chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Coronary artery disease, Drug screen negative, Echocardiogram abnormal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal
Clinical narrative: positive cardiac enzymes; myocarditis; hypotension 3 days post 2nd vaccination who was admitted; left-sided chest pain; sob; diaphoresis; dizziness; paresthesia's to his hands; transient fever; chills; headache; body aches; This is a spontaneous report from a contactable physician. A 22-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, in the left arm on 17Apr2021 (Batch/Lot Number: ER8731) (at the age of 22-years-old) as a single dose for COVID-19 immunisation as a single dose for COVID-19 immunisation. Medical history included scoliosis from an unknown date and unknown if ongoing , depression from an unknown date and unknown if ongoing. There were no concomitant medications.  The patient previously received the first dose of BNT162b2 on 22Mar2021ont at 08:45 in intramuscularly in the left arm (Lot Number: ER8727) for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. In Apr2021, the patient developed transient fever, chills, headache, and body aches which resolved 24 hours after his 2nd Pfizer vaccine, followed by left-sided chest pain, shortness of breath (SOB), diaphoresis, dizziness, paresthesias to his hands; hypotension 3 days post 2nd vaccination, on 20Apr2021, patient was admitted to hospital with positive cardiac enzymes, initially troponin T baseline at 663, 1 hour follow-up troponin T at 943 with troponin T delta at 42%. A 3-hour troponin T at 1913 with a troponin T3HR delta at 189% and CPK >1000 with the diagnosis of myocarditis. Covid screen was negative, Covid antibody was negative, HIV was negative, drug screen negative and rest of work up for other causes so far negative. On 20Apr2021, he was transferred to another hospital for further cardiac care. Treatments for the events included pressor, cardiac medications, cath, etc. Patient remains hospitalized. In Apr2021, the patient recovered from the events, body aches, headache, chills, transient fever. The patient had not recovered from the events, positive cardiac enzymes, myocarditis, hypotension, left-sided chest pain, SOB, diaphoresis, dizziness, and paresthesias to his hands.; Sender's Comments: A contributory role of BNT162B2 to the reported events cannot be fully excluded based on temporal relationship and lack of alternate explanation at this time. 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: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Epstein-Barr virus antibody negative, HIV test negative, Hepatitis B core antibody negative, Left ventricular end-diastolic pressure increased, Musculoskeletal stiffness
Clinical narrative: positive cardiac enzymes; myocarditis; hypotension 3 days post 2nd vaccination who was admitted; left-sided chest pain; sob; diaphoresis; dizziness; paresthesia's to his hands; transient fever; chills; headache; body aches; This is a spontaneous report from a contactable physician. A 22-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, in the left arm on 17Apr2021 (Batch/Lot Number: ER8731) (at the age of 22-years-old) as a single dose for COVID-19 immunisation as a single dose for COVID-19 immunisation. Medical history included scoliosis from an unknown date and unknown if ongoing , depression from an unknown date and unknown if ongoing. There were no concomitant medications.  The patient previously received the first dose of BNT162b2 on 22Mar2021ont at 08:45 in intramuscularly in the left arm (Lot Number: ER8727) for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. In Apr2021, the patient developed transient fever, chills, headache, and body aches which resolved 24 hours after his 2nd Pfizer vaccine, followed by left-sided chest pain, shortness of breath (SOB), diaphoresis, dizziness, paresthesias to his hands; hypotension 3 days post 2nd vaccination, on 20Apr2021, patient was admitted to hospital with positive cardiac enzymes, initially troponin T baseline at 663, 1 hour follow-up troponin T at 943 with troponin T delta at 42%. A 3-hour troponin T at 1913 with a troponin T3HR delta at 189% and CPK >1000 with the diagnosis of myocarditis. Covid screen was negative, Covid antibody was negative, HIV was negative, drug screen negative and rest of work up for other causes so far negative. On 20Apr2021, he was transferred to another hospital for further cardiac care. Treatments for the events included pressor, cardiac medications, cath, etc. Patient remains hospitalized. In Apr2021, the patient recovered from the events, body aches, headache, chills, transient fever. The patient had not recovered from the events, positive cardiac enzymes, myocarditis, hypotension, left-sided chest pain, SOB, diaphoresis, dizziness, and paresthesias to his hands.; Sender's Comments: A contributory role of BNT162B2 to the reported events cannot be fully excluded based on temporal relationship and lack of alternate explanation at this time. 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: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: N-terminal prohormone brain natriuretic peptide increased, Parvovirus B19 test negative, Pyrexia, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: positive cardiac enzymes; myocarditis; hypotension 3 days post 2nd vaccination who was admitted; left-sided chest pain; sob; diaphoresis; dizziness; paresthesia's to his hands; transient fever; chills; headache; body aches; This is a spontaneous report from a contactable physician. A 22-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, in the left arm on 17Apr2021 (Batch/Lot Number: ER8731) (at the age of 22-years-old) as a single dose for COVID-19 immunisation as a single dose for COVID-19 immunisation. Medical history included scoliosis from an unknown date and unknown if ongoing , depression from an unknown date and unknown if ongoing. There were no concomitant medications.  The patient previously received the first dose of BNT162b2 on 22Mar2021ont at 08:45 in intramuscularly in the left arm (Lot Number: ER8727) for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. In Apr2021, the patient developed transient fever, chills, headache, and body aches which resolved 24 hours after his 2nd Pfizer vaccine, followed by left-sided chest pain, shortness of breath (SOB), diaphoresis, dizziness, paresthesias to his hands; hypotension 3 days post 2nd vaccination, on 20Apr2021, patient was admitted to hospital with positive cardiac enzymes, initially troponin T baseline at 663, 1 hour follow-up troponin T at 943 with troponin T delta at 42%. A 3-hour troponin T at 1913 with a troponin T3HR delta at 189% and CPK >1000 with the diagnosis of myocarditis. Covid screen was negative, Covid antibody was negative, HIV was negative, drug screen negative and rest of work up for other causes so far negative. On 20Apr2021, he was transferred to another hospital for further cardiac care. Treatments for the events included pressor, cardiac medications, cath, etc. Patient remains hospitalized. In Apr2021, the patient recovered from the events, body aches, headache, chills, transient fever. The patient had not recovered from the events, positive cardiac enzymes, myocarditis, hypotension, left-sided chest pain, SOB, diaphoresis, dizziness, and paresthesias to his hands.; Sender's Comments: A contributory role of BNT162B2 to the reported events cannot be fully excluded based on temporal relationship and lack of alternate explanation at this time. 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: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Streptococcus test positive, Toxoplasma serology negative, Tricuspid valve incompetence, Troponin T increased
Clinical narrative: positive cardiac enzymes; myocarditis; hypotension 3 days post 2nd vaccination who was admitted; left-sided chest pain; sob; diaphoresis; dizziness; paresthesia's to his hands; transient fever; chills; headache; body aches; This is a spontaneous report from a contactable physician. A 22-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, in the left arm on 17Apr2021 (Batch/Lot Number: ER8731) (at the age of 22-years-old) as a single dose for COVID-19 immunisation as a single dose for COVID-19 immunisation. Medical history included scoliosis from an unknown date and unknown if ongoing , depression from an unknown date and unknown if ongoing. There were no concomitant medications.  The patient previously received the first dose of BNT162b2 on 22Mar2021ont at 08:45 in intramuscularly in the left arm (Lot Number: ER8727) for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. In Apr2021, the patient developed transient fever, chills, headache, and body aches which resolved 24 hours after his 2nd Pfizer vaccine, followed by left-sided chest pain, shortness of breath (SOB), diaphoresis, dizziness, paresthesias to his hands; hypotension 3 days post 2nd vaccination, on 20Apr2021, patient was admitted to hospital with positive cardiac enzymes, initially troponin T baseline at 663, 1 hour follow-up troponin T at 943 with troponin T delta at 42%. A 3-hour troponin T at 1913 with a troponin T3HR delta at 189% and CPK >1000 with the diagnosis of myocarditis. Covid screen was negative, Covid antibody was negative, HIV was negative, drug screen negative and rest of work up for other causes so far negative. On 20Apr2021, he was transferred to another hospital for further cardiac care. Treatments for the events included pressor, cardiac medications, cath, etc. Patient remains hospitalized. In Apr2021, the patient recovered from the events, body aches, headache, chills, transient fever. The patient had not recovered from the events, positive cardiac enzymes, myocarditis, hypotension, left-sided chest pain, SOB, diaphoresis, dizziness, and paresthesias to his hands.; Sender's Comments: A contributory role of BNT162B2 to the reported events cannot be fully excluded based on temporal relationship and lack of alternate explanation at this time. 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: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood creatine phosphokinase, COVID-19 screening, Chest pain, Chills, Dizziness
Clinical narrative: positive cardiac enzymes; myocarditis; hypotension 3 days post 2nd vaccination who was admitted; left-sided chest pain; sob; diaphoresis; dizziness; paresthesia's to his hands; transient fever; chills; headache; body aches; This is a spontaneous report from a contactable physician. A 22-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, in the left arm on 17Apr2021 (Batch/Lot Number: ER8731) (at the age of 22-years-old) as a single dose for COVID-19 immunisation as a single dose for COVID-19 immunisation. Medical history included scoliosis from an unknown date and unknown if ongoing , depression from an unknown date and unknown if ongoing. There were no concomitant medications.  The patient previously received the first dose of BNT162b2 on 22Mar2021ont at 08:45 in intramuscularly in the left arm (Lot Number: ER8727) for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. In Apr2021, the patient developed transient fever, chills, headache, and body aches which resolved 24 hours after his 2nd Pfizer vaccine, followed by left-sided chest pain, shortness of breath (SOB), diaphoresis, dizziness, paresthesias to his hands; hypotension 3 days post 2nd vaccination, on 20Apr2021, patient was admitted to hospital with positive cardiac enzymes, initially troponin T baseline at 663, 1 hour follow-up troponin T at 943 with troponin T delta at 42%. A 3-hour troponin T at 1913 with a troponin T3HR delta at 189% and CPK >1000 with the diagnosis of myocarditis. Covid screen was negative, Covid antibody was negative, HIV was negative, drug screen negative and rest of work up for other causes so far negative. On 20Apr2021, he was transferred to another hospital for further cardiac care. Treatments for the events included pressor, cardiac medications, cath, etc. Patient remains hospitalized. In Apr2021, the patient recovered from the events, body aches, headache, chills, transient fever. The patient had not recovered from the events, positive cardiac enzymes, myocarditis, hypotension, left-sided chest pain, SOB, diaphoresis, dizziness, and paresthesias to his hands.; Sender's Comments: A contributory role of BNT162B2 to the reported events cannot be fully excluded based on temporal relationship and lack of alternate explanation at this time. 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: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug screen, Dyspnoea, HIV antibody, Headache, Hyperhidrosis
Clinical narrative: positive cardiac enzymes; myocarditis; hypotension 3 days post 2nd vaccination who was admitted; left-sided chest pain; sob; diaphoresis; dizziness; paresthesia's to his hands; transient fever; chills; headache; body aches; This is a spontaneous report from a contactable physician. A 22-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, in the left arm on 17Apr2021 (Batch/Lot Number: ER8731) (at the age of 22-years-old) as a single dose for COVID-19 immunisation as a single dose for COVID-19 immunisation. Medical history included scoliosis from an unknown date and unknown if ongoing , depression from an unknown date and unknown if ongoing. There were no concomitant medications.  The patient previously received the first dose of BNT162b2 on 22Mar2021ont at 08:45 in intramuscularly in the left arm (Lot Number: ER8727) for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. In Apr2021, the patient developed transient fever, chills, headache, and body aches which resolved 24 hours after his 2nd Pfizer vaccine, followed by left-sided chest pain, shortness of breath (SOB), diaphoresis, dizziness, paresthesias to his hands; hypotension 3 days post 2nd vaccination, on 20Apr2021, patient was admitted to hospital with positive cardiac enzymes, initially troponin T baseline at 663, 1 hour follow-up troponin T at 943 with troponin T delta at 42%. A 3-hour troponin T at 1913 with a troponin T3HR delta at 189% and CPK >1000 with the diagnosis of myocarditis. Covid screen was negative, Covid antibody was negative, HIV was negative, drug screen negative and rest of work up for other causes so far negative. On 20Apr2021, he was transferred to another hospital for further cardiac care. Treatments for the events included pressor, cardiac medications, cath, etc. Patient remains hospitalized. In Apr2021, the patient recovered from the events, body aches, headache, chills, transient fever. The patient had not recovered from the events, positive cardiac enzymes, myocarditis, hypotension, left-sided chest pain, SOB, diaphoresis, dizziness, and paresthesias to his hands.; Sender's Comments: A contributory role of BNT162B2 to the reported events cannot be fully excluded based on temporal relationship and lack of alternate explanation at this time. 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: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypotension, Myocardial necrosis marker, Myocardial necrosis marker increased, Myocarditis, Pain
Clinical narrative: positive cardiac enzymes; myocarditis; hypotension 3 days post 2nd vaccination who was admitted; left-sided chest pain; sob; diaphoresis; dizziness; paresthesia's to his hands; transient fever; chills; headache; body aches; This is a spontaneous report from a contactable physician. A 22-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, in the left arm on 17Apr2021 (Batch/Lot Number: ER8731) (at the age of 22-years-old) as a single dose for COVID-19 immunisation as a single dose for COVID-19 immunisation. Medical history included scoliosis from an unknown date and unknown if ongoing , depression from an unknown date and unknown if ongoing. There were no concomitant medications.  The patient previously received the first dose of BNT162b2 on 22Mar2021ont at 08:45 in intramuscularly in the left arm (Lot Number: ER8727) for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. In Apr2021, the patient developed transient fever, chills, headache, and body aches which resolved 24 hours after his 2nd Pfizer vaccine, followed by left-sided chest pain, shortness of breath (SOB), diaphoresis, dizziness, paresthesias to his hands; hypotension 3 days post 2nd vaccination, on 20Apr2021, patient was admitted to hospital with positive cardiac enzymes, initially troponin T baseline at 663, 1 hour follow-up troponin T at 943 with troponin T delta at 42%. A 3-hour troponin T at 1913 with a troponin T3HR delta at 189% and CPK >1000 with the diagnosis of myocarditis. Covid screen was negative, Covid antibody was negative, HIV was negative, drug screen negative and rest of work up for other causes so far negative. On 20Apr2021, he was transferred to another hospital for further cardiac care. Treatments for the events included pressor, cardiac medications, cath, etc. Patient remains hospitalized. In Apr2021, the patient recovered from the events, body aches, headache, chills, transient fever. The patient had not recovered from the events, positive cardiac enzymes, myocarditis, hypotension, left-sided chest pain, SOB, diaphoresis, dizziness, and paresthesias to his hands.; Sender's Comments: A contributory role of BNT162B2 to the reported events cannot be fully excluded based on temporal relationship and lack of alternate explanation at this time. 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: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Pyrexia, SARS-CoV-2 antibody test, SARS-CoV-2 test, Troponin T
Clinical narrative: positive cardiac enzymes; myocarditis; hypotension 3 days post 2nd vaccination who was admitted; left-sided chest pain; sob; diaphoresis; dizziness; paresthesia's to his hands; transient fever; chills; headache; body aches; This is a spontaneous report from a contactable physician. A 22-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, in the left arm on 17Apr2021 (Batch/Lot Number: ER8731) (at the age of 22-years-old) as a single dose for COVID-19 immunisation as a single dose for COVID-19 immunisation. Medical history included scoliosis from an unknown date and unknown if ongoing , depression from an unknown date and unknown if ongoing. There were no concomitant medications.  The patient previously received the first dose of BNT162b2 on 22Mar2021ont at 08:45 in intramuscularly in the left arm (Lot Number: ER8727) for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. In Apr2021, the patient developed transient fever, chills, headache, and body aches which resolved 24 hours after his 2nd Pfizer vaccine, followed by left-sided chest pain, shortness of breath (SOB), diaphoresis, dizziness, paresthesias to his hands; hypotension 3 days post 2nd vaccination, on 20Apr2021, patient was admitted to hospital with positive cardiac enzymes, initially troponin T baseline at 663, 1 hour follow-up troponin T at 943 with troponin T delta at 42%. A 3-hour troponin T at 1913 with a troponin T3HR delta at 189% and CPK >1000 with the diagnosis of myocarditis. Covid screen was negative, Covid antibody was negative, HIV was negative, drug screen negative and rest of work up for other causes so far negative. On 20Apr2021, he was transferred to another hospital for further cardiac care. Treatments for the events included pressor, cardiac medications, cath, etc. Patient remains hospitalized. In Apr2021, the patient recovered from the events, body aches, headache, chills, transient fever. The patient had not recovered from the events, positive cardiac enzymes, myocarditis, hypotension, left-sided chest pain, SOB, diaphoresis, dizziness, and paresthesias to his hands.; Sender's Comments: A contributory role of BNT162B2 to the reported events cannot be fully excluded based on temporal relationship and lack of alternate explanation at this time. 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: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Hemiparesis, Magnetic resonance imaging head abnormal, Thrombosis
Clinical narrative: He completely lost mobility on the left side of his body; Stroke; They found they clot, but could not extract it from what he understood; This is a spontaneous report from a contactable consumer.  A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose (at the age of 46 years old) for COVID-19 immunisation.  The patient has no medical history. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported.  Since his stoke, he is doing better. He completely lost mobility on the left side of his body. His mobility on the left side of his body is slowly coming back. His job is in jeopardy. The doctors told him that there is no guarantee that he will regain full mobility. They did not give him a patient record card. If they did give him one, he left it at the house. He has been in the hospital ever since his stroke. They put him on blood thinners after his stroke. Whenever he was in the ambulance, he did not have high blood pressure. They were able to catch his stroke quick. They found they clot, but could not extract it from what he understood. Adverse events reqiored Emergency Room.  The patient was hospitalized on 01Apr2021. The outcome of clot was unknown and other events was recovering.   Information on the lot/batch number has been requested.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Mobility decreased, Thrombosis
Clinical narrative: He completely lost mobility on the left side of his body; Stroke; They found they clot, but could not extract it from what he understood; This is a spontaneous report from a contactable consumer.  A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose (at the age of 46 years old) for COVID-19 immunisation.  The patient has no medical history. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported.  Since his stoke, he is doing better. He completely lost mobility on the left side of his body. His mobility on the left side of his body is slowly coming back. His job is in jeopardy. The doctors told him that there is no guarantee that he will regain full mobility. They did not give him a patient record card. If they did give him one, he left it at the house. He has been in the hospital ever since his stroke. They put him on blood thinners after his stroke. Whenever he was in the ambulance, he did not have high blood pressure. They were able to catch his stroke quick. They found they clot, but could not extract it from what he understood. Adverse events reqiored Emergency Room.  The patient was hospitalized on 01Apr2021. The outcome of clot was unknown and other events was recovering.   Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Petechiae, Pyrexia, Rash, Rash erythematous, Seizure
Clinical narrative: SEIZURE; RED PETECHIAE ON ABDOMEN; FEVER OF 103; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included stroke from patent foramen ovale (PFO), and concurrent conditions included lupus, epilepsy, menopause, and patent foramen ovale. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 29-APR-2021 at 17:00PM, for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 29-APR-2021, within an hour after vaccination, the patient experienced seizure and about five hours later the patient experienced red petechiae on abdomen and fever of 103 F. The patient consulted doctor and started taking 10 mg of prednisone. The patient's seizures were still spiking; they were trying to control the seizures with Lorazepam. The patient was expecting that prednisone will help. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from seizure, and the outcome of red petechiae on abdomen and fever of 103 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210503252-COVID-19 VACCINE AD26.COV2.S-SEIZURE. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE
Age: 54.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Body temperature, Petechiae, Pyrexia, Seizure
Clinical narrative: SEIZURE; RED PETECHIAE ON ABDOMEN; FEVER OF 103; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included stroke from patent foramen ovale (PFO), and concurrent conditions included lupus, epilepsy, menopause, and patent foramen ovale. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 29-APR-2021 at 17:00PM, for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 29-APR-2021, within an hour after vaccination, the patient experienced seizure and about five hours later the patient experienced red petechiae on abdomen and fever of 103 F. The patient consulted doctor and started taking 10 mg of prednisone. The patient's seizures were still spiking; they were trying to control the seizures with Lorazepam. The patient was expecting that prednisone will help. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from seizure, and the outcome of red petechiae on abdomen and fever of 103 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210503252-COVID-19 VACCINE AD26.COV2.S-SEIZURE. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Activated partial thromboplastin time, Angiogram, Back pain, Dyspnoea, Echocardiogram
Clinical narrative: blood clots and I suffered a pulmonary embolism.; blood clots and I suffered a pulmonary embolism.; pain; Maternal exposure during pregnancy, third trimester; other vaccine same date: Pfizer, Er8732, 03/Mar/2021, dose number 2; This is a spontaneous report from a contactable consumer (patient). A 36-years-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 17:15 (Batch/Lot Number: En6199) as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 03Mar2021 (Batch/Lot Number: Er8732) as single dose for covid-19 immunization. Medical history included ITP as a kid. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient received Synthroid 100mg and Prenatal Vitamin within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was pregnant at the time of vaccination. Her Last menstrual date was 21Jul2020 and delivered on 16Apr2021. Gestational period was 38 weeks. Since the vaccination, the patient has been tested for COVID-19. On 12Apr2021, the patient had tested Oral swab which was Negative and on 23Apr2021, Nasal Swab was tested and result was Negative. On Friday 23Apr2021 21.00, the patient was rushed to ER by ambulance, where they found blood clots and she suffered a pulmonary embolism. She was admired critical and later sent home to manage pain in blood thinners. With zero history of blood clots. AE resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for 3 days. The patient was treated with Hephrin and blood thinners for at least 3 months. The patient was recovered with lasting effects. Outcome of events thrombosis, pulmonary embolism, pain was recovered with sequelae and other events were unknown.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Exposure during pregnancy, Full blood count, Hepatic function abnormal, Hyperhidrosis
Clinical narrative: blood clots and I suffered a pulmonary embolism.; blood clots and I suffered a pulmonary embolism.; pain; Maternal exposure during pregnancy, third trimester; other vaccine same date: Pfizer, Er8732, 03/Mar/2021, dose number 2; This is a spontaneous report from a contactable consumer (patient). A 36-years-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 17:15 (Batch/Lot Number: En6199) as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 03Mar2021 (Batch/Lot Number: Er8732) as single dose for covid-19 immunization. Medical history included ITP as a kid. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient received Synthroid 100mg and Prenatal Vitamin within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was pregnant at the time of vaccination. Her Last menstrual date was 21Jul2020 and delivered on 16Apr2021. Gestational period was 38 weeks. Since the vaccination, the patient has been tested for COVID-19. On 12Apr2021, the patient had tested Oral swab which was Negative and on 23Apr2021, Nasal Swab was tested and result was Negative. On Friday 23Apr2021 21.00, the patient was rushed to ER by ambulance, where they found blood clots and she suffered a pulmonary embolism. She was admired critical and later sent home to manage pain in blood thinners. With zero history of blood clots. AE resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for 3 days. The patient was treated with Hephrin and blood thinners for at least 3 months. The patient was recovered with lasting effects. Outcome of events thrombosis, pulmonary embolism, pain was recovered with sequelae and other events were unknown.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lipase, Metabolic function test, Pulmonary arterial pressure, Pulmonary embolism
Clinical narrative: blood clots and I suffered a pulmonary embolism.; blood clots and I suffered a pulmonary embolism.; pain; Maternal exposure during pregnancy, third trimester; other vaccine same date: Pfizer, Er8732, 03/Mar/2021, dose number 2; This is a spontaneous report from a contactable consumer (patient). A 36-years-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 17:15 (Batch/Lot Number: En6199) as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 03Mar2021 (Batch/Lot Number: Er8732) as single dose for covid-19 immunization. Medical history included ITP as a kid. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient received Synthroid 100mg and Prenatal Vitamin within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was pregnant at the time of vaccination. Her Last menstrual date was 21Jul2020 and delivered on 16Apr2021. Gestational period was 38 weeks. Since the vaccination, the patient has been tested for COVID-19. On 12Apr2021, the patient had tested Oral swab which was Negative and on 23Apr2021, Nasal Swab was tested and result was Negative. On Friday 23Apr2021 21.00, the patient was rushed to ER by ambulance, where they found blood clots and she suffered a pulmonary embolism. She was admired critical and later sent home to manage pain in blood thinners. With zero history of blood clots. AE resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for 3 days. The patient was treated with Hephrin and blood thinners for at least 3 months. The patient was recovered with lasting effects. Outcome of events thrombosis, pulmonary embolism, pain was recovered with sequelae and other events were unknown.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Maternal exposure during pregnancy, Pain, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: blood clots and I suffered a pulmonary embolism.; blood clots and I suffered a pulmonary embolism.; pain; Maternal exposure during pregnancy, third trimester; other vaccine same date: Pfizer, Er8732, 03/Mar/2021, dose number 2; This is a spontaneous report from a contactable consumer (patient). A 36-years-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 17:15 (Batch/Lot Number: En6199) as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 03Mar2021 (Batch/Lot Number: Er8732) as single dose for covid-19 immunization. Medical history included ITP as a kid. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient received Synthroid 100mg and Prenatal Vitamin within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was pregnant at the time of vaccination. Her Last menstrual date was 21Jul2020 and delivered on 16Apr2021. Gestational period was 38 weeks. Since the vaccination, the patient has been tested for COVID-19. On 12Apr2021, the patient had tested Oral swab which was Negative and on 23Apr2021, Nasal Swab was tested and result was Negative. On Friday 23Apr2021 21.00, the patient was rushed to ER by ambulance, where they found blood clots and she suffered a pulmonary embolism. She was admired critical and later sent home to manage pain in blood thinners. With zero history of blood clots. AE resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for 3 days. The patient was treated with Hephrin and blood thinners for at least 3 months. The patient was recovered with lasting effects. Outcome of events thrombosis, pulmonary embolism, pain was recovered with sequelae and other events were unknown.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots and I suffered a pulmonary embolism.; blood clots and I suffered a pulmonary embolism.; pain; Maternal exposure during pregnancy, third trimester; other vaccine same date: Pfizer, Er8732, 03/Mar/2021, dose number 2; This is a spontaneous report from a contactable consumer (patient). A 36-years-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 17:15 (Batch/Lot Number: En6199) as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 03Mar2021 (Batch/Lot Number: Er8732) as single dose for covid-19 immunization. Medical history included ITP as a kid. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient received Synthroid 100mg and Prenatal Vitamin within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was pregnant at the time of vaccination. Her Last menstrual date was 21Jul2020 and delivered on 16Apr2021. Gestational period was 38 weeks. Since the vaccination, the patient has been tested for COVID-19. On 12Apr2021, the patient had tested Oral swab which was Negative and on 23Apr2021, Nasal Swab was tested and result was Negative. On Friday 23Apr2021 21.00, the patient was rushed to ER by ambulance, where they found blood clots and she suffered a pulmonary embolism. She was admired critical and later sent home to manage pain in blood thinners. With zero history of blood clots. AE resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for 3 days. The patient was treated with Hephrin and blood thinners for at least 3 months. The patient was recovered with lasting effects. Outcome of events thrombosis, pulmonary embolism, pain was recovered with sequelae and other events were unknown.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Deafness, Facial paresis, Nerve injury
Clinical narrative: Sudden left sensorineural hearing loss started 3 days after injection Left facial paralysis started 11 days after injection
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Audiogram, Deafness neurosensory, Facial paralysis
Clinical narrative: Sudden left sensorineural hearing loss started 3 days after injection Left facial paralysis started 11 days after injection
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Facial pain, Herpes zoster oticus, Pain of skin, Sensitive skin
Clinical narrative: Ramsay Hunt syndrome; excruciating pain on the left side of my face. Especially deep within my left ear; This is a spontaneous report received a contactable consumer, the patient. A 65-year-old [non-pregnant] elderly female received the first dose of BNT162b2 (solution for injection; Lot EWO162 and expiry information not provided) as a single dose via unspecified route in the left arm on 12Apr2021 at 08:15  (at 65-years-old) for COVID-19 immunisation. Relevant medical history included Hashimoto's disease, Irritable Bowel Syndrome (IBS), and sulfonamide allergy. Concomitant medications sans therapy dates included levothyroxine sodium (SYNTHROID). The patient denied COVID-19 prior to the vaccine and the patient was not pregnant at the time of vaccination. The patient denied receiving any other vaccine within four weeks prior to this vaccine. On 19Apr2021 at 12:00, reported as exactly one week after receiving the vaccine, the patient began to experience an excruciating pain on the left side of her face, especially deep within her left ear. The patient described that it felt like someone was jabbing her with an ice pick in her ear. The patient reported that it was still bad the next day and then subsided a little. The patient went to the doctor on 23Apr2021 where she was diagnosed with Ramsay Hunt syndrome. The patient reported that she had some other side effects shortly after she received the vaccine, but they were nowhere near as bad as this (pending clarification). The events resulted in a visit to the doctor or other healthcare professional office/clinic visit. The patient denied any COVID testing since receiving the vaccine. Treatment for the events included valacyclovir. The outcome of the events vaginal pain, excruciating pain on the left side of her face, and Ramsay Hunt syndrome, was not recovered.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial pain, Herpes zoster oticus
Clinical narrative: Ramsay Hunt syndrome; excruciating pain on the left side of my face. Especially deep within my left ear; This is a spontaneous report received a contactable consumer, the patient. A 65-year-old [non-pregnant] elderly female received the first dose of BNT162b2 (solution for injection; Lot EWO162 and expiry information not provided) as a single dose via unspecified route in the left arm on 12Apr2021 at 08:15  (at 65-years-old) for COVID-19 immunisation. Relevant medical history included Hashimoto's disease, Irritable Bowel Syndrome (IBS), and sulfonamide allergy. Concomitant medications sans therapy dates included levothyroxine sodium (SYNTHROID). The patient denied COVID-19 prior to the vaccine and the patient was not pregnant at the time of vaccination. The patient denied receiving any other vaccine within four weeks prior to this vaccine. On 19Apr2021 at 12:00, reported as exactly one week after receiving the vaccine, the patient began to experience an excruciating pain on the left side of her face, especially deep within her left ear. The patient described that it felt like someone was jabbing her with an ice pick in her ear. The patient reported that it was still bad the next day and then subsided a little. The patient went to the doctor on 23Apr2021 where she was diagnosed with Ramsay Hunt syndrome. The patient reported that she had some other side effects shortly after she received the vaccine, but they were nowhere near as bad as this (pending clarification). The events resulted in a visit to the doctor or other healthcare professional office/clinic visit. The patient denied any COVID testing since receiving the vaccine. Treatment for the events included valacyclovir. The outcome of the events vaginal pain, excruciating pain on the left side of her face, and Ramsay Hunt syndrome, was not recovered.