chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Immune complex assay, Investigation, Laboratory test, Metabolic function test, Urticarial vasculitis
Clinical narrative: Urticarial vasculitis; This is a literature report.  A 86 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, SINGLE), for COVID-19 immunization. The following information was reported: URTICARIAL VASCULITIS (medically significant), outcome "recovered", described as "Urticarial vasculitis". The patient underwent the following laboratory tests and procedures: biopsy skin: revealing superficial perivascular inflammation, notes: with rare eosinophils and leukocytoclastic debris, raising suspicion for prior vascular injury; c1 esterase inhibitor test: within normal limits; full blood count: acceptable limits; hepatitis b virus test: negative; hepatitis c virus test: negative; immune complex assay: within normal limits; investigation: within normal limits; within normal limits; within normal limits; within normal limits; laboratory test: showed results; metabolic function test: acceptable limits. Therapeutic measures were taken as a result of urticarial vasculitis.  Clinical course: The patient was treated with oral prednisone 40 mg daily for 5 days,topical triamcinolone ointment, oral fexofenadine, and oral diphenhydramine as needed for itch. She reported progressive improvement with resolution within 2 weeks of treatment initiation.; Sender's Comments: Based on information provided and temporal association, causal relationship between the reported event urticarial vasculitis and the suspect 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-202200312449 Same article/drug and different patient/event
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested covid-19 positive; Tested covid-19 positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Tested covid-19 positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: sx 2/21 & + home Ag test 2/21 sx mild fevers ST rhinorrhea congestion in the head and mild body aches/Home Ag: Positive; sx 2/21 & + home Ag test 2/21 sx mild fevers ST rhinorrhea congestion in the head and mild body aches/Home Ag: Positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 39 year-old male patient received bnt162b2 (BNT162B2), administration date 19Oct2021 (Lot number: FF2589) at the age of 38 years as dose 3 (booster), single, administration date 28Jan2021 (Lot number: EL3247) as dose 2, single and administration date 18Jan2021 (Lot number: EL3247) 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) all with onset 21Feb2022, outcome "unknown" and all described as "sx 2/21 & + home Ag test 2/21 sx mild fevers ST rhinorrhea congestion in the head and mild body aches/Home Ag: Positive". The patient underwent the following laboratory tests and procedures: body temperature: (21Feb2022) mild; sars-cov-2 test: (21Feb2022) positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events  and suspect drug BNT162B2 cannot be excluded.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: UK NHS Rapid Test:postive; Rapid Test:postive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Dec2021 11:30 (Lot number: FL3197) at the age of 43 years as dose 3 (booster), single, administered in arm left, administration date 16Apr2021 12:00 (Lot number: ER8731) as dose 2, single and administered in arm left, administration date 28Mar2021 13:00 (Lot number: ER8733) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jan2022, outcome "unknown" and all described as "Rapid Test:postive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Jan2022) positive, notes: Nasal Swab.  The patient did not receive any other vaccine in four weeks. The patient developed severe swelling/pain in both axillary lymph nodes starting a few days after 3rd (booster) injection and lasting for 2 weeks. Followed by dull ache in armpits and intermittent pain in hands and feet (most severe in left, injection-side hand) that still persists at time of reporting 2 months after injection. The onset on the adverse events was 23Dec2021. The patient received treatment with 10 day course of Cephalexin 500 mg but was not recovered. The patient had not tested covid positive prior to vaccination. The patient tested positive for Nasal Swab Rapid Test, post vaccination on 18Jan2022.The patient had no known allergies and other medical history.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Lymphadenopathy, Pain in extremity, SARS-CoV-2 antibody test
Clinical narrative: UK NHS Rapid Test:postive; Rapid Test:postive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Dec2021 11:30 (Lot number: FL3197) at the age of 43 years as dose 3 (booster), single, administered in arm left, administration date 16Apr2021 12:00 (Lot number: ER8731) as dose 2, single and administered in arm left, administration date 28Mar2021 13:00 (Lot number: ER8733) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jan2022, outcome "unknown" and all described as "Rapid Test:postive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Jan2022) positive, notes: Nasal Swab.  The patient did not receive any other vaccine in four weeks. The patient developed severe swelling/pain in both axillary lymph nodes starting a few days after 3rd (booster) injection and lasting for 2 weeks. Followed by dull ache in armpits and intermittent pain in hands and feet (most severe in left, injection-side hand) that still persists at time of reporting 2 months after injection. The onset on the adverse events was 23Dec2021. The patient received treatment with 10 day course of Cephalexin 500 mg but was not recovered. The patient had not tested covid positive prior to vaccination. The patient tested positive for Nasal Swab Rapid Test, post vaccination on 18Jan2022.The patient had no known allergies and other medical history.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Nasal discomfort, Neuropathy peripheral, Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: exacerbation of neuropathy in hands, feet, and legs; severe itching; pain in throat and nose; pain in throat and nose; swelling of throat; exacerbation of weakness in hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17Feb2022 13:00 (Lot number: Fj1620) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lupus" (unspecified if ongoing); "MS" (unspecified if ongoing); "chronic upper respiratory illness" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "RA" (unspecified if ongoing); "Known allergies:avocados, pineapple" (unspecified if ongoing); "Known allergies: sulfur" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; DULOXETINE; BUSPAR; nettle leaf liquid. Past drug history included: Known allergies: NSAIDs, salicylic acid, ibuprofen, acetaminophen, avocados, pineapple, sulfur, all Over The Counter drug for pas The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 18Feb2022 03:30, outcome "not recovered", described as "exacerbation of neuropathy in hands, feet, and legs"; PRURITUS (non-serious) with onset 18Feb2022 03:30, outcome "not recovered", described as "severe itching"; OROPHARYNGEAL PAIN (non-serious), NASAL DISCOMFORT (non-serious) all with onset 18Feb2022 03:30, outcome "not recovered" and all described as "pain in throat and nose"; PHARYNGEAL SWELLING (non-serious) with onset 18Feb2022 03:30, outcome "not recovered", described as "swelling of throat"; MUSCULAR WEAKNESS (non-serious) with onset 18Feb2022 03:30, outcome "not recovered", described as "exacerbation of weakness in hands". Benadryl was taken as a Therapeutic measure of neuropathy peripheral, pruritus, oropharyngeal pain, nasal discomfort, pharyngeal swelling, muscular weakness. Clinical course included "On second day after dose 1 severe itching and pain in throat and nose, exacerbation of neuropathy in hands, feet, and legs, swelling of throat, exacerbation of weakness in hands."  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: exacerbation of neuropathy in hands, feet, and legs; severe itching; pain in throat and nose; pain in throat and nose; swelling of throat; exacerbation of weakness in hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17Feb2022 13:00 (Lot number: Fj1620) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lupus" (unspecified if ongoing); "MS" (unspecified if ongoing); "chronic upper respiratory illness" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "RA" (unspecified if ongoing); "Known allergies:avocados, pineapple" (unspecified if ongoing); "Known allergies: sulfur" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; DULOXETINE; BUSPAR; nettle leaf liquid. Past drug history included: Known allergies: NSAIDs, salicylic acid, ibuprofen, acetaminophen, avocados, pineapple, sulfur, all Over The Counter drug for pas The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 18Feb2022 03:30, outcome "not recovered", described as "exacerbation of neuropathy in hands, feet, and legs"; PRURITUS (non-serious) with onset 18Feb2022 03:30, outcome "not recovered", described as "severe itching"; OROPHARYNGEAL PAIN (non-serious), NASAL DISCOMFORT (non-serious) all with onset 18Feb2022 03:30, outcome "not recovered" and all described as "pain in throat and nose"; PHARYNGEAL SWELLING (non-serious) with onset 18Feb2022 03:30, outcome "not recovered", described as "swelling of throat"; MUSCULAR WEAKNESS (non-serious) with onset 18Feb2022 03:30, outcome "not recovered", described as "exacerbation of weakness in hands". Benadryl was taken as a Therapeutic measure of neuropathy peripheral, pruritus, oropharyngeal pain, nasal discomfort, pharyngeal swelling, muscular weakness. Clinical course included "On second day after dose 1 severe itching and pain in throat and nose, exacerbation of neuropathy in hands, feet, and legs, swelling of throat, exacerbation of weakness in hands."  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Cutaneous vasculitis
Clinical narrative: Leukocytoclastic vasculitis; This is a literature report.  A 65 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "diabetes" (ongoing); "hypertension" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Metformin for diabetes; Lisinopril for hypertension. Vaccination history included: Bnt162b2 (Dose 1, single, 4 months prior to receiving his booster injection), for COVID-19 immunisation; Bnt162b2 (Dose 2, single, 4 months prior to receiving his booster injection), for COVID-19 immunisation. The following information was reported: CUTANEOUS VASCULITIS (medically significant), outcome "unknown", described as "Leukocytoclastic vasculitis". The patient underwent the following laboratory tests and procedures: biopsy: showed neutrophilic inflammation with fibrinoid, notes: necrosis and fragmented neutrophilic nuclei (leukocytoclasis), consistent with leukocytoclastic vasculitis (LCV). Therapeutic measures were taken as a result of cutaneous vasculitis.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Cutaneous vasculitis 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 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: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Diabetes mellitus, SARS-CoV-2 test
Clinical narrative: Sudden onset of diabetes / Diagnosed 10Feb22 after having severe symptoms for many months; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Dec2021 12:00 (Lot number: FE3594) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NEXIUM [ESOMEPRAZOLE SODIUM]. Past drug history included: Tetraycyclines, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (lot number=EN6201, prev dose administration time=12:00 PM, prev dose vaccine location=Left arm, dose 2, single), administration date: 16Feb2021, when the patient was 30 years old, for COVID-19 immunization; Bnt162b2 (lot number=EL8982, prev dose administration time=12:00 PM, prev dose vaccine location=Left arm, dose 1, single), administration date: 26Jan2021, when the patient was 30 years old, for COVID-19 immunization. The following information was reported: DIABETES MELLITUS (disability) with onset 10Feb2022, outcome "not recovered", described as "Sudden onset of diabetes / Diagnosed 10Feb22 after having severe symptoms for many months". The event "sudden onset of diabetes / diagnosed 10feb22 after having severe symptoms for many months" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Feb2022) negative.  Clinical course: Facility type of vaccine was Pharmacy or Drug Store. The patient took no other vaccine in four weeks. Patient had no covid prior vaccination and was tested for covid post vaccination. The patient took Nexium 40 mg in two weeks. The patient no family history of diabetes. The patient experienced Sudden onset of diabetes subsequent to administration of Pfizer COVID 19 vaccines. Diagnosed 10Feb2022 after having severe symptoms for many months. Treatment for Adverse Event was prescription insulin-mealtime and long acting.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Immune thrombocytopenia, SARS-CoV-2 test, Thrombocytopenia
Clinical narrative: Sub dural brain hemorrhage; Thrombocytopenia; ITP; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12May2021 (Lot number: EW0176) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose number=1, product=COVID 19,, brand= Pfizer,, lot number=ER8731, administration date=21Apr2021 , vaccine location=Left arm), administration date: 21Apr2021, when the patient was 60 years old, for COVID-19 immunization. The following information was reported: CEREBRAL HAEMORRHAGE (hospitalization, medically significant, life threatening) with onset 09Nov2021, outcome "recovered with sequelae", described as "Sub dural brain hemorrhage"; THROMBOCYTOPENIA (hospitalization, medically significant, life threatening) with onset 09Nov2021, outcome "recovered with sequelae", described as "Thrombocytopenia"; IMMUNE THROMBOCYTOPENIA (hospitalization, medically significant, life threatening) with onset 09Nov2021, outcome "recovered with sequelae", described as "ITP". The events "sub dural brain hemorrhage", "thrombocytopenia" and "itp" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were taken as a result of cerebral haemorrhage, thrombocytopenia, immune thrombocytopenia.  Clinical Course: Patient had no other vaccines in four weeks and no other medications in two weeks. AE treatment included surgery. Patient was not tested covid prior vaccination. Patient was tested covid post vaccination. Patient had no known allergies.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Neuropathy peripheral, Pain in extremity
Clinical narrative: increase in peripheral neuropathy; sore left arm; Daily since then have had worsening symptoms until much of the day I'm now unable to walk.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jan2022 12:00 (Lot number: FJ1614) at the age of 63 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "Parkinson's" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: SINEMET CR; XANAX; BACLOFEN; CLONAZEPAM. Past drug history included: Pineapple, reaction(s): "Known allergies: Pineapple". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8731), administration date: 11Apr2021, when the patient was 62 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8727), administration date: 21Mar2021, when the patient was 62 years old, for COVID-19 Immunization. The patient did not receive any other vaccine in four weeks of covid vaccine. The patient was not tested for covid post vaccination.  The following information was reported: NEUROPATHY PERIPHERAL (disability, medically significant) with onset 25Jan2022, outcome "not recovered", described as "increase in peripheral neuropathy"; PAIN IN EXTREMITY (disability) with onset 24Jan2022 06:00, outcome "not recovered", described as "sore left arm"; GAIT INABILITY (disability) with onset 2022, outcome "not recovered", described as "Daily since then have had worsening symptoms until much of the day I'm now unable to walk.". The events "increase in peripheral neuropathy", "sore left arm" and "daily since then have had worsening symptoms until much of the day i'm now unable to walk." were evaluated at the physician office visit. Therapeutic measures were not taken as a result of neuropathy peripheral, pain in extremity, gait inability.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200313644 Same patient and drug, different event separated in time
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: The patient diagnosed with COVID-19; Patient diagnosed with COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 11Apr2021 09:30 (Lot number: ER8731) at the age of 62 years as dose 2, single and administered in arm left, administration date 21Mar2021 09:00 (Lot number: ER8727) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Parkinson's" (unspecified if ongoing), notes: other medical history: Parkinson's; "Known allergies: Pineapple" (unspecified if ongoing), notes: Known allergies: Pineapple. Concomitant medication(s) included: SINEMET; XANAX; BACLOFEN; CLONAZEPAM. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "The patient diagnosed with COVID-19"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "Patient diagnosed with COVID-19". Therapeutic measures were not taken as a result of suspected covid-19.  Clinical course: No other vaccine in four weeks. The patient had Covid prior vaccination. Patient had no Covid tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200313386 Same patient and drug, different event separated in time
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Crohn's disease
Clinical narrative: Crohn's aggravated; MARKETING PROGRAM NAME IS NOT AVAILABLE  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-163-4278994-00 (Abbvie).  A 19 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 19 years as dose 3 [booster], single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01, Route of Admin: Intramuscular), administration date: 28Apr2021, for Covid-19 immunization; Bnt162b2 (Dose: 02, Route of Admin: Intramuscular), administration date: 19May2021, for Covid-19 immunization. The following information was reported: CROHN'S DISEASE (medically significant), outcome "unknown", described as "Crohn's aggravated". The action taken for adalimumab was unknown.  Clinical Course: Solicited report from a consumer of an adult male with an event of non-serious Crohn's Flare Ups with HUMIRA (ADALIMUMAB). There was no reported medical history. On an unknown date, the patient experienced Crohn's Flare Ups. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Event abate after stopping drug was not applicable. Concomitant drugs and dates of administration (Exclude those used to treat event and other Relevant History was not reported.  Drug: PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN), UNKNOWN, UNKNOWN, UNKNOWN. Causality: Crohn's aggravated (Crohn's disease), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Possible, Dechallenge: N/A  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of Crohn's Flare Ups was not provided. Causality: Crohn's aggravated (Crohn's disease), Action(s) taken with drug: unknown, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A  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 information provide and plausible temporal association, the causality between BNT162B2 and CROHN'S DISEASE cannot be completely 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; 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-163-4277215-00.  A 37 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 08Dec2021 (Batch/Lot number: unknown) at the age of 37 years as dose 1, single and intramuscular, administration date 29Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (ongoing) (Batch/Lot number: unknown) for rheumatoid arthritis. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up". The action taken for upadacitinib was dosage not changed.  The reporter's assessment of the causal relationship of the event Rheumatoid arthritis flare up (Rheumatoid arthritis) with the suspect product Rinvoq (Upadacitinib) was provided as Reasonable possibility. The reporter's assessment of the causal relationship of the event Rheumatoid arthritis flare up (Rheumatoid arthritis) with the suspect product BNT162B2 (Pfizer Biontech COVID-19 Vaccine) was provided as Possible. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; 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 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: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Blood sodium, Haematocrit, Haemoglobin, Plasma cell myeloma, Pulmonary embolism
Clinical narrative: pulmonary embolism; multiple myeloma; This is a spontaneous report received from contactable reporter(s) (Physician).  A 80 year-old male patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Lot number: EL9269) at the age of 80 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "TIA", start date: 30Nov2021 (unspecified if ongoing); "Late onset Alziemers", start date: 28Dec2021 (unspecified if ongoing); "chronic leukemia", start date: 04Aug2020 (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot number: EL9265), administration date: 23Feb2021, when the patient was 80 years old, for COVID-19 Immunization, reaction(s): "pressure in his head", "Dizzy", "nausea", "Headache", "Vomiting", "waves of vertigo/ dizziness", "not feeling well", "achy", "first week he had a typical virus like the flu", "tired", "chills", "sick", "he couldn't stand"; Zoster, administration date: 01Oct2006, when the patient was 66 years old, for Immunization; Flu, administration date: 25Aug2020, when the patient was 80 years old, for Immunization. The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "unknown", described as "pulmonary embolism"; PLASMA CELL MYELOMA (medically significant) with onset 05Jan2022, outcome "unknown", described as "multiple myeloma". The patient underwent the following laboratory tests and procedures: blood sodium (136-145): (07Feb2022) 135 MiU/L; haematocrit (39.0-53.0): (07Feb2022) 36.5 %; haemoglobin (14.0-17.5): (07Feb2022) 12.3 g/l; white blood cell count (4.8-10.8): (07Feb2022) 4.0 10*9/uL.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the events and the suspect BNT162B2 cannot be excluded. 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: 80.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count
Clinical narrative: pulmonary embolism; multiple myeloma; This is a spontaneous report received from contactable reporter(s) (Physician).  A 80 year-old male patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Lot number: EL9269) at the age of 80 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "TIA", start date: 30Nov2021 (unspecified if ongoing); "Late onset Alziemers", start date: 28Dec2021 (unspecified if ongoing); "chronic leukemia", start date: 04Aug2020 (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot number: EL9265), administration date: 23Feb2021, when the patient was 80 years old, for COVID-19 Immunization, reaction(s): "pressure in his head", "Dizzy", "nausea", "Headache", "Vomiting", "waves of vertigo/ dizziness", "not feeling well", "achy", "first week he had a typical virus like the flu", "tired", "chills", "sick", "he couldn't stand"; Zoster, administration date: 01Oct2006, when the patient was 66 years old, for Immunization; Flu, administration date: 25Aug2020, when the patient was 80 years old, for Immunization. The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "unknown", described as "pulmonary embolism"; PLASMA CELL MYELOMA (medically significant) with onset 05Jan2022, outcome "unknown", described as "multiple myeloma". The patient underwent the following laboratory tests and procedures: blood sodium (136-145): (07Feb2022) 135 MiU/L; haematocrit (39.0-53.0): (07Feb2022) 36.5 %; haemoglobin (14.0-17.5): (07Feb2022) 12.3 g/l; white blood cell count (4.8-10.8): (07Feb2022) 4.0 10*9/uL.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the events and the suspect BNT162B2 cannot be excluded. 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.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, SARS-CoV-2 test, Transient ischaemic attack
Clinical narrative: Stroke; Transient Ischemic attack; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes type 1" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: prior to vaccination; there were no known allergies. The patient's concomitant medications were not reported. Vaccination history included: COVID-19 VACCINE (DOSE 1; MANUFACTURER UNKNOWN), administration date: 26Mar2021, for COVID-19 immunisation. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (caused and prolonged hospitalization ("vaccine received during existing hospitalization"), disability ("or permanent damage"), medically significant, life threatening ("immediate risk of death from the event") with onset 09Jul2021, outcome "recovered with sequelae" ("recovered with lasting effects"), described as "Transient Ischemic attack"; CEREBROVASCULAR ACCIDENT (caused and prolonged hospitalization ("vaccine received during existing hospitalization"), disability ("or permanent damage"), medically significant, life threatening("immediate risk of death from the event") with onset 13Aug2021, outcome "recovered with sequelae" ("recovered with lasting effects"), described as "Stroke". The patient was hospitalized and prolonged hospitalization for transient ischaemic attack, cerebrovascular accident (hospitalization duration: 2 days). The events "transient ischemic attack" and "stroke" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Nasal Swab (SARS-CoV-2 test): negative, notes: post vaccination. Therapeutic measures were taken as a result of transient ischaemic attack, cerebrovascular accident which included apixaban (ELIQUIS).  Clinical course: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Hysteroscopy, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: covid test date=22Jan2022 / covid test result=Positive; covid test date=22Jan2022 / covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 15:00 (Lot number: FJ8762) at the age of 45 years as dose 3 (booster), single, administered in arm left, administration date 19Apr2021 11:00 (Lot number: EN6208) as dose 2, single and administered in arm left, administration date 27Mar2021 11:00 (Lot number: EW0161) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Jan2022, outcome "unknown" and all described as "covid test date=22Jan2022 / covid test result=Positive". The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) unknown results; hysteroscopy: (unspecified date) unknown results; sars-cov-2 test: (22Jan2022) positive, notes: Nasal Swab; ultrasound scan: (unspecified date) unknown result. clinical course: Patient did not received any other vaccine in four weeks. Patient had no covid prior vaccination, but was diagnosed post vaccination. Patient did not had any known allergies.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: covid test date=22Jan2022 / covid test result=Positive; covid test date=22Jan2022 / covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 15:00 (Lot number: FJ8762) at the age of 45 years as dose 3 (booster), single, administered in arm left, administration date 19Apr2021 11:00 (Lot number: EN6208) as dose 2, single and administered in arm left, administration date 27Mar2021 11:00 (Lot number: EW0161) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Jan2022, outcome "unknown" and all described as "covid test date=22Jan2022 / covid test result=Positive". The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) unknown results; hysteroscopy: (unspecified date) unknown results; sars-cov-2 test: (22Jan2022) positive, notes: Nasal Swab; ultrasound scan: (unspecified date) unknown result. clinical course: Patient did not received any other vaccine in four weeks. Patient had no covid prior vaccination, but was diagnosed post vaccination. Patient did not had any known allergies.
Age: 32.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Biopsy colon, Colitis, Colonoscopy, Rectal haemorrhage
Clinical narrative: Colon inflammation; Rectal bleeding; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (Not aplicable). The reporter is the patient. Other Case identifier(s): 22K-163-4276982-00 (Agency).  A 32 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 22Nov2021 (Batch/Lot number: unknown) at the age of 32 years as dose 3  (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous since Sep2020 (ongoing) (Batch/Lot number: unknown) at 40 mg (40 mg (citrate free 40 mg, 1 in 2 week)) for crohn's disease, colitis ulcerative. Relevant medical history included: "Alcohol use", start date: 2008 (unspecified if ongoing), notes: Alcohol use, weekends or two to three times a week, beer, drinking alcohol (started  2008); "Non smoker" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing), notes: Penicillin allergy Manifested by hives. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Route of administration: Intramuscular), administration date: 01Apr2021, when the patient was 31 years old, for COVID-19 Immunization; Bnt162b2 (Dose:2, Route of administration: Intramuscular), administration date: 22Apr2021, when the patient was 31 years old, for Covid-19 immunization. The following information was reported: RECTAL HAEMORRHAGE (medically significant) with onset Dec2021, outcome "not recovered", described as "Rectal bleeding"; COLITIS (non-serious) with onset Jan2022, outcome "not recovered", described as "Colon inflammation". The patient underwent the following laboratory tests and procedures: biopsy colon: (Jan2022) mild inflammation, no cancer nor any abnormal, notes: findings found; colonoscopy: (Jan2022) mild inflammation, no cancer nor any abnormal, notes: findings found. The action taken for adalimumab was dosage not changed.  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 information in the case report and a plausible temporal relationship, a possible causal association between the events and 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.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Amyotrophic lateral sclerosis, Headache
Clinical narrative: Amyotrophic lateral sclerosis; Headache; 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): 2K-163-4277320-00 (AbbVie).  A 62 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 62 years as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AMYOTROPHIC LATERAL SCLEROSIS (medically significant), outcome "not recovered", described as "Amyotrophic lateral sclerosis"; HEADACHE (medically significant), outcome "recovered", described as "Headache". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of amyotrophic lateral sclerosis.  The reporter's assessment of the causal relationship of the events with the suspect product was provided at the time of this report. Since possible determination has been received, the case is managed based on the company causality assessment.   Causality for Humira (Adalimumab): AbbVie's opinion is that the event of amyotrophic lateral sclerosis is not assessable. AbbVie's opinion is that there is no reasonable possibility that the event of bad headache is related to humira (adalimumab).  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 information in the case report and a plausible temporal relationship, a possible causal association between the events and 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.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: she had a blood clot and a week later she was dead; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female 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: THROMBOSIS (death, medically significant), outcome "fatal", described as "she had a blood clot and a week later she was dead". The patient date of death was unknown. The reported cause of death was thrombosis. It was not reported if an autopsy was performed.  Clinical information: The reporter stated she would love to take the vaccine to be safe, but she was still afraid, my next door neighbour across the street died from the covid shot, she walked 5 miles every day and I am petrified. The reporter asked "Could I get a blood clot, That's what happened to her (the neighbour) she had a blood clot and a week later she was dead.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: she had a blood clot and a week later she was dead
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Ag positive Feb2022 and no symptoms; Ag positive Feb2022 and no symptoms; Exposed on 2/17; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 32 year-old male patient received bnt162b2 (BNT162B2), administration date 12Nov2021 (Lot number: FF2589) at the age of 32 years as dose 3 (booster), single, administration date 16Feb2021 (Lot number: EL3247) as dose 2, single and administration date 26Jan2021 (Lot number: EL3247) 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: VACCINATION FAILURE (medically significant), ASYMPTOMATIC COVID-19 (medically significant) all with onset 22Feb2022, outcome "unknown" and all described as "Ag positive Feb2022 and no symptoms"; EXPOSURE TO SARS-COV-2 (non-serious) with onset 17Feb2022, outcome "unknown", described as "Exposed on 2/17". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Feb2022) negative, notes: Other; (22Feb2022) positive, notes: Other. It was unknown if therapeutic measures were taken as a result of vaccination failure, asymptomatic covid-19, exposure to sars-cov-2. It was unknown the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination.  Since the vaccination, the patient had been tested for COVID-19. No follow-up attempts are possible. No further information is expected.