his coffee out of mug. 10:45am patient states tingling in eyes has lessened. 10:52 am patient states tingling completely gone. Patients states it is not unusual for him to experience tingling sensation in the knees when changing positions occasionally.
55 2021-04-21 tingling Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient described ... Read more
Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient described tingling around mouth. No swelling of mouth or lip color change, nor were there any changes in speech. Patient accepted a Benadryl and 10 minutes later, the tingling subsided. Patient is waiting the full advised 30 minutes after shot and is doing well. Patient's wife will drive him home.\r\n
55 2021-04-22 weakness Patient Sick- Can?t get up, Fever, chills, Had Covid Shot yesterday. T 101.0-.5-6 P 72 R 32 BP 150/... Read more
Patient Sick- Can?t get up, Fever, chills, Had Covid Shot yesterday. T 101.0-.5-6 P 72 R 32 BP 150/80 Sat 92 % ?no strength.? Hospitalized on 4/9/2021 with Sickle Cell Crisis
55 2021-04-22 weakness Shoulder swelled and became sore. Eventually whole body became sore, weak, hot and sleepy. Developed... Read more
Shoulder swelled and became sore. Eventually whole body became sore, weak, hot and sleepy. Developed fever/chills 99.5. Headache all day. Cough for about two hours. Symptoms faded overnight. No treatment.
55 2021-04-23 feeling cold fever; Feeling cold; This is a follow up spontaneous from a contactable consumer. This 55-year-old m... Read more
fever; Feeling cold; This is a follow up spontaneous from a contactable consumer. This 55-year-old male consumer reported that the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, LOT number: unknown), via an unspecified route of administration on an 10Feb2021 5.00 (Age at vaccination:55-year-old) at single dose for Covid-19 immunization. The patient's medical history and concomitant medications was not reported. The patient did not have anything done on Thursday, but on Friday evening he got a fever and that was right after 2 days of getting the vaccine and he still has a fever. So, Friday night, Saturday night, Sunday night he had fever and on Monday morning he still has it. It goes down when taking Tylenol. Temperature went as high as 100.7.This morning he didn't have any fever, it was 97.9 and now it's at 98.9. He is also feeling cold. The patient wants to know if this is normal or is it because of the vaccine or did he actually get Covid after the shot. Could it be flu or anything, should he get Covid testing. On 10-Feb-2021, the patient was feeling cold and 12-Feb2021 the patient had fever. The patient was taking Tylenol for fever since 12Feb2021, and Tylenol therapy was still ongoing. The outcome of the events was reported as nor recovered. Information about lot/batch number has been requested.
55 2021-04-23 night sweats I had pain at injection site, mild night sweats, and increased tinnitus (I have had tinnitus for man... Read more
I had pain at injection site, mild night sweats, and increased tinnitus (I have had tinnitus for many years) the night of / after the first and second shots (03/26/21 and 04/16/21) After the second shot, I had less pain at the injection site, mild body aches, and increased tinnitus the night of the second injection. However, the real reason I am reporting this is because after the second dose, the increased tinnitus continued intermittent, usually in the evenings. The tinnitus became especially pronounced on day 2 or 3, 4, 5 and day 8 - the ringing became so loud on the evening of day 2 that it seemed I was having trouble hearing the television. And on the evening of day 8 after the second dose, the tinnitus again became quite loud, with the additional symptom that external noises were annoying / irritated me. I have had constant tinnitus for at least 20 years, and it almost never bothers me (or is even noticeable.) However, the tinnitus symptoms after the second Pfizer shot were pronounced enough that I thought I would report it. Of course, I can't be sure the tinnitus symptoms - especially those at days 4, 5 and 8 - are indeed side effects of the second dose of the Pfizer vaccine, but since I had increased tinnitus symptoms the night after both the first and second Pfizer doses, it would seem to me to probably not be a coincidence.
55 2021-04-24 weakness feeling dizzy when he went to bed/dizziness occasionally throughout the day; feeling weak; a little ... Read more
feeling dizzy when he went to bed/dizziness occasionally throughout the day; feeling weak; a little bit out of breath; This is a spontaneous report from a contactable consumer. A 55-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 55 years old on 02Apr2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced feeling dizzy when he went to bed/dizziness occasionally throughout the day on 02Apr2021, feeling weak in Apr2021, a little bit out of breath in Apr2021. The patient was calling on behalf of her husband, the patient had first dose on 02Apr2021 and started feeling dizzy when he went to bed that night, he's dizzy when laying down in bed sometimes it woke him up, he had dizziness occasionally throughout the day and he was also feeling weak and a little bit out of breath. The patient was concerned on getting second. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
55 2021-04-25 bell's palsy Bell's palsy.
55 2021-04-25 burning sensation At 7:00 pm feeling burning sensation on upper lips with bumps
55 2021-04-25 difficulty speaking Dysphora lose of appetite unable to preform routine work tasks unstable on feet unable to drive safe... Read more
Dysphora lose of appetite unable to preform routine work tasks unstable on feet unable to drive safely removed from work position
55 2021-04-25 flushing As the client was exiting the vaccination hallway, the client informed a vaccinator that he felt tin... Read more
As the client was exiting the vaccination hallway, the client informed a vaccinator that he felt tingling in his mouth, was experiencing an indescribable taste and his eyes hurt. The client looked flushed. The client was instructed to lay on a mat on the floor. Client drank some juice and ate some pretzels. After 20 minutes he reported that he was no longer experiencing any symptoms. As the client was standing up he reported that he felt dizzy but this resolved as he walked around the room. He then wanted to sit outside so two nurse's went with him . After 40 minutes he reported that all of his symptoms had resolved. We followed up with the client on 4/25/21 and the client reported that he had not experienced any additional symptoms.
55 2021-04-25 night sweats, tremor 12 hours after receiving the second Pfizer Covid 19 vaccination dose, I started getting chills and b... Read more
12 hours after receiving the second Pfizer Covid 19 vaccination dose, I started getting chills and body shakes for about 24 hours. I had significant night sweats waking up completely soaked. I measured a fever at 101.7 in the morning of the next day after the dosing of 2 advils clearly had worn off. I continued to take 1 advil every 4 -6 hours when i noticed getting chills again until the afternoon on 4-25-2021 when I started to feel better. i had no other sideeffects with the exception of body aches which I contribute mostly to staying in bed for over 24 hours.
55 2021-04-27 pain in extremity Sore/achy arm.; This is a spontaneous report from a contactable consumer (patient). An 55-year-old m... Read more
Sore/achy arm.; This is a spontaneous report from a contactable consumer (patient). An 55-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE (age at vaccination was 55 years), solution for injection, lot number: EN6207 and expiry date was not provided), via an unspecified route of administration in the left arm, on 25Mar2021 at 10:00, as single dose for COVID-19 immunisation. Medical history included allergy with penicillin. Patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 25Mar2021 at 15:30, the patient had sore and achy arm. Treatment mediations were not reported. Outcome of the event recovered in Mar2021.
55 2021-04-27 tingling, numbness right leg numb in the following areas, right buttocks, right calf, and right side of foot. After se... Read more
right leg numb in the following areas, right buttocks, right calf, and right side of foot. After several days is was just the foot. After second shot numbness continues.. It felt like something had fallen asleep, like when you set on your leg wrong.
55 2021-04-28 numbness Bilateral facial numbness, persistent, unknown etiology, x2 normal MRI, normal MRA
55 2021-04-28 muscle twitching Upon second dose I have constant twitching at and around injection site of left upper arm, it is ver... Read more
Upon second dose I have constant twitching at and around injection site of left upper arm, it is very disturbing and persists to this moment. I noticed it about 24 hours after the shot. I also have the totally normal soreness at the injection site that persists to this moment. I did have flu like symptoms (body aches, limb weakness arms and legs, malaise) on 4/28/21 from 1pm till 9pm but has resolved. The First shot I do not remember which arm, I think it was the left but cannot be certain, but I had no side effects at that time. I also have a very occasional twitch in my right upper arm that persists to this moment which is similar to the twitch in my left arm but is much much less severe and very infrequent. Note I have specifically nickel allergy and a number of other minor allergies. I also used to have benign fastulations that were random though my body which resolved and has not been an issued since 2017.
55 2021-04-28 tenderness, pain in extremity, numbness LEFT LOWER EXTREMITY ISCHEMIC LIMB; ARTERIAL THROMBOSIS A week after the first dose, patient develop... Read more
LEFT LOWER EXTREMITY ISCHEMIC LIMB; ARTERIAL THROMBOSIS A week after the first dose, patient develop acute onset of left 3rd toe tip pain and tenderness.This gradually progressed to pain under his metatarsal head in the left foot. Gradually over the last 2 weeks, he has also noted increasing hip and buttock muscle fatigue with walking. Two nights ago, he developed increasing pain in his left forefoot. Yesterday, his left foot became numb and he went to Medical Center for evaluation. While there, he was found to have an ischemic left leg with lack of Doppler signals in his left foot and subsequently underwent CT angiography. This CT scan demonstrated left internal iliac occlusion, partially occlusive thrombus within the left external iliac artery with widely patent femoral popliteal system bilaterally. However, his left peroneal and anterior tibial arteries were occluded for segments, while the distal left posterior tibial artery appears occluded, although this may represent contrast bolus timing issues He has no known prior history of thrombotic issues. He has no family history of clotting abnormalities. He denies any palpitations or history of cardiac arrhythmia. He has been in sinus rhythm since his initial presentation.
55 2021-05-02 burning sensation Two days after my second shot, I started experiencing really bad joint pain, a headache, a fever an... Read more
Two days after my second shot, I started experiencing really bad joint pain, a headache, a fever and what felt like my veins were on fire. I received the shot on Wednesday and was fine on Thursday and Friday morning, but I had taken Tylenol and Airborne all day Wednesday Thursday and Friday morning in the hopes of reducing symptoms. The headache started on Friday afternoon. The other symptoms on Saturday morning and lasted on and off all weekend. It went a way for a bit, but then came back. The weather was very rainy, so I wrote it off as mild arthritis pain, but it persisted and kept getting worse. But, we had a rainy March and April. It is now May and the pain continues. Sometimes in my joints. Sometimes not. Across the back of my right hand is the worst and almost constant. On and off, I get the headaches, pains in my joints or muscles, or just across my thigh, or my calf. None of this happened before the shot, so I am thinking it may be elated.
55 2021-05-02 numbness Pain, discomfort at injection site - feels like punched hard in the arm. Numbness, tingling below th... Read more
Pain, discomfort at injection site - feels like punched hard in the arm. Numbness, tingling below the wrist on the injection arm (lasted about an hour or so). Worst side effect was the "brain fogginess" - that lingered for almost 4-5 hours. Felt very odd, out of sorts.
55 2021-05-02 pain in extremity He had a second Covid shot 8 days ago. Yesterday he noticed the onset of a painful red swelling in ... Read more
He had a second Covid shot 8 days ago. Yesterday he noticed the onset of a painful red swelling in his left medial calf. Left calf shows varicose veins. There is marked erythema and tender swelling along the vein of the medial calf. There is no palpable clot. Negative Homans sign.
55 2021-05-03 numbness numbness in the left foot after the covid-19 vaccine. I still have the numbness from April 17, 2021... Read more
numbness in the left foot after the covid-19 vaccine. I still have the numbness from April 17, 2021, to this day.
55 2021-05-03 pain in extremity Afib; sometimes sharp and sometimes dull pains that would last 10-60 seconds throughout her body-cal... Read more
Afib; sometimes sharp and sometimes dull pains that would last 10-60 seconds throughout her body-calfs, things, forearms, toes, finger and even his stomach; sometimes sharp and sometimes dull pains that would last 10-60 seconds throughout her body-calfs, things, forearms, toes, finger and even his stomach; sometimes sharp and sometimes dull pains that would last 10-60 seconds throughout her body-calfs, things, forearms, toes, finger and even his stomach; This is a spontaneous report from a contactable consumer (patient). A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03Mar2021 (Batch/Lot Number: EN6198) (age at vaccination: 55-year-old) as SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included nebivolol nebivolol hydrochloride (BYSTOLIC) taken for an unspecified indication from 2013 and ongoing; doxycycline (ORACEA) taken for an unspecified indication from Jul2020 and ongoing. Historical vaccine included first dose of bnt162b2 (Batch/Lot number: EC9269) on 02Feb2021 as single dose in Left arm for covid-19 immunisation. The patient had been experiencing pains on and off for about5-6 days after his first slot. Then he read an article (he swear, he was not researching anything online) about a 56 year old man who developed ITP days after receiving Pfizer vaccine. since he had Afib this article worried him. He had no idea what blood clots felt like, but he was having sometimes sharp and sometimes dull pains that would last 10-60 seconds throughout her body-calfs, things, forearms, toes, finger and even his stomach. The doppal came back negative. The doctor suggested symptoms finally disappeared for good about two days after his second dose. The outcome of the events was unknown.
55 2021-05-04 pain in extremity About 12 h after vaccination, I got headache, chills, body aches and low fewer which lasted until ne... Read more
About 12 h after vaccination, I got headache, chills, body aches and low fewer which lasted until next day; About 12 h after vaccination, I got headache, chills, body aches and low fewer which lasted until next day; About 12 h after vaccination, I got headache, chills, body aches and low fewer which lasted until next day; About 12 h after vaccination, I got headache, chills, body aches and low fewer which lasted until next day; This is a spontaneous report from a contactable consumer (reported for himself). A 55-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown) via an unspecified route of administration on 16Feb2021 at 07:45 as SINGLE DOSE (at the age of 55-years) in left arm for covid-19 immunization. Medical history included high cholesterol. The patient had no known allergies. Historical vaccine included: the patient received first dose of bnt162b2 via an unspecified route of administration on 26Jan2021 at 07:30 as SINGLE DOSE (at the age of 55-years) for covid-19 immunization. The patient did not receive any other vaccine in four weeks. Concomitant medications included: atorvastatin (Lipitor), diphenhydramine hydrochloride (Benadryl), Ibuprofen and unspecified multivitamins. Prior to the vaccination the patient was not diagnosed with COVID-19. On 16Feb2021 at 20:00, about 12 hours after vaccination, the patient experienced headache, chills, body aches and low fewer which lasted until next day. It was reported that there was no treatment for events. Since the vaccination the patient had not been tested for COVID-19. The outcome of the events was recovering.
55 2021-05-06 night sweats Coughing blood; Trouble Breathing; Lungs Damaged; Coughing; Headache; Fever; Body Shakes a Lot with ... Read more
Coughing blood; Trouble Breathing; Lungs Damaged; Coughing; Headache; Fever; Body Shakes a Lot with Cold; Night Sweats, states it is like he took a shower; Diarrhea, states when he goes to the bathroom, it is water; Lost 14 Pounds; felt really bad; This is a spontaneous report from a contactable consumer reported for himself. A 55-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left at 55 years old on 06Apr2021 08:45 (Lot Number: ER8733; Expiration Date: 31Jul2021) at single dose for covid-19 immunisation. Medical history included ongoing high blood pressure, diagnosed 20 years prior to the report. The patient's concomitant medications were none. There were no other vaccines Administered on Same Date of the Pfizer Suspect or within 4 weeks. The patient experienced coughing, headache, fever, body shakes a lot with cold, night sweats, states it is like he took a shower; diarrhea, stated when he went to the bathroom, it was water, coughing blood, trouble breathing, lungs damaged, lost 14 pounds, all on 06Apr2021. Patient stated he was calling because his doctor told him to call. Stated he got his first injection on 06Apr2021. Told to sit for 15 minutes, and he felt fine and went to work and felt really bad after 1 hour; 09:45-10:00. Since then he had been super sick and at the hospital 3 times, later confirmed ER, not hospitalized. Patient stated the doctor also told him his lungs are damaged and they were sending him to see a specialist. Patient was asking what was going on with his body, is this a normal reaction? Stated his doctor said to call because it had been too long, stated usually it lasted 2-3 days and with Tylenol, it was gone, then it should be clear, but it had been almost 16 days for him. Stated one hour after his injection, he started feeling really bad. Stated he was coughing up blood from coughing so much. Stated he was 154 pounds, but he has lost 14 pounds. Patient stated his first injection was on 06Apr2021. Stated his second vaccine is supposed to be on 28Apr2021 but he was not going because he was afraid to go back in case it got worse. Treatment received for the events included 3 Different Antibiotics; Tylenol and Drinking Hot Tea. Patient clarified that he has had 3 Emergency Room Visits (10Apr2021, 19Apr2021, and 20Apr2021), Physician Office on 21Apr2021, but he was never admitted to hospital. Patient stated one time they kept him in the ER for 20 hours. Patient stated once he went to Hospital and then yesterday and the other day, he went to Hospital because he was having trouble breathing. The outcome of the events was not resolved. No follow-up attempts are needed. No further information is expected.
55 2021-05-07 bell's palsy, facial paralysis Facial paralysis on the right side (Bell palsy)
55 2021-05-07 pain in extremity, numbness, muscle spasms Extreme fatigue; Back of knees were cramping; Small bruise marks; Upper right arm inside he could se... Read more
Extreme fatigue; Back of knees were cramping; Small bruise marks; Upper right arm inside he could see all of his veins; Head rush; Felt like he was going to spazz out; Sweating; Diarrhea; Headache and pressure at his temples; His ears were ringing; Left arm pain from injection site; Drop foot; Legs went to sleep; Arms were roided out or supercharged/Forearms did not feel like his blood was right; Difficulty/pain breathing in the upper chest; Difficulty/pain breathing in the upper chest; Pretty big at the base of his left index finger, red spot; Pain in the right thumb base/Pain in base of right foot; He felt like he was going to die 5 times; Thought he was having a stroke; Heart rate would go up or be faint; Lost four pounds during this, and gained one back; Stiff right arm/Left thigh was stiff; Thrashing event; Heart rate went up; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, expiration date: 28Mar2021) via an unspecified route of administration on left arm 24Mar2021 10:00 at single dose for covid-19 immunization. Medical history included cytomegalovirus from on an unspecified date 2010 and Palpitations. The concomitant medications were not reported. The patient reported, he has gained back a pound and that he is starting on the road to recovery in the last week. Stiff right arm lasted the first and second week. It started the first day of when he got the shot. The next morning, he calls a thrashing event where he felt like his limbs would not work. They did work, but it felt like he needed to move them around. He was thrashing in bed and making the motion with his big joints, then getting into the small joints. It was his arms and legs. Over the course of like an hour, his heart rate went up to like 120. He does not qualify this as racing, but his heartrate is normally 60. This was several times over the course of the first week so it would have been around 04Apr2021 or 03Apr2021. Events occurred 9 days later, which is what he is considering this first week. His left arm was where he got the vaccine, but his right arm was stiff. He felt like he was going to die 5 times. He also had extreme fatigue. He never went to the emergency room. At this time, his glucose was high and his zinc was low. The doctor thinks the extreme fatigue was the antibodies reacted to the cytomegalovirus. He adds that the back of his knees was cramping in the first and second week. In the right arm, he had some small very small bruises. His forearms did not feel like his blood was right. He does not know how to describe it, but he has had metal slivers in his arm in the past and it felt like that, like an infection. He does not know how to describe it. He adds that in his upper right arm inside, he could see all of his veins, like a roadmap. He also had some other things, like his left side of his head rush, like it felt like blood was rushing from the top to left side of his brain. At dinner and meals he had several instances he could barely sit there, he felt like he was going to pass out or spazz out. His limbs felt like they were going to spazz out. In second week, he had several nights where he sweated a lot overnight. The second week into the third week, he did not have the thrashing stuff anymore but for pretty long his heart would go up a notch and/or the heart would be faint. He had diarrhea when he got up. It did not go up to 120, but maybe 80, Headache and pressure at his temples, ears ringing. Left arm pain from injection site. It started with a bang and really hurt. It was really sore and kind of spread into cramping. It was stiff and the source was the injection site. At work, he thought he was having a stroke. His left leg and thigh were stiff and spreading feeling. About 20 minutes after sitting, his legs did not work, and he collapsed. He had Drop foot when his legs got stiff. It took like a week to retrain his arm and leg, like he had a mini stroke. He did therapy for himself and retrained his arm to play guitar. He had a little bit of stiffness in his left arm that comes and goes, stiffness in his left thigh that comes and goes, and his ears are ringing a little bit and it comes and goes. He is not getting second vaccine. He took zinc per his doctor recommendation, but it did not go well. He felt like his arms were roided out or supercharged. He had difficulty/pain breathing in the upper chest, a pretty big at the base of his left index finger red spot like blood collection, and pain in the right thumb base. He had pain in the base of his right foot. Blood tests were in the second week. Glucose was high and he is hypoglycemic. Glucose 117 mg/dl (79-115 normal range), zinc 54 mcg/dl (60-120 normal range), CMV IGG AB >10 u/mL (positive is > or = 0.7 range). The outcome of the events was unknown.
55 2021-05-08 muscle twitching Fever 101.4, chills, exhaustion, body & head electrical jolts, tinnitus. Electrical jolts starting... Read more
Fever 101.4, chills, exhaustion, body & head electrical jolts, tinnitus. Electrical jolts starting to subside 5/9/21. Tinnitus continues still.
55 2021-05-11 bell's palsy Bell's palsy symptoms started up a few hours after the shot/had it two years ago; Bell's palsy sympt... Read more
Bell's palsy symptoms started up a few hours after the shot/had it two years ago; Bell's palsy symptoms started up a few hours after the shot/had it two years ago; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on 26Apr2021 14:00, as 2nd dose, single, for COVID-19 immunisation. Medical history included Bell's palsy in 2019 (had it two years ago). The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC); and cimetidine (TAGAMET), both taken for unspecified indications, start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported) at age 55 years, administered in the left arm, on 05Arp2021 14:00, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. Bell's palsy symptoms started up a few hours after the shot, on 26Apr2021 at 16:00. The patient had it two years ago. The patient was recovering from the event (reported as subsiding 24 hours later). Follow-up needed. Information about batch/lot number has been requested.
55 2021-05-12 tingling About 3 days after first vaccine I started experiencing tinnitus, pressure/tension at the base of my... Read more
About 3 days after first vaccine I started experiencing tinnitus, pressure/tension at the base of my skull and symptoms of occipital neuralgia as significant tingling over my scalp and mildly in my face. I did not put this together with the vaccine until is clearly worsened after my second.
55 2021-05-13 facial pain Left Side of Head and Face Hurt Teeth, Head, Ear, Sinus, Neck Pain
55 2021-05-13 pain in extremity the pain was shooting down to his heart; severe pain in his left shoulder after that second dose; in... Read more
the pain was shooting down to his heart; severe pain in his left shoulder after that second dose; injection site pain; pain is around his arms/going on the top of his legs; back and wraps down to the heart; major pain up around his shoulders and around the back of neck; I have stomach problems, I am collapsed stomach; This is a spontaneous report from a contactable consumer (patient). This 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in his left arm on 05Apr2021 at single dose for COVID-19 immunisation. Medical history included Arthritis, Sinus problem, Asthma, Bipolar disorder. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 on unspecified date at age of 55 years old for COVID-19 immunisation. The patient experienced injection site pain, severe pain in his left shoulder after that second dose. Some major pain up around his shoulders and around the back of neck, his left side was worst. He said that the pain was shooting down to his heart. So he went to the hospital because he thought it was something to the heart. They tested him, they evaluated him but they ruled out anything that has to do with the heart. They checked his heart, he had a cardiac catheterization, and was ruled out, everything came out negative. So, he just got out of hospital and was still developing the pain and it's on his left side, it's on his right side (as reported). He called all his doctors, they had no answers for him, now he was still in a lot of pain in both of shoulders like he was saying his left side was still the worst, and it has not gone away and the pain is still shooting down around his heart and shooting down around the back of neck and now it's going on the top of his legs. He went to the bone doctor and he was getting an MRI done, because the doctors said nothing was torn in his arms or tissues. He stated the pain was around his arms, back and wraps down to the heart. He was in dire pain, 8.5/10 and had a feeling of it was related to the vaccine. He clarified the pain was in both shoulders and the left side was worse and that was the side he had his shot on. Patient stated he had stomach problems, he was collapsed stomach. The outcome of events was unknown. Information on the lot/batch number has been requested.
55 2021-05-13 tremor Pulmonary embolism in his left lung; Chills; Hard to breathe; shaking a lot; This is a spontaneous r... Read more
Pulmonary embolism in his left lung; Chills; Hard to breathe; shaking a lot; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0164) via an unspecified route of administration on 19Apr2021 at 12:00 (at the age of 55-years-old) as a single dose in the left shoulder for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) from an unspecified date and ongoing and urinary tract infection (UTI) from an unspecified date and unspecified if ongoing. Concomitant medications were reported as none. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: first letter is either a G or O but he thought it was OE8732) via an unspecified route of administration on 29Mar2021 at 11:45 (at the age of 55-years-old) as a single dose in the left shoulder for COVID-19 immunisation. Illness at vaccination was UTI. On 20Apr2021 the patient experienced pulmonary embolism in his left lung, chills, hard to breathe and shaking a lot. The patient was hospitalized for pulmonary embolism in his left lung (blood clot) from 20Apr2021 to 26Apr2021. The clinical course was reported as follows: The patient stated that he had the second Pfizer shot on 19Apr2021 and on the 20Apr2021 he had a really bad reaction to it. He had chills, it was hard to breath, he was shaking a lot and had a UTI and COPD and had to call an ambulance to come get him. When he went to the emergency room, they did a CT (computerized tomography) scan of his chest and found a pulmonary embolism in his left lung and he was put on a Heparin drip for 7 days and stayed in the hospital for 7 days. The event hard to breathe ended shortly after he got to the emergency room since he was on oxygen. The patient had a history of COPD, so sometimes he had trouble breathing, but right now he did not. The event shaking a lot ended a little after he got to the emergency room. The patient also stated that he had a history of UTI in the past and had a UTI during the vaccine but was not treated for the UTI until he was at the hospital. The clinical outcomes of the event pulmonary embolism in his left lung was unknown; chills, hard to breathe and shaking a lot were all recovered/resolved on 20Apr2021.
55 2021-05-14 muscle spasms, seizure I felt absolutely fine after eating dinner, but was tired so got in bed around 9:30. I had some ver... Read more
I felt absolutely fine after eating dinner, but was tired so got in bed around 9:30. I had some very vivid dream & woke up at 11:00, the sheet on the bed was wet with sweat, drool on pillow & every muscle in my body was cramped up. I think it was a convulsion/seizure, but was alone in the hotel room. Today, I feel perfectly normal -
55 2021-05-15 cold sweat, pain in extremity pain in arm, within 5 days-very tired and no apatite, fever/chills/cold sweats. within 30 days, sin... Read more
pain in arm, within 5 days-very tired and no apatite, fever/chills/cold sweats. within 30 days, sinus tachycardia, low Sp02, started having a cough. Sepsis secondary to severe right lung necrotizing pneumonia with empyema, hospitalized for 5 days. Discharged with a right chest tube with Pleur-evac. Will require at least 6 weeks of antibiotics.
55 2021-05-17 bell's palsy Bell's palsy started 5-6 days after dose #2 of Pfizer COVID vaccine.
55 2021-05-18 pain in extremity Long term painful arm, then a crazy fluctuating fever with headache and chills for 5 days 3 weeks af... Read more
Long term painful arm, then a crazy fluctuating fever with headache and chills for 5 days 3 weeks after shot, followed by congestion, coughing and then a growing red rash patch at sight of injection. Now 5 weeks later, hives all over my body including rash at injection site. Becoming itchier daily, not responding to antihistamines.
55 2021-05-19 burning sensation severe fever, chills, burning headaches.
55 2021-05-21 numbness, bell's palsy the muscles in my face felt weak as if I was having an onset of Bell's Palsy; it was a strange feeli... Read more
the muscles in my face felt weak as if I was having an onset of Bell's Palsy; it was a strange feeling of numbness like a mask covering my face; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 19Feb2021 09:15 as 2nd dose, single for COVID-19 immunization in a clinic. The patient's medical history and concomitant medications were not reported. The patient did not receive other vaccines within 4 weeks of vaccination. Not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since vaccination. The patient previously received the first dose of bnt162b2 on 29Jan2021 09:45 PM (lot number: not provided), at 55 years old in the right arm for COVID 19 immunization. On 19Feb2021 10:45 AM, the patient had muscles in his face felt weak as if was having an onset of Bell's Palsy. The patient reported that he never lost use of his muscles but it was a strange feeling of numbness like a mask covering his face. This lasted for approximately 7 hours. The patient massage and move all his muscles periodically through this event. No treatment was received. The outcome of the events was recovered on 19Feb2021 17:45. Information about lot/batch number has been requested.
55 2021-05-22 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.).
55 2021-05-23 tingling I received the vaccine in the right arm and within about 20 seconds I felt like I was going to faint... Read more
I received the vaccine in the right arm and within about 20 seconds I felt like I was going to faint and had rapid heart rate (pulse of 155) measured by EMT. I needed to remove the mask as I was having difficulty with the rapid heart rate and feeling of fainting. I also felt pins and needles type feeling in my legs and my face felt slightly swelled. I felt tired and that tired feeling lasted for the entire day. I stayed at the vaccination site for approximately 30 minutes at the advice of the EMT and went home. Later I had a slight headache but heart rate became more normal.
55 2021-05-24 pain in extremity experienced nausea; sore arm at the injection site; sore arm at the injection site; at night felt re... Read more
experienced nausea; sore arm at the injection site; sore arm at the injection site; at night felt really tired; This is a spontaneous report from a non-contactable consumer (patient himself). A 55-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration on 15Feb2021 (at the age of 55-year-old) at single dose for COVID-19 immunisation. The patient received the first dose of BNT162b2 on 26Jan2021 at the age of 55-year-old without any side effect. Concomitant medications were not reported. On 15feb2021 after second dose of vaccine the patient experienced sore arm at the injection site and at night felt really tired. On the morning of 16Feb2021 he experienced nausea lasting for a day. On 17Feb2021 the patient felt fine and the events resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
55 2021-05-24 tingling, numbness Complete numbing of the left upper biceps and shoulder with tingling of the left hand and fingers. S... Read more
Complete numbing of the left upper biceps and shoulder with tingling of the left hand and fingers. Soreness in left shoulder. Has lasted since doses were given.
55 2021-05-24 cold extremities, tingling Metallic taste in mouth after injection; dizziness; nausea; confusion; cold tingling hands and feet.... Read more
Metallic taste in mouth after injection; dizziness; nausea; confusion; cold tingling hands and feet. Pt states he felt really bad and had the urge to defecate.
55 2021-05-25 feeling hot anxiety attack; heart racing; intense feeling of heat in body; tired; shortness of breath; This is a... Read more
anxiety attack; heart racing; intense feeling of heat in body; tired; shortness of breath; This is a spontaneous report from a contactable other HCP (patient). A 55-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 24Apr2021 16:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included allergy. There were no concomitant medications and the patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient previously took levofloxacin and experienced allergy. The patient reported that approximately three minutes after taking the vaccine 24Apr2021 16:33 (also reported as 17:15), still waiting for the recommended 15 minutes to be released, he started to feel his heart racing and a very intense feeling of heat in body. After reporting to the nurse at the location, she listened to his heart asking him to take a deep breath several times. According to the nurse, he had an anxiety attack, as she did not show any signs of anaphylaxis. However, he felt very tired and the night with a little shortness of breath. He would like to know if he go for the second dose or look for another vaccine. the patient did not receive treatment for the events and the outcome of the events was resolved in 2021. Information on the lot/batch number has been requested.
55 2021-05-25 pain in extremity Right acute lumbosacralplexopathy dx on EMG. Severe pain and weakness right thigh, leg began approxi... Read more
Right acute lumbosacralplexopathy dx on EMG. Severe pain and weakness right thigh, leg began approximately 3 days post second vaccine. Progressive pain, weakness, atrophy.
55 2021-05-26 involuntary muscle movements, tremor Pt was responding well before the injection. After receiving the vaccine, he walked over to the wait... Read more
Pt was responding well before the injection. After receiving the vaccine, he walked over to the waiting area to sit for his 15 minutes. After a few minutes, pt was seen slumped over in his chair and his phone fell to the floor. Nurse came out to check on him and started rubbing his back. Pt was rocking back and forth in his chair and looked like he was slightly shaking. Paramedics were called. Several seconds later, pt stated he saw spots and felt dizzy and nauseous. Pt was given a cup of water. Then after a few minutes, pt stated he felt better than earlier. Paramedics arrived to assess the pt and took him to the ER for further assessment.
55 2021-05-26 numbness Developed. Guillian-Barre type reaction with numbness in bothering feet. Left greater than Right. Le... Read more
Developed. Guillian-Barre type reaction with numbness in bothering feet. Left greater than Right. Left toes completely numb, top of feet also. Then started developing numbness in tip of finger gets bilaterally. So start and completed 5 injections of IgG
55 2021-05-27 pain in extremity Impressive muscular pain after heavy, but normal for me, exercise; odd muscular pain in legs after e... Read more
Impressive muscular pain after heavy, but normal for me, exercise; odd muscular pain in legs after exercise; This is a spontaneous report from a contactable physician (Patient himself). A 55-year-old male patient received both dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 17Dec2020 12:15 (Batch/Lot Number: EG1685) intramuscular in right arm , second dose on 06Jan2021 (Batch/Lot Number: EK9321) (age at vaccination 55 year) intramuscular in arm, both as single dose for covid-19 immunisation. Medical history included coeliac disease from 2009 and IgA nephropathy very mild from 2020, both ongoing. The patient had no allergies. The patient's concomitant medications were not reported. The patient has not received any other vaccine within four weeks and not other medication within two weeks. The patient experienced odd muscular pain in legs after exercise on 10Jan2021 12:00 and on 11Jan2021 12:00 impressive muscular pain after heavy, but normal for patient, exercise. The patient underwent lab tests and procedures which included COVID-19 (Nasal swab) test: negative on. The outcome of event leg pain was unknown, of other event was recovered. Reporter consider that the Pfizer product had not had a causal effect to the adverse event. Follow-up (07May2021): Follow-up attempts completed. No further information expected. Follow-up (PRD 26Apr2021): New information form a contactable physician (patient) included: route of administration, second dose date of vaccine, non serious event myalgia, reporter's causality. No Follow up attempts needed. No further information is expected.; Sender's Comments: The events event leg pain and myalgia considered intercurrent conditions and unlikely related to both both dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 17Dec2020 12:15 (Batch/Lot Number: EG1685) intramuscular in right arm , second dose on 06Jan2021 (Batch/Lot Number: EK9321).
55 2021-05-28 weakness muscle soreness; flu; headache; chills; weakness; fatigue; difficulty thinking straight; could barel... Read more
muscle soreness; flu; headache; chills; weakness; fatigue; difficulty thinking straight; could barely stand; could not eat; fever; lots of sweating; muscle fatigue; hard to breath; body aches all over; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in Arm Left on 11May2021 17:00 (Batch/Lot Number: EW0153) as 2nd dose, single for covid-19 immunisation. Medical history included asthma and samters syndrome. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously took pencillin and aspirin and experienced allergies. On 12May2021 12:30, the patient experienced muscle soreness which is much less and is gone at the time of the report, patient came down with the flu which began around 11:30 am to 12 pm, 20 hours after receiving the second shot. It began with headache, muscle aches, chills, weakness and fatigue. The patient also began having difficulty thinking straight. The patient is a truck driver and was on the road trying to finish up so he just could go home and call in sick. When the patient got out of the truck, he could barely stand as he was so weak. It was both fatigue but also his body had no energy to give. The patient had a hard time getting energy to finish and get ho//2021nt then got home and felt worse, like a full blown flu, could not eat, fever and lots of sweating yet lots of chills all over, weak, headache was worse, body aches all over, hard to breath from muscle fatigue, woke up soaked in sweat. The patient added that he has not felt this bad in years. The patient did not receive treatment for the events. Event muscle soreness was recovered on unspecified date; all other events was recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
55 2021-05-31 pain in extremity 2 days after receiving the second shot I woke up with throbbing hands and fingers. My fingers and ha... Read more
2 days after receiving the second shot I woke up with throbbing hands and fingers. My fingers and hands have been swollen and throbbing since the second vaccine. My doctor and myself believe it is rheumatoid arthritis triggered from the vaccine. I will have test done to confirm this in 3 months when I received my healthcare back from my employer... The joints in my fingers feel like they are under attack and I believe this to be the case they were perfectly fine before the vaccine and now I can hardly open a can of pop..
55 2021-06-01 bell's palsy Bells Palsy
55 2021-06-01 feeling hot First dose: soreness in left arm for 1 day. Second dose: Day 1 and 2: Heat sensations from the... Read more
First dose: soreness in left arm for 1 day. Second dose: Day 1 and 2: Heat sensations from the inside of my body. Opposite of a flu like feeling. Day 1 thru 4: Insomnia
55 2021-06-01 seizure R56.9 - Unspecified convulsions.
55 2021-06-02 sciatica Developed lower back pain, sciatica and skin sensitivity in right hip and leg approximately 10 days ... Read more
Developed lower back pain, sciatica and skin sensitivity in right hip and leg approximately 10 days after second dose. Managed pain with OTC medications, stretching and massage over ensuing week as symptoms worsened. Approximately nine days following onset of symptoms, began developing blisters in patches on lower right leg. Visited urgent care and confirmed shingles, which is now being treated with valacylovir and predinsone. Symptoms are abating. This is my third bout with shingles as an adult. There is no confirmed linkage to my COVID vaccinations but I thought I should report this as a possible vaccine reaction given the close proximity of shingles onset to my last COVID shot.
55 2021-06-03 weakness, cold sweat 5:40 am 6/2/2021 awakened to cold sweat. 8:00 am unable to keep morning coffee down. 11:00 eat 1/2 b... Read more
5:40 am 6/2/2021 awakened to cold sweat. 8:00 am unable to keep morning coffee down. 11:00 eat 1/2 bagel with peanut butter, unable to keep it down. 2:00 and after further attempts at water, saltine cracker, unable to keep anything down 11:00 pm, attempt to drink sparkling water, unable to keep down. No appetite, inability to keep food down and cold sweats after vomiting each occurrence. June 3, once again able to tolerate food, energy low I assume from available energy from lack of food, progressive improvement through the day. Self managed care.
55 2021-06-03 pain in extremity About 4 hours after the shot I developed a burst blood vessel on the index finger (midway)of my righ... Read more
About 4 hours after the shot I developed a burst blood vessel on the index finger (midway)of my right hand, which left a painful purple subcutaneous mark.
55 2021-06-07 impaired body coordination On May 21st 2021 I suffered a cerebellar left hemisphere stroke resulting in a taxia on my left side... Read more
On May 21st 2021 I suffered a cerebellar left hemisphere stroke resulting in a taxia on my left side. After repeated CAT scans MRIs echocardiograms including t e e there is no explanation for where the 40 to 50 lesions came from in my cerebellum.
55 2021-06-07 facial pain, trigeminal neuralgia, nerve pain Shingles to face/outbreak of Shingles; nerve pain to the right side of face and upper right teeth; u... Read more
Shingles to face/outbreak of Shingles; nerve pain to the right side of face and upper right teeth; upper right teeth are still numb and throb; right side of head hurt; right eye was swollen and almost fully closed; blister; terrible sunburn top of head and entire right side of face; trigeminal neuralgia; additional pain to front upper teeth from center to the right side of mouth; some pain on right side of face above mouth/ lot of pain all to the right side of face/terrible pain right side of face; pain to front upper right tooth/upper teeth ached/terrible pain upper right side of teeth/upper right teeth are still numb and throb; This is a spontaneous report from a contactable consumer (patient). A 55-years-old male patient received second dose of bnt162b2 (Pfizer Covid-19 vaccine, formulation: solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 15Mar2021 (at the age of 55-years-old) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient received the first dose of bnt162b2 (Pfizer Covid-19 vaccine, formulation: solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 22Feb2021 as first dose single dose for covid-19 immunisation. Concomitant medication included methylprednisolone (MEDROL [METHYLPREDNISOLONE]) taken for; amoxicillin (AMOXICILLIN) and secukinumab (COSENTYX) taken for psoriasis. On an unspecified date, the patient experienced shingles to face/outbreak of shingles. On 14Apr2021, the patient experienced pain to front upper right tooth. The patient saw dentist and the tooth looked fine. On 17Apr2021, the patient had additional pain to front upper teeth from center to the right side of mouth and some pain on right side of face above mouth. On 18Apr2021, the patient saw three different dentists, and none found any issues with teeth. On 19Apr2021, the patient had terrible sunburn on top of head and entire right side of face, upper teeth ached, having more pain to the right side of my face and the dentist thought he had trigeminal neuralgia. On 20Apr2021, in the evening the patient was in a lot of pain all to the right side of face and contemplated going to the hospital but did not go. On 21Apr2021, the patient woke up in terrible pain (right side of face and upper right side of teeth) and right side of head hurt, right eye was swollen and almost fully closed, and a blister was visible. The patient reported that, he saw a Rheumatologist who diagnosed Shingles and he started taking Valtrex and Gabapentin. The patient also saw an ophthalmologist who prescribed an antibiotic eye drop. The patient reported that, she was in bad shape, which is evident in a picture she took by 23Apr2021. The patient saw an ENT who had sent him back to the ophthalmologist and he consulted with Rheumatologist. The patient reported that, ENT gave him a Medrol Steroid for six days and Amoxicillin. The patient had been suffering greatly since this began. On 10May2021, the patient's swelling has receded, but still had significant nerve pain to the right side of face and upper right teeth and upper right teeth are still numb and throb. Therapeutic measures were taken as a result of herpes zoster, toothache, oral pain and eye swelling. Outcome of the events was unknown. Information on the lot/batch number has been requested.
55 2021-06-07 facial paralysis, speech disorder, weakness He had a stroke- sudden onset of weakness,- facial drooping, speech impairment, lethargy, and confus... Read more
He had a stroke- sudden onset of weakness,- facial drooping, speech impairment, lethargy, and confusion obvious symptoms did resolve over 24 hour- he has some residual fatigue and questionable changes post stroke
55 2021-06-07 night sweats Chills, Sweats all night
55 2021-06-08 pain in extremity The day after the shot, the patient got the usual headaches, bodyaches, fatigue, arm soreness, such ... Read more
The day after the shot, the patient got the usual headaches, bodyaches, fatigue, arm soreness, such that it was difficult to raise his arm, nausea, dizziness and fatigue. That all resolved after two days. He then felt well for one week. Then, on May 29th, 9 days after vaccination, he got fever to 102, chills, fatigue, itchy vesicular whole body rash, headaches and bodyaches, such that, had he been working, he would have missed work for one week. He was seen, and put on Valacyclovir 1 gram tid * 1 week for probable recurrent varicella illness. Viral PCR was positive for VZV. He recovered over the course of 7 days.
55 2021-06-10 nerve injury Shingles outbreak, Nerve damage, severe exhaustion
55 2021-06-11 flushing, unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild
55 2021-06-11 numbness Tightening of the left bicep muscles causing the radial nerve to not function properly with left for... Read more
Tightening of the left bicep muscles causing the radial nerve to not function properly with left forefinger and thumb to go numb. Pain in the shoulder rated 10 of 10 on pain scale commonly used in the medical profession.
55 2021-06-13 night sweats Eye piercing headaches for 2 days and night sweats for 2 days. Injection site sore for 4 days.
55 2021-06-14 inability to speak I suffered a Subarchnoid brain hemorrhage. The was bleed in the subarachnoid space surrounding the b... Read more
I suffered a Subarchnoid brain hemorrhage. The was bleed in the subarachnoid space surrounding the brain. I went to emergency at hospital with worst headache of my life. After a brain hemorrhage was confirmed by CT-scan, I was rush to hospital were I was treated in the Cerebral critical unit. I suffered through the worst pain of my life for 10 days as the blood from the hemorrhage drained. It 2.5 months later and I am still dealing with the effects of the hemmorhage (headaches, exhaustion, light sensitivity, short term memory loss and speech issues,
55 2021-06-15 slurring Wife stated that about a week after patient received the 2nd dose of pfizer vaccine, the patient sta... Read more
Wife stated that about a week after patient received the 2nd dose of pfizer vaccine, the patient started to voice his speech. and now it is to the point where she can just barely understand him at times. Wife stated that she has been to PCP, and several other doctors and no one is able to help.
55 2021-06-15 pain in extremity Slight arm pain day after injection. On 6/14/21 nausea with abdominal cramps thru the evening with ... Read more
Slight arm pain day after injection. On 6/14/21 nausea with abdominal cramps thru the evening with chills. On 6/15 and 6/16 severe diarrhea throughout the day. Treatment to this point has been maintaining fluids , water, sports drink and pedialyte. Immodiium taken on 6/16 at 5pm
55 2021-06-16 weakness Brain fog; Nausea; weakness; Weird sensation on [his] tongue 5-10 mins; Weird taste in [his] mouth s... Read more
Brain fog; Nausea; weakness; Weird sensation on [his] tongue 5-10 mins; Weird taste in [his] mouth soon after that/funny taste in mouth; Shortness of breath/difficulty in breathing; Dizziness/Light headedness; Weakness in his upper chest and in both arms; Weakness in his upper chest and in both arms; Diarrhoea; Headache; felt like my throat is gonna close, I won't say I had any difficulty in swallowing, but it was not normal; This is a spontaneous report from a contactable consumer (patient). A 55-years-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date, NDC and UPC number was unknown), via an unspecified route of administration on 06Jun2021 at 11:30 hours as 1st dose, single dose (at the age of 55-years-old) for COVID-19 immunisation. Regarding lot number patient stated that it looks like EW, patient thought he was not sure if it was 6185 or 0185, not sure it looks like 0 but it looks like 6 too but patient think it was 0. The patient medical history included shortness of breath, sleep apnea and kidney disease (from an unknown date and unknown if ongoing). Patient sees a doctor for lot of conditions one was for shortness of breath and sleep apnea and sees a neurologist for Bph. The patient concomitant medications were not reported. Patient explained he was reluctant from getting vaccinated and nervous before the shot. On 06Jun2021, after patient took the shot, probably around 11:30 in the morning, patient was same, soon after 5 min maybe more, patient got a sensation on the left side of his tongue 5-10 mins, then kind of a weird taste came to his mouth, patient started to get a little dizzy, a little light headedness, weakness in his chest and both his arms, got shortness of breath but had been seeing a doctor for shortness of breath prior taking the Covid shot and had kind of reluctant of taking the shot but some other issues going on side, patient decided to take it, a couple of hours after the shot, patient had a headache, had the diarrhea. Patient described the weird taste like having a penny in his mouth. Patient explained he consulted a doctor on that Monday (07Jun2021), who said she encountered patients who also had the sensation on their tongues following vaccination, and that it was normal. Today (08Jun2021) patient had feeling just a little bit of nausea and patient kind a feel like a little brain fog, it was just his head doesn't feel right, the major concern was says some things risks factors and some of them had severe reactions, patient had a reaction difficulty in breathing, dizziness and feel little bit weakness, patient kind of a felt like his throat was going to close and he won't say he had any difficulty in swallowing, but it was not normal. Patient developed symptoms which spooked and scared him. Patient did not have his lab test but was constantly going to patient had just had right heart catheter right two weeks ago, you know last for him, patient was supposed to take another lab test to conduct at the end of the month for cholesterol, but patient saw neurologist for kidney disease. Events did not improve, patient just had this brain fog you know. Patient had to call a doctor after he got home, they did not prescribe him anything, patient mean he did bunch of appointment with doctor with the phone as soon as he got home from taken a Covid shot he was little worried. Patient stated he was concerned about getting the second dose of vaccine scheduled on 27Jun2021. Patient stated he will not be able to consult his doctor before the vaccination appointment and was not able to get further assistance from a pharmacist. Patient repeated he does not know what to do about the second dose. Patient was kind of reluctant taking the next shot, if he was going to feel the something like this again, he don't want to, as he already had uneasy you know just had and patient did not had difficulty in breathing all of time this comes and go, from the sentence he described it says on pamphlet that there was severe reaction to the shot and don't want to take the second shot and then end up in hospital because patient had more from it so his question was he was afraid to take the second shot. Patient don't had answer to that he means he would like to talk to somebody who can give him information kind of help me to relax little bit if it was normal and in in response it was responded that decision to receive the second dose for any other reason cannot be made by the company. Patient was referred to speak to his healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection, as healthcare provider knows his health situation and had access to information that can better help inform this decision. The outcome of brain fog was not recovered and outcome for other events was unknown. Information about lot/batch number is requested.
55 2021-06-16 pain in extremity Sniffles/ runny nose; not feeling normal after all; Sinus congestion; cough; COVID-19 PCR test posit... Read more
Sniffles/ runny nose; not feeling normal after all; Sinus congestion; cough; COVID-19 PCR test positive; arm soreness; This is a spontaneous report from a contactable consumer (patient). A 55-years -old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8732), via an unspecified route of administration as single dose on 08Apr2021 at 19:00 into left arm for COVID-19 immunisation. Medical history included pancreatitis. The concomitant medications were not reported. Patient had no other vaccinations the same day as his first dose of the COVID-19 vaccine or in the four weeks prior. On 8Apr2021, patient experienced arm soreness. On 19Apr2021, patient COVID-19 PCR test was positive. Patient stated that he was diagnosed 34 years ago, he has been battling it since then and has numerous surgeries and numerous things since. He had symptoms starting Friday. He says this Friday will have been 7 days, on the 23rd. He says on the following Friday, which is the 30th he was told he could get his second shot, but he was scheduled to get his second shot on the 29th, he wonders if that day made a difference. He says he was symptomatic, so he didn't know where he is at on a timeline to getting the second dose. He says he got the first dose shot the week prior and then that happened to his mom, so going into that weekend he had the allergy symptoms and obviously to play it safely they got tested and they were all negative. He says that following Friday he thought he had normal sinus congestion after cutting the grass, he is also always getting the sniffles from his neighbor's white pollen tree. He says to play it safe he got tested again Monday and that turned out to be positive. He says on the Wednesday the week prior it was negative after the shot they had on the 8th, then this test he had it. He says that his mom passed on the 13th, then on Tuesday which was the 14th they all were tested and all were negative. He says that he got tested again and it was positive after he felt his runny nose and cough that he had originally thought was normal over the course of the weekend was not feeling normal after all, and to play it safe he got tested. He says after his positive test after his first test was negative, because he was positive the second time everyone got tested, and his daughter was the only one who was negative the second test. Enquired ask how they could get information from the facility about when it would be ok to get the second dose, if it was when they had no more symptoms or if it was after a person tested positive or was asymptomatic 10-14 days that they can go get second dose. Enquired when is the best time to get the second dose after testing positive, whether they are symptomatic or asymptomatic.The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
55 2021-06-17 pain in extremity covid arm starting about 5 plus weeks after 2nd shot that is lasting... red and very painful stayin... Read more
covid arm starting about 5 plus weeks after 2nd shot that is lasting... red and very painful staying localized but not going away. Pain is bad enough to regularly take Tylenol for it and I usually don't take meds for paii
55 2021-06-20 pain in extremity Beginning shortly after receiving the 2nd vaccine, I've been having hip pain/a general achy discomfo... Read more
Beginning shortly after receiving the 2nd vaccine, I've been having hip pain/a general achy discomfort in my hip joints that continues to shoot down my left leg. I have not gone to a doctor for this. I am just reporting it in case others are experiencing and to have this possible side effect logged.
55 2021-06-21 weakness Starting on 5/16/2021, I was very weak, I was headed to work the following Monday, I was urinating a... Read more
Starting on 5/16/2021, I was very weak, I was headed to work the following Monday, I was urinating a lot, sic, feeling better until the next day I experienced the same symptoms again, this went on for 5 days, The following Monday I wasn't feeling better so I called Doctor. I decided to go to urgent Care and they said I was Jaundiced, they wanted me to go to the hospital, I spent 4 days in hospital, they said I was having an auto immune response to something, did scan on liver and it looked fine, however liver biopsy did not look good, they won't tell me what I have to go in for more testing. My doctor consulted with a specialist and they concluded it may be an auto immune reaction and I was told my gallbladder is also inflamed, but it looks fine , my bilirubin numbers were off the chart. I am going to see a liver specialist at medical center at the end of July. My blood sugar has since raised into diabetic range due to steroids. I had no reaction to my first dose of covid vaccine.
55 2021-06-21 pain in extremity, tingling Patient states that his arm started hurting about 30 minutes after the shot. He described the pain ... Read more
Patient states that his arm started hurting about 30 minutes after the shot. He described the pain as soreness that prevented him from lifting his arm. He also stated that he also had tingling that developed the next day and had off and on since the first shot. The soreness did not go away after a few days.
55 2021-06-23 numbness and pain in extremities Patient reports an exacerbation of peripheral neuropathy after receiving first covid vaccination. ... Read more
Patient reports an exacerbation of peripheral neuropathy after receiving first covid vaccination. Patient has had in but reports this is worse that before There has been no further medication intervention for this event
55 2021-06-24 pain in extremity Having pain in the other side of his arm; This is a spontaneous report from a contactable Pharmacist... Read more
Having pain in the other side of his arm; This is a spontaneous report from a contactable Pharmacist. A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0177), via an unspecified route of administration, administered in an unspecified arm on 24May2021 (at the age of 55-years-old) as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that she has a patient there that came for his second dose of the Pfizer and he complained about having pain in the other side of his arm from the first dose. The reporter stated that she knew the sore arm goes away after a week or so and it should be on the same side of the arm that you were poked at. The patient said he "feels like" there was a bee sting on the other side of his armpit. The reporter stated that she knew that was not a part of the listed side effects for not giving a second dose, like an anaphylaxis reaction. The reporter wants to know if this would be something that was an issue for giving the patient his second dose and the patient has an appointment with his doctor on 01Jul2021. The reporter seriousness and investigation assessment were not provided. The outcome of the event was reported as unknown. Communication:"Specific product name was not provided by the caller and was only referred to as "The Pfizer" and by First and Second dose. DSU agent was unable to verify a specific product name, as caller declined to complete report". No further details were obtained or provided.
55 2021-06-27 pain in extremity Pain in the arm for few days. Two weeks later, I started having swelling legs.
55 2021-06-27 pain in extremity I don?t know the lot number. I guess my vaccination. Card might have that info. I started having sev... Read more
I don?t know the lot number. I guess my vaccination. Card might have that info. I started having severe chest pain & into my neck & L arm. All the symptoms of Pericarditis.
55 2021-06-29 weakness Difficult time trying to focus; Low energy; Headache; This is a spontaneous report received from a c... Read more
Difficult time trying to focus; Low energy; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 56-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration to left arm on 17Mar2021 at 13:30 (at the age of 56-year-old) as single dose for COVID-19 immunisation. Medical history and concomitant medications 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 receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 07:00, the patient experienced extreme headache, very low energy and he had a difficult time trying to focus currently (at the time of this report). The events did not result in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse events. The clinical outcome of extreme headache, very low energy and difficult time trying to focus were not resolved at the time of this report. Information about lot/batch number cannot be obtained. No further information expected.
55 2021-06-29 bell's palsy G51.0 - Bell's palsy
55 2021-06-29 electric shock sensation Extremely fatigued; mucus and sinus drainage increased by 500%; electrical shock in muscles and tend... Read more
Extremely fatigued; mucus and sinus drainage increased by 500%; electrical shock in muscles and tendons; breathing issues 02 sat is staying between 70 and 90; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 55-years-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Formulation: Solution for injection, Lot number: er8729 and Expiration date: unknown), via an unknown route of administration, in left arm on 22Apr2021 at 12:00 (at the age of 55-years-old) as dose number unknown, single for COVID-19 immunisation. Medical history included congestive heart failure, diabetes, bundle bunch blockage, coronary heart disease from an unknown date. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received long list of other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested positive for COVID-19. On 23Apr2021 at 10:00, the patient was extremely fatigued, mucus and sinus drainage increased by 500%, electrical shock in muscles and tendons, breathing issues 02 sat is staying between 70 and 90. The patient still have ongoing symptoms and issues from shot three months later. Doctor requested him not take second dose. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment for events included Steroids and increased treatment for congestive heart. Outcome of events reported as recovered with sequelae on an unknown date in 2021. Follow up needed, further information has been requested.
55 2021-07-02 pain in extremity, numbness and pain in extremities Significant pain in hands and feet within 24 hours of injection. Persistent pain in fingers (neurop... Read more
Significant pain in hands and feet within 24 hours of injection. Persistent pain in fingers (neuropathy) still lingering and not improving 9 weeks after the second injection.
55 2021-07-08 feeling hot, flushing On May 3rd I received my first jab. Days 2 and 3 my arm was pretty sore. Like a Charlie horse combi... Read more
On May 3rd I received my first jab. Days 2 and 3 my arm was pretty sore. Like a Charlie horse combined with a sore arm workout. Day 4 that soreness went away but I felt fatigued. It was like I was trying to move around under water. That lasted only one day. Day 5 my lymph node under my arm started to get sore. That lasted 3 days. Day 8 - Last night my outer arm started to feel funny. I looked down and had this good sized welt raised up. It was about 5? by 1?. On May 24th I received my second jab. About 4 hours after my jab my face became flush. The tips of my ears got hot. I went to bed and woke up with a fever between 100.4 to 100.9 in the morning. My body ached, my eyeballs hurt to move side to side. In the afternoon I had swelling in my scrotum sack and testicles ached. My fever topped out at 101.2 in the evening. The next day my fever went away and the swelling in my scrotum was gone. My testicles still occasionally ache during the day.
55 2021-07-08 pain in extremity, hot flush Starting about 14 hours after vaccine administration, patient experienced difficulty concentrating w... Read more
Starting about 14 hours after vaccine administration, patient experienced difficulty concentrating with periods of hyperactivity, pain/soreness in bilateral hands with extreme pain at times with movement, soreness in bilateral feet, soreness across the back in the area of the kidneys, occasional mild dizziness, fatigue, mild nausea, hot flashes, a cold sore, poor sleep quality since vaccine, mild dyspnea on exertion, and increased temperature of about 0.5-1 degree F.
55 2021-07-11 pain in extremity Arm soreness only for 36 hours. Occasional heart palpitations noticed approximately three weeks lat... Read more
Arm soreness only for 36 hours. Occasional heart palpitations noticed approximately three weeks laters. Second dose 6/15/2021. Arm soreness and mild fever, aches, fatigue for 48 hours. Occasional palpitations continued. ER for treatment. Diagnosis: sinus arrhythmia with occasional premature ventricular complexes. Patient had normal ECG pre-vaccine (5/5/2021) based on annual wellness exam.
55 2021-07-12 numbness pain at injection site; swelling at injection site; whole body swollen; my legs and arms were swolle... Read more
pain at injection site; swelling at injection site; whole body swollen; my legs and arms were swollen; ankles, elbows, wrists, shoulders had less mobility.; numbness at hands; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the right arm on 24Mar2021 at 10.15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included HIV and COVID-19 on May2020. Concomitant medications included abacavir sulfate, lamivudine, dolutegravir sodium, (TRIUMEQ), naproxen (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN), hydroxyzine (MANUFACTURER UNKNOWN); all from unknown for unspecified indications. The patient previously took bioflavonoids on unknown date and experienced an food allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On the day of vaccination (24Mar2021), the patient experienced bit fatigued. Nothing bothersome. On 25Mar2021, the next morning, the patient woke up with a good deal of pain and swelling at the injection site. In addition, whole body was swollen, in particular the legs and arms were swollen, to the point that was much harder than usual to be ambulatory. The ankles, elbows, wrists, shoulders had less mobility and also had numbness at hands. Thankfully, by mid-afternoon of the 25th, felt much better and much of the swelling had subsided. The patient did not receive any treatment for the reported events. The 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 fatigue, pain at injection site, swelling at injection site, swelling at whole body, legs and arms, decreased mobility of ankles, elbows, wrists, shoulders and numbness at hands were resolving. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
55 2021-07-13 seizure Patient was admitted for seizures on 5/5/2021 with plan to discharge to a post acute facility. He wa... Read more
Patient was admitted for seizures on 5/5/2021 with plan to discharge to a post acute facility. He was negative for COVID-19 at admission. During discharge screening for facility, he was found to be COVID-19 positive. He was asymptomatic for COVID-19 and was discharged to facility on 5/22/2021. On 5/26/2021 he presented to the hospital again and was found to have a pulmonary embolism. He remained admitted until 6/6/2021.
55 2021-07-17 feeling cold, tremor 23Mar2021 at 09:15 (at the age of 55-year-old) as single dose for COVID 19 immunisation. Medical his... Read more
23Mar2021 at 09:15 (at the age of 55-year-old) as single dose for COVID 19 immunisation. Medical history and concomitant medication have not been provided. 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 vaccine within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318), via an unspecified route of administration in left arm on 02Mar2021 at 09:15 AM (at the age of 55-year-old) as single dose for COVID 19 immunisation. On 23Mar2021 at 09:15, the patient experienced (reported as only for second dose) chills with shivering, shaking and feeling cold for lasted four hours. Chills came back on next day and milder without shivering and shaking. Tiredness, headache continued the next day and also experienced mild pain at side of injection for first 24 hours. Treatment received for the adverse events was reported as no. The clinical outcome of the event chills with shivering, shaking, feeling cold, tiredness, headache and mild pain at side of injection was resolved on an unknown date in Mar2021. No follow up attempts are needed. No further information is expected.
55 2021-07-17 tingling I have a tingling sensation on my fingertips 3 days after shot. My face is tingling, my lips tingle... Read more
I have a tingling sensation on my fingertips 3 days after shot. My face is tingling, my lips tingle.; I have a tingling sensation on my fingertips 3 days after shot. My face is tingling, my lips tingle.; This is a spontaneous report from a contactable consumer(patient). A 55-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot/batch number not provided), via an unspecified route of administration on 06Mar2021 at 10:45 (at the age of 55-years-old) into right arm as a single dose for COVID-19 immunization at pharmacy or Drug Store. The patient medical history included high blood pressure, prediabetic, high cholesterol, rosacea. Prior the vaccination, patient was not diagnosed with COVID. Post vaccination, patient was not tested for COVID. The concomitant medications were farxiga, victoza, doxyclycline. Patient had allergies to codiene, shrimp. Patient did not receive any other vaccine in four weeks. On 07Mar2021 at 06:00 am, the patient experienced tingling sensation on my fingertips 3 days after shot. His face was tingling, lips tingle. No treatment was given for the events. The outcome of the events was not recovered. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
55 2021-07-20 pain in extremity Patient had first Pfizer vaccine 3/11/21. Tested positive for Covid on 3/27/21. Had second Pfizer va... Read more
Patient had first Pfizer vaccine 3/11/21. Tested positive for Covid on 3/27/21. Had second Pfizer vaccine 4/10/21. Acute onset severe low back pain radiating to both feet and up spine into both hands within a few days of the second dose. Still continuing to today 7/21/21
55 2021-07-21 pain in extremity Bilateral pain in shoulders that radiates into bilateral upper arms and elbows and down into wrist ... Read more
Bilateral pain in shoulders that radiates into bilateral upper arms and elbows and down into wrist with associated weakness in upper extremities. Unable to adduct arms without severe pain in shoulders. Unable to perform daily activities without assistance at times due to the pain that debilitates the writer. for appx 5-10 minutes until spasms resolve. Writer is unable to open jars which is a new symptom since receiving the vaccine along the pain in the upper extremities. I feel that I am currently at appx 40% of my usual strength which is causing myself a great difficulty with ADLS and performing my work duties as a clinical nurse. The above symptoms are new since the vaccine and seem to be increasing in frequency regularly. The pain is symmetrical in nature and is on the medial aspect in bilateral elbow joints.
55 2021-07-25 weakness July 27, 2021 12:45 PM. Started getting weak with exhaustion, Started getting shortness of breath, s... Read more
July 27, 2021 12:45 PM. Started getting weak with exhaustion, Started getting shortness of breath, shortness of breath while exerting myself just walking across room or doing basic kitchen chores, pressure and heaviness in chest, shortness breathing trying to sleep even with a c-pap machine, and every night for the first two weeks major chest pains so much so had to hold two pillows against my chest trying to sleep, and was able to feel heart in my chest. After two weeks of this, my mother talked me into seeing my doctor 7/7/2021. Had an x-ray of my chest. 7/22/2021 had a stress test and the results were no blockages. Now waiting for a referral from my doctor to see a heart specialist and waiting for cat scan appointment. Note: I was walking 3 to 5 miles a week before this.
55 2021-07-27 pain in extremity Pain in arm first week that migrated to my neck and then back. Second week my blood pressure went to... Read more
Pain in arm first week that migrated to my neck and then back. Second week my blood pressure went to 200/100 and took three months to get under control. To this day my joints still hurt, especially my back. I have gone to the doctors to discuss all these isuues and I am currently under diagnoses/treatment.
55 2021-07-27 pain in extremity Left arm from injection site became very sore.; lower neck became very sore.; shoulder blade became ... Read more
Left arm from injection site became very sore.; lower neck became very sore.; shoulder blade became very sore.; fore arm area became very sore.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158), via an unspecified route of administration in the left arm on 11Apr2021 at 17:00 (at the age of 55-year-old), as a single dose for COVID-19 immunisation. Medical history included hypertension and asthma. Concomitant medications included metoprolol succinate (METOPROLOL), atorvastatin (MANUFACTURER UNKNOWN), lamotrigine (MANUFACTURER UNKNOWN) and fluticasone furoate; umeclidinium bromide; vilanterol trifenatate (TRELEGY) for an unknown indication from an unknown date. The patient did not have a history of past drug therapy. 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. On 19Apr2021, the patient had experienced very sore left arm from injection site to lower neck to shoulder blade and down my arm to my fore arm area which started about 7 days after injection and was still feeling the same till the day of report. Therapeutic measures were taken as the result of adverse events, which included treatment with heating pad. The clinical outcome of the events very sore left arm from injection site to lower neck to shoulder blade and down my arm to my fore arm area was not resolved at the time of report. No follow-up attempts are needed. No further information is expected.
55 2021-07-27 pain in extremity Pain and hardness at injection site, radiates down arm and into joints, shoulder, elbow, bicep, fore... Read more
Pain and hardness at injection site, radiates down arm and into joints, shoulder, elbow, bicep, forearm all the way to fingers. Still happening a month later.
55 2021-07-28 weakness Feeling dizzy; Feeling some weakness; Occasionally short of breath; This is a spontaneous report fro... Read more
Feeling dizzy; Feeling some weakness; Occasionally short of breath; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732), via an unspecified route of administration in the left arm on 02Apr2021 at 14:00 (at the age of 55-year-old), as a single dose for COVID-19 immunisation. Medical history included colon cancer in 2015 (treatment successful). The patient did not have any allergies to food, medications, or other products. The patient did not receive any other medications within two weeks 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. On 02Apr2021 at 23:00, the patient was feeling dizzy, feeling some weakness and occasionally short of breath. The first night the patient started feeling dizzy when laid down to go to sleep and felt dizzy all night, whenever the head was moved. This feeling has not gone away at night. The patient also felt it off and on during the day. Also, the patient has been felt some weakness, and occasionally short of breath. No therapeutic measures were taken for the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events feeling dizzy, feeling some weakness and occasionally short of breath was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.
55 2021-07-28 numbness The patient experienced numbness in his forearm of the injection arm about 2 weeks following the fir... Read more
The patient experienced numbness in his forearm of the injection arm about 2 weeks following the first dose of the vaccine, The numbness spread to his thumb. He is still experiencing numbness today. He has an appointment scheduled with his doctor
55 2021-07-28 paralysis After my March 6, 2021 Pfizer vaccine (1st dose) I experienced a very severe headache behind my righ... Read more
After my March 6, 2021 Pfizer vaccine (1st dose) I experienced a very severe headache behind my right eye that continued for approximately 2 months along with loud high pitched ringing in both ears. I treated initially with an ENT who also diagnosed hearing loss in my right ear, prescribed steroids, and recommended that I not receive the 2nd dose of the vaccine. Three weeks post vaccine I began to experience double-vision and treated with both a neurologist and an ophthalmologist. I received two MRIs and a spinal tap which confirmed brain inflammation. Based on these findings ? with input from my initial ophthalmologist and a neuro-ophthalmologist - the diagnosis became cranial nerve inflammation/palsy. My symptoms have improved greatly and, thankfully, the double-vision resolved after three weeks and the headaches have diminished. I still suffer from tinnitus and plan to see my ENT to determine whether there are other treatments available and to monitor my hearing loss. Other than a brief course of steroids, I have not had any treatment for these symptoms.
56 2021-01-02 weakness Fatigue, lightheadedness, Fever (99.9-100.1), nausea and weakness.
56 2021-01-03 flushing HA, flushing, HTN
56 2021-01-03 flushing flushing, HTN, HA
56 2021-01-06 feeling cold Feels very cold like ice on left arm
56 2021-01-06 pain in extremity, feeling hot At 01:30, 1/7/21, I developed Extreme chills, then body became hot but temperature was normal, At ar... Read more
At 01:30, 1/7/21, I developed Extreme chills, then body became hot but temperature was normal, At around 02:30, my whole body ached with a sharp pain just above my right wrist and a sharp pain at the ball of my right foot. It's 07:05 right now and still have body aches, pain in right foot and right wrist.
56 2021-01-06 pain in extremity positive COVID test; positive COVID test; fever; chills; sore throat; cough; nasal congestion; runny... Read more
positive COVID test; positive COVID test; fever; chills; sore throat; cough; nasal congestion; runny nose; little diarrhea; tiny bit of shortness of breath; Caller received the COVID-19 vaccine on 17Dec2020 and is scheduled to take the second dose on 5Jan2021.; Caller received the COVID-19 vaccine on 17Dec2020 and is scheduled to take the second dose on 5Jan2021.; sore arm; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect via a contactable physician (patient himself). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH9899), via intramuscular route on 17Dec2020 at single dose (dose 1, left deltoid) for COVID-19 immunization. The patient medical history included non-smoker. Concomitant medications were reported as none. The patient was scheduled to take the second dose on 05Jan2021, also reported as 08Jan2021. The patient experienced sore arm for 24 hours afterwards on Dec2020. Patient experienced mild COVID symptoms such as fever, chills, sore throat, cough, nasal congestion, runny nose, little diarrhea, and tiny bit of shortness of breath on 24Dec2020, but stated he was better now. The patient was positive in the COVID test on 28Dec2020. He wanted to know if it was normal to get COVID after getting the vaccine and if he should get the booster shot if he gets better. He commented that testing positive for COVID was medically concerning. The patient did not require supplemental oxygen (including high flow ECMO) or receive a mechanical ventilation. Treatment included over the counter medication. No additional testing was done. The patient was not hospitalized. Outcome of the event sore arm was unknown; cough was not recovered; fever, chills, sore throat, nasal congestion, runny nose, little diarrhea, tiny bit of shortness of breath was recovering. No follow-up attempts are needed. Information about lot/batch number was already obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 virus test positive cannot be totally excluded. The case will be reassessed if additional information becomes available.
56 2021-01-07 weakness fever 103.5; Chills; achy; has no energy; This is a spontaneous report from a contactable consumer (... Read more
fever 103.5; Chills; achy; has no energy; This is a spontaneous report from a contactable consumer (patient's wife). A 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK9231), intramuscular (right deltoid) on 30Dec2020 0900, at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient has been in bed since 30Dec2020. The patient was achy, has no energy, and has chills on 30Dec2020. Patient also has a fever with temperature of 103.5 on 31Dec2020. Reporter asked if this was normal. Event outcome for achy and chills was recovered on 31Dec2020, not recovered for has no energy and unknown for fever 103.5.
56 2021-01-07 pain in extremity Headache sore arm, chills Narrative; 12/18 0100 AM woke up with a sore arm. Went back to sleep then... Read more
Headache sore arm, chills Narrative; 12/18 0100 AM woke up with a sore arm. Went back to sleep then woke up in the morning with ongoing sore arm, chills, and headache. He took 400 mg ibuprofen. All symptoms resolved by mid-afternoon on 12/18.
56 2021-01-07 pain in extremity body ache arm sore chest pain
56 2021-01-08 pain in extremity Headache Left Arm soreness Narrative: Patient developed arm soreness at injection site and headache... Read more
Headache Left Arm soreness Narrative: Patient developed arm soreness at injection site and headache following vaccine administration. Resolved as of 1/2/21.
56 2021-01-09 pain in extremity I had fever, chills, arm pain and swelling
56 2021-01-10 pain in extremity Arm soreness, severe muscle and joint pain, low grade fever, fatigue Treatment: Tylenol/ Motrin Outc... Read more
Arm soreness, severe muscle and joint pain, low grade fever, fatigue Treatment: Tylenol/ Motrin Outcome: symptoms better after 48 hours
56 2021-01-10 tremor shaking chills fever
56 2021-01-12 numbness and pain in extremities neuropathy; pain; nausea; fatigue; bone, muscle, stomach pain; bone, muscle, stomach pain; bone, mus... Read more
neuropathy; pain; nausea; fatigue; bone, muscle, stomach pain; bone, muscle, stomach pain; bone, muscle, stomach pain; flare; increase in joint pain from his baseline; This is a spontaneous report from a Pfizer sponsored program Accredo Xeljanz Program. A contactable nurse and contactable consumer (patient) reported that a 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization and tofacitinib citrate (XELJANZ XR), orally from 02Oct2020 at 11 mg, daily for rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. On 19Dec2020, the patient experienced neuropathy, pain, nausea, fatigue, bone, muscle, stomach pain and flare. In Dec2020, the patient experienced increase in joint pain from his baseline. The physician was aware. The patient was placed on unspecified steroids for the events, neuropathy, pain, nausea, fatigue, bone, muscle, stomach pain and flare which minimized symptoms. While weaning off steroids, the severity of symptoms returned. The patient was instructed by the doctor to stop taking tofacitinib citrate which was stopped on 29Dec2020. The action taken in response to the events for BNT162B2 was not applicable and for tofacitinib citrate was permanently withdrawn on 29Dec2020. The patient reported slight improvement after stopping tofacitinib citrate. The outcome of neuropathy, pain, nausea, fatigue, bone, muscle, stomach pain and flare was recovering and of increase in joint pain from his baseline was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information available, the reported events are most likely due to patient underlying contributory factors and unlikely that it is related to the suspect product. However due to temporal association with the vaccine, a possible contributory role of vaccine cannot be ruled out. Case will be reevaluated based on additional information during the follow-up. 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.
56 2021-01-12 tenderness 01/11/2021: 0901 assoc felt light headed b/p 139/96. felt well enough to leave site, no intervention... Read more
01/11/2021: 0901 assoc felt light headed b/p 139/96. felt well enough to leave site, no intervention. 01/13/2021: 0923 pt went to ED for reaction to vaccine. left supraclavicular node swelling extending up neck with erythema, tenderness. was seen in ED
56 2021-01-13 migraine H/A chills, fever, malaise, then migraines. Then 1-2 migraine H/A every day. No H/A for the past 3... Read more
H/A chills, fever, malaise, then migraines. Then 1-2 migraine H/A every day. No H/A for the past 36 hours. Went to see pcp.
56 2021-01-13 unresponsive to stimuli Cardiac arrest within 1 hour Patient had the second vaccine approximately 2 pm on Tuesday Jan 12t... Read more
Cardiac arrest within 1 hour Patient had the second vaccine approximately 2 pm on Tuesday Jan 12th He works at the extended care community and was in good health that morning with no complaints. He waited 10-15 minutes at the vaccine admin site and then told them he felt fine and was ready to get back to work. He then was found unresponsive at 3 pm within an hour of the 2nd vaccine. EMS called immediately worked on him 30 minutes in field then 30 minutes at ER was able to put him on life support yet deemed Brain dead 1-14-21 and pronounced dead an hour or so later
56 2021-01-14 pain in extremity Headache, Myalgia, heavy head pressure, chills and body aches; today dizziness and arm soreness Narr... Read more
Headache, Myalgia, heavy head pressure, chills and body aches; today dizziness and arm soreness Narrative:
56 2021-01-17 numbness After 4
56 2021-01-19 pain in extremity Very sore left arm. Feels like someone hit it with a pipe.
56 2021-01-20 weakness Onset of symptoms on 12 January, including weakness, fatigue, headache, muscle and joint stiffness.
56 2021-01-20 pain in extremity, tremor Felt brain fatigue; Felt very hungry before dinner; On 07Jan, after breakfast I suddenly felt tired,... Read more
Felt brain fatigue; Felt very hungry before dinner; On 07Jan, after breakfast I suddenly felt tired, so took a nap; During the whole day I took three naps; Had sore arm; Between 15-30 min after injection, I felt light arrhythmia twice and I tried to do deeper breath to control it. About 1.5 hours after injection, in between my pull-up exercises I felt light arrhythmia; his legs were shaking which had never happened before; This is a spontaneous report from a contactable consumer reporting for himself. A 56-years-old male patient received the first dose of bnt162b2 (BNT162B2; Lot # EL0140) vaccine , in the right arm on 05Jan2021 16:00 at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced light arrhythmia on 05Jan2021 16:30 with outcome of recovered , his legs were shaking which had never happened before on 05Jan2021 with outcome of unknown, had sore arm on 06Jan2021 with outcome of recovered; felt brain fatigue on 07Jan2021 with outcome of recovered , , felt very hungry before dinner on 07Jan2021 with outcome of recovered , on 07Jan, after breakfast felt tired, so took a nap on 07Jan2021 with outcome of recovered , during the whole day i took three naps on 07Jan2021 with outcome of recovered. Course of the event: Between 15-30 min after injection, the patient felt light arrhythmia twice and tried to do deeper breath to control it. About 1.5 hours after injection, in between his pull-up exercises he felt light arrhythmia 2-3 times, and after doing the third set of pull-ups his legs were shaking which had never happened before. Next morning the patient woke up a couple hours later than his normal time. Noting that the night before he went to bed one hour earlier for no reason. When semi-waking up, he had a strong arrhythmia, followed by a couple more light ones. In the past arrhythmia did occur to him when he was very stressed or very tired, but had not have it for a few years. The patient had sore arm but tolerable. On 07Jan2021, after breakfast the patient suddenly felt tired, so took a nap. During the whole day he took three naps, which he had never done before. No arrhythmia though. The patient felt brain fatigue, but physically no problem. He felt very hungry before dinner, same as the day before, but not in other days.
56 2021-01-21 burning sensation Burning sensation, difficult to swallow, dizziness, redness in the chest, deep pain in the puncture ... Read more
Burning sensation, difficult to swallow, dizziness, redness in the chest, deep pain in the puncture area, iron flavor,
56 2021-01-21 cold sweat, tingling Pt received his first dose of Pfizer Covid vaccine today and after sitting for approximately 15 min.... Read more
Pt received his first dose of Pfizer Covid vaccine today and after sitting for approximately 15 min. He was observed getting up from his chair and appeared to sway. Immediately went to pt to assess and asked how he was feeling. Pt states "feel a little dizzy". When asked if experiencing any other symptoms describes "my left arm is tingling". Pt denies any difficulty breathing or other symptoms. Pt did not want to try anything to drink. 1557: BP= 158/80 and Apical HR=80-82/min and regular. Resp. Rate 16/min. Pt began feeling dizzy while sitting so had another nurse assist to try to get to the floor and pt unable to stand or scoot. Had medical emergency team called. Able to get pt down to the floor with further assistance of two nurses. Pt alert and oriented the entire time. Pt able to move all extremities including the left arm which continues to feel tingling sensation. Pt is feels clammy while on the floor. BP: 140/100, HR 82/min. Med team arrived and decision made to transport to the ED. Pt lifted to gurney by team and transported. Accompanied pt. and contacted his wife to notify of pt. situation. She was at doctor appointment and will arrive in approximately 30 minutes. Report given during transport and on arrival to ED. Pt remained alert and oriented throughout episode. Pt was given IV Benadryl in the ED along with a liter of normal saline. Pt discharged after approximately 2 hours.
56 2021-01-24 numbness and pain in extremities My autoimmune disorder went into overdrive and stayed there. I had joint pain and swelling, severe n... Read more
My autoimmune disorder went into overdrive and stayed there. I had joint pain and swelling, severe neuropathy, muscle pain, extreme fatigue and nausea that seems to never end. I still feel nauseated three hours after eating.
56 2021-01-25 feeling cold I did not experience any adverse symptoms with the first dose of Pfizer-BioNTech vaccine with the ex... Read more
I did not experience any adverse symptoms with the first dose of Pfizer-BioNTech vaccine with the exception of injection site pain after the first dose that began on day 2 through day 5 or for 3 days. The first Pfizer-BioNTech dose was received on December 30, 2020, LOT EK5730. I would rate the pain as a 5 out of 10 on VAS on 12/31/20. Please note that I completed the same pretreatment protocol 1.5 hours prior to dosing with Pfizer-BioNTech of Diphenhydramine 25 mg plus Pepcid 20 mg for both COVID-19 doses. I elected to complete a self-administered pretreatment protocol due to a shellfish allergy and literature reports of anaphylaxis with COVID-19 mRNA vaccines in food allergy recipients. I did not experience any adverse symptoms on Saturday afternoon after receiving the second dose of the Pfizer-BioNTech vaccine at 4:45pm on 1/23/21. On Sunday morning 1/24/21, I awoke feeling "cold." I dressed warmly, but the feeling progressed to chills by 3pm. Malaise ensued around 1pm. I also experienced injection site pain on the morning of 1/24/21 beginning at 7am. The pain lasted until 1/25/21. I would rate the pain as a 5 out of 10 on VAS ON 1/24/21. I began to feel uncomfortable with malaise and chills at 6:15pm on 1/24/21 and self-administered one dose of OTC Aleve, Naproxen sodium 220mg plus one dose of Benadryl 25 mg. I began to feel better by 9pm on 1/24/21. I awoke on 1/25/21 without any symptoms or discomfort with the exception of some injection site pain (2 out of 10 on VAS). I have been asymptomatic since 1/26/21.
56 2021-01-26 night sweats 4-6 HRS post injection loose stool. 8-12 hrs fatigue, body aches. 12-22 hrs flu like body aches, no ... Read more
4-6 HRS post injection loose stool. 8-12 hrs fatigue, body aches. 12-22 hrs flu like body aches, no sleep, comfort at all. 36-48 hrs after, fever > 100 F. Slept 12 hrs straight, woke up soaking wet, 49 hrs after, Fine..... shoveiing snow
56 2021-02-01 tremor FOLLOWING THE Pfizer BioNTech COVID-19 Vaccine EUA, EVENTS: DIAPHORESIS AND SHAKINESS STARTED BY 095... Read more
FOLLOWING THE Pfizer BioNTech COVID-19 Vaccine EUA, EVENTS: DIAPHORESIS AND SHAKINESS STARTED BY 0953 AM ON 02/02/2021 AND LASTED 15 MINUTES. HEART PALPITATION AND TACHICARDIA STARTED BY 0953 AM ON 02/02/21 AND ENDED AROUND 1025 AM INTERVENTIONS: RELAXATION OUTCOMES: DIAPHORESIS AND SHAKINESS ENDED BY 10:18 HEART PALPITATION AND TACHICARDIA ENDED AROUND 1025 AM PT NOTIFIED TO FOLLOW-UP WITH PCP IF NEW SYMPTOMS OR SYMPTOMS WORSEN
56 2021-02-03 weakness Uveitis (underlying condition occurring once every 2-3 years, I was NOT in a flare up at the time of... Read more
Uveitis (underlying condition occurring once every 2-3 years, I was NOT in a flare up at the time of the injection), and mouth ulcers (underlying condition occurring 2-3 times a year, I was NOT in a flare up at the time of the injection). For the Uveitis I went to my eye doctor and started a prednisolone regimen and am still on it. I received the 2nd does (lot EL9264) yesterday on 3 Feb at 09:00am. The mouth ulcers were treated with oral medication-Valtrex. 2nd dose does not seem to have aggravated the above noted reactions. Other symptoms common to the injection are occurring but seem more intense after the 2nd dose (aches, low energy, some minor coughing)
56 2021-02-03 tingling, numbness Lightheaded, dizzy for 4 hours; Toes, fingers and lips numb and tingly for 2 hours; Toes, fingers an... Read more
Lightheaded, dizzy for 4 hours; Toes, fingers and lips numb and tingly for 2 hours; Toes, fingers and lips numb and tingly for 2 hours; Toes, fingers and lips numb and tingly for 2 hours; Toes, fingers and lips numb and tingly for 2 hours; This is a spontaneous report received from a contactable physician (who is also the patient). A 56-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiry date: unknown), via an unspecified route of administration in the left arm, on 19Jan2021 13:30, at single dose, for COVID-19 immunization, in the hospital. Medical history included asthma and environmental allergies. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not have other vaccine in four weeks. Concomitant medications were unspecified (had other unspecified medications in two weeks). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date unknown), via an unspecified route of administration in the left arm, on 31Dec2020 13:30, for COVID-19 immunization. The patient was lightheaded, dizzy for 4 hours and experienced toes, fingers and lips numb and tingly for 2 hours, all on 19Jan2021 16:45. The events resulted in emergency room/department or urgent care visit. No treatment was provided. The patient recovered from dizzy for 4 hours on 19Jan2021 20:45 and from toes, fingers and lips numb and tingly for 2 hours on 19Jan2021 18:45.
56 2021-02-03 tingling Right Leg tingling; Strange Feeling; This is a spontaneous report from a contactable consumer (patie... Read more
Right Leg tingling; Strange Feeling; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 via an unspecified route of administration on 20Jan2021 10:00 AM at a single dose as COVID vaccine. There were no medical history and no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). The patient had no known allergies. The patient experienced right leg tingling and strange feeling on unspecified dates. Treatment was not received for the events. He had no COVID prior to vaccination. He did not have COVID tested post vaccination. The outcome of the events was unknown. Information on the lot/batch number has been requested.
56 2021-02-06 pain in extremity Pain on left arm and chest, increase in arterial blood pressure and sugar. The employee clinic docto... Read more
Pain on left arm and chest, increase in arterial blood pressure and sugar. The employee clinic doctor told me it was not related to the vaccine and it could be inflammation and suggested to make an appointment with my cardiologist, I wanted to let you know what I experienced, I respect my health professional's opinion.
56 2021-02-07 cold sweat Blood pressure sky high; Severe vertigo; Nausea; Vomiting; Cold sweats; This is a spontaneous report... Read more
Blood pressure sky high; Severe vertigo; Nausea; Vomiting; Cold sweats; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ELO3249; Expiration date was not reported) on 20Jan2021 (12:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. Medical history included watermelon allergy. Concomitant medications included celecoxib (CELEBREX), metoprolol tartrate, simvastatin and lisinopril. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ELO140; Expiration date was not reported) on the right arm on 30Dec2020 (when the patient was 56 years old) for COVID-19 immunization. On 21Jan2021 (03:45), in the morning, the patient's blood pressure was sky high; had severe vertigo; nausea; vomiting; and cold sweats. The patient had resulted in the emergency room/department or urgent case for the reported events. The patient had received unspecified medications as treatment for the nausea and vertigo. The outcome of the events, 'blood pressure was sky high', 'severe vertigo', 'nausea', 'vomiting' and 'cold sweats', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and had been tested for COVID-19 (nasal swab) post-vaccination which was negative on 21Jan2021.
56 2021-02-11 pain in extremity Pain on the upper arm. It lasted around 24 hours The lymph nodes at the neck also had pain and swoll... Read more
Pain on the upper arm. It lasted around 24 hours The lymph nodes at the neck also had pain and swollen the next day after shot. It disappeared after 24 hours
56 2021-02-14 pain in extremity had to close my eyes due to the faint feeling; palpitation; Fatigue; chills in the back of the head;... Read more
had to close my eyes due to the faint feeling; palpitation; Fatigue; chills in the back of the head; Arm soreness; felt a mild palpitation but not as strong as the strong one I experienced after the first injection/Arm soreness was much less than after the first dose/Fatigue was comparable; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3246), via an unspecified route of administration in right arm on 26Jan2021 12:30 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical Vaccine included received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140), via an unspecified route of administration in right arm on 05Jan2021 at single dose for COVID-19 immunization and experienced palpitation, Arm soreness and Fatigue. 30 min after injection, the patient felt a mild palpitation-stronger than any previous mild ones but not as strong as the strong one he experienced after the first injection, and he had to close his eyes due to the faint feeling. This was followed by a mild one 3 min later. In the next few days he had several additional mild to weak palpitations. The strong one that he experienced 12-14 hours after receiving the first dose did not show. Arm soreness was much less than after the first dose. Fatigue was comparable, and in third day still had to take a nap immediately after the breakfast. Additional nap was taken during the day-needed more but did not have time. The patient felt some chills in the back of the head some days but did not get "sick" at all. All events occurred on 26Jan2021 13:00. No treatment received for the events. The patient did not receive any other vaccines in four weeks. The patient had no COVID prior vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolved in Jan2021.
56 2021-02-18 pain in extremity Soreness at injection site and all of arm - within 6 hours through about 36 hours Fatigue - 6-8 hour... Read more
Soreness at injection site and all of arm - within 6 hours through about 36 hours Fatigue - 6-8 hours Body aches, headache, chills, fever - one week after for about 48 hours
56 2021-02-19 weakness Pain throughout the body and some weakness Headaches Pain at injection site on left arm Had symptom... Read more
Pain throughout the body and some weakness Headaches Pain at injection site on left arm Had symptoms for two full days and treated with ibuprofen and or Tylenol
56 2021-02-19 tremor Severe Chills, uncontrolled shaking, for 2 hours, moderate fever 102.4, moderate muscle aches. Each ... Read more
Severe Chills, uncontrolled shaking, for 2 hours, moderate fever 102.4, moderate muscle aches. Each for 2 nights.
56 2021-02-21 numbness Approximately 12 hours after vaccination, woke up with numbness and tingling on complete right side ... Read more
Approximately 12 hours after vaccination, woke up with numbness and tingling on complete right side of my body. Reaction has not gone away since the vaccination, 3 weeks ago. The reaction has decreased butt still exist up and down my right arm and hand, along on the right side of stomach.
56 2021-02-22 tremor Tiredness, shaky feeling, chills, mild lymph node swelling, low grade fever(<=99degreesF), loss of a... Read more
Tiredness, shaky feeling, chills, mild lymph node swelling, low grade fever(<=99degreesF), loss of appetite. Treated w/ bed rest, water, and ibuprofen. Lasted three days after shot. Fourth day, no fever, no swollen glands, and appetite returning.
56 2021-02-25 burning sensation upper lip edema; roof of mouth irritation and burning; gum irritation and burning; nose irritation a... Read more
upper lip edema; roof of mouth irritation and burning; gum irritation and burning; nose irritation and burning TRX: Benadryl 25mg X1 then Benadryl 50mg TID x 5 days Patient improved
56 2021-03-01 bell's palsy, face paralysis Bell Palsy, Rt face weakness, Adult. Treating with Valacyclovir HCL 1gm tab #21/21, 1 tab for 7 day... Read more
Bell Palsy, Rt face weakness, Adult. Treating with Valacyclovir HCL 1gm tab #21/21, 1 tab for 7 days; and Prednisone 20mg tab, 3 tabs per day for 7 days.
56 2021-03-02 pain in extremity Mild palpitation; faint feeling; Arm soreness; This is a spontaneous report from a contactable consu... Read more
Mild palpitation; faint feeling; Arm soreness; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received first single dose of BNT162B2 (Pfizer, lot number: EL0140, exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 05Jan2021 for COVID-19 immunization. Facility type vaccine: Hospital. The patient's medical history and concomitant medications were not reported. The patient had no Covid prior to vaccination. On 05Jan2021, 30 min after injection, felt a mild palpitation-stronger than any previous mild ones but not as strong as the strong one he experienced after the first injection, and he had to close his eyes due to the faint feeling. This was followed by a mild one 3 min later. In the next few days, he had several additional mild to weak palpitations. The strong one that he experienced was 12-14 hours after receiving the first dose, did not show. The patient also experienced arm soreness after the first dose (Jan2021). The patient was not Covid tested post vaccination. The patient recovered from the events on an unspecified date in Jan2021.
56 2021-03-04 tingling On the night of vaccine I had a fever up to 101 degrees, aches and fatigue into the next day. Two d... Read more
On the night of vaccine I had a fever up to 101 degrees, aches and fatigue into the next day. Two days later I started having diffuse sporadic and intermittent tingling on various parts of my body. That lasted about 2 days in its greatest severity. On day 6 post vaccine, I was walking in an airport and developed chest pain, tachycardia, and shortness of breath out of proportion to my level of exertion. This chest pain, shortness of breath and tachycardia with minimal exertion (a flight of stairs. A walk to the end of driveway.) has persisted since then. A cardiac w/u with Echo and treadmill stress ECHO were negative. I also have intermittent fatigue, headaches, and a mild "brain fog."
56 2021-03-08 weakness Extreme nausea, headache, weakness, mentally unawares, dizziness, and at the gym on a cardio machine... Read more
Extreme nausea, headache, weakness, mentally unawares, dizziness, and at the gym on a cardio machine, couldn't get enough oxygen circulation in the lungs, swollen inner ear in both ears, swollen hands, just overall feeling of fatigue.
56 2021-03-10 pain in extremity Starting 24 hours after vaccination, had mild influenza like illness-bodyaches, fatigue, cough. No m... Read more
Starting 24 hours after vaccination, had mild influenza like illness-bodyaches, fatigue, cough. No measured fever or chills. Left sided tender but non painful axillary lymphadenopathy. Treated symptomatically with ibuprofen. Symptoms resolved within 36 hours. Left arm soreness resolved within approx 72 hours post vaccine; no injection site redness or swelling.
56 2021-03-13 weakness First injection - only a sore right deltoid (injection site). Fairly intense but only lasted 24 hou... Read more
First injection - only a sore right deltoid (injection site). Fairly intense but only lasted 24 hours and easily alleviated by Tylenol. Second injection - Ringing in my ears - noticeable starting about 9pm the day of the second injection (3/11/21) and it's still going strong. Intensity of ringing has remained constant to date unfortunately. Headache was minor and on & off starting the night of the injection date and appear to still encounter them but intensity has been low. Taken Tylenol to alleviate symptom with success. Soreness at injection site - less intense on second shot than first but it lasted about 48 hours. The Tylenol I took for the headache seemed to help with the arm pain. On the day after the injection, my right latissimus dorsi (same side as shot) became sore but only for about 24 hours. Tiredness - didn't feel the exhaustion until about 9pm on the day of the injection. Exhaustion/tiredness set in more than expected so very low activity the day after and went to bed several hours earlier than normal. Still feeling tired but emerging from that as i'm starting to feel more energy come back.
56 2021-03-14 feeling hot At 1005 Patient, a 56 yo Male was sitting in a 15 minute observation after receiving a first dose Pf... Read more
At 1005 Patient, a 56 yo Male was sitting in a 15 minute observation after receiving a first dose Pfizer (Lot EP7534 Expiring 07/31/2021) five minutes prior. Patient reported feeling lightheaded and feeling a "heart warmth". Client reported past medical history of Neuropathy, Mechanical mitral valve replacement, aortic valve repair, hyperlipidemia, coronary artery disease, hypertension, DMII, dyspnea, obesity, depression and pulmonary hypertension. Client denied any allergies to medication, food or seasonal allergies. Client stated he last ate at 1030pm on 3/14/2021. Denied having any food, drink or diabetic medication this morning. Client rated the severity of heart warmth as a 2/10. Client stated warmth in his heart was similar to the sensation he had when doing a heart stress test. Client denied chest pain, shortness or breath, blurry vision, dizziness, headache, nausea, vomiting, diarrhea, recent illness or lifestyle changes. At 1018am client had water and ate a fruit bar he had. At 1022am client stated the warm sensation had diminished and he felt better after eating and drinking. Client denied dizziness, blurry vision and chest pain. Site offered to call 911 to have an ALS assessment. Client declined further evaluation and care. At 1045am Client was able to ambulate without assistance and had a steady gait as he left the observation site.
56 2021-03-14 tremor Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
56 2021-03-15 bell's palsy, facial paralysis Developed new onset unilateral facial drooping, difficulty with eyelid closure, loss of nasolabial f... Read more
Developed new onset unilateral facial drooping, difficulty with eyelid closure, loss of nasolabial fold, and loss of forehead furrow on 3/7/2021 diagnosed as Bell's palsy
56 2021-03-17 discomfort discomfort; did not sleep a wink last night; Nauseous; blood pressure elevated/139/94; heart rate el... Read more
discomfort; did not sleep a wink last night; Nauseous; blood pressure elevated/139/94; heart rate elevated/His heart rate is currently 139; This is a spontaneous report from a contactable consumer (patient). A 56 -year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9264), intramuscular (on left arm) on 28Jan2021 12:30 (at the age of 56 -years-old), single dose for COVID-19 immunization. No relevant medical history. The patient's concomitant medications were not reported. Patient is calling about the first dose of the Pfizer covid19 vaccine which he received on Thursday. Yesterday, he started getting nauseous, it is terrible and very strong. The nausea has been continuous since yesterday. His blood pressure and heart rate is pretty elevated. Declines any treatment. The nausea was bad yesterday and stayed bad, he did not sleep a wink last night. His last blood pressure taken about 10 minutes ago was 139/94. His blood pressure is normally 125 over 65 or 70. His heart rate is currently 139. His heart rate and blood pressure became elevated yesterday. States it might have to do with how much discomfort he is in. When querying other medications and medical conditions, he reports nothing out of the ordinary. The outcome of the events sleep disorder and discomfort was unknown, other events was not recovered. No Prior Vaccinations (within 4 weeks).No AE(s) following prior vaccinations.
56 2021-03-17 tingling pt. complain of numbness and tingling of his left hand from the site of the vaccination to his finge... Read more
pt. complain of numbness and tingling of his left hand from the site of the vaccination to his fingers. They symptoms were resolved and the patient went home.
56 2021-03-18 flushing A little,flush around neck and ears. But almost not noticeable.
56 2021-03-18 numbness 1:45 presented himself in observation w/ c/o numbness in lt.arm. Skin W/D, capillary refill left ha... Read more
1:45 presented himself in observation w/ c/o numbness in lt.arm. Skin W/D, capillary refill left hand quick. No other symptoms. Second observation. Very talkative, laughing, telling jokes, w/ no further c/o lt.arm numbness. Advised if reoccurs seek medical attention.
56 2021-03-18 pain in extremity headache, arm soreness
56 2021-03-19 pain in extremity sore arm day after, which cleared. (I expected this) However, a couple days after vaccine, I starte... Read more
sore arm day after, which cleared. (I expected this) However, a couple days after vaccine, I started developing hive like rash on right side. At first I thought it might be scratches/irritation from sharp edges on a torn leather sofa, but more red welts appeared in unrelated locations: chest and back. I have had childhood chickenpox, and have also considered stress as a possible trigger for shingles, but that seems remote to me.
56 2021-03-21 numbness 48 hours after vaccination numbness in the facial area... including lips, left ear, forehead and che... Read more
48 hours after vaccination numbness in the facial area... including lips, left ear, forehead and cheek. Not severe and no visual effects to date.
56 2021-03-22 bell's palsy Bells palsy R side
56 2021-03-23 tingling Uncomfortable aching in right shoulder and elbow for 3 weeks, continued tingling in 3 middle fingers... Read more
Uncomfortable aching in right shoulder and elbow for 3 weeks, continued tingling in 3 middle fingers on right hand at times.
56 2021-03-25 burning sensation no visible redness or other sign but softball sized burning sensation of skin on upper thigh.
56 2021-03-25 burning sensation Burning sensation of bilateral hands. dryness of mouth/throat
56 2021-03-25 feeling hot It began with a headache around 2 am, March 26, 2021. Around 8:30 am I began to experience nausea a... Read more
It began with a headache around 2 am, March 26, 2021. Around 8:30 am I began to experience nausea and fatigue. At 3:30 pm I vomited one time. Since 8:30 am I have slept about six hours. I also felt hot on and off during this time, but I have checked my temperature 3 times and it was normal all three times.
56 2021-03-25 unresponsive to stimuli Patient here for COVID 19 vaccine Arrived to drive through as passenger in car. He did let RN know... Read more
Patient here for COVID 19 vaccine Arrived to drive through as passenger in car. He did let RN know before vaccine he has felt faint and has had syncopal episodes after injections or blood draws. Immediately after injection he had a loss of conciseness. Lasting approximately 1min. Partner states this was a normal reaction. He then had a second episode lasting longer than first. Partner states this is not a normal reaction for him. He was not responding to voice or touch after approximately 1-2 mins he was alert and responsesive to person, place and situation. RN stayed with Patient as he remained in car. 911 called to evaluate RN gave report and hand of to EMS. per RN
56 2021-03-26 weakness Shoulder pain, loss of range of motion, weakness
56 2021-03-27 weakness Aches, no energy, fatigue, spotty rash, itchy
56 2021-03-28 facial paralysis, tenderness, discomfort Per MD note: Notably patient received Pfizer COVID 19 vaccine on March 12 th. He was doing well but... Read more
Per MD note: Notably patient received Pfizer COVID 19 vaccine on March 12 th. He was doing well but then 3/24/21 patient noted his right eye was feeling "funny" and the next day or 2 it continued and then was hard to close eye on its own. In the last 1-2 days he is having a right facial droop and cannot hold his mouth closed with puffing out cheeks. Separately he also has tenderness like a bruised area just anterior to the right ear and describes a fullness/swelling of the tissue there and more anteriorly on the cheek. He does not recall similar sensation with his prior Bell's Palsy which was on the left side 2 years ago. He denies other symptoms , with out fever or chills. No other suggestion of sicknesses.
56 2021-03-28 cold extremities cold shooting through extremities, torso going to jelly, heat on back of neck. Would come in waves ... Read more
cold shooting through extremities, torso going to jelly, heat on back of neck. Would come in waves every 5-10 mins. Started about 30 mins after injection. Hospital treated with benedryl, and high dose anti-inflammatory. Observed for 3 hours. Symptoms quit.
56 2021-03-31 numbness, tremor, tingling Symptoms starting coming on about 20 Hours after the shot. Sever Chills and shaking for about 2 hour... Read more
Symptoms starting coming on about 20 Hours after the shot. Sever Chills and shaking for about 2 hours. Top of head numb and tingling . Severe Fatigue. Sore across the shoulders. Slight Blurred Vision. Fever of 100.5 Usually run around 97.1 on a normal day. Body ache to the point walk very slowly. Lose of appetite and only had about 10 oz of water during the adverse event time. With Tylenol and resting through the evening by 5:00 AM the next morning I was close to full recovery. Top of Head was still still slightly numb. 24 hours after the onset of the event I am back to normal.
56 2021-04-01 feeling cold Client called for assistance feeling a cold sensation down his throat. Firefighters first responded.... Read more
Client called for assistance feeling a cold sensation down his throat. Firefighters first responded. Client stated he was feeling good. Client was released to his home at 4:00pm.
56 2021-04-01 numbness numbness in cheeks, dry throat. Evaluated by EMS-Cleared
56 2021-04-01 pain in extremity, tingling, numbness Initial shoulder soreness developed into severe shoulder pain that continues after 4 week. Stinging ... Read more
Initial shoulder soreness developed into severe shoulder pain that continues after 4 week. Stinging and constant pain beneath scapula, running through armpit to fingers. Index finger is numb, middle finger and thumb tingle. Based on my web searchers in sounds like SIVAR.
56 2021-04-01 pain in extremity Nausea, Diarrhea, Body Aches, Arm pain, Fatigue,Feel Unwell,Light Headed
56 2021-04-02 flushing Flushing/sweating, dizziness, chest tightness. BP 162/110 (pulse 76). Final BP 153/104 (pulse 80). O... Read more
Flushing/sweating, dizziness, chest tightness. BP 162/110 (pulse 76). Final BP 153/104 (pulse 80). O2 sats 99%-100%. Apple juice and water given.
56 2021-04-03 cold sweat At 8:35pm on 3/30, sudden onset severe vertigo while lying down - lasting only a minute - followed b... Read more
At 8:35pm on 3/30, sudden onset severe vertigo while lying down - lasting only a minute - followed by severe nausea and cold sweat. Couldn't open eyes or move head for fear of repeating episode. A few hours later, a repeat episode lasted a few minutes and triggered vomiting. Around 7am the next morning, a third episode violent enough to trigger vomiting again. The severe nausea and headache lasted around 12 hours, but the mild nausea and severe headache lasted 48 hours. At 5 days after vaccination, still feel lightly dizzy with a sense of confusion or fogginess.
56 2021-04-03 numbness On Thursday April 1, 10 days after the vaccine (1st shot) I began to experience itch hives all over... Read more
On Thursday April 1, 10 days after the vaccine (1st shot) I began to experience itch hives all over my body. I took Benadryl at 2 pm and 8 pm to relieve the symptoms. It helped. At 7 am, morning of Friday April 2, I took Claritin to relieve symptoms but it was not effective. At 9:15 am, morning of Friday April 2, my lips and cheeks began to go numb, and it felt as if my throat and tongue were swelling. At 9:30 am. I checked in to the ER. They monitored my condition and indicated my blood pressure and oxygen levels were normal. At approximately 10:15 am, my mouth began to feel normal again. While at the ER, the doctor checked out my hives and gave me Prednisone. She also gave me a prescription for 4 days of Prednisone, 50 mg tablets, and advised to continue taking Benadryl to relieve symptoms. I have taken Prednisone once a day for past couple days and Benadryl 3 times a day. Hives are still present today Sunday April 4, 2021 but milder than previous days.[Not certain if this is important, but on day 3 and 4 after the vaccine, I reported dizziness on mobile app check-in. The dizziness went away by day 5. I had no other symptoms appear until day 10 reported here.
56 2021-04-04 facial pain, bell's palsy, facial paralysis Participant reported waking up the next morning after his Pfizer vaccine with right facial paralysis... Read more
Participant reported waking up the next morning after his Pfizer vaccine with right facial paralysis and severe facial pain. Pt went to his primary care physician and was diagnosed with bell's palsy and instructed not to receive second dose of Pfizer.
56 2021-04-04 pain in extremity I got home at 5 am from getting the shot, and laid down, I woke up at 9 am for a 10 am meeting with ... Read more
I got home at 5 am from getting the shot, and laid down, I woke up at 9 am for a 10 am meeting with left arm soreness at the site of the injection. I then developed body chills, ackey sore muscles Back, chest, arms and a really nagging headache. I was very groggy. Saturday, I was a mess, I bundled up with an electric blanket to stay warm. I slept most of the day. The symptoms lasted until Sunday (Easter) around noon, when I started to feel normal again
56 2021-04-05 pain in extremity, muscle spasms He had the vaccine, and had some pain in his arm and a headache. He woke up Thursday morning 4/1/2... Read more
He had the vaccine, and had some pain in his arm and a headache. He woke up Thursday morning 4/1/21 with severe back pain, spasm, and not able to more. He did not have this pain before the vaccine. He did alternate between Ibuprofen and Tylenol for the pain and it did not help.
56 2021-04-06 numbness, tingling full body rash, worse on hands. itching, feeling of tingling and numbness. fluttering feeling in che... Read more
full body rash, worse on hands. itching, feeling of tingling and numbness. fluttering feeling in chest.
56 2021-04-06 muscle spasms After shot, started getting muscle spasms in entire body and muscle aches, bad headache, fever of 10... Read more
After shot, started getting muscle spasms in entire body and muscle aches, bad headache, fever of 100.8 . Started the same night as the vaccine was given, worse the next day.
56 2021-04-06 seizure Complex seizures; Explosive diarrhea; Profuse vomiting; Chills; sweats; This is a spontaneous report... Read more
Complex seizures; Explosive diarrhea; Profuse vomiting; Chills; sweats; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN6207), via an unspecified route of administration in the left arm, on 22Mar2021 at 09:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced complex seizures, explosive diarrhea, profuse vomiting, chills, and sweats on 22Mar2021 at 19:00. All of the events required hospitalization from an unspecified date to an unspecified date for one day. The patient underwent lab tests and procedures which included nasal swab: negative on 22Mar2021. Therapeutic measures were taken as a result of all of the events, which included intravenous fluids. The clinical outcome of complex seizures, explosive diarrhea, profuse vomiting, chills, and sweats was recovered on an unspecified date. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
56 2021-04-07 tremor, muscle spasms Autoimmune response involving all previous symptoms of PTLDS especially dizziness, multiple joint pa... Read more
Autoimmune response involving all previous symptoms of PTLDS especially dizziness, multiple joint pain especially spine, shoulders and hands along with uncomfortable stomach pain and severe headache. Treatment -water, some pepto, and 2 ibuprofen. Started previous evening with fatigue and hands, woke up around two AM with tremors and cramping, all symotoms worsening to the mid afternoon. Unable to stand or walk with confidence or safely hold objects
56 2021-04-08 pain in extremity double pneumonia; body aches/I started aching; headache; tired/fatigue/exhausted; I got the chills; ... Read more
double pneumonia; body aches/I started aching; headache; tired/fatigue/exhausted; I got the chills; my skin felt like it was sunburned; cough; fog; no appetite; sweating; my arm hurt/sore arm; he had a previous flu like symptoms after the shingles vaccine.; This is a spontaneous report from a contactable consumer (Patient). A 56-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8727), via an unspecified route of administration in the left arm on 24Mar2021 at 10.30 (at the age of 56-years-old) as single dose for covid-19 immunisation. Medical history included hypertension diagnosed 20 years ago, blood cholesterol diagnosed about 7 years ago, Covid-19 in Dec2020 which hit him pretty hard, double pneumonia, he was wiped out, patient had a shingles vaccine a couple of years ago he had a fever and it felt like he had the flu, for about 48 hours he was wiped out. This happened with both doses of the shingles vaccine. Concomitant medication(s) included colecalciferol (VITAMIN D [COLECALCIFEROL]) and vitamin C (ascorbic acid) (VITAMIN C [ASCORBIC ACID]). On 24Mar2021 (Wednesday), patient experienced double pneumonia, body aches/i started aching, my arm hurt, headache, tired/fatigue/exhausted, i got the chills, my skin felt like it was sunburned, cough, fog, no appetite, sweating, sore arm, he had a previous flu like symptoms after the shingles vaccine. It was reported that all the same symptoms the patient had with COVID, the caller had after the vaccine. The next morning was much worse and through that next day. Patient describes his side effects like a mini Covid 19 reaction. The symptoms were very similar to the symptoms he had 4 days into his Covid-19 diagnosis. It was reported that on Friday (26Mar2021) he felt normal and was able to workout on Saturday (27Mar2021) as usual. The patient believes his antibodies are strong following his virus and then the 1st Pfizer vaccine dose. The patient doesn't think he had a fever, but he didn't have that with covid along with no loss of taste and smell. The patient was very grateful for the vaccine. Patient had no other vaccinations within 4 weeks prior vaccination. The patient underwent lab tests which included blood cholesterol and blood pressure whose results are reported as high on an unknown date. The outcome of the event double pneumonia was unknown, and for all other events it was recovered.
56 2021-04-09 weakness, pain in extremity Left arm pain for 48 hours; Weakness for 48 hours; Lightheadedness for 24 hours; This is a spontaneo... Read more
Left arm pain for 48 hours; Weakness for 48 hours; Lightheadedness for 24 hours; This is a spontaneous report from a contactable other hcp. A 56-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in Arm Left on 04Feb2021 10:15 as SINGLE DOSE for an unspecified indication. Medical history included depression, bipolar i disorder, insomnia, hypercholesterolaemia from an unknown date. Concomitant medications included asa (ASA); atomoxetine hydrochloride (STRATTERA); escitalopram oxalate (LEXAPRO); gabapentin (NEURONTIN); trazodone. The patient experienced left arm pain for 48 hours (pain in extremity), weakness for 48 hours (asthenia), lightheadedness for 24 hours (dizziness) on 04Feb2021 at 12:00. Therapeutic measures were taken as a result of left arm pain for 48 hours (pain in extremity), weakness for 48 hours (asthenia), lightheadedness for 24 hours (dizziness), acetaminophen was provided. The action taken in response to the event(s) for bnt162b2 was not applicable. Outcome of the event lightheadedness was recovered on 05Feb2021 at 12:00 and event left arm pain and weakness was recovered on 06Feb2021 at 12:00. Follow-up attempts are completed. No further information is expected.
56 2021-04-09 weakness Heavy Vomiting headache being very weak next day very weak no energy very weak slight headache arm i... Read more
Heavy Vomiting headache being very weak next day very weak no energy very weak slight headache arm is very very sore swollen for injection was injected
56 2021-04-09 bell's palsy Bell's Palsy; administered in the left leg; This is a spontaneous report from a contactable consumer... Read more
Bell's Palsy; administered in the left leg; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727, expiry date: unknown), via an unspecified route of administration, administered in the left leg, on 21Mar2021 09:45, as single dose, for COVID-19 immunization. The patient medical history was not reported. The patient did not have COVID-19 prior to vaccination. There were no concomitant medications (no other medications in two weeks). The patient did not receive other vaccines in four weeks. On 22Mar2021, the patient experienced Bell's palsy. This event required hospitalization for 2 days (unspecified dates). Treatment included steroids. The patient underwent COVID Nasal Swab and tested negative on 22Mar2021. The outcome of the event Bell's palsy was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
56 2021-04-10 tingling pt reports that he developed paresthesia left side of face approximately 24 hours after receiving th... Read more
pt reports that he developed paresthesia left side of face approximately 24 hours after receiving the 2nd vaccine; very mild facial asymmetry; hx of bells palsy in past
56 2021-04-11 weakness Woke up with tinnitus in right ear on 2/27/21, almost exactly 2 weeks after second vaccination shot ... Read more
Woke up with tinnitus in right ear on 2/27/21, almost exactly 2 weeks after second vaccination shot (Pfizer). Within days, fatigue and weakness set in with some sporadic joint and stomach pain. Symptoms persist today, six weeks later.
56 2021-04-11 weakness 40 hours after the second vaccine, I woke up and felt drained and exhausted with no energy. No other... Read more
40 hours after the second vaccine, I woke up and felt drained and exhausted with no energy. No other symptoms. I took a 4 hour nap and when I woke from the nap I felt perfectly fine and full of energy.
56 2021-04-11 numbness Date and time adverse event started: ringing of the ears 3-28-21, 4-5-21 numbness face 4/8-recomme... Read more
Date and time adverse event started: ringing of the ears 3-28-21, 4-5-21 numbness face 4/8-recommended he get seen by his pcp or local ER to r/o bells palsy or stroke like symptoms related to his reported numbness to unilateral side of his face. caller verbalized understanding. caller spoke with no slurr and was oriented X4 during the call
56 2021-04-11 pain in extremity Bruising around the are of shot administration, general fatigue with arm soreness and occasional min... Read more
Bruising around the are of shot administration, general fatigue with arm soreness and occasional minor throbbing.
56 2021-04-12 weakness Severe, debilitating dizziness and weakness that lasted 48 hours.
56 2021-04-12 feeling hot I started having a severe headache, chills and I thought I had fever I was feeling hot but I did not... Read more
I started having a severe headache, chills and I thought I had fever I was feeling hot but I did not have fever, I had nausea , then after 3 hours of the above symptoms I vomited. From then I fully recover just I had light headache for a few hours.
56 2021-04-12 pain in extremity, feeling cold, numbness Developed chills, body aches and low grade fever starting at 5pm on 3/30 (more than 24 hrs after rec... Read more
Developed chills, body aches and low grade fever starting at 5pm on 3/30 (more than 24 hrs after receiving vaccine), fever topped out at 101.7 degrees, fever remained overnight, broke by 10am next day, chills remained for about another 24 hours. Likely unrelated, developed right knee, calf and foot pain and had numbness in 2 left foot inner toes, off and on for 3-4 days after fever broke. Took 2 Advil, pain completely disappeared by 2 days later. I have arthritis and have had 2 right/1 left knee surgeries, and the temperature rose right about the time the pain disappeared, but the cold has returned and no pain. Just odd, almost like a side effect of producing anti-bodies was excessive inflammation in parts of my body prone to inflammation. I get the flu vaccine every year, and I have flu-like symptoms (chills, aches, low-grade fever) for several days within 24 hrs every year.
56 2021-04-13 numbness, facial paralysis, tingling, slurring The adverse event was a small stroke which occurred after/during a severe headache . There was numbi... Read more
The adverse event was a small stroke which occurred after/during a severe headache . There was numbing/tingling and muscle contractions in my left hand followed my face drooping and slurred speech. It was never said that the stroke was caused by the vaccine. It may have been a factor though.
56 2021-04-13 numbness Facial numbness.
56 2021-04-13 pain in extremity On the evening of the injection, he had fever of greater than 104 degrees with shaking chills. He ca... Read more
On the evening of the injection, he had fever of greater than 104 degrees with shaking chills. He called the Health Dept. because he feels that the shot was given into the shoulder joint. He describes pain in the shoulder joint at a level of 2-3 on a 10 point scale. By yesterday, his fever was down to ~99degrees. Today, he is feeling better, but his arm is still tender and he increased tenderness when he raises his elbow.
56 2021-04-14 numbness Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe, ... Read more
Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Unable to Sleep-Medium, Additional Details: Patient reports experiencing numbness in both arms, has doctor's appt scheduled for further follow-up
56 2021-04-14 numbness After 20 minutes I lost feeling in the left side of my face. It also radiated down my left arm. It... Read more
After 20 minutes I lost feeling in the left side of my face. It also radiated down my left arm. It subsided after 7 hours and was gone after 18 hours. The following morning I woke to a sore back in an area I have had issues with. The pain progressed and has gotten worse over the past two months. I have gone from training for a triathlon to only being able to walk about one mile with pain. I am in pain 24 hours a day now.
56 2021-04-14 pain in extremity Fatigue, diarrhea, joint pain, muscle weakness, pain in both hands, headache, neck pain. Fatigue on... Read more
Fatigue, diarrhea, joint pain, muscle weakness, pain in both hands, headache, neck pain. Fatigue onset 4/10/21, symptoms worsened 4/13/21.
56 2021-04-14 pain in extremity Bilateral foot pain in ball of foot and toes, stiffness in the plantar fascia.
56 2021-04-14 pain in extremity Very sore arm. Mild swelling. Very painful to move my arm. Especially painful moving upwards over my... Read more
Very sore arm. Mild swelling. Very painful to move my arm. Especially painful moving upwards over my head.
56 2021-04-15 weakness Patient complained of feeling weak and sweaty. No chest pain or shortness of breath or rash. Treatme... Read more
Patient complained of feeling weak and sweaty. No chest pain or shortness of breath or rash. Treatment- NO po water or juice given as patient is muslim and was fasting VS 203/138, HR 69, RR 12, Pulse Ox 99% EMS called for elevated BP and symptoms EMS arrived and repeated BP with manual cuff and BP was 137/86, accucheck normal and was released to go home Patient was obsed for one hour and DCed home
56 2021-04-15 discomfort, pain in extremity Patient presents to clinic for swollen left axillary lymph nodes. Patient states he had his 2nd COVI... Read more
Patient presents to clinic for swollen left axillary lymph nodes. Patient states he had his 2nd COVID-19 vaccine on 4/6/21 and he noticed the swelling on 4/9/21. Swelling is now staying the same. Denies pain but there is some discomfort. No change in deodorant. COVID vaccine received in left arm. Patient states intermittent pain of left forearm for the past two week. States an achy feeling. Pain will wake him up at night. States he normally has to turn or stretch arm to make it feel better. ED visit after 1st COVID vaccination- shortness of breath. He notices if he is taking a strenuous walk he will get short of breath. This has continued since his 1st COVID vaccination.
56 2021-04-15 pain in extremity Caller stated he had Pfizer first vaccine last Friday. Next day had arm pain and was tired. Then on ... Read more
Caller stated he had Pfizer first vaccine last Friday. Next day had arm pain and was tired. Then on Monday through Wednesday felt more fatigued with diarrhea. He stated feelin a bit better today.
56 2021-04-16 pain in extremity Sore arm, stomach pain
56 2021-04-17 bell's palsy bell palsy; Got shingles; This is a spontaneous report from a contactable consumer (patient). A 56... Read more
bell palsy; Got shingles; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 15Mar2021 12:00 (Lot Number: En6208), at the age of 56-years at vaccination, as SINGLE DOSE for covid-19 immunisation. Medical history was none. The patient previously took Advil and experienced allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included vitamins nos and 'Acid pill' taken for an unspecified indication, start and stop date were not reported. On 2021, the patient experienced bell palsy and shingles. The event involved physician office visit. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): inconclusive on 31Mar2021. The outcome of the events was not recovered. Therapeutic measures were taken as a result of the events which includes viral pill and strides. Follow-up attempts are completed. No further information is expected.
56 2021-04-17 bell's palsy Bell's palsy; Foggy brain; Loss of feeling in lips and tongue; This is a spontaneous report from a c... Read more
Bell's palsy; Foggy brain; Loss of feeling in lips and tongue; This is a spontaneous report from a contactable consumer (patient, self-reported). A 56-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, in Arm Left, on 30Mar2021 at 17:30 (age at vaccination was 56 years), as a single dose for COVID-19 immunisation. Patient's medical history included diabetes and cancer survivor. The concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (lot number and expiry dates were not provided) via an unspecified route of administration, in Arm Left, on 09Mar2021 at 03:00 PM (age at vaccination was 56 years), as a single dose for Covid-19 immunisation. On 31Mar2021 at 09:00, the patient experienced bell's palsy, foggy brain and loss of feeling in lips and tongue. Patient did not receive other vaccines within 4 weeks or prior vaccination. Patient's treatment medications included unspecified steroid for the adverse events. The patient was hospitalized for the events on an unknown date in 2021 (for two and half days). Seriousness of the events was reported as hospitalization. Outcome of events was not recovered. Information on the lot/batch number has been requested.
56 2021-04-17 feeling hot Both feet bottom of feet and top of feet extreme heat started on April 15 and still happening now S... Read more
Both feet bottom of feet and top of feet extreme heat started on April 15 and still happening now Since 4/15/21 had approximately 4 hrs of sleep. Not sleepy or tired. Feeling heat sensation on a scale of 1 to 10 heat is about 10. Continuous have no relief And cannot sleep
56 2021-04-17 night sweats Flu like symptoms-- night sweats abs chills, low grade fever, headache, muscle aches.
56 2021-04-17 pain in extremity Inflamation and pain on left side of the body, beginning in the arm/shoulder and spreading to neck a... Read more
Inflamation and pain on left side of the body, beginning in the arm/shoulder and spreading to neck and left tonsil. Tonsil swelling was quite pronounced by 2am (nearly twelve hours after the injection) and blocked the airway when head was turned to the left, necessitating a makeshift pillow brace to keep head turned to the right overnight. Tonsil swelling began to diminish by about 6am and only slight enlargement remains thirty hours after injection. Additionally, a low-grade fever began at about 10 pm (~7 hours after injection) and reached a maximum of 100.5 degrees F approximately twenty-four hours after the injection. By twenty-eight hours, temperature was within normal limits (though still nearly a degree higher than typical for this patient). As of this writing, some thirty hours after the injection, headache, neck ache, and eye-ache persist, but none is severe. Symptoms appear to be continuing their improvement. I (the patient/recipient) hope the second installment of the vaccine is no worse than this one. The only truly alarming symptom was the swollen tonsil and some thought was given to seeking medical attention, but the pillow brace seemed to do the trick for keeping the airway open, so no assistance was sought. I have no doubt that these short-lived symptoms are much better than actual disease and I will not hesitate to follow up with the second vaccine installment?but I will monitor the tonsil situation very carefully.
56 2021-04-17 pain in extremity 04/01/2021 around 5:00 PM: 1. Sore Arm, Shortness of Breath, Chest Pains, Fatigue. | Thought was He... Read more
04/01/2021 around 5:00 PM: 1. Sore Arm, Shortness of Breath, Chest Pains, Fatigue. | Thought was Heartburn, took tums and had a little relief 04/02 to 04/05/2021: Same Symptoms throughout those day, had No appetite, increased fatigue. and Tums No longer gave relief. 04/06/2021 6:00 AM: Went to emergency room and had to receive emergency heart surgery as I was diagnosed with blood clogged arteries and had been having a heart attack for the past several days
56 2021-04-17 tingling Tingling, nausea, headache day of vaccination. Brain fog for following 36 hours.
56 2021-04-19 weakness For the first three days, it was severe nausea, body & head aches, tiredness with flank pain on the ... Read more
For the first three days, it was severe nausea, body & head aches, tiredness with flank pain on the left side toward the kidney area. Three days later, the severe nausea returned and caused weakness. The flank pain increased to my lower ribcage on the leftside and am still dealing with it. (4/20/2021)
56 2021-04-19 migraine Pfizer-BioNTech COVID-19 Vaccine EUA Severe Migrane Headache, Severe pain in left eye swelling and l... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Severe Migrane Headache, Severe pain in left eye swelling and loss of vision, Nausea and Vomiting, Severe Fatigue
56 2021-04-19 pain in extremity Right soleal vein DVT; patient developed signs of right lower extremity swelling, erythema, pain app... Read more
Right soleal vein DVT; patient developed signs of right lower extremity swelling, erythema, pain approximately 3 days after vaccination; patient presented to hospital approximately 3 weeks after these symptoms started. Was started on Xarelto in the hospital.
56 2021-04-19 tingling Injection site tenderness, ipsilateral rotator cuff tendinopathy, ipsilateral hand tingling, ipsil... Read more
Injection site tenderness, ipsilateral rotator cuff tendinopathy, ipsilateral hand tingling, ipsilateral medial biceps tenderness
56 2021-04-19 seizure Seizure
56 2021-04-20 pain in extremity Patient states that after receiving his first Pfizer COVID19 vaccine, a previous cut that had alread... Read more
Patient states that after receiving his first Pfizer COVID19 vaccine, a previous cut that had already scabbed over and was healing on his arm started to swell and become infected. The initial wound has not healed and has become painful. Now, after receiving his second Pfizer COVID19 vaccine the patient has a total of 3 wounds, all circular and approximately 3/4" diameter on his arms. The additional two wounds were the same as the first, previous cuts that were healing and then turned into these identically sized & shaped wounds.
56 2021-04-20 pain in extremity Pain in bilateral lower extremities that started after 1st dose of COVID vaccine. US completed on 4/... Read more
Pain in bilateral lower extremities that started after 1st dose of COVID vaccine. US completed on 4/16/21 showed superficial blood clot in right leg. Treatment included: warm compresses, taking ibuprofen 600 mg with food three times daily, and elevation of your right lower extremity. Outcome: unknown.
56 2021-04-21 tingling, nerve pain, electric shock sensation, feeling of insects crawling on skin Within 30 minutes of receiving vaccination started having minor nerve sensations at random places t... Read more
Within 30 minutes of receiving vaccination started having minor nerve sensations at random places throughout body. The sensations (pins & needles, itching, crawling, tingling and minor energy zaps well below skin) continued regularly but were never severe. On April 10th I started taking. 1 tsp of L-glutamine Supplement which I have previously taken with no issues. Neurological paresthesia increased once I?ve started taking supplements. After about one week I made the connection and stopped. Symptoms decreased but have not ceased. Rather they went back to levels they were before taking the L glutamine.
56 2021-04-21 tremor, cold extremities, feeling hot Approximately 20 hours after receiving the vaccine, my hands and feet became very cold, and my whole... Read more
Approximately 20 hours after receiving the vaccine, my hands and feet became very cold, and my whole body began to shake - have chills, and my teeth began chattering. Approximately 3 hours later, I began to feel warm; my eyelids were very warm whenever I blinked. Slowly but surely I began to feel better.
56 2021-04-22 weakness Headache, body aches, low grade fever and loss of energy
56 2021-04-22 feeling hot Systemic: throat thigtness, warmness in chest, no difficulty building but\"funny feeling\" when swal... Read more
Systemic: throat thigtness, warmness in chest, no difficulty building but\"funny feeling\" when swallowing, patient is alert, able to answer questions, able to complete sentences-Mild, Additional Details: patient describes tightening of throat, warmness of chest, no difficulty breathing but \"funny feeling\" (cottony feel according to patient) when swallowing. patient is alert, able to answer questions and able to complete sentences. pharmacist on duty immediately called 911, have epipen ready. per 911 dispatcher, rph must answer some questions first, but paramedics arrived immediately to the scene and took over. patient interviewed by paramedics and patient walked with paramedics out of building.
56 2021-04-22 feeling hot Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: warmness in chest,tighte... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: warmness in chest,tightening of throat, no difficulty breathing but \"funny feeling\", able to complete sentences, able to answer questions, patient is alert-Mild, Additional Details: patient describes tightening of throat, warmness of chest, no difficulty breathing but \"funny feeling\" (cottony feel according to patient) when swallowing. patient is alert, able to answer questions and able to complete sentences. pharmacist on duty immediately called 911, have epipen ready. per 911 dispatcher, rph must answer some questions first, but paramedics arrived immediately to the scene and took over. patient interviewed by paramedics and patient walked with paramedics out of building.
56 2021-04-23 burning sensation Itchy, burning,painful,fine papular rash,dry and rough.10 intertriginous areas.
56 2021-04-23 migraine Systemic: Headache-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient... Read more
Systemic: Headache-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient had visual disturbances within 1 hour of vaccination and lasted for an hour. then a migraine proceeded after the visual disturbances. the migraine last 3 hours, that is the first migraine he has ever had in his life. he managed the migraine with tylenol and ibuprofen. after 3 hours the migraine turned into a headache and last until late in the evening
56 2021-04-24 tremor, feeling cold Chills starting at 5 pm day 1; severe chills and shaking for 10 minutes on preparing for bed at 8 pm... Read more
Chills starting at 5 pm day 1; severe chills and shaking for 10 minutes on preparing for bed at 8 pm, fever 98.9, which resolved upon lying down under warm blankets; fever 101.1 at 11 pm day 1, 102.0 at 5 am day 2, 100.7 at noon, 101.8 at 5 pm on day 2, with muscle ache and headache throughout day 2;100.5 at 2:30 am on day 3. Fever went down to 100.0 at 5 am and was normal thereafter, mild headache through daytime of day 3. No symptoms since.
56 2021-04-25 feeling hot, feeling cold, tremor Pt. received first Pfizer covid vaccine at 5:45pm. He was brought to the observation area for 30 min... Read more
Pt. received first Pfizer covid vaccine at 5:45pm. He was brought to the observation area for 30 minutes of observation due to hx of anaphylaxis to penicillin. At approximately 5:55pm, RNs noticed that Pt had his head in his hands. When questioned, he stated he didn?t feel well. He was helped to the ground and his legs were elevated. His vitals were 190/90, P 88, Resp 34. The nurses helped him to a sitting position as he was feeling better and he answered some medical history questions. He shared that he was Type I Diabetic. He stated he checked his blood sugar last yesterday. He ate breakfast today and took insulin. No food since this morning. Patient had no symptoms of anaphylaxis and no chest pain or other complaints. Patient denied SOB or ?throat tightening?. No hives. Patient became diaphoretic and stated he was overheated. RNs helped to remove his shirt. Observation RN alerted Nurse practitioner of the ongoing incident. Nurse Practitioner went to seek sugar sources, suspecting the patient was severely hypoglycemic. Patient, still conscious and responsive and sitting up, took 10 oz. orange juice and frosting was massaged by APRN, in buccal area with patient consent. Patient initially seemed to be improving per APRN and RNs caring for patient. BP was 170/90 at next check. P 80. Regular respirations. Still no anaphylaxis symptoms (no hives, no angioedema, no throat tightening or wheezing). A few minutes later, Pt started shaking and said he was chilled. Patient was returned to supine position with legs elevated. He continued to shake and patient lips blue ? sweatshirt placed over him. RN noted that Pts? eyes rolled back in his head. RN went to alert the Clinical Team Manager/RN of the situation and stated that 911 should be called as patient not improving. Clinic Team Manager/RN concurred. While RNs stayed with patient and informed patient?s friend about what would occur, Clinic Site Manager called 911. BP 140/80 at next check. Patient continued to sweat and have chills. Rescue squad arrived ? blood sugar was 116. After emergency services assessment of patient, emergency services checked blood sugar again and it had dropped to 88 within those ~5 minutes. Patient was taken by Emergency Services at 6:36pm. RN noted that the patient remained with emergency services in parking lot for several minutes and then pt was transported to the hospital by the emergency services. His wallet, glasses and hat were given to his friend who had accompanied patient to the vaccination clinic. His friend stated that she would call patient?s wife to inform her that patient was taken to ED by emergency services.
56 2021-04-26 weakness 4-16 Friday 2nd COVID shot, feeling ok. A little tired; 4-17 Saturday tired, low grade fever, achy;... Read more
4-16 Friday 2nd COVID shot, feeling ok. A little tired; 4-17 Saturday tired, low grade fever, achy; 4-18 Sunday Rash on tops of both feet, tired achy, low grade fever, chills; 4-19 Monday Fatigue, slight rash on torso, feet better, low grade fever, chills; 4-20 Tuesday Rash entire torso front and back small red raised blisters, fever 100+, fatigue, easily winded and tired, runny nose, contacted Doctor, told to wait 7 days to call back if symptoms don?t improve; 4-21 Wednesday Severe Rash on torso, arms, legs, buttocks, no pain or itching; 4-22 Thursday Rash spreading to all parts of the body from head to soles of feet, difficulty breathing, fever hard to manage 101-102, mouth sores, eyes bloodshot, Went to urgent care, Negative Rapid Covid test, put on 50 mg Prednisone and 1 tab claritin; 4-23 Friday Rash more red, blisters gone no white on torso, some white areas on legs, arms, and other parts of the body. Breathing worse, coughing, chills, fever hard to manage 101-102, chills, no appetite, diarrhea, rash painful on sides of torso; 4-24 Saturday Went to ER for difficulty breathing, no unaffected skin on torso, general ill feeling, eyes still bloodshot, mouth sores, *Intravenous steroids, chest CT scan and xray showed inflamed lymph nodes, inflamed lung walls, no blood clots, bronchial walls thickening and faint peripheral ground glass opacities in the right lobe, mediastinal and right hilar lymphadenopathy as well as air-trapping in the right middle lobe and left upper lobe *strep test negative; 4-25 Sunday rash a little better after intravenous steroids, breathing worse, fever still 101-102 managing with tylenol and advil; 4-26 Monday Dermatology consult punch skin biopsy to rule out viral cause of rash, blood work done to rule out pneumonia, put on reducing course of prednisone 60/40/20/10/5 - Allergy consult no diagnosis; 4-27 Tuesday primary care doctor, added Symbocourt, rash peeling and flaking and painful, slowly receding, breathing still labored and difficult, no appetite, no energy, fatigued, eyes still bloodshot, mouth still sore and raw/canker sore like, ruled out any other cause diagnosed as vaccine reaction. Advised to contact in two weeks if breathing it still difficult.
56 2021-04-26 pain in extremity Left arm pain, hard area-lump, decreased range of motion of left upper extremity. Symptoms started w... Read more
Left arm pain, hard area-lump, decreased range of motion of left upper extremity. Symptoms started within a few hours after vaccination and have worsened over the past 6 weeks. Symptoms still present.
56 2021-04-26 pain in extremity Patient complains of sore arms with big knot on one and burns.
56 2021-04-27 feeling of body temperature change Flu like symptoms. Body aches, hot and cold with chills, bad headache, back hurts, slight fever
56 2021-04-27 numbness 185/100 blood pressure (usually 130/75) high heart rate; cheeks feeling numb; airplane ear; lasted a... Read more
185/100 blood pressure (usually 130/75) high heart rate; cheeks feeling numb; airplane ear; lasted about an hour and a half; felt week for three days after with slight chest pain. very similar symptoms but lasting much longer occurred again 04/27/2021
56 2021-04-28 feeling hot Within 10-minutes of vaccination, the patient experienced dizziness and a syncopal episode. EMS eval... Read more
Within 10-minutes of vaccination, the patient experienced dizziness and a syncopal episode. EMS evaluated the patient on-site. The patient was hypotensive (86/53) with a FSBG of 98mg/dL. EMS administered 700mL IV normal saline. EKG was normal. EMS transported to Hospital Emergency Department. En-route to ED, the patient's blood pressure improved (146/97) with fluids. In the ED, the patient stated that their syncope was preceeded by "feeling very warm" and nausea, but now feels improved with fluids. Labs and tests were unremarkable. Physician discharged the patient with diagnosis of vasovagal like syncope.
56 2021-04-28 numbness Pt c/o Left side facial numbness from eye socket to chin noted after he got home from receiving th... Read more
Pt c/o Left side facial numbness from eye socket to chin noted after he got home from receiving the second Covid vaccine on 4/27/21. This started on Tuesday but is now beginning to diminish. No effects to vision , smell, taste or hearing, Pt did not have any drooling or numbness inside mouth or bite marks. No tingling on scalp or neck area, only front facial numbness, no other numbness on body occurred.
56 2021-04-28 pain in extremity 2 days after second COVID vaccine patient began to have purple spots on his legs and erythematous sp... Read more
2 days after second COVID vaccine patient began to have purple spots on his legs and erythematous spots on the rest of his body. lower extremity rash become bullous purpura with eventually necrotic tissue in the center of the larger lesions that became up to 3 inches in diameter and many 1/2 inch to inch size lesions as well. swelling of ankles and feet all causing severe pain. seen over several weeks and had biopsy and placed on Norco for pain control and prednsione for inflammation.
56 2021-04-28 tingling Patient is a 56yo male who presents for evaluation of symptoms of paresthesia that he experienced af... Read more
Patient is a 56yo male who presents for evaluation of symptoms of paresthesia that he experienced after receiving the first Pfizer COVID-19 vaccine. He received the first dose on April 10th at 0900 at a church near his home. 15 minutes after receiving the vaccine he reports experiencing sensation of pins and needs of his tongue, lip and face. He left the vaccine site and the symptoms became more noticeable. 90 minutes after the injection he took Benadryl which resolved his symptoms of pins and needle sensation, but it returned 4 hours later. He continued to take Benadryl every 4-6 hours from the 10th to the 14th until finally he decided to stop by the Emergency Department. There he was given a 5 day course of prednisone (40mg daily) and switched from Benadryl to Zyrtec BID. He reports good symptoms control on the Zyrtec but states that it still doesn?t feel completely resolved. He didn?t feel like the steroids helped at all. If he misses a dose of Zyrtec he feels the symptoms start to worsen again which prompts him to take another dose of Zyrtec. He denies any numbness, tingling, weakness anywhere else on his body. He denies difficulty speaking or swallowing. He has not experienced any syncope, shortness of breath, hives, flushing, vomiting, or diarrhea in conjunction with the injection. The only other time he has experienced symptoms like this was when he was given an IM injection of PCN > 10 years ago. He was then given a one-time dose of Benadryl and the symptoms resolved within an hour and never returned.
56 2021-04-29 bell's palsy patient with bells palsy 1 day after covid vaccination - on the left side of the face
56 2021-05-01 feeling hot Patient received his second dose of the Pfizer vaccine and while sitting in the waiting area began t... Read more
Patient received his second dose of the Pfizer vaccine and while sitting in the waiting area began to feel hot all over and light-headed. Emergency personnel were called and checked the patient. They concluded that he may have just had an anxiety attack about receiving the vaccine.
56 2021-05-01 tingling, numbness Tingling in left arm and hand/fingers, numbness in hand. Constant first 2 weeks then intermittent. ... Read more
Tingling in left arm and hand/fingers, numbness in hand. Constant first 2 weeks then intermittent. Still occurring intermittent (a couple hours a day). Had second shot 4/26
56 2021-05-01 tremor, unresponsive to stimuli, weakness Systemic: Confusion-Severe, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, S... Read more
Systemic: Confusion-Severe, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium
56 2021-05-02 facial paralysis, bell's palsy I received my second Pfizer COVID-19 vaccine on 4/23. Symptoms began on 4/26 and worsened, slowly, ... Read more
I received my second Pfizer COVID-19 vaccine on 4/23. Symptoms began on 4/26 and worsened, slowly, over the course of the next three days. My symptom included a pain behind my right ear and partial paralysis of right side of my face including forehead, eye, and mouth. I called my primary care physician who sent me directly to the Medical Center in for a stroke evaluation including various blood tests. No imaging was performed.
56 2021-05-03 burning sensation Joints and tendons hurting; I had damaged tendons from older events; the damage feels like it is ex... Read more
Joints and tendons hurting; I had damaged tendons from older events; the damage feels like it is exasperating. As I feel burning sensation (micro tears) on my lower back and shoulders.
56 2021-05-03 facial paralysis, bell's palsy Patient received second Pfizer COVID vaccine on 4/23/2021. On 4/26/2021, he had onset of facial dro... Read more
Patient received second Pfizer COVID vaccine on 4/23/2021. On 4/26/2021, he had onset of facial drooping and was seen in the emergency room and diagnosed with Bell's Palsy. He was prescribed prednisone and valtrex. He had follow up with his PCP on 4/30 and had an improvement of symptoms at that time although persistent facial drooping.
56 2021-05-03 pain in extremity ON 4/28 felt intense pain in legs and blurry eyes, slowly went away after taking advil, came back at... Read more
ON 4/28 felt intense pain in legs and blurry eyes, slowly went away after taking advil, came back at night, on thursday 4/29 pain continued and had shortness of breath decided to go to urgent care made appt for 4/30 813AM, at Urgent Care symptoms pointed to blood clots was told to go to local imaging company to get sonogram, sonogram showed blood clots in leg told to go to emergency room, went to Hospital and was admitted, confirmed blood clots and put on blood thinner neprin IV, released 5/2 at 1PM, at home now on blood thinner pills 10mg Eliquis
56 2021-05-04 tingling, numbness allergic reaction; tingling in his tongue; slight tingling on the left side of his face.; numbness i... Read more
allergic reaction; tingling in his tongue; slight tingling on the left side of his face.; numbness in lips; tingling in his tongue and slight tingling on the left side of his face.; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ER2613) on 10Apr2021 10:00 AM at right deltoid (Right shoulder) at single dose for COVID-19 immunisation (to prevent COVID) in a church that had a partnership with (Facility name) in a breakroom area. Medical history included ongoing Barrett's esophagus and allergic to penicillin. No Prior Vaccinations (within 4 weeks). he states that he had a similar reaction to penicillin, and he let the people know that he was allergic to penicillin at the facility. NO Family Medical History Relevant to event. No Relevant Tests. Concomitant medication included pantoprazole from unspecified date in 2021 (He states he started taking it about 3 months ago) and ongoing for Barrett's esophagus. The patient stated he just reported an allergic reaction to the first dose of the vaccine that he took last Saturday. About an hour after he had an allergic reaction to it where he had tingling in his tongue and slight tingling on the left side of his face. He took Benadryl and it cleared up. However, the symptoms have not subsided and they have been persistent since last Saturday. He had been taking Benadryl since Saturday and then went to the Emergency Room on Wednesday and they put him on Zyrtec and a steroid. He asked if he should take the second dose. He then mentioned there are alternatives if you don't get the second dose where you wait a certain amount of time and can take a different vaccine. Patient further states that he received vaccine last Saturday, and about an hour after receiving the vaccine he was having tingling sensation in his tongue. He states that it was an allergic reaction. He says that he also had slight numbness in lips and on the side of his face. He states he took Benadryl (22May lot smf011). He states that the Benadryl helped him out for 4 hours. He states that the symptoms went away for 4 hours and then started reoccurring. He states that it was happening like that, that cycle, since last Saturday. He states that he went to the hospital on Wednesday and they prescribed him a steroid which he has been taking for a 4 day cycle. He states that he just ran out of the steroid yesterday. He states that the steroid was Prednisone, and he takes 20 mg, two tablets by mouth daily. Caller states that the numbness is progressive. He states that if he doesn't take the medicine on time then it progresses. He states as long as he is taking his medication on time than the symptoms are mild. events require a visit Emergency Room and Physician Office. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
56 2021-05-05 facial paralysis, bell's palsy woke up on 3/23 with left facial paralysis; confirmed no balance, cognitive or motor function loss M... Read more
woke up on 3/23 with left facial paralysis; confirmed no balance, cognitive or motor function loss Met with Dr on 3/24. Confirmed Bells Palsy. Started on Valtrax (7 days) and Prednisone (10 days) Now 6 weeks post-event; have some movement on left side of face; estimate 40% recovery so far No plans for additional medication No plans for 2nd dose due to uncertainty on how it will impact current condition
56 2021-05-05 facial paralysis, bell's palsy Woke up 3/23 with left facial paralysis 3/24 Dr visit confirmed Bells Palsy. Started on Valtrex (7 ... Read more
Woke up 3/23 with left facial paralysis 3/24 Dr visit confirmed Bells Palsy. Started on Valtrex (7 days) and Prednisone (10 days) 6 weeks later, starting to see some improvement on left side
56 2021-05-07 weakness The first shot, I got it on 4/17/2021 around 3:30 pm and I felt only my arm for couple days. For the... Read more
The first shot, I got it on 4/17/2021 around 3:30 pm and I felt only my arm for couple days. For the second shot, I got it on 5/7/2021 around 10:10 am, I wakeup around 4:30 am feeling sick, all my body weak no energy, headache and diarrhea. It's know 2:00 pm and I still feeling sick.
56 2021-05-09 numbness, bell's palsy Diagnosed with Bells Palsy - noticeable facial impairment on right side of face , crooked smile, sli... Read more
Diagnosed with Bells Palsy - noticeable facial impairment on right side of face , crooked smile, slightly drooping eye, pain at outside of right ear, numb cheek like received shot of novocaine at dentist, trouble chewing food/drinking fluids on that side of mouth.
56 2021-05-09 numbness First dose 3/23/21; second dose 4/24/21. First dose I had face numbness within an hour of injection... Read more
First dose 3/23/21; second dose 4/24/21. First dose I had face numbness within an hour of injection, symptoms subsided by next day however would return intermittently for the next 2-3 weeks. After second dose once again returned and have been on going ever since, I advised PHCP and he advised it was a side affect and there was nothing that he could do. Overall feeling is a numbness from cheek bones down to mouth, lower lip tingles at times, face feels swollen but not visually noticeable, feels restrictive when I smile,
56 2021-05-09 pain in extremity, limb paralysis, fibromyalgia Severe arm pain and full paralysis from left shoulder to fingers in left arm from about 9:00pm Frid... Read more
Severe arm pain and full paralysis from left shoulder to fingers in left arm from about 9:00pm Friday 05/07/21 to about 7:30am Saturday when pain reduced about 15% and paralysis reduced about 20%. Paralysis and pain were about 80% gone and 100% gone by around 5:00pm Saturday 05/08/21. New symptoms showed all at once around 4:50pm Sunday 05/09/21. Symptoms came on without warning: Sever arthritis in right foot, fibromylagia pain in upper and mid back, acid reflux attack mild. Severe arthritis continues currently making it too painful to walk. Fibro pain still modrate in upper back and shoulders. I had no symptoms of anything for 4 months prior up to two days after the vaccine!
56 2021-05-10 weakness WEAKNESS AND COUGH COVID-19 pneumonia and urinary retention
56 2021-05-10 pain in extremity, flushing This is a spontaneous report from a contactable consumer (patient) and another contactable consumer ... Read more
This is a spontaneous report from a contactable consumer (patient) and another contactable consumer (patient's wife). A 56-year-old male patient received the first dose of bnt162b2 (COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Apr2021 at 08:30 (Batch/Lot Number: ER8729) as single dose for covid-19 immunisation. Medical history included ongoing heart patient, and penicillin allergy from an unknown date. Ongoing concomitant medications included carvedilol, lisinopril, clopidogrel bisulfate (PLAVIX), and acetylsalicylic acid (ASPIRIN (E.C.)). The patient experienced wiped out, tired and slept on 08Apr2021, left arm tenderness on 08Apr2021, lower back pain, pain in his abdomen, pain in his shoulders, vomiting, lightheaded and dizzy, really super flushed and turn almost a reddish purple on 10Apr2021, kidney pain on 11Apr2021 at 04:00, parotid cheek gland pain and yellow pus coming out of it on 13Apr2021. The events required physician office visit. Seriousness was not reported for events. Clinical course: The reporter stated her husband got his first dose of the vaccine on 8Apr2021. States on the 8Apr2021 and 9Apr2021, he was wiped out, which was normal. He developed kidney pain, lower back pain, pain in his abdomen and pain in his shoulders. He also developed an area in his cheek gland inside of his mouth that had disgusting yellow stuff coming out of it. He was at a doctor's appointment at Hospital being seen by a specialist for it now because it was so painful. The patient was tired and slept and had left arm tenderness from 8Apr2021-9Apr2021. The patient had vomiting from 10APR-13APR2021. He would get really super flushed and turn almost a reddish purple and lay on the ground to make it go away and also complaining of pain. The patient would start feeling lightheaded and dizzy, and had to run to the bathroom and throw up and then he would be okay for an hour or two and then it would come again. The pain was off and on, certain times he was doubled over in pain and it started again. It was the gland inside of his cheek, up by his upper gum line on the inside of his cheek gland, and it had yellow pus coming out of it. He had a stone removed from that cheek gland 3 years ago but he has had zero problems since then. States it was the parotid gland that came out of the salivary gland where it came in to the mouth. States that was where it has pus on the inside of his cheek. The outcome of events wiped out, tired and slept, left arm tenderness was resolved on 09Apr2021, outcome of events vomiting, lightheaded and dizzy, really super flushed and turn almost a reddish purple was resolved on 13Apr2021, outcome of other events was not resolved. No follow-up attempts are needed. No further information is expected.
56 2021-05-11 night sweats, pain in extremity Soreness in arm soon after shot. Fatigue, mental fogginess, body aches at joints and back, insomni... Read more
Soreness in arm soon after shot. Fatigue, mental fogginess, body aches at joints and back, insomnia, night sweats. All began that evening and continued. I expected them to moderate but they continue. Also experiencing stomach queziness intermittently.
56 2021-05-11 pain in extremity Patient presented to the ED with acute onset right calf pain, in the absence of trauma or injury, 5 ... Read more
Patient presented to the ED with acute onset right calf pain, in the absence of trauma or injury, 5 days after receiving the 2nd dose of the Pfizer Covid vaccine. He reported flulike symptoms and being fairly sedentary in that time. He was found to have a lesser saphenous vein embolism that did not require anticoagulation.
56 2021-05-11 tingling Sore Left shoulder around shot site (deltoid mucsle). Swollen lymph node in underarm (left arm) and... Read more
Sore Left shoulder around shot site (deltoid mucsle). Swollen lymph node in underarm (left arm) and tingling in left arm down to fingers.
56 2021-05-12 pain in extremity sore arm; headache; transitory fever for about one hour; This is a spontaneous report from a contact... Read more
sore arm; headache; transitory fever for about one hour; This is a spontaneous report from a contactable pharmacist. A 56-years-old male patient received second dose of bnt162b2 (BNT162B2 solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 27Jan2021 as single dose for covid-19 immunisation. Medical history included seasonal allergy. The patient's concomitant medications were not reported. He received his seasonal allergies SC injection 24 hours before receiving the second BNT 162 b2 injection. patient reports that he received his seasonal allergies SC injection 24 hours before receiving the second BNT 162 b2 injection on 27Jan2021 in his right deltoid muscle. Patient also reports that he took 50mg of Benadryl prior to his BNT162b2 injection. A couple hours after receiving the BNT 162b2 vaccine he experienced a transitory fever that lasted 1-2 hours and resolved. The next morning,28Jan2021, patient stated that he had a headache that lasted for a day and a half which was unresolved by sleep or ibuprofen, 400 mg taken 3-4 times in the day and 1/2 time period. On Thursday 28Jan he noticed a lump in his Right arm pit which was visible and sore. The lump resolved by after 4-5 days and he has been symptom free. On 27Jan2021, the patient experienced transitory fever for about one hour and sore arm, headache on 28Jan2021.The outcome of the events was recovered. This is a supplement to the previous report submitted 28Jan. Patient emailed (Name) with additional information pertaining to the original report, information was added. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
56 2021-05-12 tenderness Normal side effects to expect with the exception of after the third day of the second dose my lymph ... Read more
Normal side effects to expect with the exception of after the third day of the second dose my lymph nodes are swollen and tender in my right armpit and right neck which I have not read about any reports of this reaction. My lymph nodes are only on the same side as where the second dose Pfizer injection was administered.
56 2021-05-18 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
56 2021-05-19 difficulty speaking Patient developed swelling to eyelid approximately 15 minutes after injection. Developed voice hoars... Read more
Patient developed swelling to eyelid approximately 15 minutes after injection. Developed voice hoarseness and salivating about 1 hour after vaccine
56 2021-05-19 pain in extremity Pain in upper arm the day after and has not subsided after two weeks. Shoulder not frozen but very s... Read more
Pain in upper arm the day after and has not subsided after two weeks. Shoulder not frozen but very sore and arm movement much more limited than it was. Pain progressively getting worse instead of better. Have used stretching, painkillers and liniment to treat condition. Relief only temporary.
56 2021-05-20 discomfort, burning sensation LUQ Abdominal Pain: Patient reports that he was in his usual state of health until last week when he... Read more
LUQ Abdominal Pain: Patient reports that he was in his usual state of health until last week when he received his COVID 19 vaccination. He received 1st dose of Pfizer vaccination. Prior to this he was healthy. He reports 10 minutes after injection, he felt a knot/burning sensation in the LUQ of his abdomen. He states that it progressively worsened to the point where he couldn't sleep the following night. Over the weekend, he felt like he was improving. However, last night it was significantly uncomfortable. He feels an achiness/bruising sensation over his LUQ. He reports that there is a baseline discomfort but then it will become so bad that he has a hard time walking. He states that if he gets in a certain position he will feel improved but if he moves the wrong way it feels like it pinches. No changes with food. He reports decreased appetite. No fever, chills, nausea or vomiting. He had diarrhea x 1. No constipation.
56 2021-05-21 fibromyalgia, limb paralysis, tremor Caller has previously been diagnosed with arthritis, fibromyalgia and acid reflux. On Sunday, 09 May... Read more
Caller has previously been diagnosed with arthritis, fibromyalgia and acid reflux. On Sunday, 09 May 2021, at 4:00PM, at that time, all three activated at once; Caller has previously been diagnosed with arthritis, fibromyalgia and acid reflux. On Sunday, 09 May 2021, at 4:30PM, at that time, all three activated at once; Caller has previously been diagnosed with arthritis, fibromyalgia and acid reflux. On Sunday, 09 May 2021, at 4:30PM, at that time, all three activated at once; his arm pain became sever; Caller had pain at the injection site; He felt his arm shutting down from his shoulder to his fingers, becoming paralyzed; felt shaky inside; did not sleep at all; This is a spontaneous report from a contactable consumer (Patient) The 56-year-old male patient received first dose of BNT162B2 (Solution for injection, Lot number unknown), via an intramuscular route of administration (standard 0.3mL according to patient) on 07May2021 at 02:30 PM (at the age of 56-years), for COVID-19 immunization. The patient had a family and medical history of hypertension but was not on any medications. He was on blood pressure medication (unspecified) but they took him off because he was doing fine. He had been diagnosed with arthritis, fibromyalgia and acid reflux. The patient was allergic to Tetracycline: His arm shutting down, and being paralyzed after taking tetracycline happened years ago and the paralysis was much more severe. They told him no more tetracycline for him, and he has not taken it since. He got a flu shot 26 years ago, and it put him in the hospital. He has not had a flu shot since. The patient did not receive any vaccines within 4 weeks prior vaccinations. Patient had no history of other previous immunization with the Pfizer vaccine or additional vaccines administered on same date of vaccination Concomitant medications were not reported. After first dose on 07May2021, patient had a rough time from it and felt some pain in the injection site, right after he went down to rest and felt shaky inside. Shakiness occurred right after the injection, it was subtle and at 8:00 PM his arm pain became severe, as it went on, he did not sleep at all. Patient arm pain went through out Friday night, and into Saturday morning. His arm pain was gone by 5:00 AM on Saturday morning. He felt his arm shutting down from his shoulder to his fingers, becoming paralyzed. At 8:00 AM Saturday, the paralysis sub-sided partially and at 5 pm that day he was perfectly fine. On Sunday, 09May2021, at 4:00 PM, all three: arthritis, fibromyalgia and acid reflux activated at once with no warning. That morning he had no symptoms except from the arthritis pain. He made a VAERS report and that his doctor recommended taking Ibuprofen right after taking his second dose. Event did not require Emergency Room/ Physician Office visit. He was scheduled to receive the second dose on Friday 28May2021, but due to his doctor suggestion he would like to know if he can reschedule it for Thursday 27May2021. The outcome of the events of arm shutting down from his shoulder to his fingers, becoming paralyzed; his arm pain became severe; pain at the injection site; did not sleep at all was recovered on 08May2021, and events fibromyalgia and acid reflux on 11May2021, felt shaky inside was recovered on an unspecified date in May2021, while that of arthritis was unknown. Information on the lot/batch number had been requested.
56 2021-05-22 hot flush 5/21?severe headache and shaky feeling 5/22?vomiting, headache better but still bad, hot flashes, sw... Read more
5/21?severe headache and shaky feeling 5/22?vomiting, headache better but still bad, hot flashes, sweating, shaky feeling, tongue feels ?thick? 5/23?vomiting, shaky feeling, tongue feels ?thick? and this feeling is worse today
56 2021-05-23 pain in extremity PATIENT IS COMPLAINING OF RIGHT ARM PAIN. SAYS THAT THE DR HAS DETERMINED THAT HE HAS A TEAR IN HIS ... Read more
PATIENT IS COMPLAINING OF RIGHT ARM PAIN. SAYS THAT THE DR HAS DETERMINED THAT HE HAS A TEAR IN HIS RIGHT ROTATOR CUFF
56 2021-05-24 pain in extremity Sore arm; fever of 100.2; Blood sugar keeps dropping; This is a spontaneous report from a contactabl... Read more
Sore arm; fever of 100.2; Blood sugar keeps dropping; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male adult patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN5318), via an unspecified route of administration, administered in Arm Right on 28Jan2021 14:30 as 1ST DOSE, SINGLE for covid-19 immunization. No Known allergies. Facility type Vaccine was Workplace clinic. No other vaccine in four weeks. No covid prior vaccination, No covid tested post vaccination. Medical history included hypertension, diabetic. Concomitant medications in two weeks included metformin (METFORMIN); nebivolol hydrochloride (BYSTOLIC). On 28Jan2021, the patient experienced sore arm, fever of 100.2, blood sugar keeps dropping. No treatment provided for the events. The patient underwent lab tests and procedures which included blood sugar keeps dropping, body temperature was 100.2. The outcome of all the events was not recovered. Follow-up attempts are completed. No further information is expected.
56 2021-05-25 pain in extremity Fatigue; Headache; Right arm pain; Muscle soreness; This is a spontaneous report from a contactable ... Read more
Fatigue; Headache; Right arm pain; Muscle soreness; This is a spontaneous report from a contactable consumer or other health professional. A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the right arm on 15Mar2021 at 14:30 (at the age of 56-years-old), as a second single dose for COVID-19 immunisation. The patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the right arm on 22Feb2021 at 14:45 (at the age of 56-years-old), as a first single dose for COVID-19 immunisation. No relevant medical history and concomitant medications was reported. The patient did not have any known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021, the patient experienced pain in right arm, headache, fatigue, and muscle soreness. There was No fever or other symptoms. The patient received Tylenol 500 mg for the adverse events. The clinical outcome of right arm pain, headache, fatigue, and muscle soreness was recovering. No follow-up attempts are possible. No further information is expected.
56 2021-05-26 weakness, pain in extremity couple pains in the left chest area behind the breast; his stomach was feeling sick and his body was... Read more
couple pains in the left chest area behind the breast; his stomach was feeling sick and his body was hurting; His whole torso hurt and his stomach; The pain now is not like where it hit him with the back. He has back pain every day but more than he used to. the back pain was just the one day.; his arm was a little sore; He was lethargic and had no energy; He was lethargic and had no energy/weakness; diarrhea; Responding strangely to people/but is still there and is so weird; dizzy; getting really irritable; Slept all day for several days; Arm started hurting where he got the shot; been sick pretty much everyday; not feeling good in his stomach; he passed out for 2 days; breathing hard; wouldn't feel good; a fast heartbeat; chills; nausea; headache; he gets really short and impatient; forget a little something still, but just once in a while; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 14:30 (Lot Number: WR8783) as 1ST DOSE SINGLE for covid-19 immunisation. Medical history included ongoing sciatica, back problems, stomach was sensitive, lower back pain, bone spurs down his spine. He was a medical marijuana patient, he had Shigella when he was a baby. He was 2 or 3 and almost died but came out of it; His mom had cancer from smoking, he got the worse flu sick of his life. His stomach was sensitive all of the time. If he was too happy or too nervous get upset. He can eat spicy food, not super hot, but he can eat anything and it doesn't go crazy. He has a little bit of a sensitive stomach sometimes. He can't take a multivitamin or supplements because he would get sick to his stomach, this was before the vaccine. He was getting that same sick feeling now that he would get if he was taking a multivitamin. He had his blood drawn a week before he had the vaccine to check his kidneys with the pills he is on. It was perfect and normal, and he has had nothing since then. In his 20s he had the flu vaccine, and he had never had the flu in his life. That year he got the worse flu sick of his life. He never got the flu vaccine or other vaccines after that. That was probably between 1987 to 1990. His folks passed away. He had been in the hospital when he was little.Concomitant medications included acetaminophen taken for back pain, sciatica from an unspecified start date and ongoing; nabumetone taken for sciatica, back pain from an unspecified start date and ongoing. The patient experienced he passed out for 2 days (medically significant) on Apr2021 with outcome of unknown, been sick pretty much everyday (non-serious) on 07Apr2021 22:00 with outcome of not recovered, not feeling good in his stomach (non-serious) on 07Apr2021 with outcome of not recovered, slept all day for several days (non-serious) on 08Apr2021 with outcome of unknown, responding strangely to people/but is still there and is so weird (non-serious) on 12Apr2021 with outcome of not recovered, his stomach was feeling sick and his body was hurting (non-serious) on 15Apr2021 with outcome of not recovered, his whole torso hurt and his stomach (non-serious) on 15Apr2021 with outcome of unknown, diarrhea (non-serious) on 12Apr2021 with outcome of not recovered, getting really irritable (non-serious) on 09Apr2021 with outcome of not recovered, he had no energy (non-serious) on 12Apr2021 with outcome of recovering, he was lethargic/weakness (asthenia) (non-serious) on 12Apr2021 with outcome of not recovered, dizzy (non-serious) on 10Apr2021 with outcome of not recovered, couple pains in the left chest area behind the breast (non-serious) on 17Apr2021 with outcome of not recovered, breathing hard (non-serious) on Apr2021 with outcome of not recovered, wouldn't feel good (non-serious) on Apr2021 with outcome of not recovered, arm started hurting where he got the shot (non-serious) on 08Apr2021 with outcome of not recovered, headache (non-serious) on Apr2021 with outcome of unknown, his arm was a little sore (non-serious) on 13Apr2021 with outcome of unknown, a fast heartbeat (non-serious) on Apr2021 with outcome of unknown, chills (non-serious) on Apr2021 with outcome of unknown. Patient got sick around 10:00 at night. He was supposed to get his second dose but he was so sick and they said lets give it a week. Then he talked to his doctor and he said to wait 2-3 weeks to make sure he is back to normal. So he is scheduled for the second dose next week at 6 weeks. He asked if it was okay that the shot was given in the sunlight. He stated that he saw that it was in an ice chest but the person had to walk it over to him 20 feet and deal with his sleeve for a second or two so it was in the sun. He said all that walking it was 100% in the sun and he has read that it should not be in the sun. He asked if this could have caused bacteria and caused his symptoms. He stated his doctor was only concerned about giving him antibiotics for bacteria if it was in the sun and if that was a problem. He just read from CDC, once mixed the vaccine can be left at room temp for 6 hours and mixed vaccine does not need to be protected from light. So it sounds like his first shot was good. He had gotten the shot at about 1430 in the afternoon. He was like he is going to get the shot and everything will be great. He didn't think there would be an effect. Then strangely enough at about 2200 he was about to eat dinner and he got to not feeling good in his stomach. It had been close to 8 hours. The next day he slept all day, got up and had coffee, and Saturday he was in the chair in the living room. He is never in the chair during the day because he works. He slept all day and all night and the next day. He was responding strangely to people, and he was in and out of it. He had the shot on Wednesday and then his stomach was feeling sick and his body was hurting. He has back pain anyway and bone spurs on his spine. He was telling his wife whatever pain he is normally in was enhanced. His whole torso hurt and his stomach. The following Monday he had diarrhea. Then he started getting really irritable and didn't want to talk and was impatient. He was lethargic and had no energy. That was the second week. By the end of the second week he had a couple pains in the left chest area behind the breast. He thought it was a heart attack, then thought it was just pain not a heart attack. Every time he wouldn't feel good he would start breathing hard. Once in a while he gets pain through his chest area. His stomach would start and he would breath hard every time he didn't feel good. The third week he was supposed to get the second shot. He called the department of health for New Mexico. The nurse called back and said not to do the shot that week but to wait a week. He rescheduled for a week later. By the third week he was still not feeling good and called the doctor. He asked about the pain in his chest 3 times and he said it seemed to be okay. His arm started hurting where he got the shot in the second week. He still had no energy and he told the doctor this. Patient started taking 2 extra Tylenol during the day for pain. Lately he has been good until one little thing and then all of a sudden his stomach is hurting and he is holding his stomach. He was good today, all he did was eat a cookie and he didn't get sick. He was worse for a little while in the first or second week, he was really bad. It came and went over the next 2 weeks and now it is coming and going less frequently. He slept through 2 or 3 days. Thursday, Friday, and then Saturday he was in and out. He woke up to take the garbage out on Friday then saw he already took it out and forgot it was out there. And it was Saturday. He was kind of out of it. When he would respond strangely he would respond with a question he just asked and someone answered. It is like brain fog or like he is on something. It started after the weekend, more on 12Apr2021. Once in a while he will forget a little something still, but just once in a while. He would walk and hold his rib cage with both arms when he was hurting. He wrote down that it felt like somebody had hit him in the back with a bat in the lower back. One day it was that bad. His back pain was on Thursday 15Apr2021. The pain now is not like where it hit him with the back. He has back pain every day but more than he used to. The sore like he was hit in the back pain was just the one day. He had diarrhea 12Apr2021, 13Apr2021, and 14Apr2021 then it left for probably a week. Then it came back last week one day. Instead of every day it was every 3 or 4 days. He has not had it in the last 4 days. He hopes it is done. He noticed any time he has salad or lettuce he feels bad in the morning so he stopped eating those. He felt irritable more when he started not feeling good. The last 5 days or so more towards the evening at 1800 or 1900 he starts not feeling good and gets irritated. His wife will ask him something and he gets really short and impatient. He felt irritable more when he started not feeling good. The last 5 days or so more towards the evening at 1800 or 1900 he starts not feeling good and gets irritated. His wife will ask him something and he gets really short and impatient. The irritable feeling started right away the Friday of the week he got the shot. He is still struggling some, it will come and go. Yesterday he was zonked. With having no energy it is a big thing. He has to do something instead of what he would be doing. He works all day and takes long orders and stuff. Now he does like one order when normally he did 10. One for him is a huge little sore so he will lay on his right side. His left arm still hurts like a pulling hurt from his neck to his arm. It has been every day from 13Apr2021. It is much better and he will move and it will relax a little bit. It was really weird. The whole time he held the phone with his left hand up until one second he moved his phone and it was the same pain. At night the left side where he had the injection pulls on his neck muscle coming from his arm. He was actually taking two Tylenol in the morning and two at night when he went to bed. With the pain he takes 2 during the day, 650mg each. He was just taking 500mg and then his wife said take these. It seems to have gotten a little better. He always took them 2 times a day and now he takes them 3 times a day. After the first dose he experienced difficulty breathing dizziness, weakness, a fast heartbeat, chills, nausea, headache, he passed out for 2 days and has been sick for 5 weeks. He started having some dizziness a couple of days later and reports, it's like I would stand up too quickly and get a head rush, that kind of dizzy feeling. He confirmed that his dizziness did not start until a couple of days after he received his first dose.
56 2021-05-28 burning sensation, numbness, tingling Within a week after first vaccine dose, burning in legs from above the knee to feet. Numbness and ti... Read more
Within a week after first vaccine dose, burning in legs from above the knee to feet. Numbness and tingling in fingers and feet. Symptoms continue. Within a week after second vaccine, onset of bilateral upper quadrant pain, thoracic and flank pain that worsened over time. Unable to lie down due to sharp pain. Reached out to Oncology and PCP offices after symptoms of both vaccines for awareness and guidance. 5/4/21 - Emergency and inpatient visit - diagnosed with bilateral pulmonary emboli.
56 2021-05-30 slurring Pain in my jaw and temple to start then my words started to slur then created a stroke and confirmed... Read more
Pain in my jaw and temple to start then my words started to slur then created a stroke and confirmed my the hospital. I have had a CT scan them MRI. I am in ICU. Who is going to pay for my bills since I have no insurance.
56 2021-06-02 flushing 09:12, PA-C informed pt. was getting flushed right after receiving the second dose of Pfizer vaccin... Read more
09:12, PA-C informed pt. was getting flushed right after receiving the second dose of Pfizer vaccine. Pt. immediatly assessed: AAO x 3 and in no distress. Pt. states hx. of this reaction with vaccines and allergy shots. Pt. states he had similar reaction after the 1st Pfizer vaccine. Pt. was given Benadryl on the 1st vaccine and symptoms resolved. Currently, no breathing or swelling issues but, remains flushed on face, upper chest and arms. Does not appear to be hives. At 09:15 Pt. given Benadryl 25mg liquid. VSS stable, 65hr, 96% O2. 09:20 flushing on skin almost gone and pt. reports feeling better with no complaints. 09:28 pt. discharged to leave clinic.
56 2021-06-02 numbness, weakness Numbness and pain in his arm where the shot was given and then continued to his left shoulder.; Numb... Read more
Numbness and pain in his arm where the shot was given and then continued to his left shoulder.; Numbness and pain in his arm where the shot was given and then continued to his left shoulder.; Numbness and pain in his arm where the shot was given and then continued to his left shoulder.; Back hurts; Severe fatigue; He feels dizzy; Does not feel well; Coughing; Sore throat; Wasn't eating/Not eating; Body aches; Feeling down; Weak; Eyes burning; Headache/a very bad headache; This is a spontaneous report from a Pfizer sponsored program, report from a contactable consumer (patient). A 56-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0186), via an unspecified route of administration on 24May2021 (at the age of 56-years-old) as single dose for COVID-19 immunisation.The patient medical history included COVID-19 in December 2020. The patient concomitant medications were not reported. On 25May2021, the patient experienced numbness and pain in his armed where the shot was given and then continued to his left shoulder and body aches, feeling down, weak, a very bad headache, eyes burning, backed hurt, severe fatigue and he felt dizzy and he had a coughed and fatigue, sore throat, not ate. Patient states that he did some construction worked yesterday before receiving the vaccine and next day he have had been experienced the same symptoms when he had covid-19 in december 2020. Patient states he knew that the vaccine has not had anything in it that would caused him to got covid-19 so he would liked to knew if his side effects were normal. Patient would also liked to knew what could've he took to eased his headache. Patient took Tylenol and it hadn't worked. He also put ice and cold watered on it. Patient states if his symptoms were not better by next day then he would contact a health care provider. Patient states when he had covid-19 in december he was a little sick but hadn't require hospitalization and his oxygen level was between 90-92. He was not experienced a fever or chest pain as he did when he had covid-19. He was positive for covid 19 in december and had coughing, sweating, sore throat, wasn't ate, body aches, feeling down, feeling weak, eyes burning, backed hurting, headache, chest pain, and sweating. After reading the side effects that had been reported patient states he was experienced everything he mentioned except a fever, rash, itching, hives and swelling of the faced. He was fine after the covid vaccine. Next day he have had all the symptoms that he listed that he had when he had covid 19 except for the chest pain and sweating. Patient states that he just wants to knew what he could've took and did. Patient took Tylenol. He have had Tramadol but he hadn't taken it. Patient states he has not wanted have been on the phone long because he has not felt well. He stated that he knew he hasn't had covid 19 again and stated that he may did a report later. The outcome of the events was unknown. PSCC Communication: Warm transfer to (withheld) at company attempted. INT-#. Caller disconnected right before the transfer. (withheld) from company, caller states that she will reach out to the caller.
56 2021-06-02 numbness Patient stated he was encouraged by friend to call health dept now because his effects after the sho... Read more
Patient stated he was encouraged by friend to call health dept now because his effects after the shot didn't seem normal. He stated appx 50 minutes after shot #1 (4-1-2021), he had c/o of H/A that lasted 1 wk, brain fog for 1 wk, stomach cramps for 2 days & achy x1 wk, sore arm. He stated 90 minutes after 2nd shot (4-23-2021) he had c/o pounding H/A, arm fatigue, feverish off n on for 1 wk, all 4 extremities (hips to toes, shoulders to fingers) went numb for 2 hours & head fog for 2 days. No vaccines prior to covid vaccine. No issues with health history. Advised to call PCP with his complaints of side effects after the covid vaccine to decide about future booster doses, if they are offered in the coming months.
56 2021-06-05 weakness, feeling hot, flushing Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-M... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Weakness-Mild, Additional Details: Patient fainted after 15-20 minutes of getting vaccination. He said he felt overheated and exhausted before passing out. Gave him ice pack and water and had him lie down for several minutes. His bloodpressure was low then rose after a few minutes. Patient declined to be checked out by EMTs and stated was fine to go home and lay down. Figured he was probably anxious about getting the shot
56 2021-06-05 feeling hot, tingling, numbness 5 minutes after vaccine stomach and sides felt heat, upset stomach, lightheaded and blood pressure e... Read more
5 minutes after vaccine stomach and sides felt heat, upset stomach, lightheaded and blood pressure elevated way up. felt very sick, went thru 3 extended observations that lasted about 1 hour and things started to calmed down except light headed and anxious. Finally felt like I could drive home then while driving home my temple and side face started tingling and went numb, pain in the back of my right eye this lasted about 20 minutes and the numbness went away however I had a sensation for a week in my temple and forehead. Could not go to work the next day, felt bad on and off for 8 days. Triggered anxiety for several days, did not get second dose..
56 2021-06-06 nerve pain About 16 days after the 2nd shot, I began feeling very tired, fatigued, nauseous, and had a headache... Read more
About 16 days after the 2nd shot, I began feeling very tired, fatigued, nauseous, and had a headache. About 18 days after the shot, I still had the same symptoms but also developed a red rash on my left upper bac, left arm, and left shin. The rash was painful and burned. When touched, I could feel the pain shoot through my nerves. I was seen by the PA referenced above, who treated it as shingles, but diagnosed it as a plant based reaction, as he could not be sure it was shingles. I was prescribed Mupirocin and valACYclovir HCI. I still had the fatigue and nausea for several days after starting the medication. Despite receiving my 2 shingles vaccinations in September and December of 2020, it appears the Pfizer vaccine may have triggered a mild case of shingles.
56 2021-06-07 weakness This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient rece... Read more
This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left on 25Feb2021 13:00 (Batch/Lot number was not reported) as single dose at the age of 56-year-old for COVID-19 immunisation, administered at hospital. Medical history included known allergies to nut, ongoing hospitalisation Vaccine received during existing Hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) at 112mcg, and isosorbide mononitrate (ISOSORBIDE MONONITRATE) at 60mg, both taken for an unspecified indication, start and stop date were not reported. The patient had not received other vaccines within 4 weeks prior to BNT162B2. The patient experienced tightens of chest, difficult breathing, light headed, pulmonary embolism on 26Feb2021. The outcome of events was not recovered. The patient was hospitalized for events in 2021 for 21 days. Seriousness criteria for the evens were Life threatening and prolonged hospitalization. The patient underwent lab tests and procedures which included Sars-cov-2 test (nasal swab): negative in Sep2020. Therapeutic measures were taken as a result of tightens of events. Information on the lot/batch number has been requested.
56 2021-06-07 pain in extremity feel a constant and migrating thrombosis/palpitations on the right side of my head; palpations; mild... Read more
feel a constant and migrating thrombosis/palpitations on the right side of my head; palpations; mildly painful -not quite a headache; painful sensations in the lower left leg; a slight discomfort of the arm where the shot was administered; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in right arm on 11May2021 10:30 (at the age of 56 years old) (Lot Number: EW0182) as 1st dose, single for COVID-19 immunization. Medical history included high blood pressure, allergies: contrast dye. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were not 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. Patient reported that there was a slight discomfort of the arm where the shot was administered (11May2021) - not enough to worry about & expected. The next morning (12May2021) he felt painful sensations in the lower left leg - sensations similar to stress fractures and palpations. It subsided and has not returned. About three/four days later (reported as 14May2021 18:00) continuing two weeks leading to the second dose - he felt a constant and migrating thrombosis/palpitations on the right side of his head. It was mildly painful - not quite a headache yet persistent and localized to the RT temporal lobe above the temple & slightly above that region. It became exacerbated by critical thinking when it occurred & persisted for long periods of time. The cognitive effect has become slightly debilitating & stressful. No treatment received. The outcome of the event 'a slight discomfort of the arm where the shot was administered' was unknown, of the event 'painful sensations in the lower left leg' was recovered, of the other events was not recovered.
56 2021-06-08 muscle twitching, throat numbness, numbness Facial numbness, traveling down to neck, throat, and Shoulder. Muscle twitching, mainly at night.
56 2021-06-08 pain in extremity Joint pain in fingers and toes. 2 days later, it was better except for 2 fingers. (Left thumb and l... Read more
Joint pain in fingers and toes. 2 days later, it was better except for 2 fingers. (Left thumb and left ring finger). Now after 2 months, both fingers still have pain and limited mobility. (Can not make a closed fist)
56 2021-06-09 numbness Patient said he is experiencing shooting pain and numbness in his left arm. The same as the inject... Read more
Patient said he is experiencing shooting pain and numbness in his left arm. The same as the injection site. It has been 34 days since his vaccination.
56 2021-06-09 tingling Pfizer 2nd dose.. stared with tinging in eyelids, 30 seconds of tingling in arms, tingling in lower ... Read more
Pfizer 2nd dose.. stared with tinging in eyelids, 30 seconds of tingling in arms, tingling in lower legs, blood pressure was low100/61(took blood pressure twice). After calling paramedics, discoloration in face, also felt like he was going to pass out.
56 2021-06-09 tremor felt a "rush" and shakiness as if I just had a cup of coffee; felt a "rush" and shakiness as if I ju... Read more
felt a "rush" and shakiness as if I just had a cup of coffee; felt a "rush" and shakiness as if I just had a cup of coffee; felt nervous; This is a spontaneous report from a contactable consumer (patient's himself). A 56-year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unspecified route of administration in the left arm (Batch/Lot number unknown) on 06Mar2021 at 09:30 AM at the age of 56-year old as single dose for Covid-19 immunization and alprazolam (XANAX) 0.25 mg two hours before the vaccine (06Mar2021 at 07:30 AM) Relevant medical history included high blood pressure. Concomitant medications were not reported. The patient reported that he was very relaxed and calm and had taken less than 0.25 mg of alprazolam two hours prior. In less than two minutes after receiving the injection he felt a "rush" and shakiness as if he just had a cup of coffee. He was not short of breath and had no other symptoms. The patient tried to remain calm. The symptoms subsided in less than 30 seconds. He still felt nervous but may have been out of concern after the "rush" feeling. The site monitor approximately 8 mins. after the injection asked him how he was doing. He told him he was shaky but may have been nervous. He said he was free to leave. The patient took alprazolam that morning because he had prior Emergency Medical experience and was aware of potential anaphylaxis. The outcome of the events was recovered. No follow-up attempts are possible. Information on Lot/batch number cannot be obtained.
56 2021-06-15 tremor Heart palpitation; Tachycardia; Diaphoresis; Shakiness; This is a spontaneous report from a contacta... Read more
Heart palpitation; Tachycardia; Diaphoresis; Shakiness; This is a spontaneous report from a contactable Other HCP. A 56-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3302) intramuscularly, administered in Arm Left on 02Feb2021 at 09:25 AM (at an age of 56-years, 7 months during vaccination) as single dose for COVID-19 immunisation. The patient's medical history included enlarged prostate, urinary frequency with no infection, hypertension. The patient previously took Doxycycline. The patient was allergic to medication, food, or other products including Doxycycline. The patient's concomitant medications included amlodipine, tamsulosin hydrochloride (FLOMAX [TAMSULOSIN HYDROCHLORIDE]). The patient had not experienced adverse event following any previous vaccine. On 02Feb2021 at 09:53 AM, the patient experienced diaphoresis, shakiness, heart palpitation and tachycardia. Diaphoresis and shakiness ended by 10:18 AM and Heart palpitation and tachycardia ended around 10:25 AM. On an unknown date, the patient underwent lab test and procedure which included: Blood glucose: 126 mg/dl. The patient was advised for relaxation. On the 02Feb2021, the outcome of the events was recovered for Diaphoresis and shakiness at 10:18 AM and Heart palpitation and tachycardia ended around 10:25 AM. Follow-up attempts are completed. No further information is expected.
56 2021-06-16 feeling hot, weakness he had some pink spots underneath the band-aid on the injection site; the area got very itchy and re... Read more
he had some pink spots underneath the band-aid on the injection site; the area got very itchy and real hot (felt like he have a fever on the arm); the area got very itchy and real hot (felt like he have a fever on the arm); weakness; tiredness; headache; some pressure on the administration site up to his ear; having some pink spot like a rash its like a little itchy but I haven't scratched; It was real real hot but its warm now; it was before it was inflamed, it was like real hot and it was pink but it's still pink but it's not as hot as it was before; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), via an unspecified route of administration on 01Jun2021 (Batch/Lot Number: EW0187) as Unknow, 0.3ml Single for COVID-19 immunization. The patient also received Lisinopril via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 10mg once a day for hypertension. Medical history included Arthritis, Blood Pressure and Overweight. Concomitant medication included Celecoxib twice a day 200mg tablet for arthritis and Chlorthalidone 25 mg for High Blood Pressure. On an unspecified date, the patient received Pfizer Injection morning around 10:00 and now he was having under the injection site in the shoulder, he was having some pink spot like a rash it's like a little itchy but he hadn't scratched it he did put some camphor lotion and then wipe the excess of it all and now its itchy and now it's warm so, he put cold press on it with ice and it comes down a little bit and he took Acetaminophen. The patient did not know if he did something wrong but he did not want to damage the vaccine. The patient was bit of pressure and little bit of tired. He tried to water and anything if it's okay just stay there that's is and if it's okay it's just there. The patient did not feel anything else bad in the body or anything like that. it's a little worm now but it's gone down a little bit. It's not bad like it was before it was inflamed. In the afternoon (about 20-30 mins ago) the area got very itchy and real hot (felt like he has a fever on the arm). The patient did not receive any other vaccine within 4 weeks prior to Covid vaccine. The outcome of the events was unknown. Follow-up attempts are possible. Further information is expected.
56 2021-06-16 pain in extremity had some blood on it, something dark; had a little bit of chills; soreness is very light; he has som... Read more
had some blood on it, something dark; had a little bit of chills; soreness is very light; he has some injection site pain; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 26May2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. A 56-years-old male patient received bnt162b2, dose 2 via an unspecified route of administration on 25May2021 (Batch/Lot number was not reported) as 2ND DOSE, for covid-19 immunization. The patient medical history was not reported. Concominent medications include ibuprofen for sneezes, Nasonex for pollen allergy, Tylenol. Patient previously took his first dose of bnt162b2 vaccine on 03-may2021 for immunization. Patient experienced Tiredness, arm soreness, Fever, chills, flu like symptoms, sneezing headache after first dose. The patient experienced had some blood on it, something dark, had a little bit of chills, soreness is very light and he has some injection site pain on an unspecified date.The patient stated that he had the second dose of the Pfizer covid 19 vaccine yesterday at 3 o'clock noting it has almost been 24 hours. The patient stated it was documented that side effects are more bad after the second dose stating that was not true for everyone. The patient stated he did not get a fever but had a little bit of chills last night. The patient stated his temperature stayed in 98.7 and 99 range. The patient asked was there a correlation between chills and fever. The patient stated the first dose on 03May2021 was no big deal, pretty ok, had tiredness but no fever. The stated that by day 3 the injection pain was gone. The patient stated that he had slight soreness after the first dose stating it was like the flu shot. The patient stated the pharmacist told him to take regular ibuprofen after the first dose if he had a fever noting he took two tablets after the first dose. The patient stated he has taken ibuprofen and tylenol pm and has taken tylenol pm for the last 2 to 3 years for sleeping. The patient stated he took a couple of days off work after the first dose. The patient stated the soreness is very light after the second dose stating the soreness was gone. The patient asked was that a good sign no fever or is that a bad thing when you do not have a fever. The patient wanted to know what percentage of participants showed low grade symptoms. The patient wanted to know which had the most significant amount, mild moderate or severe side effects. The patient stated he has some injection site pain noting no severe symptoms after the second dose. The patient asked if side effects have been shown to come back again. The patient asked does Pfizer have a plan for people that are uninsured and have to go to the emergency room. The patient also stated he would call back on Friday because maybe he would see more side effects. The patient stated that the second time when he took the tape off it had some blood on it, something dark. The patient underwent lab tests and procedures which included body temperature: 98.7 and 99 fahrenheit on an unspecified date 98.7 and 99 range. The outcome of events was unknown. Information about lot/batch number is requested.
56 2021-06-18 tingling Approximately 1 hour after I received the shot I pressure and stiffness on the left half of my head ... Read more
Approximately 1 hour after I received the shot I pressure and stiffness on the left half of my head and face. I did not have muscle weakness any where or slurred speech. That sensation was not painful, but it was very noticeable like someone's hand was on your face. That was present for about two days at a significant level. Five weeks later it is still present but at a much milder degree. Also persistent over the entire 5 weeks since the shot is mild dizzyness off and on each day, along with increased headaches. Since i have chronic post concussion syndrome, it is normal for me to get headaches, but since the vaccination I have been getting headaches more frequently and I am a lot more sensitive to the usual triggers. I have a persistent mild pain in or around my left eye that never existed before.
56 2021-06-20 weakness Admitted to ER with complaints of generalized weakness and report of insomnia for 4 days to getting ... Read more
Admitted to ER with complaints of generalized weakness and report of insomnia for 4 days to getting his second covid shot. He reports having one episode diarrhea and emesis pta. He reports there was no blood in his stool , no black stool, no blood in emesis tonight pta. He reports he saw blood in emesis one day prior
56 2021-06-21 weakness approximately 5pm my heart started RACING. similar to when I have one of my irregular heartbeat epi... Read more
approximately 5pm my heart started RACING. similar to when I have one of my irregular heartbeat episodes. i laid down and relaxed. usually they will stop within 1 hour. this was different, it continued all night, weakening me as the night progressed. i stayed in bed hoping i wasn't having a heart attack, ready to call an ambulance if necessary. after quite a few hours, it subsided and my heartbeat went back to normal. it was a very scary event.
56 2021-06-23 pain in extremity extremely sore arm for 4 days
56 2021-06-27 seizure The patient stated they had a seizure 3 days after the second COVID vaccine. He was taken by ambulan... Read more
The patient stated they had a seizure 3 days after the second COVID vaccine. He was taken by ambulance to the hospital for treatment.
56 2021-06-29 weakness, tingling Continuous soreness at injection site. Intermittent tingling from upper arm down to tips of fingers.... Read more
Continuous soreness at injection site. Intermittent tingling from upper arm down to tips of fingers. Have lost significant strength in arm.
56 2021-06-29 weakness Extremely strong headache; Nausea; weakness; Some dizziness.; This is a spontaneous report from a no... Read more
Extremely strong headache; Nausea; weakness; Some dizziness.; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 19Mar2021 at 10:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included CRESTOR and SYNTHROID, both for unknown indication from unknown dates. The patient did not had allergy to any medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, it was unknown if the patient diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 19Mar2021 at 16:30, the patient experienced an extremely strong headache for three days, nausea, weakness and some dizziness. The patient did not receive any treatment for the events. 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 headache, nausea, weakness and dizziness was resolving at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
56 2021-06-29 pain in extremity Stomach cramping and spasming below naval; Diarrhea all day; vomiting bile x3 in morning; Chills but... Read more
Stomach cramping and spasming below naval; Diarrhea all day; vomiting bile x3 in morning; Chills but no fever; headache; very sore body; I woke up feeling like I had pinkeye; No crust but a little redness; Eyes felt dry and tired by the end of the day.; Day 1 - No problem. Arm got sore.; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 56-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6201 and Expiration date not reported), (at the age of 56-Year-old) via an unspecified route of administration on 13Feb2021 at 14:30 on left arm as single dose for COVID-19 immunisation. The patient's medical history was not reported. He was allergic to dust, grass, english plantain and iodine dye. Concomitant medications were Losartan potassium 25 mg and Rosuvastatin calcium 10 mg. No other vaccine received in four weeks. On 15Feb2021 at 07:00, the patient experienced "Day 1 - No problem. Arm got sore". On 16Feb2021, he noticed eyes felt dry and tired by the end of the day and arm still very sore. On 17Feb2021, he woke up feeling like he had pinkeye and no crust but a little redness. It annoyed him all day. On 18Feb2021, he had lubricating eye drops so that helped. Stay developed on lower left lid. He used the drops in the morning. Otherwise, ok. On 20Feb2021, He informed that eyes still dry. Stomach cramping and spasming below naval. Diarrhea all day and vomiting bile x3 in morning. Chills but no fever. Headache and very sore body. Slept on and off all day. On 21Feb2021, he started with diarrhea x3 at 4am. Slept until 10:30. More diarrhea x3. Still fatigued but feeling better. Took Imodium to slow things down. Lost 4 pounds. He was thinking he would be 100% by Sunday. Not looking forward to second shot. The patient treated himself for adverse event. The patient tested COVID neither prior vaccination nor post vaccination. The outcome of the events was not recovered. Follow-up (13May2021): Follow-up attempts completed. No further information expected.
56 2021-06-29 pain in extremity Pain in arm; Headaches; This is a spontaneous report from a non-contactable consumer. A 56-year-old ... Read more
Pain in arm; Headaches; This is a spontaneous report from a non-contactable consumer. A 56-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in left arm, on 12Mar2021 at 10:00 (at the age of 56 years) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient received unspecified medications within 2 weeks of vaccination. On 12Mar2021 at 10:15 hours, the patient experienced pain in arm for about two days, headaches starting about 10 minutes after injection. still having multiple daily headaches eight days later. No therapeutic measures were taken as result of the events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for the events pain in arm and headache were not recovered at the time of report. Information about lot/batch number cannot be obtained. No further information is expected.
56 2021-06-29 tingling, numbness Swelling; Bruising and hardness; Tingling; Numbness sensations; Achy and uneasy feeling through the ... Read more
Swelling; Bruising and hardness; Tingling; Numbness sensations; Achy and uneasy feeling through the forearm to date; Rapid heart rate; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in the left arm on 09Mar2021 at 00:30 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. The medical history included allergic to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient was not taking any concomitant medications. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 11Mar2021, the patient experienced left hand ring finger, swelling, bruising, hardness, tingling/numbness sensations. The patient also experienced achy and uneasy feeling through the forearm to-date. The patient had continued swelling and hardness in the area and experienced rapid heart rate. The patient did not receive any treatment for the reported events. 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 clinical outcome of the events swelling, bruising and hardness, tingling, numbness sensations, achy and uneasy feeling through the forearm to-date and rapid heart rate was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
56 2021-06-29 tremor About 26 hours after vaccine shot, my skin felt like it was burning and turned very red, had to put ... Read more
About 26 hours after vaccine shot, my skin felt like it was burning and turned very red, had to put wet towels on skin to ease the pain, had slight fever (100.2) and a headache. Contacted Dr on call. Dr told me to go to urgent care or the ER and to take any allergy medication I happened to have. I took Claritin-D and waited for half hour. By then burning sensation was a lot better, but I started shaking and could not stop, even outside the house at a 100-degree heat. Went to the Urgent care clinic, I was given dexamethasone sodium phosphate and the doctor there told me to take benadryl every six hours as needed.
56 2021-06-30 pain in extremity swollen lymph node; Hip ache; lower back aches; sore arm; This is a spontaneous report from a contac... Read more
swollen lymph node; Hip ache; lower back aches; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 56-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: PGZER EP7534), via unspecified route of administration, in left arm on 20Mar2021 (at the age of 56-years-old) at 14:30 as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes and the patient was allergic to ace inhibitors. 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 four weeks prior to the COVID-19 vaccination. On 21Mar2020 at 01:00, after the vaccination the patient experienced sore arm after first day, on third day i.e.,23Mar2021 with swollen lymph node in the same arm and hip and lower back aches. Therapeutic measures and treatments were not taken for the reported events. The clinical outcome of the events pain in arm, swollen lymph node, hip pain, and lower back aches was resolving at the time of report. No follow-up attempts are needed. No further information is expected.
56 2021-07-01 night sweats On Sunday June 20th I was feeling sick, Fever, body aches, head ache, fatigue. I also had an infecti... Read more
On Sunday June 20th I was feeling sick, Fever, body aches, head ache, fatigue. I also had an infection in my gums around my teeth that was burning as if someone poured hot coffee in my mouth non-stop. especially the roof of my mouth and right behind my upper front teeth. After 4 days of trying to sweat it out the night sweats stopped. But my heart rate was at 161 beats per minute but I could not feel my heart beating at all. We went to an urgent care that immediately sent me by ambulance to the hospital. Right away they got my heart rate under control but they spent 4 more days trying fight the infection. Finally on June 29th I was well enough to go home.
56 2021-07-04 breast pain Per patient, "tired and thirsty" the next day; experienced "pain under left armpit that radiates to ... Read more
Per patient, "tired and thirsty" the next day; experienced "pain under left armpit that radiates to left breast and up to jaw when walking or going up steps" the following day and continues to persist at this time; patient is currently followed by a cardiologist for pre-existing health condition ("cardiac stents") >> seen by cardiologist and "nuclear cardiac stress test" was performed one week ago; "cardiac scans" also completed and results were no different than results from routine scans in March 2021; states cardiologist "cleared" him for work and has no intentions to follow up but patient states pain persists. Patient plans to seek second opinion and referral to different provider.
56 2021-07-06 difficulty speaking Diarrhea , Voice has changed
56 2021-07-07 pain in extremity Pt called call center at 5/10/2021 stated pt got 1st covid vaccine Pfizer 4/9/2021 at vaccination ... Read more
Pt called call center at 5/10/2021 stated pt got 1st covid vaccine Pfizer 4/9/2021 at vaccination site and pt got headache for 10 days, lower back and leg pain that pt couldn't walk normally. Pt said pt took tylenol and Advil by herself. Pt contacted pt's private MD and blood works done; normal. MD prescribed Aleve for symptoms however pt stopped taking Aleve since it gave stomach pain. Pt switched taking Advil by herself currently for lower back and buttock pain(3-4/10). Pt said pt contacted another MD to ask about covid vaccine pt to get 2nd vaccine regarding of symptoms(Headache, lower back, leg, buttock pain) and that MD recommended pt to get 2nd covid vaccine. Pt is educated covid vaccine side effects. Pt agreed and verbalized understanding.
56 2021-07-08 night sweats Severemuscle soreness radiating frominjection site; General malaise; Mild chills; Night sweats; Arm ... Read more
Severemuscle soreness radiating frominjection site; General malaise; Mild chills; Night sweats; Arm of limited use; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old male 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 19Mar2021 at 18:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Relevant medical history included high blood pressure. No concomitant medication was reported. 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 4 weeks prior to the COVID-19 vaccine. On 25Mar2021 at 11:00, after 5.5 days of the injection, the patient had severe muscle soreness radiating from injection site, to the point where arm was of limited use, mild chills, generalised malaise and night sweats and no known fever. Temperature was taken in the evening and again in the morning. The patient did not have any other COVID or flu symptoms. Therapeutic measures were taken as a result of the events that included treatment with over the counter (OTC) cold and flu medications. The adverse events did not result in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events muscle soreness, arm of limited use, mild chills, generalised malaise and night sweats was resolving. No follow-up attempts are possible; Information about lot number cannot be obtained.
56 2021-07-12 feeling of body temperature change, pain in extremity, numbness arm sore (could not lift); tight shoulders; tight neck; fingers numb; fingers feel swollen; forearms... Read more
arm sore (could not lift); tight shoulders; tight neck; fingers numb; fingers feel swollen; forearms heavy; dizzy; fatigued; unwell feeling; bright lights bother my eyes; achy bones; a little difficult breathing; I feel hot then cold back & forth; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received the second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EW0150) via intramuscular route of administration in right arm on 14Apr2021 at 7:45 am (at the age of 56 years old) as single dose, for COVID-19 immunization. The patient's medical history was not reported. Historical vaccine included the first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EN6207), via intramuscular route of administration in right arm on 24Mar2021 at 07:30 (at the age of 56 years old) as single dose for COVID-19 immunization. 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 have any known allergies. Patient did not receive any other vaccines within 4 weeks. It was reported that on 24Apr2021 at 07:30 AM patient experienced arm sore (could not lift), tight shoulders, tight neck, fingers numb, fingers feel swollen, forearms heavy, dizzy fatigued, unwell feeling, bright lights bother his eyes, achy bones, a little difficult breathing, he was feeling hot then cold back & forth. The patient did not receive any treatment for the events. Outcome of the events was resolved on unspecified date. Follow up attempts are needed. Further information is expected. Follow-up (14Jun2021): New information reported from a contactable consumer includes: Aanatomical site of first and second dose injection updated from left arm to right arm, route of administration for both doses, date of the second vaccine dose and first dose changed from suspect dose to historical vaccine. Follow-up attempts are completed. No further information is expected.
56 2021-07-13 pain in extremity, tenderness, tingling APPROXIMATELY 2 DAYS AFTER VACCINATION PAYMENT ARM BECAME VERY SORE AND TENDRER, AT TIMES UNABLE TO ... Read more
APPROXIMATELY 2 DAYS AFTER VACCINATION PAYMENT ARM BECAME VERY SORE AND TENDRER, AT TIMES UNABLE TO MOVE, TINGLE IN FINGERS. CONTINUES TO THIS DAY.
56 2021-07-15 migraine Migraines, dizziness, Tinnitus, Vertigo. Fatigue, Difficulty concentrating, difficulty sleeping
56 2021-07-15 muscle spasms Muscles tightening up and cramping
56 2021-07-15 pain in extremity Extreme pain limiting mobility of left arm. Alternating ice packs and heat pad over the course of we... Read more
Extreme pain limiting mobility of left arm. Alternating ice packs and heat pad over the course of weeks with stretching in an attempt to regain mobility.
56 2021-07-16 bell's palsy, tenderness The very next morning had a severe stabbing headache, the headache subsided some the following day ... Read more
The very next morning had a severe stabbing headache, the headache subsided some the following day but was still bothersome. A couple days later developed a pain behind my right eye and the headache moved to the top middle of my head and was sore to touch. A few days later I woke up with severe double vision. I had pain in the right side of my neck and in my right temple area. My right eye also developed a redness on the lower right side. This all lasted for about 4 weeks. Everything seemed to go away at the same time.
56 2021-07-17 cold sweat, weakness hard time breathing; heart attack; minor chest pain which he thought was indigestion and heart burn;... Read more
hard time breathing; heart attack; minor chest pain which he thought was indigestion and heart burn; had clot arteries based in blood clots; 1 artery was 99% blocked; cold sweats; afraid to eat because he was so bloated/acid reflux; could not hold food down; out of energy; fatigued, totally out of energy; minor chest pain which he thought was indigestion and heart burn; This is a spontaneous report form a contactable consumer (patient). A 56-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ) on 30Mar2021 for covid-19 immunisation at the age of 56-year-old. Lot number was EP7533. Medical history included diabetes in 2018. Concomitant medications were unknown. Patient received first dose of BNT162B2 on 09Mar2021 for covid-19 immunisation (Lot Number: EN6198 Anatomical Location: Left Arm). On unknown date, electrocardiogram showed shows heart attack. The patient experienced heart attack on 06Apr2021 (treated with surgery, and received 2 stents in his heart), hard time breathing on 11Apr2021, minor chest pain on 02Apr2021 which he thought was indigestion and heart burn on 06Apr2021, had clot arteries based in blood clots, 1 artery was 99% blocked, cold sweats, fatigued and totally out of energy on 06Apr2021, afraid to eat because he was so bloated/acid reflux, vomit on 06Apr2021. The patient was hospitalized for myocardial infarction, dyspnea and chest pain. The outcome of the events was unknown. Follow up attempts are needed. Further information has been requested.
56 2021-07-17 discomfort When I lay down myself, I feel uncomfortable in lung, and feel a little bit of difficulty to breath.
56 2021-07-17 pain in extremity Golf ball to baseball size lump under his left armpit; Soreness underneath his left arm; This is a s... Read more
Golf ball to baseball size lump under his left armpit; Soreness underneath his left arm; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0196), dose 1 via unspecified route of administration, administered in left arm (left shoulder) on 30Jun2021 (at 10:45AM) as single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 01Jul2021, the patient experienced soreness underneath his left arm. On 02Jul2021 (late afternoon the day after the first injection), the patient experienced golf ball to baseball size lump under his left armpit. When he just got into the shower a little bit ago he discovered the source of the soreness. There is a golf ball to baseball size lump under his left armpit, the same arm he received the Covid 19 vaccine. Patient has not seen his primary care doctor or gone to the emergency room. He noticed the soreness in his left armpit late yesterday afternoon, 01Jul2021. When he got into the shower today, 02Jul2021 and lifted his arm, he thought holy cow, there's a lump. When probing for reason why he decided to get the Covid 19 vaccine he reports it was work related. He either had to wear a mask or get the Covid 19 vaccine. He adds if this persists for another day or two he was going to see his primary care doctor. He had a Covid 19 test done on the 23Jun2021 that came back negative. When probing adverse events with any other vaccine he reports soreness or stiffness. He has served in the military and has had multiple vaccinations. He doesn't recall any vaccine specifically that caused stiffness or soreness. He was asking if there are any other recommendations on how to get rid of the lump under his armpit. The outcome of all the events was not recovered.
56 2021-07-17 pain in extremity can't lift arm up; left arm and shoulder still very painful; Painful from the shoulder blade to the ... Read more
can't lift arm up; left arm and shoulder still very painful; Painful from the shoulder blade to the fingers; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 23Mar2021 at 10:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included muscle disease and chronic fatigue syndrome. Concomitant medications were not reported. 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 24Mar2021 at 01:00, the patient's left arm and shoulder were still very painful and it was 8 days for now. The patient notified the doctor and had scheduled an appointment. It was painful from the shoulder blade to the fingers and the patient could not lift the arm up. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcomes of the events left arm and shoulder still very painful, painful from the shoulder blade to the fingers and can't lift arm up were not resolved at the time of the report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
56 2021-07-20 numbness, tingling, pain in extremity Neck pain/ severe neck pain on right side of neck; He got vaccine in left shoulder, he had a little ... Read more
Neck pain/ severe neck pain on right side of neck; He got vaccine in left shoulder, he had a little soreness within the next day of his left shoulder; Numbness in hand/ severe numbness in right hand and fingers are tingly; Tingly fingers/ severe numbness in right hand and fingers are tingly; Had minor ear pain; Head pain/ severe head pains back of head; Minor leg pain; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0178; Expiration Date: Aug2021; NDC number: unknown) via an unspecified route of administration on 27May2021 (at the age of 56-years-old) in left shoulder as a single dose for covid-19 immunization. The patient's medical history, other products, other conditions, and concomitant medications were not reported. After receiving the vaccine on his left shoulder he experienced side effect on the right side of his body: severe head pain, severe neck pain, numbness in hand, tingly fingers. He stated he decided not to get the second dose due to this side effects that he was still experiencing. The patient experienced little soreness in his left shoulder on 28May2021, which was normal for any shot, but all the stuff was on his right side. On 31May2021 he experienced severe neck pain on right side of neck, it comes and goes, but definitely comes, it hasn't gone completely. He had severe head pains at back of head, it travels from back of head to the right, which he never had before, it started soon after neck pain but was there 6 weeks later. He also had severe numbness in right hand and fingers are tingly, which started after the other two, the other were generally at the same time, this started a couple weeks later. He also experienced minor ear pain and leg pain, all on right side, leg pain was within the last week, and was ongoing and improving, hasn't continued, and ear pain started about two weeks ago, and it was ongoing but hasn't continued. The events were assessed as non-serious. His second dose was supposed to be 17Jun2021. It's been 6 weeks he hasn't received the second dose as he had lot of side effects from the first vaccine was afraid to get the second one. He stated he has family and friends who received the vaccine but didn't experience side effects after the first dose, only after the second dose. He asked if someone gets the vaccine in left shoulder does the events happen on right side and why does it go to the other side. He stated a packet was delivered to him with a letter and a bottle. But he wanted to know the substance in the white packet. He was explained about the process of prepaid mailer. He stated that Pfizer believed he was a healthcare provider. Investigations was not provided. He was concerned about whether he had received the Pfizer one, because he looked at the bottle and he didn't see Pfizer on it. His vaccine card said Pfizer, but he wanted to verify the lot to see if it was the product. Product strength and count size dispensed was not provided. Additional lot numbers was not provided. A sample of the product available to be returned, if requested (Y/N) was not provided. Packaging sealed and intact was not provided. The outcome of the events neck pain and ear pain was not recovered, for headache and pain in extremity was recovering and for all other events was unknown. Follow-up attempts are needed. Further information is requested.
56 2021-07-22 slurring, tingling, facial paralysis, numbness On 5/23/21 wife noticed patient had left facial droop, slurred speech, stumbling, off balance. Seen ... Read more
On 5/23/21 wife noticed patient had left facial droop, slurred speech, stumbling, off balance. Seen by doctor on 5/24/21 also on 5/25/21 diagnosed with Thalamic stroke. 5/26/21 seen by cardiology. 6/29/21 seen by specialist. Seen on 7/23/21 by another doctor who requested event be reported and documented in VAERS as recommended per supervisor. Still having right hand numbness and tingling.
56 2021-07-22 numbness and pain in extremities nerve neuropathy; lymphoma getting worse; Premature atrial contraction had gotten worse; Premature a... Read more
nerve neuropathy; lymphoma getting worse; Premature atrial contraction had gotten worse; Premature atrial contraction had gotten worse/ lymphoma getting worse; his arthritis is flaring up and "acting up".; pain; This is a spontaneous report from a consumer (patient) via regulatory authority. A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 14Apr2021 15:00 (Lot Number: ER8731) as dose 2, single at the age of 56-years-old for covid-19 immunization. Medical history included ongoing rheumatoid arthritis, ongoing lupus, ongoing lupus anticoagulant, this leaves him immunocompromised, ongoing premature atrial contraction, ongoing lymphoma. Patient said that he was included on the high risk priority for the vaccine. He has lupus, rheumatoid arthritis and other things going on. Concomitant medication included hydroxychloroquine sulfate (HYDROXYCHLOROQUINE ACTAVIS) ongoing for lupus. The patient received first dose of bnt162b2 (Lot: EM9810) on 16Mar2021 around 1pm in the left arm for covid-19 immunization. Prior vaccinations (within 4 weeks): none. AEs following prior vaccinations: none. After getting the second shot of the vaccine, his arthritis was flaring up and "acting up". The pain is "very bad" and that his doctor was telling him it went back to the vaccine. He also stated that the last month was "brutal" since he can barely get up from his chair and his bed and that he was not allowed to take Ibuprofen and most of rheumatoid arthritis medications. The patient explained that for the for past 2 months he has been feeling crappy and there are days when he cannot walk related to the arthritis. He mentioned that he had a lymphoma stage 4 before and it has gotten worse as well after the second dose. The patient clarified that his lymphoma has been inflamed. He also stated that he had premature atrial contraction (PAC), this has flared up too. Premature atrial contraction had gotten worse and confirmed that he was experiencing symptoms of chest pain, shortness of breath, and a pounding heart. The patient notes that with his PAC, he noticed his heart was palpating and racing more. Since having chemo he had side effects after that but this was 3 years ago and he had nothing since then until now. The doctor did not know if this is related to getting the vaccine. Patient felt like maybe he shouldn't have gotten the vaccines. He was taking tramadol for pain but he did not want to be on pain killers and did not want to go back on taking hydrocodone. Patient also reiterated that before getting the shot he was okay and now he was moving "backwards". He also added that nerve neuropathy is what he got out of it. Patient also said his hydroxychloroquine and tramadol are not working anymore since getting the vaccine and wants to know for potential interaction. All the events were noticed in Jun2021. For arthritis, this was noticed about a month afterward but he didn't know until Jun2021 what was really going on. He went to his rheumatologist and they did a sedimentation rate that showed his inflammatory marks were like they were when doing chemo. They hadn't been that level for 3 years, since he was on chemo. She also noticed the lymphoma in his right arm was swollen. This was the same time, in Jun2021. The patient reported he had rheumatoid arthritis and the doctor think it is a flare up of that. He reported joint pain, when he sits it is hard to get up. Patient confirmed this is the arthritis mentioned above, it is all the same event. The patient stated he thought he was getting sick again, that his cancer was back or something was going on. The oncologist did note that his lymph node were going down. It was confirmed this statement is related to the above mentioned events already covered in the report. AEs require a visit to: physician office (Patient also stated he saw his doctor's regularly). Relevant test included: Sedimentation rate: 24 on Jun2021; 22 on 02Jul2021. Outcome of the event lymphoma getting worse, premature atrial contraction had gotten worse, arthritis is flaring up was not recovered, of other events was unknown.
56 2021-07-22 numbness and pain in extremities increase pain in stomach and intestine also increase spread of nephropathy from feet to lower legs a... Read more
increase pain in stomach and intestine also increase spread of nephropathy from feet to lower legs and forearms and hands
56 2021-07-27 discomfort, pain in extremity Besides sore arm feeling a little dazed I Noticed a rash on left arm few days after vaccine, they we... Read more
Besides sore arm feeling a little dazed I Noticed a rash on left arm few days after vaccine, they weren?t to itchy, but blotchy and spreading.contact my physician at the time and he saw me same day. I was diagnosed with shingles. Very uncomfortable and painful on my left side. Waited longer before 2nd vaccine . Got that on 5/10/2021
56 2021-07-27 numbness Carpal Tunnel both hands; pain; numbness; This is a spontaneous report from a contactable consumer, ... Read more
Carpal Tunnel both hands; pain; numbness; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 04Apr2021 at 13:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included metformin (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. 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 09Apr2021 the patient experienced Carpal Tunnel both hands, pain, numbness. The patient received treatment for the events. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event carpal tunnel syndrome, pain, numbness was not recovered. No follow-up attempts are needed. No further information is expected.
56 2021-07-29 facial paralysis Shingles erupted after about 10 days of first dose of vaccine. Shingles then led to Ramsey Hunt Synd... Read more
Shingles erupted after about 10 days of first dose of vaccine. Shingles then led to Ramsey Hunt Syndrome. Lost complete hearing in left ear still to this date. Face was paralyzed on left side but is; Shingles erupted after about 10 days of first dose of vaccine. Shingles then led to Ramsey Hunt Syndrome. Lost complete hearing in left ear still to this date. Face was paralyzed on left side but is; Face was paralyzed on left side; Lost complete hearing in left ear still to this date. Face was paralyzed on left side but is; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient reported for himself that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0168), via an unspecified route of administration, administered in left arm on 21May2021 at 03:00 PM (age at the vaccination was 56 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history includes heart attack in November of 2020. No known allergies. Concomitant medication included atorvastatin, prasugrel and acetylsalicylic acid (ASPIRIN LOW); All were taken for an unspecified indication, start and stop date were not reported and the patient received within 2 weeks of vaccination. The patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was reported as other. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Jun2021 at 12:00 AM, the patient experienced shingles erupted after about 10 days of first dose of vaccine. Shingles then led to Ramsey Hunt Syndrome. Lost complete hearing in left ear still to this date. Face was paralyzed on left side but is now getting back movement. Still out of work and dealing with shingles after 6 weeks. In pain constantly from the shingles. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. For adverse events given medication to try and deal with nerve pain. The serious criteria was reported as disabling/incapacitating. Outcome of the events was not recovered.
57 2021-01-05 pain in extremity Four days after immunization onset of arthropathy in left fifth toe (red, pain, edema) progressed o... Read more
Four days after immunization onset of arthropathy in left fifth toe (red, pain, edema) progressed on seventh day with enthesitis /Swelling left medial malleolus. Day 12 progressed to tender, swelling Achilles? tendon left side, day 14 stiff great toe and foot edema. Difficulty ambulating on left foot. Prednisone prescribed but not started to this point. This flare similar to IBD arthropathy in past but have been in remission until vaccinated.
57 2021-01-08 flushing 3 am chills, headache and dry throat, 9:30 am chills, headache and dry throat and I took my first te... Read more
3 am chills, headache and dry throat, 9:30 am chills, headache and dry throat and I took my first temp 102. took two Tylenol and temp went down. 8Pm I was flush and my temp was 105.5, 5minutes later 106. PCP called and advised my wife to take me to the ER and took two more Tylenol. Arrived at ER Temp was down 100.2
57 2021-01-10 pain in extremity Headache, Myalgia, Fever, NauseaVomiting, fatigue, sore arm Narrative: Employee reports 1/7 one hour... Read more
Headache, Myalgia, Fever, NauseaVomiting, fatigue, sore arm Narrative: Employee reports 1/7 one hour later his arm started hurting. Then throughout the day the pain got worse and he took Tylenol and ibuprofen. Onset of fatigue and body aches last night. 1/8 0300 woke up with nausea and started throwing up. This afternoon he still has headache, body aches and arm pain. He continues to experience vomiting. Temp to 99.1 He's drinking ginger tea and water and can keep that down. He's staying hydrated. 1/11 employee reports all symptoms have resolved. He felt better around 7:30-8:00 Saturday night.
57 2021-01-11 feeling hot, feeling cold Achy Joints, Cold and hot at the same time, headache on 1-10-2021 from 2am until 2pm. Took Aleve at ... Read more
Achy Joints, Cold and hot at the same time, headache on 1-10-2021 from 2am until 2pm. Took Aleve at 10am
57 2021-01-11 night sweats Night sweats x 4 hours and fatigue x 48 hours despite alternating ibuprofen 800 mg q3h with acetamin... Read more
Night sweats x 4 hours and fatigue x 48 hours despite alternating ibuprofen 800 mg q3h with acetaminophen 1000 mg from time of vaccination
57 2021-01-11 pain in extremity He received the first dose of the Covid-19 Vaccine on 18Dec2020/ received the second dose of Covid-1... Read more
He received the first dose of the Covid-19 Vaccine on 18Dec2020/ received the second dose of Covid-19 vaccine 04Jan2021; he experienced fever 102.5F; muscle and joint pain; muscle and joint pain; it hurts to raise his arms above his head; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient (Weight (kg): 79.38, height (cm): 170) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140, Expiry Date: Mar2021), intramuscularly in upper left arm on 04Jan2021 13:00 for covid-19 prophylaxis. The patient had no relevant medical history and concomitant medications. Prior vaccinations (within 4 weeks) was none, relevant tests was none. The patient previous received first dose of Covid-19 Vaccine on 18Dec2020 and had no side effects, received flu vaccine in Oct2020 for immunization. The patient experienced fever 102.5f, muscle and joint pain, it hurts to raise his arms above his head all on 05Jan2021 01:00. The event was not required a visit to emergency room or physician office. The patient underwent lab tests and procedures which included fever: 102.5 F on 05Jan2021. Vaccination Facility Type was hospital. Caller stated that he worked at a hospital, but he was not a doctor, nurse, or pharmacist. The caller said that he received the second dose of Covid-19 vaccine 04Jan2021 and 12 hours after receiving the vaccine he started running a fever of 102.5. He said that he got the second dose at 13:00 and started feeling the fever symptoms about 12 hours later at about 01:00 05Jan2021. His vaccination was done at the hospital. He said that with his first dose he had no side effects. He received the first dose of the Covid-19 Vaccine on 18Dec2020. He said that he had his flu vaccine in Oct2020. Caller also reported that he was having muscle and joint pain. He said that it hurts to raise his arms above his head. He let his employee health know about the symptoms he was experiencing. Caller wanted to know if his side effects are normal, especially the "mild - moderate". The outcome of events was not resolved.
57 2021-01-12 pain in extremity arm sore; tired; This is a spontaneous report from a contactable consumer. A 57-year-old male patien... Read more
arm sore; tired; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration in the left arm on 28Dec2020 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 28Dec2020, the patient experienced arm sore and tired a couple of days. No treatment was received for the adverse events. Outcome of the events was recovered on an unspecified date. The events were considered non-serious by the reporter. Information on the lot/batch number has been requested.
57 2021-01-15 pain in extremity 24 hours after the second vaccine I had crushing, tightness in my chest. It felt like a myocardial i... Read more
24 hours after the second vaccine I had crushing, tightness in my chest. It felt like a myocardial infarction. It lasted 24 hours. I had difficulty doing my job. I considered going to the ER to rule out a myocardial infarction not related to the vaccine. I also had bone pain in right forearm and hand which lasted 24 hours. In addition, I had muscle pain in my entire upper body but not lower body. On day 2 I had right axillary swelling and pain.
57 2021-01-16 weakness 3 days after receiving the first dose of the vaccine on 12/21/2020, experienced flu-like symptoms th... Read more
3 days after receiving the first dose of the vaccine on 12/21/2020, experienced flu-like symptoms that lasted 24 hours. About 17 hours after receiving the second does on 1/11/2021, flu-like symptoms reoccurred. The following day (1/13/2021) severe chills, and difficulty breathing occurred. Patient was admitted to Medical Center, where blood work, EKG, and oxygen were given and ordered. After overnight observation, the patient was discharged and informed that he had a severe reaction due to the Pfizer vaccine for Covid-19. As of 1/17/2021, patient still recovering and feeling generally weak and tired without much appetite.
57 2021-01-18 pain in extremity This morning it started all these different side effects and it's progressively getting worse, so I ... Read more
This morning it started all these different side effects and it's progressively getting worse, so I left work; Body aches; Headache; Stomach issues; pain; Diarrhea; Chills; Fever I just checked it's 102.4; Little sore arm at night; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Batch/lot # EK9231) at single dose on 06Jan2021 around 2 O'clock for Covid-19 immunisation, administered ad hospital. Medical history included high cholesterol, hypertension, irregular heart beats, arrhythmia, acid reflux. Concomitant medication included amlodipine (AMLODIPINE) 10 mg once a day for hypertension, acetylsalicylic acid (BABY ASPIRIN) at 81 mg, once a day, carvedilol (CARVEDILOL) at 12.5 mg, two times a day hypertension, flecainide (FLECAINIDE) at 50 mg, twice a day for irregular heart beats, arrhythmia, olmesartan (OLMESARTAN) at 40 mg once a day for hypertension, omeprazole (OMEPRAZOLE) at 40 mg when needed for acid reflux, rosuvastatin (ROSUVASTATIN) at 20 mg, once a day for high cholesterol. The patient experienced little sore arm at night on 06Jan2021. Then, on 07Jan2021 morning he went in to work and it started all these different side effects and it's progressively getting worse, so he left work at abut 10 O' clock AM. He was getting body aches, headache, stomach issues, pain, diarrhea, chills, and fever I just checked it's 102.4 on 07Jan2021. The patient underwent lab tests physical examination with unknown results in Dec2020 3 weeks before this report (he had complete physical lab work with his doctor). Treatment included taking Tylenol and Advil. The outcome of all events was not recovered. Due date of second shot will be 23Jan2021.
57 2021-01-20 feeling cold, pain in extremity fever of 102, chills nausea, lack of appetite. fatigue .over 36 hours/ arm pain lasted for 4days///... Read more
fever of 102, chills nausea, lack of appetite. fatigue .over 36 hours/ arm pain lasted for 4days/// fever of 100 at 4am then fever of 102.2 at 5am, took medicine but temperature was consistent. struggle to get out of bed, only for restroom- also I was covid positive on 12-8-20 . Was recovered for approximately 2 weeks before I received the vaccine. Was told I could and should receive the vaccine.
57 2021-01-23 tremor Chills lead to severe shaking / seizure-like activity for approximately 1 hour. Condition abated af... Read more
Chills lead to severe shaking / seizure-like activity for approximately 1 hour. Condition abated after taking 1000 mg apap, 200 mg Motrin and 10 mg prednisone. This occurred about 12 hours post vaccine. Reaction preceded by brain fog.
57 2021-01-26 weakness Covid 19 symtoms (cough, difficult to breath, tiredness and weakness.
57 2021-01-26 unresponsive to stimuli, seizure like phenomena Systemic: Exhaustion, Systemic: described by the EMT as a vasovegal reaction. patient passed out and... Read more
Systemic: Exhaustion, Systemic: described by the EMT as a vasovegal reaction. patient passed out and had seizure like reactions. was unresposive and given epi pen. after EMT arrived, patient was monitored and allowed to leave; symptoms lasted 1 day
57 2021-01-27 tingling, numbness, weakness Too large dose injected. Bolus was 1ml. Initial metallic taste and mouth 15 min after injection. Num... Read more
Too large dose injected. Bolus was 1ml. Initial metallic taste and mouth 15 min after injection. Numbness, tingling, muscular weakness in the left arm radiating to fingers along C7 dermatome. Severe fevers, chills, mental confusion, muscular weakness, exquisite tenderness at injection site, severe fatigue. Had to leave work. Slept 12 hours. Lingering muscular pain and fatigue for 48 hours following injection.
57 2021-01-28 tenderness Armpit lymph node swelling and tender after vaccine. Submandibular and neck lymph node also swollen ... Read more
Armpit lymph node swelling and tender after vaccine. Submandibular and neck lymph node also swollen on left side, persisting for several days.
57 2021-02-01 weakness, muscle spasms Near-syncope - lightheaded, generalized weakness, thigh cramps beginning around 15' post vaccination... Read more
Near-syncope - lightheaded, generalized weakness, thigh cramps beginning around 15' post vaccination Was placed supine, BP transiently elevated Pt transported to emergency dept. where he felt better, vitals normalized, observed In ED pt denied any focal weakness
57 2021-02-03 tenderness tennis ball size lump under left arm, only tender; tennis ball size lump under left arm, only tender... Read more
tennis ball size lump under left arm, only tender; tennis ball size lump under left arm, only tender; This is a spontaneous report from a contactable other hcp (patient). A 57-year-old male patient received first dose of BNT162B2 (lot number: EK9231), intramuscular on 16Jan2021 12:00 at single dose in the left arm for COVID-19 immunization. Medical history included allergies to penicillin and environmental. Concomitant medication included allopurinol. The patient experienced tennis ball size lump under left arm, only tender on 17Jan2021 23:00. The patient did not receive any treatment for the event. 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 event was recovering.
57 2021-02-04 weakness weakness; chills; nausea; temp was 101.3/fever; swollen lymph nodes; This is a spontaneous report fr... Read more
weakness; chills; nausea; temp was 101.3/fever; swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration on left arm on 18Jan2021 19:45 at a single dose for COVID-19 immunization. The patient had no medical history. The patient had no known allergies. The patient received other vaccines within 4 weeks prior to the COVID vaccine including Whooping cough vaccine (Pertussis vaccine) on 11Dec2020 (dose number 1, left arm). On 19Jan2021 19:30, the patient had weakness, chills, nausea and his temperature (temp) was 101.3. He came home Wednesday from work at the 44th hour and had all symptoms "accept" (as reported) for swollen lymph nodes. Patient's fever broke 6 hours later at 22:00 (as reported) Wednesday night (on 20Jan2021, also reported as 50 hours after the injection), he slept all night comfortably, woke up with no issues and temp was 96.1 (21Jan2021). At the time of the report the patient felt fine. There was no treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event fever was recovered on 20Jan2021 and other events recovered in Jan2021.
57 2021-02-04 migraine migraine type headache, severe at times dizzy, felt like head was in a tunnel and unable to clear it... Read more
migraine type headache, severe at times dizzy, felt like head was in a tunnel and unable to clear it; migraine type headache, severe at times dizzy, felt like head was in a tunnel and unable to clear it; migraine type headache, severe at times dizzy, felt like head was in a tunnel and unable to clear it; This is a spontaneous report from a contactable 57-year-old male other health care professional reported for himself. A 57-years-old male patient started to receive second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284), via an unspecified route of administration at Left arm on 07Jan2021 at SINGLE DOSE for covid-19 immunization. Medical history included pinched nerve in left leg and kidney stones (recovered). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685) Intramuscular at Left arm on 17Dec2020 04:00 PM for covid-19 immunization. The patient experienced migraine type headache, severe at times dizzy, felt like head was in a tunnel and unable to clear it. it had been going on since second dose and got worse, not sure if can continue work. The event started on 08Jan2021 02:00 AM, no treatment received for the adverse events. The events were reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No allergies to medications, food, or other products. The outcome of the event was not recovered.
57 2021-02-04 pain in extremity sore arm; headache; This is a spontaneous report from a contactable pharmacist reporting for self's ... Read more
sore arm; headache; This is a spontaneous report from a contactable pharmacist reporting for self's father. A 57-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown as not available/provided to reporter at the time of report completion), intramuscular at left arm on 20Jan2021 14:30 at single dose for COVID-19 immunization at a Nursing Home. The patient's medical history included hypertension and increased blood cholesterol. For concomitant medications, there was no other vaccine in four weeks. The father experienced sore arm and headache on 20Jan2021 after his first dose vaccination. He was scheduled for 2nd dose on 10Feb2021. Overall, the father was fine with the vaccine. Treatment was received for the events included Tylenol. The outcome of the events was recovered (in Jan2021). The father had no COVID-19 prior to the vaccination. The father had tested post vaccination, included COVID-19 virus test (Nasal Swab) on an unspecified date: Negative. Information on the lot/batch number has been requested.
57 2021-02-05 pain in extremity Chills, strong pain in left arm and left shoulder, light headed, foggy thinking.
57 2021-02-07 weakness Stuffed nose, developed after 7 days; Nose became painful to touch; Light chills; light headache; la... Read more
Stuffed nose, developed after 7 days; Nose became painful to touch; Light chills; light headache; lack of strength; This is a spontaneous report from a contactable other hcp (patient himself). A 57-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. EL1284, expiry date not reported), via an unspecified route of administration on 08Jan2021 12:00 at a single dose on right arm for covid-19 immunization. Medical history included hay fever. Prior to vaccination patient was not diagnosed with Covid-19. Concomitant medication included melatonin taken within 2 weeks of vaccination on unspecified date for unspecified indication. On 15Jan2021 (also reported as 17Jan2021-pending clarification), it was reported that patient had stuffed nose, developed after 7 days of vaccination. Nose became painful to touch. Light chills, light headache and lack of strength. Patient received treatment of TYLENOL and decongestant. Since the vaccination the patient has been tested for Covid-19. On 11Jan2021, patient had PCR and nasal swab, and both were negative. The facility where the most recent Covid-19 vaccine administered was in a hospital. The outcome of events was recovering.
57 2021-02-10 muscle spasms On January 8, I started having a cramping feeling in my right calf. It went on throughout the day ... Read more
On January 8, I started having a cramping feeling in my right calf. It went on throughout the day without a event. I woke up the next morning, and the crap was worse. I ran some errands and came home and then looked at my calf of my leg and it was twice the size as my other leg. I had four spots of bruising from ankle to knee. I immediately went to the emergency room. I was hospitalized and had bloodwork and an MRI done which showed that I had a DVT and a pulmonary embolus in my right lung. I was hospitalized for two days on blood thinners. I had no shortness of breath or heart problems during this time. I was then released from the hospital on blood thinners which I have to take for the next six months.
57 2021-02-15 bell's palsy, facial paralysis Onset of Bell's Palsy; facial drooping on left side, sore behind left ear and down left side of neck... Read more
Onset of Bell's Palsy; facial drooping on left side, sore behind left ear and down left side of neck Prednisone 20 mg 3 times per day for 7 days; Valacyclovir 1 g 3 times per day for 7 days; Eye is not as inflamed as it was previously; Patient and his wife feel that symptoms are drastically improving as of this report which is 4 days after the onset of the Bell's Palsy
57 2021-02-19 numbness Numbness in the nose
57 2021-02-21 weakness, pain in extremity, feeling of insects crawling on skin, feeling of body temperature change, feeling hot, burning sensation Day after vaccine arm was very very sore, with a hard lump on arm at injection site. He states he fe... Read more
Day after vaccine arm was very very sore, with a hard lump on arm at injection site. He states he felt hot flashed and then cold flashes that continue to this day. States ' I feel like I have critters crawling up my skin starting at my legs and going through my body. Has headaches that start at the top of his head then pain radiates down the left side and then head feels very warm. At times he feels "like I am in a tunnel " and "everything slows down (mental/cognitive)" Continues s to this day to feel like there are "lumps within soft tissue areas on inner thigh, back and burning sensations. Chills on and off daily Exceptionally tired, no energy, feels drained. No changes in blood pressure
57 2021-02-28 muscle spasms This 57yo employee - reports he received his first Pfizer Covid vaccine on 1/13/2021 (Emergency resp... Read more
This 57yo employee - reports he received his first Pfizer Covid vaccine on 1/13/2021 (Emergency response provider). Approximately 3 hours post vaccination he c/o prickly stabbing itchy pain to vaccine site with left arm pain x 24 hours. He stated day 1 post vaccination the roof of his mouth, lips felt swollen and sensitive with a random frontal dull headache that lasted for a few seconds but noted on/off for 3 min duration a few times a day. He also reported a few days of altered sense of smell, especially to automotive products that has resolved. He states this prickly-itch stabbing pain varies all over his body, in his mouth, eyes, torso, extremities, again lasting a few seco
57 2021-03-03 weakness Had fever headache, dizziness, week and tired ness
57 2021-03-07 numbness, tingling, muscle spasms Numbness and tingling down my left arm to my middle and ring finger; Numbness and tingling down my l... Read more
Numbness and tingling down my left arm to my middle and ring finger; Numbness and tingling down my left arm to my middle and ring finger; Occasional thoracic spasms; chills; This is a spontaneous report received from a contactable consumer (patient). A 57-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELD26U, expiry date: unknown), via an unspecified route of administration in the left arm, on 05Feb2021 09:00, at single dose, for COVID-19 immunization, at a physician's office. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3303, expiry date: unknown) received at 57 years of age, via an unspecified route of administration in the left arm, on 15Jan2021 10:45, at single dose, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 06Feb2021 at 10:00, the patient experienced "numbness and tingling down my left arm to my middle and ring finger and occasional thoracic spasms and chills". It was unknown if treatment was provided. The outcome of the events was unknown. The reporter assessed the events as non-serious.
57 2021-03-09 impaired body coordination, slurring Miller Fisher syndrome, an acute inflammatory demyelinating polyneuropathy (GBS) variant. Acute ons... Read more
Miller Fisher syndrome, an acute inflammatory demyelinating polyneuropathy (GBS) variant. Acute onset of transient diplopia, and persistent dysarthria, ataxia, and areflexia starting approximately 1 week after vaccination. Patient was treated with IVIG, with good improvement in symptoms, allowing discharge home.
57 2021-03-11 cold sweat, feeling cold 5 minutes after receiving immunization he became confused and foggy, complained of being faint, fogg... Read more
5 minutes after receiving immunization he became confused and foggy, complained of being faint, foggy, and having issues with his cognitive processing, he was also cool and clammy. He stated that he was feeling light headed and dizzy. He was monitored for about 5 more minutes in the pod and his symptoms continued . He brought back to the observation area, vital signs 119/78, oxygen 92% on room air and heart rate 63. He was given apple juice and applesauce and his mask removed, he was also placed on a liter. He was continued to be observed and follow up vital signs were 125/85, heart rate 66 @ 0849. Patient skin was less clammy and patient reporting symptoms improved. patient was able to move to sitting and standing position without any issues he was escorted to the site exit without incident.
57 2021-03-11 feeling cold Pfizer-BioNTech COVID-19 Vaccine EUA. On Friday morning, at 6-7am, less than 24 hours from the time... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA. On Friday morning, at 6-7am, less than 24 hours from the time I received my vaccination, I was experiencing chills and could not get warm. I tried to go to work...well, I did go to work. When it became apparent that I was not going to get warm, I left work. When I got home, my wife made me breakfast between 8:30 & 9:00am. After i eat, I slept under a sheet and two blankets...fully dressed for 5 hours. When I came to, it was the first time all day that I felt some warmth.
57 2021-03-11 tingling, flushing tingling of tongue and feet, high spike in blood pressure (208/127), red flushed face and neck, dizz... Read more
tingling of tongue and feet, high spike in blood pressure (208/127), red flushed face and neck, dizziness and light headedness, increase in heart rate.
57 2021-03-12 weakness, feeling cold From Dose on Thur 11:30am, became extremely fatigued around hour 4. Hour 12 - I had on and off agai... Read more
From Dose on Thur 11:30am, became extremely fatigued around hour 4. Hour 12 - I had on and off again shivering chills for about 45 minutes. Hour 20 - I had sever body aches and overall weakness when I woke up the next day around 7-8am. The body aches continued for about 6-8 hours. The weakness continued for another few hours. No symptoms around hour 32 (7-8pm) on Friday.
57 2021-03-12 weakness Headache, muscle pain, weakness, tiredness, feverish feelings, general malaise
57 2021-03-12 seizure I experienced a seizure the next day...broke my foot during seizure
57 2021-03-14 feeling cold, depressed level of consciousness, tremor PRESENTING PROBLEM: Syncope and collapse [R55] HOSPITAL COURSE: History of Present Illness: 57-ye... Read more
PRESENTING PROBLEM: Syncope and collapse [R55] HOSPITAL COURSE: History of Present Illness: 57-year-old man known to me for bilateral lung transplant for bronchoalveolar cell carcinoma complicated by bilateral pleural effusions of unknown etiology and mild decrease in pulmonary mechanics, DVT on Eliquis who came to the Emergency Room 3/12/21 with a chief complaint of near syncope. Patient and woke up in the early morning hours of 3/12/21 to use the restroom. While urinating, he became very dizzy and nauseated and had a sense like he needed to lay down to rest. Other than nausea he did not have any other symptoms. He returned to his bed and fell upon his wife and had decreased level of consciousness but without total loss of consciousness (he was able to hear his wife talking to him but was unable to respond). This lasted about a minute and slowly he came back to his senses. After this he felt quite cold and did have some shaking but is not clear whether these were true rigors. He did not have any preceding fevers nor did he have any fevers in the emergency room. After about 5-10 minutes he was feeling back to his normal self but want to come into the hospital to get checked out. He has never had anything like this before.The patient has had chest pressure since his COVID vaccine which he had on Wednesday. This is been intermittent, mostly positional and better with laying on his side and leaning forward, worse with recumbency. It is not pleuritic in nature. No associated shortness of breath. No other fevers chills sweats. No sick contacts. Evaluation in the emergency room was done and a CT scan was done and no pulmonary embolus was found. No parenchymal abnormalities. The patient's pleural effusions remain, and her mildly worsened, personally reviewed. Baseline labs were unremarkable for anemia, kidney injury.EKG personally reviewed, normal sinus rhythm. High sensitivity troponin was done and negative. Family otherwise feels well, no sick contacts, eating well no nausea vomiting diarrhea blood in his stool. Pt admitted for observation. Continued to feel well VSS, ekg stable, ECHO without acute findings (see below), UA neg, cardiac monitoring uneventful, orthostatics negative, walking in halls and eating well. Appears to have had vaso vagal episode. Will be getting routine head imaging in the coming month with cancer history See below testing Care plan upon discharge > To call if any return of symptoms > To hold metformin until Monday due to recent dye load > Blood cultures Pending, low clinical suspicion > To change H2 blocker to PPI due to GERD on 3 month esophagram > Follow up in clinic when return from break > Dr discussing with pulmonary team most recent CT (see below) and treatment plan moving forward Brief exam: awake, alert, oriented, not in any distress. PERRL, EMOI, tongue midline. Upper and lower extremities at full strength 5/5 in the arms, hands, dorsi flex and flexion at the ankles, knees and legs. Sensation not tested. Brief history and medical decision making: s/p bilateral lung transplant for bronchoalveolar cell carcinoma complicated by bilateral loculated pleural effusion, DVT on eliquis presenting post syncopal event. Syncopal event without evidence of seizure like activity, fast recovery, and no sudden changes consistent with an acute cardiac event. Thus symptoms were likely due to vasovagal event possibly post COVID_19 related side effect (headache, achy muscles, not feeling well overall). He has no neurologic deficit, CTA thorax without PE, negative EKG, troponin and echocardiogram. He is not on antihypertensives and blood pressures have been normal. Given his initial diagnosis of BAC, there may be concern for metastatic disease, though symptoms have not persisted and he has no focal deficit. He also received contrast for his CTA today, thus will defer further imaging for now. Syncope: - defer 2nd dose of COVID-19 vaccine as its effectiveness in transplant patient is not established and patient potentially had an adverse event. - oral hydration encouraged - monitor for additional ongoing neurologic symptoms such as headaches, vision changes, neck stiffness, fevers, night sweats, weight loss, weakness or paraesthesias - patient advised to avoid driving until further evaluation - consider MRI brain with and without contrast if any symptoms persist or reoccur Complex loculated pleural effusion
57 2021-03-14 flushing Experienced a delayed reaction to vaccine that occurred at 11 p. m. Administration was at 8:23 a. m... Read more
Experienced a delayed reaction to vaccine that occurred at 11 p. m. Administration was at 8:23 a. m. earlier in the day. Symptoms began as build up of mucous in back of throat and reflux. Very early the next morning symptoms progressed to near inability to swallow, Took 50 mg of Benadryl which gave a bit of relief. Very hard to drink the water and get it down with the two pills. The symptoms included swollen lips and inside of the mouth swelling. Went to the emergency room at the Clinic at 7:30 a. m. I was given 60 mg of Prednisone, Pepsid to coat the stomach re the steroids. Was sent home with prescription for epi pen, medrol dose pack, Pepsid and Zyrtec. Symptoms improved except for swelling of lips. However, on 3/11/21, despite taking the medication, the symptoms worsened in terms of renewed lip swell as well as new symptoms of facial flushing and chest flushing. Symptoms then abated with medication. On 3/13/21, symptoms flared again with renewed lip swelling, inside and outside check swelling and outside face and chest flushing. They they abated again with medication. On 3/14/21, lip swelling renewed as a symptom. To date, my lips do not feel right but tingly and bloated and irritated. Saw an allergist this morning who thinks I am allergic to polyglycol a preservative in the vaccine.
57 2021-03-16 pain in extremity 3/12/21 I began to experience soreness in both my legs. 3/13/21 I began to experience swelling in b... Read more
3/12/21 I began to experience soreness in both my legs. 3/13/21 I began to experience swelling in both my knees, but primarily in my left knee and leg. 3/14/21 I could barely bend my left knee, but there were no issues with my right knee. By 3/16/21 some of the swelling had gone down on my left knee. As of today 3/17/21 I still have some swelling in my left knee and lower leg.
57 2021-03-18 muscle spasms Back muscle tighten/spasm 20 minutes after vaccination shot
57 2021-03-19 seizure, unresponsive to stimuli Seizure (staring, unresponsive to verbal stimuli) started approx. 5 min post vaccination.
57 2021-03-21 feeling cold Fever - 101, chills and dizziness. Rotating Tylenol and Motrin every 6 hours. Was seen by primary c... Read more
Fever - 101, chills and dizziness. Rotating Tylenol and Motrin every 6 hours. Was seen by primary care physician.
57 2021-03-21 pain in extremity I had my first vaccine on the 3/9/2021 Pfizer - Biontech ENG199 and am scheduled to have the second ... Read more
I had my first vaccine on the 3/9/2021 Pfizer - Biontech ENG199 and am scheduled to have the second injection on the 3/30/2021 I had a slight arm pain 5 hours after the injection that wen away after 30 hours However on 3/15/2021 I had began to experience a stiff neck on the left side (I had the injection on the left side) Later on the evening of the 3/19/2021 I began to experience pressure in the left ear which is still persistant today. I really never had these issues before is this from the vaccine? What should I do?
57 2021-03-22 numbness Roof of mouth swelling, soft pallet swelling (@10 minutes),right side of upper scalp went numb (@20 ... Read more
Roof of mouth swelling, soft pallet swelling (@10 minutes),right side of upper scalp went numb (@20 mins) spreading to brow ridge -right side then spreading to left upper lip swelling (@30 mins). tongue and throat @40mins. Epipen given, swelling improved within a minute observed for 4 hours then released
57 2021-03-22 numbness and pain in extremities Joint pain; lower back pain; bowel issues; stomach issues; chills; severe neuropathy attack/both fee... Read more
Joint pain; lower back pain; bowel issues; stomach issues; chills; severe neuropathy attack/both feet were on fire when with proper medication, he has been under control for years; This is a spontaneous report from a contactable consumer. A 57-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date: unknown), via an unspecified route of administration in the left arm on 05Mar2021 at 15:45 at a single dose for COVID-19 immunization. Medical history included gout, neuropathy, high cholesterol and heart disease with 4 heart 'stints' and known allergies to dairy. Concomitant medications included colchicine (COLCHICINE), gabapentin (GABAPENTIN), acetylsalicylic acid (ASPRIN). The patient had no other vaccine in four weeks. The patient previously took and had allergies with Cipro [ciprofloxacin] and Erythromycin. It was reported that 20 hours plus after the shot, on 06Mar2021 at 13:15, the patient experienced the most severe neuropathy attack of his life - both feet were on fire when with proper medication, he has been under control for years. The patient also reported joint pain, lower back pain, bowel and stomach issues and chills on 06Mar2021 at 21:15. The patient had no COVID prior to the vaccination and had not tested post vaccination. No treatment administered for the events. The events had not resolved. Information on the lot/batch number has been requested.
57 2021-03-23 pain in extremity left arm soreness has continued since first immunization received on 2/14/2021, as well as since 2nd... Read more
left arm soreness has continued since first immunization received on 2/14/2021, as well as since 2nd immunization on 3/7/2021. Although mild in most positions, it is painful when I attempt to extend my arm laterally in an upward direction. The discomfort is mild under most circumstances, but is quite painful when, and only when, my arm is extended in the aforementioned manner. It has not required medication, and has not required me to seek medical attention. It has been persistent, and the severity has neither increased nor decreased. I've simply adjusted my range of motion to avoid those positions that elicit the pain. I would have expected the pain to gradually lessen, but it is not doing so. I suspect that there may be others experiencing the same side effect, so I want to report it.
57 2021-03-24 muscle spasms Symptoms started with frequent urination night of receiving vaccine(got up at least 4-5 times in the... Read more
Symptoms started with frequent urination night of receiving vaccine(got up at least 4-5 times in the middle of the night to pee, felt like I couldnt get it all out.), cramping in the bladder area, blood in the urine(pink urine). Little cramping but not urinating blood for now Drank a lot of water and went away This more than likely unrelated. The next step you would need to take is to go to your primary care physician to get checked, if you have any updates on this please give us a call.
57 2021-03-24 pain in extremity Arm hurt really bad; Little bit of fever; Little bit of body aches; vitamin D deficiency; stage 4 ch... Read more
Arm hurt really bad; Little bit of fever; Little bit of body aches; vitamin D deficiency; stage 4 chronic kidney disease; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 57-years-old via an unspecified route of administration, administered in arm left on 23Feb2021 10:30 (Batch/Lot Number: EL9267, expiry date not reported) as single dose for covid-19 immunisation. Medical history included ongoing diabetic, heart patient from 2005 and ongoing, cardiomyopathy from 2005 and ongoing, covid-19 from 14Jan2021 to an unknown date. The patient's concomitant medications were not reported. The reporter reported that her husband (patient) was diagnosed 2 days ago with a vitamin D deficiency and diagnosed at the end of last week with stage 4 chronic kidney disease. The patient just started on his Vitamin D pill until yesterday. He didn't know he was lacking Vitamin D until the doctor found out. She wants to know if her husband should go ahead and get the second vaccine tomorrow or should he wait a week and let the Vitamin D pill kick in. It was also reported that the patient's arm started hurting about 5 or 6 hours later after getting the shot on 23Feb2021. The next day, it felt really bad. The patient also had a little bit of fever and body aches on 23Feb2021. The patient had a bunch of labs done and is going back again on 25Mar2021 to have another extensive tests done. It was clarified that it was for the chronic kidney disease and this was also when he found out he had the vitamin D Deficiency. The patient is also getting an ultrasound done on his kidneys to see what is going on. Therapeutic measure were taken as a result of vitamin D deficiency which included treatment with vitamin D pill and for little bit of fever and body aches which included Tylenol PM. The patient did not recover from stage 4 chronic kidney disease and vitamin D deficiency, recovered from arm hurt really bad and little bit of body aches on 25Feb2021, a little bit of fever on 24Feb2021.
57 2021-03-24 tingling, flushing Hives appeared about 15 minutes after injection - tingly & slightly itchy skin, feeling flush, hands... Read more
Hives appeared about 15 minutes after injection - tingly & slightly itchy skin, feeling flush, hands slightly red. Symptoms lasted about 24 hours.
57 2021-03-26 weakness Nausea with slight chills and sweating the next morning. Fatigue and low energy with body aches for... Read more
Nausea with slight chills and sweating the next morning. Fatigue and low energy with body aches for 12-16 hours after.
57 2021-03-26 tremor Dizziness. Severe at times, especially when moving. Nausea. Weakness, very shaky. Onsite nurses an... Read more
Dizziness. Severe at times, especially when moving. Nausea. Weakness, very shaky. Onsite nurses and doctor gave me water, peanut butter crackers, and a juice box. No change. BP elevated, 157/109 p:98 O2s: 99 on site. Transferred to the Hospital via ambulance. After 2-3 hours, dizziness began to resolve. Doctor ordered blood tests and IV fluids, 1L.
57 2021-03-29 feeling hot is a 57 y.o. male who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 ... Read more
is a 57 y.o. male who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER8734 on 3/30/2021. The patient experienced the following reaction(s) during the immediate of observation: PT reports feeling "warm" Patient was treated/managed as follows: Vitals were taken and are as follows: 1249: BP- 132/84 HR: 54 RR 18 O2 sat- 97% RA Pt reports symptoms are the same. Water offered. VS retaken 1300: BP- 128/82 HR: 54 RR: 18 O2: 98% Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt escorted to car at 1308 by wife.
57 2021-03-29 pain in extremity Arm pain immediately at injection. Whole arm to fingers. Bad metallic taste in mouth. Water also ... Read more
Arm pain immediately at injection. Whole arm to fingers. Bad metallic taste in mouth. Water also tastes different. Arm pain is moderate to accute. Not resolved 6 hrs post vaccine.
57 2021-03-29 pain in extremity After both doses, I could not sleep well the night after. I had no other adverse reactions, other th... Read more
After both doses, I could not sleep well the night after. I had no other adverse reactions, other that a sore arm.
57 2021-03-29 tingling Client stated that the injection of the vaccine stung and shortly after his arm began to itch and fe... Read more
Client stated that the injection of the vaccine stung and shortly after his arm began to itch and feel tingly. Nurse applied an ice pack to site and gave client 25mg benadryl the injection site was also red at this time. About 5 min after Benadryl was taken, client stated that itchiness had improved. Denied shortness of breath, and dizziness. Nurse observed that redness of site was improved. Client released to leave via personal vehicle by RN.
57 2021-03-29 tenderness Persistent sore throat, right side, not inside esophagus, tender/sore when swallow and when pressed,... Read more
Persistent sore throat, right side, not inside esophagus, tender/sore when swallow and when pressed, lymph node area Tylenol little effect
57 2021-03-29 unresponsive to stimuli Per ED Provider Report, the patient collapsed while outside on 3/25/21. Ambulance was called to the ... Read more
Per ED Provider Report, the patient collapsed while outside on 3/25/21. Ambulance was called to the scene where patient was found unresponsive. Patient was transferred to Hospital. Patient was in full cardiac arrest upon arrival. CPR was initiated. Patient deceased. Patient's mother stated the patient had been feeling badly for 2-days, but refused to seek medical treatment.
57 2021-03-30 cold sweat, weakness Patient felt dizzy and felt like passing out. V.S. taken Pulse 42, became clammy, diaphoretic, and v... Read more
Patient felt dizzy and felt like passing out. V.S. taken Pulse 42, became clammy, diaphoretic, and very weak. Rapid Response called, patient to the Emergency Room.
57 2021-03-31 pain in extremity Blood clot/very large blood clot from his thigh to his calf; Joint pain; chills; he can't even walk ... Read more
Blood clot/very large blood clot from his thigh to his calf; Joint pain; chills; he can't even walk now; leg pain; This is a spontaneous report received from a contactable consumer (patient's wife). A 57-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6202), via an unspecified route of administration, on 25Feb2021 (at the age of 57-years-old), at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The consumer stated she's asking on behalf of her husband. He received his first dose of Pfizer-BioNTech COVID-19 Vaccine on 25Feb2021 and had Joint pain and chills after that (on unspecified date in 2021) he was diagnosed with Blood clot (unspecified date in 2021); she stated he had no history of similar health issues and wanted to know if it could be directly linked to this vaccine. The wife further reported that it's dramatically changing his life, he can't even walk now. He had the Covid vaccine on 25Feb2021 and he has no history of blood clots. He developed a leg pain (on unspecified date in 2021) which was odd and they thought that maybe it was some arthritis or something like that. They went to the orthopedist and he was being treated for what the orthopedist thought was a bakers cyst. But then they discovered it was a very large blood clot from his thigh to his calf. They would like to know about this. They have been looking into what he had experienced, and it seems very unusual. It just seems too coincidental that this happened after the Covid vaccine. The emergency room doctor of course shut them down immediately and said that the Covid vaccine never would have done this. But the patient's doctor yesterday said that there are too many unknowns to say for sure that the Covid vaccine didn't cause this. She is not saying that they are against the Covid vaccine, but they are concerned. The patient is on blood thinners now and they just need to know if there is a possible correlation. She had heard on the world news that there is a connection after receiving the (company name) Covid vaccine and now they are shutting this vaccine down in (region name). She saw on the news last night they were asking if there is a correlation with the Pfizer and (company name) Covid vaccines and this. It is very concerning. They have been trying to do research and there is nothing that you can find. The only thing that they did see online was about the doctor that died of a blood disorder in (state name), he had thrombocytopenia. The patient is going to be sent to see a vein doctor. She stated that he has a lot of things ahead of him and he is too young to be dealing with all of this. They are going to be following up with the vein doctor and she would like to have this information when the vein doctor calls later today. The reported adverse events resulted to an emergency room and physician office visit (went to the orthopedist). The patient received corrective treatment as response to the reported events. Outcome of the events was unknown.
57 2021-04-01 muscle spasms My Husband has a swollen lymph node on his left armpit the size of a golf ball or larger. He is expe... Read more
My Husband has a swollen lymph node on his left armpit the size of a golf ball or larger. He is experiencing cramping all over his body but especially his legs. He has a terrible headache, feels nautious and dizzy. Today has been the worst. This is day 3 after the Pfizer shot. The internet says it is normal for the lymph node in about 14% of patients. Your flyer handed out at injection day didn't mention all of this.
57 2021-04-01 night sweats headache, sore muscles, chills, night sweats for approx 24 hrs
57 2021-04-01 pain in extremity vaccine was administered on Monday afternoon. arm soreness started Monday evening. symptoms: arm sor... Read more
vaccine was administered on Monday afternoon. arm soreness started Monday evening. symptoms: arm soreness, full body aches, chills, fever of 102, lymph nodes swollen the size of a racquetball, headache. all symptoms peaked in severity on Wednesday. improved on Thursday. resolved by Friday.
57 2021-04-01 seizure patient was in 15 minute observation when nurses witnessed patient seizing. patient was on floor, p... Read more
patient was in 15 minute observation when nurses witnessed patient seizing. patient was on floor, pulse and respiration was monitored. pulse diminished ; oxygen was administrated, CPR started AED applied patient shocked and transported to ER
57 2021-04-02 inability to speak Lethargy, erythema at site, fever to 104.2, loss of ability to stand or walk, confusion, reduction i... Read more
Lethargy, erythema at site, fever to 104.2, loss of ability to stand or walk, confusion, reduction in speech ability. Symptoms started during the evening of 3/30/21 after vaccination. PCP was contacted on 3/31/21 and we were told the effects would only last 48 hours. Fever was reduced with Acetaminophen 1000 mg q6h x 2 doses, oral fluids, and icing the axillary. 911 was called on 4/1/21 when pt lost ability to stand and and was minimally vocal but alert. Pt was hospitalized and remains in that situation at this time.
57 2021-04-02 flushing a few minutes after injection patient began to feel flush in the face, soon followed by hives neck, ... Read more
a few minutes after injection patient began to feel flush in the face, soon followed by hives neck, chest, abd. complained at that time of tight breathing, epipen delivered and patient further observed by ems
57 2021-04-02 night sweats Ive had significant night sweats waking up with the bed and sheets soaked and subsequent feeling col... Read more
Ive had significant night sweats waking up with the bed and sheets soaked and subsequent feeling cold from the wet bed. I have not monitored completely but it seems I?ve had some degree of this sequelae in varying degree of sweating every night for the week since I was vaccinated. I don?t feel sick but feel slightly more tired than usual. I cycle on average 5-6 days a week riding 15 miles a day. On off days I walk for 3 miles. My health is generally good.
57 2021-04-02 tingling, numbness Facial numbness and tingling in addition to lip and tongue swelling. Left eyelid became droopy. Swel... Read more
Facial numbness and tingling in addition to lip and tongue swelling. Left eyelid became droopy. Swelling did not obstruct airway.
57 2021-04-04 facial paralysis, face paralysis, bell's palsy Patient reports Bell's Palsy in face following vaccination. Has continued for days since vaccine and... Read more
Patient reports Bell's Palsy in face following vaccination. Has continued for days since vaccine and was still unresolved as of Thursday 4/1/2021. Unsure at this point if resolved. Reports facial weakness and drooping.
57 2021-04-06 slurring, numbness, facial paralysis About 7 - 8 days after the vaccination, the patient began experiencing numbness in his chin that cam... Read more
About 7 - 8 days after the vaccination, the patient began experiencing numbness in his chin that came and went. By Friday, April 2, the patient began experiencing left side numbness and droopiness in his face, had slurred speech and increased blood pressure. Patient thought he was having a stroke, so wife took him to the ER. All lab work and medical tests came back normal. The patient has an appointment with their family doctor on 4/8 and an appointment with a neurologist next month.
57 2021-04-06 pain in extremity Pain, swelling, and redness right calf for 2 days. Diagnosed with acute DVT.
57 2021-04-06 tingling Stomach felt queesy and then my face began to tingle and feel very strange. This lasted about 2 hou... Read more
Stomach felt queesy and then my face began to tingle and feel very strange. This lasted about 2 hours and then went away. I went to bed and slept it off and have not had any other affects.
57 2021-04-06 tingling Paresthesia within a minute, but only in right fingers at first. Then within the hour the left fin... Read more
Paresthesia within a minute, but only in right fingers at first. Then within the hour the left fingers had the effect. This sensation went on and off for about 5 days and after the first day began to include both feet. After a week it seemed to resolve, however, at the 2 weeks and 1 day point, paresthesia returned stronger, in both hands and forearms, both feet and lower leg starting at around 12:30pm on 4/7/21. It continues at this writing which is 9:00pm on 4/7/21. The sensation is more severe than the first week and not intermittent this time.
57 2021-04-07 flushing After receiving the vaccine and waiting the 15min, I left the vaccination site and headed home in my... Read more
After receiving the vaccine and waiting the 15min, I left the vaccination site and headed home in my vehicle. After about 10 to 15 mins I encountered a metallic taste in my mouth and my mouth almost felt as though it was vibrating almost like a surging feeling. I then became flushed in the face and my tongue felt odd as if it was swelling. My throat became dry. I waiting five more minutes and decided to take the next exit off of I87 and drove directly to a urgent care center. Upon arrival I sat in my car for 20 more minutes to see if my symptoms would pass and they did. I did not need to enter into the urgent care facility. I have not had any other symptoms since this event.
57 2021-04-07 flushing Rash, itching, hives. Started in groin area, then moved to triceps, then on both sides of trunk, th... Read more
Rash, itching, hives. Started in groin area, then moved to triceps, then on both sides of trunk, then behind knees. Redness and flushing of face but no swelling/rash/hives/itching. As rash has subsided, low grade fever came on (100 degrees F).
57 2021-04-07 muscle spasms Adverse events I?m all pissed off. cramps all over my body legs arms hands both sides of my rib cage... Read more
Adverse events I?m all pissed off. cramps all over my body legs arms hands both sides of my rib cage neck I?m sick fatigued the runs just yesterday and Today
57 2021-04-07 tingling all body tingling, foggy mind, unable to fully focus eyes, SOB and pain in lungs. Gave benadryl 25mg... Read more
all body tingling, foggy mind, unable to fully focus eyes, SOB and pain in lungs. Gave benadryl 25mg. and monitored. Resolved 70 minutes following start.
57 2021-04-08 feeling hot Redness, slight-swelling, warmth, and pain in left knee. No previous injury, diagnosed RA, or other... Read more
Redness, slight-swelling, warmth, and pain in left knee. No previous injury, diagnosed RA, or other known issue with left knee. Mentioned to physician during routine check-up, but he made no recommendations. Knee no longer swollen, red, or warm, but is tender when pressure is applied.
57 2021-04-09 pain in extremity pain in left leg calf, left side of chest DVT and PE 2 visits to Urgent Care Lovenox and Pradaxa
57 2021-04-09 pain in extremity Sore Left Arm day/night of injection resolved next day Extreme Fatigue day of and next day after in... Read more
Sore Left Arm day/night of injection resolved next day Extreme Fatigue day of and next day after injection resolved third day
57 2021-04-09 tingling Fever (103) and chills for 12 hours, myalgia (arms, shoulders, gluts, quads), arthralgia and parasth... Read more
Fever (103) and chills for 12 hours, myalgia (arms, shoulders, gluts, quads), arthralgia and parasthesia in right hand.
57 2021-04-10 weakness, discomfort Low grade fever Significant body discomfort Weakness
57 2021-04-11 feeling cold Fever, body aches,cold chills
57 2021-04-12 feeling cold My face and lips feel frozen. This has been ongoing since the evening of the vaccination. The best... Read more
My face and lips feel frozen. This has been ongoing since the evening of the vaccination. The best way to describe the feeling is that it feels like your face feels when you put soap on it before you rinse it off...it feels tight.
57 2021-04-12 pain in extremity, burning sensation I had my first Covid vaccine (Pfizer - Lot ER2613) on March 17. No issues other than a soar arm the... Read more
I had my first Covid vaccine (Pfizer - Lot ER2613) on March 17. No issues other than a soar arm the next day. In fact, I went on a hard 7 mile run the next day as part of my normal training routine (currently training for a half Marathon.) This past Thursday, April 8, at 6:00 pm EST, I had my 2nd shot (Lot EW0161). For about the next 18 hours, I was fine other than the arm being a little sore in the morning. Late in the morning I noticed my back was getting very stiff and a bit sore when I moved around. I have a desk job and spend a lot of time in front of the computer, but I normally stretch and move throughout most days, so I don?t have many back issues. This was a bit worse than normal. Usually, when I feel something like this, my go to remedy is an easy run. I had a 5 mile easy run planned for that day, so later in the afternoon, after some dynamic stretching, I went for a run. As I started, I felt some of the worse back pain I could remember and stopped running after about 50 yards. I stretched a little more, questioning if I should continue, but decided that movement would be better than doing nothing. I started running again and although the first mile was much more uncomfortable and painful than normal, I continued on for the 5 miles with everything eventually loosening up as the blood starting flowing. I felt pretty good the rest of the day and into the evening. In the middle of the night, I awoke numerous times with a bad ache in my back, which is very unusual for me. I tossed and turned all night from side to side, from front to back but could not stop the burn and pain in my lower back. I took 2 Advil, but that did little to help. I got out of bed about an hour earlier than normal and after a little light stretching, my back felt fine again. I went for my weekly long 14 mile run an hour later and everything was good again and for the rest of the day. The next 3 days / nights have been similar. I continue waking each night with a burning and aching in my lower back and it continues all night long. Once I stand up, get out of bed and start moving around, the pain and burning go away almost immediately. I?ve never felt anything like this before. I?m 57, male, am very healthy and fit (aiming for a 1:30 half marathon in 10 days.) Never had issues with sleeping before this and haven?t experienced any back pain in a very long time. I can?t think of anything I?ve done recently to trigger this other than the coincidence of the 2nd Pfizer vaccine shot.
57 2021-04-12 tingling Woke up in the middle of the night twice with Tingling in my finger tips even though I was sleeping... Read more
Woke up in the middle of the night twice with Tingling in my finger tips even though I was sleeping on my back and not having any pressure on my arms like you would normally experience if your arm fell asleep? This happened again last night . After waking and moving my hands and fingers the tingling stopped.
57 2021-04-13 tingling, numbness Blood Clot-Bad swelling in right arm. Arm tingling, numbness and discolored. Arm is swollen from top... Read more
Blood Clot-Bad swelling in right arm. Arm tingling, numbness and discolored. Arm is swollen from top of arm to fingers. Notice first sign on Monday morning (04/12/2021) when i awoke from bed around 7:00am.
57 2021-04-13 tingling, pain in extremity *Pfizer-BioNTech COVID-19 vACCINE eua, Patient complained of pain and tingling starting 7 days post... Read more
*Pfizer-BioNTech COVID-19 vACCINE eua, Patient complained of pain and tingling starting 7 days post vaccination from the knees down to the bottom of the feet. The pain and tingling in his feet is most severe. The pain wakes him up at night during sleep to the point that he is unable to fall back asleep, and the pain and tingling is still there when he wakes . The tingling and pain is not noticeable once the patient is working, and once he wakes he still has the symptoms, but it is not as bad as it is during the night. He had not experienced this pain or tingling ever before having the vaccination.
57 2021-04-15 bell's palsy, facial paralysis Developed right facial eyebrow sagging, inability to close eye, disappearance nasolabial fold, droop... Read more
Developed right facial eyebrow sagging, inability to close eye, disappearance nasolabial fold, drooping corner mouth, and decreased tearing; onset 4/8/21; diagnosed with right Bells Palsy
57 2021-04-15 numbness Several hours after receiving the 2nd shot I notice the right side of my mouth, lip, and down toward... Read more
Several hours after receiving the 2nd shot I notice the right side of my mouth, lip, and down towards my chin started feeling numb. I thought prehaps the next day or 2 my feeling would return and the numbness would be gone. It's now 4/16/21 and the numbness is still there.
57 2021-04-16 weakness Fever, headache, body aches, joint aches, weakness, chills. abdomen pain, severe trembling. Had sho... Read more
Fever, headache, body aches, joint aches, weakness, chills. abdomen pain, severe trembling. Had shot at 4:30pm, woke up the next morning at 6 am and symptoms were there. They got worse during the day. Had issues getting fever down. In the evening was able to break fever and was able to eat. Now second day since injection only have a headache and fatigue.
57 2021-04-17 inability to speak Pt developed fever as high as 104.2; confusion, inability to form sentences; restlessness; inability... Read more
Pt developed fever as high as 104.2; confusion, inability to form sentences; restlessness; inability to ambulate.; inability to form sentence; This is a spontaneous report from a contactable nurse. A 57-year-old male patient received the first dose of BNT162B2 (lot no. and expiry date were unknown), via an unspecified route of administration, administered in right arm on 30Mar2021 (at the age of 57-year-old) as single dose for COVID-19 immunization. Medical history included Cancer Stage 4 - renal with mets. The patient's concomitant medications were not reported. The patient previously took ciprofloxacin (CIPRO) and sulfamethoxazole, trimethoprim (BACTRIM) in which he experienced allergies to both drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Mar2021, the patient developed fever as high as 104.2, confusion, inability to form sentences, restlessness, and inability to ambulate. He was hospitalized on unspecified date due to the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient had nasal swab on 01Apr2021 with negative result. The outcome of the events was not recovered. Information on lot/batch number has been requested.; Sender's Comments: The information currently available is extremely limited and does not allow a meaningful case assessment. However, based solely on an implied temporal association, a causal relationship between events fever,confusion,aphasia,movementdisorder adverse events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The case will be reevaluated should additional information become 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.
57 2021-04-18 weakness, cold extremities Immediately upon being vaccinated, the patient felt weak, tachycardic, and had chills and nausea. He... Read more
Immediately upon being vaccinated, the patient felt weak, tachycardic, and had chills and nausea. He was observed for 20 minutes, at which time his symptoms abated and he left the vaccination facility. However, his symptoms returned later in the day. He presented to our office 15 days after vaccination. At that point, he was suffering coldness in his extremities with peripheral cyanosis of hands, feet, and nose. He reported chest pain and had an abnormal EKG with ST depressions in several leads. He stated that over the past two weeks, his symptoms would come and go, lasting for hours at a time and constituting weakness, extreme fatigue, cold extremities, and body aches.
57 2021-04-18 discomfort Started with a bad headache that wouldn't go away. Then heavy pressure over my eyes, and feeling ver... Read more
Started with a bad headache that wouldn't go away. Then heavy pressure over my eyes, and feeling very tired. Symptoms went away for a few days, then returned. Got tested for COVID-19, with a PCR lab test, and the results were positive.
57 2021-04-18 facial paralysis Had a blood clot and a stroke and blind in right eye, and some paralysis in face. Happened day after... Read more
Had a blood clot and a stroke and blind in right eye, and some paralysis in face. Happened day after first vaccine.
57 2021-04-19 cold sweat After 8 minutes I broke out in a cold sweat and immediately passed out for 30-45 seconds. I woke up ... Read more
After 8 minutes I broke out in a cold sweat and immediately passed out for 30-45 seconds. I woke up laying on my back not knowing how I got there.
57 2021-04-20 bell's palsy Bell's Palsy; This is a spontaneous report from a contactable consumer. A 57-year-old male patient r... Read more
Bell's Palsy; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 01:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included ADHD, depression, High Blood Pressure, high cholesterol, Allergies to medications, food, or other products:Penicillin. Concomitant medications included losartan (LOSARTAN); paroxetine hydrochloride (PAXIL CR); atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); all taken for unspecified indications, start and stop dates were not reported. On 04Apr2021 12:00, the patient experienced Bell's Palsy. The patient did not receive treatment for the event. The outcome of the event was not recovered. Information about batch/lot number has been requested.
57 2021-04-20 discomfort Slight discomfort in left arm injection site by 6PM and went to bed 9:30PM. Woke up 12:30AM with ch... Read more
Slight discomfort in left arm injection site by 6PM and went to bed 9:30PM. Woke up 12:30AM with chills and did not sleep well for the remainder of night. Got up 5:30AM ate something and had some coffee. What was noticeable initially was fatigue, followed by chills. My temperature was 99.2 and 99.4. I never took any medication until going to bed. I reported in sick to work and went back to bed for 4 hours approximately. I felt bad all day even as I went to bed.(chills and very fatigued). I tried to keep very warm and took Tylenol PM to sleep. 100% recovery 1 day later
57 2021-04-20 numbness, tingling patient received Pfizer covid vaccine on 4/12. On 4/13 patient presented to ER with purple fingers ... Read more
patient received Pfizer covid vaccine on 4/12. On 4/13 patient presented to ER with purple fingers and toes. bilateral feet numb and tingling. patient admitted to hospital. by morning 4/14 patien resp status declined, ciwa score 15, afib rvr, ams, low bp. septic shock. source unclear.
57 2021-04-20 pain in extremity Severe Flare-up of joint pain in ankles, knees, shoulders, elbows, wrist, & hands. Treating with pr... Read more
Severe Flare-up of joint pain in ankles, knees, shoulders, elbows, wrist, & hands. Treating with prednisone 5mg tablet daily and at night before bed, also Equate 8 hr arthritus pain relief, 650mg, 1 tablet up to twice a day.
57 2021-04-21 feeling cold Severe cold chills, headache, entire body is sore
57 2021-04-21 flushing 1545 TO NSG DESK POST INJECTION. COMPLAIN OF FEELING FLUSHED AND LIGHT HEADED. PT ASSISTED TO STRETC... Read more
1545 TO NSG DESK POST INJECTION. COMPLAIN OF FEELING FLUSHED AND LIGHT HEADED. PT ASSISTED TO STRETCHER.BP 143/110 HR 134 DENIES SOB, NO RASH NOTED. PT WITH NO OTHER COMPLAINTS 1550 BP 156/92 HR 140, ENCOURAGED TO RELAX. NO RAPID BREATHING, DENIES SOB. 1555 BP 154/94 HR 130 1558 BP 152/98 HR 142 1607 BP 141/89 HR 115 EMS HERE SO AT BEDSIDE TO AMBULANCE VIA STRETCHER
57 2021-04-21 pain in extremity Sore arm into armpit and sharp headaches(off and on for a week)
57 2021-04-23 weakness, coordination abnormal My left arm and shoulder, where shot was given, is very weak and uncoordinated. I am now getting ti... Read more
My left arm and shoulder, where shot was given, is very weak and uncoordinated. I am now getting tingling/numb sensations. This started one day after shot, and conditions have existed for 3 weeks.
57 2021-04-23 flushing On 4/8 felt flush and very tired. On 4/9 developed a large sore on my tongue that was very painful u... Read more
On 4/8 felt flush and very tired. On 4/9 developed a large sore on my tongue that was very painful until 4/12. Continued to be tired until 4/15.
57 2021-04-24 pain in extremity, night sweats This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient recei... Read more
This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247 and expiration date not provided), via an unspecified route of administration, on 06Apr2021 10:30 (at the age of 57-year-old), at single dose, for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD) from 2018 and ongoing, and had a shot, a steroid for COPD; high blood pressure from 2016 and ongoing, and patient took medication for it; 7 heart attacks; 8 stents in his heart; patient was a smoker (ongoing, had been smoking for a long time. He was a walking post card for don't smoke. He stated that he can only walk twenty feet before he was out of breath); and patient was allergic to penicillin and Lortab. Family history included patient had a family member die of cancer and lupus. Patient had two biopsies for skin cancer (unknown date) within 4 weeks prior vaccinations. Concomitant medications were not reported. On 07Apr2021, the patient experienced extremely high blood pressure, arm aching, body aches, night sweats, and headaches. The patient stated since receiving the vaccine, that his blood pressure was very high and his medications were not bring it down. He stated that one of his blood pressures was 197/121 and this morning it was 181/130, which was extremely high for him. He stated that he went through the aches and his arm was hurting. He even had sweats last night. Patient stated that his blood pressure still hadn't come down and he could feel headache from the pressure. He stated he already called the doctor, and the doctor told him that if it persisted to go to the emergency room. He stated that he took a couple of medications for his blood pressure and he declined giving medication information. He said that one started with an R and he took another one twice a day. He said that all the names of them, remembering them at his age was hard. He stated that he could read that small writing he had to get a magnifying glasses. Patient was scheduled for next vaccine on 04May2021. He stated that his blood pressure was not so unbearable but it was pretty high, he checked his blood pressure twice a day for everyday. He stated whatever he was lucky if he remembers if he had breakfast in the morning, until he remembered that he hadn't had breakfast. He stated that his arm started aching on 07Apr2021, it had improved but was still ongoing. He stated that it felt pretty good. Patient's blood pressure had been constant since today was the 8th it's only been a little over 24 hours now. On 07Apr2021 he had night sweats. He woke up pillow was soaking wet. He stated that his body aches still ongoing started about the same time. His headache started at the same time and was still going on. Patient stated he had a heart attack in 2016 and he hadn't had a normal blood pressure since. He hadn't been able to keep it all in check since the vaccine. His blood pressure medicine had been changed from 20 mgs to 40 mgs. He was under constant doctor care. The patient underwent lab tests and procedures, which included blood pressure was 197/121 (unknown date), 181/130 (08Apr2021), and 165/116 (08Apr2021). Patient's heart rate was 85 (unknown date). Patient stated his normal blood pressure was 135/85, his normal heart rate was 75. The outcome of the events "extremely high blood pressure", "body aches", "headaches" was not recovered; of event "arm aching" was recovering; of other events was unknown. No follow-up attempts are needed. No further information is expected.
57 2021-04-25 burning sensation Patient received first dose of the Pfizer Covid19 vaccine on Wednesday 4/21/21 at 0858. He stated th... Read more
Patient received first dose of the Pfizer Covid19 vaccine on Wednesday 4/21/21 at 0858. He stated that on Thursday 4/22/21 his feet began to itch. He also reported that his hands started to have small red bumps which did not really itch. Patient reported that by Saturday the rash had spread to cover his entire foot to include his toes and heels. He stated he feet began to burn. He also stated the rash to his hands got worse; minor itching to the areas. Seen on 04/26/21 at 11:28 am. On exam today patient's rash is not blanchable. He has rash like areas to his upper and lower legs, hands, upper arms, feet. The rash is different in appearance- some areas are round red circles with a white center, some areas are thick red patches, and some areas are small red bumps. Patient reports that areas that experience friction itch more (like the tops of his feet from rubbing on his shoes). Patient given 50 mg diphenhydramine (oral) at 12:00 pm. At 1:50 pm patient reports the itching has lessened with the medication but does not wish to continue to take. Have noted adverse reaction in patient's medical record.
57 2021-04-25 pain in extremity Fatigue, fever of 101.2, sore arm, red rash at injection site, for 24 hours following second Pfizer ... Read more
Fatigue, fever of 101.2, sore arm, red rash at injection site, for 24 hours following second Pfizer dose ER8731. Five days after vaccination with ER8731, on 04/21/2021, was rushed to hospital at 3 pm with acute idiopathic pancreatitis attack.
57 2021-04-26 inability to speak Approximately 1-2 minutes after injection, my throat began to close and I was having difficulty brea... Read more
Approximately 1-2 minutes after injection, my throat began to close and I was having difficulty breathing and speaking. Dizziness followed. I told the attendant that I needed help. They knew that I had my epipen with me. From that time on, all I recall was asking someone to use the pen. An employee successfully administered the epipen. I was then placed on the floor with my head raised as I could no longer swallow or breathe. All that I can recall from that point was speaking with paramedics at the CVS and was feeling successful results from the epi pen. I was taken to Rockledge Medical ER where they took me in immediately and administered steroids and other antihistamines.
57 2021-04-26 bell's palsy Right side of face freezes (possible Bell's palsy) upon awakening from sleep; This is a spontaneous ... Read more
Right side of face freezes (possible Bell's palsy) upon awakening from sleep; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER20150), via an unspecified route of administration in right arm, on 12Apr2021 at 07:00 PM (19:00), at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. No other vaccine was administered in four weeks. On 13Apr2021 at 06:30 AM, the patient's right side of face freezes (possible Bell's palsy) upon awakening from sleep. No treatment was administered for the event. The patient has not been tested for COVID-19 post-vaccination. The outcome of the event was unknown.
57 2021-04-26 burning sensation burning redness on vaccination site but tolerate.
57 2021-04-27 pain in extremity Left leg pain and swelling a couple weeks after shot one of Pfizer vaccine. After a few more days of... Read more
Left leg pain and swelling a couple weeks after shot one of Pfizer vaccine. After a few more days of leg not getting any better, saw Doctor who ordered Ultra sound of left leg and CT scan of lungs. Extensive DVT clot found in left leg, low density bi lateral pulmonary embolism in both lower lobes of lungs found from CT scan. Hospital stay for 2 days, Heparin given in hospital and now I'm on eliquis blood thinner. Had gotten my second Pfizer shot 3 days before admittance to hospital.
57 2021-04-28 feeling hot Patient stated he was sensitive to the smell of alcohol and needed to turn away after the administra... Read more
Patient stated he was sensitive to the smell of alcohol and needed to turn away after the administration of the vaccine. He stated like he was feeling like he might pass out. He removed mask, stated he was getting warm, hat removed. He asked to be lowered to the floor. Never lost consciousness. Color pale. Skin diaphoretic. BP 137/84 pulse 80, SpO2 96%. Cold washcloth applied. Rapid response team called. Vital signs monitored. Patient assisted to chair for observation. 10:02 am patient recovered and left the facility in stable condition.
57 2021-04-30 pain in extremity Parts of the face, sides of cheek and neck had an itchy, rash; Eyelids puffy and swollen; Underneath... Read more
Parts of the face, sides of cheek and neck had an itchy, rash; Eyelids puffy and swollen; Underneath eye and part of cheek, swollen and puffy; Face got red, like a sunburn; Pain in arm; Tiredness and fatigue; This is a spontaneous report from a contactable male consumer. The 57-year-old male consumer (patient) received second dose (Batch/Lot Number: unknown) on 12Apr2021 at 3 pm and first dose (Batch/Lot Number: ER8727) on 22mar2021 via unspecified route of administration as a single dose for Covid-19 immunisation. The medical history was not reported. Patient reported he was on 9 medications. The patient experienced Pain in arm on 12Apr2021 in the evening and it was resolved on 13Apr2021, Tiredness and fatigue on 12Apr2021 at 3 PM, Face got red, like a sunburn on 13Apr2021 in the evening, Parts of the face, sides of cheek and neck had an itchy, rash on 13Apr2021 at 5 PM, Eyelids puffy and swollen on 13Apr2021, Underneath eye and part of cheek, swollen and puffy on 13Apr2021 at 5 PM. Patient did not specified seriousness. Patient did not have prior Vaccinations within 4 weeks. Patient did not have any relevant tests. Patient reported that there were side effects to the first shot, patient reclarified, his face getting super red, eyes swelling, upper cheeks swollen, under eyes swollen, face was very itchy, earlobes red and swollen" all occurring 24 hours after he got the second dose of the vaccine. Patient stated then last night his face got red, stated it was like he had sunburn on his face and he had an itchy, rash, swollen under his eyes. Patient had a skin Cancer treatment a couple of months ago and he was told to stay out of the sun. Patient did not think about the vaccine being the cause of, his skin being red. Patient used this new facial cream and he thought he was having a reaction to that, but now he doesn't thing so, it could be from the vaccine. Patient stated redness hasn't gone away, and he is itching in certain areas of his face and neck. He had looked on the internet to see what anaphylaxis looks like, and the pictures do not look like what he is experiencing. Patient's rest of face is super red, like sunburn with a red, itchy rash. Patient took Benadryl and it Benadryl relieved the itching and swelling. Patient didn't think he was allergic to the main ingredient in the vaccine. Patient stated that he had an allergy to Tegretol. patient stated he had a reaction, a rash, and the medication was stopped immediately. Patient doctor put him on a strong antihistamine with good effect. Patient did not get any vaccine on the same day. Patient did not require visit to Emergency Room and Physician Office. Patient stated that his friend that got the Pfizer vaccine and her throat closed up on her at night and she was told not to get her second vaccine. Upon follow-up further information was received patient stated 45 days ago he had a preventative skin cancer procedure on his face and used Fluorouracil 5% topical cream applied daily on his face. patient said it made his face get "super red", which is what it was supposed to do. Patient stated that the medication contained Polysorbate 60. He is wondering if his reaction to the vaccine could be a "cross reactive. Patient further reported a delayed reaction to the second dose of the Pfizer Covid 19 vaccine. Patient stated he had no side effects after the first dose. However he reported the following: face getting super red, eyes swelling, upper cheeks swollen, under eyes swollen, face was very itchy, The outcome Pain in arm was recovered, tiredness and fatigue – recovering, face got red, like a sunburn was not recovered, parts of the face, sides of cheek and neck had an itchy, rash was not recovered, underneath eye and part of cheek, swollen and puffy was not recovered, eyelids puffy and swollen was not recovered. No follow-up attempts are possible. No further information is expected.
57 2021-05-03 seizure Pfizer COVID-19 Vaccine EUA Patient received dose #1 of Pfizer COVID-19 vaccine on 3/6/2021 and Dose... Read more
Pfizer COVID-19 Vaccine EUA Patient received dose #1 of Pfizer COVID-19 vaccine on 3/6/2021 and Dose #2 on 4/24/2021. Patient was found down on 4/25/2021 for an unknown amount of time and EMS was called. Patient noted to be seizing on EMS arrival. Blood glucose was noted to be 32 and an amp of D50 was administered. Patient arrested, received CPR (approximately 1 round) and was intubated in the field. His second glucose reading was undetectable and he received a second amp of D50. Patient also received sodium bicarb, calcium, and epinephrine and transported to ED. Patient subsequently transferred to Medical Center. He was treated for septic shock. His mentation remained very poor after pressors weaned off and sedation stopped. He likely had severe brain injury from hypoglycemia and anoxia - poor brainstem reflexed but did have spontaneous breathing - very poor prognosis - patient was extubated for comfort measures and all interventions stopped after family discussion and per their plan.
57 2021-05-04 numbness During the two weeks after the first injection the Left shoulder continued with pain and increased i... Read more
During the two weeks after the first injection the Left shoulder continued with pain and increased in pain. during these same two weeks he noticed gradual and increasing arm weakness and numbness in the outer arm and forearm to the hand. The weakness is so severe that he could not bend the elbow to lift (flexion)the hand up, nor lift the shoulder forward or out.(no flexion or abduction). no new symptoms in the Right arm or either leg. there is severe atrophy of the proximal musculature of the left shoulder and upper arm.
57 2021-05-04 tingling Pressure in chest, light-headedness, tingling in arms continuing for two weeks after initial symptom... Read more
Pressure in chest, light-headedness, tingling in arms continuing for two weeks after initial symptoms.
57 2021-05-06 bell's palsy Bell's Palsy; This is a spontaneous report from a contactable Other healthcare professional (HCP). A... Read more
Bell's Palsy; This is a spontaneous report from a contactable Other healthcare professional (HCP). A 57-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular on 03Apr2021 (Lot number was not reported) as SINGLE DOSE (at age of 57 years old) for covid-19 immunisation. Medical history included diabetes from an unknown date and unknown if ongoing , covid from an unknown date and unknown if ongoing. Patient did no have any known allergies. Concomitant medication(s) included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported; atorvastatin taken for an unspecified indication, start and stop date were not reported; lisinopril taken for an unspecified indication, start and stop date were not reported; glipizide taken for an unspecified indication, start and stop date were not reported; metformin taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The vaccination was given in a hospital. The patient experienced bell's palsy on 11Apr2021. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of bell's palsy which included Prednisone, Valacyclovir. Outcome of the event was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information about lot/batch number has been requested.; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between event Bell's Palsy 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.
57 2021-05-06 slurring Pale, some slurred speech. Vitals wnl.
57 2021-05-06 pain in extremity 2 days after 2nd shot, I couldn't walk or use my right leg. Days later, soreness spread to my arms, ... Read more
2 days after 2nd shot, I couldn't walk or use my right leg. Days later, soreness spread to my arms, neck and hands
57 2021-05-07 numbness, muscle twitching, slurring, facial paralysis stroke like symptoms; on his left side he had face droop; he had a speech slur; he couldn't move his... Read more
stroke like symptoms; on his left side he had face droop; he had a speech slur; he couldn't move his left arm/couldn't lift his left arm; low blood pressure; his face was numb; his lip was twitching; bad headache; brain fog; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 21Apr2021 14:00 (Batch/Lot Number: EW0169) as single dose (at the age of 57-years-old) for COVID-19 immunisation. Medical history included stroke from 02Feb2020 to 02May2020 (not ongoing). The patient had 3 stroked last year and he was put on ELIQUIS and baby aspirin and a regimen for his strokes. The last one he had was 02May2020 and he has had no problems since then. Last year when he had strokes it wasn't because of his heart it was because of an artery in his brain that went 90 degrees. In Jun2020 they found out that the problem was an artery and that's when the doctor to do the double dose baby aspirin and then everything was fine and he had no episodes at all. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), lot number: P116218, expiration date: Jan2022 taken for stroke from 02Feb2020 to an unspecified stop date; and apixaban (ELIQUIS), lot number: 1796050, expiration date: Sep2023 taken for stroke from 02Feb2020 to an unspecified stop date. The patient had no additional vaccines on the same date as Pfizer vaccine and had no prior vaccine within 4 weeks. The patient had his first shot of the Pfizer COVID vaccine on 21Apr2021 at 14:00 and stated that they made him go wait for 15 minutes in his car. 10 minutes into waiting after the COVID vaccine, he had to call over the EMT because he had stroke like symptoms. On his left side he had face droop, he had a speech slur and he couldn't move his left arm. The patient was transferred to the hospital and was hospitalized. His CT scan was fine, the CT scan with dye was fine, his MRI was fine, and his heart was fine. The patient wanted to know if he should get the second COVID vaccine because of the reaction that he had from the first COVID vaccine. The patient got the COVID vaccine on 21Apr2021 and on 23Apr2021 he was still having a bad headache, brain fog and there was a deficit on his left side. He can't grab and hold something in his left hand and he has a slight deficit on the left side corner of his mouth. The patient was planning on seeing the provider in the first week of May2021. The patient added that he was told to wait 15 minutes and then 10 minutes in he could feel his face was numb and his lip was twitching and he couldn't lift his left arm. He laid on the horn and the EMS came over and they said that he had stroke like symptoms so they transferred him out of his car and into an ambulance where he had vitals taken and he had another episode of stroke like symptoms. They took him into a different ambulance and had another episode in that ambulance when they were on the way to the hospital. He didn't have anything after that except a bad headache and a slight deficit on his left side, according to them, and just a brain fog like when he was trying to figure out how to put things together and he was still having those at the time of the report. The patient was discharged from the hospital on 22Apr2021. The patient stated that his last stroke was on 02May2020 and he has had no headaches since until he had the COVID vaccine on 21Apr2021. According to the doctors and the neurologist at the hospital he could've had a stroke, he could've had low blood pressure from the vaccine or he could've had a multitude of other things but they recommended him to call Pfizer and CDC for the report. While in the hospital, he had a CT scan without contrast, a CT with contrast on 21Apr2021; an MRI without contrast on 21Apr2021; an echocardiogram without dye and with dye on 22Apr2021 and they did another MRI but of his neck on 22Apr2021; all were normal. The patient was hospitalized for stroke like symptoms, on his left side he had face droop, he had a speech slur and he couldn't move his left arm from 21Apr2021. The event stroke like symptoms resolved with sequel on 22Apr2021. The patient recovered from on his left side he had face droop, he had a speech slur, and he couldn't move his left arm on 22Apr2021. The patient has not recovered from bad headache, brain fog. The outcome of his face was numb was unknown, his lip was twitching and low blood pressure was unknown.
57 2021-05-08 slurring Pale, some slurred speech. Vitals wnl.
57 2021-05-09 pain in extremity, numbness Lower back muscle tightness and pain, targeting L5-S1 weak spot from three prior surgeries there, wi... Read more
Lower back muscle tightness and pain, targeting L5-S1 weak spot from three prior surgeries there, with another slight disc bulge previously found Jan 2020. Within the week, pain and stiffness progressed. Video appt doc prescribed muscle relaxer and steroid taper. As soon as that course finished, received second dose, and pain kicked back in immediately. Within a week, pain progressed to include shooting pains down right leg. MRI confirmed herniated disc worsened since last seen Jan 2020. Unbearable pain, leg weakness, and numbness down through calf. Awaiting further treatment.
57 2021-05-10 weakness Extreme headaches in the back of my head, then radiating to the frontal lobe. Second stage was dizzi... Read more
Extreme headaches in the back of my head, then radiating to the frontal lobe. Second stage was dizziness/ vertigo seemed like my brain was going to explode. Ringing in ears and then intense vivid dreams. It?s been two weeks since the second shot and I am still dealing with the dizzy spells. The headaches have gone . Also another symptom was I would get weak at times not for long but in spells. Still trying to over come this pressure and dizzy feeling other than that now I am getting better.
57 2021-05-10 pain in extremity Sore left arm; This is a spontaneous report from a contactable consumer (patient). A 57-year-old mal... Read more
Sore left arm; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of (Pfizer/BioNTech COVID-19 Vaccine, Solution for injection, and expiry date: not reported) via an unspecified route of administration in the region of left arm on 09APR2021 at single dose for Covid19 immunisation. Medical history of the patient was reported as cataract, which the patient had for over a year and Left eye surgery for cataracts. The patient's concomitant medication was not reported. The patient had cataract surgery in the left eye on 20Apr2021, the outcome of which at the time of observation was reported as recovered. On an unspecified date after the vaccination the patient experienced soreness in the left arm that went away in 4-5 days. The outcome of the event soreness in the left arm was unknown. No follow-up attempts are needed. No further information is expected. .
57 2021-05-11 bell's palsy Onset of Bells Palsy affecting right eye and developed to Dilopia.
57 2021-05-12 slurring, weakness slurred speech; Right arm and right leg weakness; TIA; Fever; Weakness; This is a spontaneous report... Read more
slurred speech; Right arm and right leg weakness; TIA; Fever; Weakness; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8737), via an unspecified route of administration in right arm on 16Apr2021 16:00 as 2nd dose, single for COVID-19 immunization. Medical history included hypertension (Htn) and non-insulin dependent diabetes mellitus (Niddm). Concomitant medications included amlodipine and vitamins nos (MULTIVITAMINS). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8730) in the left arm on 26Mar2021. The patient experienced slurred speech, right arm and right leg weakness, transient ischaemic attack (TIA), fever, and weakness, all on 18Apr2021 08:00. The events resulted to ER visit (Emergency room/department or urgent care) and patient was hospitalized for 2 days. Therapeutic measures were taken as a result of the events and reportedly included treatment with blood thinners. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. The outcome of the events were recovered with sequel. Events seriousness was hospitalization and disability. Information on lot/batch number was available. Additional information has been requested.
57 2021-05-12 pain in extremity shooting pains in arm shoulder fingers left side and right
57 2021-05-13 weakness Aches and pains, feeling weak, foggy head Symptoms started 18 hours after injection, 36 hours after ... Read more
Aches and pains, feeling weak, foggy head Symptoms started 18 hours after injection, 36 hours after injection symptoms were gone.
57 2021-05-13 seizure Person suffer a stroke and started having seizures and continuously having Seizures
57 2021-05-14 weakness Patient contacted the pharmacy stating that he received the vaccine from us and he informed us of a ... Read more
Patient contacted the pharmacy stating that he received the vaccine from us and he informed us of a cough but with no fever or other symptoms. The same day the patient had headache, diarrhea, and fever, and eye pain. The cough also worsen and did not go away. He was then treated in the hospital with IV fluids and medication. He spent many days without food and was very weak.
57 2021-05-14 muscle spasms immediate muscle contractions and spasms in the arm and neck upon injection. Flu like symptoms (ac... Read more
immediate muscle contractions and spasms in the arm and neck upon injection. Flu like symptoms (aches throughout the body and and fatigue started at about 8:00 pm. And have continued through the next day
57 2021-05-17 weakness, feeling hot 24hrs post 2nd Dose Pfizer. Bradycardia, chest pain, fever, skin patches heat sensation, swollen te... Read more
24hrs post 2nd Dose Pfizer. Bradycardia, chest pain, fever, skin patches heat sensation, swollen testicals, lymph nodes swollen, entire body joint pain, severe headache, foggy, extremely tired. At 9:25am (24hrs after 2nd dose) I was able to muster enough energy to text. 15 minutes later my heart was beating so slow I was unable to move my hand to grab my phone. It was like I was paralyzed for a couple hours other than my heart beat hurt and below 30 bpm for a couple hours. In and out of being awake. After a couple hrs I was able to move and my heart was beating faster. My chest hurt significantly for 12 days. May 13th, (9days post) I went to Emergency Room in evening. Fear of blood clots with chest hurting and extreme fatigue. ER preformed an XRAY for heart size and lungs, Blood work for blood clots and markets for heart attach. All came in negative to a heart related event causing pain.
57 2021-05-17 burning sensation inflammation; MCP and PIP joints and SI joints started burning close to 3rd week; MCP and PIP joints... Read more
inflammation; MCP and PIP joints and SI joints started burning close to 3rd week; MCP and PIP joints and SI joints started burning close to 3rd week; This is a spontaneous report from a contactable physician reporting for himself. A 57-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, in Hospital, administered via intramuscular route in left arm on 22Dec2020 (Batch/Lot Number: EJ1685) as single dose, and the second dose via an unspecified route of administration, administered in right arm on 01Feb2021 (Batch/Lot Number: EL3249) as a single dose for COVID-19 immunization. Medical history included allergy to penicillin and benign prostatic hyperplasia from an unknown date and unknown if ongoing. Concomitant medications included tamsulosin and metoprolol tartrate, both taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with CVID-19 prior vaccination and was not tested for COVID-19 post vaccination. On 20Jan2021, close to 3rd week, the patient's MCP (Metacarpal, Carpal and Phalanges) joints, PIP joints (proximal interphalangeal joints) and SI joints (sacroiliac joint) started burning and the patient also experienced inflammation on an unspecified date. He had had some minor SI pains intermittently before but none with hands. It continued hurting enough so the patient started taking condroitin sulfate/glucosamine hydrochloride (OSTEOBIFLEX) and fish oil and more paracetamol (TYLENOL) for inflammation. After the second vaccine on 01Feb2021 the symptoms have been getting worse. Now the patient's hands burn all the time, at times bad enough that they keep him awake. The patient has red nodular areas on some of his knuckles and a distinct nodule at the proximal ulnar aspect of his left 4th finger PIP that is uniformly erythematous. Not all knuckles have the same degree of burning, but all, including thumbs, have it. The SI is more variable and at time does not bother the patient, but the hands get swollen and tight to close everyday. The patient plan to start some prednisone the following day due to the progression of the burning, moreover the events were treated with glucosamine, paracetamol (TYLENOL), ibuprofen, fish oil and turmeric. The event "MCP joints, PIP joints and SI joints started burning" had not resolved yet at the time of the report, whereas outcome of the event inflammation was unknown. Follow-up attempts are completed. No further information is expected.
57 2021-05-17 numbness Have slight headaches 3-4 days after 2 bday shot . Had an episode of entire body numbing and feeling... Read more
Have slight headaches 3-4 days after 2 bday shot . Had an episode of entire body numbing and feeling disconnected from my body while driving. Came in suddenly and went away .
57 2021-05-17 nerve pain, pain in extremity, burning sensation 10 mins after injection became very faint and broke out in cold sweat. Pharmacy gave me oral Benadry... Read more
10 mins after injection became very faint and broke out in cold sweat. Pharmacy gave me oral Benadryl. For the next three days i was very fatigues and slept 60% of the time. Starting on day 4 my upper back and neck started to very pain like a sunburn feeling, but the skin was not red and there was no rash and did not hurt when touched. The sunburn feeling was constant and annoying from day 4-14, then it started to become more intermittent. I decided to get the second vaccine shot(Pfizer ER8734) on 4/5/21. Since that time the sunburn feeling has spread to my shoulders and arms and the inside of my legs. As of this date it is pretty much a constant pain. In the last couple of weeks I have also started feeling random nerve pain on all different parts of my body.
57 2021-05-18 tingling, numbness after shot, his mind suddenly went blank, followed with the inability to move his legs at all; Legs ... Read more
after shot, his mind suddenly went blank, followed with the inability to move his legs at all; Legs became weak. Within 15 minutes of the shot. Went home and rested with weakness in left leg; after shot, his mind suddenly went blank, followed with the inability to move his legs at all; slight numbness; tingling; pain; legs have been heavy; central vestibular disorder; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Apr2021 10:15 (Lot Number: ER8731) as 2nd dose, single for covid-19 immunisation. Medical history included Epilepsy, Migraine, Central Vestibular Disorder, and Known allergies: Sulpha Drugs and Shellfish. Historical Vaccine included first dose of bnt162b2 (lot number:ER8727, Administration date= 26Mar2021, Administration time= 12:15 AM, Dose number= 1, Vaccine location= Left arm) for COVID-19 immunisation; Adacel (DTAP) PMC (Sanofi) (vaccine date=11Mar2021, lot number=C5667AA, dose number=1, vaccine location=Left Arm) for immunisation. After bnt162b2 first dose, the pateint had Legs became weak; Could move them, but not stand up on them; Lasted approximately 2-3 hours; Reaction occurred within 15 minutes after the shot; Nurses made her go to the emergency room (ER). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included clonazepam taken for an unspecified indication, start and stop date were not reported; lacosamide taken for an unspecified indication, start and stop date were not reported; lamotrigine taken for an unspecified indication, start and stop date were not reported; omeprazole taken for an unspecified indication, start and stop date were not reported. After bnt162b2 second dose, the patient experienced Legs became week. Within 15 minutes of the shot. Went home and rested with weakness in left leg. Day after shot, his mind suddenly went blank, followed with the inability to move his legs at all. He could feel them. There was slight numbness, tingling, and pain, but he was not able to move them. He was transported to the ER via ambulance. This reaction lasted about 4 hours. Since then his legs have been heavy and the progress he had made with his central vestibular disorder has thrown him back to almost square one and his physical therapy is now not helping as it did. The adverse events (AE) resulted in Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered with sequelae. Information on Lot/Batch number was available. Additional information is expected.
57 2021-05-19 flushing difficulty breathing; face was flushed; heart rate went up; Wheezing; This is a spontaneous report f... Read more
difficulty breathing; face was flushed; heart rate went up; Wheezing; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left, at the age of 57 years, on 26Apr2021 (Batch/Lot Number: EW0170) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included autoimmune thyroiditis, allergies, hay fever, allergies to grasses, cheese and weeds; all from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN) taken for autoimmune thyroiditis, start and stop date were not reported and an unspecified Antihistamine. The patient stated that 45 minutes later (26Apr2021) he stated that his face was flushed, his heart was beating fast, he was wheezing and had difficulty breathing but, not severe. He states that these conditions were not serious enough to seek medical attention and reports that they were gone by the end of the next day. The patient reported 5 hours after shot at his symptoms were at about 50 percent of what they were, By the next morning, they were down to about 10 percent and by the end of the day, on 27Apr2021, they were gone. The patient would like to know if this will keep him from getting his second dose of the vaccine. The patient underwent lab tests and procedures which included heart rate: increase on 26Apr2021. The outcome of the events was recovered on 27Apr2021.
57 2021-05-21 weakness Patient is feeling dizzy and having trouble breathing. I asked the patient how he was feeling. Patie... Read more
Patient is feeling dizzy and having trouble breathing. I asked the patient how he was feeling. Patient states that he is feeling like his heart is racing and still feeling dizzy . Took the patients vitals at 12:05 pm heart rate 126, o2 99, blood pressure 191/125, at 12:10 pm heart rate 123, o2 100, blood pressure 170/113, at 12:13 am heart rate 107, o2 99, blood pressure 161/111, at 12:18 pm heart rate 96, o2 99, blood pressure 152/99, and again at 12:23 pm blood pressure was 156/99. I asked how patient was feeling and he stated that the dizziness was a little better but still felt weak.. I asked the patient how he was feeling. The patient stated that he still feels dizzy and weak.
57 2021-05-24 night sweats Patient received a 2nd dose of Pfizer vaccine on 5/3/2021. Patient presents to the ED on 5/23/2021 w... Read more
Patient received a 2nd dose of Pfizer vaccine on 5/3/2021. Patient presents to the ED on 5/23/2021 with chief complaint of fatigue, chest pain, shortness of breath on exertion. Patient reports fatigue of 2 week duration associated with right-sided chest discomfort, dyspnea, and night sweats. He reports approximately 1 week ago onset of pleuritic R-sided, nonradiating chest pain, with provocative factor of cough and palliative factor of lying supine. He additionally reports dyspnea on exertion and at rest and night sweats of 1 wk duration. CT chest angio showed Large Pericardial effusion, moderate Left pleural effusion, mild right pleural effusion, ascites. On 5/24/2021, patient underwent pericardiocentesis with 800cc of reddish fluid drainage, and left thoracocentesis with transudative fluid. Cytology is pending.
57 2021-05-27 seizure, feeling of body temperature change body aches; chills; headache; dizziness; goes from being cold and hot; passing out a few times; shak... Read more
body aches; chills; headache; dizziness; goes from being cold and hot; passing out a few times; shaking similar to seizure/eyes kind of glazed; This is a spontaneous report from a contactable consumer (patient's wife) reported that a 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19, lot number: EW0182), via an unspecified route of administration, administered in arm left on 11May2021 08:00 (at the age of 57-years-old) as 2nd dose, single dose for covid-19 immunisation. The vaccine was administered at the Pharmacy/drugstore. The patient medical history included covid before, he had a bad case of it from Nov2020. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19, lot number was not reported) on 20Apr2021 (at the age of 57-years-old) as 1st dose, single dose for covid-19 immunisation, and experienced all of the same symptoms (body aches, chills, goes from being cold and hot, headache and dizziness) but he did not pass out. The patient always gets the flu vaccine. The patient's concomitant medications were not reported. On 11May2021 15:15, the patient experienced passing out a few times, eyes kind of glazed, and shaking similar to seizure; and at 19:00, the patient body pain, chills, headache, dizziness and goes from being cold and hot. The outcome of the events was unknown.
57 2021-05-28 feeling of body temperature change body aches; chills; headache; dizziness; goes from being cold and hot; This is a spontaneous report ... Read more
body aches; chills; headache; dizziness; goes from being cold and hot; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 20Apr2021 08:00 (Batch/Lot Number: EW0171) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Apr2021, body aches, chills, goes from being cold and hot, headache and dizziness. Reporter clarifies that after the first dose of the covid vaccine, patient had all of the same symptoms but he did not pass out. Patient never felt 100 percent after receiving the first dose of the covid vaccine. All of the same symptoms after the first dose began the night patient received the first dose of the covid vaccine, 20 Apr 2021. The outcome of the event goes from being cold and hot was unknown while not recovered for the other events.
57 2021-05-30 hypersensitivity of all senses Skin hurting/sensitivity (Day 1 forward), severe chills (day 2 forward), headache (day 1 forward), f... Read more
Skin hurting/sensitivity (Day 1 forward), severe chills (day 2 forward), headache (day 1 forward), fatigue (day 1 forward), mild cough on/off, eye pain (? day 4 forward), achey (day 1 forward), chest rash (? day 3 forward), fever (? day 5 forward 101.9 day 5), back pain (? day 5 forward), labored breathing (? day 5 forward), diarrhea (? day 5 forward), sore throat (? day 5 forward) vomit (day 7). Symptoms of chills and miserable feeling increased day 4 on. Tylenol, Albuterol on day 6, Day 8 hospitalized, antibiotics and oxygen, Sepsis and shock, less than one day in hospital - passed on 3/2/21 am.
57 2021-05-31 burning sensation At 4:00 p.m. after shot, had nausea, fever, chills and headache. This lasted until 8:00 p.m (4hrs). ... Read more
At 4:00 p.m. after shot, had nausea, fever, chills and headache. This lasted until 8:00 p.m (4hrs). Symptoms went away but started again at 1:15 a.m and lasted until 4:15 a.m. After waking up at 8:00 a.m. noticed pronounced ringing in my right ear. Later that day noticed that the top of my toes (at the base of my toes) had a burning sensation, my lower back hurt and a general overall unwell feeling. The ringing in my right ear has been nonstop since it started. The other symptoms have come and gone intermittently but are still present.
57 2021-05-31 numbness, pain in extremity Deltoid numbness. persists. Increasing pain in deltoid
57 2021-06-04 flushing, pain in extremity Pain at injection site; Pain in side of neck; severe headache; feeling flushed; aching in back; achi... Read more
Pain at injection site; Pain in side of neck; severe headache; feeling flushed; aching in back; aching in legs; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old adult male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the left arm on 16Mar2021 at 11:45 AM, as a single dose for COVID-19 immunisation. Medical history was not reported. The patient reported that he did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications reported as none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: El3247), via an unspecified route of administration in the left arm on 23Feb2021 at 13:30 PM, as a single dose for COVID-19 immunisation. On 17Mar2021 at 02:00 AM, the patient experienced significant pain at injection site spreading up the side of his neck, severe headache, feeling flushed, aching in back and legs. No therapeutic measures were taken for the adverse events. The clinical outcome of pain at injection site, pain inside of neck, severe headache, feeling flushed, aching in back and legs were recovering at the time of this report. No follow up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: patient's first name added in patient tab, patient's Country added and phone/email added in patient tab, Patient's age/unit added in patient tab, Patient's Race information and Ethnic group added in patient tab, duplicate Reported Indication of BNT162B2 removed, For Past Drug Event with BNT162B2 1st dose: Condition Type updated from Past Drug Event to Historical Vaccine; Age/Units captured as 57 years per vaccination date was 23FEB2021, duplicate Reported Indication of BNT162B2 removed, treatment received ticked as No. Follow-up (02Jun2021) Amendment: This follow-up report is being submitted to amend previously reported information patient information and treatment information added.
57 2021-06-06 numbness, tingling For 2-3 weeks, episodes of L ear numbness, top of ear, lasting for 10-15 seconds multiple times duri... Read more
For 2-3 weeks, episodes of L ear numbness, top of ear, lasting for 10-15 seconds multiple times during the day and then goes away. But comes back, sometimes some electric feeling.
57 2021-06-07 pain in extremity Reports pain in left arm since second shot, pain progressed 2-3 days after injection. Unable to use... Read more
Reports pain in left arm since second shot, pain progressed 2-3 days after injection. Unable to use his arm at his doctor visit on 5/4/21. Diagnosed with shoulder injury related to vaccine administration. F/U appointment on 6/7/21 reports able to use his left arm, still has pain off/on . Has been going to PT for three weeks and has shown increased range of motion. Improved but still not back to normal, still unable to sleep on left side. Continuing PT.
57 2021-06-09 pain in extremity dizziness 15 min after vaccine, called patient, only sore arm now, will follow up with PCP if any ot... Read more
dizziness 15 min after vaccine, called patient, only sore arm now, will follow up with PCP if any other symptoms
57 2021-06-10 pain in extremity, numbness Patient called health system call center on 5/10/21. Per pt, he had received dose 2 of pfizer vaccin... Read more
Patient called health system call center on 5/10/21. Per pt, he had received dose 2 of pfizer vaccine on 4/20/21. Pt said about 5/6/21, he started to feel pain in arm, back and chest. Pt said, he feels congestion, lost appetite, have difficulty when swallowing, itchy and numbness in hands and fingers sometimes. Per pt, heTakes 2tablets of 500mg tylenol twice daily since pain began 5/6/21 . URgent care visit made for patient for 5/10/21
57 2021-06-11 bell's palsy pt reported symptoms of bell's palsy 2 weeks following initial pfizer vaccine. pt was diagnosed and ... Read more
pt reported symptoms of bell's palsy 2 weeks following initial pfizer vaccine. pt was diagnosed and treated by physician with 60mg prednisone per day.
57 2021-06-13 tingling Ringing in ears, dizziness, lethargy and constant tingling in lower legs and feet.
57 2021-06-15 flushing Starting on the day of the vaccine 1st dose- I felt a little dizzy in the waiting area. A day later... Read more
Starting on the day of the vaccine 1st dose- I felt a little dizzy in the waiting area. A day later, I felt tired and fatigued. About 6 days post vaccine, I woke up with flushing and both ears started to ring, more signficantly in the left ear. I took my blood pressure and it was elevated at 160/90. I went to the doctor the next day and had an MRI (came back normal). I was prescribed blood medication (amlodipine). I went to an audiologist and was found to have hearing loss. I went back to my PCP and my BP was still elevated and was prescribed atenolol in addition to amlodipine. Currently, I am still having flushing, fatigue, and tinnitus.
57 2021-06-16 facial paralysis, bell's palsy Patient reported to Hospital ED on 6/14/21 and 6/17/21 with left sided face dropping. Patient was to... Read more
Patient reported to Hospital ED on 6/14/21 and 6/17/21 with left sided face dropping. Patient was told of diagnosis on 6/17/21 of COVID-19 vaccination associated Bell's Palsey after multiple tests performed on both visits. Patient was alert when coming to pharmacy and had clear signs of face dropping on left side. He was told to report to pharmacy by ED to submit a VAARS.
57 2021-06-16 pain in extremity This is a spontaneous report from a contactable consumer reported for himself. This is the one of 4 ... Read more
This is a spontaneous report from a contactable consumer reported for himself. This is the one of 4 reports from the same reporter. A 57-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection, Lot# and expiration date were not reported) via an unspecified route of administration, administered in Arm Left on 01Apr2021 as SINGLE DOSE for COVID-19 immunization. Concomitant medication included VITAMIN D. He did not take any other medications. The patient medical history was not reported. It was reported that, he received his first dose 01Apr2021, and had mild pain in left arm on the same day. It was nothing bad and improved. The outcome of event was reported as resolving. Follow-up attempts are possible. Further information is expected.
57 2021-06-16 pain in extremity He woke up in the middle of the night and felt like he got punched in the left arm. It really hurt; ... Read more
He woke up in the middle of the night and felt like he got punched in the left arm. It really hurt; Fever; headache; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6209, expiration date: unknown), intramuscularly in the left arm on 22Apr2021, as a single dose for COVID-19 immunisation. The patients medical history was not reported. The patients concomitant medication included calcium carbonate, colecalciferol (VITAMIN D 2000) for unspecified indications (start and stop date were not reported). Historical vaccination included patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number was not reported) via in tramuscularly in the Arm left on 01Apr2021, as a single dose for COVID-19 immunization. After vaccination the patient experienced pain in extremities. On 22Apr2021, the patient stated that he woke up in the middle of the night and felt like he got punched in the left arm. It really hurt. On an unspecified date in Apr2021, that patient experienced fever and headache and he stayed home that Friday. By that evening, he felt better. The next morning, he was 100% better. He felt so great, he went for a really long bike ride. All the events were non-serious. The outcome of the event pain in extremity was recovering. The outcome of the events fever and headache was recovered on an unspecified date in the Apr2021. No follow-up attempts are possible; Information about lot/batch number has been requested.
57 2021-06-16 tingling, sensory loss, numbness He lost feeling in his entire arm.; He had complete numbness in his arm; Later in the day he got tin... Read more
He lost feeling in his entire arm.; He had complete numbness in his arm; Later in the day he got tingling and then had feeling back in his arm and hands; This is a spontaneous report from a contactable consumer (patients wife). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 57-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications. On an unspecified date, the patient had a reaction at the site and they kept him there to monitor him. He lost feeling in his entire arm. He had complete numbness in his arm. Later in the day he got tingling and then had feeling back in his arm and hands. Outcome of the events are reported as unknown at this point of time. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
57 2021-06-24 flushing low grade fever ( 100 degrees F) developed; Rash/itching/hives, starting in groin area, moving to ar... Read more
low grade fever ( 100 degrees F) developed; Rash/itching/hives, starting in groin area, moving to arms, then both sides of trunk, then behind knees.; Rash/itching/hives, starting in groin area, moving to arms, then both sides of trunk, then behind knees.; Rash/itching/hives, starting in groin area, moving to arms, then both sides of trunk, then behind knees.; Flushing and redness in face; Flushing and redness in face; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0158), via an unspecified route of administration, administered in arm left on 07Apr2021 at 13:15 (at the age of 57-year-old) as a single dose for COVID-19 immunization at hospital. Medical history included pollen allergies and no known allergies with medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included omeprazole 20 mg, atorvastatin 10 mg and tadalafil 5 (units not provided) (received within 2 weeks of 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 patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in left arm on 17Mar2021 at 10:45 as a single dose for COVID-19 immunization. On 08Apr2021 at 13:15, the patient experienced rash/itching/hives, starting in groin area, moving to arms, then both sides of trunk, then behind knees and had flushing and redness in face but no swelling/itching. As rash was subsided, low grade fever (100 degrees Fahrenheit) developed. Patient did not receive any treatments for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event rash was recovered on an unspecified date in 2021 and the rest of the events was recovering. Information on Lot/Batch number was available.
57 2021-06-29 discomfort extreme exhaustion; flu like symptoms set in; chills; body aches; uncomfortable; a little achy; This... Read more
extreme exhaustion; flu like symptoms set in; chills; body aches; uncomfortable; a little achy; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot/Batch number: unknown) via an unspecified route of administration on 05Feb2021 at 04:45 pm on the left arm as a single dose for COVID-19 immunisation. The patient's medical history included depression. The patient's concomitant medications were not reported. Patient did not take any other medications with in four weeks of vaccination. Patient's other medications within two weeks included Effexor. The patient was not tested for COVID prior vaccination. Patient's COVID past vaccination was none. The patient stated that within the 1st 24 hrs of vaccination on 06Feb2021 at 08:00 am, the patient felt uncomfortable& a little achy. On the second day after vaccination, the patient had flu like symptoms, chills, body aches in joints and lower back. On the third day, the patient experienced chills, body aches and extreme exhaustion. The patient was treated with OTC medication for the events. The outcome of the events was resolving. No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information is expected.
57 2021-06-29 numbness, pain in extremity After the second dose my chest started to feel very tight at first. Yet, it progressed to my right c... Read more
After the second dose my chest started to feel very tight at first. Yet, it progressed to my right calf. I was experiencing very severe pain in my right calf. I thought the pain will eventually go away yet it still continued. About three weeks after my second dose, May 24th, I drove myself to a local clinic, and they directed me to the emergency room to get a X-Ray of my right calf. They found a blood clot. The doctors bandaged my calf and prescribed me Xarelto to treat the pain. In addition to the prescription, they directed me to a Vascular doctor to documented the recovery. As of now it is unclear if the blood clot is completely gone, however, my calf is still swollen. In addition to that, my little toe and the heel of my right foot is numb to any sensations.
57 2021-06-29 tingling Patient presents to the hospital with constant left sided chest pain, intermittent left arm tingling... Read more
Patient presents to the hospital with constant left sided chest pain, intermittent left arm tingling, nausea, vomiting, confusion and shortness of breath. Chest pain is worse with deep inspiration. Tests ran include EKG/CXR, chest CT, and labs. Admitted to hospital for observation work up. Serial EKG, serial troponin, CT head Patient was discharged AMA with cardiology and pulmonary consults. Medications on discharge: Aspirin 81, Spiriva, and albuterol HFA. Symptoms likely a result of exacerbation of other disease processed, but cannot rule out contributory effects of the vaccine
57 2021-07-02 unresponsive to stimuli, flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: 10-15 mins after vaccine, pt stated he was feeling dizzy. RPh went to take pt's BP, but pt fainted. called 911. pt woke up after 5 mins, no trouble breathing, but sweating. BP was 167/93 & pulse 78. First responders came and took BP and blood sugar. pt fainted again for 5-10 mins, stopped beathing few mins and decided to transport him to nearest ER. RPh called next day 6/29 & 7/1 but no response and left message.
57 2021-07-06 weakness Lost energy, head spins, tird all the time. Failed stress test, quad pupils surgury. Lost 3 months i... Read more
Lost energy, head spins, tird all the time. Failed stress test, quad pupils surgury. Lost 3 months income (17500) 225,000 dollar surgury, Is this long term effect. Sent email a couple time in the last 3 weeks
57 2021-07-10 cold sweat Woke up at 3:36 am on May 27th. I was feeling lightheaded when I got up to pee. Laid down and the fe... Read more
Woke up at 3:36 am on May 27th. I was feeling lightheaded when I got up to pee. Laid down and the feeling didn?t go away. Went into another room to put my head between my legs and the feeling did not go away. And then began to feel a pressure sensation in my chest and feeling clammy. Woke up my family and I went to the ER. When I arrived at the ER my heart rate was 32 bpm.
57 2021-07-12 discomfort On 05/01/2021 around mid-afternoon, the right side of stomach began to swell and I was in discomfort... Read more
On 05/01/2021 around mid-afternoon, the right side of stomach began to swell and I was in discomfort. I didn't want to eat. I knew there was something wrong. The next day I was going to go to the ER but I thought I would wait. I Saw my primary Doctor on 05/03/2021 and he told me drive to the ER and not to stop. He had arranged for the ER doctor to see me right away. They took a CT scan and they confirmed I had appendicitis and 7 am the next morning 05/04/2021 they took it out laparoscopically. I had ten hours before it was going to burst. I was in the hospital for two days. After my Doctor looked at CT scan, they found cysts on my kidney's, not in kidneys but on and they are simple cysts and not malignant. That could have come from the vaccine in hindsight. It was multiple cysts. I have a f/u with urologist on 12/15/2021.
57 2021-07-12 pain in extremity, numbness Constant lower extremities related pain unable to repair from day to day. Missing a ton of work. I ... Read more
Constant lower extremities related pain unable to repair from day to day. Missing a ton of work. I am currently awaiting scheduleing for nerve compression surgery on both arms with possible transposition. Numbness in both arms.
57 2021-07-15 numbness Developed numbness in left foot. Numbness is constant and similar to foot falling asleep. Experienc... Read more
Developed numbness in left foot. Numbness is constant and similar to foot falling asleep. Experiencing extreme fatigue.
57 2021-07-17 weakness shortness of breath; Low heart rate at 38 to 45; facial swelling; cough; low blood pressure 98/52 - ... Read more
shortness of breath; Low heart rate at 38 to 45; facial swelling; cough; low blood pressure 98/52 - 98/50; generalized weakness; This is a spontaneous report from a contactable other Healthcare professional (patient) reported for himself. A 57-years-old male patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was 57 years) as dose number unknown, single for COVID-19 immunization. The patient did not have any relevant medical history, concurrent conditions, relevant past drug history and known allergies. Concomitant medications were not reported. 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 had not been tested for COVID-19. On 06Jun2021 at 15:00 pm, the patient experienced low heart rate at 38 to 45, low blood pressure 98/52 - 98/50, generalized weakness, facial swelling, cough, shortness of breath. The patient was not hospitalized for the events. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests which included blood pressure measurement: low (98/52 - 98/50) and heart rate: low (38 to 45) on 06Jun2021. The patient received treatment with Amoxicillin, Benadryl, bedrest and oral hydration. The device date was reported as 27Jun2021. The outcome of the events at the time of last observation was resolving. Information about lot/batch number has been requested.
57 2021-07-17 hot flush Injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection side swe... Read more
Injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection side swelling, feeling unwell, hot flashes.
57 2021-07-17 pain in extremity Mild soreness in right arm; This is a spontaneous report from a contactable consumer, the patient. A... Read more
Mild soreness in right arm; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 30Mar2021 at 09:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient was allergic to pollen and dust mites. Concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 09Mar2021 at 09:15 (at the age of 57-years-old) 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 21:00, about 705 minutes after the second dose of vaccination (approximately 10 hours post injection as reported), the patient experienced mild soreness in the right arm and lasting into the next morning. Soreness continues to diminish. 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 event. The clinical outcome of the event mild soreness in right arm was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
57 2021-07-18 muscle spasms Cramping in my left hand index finger. Becomes stiff and unable to move
57 2021-07-19 tremor Serious chills; Had a 101 degree fever; Shaking; Yawning constantly (very weird); Creeping body ache... Read more
Serious chills; Had a 101 degree fever; Shaking; Yawning constantly (very weird); Creeping body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old male 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 25Mar2021 at 10:30 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no 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. The patient did not receive any other medications within 2 weeks of vaccination. On 29Mar2021 at 20:30, four days after getting first vaccine shot, the patient had sudden and severe reaction of side effects. At 8:30 PM, the patient was fine and then within minutes, the patient was having serious chills (the patient had a 101-degree fever), shaking, yawning constantly (very weird) and having creeping body aches. The patient struggled to bed and thankfully, the worst of it had receded within a couple of hours and patient had recovered in about 36 hours. While the patient cannot be 100 percent sure this was vaccine related. 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 treatments for the events of general body pain, yawning, shaking, fever and chills. The clinical outcomes of the events general body pain, yawning, shaking, fever and chills were resolved in 31Mar2021 at 08:30. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
57 2021-07-20 flushing, tingling Tingling hands, Lungs diminishing, rash, congestion, throat swollen, cough, flushed appearance, dila... Read more
Tingling hands, Lungs diminishing, rash, congestion, throat swollen, cough, flushed appearance, dilated pupils, burning sensation at the site
57 2021-07-20 flushing 15 minutes after injection, hives; red skin; feeling flushed; itchy; tight skin; This is a spontaneo... Read more
15 minutes after injection, hives; red skin; feeling flushed; itchy; tight skin; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 23Mar2021 at 20:00(at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included, the patient was allergic to iodine-based x-ray with contrast dye. Concomitant medications included, multivitamin (MANUFACTURER UNKNOWN), magnesium calcium supplement (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination the patient had not been tested for COVID-19 . On 23Mar2021,after 15min of vaccination, at 20:15 the patient experienced hives, red skin, feeling flushed, itchy and tight skin. Therapeutic measures included treatment with Benadryl tablet. The clinical outcome of the event hives, red skin, itchy, feeling flushed, tight skin were recovered. No follow-up attempts are needed. No further information is expected.
57 2021-07-21 pain in extremity, numbness, tingling After receiving the vaccine, I had the initial symptoms like a headache and arm soreness. Wednesday ... Read more
After receiving the vaccine, I had the initial symptoms like a headache and arm soreness. Wednesday night at 9 o'clock, the bottom of my left foot was asleep and had a tingling feeling, like lack of circulation. The next day Thursdays, it was now on my right foot just not as bad. By Friday morning, I couldn't walk. My left foot was much worse than the right foot. I had to wobble around because I couldn't walk properly. By Friday afternoon, I went to an urgent care and the doctor said it could be a blood clot so she told me to go to the ER to check to see if I had a blood clot. I decided not to go to the ER and get that checked. On Monday I made an appointment with Dr. because it didn't get any better. I seen him and he said it is possible that this is a side effect of the vaccine. There was no test he could run on me so he informed me to sit back and keep an eye on it. I have a follow up appointment with him on July 26th because the left foot at the bottom is still asleep and tingly. I still have a tingly feeling in my right foot as well, but I am able to walk now. About 2 weeks ago, I started to get a tingly feeling in the palm of my left hand. My feet has not got any better or worse. They are just tingling. I only had this happened to me after taking the 2nd dose because I have never had this issues before.
57 2021-07-22 migraine, pain in extremity Extremely sore Arm, fatigue, migraine and cloudy mind starting 12 hours after injection
57 2021-07-23 tingling Patient received first dose of pfizer at 12:10pm, at 12:25pm patient reported tingling (from elbow t... Read more
Patient received first dose of pfizer at 12:10pm, at 12:25pm patient reported tingling (from elbow to fingers) that lasted 10 min. Patient said after 10 min, it went away. He left after 30 min of observation
57 2021-07-26 bell's palsy Right Bells Palsy
57 2021-07-27 coordination abnormal, weakness, numbness Numbness in left theigh and both lower legs; Then progresses to numbness forearms, hands back of hea... Read more
Numbness in left theigh and both lower legs; Then progresses to numbness forearms, hands back of head, face and back...loss of strength coordination. Starting in May but really noticed after 2nd shot and got progressively worse in June saw local doctor in June had blood work done. Then starting July 17th having numbness increasing and trouble walking went to local Physicians Immediate Care on July 23, checked vitals, sensory tests and cognitive tests...at that time no need to go to ER with recommendation to see primary care provider within 3 days for follow up...went to ER on July 25 11pm checked in after midnight July 26...vitals, blood work, cat scan or MRI on brain...all came back fine...no issues
57 2021-07-27 pain in extremity This is a spontaneous report from a contactable consumer (patient). A 57 years old male patient rece... Read more
This is a spontaneous report from a contactable consumer (patient). A 57 years old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 31Mar2021 12:00 (at the age of 57 years)(Batch/Lot Number: ER8732) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 from 27Nov2020 to an unknown date. There were no concomitant medications. The patient previously took allegra and experienced allergies. Patient historical vaccine included Shingrix (he got Shringrix closer to 2 months ago). It was reported that, caller would like to know why he got sicker from the covid vaccine than from the natural infection itself which he had 27Nov2020. DSU: E-transmitting possible duplicate AE as caller stated they already reported AE to previous agent. Report# #. Caller states 'how do I have more symptoms than when I actually caught the virus?' after receiving the 1st dose of the covid vaccine. It was not anaphylaxis or an allergic reaction as his shortness of breath happened 1-2 days after receiving the dose and today was the 5th day and he was starting to feel better. Caller used the term (Withheld) information referring to information he has received so far. Unclear from who exactly. Additional Context: States he was calling about the Pfizer covid vaccine and was calling to report severe side effects he experienced last week and for some questions he had. States he had COVID four months ago on 27Nov2020 for about 2 weeks it took to shake it and he was no worse for wear but had 103 degree Fahrenheit temperature, lost 13 pounds, had a cough that drug on and he figured he was building immunities. States he does not know how long the immunity would last from having covid so he got the Pfizer COVID Vaccine and took the 1st dose on 31Mar2021; states the vaccine made him sicker with more symptoms and he was worse with the vaccine than he was with the actual disease covid. HCP information: Caller declined to provide HCP information and states he feels that is not necessary. Reporter details: Caller declined to provide email address. States by the evening on 31Mar2021, he had a headache, a very sore arm and never had a vaccine or shot that hurt as much as the Pfizer COVID Vaccine did; no further details provided. States what he experienced was listed as potential side effects and by that evening, he was feeling shivers, had a temperature, it made him really tired, pounding headache and elevated pulse; states his fever got up to 102.2 degrees Fahrenheit and he has probably hotter than that when he checked his temperature. Caller states these symptoms lasted through about 2 days; states the fever resolved with Tylenol and has not taken it this morning and kind of had leftovers and was trying to shake it; states he had 3-4 days of Tylenol and last night it seems to take the fever out. States the elevated pulse was up by 30 and he clarified to state his pulse usually runs normally by his wrist 55-75 resting heart beat and his pulse was 87 for about three days and the Pfizer vaccine jacked him up. States he had muscle joints, aches and pains and chills and doesn't know if the vaccine caused the fever or how severe but he had to get in bed and the 2nd day he did not get up. States the injection site was swelling and had pain and he had swollen lymph nodes. States if he had not felt better on Saturday morning he would have gone to the urgent care or to his HCP but he started to feel a little better. States the Pfizer vaccine caused a cough and shortness of breath for about 2 of the three days after he got the vaccine. States the elevated pulse struck him as strange and he did not experience this with the covid he had last fall and he did have the cough last fall with covid after Thanksgiving but was not short of breath and was able to keep exercising at that time and going through that hit him harder with the vaccine. Caller states he slept in his chair which cleared his lungs and it really surprised him that this occurred. States he takes vitamins and an allergy pill Allegra and takes Tamsulosin in the morning for his prostate deal and has taken all of these for years and started the Allegra probably last month since it was spring and he has allergies. States he got the 1st dose of Shingrix weeks earlier than the Pfizer vaccine but does not know the date; states he got Shringrix closer to 2 months ago when he had his annual physical and follow up and checked before scheduling the Shingrix and was told as long as it was two weeks apart from the Pfizer vaccine he was good and thought it might be around 6 weeks that he had the Shingrix and the HCP is his primary doctor and it was Dr. (Withheld). States he tried to do the online filing with the CDC website from the sheet they gave him but the website did not work and when the channels and numbers don't work it wastes everyone's time. States he got the Pfizer vaccine and the Shingrix vaccine in different arms on purpose. States his questions are if he can't get the disease from the Pfizer vaccine, why did he get additional symptoms that were more severe than when he had the disease covid; what is the level of effects with one dose of the Pfizer Vaccine and he would not have taken it if he knew how severe he would react and is not planning on getting the 2nd dose; if this is normal and was it expected and Pfizer is keeping quiet to coax everyone to get the vaccine right now he is not taking the 2nd dose, so what is good for the 1st and he feels like he had a booster with his 1st dose and feels like he had 2 doses since he actually had covid prior to the vaccine; people his age are older and have more severe side effects with the 2nd dose he has read and maybe this is the 2nd dose so why would he get the 2nd dose. Caller states he will take his chances on getting the disease. States he thinks it had been more than a month since he had the Shringrix vaccine and states he has no lot number, expiry date or NDC to provide. The patient underwent lab tests and procedures which included on an unspecified date, shake: 103 fahrenheit, shake 102.2 fahrenheit, heart rate: up by 30, heart rate: 87. Therapeutic measures were taken as a r Therapeutic measures were taken as a result of event fever got up to 102.2 degrees Fahrenheit. The outcome of the events fever got up to 102.2 degrees Fahrenheit was recovered on 02Apr2021, shortness of breath was recovering, for other events outcome was unknown. No follow-up attempts are possible. No further information is expected.
57 2021-07-28 tingling Shingles, maybe eye infection too? I got grit in my eye while working on my car 5 days after my firs... Read more
Shingles, maybe eye infection too? I got grit in my eye while working on my car 5 days after my first Pfizer shot. In the following days I began to be bothered by my eye and possible infection. A doctor video call 9 days after my Pfizer shot suggested antibiotics for my eye (Cephalexin). My girlfriend thought possibly shingles and suggested I ask doctor. 2nd doctor video visit, 11 days after Pfizer shot, doctor agreed Shingles likely - began antiviral Valacyclovir that evening for 7 day prescription . Continued with my 7 day prescription of Cephalexin as well. I had a relatively light bout of Shingles but the scaring and nerve tingling is still present two months later. I had face breakouts for about a month.
58 2020-12-31 weakness Tested positive Covid-19 infection, Cough, bronchospasm, weakness, muscle pain, chest congestion, n... Read more
Tested positive Covid-19 infection, Cough, bronchospasm, weakness, muscle pain, chest congestion, nasal congestion, Loss of appetite since vaccine given,
58 2021-01-01 pain in extremity Injection site pain and tiredeness day after injection. Severe left sided low back pain centered in ... Read more
Injection site pain and tiredeness day after injection. Severe left sided low back pain centered in sacroiliac joint, next day radiating into left leg and left thorax on Sunday, five days after injection. Severe disruption in all ADLs necessitating narcotic pain medication and an emergent visit with chiropracter. This pain is somewhat better but still persists today 14 days after onset!! This is absolutely miserable. I think I'd rather have COVID
58 2021-01-04 pain in extremity sinus issues; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; right arm ... Read more
sinus issues; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; right arm sore; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that a 58-year-old male patient received the first dose of BNT162B2 (lot number: EH9899; Expire Date: 31Mar2021), via an unspecified route of administration, in arm, right upper, on 16Dec2020 11:10 AM at single dose for COVID-19 immunization. The vaccination facility type was hospital. The vaccine was not administered at military facility. Patient's medical history (including any illness at time of vaccination) was none. The patient got ill from all pain medications- from prescription strength pain killers to OTC products such as tylenol, ibuprofen and aspirin. All of them make him sick- experienced hot flashes and nausea. No additional vaccines administered on same date of the Pfizer suspect vaccine. Prior vaccinations (within 4 weeks) was none. The concomitant medication included 2 different blood pressure pills, mentioning Lisinopril, but stated he did not think his blood pressure pills were relevant to what he was experiencing with the COVID-19 Vaccine. A MRI tech (clarified by caller as MRI technologist) at a hospital who received the COVID-19 Vaccine on 16Dec2020 (caller clarified he received the vaccine at 11:10 AM on 16Dec2020). Caller stated on 17Dec2020 he had signs of aches and pains allover, a sore arm (clarified as his right arm), no fever. He also experienced sinus issues and a loss of sense of smell. Clarified his right arm was sore for only a day, his sinus issues started on 20Dec2020, and his loss of the sense of smell gradually started on 22Dec2020. He stated on 23Dec2020 he had a COVID-19 test performed and the test result was positive for the COVID-19 virus. Caller asked since he had the first COVID-19 Vaccine dose, and has now tested positive for the COVID-19 virus, should he get the second COVID-19 Vaccine dose scheduled for 06Jan2021. Patient's Height: 5' 8'' as provided by caller, who stated he has shrunk 1''. No further details provided. Patient's Weight: 169 lbs. as provided by caller, who stated his weight was as of today. Reported he worked an overnight shift, clarifying he was injected with the COVID-19 Vaccine after his overnight shift was finished on the morning of 16Dec2020. He stated he came back to work later in the day on 16Dec2020 to work another overnight shift from 9:00 PM to 7:30AM. He said after he finished is overnight shift on the morning of 17Dec2020, he went home to bed, and woke up around 12:00 PM on 17Dec2020. He said when he woke up, he started to feel aches and pains allover, and after that noticed he was getting chills periodically. Clarified he experienced the aches and pains allover for a couple of days, and then the aches and pains went away. He said he then started to get the feeling a sinus infection was coming on, but he never got a sinus infection. He said the aches, pains, and chills came back. Reported his co-worker received the COVID-19 Vaccine on Saturday, 19Dec2020, clarifying his co-worker did well with the COVID-19 Vaccine. He clarified his employer was concerned that he may have exposed his co-worker to COVID-19 when the two worked together on the overnight shift of 22Dec2020. He said both he and his coworker kept their PPE on the whole time they worked except when the two ate dinner. He said the two of them sat at a round table about 6 feet apart, and took off their masks to eat. He said his partner agreed that the two of them were right at 6 feet apart when the sat at the table to eat dinner, so their employer deemed his coworker as low risk. Reported on 22Dec2020 he had to go back to work, so he was asked for his temperature at the time, which was 98.8 degrees. He did have a flu shot previously. He was instructed as long as he doesn't have a fever over 100 degrees, he can work. The caller said he went to work on 22Dec2020, and read an email from his employer's wellness office. He said the wellness office email spoke about the COVID-19 Vaccine side effects, and instructed employees to contact the wellness office with any COVID-19 Vaccine side effects experienced. He said he left a voicemail with his employer's wellness office explaining exactly what his COVID-19 Vaccine side effects were. He said he instructed his employer's wellness office call him in the afternoon because he was going to go home, go to bed, and wake up at noon on 23Dec2020. He stated he spoke with his employer's wellness office at around 11:30 AM on 23Dec2020, and the wellness office asked for him to go to the hospital, and have a COVID19 test. Caller stated his employer performed a COVID-19 nasal swab test, and on 24Dec2020, he was told he was COVID-19 positive. He said his employer backed up his quarantine start date to 17Dec2020 (the first day he experienced symptoms), and had him follow a 10-day quarantine until 27Dec2020. He stated today, 28Dec2020, was the first day he has been off quarantine. Reported he was not saying he got COVID-19 from receiving the COVID-19 Vaccine, but should he have the second COVID-19 Vaccine injection. Clarified his symptoms were intermittent, and started coming back around 20Dec2020. Reported he was not experiencing any scratchiness in his throat, and his eyes were not watering. He said he has had no cough, no sneezing, and no trouble breathing. He said in general, it felt like something was coming on, saying it was building up, but not getting out. Clarified he had gone back to work on 23Dec2020 to have his COVID-19 nasal swab test performed, and was told by his employer on 24Dec2020 that the COVID-19 nasal swab test was positive. No AE required a visit to emergency room or physician office. The outcome of the event right arm sore was recovered on 18Dec2020 and the other events was unknown.
58 2021-01-05 tingling Patient reported a fever and tingling to his face in the morning on 12/17/20. EHS followed up with h... Read more
Patient reported a fever and tingling to his face in the morning on 12/17/20. EHS followed up with him at 11:30 am on 12/17. He reported that the fever had resolved, and he was no longer having tingling to his face. He denied paralysis to his face, shortness of breath, and chest pain.
58 2021-01-06 numbness LEFT FACIAL AND TONGUE NUMBNESS - WORK UP CVA NEG Narrative: Developed left facial and tongue numbn... Read more
LEFT FACIAL AND TONGUE NUMBNESS - WORK UP CVA NEG Narrative: Developed left facial and tongue numbness 4 hours after vaccine - went to ER and admitted for 2 days, negative workup for CVA or other acute etiology. Symptoms resolved prior to discharge from hospital
58 2021-01-06 pain in extremity 01/06/2021 2nd dose: Sore arm, metallic taste in mouth mild nausea tired feeling 12/17/2020 1st dos... Read more
01/06/2021 2nd dose: Sore arm, metallic taste in mouth mild nausea tired feeling 12/17/2020 1st dose Pfizer vaccine :Sore arm, metallic taste in mouth mild nausea tired feeling and headache .
58 2021-01-06 tingling Facial redness and tingling sensation
58 2021-01-07 pain in extremity Heart rate increased; Swelling arm; Arm soreness; soreness at the vaccine injection site; This is a ... Read more
Heart rate increased; Swelling arm; Arm soreness; soreness at the vaccine injection site; This is a spontaneous report from a contactable consumer. A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1686, expiration date unknown) via an unspecified route of administration on 28Dec2020 at 13:00 (at the age of 58-years-old) at an unspecified dose in the upper left arm for COVID-19 vaccination. Medical history was reported as "no pre-existing conditions." He mentioned that he reviewed his allergies with a pharmacist prior to vaccination but did not specify what his allergies were. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was a tobacco user from an unknown date. The patient also reported a history of pneumonia which was reported to have occurred on seven different occasions following each of seven different vaccinations with the flu vaccine (manufacturers unknown) prior to 2013. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. He stated that after receiving the COVID 19 Vaccine he had side effects. He said the side effects went away at twenty four hours later, but he is still having one side effect, and has a concern. He clarified that he has an elevated heart rate since getting the COVID 19 Vaccine. He said he has never had an elevated heart rate before getting the COVID 19 Vaccine. He reported his heart rate is normally low, between 62-65. He said when he was at work on 28Dec2020 his heart rate was OK, but prior to going to bed that night his heart rate was 93 - 95. He said he thought at first he was just stressed. He also reported the COVID 19 Vaccine is the only thing he has taken. He mentioned that his heart rate has been down to 93, but then up to 105, and higher. He specified that he first presented with an elevated heart rate between 4:00 5:00PM on Tuesday, 29Dec2020. He said the elevated heart rate subsided enough for him to sleep later that day. He said he then started work around 10:00AM today, 30Dec2020, and felt the elevated heart rate in himself, and didn't say anything to anyone at work. He said when his heart rate got bad, it was about 12:30PM today and that today (30Dec2020) at work he didn't feel right at lunch, so he took his oxygen level and heart rate. He said his heart rate was 141. He said he called his primary care doctor, but didn't go to the emergency room. He said he doesn't have chest pain. He said he said something about his heart rate to a staff member at work, and the staff member tested his heart rate, and told him it was 141. He said he spoke to the nurse at his doctor's office, and the nurse said the doctor couldn't do much, and that he could go to emergency room or their practice's urgent care that is open until 7:00PM. He said he tried to go to the hospital emergency room, but ended up driving by because the hospital was so busy they were triaging patient's in the parking lot. The patient also experienced arm swelling and arm soreness following the vaccination on 28Dec2020. He said he could feel the soreness at the vaccine injection site when he moved his left arm. He stated that the swelling was down to his biceps and it resolved within 12- to 14 hours after the vaccination. As treatment, the patient took a generic 81 mg Baby Aspirin (UPC Number: 050428323922, Lot Number: P110657 Expiration Date: May2020) on 30Dec2020 between 3:00 and 3:30. The patient stated that the generic 81mg baby aspirin was an expired product. The clinical outcome of heart rate increased was not recovered and the clinical outcome of arm swelling, arm soreness and vaccination site soreness was recovered on 28Dec2020.
58 2021-01-10 feeling hot, flushing, tremor Patient complained of non visible arm shaking. Shortly thereafter complained of feeling warm and was... Read more
Patient complained of non visible arm shaking. Shortly thereafter complained of feeling warm and was becoming flushed. Nurse checked NP with reading of 212/104. Patient complained of headache and was taken to emergency department where BP was 240/112.
58 2021-01-10 hypersensitivity of all senses, flushing Taste of the vaccine in my mouth as soon as administered followed by full body flushing and sweating... Read more
Taste of the vaccine in my mouth as soon as administered followed by full body flushing and sweating and hypersensitivity to sound and touch sense of depersonalization, anxiety Next morning, severe muscle and joint pain
58 2021-01-11 speech disorder, sensory loss right arm weakness; loss of sensation intermittently; lightheaded, dizzy; briefly difficult to speak... Read more
right arm weakness; loss of sensation intermittently; lightheaded, dizzy; briefly difficult to speak on one occasion; This is a spontaneous report from a contactable physician. A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ELO142, expiry date: unknown), intramuscular on the right arm on 04Jan2021 15:00 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient experienced right arm weakness/loss of sensation intermittently lasting <5 minutes on at least 5 occasions on 05Jan2021. Patient also experienced lightheaded, dizzy, and briefly difficult to speak on one occasion on 05Jan2021. The events resulted in an emergency room visit but no treatment was given. Outcome of the events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. There were no other vaccine administered within 4 weeks prior to the COVID vaccine.
58 2021-01-12 weakness, pain in extremity Severe arm pain Fatigue No energy
58 2021-01-12 bell's palsy, slurring Less than 2 days after having the 1st shot of the COVID-19 vaccine, I woke up at 2am and experienced... Read more
Less than 2 days after having the 1st shot of the COVID-19 vaccine, I woke up at 2am and experienced Bell's palsy on the left side of my face...and had minor heart pain...was dizzy...had loss of balance...slurred speech, I had all of the symptoms of a stroke. Later in that same morning the swelling starting going down, so I waited to go to the emergency room...did not want to spend the money for all of the tests. I woke up the next morning and still had heart pain, so I decided to go to emergency room .
58 2021-01-12 pain in extremity fatigue; threw up a little; patient received the second dose of BNT162B2 on 06Jan2021; soreness in h... Read more
fatigue; threw up a little; patient received the second dose of BNT162B2 on 06Jan2021; soreness in his right arm/soreness in his legs/legs were hurting; did not sleep good; sick to his stomach; This is a spontaneous report from a contactable consumer (patient himself). A 58-year-old male patient the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0140), via intramuscular on 06Jan2021 15:00 in right arm at 0.3 mL (30mcg), single for preventative. There were no medical history and concomitant medications. Patient had the first dose of BNT162B2 vaccine on 19Dec2020 for covid-19 immunization. No investigation assessment was received. Patient had the second Pfizer COVID19 vaccine shot yesterday around 15:00 on 06Jan2021. He was asking if it was normal to be sore, patient had a little fatigue on 07Jan2021 and be sick to his stomach in Jan2021. The soreness in his right arm started last night (06Jan2021). He experienced soreness in his legs. He did not sleep good and his legs were hurting last night through the night. As of now his legs do not seem as bad. Patient went to work this morning and then he left work to go back home. He ate a cake and milk before he left for work. He threw up a little on 07Jan2021. It did not take much for him to gag, he even gags when brushing his teeth. Right now and within the last hour, he had not felt sick to his stomach. Outcome of soreness in his right arm/soreness in his legs/legs were hurting was not recovered, of fatigue was recovering, of sick to his stomach was recovered on 07Jan2021, of other events was unknown.
58 2021-01-13 mild one side paralysis He collapsed with left sided hemiparesis; Stroke; Rt basal ganglia hemorrhage w/ edema and mass effe... Read more
He collapsed with left sided hemiparesis; Stroke; Rt basal ganglia hemorrhage w/ edema and mass effect.; Rt basal ganglia hemorrhage w/ edema and mass effect.; Low platelets, 114; His bp as high as 200s/100; Hand weakness; Myalgia; Fever; Severe fatigue; This is a spontaneous report from a contactable physician. A 58-year-old male patient received first dose of bnt162b2 (Pfizer BioNTech COVID vaccine), intramuscularly on 16Dec2020 at a single dose for COVID-19 immunization. Medical history included hypertension with reported med noncompliance in the last few months due to stress. Concomitant medication included hypertension medications in two weeks. The patient was presumed neg covid status prior to vaccine. He worked as a Pulm/critical care physician. He reported fever, myalgia, fatigue on 16Dec2020. Next day (17Dec2020), he took off from work due to his symptoms. The following day (18Dec2020), he came to work. He c/o ongoing severe fatigue & hand weakness in am. Staff noted him to be evaluating his hands during clinic. At 12:15, he collapsed with left sided hemiparesis. The reporter had suspicion for stroke. He was transported to the Emergency Room (ER), head CT showed Rt basal ganglia hemorrhage w/ edema and mass effect. Labs notable for Low platelets, 114 (unknown baseline) on 18Dec2020, normal coags on an unspecified date. BP recorded as 179/101, but it was noted in trauma room his bp as high as 200s/100. He had a history of hypertension with reported med noncompliance in the last few months due to stress. Patient was transferred for further care. Full course was unknown but had rebleed there with low plts. Adverse event (he collapsed with left sided hemiparesis) resulted in hospitalization (22 days), life threatening illness (immediate risk of death from the event), disability/incapacitating or permanent damage. Treatment was received for adverse events. Results of tests and procedures for investigation of the patient: on 18Dec2020, Nasal Swab test: negative. The outcome of events was not recovered. Unknown if 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 not tested for COVID-19. Information on the lot/batch number has been requested.; Sender's Comments: Collapsed with left sided hemiparesis/suspicion for stroke are as consequences of basal ganglia hemorrhage with edema, which is caused by worsening of hypertension. Low platelet also contributes to brain hemorrhage. All these serious events are unrelated to the vaccine use. 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.
58 2021-01-13 tingling Tingling sensation, flu like symptoms, chest pain, sore throat, tiredness. ER visit for chest pains... Read more
Tingling sensation, flu like symptoms, chest pain, sore throat, tiredness. ER visit for chest pains, labs and testing done, heart attack ruled out. Patient reported that symptoms were result of Covid Vaccine side effects. Onset of symptoms began on 1/11/21, ER visit on 1/13/21 for chest pains, returned home on 1/13/21 after tests were completed. Patient reports feeling better.
58 2021-01-15 impaired body coordination, tremor Patient had COVID-19 infection April 2020, ataxia and myoclonus developed, treated with IVIG and ste... Read more
Patient had COVID-19 infection April 2020, ataxia and myoclonus developed, treated with IVIG and steroids at that time. June 2020 had full recovery after PT. Pt received Pfizer COVID-19 dose 1 on 12/22/20 and developed similar symptoms to above on 1/7/2021. Ataxia and tremor on examination, no myoclonus at this time.
58 2021-01-16 pain in extremity, tremor Severe body aches, chills, fever, shaking, lethargy all staring about 12 hours after 2nd dose; sympt... Read more
Severe body aches, chills, fever, shaking, lethargy all staring about 12 hours after 2nd dose; symptoms lasted about 18 hours. Mild arm soreness occurred with both doses.
58 2021-01-19 pain in extremity initial symptoms 1 hour post vaccine: joint pain left arm (shoulder/elbow/wrist), joint pain bilater... Read more
initial symptoms 1 hour post vaccine: joint pain left arm (shoulder/elbow/wrist), joint pain bilateral ankles and joint pain to right foot specifically 2nd and 3rd MTP, back pain and headache. Left arm pain, back pain and headache resolved within 48 hours. Patient has continued with moderate pain into right foot (2-3rd MTP joints), now with forefoot edema and erythema and continued bilateral ankle pain.
58 2021-01-20 feeling cold Came down with cold chills and sweats. And feeling run down
58 2021-01-20 tremor Hands started to shake; shaking of the hands that I could barely write/My legs were shaking very bad... Read more
Hands started to shake; shaking of the hands that I could barely write/My legs were shaking very bad while I was walking down three slides of stairs; My hands became weak; Soreness of the arm the injection site for 2 days; This is a spontaneous report from a contactable physician (patient himself). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685; expiry date: unknown) via an unspecified route of administration, on 22Dec2020, at a single dose, for COVID 19 immunization. Relevant medical history included COVID infection last Apr2020. On the peak of the COVID pandemic he had the COVID infection, he lost the sense of taste and smell, had diarrhea although he did not have fever and did not have coughing. He also has medical history of opsoclonus myoclonus ataxia syndrome. He was tested for COVID, he was positive 2 times and then they did PET scan, MRI from head to toe. They were looking for tumor, neuroblastoma, what was causing the shaking, the myoclonus, the opsoclonus, the ataxia, they could not find anything. They gave him convalescent plasma and then they gave him immunoglobulin human normal (IVIG) 5 doses and they gave him high dose of steroid to the point that his blood sugar was reaching sky high they have to give him insulin. He was hospitalized 2 times, 3rd time was 2 days and sent home and then it got worst, so he was readmitted for another '3' days. So, he was sent home on clonazepam, it makes him drowsy and he went for physical therapy and slowly after almost after 8 weeks his symptoms disappear, and he was able to go back to work. His symptoms all recovered by the end of May, towards the beginning of Jun2020 he went back for the swab test, it was negative, COVID PCR negative and my antibody was positive. Concomitant medications included clonazepam, metformin and simvastatin. Patient went back to work and have no symptoms until this 07Jan2020. Like almost 3 week or two and half weeks after he received the Pfizer COVID vaccine. Two and half weeks later he started having symptoms like shaking of the hands that I could barely write and yesterday he could barely walk down the stairs. The patient received the Pfizer COVID vaccine on 22Dec2020. Immediately after the vaccination the patient felt that his hands became weak. He ignored it because it went away, like after a minute or so it went away. He went home and nothing happened, except for the soreness of the arm the injection site for 2 days, which really did not bother him. Then this past Thursday, 07Jan2021, he went to the church, he was lightning a candle and his hands started to shake, he can barely light a candle. He was able to do it although his hands were shaking. So, he went home. He ate breakfast, and called his neurologist and he said just to observe and then it went away. On Saturday night (09Jan2021) he noticed that his hands were shaking again when he was typing in the keyboard. He can manage to type but his hands were shaking. He went to sleep and just ignored it. Then yesterday, Sunday he worked again, it became worse, his handwriting was shaking. He was really holding on to the pen to write legibly and then he was in the third floor hospital, elevators did not work. So, he walked down through the stairs, both of his legs were shaking very bad while he was walking down three slides of stairs but he thought he came to the ground so he was able to walk on the flat floor on the street and able to walk home. The patient did not receive treatment for the events. Outcome of the event tremor was unknown, while for the other events was unknown. The consumer considered a causal relationship between the events and the vaccine.
58 2021-01-21 weakness Tempeture of 101, Spike in blood pressure, Spike in sugar of 310, Pains in Joints weakness, Dizzines... Read more
Tempeture of 101, Spike in blood pressure, Spike in sugar of 310, Pains in Joints weakness, Dizziness
58 2021-01-21 numbness Has onset of symptoms after receiving the COVID vaccine: abdominal tightness, shooting pains in fac... Read more
Has onset of symptoms after receiving the COVID vaccine: abdominal tightness, shooting pains in face, numbness to back of head over the next 3 days. He is unsure if it is vaccine related. He is following up with Clinic to determine if this is a reaction to the vaccine or if he has something else going on.
58 2021-01-21 pain in extremity upper bicep pain/soreness around upper part of bicep; tendonitis; lymphadenopathy; sore deltoid; Thi... Read more
upper bicep pain/soreness around upper part of bicep; tendonitis; lymphadenopathy; sore deltoid; This is a spontaneous report from a contactable Other Healthcare Professional (patient). This 58-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot # EI0142, expiry date Mar2021), intramuscular once to the left deltoid, on 28Dec2020 at single dose for COVID-19 immunisation. Age at vaccination was 58-years-old. Medical history was none. Concomitant medications included an antihypertensive medication taking for several years. On 28Dec2020 the patient experienced side effects including sore deltoid (lasted for 2 days, Dec2020), and on 01Jan2021 the patient experienced upper bicep pain which he felt 5 days later (his friend said it may be lymphadenopathy). The caller had the COVID vaccine on 28Dec2020, and from 28Dec2020 he had a sore deltoid for a couple days, but then almost a week later developed, he thought it was tendonitis, it was the upper part of his bicep, really he could not extend his arm all the way, it was so painful in that area, and it's still somewhat painful, but better. The sore deltoid was pretty much after the shot and into the next 48 hours, that went away, then he noticed this soreness around the upper part of his bicep, not until, probably, maybe 5 days later, on 01Jan2021. He was chatting with someone, who mentioned soreness in the underarm area, that person felt it was lymph nodes, so maybe, there is possibility, caller thought this was muscle pain, as it hurts when he tried to extend his arm, it does not hurt when sitting here, but when he extends, especially over his head, it is really quite painful but it's lessened, he thought it was a tendonitis, but it could be the lymph nodes active or enlarged, he is not sure, he has never noticed lymph node pain, so he never knew what it was. Causality for soreness around upper part of bicep was reported as yes. He is pretty sure, since he has not done anything that aggravated that muscle, he can't think of anything, and it is in the general vicinity of the injection. States he is on an antihypertensive medication, but has been taking it for several years. He doesn't want to go through a report for the person he spoke to, who mentioned soreness in the underarm area, but it is interesting: the caller told him that had soreness, caller knows he also did report it, he reported it to Pfizer, actually he doesn't know if it was Pfizer or Moderna, but he reported it to whichever company, and said he thought was inflamed lymph nodes, so that was the first time he thought it was not muscle, but maybe the lymph node's reaction to vaccine, he has never experienced this kind of discomfort, he could not straighten his arm, as he would straighten the pain was at the upper insertion at the bicep, so that is where he came to this conclusion, his preliminary conclusions, he never thought it would persist this long. He thought, as time went by, it would be better tomorrow, and it has gotten better, but has not gone away. Sore deltoid was reported as non-serious while soreness around upper part of bicep was reported as serious medically significant because it has persisted for so long, he would have not expected it to keep going on, but it is almost going on two weeks. Outcome of the event soreness around upper part of bicep, lymphadenopathy, and tendonitis was not recovered while the outcome of the sore deltoid was recovered in Dec2020. His second dose is scheduled tomorrow (14Jan2021) and wants to know if he can still take it.; Sender's Comments: There is a reasonable possibility that the events myalgia and lymphadenopathy were related to BNT162b2 based on known drug safety profile. Based on the close temporal relationship, the association between the event tendonitis 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.
58 2021-01-22 muscle spasms Chest pain and cramping with difficulty breathing.
58 2021-01-22 sciatica Left lower extremity sciatica came on gradually beginning Dec 31, 2020. Symptoms worsened requiring... Read more
Left lower extremity sciatica came on gradually beginning Dec 31, 2020. Symptoms worsened requiring hospitalization on January 11, 2021. MR Lumbar spine demonstrated a stable mild disc bulge left paracentral at L5S1 unchanged from 2013.
58 2021-01-24 weakness Body aches, fatigue, weakness
58 2021-01-28 tingling, pain in extremity, tenderness Pfizer vaccine in LH arm, arm was sore for 2 days, arm continues to feel tender and has pins and nee... Read more
Pfizer vaccine in LH arm, arm was sore for 2 days, arm continues to feel tender and has pins and needles feeling, worse when elevated or moved
58 2021-01-28 tremor, feeling cold Pt reported to Covid-19 vaccination clinic for Pfizer lot #EL3302 first dose.Reported allergy to sul... Read more
Pt reported to Covid-19 vaccination clinic for Pfizer lot #EL3302 first dose.Reported allergy to sulfa drugs and was in observation for 30 minutes. At approximately 25 minutes post vaccination at 10:15am, Pt signaled that he wanted to leave & was instructed to stay 5 more minutes. Pt anxious and began to shake, saying he could not breathe. Vitals were 147/88, HR 86, O2 98% on RA. Pt was reclined on floor and reported being cold and was striking his head on the blanket; head stabilized. Patient was alert and oriented x3, but complained of chest pain. EMS called, arrived at 10:25, Vitals: 144/92, HR83 O2 99% on 2L. Pt stable & transported to hospital by EMS at 10:35am
58 2021-01-29 pain in extremity Severe pain in injection arm, profuse sweating on second day. A lot of vomiting causing me pass out... Read more
Severe pain in injection arm, profuse sweating on second day. A lot of vomiting causing me pass out out and be taken to the hospital via ambulance.
58 2021-01-31 pain in extremity General malaise; Back pain; flu like symptoms; couldn't go back to sleep; generalized muscle pain; C... Read more
General malaise; Back pain; flu like symptoms; couldn't go back to sleep; generalized muscle pain; Chills; Injection site pain; arm soreness; he did have injection site pain again and arm soreness after the second injection; This is a spontaneous report from a contactable physician (patient). A 58-year-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL1203), via an unspecified route of administration in left arm on 14Jan2021 09:00 at single dose for COVID-19 immunization. Vaccination facility type was hospital. Medical history included hypertension, high cholesterol, heart rate irregular. Ongoing concomitant medications included metoprolol for heart rate control, telmisartan (TELMISARTAN) oral at once daily for Hypertension, rosuvastatin calcium (CRESTOR) oral at 40mg once daily for high cholesterol. The patient received first dose bnt162b2 (Lot Number: EJ1685) at the age of 58-year-old for COVID-19 immunization and experienced injection site pain and arm was pretty sore. Reports he received the first dose of the Pfizer COVID 19 vaccine three week prior to the second dose. First states that was about 14Dec2020, but then clarified from his vaccine card, he received the first dose of the vaccine 23Dec2020 at 09:00AM in the left arm. He noticed injection site pain that lasted about two days and his arm was pretty sore. Both of these effects all completely resolved before the second dose. He received the second dose of the vaccine 14Jan2021 at 09:00 in the left arm. That night on 15Jan2021 at about 03:00AM in the morning he woke up with chills and general muscle pain, which he described as flu like symptoms. Adds he took his temperature but it was normal on 15Jan2021. He couldn't go back to sleep on 15Jan2021 so he took some Motrin. The next morning 15Jan2021 at 07:00 AM when he woke up, he felt okay but then in the late afternoon he started to feel the pain in his back and chills. He took Motrin and his pain and chills were gone after four or five hours. Adds it seemed like it took awhile for the Motrin to have an effect that time. Then the third day 16Jan2021, he had the same back pain and chills. He took Motrin and the pain and chills went away after 2 hours. The fourth day he only felt mild muscle pain in his back and just a little chills. He took Motrin again and it went away pretty quickly. Clarified he took Motrin at 16:00 and his pain had gone away by 16:30. He was fine by 19:00PM that evening. Adds he felt general muscle pain starting the first night he woke up and continuing with the back pain but each day all his symptoms got milder. The generalized muscle pain was minimal yesterday. He was still sore but not as bad. All of his symptoms are gone now; so far today he has not had any symptoms of the effects he reported. Adds he did have injection site pain again and arm soreness (Jan2021) after the second injection but it resolved completely by the next day (15Jan2021) after the second dose and was not as bad. Adds he felt a generalized malaise from the time he woke up on 15Jan2021 at 03:00AM after the second dose that has completely resolved when all his other symptoms resolved yesterday (17Jan2021). No any AEs require a visit to physician or ER. Therapeutic measures were taken as a result of the events. The outcome of events Injection site pain and arm soreness was recovered on 15Jan2021. The outcome of other events was recovered on 17Jan2021. Relatedness of drug to reaction(s)/event(s) was reported related.
58 2021-02-01 pain in extremity mild numbness of teeth and tongue; mild numbness of teeth and tongue; heaviness of head; I was very ... Read more
mild numbness of teeth and tongue; mild numbness of teeth and tongue; heaviness of head; I was very tired; arm pain lasted 2 days; This is a spontaneous report from a contactable Other HCP. This Other HCP reported himself that the 58-year-old male patient received second dose of bnt162b2 (COVID 19, Pfizer), via Intramuscular on 11Jan2021 10:00 AM on Left arm at single dose for covid-19 immunisation. Medical history included history of mitral valve repair and pacemaker. Known allergies was not known. Concomitant medications included Metoprolol 25 mg, Baby aspirin 81 mg, Antihistamine( Certizine hidrocloride 10mg,Costco brand). The patient previously took first dose of bnt162b2 (COVID 19, Pfizer), via Intramuscular on 21Dec2020 10:00 AM on Left arm at single dose for covid-19 immunisation. No other vaccine in four weeks. Side effect occurred after his 2nd dose (11Jan2021) he was feeling mild numbness of teeth and tongue heaviness of head after 30 minutes of vaccine. It lasted 5-6 hours, also he was very tired, and arm pain lasted 2 days. The events started from 11Jan2021 10:00 AM. The outcome of the events feeling mild numbness of teeth and tongue, heaviness of head was recovered on 11Jan2021. The outcome of the other event was recovered in Jan2021. No Covid prior vaccination. Covid tested post vaccination. covid test post vaccination included Rapid test on 09Jan2021 with covid test result: Negative. Information on the lot/batch number has been requested.
58 2021-02-03 facial paralysis, bell's palsy Had 1st COVID-19 vaccine (pfizer) 1/5 1/13 noticed right lower eyelid started twitching (this is not... Read more
Had 1st COVID-19 vaccine (pfizer) 1/5 1/13 noticed right lower eyelid started twitching (this is not a new issue for him and frequently happens when fatigued) 1/20 sharp intermittent pain in right inner hear pinna which stopped 1 week ago 1 week ago noted some slight right facial droop which has persisted 2nd vaccine given 1/26 (prior to him seeking care for symptoms) He was seen in my office on 1/29 where he was treated for Bells Palsy.
58 2021-02-03 pain in extremity Injection site pain; Arm pretty sore; This is a spontaneous report from a contactable physician who ... Read more
Injection site pain; Arm pretty sore; This is a spontaneous report from a contactable physician who reported for himself. A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EJ1685) via an unspecified route of administration on 23Dec2020 at 09:00 (at the age of 58-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included a history of anaphylaxis to latex which predated treatment with the Pfizer COVID-19 vaccine, heart rate control, hypertension and high cholesterol; all from unspecified dates and unspecified if ongoing. It was also reported that the patient's medical history was "none" and that the patient had no illness at the time of vaccination. Family medical history was reported as "none". Concomitant medications included ongoing metoprolol taken for heart rate control taken from an unspecified date ("taking for two years"), ongoing telmisartan taken for hypertension orally from an unspecified date ("taking for two years") at 1x/day (take once daily by mouth) and ongoing rosuvastatin calcium (CRESTOR; strength: 40mg) taken for high cholesterol from an unspecified date ("taking for 10 years") at 40mg, 1x/day. The patient did not receive any additional vaccines on the same date of the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Dec2020 the patient experienced "injection site pain" and "arm pretty sore". It was reported that "a physician called regarding the Pfizer COVID-19 vaccine. The patient reported that he received the second dose of the vaccine on Thursday and was advised by his medical director to call Pfizer to report his symptoms. He reported that he received the first dose of the Pfizer COVID-19 vaccine three weeks prior to the second dose. The patient first stated that was about 14Dec2020, but then clarified that per his vaccine card, he received the first dose of the vaccine on 23Dec2020 at 0900AM in the left arm. The patient stated that he noticed injection site pain that lasted about two days and his arm was pretty sore. Both events completely resolved before the second dose." It was reported that the events did not require a visit to the physician or to the ER. It was reported that there were no relevant tests. The clinical outcomes of the events "injection site pain" and "arm pretty sore" were both recovered/resolved on 15Jan2021. The reporter considered that there was reasonable possibility (method of assessment: Global introspection) that the events "injection site pain" and "arm pretty sore" were related to BNT162B2.
58 2021-02-04 pain in extremity Sore arm; mild fatigue for 24 hours; mild shortness of breath upon exertion (persists); cough began ... Read more
Sore arm; mild fatigue for 24 hours; mild shortness of breath upon exertion (persists); cough began within 1 hour of 2nd vaccination; This is a spontaneous report from a contactable nurse, the patient. A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL3248), via intramuscular route in the right arm on 19Jan2021 16:30 as a single dose for COVID-19 immunization. Historical vaccine data included the first dose of BNT162B2 on 29Dec2020 at 16:30 (at the age of 58-years) via intramuscular route in the right arm. Medical history included rheumatoid arthritis. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included tofacitinib citrate (XELJANZ XR), methotrexate, atorvastatin (LIPITOR), lansoprazole (PREVACID), and celecoxib (CELEBREX). The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 19Jan2017 at 17:30, the patient experienced sore arm, cough began within 1 hour of 2nd vaccination and persisted 2 days later, mild shortness of breath upon exertion which persisted, and mild fatigue for 24 hours. The patient did not receive any treatment for the events. The patient was not tested for COVID-19 post vaccination. The clinical outcome of the events sore arm, fatigue, shortness of breath, and cough was reported recovering. No follow-up attempts are possible. No further information is expected.
58 2021-02-07 facial paralysis, face paralysis Bell' Palsy . Right side facial weakness. Sudden onset ten days after vaccine.
58 2021-02-10 numbness Facial numbness around right eye; This is a spontaneous report from a contactable physician (patient... Read more
Facial numbness around right eye; This is a spontaneous report from a contactable physician (patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular first dose (lot number: EH9899) on the left arm on 26Dec2020 07:15 and the second dose (lot number: EL1283) on the left arm on 25Jan2021 07:15 at a single dose for COVID-19 immunization. Medical history included allergies, high cholesterol; known allergies: dust, pollen, trees, grasses. Concomitant medication included ubidecarenone (COQ10 [UBIDECARENONE]), colecalciferol (VITAMIN D [COLECALCIFEROL]), fexofenadine, atorvastatin calcium (ATORVASTIN), montelukast and multivitamins. The patient experienced facial numbness around right eye and migrating 11 hours after injection. Similar sensation 2 weeks after first vaccination in Jan2020. No treatment was received for the event. 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 event was unknown.
58 2021-02-10 pain in extremity Pain in arm spreading to torso. Shooting pains in torso and upper legs. Fatigue, headache. Symptoms ... Read more
Pain in arm spreading to torso. Shooting pains in torso and upper legs. Fatigue, headache. Symptoms started 12 hours after vaccination, and persisted until 36 hours.
58 2021-02-16 weakness Immediately experienced chills; elevated pulse/heart rate and low oxygen; elevated fever; pulse/hea... Read more
Immediately experienced chills; elevated pulse/heart rate and low oxygen; elevated fever; pulse/heart rate went to 120; fever went to 102.5; and oxygen at 94. After 4 hours, metrics returned to within normal range. Weak and tired the rest of evening and into the next day.
58 2021-02-20 tremor Onset of sweating, lightheadedness, dizziness, shakiness, about 5 minutes after vaccination. Taken t... Read more
Onset of sweating, lightheadedness, dizziness, shakiness, about 5 minutes after vaccination. Taken to medical area, BP 180/100s, HR 90, Temp normal. Exam normal except for hand tremors. Minimal liquid and no food intake in last 24 hours. POC glucose 96 a minute or two after eating crackers. Given more food and water. Initial symptoms improved but continued hand tremors and persistent hypertension to high 170s/high90s for over 1 hour, HR 70s. One BP 160s/90s HR 60 but then back to BP systolic 170s. Transferred patient to local emergency room for further evaluation. Patient reported that he was discharged from ED after several hours that evening.
58 2021-02-24 flushing Lightheaded and flushed, slightly dizzy when standing. 3:56pm evaluated by EMS. BP 140/92, HR-98,... Read more
Lightheaded and flushed, slightly dizzy when standing. 3:56pm evaluated by EMS. BP 140/92, HR-98, O2-98% on room air. 4 pm so resolved and discharged.
58 2021-02-26 cold extremities, burning sensation, pain in extremity, tingling No initial symptoms other than sore arm at injection site which lasted for about 23 hours. On Januar... Read more
No initial symptoms other than sore arm at injection site which lasted for about 23 hours. On January 28 in the middle of the night woke up with pain in left hand. Could not move left hand. Was sleeping on back - not on arm or hand. No restricted blood-flow. Massaged hand and it became responsive. This was followed by burning and tingling sensation in hand. Hand was cold to touch first day. Burning and tingling and muscle tension increased for first couple days. Would be intermittent and location varied. Hands and feet most common. Left back scapular area and left pectoral muscle common. Muscle tightness would cause joint pain without signs of any redness. No temperature. No discoloration. Not as bad in middle of the day. After a few days. When second shot was administered on February 9 at 12:10 AM went home and all sensations stopped for about 12 hours. Took Tylenol with some benefit to diminish but not end symptoms. In past few days have read about taking antihistamines which has often helped. Symptoms are not as intense as they started out to be, but they continue to linger. Muscle tightness has largely given way to fluttering sensation or paresthesia and burning is mostly in bottom of left foot only. Any muscle tightness can be rubbed out (massage) for the most part. Occasional joint tightness continues in fingers - crack knuckles and it improves.
58 2021-02-27 pain in extremity Next day had sore left arm 2 days after injection had mild nausea, mild fever and moderate headache ... Read more
Next day had sore left arm 2 days after injection had mild nausea, mild fever and moderate headache 3 days woke with all symptoms gone except one new symptom - very red conjunctivitis - left eye red cornea
58 2021-03-01 numbness Tongue and right side of face went numb within minutes of receiving in right arm. Continued getting ... Read more
Tongue and right side of face went numb within minutes of receiving in right arm. Continued getting worse. After getting home, I waited 2 hours and took Benadryl and went to bed. Morning still numb but better. Feels like I can?t taste on that side. Also have a headache and just overall feeling lethargic.
58 2021-03-01 paralysis Pt reported he got the second COVID vaccine at 8:33 am at the Center at an event run by Health Clin... Read more
Pt reported he got the second COVID vaccine at 8:33 am at the Center at an event run by Health Clinic. At 10 am he began to feel unwell describing "disorientation" which upon further explanation seems he is describing difficulty with his proprioception, ie not able to tell where his body is in space, and disequilibrium, ie having to stop and hold on to something while walking. This lasted most of the day and subsided by evening. He has continued to have ongoing shorter episodes 3-4 times per day lasting 5-10 minutes. In addition he has noted increasing weakness in his right thigh, particularly when going from sitting to standing and the through swing while walking. He describes these as "paralytic attacks" that occur once or twice per day and last hours. Both symptoms are similar to those he had post CVA in 2019 and greatly improved with PT and home exercises. In addition he has noted fecal urgency and fecal incontinence in the last couple of weeks, he is unsure if this is directly related to the vaccine.
58 2021-03-02 feeling hot 103 degree fever; chills; body aches; headache; feeling hot through the night; Got sick; This is a s... Read more
103 degree fever; chills; body aches; headache; feeling hot through the night; Got sick; This is a spontaneous report from a contactable consumer (the patient). A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided, expiry date May2021), via an unspecified route of administration in the left arm on 30Jan2021 10:00 (at the age of 58-years-old) as a single dose for COVID-19 immunization; and apixaban (ELIQUIS, lot number ABA8272S, NDC 0003089421, expiry date Oct2021) film-coated tablet, via an unspecified route of administration from an unspecified date to 31Jan2021 at 5 mg, twice daily for cerebrovascular accident prophylaxis. Medical history included: he had tested positive asymptomatically for COVID due to contact contamination on 02Jan2021 or 03Jan2021, blood pressure, and A-fib (atrial fibrillation). Concomitant medication included ongoing metoprolol for blood pressure. There were no vaccines administered on same date with the Pfizer vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient stated that he got sick after getting the vaccine (on 30Jan2021) and had an important question. He got a fever (31Jan2021) and all that stuff that lasted like a day and a half after getting the vaccine, just like a million other people. But he missed the part about asking a doctor about taking his blood thinner, which he took as normal up through the day that he got the vaccine and the next morning, then he stopped it. The patient clarified that he got the vaccine on Saturday (30Jan2021), stopped the blood thinner on Sunday (31Jan2021), the sickness subsided around Monday (as reported), but he still hasn't gone back on the blood thinner. He wanted to know when it was safe for him to start taking the blood thinner again, and he needed to know what to do for the second vaccine. The clinical course was as follows: He got the first dose of the vaccine on 30Jan2021 at 10:00 and at 22:00 he started feeling hot through the night. On Sunday, 31Jan2021, he had 103 degree fever, chills, body aches, and a headache. He clarified that he recovered completely by Wednesday, 03Feb2021. He had been on Eliquis for years for A-Fib. He stopped taking it once he got sick after getting the vaccine and went back and read the material and noticed what it said about the blood thinner. He did not go to the emergency room or physician's office. The action taken in response to the events for apixaban was temporarily withdrawn. The outcome of the events was recovered on 03Feb2021. Follow-up (05Feb2021): This is a spontaneous report from a contactable consumer based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-013684), license party for apixaban (ELIQUIS). This case was received via Pfizer Inc (Reference number: #) on 05Feb2021 and was forwarded to BMS on 09Feb2021. This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (103 degree fever), CHILLS, PAIN (bodyaches) and HEADACHE in 58-year-old male patient who received apixaban (Eliquis) film-coated tablet (batch no. ABA8272S) for Cerebrovascular accident prophylaxis. CO-SUSPECT PRODUCTS included Covid-19 Vaccine injection for COVID-19 immunisation. Concurrent medical conditions included Blood pressure abnormal. On an unknown date, the patient started Eliquis (batch no. ABA8272S) (unknown route), 5 milligram twice a day. On 30Jan2021, the patient started Covid-19 Vaccine (unknown route) Unknown dose by injection in left arm. On 31Jan2021, an unknown time after starting Eliquis, the patient experienced PYREXIA (103 degree fever), CHILLS, PAIN (bodyaches) and HEADACHE. Eliquis (Unknown) was interrupted due to event. On 03Feb2021, PYREXIA, CHILLS, PAIN and HEADACHE resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31Jan2021, Body temperature: 103 degree. For Eliquis (Unknown), the reporter did not provide any causality assessments. Information about lot/batch number has been requested.
58 2021-03-02 fibromyalgia Achy after day 1. Big fibromyalgia flare days 2-8, unable to pursue normal activity but not bed-ridd... Read more
Achy after day 1. Big fibromyalgia flare days 2-8, unable to pursue normal activity but not bed-ridden. Very tired, lots of naps. On day 9, nausea began. Day 12, fever (100 degrees), nausea, vomiting, diarrhea
58 2021-03-04 facial paralysis, face paralysis PRESENT OF FACIAL PARALYSIS ON THE RIGHT SIDE OF THE FACE AFTER THE SECOND DOSE OF THE VACCINE. LO... Read more
PRESENT OF FACIAL PARALYSIS ON THE RIGHT SIDE OF THE FACE AFTER THE SECOND DOSE OF THE VACCINE. LOSS OF STRENGTH RIGHT SIDE OF THE FACE FROM EYE TO THE MOUTH. I CAN NOT MOVE THE LIPS AND CLOSED THE RIGHT EYE.
58 2021-03-06 numbness Within a minute of receiving vaccine I felt a very cold lump/ feeling in my throat that got worse ov... Read more
Within a minute of receiving vaccine I felt a very cold lump/ feeling in my throat that got worse over the next few minutes making it difficult to swallow. At the same time I felt very fuzzy and numb all over my face and body and very light headed. My arms and legs felt very heavy. The EMT took my blood pressure and told me it was 174/125. My normal BP is 110/60. I have had my BP taken once a month over last 20 years at my monthly pain center appointments. They hooked me up to a 4 lead cardiac monitor and said I had A -Fib. They then hooked me up to a 12 lead ekg monitor and said I didn?t have A-Fib. I have had 3 EKG?s in last year because I was scheduled to have total knee replacement surgery which was rescheduled 2 times and all 3 EKG?s were completely normal. After about 1 hour my symptoms improved to the point where I could go home. I Have had between 20-30 knee procedures over the last 40 years and my reaction to the vaccine felt exactly like I was being put to sleep by sodium pentothal or a very high dose of Versed.
58 2021-03-09 tremor Shaking, Confusion, Head Ache
58 2021-03-10 pain in extremity I had a single red blotch on my right ankle appear the day after my first vaccination. I did not com... Read more
I had a single red blotch on my right ankle appear the day after my first vaccination. I did not complete an adverse reaction form for it because I was not sure it was related. When I got my second dose, I did not experience any reaction other than a sore arm until three days later. I developed red blotches/hives on my arms, legs, and torso (front and back). I took two Benadryl on Sunday morning and two more that night. They tended to go away and then others would pop up in other locations of my body. The Benadryl did not seem to have any significant affect. I was very itchy for several days. i went to see my doctor on the 5th day since it occurred over the weekend and I had an epi pen if I needed it. It was getting better when I saw her so I didn't want anything other than a topical, which didn't come in to the pharmacy until they cleared up. I stopped itching by Monday and they were pretty well gone by Wednesday, which was 7 days later. I took photos of the spots.
58 2021-03-13 muscle spasms, feeling cold, muscle twitching Ihave high blood pressure. I became light headed after 10 minutes of receiving vaccine. Doctor told ... Read more
Ihave high blood pressure. I became light headed after 10 minutes of receiving vaccine. Doctor told me it lowers blood pressure. My blood pressure was low all day. The next day my blood pressure was still not right and I was cold and could not warm up and it was 75 degrees in the house.I had mild spasms and twitches.
58 2021-03-14 numbness, mild one side paralysis Patient woke up the morning following vaccine administration with numbness and weakness of his right... Read more
Patient woke up the morning following vaccine administration with numbness and weakness of his right arm and hand. He later woke up from a nap that afternoon with numbness and weakness also in his right leg.
58 2021-03-15 flushing Pt came back into clinic on 3/16/2021 to ask if we would submit an adverse event request. Pt waited ... Read more
Pt came back into clinic on 3/16/2021 to ask if we would submit an adverse event request. Pt waited 15 minutes and had no reaction in clinic and then on drive back home pt states that his face became flush, he began having shortness of breath, and palpitations. Pt states that he pulled of onto side of road and waited approximately 15 minutes and then symptoms began to dissipate. Pt has had no further symptoms and the symptoms he states that he had were unwitnessed by medical staff at clinic. Once again pt waited till 3/16/2021 to report this to the clinic.
58 2021-03-16 pain in extremity, numbness Severe left arm pain for 2 weeks after injection. Left lateral numbness on the outside of left leg j... Read more
Severe left arm pain for 2 weeks after injection. Left lateral numbness on the outside of left leg just above, through, and below the knee.
58 2021-03-17 pain in extremity I became a little light-headed about 30 minutes after the shot it lasted about 30 minutes. And about... Read more
I became a little light-headed about 30 minutes after the shot it lasted about 30 minutes. And about 9:00 p.m. my arm got a little sore and then increased about twice as bad as a flu shot does cleared up in about 24 hours.
58 2021-03-18 numbness, weakness The first sign was numbness in my chin and cheeks which would come and go. The next sign was muscle... Read more
The first sign was numbness in my chin and cheeks which would come and go. The next sign was muscle pain followed by severe joint pain followed by nausea,and a loss of appetite.The next sign was chills and weakness.This went on for a day and a half and went away .During this time I took extra strength tylenol
58 2021-03-18 migraine I developed a headache about an hour after the shot. It was like a migraine type headache. I took 2-... Read more
I developed a headache about an hour after the shot. It was like a migraine type headache. I took 2- 500 mg Tylenol tablets about 7 PM. Hard to get to sleep but finally slept about 6 hours and woke up with no more headache and have felt fine ever since.
58 2021-03-18 unresponsive to stimuli, flushing Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild
58 2021-03-20 feeling hot Body rash appears after 33hours; feels very hot; itchy; This is a spontaneous report from a contacta... Read more
Body rash appears after 33hours; feels very hot; itchy; This is a spontaneous report from a contactable consumer, the patient. This 58 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN9581), dose 1, single dose, via an unspecified route of administration in the left arm on 08FEB-2021 at 10:45 (at the age of 58 years-old) for COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. There was no relevant medical history reported. Historical vaccine included flu shot on 18Jan2021. Concomitant medications included calcium sulfate dihydrate, dryoptieris crassirhizoma rhizome, ephedra Spp, herb, forsythia suspensa, glycyrrhza glabra root, houttuynia cordata herb, isatis tinctorial root, lonicera Japonica flower, menthol, pogostemom cablin herb, prunius SPP, seed, rheum SPP, rhodiola crenulate (LIAN HUA QING WEN) capsules. On 10Feb2021 at 15:00, the patient experienced body rash after 33 hours, was itchy and very hot. No treatment was received for body rash, itchy and very hot. The clinical outcome of body rash, itchy and very hot was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
58 2021-03-20 pain in extremity, weakness Low fever, body aches, joint pain, diarrhea, headache, sore arm. Began within 3 hours of shot, laste... Read more
Low fever, body aches, joint pain, diarrhea, headache, sore arm. Began within 3 hours of shot, lasted the rest of that day, night, and the next day. Still feeling weak and feverish at present time.
58 2021-03-20 pain in extremity Symptoms resembling Covid-Toes. Swelling, redness, pain of toes of both feet.
58 2021-03-20 tremor Developed fever of 101-103, violent chills, uncontrolled shaking and extreme headache. Lasted 3 sol... Read more
Developed fever of 101-103, violent chills, uncontrolled shaking and extreme headache. Lasted 3 solid, then fever began to drop day 4, but headache persisted along with sweats and violent chill. No real appetite. Also experienced body ache, but not as bad as other symptoms. No, or little bowel movement during this time. On day five (today) urine output is dark, but went 18 hours without Tylenol. Piot to that i need 2 extra strength Tylenol every 5 hours for 4 days straight. No nausea or vomiting associated with any of this. I have extreme fatigue due the extreme headache pain keeping me awake. Headache on the left and right side of the head, not front or behine the eyes, more over the ears. Today I just feel wiped out by it all, but much improved. I have never had any reaction to any vaccines previously, including allergy, flu, shingles and pneumonia.
58 2021-03-22 pain in extremity Right Foot started hurting the night after the vaccine. The next day, it hurt to walk on it. Mainly... Read more
Right Foot started hurting the night after the vaccine. The next day, it hurt to walk on it. Mainly around the base of my 2nd and 3rd toes. The next day it hurt so bad I couldn't walk on it and saw the doctor. A red area had developed on top of my foot at the base on my toes. Doctor though could be Gout but didn't really look like it and usually that is in the big toes. Plus the timing of this issue and my vaccine were suspect. Had X-ray on that Friday, two days after vaccine and everything looked fine they said. I was prescribed Celebrex and over the weekend took two per day due to the pain. I stayed in bed all weekend and pain got worse before taking another dose of medicine which helped for a while. Swelling continued to be about the same or a bit more and the redness moved over to my big toe and then up my foot around towards the right side. Today my right side of foot is really soar now as well and still can't walk on it and still swollen. Doctor at a urgent care sports medicine location prescribed me Prednisone steroid to see if that helps. But so far 5 days after vaccine and my foot is still swollen, red across the top and so painful it keeps me up at night and I can't walk on it. I'm hoping the steroids work.
58 2021-03-23 weakness On 3-11-21 at 0930, I developed low grade headache up neck over top left side of head in morning, by... Read more
On 3-11-21 at 0930, I developed low grade headache up neck over top left side of head in morning, by 1300 hours I felt very crappy similar to how it feels days after a fever breaks when having the influenza. At bedtime 3-11-21, I had a fever 100.1. At 0100, fever rose to 101.1. At 0500 fever rose to 102.6. During day on 3-12-21, I felt like I had the flu, fever broke mid-morning. on 3-13-21, I felt OK. On 3-15 and 16, I felt like I generally like I had a flue bug. I felt better days later and then around March 21-24th I've had a pretty continuous headache and neck ache which I have not had before the vaccine. Lack of energy and feeling crappy. Scheduled for second vaccine April 2nd.
58 2021-03-24 nerve pain Developed itchy rash-like symptoms on torso, arms, hands, neck, and face, as well as upper back, and... Read more
Developed itchy rash-like symptoms on torso, arms, hands, neck, and face, as well as upper back, and legs. Nerve inflammation, also.
58 2021-03-24 tremor I have had Post Acute Covid-19 syndrome since Nov 4, 2020. The first night after receiving my firs... Read more
I have had Post Acute Covid-19 syndrome since Nov 4, 2020. The first night after receiving my first vaccine I got the chills about 16 hours after my shot went away after a few hours. Woke of the next day with my post acute syndrome symptoms much worse than I had prior to shot, my fatigue in my legs were to the point I could hardly walk, my brain fog and tremors were much worse, that lasted about 1 day then the next two nights I woke up in the middle of night with severe sweating. I was then felling like I had before the shot. Then about 4 days after receiving the vaccine the post acute syndrome symptoms again were much worse than before. This last for about 2 weeks then gradual worked back the my original feeling of fatigue, brain fog and tremors that I had prior to vaccine
58 2021-03-25 bell's palsy Bells Palsy
58 2021-03-27 weakness, tremor Received first Pfizer Covid19 vaccine on 2/28/21. Developed fever 102.8, chills, SOB on 3/2/21 and w... Read more
Received first Pfizer Covid19 vaccine on 2/28/21. Developed fever 102.8, chills, SOB on 3/2/21 and was transported by EMS to ER and admitted. He was tested 3 times for COVID 19 and found to be negative. CT scan was concerning for viral pneumonia and suspected COVID. He was treated and released to home on 3/4/21. Followed by pulmonologist. Received second Pfizer COVID19 vaccine on 3/21/21. On 3/23/21 developed fatigue, weakness, shakiness, nausea and vomiting. had significant decline over the week. Has acute event on 3/27/21 and was pronounced dead at home.
58 2021-03-27 weakness Ongoing headaches, severe at times along with nausea and dizziness. Some days it is completely de... Read more
Ongoing headaches, severe at times along with nausea and dizziness. Some days it is completely debilitating. These started about a week after second shot. They have continued with some days being less present. I also have been learning to cope with symptoms.
58 2021-03-27 cold sweat Dizziness, shortness of breath, cold sweats, fatigue, unsteady on feet, feeling of heart racing, sev... Read more
Dizziness, shortness of breath, cold sweats, fatigue, unsteady on feet, feeling of heart racing, severe vomiting, total exhaustion. These symptoms were severe, much worse than when I had the virus in December. I thought I was having a stroke and was minutes away from dialing 911.
58 2021-03-27 involuntary muscle movements Vaccinated at 12:20pm. At approx 12:34 pt told wife he felt faint, was sitting in observation area i... Read more
Vaccinated at 12:20pm. At approx 12:34 pt told wife he felt faint, was sitting in observation area in drivers seat of his own vehicle. Had brief syncopal episode witnessed by his wife with jerky motions of legs and arms lasting a few seconds. Patient awoke immediately with memory of event, was oriented and remember events leading up to being vaccinated. No incontinence. Car seat reclined. Reports no pain, pt appeared pal but no diaphoretic. BP 140/82, P 64 regular RR 14 unlabored. Oxygen sat 98%. EMS called, patient refused transport to hospital but agreed to follow up with primary care provider. Wife sis he was very anxious about his vaccine.
58 2021-03-28 cold sweat Cold sweat, dizziness, tachycardia, headache, persists after 24 hours but not as much
58 2021-03-29 bell's palsy bells palsy seen at ER on 03-26-21; treated by ER physician with prednisone, valtrex
58 2021-03-29 bell's palsy Systemic: Bell's Palsy-Medium
58 2021-03-29 cold sweat, tenderness Swelling at injection site immediately after injection. Slight light-headedness Vital Signs: BP 180... Read more
Swelling at injection site immediately after injection. Slight light-headedness Vital Signs: BP 180/96 HR 86 O2sat 98% Skin Signs: Warm and dry, Clammy, other: swelling at injection site Circulation: Cap refill <2sec Respiratory: Breath and sound clear bilaterally Initial Treatment: Observed swelling marked out original size checked for enlargement or skrinking. 1:48 PM: BP 160/96 HR 86 O2sat 98% Skin Signs: Cool and dry, clammy, diaphoretic, other: plush 2:08 PM: BP 156/104 HR 93 O2sat 96% Skin Signs: Warm and dry (neck/head), cool and dry (arms) 2:30 PM: BP 142/100 HR 90 O2sat 96% Up and walking, no dizziness of pink warm dry, alert x3 continues to have decreasing swelling in left deltoid, tender to touch, decreasing redness at site, attempted to call wife x2 and friend x1 Disposition: Other: Pt will wait for friend who will follow pt in his car to where he will meet up w/ wife. Pt advised to notify PCP of rxn to vaccine and to notify future vaccinators of this fact.
58 2021-03-29 numbness Approximately 45 minutes after receiving the shot I started experiencing some mild tingling/burning ... Read more
Approximately 45 minutes after receiving the shot I started experiencing some mild tingling/burning in my right shoulder (at the injection site). Shortly afterwards, I also noticed swelling and numbness in my hands and face. The swelling in my hands increased to the point where my ring finger on my left hand began throbbing. The ring is already tight due to weight gain, but I became concerned that I may need to cut the ring off. Throbbing plateaued and continued for about an hour then subsided. Swelling and numbness also plateaued and subsided, though those took longer (about 2 days). Overall, it felt a bit like the time I discovered that I was allergic to shrimp/lobster/crab but it did not progress to the same level (no trouble breathing with this episode).
58 2021-03-29 tingling, numbness Numbness and tingling in the ring finger and little finger on left hand. Treatment included OTC anti... Read more
Numbness and tingling in the ring finger and little finger on left hand. Treatment included OTC anti-inflammatory, and stretching to reduce common symptoms of ulnar nerve entrapment. Condition has not lessened in 28 days.
58 2021-03-30 muscle spasms I started having some joint pain in my knees and a little in my fingers and then got back spasms. B... Read more
I started having some joint pain in my knees and a little in my fingers and then got back spasms. Back spasms may have been a result of the joint pains. On a pain scale of 1-10 with 10 being severe, I'd say it was a 4 although the back spasms were much higher. Just wanted to document this.
58 2021-03-31 pain in extremity Arm pain both at injection site and also ache throughout left arm. Pain was more intense on day a... Read more
Arm pain both at injection site and also ache throughout left arm. Pain was more intense on day after the injection. (Wednesday 03/31). By. Thursday, 04/01, the pain was reduced and was very subtle.
58 2021-04-01 seizure 1st dose Pfizer administered at 0940 at clinic. patient experienced no reactions or symptoms during ... Read more
1st dose Pfizer administered at 0940 at clinic. patient experienced no reactions or symptoms during observation period at the clinic. Patient had been home for approximately 2 hours when he started experiencing some chest pain prior to his seizures around 1210. He does have a history of seizures which are uncontrolled ranging from having them twice a week to twice a month. patient reports the seizures were no worse than any other seizure he has had in the past. The seizures lasted periodically for approximately 20 minutes. patient reports he didn't consult with his PCP or neurologist prior to the vaccine. The patient was encouraged to seek medical treatment if symptoms persist or worsen over the next hours. He was also encouraged to reach out to his neurologists prior to the second dose.
58 2021-04-01 speech disorder At 1300 on March 26 I received the shot in my left arm. I went back to work after receiving the vacc... Read more
At 1300 on March 26 I received the shot in my left arm. I went back to work after receiving the vaccine I returned to work. At 1720 I was at home and started itch all over my, arms legs, and stomach. Broke out in a rash on my stomach and chest. At 1830 my tongue was swelling and had a hard time speaking. I call a friend and told her. She told me to take some Benadryl. I did. I then went to bed. My friend came over at about 2100 because she was worried and found me in bed. My breathing was off and she tried to wake me. She called 911 and I was transported to the hospital. I am now in rehab with undetermined results as to what happened.
58 2021-04-02 muscle twitching, flushing, feeling hot, tremor the right side of my neck begin to start hurting if I turn my head forward or sideways/general neck ... Read more
the right side of my neck begin to start hurting if I turn my head forward or sideways/general neck pain/also tender across the entire neck area; warm to touch; stabbing pain; muscular twisting; constant feeling of flushing; shaking/severe shaking at night; chilling; profuse sweating; This is a spontaneous report from a contactable healthcare professional (patient). A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration, administered in left arm on 19Mar2021 17:00 (at the age of 58-years-old) as single dose for covid-19 immunisation. The vaccination facility type was reported as other. No other vaccine in four weeks. The patient was not covid tested post vaccination. Medical history included neck and back injuries, and covid prior vaccination: Yes. The patient had no known allergies. Concomitant medication included gabapentin (NEURONTIN). On 19Mar2021 at 17:45 (approximately within one hour of the injection), the right side of the patient's neck begin to start hurting if he turned his head forward or sideways. It was warm to touch and also tender across the entire neck area. This only turned into a more severe that was excruciating one turning head in any direction. As well as lying down the patient had to sleep sitting up in a recliner. With absolutely no relief all the pain the stabbing pain and muscular twisting and general neck pain additionally there was a constant feeling of flushing but at the same time shaking and chilling with severe shaking at night and profuse sweating. Treatment included ibuprofen (MOTRIN), paracetamol (TYLENOL) to tizanidine. The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The outcome of the events neck pain, pain and muscle twitching was not recovered while for the remaining events was recovering. Information on the lot/batch number has been requested.
58 2021-04-02 tremor, flushing, weakness Systemic: Chills-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Syste... Read more
Systemic: Chills-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Mild
58 2021-04-03 pain in extremity Extreme pain in arm feels deep inside hurts bad.
58 2021-04-03 cold extremities Joint aches and pains, headache, fatigue, coldness in my hands and feet. Symptoms lasted about 20 h... Read more
Joint aches and pains, headache, fatigue, coldness in my hands and feet. Symptoms lasted about 20 hours, with a bit of residual fatigue and odd feelings for about 1 more day.
58 2021-04-06 inability to speak, tremor, speech disorder I woke at 6:30am on 04/07/2021 in a state of complete confusion and disorientation. It was a level ... Read more
I woke at 6:30am on 04/07/2021 in a state of complete confusion and disorientation. It was a level of disorientation I have never experienced before in my lifetime. I fainted one time and was having extreme difficulty getting my bearings and walking and was simply in total "mental disarray". I was having difficulty producing words, a prolonged stutter, you might say. I was shaking. The local paramedics came and I was taken to the local ER. Because I was having difficulty speaking, the paramedics (and later the physicians) thought I might have had a TIA. An MRI on 04/07/2021 at 5pm produced a negative result. So i can only attribute my reaction to the vaccine. It was very significant, and i thought it made sense to report it.
58 2021-04-06 muscle spasms, tingling, pain in extremity Fever, fatigue, headache,lung congestion,eye pain,hand and feet pain(cramps needle/pins poking)eyes ... Read more
Fever, fatigue, headache,lung congestion,eye pain,hand and feet pain(cramps needle/pins poking)eyes blurred,sleepness
58 2021-04-06 tremor, cold extremities, numbness Within 15 minutes, felt extremely tired. This was the same response when taking the 1st shot, howe... Read more
Within 15 minutes, felt extremely tired. This was the same response when taking the 1st shot, however, it didn?t seem as bad. After waiting 30 minutes, began driving home, but within 10 minutes, began to feel like heart was racing, and whole body was kind of numb feeling. I did check heart with my watch which only showed 89bpm. After another 10 minutes, I arrived home, and I was shaking uncontrollably and my hands and feet were cold. Temp was only 97.4. After another 20 minutes, the symptoms all went away.
58 2021-04-07 weakness Fever & chills Lack of energy Headache
58 2021-04-07 pain in extremity Bad gout flare-up, worst symptoms and longest lasting flare-up to date. Three days of intense pain ... Read more
Bad gout flare-up, worst symptoms and longest lasting flare-up to date. Three days of intense pain in left knee, ankle, and foot 4/1-3. Whole leg was swollen and currently (4/8) ankle and foot are still swollen and achy. Low-mid grade fever from 4/1 to 4/6. Still experiencing fatigue. Consulted primary care physician, 4/8, and may do a video visit next week if symptoms persist.
58 2021-04-09 weakness passed out/unconscious; feel weak; dizzy; not normal; This is a spontaneous report from a contactabl... Read more
passed out/unconscious; feel weak; dizzy; not normal; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in arm left on 26Mar2021 09:45AM (Lot Number: ER8730) as single dose for COVID-19 immunisation. The patient had COVID prior vaccination. The patient had no other medical history or known allergies. The patient's concomitant medications were reported as none. The patient did not have COVID test post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After taking the vaccine the patient waited for 15 minutes prior to departing the facility in order to make sure there was no adverse reactions. At approximately 10:15 10:30 AM the patient drove back home. After driving for about five minutes while stopped at a traffic light the patient completely passed out at 10:45, he was unconscious for approximately 2 to 3 minutes, almost crashed his car and EMT support had to be called. The patient regained his conscience but it took him over a half hour to feel 50% better. Until 8:30 PM 26Mar2021, the patient still felt weak and dizzy and not normal. No treatment was received for events. The outcome of events was recovering.
58 2021-04-09 feeling hot, feeling cold 11 hours after shot (Sat 3/27/21 2:00am): Chills, high temp & hallucinations, then hot, neck, back, ... Read more
11 hours after shot (Sat 3/27/21 2:00am): Chills, high temp & hallucinations, then hot, neck, back, arms & legs muscles tightened, freezing for a few hours. 8:00a: wiped out. 1:00pm (Sat): chills, hot, body aches, upset stomach, slept on/off until 4 or 5pm when I started shivering, vomiting, some hallucinating. Armpit glands felt twisted and pulled. I felt worse & asked my wife to call 911. Paramedics came, took vitals, blood, offered to take me to hospital (didn?t go). They stayed an hour until I felt stable. Sun 3/28/21am, exhausted, slightly better but my mind was spacey, body achy & armpits hurt. 12:00pm: noticed short term memory loss, ate a few crackers, drank water, napped on/ off, went to bed around 900pm. Mon, 3/29/21, still achy and mentally fuzzy. Side effects diminished over a few days.
58 2021-04-09 mild one side paralysis I hadn't been feeling well. Called my Doctor the day after receiving the shot and made an appointmen... Read more
I hadn't been feeling well. Called my Doctor the day after receiving the shot and made an appointment for the first available time (Friday April 2). On Thursday morning I was having vision problems, high blood pressure, weakness on left side. I was rushed to the hospital administered tPA and was diagnosed with a stroke.
58 2021-04-11 difficulty speaking dizziness and throat was hoarse, monitored in the EMS room and discharged in stable condition
58 2021-04-11 numbness Left arm went numb from site of injection down to hand. It has not improved since onset. Tylenol an... Read more
Left arm went numb from site of injection down to hand. It has not improved since onset. Tylenol and ice treatment has been tried
58 2021-04-12 muscle spasms Day 2 Extreme fatigue and foggy head. I had to leave work as I was extremely tired and just driving ... Read more
Day 2 Extreme fatigue and foggy head. I had to leave work as I was extremely tired and just driving home was as if I was under the influence. Day 3 - Extreme fatigue and sever body aches Day 4 - Slightly better, but still not able to resume normal activities Day 5 - Tried to resume normal activities (bike ride), but I have to stop due to extreme fatigue and severe muscle cramping. Day 6 - Actually felt normal Day 7 - Back to 100%...
58 2021-04-12 pain in extremity, fibromyalgia Horrible pain all thru my body. The vaccine cause one hell of a Fibromalgia reaction. I can not ea... Read more
Horrible pain all thru my body. The vaccine cause one hell of a Fibromalgia reaction. I can not eat, I'm cold all the time. My apartment is 88 degrees and I'm still cold. I can't take this pain much longer. And my lungs are congested and burning. It's hard to breathe. HELP ! ! !
58 2021-04-12 pain in extremity 58 year old white male with history of blood clots developed symptoms of leg pain during 4/11 early... Read more
58 year old white male with history of blood clots developed symptoms of leg pain during 4/11 early am . pt received COVID vaccine on 4/8 developed leg pain on 4/11 early am and went to er and was advised he was clotting in leg at point of previous procedure. he was given eliquis and was told to follow up with specialist
58 2021-04-12 tingling, numbness Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial a... Read more
Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extremities)-Severe, Additional Details: tingling on the right side and front of face to the right temple had tingling, numbness, a bruised like feeling. PCP reviewed patients symptoms and stated everything was ok.
58 2021-04-13 involuntary muscle movements Very strong rash on the whole body. Muscular involuntary movements that still going on today, more ... Read more
Very strong rash on the whole body. Muscular involuntary movements that still going on today, more than 3 weeks after the shot.
58 2021-04-13 flushing Vomiting, dizziness, flushing/sweating. BP 134/82; HR 85, SpO2 98%, Temp 97.3. Pt reported feeling d... Read more
Vomiting, dizziness, flushing/sweating. BP 134/82; HR 85, SpO2 98%, Temp 97.3. Pt reported feeling dizzy while in observation. Pt was brought in to observation area. Pt felt dizzy, and nauseous began vomiting. Provider was called to assess pt; Pt reported feeling slightly better but still felt dizzy.
58 2021-04-13 tremor Patient received pfizer vaccine, sitting for observation for 15min and observed by next patient, who... Read more
Patient received pfizer vaccine, sitting for observation for 15min and observed by next patient, who alerted pharmacist, that he passed out, dropped phone/papers, and shakes. Pharmacist about to administer epipen but he regained consciousness in seconds, alert and stated dizzy, drank water given to him. 911 called and paramedic came to check him. BP is low, he's brought out in strecher to hospital(?) for evaluation. Wife came to pharmacy later to inquire since she got call from him being in hospital for observation. Wife stated that he is nervous about needles, vaccination
58 2021-04-14 difficulty speaking Anaphylaxis x- scratchy throat at +10 mins x- swollen tonsils at +15 mins x- difficulty swallowing a... Read more
Anaphylaxis x- scratchy throat at +10 mins x- swollen tonsils at +15 mins x- difficulty swallowing at +20 mins x- voice changed noticably at +30 mins, subsequently lost x- Some heart palpitations and chest tension at +45 mins x- Angiodema of right eye +90 mins
58 2021-04-15 numbness, tingling, burning sensation Severe numbness in my right arm and tingling like it?s asleep, then sometimes releases and burns the... Read more
Severe numbness in my right arm and tingling like it?s asleep, then sometimes releases and burns then goes back to tingling
58 2021-04-17 bell's palsy Developed Bells Palsy; This is a spontaneous report received a contactable consumer, the patient. A ... Read more
Developed Bells Palsy; This is a spontaneous report received a contactable consumer, the patient. A 58-year-old adult male received the first dose of BNT162b2 (solution for injection; Lot provided as unknown and expiry information not reported) as a single dose via unspecified route in the left arm on 25Mar2021 at 13:00 (at 58-years-old), for COVID-19 immunisation. Relevant medical history allergies to [unspecified] medications, food and/or other products. Concomitant medications included tetanus vaccine (lot unknown) dose 1 in right arm on 12Mar2021. The patient denied any COVID diagnosis prior to the vaccine. The patient reported that on 27Mar2021 at 12:00 he developed Bell's palsy; which was classified non-serious by the reporter. The patient has not been tested for COVID since the vaccine. Treatment for the event included prednisone regimen. The outcome of the event Bell's palsy was recovering. Information on the lot/batch number has been requested.
58 2021-04-17 pain in extremity I got the shot and came home ever thing was fine then arm started hurting no big deal then thr heada... Read more
I got the shot and came home ever thing was fine then arm started hurting no big deal then thr headache so bad I had tears in 58. Carpet installer most of my life now that all happened Tuesday felt si; I got the shot and came home ever thing was fine then arm started hurting no big deal then thr headache so bad I had tears in 58. Carpet installer most of my life now that all happened Tuesday felt si; Tuesday felt sick; itching; Crazy itchy once I itch it swells up; I'm broke out all over my arm. And face; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported) via an unspecified route of administration, at arm left on 22Mar2021 12:00 as single dose for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included high blood pressure. The patient had no allergies to medications, food, or other products. The patient received antibiotics within 2 weeks of vaccination. The patient concomitant medications were not reported. The patient got the shot and came home ever thing was fine then arm started hurting no big deal then the headache so bad I had tears. Carpet installer most of my life now that all happened Tuesday felt sick, we and things seemed instill till about the 26th started itching bad and it got worse and broke out all over my arm and face. Crazy itchy once I itch it swells up. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
58 2021-04-19 weakness Day after first vaccine (Tuesday March 30) was administered, developed severe headache, chills, neck... Read more
Day after first vaccine (Tuesday March 30) was administered, developed severe headache, chills, neck pain, and slight abdominal cramp. By Friday April 2, severe abdominal cramp, headaches, nausea, slight high temperature. Persisted throughout the whole weekend. Called in sick Tuesday April 6 for abdominal cramp, temperature, confusion - admitted to ER.
58 2021-04-19 pain in extremity Stiffness in injection site, next day, mild pain when lifting arm and mild cold symptoms.
58 2021-04-20 weakness Patient received the Pfizer shot at a vaccination clinic set up at his workplace. He was shockingl... Read more
Patient received the Pfizer shot at a vaccination clinic set up at his workplace. He was shockingly gray and visibly weakened for two and a half days. Patient gradually regained his strength. No other reaction was observed or mentioned.
58 2021-04-20 numbness, facial paralysis, tingling Patient presented to ED with complaint of right sided facial droop accompanied by numbness and tingl... Read more
Patient presented to ED with complaint of right sided facial droop accompanied by numbness and tingling. The patient went to bed at 0700 after working third shift with no symptoms and awoke at 1400 with these complaints. Patient was hypertensive at ED presentation. Patient was diagnosed with stroke and admitted to the hospital. Patient received clopidogrel (loaded with aspirin per self at home PTA).
58 2021-04-22 bell's palsy LEFT FACIAL NERVE PALSY
58 2021-04-22 feeling cold, cold extremities Pfizer-BioNTech COVID-19 Vaccine EUA Cold sensation in the right arm, from the shoulder to the hand.... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Cold sensation in the right arm, from the shoulder to the hand. Concern that this might be related to a blood vessel disorder with clotting problems
58 2021-04-22 severe one side paralysis Aschemia. Stroke. Paralysis on the left side of the body.
58 2021-04-22 myelitis transverse Functional neuromuscular disability left upper extremity, neuralgia left scalp and neck
58 2021-04-22 seizure Ten minutes after receiving his second Covid-19 vaccine, patient became lightheaded. As I was moving... Read more
Ten minutes after receiving his second Covid-19 vaccine, patient became lightheaded. As I was moving him to the ground, he started to have what appeared to be a seizure. I got him on his side to the ground and he proceeded to vomit twice, about 2 minutes apart. 911 was called and patient was transported by ambulance to the emergency room for follow up.
58 2021-04-23 weakness, tingling Intense tingling on palms and bottom; chills; weakness; stomach pain; chest pain; low grade fever; n... Read more
Intense tingling on palms and bottom; chills; weakness; stomach pain; chest pain; low grade fever; needed bed rest; This is a spontaneous report from a contactable consumer (Patient). A 58-years-old male patient received first dose of BNT162B2 (BNT162B2), Via an unspecified route of administration, administered in Arm Right on 09Jan2021 08:30 (Batch/Lot Number: EK9231) as single, dose 2 via an unspecified route of administration, administered in Arm Right on 30Jan2021 (Batch/Lot Number: EL9262) as single for covid-19 immunisation. The patient Medical history included glaucoma, asthma, hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications included simvastatin (SIMVASTATIN); atropine (ATROPINE); dorzolamide (DORZOLAMIDE); escitalopram oxalate (LATA) taken for an unspecified indication, start and stop date were not reported. The patient experienced intense tingling on palms and bottom (paraesthesia), chills (chills), weakness (asthenia), stomach pain (abdominal pain upper), chest pain (chest pain), low grade fever (pyrexia), needed bed rest (bed rest) on 09Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Feb2021. Therapeutic measures were taken as a result of intense tingling on palms and bottom (paraesthesia), chills (chills), weakness (asthenia), stomach pain (abdominal pain upper), chest pain (chest pain), low grade fever (pyrexia), needed bed rest (bed rest). The outcome of events was recovering.
58 2021-04-23 tingling mild tingling sensation on the back part of my tongue; metal taste; This is a spontaneous report fro... Read more
mild tingling sensation on the back part of my tongue; metal taste; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EL9264), via an unspecified route of administration, in the left arm on 29Jan2021 at 09:30 (at the age of 58-years-old) as a single dose for covid-19 immunisation. Patient's medical history included cardiovascular disease, 2 stents and hypertension (on medications). The patient was not aware of any allergies to medications, food or other products. Patient did not receive any other vaccines within 4 weeks prior to vaccination. Concomitant medications included (acetylsalicylic acid) LD ASPIRIN, metoprolol succinate (TOPROL), clopidogrel bisulfate (PLAVIX), valsartan (DIOVAN), atorvastatin (LIPITOR) and ergocalciferol (VIT D). Prior to the vaccination the patient was not diagnosed with COVID-19. On 29Jan2021 at 09:30, the patient experienced mild tingling sensation on the back part of my tongue and metal taste. Sensation peaked at approx. 30-40 minutes then started to subside. Fully subsided after approx. 2 hours. Treatment was received. Patient underwent Blood pressure measurement, pulse rate and oxygen saturation on 29Jan2021 and results were unknown. Since the vaccination the patient had not been tested for COVID-19. The outcome of the event paraesthesia was recovered on 29Jan2021 at 11:30 and Dysgeusia was recovered on an unspecified date in 2021.
58 2021-04-24 muscle spasms, nerve pain Felt like all my nerve endings were being electrified while on Fire; I could not keep down food for ... Read more
Felt like all my nerve endings were being electrified while on Fire; I could not keep down food for 10 days. Then, could not keep down liquids for 3 days then went to the E/R; High Clotting Factor; dehydration; chest pains/Had pains in my heart also; Heart was not beating correctly; body cramps all over; High temperature along with sudden chills; High temperature along with sudden chills; frequent sweats; Extreme pain; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration in left arm on 06Apr2021 at 07:00 PM, at single dose for COVID-19 immunisation. The patient had medical history of fibromyalgi, anxiety and allergy to all anti-depressants. The concomitant medication included clonidine once a day for anxiety. It reported that, on 07Apr2021 at 8:00 AM, patient experienced extreme pain felt like all nerve endings were being electrified while on fire such extreme pain ever since the vaccine. After 10 days he could not take it anymore. Patient could not keep down food for 10 days. Then, could not keep down liquids for 3 days then went to the E/R. Had a high clotting factor along with dehydration and chest pains. Heart was not beating correctly, and they were worried his blood would clot, heart attack, aneurism and death. He had pains in heart also, body cramps all over. High temperature along with sudden chills and frequent sweat. Contact the ICU ward at for all the details on the problem vaccine caused. The all adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. Patient hospitalized for the 2 days and treated with the morphine for pain, 5 bags of Saline and blood Thinner. Vaccination facility: Pharmacy or Drug Store. Patient did not take any other vaccine in four weeks. There was no COVID prior vaccination and COVID tested post vaccination (Nasal Swab, result negative) on 16Apr2021. Information about lot/batch number has been requested.
58 2021-04-24 pain in extremity extreme arm pain; shoulder pain; arm and shoulder pain/it was not really a soreness, it was an injur... Read more
extreme arm pain; shoulder pain; arm and shoulder pain/it was not really a soreness, it was an injury; This is a spontaneous report from a contactable consumer (patient). This 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left shoulder or arm on 16Mar2021 15:00 (Lot Number: EN6200; Expiration Date: 30Jun2021) at single dose for COVID-19 immunization. Medical history included sports injuries. Patient said he has had sports injuries, when he used to play tennis, but nothing on his left side. The patient's concomitant medication was none. Patient said they have not had any other recent vaccinations or started any new medications. He said there was a new med he thought he started before getting the first vaccine, it said March 30th, so it had to be in February that he started this, this was date for second dose, so he didn't think that there was anything close to second vaccine dose. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age of 58-year-old, administration on 23Feb2021 4:00 PM in left shoulder or arm (Lot number: EN6200, Expiration date: 30Jun2021) for COVID-19 Immunization. Patient has had vaccines all his life with no problems. He has had extreme arm pain mostly to his shoulder into his arm after he took the second shot dose roughly three weeks ago. He said that his arm and shoulder pain began 17Mar2021, and had lasted to today. He said it was not really a soreness, it was an injury. He said it had gotten a little worse the last couple of days. He said he stopped taking Aleve since you are not supposed to take that long because of bleeding problems. He was taking 4 a day for a week then stopped taking it. He said he was taking two in the morning and two at night, strength unknown. He said his pain was almost getting better, but it seemed worse since he stopped taking the Aleve. He said the pain affect what he normally did like tennis and yard work, it woke him in the middle of the night with pain, he was right handed. He said he also tried Bengay and things that didn't seem to work. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
58 2021-04-24 pain in extremity Four hours later he passed out/ Four hours after getting vaccine he was on the floor and out like a ... Read more
Four hours later he passed out/ Four hours after getting vaccine he was on the floor and out like a light; Sore right arm; goofy; This is a spontaneous report from a contactable consumer. A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 58-years-old intramuscular, administered in Arm Right on 04Mar2021 09:30 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation and prophylaxis. Medical history included high cholesterol, allergy (When pollen is heavy, it is worse) from an unknown date and unknown if ongoing, fractured his shoulder in 05Feb2021, sinus jacked up from an unknown date and unknown if ongoing, covid-19 from Nov2020 to an unknown date, anemic from Dec2020 to an unknown date, nasal surgery on an unknown date, fever blisters from an unknown date and unknown if ongoing, immune system disorder from an unknown date and unknown if ongoing. Concomitant medications included zolpidem tartrate (AMBIEN) taken to help sleep; atorvastatin (LIPITOR) taken for high cholesterol; loratadine taken for allergy; cetirizine hydrochloride (ZYRTEC) taken for allergy; mometasone furoate (FLONASE) taken for allergy; start and stop date were not reported for all; fish oil (OMEGA 3) and selenium (SELENIUM) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D3 1000) taken for immune system disorder; iron (IRON) taken for anaemia; lysine taken for fever blisters ; zinc taken for immune system disorder, start and stop date were not reported for all and multivitamin. It was reported that four hours after getting vaccine on 04Mar2021, he was on the floor and out like a light. This is the first one he received and his doctor said not to get second one. He had the first one and about 4 hours later, he was on the kitchen floor and out like a light. He doesn't know if it was connected to shot or not. He never had problems before. He got the vaccine around 09:30 and around 13:30, his friend came in for lunch and found him on the floor. She freaked out. She said she liked to never got him awake and said he was goofy for a good half hour. He does not know how long he was on the floor. His arm was sore on 04Mar2021 09:30 for about 4 days. The patient underwent lab tests and procedures which included blood iron: so low on an unspecified date. The patient was recovering from passed out and sore arm while recovered from goofy on 04Mar2021.
58 2021-04-24 slow speech, seizure Full blown seizure; Fatigue; Confusion; Breathing was off; breath was heavier; patient's blood press... Read more
Full blown seizure; Fatigue; Confusion; Breathing was off; breath was heavier; patient's blood pressure was very low; Real sluggish/get slow; Speech started to get slow; This is spontaneous report from a contactable consumer (patient's wife). A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8734) via an unspecified route of administration in left arm on 04Apr2021 12:00 at age of 58-year-old at single dose for COVID-19 immunization. It also stated the patient was one of the most vulnerable against virus so he took the Covid-19 Vaccine. Medical history included ongoing cardiac failure congestive diagnosed probably 10 years ago, ongoing diabetes mellitus diagnosed probably 20 years ago, ongoing dialysis for 3.5 years. Concomitant medication included ongoing unspecified blood thinner. Caller reported that the patient didn't take any blood pressure medications and that she knew the patient took a blood thinner. Caller unable to provide further detail for the patient's medications as she doesn't have the patient's list of medications with her. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EP7534) injected in left arm in Mar2021 at age of 58-year-old for COVID-19 immunization and experienced fatigue after the first dose of the Covid-19 vaccine. Caller reported that it was hard to determine the cause of the fatigue because the patient was on dialysis, but that the patient has been more fatigued since he received the first dose of the Covid-19 vaccine. The patient was a compromised fellow with a host of pre-existing conditions as far as heart disease, diabetes, and dialysis. Caller was calling in regard to the Pfizer Covid-19 vaccine. Caller reported that she was calling to report a bad reaction that her husband, the patient, received on Sunday, 04Apr2021, following his second dose of the Covid-19 vaccine. Approximately 3 hours after receiving the Covid-19 vaccine, the patient had a full blown seizure at 15:00 on Sunday, 04Apr2021. Caller reported that she had to call emergency responders following the patient's seizure. The patient was doing better but the experience with his seizure was quite traumatic. Caller stated that if it was going to happen, it was going to happen to us. About 3 hours after receiving his Covid-19 vaccine on 04Apr2021, the patient became real sluggish and his speech started getting slow before the seizure occurred. Caller reported that the patient made a gradual descent downwards. Caller reported that she swears the patient has not been the same as far as fatigue goes since the patient received his first dose of the Covid-19 vaccine 3 weeks prior. Caller reported that she thought the fatigue was maybe from dialysis. The patient started to get slow just before the seizure, about 2.5 hours after he received the second dose of the Covid-19 vaccine. The patient was laying down following the second dose of the Covid-19 vaccine. Caller reported that the patient's breathing was off. The patient's breath was heavier. Caller reported that after she noticed the patient's breathing was off, she asked the patient if he was ok. Caller reported that this is when she noticed that the patient's speech was really slow and that he was experiencing confusion. The patient has had no more seizure activity. The patient was still being monitored in the hospital. Caller reported that the patient didn't remember any of it. It's hard to say if the patient's sluggishness and fatigue were ongoing. Caller reported that she couldn't go see the patient while he was in the hospital but that the patient's voice sounds much stronger. For Confusion and Speech: Caller reported that the patient seems to be back/ returned to normal. Caller reported that she knew that the patient's cardiologist went to see the patient. The patient's cardiologist said that there was nothing that happened to the patient's heart, that what the patient experienced was not a heart issue, and that the event had no effect on the patient's heart. The medical staff stated that the seizure the patient experienced was related to a blood pressure drop. Caller reported that the patient's blood pressure was very low on 04Apr2021. The patient required a visit to Emergency Room for event seizure, no visit of physician office. Admitted on Sunday, 04Apr2021 for seizure, and still hospitalized. For investigations: Caller reported that the medical staff at the hospital definitely did lab work but she was not sure if any imaging was performed. Caller reported that she has no results available for tests that were performed. The outcome of events confusion and "speech started to get slow" was recovered in Apr2021, the outcome of other events was unknown. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021380129 same patient, different product(dose)/event
58 2021-04-26 bell's palsy Bells Palsy; This is a spontaneous report from a contactable consumer reporting for husband. A 58-ye... Read more
Bells Palsy; This is a spontaneous report from a contactable consumer reporting for husband. A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EW0153/expiration date: 31Jul2021), via an unspecified route of administration, on 11Apr2021 (at the age of 58 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EM8727/expiration date: 31Jul2021), via an unspecified route of administration, on 21Mar2021 (at the age of 58 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included ongoing hypertension, when he was about 45, probably 10 years and was recovering from leukemia onset 2 years ago, in 2019 and he has been recovering from leukemia since about 2020; the patient had an ongoing history of being a little overweight, with onset unknown other than over 10 years ago. Concomitant medication included nebivolol hydrochloride (BYSTOLIC) 10mg tablet taken by mouth once daily for hypertension. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Apr2021, late afternoon the patient experienced swelling in his face, couldn't blink, drooping and was diagnosed with Bells Palsy which required an emergency room visit. He was not admitted to the hospital for this event, was kept under observation only in the emergency room on 12Apr2021. He was given some medication and then discharged. Bell's Palsy affected his right side of his face. The outcome was improved, the pain was a little less; but he still does not have, nothing works on the right side of his face. His right eye does not blink, eyebrow does not move, and he still can't speak very good. Treatment was received for the event. The outcome of the events Bells Palsy was recovering. Since the vaccination, the patient had not been tested for COVID-19.
58 2021-04-26 seizure At about 1030 patient had a seizure..
58 2021-04-26 tremor, muscle spasms Acute onset severe muscle spasming of right semitendinosis muscles and daily muscle tremors of same ... Read more
Acute onset severe muscle spasming of right semitendinosis muscles and daily muscle tremors of same muscles to date.
58 2021-04-27 numbness The patient noticed itchiness and a rash that spread up his arm over his collar bone. He said that t... Read more
The patient noticed itchiness and a rash that spread up his arm over his collar bone. He said that the area was very read and on about day 5 the area of the rash went numb.
58 2021-04-28 facial paralysis, slurring, numbness Suspected TIA; Experienced a numbness in right hand, arm, drooping right side of face; Experienced a... Read more
Suspected TIA; Experienced a numbness in right hand, arm, drooping right side of face; Experienced a numbness in right hand, arm, drooping right side of face; slurred speech; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose in right arm on 05Mar2021 14:30 (Lot: EN6199) and second dose in left arm on 26Mar2021 14:30 (Lot: ER8732); both via an unspecified route of administration (at the age of 58-years-old) as single dose for covid-19 immunisation. The vaccination facility type was a public health department. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to bnt162b2. Medical history included allergy induced asthma and seasonal allergies. The patient's concomitant medications were not reported. The patient experienced a numbness in right hand, arm, drooping right side of face and slurred speech, it lasted for 1-2 minutes. The patient went to the ER. Suspected TIA. These events started on 11Apr2021 at 10:00. The events resulted in emergency room/department or urgent care. The patient received unspecified treatment for the events. On 10Apr2021, nasal swab was negative. On 11Apr2021, Covid test type post vaccination with unknown results, rapid and nasal swab was negative. It was reported that the patient had MRI, CT, EKG with unknown results on unspecified dates. The outcome of the events was recovering.
58 2021-04-28 paralysis, weakness On or about April 14, 2021 patient yelled out to a friend to come help him. Patient stated that he "... Read more
On or about April 14, 2021 patient yelled out to a friend to come help him. Patient stated that he "could not see or move". The friend called the ambulance and patient was taken to hospital. One of the doctors tending to patient told me patient had several strokes (over 5). These strokes have left him blind and incapacitated. He is still currently at hospital.
58 2021-04-30 seizure Low fever beginning on 1:00AM Monday 12Apr; Experienced nausea Monday 12Apr evening and seizure; Exp... Read more
Low fever beginning on 1:00AM Monday 12Apr; Experienced nausea Monday 12Apr evening and seizure; Experienced nausea Monday 12Apr evening and seizure; This is a spontaneous report from a contactable consumer. A 58-year-old male patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on 07Apr2021 (Batch/Lot Number: ENG201) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced nausea monday 12Apr evening and seizure and low fever beginning on 1:00am monday 12apr at 01:00. The patient was hospitalized for experienced nausea monday 12apr evening and seizure and for low fever beginning on 1:00am monday 12apr for 4 days. Therapeutic measures were taken as a result of low fever beginning on 1:00am monday 12apr. It was unknown if therapeutic measures were taken for the events Experienced nausea Monday 12Apr evening and seizure. The outcome of the events was unknown.
58 2021-05-01 pain in extremity Swelling and pain in left foot with a dark red lesion on the left pinkie toe. Difficult and painful ... Read more
Swelling and pain in left foot with a dark red lesion on the left pinkie toe. Difficult and painful to put pressure on the foot when first standing, but will gradually subside enough to walk with a limp. Started as a sore pinkie that gradually increase in soreness. Lesion and swelling was very pronounce on 4/30/2021. Swelling hit a peak on 5/01/2021, appears to be significantly less on 5/02/2021.
58 2021-05-02 discomfort, weakness PERNICIOUS PALPITATIONS (RACING HEARTBEAT, 130/MIN?), ABOUT 5 EPISODES IN 5 HOURS. THE SECOND EPISOD... Read more
PERNICIOUS PALPITATIONS (RACING HEARTBEAT, 130/MIN?), ABOUT 5 EPISODES IN 5 HOURS. THE SECOND EPISODE WAS THE WORST. ELEVATED BLOOD PRESSURE (180/110?) DURING PALPITATIONS. OVERALL DISCOMFORT IN WHOLE BODY. STAYED IN EMERGENCY ROOM FOR ABOUT 5+ HOURS. EVEN AFTER DISCHARGE, MUCH MILDER EPISODES LASTED THROUGHOUT THE NIGHT. EMERGENCY ROOM TREATMENT WAS ONLY SALINE. PATIENT TOOK 160 MG MAGNESIUM AFTER SECOND EPISODE. AT HOME PATIENT TOOK SOME MORE MAGNESIUM (~50 MG) AND VERAPAMIL (~60MG). 30 HOURS AFTER THE INCIDENT, MOSTLY RECOVERED BUT FEELING WEAK.
58 2021-05-02 numbness, face paralysis Patient called the department 2-weeks after vaccination to report event. Within 2-3 hours of vaccina... Read more
Patient called the department 2-weeks after vaccination to report event. Within 2-3 hours of vaccination, the patient experienced left-sided facial and eye numbness and weakness. The patient stated the left-side of their face felt "hollow". The numbness began in the lower half of the left eye and traveled across the left cheek to the left ear. The patient further noted excessive eye drainage from the lower palpebra of the left eye. The patient is uninsured and could not present to an ED. The issue is still ongoing as of 5/3/21 and the patient was advised to seek care at the clinic or a local free clinic. They are scheduling an appointment for this week.
58 2021-05-02 muscle twitching Approximately 2 days after second shot, my right arm (not the arm injected) started involuntarily tw... Read more
Approximately 2 days after second shot, my right arm (not the arm injected) started involuntarily twitching periodically throughout the day. It happens about 5 - 7 times per day and has not gone away since it started. I have no history of this occurring previously. I believe it is neurological as I can concentrate on the twitch and it will stop.
58 2021-05-02 pain in extremity 1st day much arm pain at shot site . 2nd day severe indegestion, stomach cramp, nausea , very painf... Read more
1st day much arm pain at shot site . 2nd day severe indegestion, stomach cramp, nausea , very painful to touch stomach , 3rd day fatigue, slept all day
58 2021-05-02 unresponsive to stimuli On 4/14/2021 pts sugar dropped to 40. EMT was called. They gave him some meds to bring it back up.... Read more
On 4/14/2021 pts sugar dropped to 40. EMT was called. They gave him some meds to bring it back up. He was still not feeling well that night he took some more sugar meds and went to bed. Next morning he was foaming at the mouth and unresponsive. EMT was called again. On 4/15/2021 Pt was taken to the ER. He was intubated and transferred to another ER. He has a trach, has a feeding tube and has swelling of the brain.
58 2021-05-03 pain in extremity Arm pain and cough.
58 2021-05-04 burning sensation, pain in extremity Immediately following the injection, my right shoulder, elbow, forearm and wrist started to get sore... Read more
Immediately following the injection, my right shoulder, elbow, forearm and wrist started to get sore. Each day thereafter my shoulder was really sore, I am having these burning sensations in my right forearm and my wrist is in pain. It has been 5 days since my second vaccine and each day has been very rough to get through. I have 2 jobs and the pain is interfering with my job duties. And when I'm trying to sleep, it's very uncomfortable and I haven't been able to get a full night's rest. I haven't seen any doctors or taken any medication because I thought that the symptoms would go away but they haven't. I don't know what to do
58 2021-05-04 cold sweat Cold Sweats; Chills; getting frustrated; This is a spontaneous report from a contactable consumer (p... Read more
Cold Sweats; Chills; getting frustrated; This is a spontaneous report from a contactable consumer (patient). male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 14Apr2021 (Lot Number: ER8735) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received dose 1 (Lot: ER2616) on 24Mar2021 for covid-19 immunisation. The patient got the second shot and he had cold sweats in the middle of the day (15Apr2021) and chills on and off, patient was getting frustrated with all of these questions. None treatment was received. The outcome of cold sweats, chills was not recovered, getting frustrated was unknown. No follow-up attempts are needed. No further information is expected.
58 2021-05-04 pain in extremity sore arm, from the injection, for only 1-2 days"; left arm discomfort; shoulder pain; This is a spon... Read more
sore arm, from the injection, for only 1-2 days"; left arm discomfort; shoulder pain; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old male patient received bnt162b2 (PFIZER; Solution for injection; Lot number: EL3248) dose 1 via an unspecified route of administration, administered in left arm on 24Jan2021 as single dose for COVID-19 immunization. The patient's medical history included Chronic lymphocytic leukemia patient since Jul2015 and disrupt GI. Concomitant medications included ibrutinib taken for chronic lymphocytic leukaemia, meloxicam for arthralgia, flecainide taken for arrhythmia, aciclovir taken for antiviral treatment, guaifenesin, sulfamethoxazole, trimethoprim. The patient had a sore arm, from the injection, for only 1-2 days and was also taking meloxicam daily at the time. He then developed some "GI problems, due to the possible side effects of the meloxicam, and PCP told him to stop taking this medication. The patient stated that on day 8 the soreness reappeared and became worse each day, then on day 10 took a meloxicam and the arm pain was better. The patient stated that he can no longer take the meloxicam and he still had moderately sore. Upon follow up received on 05Feb2021, His oncologist recommended him to get it. 12 days after he got the vaccine his side effect came back. He got it in his left arm. He had left arm discomfort for a couple of days. The discomfort disappeared. He was also taking Meloxicam 7.5mg because he needs his hip replaced. It started to disrupt his GI, so he discontinued it. After he discontinued the Meloxicam, the arm soreness came back. He believes the Meloxicam was masking the shoulder soreness. He discontinued the Meloxicam, and 12 days later after the vaccine, his shoulder pain came back. He thinks once the anti-inflammation medication wore off it came back. His symptoms came back. He was just wondering how long people have been symptomatic after the injection. His next vaccine on 17Feb2021, and his arm was still sore from the first. He felt like this should have been more transient, and in a quicker time frame. The outcome of the events was reported as an unknown. Follow up received on 05Feb2021: New significant information was received. Follow-up attempts are completed. No further information is expected.
58 2021-05-04 tingling, numbness Onset of moderate to severe dizziness, immediately followed by tingling sensation, then severe numbn... Read more
Onset of moderate to severe dizziness, immediately followed by tingling sensation, then severe numbness on entire left side of face (left lips) and entire outside left side body, from head to toes. Face, neck shoulder, arm, torso, leg, foot and toes
58 2021-05-05 numbness 4/30-Date and time adverse event started: numbness L side of face affecting L eye; sx similar to whe... Read more
4/30-Date and time adverse event started: numbness L side of face affecting L eye; sx similar to when he had bells palsy in the past What happened as a result of the adverse event? (doctor visit, ED or urgent care visit, hospitalization, life threatening illness, disability/permanent damage, death, none of these): Does not have PCP d/t no health insurance; did take steroids that he had at home that he used for previous Bells Palsy treatment. 4/30-Number provided to health department to have facial numbness evaluated in Primary Care Clinic. Caller accepting of info provided 5/1-f/u call made; message left to call back with any further questions or concerns
58 2021-05-06 pain in extremity 4/28/21 second dose Pfizer administered No Issues 4/28- 5/3/21 noon 5/3/21 All muscles arms legs ba... Read more
4/28/21 second dose Pfizer administered No Issues 4/28- 5/3/21 noon 5/3/21 All muscles arms legs back locked up hard 5/4/21 most symptoms passed still had very sore calves hard to walk 5/6/21 ( 1:00 PM EDT)to now. Massive ankle and foot swelling came on almost instantly no warning not too painfull but i can not put shoes on.
58 2021-05-07 pain in extremity I don't know it is stroke or something; heart burn something; its like I am having a heart attack; f... Read more
I don't know it is stroke or something; heart burn something; its like I am having a heart attack; feeling crappy/ feeling funny/ I can feel like the drug was inside me like something was changing/ something happening with my body; Headache/ slight headache; Chest pain/ I can feel a pain where my heart is; arm was sore; heart burn; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 09Apr2021 at a single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of BNT162B2 on 18Mar2021 for COVID-19 immunisation (left arm). Patient stated, "the second was really bad my arm was sore for like over a week I mean it was sore. I don't know I have not felt the same since. I can feel like the drug was inside me like something was changing and I never had no problem for anything but now its been like at the last when I got the shot was 9th of April of this month, its been like 2 weeks now almost and it is like I feel crappy. I have headache I have like a chest pain u know in my chest. I have like my heart is I don't know its like I am having a heart attack or something I don't know it is stroke or something. I do not know it is feeling funny. I have no problem I do, may be I have may be heart burn something. I don't know because on every single day everyday I have chest pain my heart, headache I have slight headache now. I don't know why I can feel a pain where my heart is on left side now I got the pain on right side you know I have the pain there and I wondering what's going on so I don't know". Consumer stated, "First its both side that is what I am saying now right now so as I am talking to I have pain in my heart and like it feels the heart u know I don't know there is a weird thing in my heart. I feel like you have a heart attack or so, I you feel like a chest pain or you had a heart burn or something and then on my right side has started it is like something happening with my body you know now its the right side. I don't really know, I can feel me liver, my kidneys are like something is like I can feel something is going I don't know what's going on with my body. You know after getting the shot right now I have the slight headache. I took a quite couple of Tylenol as stuff but that seems like no. This every single day you know that you I thought it will go away but it did not go away". Consumer stated, "Yes, it is the first time. Like I said I thought it will go away but it is not getting any better. I am getting concerned. I do not know I have to be admitted to hospital. I do not have no insurance or anything. I am really worried." The patient hasn't been to the doctor, he was calling first for help. He has no insurance so he cannot just go to the doctor. Consumer stated, "It never improved no. Persisting." Outcome of the events was not recovered. Information on the lot/batch number has been requested.
58 2021-05-07 tremor Patient received vaccine around 5:15 pm on 4/13/21 and later that night he experienced small tremors... Read more
Patient received vaccine around 5:15 pm on 4/13/21 and later that night he experienced small tremors in both arms, shortness of breath, and a pounding heart. All symptoms lasted about 3 days. He did not notify pharmacy or doctor until he was ready for the second dose which he did not receive. He will follow up with his doctor. Patient mentioned he thinks he was Covid 19 positive in January 2020 but was never tested to confirm.
58 2021-05-10 pain in extremity This is a spontaneous report from a contactable consumer (patient). A 58-years-old male patient rece... Read more
This is a spontaneous report from a contactable consumer (patient). A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 14Apr2021 (Batch/Lot Number: EW0161) as single dose for COVID-19 immunization. Medical history included ongoing type 2 diabetes mellitus (Diagnosed 1 year and a half or 2 years ago), ongoing hypertension (Diagnosed 1 year and a half or 2 years ago Blood pressure was 130/90 and it used to be a lot higher), ongoing blood cholesterol (Diagnosed 1 year and a half or 2 years ago), He threw his back out (He threw his back out when he worked at a nursery in the 1980s), back pain (He has not missed work due to back pain in 15 years) ongoing Herniated disc, His A1c was 9.3, now it is down to 6.1. Concomitant medication included metformin taken for type 2 diabetes mellitus, chlorthalidone taken for hypertension, rosuvastatin taken for blood cholesterol, hydrocodone taken for an unspecified indication. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 17 Mar 2021 (Batch/Lot Number: EP6955) as single dose for COVID-19 immunization and tetracycline and Got knots in his stomach. On Apr 2021, the patient experienced back ache/couple or three days after the vaccine he had pain. it was a gradual pain that got worse/he has to pick up his left leg; if he lifts it on his own it hurts his left lower back, his back was totally wrenched. he feels the vaccine aggravated an old back injury on an unspecified date, his arm was sore for one or two days on Apr 2021, his blood sugar yesterday was 144 on 29Apr2021. Patient visited physician for back pain. Patient stated he has not missed work due to back pain in 15 years. a couple or three days after the vaccine he had pain. It was a gradual pain that got worse until he had to miss work for a couple of days. States this was after the second dose of the vaccine. Says it was back pain. States it took him 10 minutes to get out of bed, his back was totally wrenched. He feels the vaccine aggravated an old back injury. States it wasn't like when he threw his back out because that pain was immediate. States this was a gradual pain that got the point he couldn't work with it. Patient believes the vaccine caused 2 weeks of back ache. The patient underwent lab tests and procedures which included blood glucose: 144 on 29Apr2021. The action taken in response to the event for BNT162B2 was not applicable. Outcome of event His back was totally wrenched. He feels the vaccine aggravated an old back injury, His blood sugar yesterday was 144 was unknown, His arm was sore for one or two days was recovered and for Back ache/Couple or three days after the vaccine he had pain. It was a gradual pain that got worse/He has to pick up his left leg; if he lifts it on his own it hurts his left lower back, His back was totally wrenched. He feels the vaccine aggravated an old back injury it was recovering. No Follow-up attempts are needed. No further information is expected.
58 2021-05-10 tremor Super, heavy fever, intense; Chills, later described with heavy sweating and shaking; Arm sore, desc... Read more
Super, heavy fever, intense; Chills, later described with heavy sweating and shaking; Arm sore, described as left arm at injection site; Chills, later described with heavy sweating and shaking; Chills, later described with heavy sweating and shaking; Low grade fever; Terrible headache; Bumpy rash on opposite arm, near elbow; This is a spontaneous report from a Pfizer. A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0158), via an unspecified route of administration, administered in Arm Left on 14Apr2021 13:00 at SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included paracetamol (TYLENOL), ibuprofen (IBUPROFEN). On 14Apr2021, 5 hours after vaccination patient experienced arm sore, described as left arm at injection site; chills, later described with heavy sweating and shaking (hyperhidrosis), chills, later described with heavy sweating and shaking (chills), low grade fever, terrible headache, bumpy rash on opposite arm, near elbow (rash), chills, later described with heavy sweating and shaking (tremor), On 25Apr2021 16:00, super, heavy fever, intense. Both has had doses of covid vaccine. Patient Said 12 hours after 2nd dose had unusual side effect and went away 36 hours after vaccine. Suddenly side effect is back. The patient was taking Pfizer Covid 19 vaccine protection, doing his duty. Caller stated that then reclarifies, he did not have a primary care provider right now. Caller stated that he would also volunteer to donate blood if it is needed in the future for evaluation. Caller states after the second vaccine, on the same day, 14Apr2021, his arm was sore, he had chills with heavy sweats every 3 hours, a low grade fever, terrible headache and a bumpy rash on the opposite arm near his elbow, that was 3 inches by 3 inches. Caller stated he took Tylenol, which helped, and the symptoms went away. Caller stated that yesterday, the bumpy rash came back, but it was worse. Caller stated he thought it was unusual for his symptoms to come back a week later. Caller stated he does not have a healthcare provider presently. Caller restated that his fever, chills, headache and rash, all appeared on 14Apr2021 and then went away on the 16th and then came back on 25Apr2021. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available. Caller added at the end of the report that he is fair skinned, and has freckles, and felt that was important to add. Caller mentioned again that if Pfizer would like a sample of his blood in the future, he is willing to provide it. Or if Pfizer does want to contact him, he is willing to answer questions. Caller spoken quickly at times and provided a lot of details, multiple reclarifications made to capture the information. The outcome of events (vaccination site pain), chills, low grade fever, rash) were recovered and events (hyperhidrosis, terrible headache, super, heavy fever, intense, tremor) were not recovered. No any unaddressed medical questions were referred or forwarded to Medical Information. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
58 2021-05-11 cold sweat Woke up in @ 2:30AM in cold sweat like a fever had broken. Incident was minor and brief.
58 2021-05-11 pain in extremity, weakness, night sweats Per pt, body aches, night sweats, no energy, SOB, and pain in extremities after receiving vaccine at... Read more
Per pt, body aches, night sweats, no energy, SOB, and pain in extremities after receiving vaccine at Health Systems.
58 2021-05-11 unresponsive to stimuli After receiving his 1st dose of Pfizer Vaccine. Our pt was waiting in the observation area when he s... Read more
After receiving his 1st dose of Pfizer Vaccine. Our pt was waiting in the observation area when he slumped to the ground. He was unresponsive for about 20 seconds. When he came to he was awake and oriented. He reported that he has a history of seizures. He is not on medication and has not had a seizure in 9 years. 911 was called and the paramedics took the pt to the hospital for further evaluation.
58 2021-05-12 burning sensation Hypersensitivity and burning sensation located on right side forehead, right eyebrow, surrounding ri... Read more
Hypersensitivity and burning sensation located on right side forehead, right eyebrow, surrounding right eye, radiating to temple. Started 2 days after vaccination and has been constant since then as of 5/13/2021
58 2021-05-12 pain in extremity Patient has had pain and decreased ROM in his arm since the second vaccine that he has received. To ... Read more
Patient has had pain and decreased ROM in his arm since the second vaccine that he has received. To the point that he is dealing with PT. Patient is a surgeon, so the impaired mobility is quite an issue.
58 2021-05-14 numbness I had the same reaction after the second shot that I had with the first it started with slight numb... Read more
I had the same reaction after the second shot that I had with the first it started with slight numbing in my face and then 2 days of severe flu like symptoms including aches from head to toe and freezing and not being able to get warm I was very tired and stayed in bed for a day and a half and then it went away with no further problems
58 2021-05-15 slurring, flushing Patient received the 2nd COVID vaccine (Pfizer, lot #EW0182, use by date 05/17/21 at 1515) at 1438. ... Read more
Patient received the 2nd COVID vaccine (Pfizer, lot #EW0182, use by date 05/17/21 at 1515) at 1438. The patient reported feeling dizzy to EMT, who immediately moved him to the anti-gravity chair. RN assisted in positioning him in a Fowler's position and ice packs were placed on his back and behind his neck. Patient's face mask was removed and his vital signs were taken at 1459, the patient was wearing a thick jacket, so the palpable radial pulse on the left forearm was 145, HR 83, RR 16, oxygen saturation was 97%., and pupils were equal. The patient denied any shortness of breath, difficulty breathing, difficulty swallowing, chest pain, or loss of consciousness. The patient was alert and oriented to person, place, time, and situation. The patient was speaking in full sentences and immediately responsive to questions. The patient was given a bottle of water and reported last eating around 1300. The patients color slowly reappeared when he was placed in Fowler's position. Reported being allergic to penicillin and taking Seroquil, 400mg, daily and Hydroxyzine, 25 mg for anxiety. Denied any chronic medical disorders other than general anxiety. Vitals were retaken at 1459, BP: palpable radial pulse, 140, RR 16, HR 79, and oxygen saturation at 98%. The patient stated that he felt flushed in his face, and the patient was immediately offered Benadryl but he stated, " Let's wait a few minutes, I don't like taking anything if I don't have to."The patient denied any shortness of breath, difficulty breathing or swallowing, lip tingling, or facial swelling. The patient decided to take the oral Benadryl at 1503 and was given Benadryl, 50mg oral suspension, PO. At 1505 we attempted to position him to a sitting upright position in the gravity chair and he stated, " I feel lightheaded, can we place me back how I was?" EMT and RN repositioned the patient in the anti-gravity chair to a Fowler's position and assisted the patient with removing two layers of shirts, as he was wearing multiple layers. Vitals were retaken at 1506: 120 palpable radial pulse, RR 16, HR 78, and oxygen saturation at 97%. The patient was alert and oriented to person, place, time, and situation. The patient was able to follow commands, had strength equal bilaterally in the upper extremities, and had a symmetrical smile. Vitals were retaken at 1515, BP: 120/82 (R arm), HR 81, RR 16, oxygen saturation at 97%. The patient was given juice and repositioned to a semi-Fowler's position. Denied dizziness or lightheadedness. The patient stated, " I'm usually pretty sensitive to medication, now I just feel like I could go to sleep." Denied experiencing shortness of breathing, difficulty swallowing, or difficulty breathing. Vitals were retaken at 1528, BP 120/85, HR 66, RR 16, oxygen saturation at 98%. The patient was able to follow commands, and stated, " I feel a pressure in my head." RN was going to call 911 to have EMS transport the patient to a hospital, but the patient denied EMS services and did not want 911 to be called when it was offered at 1528. The patient was repositioned to a Fowler's position. Patient reported no longer feeling flushed on the left side of his face at 1535. At 1540, vitals were retaken, BP 120/85 ( R arm, sitting upright), HR 79, RR 16, and oxygen saturation at 97%. The patient's color returned and he denied feeling lightheaded or dizzy. RN instructed the patient about emergency precautions and to follow up with his primary care provider. RN educated the patient about not operating machinery as the patient was given Benadryl and this may cause him to be drowsy. The patient contacted a friend to pick him up from the site. RN gave the patient reporting information. Vitals were retaken at 1550, BP: 120/82, HR 76, RR 16, and oxygen saturation at 98%. The patient's mouth was moving with regular movements and the patient was rapidly responding to questions. Patient called friend to coordinate his ride home. RN educated him about ER precautions again. The patient was alert and oriented to person, place, time, and situation, and his facial color had returned to baseline. EMT was instructed to stay with the patient until patient's friend arrived on site. At 1610 EMT reported to RN that patient reported feeling flushed and lightheaded again. EMT immediately placed him in a Fowler's position and RN called 911, EMS. The patient stated, " It's hard for me to recall things, like my head is really foggy." Patient's speech was slower than baseline, no facial swelling was observed and patient denied any difficulty breathing, shortness of breath, chest pain, or loss of consciousness. Patient was alert and oriented to person, place, time, and situation. Fire Department assumed care at 1615, RN gave report to the responders. The responders completed an EKG on site and completed a set of vitals. Patient denied transportation by EMS to hospitaland signed AMA paperwork given to him by the responders. Patient's friend arrived on site at 1618. RN educated patient's friend about transporting patient to hospital, as patient stated, " I'm going to have my friend take me to the hospital." RN quickly educated patient's friend that if while transporting patient to hospital, he began to experience shortness of breath, loss of consciousness, or difficulty breathing, to immediately pull over and call 911. Patient's friend verbalized understanding and patient was pushed in a wheelchair to the friend's vehicle, as he was very lightheaded. EMT, EMT, and RN assisted patient into the vehicle. Patient and friend stated that they were going to pick up a few items from patient's car and then go to the hospital immediately. Patient left the site at 1621.
58 2021-05-15 pain in extremity, weakness The initial symptoms were a strange feeling in several places in the upper left arm, but not at the ... Read more
The initial symptoms were a strange feeling in several places in the upper left arm, but not at the injection site. Not exactly itchy, but just slightly sore. Was intermittent. This was first noticed about 12 days after the first COVID-19 shot. It was noticed several times over the next two days or so. Around midnight on the 15th day after the shot I noticed a red rash developing on my chest. Just a few red blotches, flat and not itchy or sore. On the 16th day I noticed a marked decrease in energy and some general soreness in the body, similar to a fluish feel. These symptoms increased on days 17 and 18 and the rash got progressively worse, getting much redder and becoming raised. It developed over the left side of my upper chest, starting just outside the left armpit and spreading over to mid-chest, but not past. The lowest part is on the left nipple. On the back the rash is slight on the back of the upper left arm, and starts on the upper back just outside the left armpit and spreads over almost to the mid-back, maybe 5 inches from top of rash to bottom.
58 2021-05-17 feeling cold, seizure foaming from the mouth/foaming at the mouth; blood sugar dropping; He would not wake up and was unre... Read more
foaming from the mouth/foaming at the mouth; blood sugar dropping; He would not wake up and was unresponsive; seizures; swelling on brain; Pneumonia aspirating; so cold he could not work or anything; This is a spontaneous report from a contactable consumer reporting on behalf of her fiance. A 58-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 08Jan2021 (Batch/Lot Number: EL3248) as SINGLE DOSE for covid-19 immunization at the age of 58 years old. Medical history included sugar /diabetic, blood pressure. None vaccines administered on same date with the Pfizer vaccine considered as suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Family Medical History Relevant to AEs was none. Concomitant medication(s) included metformin hcl for Diabetes, he has been on for a long time; pregabalin for his back and leg because he had 2 pinched nerves or something and he has to get it repaired with injections. He has not gotten injections because of what he has been going through right now. It is 25 mg and he has been on this for a little while; lisinopril for cholesterol and is a blood pressure and heart pill; vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) for his vitamin D was low; diclofenac sodium (DICLOFENAC NA) for inflammation, he has been on this for as long as she knows; potassium chloride (POTASSIUM [POTASSIUM CHLORIDE]) for his potassium is low, She has been giving this to him. Whenever he gets blood work, sometimes they say his potassium is low so she gives it to him everyday; amlodipine besylate for blood pressure and heart; sertraline hcl for a mood pill, he has been on a long time; Metoprolol succinate for blood pressure and heart, He has been on for a long time. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 28Dec2020 (Batch/Lot Number: EJ1682) as SINGLE DOSE for covid-19 immunisation. The patient experienced foaming from the mouth/foaming at the mouth, blood sugar dropping, he would not wake up and was unresponsive, seizures, swelling on brain, pneumonia aspirating, so cold he could not work or anything in Apr2021. Reported as: He had the Pfizer shot, but he is currently hospitalized, he had an experience of foaming from the mouth, 3 months after the vaccine. He is on a trach/ requires trach and feeding tube. He is also on dialysis to clean the toxins in his blood. Caller stateed she is calling on behalf of her fiance. He can not talk to anyone at the moment. The reason she is calling is because he had his vaccine 08Jan2021. Caller states but the thing is that nobody knows what symptoms anybody is going to have. It has been what, 3 months, but his sugar dropped to 40 one day, and 30 one day. He was foaming at the mouth and had seizures. Aspirated, pneumonia: caller states that her fiance aspirated and had pneumonia in his right lung and has been in the hospital ever since. Foaming at the mouth: He is on a trach and feeding tube, dialysis in his neck, and caller is trying to figure out what is going on. Caller adds that he was foaming at the mouth. Blood sugar dropping, so cold he could not work or anything: caller states this happened Tuesday 2 weeks ago. She has been working and going there to see him. This is the first time she has trying to think and get answers herself. Caller adds that she tested his blood sugar and must have touched it with her own finger because it said 197. The paramedic said no it was 40. Caller states the paramedic gave her fiance IV stuff that shot it up and brought it up to 290, which was good. They wanted him to eat peanut butter and jelly and he said no and fought with them. The sugar was still not going up, and sugar was out of sorts. He took a few bites and it was okay. He asked for soup because he was so cold he could not work or anything. Caller becomes tearful and adds that her fiance's mom passed 6 months ago and they were talking. He got 20 units of lantus, normally he takes 50. They went to bed and caller adds she guesses because her nerves were shot or something she called off of work that night. She got up to go to the bathroom and let the dogs out and went to check on him. She did not have the light on and when she turned the light on she saw her fiance foaming at the mouth. He would not wake up and was unresponsive. Paramedics came and gave him a shot and IV to put sugar back in. They asked which hospital she would like him to go to and they said they could not take him to that hospital so they took him to another place. Seizures: They then put a breathing tube into him. The doctor said she was sorry but she knocked the man's tooth out. Then, they had to switch him to the mother hospital because they had to put probes on his head to monitor his seizures because he had seizures. He had swelling on the brain, pneumonia, and was aspirating. Caller adds she is not sure if she touched the strip with her finger and that was the false reason, and his blood sugar was only 40. caller confirmed that the blood sugar increased to 290 following the paramedics giving her fiance sugar. Caller adds she does not know how to work that stupid thing. He never showed her how to do it. If he had showed her, she would know what to do. She said it said 197 but the paramedics told her it was 40. She has to learn how to do this. Patient requires trach, feeding tube, and dialysis: Caller was asked to clarify dates and she states that this was Wednesday, the next day. He has not foamed from the mouth since then, and they are not sure if he is doing seizures or not. They asked and the hospital said they are not sure because they do not have probes on him. Now, he is on a trach and feeding tube. They are also giving him some type of dialysis through his neck to get rid of toxins in the blood and filtering it back to him. Caller clarifies date of hospitalization as 15Apr2021 she would think, but she does not even know. Caller thinks it has been two or three weeks. First, he went to the place she mentioned and then he was transferred to the other and that is where he has been since. Indication: he worked up on 4 a lot which he is the maintenance where he works. They wanted him to get the Pfizer because not too many people wanted to go up there. He figured he would take it and with his blood pressure and sugar it would help. He was up there fixing things and stuff like that, or at least that is what she was told by someone else. Caller verifies that the low blood sugars, foaming at the mouth, and being unresponsive were what hospitalized the patient. She does not know dates, she thinks it was around 15Apr2021, and he is still in the hospital. Investigations: caller states that she knows he went back, she does not know when, and that since it is May now, he must have gone back a few months ago for lab work. It was in the morning, he went before work, and they did all kinds of stuff and to see where his A1C was. Caller adds that it was 11. Whatever else they are checking him for now she is not sure. Reporter details: caller states that she is a health care professional right no. She adds she is in housekeeping and in the health field and that she hears a lot of things, just because she does not say them. caller does not clarify statement regarding hearing a lot of things. Her head is going all sorts of ways. Caller adds she is batting her head against the wall. She is trying to put her head around everything happening. This is the only thing different. Everybody's body is different. No AEs required a visit to Physician office. but leading to Emergency Room, She states that it is the MIC Unit, and then clarifies as MICU. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
58 2021-05-18 flushing Typically reported aches along with flushness of skin, especially both arms. Adverse condition was m... Read more
Typically reported aches along with flushness of skin, especially both arms. Adverse condition was mild blue and black bruising over 10 to 15% of both legs - calves and thighs. Majority of bruising faded over a 6 to 8 hour following its discovery.
58 2021-05-18 pain in extremity Patient stopped by Pharmacy consultation window on 05/19/2021 and asked if arm and shoulder pain cou... Read more
Patient stopped by Pharmacy consultation window on 05/19/2021 and asked if arm and shoulder pain could have been associated with the covid vaccine he received. He received his Pfizer covid vaccine on 05/05/2021 in his right arm. He stated that after the vaccine he had a sore arm for a few days and then the bilateral shoulder pain and increased pain in the right arm started a few days after that. He also has arthritis and asked if that could be his arthritis flaring up. He also mentioned he gets cortisone shots in his arms. He wanted to know if he should get his second dose (which would be due in a week) in his left arm instead. I informed him that it's hard to tell and I could not rule out either if it's the vaccine or the arthritis since the pain is in both shoulders and he stated he has a history of arthritis. I encouraged him to check with his physician to rule out arthritis and to determine if it is the vaccine and whether he should receive the second dose. He said he would consult with his physician before his second dose vaccine date. I asked him to let us know what his Physician says and he said he would.
58 2021-05-21 bell's palsy Patient exhibits cough, severe HTN, fatigue, and development of Bell's palsy. Treatment: Patient sta... Read more
Patient exhibits cough, severe HTN, fatigue, and development of Bell's palsy. Treatment: Patient started Ivermectin
58 2021-05-22 weakness 2021.05.20, 11:30PM felt unusually tired after my daily evening 3-mile walk. Muscles all over my bod... Read more
2021.05.20, 11:30PM felt unusually tired after my daily evening 3-mile walk. Muscles all over my body ached. 2021.05.20 12 midnight - 2021.05.21 8:00AM - slept very poorly with several interruptions, lots of sweating, mattress and bedding damp by the morning. I did not feel hot like when I have a fever. 2021.05.21 - 8:00AM - 9:00PM - Felt weak and lethargic. Muscle pain all over body continued. I needed to nap for two hours during the day. My heart rate was elevated about 15 percent above normal. After the nap I still felt tired. Food helped a little, but I went to be early, at 9PM. 2021.05.21 - 9:00PM - 2021.05. 22 - 8:00AM - Slept poorly with several interruptions, chills, and night sweats. Again awoke with damp mattress and bedding. For the first 10 minutes after rising I felt a little better, but then the muscle pain intensified and the lethargy too. I spent several hours of the day lying down in bed. Ate normally, which improved my overall feeling and energy level. Also consumed electrolytes and water. In the evening I started to feel not fully recovered, but a lot better than 24 hours prior. I went to bed at 11PM. 2021.05.22 - 11PM - 2021.05.23 - 10AM - I had some chills on preparing my bed, but overall slept better. Some sweating still. 2021.05.23 10AM - present 8PM - Felt much better. 95 percent of normal.
58 2021-05-25 mild one side paralysis, numbness Patient received the vaccine on 3-31-21. Then at 4:00 am on 4-1-2021, he became lightheaded and rep... Read more
Patient received the vaccine on 3-31-21. Then at 4:00 am on 4-1-2021, he became lightheaded and reports passing out. He had several weeks of general malaise and mild headache. He does not recall head trauma and had no bruising, "goose egg", etc. He felt generally unwell with a mild headache since then. Then on May 16th, 2021, while traveling with his wife, his left hand and arm and left side of tongue became numb and week. He was mildly confused. His wife took him to the ER and he was transferred to hospital for neurosurgery admission. Hospital records note that they presume the subdural bleed was triggered from the fall the morning of May 5th.
58 2021-05-26 cold sweat Approx 5 min after receiving the 2nd Pfizer COVID vaccine the patient fainted hitting head against w... Read more
Approx 5 min after receiving the 2nd Pfizer COVID vaccine the patient fainted hitting head against wall, scraping knee from falling and biting his lip. Pt was unconscious for approx 45 secs to 1 min. Vitals remained within normal limits during entire encounter except for increase in respiration rate of about 26-28. After regaining consciousness the pt was confused, nauseas, vomiting, diaphoretic and clammy to the touch. EMS arrived un scene approx 5-10 minutes after pt hitting his head and was transported to Hospital
58 2021-05-26 discomfort Sudden sensorineural hearing loss on the right ear. Symptoms started 1 week after the 2nd dose of th... Read more
Sudden sensorineural hearing loss on the right ear. Symptoms started 1 week after the 2nd dose of the COVID-19 vaccine on Monday 5/17. The hearing loss was accompanied by continuous buzzing sound, static noise, sensation of ear fullness, local discomfort, headache. It progressed over the first week. On saturday 5/22, I performed an online hearing test that confirmed the hearing loss (see section 19 for results). I went to urgent care to get the ear checked and cleaned, with no noticeable improvement in symptoms. On Sunday 5/23 I was started on 30 mg predinsone po. On Monday 5/24, I went to specialist care, she increased dose to 60 mg of prednisone and order additional tests.
58 2021-05-26 feeling cold Patient received their 2nd Pfizer COVID vaccine and about 5 minutes afterwards in the observation ar... Read more
Patient received their 2nd Pfizer COVID vaccine and about 5 minutes afterwards in the observation area the patient became lightheaded and collapsed hitting his head against the wall, EMS was called. While collapsing the patient bit his tongue, scraped his knee, and developed a visible bump on his head. Patient was unconscious while collapsed lasting approximately 45 seconds to 1 minute. When he regained consciousness he was confused and unaware where he was or what happened. Vitals were taken throughout being unconscious every 5 minutes until EMS arrived which was about 5-10 minutes after the patient collapsed. After regaining consciousness patient was cold, diaphoretic, nauseas, and emesis x 2. Report was given to EMS and transported to Hospital.
58 2021-05-30 weakness, tremor Serious diarrhea, vertigo, headaches, nausea, shaky, weak Dicyclomine 20 mg 3x daily May 20-28th di... Read more
Serious diarrhea, vertigo, headaches, nausea, shaky, weak Dicyclomine 20 mg 3x daily May 20-28th did not help, still have diarrehea, vertigo, etc metroNidazole 500mg 2x daily - still have loose bowels, vertigo, etc
58 2021-05-30 myelitis transverse, numbness Transverse myelitis with lower limb weakness and numbness. Treated with steroids and IVIG.
58 2021-05-31 feeling cold Saying he could not breath; anxious; reported being cold; complained of Chest pain; began to shake; ... Read more
Saying he could not breath; anxious; reported being cold; complained of Chest pain; began to shake; This is a spontaneous report from a contactable other hcp reported that a 58-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL3302 and expiration date: unknown), via intramuscularly in Arm Left on 29Jan2021 at 09:45 (at the age of 58 years old) as a single dose for COVID-19 immunisation. Medical history included allergies to Sulfa drugs from an unknown date and unknown if ongoing, Cardiac stents from 2004 to an unknown date. Concomitant medications included Lipitor, Aspirin, Plavix, Nitroglycerine for an unspecified indication from an unspecified date. No other illness reported at the time of vaccination and up to one month prior. The patient was in observation for 30 minutes. At approximately 25 minutes post vaccination at 10:15am, Patient signaled that he wanted to leave and was instructed to stay 5 minutes. Patient anxious and began to shake, saying he could not breathe. Vitals were 147/88, HR 86, O2 98% on RA. Pt was reclined on floor and reported being cold and was striking his head on the blanket; head stabilized. Patient was alert and oriented X3 but complained of Chest pain. EMS called, arrived at 10:25, vitals: 144/92, HR83 O2 99% on 2L. Pt stable & transported by EMS at 10:35am. The patient underwent lab tests and procedures which included heart rate: 86, 83, investigation: 147/88, 144/92, oxygen saturation: O2 98% on RA , oxygen saturation: 99 % on 29Jan2021. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
58 2021-06-01 pain in extremity headache; chills; joint pain; 100.4 fever; injection site swelling; little bit of redness on the sit... Read more
headache; chills; joint pain; 100.4 fever; injection site swelling; little bit of redness on the site/injection site redness; injection site redness, pain, and swelling; nauseated; pain in the arm/arm started hurting/his arm and all the way up to his jaw was hurting; It felt like he had the flu and he had body aches.; It felt like he had the flu and he had body aches; He felt like what he was experiencing was COVID symptoms.; tiredness; general feeling of unwell; This is a spontaneous report from a contactable consumer (patient's wife) via Medical Information Team. A 58-year-old male patient (Reporter's husband) received first dose of bnt162b2 (FIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0177), via an unspecified route of administration, administered in left arm on 14May2021 in the evening (at the age of 58-years-old) as single dose for covid-19 immunization in pharmacy. Medical history included covid-19 in 2020. Family history included COVID (They all had COVID last year). Concomitant medications included acetylsalicylic acid (ASPIRIN), oral at 81 mg, daily started a couple of months ago and ongoing rosuvastatin at 40 mg, daily, has been taking it for a couple of months; paracetamol (TYLENOL, Strength: 650mg, Lot: SEA002, Expiry: Mar2021) at 650 mg. No additional Vaccines were administered on same Date of the Pfizer Suspect. It was unknown if he had prior Vaccinations (within 4 weeks). When he goes to the doctor he goes by himself. It was reported that reporter's husband had the first dose of the Pfizer Friday and enquired some people say on the second dose the symptoms are worse, if it was true. He had tiredness and had general feeling of unwell on 14May2021; on 15May2021 he had headache, chills, joint pain, 100.4 fever, little bit of injection site redness, pain, and swelling/ injection site swelling, was nauseated. It felt like he had the flu and he had body aches. He went to sleep early on Friday night. She asked if he wanted Tylenol he said no. He mentioned in the middle of the night his arm started hurting. Then in the morning his arm and all the way up to his jaw was hurting. For the past two days their son has been sick and caller hasn't been able to talk to her husband much. He comes home from work and goes to bed. It is unknown if symptoms are ongoing. It was the 8 hour muscle ache and pain. He took Tylenol twice on Saturday. On Sunday, he was feeling better. He felt like what he was experiencing was COVID symptoms. Reporter asked if he could wait a couple of days for getting the second so he can be off work. The second vaccine was scheduled for 04Jun2021. That is a Tuesday and he prefers a Thursday so he could have Friday and Saturday off. A visit to emergency room or physician office was not required. Seriousness for the events was reported as unspecified. The outcome of the events was unknown. Information on the lot/batch number has been requested.
58 2021-06-02 tingling, numbness, pain in extremity Left arm was only sore for 36 hours; Within 1 minute throat got ice cold; Difficult to swallow; Fuzz... Read more
Left arm was only sore for 36 hours; Within 1 minute throat got ice cold; Difficult to swallow; Fuzzy feeling over entire body; Numb face; Tingly feeling; Heavy arms and legs; Light headed, felt very woozy; Blood Pressure went up to 170/120; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Lot number: EN6205), via an unspecified route of administration in the left arm on 05Mar2021 at 11:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple (20 to 30) bilateral knee surgeries and total right knee joint replacement on 02May2020. Concomitant medications included oxycodone 5mg (MANUFACTURER UNKNOWN) as needed, aspirin 88mg/day (MANUFACTURER UNKNOWN) for unspecified indication. 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 4 weeks prior to the COVID-19 vaccination. On 05Mar2021 (within 1 minute of vaccination), the patients throat got ice cold and more difficult to swallow, fuzzy feeling over entire body, numb face, tingly feeling, heavy arms and legs. Light headed, felt very woozy. It felt exactly like patient had been administered general anaesthesia right before surgery. The patient blood pressure (BP) went up to 170/120 (unspecified unit). As symptoms started getting better after 1 hour, BP went down to 140/70. On an unknown date, the left arm was only sore for 36 hours. It was reported that, emergency medical technician (EMT) did multiple blood pressure checks and electrocardiogram (EKG) at the vaccine site. The patient did not received treatment for adverse events. The clinical outcome of events throat discomforts, swallowing difficult, fuzzy, numbness in face, tingling, heavy feeling in arms and legs, light headed and blood pressure increased was recovered on 05Mar2021 (symptoms were gone after 3 to 4 hours from onset of reaction) and the event pain in arm was recovered on an unknown date (left arm was sore for 36 hours). No follow-up attempts are needed. No further information is expected.
58 2021-06-03 sciatica Prior to receiving the vaccine I had mild sciatica. I was able to walk a mile before it bothered me.... Read more
Prior to receiving the vaccine I had mild sciatica. I was able to walk a mile before it bothered me. The pain was perhaps a 3 on a scale of 1 to 10. After receiving the vaccine it became so severe that I was unable to walk or stand for more than a couple minutes, the pain was a 7 on a scale of 1 to 10, and it therefore interfered with daily tasks such as cooking, cleaning, showering, shopping and so on.
58 2021-06-04 tremor Large Amount of Histamine; he still did not feel well/ felt terrible this morning; Earache and Ear D... Read more
Large Amount of Histamine; he still did not feel well/ felt terrible this morning; Earache and Ear Drainage; Dizziness; Chills; Fever; Soreness; Spitting up Blood; Problems Breathing; Shaking worse than usual; Headache; Nausea; Chest Pains; The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on 21May2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 doses. This is the second of two reports for dose 2. This 58-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in arm left on 05May2021 11:30 (Lot Number: EW0179) at single dose for COVID-19 immunization. The patient's medical history included seasonal allergies and ear trouble. The patient's family medical history was none. The patient's concomitant medication was none. The patient no adverse effect following prior vaccinations. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 14Apr2021 (Lot Number: EW0164) at single dose for COVID-19 immunization and experienced events including earache and ear drainage from 17Apr2021 to 20Apr2021; dizziness from 15Apr2021 to Apr2021; chills and fever from 15Apr2021 to Apr2021; soreness from 15Apr2021 to Apr2021; spitting up blood from 15Apr2021 to Apr2021; problems breathing from 15Apr2021 to Apr2021; shaking worse than usual from 15Apr2021 to Apr2021; headache from 15Apr2021 to Apr2021; nausea from 15Apr2021 to Apr2021; chest pains from 15Apr2021 to Apr2021. The patient stated all of the symptoms from the first dose started on 15Apr2021 and recovered by 18Apr2021 or 19Apr2021. The patient stated he almost called the ER after the first shot because it was new to him and he did not know what he was dealing with. The patient had no other vaccine within 4 weeks. The patient received the second dose on 05May2021. The patient experienced earache and ear drainage from 08May2021 to 11May2021; dizziness from May2021 to 18May2021; chills and fever from May2021 to 18May2021; soreness from May2021 to 18May2021; spitting up blood from May2021 to 18May2021; problems breathing from May2021 to 18May2021; shaking worse than usual from May2021 to 18May2021; headache from May2021; nausea from May2021; chest pains from May2021. The patient stated he had the same side effects with both the first and second doses, but with the second shot they were worse and longer. The patient stated he still did not feel well. The patient stated the side effects from the second vaccine started either the 06May2021 or 07May2021 and recovered 18May2021, except the headache, nausea, and chest pain were persisting. The patient stated he felt terrible this morning (21May2021) and he realized this could be from something else. The patient also experienced large amount of histamine; more than usual after the second dose. The events did not require a visit to emergency room neither physician office. All the events except earache did not require treatment. The patient stated he got both vaccines at the beginning of allergy season, but he had no reason to believe it was all from his allergies, it was seemingly related to the vaccine. The outcome of event large amount of histamine; more than usual was resolving. The outcome of event headache, nausea, chest pains, did not feel well/ felt terrible was not resolved. The outcome of other events was resolved.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021582540 same drug/ patient, different dose number/ event
58 2021-06-04 tremor Earache and Ear Drainage; Dizziness; Chills; Fever; Problems Breathing; Shaking worse than usual; He... Read more
Earache and Ear Drainage; Dizziness; Chills; Fever; Problems Breathing; Shaking worse than usual; Headache; Nausea; Chest Pains; Soreness; Spitting up Blood; The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on 21May2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 doses. This is the first of two reports for dose 1. This 58-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 14Apr2021 (Lot Number: EW0164) at single dose for COVID-19 immunization. The patient's medical history included seasonal allergies and ear trouble. The patient's family medical history was none. The patient's concomitant medication was none. The patient no adverse effect following prior vaccinations. The patient had no other vaccine within 4 weeks. The patient experienced events including earache and ear drainage from 17Apr2021 to 20Apr2021; dizziness from 15Apr2021 to Apr2021; chills and fever from 15Apr2021 to Apr2021; soreness from 15Apr2021 to Apr2021; spitting up blood from 15Apr2021 to Apr2021; problems breathing from 15Apr2021 to Apr2021; shaking worse than usual from 15Apr2021 to Apr2021; headache from 15Apr2021 to Apr2021; nausea from 15Apr2021 to Apr2021; chest pains from 15Apr2021 to Apr2021. The patient stated the symptoms from the first dose started on 15Apr2021 and recovered by 18Apr2021 or 19Apr2021. The patient stated he almost called the ER after the first shot because it was new to him and he did not know what he was dealing with. The events did not require a visit to emergency room neither physician office. All the events except earache did not require treatment. The patient stated he got both vaccines at the beginning of allergy season, but he had no reason to believe it was all from his allergies, it was seemingly related to the vaccine. The outcome of events was resolved.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021580978 same drug/ patient, different dose number/ event
58 2021-06-07 migraine I waited 10-15 minutes after receiving the shot and I started to get an overwhelming migraine headac... Read more
I waited 10-15 minutes after receiving the shot and I started to get an overwhelming migraine headache. I was at the center, so I went to the ER. They put me in a dark room I received a Toradol shot and another shot to get rid of my headache. I was in the hospital for 3 days so they could monitor my migraine. While I was in the hospital, they changed my medicine. I was on 40 mg of Lexapro and they moved me down to 20mg. The first night I was in the hospital was horrible, but I feel that was from the vaccine. I kept pacing back and forth and didn't want to sit down. I do have anxiety and depression. Nothing has really helped with the headaches. I was given medications to take, but I don't remember to take them.
58 2021-06-07 pain in extremity sore arm; chest area feels like gas; chest pain/muscle pain in the rib in the chest ribs; chest pain... Read more
sore arm; chest area feels like gas; chest pain/muscle pain in the rib in the chest ribs; chest pain/muscle pain in the rib in the chest ribs; teeth pain; teeth sensitivity; anxiety; When I take a death breathe it hurts and sometimes it doesn't; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (Age at vaccination 58-year) on 07Mar2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took Advil 12 hours back for arthralgia. The patient stated, she received the first dose of her Pfizer vaccine that morning at 9:45am or 10am. she was fine. she just had a sore arm. About 2 and 1/2 hours later experienced: chest area feels like gas; chest pain/muscle pain in the rib in the chest ribs. Minor issue: teeth pain/sensitivity there. she talked to her PCP and he said she had anxiety, so took CBD oil. She stated "When I lie down the pain wakes me up because of the pain. When I take a death breathe it hurts and sometimes it doesn't. It's been almost 8 hours, there's no gas that I'm passing. I'm eating very light food (it's not due to the food I'm eating). It's a unique experience. Something new. not very severe. Question asked whether to take Advil or pain medicine. I was taking Advil for my joint pain, yesterday last night around 10:30 I took the last dose. Today I didn't take anything. Question asked if I should monitor for anything else." On 07Mar2021 the patient experienced sore arm, chest area feels like gas, chest pain/muscle pain in the rib in the chest ribs, teeth pain, teeth sensitivity, anxiety and when I take a death breathe it hurts and sometimes it doesn't. Therapeutic measures were taken as a result of anxiety. The clinical outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
58 2021-06-07 pain in extremity arm really sore/ arm hurt all night; "uncomfort" in his arm; This is a spontaneous report from a con... Read more
arm really sore/ arm hurt all night; "uncomfort" in his arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot number was not reported as patient did not card with him), via an unspecified route of administration, on an unspecified date (at age of 58-year-old) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration, on an unspecified date as single dose for covid-19 immunization. On an unspecified date, the patient stated that he woke up in the morning with a sore arm after receiving the second dose of the Pfizer COVID vaccine yesterday. He said that he did not have any issues with the first dose. The patient said that he talked to three people as wanted to know if this side effect was normal or if he should seek emergency care from a doctor. The patient had "uncomfort" in his arm and arm was sore. His arm was hurting all night and was uncomfortable. The patient was concerned because he had never experienced this before, and he did not know if he needed to see a doctor for the arm pain. The patient was informed about the role of Pfizer. When probed, patient stated that he was not at his home and did not have vaccination card with him. Product details (ndc# upc# and treatment) and pharmacy details could not be probed as he was unwilling to share further information. Hence, further probing could not be done and limited information available over the call. The outcome of the events was unknown. Follow-up attempts are needed. Further information is expected.
58 2021-06-08 pain in extremity Patient complained of having full body aches and joint paint (multiple joints affected: knees, ankle... Read more
Patient complained of having full body aches and joint paint (multiple joints affected: knees, ankles, toes, hands, wrist and elbows) and continued arthritis type symptoms.; Patient complained of having full body aches and joint paint (multiple joints affected: knees, ankles, toes, hands, wrist and elbows) and continued arthritis type symptoms.; Patient complained of having full body aches and joint paint (multiple joints affected: knees, ankles, toes, hands, wrist and elbows) and continued arthritis type symptoms.; Patient complained of having full body aches and joint paint (multiple joints affected: knees, ankles, toes, hands, wrist and elbows) and continued arthritis type symptoms.; This is a spontaneous report from a contactable consumer or other non-healthcare professional. This consumer reported for a 58-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, patient complained of having full body aches and joint paint (multiple joints affected: knees, ankles, toes, hands, wrist and elbows) weeks after taking 2nd dose of COVID vaccine and continued arthritis type symptoms. It was reported that onset linked to after 2nd dose of vaccine and no other changes in diet, medications or physical exercise attributed to joint pain. Event took place after use of product. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
58 2021-06-09 night sweats lost of the sense of smell; diarrhea one day; hot and cold sweats; stuffy nose; Headache; night swea... Read more
lost of the sense of smell; diarrhea one day; hot and cold sweats; stuffy nose; Headache; night sweats; They are wondering did they get COVID from the shot or should they have been tested before they got the shot; This is a spontaneous report from a contactable consumer reported for a male patient via medical information team. A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot number and expiration date: Unknown), via an unspecified route of administration in the upper left arm on 18Feb2021 at 16:00 (at the age of 58-year-old) as 1st dose, single dose for COVID-19 immunization. Medical history included asthma growing up as a child. It was an underlying medical condition and high blood pressure. No investigation assessment was not provided. Concomitant medication included Metoprolol for high blood pressure and one other but doesn't know the name of the other one. Patient also took a water pill. The patient did not receive any other vaccines within four weeks prior to the vaccination. Consumer reported that patient received first dose of COVID vaccine on 18Feb2021. He had symptoms ever since. The reporter wanted to know did he get COVID from the shot or should he have been tested before he got the shot and how long would the side effects could last. The reporter clarified patient symptoms as lost sense of smell, stuffy nose, hot and cold sweats, diarrhea one day, night sweats and headache on an unknown date in Feb2021. She mentioned that she finds it strangely coincidental that they received the shot and then "all of the sudden they can't smell". The vaccination card given to him was in the car. The reporter doesn't have it on hand to provide lot number. It was given on the same date and at the same time as consumer, so probably the same lot number she received. Consumer's lot number was EN6200. No adverse events resulted in physician's office visit nor emergency Room. The events were assessed as non-serious. The clinical outcome of events was reported as unknown. No follow-up attempts are possible. No further information is expected.
58 2021-06-15 weakness I woke this morning feeling muscle aches; weakness; Temperature 99.5; This is a spontaneous report f... Read more
I woke this morning feeling muscle aches; weakness; Temperature 99.5; This is a spontaneous report from a contactable consumer (reported for himself). A 58-years-old male patient received second dose of BNT162B2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number was not reported) via an unspecified route of administration, administered in arm right on 23Feb2021 at 08:15 (at the age of 58-years-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of 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 patient has no reported allergies. The patient previously received first dose BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number was not reported) via an unspecified route of administration, administered in arm right on 01Feb2021 at 08:10 (at the age of 58-years-old) as single dose for COVID-19 immunisation. On 24Feb2021, at 05:00, the patient experienced she woke up in the morning feeling muscle aches, weakness and temperature 99.5. The patient underwent lab tests and procedures which included pyrexia: 99.5 on 24Feb2021. No treatment was given for the events. The outcome of the events was resolving. Information about Lot/batch number has been requested.
58 2021-06-15 pain in extremity Started pain in the left leg after 3 weeks, Found DVT in left leg after ultrasound
58 2021-06-16 pain in extremity Sore arm and pain in arm; This is a spontaneous report from a contactable male consumer (patient) re... Read more
Sore arm and pain in arm; This is a spontaneous report from a contactable male consumer (patient) reported for himself. A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unspecified), via unspecified route, administered in left arm on 09Apr2021 at 10:00am (at the age of 58-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history includes cancer, Caller clarified that he had had chemo, radiation and 5 surgeries with sarcoidosis of lungs in 2007-2008. Concomitant medications were not reported. On 09Apr2021 10:00 am, after the vaccination, the patient experienced sore arm and pain in arm. The reporter assessed the event as non-serious. Caller clarified that the pain was just from the needle. He did not have any discomfort where he had symptoms. Caller also states he lost his card, and he wants it back, He stated that he can go back to his vaccine site, but they are talking about closing the massive vaccination sites. He does not know if it is closed yet. He heard them say they are starting to close the sites as they have them at the drugs stores now. The caller also said everybody he knows that took other vaccines were halfway sick, but he took Pfizer, and he did not feel anything except for pain in his arm. He heard other things besides Pfizer that people were getting sick a little bit, but not him. The outcome of the event pain was recovered/resolved on an unspecified date. No follow-up attempts possible. No further information expected.
58 2021-06-18 hot flush Caller states its hurting now like his whole head is swollen; He states he has COPD and seemed like ... Read more
Caller states its hurting now like his whole head is swollen; He states he has COPD and seemed like it made it worst; he gets hot flashes; he was exposed at work to the coronavirus; he is not eating; he feel like his voice is going; throat feels like he swallowed a hot pepper, like there is fire inside of it.; cough is always there due to smoking but it has gotten worse; can't hardly smoke a cigarette right now; headache; cough; diarrhea; sore throat; shortness of breath; he felt fine until he took it and he has not felt good since; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number END162; Expiration date was not reported), via an unspecified route of administration, administered in arm left on 09Jun2021 (at the age of 58-years-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (He states he has COPD and seemed like it made it worst, patient stated he had COPD and seemed like it made it worst), tobacco user (he smokes and can't hardly smoke a cigarette right now). The patient concomitant medications were not reported. Prior vaccinations (within 4 weeks) to the first administration date of the suspect vaccine included flu shot or pneumonia shot. Patient stated it was one of those shots that is supposed to last for 7 years (NO LOT, NDC or EXP date unknown) and did not know what he did with the paper and stated he got it about 2-3 weeks ago. No adverse events noted following the prior vaccinations. No family medical history relevant to the events. No additional vaccines administered on same date of the Pfizer Suspect. On 09Jun2021, the patient experienced sore throat, shortness of breath. On an 10Jun2021, the patient experienced diarrhea. On 11Jun2021, the patient experienced cough. On 12Jun2021, the patient experienced headache. Caller states its hurting now like his whole head is swollen on an unspecified date, he states he has COPD and seemed like it made it worst on an unspecified date, he gets hot flashes on an unspecified date, he was exposed at work to the coronavirus on an unspecified date, he is not eating on an unspecified date, he feel like his voice is going on an unspecified date, throat feels like he swallowed a hot pepper, like there is fire inside of it on an unspecified date, cough is always there due to smoking but it has gotten worse on an unspecified date, can't hardly smoke a cigarette right now on an unspecified date, he felt fine until he took it and he has not felt good since on 09Jun2021. Caller reported the outcome of the events. Patient stated the reason for taking Pfizer covid vaccine as it was offered at work and said insurance would be cheaper so took it and plus to be safe. Patient was told to call and report his symptoms and wanted to know if his symptoms been reported before. Patient stated he does not have a doctor. Caller stated he was on this way to work when the diarrhea hit, then it was ok for two days and then the diarrhea hit again on Friday, Saturday and Sunday. He stated this morning he was having diarrhea as well. It seems to be getting better today, although he was not eating. He stated the diarrhea mainly hit him when he coughed and then he has a mess to clean up, especially with a deep cough. With headache, caller stated its hurting now like his whole head is swollen and outcome stayed the same. Caller stated his sore throat was way worse in some ways and way not in others, feel like his voice was going. He states he had COPD and seemed like it made it worst. He also mentioned, he smokes and can't hardly smoke a cigarette right now and maybe that is a good thing he guesses it was keeping him from smoking because it makes him cough. Caller stated his throat feels like he swallowed a hot pepper, like there is fire inside of it. Caller stated his shortness of breath stayed about the same, his cough is always there due to smoking, but it has gotten worse. He stated that on Friday even he took one puff of his cigarette and coughed his head off. He thought that might be why he had a headache. It hurts when he coughs. He states it has him worried and he just wants to be truthful and honest about all these symptoms. He was just curious of what was going on. He was tested for coronavirus, said tested negative, but wants to know what was going on. About Cough, caller stated it has gotten no different, staying about the same. Caller stated was not understanding why he is having all these side effects and stuff. Caller gave the number from the vaccine card as END162 and stated he can hardly read the writing. Caller stated if he would have known this, he wouldn't have taken it and he felt fine until he took it and he has not felt good since. Caller stated he has not had taken any other vaccines that he can remember, unless he did as a kid. He stated he was pretty healthy. The last 6-7 days though he hasn't felt like himself because he has been going to bathroom, headaches, coughing, and sometimes he gets hot flashes, and having the sore throat for over a week now or right around week, 09Jun2021 to now, over the last 6 days and with the headache the last 3-4 days. Commented he feels like a whiny butt. Patient did not require to visit physician office due to the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. Other relevant tests or investigations assessment included none. The clinical outcome of the sore throat, headache, shortness of breath, diarrhea, cough, headache, caller states its hurting now like his whole head is swollen were not recovered and for the other events unknown.
58 2021-06-18 paralysis, weakness After taking the 1st vaccine in March 2021, His skin peeled over his entire body, with minimal itchi... Read more
After taking the 1st vaccine in March 2021, His skin peeled over his entire body, with minimal itching. He was only given skin cream and tried different lotions. In april, he took the 2nd vaccine he had the normal side effects for a little over a week, and then he started getting weaker, eventually he was rushed to the hosptial on May 7. He had spiked fevers and sugar levels from him being so ill. He is now paralyzed from the waist down and still in the hospital fighting it.
58 2021-06-22 night sweats 27 years ago I had Epstein Barr ( Mono). One week after my second dose I have a resumption of sympto... Read more
27 years ago I had Epstein Barr ( Mono). One week after my second dose I have a resumption of symptoms including night sweats, fatigue and sore joints. These symptoms are still present
58 2021-06-26 numbness On April 30, 2021, I received the 2nd dose of the COVID-19 (Pfizer-BioNTech) vaccine which was 3 wee... Read more
On April 30, 2021, I received the 2nd dose of the COVID-19 (Pfizer-BioNTech) vaccine which was 3 weeks after receiving the 1st dose. Then on May 3rd, I experienced pronounced shortness-of-breath while at work lifting objects up to 20 lbs and walking short distances of 20 to 40 m on flat ground. Then on May 4th, 2021, I went into a nearby Urgent Care Clinic (UCC) with shortness-of-breath and exertional dyspnea as the main symptoms. At the UCC blood tests were done along with EKG and chest x-ray. Blood tests revealed several results that were not within standard ranges: troponin (1.25 ng/mL), BNP (5130 pg/mL), D-dimer (1320 ng/mL FEU), and C-reactive protein (75.5 mg/L). I was told that I had congestive heart failure and NSTEMI. UCC then directed me to go to the Emergency Department (ED) at a nearby hospital. In the ED, more tests were done: EKG, CT scan chest (no blood clots were found in the lungs), and cardiac ultrasound (estimated ejection fraction 40-45%). That evening I was transferred to the main hospital for further observation and tests. Not much happened on May 5th and I was not seen by a doctor until 5pm. Then early in the morning of May 6th, I experienced chest pain which lasted between 5 and 10 minutes. I was given oral nitroglycerine. My primary care physician (PCP) and a cardiologist elected to move forward with an angiogram. On May 6th, I underwent cardiac catheterization (CC). The CC report states: (a) 2nd Diag lesion is 50% stenosed (b) Mid RCA to Dist RCA lesion is 80% stenosed,(c) RV branch lesion is 80% stenosed, (d) RPDA lesion is 80% stenosed. Likely spontaneous coronary artery dissection of the mid to distal RCA and postal to mid PDA status post PCI with 2 Xience drug-eluting stents. Post-angiogram+angioplasty tests were done, including carotid artery ultrasound (results within normal limits. No hemodynamically significant stenoses) and MRI brain (punctate foci of restricted diffusion in both cerebral hemispheres. Multiple vascular distributions w/o larger territorial infarct suggest emboli). Other blood test results were: antinuclear antibody (ANA) IFA screen (positive), BNP (8631 pg/mL). I was released from the hospital on May 8, 2021. Follow-up care included cardiac rehab therapy and consultations with the cardiologist, PCP, a neurologist and rheumatologist. Incidentally, 12 days after the angiogram and angioplasty, I experienced temporary numbness and loss of movement in my right arm which lasted no more than a minute, indicative of a transient ischemic attack (TIA). Root cause investigations focusing on SCAD and TIA are on-going.
58 2021-06-26 pain in extremity Unusual leg pain upper thigh back of thigh prolonged Standing makes worse, did not happen 1st dose.... Read more
Unusual leg pain upper thigh back of thigh prolonged Standing makes worse, did not happen 1st dose. No treatment necessary just taken ibuprofen.
58 2021-06-26 pain in extremity Pain in left arm, sleepy, sore muscles.
58 2021-06-27 numbness As noted, I have pre-existing numbness in my left arm and fingers that varies from perhaps 20% to 10... Read more
As noted, I have pre-existing numbness in my left arm and fingers that varies from perhaps 20% to 100%, but most of the time the past two years has been 20 - 50%. A few days after getting the first shot, my left index finger suddenly went 100% numb at the last digit and my thumb went about 90% numb. This lasted for a few days and then subsided to probably 50% and a bit better. I was unsure if this was the result of the vaccine, so I noted it, mentioned it to my doctor, and to the pharmacist when I went in for the second dose. The pharmacist suggested we try the right arm this time, which we did. Two days after the injection, my index finger and thumb both got significantly more numb again - though not quite 100%. My left middle finger is now also partially numb for the first time. It had been 1 days now since the second injection and my index finger and thumb remain significantly more numb than normal, and my middle finger remains a bit numb. It seems reasonably clear that the injections triggered the reactions. One thing I noted after the first reaction was that I have previously wondered if other previous issues I have experienced were related to the multiple vaccinations and Anthrax vaccine I received. A few people involved in the healthcare industry had previously mentioned that some of my symptoms were similar to those with a work related illness, but these were dismissed since I never actually worked there. I am now wondering if the multiple vaccinations have, indeed, impacted my immune system and if this might be linked to my response to the Covid Vaccines. Regardless the past history, my best first guess is that the vaccine response is either related to increased swelling putting pressure on the nerve in my neck, or that it is increasing the damage to the injured nerve. Especially given the sheer number of subjects who received mass vaccinations for work and given that most of those people are now older in age I feel this is an important potential reaction to be aware of.
58 2021-06-29 numbness Initially circulation lost in 3 fingers on my right hand; Numbness from the elbow to thumb on my rig... Read more
Initially circulation lost in 3 fingers on my right hand; Numbness from the elbow to thumb on my right arm; This is a spontaneous report from a contactable consumer (Patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: en5318) via an unspecified route of administration, administered in right arm on 31Jan2021 at 09:00 (at the age of 58-years-old) as dose 1, single for COVID-19 immunization. Vaccination Facility type was School or Student Health Clinic. Medical history included penicillin allergy. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included plantago afra (COLON CLEANSER); atorvastatin (LIPITOR); omeprazole and lisdexamfetamine mesilate (VYVANSE); all taken for an unspecified indication, start and stop date were not reported. On 31Jan2021 at 09:15 (15-minutes after vaccination), patient initially circulation lost in his three fingers in right hand followed by numbness from elbow to thumb in right arm. The patient did not receive any treatment. Post vaccination, the patient had not been tested for COVID-19. The outcome of both the events was recovered on an unspecified date in 2021. Follow-up attempts completed. No further information expected.
58 2021-06-29 pain in extremity Body aches; Fever; Diarrhea; Joint pain; Headache; Sore arm; This is a spontaneous report from a con... Read more
Body aches; Fever; Diarrhea; Joint pain; Headache; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 58-years-old adult male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: ER8727), via an unspecified route of administration in the left arm on 20Mar2021, at 10:30 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes, high blood pressure and high cholesterol. The patient had no allergies to food or medications. Concomitant medications included diltiazem (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and fluvoxamine (MANUFACTURER UNKNOWN), all from an unknown date and for unknown indication. Prior to vaccination, the patient had no symptoms associated for COVID-19. Since the vaccination, the patient was not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 19Mar2021 at 13:00, the patient experienced fever, body aches, diarrhea, joint pain, headache and sore arm. No therapeutic measures were taken as a result of events. The clinical outcome of events fever, body aches, diarrhea, joint pain, headache and sore arm were resolving at the time of this report. No follow-up attempts are possible. No further information is expected.
58 2021-06-29 tenderness Left side of face tender and swelling; Left side of face tender and swelling; This is a spontaneous ... Read more
Left side of face tender and swelling; Left side of face tender and swelling; This is a spontaneous report received from a contactable consumer, the patient. A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration in the left arm on 12Mar2021 at 08:30 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroid. The patient did not have any allergies to medications, food, or other products. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown 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 four weeks prior to the COVID vaccine. On 18Mar2021 at 08:00, the patients left side of face was tender and had swelling. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse event left side of face tender and swelling. The clinical outcomes of the events tenderness and swelling face were not recovered at the time of report. No follow-up attempts are needed. No further information is expected.
58 2021-06-30 pain in extremity Joint pain hands and feet; severe pain in feet and knees, not in hips, but more in extremities; musc... Read more
Joint pain hands and feet; severe pain in feet and knees, not in hips, but more in extremities; muscle fatigue; Joint pain hands and feet; severe pain in feet and knees, not in hips, but more in extremities; almost arthritic feeling; severe pain in feet and knees, not in hips, but more in extremities; Couldn't open jar of pickles; Making fists not a normal reaction anymore; thumbs feel like they're dislocated; Clicking going on in hands and wrists; Muscle pain in every part of his body; Hands and wrists painful, swollen and inflamed; Pain in hands when going to bed and making contact with mattress; Hands and wrists painful, swollen and inflamed; Hands and wrists painful, swollen and inflamed; This is a spontaneous report from a contactable consumer. A 58-years-old male consumer (patient) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ER8735) via an unspecified route of administration in right arm on 27Apr2021 in the afternoon around 13:30 or 14:00 hr (at the age of 58-years-old) as a DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history (including any illness at time of vaccination), prior vaccinations received within 4 weeks, adverse events following prior vaccinations, family medical history relevant to adverse events, additional vaccines administered on same date of the Pfizer suspect and concomitant medications were reported as none. Patient stated that he took nothing, not even over the counter. This report was not related to a study or programme. Investigation assessment was not reported. Patient stated he took vaccine as he was trying to be a good human. Patient didn't know but he believed he was having a reaction and said nothing else was going on in his life and the timeliness to the first and second shot was there. He was having joint pain in his hands and wrists. It was almost arthritic feeling. Patient said that with shot number one, he had muscle fatigue. And wanted to know if anyone else had been reporting this. Patient said that he was certainly not a doctor. He was having muscle pain in every part of his body. It started in the feet, knees, and hands. He couldn't open a jar of pickles. When he was going to bed, he put his hands down to migrate to put his body down. It was painful making contact with the mattress. Patient said he had nothing in his hips or lower back. It was slightly in his neck. He described his elbows as wow. They were pretty extreme. He had clicking going on in his hands especially his wrists. They were painful, swollen and inflamed. There was no redness. It felt like a bee sting reaction. He could feel the inflammation. Making fists was not a normal reaction anymore. Shaking hands, he could not do anymore as it was painful. Patient clarified how it was when he got into bed. He stated that people ease themselves down with their hands. It was painful for him. Patient stated that he got the vaccine so this nonsense would go away and it was the convenience of the supermarket. He was on the government waiting list, but his time was not being called. Patient stated that he was not a hypochondriac or complainer. The injection site where he went told him to call. He wanted to know if anyone else was having this kind of reaction. Patient said that he had not gone to the doctor or ER. He had not gone to the doctor yet. He said the ER would be a waste of time. They would do lots of tests. He had a call into his doctor. He would get in in a few weeks. He had been negligent, and his symptoms were not getting any better, they were getting worse. He would call and get in as soon as possible. He was thinking this would go away. He stated that if events went on for 6 to 8 weeks, he would probably get into his doctor. He did not like running to the doctor. Patient said that if he cut off his leg, he would probably not go for 3 days, he did not like the process. He reported that all of his family had been vaccinated with no issues at all. Relevant tests were reported as none. On additional follow-up on 23Jun2021, patient stated that after dose 1, he had some muscle fatigue. Says it is progressing to the point where he gets in bed and has severe pain in feet and knees, not in hips, but more in extremities. Also stated that thumbs feel like they're dislocated. He did not require emergency room and physician office visit. He stated that had not been to doctor yet but considering getting an appointment. He had not gone to the doctor or ER as it would be a waste of time because if there was a .0001 percent chance of a reaction, he doesn't want unneeded tests and procedures. He asked if it's common, and if it was, he might wait a little longer to see his HCP. He wanted to know how long the effects had lasted with others that reported similar effects. Patient was directed to cvdvaccine.com for further reading at his discretion. Referred to HCP for ongoing management of symptoms. Patient stated that he felt better knowing he was not the only one that has experienced theses side effects. The outcome of all the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021764854 similar report from same reporter
58 2021-07-01 pain in extremity On April 17, 2021 I woke up with unexplained inflammation and pain in shoulders and hips/groin/ thig... Read more
On April 17, 2021 I woke up with unexplained inflammation and pain in shoulders and hips/groin/ thighs. I thought possibly it was from swimming the day before but swimming was very minimal. I was on vacation. I came back home and went to my PCP. He ran blood tests and c-reactive protein seemed to be the only test elevated. I was referred to rheumatologist. Unable to get in for months. I visited ER because of persistent pain and inflammation. They ran blood tests and covid test. Negative covid and again high levels on c reactive protein. Finally able to get into rheumatologist.
58 2021-07-01 cold extremities Woke up with anxious feeling, heart was beating faster than normal, hands/fingers cold. Tested ecg ... Read more
Woke up with anxious feeling, heart was beating faster than normal, hands/fingers cold. Tested ecg with Watch and it indicated Atrial Fibrillation. I didn?t believe it and retried several times over the next hours and finally went to ER.
58 2021-07-01 tremor, muscle spasms, weakness Dizzyness for days after vaccine, then weakness, nausea, cramps, shortness of breath, trembling. and... Read more
Dizzyness for days after vaccine, then weakness, nausea, cramps, shortness of breath, trembling. and chest pain a few times a week
58 2021-07-08 pain in extremity, tenderness Fatigue, Chest pangs (not significant enough to call them pains), sensitive spleen / liver, upper bo... Read more
Fatigue, Chest pangs (not significant enough to call them pains), sensitive spleen / liver, upper body aches, swollen feet, inner thigh pain. Fatigue started day after 2nd shot and has continued. Additional systems started ~ 2 weeks post second shot and continued. Intensity of additional symptoms have reduced over the past 3 weeks.
58 2021-07-08 pain in extremity severe pain in entire arm, Severe fatigue, GI discomfort, Headache, This lasted 3 full weeks
58 2021-07-10 feeling hot, pain in extremity headache; chills; warm forehead; sore left arm; second shot on 21Apr2021; he has not been able to ge... Read more
headache; chills; warm forehead; sore left arm; second shot on 21Apr2021; he has not been able to get good sleep; tiresome.; This is a spontaneous report from a contactable consumer (patient). A 58-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: ER8729), via an unspecified route of administration in Arm Left on 21Apr2021 as single dose (at the age of 58-year-old) for precautionary measures. Medical history included left eye surgery for cataracts on 20Apr2021 and cataracts, had for over a year. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0158), on 09Apr2021 as single dose for precautionary measures and experienced Sore left arm. Reported that patient had second vaccine shot from Pfizer yesterday. Was on way to work and was tiresome. Stated that he has not been able to get good sleep. Stated that he woke up at 3am with a headache and warm forehead. On 28Apr2021, the patient had chills. Stated that he had no effects from first vaccine but a left sore arm. Stated that his left arm is sore from the second one. Later clarified as Pfizer Covid 19. Stated that he had cataracts before the vaccines. Stated that when he picks something up, strains or moves his left arm that its sore. Stated that the first time he had a sore left arm that it went away in 4-5 days. Stated that he did not take Ourezel and Besivence today. Started using Ourezel and Besivence on 18 Apr or 19 Apr. The outcome of events headache, chills, warm forehead, sore left arm was not recovered, and for other events it was unknown. No follow-up attempts are needed. No further information is expected.
58 2021-07-11 migraine I am a migraine sufferer. After getting the first Pfizer Vaccine my migraine headaches escalated I h... Read more
I am a migraine sufferer. After getting the first Pfizer Vaccine my migraine headaches escalated I had three headaches between the first and second vaccine shot. I have also continued to have more headaches than normal since receiving the vaccine. I have had a total of six headaches to date since receiving the first vaccine.. Normally I have less than six migraine headaches in a whole year. I have also developed a constant ringing in my ears which started the day of or the day after I got the first shot.
58 2021-07-14 pain in extremity Took shot at 5pm, had Sore arm & diarrhea, by 1130pm
58 2021-07-16 tingling Heart rate increase. Short of breath. Tingling in hands and arms. Light headed. Bad taste in mouth.
58 2021-07-17 muscle spasms very bad neck cramps; gave headache; blurry vision now; This is a spontaneous report from a contacta... Read more
very bad neck cramps; gave headache; blurry vision now; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: box-18) via an unspecified route of administration in the arm left on 29Mar2021 at 09:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have allergies to medications, food, or other products. Concomitant medications included levocetirizine dihydrochloride (XYZAL) and fluticasone propionate(FLONASE) on unknown date and for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was reported as unknown if the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 01:00 PM the patient experienced very bad neck cramps, had headache and blurry vision. It was unknown if the patient took any treatment for the reported adverse events. The event resulted in doctor or other healthcare professional office or clinic visit. The clinical outcome of the events was unknown at the time of report. No follow-up attempts are needed. No further information is expected.
58 2021-07-17 night sweats Headache; Vision problems; Fever; Night sweats; Bodyaches; Confusion is turning yellow again; This i... Read more
Headache; Vision problems; Fever; Night sweats; Bodyaches; Confusion is turning yellow again; This is a spontaneous report from a contactable consumer, the patient. A 58-years old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) as a single dose on left arm via unspecified route on 22Mar2021 at 03:00 PM (at the age of 58-years old) for COVID-19 immunisation. The patient medical history included major cirrhosis of the liver needs a liver transplant. The patient was allergic to morphine cipro and motto patch.Concomitant medications was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021, at 20:00 the patient experienced major headache vision problems as well both on left side of head, fever night sweats body aches confusion was turning yellow again. The patient did not receive treatment for the reported events. The clinical outcome of major headache vision problems as well both on left side of head, fever night sweats body aches confusion was turning yellow again was not recovered. No follow-up attempts needed. No further information expected. Amendment: This follow-up report is being submitted to amend previously reported information: Verbatim of Relevant Med History updated as same as source document, note added, "Concomitant medications were not reported" updated as "Concomitant medications was reported as none", "on left arm", "The patient did not receive treatment for the reported events " added in narrative and Reference No. added.
58 2021-07-17 pain in extremity Had pain in his arm/ The arm pain happened after his second dose/ He is still experiencing pain in h... Read more
Had pain in his arm/ The arm pain happened after his second dose/ He is still experiencing pain in his arm; This is a spontaneous report from a contactable consumer (wife of the patient). A 58-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date were not provided), via an unspecified route of administration, administered in Arm on 19Apr2021 (24 days after the first dose) as dose 2, single (age at vaccination: 58 years), for covid-19 immunization. The reason why lot/batch details were not shared is the reporter was unwilling to complete the report. The patient medical history and concomitant medications were not reported. The patient previously received dose 1 of bnt162b2 (Lot number was not reported, age at vaccination: 58 years), on 26Mar2021 with his wife on the same day, for covid-19 immunization. The wife reported that, her husband had the same shot, on the same days as of her and he had pain in his arm since an unknown date in Apr2021, after his second dose, but the pain was not as severe as her pain. She also stated that, he was still experiencing pain in his arm and she was not sure in what arm he was experiencing the pain. The outcome of the event was not recovered. Information on lot/batch number has been requested.
58 2021-07-19 numbness Pt reported arms going numb
58 2021-07-21 discomfort Site: Pain at Injection Site-Medium, Additional Details: body felt heavy, decreased arm extension, m... Read more
Site: Pain at Injection Site-Medium, Additional Details: body felt heavy, decreased arm extension, md visit on 7/20/21, when lift arm, feels like it locks
58 2021-07-25 muscle twitching Day after the shot my left kidney started twitching about once a hour. next day it was very painful ... Read more
Day after the shot my left kidney started twitching about once a hour. next day it was very painful and lasted about a month. A week after is subsided my right kidney started hurting and is still painful when I move around.
58 2021-07-26 bell's palsy, weakness Systemic: Bell's Palsy-Severe, Systemic: Headache-Severe, Systemic: Visual Changes/Disturbances-Seve... Read more
Systemic: Bell's Palsy-Severe, Systemic: Headache-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: wife came to the pharmacy and explained that after the shot the patient had one side weakness went to er and the er stated that the covid shot was the cause of bells palsy severe headaches, and visual changes. she states that it isnt resolving and they are going for more doctors visits
58 2021-07-26 seizure It was reported to us today (7/27) that the patient started experiencing seizures last night.
58 2021-07-28 pain in extremity Pt stated pt got 1st covid vaccine Pfizer 5/1/2021 and pt got arm pain, neck pain and headache with ... Read more
Pt stated pt got 1st covid vaccine Pfizer 5/1/2021 and pt got arm pain, neck pain and headache with nausea until 2nd covid vaccine scheduling. Noted no show of 2nd covid vaccine schedule on file. Pt said that pt still have neck pain when pt moves his neck side to side and headache with nausea at least a month. Noted pt has no emergency s/sx. Pt is educated covid vaccine side effects. Informed pt to call 911 or go to ED if pt experienced emergency s/sx. Pt scheduled 9:40am 7/21/2021 urgent care provider for consultation
59 2021-01-03 tingling, facial paralysis Patient received his vaccine and waited the 15 minute observation period before leaving the clinic. ... Read more
Patient received his vaccine and waited the 15 minute observation period before leaving the clinic. At 2:00 he returned to the clinic, stating to the paramedic that he felt like he was having an episode of Bell's Palsy. His vital signs were checked and were as follows: BP 169/96 mmHg, HR 72 bpm, O2 sat 99%. The patient has right sided tingling extending from the eye to the mouth. He had no visual changes. The patient was offered transport to the hospital and further medical treatment. He refused transport or treatment and left the vaccination clinic.
59 2021-01-05 discomfort, pain in extremity "I've got 1st vaccination shot at 11 am 12/21/2020. Got moderate (3 to 5 on 10-steps scale) pain ... Read more
"I've got 1st vaccination shot at 11 am 12/21/2020. Got moderate (3 to 5 on 10-steps scale) pain in left upper arm/shoulder around 9 pm, limited mobility. Took 2 extra-strength Tylenols. Between 2 and 3 am woke up because of severe headache (7 to 8), couldn't normally sleep because of that. Temperature 99.6 F. Another 2 Tylenols about 4 am. Not effective. Drinking a lot of water. Decided to stay home. Contacted my supervisors by text and e-mail, left a voice message for EH. 8 am - another 2 Tylenols. Tried to sleep - slept till 1 pm. Headache improved (3-5), 99.3 F. Water and tea, minimal activity. Received instructions from EH - to stay at home if any symptoms will take place, to get COVID test upon returning to the hospital. Condition was improving during the day. Low pain and discomfort in the evening (2-3). Sleeping normally during the night. No symptoms in the morning. No reason to delay returning to work. Took COVID test at 9 am. Negative. No symptoms since then"
59 2021-01-06 pain in extremity, tingling Sore arm, tingling in hand and fingers. severe nausea and head ache. fatigue
59 2021-01-07 numbness, pain in extremity Got the vaccine in left arm on 12/31, sat for 15 minutes for observation. After leaving and driving ... Read more
Got the vaccine in left arm on 12/31, sat for 15 minutes for observation. After leaving and driving home, started feeling worse pain in left arm and numbness around the left ear and left cheek. Went back, they examined and observed for another hour, then released. It went away and returned; has been intermittent since. Left V2/3 distribution
59 2021-01-07 pain in extremity Dizziness, Constipation, Extreme Fatigue, pain in arm form shot Narrative: Significant impact on li... Read more
Dizziness, Constipation, Extreme Fatigue, pain in arm form shot Narrative: Significant impact on life as he missed work due to this
59 2021-01-09 flushing 59 year male with history of HTN, became flushed and dizzy 7 minutes after vaccine. BP 170/100 P 78... Read more
59 year male with history of HTN, became flushed and dizzy 7 minutes after vaccine. BP 170/100 P 78 O2 sat 97-99%. Denied SOB.
59 2021-01-10 tingling, flushing, cold sweat Vaccine recipient developed headache, dizziness, fogginess, feeling flushed, cold sweats and a weird... Read more
Vaccine recipient developed headache, dizziness, fogginess, feeling flushed, cold sweats and a weird tingling sensation hours after receiving the vaccine. He also noted developing mental confusion. He did not have to go to the ED and went home for the rest of the day. For 1.5 days, he was home resting. On a follow-up call on 1/11/2021, vaccine recipient reported feeling better. Pfizer-BioNTech COVID- 19 Vaccine EUA.
59 2021-01-11 sensory loss, numbness and pain in extremities Received vaccine on Saturday 1/9/21, had usual symptoms low grade fever, general malaise. On Sunday ... Read more
Received vaccine on Saturday 1/9/21, had usual symptoms low grade fever, general malaise. On Sunday begin to experience left arm neuropathy at the media aspect of elbow, no sensation in affected area. Lateral aspect is fine, can move fingers and complete activities of daily living.
59 2021-01-12 numbness Symptoms were first noted on 12/22/2020 in 15 minutes after getting the Covid Pfizer vaccine. He had... Read more
Symptoms were first noted on 12/22/2020 in 15 minutes after getting the Covid Pfizer vaccine. He had numbness of his face and right hand. It resolved in two hours. He did have soreness for two days after the vaccine. He did not have any other symptoms like rashes or difficulty breathing. He could lift his arm. It made him a little nervous. It was bad enough that he pulled over from the freeway and rested for a few hours. He used an ice pack that helped the soreness, but this was after then numnbness resolved.
59 2021-01-12 pain in extremity "Pfizer-BioNTech COVID-19 Vaccine EUA". Symptoms: Tiredness throughout day at approx 2 hrs after va... Read more
"Pfizer-BioNTech COVID-19 Vaccine EUA". Symptoms: Tiredness throughout day at approx 2 hrs after vaccination. Felt feverish around midnight, headache, some nausea, pain on arm where vaccination was applied, overall upper discomfort, joint pain (shoulders) and kind of disoriented. Took Tylenol Extra Strength, 500mg, to ease the discomfort.
59 2021-01-17 pain in extremity Had my 2nd COVID vaccination shot at 2 pm on Monday, January 11, 2021. Next morning - moderate pa... Read more
Had my 2nd COVID vaccination shot at 2 pm on Monday, January 11, 2021. Next morning - moderate pain in upper left arm/shoulder (place of injection). Working full shift. Around 4 pm on Tuesday (after almost 3hrs OR case) - feeling very tired. Completed the working shift at 6 pm. Minor to moderate headache started to develop later in the evening. Two pills of Tylenol at 9 pm, another two around 2 am - while headache was getting worse. @6:30 am Wednesday - informed managers that I'll have to stay off work because of bad headache (7 to 8 from 10), called EH as well. During the day - mostly staying in the bed. Tylenol, water, tea with lemon, apples for hydration. Headache -- up and down (between 4 and 8), occasional fatigue and nausea (after staying upright more than 10-15 minutes), left upper arm pain, moderate pain in joints (knees, hips, low back). No fever. Troubled night-time sleeping because of headache. 7 am - informed managers and EH about my condition, Got approval for another day off - with request to have a C-Test after that. Similar feeling and treatment. Slow improvement during the day. Around 5 pm - feeling good enough to start moving more actively, headache and shoulder pain on low level, though getting tired quickly still. Much better sleeping. No symptoms in the morning. Had a COVID test before returning to work.
59 2021-01-20 weakness onset of left sided mouth numbness & weakness associated with change in taste but no change in se... Read more
onset of left sided mouth numbness & weakness associated with change in taste but no change in sense of smell over the past 2 days- woke up 2 days ago with subtle changes to the left mouth - no associated other symptoms of headache, sore throat ear pain or drainage & no skin lesions to the nose, ear or left cheek; no stiff neck , sore throat, fever, chills, rigors * no recenbt URI symptoms or trauma to the left ear ie using Qtips; denies prior similar symptoms & no associated visual changes , double vision or partial visual field changes ie amuarosis fugax, teichopsia or pallisading;
59 2021-01-20 feeling hot hot and sweaty lasting two minutes after rash
59 2021-01-20 pain in extremity next day was very tired with a slight headache; next day was very tired with a slight headache; 12 h... Read more
next day was very tired with a slight headache; next day was very tired with a slight headache; 12 hours after the injection I got the chills while I was in bed trying to sleep; I did not sleep well that night; 4 hours after the injection my arm was very sore; This is a spontaneous report from a contactable consumer. A 59-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Dec2020 09:00 at single dose at left arm for COVID-19 immunization. Medical history included none. There were no concomitant medications. The patient reported 4 hours after the injection/reported as 30Dec2020 14:00, my arm was very sore. On 30Dec2020 21:00, 12 hours after the injection, "I got the chills while I was in bed trying to sleep. I did not sleep well that night. The next day (31Dec2020) was very tired with a slight headache. The patient only rested all day. The next day he felt better but was slightly fatigued all day. The day after that the patient was back to being himself. His arm continued to be sore for a total of 5 days. The patient did not receive treatment for the events. The outcome of the events was recovered. Information on the Batch/Lot number has been requested.
59 2021-01-20 pain in extremity Had first injection in the upper left arm and now arm is still extremely sore and makes for restless... Read more
Had first injection in the upper left arm and now arm is still extremely sore and makes for restless sleep. Second injection done in right arm and know soreness except slight at injection site if touching it.
59 2021-01-20 tingling 3 days after vaccine, second dose given on day 16, developed ascending paresthesia, no weakness, up ... Read more
3 days after vaccine, second dose given on day 16, developed ascending paresthesia, no weakness, up to abd from LEs and to elbows on BUE
59 2021-01-25 weakness, pain in extremity EVENINING OF 1ST DOSE - LEFT ARM AND SHOULDER WAS EXTREMELY SORE. MIDNIGHT - NECK STARTED HURTING AN... Read more
EVENINING OF 1ST DOSE - LEFT ARM AND SHOULDER WAS EXTREMELY SORE. MIDNIGHT - NECK STARTED HURTING AND FELT A FLASH HEADACHE. SOON AFTER, BACK STARTING HURTING, (LOWER RIGHT & LEFT FLANKS OF BACK), NECK AND LEGS FELT WEAK. 9AM NEXT DAY, HEADACHE RETURNED.
59 2021-01-25 unresponsive to stimuli, seizure On 1/4/21 Client had what appeared to be a seizure and went unresponsive. He foamed from the mouth a... Read more
On 1/4/21 Client had what appeared to be a seizure and went unresponsive. He foamed from the mouth and turned blue. O2 Sat was in the 60's, O2 was applied previous to paramedics arrival. BP was high. Unresponsive for 30 minutes. When he woke he did not recognize anyone, did not know where he was at or what day of the week it was. He was transported to the Hospital. Multiple tests were ran and nothing out of the ordinary was found. Started seizure medication.
59 2021-01-27 pain in extremity Chronic acute systemic pain now at much higher pain levels. Tendinitis in right arm was at 3, now at... Read more
Chronic acute systemic pain now at much higher pain levels. Tendinitis in right arm was at 3, now at 7. Back and neck was at 6, now at 9. Hips and knees were at 5 now at 7.5.
59 2021-01-28 numbness Dizziness, numb hands, heavy tongue, and somnolence
59 2021-01-28 tingling Pt developed palpitations, tingling of left sided face, vomiting
59 2021-01-29 pain in extremity On day 04 After receiving the 2nd Covid 19 Pfizer vaccine, I experienced a deep pain in my upper inn... Read more
On day 04 After receiving the 2nd Covid 19 Pfizer vaccine, I experienced a deep pain in my upper inner right thigh around 0600 am of the 16th of January. At the same time my calf muscle of that same right leg was in pain. I thought it to be muscular pain as I was told by the reading material regarding symptoms of the covid 19 vaccine there could be aches an pains attributed to the 2nd shot. I used a deep heating rub on both areas of my right leg and put heat on them to treat the soreness. This occured over the next few days feeling this pain in my right leg and treated the same way applying heat. Within about 24 hours of the pain in my legs I started experiencing a shortness of breath while walking up and down st. On day 04 After receiving the 2nd Covid 19 Pfizer vaccine, I experienced a deep pain in my upper inner right thigh around 0600 am of the 16th of January. At the same time my calf muscle of that same right leg was in pain. I thought it to be muscular pain as I was told by the reading material regarding symptoms of the covid 19 vaccine there could be aches an pains attributed to the 2nd shot. I used a deep heating rub on both areas of my right leg and put heat on them to treat the soreness. This occured over the next few days feeling this pain in my right leg and treated the same way applying heat. Within about 24 hours of the pain in my legs I started experiencing a shortness of breath while walking up and down stairs as part of my daily activities. The symptoms of shortness of breath only seemed to appear when I was on any form of extended walking activity or physical movements or exercise this would of have been starting around the 17th of January. The right leg pain was masked by the heating rub while the shortness of breath continued for the next few days. On the 19th of January, I went to an Urgent Care Facility at 0800 am to see a Medical professional to discuss my symptoms I was previously experiencing and to figure out why I was having a shortness of breath and the pain in my right leg. The on staff Physician's Assistant had a Nurse conduct a Covid 19 Rapids test (negative) and a second swab was administered and sent to the Lab. Which produced a (negative for Covid 19) on the 20th of January. An Xray was not taken to determine my shortness of breath. The Dr listened to my lungs and heart, though I did let the PA know I had received both Pfizer shots and when they were administered. I was carrying My Shot record for the vaccine with the dates and lot number. He didnt appear to be interested in further diagnosis and made sure I had the paperwork to track the results of my Covid swab sent to the lab. The visit was completed and I was released to go back to work/home. I carried on the symptoms of the shortness of breath from the 19th of January to the 22nd of January monitoring my O2 (oxygen levels) with a pulse oximeter. They ranged from 90-93. On the evening of the 22nd of January I was becoming very uncomfortable with my breathing climbing the stairs in my home and monitored my O2 readings with the oximeter on my finger when walking upstairs and they dropped down to 60-65. My wife drove me to the emergency room at Hospital. I walked into the ER and checked myself in for shortness of breath and leg pain in my right leg. I was admitted into the emergency room and put on 15 litres of oxygen. The emergency room Dr ordered a chest Xray, Cat Scan of my chest and heart and a sonogram of my right leg. The testing results came back with a noted large pulmonary emboli on my lungs/heart area and blood clots throughout my right leg (right lower extremity DVT). Surgery was performed to remove the pulmonary emboli and I was put on a Heprin Drip to thin out my blood for the remaining clots in my chest and my right leg. The attending physician ordered a T.E.E. (transesophageal Echocardiogram) to observe my heart functions. I was told the TEE did not demonstrate any further recommend surgeries. I was administered a test for my cardio and heart functions prior to my discharge on 27 January 2021. I was prescribed Eloquis for maintenance medication to be monitored by followup visits to my cardiologist and Hemotologist within the next few weeks. I have not family or personal history of Blood Clots. I do perform administrative duties as part of my job, which requires sitting and working on a computer. Note however I move around very often during a work day and operate a farm tractor and have an active life style. I have not recently had any extended trips more than 2 hours nor have I flown within the past year or so.
59 2021-01-31 weakness Sudden light headedness, room spinning, increased heart rate, slight ringing in the ears. Weakness.... Read more
Sudden light headedness, room spinning, increased heart rate, slight ringing in the ears. Weakness. Lasted about 15 minutes. Felt mildly lightheaded, and had loss of energy symptoms for about 12 hours. Felt good for about 1hour after that then a second episode happened about 10pm. The second episode was about half as severe as the first and only lasted about a minute or two. Woke up this morning 02/01/2021 feeling fairly normal.
59 2021-02-03 pain in extremity Swollen painful toes 5 days
59 2021-02-08 pain in extremity right arm sore with difficulty lifting the arm without pain, stomach spasms, throat feels like closi... Read more
right arm sore with difficulty lifting the arm without pain, stomach spasms, throat feels like closing off, coughing Narrative: Patient received vaccine on 01/26/2021. Was assessed per the protocol and showed no signs of being unwell and was healthy looking. Vaccine was administered IM to RT arm. Patient then was monitored for 15 mins by staff over seeing monitor in clinic that day. After 15 mins time, patient was released. Pt call the call center the next day 01/27/2021 with a complaint of stomach spasms, sore arm that is difficult to lift with out pain being present, feeling like his throat is going to close off and starts to cough.
59 2021-02-09 inability to speak, tingling, mild one side paralysis, slurring On Saturday 2/6 unwitnessed fall without loss of consciousness. Gait was unstable, weakness on righ... Read more
On Saturday 2/6 unwitnessed fall without loss of consciousness. Gait was unstable, weakness on right side (RUE, RLE) slurred speech, difficulty with finding words. Transported by POV to ED for evaluation of stroke - same sx with onset of parasthesia in right upper arm. Stroke protocol done - received tPA with resolution of symptoms during infusion. Stayed in hospital until protocol completed. Symptoms resolved over the course of the hopsitalization.
59 2021-02-10 weakness Patient experienced generalized weakness and was unable to support himself. Patient was taken to hos... Read more
Patient experienced generalized weakness and was unable to support himself. Patient was taken to hospital ER. Patient has a history of episodes of weakness. ER diagnosed patient as having an allergic reaction to COVID-19 Vaccine. He was discharged to this group home.
59 2021-02-17 feeling cold 12 hours after vaccine started having chills-could't get warm. 15 hours after vaccine developed sev... Read more
12 hours after vaccine started having chills-could't get warm. 15 hours after vaccine developed severe vomiting for about 7 hours.
59 2021-02-17 pain in extremity Chest pain; shortness of breath; pain radiating down left arm; This is a spontaneous report from a c... Read more
Chest pain; shortness of breath; pain radiating down left arm; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 06Feb2021 12:00 at single dose in left arm for COVID-19 immunisation. Medical history included allergies to iodinated contrast, chronic lymphocytic leukaemia (CLL), herniated discs. The patient didn't have COVID prior vaccination. Concomitant medications included tamsulosin hydrochloride (FLOMAX), sertraline hydrochloride (ZOLOFT), valacyclovir, ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, xantofyl, zinc (CENTRUM SILVER). The patient previously received the first dose of bnt162b2 on 16Jan2021 02:00 PM in left arm for COVID-19 immunisation. There were no other vaccine in four weeks. The patient experienced chest pain, shortness of breath, pain radiating down left arm. Adverse events start from 07Feb2021 05:45 AM. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and hospitalization for 1 day. Treatment was received for the events. The patient underwent lab test which included Blood tests, EKG on unknown date. The outcome of the events was recovering. COVID was not tested post vaccination. Information on Lot/Batch has been requested.
59 2021-02-22 pain in extremity, weakness 2 days later developed chest tightness, left arm pain, weakness, HTN
59 2021-03-07 pain in extremity arm is sore; little muscle soreness; This is a spontaneous report received from a contactable consum... Read more
arm is sore; little muscle soreness; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old male 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 05Feb2021, at single dose, for COVID-19 immunization. Medical history included being disabled. The patient's concomitant medications were not reported. The patient reported he had his shot on 05Feb2021. In Feb2020, his arm was sore and had a little muscle soreness. The patient stated that he goes to the gym and has a hard work out and asked if it was okay to take Tylenol or Motrin. The outcome of the events was unknown. Information on the lot/batch number has been requested.
59 2021-03-08 tremor, pain in extremity Maybe Important: I had COVID-19 Oct 2020 for 4 weeks, bad case, still have deep breathing issues, s... Read more
Maybe Important: I had COVID-19 Oct 2020 for 4 weeks, bad case, still have deep breathing issues, shortness of breath and get tired much quicker than I used to (I'm an avid Tennis player, several times a week). Shot Info: from 3/5 10am to 3/6, no issues, I didn't even feel the shot, no soreness or other symptoms. woke up at 2am (first noticed): Very sore arm, Sore from head to toes, headache, sever chills/shaking, very tired, severe shortness of breath, joints (knees, hips, wrist) constant (not overly severe) pain. Severe symptoms lasted for 24 hours before starting to taper off, felt pretty good by Sunday 3/7 12pm/Noon. My chills were so bad, just getting up to go to the restroom 15 ft away, didn't know if I could make it back to the bed. Headaches was the last thing to go.
59 2021-03-11 pain in extremity Pain at injection site. It has progressed to severe shoulder and arm pain starting 03/08/2021 that i... Read more
Pain at injection site. It has progressed to severe shoulder and arm pain starting 03/08/2021 that is still increasing
59 2021-03-11 tremor General Fatigue during the day went to sleep and had terrible shivers to violent shaking. Fell bac... Read more
General Fatigue during the day went to sleep and had terrible shivers to violent shaking. Fell back asleep and then awoke to being being drench. Cotton pajamas were thoroughly wet as was bedding. It would have taking a pint or two of water to have made this wetness. [and no it was no urine! ;) ] had to get new pajamas and throw a towel on the bed to have dry bedding.
59 2021-03-12 weakness Immediate after the shot i had a weird taste and slight feeling of nausea which soon went away. Ar... Read more
Immediate after the shot i had a weird taste and slight feeling of nausea which soon went away. Around 6 pm on the day of the injection I noticed that my taste buds were more sensitive. Following that I became very sluggish. So I went to bed shortly afterwards. The following morning I was still sluggish and there was a feeling of openness in my upper chest area. The feeling of tiredness an no energy started and continued until Wednesday the 3rd of March. That morning I awaken feeling better. I still have a feeling of openness in my upper chest area. But overall I feel great.
59 2021-03-13 numbness Numbness on left side of face
59 2021-03-14 pain in extremity Headache; Chills; Body aches; Sore arm; This is a spontaneous report from a non-contactable consumer... Read more
Headache; Chills; Body aches; Sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 59-year-old male patient received BNT162B2 (Lot Number: EL3248), via an unspecified route of administration in left arm, on 02Feb2021 at 07:00 AM, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. On 02Feb2021 at 11:00 PM (23:00), the patient experienced headache, chills, body aches, and sore arm. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events in Feb2021. No follow-up attempts are possible. No further information is expected.
59 2021-03-15 burning sensation About 32 hours after given the shot, chills, fever and nausea began. This quickly escalated to not b... Read more
About 32 hours after given the shot, chills, fever and nausea began. This quickly escalated to not being able to breath. Face and neck were turning purple. My dad was about to call 911 when he finally was able to calm down and catch his breath. His lungs and chest burned afterwards and he was completely spent for days after.
59 2021-03-15 tingling Pt. was in observation lane. Was feeling dizzy and tingling on arm. BP was 150/89. Paramedic asse... Read more
Pt. was in observation lane. Was feeling dizzy and tingling on arm. BP was 150/89. Paramedic assessed pt. Once symptoms subsided, pt. was released to go home.
59 2021-03-17 burning sensation, tingling Tingling , burning sensation in legs and feet.
59 2021-03-17 pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA Approximately three weeks after this injection, I began to fee... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Approximately three weeks after this injection, I began to feel a pain in my left leg. I assumed it was a cramp. I then received a second dose (Lot # EN6206) on 3/13/21. Over that weekend the pain in my leg grew worse and the leg began to swell. on 3/15, I went to my primary care physician who said it looked like a blood clot. He sent me to a radiologist for an ultrasound (?) of the leg. After confirming the clot, I went to a local ER. They started me on Eliquis to treat the clot
59 2021-03-17 tremor, unresponsive to stimuli Pfizer-BioNTech COVID-19 Vaccine EUA Pt chronic schizophrenia with subsequent mild cognitive impairm... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Pt chronic schizophrenia with subsequent mild cognitive impairment over the past year who was brought to hospital after 4 days of food/medication refusal, withdrawal from care and more recently disorientation and tremor. Pt was recently transitioned from haldol decanoate to clozapine. Last dose haldol decanoate was on 2/16/21. First dose clozapine 12.5 mg was on 2/24/21. Increased to 12.5 BID the following day. Increased to 25 mg BID on March 2, without reported side effects or other issues. Pt got his first dose of Pfizer COVID vaccine on March 4, and that night was less engaged with staff, felt feverish. Did not spike a temp per bedside accompaniment who was with him that day. The following day, he barely ate any food and did not get out of bed all day. This continued for the entirety of the weekend - bed bound, turning to look at staff when called but did not engage/respond verbally. He was incontinent of urine over the weekend. Treated for Neuroleptic malignant syndrome 2/2 clozapine Uncertain if vaccine contributed to event, but recent case report published relating clozapine toxicity and Pfizer COVID vaccine, so submitting to VAERS for evaluation
59 2021-03-19 tremor At 7:00 pm I started experiencing sinus drainage & stuffiness. When I went to bed at around 8:30 P.M... Read more
At 7:00 pm I started experiencing sinus drainage & stuffiness. When I went to bed at around 8:30 P.M. I Noticed some difficulty getting enough air into my lungs ( 11/2020 Ablation for A fib, compromised phrenic nerve Not usually SOB unless high physical demand ) At 9: 30 P.M started moderate shacking/Chills until around 3 A.M. with little sleep. Then some sleep until 5:00 A.M. woke up with 102.4 temp and felt lousy with joint pain in various joints that do not typically hurt. Did not go to work spent most of the day in bed until 4:00 P.M. Feeling somewhat better now
59 2021-03-23 tingling, numbness Patient had vaccine 1/28/2021. Two days later developed left sided abdominal pain that was severe e... Read more
Patient had vaccine 1/28/2021. Two days later developed left sided abdominal pain that was severe enough to warrant multiple ER visits, one admission, multiple negative tests including but not limited to CT scan and endoscopy. He lost 30 pounds. In the beginning of March he began noticing tingling and numbness in arms and legs which has progressed to paralysis of his bilateral lower extremities. He is now hospitalized for same and has a working diagnosis of CIDP (chronic inflammatory demyelinating polyneuropathy).
59 2021-03-24 pain in extremity, cold sweat Very sore arm. Cold sweets. Elevated temp for 2 days reaching 101.5 degrees. Sick stomach. Nearly pa... Read more
Very sore arm. Cold sweets. Elevated temp for 2 days reaching 101.5 degrees. Sick stomach. Nearly passed out one evening when I got up out of bed. Nearly didn't make it back to bed. Body aches. Used cold compresses and took extra strength Tylnol and Aspirin. Lots of water and Ensure. Dressed in layers to stay warm. My wife and I are sick at the same time from vaccine injection. Missed 2 days of work. Also had skjn hypersensitivity in my upper back. Had fatuque, but not as bad as my wife.
59 2021-03-24 pain in extremity Severe fever lasting still on day 5 most days over 100 brought down only with ibuprofen, dizzy and l... Read more
Severe fever lasting still on day 5 most days over 100 brought down only with ibuprofen, dizzy and lightheaded that prevents me from working and driving. I've missed 2 days of work so far. Soreness continues in my arm as well. I've also had nausea at times and appetite that varies.
59 2021-03-25 inability to speak Dizzy, vertigo, difficulty breathing immediately after shot. Dizziness subsided after a few hours, t... Read more
Dizzy, vertigo, difficulty breathing immediately after shot. Dizziness subsided after a few hours, typical arm pain at the injection site a few days after. Fatigue and difficulty breathing increased over the next few days. On the third day after injection, experienced cognitive difficulty using words, vertigo. Went to emergency for possible stroke symptoms. Cognitive testing, Brain CT scan w/contrast, MRI, Echocardiogram, 24 hour in patient observation. All negative. Still experiencing shortness of breath and anxiety a week after injection.
59 2021-03-25 bell's palsy 3/18/2021 I noticed that I could not clear my ear the next morning my eye lid felt like it was dragg... Read more
3/18/2021 I noticed that I could not clear my ear the next morning my eye lid felt like it was dragging across my right eye and I developed Severe pain in and around my left ear running down into my neck. Shortly later I had less and less control of the right side of my head, now I can't move it. I have since discovered that I have Bell's Palsy due to the vaccine. I didn't know what it was until I went to the doctor as this has never happened to me before.
59 2021-03-25 pain in extremity At 11pm that evening headache (worst ever in my life), joint pain in hands, hips, knees, muscular pa... Read more
At 11pm that evening headache (worst ever in my life), joint pain in hands, hips, knees, muscular pain in thighs and lower back, lasting about 6 hours. Diminished gradually over the next 4 hours. Fatigue ongoing.
59 2021-03-25 tingling Feet and legs Tingly like falling asleep. Pins needles also occasionally all over. Head feels press... Read more
Feet and legs Tingly like falling asleep. Pins needles also occasionally all over. Head feels pressure like sinus but not sinus. Hands feel slight vibration like small amount of electricity going through my body. No symptoms felt while laying in bed. Start in the morning when moving around.
59 2021-03-26 discomfort Left arm very sore about 8 hours later and the next day. Discomfort stopped around 12 noon 2nd day. ... Read more
Left arm very sore about 8 hours later and the next day. Discomfort stopped around 12 noon 2nd day. Also, 2nd day, sluggish and exhausted beyond normal after my work day (PT 1:30 to 5:30 pm.)
59 2021-03-28 hypersensitivity of all senses Stiff arm immediately, Stiff neck left side 24 hours after, Shingles presents 48 ours after inject... Read more
Stiff arm immediately, Stiff neck left side 24 hours after, Shingles presents 48 ours after injection on scalp left side from center line top to neck coving all of hair line with touch sensitivity. Rash begins on left side jaw, cheek and under chin 24 hours later. Rash continues to spread to all of scalp, and behind ear and around back of neck. Blisters follow and pain increases. First suspected an allergic reaction but after no response to Benadryl and increased pain sought medical care and was confirmed Shingles. Treaded with Valacyclovir and has responded well to treatment.
59 2021-03-29 numbness I received my second vaccine yesterday. Approximately half an hour after receiving the vaccine, I de... Read more
I received my second vaccine yesterday. Approximately half an hour after receiving the vaccine, I developed numbness in my left cheek. It subsided within about 90 minutes. I had a more intense reaction after my first vaccine, when my left cheek, jaw, left arm and leg felt numb. When I got the first vaccine it felt like the needle hit the bone and like the injection was into the shoulder joint. The second vaccination as a little bit lower down.
59 2021-03-30 tingling miniature shocks like pins needles that goes up his back and into his neck; This is a spontaneous r... Read more
miniature shocks like pins needles that goes up his back and into his neck; This is a spontaneous report from a contactable consumer. A 59-year-old male patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on 22Feb2021 (Batch/Lot Number: EN5318) as single dose for covid-19 immunization. The patient's medical history includes dental work in Dec2020. There were no concomitant medications. The patient was previously administered first dose with BNT162B2 for covid-19 vaccination (Lot number EL9261, expiration unknown, Right Arm, (First dose). The patient also previously used novocaine (he had dental work in Dec2020 and stated that they only gave him Novocaine). The patient experienced miniature shocks like pins needles that goes up his back and into his neck on 28Feb2021. Reporter states that he is experiencing little miniature shocks like pins needles that goes up his back and into his neck. It has never been below his waist. They are not in his arms, legs, or head. It is like is annoying pricking like when you have been in contact with fiber glass. It does not hurt or itch, it is a tingling sensation. He never had it before or any blood or breathing issues. He said that he has not had any other medications, a change in diet, or been exposed to anything hazardous. He said that he had dental work in Dec2020 and stated that they only gave him Novocaine and it did not affect him like this. The outcome of the event was not recovered.
59 2021-03-31 discomfort, weakness He will keep him up until 3 in the morning and he stays awake; headache; it is really frustrating; p... Read more
He will keep him up until 3 in the morning and he stays awake; headache; it is really frustrating; pain in his joints and his bones and it was getting worse; pain in his joints and his bones and it was getting worse; pain all over; Any place in his body, his muscles, joints, and bones have had pain previously/ pain in his joints and his bones and it was getting worse/ pain all over on the day after his COVID vaccine; body is so weak/ doesn't have any energy to move; tired; a little bit of small itching, not much, just a little bit that made him feel not comfortable with it; a little bit of small itching, not much, just a little bit that made him feel not comfortable with it; ribs moving quicker; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received first dose of BNT162B2, via an unspecified route of administration (left arm) on 06Mar2021 at a single dose for COVID-19 immunisation. Medical history included pain, high cholesterol, and testosterone low, joint pain, bone pain, muscle pain, any place in his body had pain, and doesn't have good memory, all ongoing. Concomitant medications included ongoing hydrocodone for pain, ongoing atorvastatin for high cholesterol, ongoing clomiphene citrate for testosterone medication because it was low because of his age, ongoing colecalciferol (Vitamin D), ongoing ascorbic acid (Vitamin C), ongoing oxycodone for pain, and unspecified eye medication. He had many different medications that he was taking. Historical vaccines included chicken pox vaccine for immunization and shingles vaccine in Jan2020 for immunization and experienced pain all over. The patient stated that he was a torture survivor and he has been taking pain medication because of him being tortured previously. He was taking medications for the pain, clarified to be hydrocodone and oxycodone. These medications kept his body stable. He was able to sleep and relax. One day after he received his Pfizer COVID vaccine (07Mar2021), he started feeling the pain in his joints and his bones and it was getting worse but the pain used to be stable with the way he was using his medicines. But now his body was not stable. Any place in his body, his muscles, joints, and bones have had pain previously because of the damage of torture but now it all came up after the COVID vaccine. Every piece of his body hurt even if he takes his medications. He still had the pain and his body was so weak for about 4 to 5 hours. He used to be able to do his business all day but now after about 3 to 4 hours on his feet he got so tired and he needed to sit. He didn't know why this happened. He has talked to others that have received COVID vaccines and none have had this kind of reaction like him. He has asked them about it. It was very frustrating to him on an unspecified date. Every month he sees a physician. He would like for Pfizer to contact him with further questions, he can't understand the pain. This was really killing him especially when the pain goes to his bones. He will keep him up until 3 in the morning and he stays awake on an unspecified date. He then took medicine and he had to wait for 30 minutes for it to start working and then he will be able to sleep. But other than that, the pain jumped. He has had the chicken pox and the shingles vaccines and none did like that. The pain was not going away in his muscles or joints. And now he was getting a headache on an unspecified date, it was really frustrating. He didn't have good memory from the torture. This morning, when he woke up, he had the pain in his joints and his bones. He didn't like to use too much medication. He liked to use it only as he needs it. Pain medications are strong. But this COVID vaccine somehow made him need to use more medication and then that caused him to have a headache. His pain should get better with his medications but today, he had pain all over him and he didn't have any energy to move. He didn't know how to explain it. The COVID vaccine had really kind of made him weak. Sometimes he drinks a lot of cranberry juice to try and take the vaccine out of his system and it was frustrating because he hasn't ever been like this. When he had pain like this it reminded him of his torturing and what had happened to him. When the pain came on strong was when it reminded him of that. The medications he was taking were supposed to kill the pain. That was the reason he got so pissed and was trying to ask what was going on. This COVID vaccine is not safe he believed because it has been almost 10 days and it was not helping him. He was still not good. After he got his COVID vaccine on 06Mar2021, he had a little bit of small itching, not much, just a little bit that made him feel not comfortable with it. That was why they kept him for 20 minutes after his vaccine. When he got back home, he was okay, it was nothing serious. But then the day after his COVID vaccine on 07Mar2021, his joints, his muscles and his bones had pain. On 06Mar2021 the itching lasted about 20 minutes. He felt like he was chewing his lip, he was a little uncomfortable and he felt his ribs moving quicker. Nothing happened but he could feel it. He tried to chew his lips a couple of times, but not that much. But after that, he had pain all over on the day after his COVID vaccine, 07Mar2021. By the time this vaccine started getting into his body, it was really hurting and getting worse. He had the shingles vaccine and for 1 1/2 to 2 days, he had pain all over and then 2 days after it was all gone, he was back to normal life. The pain was gone. With this COVID vaccine he thought that maybe it was going to be the same but it was not the same and it was hurting. The shingles vaccine was last year in 2020, 3 months before people knew about the coronavirus that was when he got the vaccine for shingles, so maybe Jan2020 was when he had the shingles vaccine. He had no medical conditions or heart and chest problems. No other vaccine he has taken has ever had this type of side effect to him. He took his shingles vaccine in his right arm and the COVID vaccine was in his left. With both he had the same start of having the bad pain. This COVID vaccine goes deeply to the body. The vaccines job is to wake the body. The vaccine's job is to wake up the body for the virus. The body has to make some kind of soldiers to stand up on the virus and this COVID vaccine had actually made his body weak. After the vaccine is supposed to wake the body, little by little the side effects are supposed to go away. His body was not learning this vaccine. It kept fighting to learn whatever was in this COVID vaccine, his body can't learn it and fight it. That was the reason his body got weak and the pain has not gone away. His body is still in alert and that's why the pain was still there. His body was still fighting. Somehow it didn't match the inside of the body. Maybe for some people that this will happen to, they will be okay but for some they will not be okay. It is not because some people have nothing wrong with them. The patient recovered from itching and discomfort on 06Mar2021; not recovered from any place in his body, his muscles, joints, and bones have had pain previously/ pain in his joints and his bones and it was getting worse/ pain all over on the day after his COVID vaccine; while outcome of other events was unknown. Information about lot/batch number has been requested.
59 2021-03-31 feeling hot Occurrence Date: 03/19/2021. Patient c/o feeling hot, and sweaty during the observation around 10:1... Read more
Occurrence Date: 03/19/2021. Patient c/o feeling hot, and sweaty during the observation around 10:15 after receiving his Covid-19 vaccine. V/S taken, and first reading: BP: 179/103, HR: 100, and Spo2: 96% . Hydration provided. Patient was asked about medications. Patient stated that he had taken his meds @ 06:00. Patient did not remember his baseline. Patient was taken to the ED.
59 2021-04-01 weakness Day of shot, 9 hrs later chills, 18 hrs later fever of 103 Day 2, fever 102, chills, fatigue, body a... Read more
Day of shot, 9 hrs later chills, 18 hrs later fever of 103 Day 2, fever 102, chills, fatigue, body aches Day 3, fever 101.3, chills, fatigue, body aches, rash at injection site, arm pits, feet, headache, unable to sleep, stomach ache Day 4 , no fever, very weak, headache, same rash, can not concentrate, stomach ache
59 2021-04-01 pain in extremity Headache, nausea, dizziness, sore arm from 2nd shot
59 2021-04-02 cold sweat, unresponsive to stimuli PATIENT HAD SYNCOPAL EPISODE, UNAROUSABLE TO STERNAL RUB, PALE, CLAMMY, DIAPHORETIC. VITAL SIGNS OBT... Read more
PATIENT HAD SYNCOPAL EPISODE, UNAROUSABLE TO STERNAL RUB, PALE, CLAMMY, DIAPHORETIC. VITAL SIGNS OBTAINED. 911 WAS CALLED FOR TRANSPORT.
59 2021-04-03 feeling cold Muscle soreness throughout the body, fever, chills. The symptoms were gone by 4/3/21
59 2021-04-04 weakness The achiness and pain left me unable to get out of bed for 24 hours. It was, honestly, the worst am... Read more
The achiness and pain left me unable to get out of bed for 24 hours. It was, honestly, the worst amount of pain I have ever experienced with a vaccine. I got the vaccination around 10:15am and it was around midnight that the full effect hit me. The pain was unbearable for 4-6 hours. Then I was strong enough to get up to go to the bathroom for a Tylenol; it barely made a difference. The nausea is so bad that, as I write, I still can't get myself to overcome the feeling to get something to eat. I'm feeling a bit hungry but the nausea is stronger.
59 2021-04-04 burning sensation Extreme fatigue / tiredness, couldn't get up and stay up for 16 hours. Developed hive like rash on 7... Read more
Extreme fatigue / tiredness, couldn't get up and stay up for 16 hours. Developed hive like rash on 75% of facial skin that was painful / burning sensation for 24 hours and itchy after that. Still have the rash 60 hours after onset of rash, but it has subsided to approximately 50% of facial skin.
59 2021-04-04 pain in extremity Inflammation in neck, fever, general malaise, muscle pain, loss of mobility in the left arm that las... Read more
Inflammation in neck, fever, general malaise, muscle pain, loss of mobility in the left arm that lasts two days. Acetaminophen 500 mg, 2 tabs every 4 hours
59 2021-04-05 weakness Fever, Dizziness, Weakness, confusion for 3 day. racing heart and sore throat. Ladder brought patien... Read more
Fever, Dizziness, Weakness, confusion for 3 day. racing heart and sore throat. Ladder brought patient to Doctor office for treatment. Antibiotics treatment for sore throat to no effect. 2nd dose started and to date same effect. Patient is in pain.
59 2021-04-06 weakness Very tired and weak
59 2021-04-06 burning sensation Blisters (4) and slight swelling / redness on upper lip. Slight irritation and burning pain. Possibl... Read more
Blisters (4) and slight swelling / redness on upper lip. Slight irritation and burning pain. Possible blister(1) on inside of mouth on lower lip.
59 2021-04-06 muscle twitching Muscle twitching in left tricep below injection site. Started 5 days after injection and has persis... Read more
Muscle twitching in left tricep below injection site. Started 5 days after injection and has persisted for 6 days. Comes and goes 24x7. Not painful. Seems to have subsided today (day6) and preceding night.
59 2021-04-07 pain in extremity, feeling hot, weakness He got his vaccine, he felt achy, kind of weak at about 4:00 PM on the day of the vaccine. Later on... Read more
He got his vaccine, he felt achy, kind of weak at about 4:00 PM on the day of the vaccine. Later on he took his temperature and it was 99 range. It then went up to 101.4 that evening, but he felt very hot. He felt very hot, face was red. Somebody brought him over a thermometer and checked it again and it was 101.7, felt terrible and he took Tylenol. The next day he felt achy like he had the flu, a headache, body aches and weakness, nauseous as well. Then the next morning it was 102.3. It fluctuated throughout the day. Then later it went to 102.7 at 9:00 PM. Then about 2 hours later before he went to bed it came down to 101. Then he woke up on Sunday morning 3/28/21 his temperature was normal, he was exhausted from the fever. He felt run down for a few days after that, knocked out and the nausea came back on 4/3/21. No reaction at the injection site, just standard arm soreness, rash below the area of injection that lasted for about a week and went away. He is still more tired than usual this week, but doesn't know if that's related to the vaccine or not. The right arm 8 days later he got a rash at the injection site and a little bump that felt swollen. That also ended up going away after a day or so.
59 2021-04-08 feeling hot, flushing Began feeling a little warm and flushed and tired. I felt off overall. On the 8th around 12pm. I cam... Read more
Began feeling a little warm and flushed and tired. I felt off overall. On the 8th around 12pm. I cam e home from work around 4:30 and laid down til 5:30 and I woke up feeling a little better but around 6:15 I felt the same as earlier that day and then it got worse. My ears were ringing loudly and I had shortness of breath, I had difficulty breathing, and my chest was tight and I had pain in the center of my chest and I was nauseous and hungry but really couldn't eat anything. I checked my BP at home and it was 189/127 and then 192/122. I was well hydrated but I drank 2 16 ounce glasses of water and sat down to try and relax. An hour later the ringing stopped and I was feeling much better. I took my BP again and it was up to 202/126. I decided to go to the ER at this time. around 11pm it was 143/89. Ringing and flushed still present with some stomach issues (4/9)
59 2021-04-08 feeling hot Uncontrollable shivering, chills for more than an hour followed by being hot. The whole episode las... Read more
Uncontrollable shivering, chills for more than an hour followed by being hot. The whole episode last 2-3 hours.
59 2021-04-08 tingling Unusual tingling and sensitivity on skin, of right side of torso (stomach, side and back). Not pain... Read more
Unusual tingling and sensitivity on skin, of right side of torso (stomach, side and back). Not painful, but sensitive. No rash, or visible difference from skin on left side of torso . Symptoms are mild-not severe.
59 2021-04-08 tremor pt says his heart started racing, he was dizzy, had SOB, and hands were shaking. Pt called PCP whic... Read more
pt says his heart started racing, he was dizzy, had SOB, and hands were shaking. Pt called PCP which told him to get to an ER. He went to ER. They did several test. His heart was miss-firing. They gave him some medication which brought heart rate down but needed to had have an electrical shock. This brought his heart rate down to 85. He has been referred to a Cardiologist which he will schedule appt today.
59 2021-04-10 cold sweat Symptoms of mild headache, body ache, fatigue, cold sweat, and nausea and diarrhea began on Saturday... Read more
Symptoms of mild headache, body ache, fatigue, cold sweat, and nausea and diarrhea began on Saturday afternoon.
59 2021-04-10 feeling hot dizzy, shakey, hot nausea
59 2021-04-10 flushing Patient had the vaccine at 4:03 pm and his 15 minutes was done and the patient left to go to his car... Read more
Patient had the vaccine at 4:03 pm and his 15 minutes was done and the patient left to go to his car. Patient stated that when he got to his car he felt flush and a little light headed. He decided to make his way back up to the front door because he was not feeling himself. When he got to observation we checked his vitals and his blood pressure was 191/104 and his checks were very red. I repeated the blood pressure again at 4:40 pm and it was 167/92, checked at 4:46 pm BP was 155/103, BP at 4:51 was 175/101, BP at 4:59 was 196/107 and then checked it again but this time on the left arm and the BP was 195/108. Patient was transported By EMS to the hospital for further evaluation.
59 2021-04-11 numbness, feeling hot, tingling within 2minutes i felt my feet and toes get hot. whole body. thot it was just a reaction. later that... Read more
within 2minutes i felt my feet and toes get hot. whole body. thot it was just a reaction. later that day and overnite feet very hot. now its 5days later its so much worse. very numb in whole leg, right foot the most, very tingly-painful, asleep type feeling, But Way Worse. im very scared. hands and fingers, and whole body feels real bad. . feels like dead nerves happening.
59 2021-04-12 sciatica, weakness On the 4th day after the injection I start feeling the extreme weakness and extensive heartbeat whic... Read more
On the 4th day after the injection I start feeling the extreme weakness and extensive heartbeat which forced me to spend a few days in the bed. Right after that, even if the condition in general got improved, I?m still experiencing extensive heartbeat and occasional pain within the heart area. Also, I got new symptoms for the sciatic nerve related pain.
59 2021-04-14 weakness Joint and muscle aches, low-grade fever, lethargy, loss of appetite, weakness.
59 2021-04-15 pain in extremity swollen interphalangeal joints (both hands) with pain; I developed swollen interphalangeal joints (b... Read more
swollen interphalangeal joints (both hands) with pain; I developed swollen interphalangeal joints (both hands) with pain and resolvable "locking" of my middle fingers; This is a spontaneous report from a contactable Pharmacist (Patient). A 59-Year-old male patient reported for himself that he received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection; Lot number: EL0140; Expiry date: Unknown) via an unknown route of administration in the left arm on 11Jan2021 at 12:30PM as a single dose for COVID-19 immunization. The patient did not have COVID-19 prior to vaccination. The patients past medical history included Diabetes (Type 2), Hypertension and Hypercholesterolemia. The patient did not have any known allergies. Concomitant medication were not reported. On 18Jan2021, at 07:00 AM seven days after receiving initial COVID-19 vaccine, Patient developed swollen interphalangeal joints (both hands) with pain and resolvable "locking" of my middle fingers. Nine days after second COVID-19 vaccine, the issue resolved. The patient did not receive any treatment. The clinical outcome of developed swollen interphalangeal joints (both hands) with pain and resolvable "locking" of my middle fingers were considered recovered.
59 2021-04-15 cold extremities, unresponsive to stimuli Pt has hx of vasovagal reaction when getting any sort of immunization/injection. Pt found in Vaccina... Read more
Pt has hx of vasovagal reaction when getting any sort of immunization/injection. Pt found in Vaccination boot number 1 with healthcare provider. PT had just received his Pfizer immunization. PT stated he wasn't feeling well and needed a moment. Pt then became diaphoretic, pale, cool skins. Paramedic asked patient if we could take him to cot for observation. PT agreed and stood up turned and sat in wheel chair. PT taken to cot and as we arrived pt became unconscious. Pt was unresponsive to verbal and painful stimuli. Pt remained unconscious for approximately 20 seconds. Once patient regained consciousness he was immediately Alert and Oriented x4, skins were pale, moist, cool. pt was carried to cot during his unconscious episode. pt layed down for a while, vitals were assessed at 1556: BP-128/88, HR 64, RR 22, SPO2- 94%. Pt immediately feeling much better and taken to observation for an additional 30 minutes. Pt advised to let us know if he was feeling faint again.
59 2021-04-16 discomfort Within minutes after receiving 2nd dose of Pfizer COVID vaccine (at approximately 1200) patient pres... Read more
Within minutes after receiving 2nd dose of Pfizer COVID vaccine (at approximately 1200) patient presented to this RN due to complaints of feeling like she would pass out. She was holding her head in a wheelchair and appeared quite uncomfortable. She was safely transported to a recliner to elevate legs. She was lying in a flat position. Mask taken off due to complaints of "having a hard time breathing." Patient complained of LEFT sided chest pain; unable to determine if this pain is acute or chronic. Patients slow to respond and unable to describe symptoms well. Patients slow to respond to questioning. Patient with mildly stuttered speech. Eventually patient admitted to dizziness. Given the nature of presentation, first responder called and arrived quickly. Vitals at 1200: 135/112, semi-Fowler's position, right arm. 84 bpm, apical, regular, 95%, room air. Patient denied swelling, throat tightness. No rash. Patient sat up in chair to help with breathing. Vitals at 1212: Heart rate 101 bpm. No apparent respiratory distress. NP briefly auscultated prior to immediate transport to Emergency Department. Patient transported to Emergency Department via wheelchair with First Responder.
59 2021-04-17 involuntary muscle movements, bell's palsy, numbness Bell's palsy; eye sight in that eye is getting worse every day; right eyelid was sticking on his eye... Read more
Bell's palsy; eye sight in that eye is getting worse every day; right eyelid was sticking on his eye and wouldn't shut; he couldn't move his face on the left side and he can't control it at all; blood got really thin and wouldn't clot; left hand got really swollen; entire arm bruised; edema in his hand; edema in his hand got to the point where his skin was cracking; blood got really thin and wouldn't clot; face went numb; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6207, Expiration Date: Jul2021), via an unspecified route of administration, administered in Arm Right on 11Mar2021 (at the age of 59 years old) as single dose for covid-19 immunisation. Medical history included lupus from 2020 and ongoing, ongoing High Blood Pressure, Spinal Surgeries from 1999, Chronic Pain,Retention water, blood clot issue. The patient previously had tetanus shot. Concomitant medications included losartan potassium; allopurinol; hydroxychloroquine; methocarbamol; morphine sulfate (MS CONTIN); oxycodone; furosemide. Caller states he is calling about the Pfizer Covid 19 Vaccine. Seven days later the dose of vaccine (18Mar2021), patient developed Bell's Palsy which he has never had before and has never had any other problem with. He has seen an ENT, his pain doctor, and his medical doctor and they all say the Covid vaccine has caused the problem he is having. He was told by his ENT this is very possibly permanent. Emergency Doctors are who he went to because he thought he was having a stroke, because half of his face went numb. He has been to the doctor 10 times in the last 7 days, it has not been fun at all. He didn't put it together until he saw the ENT, who said Bell's Palsy is caused from a virus. States he had no idea until he said that, that it could possibly be from the injection. States he has never had Bells Palsy before and it started 8 days after the initial shot. His right eyelid was sticking on his eye and wouldn't shut and he couldn't move his face on the left side and he can't control it at all. Clarifies he couldn't shut his right eye all of the way. Since then they have told him he needs to tape his eye shut for 12 hours a day to keep from going blind. The thing that bothers him is his eye sight in that eye is getting worse every day even though he uses the cream and tapes it shut. His wife told him even with both eyes shut, it will not completely shut because his lower eyelid is hanging down too far. The ENT told him he needs a hearing test today at 2:00p.m. to see if this is going to be a permanent problem. He is getting ready to go to the ear doctor to find out more. At the same time he developed the Bells Palsy, his blood got really thin and wouldn't clot which seems really weird. Also on 18MAR2021, his left hand got really swollen and the entire arm bruised and they said the edema in his hand got to the point where his skin was cracking because his blood got so thin that it couldn't clot at all. He had a blood clot issue in the past. States his arm and hand have improved, he can move his hand again finally. The ENT said that since he has been on Prednisone, for recovery for Bells Palsy, for over a week and gotten worse instead of better, it may be permanent. Prednisone is not working, it has actually gotten worse. Prednisone 10mg for 7 days and to decrease by one tablet every day until gone but states he has gotten worse. Treatments (assessed as for all events): Prednisone. States that it has been two weeks since this happened and the doctor told him the only other option is skull surgery. The bones in his head would be drilled out to make room for the nerves in hopes he would be able to work his mouth again, so not a good thing. Eye cream. He is on disability and his house payment is 3/4 of what he makes, so he can't take care of the medical bills himself otherwise he wouldn't worry about it. It is very depressing. His medical doctor said he hadn't seen any cases of Bell's Palsy for 2 years, and he has seen 4 in the last week so that doesn't give him a lot of confidence even though he is still encouraging people to get the vaccine because it is safer than not.He has multiple visits to the ER 3 times between 18MAR2021 and 19MAR2021 within 24 hours; states he was in the ER for hours and hours but no admission. States they did a CT Scan, MRI, CT with contrast and then after that ended up 22 saw ENT who confirmed the fact that Covid Vaccine that gave Bells Palsy and on 22-23 saw his GM again. Prior Vaccinations (within 4 weeks): None within 4 weeks; states 9 months ago he had a Tetanus Shot. No AE(s) following prior vaccinations. The outcome of the event Bell's palsy, Visual acuity decreased, Eyelid disorder, Orofacial dyskinesia, numbness in face was not recovered; other events was recovering. All events happened on 18Mar2021.
59 2021-04-17 feeling cold, hot flush Pfizer-BioNTech Covid 19 Vaccine EUA: One week post-injection I experienced extreme fatigue, body ac... Read more
Pfizer-BioNTech Covid 19 Vaccine EUA: One week post-injection I experienced extreme fatigue, body aches, chills, shivering, hot and cold flashes. At this time the symptoms have persisted for 30 hours, although the shivering subsided after sleeping through the night. The heavy fatigue and body aches continue however.
59 2021-04-17 pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA 4/14/21 12:45 pm - vaccination - no issues 11:00 pm - Chills, c... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA 4/14/21 12:45 pm - vaccination - no issues 11:00 pm - Chills, chattering teeth, nausea 4/15/21 1:00 am - loose bowels, minor headache 8:30 am - Vertigo, unable to stand, collapse on floor, major nausea, dizziness - go straight to bed 8:30 am - 8:30 pm - Sleep off/on entire period, arm pain, drink water, take tylenol, chills, nausea, lethargy 8:30 pm - Midnight - profuse sweating soaking clothes, major headaches, nausea - continue to sleep 4/16/21 Midnight - 6:00 am - Restless sleep, loose bowels at times All day - Awake, tired, occasional nausea. limited appetite 4/17/21 Limited appetite - occasional nausea
59 2021-04-18 bell's palsy Bells palsy to left side of face
59 2021-04-19 weakness Patient received vaccination at 10:15am, waited 15 minutes, then went to work. Patient reported blur... Read more
Patient received vaccination at 10:15am, waited 15 minutes, then went to work. Patient reported blurry vision, cold chills, dizziness and stomach cramping beginning 12:30pm. Patient sat down and began experiencing a new onset headache. Patient tried to get up once, sat down, then tried to get up again and reportedly blacked out. Patient was aroused by coworkers at which time was taken to his residence. Patient did not seek treatment. Roughly 24 hours after the event the patient reported still feeling weak and light headed. Patient was urged to seek medical treatment.
59 2021-04-19 weakness Fever (102.6 x 48hrs), Mialgia, Nausua, Diahrrea, severe weakness, dizziness, confusion. Abominal pa... Read more
Fever (102.6 x 48hrs), Mialgia, Nausua, Diahrrea, severe weakness, dizziness, confusion. Abominal pain & cramps. Left upper arm pain. Symptom course lasted total 5 days and completely resolved by Sunday evening(4/18/21)
59 2021-04-19 facial paralysis, bell's palsy Chief Complaint pt c/o left facial droop starting today, states received 1st dose of Pfizer vaccin... Read more
Chief Complaint pt c/o left facial droop starting today, states received 1st dose of Pfizer vaccine on 4/16. denies any other symptoms History of Present Illness 59 yo WM here with left facial droop noted by his wife this PM when coming home, wife is a NP. No other symptoms Pt noted that he was recent vaccinated at the megasite Friday, as noted above. Denies: Nausea vomiting headache chest pain SOB falls head trauma changes in vision, double vision falls recent illness new medications change in sleep patterns tinnitus history of: heavy caffeine use heavy alcohol use trauma stroke in the past exposed to meningitis BCP Gen AAOx3NAD PERRLA EOMI, lids intact able to close without issue Neck Supple, no bruits, no JVD appreciated cervical LNno lymphadenopathy CV +s1/s2 RRno RRG PulmCTA bilaterally no RRW Absoft NT/ND no RRGCVA Extremities no edema, radial pulse intact CN 2-12 intact, mm strength UE and LE 5/5, patellar reflex 2/4; no gait disturbance very settle facial droop noted at the left lip, evident at resting and with laughter, not with induced smiling Review of Systems as above Physical Exam Vitals & Measurements Temperature Temporal: 97.5 DEGF Systolic Blood Pressure Cuff: 136 mmHg Diastolic Blood Pressure Cuff: 84 mmHg Peripheral Pulse Rate: 93 BPM Oxygen Saturation: 97 % Respiratory Rate: 16 BR/MIN WT (Kgs): 72.6 kg Weight Calculated (lbs): 160.054 LBS HT (In): 68 INCH as above Assessment/Plan 1 . Left-sided Bell's palsy ( G51.0 ) Grade 2 very mild but has slight noticeable lip paraylsis treat with high dose steroids as rec, eat with it fu in 7 days with PCP supportive care please see the clinical summary (includes immunizations), patient instructions and other supporting documents - as these are supplements to the SOAP note and should be reviewed as apart of the chart. Education provided- verbal, as well as any patient instructions printed. Ordered: predniSONE 20 mg oral tablet, 60 mg 3 TAB, Oral, Daily, X 7 DAYS, # 21 TAB, 0 Refill(s): 172.72, 04/20/21 18:21:00 EDT, Height Calculated (cm), cm, 72.6, 04/20/21 18:21:00 EDT, WT (Kgs), kg
59 2021-04-19 pain in extremity Left arm is still sore after 2 weeks of vaccination. The soreness is still the same for the past 10 ... Read more
Left arm is still sore after 2 weeks of vaccination. The soreness is still the same for the past 10 days, and has not improved. I am not able to lift more than 10 pounds using my left arm with some pain in the forearm or shoulder.
59 2021-04-20 nerve pain shooting pain of sciatic nerve from hip to thigh and leg.
59 2021-04-20 pain in extremity I had minimal reaction to the 1st dose, slightly sore arm at injection site for 3 or 4 days. 2nd dos... Read more
I had minimal reaction to the 1st dose, slightly sore arm at injection site for 3 or 4 days. 2nd dose, I was feeling off by 3:30pm, mild headache and extremely tired. By 5 I was exhausted, and paranoid about a work situation, paranoia is not part of my normal state of being. By 6pm my left upper arm was very painful from shoulder to elbow. Took aspirin and went to bed at 7pm. Woke at 8am Friday with mild headache an very tired, by 10am was back in bed, slept 4 hours, Repeated the Friday pattern for 2 more days. Monday the extreme tiredness and arm pain abated. Tuesday, the paranoia abated. Now just Brain Fogged.
59 2021-04-20 pain in extremity Pain on arm and fever stating later in the same day of taking the shot. It last over a day and fev... Read more
Pain on arm and fever stating later in the same day of taking the shot. It last over a day and fever reducer was taken.
59 2021-04-21 flushing Flushing/sweating, shortness of breath. BP 150/83 (pulse 89), 99% O2 sat.
59 2021-04-21 pain in extremity very sore--neck--back legs
59 2021-04-21 pain in extremity pt had right leg swelling and pain starting on 03-22-21 and presented for medical care on 03-29-21 ... Read more
pt had right leg swelling and pain starting on 03-22-21 and presented for medical care on 03-29-21 was found to have elevated d-Dimers and Doppler RLE showed occlusive clot in right peroneal vein and non-occlusive clot in right popliteal vein
59 2021-04-22 facial paralysis Started with an ear ache, went to facility on 3-25-21 to ER Department, continued pain went to ER a... Read more
Started with an ear ache, went to facility on 3-25-21 to ER Department, continued pain went to ER at Clinic 3/31/21, sores developed on the right side of my head, in my ear and on my tongue. Paralysis on right side of mouth and eye. Lost hearing in right ear, pressure behind right eye and still struggling with severe pain.
59 2021-04-22 speech disorder On 7 April, approx 9AM, pt. experienced a TIA (Transient Ischemic Attack or Mini-stroke). Siblings ... Read more
On 7 April, approx 9AM, pt. experienced a TIA (Transient Ischemic Attack or Mini-stroke). Siblings became aware by 10:30, and by 11:45 he was at the ER. His speech was extremely restricted and he was barely able to speak a few words. Face was partially asymmetric, but gross and fine motor skills basically unaffected. He could walk and write his name, follow commands to move arm and legs. Underwent multiple tests including CAT scan, when no sign of bleed stroke confirmed. At admittance, Stroke Scale score = 4. By 3PM, speech started to return, and continued to return. Continued tests with EEG, EKG, and TTE, but no source for TIA could be pinpointed. Unable to perform MRI due to embedded medical device. By next morning speech had almost returned to normal. No physical restrictions noted on following day. Discharged 6PM on 8 April. Doctors unable to explain cause and could not comment on whether related to receiving vaccine a week prior. Recovery seems to be complete with no negative lasting effects as of 22 April, 2021.
59 2021-04-24 weakness Left arm, shoulder, and upper body severe pain. I couldn't lift my left arm. It felt as if I had the... Read more
Left arm, shoulder, and upper body severe pain. I couldn't lift my left arm. It felt as if I had the flu. Body aches, disorientation, difficulty breathing, severe body weakness, nose running. I used 8hr Tylenol for the pain. I was restless and couldn't sleep Friday and Saturday night. On Sunday, the symptoms began to subside, but the general weakness and disorientation remained.
59 2021-04-24 burning sensation Sensation that my brain was on fire or oddly fevered even though my body's temperature did not eliva... Read more
Sensation that my brain was on fire or oddly fevered even though my body's temperature did not elivate; severe joint pain; very thirsty; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Patient Program COVAES. A 59-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Mar2021 at 11:30 (Lot number: ER8730) on the left arm as single dose for COVID-19 immunization. Medical history included allergy to cats, asthma from allergy. Concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Mar2021 at 09:30 (Lot number: EN6205) on the left arm as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Patient reported that sensation that his brain was on fire or oddle fevered even though his body's temperature did not elevate, not a headache on 24Mar2021 at 22:00. On 24Mar2021 at 22:00, patient also had severe joint pain and very thirsty; lasted about 36 hours. There was no treatment received for the adverse events. The outcome of events was recovered on unspecified date. Information on the lot/batch number has been requested.
59 2021-04-24 muscle spasms, pain in extremity Became very ill..Extreme fatigue..Nausea, fever bodyaches leg cramps..Threw up from nausea..Could on... Read more
Became very ill..Extreme fatigue..Nausea, fever bodyaches leg cramps..Threw up from nausea..Could only lay down..Extreme headache and huge reaction from injection site..Blood sugars would not come down..Remained stubbornly high..Sleep...Wake up..have extreme leg cramps and body aches..Made way to bathroom brvause of nausea..Nearly threw up..Ended up just lying on the floor and going to sleep again...Got up ..Went into bedroom. Sip of diet soda..Back to sleep...Finally got up at 3pm...Signs of being able to come through..Was very close to going to Urgent Care but physically would have been too challenging to go...Had food at 10pm ...Slept through 5am...Soreness in arm has become much less..Signs of survival...Seriously have second thoughts about ever having another vaccine in future unless they improve the process...
59 2021-04-24 pain in extremity severe reaction, his muscles in his leg starting aching up. It's felt like all his muscle is moving ... Read more
severe reaction, his muscles in his leg starting aching up. It's felt like all his muscle is moving on and on. It was very, very painful in the thighs that was going on; brought back pain in his shoulder and in back that he had in the past ; it is very very bad; brought back pain in his shoulder and in back that he had in the past ; it is very very bad; I had to go to ER to give me some kind of shot but pain still there in my leg/painful in the thighs; This is a spontaneous report from a contactable consumer. A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2, via an unspecified route of administration, administered in Arm Right on 26Mar2021 (Lot Number: ER8732) as SINGLE DOSE (at the age of 59 years old) for covid-19 immunisation . Medical history included arthritis from an unknown date and unknown if ongoing, pain from an unknown date and unknown if ongoing. The patient's concomitant medications included oxycodone hydrochloride, paracetamol (PERCOCET) for pain "I am taking pain killer for it but it's not working". Historical vaccination included BNT162B2, dose 1, Lot number: EN6206, on 03Mar2021 for COVID-19 immunization at the age of 59 years old. On unknown date, the patient had severe reaction, his muscles in his leg starting aching up. It's felt like all his muscle is moving on and on. It was very, very painful in the thighs that was going on. He had to go to emergency room (ER) to give him some kind of shot but pain was still there in his leg. It brought back pain in his shoulder and in back that he had in the past and he was weak. "The reason that I stop and it felt pain went away but the back and the leg pain was still there and it is very very bad." Consumer stated, "Yes but I was not sure it was the vaccine causing it I had arthritis and I thought it might have been arthritis is causing it. It was like 10 hours later when I started to experience the side effect." The patient underwent lab tests and procedures which included complete blood count (CBC) : unknown result on unknown date , Comprehensive metabolic panel: unknown result on unknown date. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected
59 2021-04-25 weakness 1-5 days swelling and rash, pain in arm at injection side Day 3-4 Throbbing leg - felt artery flutte... Read more
1-5 days swelling and rash, pain in arm at injection side Day 3-4 Throbbing leg - felt artery flutter. 1-12 days recurring headache 3-18 days pain in shoulder and armpit near injection site Day 12-18 swelling in hand Day 2-18 - extreme fatigue, lack of energy Day 2-18 - higher blood pressure Day 4-18 ? Nausea and forgetfulness
59 2021-04-27 nerve pain Shingles on right side head, back, and neck 1 week following second dose. Painful lesions and neurol... Read more
Shingles on right side head, back, and neck 1 week following second dose. Painful lesions and neurological discomfort as well as muscle pain occured.
59 2021-04-28 pain in extremity MUSCLE PAIN THAT STARTED THE DAY AFTER THE SECOND DOSE OF PFIZER COVID VACCINE AND IS PERSISTING AND... Read more
MUSCLE PAIN THAT STARTED THE DAY AFTER THE SECOND DOSE OF PFIZER COVID VACCINE AND IS PERSISTING AND WORSENING WITH TIME. WE ARE OVER THREE WEEKS OUT AND HIS MUSCLE PAIN SEEMS TO BE SPENDING. THE PAIN STARTED IN THE LEFT SHOULDER AND IS NOW IN BOTH SHOULDERS AND ARMS.
59 2021-04-29 numbness, pain in extremity Sore left arm, armpit. Numbness/ache in forearm, slight numbness in hand. bad chills, lot of sweati... Read more
Sore left arm, armpit. Numbness/ache in forearm, slight numbness in hand. bad chills, lot of sweating starting that evening and continuing. A runny nose, nausea, fever spiked to 103.7 from a normal of ~97.3 at about the 23 hour mark. As of right now 04/30/21 14:21, 3 days later, still a little sweaty, armpit and arm sore, forearm still ache and hand still a little numb.
59 2021-04-30 pain in extremity Thumb hurt; Hand swelled up; Elbow was swollen; Intense pain in the elbow; This is a spontaneous rep... Read more
Thumb hurt; Hand swelled up; Elbow was swollen; Intense pain in the elbow; This is a spontaneous report from a contactable consumer (patient). A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, at age of 59 years old, administered in Arm Left on 09Apr2021 09:45 (Lot Number: EN6200; Expiration Date: 30Jun2021) at single dose for covid-19 immunisation. Medical history included blood pressure increased from 1995 and ongoing (It is controlled), anxiety (young and suffering from anxiety, has no clue why) and family cancer history. The patient previous received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 19Mar2021 09:45 (Lot Number: EN6200; Expiration Date: 30Jun2021), at age of 59 years old, at single dose for covid-19 immunisation. The patient's concomitant medications were not reported. He received the Covid vaccine on 09Apr2021. The following day he later noticed his elbow started bothering him that night, and around midnight it woke him up. He had intense pain in the elbow and tried to tough it out. 4 hours later he was in the ER, it was that bad. When he got there they did an ultrasound and some X-rays. The ultrasound showed his elbow was swollen, and they removed 17cc of fluid. They asked if he had any trauma to his arm and he said absolutely no way. He doesn't know what to think. He was trying to find someone to help with the issue. On a scale of 1 to 10 the pain was a strong 10. To this day it was still bothering him pretty bad. He coundn't work because of it. He could hardly straighten it out because it is so sore. It was painful, but not as bad as Saturday(10Apr2021) and Sunday(11Apr2021) morning. On 13Apr2021, his hand swelled up. That's gone away. His thumb hurt on 14Apr2021 and that had gone away, he just aced that. He put ice on his elbow. His elbow from last night(13Apr2021) to today (14Apr2021) probably had a 30 percent change. It is getting better but it is still sore. He can't straighten it and he is trying to bend it to work it so it doesn't get stiff. With the work he does he needs to use his arms. He works in construction. He got the shot on 09Apr2021, and the pain was later in the day. He received his dose around 0945, and at about 1500 to 1530 he noticed his elbow bothering him. Later that night when he went to bed he was uncomfortable and couldn't sleep. Eventually he did fall asleep and at 0000 he woke up in excruciating pain. He tried to deal with it until 0400 when he went to the ER. His pain is nowhere near what it was. When he tries to straighten it, it is very painful, about a 6. If he bends it back it is much better. If he tries to straighten it the pain level goes up. It is still swelled up a bit. It is hard to say if it has improved, he never really saw it. He went to bed and when he woke up he was in so much pain. He had on his PJs and put on his shoes and left. All he knew was he was in pain. He presumed it was more swollen then, they did the ultrasound and found all that fluid. The pain in his thumb subsided a bit. He took the ice off of it about 30 minutes before this phone call, so about 45 minutes ago. It feels a little better. At least one part of the puzzle is solved. He noticed it at about 0730 this morning. He had an ultrasound on 11Apr2021. He had 3 to 4 X-rays on 11Apr2021. Outcome for events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and 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. No follow-up attempts are needed. No further information expected
59 2021-04-30 pain in extremity he experienced a sore arm after his first dose of the Covid-19 vaccine on 23Mar2021.; This is a spon... Read more
he experienced a sore arm after his first dose of the Covid-19 vaccine on 23Mar2021.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: ER2613, Expiry Date: 31Jul2021) on 23Mar2021 15:30 in left arm as single dose for COVID-19 immunization. Medical history included ongoing hypertrophic cardiomyopathy which diagnosed probably 8 years ago; family medical history included mother and father are diabetic. Concomitant medications were none. No additional administered vaccines. No prior vaccinations (within 4 weeks). Patient experienced a sore arm after his first dose of the Covid-19 vaccine on 23Mar2021. Patient reported that he recovered completely from the sore arm following the first dose. No emergency room visit required. No physician office visit. No relevant tests. Outcome of the event was recovered. No follow-up attempts are needed. No further information is expected.
59 2021-04-30 pain in extremity Knot in arm at injection site; Achy feeling joints; Arm was really sore; Hasn't had an appetite all ... Read more
Knot in arm at injection site; Achy feeling joints; Arm was really sore; Hasn't had an appetite all day; Chills; Feels like I have the flu; metallicy taste in mouth; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Apr2021 at 14:00 (Lot number: EW0150, Expiry date: 31Jul2021) on the left arm as single dose for COVID-19 immunization. Medical history included ongoing hypertrophic cardiomyopathy that diagnosed probably 8 years ago. Family history included mother and father are diabetic. There was no concomitant medication. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Mar2021 at 15:30 (Lot number: ER2613; Expiry date: 31Jul2021) on the left arm as single dose for COVID-19 immunization, that experienced a sore arm. There were no additional administered vaccines, no prior vaccinations within 4 weeks. Patient experienced a really metallicy taste in his mouth about 10 to 15 minutes after he received the Covid-19 vaccine. On 14Apr2021, the patient reported that he had a knot on his arm at the injection site. He had experiencing an achy feeling joints following the Covid-19 vaccine. His arm was really sore this morning, 14Apr2021, he can't lift his arm up past shoulder height without it hurting, and that when he went to rub his arm to massage the soreness out, he felt the knot in his arm. Patient also hasn't had an appetite all day long, he would think about eating something and it didn't sound good. Patient reported it was very unusual for him not to have an appetite, that he normally loves to eat. On 14Apr2021, patient was experiencing the chills off and on, he also felt like he had the flu. When queried for product details, patient reported that he was going to put his cheat glasses on, that the writing on his vaccine card was like micro writing. No events required a visit to emergency room or physician office. The outcome of events "Knot in arm at injection site", "Achy feeling joints", "Feels like I have the flu" was not recovered, while the other events was unknown. No follow-up attempts are needed. No further information is expected.
59 2021-05-02 numbness, tenderness, tingling, discomfort Male patient (date of birth: 02/05/1962) received the 1st COVID Vaccine (Pfizer, Lot #: ER8731 and e... Read more
Male patient (date of birth: 02/05/1962) received the 1st COVID Vaccine (Pfizer, Lot #: ER8731 and expiration date: 08/2021) on 04/09/2021 at 12:45PM. Client returned to the vaccine site on 04/30/2021, for his second dose. Client was checked in by the ancillary staff and then sat down with a nurse vaccinator at one of the vaccination stations. As the vaccinator screened the client, some medical concerns came up so the vaccinator went over to the lead nurse for a consult. Nurse received a brief report from the vaccinator, and then walked over to the vaccination station to talk to the client. The client explained to Nurse that he received his first dose on his left arm and about 2 days later, he developed "numbness and tingling" in that same arm and it has not resolved. As Nurse asked further questions, she discovered that the client also started to develop that same sensation, of numbness and tingling, in his right hand. The client described that it is painful, if poked in those areas. Nurse also asked if this feeling radiates anywhere else and the client explained that, if he sits for a prolonged period of time, the numbness and tingling will develop in both of his lower extremities and he needs to get up and walk around. Client reported that it is not painful in a way that he can rate it on a pain scale of zero to ten, but he did describe it as being "abnormal for him" and "not comfortable." Client denied any known drug allergies as well as denied any past medical history. He stated he had his left index finger amputated "years ago, but that is it." Nurse explained to the client that there are some concerns regarding the new onset of symptoms after receiving the vaccine and that she would like to get a medical consult before deciding how to proceed with the second dose. Client agreed. Nurse sent a text message for a medical consult received an answer about 45 minutes later. The medical team recommended waiting to give the second dose until the client is assessed by either a primary care provider or neurologist. They also gave the client the option of receiving the JOHNSON and JOHNSON vaccine 28 days after the first dose, if the client does not wish to receive PFIZER again. Nurse then educated the client on the recommendations. The client expressed to Nurse that he is "very healthy and does not go anywhere," so he does not wish to be seen by a medical provider right now. The client asked questions regarding vaccine efficacy in the first and second doses and Nurse addressed them. The client told Nurse that at this time, he would like to hold off on getting a medical assessment and did not wish to reschedule for a JOHNSON and JOHNSON vaccine. Nurse respectfully acknowledged his decision and educated him on V- safe and how to proceed if he changes his mind later down the road.
59 2021-05-03 feeling hot For around 5-minute duration: - Stomach knot - Sudden strong sweating in the upper part of my body i... Read more
For around 5-minute duration: - Stomach knot - Sudden strong sweating in the upper part of my body including my forehead, felt very hot - Dizziness Never experienced such symptoms before in my life
59 2021-05-03 muscle spasms 8:30 am the day after the vaccine my lower right lip and lower right face swelled. For 14 days ever... Read more
8:30 am the day after the vaccine my lower right lip and lower right face swelled. For 14 days every day I had a headache and cramps. Daily fatigue. One day it felt like a giant hand was squeezing me around the chest and back. Random periods of nausea. One day I had overwhelming fatigue, it took every ounce of my strength to lift myself. It felt like something was laying on me pushing me down. Another day my upper right lip and upper right face swelled. Arm hurt at vaccine site. All this went on over a period of 2 weeks. To this day my upper right lip randomly swells.
59 2021-05-04 flushing, cold sweat ringing in the ears flushed face cough dizziness waken at night in a cold sweat
59 2021-05-04 pain in extremity, burning sensation, nerve injury, numbness and pain in extremities This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient recei... Read more
This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8732) at the age of 59-years-old, via an unspecified route of administration in left arm on 22Mar2021 at 15:00 at single dose for COVID-19 immunisation. The patient's medical history was reported as none. He has no known allergies and has COVID prior to vaccination. Concomitant medications included metoprolol, rosuvastatin, oxybutynin, and tamsulosin. There were no other vaccines in four weeks and no additional vaccines administered on the same date of the COVID-19 vaccine. The patient reported that he was having some wild effects from the vaccine and did not know what to do. On 26Mar2021 at 15:00, he was having neuropathy like effects. His hands, arms, legs, and feet were experiencing pain and burning sensations, they were burning like nerve damage; he also has a little burning sensation in his nose and cheeks. He has never had this before. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. He was also having some weird sensations in his calf muscles, these sensations started within the past week and a half (Apr2021) which prompted physician office visit. The physician placed him on gabapentin 100 mg to start from 12Apr2021, but it was not enough, it was titrated up to 300 mg, three times a day and he is scheduled to see specialist soon. The patient mentioned that this vaccine has ruined his health. He also went to an urgent care center because his leg was bothering him, it was swelling on an unspecified date in 2021; he thought he had a blood clot; they did some kind of test where they looked at the leg and did not find anything. He didn't have a particular question. He would just like to talk to someone to see if this was going on with anyone else, if it will go away, or if this was permanent problem he will have. The patient was not tested for COVID post vaccination. He received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0161), via an unspecified route of administration in left arm on 13Apr2021 at 15:00 at single dose for COVID-19 immunisation. The outcome of the events was not recovered.
59 2021-05-04 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
59 2021-05-04 seizure Extreme fatigue; brain fog; Passed out; Told possible seizure; Felt ill shortly after receiving shot... Read more
Extreme fatigue; brain fog; Passed out; Told possible seizure; Felt ill shortly after receiving shot; Threw up; This is a spontaneous report from a contactable consumer (the patient) and then from a contactable consumer (the patient's wife). A 59-year-old male patient received the first dose of BNT162B2 (lot number not provided), via an unspecified route of administration in the left arm on 31Mar2021 10:00 (at the age of 59-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included: fish oil (OMEGA 3 FISH OIL). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient felt ill shortly after receiving the shot. Told to sit down. Passed out. Awoke on the floor. Told possible seizure. Sat up. Threw up. Told to lie back down. Ambulance came and took him to the hospital. He spent 90 minutes in the Emergency Room. He was unable to work for a couple of days. He had extreme fatigue and brain fog. He was not back to relatively normal for at least 10 days. Treatment received was reported as yes: ran tests including 3 EKGs, on an unspecified date. The outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
59 2021-05-05 involuntary muscle movements Pt reported severe dizziness. Also reported HTN but not compliant with medications. In fact he has ... Read more
Pt reported severe dizziness. Also reported HTN but not compliant with medications. In fact he has "not taken it since yesterday". EMS attended pt. VS were consistent throughout as noted. Pt continues to report dizziness. At 3:07 PM pt requested to go to hospital for new onset "involuntary neck movements" These reported neck movements were unobservable by this nurse and multiple staff. Pt walked to elevator with fire/EMS to wait for ambulance to arrive for transport. Pt left floor under own volition with no observable signs of distress.
59 2021-05-05 night sweats Fever spiked to 100° briefly, Night Sweats every night for a week, Achy joints worse day 5/2 but st... Read more
Fever spiked to 100° briefly, Night Sweats every night for a week, Achy joints worse day 5/2 but still ongoing, better each day.
59 2021-05-06 discomfort Note 01/18/2021 Wife called patient has been ill all weekend. He is pale, passing out, Arhythmia, n... Read more
Note 01/18/2021 Wife called patient has been ill all weekend. He is pale, passing out, Arhythmia, no fever, no cough, no SOB (but hasn't been doing much either). Was going to have pt seen this am, but spoke with healthcare and wants Pt to go to ER for emergent testing. Called wife back and she was notified. CHEST PAIN, PALPITATIONS, NAUSEA, SOB
59 2021-05-06 pain in extremity 4/28/2021-Lower left leg hurting; 4/29/2021-can't put weight on leg; ER visit with doppler to confir... Read more
4/28/2021-Lower left leg hurting; 4/29/2021-can't put weight on leg; ER visit with doppler to confirm blot clot in calf; ER gave Norco 5-325 mg for pain; fever of 101; 4/30/2021-still can't put weight on leg and fever of 101.8; 5/1/2021-woke up with no pain; clot still there; 5/3/2021-saw primary doctor for ER follow-up on clot; primary doctor confirmed there is a small clot in deep vein and could take up to 6 months for it to dissolve on its own.
59 2021-05-08 pain in extremity, tremor severe upper arm pain for 4 days, fever of 101 for 1 day, feeling unwell for 2 days, headache for 4 ... Read more
severe upper arm pain for 4 days, fever of 101 for 1 day, feeling unwell for 2 days, headache for 4 days, chills and shaking sometimes for 1 day.
59 2021-05-09 weakness, tremor, muscle spasms After about 10 hours, pain at injection site. By 12 hours, pain is considerable, cannot move arm ar... Read more
After about 10 hours, pain at injection site. By 12 hours, pain is considerable, cannot move arm around without wincing. Went to bed and woke up about 3 hours later (e.g. 15 hours after injection). Suffering from full body aches, headache (even my teeth and eyes hurt), chills, uncontrolled shaking, followed by uncontrolled sweating, muscle spasms, nausea, severe pain at injection site, swollen and painful lymph node in left armpit. Little to no sleep that night. In a fog all day Sunday, low grade fever just below 100. Went to bed early (around 8:30pm) with similar but reduced symptoms. Pain at injection site has subsided by now. Shakes and chills are far less but still there. Still sweating, really bad body aches, headache, swollen and tender lymph node under left arm. Challenge sleeping but did a little better. Today, Monday, still in a serious fog. No energy. Other symptoms appear to be subsiding
59 2021-05-11 feeling cold, weakness headache, uncrollable shivering and cold, sweats and weakness
59 2021-05-11 pain in extremity Since 2 days after the shot, left arm very painful. Seen provider two times and received steroids bo... Read more
Since 2 days after the shot, left arm very painful. Seen provider two times and received steroids both times. Not red or swollen. Felt like something in arm. Negative ultrasound.
59 2021-05-12 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
59 2021-05-13 weakness Headache, feeling sick, weakness, swelling at injection site, pain at injection site, diarrhea, dizz... Read more
Headache, feeling sick, weakness, swelling at injection site, pain at injection site, diarrhea, dizziness.
59 2021-05-13 burning sensation February 7, 2021 to March 20, 2021: Same evening burning sensation in forehead, muscle aches in legs... Read more
February 7, 2021 to March 20, 2021: Same evening burning sensation in forehead, muscle aches in legs. Following three weeks: sore throat, 3 weeks laryngitis, shortness of breath, chest and upper respiratory pain, overall lethargy, late February and March: 3 weeks abdominal pains and continuous diarrhea .
59 2021-05-13 tremor About 13 hours after the shot, at about 12:45 am of 5.5.21,, I had severe shaking while getting read... Read more
About 13 hours after the shot, at about 12:45 am of 5.5.21,, I had severe shaking while getting ready for bed. This happened while standing up. The shaking was so bad that I could not use my phone to search the side effects. The shaking started to subside after I laid down. Other symptoms after this event: unable to fall asleep for about 4 hours; feeling warm at times, with some minor chills; thirsty during this 4 hour period.
59 2021-05-14 bell's palsy Face was paralyzed/Bells palsy; Tongue felt fat and my lips numb; This is a spontaneous report from ... Read more
Face was paralyzed/Bells palsy; Tongue felt fat and my lips numb; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 59-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8736), dose 1 via an unspecified route of administration, administered in Arm Right on 17Apr2021 10:30AM, as 1ST DOSE, SINGLE for covid-19 immunization. Patient did not have medical history and no known allergy. Concomitant medication's included meloxicam and Multivitamins. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. On 02May2021, (reportedly patient stated that, 8 days after the vaccination), his tongue felt fat, and had lips numb. 2 days later symptoms spread. By Wednesday 05May2021 his face was paralyzed. He went to my physician the next morning and was told he have Bell's palsy. Patient states that, my face may never be normal again. AE resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Therapeutic measures were taken as a result of adverse events as prednisone 20 mg twice a day. Outcome of the events was not recovered.
59 2021-05-14 numbness, pain in extremity fever spiked to 103.7 from a normal of about 97.3; Sore left arm, armpit/ache in forearm; Sore left ... Read more
fever spiked to 103.7 from a normal of about 97.3; Sore left arm, armpit/ache in forearm; Sore left arm, armpit; Numbness/ache in forearm, slight numbness in hand; bad chills; lot of sweating starting that evening and continuing; runny nose; nausea; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 27Apr2021 15:00 (Lot Number: EW0170) as 2nd dose, single for COVID-19 immunisation. Medical history included chronic lymphocitic leukemia, Known allergies to environmental. Concomitant medications included atorvastatin; azelastine; fluticasone propionate (FLONASE ALLERGY RELIEF); metformin, all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (lot number: EW0150) for Covid-19 immunisation on 06Apr2021 in left arm at the age of 59-year-old. The patient experienced sore left arm, armpit, numbness/ache in forearm, slight numbness in hand. bad chills, lot of sweating starting that evening and continuing, a runny nose, nausea, fever spiked to 103.7 from a normal of about 97.3 at about the 23 hour mark, since 27Apr2021 21:00. As of right now 30Apr21 14:21, 3 days later, the patient was still a little sweaty, armpit and arm sore, forearm still ache and hand still a little numb. Since the vaccination, the patient has not been tested for COVID-19. There was no treatment received. Adverse events resulted in Emergency room/department or urgent care. The outcome of events was recovering.
59 2021-05-14 pain in extremity Rheumatoid arthritis flare up; Pain in joint involving hand; Injection site papule; Bruising; Sprain... Read more
Rheumatoid arthritis flare up; Pain in joint involving hand; Injection site papule; Bruising; Sprain; Dizziness; Loss of balance; Sickness; Vision decreased / Bilateral abnormal vision; Blurring of eyes; fatigue; bumps from the injector pen; Pain in extremity / ARM PAIN; This is a solicited report from non-Pfizer sponsored program received from a contactable physician based upon information received by Pfizer from company (21K-163-3820459-00). A 59-year-old adult make received the first dose of intramuscular BNT162b2 (solution for injection; Lot EL3248 expiry information not provided) as a single dose on 12Mar2021 (at 59-years-old) for COVID-19 immunisation. The patient also started to receive subcutaneous adalimumab (HUMIRA, unspecified formulation) 40mg at an unspecified frequency from an unspecified date for arthritis. Relevant medical history included rheumatoid arthritis, inflammation, high blood pressure, red face, red skin, used cane for walking because he could not walk (before adalimumab), and a loss of hearing in the left ear (one month prior to starting adalimumab). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications included sulfasalazine for inflammation; lisinopril for high blood pressure; and another [unspecified] medication for inflammation. The patient previously received treatment for inflammation with steroids which were not good enough. On an unspecified date in Mar2021, after receiving the vaccine, the patient developed arm pain, it made him tired, he had dizziness, fatigue almost every time, and a loss of balance. The patient had bumps from the injector pen/ Injection site papule, Pain in joint involving hand, bruising, sprain, and sickness. On an unspecified date in Apr2021 the patent experienced bilateral abnormal vision/vision decreased and blurring of eyes. On 09Apr2021, patient received second dose BNT162b2 (solution for injection; Lot EL3302 expiry information not provided) as a single dose. The action taken with adalimumab was unknown. The outcome of the event Sickness was recovered on an unspecified date. The outcome of the events bilateral abnormal vision/vision decreased, blurring of eyes, and fatigue, was not recovered. The outcome of the events pain in extremity / arm pain, bruising, sprain, dizziness, loss of balance, was recovering. The outcome of the events Pain in joint involving hand, Injection site papule, and bumps from the injector pen was unknown. The reporter's assessment of the causal relationship of the event with the suspect product BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts possible. No further information expected.; Sender's Comments: Based on available information, a possible contributory role of subject product, BNT162B2 vaccine cannot be excluded for the reported events of Injection site papule, Pain in joint involving hand, bruising, dizziness, loss of balance, fatigue and sickness, based on temporal relationship. Based on the information provided by the reporter, it appears unlikely that the subject product contributed to the RA flare and other reported events, which likely represent intercurrent medical conditions. There is very limited information provided in this report. This case will be reassessed upon receipt of follow-up information. 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.
59 2021-05-16 hypersensitivity of all senses SHINGLES. Starting on or about 5.2.21, shooting pain in knees, followed by odd sensations to touch. ... Read more
SHINGLES. Starting on or about 5.2.21, shooting pain in knees, followed by odd sensations to touch. RICE'd & used roll on pain relievers. Waking up every two hours in pain. Pain moved to back a couple of days later. 5.8.21 quit using roll on because rash developed on left leg. Monday 5.10.21 rash is worse and went to Resurgens for knees and overall pain. Dr. thought shingles so went directly to Primary Care. Got positive diagnosis of Shingles, antivirals and pain meds. On or about Wednesday 5.12 ear pain and odd hearing sensations started. Went back to PCP - ear infection. Got antibiotics.
59 2021-05-16 tingling, pain in extremity, nerve pain, numbness The patient received the Pfizer COVID19 vaccine on 03/30/2021. The patient reports that two (2) week... Read more
The patient received the Pfizer COVID19 vaccine on 03/30/2021. The patient reports that two (2) weeks after receiving the vaccine he experienced numbness and tingling in both feet. He reports the numbness and tingling progressed up both legs resulting in pain in the knees and thighs. The patient reports having sought medical attention for the progressing symptoms, however, it is unknown what the cause of the adverse reaction. The patient has reported these adverse reactions to me on 05/14/21. The patient reports he currently is still feeling muscle fatigue and nerve pain.
59 2021-05-18 pain in extremity None--medication error. Dose 2 was given 15 days after Dose 1. Pt reported he forgot date of #1 and ... Read more
None--medication error. Dose 2 was given 15 days after Dose 1. Pt reported he forgot date of #1 and misreported on VAR. Pt reported only a sore arm x 24 hrs
59 2021-05-18 tingling, numbness, pain in extremity Within two weeks of 2nd shot left arm and leg went numb, spent the night at hospital and they said i... Read more
Within two weeks of 2nd shot left arm and leg went numb, spent the night at hospital and they said it was carpal tunnel. Started seeing Dr. a few weeks later and he diagnosed right shoulder pain as rotator cuff issues. Pain is currently the whole right arm a tingle in the right hand, I will be calling the doctor again tomorrow.
59 2021-05-19 pain in extremity, tremor 1. (Day of injection) minor headache, pain at injection site; confusion/wooziness 2. (Following da... Read more
1. (Day of injection) minor headache, pain at injection site; confusion/wooziness 2. (Following day) 30 minutes severe shaking of right hand followed by 30 minutes minor shaking; headache; fatigue, sense of a sharp instrument like an ice pick being pressed hard into the inner surface of my ankles and my lower thighs - but only felt this in one location at a time as it there was a ghost poking me in those locations intermittently with just one ice pick; wooziness; pain at injection site 3. (2 days after injection) morning still had wooziness but subsided by evening.
59 2021-05-23 burning sensation Three minutes following receiving the vaccination I experienced rapid heart beat, confusion, burning... Read more
Three minutes following receiving the vaccination I experienced rapid heart beat, confusion, burning in lungs, blood pressure increase. Wheeled down to emergency room. Given anti nausea medication, exrays on heart and lungs, saline IV, heart monitored
59 2021-05-24 numbness Numbness on left hand Headache Overall body aches Nausea
59 2021-05-26 weakness The patient presented to the emergency department with 2 weeks of worsening bilateral lower extremit... Read more
The patient presented to the emergency department with 2 weeks of worsening bilateral lower extremity pain, erectile dysfunction and urinary retention. 24 hours prior to presentation he had been experiencing new neck pain/headache. He had no chronic history of these symptoms apart from arthritic pain in both knees and hips.
59 2021-05-26 muscle twitching twitching nerves (including but not limited to left arm) tinnitus
59 2021-05-26 pain in extremity the patient reported that he took Tylenol for the pain in his arm but that it is still hurting into... Read more
the patient reported that he took Tylenol for the pain in his arm but that it is still hurting into his shoulder and down his arm 21 days after receiving the immunization
59 2021-05-26 pain in extremity night of 5/18 into early morning of 5/19: Pain in right arm, and upper right back, shoulder, and che... Read more
night of 5/18 into early morning of 5/19: Pain in right arm, and upper right back, shoulder, and chest. Ultimately Vomiting violently. Could not lie down without the pain returning. 5/19 Day: Had light breakfast and dinner. No vomiting, but could not lie down without same pain. Morning of 5/20: Breakfast of cereal and fruit at 9am. And noon, I experienced pain again, vomiting at noon. Then to Urgent care, then, Emergency Room, then Hospital.
59 2021-05-28 weakness s/p 2 doses of Covid-19 vaccine. Pt presented for weakness, SOB, fatigue progressive over the past ... Read more
s/p 2 doses of Covid-19 vaccine. Pt presented for weakness, SOB, fatigue progressive over the past month prior to admission. Found to be pancytopenic with bone marrow biopsy consistent with MDS. He was started on chemo but stay was complicated by neutropenic fevers, epistaxis, retinal hemorrhage, AKI, fluid overload, hypoxic respiratory failure, atrial fibrillation with RVR, and shock. He ultimately had a heart attack while admitted and was transitioned to comfort care after medical interventions could not stabilize hemodynamics.
59 2021-06-01 seizure, face paralysis I63.9 - CVA (cerebral vascular accident) I63.9 - Acute ischemic stroke R29.810 - Facial weakness R... Read more
I63.9 - CVA (cerebral vascular accident) I63.9 - Acute ischemic stroke R29.810 - Facial weakness R56.9 - Unspecified convulsions
59 2021-06-02 nerve injury, nerve pain Pain neck; Nerve problem in my neck as a result of getting the first COVID-19 Vaccination shot; Nerv... Read more
Pain neck; Nerve problem in my neck as a result of getting the first COVID-19 Vaccination shot; Nerve in my neck is causing the problem; They have called pinched nerve; I also had that shot and It's inspires a little nerve problem in my neck.; This is a spontaneous report from a contactable consumer or other non hcp(patient himself). A 59-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8727; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in left arm on 21Mar2021(not clarified further) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient previously received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number ER8729, Expiration date: 31Jul2021) in right arm on 11Apr2021 for COVID-19 immunization. The patient's medical history. On 27May2021, it was reported that he was prescribed Gabapentin, 400mg, by mouth 3 times a day .Three days after having the shot, he started having pain in the neck, so upon then he went to his primary care physician, scheduled an MRI as suggested, to see where the pain or what was causing the pain came from and it comes back out, he had a nerve problem in his neck as a result of getting the first COVID-19 Vaccination shot. On 27May2021, it was reported he had little problem in his neck on unspecified date and was called as pinched nerve. He wanted to know if he is the only one experiencing this nerve problem from getting the COVID-19 Vaccination shot. On 27May2021, it was reported that Because when I received this shot after complaint the pain in the neck 2 days after he received the shot and it has not, one away today(27May2021) so as if today(27May2021) when It happened he (word not clear) Primary care to suggest me have a MRI and it administered a little problem in my neck. Reporter seriousness for I also had that shot and Its inspires a little nerve problem in my neck and this is little problem in my neck, They have called pinched nerve: Unspecified. Investigation Assessment: Yes. The patient underwent lab tests and procedures which included magnetic resonance imaging on 05May2021: unknown. The outcome of pain neck , nerve problem in neck as a result of getting the first covid-19 vaccination shot; nerve in my neck is causing the problem, they have called pinched nerve, also had that shot and it's inspires a little nerve problem in my neck was unknown. Follow-up (27May2021): New information received from contactable consumer(patient himself) which included: Concomitant medication, Investigation and Date of Vaccine: It was the 3rd March, the 03Mar2021, 21 day of the 3rd March 2021 of this year (date is not further clarify, Hence not captured in tab). No follow-up attempts are needed. No further information is expected.
59 2021-06-02 pain in extremity Received vaccine on 3/26/21 by 3/27/21 in the afternoon, arm became real sore. On 3/28/21 started ... Read more
Received vaccine on 3/26/21 by 3/27/21 in the afternoon, arm became real sore. On 3/28/21 started running a 102 temp with body aches, by 3/29/21 whole arm was sore and that night moved into the chest area. In the middle of the night pain was unbearable and took him to hospital where we were told he was having a heart attack. Transferred him by ambulance to Regional hospital.
59 2021-06-08 feeling hot, electric shock sensation Starting on the day of the vaccine (2nd dose)- I felt "a warm, chemical and electrical sensation" in... Read more
Starting on the day of the vaccine (2nd dose)- I felt "a warm, chemical and electrical sensation" in my chest a few hours after the vaccine. The next morning, I was unable to have a bowel movement, when usually I am very regular. I was not able to have a bowel movement for a couple of days. I felt very constipated and would try to force myself to have a bowel movement. I ate more fiber and fiber pills and drink more water, which was uneffective. I was finally able to have a bowel movement but it took a lot of force and would push the point of exhaustion and almost passing out. On 2/19/2021, I decided to seek medical care for my constipation, stomach cramps, fatigue, difficulty concentrating and shortness of breath. The doctor diagnosed me with Covid long hauler (I had a previous covid infection in 11/2020). I was prescribe probotics (for constipation) and rest for 2 months. I am still feeling fatigue and having heart palpitations. They order ECG(normal) and blood work (normal).
59 2021-06-09 migraine blood pressure was elevated; a migraine like headache; persistent severe headache; This is a spontan... Read more
blood pressure was elevated; a migraine like headache; persistent severe headache; This is a spontaneous report from a contactable consumer (patient's wife). A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 20Apr2021 (Lot number and Expiry date was not reported) as 2nd dose, single dose for COVID-19 immunisation. Medical history included ongoing body mass index increased. The patient's concomitant medications were not reported. The patient received first dose of vaccine on an unspecified date for COVID-19 immunisation. History included he does not really take anything. He has had some injuries lately but that is not a medical condition. On 20Apr2021 the patient experienced a migraine like headache, on an unspecified date the patient experienced blood pressure was elevated. He has had a persistent severe headache which sometimes feels like a migraine since receiving the vaccine. She was concerned because his MD has never heard of a headache lasting this long (approximately 3 weeks) after the vaccine. She wants to know if this has been reported before. The migraine like headache from what caller's husband said was it started in the evening. He had the vaccine in the morning, but caller was a little fuzzy on that because they did not go together. By evening, he had a dull headache that got worse. He has headache ever since. He went to the doctors a week ago and they checked his blood pressure and did all kinds of things. They did say they thought there was a chance it was the vaccine even thought they had not heard of it lasting that long. This week, yesterday, they took him to the ER to get an evaluation and it just will not stop. The family doctor did full blood workup and everything was in normal ranges. They took his sugar and protein that tells you hydration. His blood pressure was elevated. When he went to the ER, caller things they repeated the screenings. They did carbon monoxide testing, CAT Scan, and Chest x-ray. Everything came out good or, well, it was negative. They want him to see a neurologist. They hooked him up to an IV and they tried to relieve the pain with a headache cocktail and it did not take the edge off of it. So, they are a little baffled by that. Caller does not know specific dates, times, or results. Caller states she does not know what the medications were, maybe it was Toradol was one thing she heard, and they also gave him Benadryl with it. They said it was something they give to people with migraines and it takes it out and helps them sleep. He usually does not take anything but she got him to try allergy medicine, a couple days of Excedrin, and a couple of days of other things. None of them seem to work. He told the ER and they said if it does not work, do not take it. Also, he took Aleve a couple of days. Caller does not have any of this information as she is at work, and she states she did buy all of them. He tried name brand Aleve, Allegra for about 3 days, generic Excedrin which she thinks was Ibuprofen, and Tylenol. Caller confirms her husband was not admitted to the hospital, they sent him home with a referral to follow up with neuro and not the family doctor, and to come back if it gets worse. Today he was supposed to call them. Caller's husband was at the ER yesterday, 09May2021. A CAT Scan showed no mass or anything. They gave him several different things to relieve the headache and nothing worked. The outcome of the events was unknown. Information on the lot/batch number has been requested.
59 2021-06-09 muscle twitching TWITCHING OF NERVE BELOW OUTER CORNER OF LEFT EYE
59 2021-06-09 tingling, numbness and pain in extremities Left ulnar neuropathy. Tingling in fingers and fatigue in arm. Soreness at injection site. Has no... Read more
Left ulnar neuropathy. Tingling in fingers and fatigue in arm. Soreness at injection site. Has not subsided.
59 2021-06-09 tremor, tingling, seizure about 2 weeks after 2nd injection, have had 3 episodes of left arm and hand (stroke affected), tingl... Read more
about 2 weeks after 2nd injection, have had 3 episodes of left arm and hand (stroke affected), tingling, then hand seemed to shake progressing to arm violently shaking for a few minutes, conscious each time, but seemed like a dream, wet the bed unknowingly until waking up and feeling nauseous. The third time 05/30/2021, went by ambulance to emergency room and told they were seizures. was prescribed Levetiracetam 500mg. No seizures so far. Followed up today 06/10/2021 with primary care physician. Have July 21,2021 follow up appointment with neurologist *The reason I am reporting is because of my primary care physicians response to a comment I made to him about my sister thinking it could be the covid vaccine, while I thought perhaps it might be mini strokes, and he said it wasn't known that it might not be the vaccine. They told me in the hospital that the mri didn't show any more stroke damage than what had occurred from the initial stroke I had earlier.
59 2021-06-10 weakness E87.1 - Hypo-osmolality and hyponatremia J18.9 - Pneumonia of both lungs due to infectious organism,... Read more
E87.1 - Hypo-osmolality and hyponatremia J18.9 - Pneumonia of both lungs due to infectious organism, unspecified part of lung WEAKNESS - GENERALIZED HEADACHE multiple hospital admissions
59 2021-06-12 mild one side paralysis Gout flare up. Got medication. Still hurts. 5/23/21 stroke like symptoms in the morning. 5/30 more s... Read more
Gout flare up. Got medication. Still hurts. 5/23/21 stroke like symptoms in the morning. 5/30 more stroke like symptoms in the morning. After a week I felt better.
59 2021-06-14 restless legs syndrome Carditis, vertigo, dizziness, shortness of breath, extreme fatigue, restless leg syndrome
59 2021-06-15 burning sensation Left arm has a burning sensation; Lack of appetite and everything taste like metal; Lack of appetite... Read more
Left arm has a burning sensation; Lack of appetite and everything taste like metal; Lack of appetite and everything taste like metal; This is a spontaneous report from a contactable consumer (patient). A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13Mar2021 10:30 (Batch/Lot number was not reported) (at the age of 59 years) as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history included allergies: Penicillin, sulfa, some miacines. The patient's concomitant medications were not reported Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. There were no other vaccine in four weeks. The patient experienced left arm has a burning sensation, lack of appetite and everything taste like metal, all on 13Mar2021 11:00, all with outcome of not recovered. Events resulted in Doctor or other healthcare professional office/clinic visit. There were no treatments received for the events. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
59 2021-06-15 tremor bad chills; shaking; Fatigue for 2 days; higher than normal sleeping heart rate; higher blood pressu... Read more
bad chills; shaking; Fatigue for 2 days; higher than normal sleeping heart rate; higher blood pressure; workouts much more difficult.; This is a spontaneous report from a contactable consumer (patient). This 59-year-old male consumer reported that received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), into the left arm on 03Feb2021 at 14:00 (at the age of 59-years-old) at single dose for COVID-19 immunization. No other medications in two weeks. Medical history included high blood pressure. After receiving the second shot, bad chills and shaking that night. Fatigue for 2 days. For the next month, higher than normal sleeping heart rate, higher blood pressure, workouts much more difficult. No treatment received. Outcome was Recovering. No Covid prior vaccination and no Covid tested post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
59 2021-06-23 bell's palsy right side Bells Palsy onseto five (5) months post injection
59 2021-06-23 brain damage Syncope; Psychosis; Encephalopathy; This is a spontaneous report from a contactable physician. A 59-... Read more
Syncope; Psychosis; Encephalopathy; This is a spontaneous report from a contactable physician. A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in arm left on 18May2021 12:00 at the age of 59-years-old (Batch/Lot Number: EW0176) as single dose for COVID-19 immunization. Relevant medical history and concurrent conditions included hypertension (HTN), overactive bladder, benign prostatic hyperplasia (BPH). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered on 22Apr2021 at the age of 59-years-old (Batch/Lot Number: ew0164) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included amlodipine, lisinopril, oxybutynin, tamsulosin, hydroxyzine. The patient experienced syncope, psychosis/encephalopathy within 2 hours at 18May2021 14:00. Duration of hospitalization was 2. AE treatment included antipsychotics. The patient underwent lab tests and procedures which included Nasal Swab: negative on 20May2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of events was not recovered.; Sender's Comments: Based on temporal association, a causal association between the reported events and BNT162B2 cannot be fully excluded. Case will be reassessed when additional information is 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 RAs, Ethics Committees, and investigators, as appropriate.
59 2021-06-24 flushing My face and hands flushed red for about 45 minutes about 30 minutes after the injection.; This is a ... Read more
My face and hands flushed red for about 45 minutes about 30 minutes after the injection.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER2613) via unspecified route of administration on 18Mar2021 (at the age of 59-years-old) at 1000 (at the age of 59-years-old), as a single dose for COVID-19 immunisation. The patient medical history included myasthenia Gravis, Barret's, benign prostate hyperplasia (BHP), asthma, degenerative disc disease. The patient was allergic to actifed, biaxin, IVP dye(contrast), morphine, cologne/perfume. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received unspecified other medications within 2 weeks of vaccination. Prior to vaccination, the patient had not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. On 18Mar2021 at 1245, the patient experienced face and hands flushed red for about 45 minutes (also reported as about 30 minutes after the injection). No therapeutic measures were taken as a result of face and hands flushed red. The clinical outcome of the event face and hands flushed red was recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
59 2021-06-25 seizure Pt received dose #2 of Pfizer-BioNTech COVID-19 vaccine on 6/26/2021. Pt had a witnessed seizure at ... Read more
Pt received dose #2 of Pfizer-BioNTech COVID-19 vaccine on 6/26/2021. Pt had a witnessed seizure at home shortly therafter. No history of seizures in the past. Pt admitted to the hospital and later noted to be febrile to 102.5 degrees F. Currently undergoing work-up for infection.
59 2021-06-29 pain in extremity Almost immediate soreness in right arm extending up shoulder and along right side of neck. Soreness... Read more
Almost immediate soreness in right arm extending up shoulder and along right side of neck. Soreness in arm subsided after a few days. However, pain in right side of neck is still present after over 2 months, and is not alleviated by ibuprofen or acetaminophen.
59 2021-06-29 pain in extremity The morning after the vaccine, sudden onset of severe left-side chest pains, left arm, and back. Per... Read more
The morning after the vaccine, sudden onset of severe left-side chest pains, left arm, and back. Persisted till the next day but gradually got better. No pain after 3rd day.; sudden onset of severe left-side chest pains, left arm,; severe left-side chest pains, left arm, and back.; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6202) via an unspecified route of administration (age at vaccination 59-year) in Right Arm on 05Mar2021 15:00 as dose 1, single for COVID-19 immunization. Medical history included Stroke history; early Alzheimers and Diverticulosis from an unknown date and unknown if ongoing. Concomitant medications included Atorvastatin (ATORVASTATIN); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); Gabapentin (GABAPENTIN); famotidine (PEPCID AC) and Tamsulosin (TAMSULOSIN) taken for an unspecified indication, start and stop date were not reported. The patient was having no known allergies. The patient was not tested COVID prior and post vaccination. It was reported that the patient did not received any other vaccine in four weeks. Facility type vaccine was school or student health clinic. On 06Mar2021 08:30 AM in the morning after the vaccine the patient experienced sudden onset of severe left-side chest pains, left arm, and back. persisted till the next day but gradually got better. no pain after 3rd day. The seriousness of the events was serious (medically significant) and AE resulted in visit emergency room/department or urgent care. Therapeutic measures were taken as a result of the adverse events; AE treatment included: Nitroglycerin, 4 aspirin, lab tests, EKG, X-ray. The clinical outcome of the events was recovered on an unspecified date of Mar2021 No follow-up attempts are possible. No further information is expected.
59 2021-07-02 tremor tiredness; headache; muscle pain; chills; un-controlled shaking; fever; nausea; loss of balance; rin... Read more
tiredness; headache; muscle pain; chills; un-controlled shaking; fever; nausea; loss of balance; ringing in the ears; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received first dose of BNT162B2 (PFIZER- BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered on Arm Left on 24Mar2021 08:15 as dose 1, single for COVID-19 immunization at hospital. Medical history included prostate cancer. The patient had no known allergies to medications, food, or other products. Concomitant medications included Escitalopram at 10 mg; Pantoprazole 40 mg; Metoprolol Tartrate; all are received within four weeks of vaccination. The patient did not receive any other vaccines within four weeks. On 24Mar2021 19:30, the patient experienced tiredness, headache, muscle pain, chills, un-controlled shaking, fever (102 degrees), nausea, loss of balance and ringing in the ears. The patient did not have Covid prior vaccination and was not tested for Covid post vaccination. No treatment was received for the events. The outcome of events was recovered in Mar2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
59 2021-07-05 pain in extremity The onset began approximately on 05/01/2021, I went to the podiatrist and she diagnosed me with burs... Read more
The onset began approximately on 05/01/2021, I went to the podiatrist and she diagnosed me with bursitis. I was having heel pain. I never had this particular pain prior to the vaccination. I'm receiving physical therapy and my adverse events are getting better.
59 2021-07-06 discomfort Chills, headache and fatigue lasted about 12 hours. Heart racing, feeling of heart pounding, not bei... Read more
Chills, headache and fatigue lasted about 12 hours. Heart racing, feeling of heart pounding, not being able to relax and extreme fatigue started on 3rd day after vaccine and lasted about 2-3 weeks.
59 2021-07-06 pain in extremity 1. Woke with a painful knot midway between my naval and groin area. Initially the knot was about the... Read more
1. Woke with a painful knot midway between my naval and groin area. Initially the knot was about the size of a nickel, but eventually grew much larger over the next few days. 1. Woke up with right outer calf pain that eventually migrated upward to the outer right hip.
59 2021-07-06 tingling Patient had sudden onset of L foot parasthesias 2-3 wks after 2nd COVID vaccine. Over the next 5 mo... Read more
Patient had sudden onset of L foot parasthesias 2-3 wks after 2nd COVID vaccine. Over the next 5 months, parasthesias rapidly progressed from intermitent to continuous and spread to all four extremtities in a stocking/glove pattern. Work-up by neurology and rheumatology specialists including labs, EMGs, MRIs, and skin biopsies led to a presumed diagnosis of immune mediated small fiber sensory polyneuropathy. Etiologies including DM, hypothyroidism, malignancies, B12 deficiency and toxins were ruled out. Patient had minimal response to steroids, but a positive clinical response to IVIG. Symptoms have stabilized, but not resolved. Local VAERS contact, has full record access.
59 2021-07-07 pain in extremity "Member has been having pain in hands and knees for one week following recent COVID vaccination. Has... Read more
"Member has been having pain in hands and knees for one week following recent COVID vaccination. Has history of gout and is still having this in his hands and knees. Feels this pain when he gets up in the morning. Indomethacin has helped a little bit, but not like normal. Noted some swelling hands and left knee. No shortness of breath or chest pain. Every other joint is fine. PE: normal insight and thought content. Normal work of breathing and speaking in full sentences. No aphasia noted.
59 2021-07-08 pain in extremity, muscle twitching, tingling Within a couple hours of the vaccine, in addition to expected arm soreness, I felt tingling up and d... Read more
Within a couple hours of the vaccine, in addition to expected arm soreness, I felt tingling up and down arm, then odd feeling throughout my body and head by the afternoon (just very odd, not pain). I did not have any cold fever or flu-like symptoms. But, within the next day or two, more concerning symptoms appeared: I felt, for lack of a better way to describe it, very "twitchy" from my chest, like a flutter. I've felt restless and fatigued at the same time nearly all the time, like excess energy and exhaustion both at once. I feel an uncomfortable feeling, like irregular heartbeat or arrhythmia in chest especially at night lying down, which as been interfering with sleep. I have felt the restlessness and fatigue off and on night and day, interfering with focus and work. This has gone on for over two months now since the first vaccine dose. My overall health and how I felt were excellent the day prior to the vaccine. There is definitely something off with my metabolism, in particular my cardiovascular and aerobic function, since the vaccine that has not yet resolved itself. I can still exercise and feel better by doing so, but, it always feels at a lower performance level than before the vaccine. The feeling in my chest, like a harder heartbeat than normal, and sometimes what fits some of the symptoms of congestive heart failure or possibly myocarditis, is most concerning. I experience some periods where it feels like almost a wheezing in the back of my throat when I breathe. This was persistent for awhile and now seems to be more off and on, becoming less often. I am slender, exercise regularly and eat fairly healthy, am fit, and have never had any major health problems. There definitely seems some kind of cardiovascular, aerobic and/or respiratory effect from the vaccine.
59 2021-07-08 pain in extremity My arm is sore; my arm was sore, it is still sore; I wasn't feeling right, my breath was not right/s... Read more
My arm is sore; my arm was sore, it is still sore; I wasn't feeling right, my breath was not right/shortness of breath; Chills; I wasn't feeling right, my breath was not right; temperature was 101; This is a spontaneous report from a contactable Consumer (patient). A 59-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6208) via an unspecified route of administration in left arm on 11Mar2021 as single dose for covid-19 immunization. The medical history included acid reflux. The concomitant medication included Pantoprazole taken for acid reflux (40 mg, Once every other day for acid reflux) and Patient had been taking it from past 3 years. In Mar2021, the patient experienced that his arm was sore and it was still sore, patient wasn't feeling right, his breath was not right, shortness of breath, don't feel good, went to the bathroom a lot and chills. Patient further explained his arm was just a little sore other stuff went away. It was also reported, that was all until last Monday, after Monday I still have sore arm, my arm is still sore but I don't have shortness of breath anymore. patient is supposed to go back on the 2nd of Apr for his shot. Patient reported that he took some Tylenol and NyQuil for the chills and all. The patient underwent lab test of blood test and diabetes check-up and temperature was 101, SWAB test and it was positive 22Feb2021. The outcome of the event arm was sore was not recovered, wasn't feeling right, breath was not right, chills was recovered. No follow-up attempt are needed. No further information expected.
59 2021-07-08 tingling, burning sensation Tingling sensation on the left lower leg; Burning sensation on the left lower leg; This is a spontan... Read more
Tingling sensation on the left lower leg; Burning sensation on the left lower leg; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration on 22Mar2021 at 14:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none also the patient did not have any allergies to medications, food, or other products. Concomitant medications included vitamin (MANUFACTURER UNKNOWN) one a day from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 01:30, the patient experienced intermittent tingling and burning sensation on the left lower leg (outside of calf). The patient stated that it started approximately 36 hours after the shot. The tingling was intense enough to wake him up from sleep. This lasted about 36 hours. The tingling frequency and intensity slowly decreased over the 36 hour time period. 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 adverse events. The clinical outcome of the events tingling and burning sensation on the left lower leg were resolving at the time of the report. No follow-up attempts are needed. No further information is expected.
59 2021-07-08 tingling tingling/slight numbness on tongue and roof of inside of mouth; tingling/slight numbness on tongue a... Read more
tingling/slight numbness on tongue and roof of inside of mouth; tingling/slight numbness on tongue and roof of inside of mouth; This is a spontaneous report from a contactable other healthcare professional (patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was EN6205 and expiration date was not reported), dose 1 via intramuscular route on 04Mar2021 at 10:45 (at the age of 59-year-old) as dose 1, single for COVID-19 immunisation. Medical history included allergies. Concomitant medications (other medications in two weeks) included rosuvastatin calcium (CRESTOR) and acetylsalicylic acid (BABY ASPIRIN); loratadine (CLARITIN) and fluticasone propionate (FLONASE), both taken for allergies; Airborne Imun system suppl, and Multi Vitamin Suppl. The patient previously took Shringx dose 1 on 04Feb2021 (other vaccine in four weeks) for unspecified indication. The patient did not have COVID prior vaccination and was not COVID tested post vaccination. On 04Mar2021 at 17:00, the patient experienced tingling/slight numbness on tongue and roof of inside of mouth. The clinical course of the event was reported as: tingling/slight numbness on tongue and roof of inside of mouth; symptoms started approximately 7hours after getting Pfizer COVID vaccine for 1st dose. Then gradually decreased into next day with slight symptoms still present 30hours after 1st dose. The patient did not lose taste. He inquired had anyone else reported this symptom and was this something he should be concerned about. The patient did not receive treatment for reported events. The outcome of the events was resolving. No follow-up attempts are possible. No further information is expected.
59 2021-07-10 tingling, numbness, pain in extremity Sore neck; Tingling around my mouth, the right side of my mouth; Tingling around the right side of m... Read more
Sore neck; Tingling around my mouth, the right side of my mouth; Tingling around the right side of my face; Numbness; my right arm is sore; My whole right side is sore; Headache; This is a spontaneous report from a contactable consumer (patient). A 59-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0177), via an unspecified route on 29May2021 (at the age of 59-years) as dose 1, single in the right arm for covid-19 immunization.The patient medical history included fibromyalgia, blood pressure, cholesterol. The patient concomitant medications included atorvastatin calcium (ATORVASTATIN [ATORVASTATIN CALCIUM]) 40 mg for Cholesterol, one tablet every day at bed time, lisinopril (LISINOPRIL) 10 mg, one tablet every day for blood pressure and acetylsalicylic acid (ASPIRIN) for unspecified indication from an unknown date and unknown if ongoing. When needed. I occasionally take low dose Aspirin but that's it.The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Jun2021, the patient experienced tingling around the right side of his face, numbness, right arm was sore, whole right side was sore, headache, on 30Jun2021 the patient had sore neck, tingling around my mouth, the right side of my mouth. Patient stated that he had both COVID shots and his primary physician feels that he might have had side effects due to that COVID shot. He had been taking some Aspirin, since he had the side effects he had been taking another medicines. He stated the diagnosis date of Fibromyalgia had been since many years ago. Patient took Gabapentin 100 mg (Intent: treatment) for tingling in the right side of my face just got a week ago. Consumer stated he had the side effect with the COVID shot. The patient had both COVID shots and my primary physician feels that I might have had side effects due to that COVID shot. When probed for the side effects, consumer stated, Tingling around the right side of my face, numbness, my right arm is sore and my whole right side is sore and also a headache and sore neck, tingling around my mouth, the right side of my mouth. Consumer stated, There was no expiration# date but I took the first one 29May2021 and the second one 24Jun2021. Consumer stated, Well I have been taking some Aspirin but that's it but also I have been (incomplete sentence), since I have the side effects I have been taking another medicines, would you like them? When again probed for the diagnosis date of Fibromyalgia, consumer stated, "Oh! It's been many years ago. Consumer stated, "The first one is Atorvastatin 40 mg for Cholesterol, one tablet every day at bed time. The next one Lisinopril 10 mg, one tablet every day for blood pressure.(Further clarification was unknown, hence not captured in tab). When probed if consumer had Cholesterol and blood pressure as well, consumer stated, "That was given to me after the first side effect, after the side effect on 14th (Further clarification was unknown if consumer was experiencing Cholesterol and blood pressure after the vaccination, hence not in captured in tab) and then I am taking one as well called Gabapentin 100 mg (Intent: treatment) and that was given to me a week ago.Indication of Gabapentin: Consumer stated, For my tingling in the right side of my face.When probed if consumer started taking these medications (Atorvastatin, Lisinopril, Gabapentin) after the vaccine, consumer stated, The first two were (incomplete sentence) yeah (Further clarification was unknown). Gabapentin I just got a weak ago.The patient underwent lab tests and procedures which included computerised tomogram: negative on 27Jun2021, magnetic resonance imaging: negative on 23Jun2021, x-ray: unknown on 27Jun2021.Therapeutic measures were taken as a result of tingling around the right side of my face (paraesthesia). The patient received Gabapentin 100 mg (Intent: treatment) and that was given tothe patient a week ago.The outcome of the events was unknown.
59 2021-07-11 burning sensation, numbness Feet and calf swelling. nerves on top of feet burn and numb.
59 2021-07-11 mild one side paralysis Left side arm and leg weakness, fatigue, weight loss,
59 2021-07-12 pain in extremity, electric shock sensation, tingling He had electrical shocks throughout his body; experience a prickly/tingling feeling in his arms and ... Read more
He had electrical shocks throughout his body; experience a prickly/tingling feeling in his arms and upper torso/the sensation migrate to his whole upper body where he felt paresthesia; sore arm; his vision was interrupted where he could see grey like on a TV screen when you do not have a channel - grey static - and it kept happening; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jun2021 at single dose in left arm for COVID-19 immunisation at the age of 59-year-old. Lot number was EW0191. Medical history and concomitant medications were none. The patient received vaccine dose on 06Jun2021 in the left arm. Later that day he started to experience a prickly/ tingling feeling in his arms and upper torso. It varied in intensity and has continued since receiving the vaccine. Patient received his first shot back on 06Jun2021 and afterward he had the typical sore arm and then it kind of migrated into paresthesia, like a prickly, tingly feeling in his arm. It lasted for a couple of weeks and was varying in intensity. On 24Jun2021, the sensation migrated to his whole upper body where he felt paresthesia in his upper torso. When, it was never a certain movement, but when he moved at all he would receive an electrical shock throughout his whole body in Jun2021. It was not that he was under paralysis, but his vision was interrupted where he could see grey like on a TV screen when you do not have a channel, grey static and it kept happening in Jun2021. The tingling had radiated in his arm throughout his body and he knew it had to do with the shot. This was new, nothing he had experienced before. Vision loss was considered medically significant. He had electrical shocks throughout his body and it would happen several times, dozens of times throughout the day and it happened just say 30 times, then the next day 15 times, then probably 10 times. Now he was just still with paresthesia throughout his upper body and a tingling feeling. The patient was not treated for the events. The outcome of the events was unknown.
59 2021-07-13 tingling, numbness Pt developed tingling in toes and fingers that have progressed to numbness and climbed up extremitie... Read more
Pt developed tingling in toes and fingers that have progressed to numbness and climbed up extremities to now include above the wrist down, and patient is now unable to ambulate. Progression has been over three days. Providers have diagnosed Guillain-Barre. Patient received Pfizer Covid vaccine on 5/6/21 and 5/27/21. Additionally, patient has underwent lumbar laminectomy in June 2021. Pt also complained of trouble swallowing and headache on admission. Pt received first dose of IVIG last night, is due to receive second dose tonight. Pt was transferred to ICU level of care over night. He is currently still admitted, there is discussion of transfer to another hospital with higher level neurology services at this time. If he remains stable he will stay here.
59 2021-07-17 electric shock sensation, tingling, pain in extremity experienced a shocking sensation throughout my entire body, like a jolt of electricity, only happene... Read more
experienced a shocking sensation throughout my entire body, like a jolt of electricity, only happened sporadically when I moved; My vision would gray-out (like static on an untuned TV channel) for a second; Typical soreness in left arm for 3 days; light tingling/prickly sensation in left arm/tingling/prickly sensation spread to upper torso and right arm; disassociated feeling from my left arm; This is a spontaneous report from a contactable consumer (patient) reporting for himself. A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0191), via an unspecified route of administration, administered in Arm Left on 06Jun2021 12:15 as dose 1, single for COVID-19 immunization in a Pharmacy or Drug Store. Medical history included arteriosclerosis from an unknown date. No known allergies. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)); atorvastatin; sotalol; and ezetimibe all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No prior COVID vaccination. Not diagnosed with COVID-19 prior to vaccination. Not tested for COVID-19 post vaccination. On 24Jun2021 16:00, the patient experienced typical soreness in left arm for 3 days, then continued light tingling/prickly sensation in left arm and spread to upper torso and right arm, disassociated feeling from my left arm, experienced a shocking sensation through-out my entire body, like a jolt of electricity which only happened sporadically when I moved and didn't happen due to repetitive movements, vision would gray out (like static on an untuned TV channel) for a second. 4 days later, the shocks have subsided and so has the tingling/prickly feeling, but they still are present. No treatment was given for the events. The reporter considered the events as non-serious and did not result in death or life threatening condition, caused/prolonged hospitalization, disabling/incapacitating, nor congenital anomaly/birth defect. The outcome of the events was not recovered at the time of report. Follow-up attempts are completed. No further information is expected.
59 2021-07-17 numbness can't lift his arm; feeling a lot of numbness; This is a spontaneous report from a contactable consu... Read more
can't lift his arm; feeling a lot of numbness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in arm right on 07Jul2021 (Lot Number: FA6780) as a single dose at the age of 59-year-old for covid-19 immunisation. Medical history included hypertension (diagnosed a million years ago). The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route on 03Jun2021 (Lot Number: EV0179 or EVI079) as a single dose at the age of 59-year-old for covid-19 immunisation. The patient's concomitant medications were not reported. The patient feeling a numbness started a few hours after the shot and unable to lift his arm started on 07Jul2021 night. The outcome of the events was not recovered. No follow-up attempts are possible; No further information is expected.
59 2021-07-17 pain in extremity fever; headache feels like a migraine; light-headed/dizzy; pain continues and left arm; nausea at ti... Read more
fever; headache feels like a migraine; light-headed/dizzy; pain continues and left arm; nausea at times; lack of desire to eat at times; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration in the left arm on 19Mar2021 at 10:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included ascorbic acid (VITAMIN C) and Prednisone (MANUFACTURER UNKNOWN) and Silver (COLLOIDAL SILVER) for unknown indication from unknown date. The patient was allergic to codeine. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 21Mar2021 at 15:00 patient experienced fever, Day 5 still fever most days over 100, headache feels like a migraine, light-headed and dizzy, pain continued and left arm, lack of desire to eat at times. It was reported he missed work for 2 days and unable to drive due to headache and light-headedness. Treatment was taken for the reported events and included ibuprofen for fever and meclizine for dizzy. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events fever, headache, dizzy, pain in arm, nausea and appetite lost was not recovered. No follow-up attempts possible. No further information expected.
59 2021-07-17 pain in extremity medications included allopurinol (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), latano... Read more
medications included allopurinol (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), latanoprost (MANUFACTURER UNKNOWN), esomeprazole (MANUFACTURER UNKNOWN), all for unknown indication received within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient received vaccine about 8 weeks after being exposed to COVID and about 4 weeks after recovery, on 22Mar2021 at 14:00, the patient experienced sore arm, fatigue, aches, chills, fever, mild nausea and loss of appetite for 2 days - began about 18 hours after injection, the events were worst about 24-30 hours after, later the events continued to be moderate for about 48 hours, finally recovered after 72 hours. The patient did not receive treatment for the reported events. The 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 sore arm, fatigue, aches, chills, fever, mild nausea and loss of appetite was recovered on 25Mar2021. Information about lot/batch number cannot be obtained. No further information is expected.
59 2021-07-17 tingling Having muscle and I would say joint pain; Having muscle and I would say joint pain; Numbness continu... Read more
Having muscle and I would say joint pain; Having muscle and I would say joint pain; Numbness continue in my right arm where I received the vaccine; Tingling in my upper arm and it still continues; They are still there and actually worsening; I started feeling the pain and the numbness and tingling in my upper arm; This is a spontaneous report from a contactable consumer (patient reported for himself). A 59-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0164), via intramuscular route of administration, administered in deltoid right (right shoulder) on 22Apr2021 at 12:30 PM (at the age of 59-year-old) as dose 2, single for COVID-19 immunization. Medical history included disability (patient stated, well I am on disability. I am disabled). The patient's concomitant medications were not reported. the patient did not receive any other vaccine 4 weeks prior to COVID shot. The patient previously took gabapentin and neurontin, both drugs for disability; first dose of bnt162b2 for COVID-19 immunization. The patient experienced having muscle and I would say joint pain, numbness continue in my right arm where I received the vaccine, I started feeling the pain and the numbness and tingling in my upper arm was reported as worsened, they are still there and actually worsening on an unspecified date in 2021. Patient stated, I was calling because I received the vaccine in May and I am still having muscle and I would say joint pain and numbness continue in my right arm where I received the vaccine. I am calling, its about 2 months 3 months now should those effects be feeling. When probed whether these adverse events took place after the first Pfizer COVID shot or Second. Patient stated, Second. When probed for the exact date for the onset of adverse events, Patient stated, Well I had the second dose on 22Apr2021. I would say two weeks later I started feeling. The day I had the injection I felt it. It was two days then it kind of went away but then like almost I would say 7 days later I started feeling the pain and the numbness and tingling in my upper arm and it still continues. Date and time for second COVID shot: Patient stated, 22Apr2021 (22Apri2021). I would say 12:30 pm. Patient stated, they are still there and actually worsening. I feel like its worsening because its happening more. (confirmed as worsening). The patient did not receive any treatment for the events. Outcome of the events was not recovered.
59 2021-07-17 restless legs syndrome Restless legs; Headache; Fatigue; Injection site pain; Muscle pain; Chills; Fever 100.6; Joint pain;... Read more
Restless legs; Headache; Fatigue; Injection site pain; Muscle pain; Chills; Fever 100.6; Joint pain; Malaise; This is a spontaneous report from a contactable healthcare professional, the patient. A 59-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot no: ER8727) via an unspecified route of administration in the left arm on 24Mar2021 at 15:30 (at the age of 59-years-old), as a single dose for COVID-19 immunisation. No medical history was reported. The patient did not take any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not report any known allergies to medications, food, or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in the left arm on 05Mar2021 at 13:30 (at the age of 59-years-old), 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 24Mar2021 at 22:15, the patient experienced headache, fatigue, injection site pain, muscle pain, chills, fever 100.6, joint pain, malaise and restless legs. The patient received treatment for event fever 100.6 with acetaminophen(TYLENOL). It was reported that the events had not resulted in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. The clinical outcomes of events headache, fatigue, injection site pain, muscle pain, chills, fever 100.6, joint pain, malaise and restless legs were resolving at the time of the report. No follow-up attempts possible. No further information expected.
59 2021-07-18 pain in extremity Extreme Joint pain in hands, wrists, shoulders, thumbs and elbows.
59 2021-07-20 migraine Vision loss; Severe Vertigo; Headaches; insomnia; High blood pressure; Tinnitis; Sleep issues; Anxie... Read more
Vision loss; Severe Vertigo; Headaches; insomnia; High blood pressure; Tinnitis; Sleep issues; Anxiety; Absolutely feel horrible/Had not feel himself in 90 days; Possible diagnosis of post vaccine psychosis.; Migraine; This is a spontaneous report from a contactable consumer (patient). A 59-years-old male patient received bnt162b2 (BNT162B2) at the age of 59-years-old, dose 2 via an unspecified route of administration, administered in Arm Left on 08Apr2021 15:30 (Batch/Lot Number: ew0162) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The COVID-19 vaccine was administered in Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The medications the patient received within 2 weeks of vaccination included Trilogy, Flownase Sensimist. Historical Vaccine included BNT162B2 for COVID-19 immunization on 18Mar2021 at the age of 59-year-old (dose 1, product=COVID 19, brand=Pfizer, lot number=ER2613, administration time=16:30, vaccine location=Left arm). The patient experienced vision loss, severe vertigo, headaches, insomnia, high blood pressure, tinnitis, sleep issues, anxiety, absolutely feel horrible, possible diagnosis of post vaccine psychosis on 11Apr2021 07:30, migraine in 2021, with outcome of not recovered. Detail information was as following reported Event: Severe Vertigo, headaches, insomnia, high blood pressure, vision loss, Tinnitis. Vertigo just about 3 days after 2 nd vaccine. Had not feel himself in 90 days. Still experiencing headaches, sleep issues, anxiety. Absolutely feel horrible. Blood pressure up significantly over historical levels. Being treated for high blood pressure, sleep, anxiety, headaches. Currently seeing a neurologist. Possible diagnosis of post vaccine psychosis. The report was reported as non-serious. The events resulted in Doctor or other healthcare professional office clinic visit Emergency room department or urgent care. Treatment received included Vertigo treatment, Migraine treatment, Ongoing. Since the vaccination, the patient has not been tested for COVID-19.
59 2021-07-26 seizure Patient walked up to the counter, said he was feeling dizzy, eyes were starting to roll back, He fel... Read more
Patient walked up to the counter, said he was feeling dizzy, eyes were starting to roll back, He fell forward, when he came to we got him a seat, then his eyes started rolling back and he started having what appeared to be a seizure, I went and grabbed a EpiPen, gave him the shot and he responded right away. He didn't know what happened. We called ems and they took over after about 5 minutes.
59 2021-07-27 weakness joint pain; feels like bursitis; became painful and weak; became painful and weak; This is a spontan... Read more
joint pain; feels like bursitis; became painful and weak; became painful and weak; This is a spontaneous report received from a contactable consumer or other non hcp via a Regulatory Authority. A 59-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: #R8727), dose 1 via an unspecified route of administration, administered in Arm Left on 08Apr2021 09:00 (at the age 97-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included fibromyalgia, glucose tolerance impaired, limb injury (Had a previous injury there decades ago) from an unknown date. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, has the patient been did not tested for COVID-19. The patient experienced joint pain, feels like bursitis, became painful and weak, became painful and weak on 10Apr2021. It was reported that "General joint pain and a few days later in left arm (shot arm) at deltoid feels like bursitis) became painful and weak. Had a previous injury there decades ago. After second shot overall joint pain increased and left arm got worse (second shot in right arm) Sacroiliac became very inflamed and painful (site of other old injury) Then right deltoid pain (feels like bursitis) Still battling mild to severe pain over a month after second shot. Some daily vertigo moments but dissipating". Outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
59 2021-07-27 pain in extremity, burning sensation Real throbbing burning pain; Little sore in left arm; Unable to move his right arm and reported pain... Read more
Real throbbing burning pain; Little sore in left arm; Unable to move his right arm and reported pain when he tries to lift it up; Unable to move his right arm and reported pain when he tries to lift it up; Real throbbing burning pain; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 59-years-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in Arm Left on 21Apr2021 (age at vaccination: 59-years-old) as single dose for covid-19 immunization. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (BNT162B2, PFIZER-BOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP6955) via an unspecified route of administration in left arm on 31Mar2021 for COVID-19 Immunization. It was reported that patient received both doses of the Pfizer covid vaccine. He was unable to move his right arm and reported pain when he tries to lift it up. He has had problems ever since the second dose on 21Apr2021. Upon date 20May2021 it was reported that patient had side effects He can't move his arm. He doesn't know who to talk to about it. It has been going on for 3 and a half weeks now and is not getting any better. His unemployment is about to run out. He doesn't know what to do. He can't pick his arm up. He works as a carpenter. Patient was keeps saying if his arm hurts it is usually okay and means the vaccine is working. Can't move his right arm: This happened about 3 or 4 days after the second shot. He got both shots in his left arm. He was a little sore in that area for a couple of days, then after 3 or 4 days his right arm started hurting and has been hurting since. He doesn't know if it might be a blood clot. He doesn't know what is going on, and he can't pick it up. His right arm was good until 3 or 4 days after the second shot. After the first shot he was fine. Then 3 or 4 days after the booster he couldn't move his right arm. It is like a throbbing pain when he tries to pick it up. If he just leaves it down it's fine, but when he tries to pick it up it's a real throbbing burning pain. It is about the same. Little sore in left arm: The soreness was when they stuck the needle, it was maybe 2 or 3 inches. It wasn't bad. His left arm is fine now. It lasted for a couple of days. The outcome for the event Unable to move his right arm and reported pain when he tries to lift it up (Joint range of motion decreased) was reported as not resolved and for remaining events outcome was reported as unknown at the time of this report. Follow-up attempts are needed. Further information is expected.
59 2021-07-28 pain in extremity Extreme fatigue, constipation, lower muscle pain down legs, severe pain in knees, difficult to climb... Read more
Extreme fatigue, constipation, lower muscle pain down legs, severe pain in knees, difficult to climb stairs. Out of work for 5-6 weeks. Went to primary care doctor and a cardiologist. Still experiencing severe fatigue
59 2021-07-29 numbness, tingling Providers have diagnosed Guillain-Barre; Pt developed tingling in toes and finger; progressed to num... Read more
Providers have diagnosed Guillain-Barre; Pt developed tingling in toes and finger; progressed to numbness and climbed up extremities to now include above the wrist down; patient is now unable to ambulate.; trouble swallowing; headache; This is a spontaneous report from a contactable pharmacist. A 60-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: EW0170), via intramuscular route of administration, administered on 06May2021 (at the age of 59-years-old) as SINGLE dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: unknown), via unspecified route of administration, administered on 27May2021(at the age of 59-years-old) for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, hyperlipidaemia from an unknown date and unknown if ongoing. Concomitant medication(s) included Amlodipine (Amlodipine) taken for an unspecified indication, start and stop date were not reported; Atorvastatin (Atorvastatin) taken for an unspecified indication, start and stop date were not reported; Benazepril (Benazepril) taken for an unspecified indication, start and stop date were not reported; Duloxetine (Duloxetine) taken for an unspecified indication, start and stop date were not reported; Omeprazole (Omeprazole) taken for an unspecified indication, start and stop date were not reported. the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19. Since the vaccination, it was unknown if the patient been tested for COVID-19.The patient experienced providers have diagnosed guillain-barre on 12Jul2021, pt developed tingling in toes and finger that have progressed to numbness and climbed up extremities to now include above the wrist down and patient is now unable to ambulate on 12Jul2021, Progression has been over three days. Patient also complained of trouble swallowing and headache on 12Jul2021, patient has underwent lumbar laminectomy on Jun2021. Therapeutic measures were taken with first dose of IVIG last night is due to receive second dose tonight as a result of providers have diagnosed guillain-barre, pt developed tingling in toes, progressed to numbness, patient is now unable to ambulate, trouble swallowing, headache, patient has underwent lumbar laminectomy. Pt was transferred to ICU level of care over night. He is currently still admitted, there is discussion of transfer to another hospital with higher level neurology services at this time. If he remains stable he will stay here. The outcome of events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events Guillain-Barre syndrome, Paraesthesia, Hypoaesthesia, Gait inability, Dysphagia and headache cannot be totally 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.