chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Presyncope, Tachycardia, Tremor
Clinical narrative: flushed; tachycardia; elevated blood pressure; dizziness; This is a spontaneous report from a contactable physician reported for herself. A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Dec2020 (Batch/Lot Number: EK9231) as 1ST dose, single (at the age of 39-year-old)  for COVID-19 immunization. Medical history included Remote history of SVT (supraventricular tachycardia) from an unknown date and Tuberculin skin tests. Concomitant medications included vitamin B complex; vitamin D [vitamin D nos]; minerals nos, vitamins nos (PRENATAL VITAMINS), all taken for an unspecified indication within 2 weeks of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at time of vaccination. The patient experienced immediately flushed, tachycardia, elevated blood pressure, and dizziness after shot on 26Dec2020. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included PCR Nasal Swab: negative on 26Mar2021, Tuberculin skin tests: unknown results on unknown date.  The patient received Prednisone as treatment for the adverse events. The adverse events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Disability or permanent damage. The outcome of events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Antinuclear antibody, Antinuclear antibody positive, Autonomic nervous system imbalance, Blood pressure increased, Burning sensation
Clinical narrative: flushed; tachycardia; elevated blood pressure; dizziness; This is a spontaneous report from a contactable physician reported for herself. A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Dec2020 (Batch/Lot Number: EK9231) as 1ST dose, single (at the age of 39-year-old)  for COVID-19 immunization. Medical history included Remote history of SVT (supraventricular tachycardia) from an unknown date and Tuberculin skin tests. Concomitant medications included vitamin B complex; vitamin D [vitamin D nos]; minerals nos, vitamins nos (PRENATAL VITAMINS), all taken for an unspecified indication within 2 weeks of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at time of vaccination. The patient experienced immediately flushed, tachycardia, elevated blood pressure, and dizziness after shot on 26Dec2020. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included PCR Nasal Swab: negative on 26Mar2021, Tuberculin skin tests: unknown results on unknown date.  The patient received Prednisone as treatment for the adverse events. The adverse events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Disability or permanent damage. The outcome of events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Colitis microscopic, Diarrhoea, Dizziness, Double stranded DNA antibody, Double stranded DNA antibody positive
Clinical narrative: flushed; tachycardia; elevated blood pressure; dizziness; This is a spontaneous report from a contactable physician reported for herself. A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Dec2020 (Batch/Lot Number: EK9231) as 1ST dose, single (at the age of 39-year-old)  for COVID-19 immunization. Medical history included Remote history of SVT (supraventricular tachycardia) from an unknown date and Tuberculin skin tests. Concomitant medications included vitamin B complex; vitamin D [vitamin D nos]; minerals nos, vitamins nos (PRENATAL VITAMINS), all taken for an unspecified indication within 2 weeks of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at time of vaccination. The patient experienced immediately flushed, tachycardia, elevated blood pressure, and dizziness after shot on 26Dec2020. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included PCR Nasal Swab: negative on 26Mar2021, Tuberculin skin tests: unknown results on unknown date.  The patient received Prednisone as treatment for the adverse events. The adverse events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Disability or permanent damage. The outcome of events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Flushing, Hypersensitivity, Malaise, Mast cell activation syndrome
Clinical narrative: flushed; tachycardia; elevated blood pressure; dizziness; This is a spontaneous report from a contactable physician reported for herself. A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Dec2020 (Batch/Lot Number: EK9231) as 1ST dose, single (at the age of 39-year-old)  for COVID-19 immunization. Medical history included Remote history of SVT (supraventricular tachycardia) from an unknown date and Tuberculin skin tests. Concomitant medications included vitamin B complex; vitamin D [vitamin D nos]; minerals nos, vitamins nos (PRENATAL VITAMINS), all taken for an unspecified indication within 2 weeks of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at time of vaccination. The patient experienced immediately flushed, tachycardia, elevated blood pressure, and dizziness after shot on 26Dec2020. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included PCR Nasal Swab: negative on 26Mar2021, Tuberculin skin tests: unknown results on unknown date.  The patient received Prednisone as treatment for the adverse events. The adverse events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Disability or permanent damage. The outcome of events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Muscular weakness, Neuropathy peripheral, Postural orthostatic tachycardia syndrome, SARS-CoV-2 test, Small fibre neuropathy
Clinical narrative: flushed; tachycardia; elevated blood pressure; dizziness; This is a spontaneous report from a contactable physician reported for herself. A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Dec2020 (Batch/Lot Number: EK9231) as 1ST dose, single (at the age of 39-year-old)  for COVID-19 immunization. Medical history included Remote history of SVT (supraventricular tachycardia) from an unknown date and Tuberculin skin tests. Concomitant medications included vitamin B complex; vitamin D [vitamin D nos]; minerals nos, vitamins nos (PRENATAL VITAMINS), all taken for an unspecified indication within 2 weeks of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at time of vaccination. The patient experienced immediately flushed, tachycardia, elevated blood pressure, and dizziness after shot on 26Dec2020. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included PCR Nasal Swab: negative on 26Mar2021, Tuberculin skin tests: unknown results on unknown date.  The patient received Prednisone as treatment for the adverse events. The adverse events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Disability or permanent damage. The outcome of events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Tachycardia, Tuberculin test
Clinical narrative: flushed; tachycardia; elevated blood pressure; dizziness; This is a spontaneous report from a contactable physician reported for herself. A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Dec2020 (Batch/Lot Number: EK9231) as 1ST dose, single (at the age of 39-year-old)  for COVID-19 immunization. Medical history included Remote history of SVT (supraventricular tachycardia) from an unknown date and Tuberculin skin tests. Concomitant medications included vitamin B complex; vitamin D [vitamin D nos]; minerals nos, vitamins nos (PRENATAL VITAMINS), all taken for an unspecified indication within 2 weeks of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at time of vaccination. The patient experienced immediately flushed, tachycardia, elevated blood pressure, and dizziness after shot on 26Dec2020. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included PCR Nasal Swab: negative on 26Mar2021, Tuberculin skin tests: unknown results on unknown date.  The patient received Prednisone as treatment for the adverse events. The adverse events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Disability or permanent damage. The outcome of events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Aldolase normal, Antibody test, Antinuclear antibody positive, Asthenia, Autonomic nervous system imbalance
Clinical narrative: flushed; tachycardia; elevated blood pressure; dizziness; This is a spontaneous report from a contactable physician reported for herself. A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Dec2020 (Batch/Lot Number: EK9231) as 1ST dose, single (at the age of 39-year-old)  for COVID-19 immunization. Medical history included Remote history of SVT (supraventricular tachycardia) from an unknown date and Tuberculin skin tests. Concomitant medications included vitamin B complex; vitamin D [vitamin D nos]; minerals nos, vitamins nos (PRENATAL VITAMINS), all taken for an unspecified indication within 2 weeks of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at time of vaccination. The patient experienced immediately flushed, tachycardia, elevated blood pressure, and dizziness after shot on 26Dec2020. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included PCR Nasal Swab: negative on 26Mar2021, Tuberculin skin tests: unknown results on unknown date.  The patient received Prednisone as treatment for the adverse events. The adverse events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Disability or permanent damage. The outcome of events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Biopsy colon abnormal, Biopsy skin abnormal, Blood catecholamines, Blood pressure increased, Blood thyroid stimulating hormone normal
Clinical narrative: flushed; tachycardia; elevated blood pressure; dizziness; This is a spontaneous report from a contactable physician reported for herself. A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Dec2020 (Batch/Lot Number: EK9231) as 1ST dose, single (at the age of 39-year-old)  for COVID-19 immunization. Medical history included Remote history of SVT (supraventricular tachycardia) from an unknown date and Tuberculin skin tests. Concomitant medications included vitamin B complex; vitamin D [vitamin D nos]; minerals nos, vitamins nos (PRENATAL VITAMINS), all taken for an unspecified indication within 2 weeks of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at time of vaccination. The patient experienced immediately flushed, tachycardia, elevated blood pressure, and dizziness after shot on 26Dec2020. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included PCR Nasal Swab: negative on 26Mar2021, Tuberculin skin tests: unknown results on unknown date.  The patient received Prednisone as treatment for the adverse events. The adverse events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Disability or permanent damage. The outcome of events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Colitis microscopic, Colonoscopy abnormal, Computerised tomogram abdomen, Computerised tomogram thorax normal, Diarrhoea
Clinical narrative: flushed; tachycardia; elevated blood pressure; dizziness; This is a spontaneous report from a contactable physician reported for herself. A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Dec2020 (Batch/Lot Number: EK9231) as 1ST dose, single (at the age of 39-year-old)  for COVID-19 immunization. Medical history included Remote history of SVT (supraventricular tachycardia) from an unknown date and Tuberculin skin tests. Concomitant medications included vitamin B complex; vitamin D [vitamin D nos]; minerals nos, vitamins nos (PRENATAL VITAMINS), all taken for an unspecified indication within 2 weeks of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at time of vaccination. The patient experienced immediately flushed, tachycardia, elevated blood pressure, and dizziness after shot on 26Dec2020. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included PCR Nasal Swab: negative on 26Mar2021, Tuberculin skin tests: unknown results on unknown date.  The patient received Prednisone as treatment for the adverse events. The adverse events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Disability or permanent damage. The outcome of events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Dizziness, Double stranded DNA antibody positive, Electrocardiogram ambulatory, Electromyogram normal, Electrophoresis protein
Clinical narrative: flushed; tachycardia; elevated blood pressure; dizziness; This is a spontaneous report from a contactable physician reported for herself. A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Dec2020 (Batch/Lot Number: EK9231) as 1ST dose, single (at the age of 39-year-old)  for COVID-19 immunization. Medical history included Remote history of SVT (supraventricular tachycardia) from an unknown date and Tuberculin skin tests. Concomitant medications included vitamin B complex; vitamin D [vitamin D nos]; minerals nos, vitamins nos (PRENATAL VITAMINS), all taken for an unspecified indication within 2 weeks of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at time of vaccination. The patient experienced immediately flushed, tachycardia, elevated blood pressure, and dizziness after shot on 26Dec2020. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included PCR Nasal Swab: negative on 26Mar2021, Tuberculin skin tests: unknown results on unknown date.  The patient received Prednisone as treatment for the adverse events. The adverse events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Disability or permanent damage. The outcome of events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Exposure to communicable disease, Fatigue, Fibrin D dimer increased, Flushing, Gait disturbance
Clinical narrative: flushed; tachycardia; elevated blood pressure; dizziness; This is a spontaneous report from a contactable physician reported for herself. A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Dec2020 (Batch/Lot Number: EK9231) as 1ST dose, single (at the age of 39-year-old)  for COVID-19 immunization. Medical history included Remote history of SVT (supraventricular tachycardia) from an unknown date and Tuberculin skin tests. Concomitant medications included vitamin B complex; vitamin D [vitamin D nos]; minerals nos, vitamins nos (PRENATAL VITAMINS), all taken for an unspecified indication within 2 weeks of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at time of vaccination. The patient experienced immediately flushed, tachycardia, elevated blood pressure, and dizziness after shot on 26Dec2020. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included PCR Nasal Swab: negative on 26Mar2021, Tuberculin skin tests: unknown results on unknown date.  The patient received Prednisone as treatment for the adverse events. The adverse events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Disability or permanent damage. The outcome of events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Immediate post-injection reaction, Immunoglobulins normal, Impaired work ability, Inflammation, Magnetic resonance imaging head normal
Clinical narrative: flushed; tachycardia; elevated blood pressure; dizziness; This is a spontaneous report from a contactable physician reported for herself. A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Dec2020 (Batch/Lot Number: EK9231) as 1ST dose, single (at the age of 39-year-old)  for COVID-19 immunization. Medical history included Remote history of SVT (supraventricular tachycardia) from an unknown date and Tuberculin skin tests. Concomitant medications included vitamin B complex; vitamin D [vitamin D nos]; minerals nos, vitamins nos (PRENATAL VITAMINS), all taken for an unspecified indication within 2 weeks of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at time of vaccination. The patient experienced immediately flushed, tachycardia, elevated blood pressure, and dizziness after shot on 26Dec2020. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included PCR Nasal Swab: negative on 26Mar2021, Tuberculin skin tests: unknown results on unknown date.  The patient received Prednisone as treatment for the adverse events. The adverse events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Disability or permanent damage. The outcome of events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging heart, Mobility decreased, Muscular weakness, Myalgia, Neuropathy peripheral
Clinical narrative: flushed; tachycardia; elevated blood pressure; dizziness; This is a spontaneous report from a contactable physician reported for herself. A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Dec2020 (Batch/Lot Number: EK9231) as 1ST dose, single (at the age of 39-year-old)  for COVID-19 immunization. Medical history included Remote history of SVT (supraventricular tachycardia) from an unknown date and Tuberculin skin tests. Concomitant medications included vitamin B complex; vitamin D [vitamin D nos]; minerals nos, vitamins nos (PRENATAL VITAMINS), all taken for an unspecified indication within 2 weeks of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at time of vaccination. The patient experienced immediately flushed, tachycardia, elevated blood pressure, and dizziness after shot on 26Dec2020. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included PCR Nasal Swab: negative on 26Mar2021, Tuberculin skin tests: unknown results on unknown date.  The patient received Prednisone as treatment for the adverse events. The adverse events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Disability or permanent damage. The outcome of events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Oesophagogastroduodenoscopy abnormal, Paraesthesia, Polyarthritis, Postural orthostatic tachycardia syndrome, Scan with contrast normal
Clinical narrative: flushed; tachycardia; elevated blood pressure; dizziness; This is a spontaneous report from a contactable physician reported for herself. A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Dec2020 (Batch/Lot Number: EK9231) as 1ST dose, single (at the age of 39-year-old)  for COVID-19 immunization. Medical history included Remote history of SVT (supraventricular tachycardia) from an unknown date and Tuberculin skin tests. Concomitant medications included vitamin B complex; vitamin D [vitamin D nos]; minerals nos, vitamins nos (PRENATAL VITAMINS), all taken for an unspecified indication within 2 weeks of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at time of vaccination. The patient experienced immediately flushed, tachycardia, elevated blood pressure, and dizziness after shot on 26Dec2020. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included PCR Nasal Swab: negative on 26Mar2021, Tuberculin skin tests: unknown results on unknown date.  The patient received Prednisone as treatment for the adverse events. The adverse events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Disability or permanent damage. The outcome of events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Small fibre neuropathy, Systemic lupus erythematosus, Tachycardia, Tilt table test positive, Urine analysis normal
Clinical narrative: flushed; tachycardia; elevated blood pressure; dizziness; This is a spontaneous report from a contactable physician reported for herself. A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Dec2020 (Batch/Lot Number: EK9231) as 1ST dose, single (at the age of 39-year-old)  for COVID-19 immunization. Medical history included Remote history of SVT (supraventricular tachycardia) from an unknown date and Tuberculin skin tests. Concomitant medications included vitamin B complex; vitamin D [vitamin D nos]; minerals nos, vitamins nos (PRENATAL VITAMINS), all taken for an unspecified indication within 2 weeks of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at time of vaccination. The patient experienced immediately flushed, tachycardia, elevated blood pressure, and dizziness after shot on 26Dec2020. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included PCR Nasal Swab: negative on 26Mar2021, Tuberculin skin tests: unknown results on unknown date.  The patient received Prednisone as treatment for the adverse events. The adverse events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Disability or permanent damage. The outcome of events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Wheelchair user
Clinical narrative: flushed; tachycardia; elevated blood pressure; dizziness; This is a spontaneous report from a contactable physician reported for herself. A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Dec2020 (Batch/Lot Number: EK9231) as 1ST dose, single (at the age of 39-year-old)  for COVID-19 immunization. Medical history included Remote history of SVT (supraventricular tachycardia) from an unknown date and Tuberculin skin tests. Concomitant medications included vitamin B complex; vitamin D [vitamin D nos]; minerals nos, vitamins nos (PRENATAL VITAMINS), all taken for an unspecified indication within 2 weeks of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at time of vaccination. The patient experienced immediately flushed, tachycardia, elevated blood pressure, and dizziness after shot on 26Dec2020. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included PCR Nasal Swab: negative on 26Mar2021, Tuberculin skin tests: unknown results on unknown date.  The patient received Prednisone as treatment for the adverse events. The adverse events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Disability or permanent damage. The outcome of events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Flushing, SARS-CoV-2 test, Tachycardia
Clinical narrative: flushed; tachycardia; elevated blood pressure; dizziness; This is a spontaneous report from a contactable physician reported for herself. A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Dec2020 (Batch/Lot Number: EK9231) as 1ST dose, single (at the age of 39-year-old)  for COVID-19 immunization. Medical history included Remote history of SVT (supraventricular tachycardia) from an unknown date and Tuberculin skin tests. Concomitant medications included vitamin B complex; vitamin D [vitamin D nos]; minerals nos, vitamins nos (PRENATAL VITAMINS), all taken for an unspecified indication within 2 weeks of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at time of vaccination. The patient experienced immediately flushed, tachycardia, elevated blood pressure, and dizziness after shot on 26Dec2020. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included PCR Nasal Swab: negative on 26Mar2021, Tuberculin skin tests: unknown results on unknown date.  The patient received Prednisone as treatment for the adverse events. The adverse events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Disability or permanent damage. The outcome of events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Tuberculin test
Clinical narrative: flushed; tachycardia; elevated blood pressure; dizziness; This is a spontaneous report from a contactable physician reported for herself. A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Dec2020 (Batch/Lot Number: EK9231) as 1ST dose, single (at the age of 39-year-old)  for COVID-19 immunization. Medical history included Remote history of SVT (supraventricular tachycardia) from an unknown date and Tuberculin skin tests. Concomitant medications included vitamin B complex; vitamin D [vitamin D nos]; minerals nos, vitamins nos (PRENATAL VITAMINS), all taken for an unspecified indication within 2 weeks of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at time of vaccination. The patient experienced immediately flushed, tachycardia, elevated blood pressure, and dizziness after shot on 26Dec2020. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included PCR Nasal Swab: negative on 26Mar2021, Tuberculin skin tests: unknown results on unknown date.  The patient received Prednisone as treatment for the adverse events. The adverse events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Disability or permanent damage. The outcome of events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 1.08
Sex: F
Vaccine: HEPA, DTAPHEPBIP, FLU4, HEPA, HIBV, MMR, PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: Gave an expired vaccine. No adverse reaction noted.
Age: 1.08
Sex: F
Vaccine: HEPA, DTAPHEPBIP, FLU4, HEPA, HIBV, MMR, PNC13
Symptoms: Expired product administered
Clinical narrative: Gave an expired vaccine. No adverse reaction noted.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Injection site pain; tiredness; headache; muscle pain; chills; fever; nausea; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EM9809), via unspecified route of administration in left arm on 09Feb2021 (reported as 09Feb2021 06:45 PM), at the age of 65-year-old, as unknown, single for COVID-19 immunisation. The patient was not pregnant. Vaccination facility type was reported as other. The patient's medical history included high blood pressure, atrial fibrillation (Afib) and COVID (prior vaccination). Not yet (NY) known allergies were reported. The patient's concomitant medications in two weeks before BNT162B2 administration included apixaban (ELIQUIS), from unspecified date. No other vaccines were administered in four weeks before BNT162B2 administration. On 09Feb2021 (reported as 09Feb2021 02:00 PM) the patient experienced injection site pain, tiredness, headache, muscle pain, chills, fever and nausea, all reported as non-serious. No treatment was received for the events. The patient was not tested for COVID post vaccination. The outcome of the events was resolving.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Injection site pain; tiredness; headache; muscle pain; chills; fever; nausea; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EM9809), via unspecified route of administration in left arm on 09Feb2021 (reported as 09Feb2021 06:45 PM), at the age of 65-year-old, as unknown, single for COVID-19 immunisation. The patient was not pregnant. Vaccination facility type was reported as other. The patient's medical history included high blood pressure, atrial fibrillation (Afib) and COVID (prior vaccination). Not yet (NY) known allergies were reported. The patient's concomitant medications in two weeks before BNT162B2 administration included apixaban (ELIQUIS), from unspecified date. No other vaccines were administered in four weeks before BNT162B2 administration. On 09Feb2021 (reported as 09Feb2021 02:00 PM) the patient experienced injection site pain, tiredness, headache, muscle pain, chills, fever and nausea, all reported as non-serious. No treatment was received for the events. The patient was not tested for COVID post vaccination. The outcome of the events was resolving.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Injection site pain; tiredness; headache; muscle pain; chills; fever; nausea; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EM9809), via unspecified route of administration in left arm on 09Feb2021 (reported as 09Feb2021 06:45 PM), at the age of 65-year-old, as unknown, single for COVID-19 immunisation. The patient was not pregnant. Vaccination facility type was reported as other. The patient's medical history included high blood pressure, atrial fibrillation (Afib) and COVID (prior vaccination). Not yet (NY) known allergies were reported. The patient's concomitant medications in two weeks before BNT162B2 administration included apixaban (ELIQUIS), from unspecified date. No other vaccines were administered in four weeks before BNT162B2 administration. On 09Feb2021 (reported as 09Feb2021 02:00 PM) the patient experienced injection site pain, tiredness, headache, muscle pain, chills, fever and nausea, all reported as non-serious. No treatment was received for the events. The patient was not tested for COVID post vaccination. The outcome of the events was resolving.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Heart rate increased, Hypertension, Tachycardia, Vision blurred
Clinical narrative: She had a pfizer vaccine and had a reaction where her BP went up high she had rapid heart beat and palpitations.  Tachycardia and blurry vision.  Had a headache overnight. Initial troponin elevated, follow up was less. No chest pain now.No dyspnea.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: She had a pfizer vaccine and had a reaction where her BP went up high she had rapid heart beat and palpitations.  Tachycardia and blurry vision.  Had a headache overnight. Initial troponin elevated, follow up was less. No chest pain now.No dyspnea.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Computerised tomogram, Electrocardiogram, Headache, Heart rate increased
Clinical narrative: She had a pfizer vaccine and had a reaction where her BP went up high she had rapid heart beat and palpitations.  Tachycardia and blurry vision.  Had a headache overnight. Initial troponin elevated, follow up was less. No chest pain now.No dyspnea.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Metabolic function test, Tachycardia, Troponin, Troponin I increased, Vision blurred
Clinical narrative: She had a pfizer vaccine and had a reaction where her BP went up high she had rapid heart beat and palpitations.  Tachycardia and blurry vision.  Had a headache overnight. Initial troponin elevated, follow up was less. No chest pain now.No dyspnea.