chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with no symptoms; Asymptomatic COVID-19; Eventually develop arrhythmia; valley fever; chills; night sweats for 1 and half week; rash looked like confetti; low grade temp; I had an irritation in my upper nose; Platelet count was found to be 90/platelet count dropped corrected with in one week; This is a spontaneous report from a contactable consumer, the patient   A 83-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration on 09Feb2021 (at the age of 83-years-old) as a single dose, for COVID-19 vaccination.  The patient medical history includes Atrial Fibrillation. Concomitant medication include Eliquis, Synthroid, Pravastatin, Diltiazem and Dofetilide  The patient experienced  arrhythmia,  valley fever, chills , night sweats, rash looked like confetti,  low grade temp, asymptomatic covid-19, had an irritation in my upper nose, platelet count was found to be 90/platelet count dropped corrected with in one week. The clinical course was reported as follows On '04Mar2020'   traveled and had an irritation in my upper nose which I later came to understand was caused my asymptomatic COVID-19. Was treated for valley fever with Antifungal med, Eventually developed arrhythmia. Sought treatment at Clinic. Initial diagnosis made at urgent care where platelet count was found to be 90 '1st week in April' 2020 also reported as an event. Treatment was give for Valley Fever. No Treatment was given for Asymptomatic COVID-19 and Platelet count was found to be 90. No hospitalization was involved  The patient underwent lab tests that included Platelet count drop/found to be 90 '1st week in April' ,  Sars-cov-2 test: tested positive on 'last week in March 2020' 'Tested positive for covid 19 in the first quarter of 2020' . The clinical outcome of the event Asymptomatic COVID-19, Drug ineffective, Arrhythmia, chills, night sweats, rash, fever, nasal discomfort were unknown, while Valley fever and Platelet count low was recovered. Consumer inquired if the vaccine might trigger another platelet drop. Did not seem to but second shot next Tuesday 02Mar2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Neuralgia, Neuropathy peripheral, Pyrexia
Clinical narrative: 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.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope
Clinical narrative: Fainted; lightheaded; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 23Feb2021 10:00 (lot number: EN6201) at the age of 77 years old, as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient previously took codeine and experienced allergies. The patient previously received first dose of bnt162b2 on 04Feb2021 for COVID-19 immunization (product: COVID 19, brand: Pfizer, lot number: EL9264, administration time: 09:45 AM, vaccine location: left arm). Next morning after vaccination (occurred on 24Feb2021 08:00), the patient felt lightheaded while bending over to empty dishwasher. The patient sat down on chair; and the patient's husband found the patient on floor, as she had fainted. The patient had no recall of fainting. No treatment was given for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination. The patient did not receive other vaccines four weeks prior to COVID vaccine. The patient recovered from the events on unspecified date.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Chillblains, Fatigue, Headache, Hypoaesthesia
Clinical narrative: severe biopsy proven perniosis of bilateral hands; headaches; fatigue; left sided facial numbness; This is a spontaneous report from a contactable physician. A 36-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), intramuscular on left arm on 16Dec2020 at single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient has no known allergies and was not pregnant. She was not diagnosed with COVID prior to vaccination and has no other vaccine in four weeks. The patient received her vaccine at a clinic. On 16Dec2020, the patient developed severe biopsy proven perniosis of bilateral hands, right after the vaccine which was still lasting. She also had headaches, fatigue for 2 weeks post vaccination (as reported) and left sided facial numbness for hours post vaccination. She had pain and swelling of the fingers which inhibits her from working as an nurse. She has been on disability leave from work. All lupus and other autoimmune work up have been negative. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/ department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with amlodipine, prednisone course, topical steroids and pentoxifylline. The patient underwent lab test and procedure which included nasal swab which was negative post vaccination on an unspecified date. The outcome of the events was not recovered. The events were assessed as serious causing disability or permanent damage.   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 perniosis of bilateral hands and other reported events  due to temporal relationship  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  There is 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.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, SARS-CoV-2 test
Clinical narrative: severe biopsy proven perniosis of bilateral hands; headaches; fatigue; left sided facial numbness; This is a spontaneous report from a contactable physician. A 36-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), intramuscular on left arm on 16Dec2020 at single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient has no known allergies and was not pregnant. She was not diagnosed with COVID prior to vaccination and has no other vaccine in four weeks. The patient received her vaccine at a clinic. On 16Dec2020, the patient developed severe biopsy proven perniosis of bilateral hands, right after the vaccine which was still lasting. She also had headaches, fatigue for 2 weeks post vaccination (as reported) and left sided facial numbness for hours post vaccination. She had pain and swelling of the fingers which inhibits her from working as an nurse. She has been on disability leave from work. All lupus and other autoimmune work up have been negative. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/ department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with amlodipine, prednisone course, topical steroids and pentoxifylline. The patient underwent lab test and procedure which included nasal swab which was negative post vaccination on an unspecified date. The outcome of the events was not recovered. The events were assessed as serious causing disability or permanent damage.   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 perniosis of bilateral hands and other reported events  due to temporal relationship  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  There is 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.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy left side of face; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202) at the age of 71-years-old, intramuscular on left arm on 28Feb2021 at 13:30 at single dose for COVID-19 immunization. Medical history included asthma, allergies, blood cholesterol abnormal (reported as cholesterol), and allergies to penicillin which were all ongoing. The patient was not pregnant. She has no COVID prior to vaccination and has no prior vaccination and other vaccines in four weeks. Ongoing concomitant medications included zileuton (ZYFLO CR) and budesonide, formoterol fumarate (SYMBICORT) for asthma; levocetirizine and azelastine hydrochloride, fluticasone propionate (DYMISTA) for allergies; immunoglobulin human normal (HIZENTRA); and atorvastatin (LIPITOR) for cholesterol. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264) at the age of 71-years-old, intramuscular on left arm on 02Feb2021 at 14:30 at single dose for COVID-19 immunization. The patient previously took aspirin and experienced allergy. The allergy was reported to be ongoing. The facility type where the vaccine was administered as reported to be other and mega-site. The patient experienced Bell's palsy left side of face on 01Mar2021 which required physician office visit. The patient was not tested for COVID post vaccination. Therapeutic measures were taken as a result of the event and included treatment with valacyclovir 1g, 3x/day. The outcome of the event was not recovered. The event was assessed as non-serious by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, SARS-CoV-2 test positive
Clinical narrative: Covid Pneumonia; covid virus/tested positive for the covid virus; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 15Feb2021 (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 received, 1st dose Pfizer covid vaccine 15Feb2021, and in between 1st and 2nd dose, she got covid virus. The patient tested positive for the covid virus on 22Feb2021, went to ER on that Friday, found covid in her lungs, Diagnosed with Covid Pneumonia. The patient is scheduled on 08Mar2020, the patient wants some advice on pushing it back, and if and when she should get it. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Colonoscopy, Diarrhoea, Endoscopy
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 16Feb2021 (lot number reported as EN9581 and EL1282; pending clarification) at the age of 79 years old, as single dose for COVID-19 immunisation. There were no relevant medical history and concomitant medications. On 23Feb2021, seven days after the vaccine shot, the patient experienced diarrhea and it was just resistant (diarrhea won't stop). The patient had been in the hospital (was admitted) from Friday morning (26Feb2021) to 01Mar2021 due to the event; and yesterday morning (02Mar2021) the patient underwent endoscopy and colonoscopy with unknown results. The adverse event required a visit to the emergency room. The patient did not receive any vaccinations 4 weeks prior to the administration of first COVID vaccine. There were no additional vaccines administered on same date as Pfizer COVID vaccine. The patient has not recovered from diarrhea as of this report.    Information on the lot/batch number has been requested.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Hallucination, Headache, Hypoacusis
Clinical narrative: hallucinations; headache; hearing disturbing noises; nausea; stomach pain; diarrhea; vision became worse; This is a spontaneous report from a contactable consumer (patient himself). A 91-year-old male patient received the second (2nd) dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6200, expiration date was not reported), via an unspecified route of administration, administered in the right arm on 23Feb2021 at 12:30 PM as a single dose for COVID-19 immunization. Relevant medical history included high blood pressure, severe anemia, diabetes, vision problems/poor vision, and spinal stenosis; all from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included bimatoprost (LUMIGAN) and insulin aspart (NOVOLOG) with "Bd Nano," and hydrochlorothiazid; all taken for an unspecified indication, start and stop date were not reported. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient had other vaccine in four weeks, but not specified. Following the 2nd dose on 25Feb2021 at 01:00 AM, the patient suffered headache, hallucinations, hearing disturbing noises, nausea, stomach pain, and diarrhea. Additionally, he has had poor vision, but following the shot, his vision became worse. The adverse events (AE) resulted in hospitalization for 3 days on an unspecified date. It was unknown if the patient received any treatment for the events. The patient was not recovered from all the events.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Visual impairment
Clinical narrative: hallucinations; headache; hearing disturbing noises; nausea; stomach pain; diarrhea; vision became worse; This is a spontaneous report from a contactable consumer (patient himself). A 91-year-old male patient received the second (2nd) dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6200, expiration date was not reported), via an unspecified route of administration, administered in the right arm on 23Feb2021 at 12:30 PM as a single dose for COVID-19 immunization. Relevant medical history included high blood pressure, severe anemia, diabetes, vision problems/poor vision, and spinal stenosis; all from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included bimatoprost (LUMIGAN) and insulin aspart (NOVOLOG) with "Bd Nano," and hydrochlorothiazid; all taken for an unspecified indication, start and stop date were not reported. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient had other vaccine in four weeks, but not specified. Following the 2nd dose on 25Feb2021 at 01:00 AM, the patient suffered headache, hallucinations, hearing disturbing noises, nausea, stomach pain, and diarrhea. Additionally, he has had poor vision, but following the shot, his vision became worse. The adverse events (AE) resulted in hospitalization for 3 days on an unspecified date. It was unknown if the patient received any treatment for the events. The patient was not recovered from all the events.
Sex: M
Vaccine: COVID19
Symptoms: Accident, Haemoglobin, Haemoglobin decreased, Haemorrhage
Clinical narrative: blood loss; hemoglobin dropped to about 10; accident; This is a spontaneous report from a contactable consumer (patient himself). A 44-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Feb2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included tetanus vaccine taken for immunization. On 25Feb2021, patient received his first Pfizer Coronavirus vaccine. The next day, the 26Feb2021, he had an accident and suffered some blood loss. He did not have a transfusion but his hemoglobin dropped to about 10. He was also given a tetanus shot. Will his vaccine still be effective and should he keep his appointment to get his 2nd vaccine on 24Mar2021 or redo them later? Outcome of events was unknown.   Information on the lot/batch number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Headache, Hypoaesthesia, Pain
Clinical narrative: Seizure; Headache; Couldn't feel lower legs; Extreme chest pains and chills; Extreme chest pains and chills; Arm swelling; Pain; Itching; This is a spontaneous report from a contactable healthcare professional (patient). A 23-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration (left arm) on 02Mar2021, 16:15, as single dose for COVID-19 immunisation. Medical history included ongoing epilepsy, covid back in Dec2020, known allergies to flu vaccine and TB test and seizure (have history). Concomitant medications included levetiracetam (KEPPRA), lamotrigine (LAMICTAL), cenobamate (XCOPRI) and magnesium. The patient had no other vaccine in 4 weeks. On 02Mar2021 16:15, the patient experienced arm swelling, pain, itching, couldn't feel lower legs, extreme chest pains and chills. On 02Mar2021, at 17:15, the patient experienced headache an hour later. On 03Mar2021 01:00, the patient experienced seizure at the middle of the night around 01:00. The events resulted in emergency room/department or urgent care. The patient had Covid prior vaccination; and was not Covid tested post vaccination. Outcome of event seizure was not recovered; outcome of the rest of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The patient had underlying epilepsy. However, based on the close temporal association, a possible contributory role of bnt162b2 to the development of seizure 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.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Seizure
Clinical narrative: Seizure; Headache; Couldn't feel lower legs; Extreme chest pains and chills; Extreme chest pains and chills; Arm swelling; Pain; Itching; This is a spontaneous report from a contactable healthcare professional (patient). A 23-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration (left arm) on 02Mar2021, 16:15, as single dose for COVID-19 immunisation. Medical history included ongoing epilepsy, covid back in Dec2020, known allergies to flu vaccine and TB test and seizure (have history). Concomitant medications included levetiracetam (KEPPRA), lamotrigine (LAMICTAL), cenobamate (XCOPRI) and magnesium. The patient had no other vaccine in 4 weeks. On 02Mar2021 16:15, the patient experienced arm swelling, pain, itching, couldn't feel lower legs, extreme chest pains and chills. On 02Mar2021, at 17:15, the patient experienced headache an hour later. On 03Mar2021 01:00, the patient experienced seizure at the middle of the night around 01:00. The events resulted in emergency room/department or urgent care. The patient had Covid prior vaccination; and was not Covid tested post vaccination. Outcome of event seizure was not recovered; outcome of the rest of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The patient had underlying epilepsy. However, based on the close temporal association, a possible contributory role of bnt162b2 to the development of seizure 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.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Chills, Communication disorder, Confusional state, Decreased appetite
Clinical narrative: hip fracture; atrial fib; could not communicate; everything the patient's wife touched he said "ouch"; rigors or chills; he was limp; loss the use of his legs; convulsion; Still not eating and confused; Still not eating and confused; This is a spontaneous report from a contactable consumer (patient's wife) medical information team.  A male patient of an unspecified age (reported as 90, no units provided) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 24Feb2021 at a single dose for COVID-19 immunisation. Medical history included dialysis receiving dialysis 3x/week; and walker (walking aid user). Concomitant medications were not reported. The patient received his second Pfizer vaccine dose on 24Feb2021. When the patient came home Thursday morning (25Feb2021) from dialysis, he was limp, loss the use of his legs, could not communicate, everything the patient's wife touched he said "ouch". They had to push the patient around on his walker. Her son was helping the patient in the bathroom and he called out and thought the patient was having a convulsion, although she thought it may be rigors or chills. The patient was brought back to the recliner and took his vital signs and he was in atrial fib. The MD was called and medicated him. On Friday (26Feb2021), he was not doing so well, his nephrologist was called and was told to watch him for another day. The patient was admitted to the hospital on Saturday (27Feb2021). The patient was still not eating and confused and he has been diagnosed with a hip fracture. The patient's wife wanted to know if other people had these kinds of side effects. The patient has not recovered from "still not eating and confused". The outcome of the remaining events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Hip fracture, Loss of control of legs, Pain, Seizure
Clinical narrative: hip fracture; atrial fib; could not communicate; everything the patient's wife touched he said "ouch"; rigors or chills; he was limp; loss the use of his legs; convulsion; Still not eating and confused; Still not eating and confused; This is a spontaneous report from a contactable consumer (patient's wife) medical information team.  A male patient of an unspecified age (reported as 90, no units provided) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 24Feb2021 at a single dose for COVID-19 immunisation. Medical history included dialysis receiving dialysis 3x/week; and walker (walking aid user). Concomitant medications were not reported. The patient received his second Pfizer vaccine dose on 24Feb2021. When the patient came home Thursday morning (25Feb2021) from dialysis, he was limp, loss the use of his legs, could not communicate, everything the patient's wife touched he said "ouch". They had to push the patient around on his walker. Her son was helping the patient in the bathroom and he called out and thought the patient was having a convulsion, although she thought it may be rigors or chills. The patient was brought back to the recliner and took his vital signs and he was in atrial fib. The MD was called and medicated him. On Friday (26Feb2021), he was not doing so well, his nephrologist was called and was told to watch him for another day. The patient was admitted to the hospital on Saturday (27Feb2021). The patient was still not eating and confused and he has been diagnosed with a hip fracture. The patient's wife wanted to know if other people had these kinds of side effects. The patient has not recovered from "still not eating and confused". The outcome of the remaining events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Vital signs measurement
Clinical narrative: hip fracture; atrial fib; could not communicate; everything the patient's wife touched he said "ouch"; rigors or chills; he was limp; loss the use of his legs; convulsion; Still not eating and confused; Still not eating and confused; This is a spontaneous report from a contactable consumer (patient's wife) medical information team.  A male patient of an unspecified age (reported as 90, no units provided) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 24Feb2021 at a single dose for COVID-19 immunisation. Medical history included dialysis receiving dialysis 3x/week; and walker (walking aid user). Concomitant medications were not reported. The patient received his second Pfizer vaccine dose on 24Feb2021. When the patient came home Thursday morning (25Feb2021) from dialysis, he was limp, loss the use of his legs, could not communicate, everything the patient's wife touched he said "ouch". They had to push the patient around on his walker. Her son was helping the patient in the bathroom and he called out and thought the patient was having a convulsion, although she thought it may be rigors or chills. The patient was brought back to the recliner and took his vital signs and he was in atrial fib. The MD was called and medicated him. On Friday (26Feb2021), he was not doing so well, his nephrologist was called and was told to watch him for another day. The patient was admitted to the hospital on Saturday (27Feb2021). The patient was still not eating and confused and he has been diagnosed with a hip fracture. The patient's wife wanted to know if other people had these kinds of side effects. The patient has not recovered from "still not eating and confused". The outcome of the remaining events was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Loss of upper field of vision Right eye; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 03Mar2021 16:15 (Lot Number: EN6198) as single dose for covid-19 immunization (age at vaccination: 66 years). Medical history included fibromyalgia, hypothyroid, hyper cholesterol, arthritis, depression, and allergies: Mango, penicillin, sulfa drugs, all from an unknown date. The patient is not pregnant. No Covid prior to vaccination and not tested for Covid post vaccination. Concomitant medications included thyroid (ARMOUR THYROID); fluoxetine hydrochloride (PROZAC); atorvastatin (LIPITOR); celecoxib (CELEBREX); zolpidem; all taken for an unspecified indication, start and stop date were not reported. The patient previously took floxacin and experienced drug allergy. The patient experienced loss of upper field of vision right eye on 03Mar2021 18:30. No treatment given for event. Outcome of the event was unknown.; Sender's Comments: Based on the information provided, and on a close temporal association,  the Company  assessed that a reasonable possibility could not be completely excluded that the reported event Loss of upper field of vision right eye  was related to the PFIZER-BIONTECH COVID-19 VACCINE..
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: some hearing loss in left ear; Ear ringing; This is a spontaneous report from a contactable other health professional (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at the age of 39-years-old on 24Feb2021 18:00 (Lot Number: EL8982) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 03Feb2021 6:00 PM (Lot Number: unknown) as a single dose for COVID-19 immunization. The patient experienced some hearing loss in left ear (medically significant) and ear ringing on 03Mar2021 19:00. Unknown if patient received treatment. The outcome of the events was not recovered. The patient was not pregnant. Facility type vaccine was Hospital. No other vaccine in four weeks. No COVID prior vaccination. Not COVID tested post vaccination.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Staphylococcal infection
Clinical narrative: First dose received 28Jan2021 approx. 1 week after 1st dose, presented with a nose infection (left nostril, suspected MRSA) prescribed Doxycycline for 7 days.  Infection reduced (but not completely; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 28Jan2021 (Batch/Lot Number: EL3248) as SINGLE DOSE for covid-19 immunisation. Medical history included panic disorder. Concomitant medications included sertraline hydrochloride (ZOLOFT); trazodone; doxycycline (DOXYCYCLINE); sulfamethoxazole, trimethoprim (BACTRIM); all taken for unspecified indications, start and stop dates were not reported.  First dose received 28Jan2021 approx. 1 week after 1st dose, presented with a nose infection (left nostril, suspected MRSA) prescribed Doxycycline for 7 days. Infection reduced (but not completely resolved). The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 04Feb2021, sars-cov-2 test: negative on 02Mar2021. Therapeutic measures were taken as a result of first dose received 28jan2021 approx. 1 week after 1st dose, presented with a nose infection (left nostril, suspected mrsa) prescribed doxycycline for 7 days.  infection reduced (but not completely (staphylococcal infection). The outcome of the event was recovering.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia, Nausea, Neuropathy peripheral, Pain
Clinical narrative: woke wet from sweat; Nausea; neuropathy was elevated to an unbearable level /neuropathy flared up; body aches; severe muscle ache; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient's daughter-in-law). An 82-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date) at 82-year-old vaccination age via an unspecified route of administration in the right arm on 11Feb2021 15:30 as a single dose for covid protection (covid-19 immunisation). Medical history included transient ischaemic attack (TIA) which she has had this happen twice, thyroid removal in 1970, stroke (last doctor screwed up her medications and could have caused a stroke), has been losing a lot of weight (prior to vaccination) and neuropathy. Concomitant medications included influenza vaccine (FLU) on an unspecified date for an unspecified indication, blood pressure medicine, and hormone medication since she had her thyroid removed in 1970. The patient did not receive vaccinations within 4 weeks prior. The reporter mentioned that the patient has experienced body aches on 12Feb2021, nausea on 13Feb2021 and she woke wet from sweat on 16Feb2021. It was mentioned that her neuropathy was elevated to an unbearable level on 12Feb2021. She didn't feel it the first day. When talking about the neuropathy, the reporter stated that it was like something stabbing her from the knees to the toes. She has to lay in bed. Her legs hurt so bad she is unable to stand and can't sit for long. She woke wet with sweat twice. The first time was on 16Feb2021 and again on 19 or 20Feb2021. She had a flu shot on an unspecified date when they came out. The events did not require emergency room or physician's office visit. The reporter mentioned that her mother in law who was due tomorrow for the second dose and wanted to cancel because their doctor advised them to wait for at least a month to receive the second dose. According to her, her mother in law was sick for almost 3 weeks after the first dose, her mother in law experienced severe muscle ache and her neuropathy flared up on an unspecified date in 2021. The outcome of the events sweaty was recovered on an unspecified date in 2021, as for the event nausea was recovered on 01Mar2021 while muscle ache was unknown. The outcome of the other events was recovering.   The following information on the batch/lot number has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Dizziness
Clinical narrative: lost the hearing in her left ear; became light headed; This is a spontaneous report from a contactable consumer (patient herself). An 82-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9269, expiration date was unknown), via an unspecified route of administration, administered in the left arm on 03Feb2021 at 15:45 as a single dose for COVID-19 immunization. The vaccine facility type was reported as "other." Relevant medical history included hydrocephalus condition, which was corrected with surgery and for which the patient was also wearing hearing aides; all from an unknown date and unknown if ongoing. The patient had no known allergies; however, she had seasonal allergies on occasion from an unknown date and unknown if ongoing. Concomitant medications included omeprazole (PROTONIX) and simvastatin (ZOCOR); both taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. Right after the patient received her first vaccine dose (while at the clinic) on 03Feb2021 at 15:45, she became light headed. The next day, on 04Feb2021, she lost the hearing in her left ear. The adverse events (AE) resulted in a doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the events. The patient was not recovered from the events.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest pain, Diarrhoea, Headache, Heavy menstrual bleeding
Clinical narrative: Bleeding started really heavy/ Soaking up a bunch of different pads; Really bad pain in stomach as well as right pelvic area; Really bad pain in stomach as well as right pelvic area; Pain in right chest area; bunch of pain; Headache; Diarrhea; Nausea; Pain where I got the shot; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6200) via an unspecified route of administration in the left arm on 28Feb2021 at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient mentioned that the only medication she was taking was birth control. The patient got the COVID-19 vaccine on Sunday and had the normal side effects like headache, diarrhea, nausea and pain where she got the shot. The patient took Excedrin extra strength on Sunday night. Then on Monday night (01Mar2021) when she went to sleep there was pain in her chest, her right chest area there was in a bunch of pain. When the patient woke up on Tuesday morning (02Mar2021), she had bleeding, and that bleeding started really, really heavy. She just came off of her period a week ago. She had a full blown period for an entire week and then on Tuesday the patient started bleeding very, very heavily. She was soaking up a bunch of different pads. She was not sure what it was, she had pain, really bad pain in stomach as well as like pain in her pelvic area, right pelvic area.  Patient weight was 135 (units unknown). The outcome of the events was unknown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pelvic pain, Vaccination site pain, Weight
Clinical narrative: Bleeding started really heavy/ Soaking up a bunch of different pads; Really bad pain in stomach as well as right pelvic area; Really bad pain in stomach as well as right pelvic area; Pain in right chest area; bunch of pain; Headache; Diarrhea; Nausea; Pain where I got the shot; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6200) via an unspecified route of administration in the left arm on 28Feb2021 at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient mentioned that the only medication she was taking was birth control. The patient got the COVID-19 vaccine on Sunday and had the normal side effects like headache, diarrhea, nausea and pain where she got the shot. The patient took Excedrin extra strength on Sunday night. Then on Monday night (01Mar2021) when she went to sleep there was pain in her chest, her right chest area there was in a bunch of pain. When the patient woke up on Tuesday morning (02Mar2021), she had bleeding, and that bleeding started really, really heavy. She just came off of her period a week ago. She had a full blown period for an entire week and then on Tuesday the patient started bleeding very, very heavily. She was soaking up a bunch of different pads. She was not sure what it was, she had pain, really bad pain in stomach as well as like pain in her pelvic area, right pelvic area.  Patient weight was 135 (units unknown). The outcome of the events was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Off label use, Product use issue
Clinical narrative: miscarriage; pregnant patient received BNT162B2; pregnant patient received BNT162B2; This is a spontaneous report from a non-contactable consumer. This consumer (patient) that a 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: en6201) at the age of 34-years, via an unspecified route of administration on 20Feb2021 at single dose for COVID-19 immunisation. Medical history was not reported. Patient was pregnant at time of vaccination, last menstrual date was 21Jan2021. No other vaccine in four weeks, no COVID-19 prior vaccination. Concomitant medication included ustekinumab (STELARA). The patient experienced miscarriage on an unspecified date (on 03Feb2021, as reported). The pregnant patient received BNT162B2 on 20Feb2021. No COVID-19 tested post vaccination. Outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021238716 Same product and AE , different patient
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Magnetic resonance imaging head, Malaise, Transient ischaemic attack, Weight
Clinical narrative: TIA; I felt really lousy; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203), dose 2 at the age of 73-year-old, via an unspecified route of administration on 26Feb2021 as single dose for COVID-19 immunisation. Medical history included high blood pressure (don't have really high blood pressure but the doctor has her on blood pressure medicine, have no diabetes or whatever, and had allergies. Concomitant medication included amlodipine besylate 5 mg, taken every morning. She takes most of her medicines in the morning and had taken that stuff at about 5 o'clock or so early in the morning. The patient was previously vaccinated with the first dose of BNT162B2 on 05Feb2021 at the age of 73-year-old and hand no problem. The patient stated that when she had the first COVID vaccination she had no problem and then Friday she went to get the second one, it was 3 weeks later, when she had first one she stated that she had allergies, so they had her wait 15 minutes, no problem. When she went for the second one, thankfully someone drove her that was outside the 'game court' location. When they gave it they said, she pull up and will let her know after she pull up and will decide if she has to wait 15 minutes or 30 minutes and they asked her if she had allergies, and she said yes, they said pull over here and she has to wait 30 minutes and all she know was, it's probably 2 minutes from the time she got the vaccine until she got to the place to wait. She would say 15 minutes after she got it on 26Feb2021, she felt really lousy and told her friend, they 'said' she was having a Trans Ischemic Attack (TIA), and took me to the hospital and everything. An ambulance was called on 26Feb2021 at around 8 o'clock that morning, right after she had the vaccine and carried her straight in the hospital. She was discharged the next day 27Feb2021 at about 7 PM. The patient had a CT scan of her brain, MRI of her brain, and then cardial, something with reference to her heart, she forgot, all with unknown results. The body weight right now was about 150 pounds. The outcome of the events was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Orbital oedema
Clinical narrative: Orbital edema; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot unknown) via intramuscular in the left arm on 02Mar2021 09:00 AM at age of 51 years old at single dose for COVID-19 immunisation. Medical history included goiter, allergies to Sulfa. There was no covid prior vaccination. Patient was not pregnant. Concomitant medication included other vaccine in two weeks estradiol, norethisterone acetate (COMBIPATCH). Patient experienced adverse event included orbital edema on 04Mar2021 02:00 AM. Patient had doctor or other healthcare professional office/clinic visit. Patient received treatment with prednisone for event. There was no covid tested post vaccination. Outcome of event was recovering.   Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported orbital edema 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.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: found blood in his stool; This is a spontaneous report from a contactable consumer (patient). This 46-year-old male patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN 6205), via an unspecified route of administration in the right arm on 02Mar2021 at 06:30 PM at single dose for COVID-19 immunization. Medical history included allergy to beef (was informed may have an allergy to beef but not be fully tested due to covid restrictions). Concomitant medications were none. The patient had no other vaccine in four weeks, no other medications in two weeks. The following day the patient found blood in his stool on 03Mar2021 at 09:30 AM. It was unsure if this was related to the vaccine but never had an issue prior to the vaccination. No treatment was received for the event. Outcome of the event was not recovered. The patient had no covid prior vaccination, no covid tested post vaccination.