chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Condition aggravated, Fatigue, Feeling abnormal, Headache
Clinical narrative: symptoms were intensified by first COVID vaccine; heart pain; severe fatigue; pain in head; heart palpitation; brain fog; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 19Mar2021 12:30 (lot number and expiration date were not reported) as single dose (at the age of 57-years-old) for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD), irritable bowel syndrome (IBS), asthma, allergies, early bone loss, allergy to penicillin, latex, lactose and sugar; all from an unknown date and unknown if ongoing. Concomitant medications included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) and unspecified allergy medications. The patient previously took codeine and experienced allergies. The patient had no other vaccine in four weeks prior to vaccination. It was unknown if the patient had COVID prior to vaccination. On 23Mar2021, the patient experienced heart pain, severe fatigue, pain in head, heart palpitation and brain fog. The patient described the events as having "long hauler" symptoms since 23Oct2020. The symptoms were intensified by first COVID vaccine. Four days after the first shot, the patient had severe fatigue, heart palpitation, heart pain, pain in head through out day which comes and goes and brain fog. The symptoms intensified and remained for 18 days after first shot. The patient had the second shot on 09Apr2021 on the left arm (lot number was unknown) and had no head pain for the first time since last Oct2020. The patient was not COVID tested post vaccination. The patient had a visit to a doctor or other healthcare professional office/clinic. There were no treatment given. The patient recovered with lasting effects on an unspecified date.   Information on the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: symptoms were intensified by first COVID vaccine; heart pain; severe fatigue; pain in head; heart palpitation; brain fog; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 19Mar2021 12:30 (lot number and expiration date were not reported) as single dose (at the age of 57-years-old) for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD), irritable bowel syndrome (IBS), asthma, allergies, early bone loss, allergy to penicillin, latex, lactose and sugar; all from an unknown date and unknown if ongoing. Concomitant medications included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) and unspecified allergy medications. The patient previously took codeine and experienced allergies. The patient had no other vaccine in four weeks prior to vaccination. It was unknown if the patient had COVID prior to vaccination. On 23Mar2021, the patient experienced heart pain, severe fatigue, pain in head, heart palpitation and brain fog. The patient described the events as having "long hauler" symptoms since 23Oct2020. The symptoms were intensified by first COVID vaccine. Four days after the first shot, the patient had severe fatigue, heart palpitation, heart pain, pain in head through out day which comes and goes and brain fog. The symptoms intensified and remained for 18 days after first shot. The patient had the second shot on 09Apr2021 on the left arm (lot number was unknown) and had no head pain for the first time since last Oct2020. The patient was not COVID tested post vaccination. The patient had a visit to a doctor or other healthcare professional office/clinic. There were no treatment given. The patient recovered with lasting effects on an unspecified date.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash on arm where site was; This is a spontaneous report received from a contactable consumer (Patient's sister). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Patient's medical history included cancer. The patient's concomitant medications were not reported. Caller stated her sister who has cancer received the same Pfizer vaccine and did not have any reactions but then stated her sister had a rash on her arm at the vaccination site but it went away. There was no investigation assessment. The report is cross referenced to report ID: QGAEOUVI. Caller did not have any further details for report. It was report 2 of 7. The outcome of the event was recovered.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Arthralgia, Magnetic resonance imaging, Myocarditis, Pain
Clinical narrative: 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.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: 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.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Alanine aminotransferase, Arthralgia, Aspartate aminotransferase, Bilirubin conjugated
Clinical narrative: 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.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood albumin, Blood bilirubin, Blood calcium, Blood chloride normal, Blood creatinine normal
Clinical narrative: 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.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood potassium normal, Blood urea normal, Carbon dioxide normal, Catheterisation cardiac, Chest X-ray normal
Clinical narrative: 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.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, EGFR status assay, Echocardiogram abnormal, Electrocardiogram abnormal, Gamma-glutamyltransferase
Clinical narrative: 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.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haematocrit decreased, Haemoglobin decreased, Lymphocyte count increased, Magnetic resonance imaging abnormal, Magnetic resonance imaging heart
Clinical narrative: 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.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mean cell volume normal, Myocarditis, Neutrophil count increased, Pericardial effusion, Platelet count normal
Clinical narrative: 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.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Protein total, Scan with contrast, Sleep disorder, Troponin, White blood cell count normal
Clinical narrative: 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.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Viral load
Clinical narrative: unusually high number of covid infections in fully vaccinated employees; unusually high number of covid infections in fully vaccinated employees; This is a spontaneous report from a contactable physician. This report is for 1st of 11 patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EH9899), dose 1 via an unspecified route of administration on 17Dec2020 and dose 2 via an unspecified route of administration in Jan2021 (Lot number: unknown), both as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, after two weeks of second dose, the patient experienced unusually high number of COVID infections in fully vaccinated employees. The physician further stated they may need some kind of investigation here because they are seeing high viral loads in these individuals and symptoms. The patient was well after two weeks. The outcome of the event was unknown.; Sender's Comments: Based on the known safety profile and a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported COVID-19.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Experienced significant increase in pre-existing tinnitus in right ear, and new onset of tinnitus and possible sudden hearing loss in left ear following vaccination; Experienced significant increase in pre-existing tinnitus in right ear, and new onset of tinnitus and possible sudden hearing loss in left ear following vaccination; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in arm left on 03Apr2021 10:30 (Batch/Lot Number: ED7533) as single dose for covid-19 immunisation. Medical history included AV block, colitis, optic neuritis, previous hearing loss in right ears and pre-existing tinnitus in right ears all from an unknown date and unknown if ongoing. Concomitant medications included montelukast; clarithromycin (CLARITIN) and bisacodyl (DULCOLAX); all taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and vancomycin and experienced allergies. The patient experienced experienced significant increase in pre-existing tinnitus in right ear, and new onset of tinnitus and possible sudden hearing loss in left ear following vaccination on 03Apr2021 13:00. Contacting doctor, the patient was hesitant to receive second vaccination. No treatment was received for the events. The patient did not recover from the events.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Influenza like illness, Lethargy, Nausea
Clinical narrative: Flu like symptoms; Chills; a lot of pain in arm; Feverish; Dizziness; feeling achy; Nausea; Lethargic; This is a spontaneous report from contactable consumer (patient's mother). A 24-year-old-female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Apr2021 12:30 on right arm at single dose for COVID-19 immunization. Vaccination facility type was at hospital. Medical history and concomitant medications were reported as none. The patient experienced a lot of pain in arm in Apr2021: Caller stated that the patient was more scrawny and weighs under 100 lbs. Flu like symptoms on 07Apr2021: Stated that they got home around 2:30pm and was feeling normal, this occurred in the evening, about 5 hours after the shot. Feverish in Apr2021: Stated that she did not know the exact temperature because it was not taken. The patient also had dizziness, been feeling achy, a little nausea and lethargic in Apr2021. Patient felt this way now but felt less feverish but still lethargic, nausea, and achy. This was ongoing now. She also had chills yesterday (07Apr2021) and in the morning today. The patient had a dentist appointment today that was canceled. Treatment was received for the events included Tylenol. The outcome of events "a lot of pain in arm, flu like symptoms and feverish" were unknown while outcome of other events were not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Weight
Clinical narrative: Flu like symptoms; Chills; a lot of pain in arm; Feverish; Dizziness; feeling achy; Nausea; Lethargic; This is a spontaneous report from contactable consumer (patient's mother). A 24-year-old-female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Apr2021 12:30 on right arm at single dose for COVID-19 immunization. Vaccination facility type was at hospital. Medical history and concomitant medications were reported as none. The patient experienced a lot of pain in arm in Apr2021: Caller stated that the patient was more scrawny and weighs under 100 lbs. Flu like symptoms on 07Apr2021: Stated that they got home around 2:30pm and was feeling normal, this occurred in the evening, about 5 hours after the shot. Feverish in Apr2021: Stated that she did not know the exact temperature because it was not taken. The patient also had dizziness, been feeling achy, a little nausea and lethargic in Apr2021. Patient felt this way now but felt less feverish but still lethargic, nausea, and achy. This was ongoing now. She also had chills yesterday (07Apr2021) and in the morning today. The patient had a dentist appointment today that was canceled. Treatment was received for the events included Tylenol. The outcome of events "a lot of pain in arm, flu like symptoms and feverish" were unknown while outcome of other events were not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Allergic cough
Clinical narrative: allergy cough; This is a spontaneous report from a contactable consumer (patient). 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, administered in arm left on 31Mar2021 about 12:30 or 1:00 in the afternoon (Lot Number: EP7534) as single dose for covid-19 immunisation. Medical history included diabetes mellitus from 2010 and ongoing, high blood pressure from 2016 and ongoing. Concomitant medications included ongoing insulin detemir (LEVEMIR) for blood sugar (it was insulin and she had been on it for maybe 4 years); ongoing lisinopril taken for blood pressure (she had been on this for about a year or two); levothyroxine sodium (SYNTHROID) from 2006 and ongoing (she had been on this since she had her thyroid taken out in 06); ongoing empagliflozin (JARDIANCE) taken for diabetes. No prior vaccinations (within 4 weeks), no events following prior vaccinations, no family medical history relevant to events. No additional vaccines administered on same date of the Pfizer Suspect. The patient took the COVID vaccine on 31Mar2021 and she had a side effect from it like a cough she thought it was allergies but it seemed a little more different. she thought the cough was just her allergies. She thought the cough started about Sunday evening (04Apr2021). She said the cough was not like it was, it settled down, it was not like it was in yesterday. She coughed like it was allergy cough but yesterday it was more than like an allergy cough last night she was grieving down with Vicks Salve and just sweated it out. She said the product was called Vicks Salve but it was a generic brand topical analgesic cough suppressant a chest rub NDC 4612215754 she saw an ABC number LOT 10209SC. She said she did not need anything else at this time and asked if she needed to go get tested to wait for the vaccine does she get the vaccine. The event did not require a visit to emergency room or physician office. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: chills; fever; 100.4 degrees F/felt very hot during the night; headache; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received second dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 60-years-old, via an unspecified route of administration, administered in Arm Right on 30Mar2021 15:30 PM (Lot Number: EN6207) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine was first dose of BNT162b2, at the age of 60-years-old, via an unspecified route of administration, administered in Arm Right on 09Mar2021 for covid-19 immunisation and only had a slightly sore arm after dose #1 and even that did not last long. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After dose #2 on 30Mar2021 21:30, 6 hours later, patient experienced headache. On 31Mar2021, middle of the night patient experienced chills, headache and fever. Patient did not get out of bed to take temperature but felt very hot during the night (100.4 degrees F at 7:30 AM - about 16 hours after injection). Patient did take some Naproxen Sodium and fever went down to 99.6 by the time she took temp again in the afternoon. Chills lasted into the afternoon and headache lasted about 24 hours total. On 01Apr2021 Temp down to 98.6 - no fever (although she usually run cool and my normal temp is 97.6-97.8). No treatment received for other event, except fever. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Event outcome of headache was recovered on 31Mar2021 21:30, of fever was recovered on 01Apr2021, of chills was recovered on 31Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: her arm got sore at the injection site; This is a spontaneous case is received from a contactable consumer (patient). A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN6200; Expiration Date: Unknown) via an unspecified route of administration, administered in arm left on 16Mar2021 as a single dose for covid-19 immunisation. Medical history included Type II Diabetes (Jun 2020), Blood Pressure runs high, History of Breast Cancer, History of having skin cancer removed, Restless leg syndrome. Concomitant medications included atorvastatin (ATORVASTATIN) for blood cholesterol, ropinirole (ROPINIROLE) taken for restless legs syndrome, metformin (METFORMIN) taken for diabetes mellitus from Jun2020 and ongoing, glimepiride (GLIMEPIRIDE) taken for diabetes mellitus, atenolol (ATENOLOL) taken for blood pressure measurement, tocopherol (VITAMIN E D ALPHA TOCOPHEROL) taken for an unspecified indication, acetylsalicylic acid (ASPIRINE) taken for an unspecified indication. The patient experienced her arm got sore at the injection site on 16Mar2021. The outcome of the event was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Erythema, Hypotension, Vomiting
Clinical narrative: She became very red; Dizziness; Vomiting; Diarrhea; Hypotension; This is a spontaneous report from a contactable healthcare professional. A 17-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0158), intramuscular, administered in left arm on 09Apr2021 16:30 as single dose for COVID-19 immunization. Medical history included 3 weeks of urticaria prior to vaccination. The patient has had no COVID history prior vaccination. The patient has not been tested for COVID post vaccination. Concomitant medications included fish oil; diphenhydramine hydrochloride (BENADRYL); cetirizine hydrochloride (ZYRTEC); ibuprofen (MOTRIN), and an unspecified multivitamin. The patient previously took Amoxicillin and experienced drug allergies. After vaccine, the patient became very red, had dizziness, vomiting and diarrhea and hypotension on 09Apr2021. The events resulted in an emergency room/department or urgent care visit and hospitalization for 1 day. Treatment included epi, Benadryl, steroids, Pepcid, and fluid boluses. The outcome of the events was not resolved.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Measles, Rash, Urticaria
Clinical narrative: Measles; hive rash all over my body; hive rash all over my body; This is a spontaneous report from a non-contactable consumer (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration, administered in left arm on 04Apr2021 as a single dose for COVID-19 immunisation. Medical history included Lupus and fibromyalgia. There were no concomitant medications. The patient previously took azithromycin and immunoglobulins and experienced allergies. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced measles and had hive rash all over her body on 07Apr2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Treatment was given in response to the events which included prednisone and allergy medicine. The patient has not been tested for COVID-19 post vaccination. The outcome of the events was not recovered.   Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Muscular weakness, SARS-CoV-2 test, Seizure
Clinical narrative: Muscles started convulsing; feeling dizzy; Vision started going in and out; Fell over; legs were weaker than ever; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Er8733) as single dose for COVID-19 immunisation. Medical history included COVID: prior to vaccination. Concomitant medications were not reported. The patient had no known allergies. The patient had no other vaccine in four weeks. 3 hours after shot, the patient started feeling dizzy. Stood up then vision started going in and out. Fell over. Muscles started convulsing and legs were weaker than ever. The patient had no treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Muscles started convulsing; feeling dizzy; Vision started going in and out; Fell over; legs were weaker than ever; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Er8733) as single dose for COVID-19 immunisation. Medical history included COVID: prior to vaccination. Concomitant medications were not reported. The patient had no known allergies. The patient had no other vaccine in four weeks. 3 hours after shot, the patient started feeling dizzy. Stood up then vision started going in and out. Fell over. Muscles started convulsing and legs were weaker than ever. The patient had no treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainted; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 15:30 (at the age of 17years) as single dose for Covid-19 immunization. The patient is not pregnant at the time of vaccination. Medical history included asthma, pediatric Kawasaki disease from 2006 to an unknown date, known allergies: Sulfa drugs, and Covid-19 from an unknown date and unknown if ongoing (Covid prior vaccination: Yes). Concomitant medications included sertraline hydrochloride (ZOLOFT) and ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1/20), 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. It was reported that the patient fainted the following morning on 08Apr2021 10:00. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of event was recovering.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Paraesthesia, Vaccination site pain
Clinical narrative: soreness around injection site later in the evening; fingers were a little stiff for about an hour after vaccination; Tingling sensation passed through arm down to fingers within 15 minutes of dosing; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in right arm at the age of 51-year-old on 07Apr2021 13:00 (Batch/Lot Number: ER8734) as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Medical history included hypertension, asthma, dust allergy, mold allergy, pollens allergy, Environmental allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant. Concomitant medications included lisinopril; salbutamol (ALBUTEROL HFA); budesonide, formoterol fumarate (SYMBICORT); fexofenadine hydrochloride (ALLEGRA); ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS); fish oil. Tingling sensation passed through arm down to fingers within 15 minutes of dosing on 07Apr2021 13:15; fingers were a little stiff for about an hour after vaccination on 07Apr2021 14:00; soreness around injection site later in the evening (7 pm) on 07Apr2021 19:00; mostly resolved by next morning. Therapeutic measures were taken as a result of events (Took Excedrin night of vaccination prior to sleeping). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of events was reported as recovering.   No follow up attempts are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Still's disease
Clinical narrative: Adult onset Still's disease; symptoms started with fever; This is a spontaneous report from a contactable physician (patient). A 36-year-old male patient 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 in left arm, on 20Jan2021 at 08:00 AM, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 30Dec2020 at 08:00 AM at the age of 36 years for COVID-19 immunization (left arm). The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccines were administered in four weeks. The vaccine was administered in a hospital facility. On 25Feb2021 at 05:00 PM (17:00), the patient developed adult onset Still's disease. That day, the patient's symptoms started with fever of unknown origin for 10 days. The event resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Treatment for the event included prednisone. The patient underwent COVID-19 nasal swab (PCR) test post vaccination that was negative both on 26Feb2021 and 28Feb2021. The patient was recovering from the event.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Based on a temporal association, a causal relationship between the event Still's disease adult onset and BNT162B2 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.