chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Nausea, SARS-CoV-2 test, Vomiting
Clinical narrative: nausea; vomiting; diarrhea; rapid heart rate; severe dehydration; unable to eat or drink; Extremely fatigued all day; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 47 years old, administered in arm right on 28Apr2021 12:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included spinach allergy, UC (Ulcerative colitis). Concomitant medication included mesalamine. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 47 years old, administered in arm right on 07Apr2021 12:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. On 29Apr2021 01:00, less than 24 hours of second vaccine there was nausea, vomiting, diarrhea and a rapid heart rate and severe dehydration. This progressed and led to hospitalization from Saturday 01May2021 to 04May2021 and resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient also experienced unable to eat or drink and extremely fatigued in 2021. As of this message (10May2021), still unable to eat or drink without vomiting and hear rate up to 170+. This was up from a normal resting heart rate of near 60. Extremely fatigued all day, vomit several times per day and loose stool to diarrhea multiple times per day. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had been tested for COVID-19, covid-test (blood test) on 02May2021: negative. Treatment was received for all events. The outcome of the events was not recovered.  Information about batch/ Lot number has been requested.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Dyspnoea, Haemorrhage, Laboratory test
Clinical narrative: Bleeding; Shortness of breath; Chest pain; Fever of 102; Viral myocarditis; This is a spontaneous report from a contactable consumer (parent). A 22-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration assuming left arm, at age 22 years, on 05May2021 (Batch/Lot Number: EW0153) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient's medical history was reported as no. Concomitant medications were not reported. Patient historically took first dose of BNT162B2 at age 22 years on 14Apr2021 for COVID-19 immunization. Reporter's son unfortunately appeared was hospitalized for adverse reaction (bleeding) and the physician told reporter to report this. Patient had has viral myocarditis of heart on an unspecified date on May2021 after he got his second dose on 05May2021. On 06May2021, patient started having symptoms of  shortness of breath, chest pain and fever of 102 (unit: unknown) after the second dose, so he went to emergency room. Then on Friday , 07May2021, he ended up with bleeding, so admission date is 07May2021 and he is still in the hospital at the time of reporting, they don't know how long. Patient also underwent lab test and procedure that includes laboratory test on May2021, 2 weeks before, patient was fine until the second dose.  The outcome of the events was unknown.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Viral myocarditis
Clinical narrative: Bleeding; Shortness of breath; Chest pain; Fever of 102; Viral myocarditis; This is a spontaneous report from a contactable consumer (parent). A 22-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration assuming left arm, at age 22 years, on 05May2021 (Batch/Lot Number: EW0153) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient's medical history was reported as no. Concomitant medications were not reported. Patient historically took first dose of BNT162B2 at age 22 years on 14Apr2021 for COVID-19 immunization. Reporter's son unfortunately appeared was hospitalized for adverse reaction (bleeding) and the physician told reporter to report this. Patient had has viral myocarditis of heart on an unspecified date on May2021 after he got his second dose on 05May2021. On 06May2021, patient started having symptoms of  shortness of breath, chest pain and fever of 102 (unit: unknown) after the second dose, so he went to emergency room. Then on Friday , 07May2021, he ended up with bleeding, so admission date is 07May2021 and he is still in the hospital at the time of reporting, they don't know how long. Patient also underwent lab test and procedure that includes laboratory test on May2021, 2 weeks before, patient was fine until the second dose.  The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Swelling
Clinical narrative: Whole body swell and itching; Whole body swell and itching; Burning sensations every where on body; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 04May2021 13:30 (Lot Number: EW013) as single dose for COVID-19 immunisation. Medical history included anaemia and recovered from Anemia, known allergies as bee stings, mango skin allergy, swelling of face response. severe itching / swelling. Concomitant medications included: thyroid medicine and multi vitamins. Two hours after shot on 04May2021, patient's whole body swell and itching, burning sensations every where on body, took antihistamine at home and went to the ER room where they gave patient steroids and EPI pen as well as more antihistamines. Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Events were reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered.  Information on lot/batch was available. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Hypoaesthesia
Clinical narrative: Bell's palsy after 2 weeks of my first dose of vaccine; Left half face feels numb and I am not able to control my left half of face.; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female non-pregnancy patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left in Apr2021 (Lot Number: EWO169, at age of 27 years old) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications included: Birth control pills. The patient experienced Bell's palsy after 2 weeks of first dose of vaccine, left half face felt numb and patient was not able to control her left half of face on 08May2021 10:00. Event resulted in: Doctor or other healthcare professional office/clinic visit. Events were reported as non-serious. The patient received treatment as Prednisone 50 mg tablet. The outcome of events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: a history of high blood pressure and says she went to the hospital due to experiencing high blood pressure; dizziness; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that 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 16Apr2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation.  Medical history included high blood pressure. The patient's concomitant medications were not reported.  The patient received her first injection of the Pfizer covid 19 vaccine and was supposed to receive her second injection on 07May2021 but she missed the appointment because she was in the hospital. The patient reported a history of high blood pressure and says she went to the hospital due to experiencing high blood pressure and dizziness on 07May2021. She was kept overnight and treated with blood pressure medication and a medication for dizziness and a vitamin. She reports being fine now. The outcome of the event was recovered on 07May2021. The patient does not feel like her high blood pressure and dizziness were due to the Pfizer covid-19 vaccine.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, A possible causal relationship between reported events and suspect drug BNT162B2 Cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Pain in extremity, Syncope
Clinical narrative: Fainting; Sore arm; Abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0164; Expiration date was not reported) on the left arm on 30Apr2021 (16:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On an unspecified date in 2021, the patient was fainting; had sore arm; and had abdominal pain. The patient did not receive any treatment for the events. The outcome of the events was recovered on an unspecified date in 2021. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Alanine aminotransferase, Alanine aminotransferase increased, Aspartate aminotransferase, Aspartate aminotransferase increased
Clinical narrative: Transaminitis; AST 392; ALT 81 IU/l; Fevers; Nausea; Vomiting; abdominal pain; dose 2 on 05May2021 and first dose on 24Apr2021; dose 2 on 05May2021 and first dose on 24Apr2021; This is a spontaneous report from a contactable physician. A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 2 intramuscular, administered in arm right on 05May2021 16:00 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included bilateral cystic kidney disease, hypertension, allergies to amoxicillin, cephalexin, ceftriaxone. Concomitant medication received within 2 weeks of vaccination included propranolol 30 mg, 3x/day. The patient previously received first dose of BNT162B2 intramuscular in right arm on 24Apr2021 04:00 PM for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced transaminitis, AST 392 IU/l, ALT 81 IU/l; normal bilirubin 0.6 on 06May2021. Fevers starting on 06May2021 to 10May2021 and continued (current at time of reporting) with nausea, vomiting, abdominal pain. These events resulted in Emergency room/department or urgent care. Treatment received for the adverse events included ondansetron; IV bolus. The outcome of events transaminitis, AST 392 IU/l, ALT 81 IU/l, Fevers and abdominal pain was recovering and other events was unknown. Events were reported as non-serious and did not resulted in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating or congenital anomaly/birth defect.  Information on the batch/lot number has been requested.; Sender's Comments: Based on temporal association, a contributory role of BNT162B2  to the reported events cannot be totally excluded.  Case will be reassessed if additional information is received.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Blood bilirubin, Inappropriate schedule of product administration, Nausea, Off label use, Pyrexia
Clinical narrative: Transaminitis; AST 392; ALT 81 IU/l; Fevers; Nausea; Vomiting; abdominal pain; dose 2 on 05May2021 and first dose on 24Apr2021; dose 2 on 05May2021 and first dose on 24Apr2021; This is a spontaneous report from a contactable physician. A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 2 intramuscular, administered in arm right on 05May2021 16:00 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included bilateral cystic kidney disease, hypertension, allergies to amoxicillin, cephalexin, ceftriaxone. Concomitant medication received within 2 weeks of vaccination included propranolol 30 mg, 3x/day. The patient previously received first dose of BNT162B2 intramuscular in right arm on 24Apr2021 04:00 PM for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced transaminitis, AST 392 IU/l, ALT 81 IU/l; normal bilirubin 0.6 on 06May2021. Fevers starting on 06May2021 to 10May2021 and continued (current at time of reporting) with nausea, vomiting, abdominal pain. These events resulted in Emergency room/department or urgent care. Treatment received for the adverse events included ondansetron; IV bolus. The outcome of events transaminitis, AST 392 IU/l, ALT 81 IU/l, Fevers and abdominal pain was recovering and other events was unknown. Events were reported as non-serious and did not resulted in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating or congenital anomaly/birth defect.  Information on the batch/lot number has been requested.; Sender's Comments: Based on temporal association, a contributory role of BNT162B2  to the reported events cannot be totally excluded.  Case will be reassessed if additional information is received.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Transaminases increased, Vomiting
Clinical narrative: Transaminitis; AST 392; ALT 81 IU/l; Fevers; Nausea; Vomiting; abdominal pain; dose 2 on 05May2021 and first dose on 24Apr2021; dose 2 on 05May2021 and first dose on 24Apr2021; This is a spontaneous report from a contactable physician. A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 2 intramuscular, administered in arm right on 05May2021 16:00 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included bilateral cystic kidney disease, hypertension, allergies to amoxicillin, cephalexin, ceftriaxone. Concomitant medication received within 2 weeks of vaccination included propranolol 30 mg, 3x/day. The patient previously received first dose of BNT162B2 intramuscular in right arm on 24Apr2021 04:00 PM for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced transaminitis, AST 392 IU/l, ALT 81 IU/l; normal bilirubin 0.6 on 06May2021. Fevers starting on 06May2021 to 10May2021 and continued (current at time of reporting) with nausea, vomiting, abdominal pain. These events resulted in Emergency room/department or urgent care. Treatment received for the adverse events included ondansetron; IV bolus. The outcome of events transaminitis, AST 392 IU/l, ALT 81 IU/l, Fevers and abdominal pain was recovering and other events was unknown. Events were reported as non-serious and did not resulted in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating or congenital anomaly/birth defect.  Information on the batch/lot number has been requested.; Sender's Comments: Based on temporal association, a contributory role of BNT162B2  to the reported events cannot be totally excluded.  Case will be reassessed if additional information is received.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Exophthalmos, Photopsia, Vision blurred, Vitreous floaters
Clinical narrative: felt pop in right eye; white light flashes; floaters in left eye; blurry vision; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 2 via an unspecified route of administration, administered in arm right on 05May2021 11:15 (Lot Number: EW0982) as 2nd dose, single for covid-19 immunisation. The patient medical history was none. Concomitant medication included metoprolol succinate ER tablet 25 mg. The patient was not pregnant. The patient previously received first dose of BNT162B2 (lot number EW0153) on 07Apr2021, 11:00 AM in Right arm. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. No known allergies. No other medical history. Within 24 hours of receiving vaccine on 06May2021 12:00 PM, the patient felt pop in right eye and experiencing white light flashes and floaters in left eye, blurry vision. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received. The outcome of events was not recovered.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhagic diathesis, Heavy menstrual bleeding, Increased tendency to bruise
Clinical narrative: ability to bleed and bruise more easily; Heavier than normally menstrual cycle with blood not clumping; ability to bleed and bruise more easily; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in arm right on 15Apr2021 12:30 at age of 26-year-old (Batch/Lot Number: EW0162) at single dose for COVID-19 immunization. Medical history included asthma, diabetes, polycystic ovary syndrome. The patient is not pregnant. The patient had known allergies to latex, berries and seasonal. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Apr2021 at 12:00, the patient experienced heavier than normally menstrual cycle with blood not clumping, and ability to bleed and bruise more easily. The events were reported as non-serious. The events did not resulted in hospitalization prolonged. Treatment was received for the events which included tranexamic acid 650mg for 5 days. The patient received second dose on 08May2021 (Batch/lot number: EW0167) in arm right for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was unknown.   No follow-up attempts are needed. further information is expected
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood bilirubin, Cholelithiasis, Computerised tomogram abdomen, Hepatitis viral test, Jaundice
Clinical narrative: jaundice; itchy skin; evidence of cholelithiasis with absence of pain; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient received the first single dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 15Apr2021 13:00 (Batch/Lot Number: EW0151) for covid-19 immunisation. Medical history included obesity. Concomitant medication(s) included amoxicillin; duloxetine hydrochloride (CYMBALTA); vitamins nos (DAILY MULTIVITAMIN); biotin, all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced jaundice, itchy skin, and evidence of cholelithiasis with absence of pain on 20Apr2021. The patient was hospitalized for the events from 03May2021 to 05May2021. The patient checked herself into Emergency Room with jaundice and itchy skin on 03May2021. No previous history of liver issues or jaundice. Discharged on 05May2021. Diagnosis of hyperbilirubinemia and moderate transaminitis on 03May2021. Viral Hep panel neg; MRCP and CT A/P unrevealing except evidence of cholelithiasis with absence of pain; Autoimmune labs pending; Serial output LFTs pending on 05May2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 on 03May2021 with Nasal Swab, Result: Negative. No treatment received for the events. Outcome of reaction/events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events "jaundice, pruritus and cholelithiasis" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Liver function test, Magnetic resonance cholangiopancreatography, Pruritus, SARS-CoV-2 test, Transaminases
Clinical narrative: jaundice; itchy skin; evidence of cholelithiasis with absence of pain; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient received the first single dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 15Apr2021 13:00 (Batch/Lot Number: EW0151) for covid-19 immunisation. Medical history included obesity. Concomitant medication(s) included amoxicillin; duloxetine hydrochloride (CYMBALTA); vitamins nos (DAILY MULTIVITAMIN); biotin, all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced jaundice, itchy skin, and evidence of cholelithiasis with absence of pain on 20Apr2021. The patient was hospitalized for the events from 03May2021 to 05May2021. The patient checked herself into Emergency Room with jaundice and itchy skin on 03May2021. No previous history of liver issues or jaundice. Discharged on 05May2021. Diagnosis of hyperbilirubinemia and moderate transaminitis on 03May2021. Viral Hep panel neg; MRCP and CT A/P unrevealing except evidence of cholelithiasis with absence of pain; Autoimmune labs pending; Serial output LFTs pending on 05May2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 on 03May2021 with Nasal Swab, Result: Negative. No treatment received for the events. Outcome of reaction/events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events "jaundice, pruritus and cholelithiasis" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer 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: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: Sudden idiopathic hearing loss of the left ear; This is a spontaneous report from a contactable consumer.A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 12Apr2021 11:15 (Batch/Lot Number: ER8729) as 2ND DOSE, SINGLE for covid-19 immunisation.  Medical history included Alcoholism, diverticulosis, allergies Penicillins. Patient previous received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204) in Mar2021 in Right arm for covid-19 immunization. Concomitant medication(s) included naltrexone taken for an unspecified indication, start and stop date were not reported; folic acid taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (VITAMIN B-12) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sudden idiopathic hearing loss of the left ear on 02May2021 12:00 with outcome of not recovered.Therapeutic measures were taken as a result of sudden idiopathic hearing loss of the left ear. Case was reported as serious as Disabling/Incapacitating.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache
Clinical narrative: A minute or so after the shot had mild headache and difficulty breathing for 20-30 seconds.; A minute or so after the shot had mild headache and difficulty breathing for 20-30 seconds.; This is a spontaneous report from a contactable consumer (patient). A 20-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration administered in arm left on 18Apr2021 10:15 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history were none. No known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient experienced a minute or so after the shot had mild headache and difficulty breathing for 20-30 seconds on 18Apr2021 10:15 with outcome of recovered on 18Apr2021. No treatment received. Seriousness criteria of difficulty breathing was medically significant.  Follow-up needed. Information about batch/lot number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: I had a miscarriage and they estimated the baby died at 16 weeks 5 days.; This is a spontaneous report from a contactable consumer (patient). A 36-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 16Apr2021 14:00 (Batch/Lot Number: EW0161) as single dose for COVID-19 immunization. Medical history included allergies penicillin and COVID-19. The patient's concomitant medications included bupropion hydrochloride (WELLBUTRIN) within 2 weeks of vaccination. Last menstrual period (LMP) was reported as 30Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 06May2021 16:00, the patient had a miscarriage and they estimated the baby died at 16 weeks 5 days. There were no genetic disorders detected, so the cause was unknown. Patient thought maybe the vaccine could have something to do with it. The adverse event result in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included fetal demise removal. Outcome of the event was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Thrombosis
Clinical narrative: Pinched middle finger, got a 1/4 diameter blood clot under skin.; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 20Apr2021 12:00 (Batch/Lot Number: er8735) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. The most recent COVID-19 vaccine was administered in facility. The patient experienced pinched middle finger, got a 1/4 diameter blood clot under skin on 09May2021 13:00. Patient was scheduled to go there tomorrow for the second dose. Had an accident yesterday and pinched the right middle finger. Usually when that happens, he gets a boil and it fills with a clear liquid pus. This time, it turned into a giant blood clot, well not giant but about a quarter inch in diameter in the tip of his finger. He has never had that happen before. He may have never damaged his finger in that way before. That is why it turned into a blood clot and not clear fluid. Patient was worried a little with the blood clot because he knew it has been an issue. When he first got a little worried about the blood clot, he thought he would take 2 aspirin and it might thin the blood a little bit. Patient ate some pineapple because he heard that was a blood thinner too. No treatment received for event. The patient underwent lab tests and procedures which included nasal swab: negative on 10Jun2020. Outcome of the event was unknown.  Information on lot/batch number was available. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Myalgia, Vaccination site pain
Clinical narrative: Lots of systemic Sx- Mild H/A; myalgia pretty strong; injection site pain; Fatigue; Poor appetite; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05May2021 at 15:45 (at the age of 61-years-old) as unknown, single for COVID-19 immunisation. Medical history included hypertension (HTN), hypercholesterol, hypothyroidism and possibly cephalosporin allergy. The patient's concomitant medications were not reported. On 06May2021 at 11:00, patient experienced lots of systemic Sx (symptoms)- Mild H/A (headache), myalgia pretty strong, injection site pain (unlike from past vaccines like flu and TPD), fatigue and poor appetite which lasted nearly entire next day after 3:45 pm shot. Patient reported it prevented her from attending to normal activities. No treatment was given to the patient. Patient did not have COVID prior and post vaccination. Outcome of events was recovered on an unspecified date.   Information on lot/ batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Swelling, Urticaria
Clinical narrative: SOB; hives; axilla swelling; This is a spontaneous report from a non-contactable other health professional. This other HCP reported for specific patient that a 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN0161) at the age of 43-years, via an unspecified route of administration on 17Apr2021 at single dose for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 03May2021, the patient experienced hives, axilla swelling and SOB. The events result in emergency room/department or urgent care. The patient received steroids as treatment to the events. Outcome of the events was recovering/resolving.    No follow-up attempts are possible. No further information expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Back disorder, Back pain, Bell's palsy, Chills, Dyspnoea
Clinical narrative: I was suffering from it, I was not able to move my mouth so, I tell my husband I couldn't move; tired; had a chills; it also made my back (incomplete sentence), I have problem with my back; My back pain was worsen; I was getting out of breath too; I can hardly walk; Bell's Palsy/she can move the rest of her body except for her face; paralyzed; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 64-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06May2021 at 10:15 (Batch/Lot Number: ER8736) as single dose for covid-19 immunisation. The medical history and concomitant medications were not reported. On 06May2021 night the patient woke up paralyzed which was what a little bit she can find out was Bell's palsy. The patient was not able to move her mouth so, she tell her husband she couldn't move. The patient was also tired and had a chills too and other than that it also made her back (incomplete sentence), the patient have problem with her back. Her back pain was worsen for some reason. The patient do not know if it was from the shot or what. She have concerns with paralysis. The patient can hardly walk and it was outside and it will take a little while. She got a bad back, a bad her and a bad shoulder. The patient was falling apart. Hopefully she can get a new her and a new shoulder. The patient was getting out of breath too. Other things are tiredness and my back hurting a lot. Yesterday she was like getting tired and out of breath, usually she do not get out of breath like this. The outcome of the events was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Movement disorder, Paralysis
Clinical narrative: I was suffering from it, I was not able to move my mouth so, I tell my husband I couldn't move; tired; had a chills; it also made my back (incomplete sentence), I have problem with my back; My back pain was worsen; I was getting out of breath too; I can hardly walk; Bell's Palsy/she can move the rest of her body except for her face; paralyzed; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 64-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06May2021 at 10:15 (Batch/Lot Number: ER8736) as single dose for covid-19 immunisation. The medical history and concomitant medications were not reported. On 06May2021 night the patient woke up paralyzed which was what a little bit she can find out was Bell's palsy. The patient was not able to move her mouth so, she tell her husband she couldn't move. The patient was also tired and had a chills too and other than that it also made her back (incomplete sentence), the patient have problem with her back. Her back pain was worsen for some reason. The patient do not know if it was from the shot or what. She have concerns with paralysis. The patient can hardly walk and it was outside and it will take a little while. She got a bad back, a bad her and a bad shoulder. The patient was falling apart. Hopefully she can get a new her and a new shoulder. The patient was getting out of breath too. Other things are tiredness and my back hurting a lot. Yesterday she was like getting tired and out of breath, usually she do not get out of breath like this. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Allergy to vaccine, Head discomfort, Hepatic enzyme
Clinical narrative: had an allergic reaction to the vaccine; hard to wrap my head around my body attacking itself; This is a spontaneous report from Pfizer sponsored program Caremark Specialty Pharmacy Sutent and Ibrance Program received from a contactable other HCP and a contactable consumer (Patient).  A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown) on an unspecified date (at the age of 42-year-old) at single dose for COVID-19 immunization. The patient was receiving tofacitinib citrate (XELJANZ XR), oral from 03Mar2021 at 11 mg, daily for rheumatoid arthritis.   Medical history of elevated liver enzymes with previous medications. Concomitant drugs were unknown. Patient reported missed 7 days of tofacitinib citrate after bnt162b2 vaccine administration per Doctor of Medicine instructions. She "had an allergic reaction to the vaccine." Medical director aware. Further she reported hard to wrap her head around her body attacking itself,  she needed to be proactive. She reported "feeling really good," no symptoms of arthritis after started tofacitinib citrate. At the time of reporting  tofacitinib citrate was ongoing and the outcome of the events was unknown.   No follow- up attempts are needed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Cough, Diarrhoea, Headache
Clinical narrative: Fever of 103; chills; sweating; body ache; nausea; vomiting; diarrhea; headache; couch; chest pain; This is a spontaneous report from a contactable consumer for herself. A 17-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 07May2021 17:00 (Lot Number: EW0176) at single dose for COVID-19 immunisation.  Medical history was none. No allergies to medications, food, or other products.  The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. The patient previously received first dose of BNT162B2 (lot number=EW0153) in left arm on 15Apr2021 04:00 PM for COVID-19 immunisation. The patient experienced fever of 103, chills, sweating, body aches, nausea, vomiting, diarrhea, headache, couch, chest pain on 08May2021 13:00 with outcome of not recovered. Events were resulted in doctor or other healthcare professional office/clinic visit. No treatment received. Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Fever of 103; chills; sweating; body ache; nausea; vomiting; diarrhea; headache; couch; chest pain; This is a spontaneous report from a contactable consumer for herself. A 17-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 07May2021 17:00 (Lot Number: EW0176) at single dose for COVID-19 immunisation.  Medical history was none. No allergies to medications, food, or other products.  The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. The patient previously received first dose of BNT162B2 (lot number=EW0153) in left arm on 15Apr2021 04:00 PM for COVID-19 immunisation. The patient experienced fever of 103, chills, sweating, body aches, nausea, vomiting, diarrhea, headache, couch, chest pain on 08May2021 13:00 with outcome of not recovered. Events were resulted in doctor or other healthcare professional office/clinic visit. No treatment received. Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: At the six week mark post 2nd vaccine, developed a severe case of Shingles; This is a spontaneous report from a contactable healthcare professional. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 25Feb2021 00:45 (Batch/Lot Number: EN6202) as 2nd dose, single (at the age of 44 years old) for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously took  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on left arm on 28Jan2021 07:30 PM (lot number:EL8982), on left arm at the age of 44 years old for COVID-19 immunisation. The patient experienced at the six-week mark post 2nd vaccine, developed a severe case of shingles. The patient had muscular adjustments as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19 and not been tested for COVID-19. The outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, SARS-CoV-2 test, Syncope
Clinical narrative: Lightheaded and fainted within 3 minutes of the shot.; Lightheaded and fainted within 3 minutes of the shot.; This is a spontaneous report from a contactable consumer reported for himself. This 38-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10May2021 16:45 Right arm at 1st dose, single (lot: Ew0182) for covid-19 immunisation. Medical history included COVID-19 from 01Feb2021 to 05Mar2021. Prior to vaccination, the patient diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. He experienced Lightheaded and fainted within 3 minutes of the shot on 10May2021. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Lab data included Nasal Swab on 01Feb2021: Positive, on 05Mar2021: Negative. Since the vaccination, the patient has been tested for COVID-19: unknown result. Cat skan was received for the events. Outcome of the events were recovered.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vomiting
Clinical narrative: vomiting; This is a spontaneous report from a non-contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 08May2021 (at the age of 64-years-old) as unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced vomiting on 08May2021. But because he takes other essential medication, he needed to be admitted to the hospital. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 09May2021. Therapeutic measures were taken as a result of vomiting. The event was assessed as serious, hospitalization. The outcome of the event was unknown.    No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Labyrinthitis, Pericarditis, Vertigo
Clinical narrative: Pericarditis found on echo; vestibular labyrinthitis with severe vertigo; vestibular labyrinthitis with severe vertigo; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient (pregnant no) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 05Apr2021 11:00 (Lot Number: ER8734) at age of 55-years-old as 2nd dose, single for COVID-19 immunization.  Medical history included Hypertrophic cardiomyopathy (HCM), Semicircular canal fistula (SSCD). There was known allergies. Concomitant medications included metoprolol (12.5mg); vitamin c [ascorbic acid]; vitamin d nos.  Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6206,) on 15Mar2021 02:45 PM at age of 55-years-old in right arm for Covid-19 immunization. On 07Apr2021 11:00 AM, the patient experienced vestibular labyrinthitis with severe vertigo. It lasted for about a month. Pericarditis found on echo by cardiologist at Clinic. The events resulted in doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The patient underwent lab tests and procedures which included echocardiogram: pericarditis.  Therapeutic measures were taken as a result of the events. Pericarditis: Advil, need another echo. There was no covid prior vaccination. There was no covid tested post vaccination. The outcome of the events was recovering.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: stabbing headache in left temple and ear starting 12 hours after vaccine - would last a few seconds and repeat every few minutes; This is a spontaneous report from a contactable consumer(patient). The 58-year-old male patient received BNT162B2, via an unspecified route of administration on 21Apr2021 15:30 (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation.  Medical history included none. She had no known allergies. There was no covid tested post vaccination, no covid prior vaccination. Concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY).  The patient experienced stabbing headache in left temple and ear starting 12 hours after vaccine - would last a few seconds and repeat every few minutes, ended up in emergency room and physician office on 22Apr2021 02:30, which also led to hospitalization for 1 day with outcome of recovering. Treatment received included pain medication infusion.  Information on the lot/batch number has been requested.