chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Chest discomfort, Dizziness, Echocardiogram, Electrocardiogram, Electrocardiogram abnormal
Clinical narrative: started about 6 hours after - headache, dizzy  at 3 days chest pressure, fast heart beat, rash  Day 7 troponin levels were high at white plains hospital and sent to Montifiore  hospital via ambulance and admitted
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Headache, Loss of personal independence in daily activities, Malaise, Myocarditis, Rash
Clinical narrative: started about 6 hours after - headache, dizzy  at 3 days chest pressure, fast heart beat, rash  Day 7 troponin levels were high at white plains hospital and sent to Montifiore  hospital via ambulance and admitted
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Sleep disorder, Troponin, Troponin abnormal
Clinical narrative: started about 6 hours after - headache, dizzy  at 3 days chest pressure, fast heart beat, rash  Day 7 troponin levels were high at white plains hospital and sent to Montifiore  hospital via ambulance and admitted
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Chest discomfort, Dizziness, Echocardiogram, Electrocardiogram abnormal, Headache
Clinical narrative: started about 6 hours after - headache, dizzy  at 3 days chest pressure, fast heart beat, rash  Day 7 troponin levels were high at white plains hospital and sent to Montifiore  hospital via ambulance and admitted
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Heart rate increased, Rash, Troponin increased
Clinical narrative: started about 6 hours after - headache, dizzy  at 3 days chest pressure, fast heart beat, rash  Day 7 troponin levels were high at white plains hospital and sent to Montifiore  hospital via ambulance and admitted
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood alkaline phosphatase, Blood bilirubin, Blood gases
Clinical narrative: elevated heart rate; shortness of breath; chest pain; This is a spontaneous report from a contactable consumer (Patient) reported that.   A 20-years-old female patient (Non-pregnant) received BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jul2021 17:00 (Lot Number: FA7485) as dose 1, single for covid-19 immunization (Age at vaccination 20 years). The patient past Medical history included Known allergies: Latex, dairy and sulfa (Sulfonamide allergy) from an unknown date and unknown if ongoing. There were no concomitant medications. Facility type vaccine  Pharmacy or Drug Store . Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient was covid tested post vaccination. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient has not received other medications in two weeks. On 14Aug2021 20:00 the patient experienced elevated heart rate, shortness of breath and chest pain. The seriousness criteria are medically significant. Patient received treatment Propranolol 10mg. The events result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: Results: Negative on 16Aug2021. The event outcome was not recovered.  Follow-Up (24Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood lactic acid, Blood thyroid stimulating hormone, Chest X-ray, Chest pain, Computerised tomogram thorax
Clinical narrative: elevated heart rate; shortness of breath; chest pain; This is a spontaneous report from a contactable consumer (Patient) reported that.   A 20-years-old female patient (Non-pregnant) received BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jul2021 17:00 (Lot Number: FA7485) as dose 1, single for covid-19 immunization (Age at vaccination 20 years). The patient past Medical history included Known allergies: Latex, dairy and sulfa (Sulfonamide allergy) from an unknown date and unknown if ongoing. There were no concomitant medications. Facility type vaccine  Pharmacy or Drug Store . Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient was covid tested post vaccination. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient has not received other medications in two weeks. On 14Aug2021 20:00 the patient experienced elevated heart rate, shortness of breath and chest pain. The seriousness criteria are medically significant. Patient received treatment Propranolol 10mg. The events result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: Results: Negative on 16Aug2021. The event outcome was not recovered.  Follow-Up (24Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Differential white blood cell count, Dyspnoea, Electrocardiogram abnormal, Fibrin D dimer, Full blood count
Clinical narrative: elevated heart rate; shortness of breath; chest pain; This is a spontaneous report from a contactable consumer (Patient) reported that.   A 20-years-old female patient (Non-pregnant) received BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jul2021 17:00 (Lot Number: FA7485) as dose 1, single for covid-19 immunization (Age at vaccination 20 years). The patient past Medical history included Known allergies: Latex, dairy and sulfa (Sulfonamide allergy) from an unknown date and unknown if ongoing. There were no concomitant medications. Facility type vaccine  Pharmacy or Drug Store . Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient was covid tested post vaccination. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient has not received other medications in two weeks. On 14Aug2021 20:00 the patient experienced elevated heart rate, shortness of breath and chest pain. The seriousness criteria are medically significant. Patient received treatment Propranolol 10mg. The events result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: Results: Negative on 16Aug2021. The event outcome was not recovered.  Follow-Up (24Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Human chorionic gonadotropin, Laboratory test, Lipase, SARS-CoV-2 test negative
Clinical narrative: elevated heart rate; shortness of breath; chest pain; This is a spontaneous report from a contactable consumer (Patient) reported that.   A 20-years-old female patient (Non-pregnant) received BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jul2021 17:00 (Lot Number: FA7485) as dose 1, single for covid-19 immunization (Age at vaccination 20 years). The patient past Medical history included Known allergies: Latex, dairy and sulfa (Sulfonamide allergy) from an unknown date and unknown if ongoing. There were no concomitant medications. Facility type vaccine  Pharmacy or Drug Store . Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient was covid tested post vaccination. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient has not received other medications in two weeks. On 14Aug2021 20:00 the patient experienced elevated heart rate, shortness of breath and chest pain. The seriousness criteria are medically significant. Patient received treatment Propranolol 10mg. The events result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: Results: Negative on 16Aug2021. The event outcome was not recovered.  Follow-Up (24Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sinus tachycardia, Troponin I
Clinical narrative: elevated heart rate; shortness of breath; chest pain; This is a spontaneous report from a contactable consumer (Patient) reported that.   A 20-years-old female patient (Non-pregnant) received BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jul2021 17:00 (Lot Number: FA7485) as dose 1, single for covid-19 immunization (Age at vaccination 20 years). The patient past Medical history included Known allergies: Latex, dairy and sulfa (Sulfonamide allergy) from an unknown date and unknown if ongoing. There were no concomitant medications. Facility type vaccine  Pharmacy or Drug Store . Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient was covid tested post vaccination. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient has not received other medications in two weeks. On 14Aug2021 20:00 the patient experienced elevated heart rate, shortness of breath and chest pain. The seriousness criteria are medically significant. Patient received treatment Propranolol 10mg. The events result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: Results: Negative on 16Aug2021. The event outcome was not recovered.  Follow-Up (24Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Heart rate increased, SARS-CoV-2 test
Clinical narrative: elevated heart rate; shortness of breath; chest pain; This is a spontaneous report from a contactable consumer (Patient) reported that.   A 20-years-old female patient (Non-pregnant) received BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jul2021 17:00 (Lot Number: FA7485) as dose 1, single for covid-19 immunization (Age at vaccination 20 years). The patient past Medical history included Known allergies: Latex, dairy and sulfa (Sulfonamide allergy) from an unknown date and unknown if ongoing. There were no concomitant medications. Facility type vaccine  Pharmacy or Drug Store . Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient was covid tested post vaccination. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient has not received other medications in two weeks. On 14Aug2021 20:00 the patient experienced elevated heart rate, shortness of breath and chest pain. The seriousness criteria are medically significant. Patient received treatment Propranolol 10mg. The events result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: Results: Negative on 16Aug2021. The event outcome was not recovered.  Follow-Up (24Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Hypoaesthesia, Joint range of motion decreased, Monoplegia, Muscular weakness
Clinical narrative: Paralysis in the hand arm or shoulder; Lack of muscle control in the hand arm and shoulder; Loss of sensation in the hand arm and shoulder; Sharp stabbing pain in shoulder; Numbness and tingling; Numbness and tingling; Overall muscle weakness; Limited range of motions and movements; This is a spontaneous report from a contactable consumer reporting for herself. A 25-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left at the age of 25 years non pregnant on 31Jul2021 (Batch/Lot Number: Ew0164) as DOSE 1, SINGLE for covid-19 immunisation. Facility Type Vaccine: Pharmacy or Drug Store. Medical history included depression, generalised anxiety disorder, sleep disorder, somatic symptom disorder. There were no concomitant medications. The patient experienced paralysis in the hand arm or shoulder (disability) on 01Aug2021 with outcome of not recovered, lack of muscle control in the hand arm and shoulder (disability) on 01Aug2021 with outcome of not recovered, loss of sensation in the hand arm and shoulder(disability) on 01Aug2021 with outcome of not recovered, sharp stabbing pain in shoulder (disability) on 01Aug2021 with outcome of not recovered, numbness and tingling (disability) on 01Aug2021 with outcome of not recovered, overall muscle weakness (disability) on 01Aug2021 with outcome of not recovered and limited range of motions and movements (disability) on 01Aug2021 with outcome of not recovered.  Therapeutic measures were taken as a result of events: oral steroids
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Sensory loss, Ultrasound Doppler
Clinical narrative: Paralysis in the hand arm or shoulder; Lack of muscle control in the hand arm and shoulder; Loss of sensation in the hand arm and shoulder; Sharp stabbing pain in shoulder; Numbness and tingling; Numbness and tingling; Overall muscle weakness; Limited range of motions and movements; This is a spontaneous report from a contactable consumer reporting for herself. A 25-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left at the age of 25 years non pregnant on 31Jul2021 (Batch/Lot Number: Ew0164) as DOSE 1, SINGLE for covid-19 immunisation. Facility Type Vaccine: Pharmacy or Drug Store. Medical history included depression, generalised anxiety disorder, sleep disorder, somatic symptom disorder. There were no concomitant medications. The patient experienced paralysis in the hand arm or shoulder (disability) on 01Aug2021 with outcome of not recovered, lack of muscle control in the hand arm and shoulder (disability) on 01Aug2021 with outcome of not recovered, loss of sensation in the hand arm and shoulder(disability) on 01Aug2021 with outcome of not recovered, sharp stabbing pain in shoulder (disability) on 01Aug2021 with outcome of not recovered, numbness and tingling (disability) on 01Aug2021 with outcome of not recovered, overall muscle weakness (disability) on 01Aug2021 with outcome of not recovered and limited range of motions and movements (disability) on 01Aug2021 with outcome of not recovered.  Therapeutic measures were taken as a result of events: oral steroids
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Hypoaesthesia, Hypokinesia, Muscle disorder, Muscular weakness
Clinical narrative: Paralysis in the hand arm or shoulder; Lack of muscle control in the hand arm and shoulder; Loss of sensation in the hand arm and shoulder; Sharp stabbing pain in shoulder; Numbness and tingling; Numbness and tingling; Overall muscle weakness; Limited range of motions and movements; This is a spontaneous report from a contactable consumer reporting for herself. A 25-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left at the age of 25 years non pregnant on 31Jul2021 (Batch/Lot Number: Ew0164) as DOSE 1, SINGLE for covid-19 immunisation. Facility Type Vaccine: Pharmacy or Drug Store. Medical history included depression, generalised anxiety disorder, sleep disorder, somatic symptom disorder. There were no concomitant medications. The patient experienced paralysis in the hand arm or shoulder (disability) on 01Aug2021 with outcome of not recovered, lack of muscle control in the hand arm and shoulder (disability) on 01Aug2021 with outcome of not recovered, loss of sensation in the hand arm and shoulder(disability) on 01Aug2021 with outcome of not recovered, sharp stabbing pain in shoulder (disability) on 01Aug2021 with outcome of not recovered, numbness and tingling (disability) on 01Aug2021 with outcome of not recovered, overall muscle weakness (disability) on 01Aug2021 with outcome of not recovered and limited range of motions and movements (disability) on 01Aug2021 with outcome of not recovered.  Therapeutic measures were taken as a result of events: oral steroids
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Paralysis, Sensory loss
Clinical narrative: Paralysis in the hand arm or shoulder; Lack of muscle control in the hand arm and shoulder; Loss of sensation in the hand arm and shoulder; Sharp stabbing pain in shoulder; Numbness and tingling; Numbness and tingling; Overall muscle weakness; Limited range of motions and movements; This is a spontaneous report from a contactable consumer reporting for herself. A 25-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left at the age of 25 years non pregnant on 31Jul2021 (Batch/Lot Number: Ew0164) as DOSE 1, SINGLE for covid-19 immunisation. Facility Type Vaccine: Pharmacy or Drug Store. Medical history included depression, generalised anxiety disorder, sleep disorder, somatic symptom disorder. There were no concomitant medications. The patient experienced paralysis in the hand arm or shoulder (disability) on 01Aug2021 with outcome of not recovered, lack of muscle control in the hand arm and shoulder (disability) on 01Aug2021 with outcome of not recovered, loss of sensation in the hand arm and shoulder(disability) on 01Aug2021 with outcome of not recovered, sharp stabbing pain in shoulder (disability) on 01Aug2021 with outcome of not recovered, numbness and tingling (disability) on 01Aug2021 with outcome of not recovered, overall muscle weakness (disability) on 01Aug2021 with outcome of not recovered and limited range of motions and movements (disability) on 01Aug2021 with outcome of not recovered.  Therapeutic measures were taken as a result of events: oral steroids
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Fatigue, Flushing, Head discomfort
Clinical narrative: Passed out twice; Tingling and pain in feet and hands; Heart flip flops; Weird head pressure; Dizziness; Vision change; Light sensitivity; High blood pressure; Chest pain; Weight loss; Very pale; Sweats; Tingling and pain in feet and hands; This is a spontaneous report from a contactable consumer (patient).   A 36-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: unknown) via an unspecified route of administration on 31Jul2021 at 17:00 (at the age of 36-years-old) in left arm as a single dose for covid-19 immunization. Medical history included ehlers-danlos syndrome, postural orthostatic tachycardia syndrome and asthma all from an unknown date and unknown if ongoing. The patient past drug history included cipro. 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. Concomitant medication received within 2 weeks of vaccination included ivabradine hydrochloride (CORLANOR) taken for an unspecified indication, start and stop date were not reported. The patient experienced tingling and pain in feet and hands, heart flip flops, weird head pressure and dizziness, vision change, light sensitivity, high blood pressure, chest pain, sweats, weight loss, passed out twice, very pale on 03Aug2021. The events were reported as non-serious. The patient did not require prolonged hospitalisation. Since the vaccination, the patient was tested for covid-19. The patient underwent lab tests and procedures which included sars-cov-2 PCR test (nasal swab): negative on an unspecified date in 2021. The patient did not receive any treatment. The outcome of all the events at the time of last observation was not resolved.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  and no alternate explanation the causal role of BNT162B2 vaccine cannot be excluded for the reported events  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Hypertension, Loss of consciousness, Pallor, Palpitations
Clinical narrative: Passed out twice; Tingling and pain in feet and hands; Heart flip flops; Weird head pressure; Dizziness; Vision change; Light sensitivity; High blood pressure; Chest pain; Weight loss; Very pale; Sweats; Tingling and pain in feet and hands; This is a spontaneous report from a contactable consumer (patient).   A 36-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: unknown) via an unspecified route of administration on 31Jul2021 at 17:00 (at the age of 36-years-old) in left arm as a single dose for covid-19 immunization. Medical history included ehlers-danlos syndrome, postural orthostatic tachycardia syndrome and asthma all from an unknown date and unknown if ongoing. The patient past drug history included cipro. 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. Concomitant medication received within 2 weeks of vaccination included ivabradine hydrochloride (CORLANOR) taken for an unspecified indication, start and stop date were not reported. The patient experienced tingling and pain in feet and hands, heart flip flops, weird head pressure and dizziness, vision change, light sensitivity, high blood pressure, chest pain, sweats, weight loss, passed out twice, very pale on 03Aug2021. The events were reported as non-serious. The patient did not require prolonged hospitalisation. Since the vaccination, the patient was tested for covid-19. The patient underwent lab tests and procedures which included sars-cov-2 PCR test (nasal swab): negative on an unspecified date in 2021. The patient did not receive any treatment. The outcome of all the events at the time of last observation was not resolved.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  and no alternate explanation the causal role of BNT162B2 vaccine cannot be excluded for the reported events  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Peripheral coldness, Tachycardia
Clinical narrative: Passed out twice; Tingling and pain in feet and hands; Heart flip flops; Weird head pressure; Dizziness; Vision change; Light sensitivity; High blood pressure; Chest pain; Weight loss; Very pale; Sweats; Tingling and pain in feet and hands; This is a spontaneous report from a contactable consumer (patient).   A 36-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: unknown) via an unspecified route of administration on 31Jul2021 at 17:00 (at the age of 36-years-old) in left arm as a single dose for covid-19 immunization. Medical history included ehlers-danlos syndrome, postural orthostatic tachycardia syndrome and asthma all from an unknown date and unknown if ongoing. The patient past drug history included cipro. 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. Concomitant medication received within 2 weeks of vaccination included ivabradine hydrochloride (CORLANOR) taken for an unspecified indication, start and stop date were not reported. The patient experienced tingling and pain in feet and hands, heart flip flops, weird head pressure and dizziness, vision change, light sensitivity, high blood pressure, chest pain, sweats, weight loss, passed out twice, very pale on 03Aug2021. The events were reported as non-serious. The patient did not require prolonged hospitalisation. Since the vaccination, the patient was tested for covid-19. The patient underwent lab tests and procedures which included sars-cov-2 PCR test (nasal swab): negative on an unspecified date in 2021. The patient did not receive any treatment. The outcome of all the events at the time of last observation was not resolved.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  and no alternate explanation the causal role of BNT162B2 vaccine cannot be excluded for the reported events  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Head discomfort, Hyperhidrosis, Hypertension
Clinical narrative: Passed out twice; Tingling and pain in feet and hands; Heart flip flops; Weird head pressure; Dizziness; Vision change; Light sensitivity; High blood pressure; Chest pain; Weight loss; Very pale; Sweats; Tingling and pain in feet and hands; This is a spontaneous report from a contactable consumer (patient).   A 36-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: unknown) via an unspecified route of administration on 31Jul2021 at 17:00 (at the age of 36-years-old) in left arm as a single dose for covid-19 immunization. Medical history included ehlers-danlos syndrome, postural orthostatic tachycardia syndrome and asthma all from an unknown date and unknown if ongoing. The patient past drug history included cipro. 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. Concomitant medication received within 2 weeks of vaccination included ivabradine hydrochloride (CORLANOR) taken for an unspecified indication, start and stop date were not reported. The patient experienced tingling and pain in feet and hands, heart flip flops, weird head pressure and dizziness, vision change, light sensitivity, high blood pressure, chest pain, sweats, weight loss, passed out twice, very pale on 03Aug2021. The events were reported as non-serious. The patient did not require prolonged hospitalisation. Since the vaccination, the patient was tested for covid-19. The patient underwent lab tests and procedures which included sars-cov-2 PCR test (nasal swab): negative on an unspecified date in 2021. The patient did not receive any treatment. The outcome of all the events at the time of last observation was not resolved.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  and no alternate explanation the causal role of BNT162B2 vaccine cannot be excluded for the reported events  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Pain in extremity, Pallor, Palpitations, Paraesthesia
Clinical narrative: Passed out twice; Tingling and pain in feet and hands; Heart flip flops; Weird head pressure; Dizziness; Vision change; Light sensitivity; High blood pressure; Chest pain; Weight loss; Very pale; Sweats; Tingling and pain in feet and hands; This is a spontaneous report from a contactable consumer (patient).   A 36-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: unknown) via an unspecified route of administration on 31Jul2021 at 17:00 (at the age of 36-years-old) in left arm as a single dose for covid-19 immunization. Medical history included ehlers-danlos syndrome, postural orthostatic tachycardia syndrome and asthma all from an unknown date and unknown if ongoing. The patient past drug history included cipro. 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. Concomitant medication received within 2 weeks of vaccination included ivabradine hydrochloride (CORLANOR) taken for an unspecified indication, start and stop date were not reported. The patient experienced tingling and pain in feet and hands, heart flip flops, weird head pressure and dizziness, vision change, light sensitivity, high blood pressure, chest pain, sweats, weight loss, passed out twice, very pale on 03Aug2021. The events were reported as non-serious. The patient did not require prolonged hospitalisation. Since the vaccination, the patient was tested for covid-19. The patient underwent lab tests and procedures which included sars-cov-2 PCR test (nasal swab): negative on an unspecified date in 2021. The patient did not receive any treatment. The outcome of all the events at the time of last observation was not resolved.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  and no alternate explanation the causal role of BNT162B2 vaccine cannot be excluded for the reported events  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Photophobia, SARS-CoV-2 test, Visual impairment, Weight decreased
Clinical narrative: Passed out twice; Tingling and pain in feet and hands; Heart flip flops; Weird head pressure; Dizziness; Vision change; Light sensitivity; High blood pressure; Chest pain; Weight loss; Very pale; Sweats; Tingling and pain in feet and hands; This is a spontaneous report from a contactable consumer (patient).   A 36-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: unknown) via an unspecified route of administration on 31Jul2021 at 17:00 (at the age of 36-years-old) in left arm as a single dose for covid-19 immunization. Medical history included ehlers-danlos syndrome, postural orthostatic tachycardia syndrome and asthma all from an unknown date and unknown if ongoing. The patient past drug history included cipro. 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. Concomitant medication received within 2 weeks of vaccination included ivabradine hydrochloride (CORLANOR) taken for an unspecified indication, start and stop date were not reported. The patient experienced tingling and pain in feet and hands, heart flip flops, weird head pressure and dizziness, vision change, light sensitivity, high blood pressure, chest pain, sweats, weight loss, passed out twice, very pale on 03Aug2021. The events were reported as non-serious. The patient did not require prolonged hospitalisation. Since the vaccination, the patient was tested for covid-19. The patient underwent lab tests and procedures which included sars-cov-2 PCR test (nasal swab): negative on an unspecified date in 2021. The patient did not receive any treatment. The outcome of all the events at the time of last observation was not resolved.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  and no alternate explanation the causal role of BNT162B2 vaccine cannot be excluded for the reported events  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: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Hypoaesthesia, Inappropriate schedule of product administration, Menstrual discomfort, Pain
Clinical narrative: slight nausea; menstruation cycles have been significantly heavier; closer in frequency; more discomfort than usual; This is a spontaneous report from a contactable consumer or other non hcp. A 50-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 10:00 age at vaccination 50 years old (Batch/Lot Number: EW0150) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma, Known allergies: Zithromax polymenorrhoea from 2018 to an unknown date. Concomitant medication(s) included levocetirizine dihydrochloride (XYZAL) taken for an unspecified indication, start and stop date were not reported. The patient previously took zithromax and experienced drug hypersensitivity. The patient did not had COVID prior vaccination and did not have COVID tested post vaccination. The patient did not received other vaccine in 4 weeks. On 23Apr2021 After the first dose, slight nausea, subsided after a few hours. Since the shots, my menstruation cycles have been significantly heavier, closer in frequency (3 weeks instead of 4) with more discomfort than usual. Considering that patient 50 years old, her periods were slowing down since 2018. The patient did not received treatment for the events. Outcome of the event nausea was recovered on unspecified date of 2021 while other events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Polymenorrhoea
Clinical narrative: slight nausea; menstruation cycles have been significantly heavier; closer in frequency; more discomfort than usual; This is a spontaneous report from a contactable consumer or other non hcp. A 50-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 10:00 age at vaccination 50 years old (Batch/Lot Number: EW0150) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma, Known allergies: Zithromax polymenorrhoea from 2018 to an unknown date. Concomitant medication(s) included levocetirizine dihydrochloride (XYZAL) taken for an unspecified indication, start and stop date were not reported. The patient previously took zithromax and experienced drug hypersensitivity. The patient did not had COVID prior vaccination and did not have COVID tested post vaccination. The patient did not received other vaccine in 4 weeks. On 23Apr2021 After the first dose, slight nausea, subsided after a few hours. Since the shots, my menstruation cycles have been significantly heavier, closer in frequency (3 weeks instead of 4) with more discomfort than usual. Considering that patient 50 years old, her periods were slowing down since 2018. The patient did not received treatment for the events. Outcome of the event nausea was recovered on unspecified date of 2021 while other events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Menstrual discomfort, Nausea, Polymenorrhoea
Clinical narrative: slight nausea; menstruation cycles have been significantly heavier; closer in frequency; more discomfort than usual; This is a spontaneous report from a contactable consumer or other non hcp. A 50-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 10:00 age at vaccination 50 years old (Batch/Lot Number: EW0150) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma, Known allergies: Zithromax polymenorrhoea from 2018 to an unknown date. Concomitant medication(s) included levocetirizine dihydrochloride (XYZAL) taken for an unspecified indication, start and stop date were not reported. The patient previously took zithromax and experienced drug hypersensitivity. The patient did not had COVID prior vaccination and did not have COVID tested post vaccination. The patient did not received other vaccine in 4 weeks. On 23Apr2021 After the first dose, slight nausea, subsided after a few hours. Since the shots, my menstruation cycles have been significantly heavier, closer in frequency (3 weeks instead of 4) with more discomfort than usual. Considering that patient 50 years old, her periods were slowing down since 2018. The patient did not received treatment for the events. Outcome of the event nausea was recovered on unspecified date of 2021 while other events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chest pain, Headache, Pain in extremity, Physical examination
Clinical narrative: pressure/pain sensation in her chest and back; pressure/pain sensation in her chest and back; pressure/pain sensation in her chest and back; nausea; This is a spontaneous report from a contactable Consumer or other non-HCP (patient reported for herself). An 85-year-old Elderly female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), dose 1 via an unspecified route of administration on 13Feb2021 (Lot number was not reported), as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced pressure/pain sensation in her chest and back. The clinical details of the events as follows: she received her first dose of Pfizer-Biontech Covid19 vaccine 13Feb2021. Since then, she had reported 2 episodes where she feels like a big pressure/pain sensation in her chest and back, she thought maybe it could be her heart. She also reported slight nausea after her dose. She wanted to know if these symptoms were normal, and if she should still get the second dose. She had a very big pressure sensation in her chest and back- pain at the same time- 30min at a time. She asked there was no reason for her not to get the second dose. The patient outcome of the events was unknown at the time of this report.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chest discomfort, Chest pain, Nausea
Clinical narrative: pressure/pain sensation in her chest and back; pressure/pain sensation in her chest and back; pressure/pain sensation in her chest and back; nausea; This is a spontaneous report from a contactable Consumer or other non-HCP (patient reported for herself). An 85-year-old Elderly female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), dose 1 via an unspecified route of administration on 13Feb2021 (Lot number was not reported), as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced pressure/pain sensation in her chest and back. The clinical details of the events as follows: she received her first dose of Pfizer-Biontech Covid19 vaccine 13Feb2021. Since then, she had reported 2 episodes where she feels like a big pressure/pain sensation in her chest and back, she thought maybe it could be her heart. She also reported slight nausea after her dose. She wanted to know if these symptoms were normal, and if she should still get the second dose. She had a very big pressure sensation in her chest and back- pain at the same time- 30min at a time. She asked there was no reason for her not to get the second dose. The patient outcome of the events was unknown at the time of this report.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Pain in extremity
Clinical narrative: Low platelets:   IVIG infusions (2) - no effect on platelet count   IVIG (1) in hospital - no effect on platelet count   Dexamethasone 4 day 40mg pluse in hospital - no effect on platelet count   Currently being treated with eltrombopag     Started with 25mg - platelets increased gradually to 64,000 over 3.5 weeks, then began dropping     Increased dose to 50mg - platelets increased from 33,000 to 57,000 in one week
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy bone marrow, Condition aggravated, Immunoglobulin therapy, Platelet count decreased
Clinical narrative: Low platelets:   IVIG infusions (2) - no effect on platelet count   IVIG (1) in hospital - no effect on platelet count   Dexamethasone 4 day 40mg pluse in hospital - no effect on platelet count   Currently being treated with eltrombopag     Started with 25mg - platelets increased gradually to 64,000 over 3.5 weeks, then began dropping     Increased dose to 50mg - platelets increased from 33,000 to 57,000 in one week
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Limb injury, Pain in extremity, Vaccination site pruritus
Clinical narrative: she still have numbness on her left arm.; When I woke up I saw that there was a red blotch around the injection site; Sunday she woke up with her left arm swollen,  red and itchy; Sunday she woke up with her left arm swollen,  red and itchy; Sunday she woke up with her left arm swollen, red and itchy/It was so itchy; itching is driving me crazy; sore arm/ the next day it hurt all day/ the day of the injection she felt on her baby toe a terrible pain; This is a spontaneous report from a contactable consumer or other non hcp.   A 60-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 30Apr2021 (Batch/Lot Number: EW0172) as DOSE 1, SINGLE for covid-19 immunisation. (60 years at the age of vaccination).The patient medical history was not reported. The patient's concomitant medications were not reported. The Historical Vaccine include BNT162B2 (1st Dose) for COVID-19 immunisation. The patient experienced sunday she woke up with her left arm swollen, red and itchy/it was so itchy; itching is driving me crazy on 01May2021, sore arm/ the next day it hurt all day/ the day of the injection she felt on her baby toe a terrible pain on 30Apr2021 20:00, when i woke up i saw that there was a red blotch around the injection site on 02May2021, she still have numbness on her left arm. on an unspecified date and sunday she woke up with her left arm swollen,  red and itchy on 01May2021. Therapeutic measures were taken for all events expect the event she still have numbness on her left arm. The outcome for the events Sunday she woke up with her left arm swollen, red and itchy/It was so itchy; itching is driving me crazy, When I woke up I saw that there was a red blotch around the injection site, she still have numbness on her left arm was not resolved and Sunday she woke up with her left arm swollen, red and itchy was Unknown  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site reaction
Clinical narrative: she still have numbness on her left arm.; When I woke up I saw that there was a red blotch around the injection site; Sunday she woke up with her left arm swollen,  red and itchy; Sunday she woke up with her left arm swollen,  red and itchy; Sunday she woke up with her left arm swollen, red and itchy/It was so itchy; itching is driving me crazy; sore arm/ the next day it hurt all day/ the day of the injection she felt on her baby toe a terrible pain; This is a spontaneous report from a contactable consumer or other non hcp.   A 60-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 30Apr2021 (Batch/Lot Number: EW0172) as DOSE 1, SINGLE for covid-19 immunisation. (60 years at the age of vaccination).The patient medical history was not reported. The patient's concomitant medications were not reported. The Historical Vaccine include BNT162B2 (1st Dose) for COVID-19 immunisation. The patient experienced sunday she woke up with her left arm swollen, red and itchy/it was so itchy; itching is driving me crazy on 01May2021, sore arm/ the next day it hurt all day/ the day of the injection she felt on her baby toe a terrible pain on 30Apr2021 20:00, when i woke up i saw that there was a red blotch around the injection site on 02May2021, she still have numbness on her left arm. on an unspecified date and sunday she woke up with her left arm swollen,  red and itchy on 01May2021. Therapeutic measures were taken for all events expect the event she still have numbness on her left arm. The outcome for the events Sunday she woke up with her left arm swollen, red and itchy/It was so itchy; itching is driving me crazy, When I woke up I saw that there was a red blotch around the injection site, she still have numbness on her left arm was not resolved and Sunday she woke up with her left arm swollen, red and itchy was Unknown  No follow-up attempts are possible; information about lot/batch number cannot be obtained.