chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Headache, Loss of consciousness, Mobility decreased, Peripheral swelling
Clinical narrative: Headache; Hives all over/tachycardia hives; tachycardia hives; Lost a lot of weight; Cannot concentrate at school; His hands are swollen; hands are swollen and he can't use them; Passed out and blacked out; This is a spontaneous report from a contactable consumer (patient's mother). A 12-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 15May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history included asthma (the asthma had been dormant for 2 years, he had asthma before he had the vaccine/was given an inhaler for asthma); epilepsy that is under control, but his immune system is low because of the seizures he gets); and had COVID in Oct2020. Concomitant medications included he was given an inhaler (unspecified) for asthma. On 17May2021 (2 days after he got his vaccine), he started getting headache and hives all over. The doctor called it "tachycardia hives". In May2021, her son lost a lot of weight and she took him to karate and he passed out and blacked out. Doctor (pediatric doctor) told her son not to get the 2nd dose right now and recommended to cancel the second dose. The reporter stated that she was stressing out from it because her son could not concentrate at school. His hands were swollen and he could not use them. After receiving the shot he got tachycardia Hives and passed out, blacked out and doctor told her to call Pfizer before he received his 2nd shot. The patient underwent lab tests and procedures which included Covid: positive in Oct2020. The outcome of the events was unknown. The reporter assess the events as non-serious.  Information about batch/lot number is requested.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tachycardia, Urticaria, Weight decreased
Clinical narrative: Headache; Hives all over/tachycardia hives; tachycardia hives; Lost a lot of weight; Cannot concentrate at school; His hands are swollen; hands are swollen and he can't use them; Passed out and blacked out; This is a spontaneous report from a contactable consumer (patient's mother). A 12-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 15May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history included asthma (the asthma had been dormant for 2 years, he had asthma before he had the vaccine/was given an inhaler for asthma); epilepsy that is under control, but his immune system is low because of the seizures he gets); and had COVID in Oct2020. Concomitant medications included he was given an inhaler (unspecified) for asthma. On 17May2021 (2 days after he got his vaccine), he started getting headache and hives all over. The doctor called it "tachycardia hives". In May2021, her son lost a lot of weight and she took him to karate and he passed out and blacked out. Doctor (pediatric doctor) told her son not to get the 2nd dose right now and recommended to cancel the second dose. The reporter stated that she was stressing out from it because her son could not concentrate at school. His hands were swollen and he could not use them. After receiving the shot he got tachycardia Hives and passed out, blacked out and doctor told her to call Pfizer before he received his 2nd shot. The patient underwent lab tests and procedures which included Covid: positive in Oct2020. The outcome of the events was unknown. The reporter assess the events as non-serious.  Information about batch/lot number is requested.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Cold sweat, Dysphagia, Mydriasis, Pallor
Clinical narrative: anaphylactic reaction; about to black out/lost consciousness; cold sweats; had a hard time /trouble swallowing; turning pale; his pupils were dilated; This is a spontaneous report from a contactable Pharmacist via Medical Information. This Pharmacist reported for two patients, this is the first of two reports regards to a male patient.  A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular, administered in left arm on 02Jun2021 between 10:00 and 11:00 am, maybe around 10:30ish (Batch/Lot Number: EW0178; Expiration Date: Aug2021, NDC number: 59267100002) as 1ST DOSE 0.3ML, SINGLE for covid-19 immunisation at pharmacy. The patient medical history and concomitant medications were not reported. No prior vaccinations (within 4 weeks). No additional vaccines administered on same date of the Pfizer suspect. A pharmacist from pharmacy had 2 patients who received the vaccine and both had a reaction after the dose, within one hour after receiving the dose, and EMS was called. The pharmacist confirmed the first patient had the reaction within 1 hour of receiving the dose. She clarified this person was having cold sweats, about to black out, had a hard time and trouble swallowing and was turning pale, his pupils were dilated. Pharmacist explained they make them sit there for 15 minutes after receiving the vaccine so this reaction happened maybe 3 minutes after he got the shot. The EMS came and he was brought to the hospital. The patient did come back afterwards and he said the doctor didn't know 100 percent what happened, but it might been a slight allergic reaction, not to the point where he lost consciousness, but they did release him. She clarified they checked his vitals and everything and released him. When pharmacist was probed for the event, the pharmacist thought it was an anaphylactic reaction. The events require a visit to Emergency Room, patient was brought by EMS. Not had a visit to Physician Office. Unknown if patient received treatment, the pharmacist wasn't be told that much information. The outcome of events was unknown. Causality: In this case, pharmacist did not think so. She thinks maybe it was anxiety but she wouldn't know.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021646208 same reporter, product, different patient and similar events.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: anaphylactic reaction; about to black out/lost consciousness; cold sweats; had a hard time /trouble swallowing; turning pale; his pupils were dilated; This is a spontaneous report from a contactable Pharmacist via Medical Information. This Pharmacist reported for two patients, this is the first of two reports regards to a male patient.  A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular, administered in left arm on 02Jun2021 between 10:00 and 11:00 am, maybe around 10:30ish (Batch/Lot Number: EW0178; Expiration Date: Aug2021, NDC number: 59267100002) as 1ST DOSE 0.3ML, SINGLE for covid-19 immunisation at pharmacy. The patient medical history and concomitant medications were not reported. No prior vaccinations (within 4 weeks). No additional vaccines administered on same date of the Pfizer suspect. A pharmacist from pharmacy had 2 patients who received the vaccine and both had a reaction after the dose, within one hour after receiving the dose, and EMS was called. The pharmacist confirmed the first patient had the reaction within 1 hour of receiving the dose. She clarified this person was having cold sweats, about to black out, had a hard time and trouble swallowing and was turning pale, his pupils were dilated. Pharmacist explained they make them sit there for 15 minutes after receiving the vaccine so this reaction happened maybe 3 minutes after he got the shot. The EMS came and he was brought to the hospital. The patient did come back afterwards and he said the doctor didn't know 100 percent what happened, but it might been a slight allergic reaction, not to the point where he lost consciousness, but they did release him. She clarified they checked his vitals and everything and released him. When pharmacist was probed for the event, the pharmacist thought it was an anaphylactic reaction. The events require a visit to Emergency Room, patient was brought by EMS. Not had a visit to Physician Office. Unknown if patient received treatment, the pharmacist wasn't be told that much information. The outcome of events was unknown. Causality: In this case, pharmacist did not think so. She thinks maybe it was anxiety but she wouldn't know.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021646208 same reporter, product, different patient and similar events.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue, Rash erythematous
Clinical narrative: Red Rash on neck and torso 1-4 days after 2nd shot; other vaccine same date; This is a spontaneous report from a contactable consumer (patient). A 39-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 30May2021 08:00 AM (Batch/Lot Number: EW0167) as 2ND DOSE, SINGLE (ALSO REPORTED AS FIRST DOSE, PENDING CLARIFICATION) for covid-19 immunisation at Hospital. The patient received other Pfizer vaccine on the same date 30May2021 (Lot number: EW0175) as first dose in right arm. Medical history included colitis ulcerative and known allergies to penicillin. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. No Covid prior vaccination. No Covid tested post vaccination. The patient experienced red rash on neck and torso 1-4 days after 2nd shot (as reported) on 31May2021 with outcome of recovering, the treatment for this event included antihistamines.
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Gait inability, Nervous system disorder
Clinical narrative: functioning neurological disorder; not able to walk; it was some issue with her knee; This is a spontaneous report from a contactable consumer (reporting for his sister). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 10May2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. She didn't have any pre-existing conditions. The patient's concomitant medications were not reported. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No Medical history, family medical history relevant to AE or relevant tests. On 11May2021 she was not able to walk, it was some issue with her knee and hospitalized from 11May2021 to 13May2021. The doctors couldn't figure out what was wrong with her so she was sent home. The patient had been to the hospital two times. She was admitted and discharged for not being able to walk and she was admitted on 01Jun2021 for seizure like symptoms and was still in the hospital. The reporter wanted to know what steps he should take to make sure his sister is treated properly. She was diagnosed with functioning neurological disorder and they said it could have been triggered after the vaccine since it happened the day after. She has to have some therapies. She is currently in the hospital and they are monitoring her. She went straight to the emergency room due to seizure like symptoms. The outcome of events was not recovered.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling abnormal, Hepatic enzyme
Clinical narrative: Neuropathy; Fever; Brain fog; Allergies; Chills; Sore throat; Fatigue; Insomnia/Insomnia got worse; Liver enzymes/liver enzymes got worse; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 15May2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included Epstein-Barr, Covid-19 from Mar2020, long haul Covid 19 from Mar2020. The patient received the first dose of bnt162b2, via an unspecified route of administration on 24Apr2021 (Batch/Lot number was not reported) for covid-19 immunisation. The patient's concomitant medications were not reported. Clinical course: She was diagnosed with covid in Mar2020 and had "long haulers syndrome" still having symptoms, like fever, brain fog, neuropathy , allergies ,chills, sore throat, fatigue ( gone away but came back after the second dose) insomnia and liver enzymes, insomnia and liver enzymes got worse with the second dose. It was stated "long haulers " were cured with the covid vaccine. Patient was taking anti-inflammatory and antiviral medications before the vaccine and took in between the first and second dose of the covid vaccine. It was stated that prior to getting the first dose of the vaccine some symptoms of her Covid 19 had gone away finally. It was stated that she was on anti-inflammatory and anti-viral medications for Epstein Barr. She stopped them before she took the vaccine. She went back on them for about a week in between the first and second dose of the vaccine. She then stopped them again before the second dose. Reporter seriousness for events was provided as unspecified. The outcome of events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event neuropathy cannot be completely excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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  committees. and investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Hepatic enzyme abnormal, Hypersensitivity, Insomnia, Neuropathy peripheral, Oropharyngeal pain
Clinical narrative: Neuropathy; Fever; Brain fog; Allergies; Chills; Sore throat; Fatigue; Insomnia/Insomnia got worse; Liver enzymes/liver enzymes got worse; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 15May2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included Epstein-Barr, Covid-19 from Mar2020, long haul Covid 19 from Mar2020. The patient received the first dose of bnt162b2, via an unspecified route of administration on 24Apr2021 (Batch/Lot number was not reported) for covid-19 immunisation. The patient's concomitant medications were not reported. Clinical course: She was diagnosed with covid in Mar2020 and had "long haulers syndrome" still having symptoms, like fever, brain fog, neuropathy , allergies ,chills, sore throat, fatigue ( gone away but came back after the second dose) insomnia and liver enzymes, insomnia and liver enzymes got worse with the second dose. It was stated "long haulers " were cured with the covid vaccine. Patient was taking anti-inflammatory and antiviral medications before the vaccine and took in between the first and second dose of the covid vaccine. It was stated that prior to getting the first dose of the vaccine some symptoms of her Covid 19 had gone away finally. It was stated that she was on anti-inflammatory and anti-viral medications for Epstein Barr. She stopped them before she took the vaccine. She went back on them for about a week in between the first and second dose of the vaccine. She then stopped them again before the second dose. Reporter seriousness for events was provided as unspecified. The outcome of events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event neuropathy cannot be completely excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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  committees. and investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Neuropathy; Fever; Brain fog; Allergies; Chills; Sore throat; Fatigue; Insomnia/Insomnia got worse; Liver enzymes/liver enzymes got worse; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 15May2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included Epstein-Barr, Covid-19 from Mar2020, long haul Covid 19 from Mar2020. The patient received the first dose of bnt162b2, via an unspecified route of administration on 24Apr2021 (Batch/Lot number was not reported) for covid-19 immunisation. The patient's concomitant medications were not reported. Clinical course: She was diagnosed with covid in Mar2020 and had "long haulers syndrome" still having symptoms, like fever, brain fog, neuropathy , allergies ,chills, sore throat, fatigue ( gone away but came back after the second dose) insomnia and liver enzymes, insomnia and liver enzymes got worse with the second dose. It was stated "long haulers " were cured with the covid vaccine. Patient was taking anti-inflammatory and antiviral medications before the vaccine and took in between the first and second dose of the covid vaccine. It was stated that prior to getting the first dose of the vaccine some symptoms of her Covid 19 had gone away finally. It was stated that she was on anti-inflammatory and anti-viral medications for Epstein Barr. She stopped them before she took the vaccine. She went back on them for about a week in between the first and second dose of the vaccine. She then stopped them again before the second dose. Reporter seriousness for events was provided as unspecified. The outcome of events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event neuropathy cannot be completely excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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  committees. and investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Systemic lupus erythematosus
Clinical narrative: Lupus; This is a spontaneous report from a contactable Physician. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 06Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced lupus on an unspecified date. The lupus patient who received second dose of product on 06Apr2021, and resulted in a negative antibody tested in May2021 for Sars-COV-2.  The outcome of the event was unknown.  Information on the batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event systemic lupus erythematosus and the suspect drug BNT 162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Inappropriate schedule of product administration, Product use issue, Pyrexia
Clinical narrative: 104 degree fernhait fever; under 16 and over 12 years of age/received the Pfizer COVID-19 vaccine; Received the second dose of the vaccine 2 weeks apart instead of 3 week from dose 1; This is a spontaneous report from two contactable consumers (patient mother and father). A adolescent male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient took the first dose of BNT162B2 in May2021 for covid-19 immunisation. The patient was under 16 and over 12 years of age. The son of reporter (patient) received the Pfizer COVID-19 vaccine one week earlier then recommended time. The patient received the second dose of the vaccine 2 weeks apart instead of 3 weeks from first dose. Reporter stated the second shot was supposed to be the 07Jun2021. That was when he was supposed to receive is second vaccine. The patient was experiencing 104 degrees fernhait fever. The reporter did not want him to die and asked what could they did. The doctor asked they to call Pfizer as he didn't know anything about the vaccine. The outcome of events was unknown.   Information about lot/batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had Covid in between doses/tested positive for Covid 19; had Covid in between doses/tested positive for Covid 19; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05May2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced had covid in between doses in May2021. It was reported that the patient received the 1st dose of the bnt162b2 and then tested positive for Covid 19. The outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Nephrolithiasis
Clinical narrative: tested positive for COVID19.; tested positive for COVID19.; caller developed several kidney stones; This is a spontaneous report from a contactable consumer (patient). A 62 years old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Mar2021 (at age of 62 years old) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. However post-vaccination, caller developed several kidney stones and tested positive for COVID19. Following his intent to travel internationally, he would like to know if he can still get his 2nd dose or does he have to re-do it given that it was over 70 days (79 days) from his first dose. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Nephrolithiasis
Clinical narrative: tested positive for COVID19.; tested positive for COVID19.; caller developed several kidney stones; This is a spontaneous report from a contactable consumer (patient). A 62 years old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Mar2021 (at age of 62 years old) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. However post-vaccination, caller developed several kidney stones and tested positive for COVID19. Following his intent to travel internationally, he would like to know if he can still get his 2nd dose or does he have to re-do it given that it was over 70 days (79 days) from his first dose. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Nephrolithiasis
Clinical narrative: After he got the vaccine, he got kidney stone; he got a COVID itself now; After he got the vaccine, he got kidney stone; he got a COVID itself now; After he got the vaccine, he got kidney stone; he got a COVID itself now; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 62-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN6200, on 16Mar2021 10:00 at single dose in left arm (at the age of 62-year-old) for COVID-19 immunisation. Medical history included Psoriatic arthropathy and Psoriasis. Concomitant medication included etanercept (ENBREL). The patient got his first dose of Pfizer Vaccine in March just a few months ago, after he got the vaccine, he got kidney stone and he got a COVID itself now he wanted to know since it's been over an two months, he can get a second dose or he had to start all over again. The patient did not have the second dose. No treatment was received for the events. The outcome of all events was resolved in 2021.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Nephrolithiasis
Clinical narrative: After he got the vaccine, he got kidney stone; he got a COVID itself now; After he got the vaccine, he got kidney stone; he got a COVID itself now; After he got the vaccine, he got kidney stone; he got a COVID itself now; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 62-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN6200, on 16Mar2021 10:00 at single dose in left arm (at the age of 62-year-old) for COVID-19 immunisation. Medical history included Psoriatic arthropathy and Psoriasis. Concomitant medication included etanercept (ENBREL). The patient got his first dose of Pfizer Vaccine in March just a few months ago, after he got the vaccine, he got kidney stone and he got a COVID itself now he wanted to know since it's been over an two months, he can get a second dose or he had to start all over again. The patient did not have the second dose. No treatment was received for the events. The outcome of all events was resolved in 2021.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Bronchitis, Chest X-ray, Dyspnoea, Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This 67-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8732), via unspecified route of administration on 06Apr2021 at 10:00 am in left arm as a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included metoprolol taken for an unspecified indication, start and stop date were not reported; omeprazole (PROTONIX) taken for an unspecified indication, start and stop date were not reported. The patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6204), via unspecified route of administration on 16Mar2021 at 10:00 am into left arm as a single dose for COVID-19 immunization. The patient did not have any allergies. Patient did not receive any other vaccine within 4 weeks prior to the vaccine.Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 at 12:00 am, two days after the vaccine, patient experienced shortness of breath and extreme fatigue as well as body aches, sore arm and headaches then went to an emergency clinic, was tested for COVID, and given antibiotics for a bronchitis infection. Patient was extremely exhausted and trouble breathing for 2 months and have been out of work since the vaccine. The patient had a second COVID test as well as bloodwork, chest X-ray with resulting negative. Pulmonary dr next. Ordered pulmonary function test, nuclear lung scan and Doppler with normal result and COVID-19 test (Nasal Swab) on 09Apr2021 with negative result. Patient visited to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity, Pulmonary function test, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This 67-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8732), via unspecified route of administration on 06Apr2021 at 10:00 am in left arm as a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included metoprolol taken for an unspecified indication, start and stop date were not reported; omeprazole (PROTONIX) taken for an unspecified indication, start and stop date were not reported. The patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6204), via unspecified route of administration on 16Mar2021 at 10:00 am into left arm as a single dose for COVID-19 immunization. The patient did not have any allergies. Patient did not receive any other vaccine within 4 weeks prior to the vaccine.Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 at 12:00 am, two days after the vaccine, patient experienced shortness of breath and extreme fatigue as well as body aches, sore arm and headaches then went to an emergency clinic, was tested for COVID, and given antibiotics for a bronchitis infection. Patient was extremely exhausted and trouble breathing for 2 months and have been out of work since the vaccine. The patient had a second COVID test as well as bloodwork, chest X-ray with resulting negative. Pulmonary dr next. Ordered pulmonary function test, nuclear lung scan and Doppler with normal result and COVID-19 test (Nasal Swab) on 09Apr2021 with negative result. Patient visited to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler, Ventilation/perfusion scan
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This 67-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8732), via unspecified route of administration on 06Apr2021 at 10:00 am in left arm as a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included metoprolol taken for an unspecified indication, start and stop date were not reported; omeprazole (PROTONIX) taken for an unspecified indication, start and stop date were not reported. The patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6204), via unspecified route of administration on 16Mar2021 at 10:00 am into left arm as a single dose for COVID-19 immunization. The patient did not have any allergies. Patient did not receive any other vaccine within 4 weeks prior to the vaccine.Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 at 12:00 am, two days after the vaccine, patient experienced shortness of breath and extreme fatigue as well as body aches, sore arm and headaches then went to an emergency clinic, was tested for COVID, and given antibiotics for a bronchitis infection. Patient was extremely exhausted and trouble breathing for 2 months and have been out of work since the vaccine. The patient had a second COVID test as well as bloodwork, chest X-ray with resulting negative. Pulmonary dr next. Ordered pulmonary function test, nuclear lung scan and Doppler with normal result and COVID-19 test (Nasal Swab) on 09Apr2021 with negative result. Patient visited to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Escherichia bacteraemia, Hypotension, Pyelonephritis, Sepsis
Clinical narrative: Postsyncopal episode; Hypotensive; CHF exacerbation; Sepsis; pyelonephritis; E.coli bacteremia; This is a spontaneous report from a non-contactable pharmacist.  A 64-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 08Apr2021 at the age of 64-years-old (Batch/Lot Number: ER8729) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation.  Medical history included atrial fibrillation, diabetes, coronary artery disease (CAD), heart failure with reduced ejection fraction all from an unknown date (HFrEF). Concomitant medication included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported.  It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine. It was unknown if the patient diagnosed with COVID-19 prior to vaccination. It was unknown if the patient had been tested for COVID-19 since the vaccination. On 08Apr2021, the patient experienced post-syncopal episode, hypotensive, CHF (Congestive heart failure) exacerbation and sepsis. Diagnosed: pyelonephritis and E.coli bacteremia, given abx coverage. 11Apr nephrostomy tube placed. 20Apr patient stable to discharge to LTAC. The patient was hospitalized for the events from 08Apr2021 to 20Apr2021. Therapeutic measures were taken included antibiotics, fluid, cardizem, nephrostomy tube. The outcome of the events was resolved in 2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available clinical data, reported events were most likely intercurrent medical conditions not related to vaccination with BNT162B2. Patient's history of diabetes, atrial fibrillation and heart failure are known risk factors for the occurrence of events that patient experienced.  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 Committees, and Investigators, as appropriate.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Postsyncopal episode; Hypotensive; CHF exacerbation; Sepsis; pyelonephritis; E.coli bacteremia; This is a spontaneous report from a non-contactable pharmacist.  A 64-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 08Apr2021 at the age of 64-years-old (Batch/Lot Number: ER8729) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation.  Medical history included atrial fibrillation, diabetes, coronary artery disease (CAD), heart failure with reduced ejection fraction all from an unknown date (HFrEF). Concomitant medication included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported.  It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine. It was unknown if the patient diagnosed with COVID-19 prior to vaccination. It was unknown if the patient had been tested for COVID-19 since the vaccination. On 08Apr2021, the patient experienced post-syncopal episode, hypotensive, CHF (Congestive heart failure) exacerbation and sepsis. Diagnosed: pyelonephritis and E.coli bacteremia, given abx coverage. 11Apr nephrostomy tube placed. 20Apr patient stable to discharge to LTAC. The patient was hospitalized for the events from 08Apr2021 to 20Apr2021. Therapeutic measures were taken included antibiotics, fluid, cardizem, nephrostomy tube. The outcome of the events was resolved in 2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available clinical data, reported events were most likely intercurrent medical conditions not related to vaccination with BNT162B2. Patient's history of diabetes, atrial fibrillation and heart failure are known risk factors for the occurrence of events that patient experienced.  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 Committees, and Investigators, as appropriate.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Brain natriuretic peptide, Brain natriuretic peptide increased, Chest pain, Dyspnoea, Myocarditis
Clinical narrative: myocarditis; pericarditis; SOB; Chest pain; troponins as high as 25; BNP of 150s; This is a spontaneous report from a contactable pharmacist. A 14-year-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular on 26May2021 (Lot Number: EW0197) at the age of 14-year-old as 1st dose, single dose for covid-19 immunisation.  Medical history included Autism, asthma and COVID-19 which was diagnosed prior to vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced pericarditis/myocarditis with "SOB" and Chest pain and troponins as high as 25 and BNP of 150s. All the events occurred on 27May2021 with outcome of not recovered. The patient underwent lab tests and procedures which included COVID-19  IgM (Nasal Swab): negative on 29May2021, COVID-19 IgG (Blood test) positive on 29May2021. The patient received NSAIDS and Opioids as treatment.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported events and the use of BNT162B2 cannot be fully excluded. There is limited information  available, which precludes a more meaningful assessment. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer drug 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: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis, SARS-CoV-2 antibody test, Troponin, Troponin increased
Clinical narrative: myocarditis; pericarditis; SOB; Chest pain; troponins as high as 25; BNP of 150s; This is a spontaneous report from a contactable pharmacist. A 14-year-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular on 26May2021 (Lot Number: EW0197) at the age of 14-year-old as 1st dose, single dose for covid-19 immunisation.  Medical history included Autism, asthma and COVID-19 which was diagnosed prior to vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced pericarditis/myocarditis with "SOB" and Chest pain and troponins as high as 25 and BNP of 150s. All the events occurred on 27May2021 with outcome of not recovered. The patient underwent lab tests and procedures which included COVID-19  IgM (Nasal Swab): negative on 29May2021, COVID-19 IgG (Blood test) positive on 29May2021. The patient received NSAIDS and Opioids as treatment.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported events and the use of BNT162B2 cannot be fully excluded. There is limited information  available, which precludes a more meaningful assessment. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer drug 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood follicle stimulating hormone, Postmenopausal haemorrhage
Clinical narrative: Two weeks after vaccine, I got a period while post-menopausal. Endocrinologist had confirmed menopause in 2019 with FSH 159. I had not menstruated since 2019 at all until vaccine.; This is a spontaneous report from a contactable consumer. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 31Mar2021 02:00 (Batch/Lot Number: ER8733) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Adenomyosis, pelvic mass, hypermobility syndrome, menopause from 2019 to an unknown date Endocrinologist had confirmed menopause in 2019 with FSH 159. I had not menstruated since 2019 at all until vaccine. The patient received first dose of BNT162B2 for COVID-19 immunisation on 10Mar2021 (Batch/lot number: EN6206   Anatomical Location: Arm Left). Concomitant medications included vitamin d [vitamin d nos] (VITAMIN D); vitamin k2 [menaquinone] (VITAMIN K2); cyanocobalamin (VIT B12) taken for an unspecified indication, start and stop date were not reported. The patient previously took penicillin [benzylpenicillin potassium], and sulfonamides and experienced Known allergies. Two weeks after vaccine, I got a period while post-menopausal. Endocrinologist had confirmed menopause in 2019 with FSH 159. I had not menstruated since 2019 at all until vaccine. The patient underwent lab tests and procedures which included blood follicle stimulating hormone: 159 in 2019. Therapeutic measures were taken as a result of the event. The outcome of the event was unknown.   Information on batch/lot number was obtained. Further information has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; This is a spontaneous report from a contactable pharmacist. This Pharmacist reported for two patients. This is the second of two reports regards to a female patient. A 29-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in Deltoid Left on 02Jun2021 (Batch/Lot Number: EW0178; Expiration Date: Aug2021) at the age of 29-year-old, as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications was reported as taking other medication (unspecified). The patient experienced anaphylactic reaction on 02Jun2021. They took her to the hospital. It was reported the vaccine shot was between 11:30 and 12:00 in the morning. The patient experienced anaphylactic reaction literally like may be within 5 minutes after taking the shot. So its again 11:30 or 12:00. The outcome of event was unknown.   Information on Lot/Batch number is available; Further information has been requested.; Sender's Comments: Based on the plausible temporal relationship and known drug safety profile, a possible causal relationship between the event Anaphylactic reaction and suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-2021641495 same reporter, product, different patient and similar events.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: Unable to fully move left arm due to severe pain.; Supraclavicular lymphadenopathy; This is a spontaneous report from a non-contactable consumer (patient). A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 22May2021 17:00 (at the age of 16-year-old) as unknown, single dose for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. There is no known allergies, no other medical history. The patient experienced unable to fully move left arm due to severe pain and supraclavicular lymphadenopathy on 31May2021 09:00. There is no other vaccine in four weeks, no other medications in two weeks. There is no covid prior vaccination. The patient did not test covid post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There is no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. AE resulted in emergency room/department or urgent care. The patient received treatment (Pain reliever) for the adverse event. The outcome of the event was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.