chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Diarrhoea, Erythema, Eyelid margin crusting
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Jan2022 10:45 (Lot number: 330368D) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Severe allergic reactions to synthetic preservatives" (unspecified if ongoing); "allergy to dyes, colors" (unspecified if ongoing); "allergy to fragrances" (unspecified if ongoing); "COVID-19" (unspecified if ongoing); "Allergy to zithithromycin" (unspecified if ongoing); "Allergy to doxycyclin" (unspecified if ongoing); "Allergy to codeine" (unspecified if ongoing); "Allergy to anaprox" (unspecified if ongoing); "Allergy to antibiotics with sofa" (unspecified if ongoing). The patient's concomitant medications were not reported.The following information was reported: URTICARIA (non-serious) with onset 05Jan2022 19:00, outcome "not recovered", described as "severe hives"; DIARRHOEA (non-serious) with onset 05Jan2022 19:00, outcome "not recovered", described as "severe diarrhea"; RASH (non-serious) with onset 05Jan2022 19:00, outcome "not recovered", described as "rash"; ERYTHEMA (non-serious), SKIN BURNING SENSATION (non-serious) all with onset 05Jan2022 19:00, outcome "not recovered" and all described as "red burning skin from scalp to knees covering entire body"; LYMPHADENITIS (non-serious) with onset 05Jan2022 19:00, outcome "not recovered", described as "inflamed lymph nodes in scalp neck underarms chest"; PRURITUS (non-serious), THROAT IRRITATION (non-serious) all with onset 05Jan2022 19:00, outcome "not recovered" and all described as "itchy ears, throat"; EYELID MARGIN CRUSTING (non-serious) with onset 05Jan2022 19:00, outcome "not recovered", described as "crusty eyes/eyelids"; ARTHRALGIA (non-serious) with onset 05Jan2022 19:00, outcome "not recovered", described as "joint and back pain"; BACK PAIN (non-serious) with onset 05Jan2022 19:00, outcome "not recovered", described as "back pain". Therapeutic measures were taken as a result of urticaria, diarrhoea, rash, erythema, skin burning sensation, lymphadenitis, pruritus, throat irritation, eyelid margin crusting, arthralgia, back pain.Therapeutic measures were taken as a result of urticaria, diarrhoea, rash, erythema, skin burning sensation, lymphadenitis, pruritus, throat irritation, eyelid margin crusting, arthralgia, back pain and included treatment with diphenhydramine hydrochloride (BENADRYL) and steroids (STEROID). Prior to vaccination, the patient was diagnosed as COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenitis, Pruritus, Rash, Skin burning sensation, Throat irritation
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Jan2022 10:45 (Lot number: 330368D) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Severe allergic reactions to synthetic preservatives" (unspecified if ongoing); "allergy to dyes, colors" (unspecified if ongoing); "allergy to fragrances" (unspecified if ongoing); "COVID-19" (unspecified if ongoing); "Allergy to zithithromycin" (unspecified if ongoing); "Allergy to doxycyclin" (unspecified if ongoing); "Allergy to codeine" (unspecified if ongoing); "Allergy to anaprox" (unspecified if ongoing); "Allergy to antibiotics with sofa" (unspecified if ongoing). The patient's concomitant medications were not reported.The following information was reported: URTICARIA (non-serious) with onset 05Jan2022 19:00, outcome "not recovered", described as "severe hives"; DIARRHOEA (non-serious) with onset 05Jan2022 19:00, outcome "not recovered", described as "severe diarrhea"; RASH (non-serious) with onset 05Jan2022 19:00, outcome "not recovered", described as "rash"; ERYTHEMA (non-serious), SKIN BURNING SENSATION (non-serious) all with onset 05Jan2022 19:00, outcome "not recovered" and all described as "red burning skin from scalp to knees covering entire body"; LYMPHADENITIS (non-serious) with onset 05Jan2022 19:00, outcome "not recovered", described as "inflamed lymph nodes in scalp neck underarms chest"; PRURITUS (non-serious), THROAT IRRITATION (non-serious) all with onset 05Jan2022 19:00, outcome "not recovered" and all described as "itchy ears, throat"; EYELID MARGIN CRUSTING (non-serious) with onset 05Jan2022 19:00, outcome "not recovered", described as "crusty eyes/eyelids"; ARTHRALGIA (non-serious) with onset 05Jan2022 19:00, outcome "not recovered", described as "joint and back pain"; BACK PAIN (non-serious) with onset 05Jan2022 19:00, outcome "not recovered", described as "back pain". Therapeutic measures were taken as a result of urticaria, diarrhoea, rash, erythema, skin burning sensation, lymphadenitis, pruritus, throat irritation, eyelid margin crusting, arthralgia, back pain.Therapeutic measures were taken as a result of urticaria, diarrhoea, rash, erythema, skin burning sensation, lymphadenitis, pruritus, throat irritation, eyelid margin crusting, arthralgia, back pain and included treatment with diphenhydramine hydrochloride (BENADRYL) and steroids (STEROID). Prior to vaccination, the patient was diagnosed as COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Jan2022 10:45 (Lot number: 330368D) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Severe allergic reactions to synthetic preservatives" (unspecified if ongoing); "allergy to dyes, colors" (unspecified if ongoing); "allergy to fragrances" (unspecified if ongoing); "COVID-19" (unspecified if ongoing); "Allergy to zithithromycin" (unspecified if ongoing); "Allergy to doxycyclin" (unspecified if ongoing); "Allergy to codeine" (unspecified if ongoing); "Allergy to anaprox" (unspecified if ongoing); "Allergy to antibiotics with sofa" (unspecified if ongoing). The patient's concomitant medications were not reported.The following information was reported: URTICARIA (non-serious) with onset 05Jan2022 19:00, outcome "not recovered", described as "severe hives"; DIARRHOEA (non-serious) with onset 05Jan2022 19:00, outcome "not recovered", described as "severe diarrhea"; RASH (non-serious) with onset 05Jan2022 19:00, outcome "not recovered", described as "rash"; ERYTHEMA (non-serious), SKIN BURNING SENSATION (non-serious) all with onset 05Jan2022 19:00, outcome "not recovered" and all described as "red burning skin from scalp to knees covering entire body"; LYMPHADENITIS (non-serious) with onset 05Jan2022 19:00, outcome "not recovered", described as "inflamed lymph nodes in scalp neck underarms chest"; PRURITUS (non-serious), THROAT IRRITATION (non-serious) all with onset 05Jan2022 19:00, outcome "not recovered" and all described as "itchy ears, throat"; EYELID MARGIN CRUSTING (non-serious) with onset 05Jan2022 19:00, outcome "not recovered", described as "crusty eyes/eyelids"; ARTHRALGIA (non-serious) with onset 05Jan2022 19:00, outcome "not recovered", described as "joint and back pain"; BACK PAIN (non-serious) with onset 05Jan2022 19:00, outcome "not recovered", described as "back pain". Therapeutic measures were taken as a result of urticaria, diarrhoea, rash, erythema, skin burning sensation, lymphadenitis, pruritus, throat irritation, eyelid margin crusting, arthralgia, back pain.Therapeutic measures were taken as a result of urticaria, diarrhoea, rash, erythema, skin burning sensation, lymphadenitis, pruritus, throat irritation, eyelid margin crusting, arthralgia, back pain and included treatment with diphenhydramine hydrochloride (BENADRYL) and steroids (STEROID). Prior to vaccination, the patient was diagnosed as COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Jul2021 (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: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 2021, outcome "unknown", described as "stroke". The patient reported that he received the pfizer second shot for COVID in Jul2021 and was scheduled for a booster shot on 14Jan2022 but he had a stroke just before holiday and he was wondering if it was safe to get booster shot.    The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate irregular, Myocarditis, Palpitations
Clinical narrative: Symptoms of myocarditis; shortness of breath; irregular/rapid heartbeat; irregular/rapid heartbeat; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 26 year-old male patient received bnt162b2 (BNT162B2), administration date 06Jan2022 (Lot number: FJ1611) at the age of 26 years as dose 3 (booster),single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 2, Lot No: EW 0173), administration date: 11May2021, when the patient was 25 years old, for COVID-19 immunization; Covid-19 vaccine (Dose Number: 1, Lot No: EW 0153), administration date: 22Apr2021, when the patient was 25 years old, for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.  The following information was reported: MYOCARDITIS (medically significant) with onset 08Jan2022, outcome "recovering", described as "Symptoms of myocarditis"; DYSPNOEA (non-serious) with onset 08Jan2022, outcome "recovering", described as "shortness of breath"; HEART RATE IRREGULAR (non-serious), PALPITATIONS (non-serious) all with onset 08Jan2022, outcome "recovering" and all described as "irregular/rapid heartbeat". The patient underwent the following laboratory tests and procedures: heart rate: (08Jan2022) irregular/rapid; sars-cov-2 test: (08Jan2022) negative. Therapeutic measures were not taken as a result of myocarditis, dyspnoea, heart rate irregular, palpitations.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Symptoms of myocarditis; shortness of breath; irregular/rapid heartbeat; irregular/rapid heartbeat; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 26 year-old male patient received bnt162b2 (BNT162B2), administration date 06Jan2022 (Lot number: FJ1611) at the age of 26 years as dose 3 (booster),single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 2, Lot No: EW 0173), administration date: 11May2021, when the patient was 25 years old, for COVID-19 immunization; Covid-19 vaccine (Dose Number: 1, Lot No: EW 0153), administration date: 22Apr2021, when the patient was 25 years old, for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.  The following information was reported: MYOCARDITIS (medically significant) with onset 08Jan2022, outcome "recovering", described as "Symptoms of myocarditis"; DYSPNOEA (non-serious) with onset 08Jan2022, outcome "recovering", described as "shortness of breath"; HEART RATE IRREGULAR (non-serious), PALPITATIONS (non-serious) all with onset 08Jan2022, outcome "recovering" and all described as "irregular/rapid heartbeat". The patient underwent the following laboratory tests and procedures: heart rate: (08Jan2022) irregular/rapid; sars-cov-2 test: (08Jan2022) negative. Therapeutic measures were not taken as a result of myocarditis, dyspnoea, heart rate irregular, palpitations.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: Soon after vaccine rash on face , next day entire face covered in rash and red certain spots looks like mini hives but not itchy; Soon after vaccine rash on face , next day entire face covered in rash and red certain spots looks like mini hives but not itchy; Soon after vaccine rash on face , next day entire face covered in rash and red certain spots looks like mini hives but not itchy; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the parent.  A 12 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Jan2022 15:45 (Lot number: 33036bd) at the age of 12 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: RASH (non-serious) with onset 10Jan2022, outcome "not recovered", ERYTHEMA (non-serious), URTICARIA (non-serious) all with onset 11Jan2022, outcome "not recovered" and all described as "Soon after vaccine rash on face , next day entire face covered in rash and red certain spots looks like mini hives but not itchy". Therapeutic measures were taken as a result of rash, erythema, urticaria.  Additional information: No covid prior vaccination. No known allergy. No other vaccine in four weeks, no other medications in two weeks. Ae treatment: Applied Benadryl day 1 and hydrocortisone cream day 2. No covid tested post vaccination.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Impaired driving ability, Panic attack, SARS-CoV-2 test
Clinical narrative: panic attack; dizziness / dizzy; I could not drive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 (Batch/Lot number: unknown) at the age of 28 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PANIC ATTACK (hospitalization) with onset 02Apr2021, outcome "recovered with sequelae", described as "panic attack"; DIZZINESS (hospitalization) with onset 02Apr2021, outcome "recovered with sequelae", described as "dizziness / dizzy"; IMPAIRED DRIVING ABILITY (hospitalization) with onset 02Apr2021, outcome "recovered with sequelae", described as "I could not drive". The patient was hospitalized for panic attack, dizziness, impaired driving ability (hospitalization duration: 1 day(s)). The events "panic attack", "dizziness / dizzy" and "i could not drive" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: Nasal Swab. Therapeutic measures were taken as a result of panic attack, dizziness, impaired driving ability. Clinical course: The patient had no other vaccine in four weeks, no other medication in two weeks. Day after the patient received vaccine, he experienced his first panic attack of my life. He then started to experience horrible dizziness. He went on to have several more what he now know they're panic attacks. He was hospitalized and so dizzy that he could not drive. The patient went to the doctor countless times, tried countless medication and finally decided it was an adverse effect of the vaccine. This had been going on for almost a year. The panic attacks had stopped and dizziness had slowed, but still experience it daily. It had ruined the last year of his life. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient had no covid prior vaccination. The patient had covid tested post vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Headache, Pain in extremity, Rheumatoid arthritis, Vaccination site pain
Clinical narrative: Rheumatoid arthritis flare up; Vaccination site pain; Fatigue; Headache; sore arm; FACILITATED COLLECT  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): 21K-163-4214650-00 (Abbvie).  A 47 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 24Mar2021 (Batch/Lot number: unknown) at the age of 46 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at weekly (unk, weekly (citrate free, 1 in 1 wk)) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), administration date: 03Mar2021, when the patient was 46 years old, for COVID-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (non-serious), outcome "not recovered", described as "Rheumatoid arthritis flare up"; VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Vaccination site pain"; FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Fatigue"; HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "sore arm". The action taken for adalimumab was unknown.  Additional information: The reporter's causality for the events Vaccination site pain, Fatigue, Rheumatoid arthritis flare up, Headache with Pfizer BioNTech Covid-19 Vaccine was Not reportable. The reporter's causality for the event(s) of vaccine caused sore arm, vaccine caused fatigue, minor flare up of rheumatoid arthritis, vaccine caused headache with humira(adalimumab) was no reasonable possibility.  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 relationship the possibility of causal association between the reported events Rheumatoid arthritis flare up and other reported events and the suspect drug BNT162B2 cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Deafness unilateral, Fatigue, Pain in extremity, SARS-CoV-2 test
Clinical narrative: approx. 40% temporary hearing loss in left ear that lasted for 15 seconds; Significant fatigue; Severe joint pain (hands, elbows, shoulder); Severe joint pain (hands, elbows, shoulder); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Jan2020 16:00 (Lot number: EL1284) at the age of 59 years as dose 1, single for covid-19 immunisation. Facility type Vaccine was Workplace clinic. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Diverticulitis" (unspecified if ongoing); " Known allergies: Raw carrots, Raw celery, Raw Almonds" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN CALCIUM; LISINOPRIL; GLIPIZIDE; METFORMIN. Within 24 hours of 1st dose, the patient had approx. 40% temporary hearing loss in left ear that lasted for 15 seconds. This has NEVER happened before. In past year it has happened approx. 8 times and included BOTH ears. Severe joint pain (hands, elbows, shoulder) that lasted approx. 10 month (no prior pain before injection). Significant fatigue. ALL these side effects occurred started within 24 hours of first dose.The following information was reported: DEAFNESS UNILATERAL (medically significant) with onset 10Jan2020 13:00, outcome "unknown", described as " approx. 40% temporary hearing loss in left ear that lasted for 15 seconds"; FATIGUE (non-serious) with onset 10Jan2020 13:00, outcome "unknown", described as "Significant fatigue"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 10Jan2020 13:00, outcome "unknown" and all described as "Severe joint pain (hands, elbows, shoulder)". The events "within 24 hours of 1st dose, i had approx. 40% temporary hearing loss in left ear that lasted for 15 seconds.  this has never happened before.", "significant fatigue", "severe joint pain (hands, elbows, shoulder)" and "severe joint pain (hands, elbows, shoulder)" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test BinaxNOW: (Dec2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of deafness unilateral, fatigue, arthralgia, pain in extremity. The patient administered second dose of bnt162b2 in arm right, on 31Jan2020 10:00 (Lot number: EL3297) as dose 2, single for covid-19 immunisation.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Breakthrough case of Covid-19; Breakthrough case of Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). An adolescent female patient (unknown if pregnant, 12-17 Years) received bnt162b2 (BNT162B2) (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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Breakthrough case of Covid-19". It was unknown if therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: sick with Covid-19 three days later; 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 male patient received bnt162b2 (COMIRNATY) (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: SUSPECTED COVID-19 (non-serious), outcome "unknown", described as "sick with Covid-19 three days later".  Additional information: The patient had an appointment to get his second dose of the Pfizer Covid Vaccine today, but he missed that appointment because he is just getting over having Covid-19 and was not sure if it was safe to do so. He asked if it was okay to take the vaccine after having Covid.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Pain, Urticaria
Clinical narrative: painful 2" red welt with a white ring around it; painful 2" red welt with a white ring around it; sore lymph nodes under arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 21Apr2021 14:00 (Lot number: EW0169) at the age of 56 years 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 Number: 1, Batch/Lot No: ER8734, Location of injection: Arm Left), administration date: 31Mar2021, when the patient was 56 years old, for COVID-19 Immunization. The following information was reported: URTICARIA (non-serious), PAIN (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "painful 2" red welt with a white ring around it"; LYMPH NODE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore lymph nodes under arm". Therapeutic measures were taken as a result of urticaria, pain, lymph node pain.  Additional information: On the 2nd dose, she had a very painful 2" red welt with a white ring around it for a few days and sore lymph nodes under arm. She took Benadryl and Ibuprofen, and it went away. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, Vaccination failure
Clinical narrative: he had the two shot vaccines and the booster shot and they all contracted Covid about a week ago; he had the two shot vaccines and the booster shot and they all contracted Covid about a week ago; he had the two shot vaccines and the booster shot and they all contracted Covid about a week ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (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: IMMUNISATION (medically significant), outcome "unknown", VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "he had the two shot vaccines and the booster shot and they all contracted Covid about a week ago". Patient said his kids had the two shot vaccines and he had the two shot vaccines and the booster shot and they all contracted Covid about a week ago. The patient and the children, all had the vaccine. Patient just said his kids. He did not say how many children. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: 12 years postmenopausal started spotting this morning-2 days after vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Jan2022 10:30 (Lot number: F51611) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "mild CADm" (unspecified if ongoing); "COPD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 12Jan2022 07:00, outcome "not recovered", described as "12 years postmenopausal started spotting this morning-2 days after vaccine". Therapeutic measures were not taken as a result of postmenopausal haemorrhage. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation
Clinical narrative: booster; had Covid; had Covid; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 60 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (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 was not reported. Concomitant medication(s) included: XELJANZ XR. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had Covid". 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 relationship between the event Immunisation, Drug ineffective, covid-19 and suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: exposed to covid, sx 11Jan2022 then resolved and BF whom she lives with tested Ag+ 12Jan and she was neg Ag 12Jan but I suspect she was just too early for the Ag to show; exposed to covid, sx 11Jan2022 then resolved and BF whom she lives with tested Ag+ 12Jan and she was neg Ag 12Jan but I suspect she was just too early for the Ag to show; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 17Feb2021 (Lot number: EL3247) as dose 2, single and administration date 27Jan2021 (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) with onset 12Jan2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 12Jan2022, outcome "recovered" and all described as "exposed to covid, sx 11Jan2022 then resolved and BF whom she lives with tested Ag+ 12Jan and she was neg Ag 12Jan but I suspect she was just too early for the Ag to show". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) negative. It was unknown if therapeutic measures were taken as a result of suspected covid-19. It is unknown that the patient received any vaccines within 4 weeks prior to the COVID vaccine. It is unknown that the patient diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: positive Covid pcr/Chills, fever; positive Covid pcr/Chills, fever; Dose Number: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 07Dec2021 (Batch/Lot number: unknown) at the age of 51 years 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: IMMUNISATION (medically significant) with onset 07Dec2021, outcome "unknown", described as "Dose Number: 3"; DRUG INEFFECTIVE (medically significant) with onset 17Dec2021, outcome " recovered", COVID-19 (medically significant) with onset 17Dec2021, outcome "recovered" and all described as "positive Covid pcr/Chills, fever". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Dec2021) positive, notes: covid test type post vaccination=Nasal Swab. Therapeutic measures were not taken as a result of the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Anxiety, Blood pressure decreased, Blood pressure measurement, Dizziness
Clinical narrative: had an anaphylactic reaction to the Pfizer Covid vaccine; it was the preservative in the vaccine that was causing this reaction; blood pressure dropped; had a racing heart; had this sense of impending doom; She got very, very dizzy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 (Lot number: PAA16596S/062) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: patient stated that in Mar2021, she had an anaphylactic reaction to the Pfizer Covid vaccine. She states that she is not someone who has anplyactic reactions. This is the first time she has ever had one and it was in response to that vaccine. The patient stated that in Mar2021 her blood pressure dropped and had a racing heart. She got very, very dizzy and had this sense of impending doom. She was told she had an anaphylactic reaction. This all lasted for about an hour. She stated that she did not require any hospitalization or anything and she was lucky. This occurred around 2:00 or 3:00pm that day it occurred in Mar2021.  She wanted to report this to Pfizer because she was told that it was the preservative in the vaccine that was causing this reaction. The preservative is PEG, polyethylene glycol, which is a nanoparticle representative in the vaccine. Therapeutic measures were not taken as a result of events. The outcome of events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Reaction to excipient
Clinical narrative: had an anaphylactic reaction to the Pfizer Covid vaccine; it was the preservative in the vaccine that was causing this reaction; blood pressure dropped; had a racing heart; had this sense of impending doom; She got very, very dizzy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 (Lot number: PAA16596S/062) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: patient stated that in Mar2021, she had an anaphylactic reaction to the Pfizer Covid vaccine. She states that she is not someone who has anplyactic reactions. This is the first time she has ever had one and it was in response to that vaccine. The patient stated that in Mar2021 her blood pressure dropped and had a racing heart. She got very, very dizzy and had this sense of impending doom. She was told she had an anaphylactic reaction. This all lasted for about an hour. She stated that she did not require any hospitalization or anything and she was lucky. This occurred around 2:00 or 3:00pm that day it occurred in Mar2021.  She wanted to report this to Pfizer because she was told that it was the preservative in the vaccine that was causing this reaction. The preservative is PEG, polyethylene glycol, which is a nanoparticle representative in the vaccine. Therapeutic measures were not taken as a result of events. The outcome of events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 test, Thrombosis, Vaginal haemorrhage
Clinical narrative: experienced abnormal bleeding; unusual blood clots; First dose: 01Mar2021; Second dose: 15Apr2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 47-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm right, administration date 15Apr2021 (Batch/Lot number: unknown) at the age of 47 years as dose 2, single for covid-19 immunisation.  Relevant medical history included: "Graves Disease" (unspecified if ongoing). No known allergies. There were no concomitant medications. Vaccination history included: Bnt162b2 (Product: COVID 19,, brand unknown: True,, brand name unknown: COVID19 Vaccine,, lot unknown: True,, Lot unknown reason: Not available/provided to reporter at the time of report completion,, Administration date: 01Mar2021, Dose number: 1, Vaccine location: Right arm), administration date: 01Mar2021, when the patient was 47 years old, for COVID-19 immunization. The following information was reported: VAGINAL HAEMORRHAGE (medically significant) with onset 05Jan2022, outcome "unknown", described as "experienced abnormal bleeding"; THROMBOSIS (medically significant) with onset 05Jan2022, outcome "unknown", described as "unusual blood clots"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 15Apr2021, outcome "unknown", described as "First dose: 01Mar2021; Second dose: 15Apr2021". The events "experienced abnormal bleeding" and "unusual blood clots" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: Covid test: (10Jan2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of abnormal bleeding, unusual blood clots. The patient was prescribed "Prevera" Pills. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: got covid; got covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administration date 09Jun2021 (Batch/Lot number: unknown) as dose 2, single and administration date 20May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Jan2021 (unspecified if ongoing). The patient took concomitant medications. Healthy 59 year old male who does vitamins. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "got covid". Patient never got booster yet but got covid for Christmas. This time was as bad as the first time fever, body pain, head confused but this one also came with a bad case if hives. Patient was allergic to nothing so thinking it's how her body fought this off. Patient was negative as of 05Jan2022 but interested in blood sample for testing. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) negative.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Attention deficit hyperactivity disorder, Body temperature, Chills, Feeling abnormal, Hyperhidrosis
Clinical narrative: got covid; got covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administration date 09Jun2021 (Batch/Lot number: unknown) as dose 2, single and administration date 20May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Jan2021 (unspecified if ongoing). The patient took concomitant medications. Healthy 59 year old male who does vitamins. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "got covid". Patient never got booster yet but got covid for Christmas. This time was as bad as the first time fever, body pain, head confused but this one also came with a bad case if hives. Patient was allergic to nothing so thinking it's how her body fought this off. Patient was negative as of 05Jan2022 but interested in blood sample for testing. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) negative.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Urticaria
Clinical narrative: got covid; got covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administration date 09Jun2021 (Batch/Lot number: unknown) as dose 2, single and administration date 20May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Jan2021 (unspecified if ongoing). The patient took concomitant medications. Healthy 59 year old male who does vitamins. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "got covid". Patient never got booster yet but got covid for Christmas. This time was as bad as the first time fever, body pain, head confused but this one also came with a bad case if hives. Patient was allergic to nothing so thinking it's how her body fought this off. Patient was negative as of 05Jan2022 but interested in blood sample for testing. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) negative.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Trisomy 21
Clinical narrative: Down syndrome; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A fetus patient was exposed to bnt162b2 (BNT162B2), transplacental (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The mother's relevant medical history and concomitant medications were not reported. The following information was reported: TRISOMY 21 (non-serious), outcome "unknown", described as "Down syndrome".  Additional information The mother's vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization. Customer Verbatim: My was was vaccinated while we were trying to conceive our child. She received her second dose 1 week before conception and now we are expecting a baby with Down syndrome. Both of us are in our 20Ts and this is a very unlikely circumstance. I need someone to call me and try to explain that the vaccine is not the reason for this genetic disorder.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200058948 same reporter/drug, different patient/event (fetus)
Sex: U
Vaccine: COVID19
Symptoms: Near death experience, Palpitations
Clinical narrative: He/she felt he/she was going to die; heart Palpitation; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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, Manufacturer unknown), for COVID-19 immunization; Bnt162b2 (Dose 2, Manufacturer unknown), for Covid-19 immunization. The following information was reported: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "He/she felt he/she was going to die"; PALPITATIONS (non-serious), outcome "unknown", described as "heart Palpitation". The patient was having heart Palpitation. He/she felt he/she was going to die. He/she called 911 already. They did not have any ambulance. He/she was really dying.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.