chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Fatigue, Nasal discomfort
Clinical narrative: developed Covid.; developed Covid.; terrible sore throat; stuffy nose; sinus pain; aches; fatigue; still had an annoying cough.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 59 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "developed Covid."; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "terrible sore throat"; NASAL DISCOMFORT (non-serious), outcome "unknown", described as "stuffy nose"; SINUS PAIN (non-serious), outcome "unknown", described as "sinus pain"; PAIN (non-serious), outcome "unknown", described as "aches"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; COUGH (non-serious), outcome "unknown", described as "still had an annoying cough.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. He did not have to go to the hospital, but suffered and tested positive for 10 days. After 3 weeks, he still had an annoying cough.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, SARS-CoV-2 test, Sinus pain
Clinical narrative: developed Covid.; developed Covid.; terrible sore throat; stuffy nose; sinus pain; aches; fatigue; still had an annoying cough.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 59 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "developed Covid."; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "terrible sore throat"; NASAL DISCOMFORT (non-serious), outcome "unknown", described as "stuffy nose"; SINUS PAIN (non-serious), outcome "unknown", described as "sinus pain"; PAIN (non-serious), outcome "unknown", described as "aches"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; COUGH (non-serious), outcome "unknown", described as "still had an annoying cough.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. He did not have to go to the hospital, but suffered and tested positive for 10 days. After 3 weeks, he still had an annoying cough.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Autopsy, Body mass index, Gene sequencing, Investigation, Microscopy
Clinical narrative: Myocarditis; This is a literature report.  An adolescent male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE,  MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (death), outcome "fatal", described as "Myocarditis". The patient underwent the following laboratory tests and procedures: autopsy: microscopic myocardial findings, notes: There was global myocardial injury similar to that  seen above, but with more widespread transmural  ischemic changes and more interstitial  inflammation, again with a predominant neutrophil  component with histiocytes and scant lymphocytes; body mass index: 30; gene sequencing: unknown results; investigation: several  sections had transmural, confluent areas, notes: of contraction bands apart from any inflammation, and florid neutrophilic inflammation with some histiocytes. In this case, a subepicardial distribution of injury was not seen.There were no acute or organizing thrombi; 520 grams with  biventricular dilatation and, notes: marked pulm onary  edema (combined  lung weight=1481  grams); microscopy: microscopic findings are not the alterations seen, notes: with typical myocarditis. This suggest a role for cytokine storm which may occur with an excessive inflammatory response, as there also is a feedback loop between catecholamines and cytokines; sars-cov-2 test: pcr tissue testing performed by the cdc on heart, notes: lung found no molecular evidence of SARS-CoV-2 infection; toxicologic test: negative for medications and drugs of abuse. Therapeutic measures were not taken as a result of myocarditis. The patient date of death was unknown. The reported cause of death was myocarditis. The autopsy revealed "biventricular dilatation" (dilatation ventricular); "pulmonary edema" (pulmonary oedema); "global myocardial injury" (myocardial injury).; Sender's Comments: Based on the currently available information the possibility of causal association between the event Myocarditis and the suspect drug BNT162B2  cannot be ruled out. 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.,Linked Report(s) : PFIZER INC-202200276862 Same drug/event, different patient; Reported Cause(s) of Death: Myocarditis; Autopsy-determined Cause(s) of Death: biventricular dilatation; pulmonary edema; global myocardial injury
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, SARS-CoV-2 test, Toxicologic test
Clinical narrative: Myocarditis; This is a literature report.  An adolescent male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE,  MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (death), outcome "fatal", described as "Myocarditis". The patient underwent the following laboratory tests and procedures: autopsy: microscopic myocardial findings, notes: There was global myocardial injury similar to that  seen above, but with more widespread transmural  ischemic changes and more interstitial  inflammation, again with a predominant neutrophil  component with histiocytes and scant lymphocytes; body mass index: 30; gene sequencing: unknown results; investigation: several  sections had transmural, confluent areas, notes: of contraction bands apart from any inflammation, and florid neutrophilic inflammation with some histiocytes. In this case, a subepicardial distribution of injury was not seen.There were no acute or organizing thrombi; 520 grams with  biventricular dilatation and, notes: marked pulm onary  edema (combined  lung weight=1481  grams); microscopy: microscopic findings are not the alterations seen, notes: with typical myocarditis. This suggest a role for cytokine storm which may occur with an excessive inflammatory response, as there also is a feedback loop between catecholamines and cytokines; sars-cov-2 test: pcr tissue testing performed by the cdc on heart, notes: lung found no molecular evidence of SARS-CoV-2 infection; toxicologic test: negative for medications and drugs of abuse. Therapeutic measures were not taken as a result of myocarditis. The patient date of death was unknown. The reported cause of death was myocarditis. The autopsy revealed "biventricular dilatation" (dilatation ventricular); "pulmonary edema" (pulmonary oedema); "global myocardial injury" (myocardial injury).; Sender's Comments: Based on the currently available information the possibility of causal association between the event Myocarditis and the suspect drug BNT162B2  cannot be ruled out. 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.,Linked Report(s) : PFIZER INC-202200276862 Same drug/event, different patient; Reported Cause(s) of Death: Myocarditis; Autopsy-determined Cause(s) of Death: biventricular dilatation; pulmonary edema; global myocardial injury
Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Fatigue, Hypoaesthesia oral, Suspected COVID-19
Clinical narrative: COVID-19; drug ineffective; Tired; lips and tongue were numb; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4272790-00.  A 47 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 17Apr2021 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous since 2018 (ongoing) (Lot number: 1153257). The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: SUSPECTED COVID-19 (medically significant) with onset Dec2021, outcome "unknown", described as "COVID-19"; DRUG INEFFECTIVE (medically significant) with onset Dec2021, outcome "unknown", described as "drug ineffective"; FATIGUE (non-serious) with onset Apr2021, outcome "unknown", described as "Tired"; HYPOAESTHESIA ORAL (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "lips and tongue were numb". The action taken for adalimumab was dosage not changed.  Additional information: Solicited report  by a consumer of a 47-year-old female with events of non-serious tired after getting off working the night shift, lips and tongue were numb and Covid-19 with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced tired after getting off of working the night shift. On an unknown date, lips and tongue were numb resolved. Pfizer Biontech Covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. Causality for Humira (Adalimumab) the reporter's causality for the events of tired getting off of working the night shift, lips and tongue were numb and Covid-19 was not provided, and Action taken with drug for all events dose not changed.  The reporter's assessment of the causal relationship of the event with the suspect product Pfizer Biontech Covid-19 Vaccine (Tozinameran) BNT162B2 was probable at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; 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 serious events fatigue, hypoaesthesia oral, drug ineffective and suspected COVID-19 cannot be totally excluded.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain, Psoriatic arthropathy
Clinical narrative: psoriatic arthritis flare up; achy; chills; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4271535-00 (AbbVie).  A 44 year-old patient received bnt162b2 (BNT162B2), intramuscular, administration date 04Mar2021 (Batch/Lot number: unknown) at the age of 44 years as dose 1, single and intramuscular, administration date 25Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Lot number: 1155994) at citrate free for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "not recovered", described as "psoriatic arthritis flare up"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "achy"; CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "chills". The action taken for adalimumab was dosage not changed.  The reporter's causality for the event(s) of Psoriatic arthritis flare up with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of Achy due to covid vaccine and Chills due to covid vaccine with HUMIRA(ADALIMUMAB) was no reasonable possibility.  The reporter's causality for the event(s) of Psoriatic arthritis flare up, Achy due to covid vaccine and Chills due to covid vaccine due to covid vaccine with bnt162b2 (BNT162B2) was not related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 76.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthenia, COVID-19, Cough, Drug ineffective, Fatigue
Clinical narrative: COVID-19 positive; COVID-19 positive; weak; tired; cough; gout worsend; psoriasis break out on left side of stomach; felt like truck hit and ran over again; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4240023-00 (AbbVie).  A 76 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Sep2021 (Batch/Lot number: unknown) at the age of 76 years as dose 3 (booster), single, intramuscular, administration date 11Mar2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 18Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Batch/Lot number: unknown) and second regimen subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovering" and all described as "COVID-19 positive"; ASTHENIA (non-serious), outcome "unknown", described as "weak"; FATIGUE (non-serious), outcome "unknown", described as "tired"; COUGH (non-serious), outcome "unknown", described as "cough"; GOUT (non-serious), outcome "not recovered", described as "gout worsend"; PSORIASIS (non-serious), outcome "recovering", described as "psoriasis break out on left side of stomach"; SENSORY DISTURBANCE (non-serious), outcome "unknown", described as "felt like truck hit and ran over again". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The action taken for adalimumab was dosage permanently withdrawn.  The reporter causality for all events with BNT162B2 was not reported.  The reporter causality for the events of covid-19 positive, weak, tired, cough, psoriasis break out on left side of stomach and felt like truck hit and ran over again, gout worsened with Humira (adalimumab) was a reasonable possibility.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2. 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: 76.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Gout, Psoriasis, SARS-CoV-2 test, Sensory disturbance
Clinical narrative: COVID-19 positive; COVID-19 positive; weak; tired; cough; gout worsend; psoriasis break out on left side of stomach; felt like truck hit and ran over again; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4240023-00 (AbbVie).  A 76 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Sep2021 (Batch/Lot number: unknown) at the age of 76 years as dose 3 (booster), single, intramuscular, administration date 11Mar2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 18Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Batch/Lot number: unknown) and second regimen subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovering" and all described as "COVID-19 positive"; ASTHENIA (non-serious), outcome "unknown", described as "weak"; FATIGUE (non-serious), outcome "unknown", described as "tired"; COUGH (non-serious), outcome "unknown", described as "cough"; GOUT (non-serious), outcome "not recovered", described as "gout worsend"; PSORIASIS (non-serious), outcome "recovering", described as "psoriasis break out on left side of stomach"; SENSORY DISTURBANCE (non-serious), outcome "unknown", described as "felt like truck hit and ran over again". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The action taken for adalimumab was dosage permanently withdrawn.  The reporter causality for all events with BNT162B2 was not reported.  The reporter causality for the events of covid-19 positive, weak, tired, cough, psoriasis break out on left side of stomach and felt like truck hit and ran over again, gout worsened with Humira (adalimumab) was a reasonable possibility.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Sinusitis, Vaccination failure
Clinical narrative: Sinus infection; COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4275676-00 (AbbVie).  A 59 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 09Oct2021 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single, intramuscular, administration date 11Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 10Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1155481) at citrate free for ankylosing spondylitis, rheumatoid arthritis. The patient's relevant medical history was not reported. There were no concomitant medications. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: VACCINATION FAILURE (medically significant) with onset Jan2022, outcome "unknown", COVID-19 (medically significant) with onset Jan2022, outcome "recovering" and all described as "COVID-19"; SINUSITIS (non-serious), outcome "recovering", described as "Sinus infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive. The action taken for adalimumab was unknown.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of COVID and SINUS INFECTION with HUMIRA(ADALIMUMAB) was no reasonable possibility.  Causality for PFIZER BIONTECH COVID-19: The reporter's causality for the event(s) of COVID and SINUS INFECTION with BNT162B2 was possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided there is a reasonable possibility of causal association between the events and the suspect product bnt162b2
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: significant arthritic pain in both hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 66-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 10Feb2021 13:00 (Lot number: EN6201) at the age of 66 years as dose 1, single for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ARTHRALGIA (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "significant arthritic pain in both hands". Therapeutic measures were taken as a result of arthralgia.  Additional information: The patient did not take any Prior Vaccinations to covid-19 vaccination. No relevant tests were none. Patient needed steady Intake of Advil or Tylenol.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Pain, Pain in extremity
Clinical narrative: large lump appeared under my right arm / The lump covered from the mid part of my under arm to the beginning of my right breast; pulsated pain under my right arm; Lump is about 4" in diameter soft around hard in the middle and painful; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Feb2022 (Lot number: FK9896) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). Concomitant medication(s) included: ZINC; VITAMIN C [ASCORBIC ACID]. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Feb2022 08:00, outcome "not recovered", described as "pulsated pain under my right arm"; AXILLARY MASS (non-serious) with onset 13Feb2022, outcome "not recovered", described as "large lump appeared under my right arm / The lump covered from the mid part of my under arm to the beginning of my right breast"; PAIN (non-serious) with onset Feb2022, outcome "not recovered", described as "Lump is about 4" in diameter soft around hard in the middle and painful". The events "pulsated pain under my right arm", "large lump appeared under my right arm / the lump covered from the mid part of my under arm to the beginning of my right breast" and "lump is about 4" in diameter soft around hard in the middle and painful" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity, axillary mass, pain.  Additional Information: 12Feb around 8 am I began to feel pulsated pain under my right arm and the next day a large lump appeared under my right arm on 13Feb2022 of Feb 2 days after I received the vaccine but, the lump covered from the mid part of my under arm to the beginning of my right breast. Lump is about 4" in diameter soft around hard in the middle and painful. I went to the doctor Monday the doctor prescribed me antibiotics Cephalexin 500mg capsules 1 every 8 hrs. for 10days and wants to see me back in 14Mar2022. AE treatment, doctor prescribed Cephalexin 500mg capsules. No covid prior vaccination. Covid not tested post vaccination. Known allergie to latex. Other medical history includes high blood pressure.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Brain natriuretic peptide, C-reactive protein, Cytomegalovirus test, Electrocardiogram
Clinical narrative: T wave inversion in lateral leads and ST segment elevation in V2-V6; This is a literature report  A 14 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERICARDITIS (medically significant), outcome "unknown", described as "T wave inversion in lateral leads and ST segment elevation in V2-V6". The patient underwent the following laboratory tests and procedures: blood test: negative; brain natriuretic peptide: 37 pg/mL; c-reactive protein: 5.03 mg/dl; 5.03 mg/dl, notes: on admission; 4.04 mg/dl, notes: on discharge; cytomegalovirus test: negative; electrocardiogram: t wave inversion, notes: in lateral leads and ST segment elevation in V2-V6; epstein-barr virus test: negative; influenza a virus test: negative; investigation: negative; parvovirus b19 test: negative; polymerase chain reaction: negative; respiratory syncytial virus test: negative; troponin i: 7.61 ng/dL; 5.52 ng/dL, notes: on admission; 3.68 ng/dL, notes: on discharge.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200257419 same article/drug/event and different patient;US-PFIZER INC-202200283444 same article/drug and different patient /event
Sex: M
Vaccine: COVID19
Symptoms: Epstein-Barr virus test, Influenza A virus test, Investigation, Parvovirus B19 test, Pericarditis
Clinical narrative: T wave inversion in lateral leads and ST segment elevation in V2-V6; This is a literature report  A 14 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERICARDITIS (medically significant), outcome "unknown", described as "T wave inversion in lateral leads and ST segment elevation in V2-V6". The patient underwent the following laboratory tests and procedures: blood test: negative; brain natriuretic peptide: 37 pg/mL; c-reactive protein: 5.03 mg/dl; 5.03 mg/dl, notes: on admission; 4.04 mg/dl, notes: on discharge; cytomegalovirus test: negative; electrocardiogram: t wave inversion, notes: in lateral leads and ST segment elevation in V2-V6; epstein-barr virus test: negative; influenza a virus test: negative; investigation: negative; parvovirus b19 test: negative; polymerase chain reaction: negative; respiratory syncytial virus test: negative; troponin i: 7.61 ng/dL; 5.52 ng/dL, notes: on admission; 3.68 ng/dL, notes: on discharge.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200257419 same article/drug/event and different patient;US-PFIZER INC-202200283444 same article/drug and different patient /event
Sex: M
Vaccine: COVID19
Symptoms: Polymerase chain reaction, Respiratory syncytial virus test, Troponin I
Clinical narrative: T wave inversion in lateral leads and ST segment elevation in V2-V6; This is a literature report  A 14 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERICARDITIS (medically significant), outcome "unknown", described as "T wave inversion in lateral leads and ST segment elevation in V2-V6". The patient underwent the following laboratory tests and procedures: blood test: negative; brain natriuretic peptide: 37 pg/mL; c-reactive protein: 5.03 mg/dl; 5.03 mg/dl, notes: on admission; 4.04 mg/dl, notes: on discharge; cytomegalovirus test: negative; electrocardiogram: t wave inversion, notes: in lateral leads and ST segment elevation in V2-V6; epstein-barr virus test: negative; influenza a virus test: negative; investigation: negative; parvovirus b19 test: negative; polymerase chain reaction: negative; respiratory syncytial virus test: negative; troponin i: 7.61 ng/dL; 5.52 ng/dL, notes: on admission; 3.68 ng/dL, notes: on discharge.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200257419 same article/drug/event and different patient;US-PFIZER INC-202200283444 same article/drug and different patient /event
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: contracted covid; contracted covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2) (Lot number: FFG1620) at the age of 30 years as dose 2, single and (Lot number: PG8762) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "contracted covid". Clinical information: Caller was a patient/nonHCP. She reported having received the first dose of the Pfizer covid 19 vaccine, then contracted covid, and had received the second dose of the vaccine after recovering from covid. The first dose LOT is FFG1620, the second dose lot is PG8762. Caller asked to schedule her next dose. Caller transferred to for report filing. Transferring agent stated, "I was calling with a patient on the other line who was reporting a safety event with the Pfizer COVID-19 Vaccine. She was 30 years old (Further not appropriately clarified hence not captured), she was a patient. She have had the first two doses of the Pfizer COVID-19 Vaccine and got COVID after her first dose () and I have their LOT.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Rhinorrhoea, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: running nose; PCR Covid Positive; PCR Covid Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 30Nov2021 (Lot number: 8B21-2A) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism", start date: 2013 (ongoing); "allergies" (ongoing), notes: since 5 years old; "Mild asthma" (ongoing), notes: since 5 years old. Concomitant medication(s) included: LEVOTHYROXINE [LEVOTHYROXINE SODIUM] taken for hypothyroidism (ongoing); ALLEGRA taken for allergy to animal (ongoing). Vaccination history included: Moderna (Dose 1, Anatomical site of injection: arm, Route of administration: Intramuscular, Batch/Lot number: Moderna 4A21A), administration date: 11Mar2021, when the patient was 39 years old, for COVID-19 immunization; Moderna (Dose 2 , Anatomical site of injection: arm, Route of administration: Intramuscular, Batch/Lot number: Moderna 8B21-2A), administration date: 08Apr2021, when the patient was 39 years old, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Jan2022, outcome "unknown" and all described as "PCR Covid Positive"; RHINORRHOEA (non-serious), outcome "unknown", described as "running nose". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (11Nov2021) sars-cov-2 total ab value 1615,0 standard 0.0-0.7, notes: SARS-Cov-2 total interp value positive standard -negative; sars-cov-2 test: (12Jan2022) negative, notes: was negative on 10Jan2022 runny nose; (17Jan2022) positive.  Clinical course: No specific relevant test for thromboembolic events with thrombocytopenia. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Received 2 Pfizer shots and a Moderna Booster (Dec2021) and also got covid; Received 2 Pfizer shots and a Moderna Booster (Dec2021) and also got covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), from Dec2021 (Batch/Lot number: unknown) to Dec2021 at single (dose 3 (booster), single) for covid-19 immunisation. Relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Received 2 Pfizer shots and a Moderna Booster (Dec2021) and also got covid". Clinical Course: Reporter said that her husband, (name withheld) received 2 Pfizer shots and a Moderna booster in Dec2021 and also got covid. Their toddler got covid and slept in our bed with her fever and sneezed on them. Reporter did hope Pfizer quickly starts trials on 0-5% with a new formula to address omicron better now that their has already had omicron.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Dry skin, SARS-CoV-2 test, Skin burning sensation
Clinical narrative: covid test result=Positive / covid test date=02Jan2022; covid test result=Positive / covid test date=02Jan2022; skin on my face and hands dried out so bad that it started peeling and burning; skin on my face and hands dried out so bad that it started peeling and burning; skin on my face and hands dried out so bad that it started peeling and burning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Sep2021 13:00 (Lot number: 30130BA) at the age of 21 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG; TRESIBA; PHENTERMINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jan2022, outcome "unknown" and all described as "covid test result=Positive / covid test date=02Jan2022"; DRY SKIN (non-serious), SKIN BURNING SENSATION (non-serious), SKIN EXFOLIATION (non-serious) all with onset 12Sep2021, outcome "not recovered" and all described as "skin on my face and hands dried out so bad that it started peeling and burning". The event "skin on my face and hands dried out so bad that it started peeling and burning", "skin on my face and hands dried out so bad that it started peeling and burning" and "skin on my face and hands dried out so bad that it started peeling and burning" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Jan2022) positive. Therapeutic measures were not taken as a result of dry skin, skin burning sensation, skin exfoliation. Clinical course: The reporter stated that it did not occur until 4 days after initial dose. She further stated that her skin on her face and hands dried out so bad that it started peeling and burning. She stated that nothing made it better, still to this day on 15Feb2022 her face and hands had gotten progressively worse. She stated that she could not wear any makeup at all because her skin was constantly peeling and having red rashes show up. No vaccine in four weeks. No covid prior vaccination. No Known allergies. She stated that she tested for Covid test post vaccination (Covid test type post vaccination was Nasal swab) on 02Jan2022 tested for Covid and got the Covid test result Positive.  No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation
Clinical narrative: covid test result=Positive / covid test date=02Jan2022; covid test result=Positive / covid test date=02Jan2022; skin on my face and hands dried out so bad that it started peeling and burning; skin on my face and hands dried out so bad that it started peeling and burning; skin on my face and hands dried out so bad that it started peeling and burning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Sep2021 13:00 (Lot number: 30130BA) at the age of 21 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG; TRESIBA; PHENTERMINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jan2022, outcome "unknown" and all described as "covid test result=Positive / covid test date=02Jan2022"; DRY SKIN (non-serious), SKIN BURNING SENSATION (non-serious), SKIN EXFOLIATION (non-serious) all with onset 12Sep2021, outcome "not recovered" and all described as "skin on my face and hands dried out so bad that it started peeling and burning". The event "skin on my face and hands dried out so bad that it started peeling and burning", "skin on my face and hands dried out so bad that it started peeling and burning" and "skin on my face and hands dried out so bad that it started peeling and burning" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Jan2022) positive. Therapeutic measures were not taken as a result of dry skin, skin burning sensation, skin exfoliation. Clinical course: The reporter stated that it did not occur until 4 days after initial dose. She further stated that her skin on her face and hands dried out so bad that it started peeling and burning. She stated that nothing made it better, still to this day on 15Feb2022 her face and hands had gotten progressively worse. She stated that she could not wear any makeup at all because her skin was constantly peeling and having red rashes show up. No vaccine in four weeks. No covid prior vaccination. No Known allergies. She stated that she tested for Covid test post vaccination (Covid test type post vaccination was Nasal swab) on 02Jan2022 tested for Covid and got the Covid test result Positive.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 antibody test, Suspected COVID-19
Clinical narrative: Passed away from Covid; Passed away from Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Aug2021 (Lot number: FA7484) at the age of 68 years as dose 3 (booster), single, administered in arm right, administration date 23Feb2021 (Lot number: EN6203, Expiration Date: Jun2021) as dose 2, single and administered in arm right, administration date 02Feb2021 (Lot number: EL3248, Expiration Date: Apr2021) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Kidney Transplant Recipient", start date: Jul2007 (unspecified if ongoing), notes: Verbatim: Kidney Transplant Recipient; "Occasional AFib", start date: 2021 (unspecified if ongoing), notes: Verbatim: Occasional AFib, Began in the Spring time of 2021. Concomitant medication(s) included: BABY ASPIRIN (ongoing).No additional vaccines administered on same date of the Pfizer suspect.no prior vaccination within 4 weeks The following information was reported: SUSPECTED COVID-19 (death, hospitalization, medically significant), DRUG INEFFECTIVE (death, hospitalization, medically significant) all with onset 17Nov2021, outcome "fatal" and all described as "Passed away from Covid". The patient was hospitalized for suspected covid-19, drug ineffective (start date: 17Nov2021). The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test (0-250): (17Nov2021) 16, notes: More information available: No. The patient date of death was 21Nov2021. The reported cause of death was covid-19. No autopsy was performed. The patient had no predisposing factors, She was restricted for two years and not going out of the house. The patient passed away from Covid. The patient was fully vaccinated including the booster dose of the Adult Pfizer Covid Vaccine. The patient was a kidney transplant recipient and had a suppressed immune system. When the patient was admitted to the hospital an antibody level test was done, the range was 0-250 with higher number being better off. After three doses of the Adult Pfizer Covid Vaccine, the patient's antibody level was 16. The patient was hospitalized on 17Nov2021 and was never discharged prior to passing away. The patient passed away while hospitalized on 21Nov2021.; Reported Cause(s) of Death: Passed away from Covid