chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Headache, Irritability, Meningitis
Clinical narrative: meningitis; bad headache; I was like really dizzy; disoriented; I was like hearing voices kind of and just irritable; venous thrombosis; 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 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Dec2021 (Lot number: FH8028) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: I am not sure I get high blood pressure once in a while. There were no concomitant medications. The following information was reported: MENINGITIS (medically significant), outcome "recovering", described as "meningitis"; HEADACHE (non-serious), outcome "recovered", described as "bad headache"; DIZZINESS (non-serious), outcome "recovering", described as "I was like really dizzy"; DISORIENTATION (non-serious), outcome "recovering", described as "disoriented"; IRRITABILITY (non-serious), outcome "recovering", described as "I was like hearing voices kind of and just irritable"; VENOUS THROMBOSIS (non-serious), outcome "recovering", described as "venous thrombosis". Therapeutic measures were not taken as a result of meningitis, headache, dizziness, disorientation, irritability, venous thrombosis. Clinical course: Patient had a "bad headache for both vaccines" and it goes away in like a day or two. After both shots, he was like really dizzy and disoriented and he was like hearing voices kind of and just irritable. No prior vaccination was taken with in four weeks.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Venous thrombosis
Clinical narrative: meningitis; bad headache; I was like really dizzy; disoriented; I was like hearing voices kind of and just irritable; venous thrombosis; 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 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Dec2021 (Lot number: FH8028) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: I am not sure I get high blood pressure once in a while. There were no concomitant medications. The following information was reported: MENINGITIS (medically significant), outcome "recovering", described as "meningitis"; HEADACHE (non-serious), outcome "recovered", described as "bad headache"; DIZZINESS (non-serious), outcome "recovering", described as "I was like really dizzy"; DISORIENTATION (non-serious), outcome "recovering", described as "disoriented"; IRRITABILITY (non-serious), outcome "recovering", described as "I was like hearing voices kind of and just irritable"; VENOUS THROMBOSIS (non-serious), outcome "recovering", described as "venous thrombosis". Therapeutic measures were not taken as a result of meningitis, headache, dizziness, disorientation, irritability, venous thrombosis. Clinical course: Patient had a "bad headache for both vaccines" and it goes away in like a day or two. After both shots, he was like really dizzy and disoriented and he was like hearing voices kind of and just irritable. No prior vaccination was taken with in four weeks.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: extreme ringing on the left side of my ears into my head. It's a constant ringing that doesn't stop; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200131555 (Pfizer).  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 28Sep2021 08:30 (Lot number: 301308A) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "pre diabetes" (unspecified if ongoing); "rheumatoid psoriatic arthritis" (unspecified if ongoing), notes: other medical history: rheumatoid psoriatic arthritis; "hyperthyroidism" (unspecified if ongoing); "asthma" (unspecified if ongoing); "walnuts" (unspecified if ongoing), notes: known allergies: walnuts; "smokes" (unspecified if ongoing), notes: known allergies: smokes; "popcorns" (unspecified if ongoing), notes: known allergies: popcorns. Concomitant medication(s) included: LOSARTAN; HYDROCHLOROTHIAZIDE; MULTIVITAMINS [VITAMINS NOS]. Past drug history included: Percocet, reaction(s): "Known allergies: percocet", notes: Known allergies: percocet. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FC3592, Location of injection: Arm Left, Vaccine Administration Time: 08:30, Route of Administration: Intramuscular), administration date: 07Sep2021, when the patient was 60 years old, for COVID-19 Immunization. The following information was reported: TINNITUS (medically significant) with onset 01Dec2021 21:00, outcome "not recovered", described as "extreme ringing on the left side of my ears into my head. It's a constant ringing that doesn't stop". The event "extreme ringing on the left side of my ears into my head. it's a constant ringing that doesn't stop" was evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus.  Clinical course: After two months of taking the vaccine the patient developed extreme ringing on the left side of her ears into the head. It's a constant ringing that doesn't stop. She had gone to her primary doctor and he started her on steroids low dose and nasal spray. The doctor advise her to follow up with ENT. After ENT visit, the patient is now taking a higher dose of steroids along with anti histamine. She has to follow up in two weeks, in February. The patient has a history of Rheumatoid arthritis and she already have an inflammatory response going on. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information
Age: 59.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: On 25Dec2021, the patient experienced contracted with covid; On 25Dec2021, the patient experienced contracted with covid; 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-163-4238018-00 (Agency).  A 59 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 23Dec2021 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1155267) at citrate free for rheumatoid arthritis. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 25Dec2021, outcome "recovered" and all described as "On 25Dec2021, the patient experienced contracted with covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive. The action taken for adalimumab was unknown. The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective and covid19 cannot be totally excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: contracted Covid after vaccination; contracted Covid after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose number unknown (booster), 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, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "contracted Covid after vaccination". 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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: contracted Covid after vaccination; contracted Covid after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Formulation: solution for injection, 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 (MANUFACTURER UNKNOWN, DOSE: 1), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "contracted Covid after vaccination". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. It was unknown if therapeutic measures were taken as a result of drug ineffective. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, VIth nerve paralysis
Clinical narrative: Right Eye - Diplopia 6th Nerve Palsy; Double vision; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Jun2021 11:15 (Lot number: EW0181) at the age of 56 years as dose 2, single for covid-19 immunisation. The patient had none relevant medical history. There were none concomitant medications. Vaccination history included: Bnt162b2 (Prev dose Lot number: EW0202, Prev dose Administration time: 11:00 AM, Prev dose Vaccine location: Left arm, Prev dose Dose number: 1), administration date: 25May2021, when the patient was 56 years old, for COVID-19 Immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received any other medications within 2 weeks of vaccination was none reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient known allergies was none reported. The following information was reported: VITH NERVE PARALYSIS (medically significant) with onset 14Aug2021 08:00, outcome "recovered" (Dec2021), described as "Right Eye - Diplopia 6th Nerve Palsy"; DIPLOPIA (non-serious) with onset 14Aug2021 08:00, outcome "recovered" (Dec2021), described as "Double vision". The events "right eye - diplopia 6th nerve palsy" and "double vision" were evaluated at the physician office visit. Reported that right eye - diplopia 6th nerve palsy. The right eye was not moving from left to right. Double vision. Started Ayurvedic and Homeopathic medicines from the first week of the eye problem. After the 6th week, the right eye moved a little bit and then took another 6 weeks to move completely towards the right side. But both eyes' speeds were not in sync and had double vision towards the right side. After another 4 weeks, both eyes were in sync and vision was normal. From Dec2021 first week onwards, eye vision was normal. He used both Ayurvedic and Homeopathic medicines until vision was normal. Patient visited doctor or other healthcare professional office/clinic. Therapeutic measures were taken as a result of vith nerve paralysis, diplopia.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Shoulder arthroplasty
Clinical narrative: Shoulder replacement; 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-163-4240225-00.  A 66 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 10Feb2021 (Batch/Lot number: unknown) at the age of 65 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at 40 mg (40 mg (40mg/0.4ml, 40 mg,1 in 2 wk)) for rheumatoid arthritis. Relevant medical history included: "Tooth extraction", start date: Sep2020 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 20Jan2021, when the patient was 65 years old, for COVID-19 immunization. The following information was reported: SHOULDER ARTHROPLASTY (medically significant) with onset 03Aug2021, outcome "unknown", described as "Shoulder replacement". The action taken for adalimumab was unknown.  Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for BNT162B2 for events shoulder replacement and tooth extraction; Causality as per reporter (Drug/Vaccine): Possible.  Causality for Humira 40mg/0.4ml (Adalimumab):The reporter's causality for the event(s) of Shoulder replacement and Tooth extraction was not provided. Agency's opinion is that there is no reasonable possibility that the events of Shoulder replacement and Tooth extraction are related to Humira 40mg/0.4ml (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 description given in the narrative, there is reasonable possibility of causal association between the serious event 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cardiac disorder, Rhinorrhoea, SARS-CoV-2 test, Vaccination failure
Clinical narrative: ST and rhinorrhea after houseguest who is COVID positive with home Ag, so she started to feel worst ST and rhinorrhea and home test + 1/20; ST and rhinorrhea after houseguest who is COVID positive with home Ag, so she started to feel worst ST and rhinorrhea and home test + 1/20; ST and rhinorrhea after houseguest who is COVID positive with home Ag, so she started to feel worst ST and rhinorrhea and home test + 1/20; ST and rhinorrhea after houseguest who is COVID positive with home Ag, so she started to feel worst ST and rhinorrhea and home test + 1/20; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 38 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 19Nov2021 (Lot number: FF2589) at the age of 38 years 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 Number: 2, Batch/Lot No: EL3247), administration date: 17Feb2021, when the patient was 37 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 26Jan2021, when the patient was 37 years old, for COVID-19 Immunization. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Jan2022, outcome "recovering" and all described as "ST and rhinorrhea after houseguest who is COVID positive with home Ag, so she started to feel worst ST and rhinorrhea and home test + 1/20"; CARDIAC DISORDER (non-serious), RHINORRHOEA (non-serious) all with onset 18Jan2022, outcome "recovering" and all described as "ST and rhinorrhea after houseguest who is COVID positive with home Ag, so she started to feel worst ST and rhinorrhea and home test + 1/20". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Jan2022) positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of covid-19, vaccination failure, cardiac disorder, rhinorrhoea. Clinical course: ST and rhinorrhea after houseguest who was COVID positive with home Ag, so she started to feel worst ST and rhinorrhea and home test + 1/20. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. C. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events vaccination failure and COVID-19, cardiac disorder and rhinorrhoea cannot be totally excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID positive; COVID positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 38 year-old female patient received bnt162b2 (BNT162B2), administration date 19Nov2021 (Lot number: FF2589) at the age of 38 years as dose 3 (booster), single, administration date 17Feb2021 (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) with onset 20Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 20Jan2022, outcome "recovering" and all described as "COVID positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Jan2022) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional Information: Reporter reported that it was Unknown if other vaccine was taken in four weeks. It is Yes if patient was Covid tested post vaccination. It was Unknown if covid was prior to vaccination. Privacy Policy consent was Yes. Device timestamp on 21Jan2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and vaccination failure cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and vaccination failure is : expected. The case will be reassessed further upon receipt of additional information.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Herpes zoster flare up in right eye 7 months/Flare ups then switched to left eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received BNT162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 08:30 (Lot number: EW0158) at the age of 29 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient did not have covid before immunization. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, lot# EW0150, in left arm, at 08:30), administration date: 31Mar2021, for COVID-19 immunisation. The following information was reported: OPHTHALMIC HERPES ZOSTER (non-serious) with onset 05Nov2021 15:00, outcome "recovered with sequelae", described as "Herpes zoster flare up in right eye 7 months/Flare ups then switched to left eye". It was reported that Herpes zoster flare up in right eye 7 months after first two vaccines. Flare ups then switched to left eye before going to Hospital ER. Local eye doctor referred me to Eye Center for further review where shingles was diagnosed. The event "herpes zoster flare up in right eye 7 months/flare ups then switched to left eye" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of ophthalmic herpes zoster: the patient was put on prescription. The patient was not tested positive for covid after vaccination. The patient then received the third dose of BNT162b2 on 12Jan2022 at 06:30 in left arm (Lot number FE3594) with VALTREX and PREDNISOL as other medications in two weeks.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Illness, Pyrexia, Rhinorrhoea
Clinical narrative: PCR test 18Jan Positive; PCR test 18Jan Positive; + sick 16Jan ST rhinorrhea with neg AG test; + sick 16Jan ST rhinorrhea with neg AG test; high fevers 101; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 27 year-old female patient received bnt162b2 (BNT162B2), administration date 03May2021 (Lot number: ER8729) at the age of 26 years as dose 2, single and administration date 12Apr2021 (Lot number: EW0172) 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), COVID-19 (medically significant) all with onset 18Jan2022, outcome "recovering" and all described as "PCR test 18Jan Positive"; ILLNESS (non-serious), RHINORRHOEA (non-serious) all with onset 16Jan2022, outcome "recovering" and all described as "+ sick 16Jan ST rhinorrhea with neg AG test"; PYREXIA (non-serious) with onset 16Jan2022, outcome "recovering", described as "high fevers 101". The events "pcr test 18jan positive", "pcr test 18jan positive", "+ sick 16jan st rhinorrhea with neg ag test", "+ sick 16jan st rhinorrhea with neg ag test" and "high fevers 101" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body temperature: (16Jan2022) 101, notes: high fevers; sars-cov-2 test: (16Jan2022) negative, notes: Other; (18Jan2022) positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, illness, rhinorrhoea, pyrexia.  It was unknown that patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown that the patient was diagnosed with COVID-19, prior to vaccination. The most recent COVID-19 vaccine was administered was withheld facility. The patient had been tested for COVID-19 since the vaccination. Adverse event result in doctor or other healthcare professional office/clinic visit.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of COVID- and Vaccination failure
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: PCR test 18Jan Positive; PCR test 18Jan Positive; + sick 16Jan ST rhinorrhea with neg AG test; + sick 16Jan ST rhinorrhea with neg AG test; high fevers 101; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 27 year-old female patient received bnt162b2 (BNT162B2), administration date 03May2021 (Lot number: ER8729) at the age of 26 years as dose 2, single and administration date 12Apr2021 (Lot number: EW0172) 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), COVID-19 (medically significant) all with onset 18Jan2022, outcome "recovering" and all described as "PCR test 18Jan Positive"; ILLNESS (non-serious), RHINORRHOEA (non-serious) all with onset 16Jan2022, outcome "recovering" and all described as "+ sick 16Jan ST rhinorrhea with neg AG test"; PYREXIA (non-serious) with onset 16Jan2022, outcome "recovering", described as "high fevers 101". The events "pcr test 18jan positive", "pcr test 18jan positive", "+ sick 16jan st rhinorrhea with neg ag test", "+ sick 16jan st rhinorrhea with neg ag test" and "high fevers 101" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body temperature: (16Jan2022) 101, notes: high fevers; sars-cov-2 test: (16Jan2022) negative, notes: Other; (18Jan2022) positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, illness, rhinorrhoea, pyrexia.  It was unknown that patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown that the patient was diagnosed with COVID-19, prior to vaccination. The most recent COVID-19 vaccine was administered was withheld facility. The patient had been tested for COVID-19 since the vaccination. Adverse event result in doctor or other healthcare professional office/clinic visit.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of COVID- and Vaccination failure
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Extreme blurry vision in one eye.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Jan2022 (Batch/Lot number: unknown) at the age of 40 years 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 Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Apr2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Mar2021, for COVID-19 immunization. The following information was reported: VISION BLURRED (non-serious) with onset 17Jan2022, outcome "recovering", described as "Extreme blurry vision in one eye.". The event "extreme blurry vision in one eye." was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of vision blurred. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, unknown the patient been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: headaches; not fell good; This is a spontaneous report received from contactable reporter (Consumer or other non HCP).  A 11 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Jan2022 16:45 (Batch/Lot number: unknown) at the age of 11 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "ADHD and asthma" (unspecified if ongoing), notes: Known allergies: No; The patient's concomitant medications were not reported. The following information was reported: HEADACHE (medically significant) with onset 21Jan2022 18:30, outcome "not recovered", described as "headaches"; MALAISE (medically significant) with onset 21Jan2022 18:30, outcome "not recovered", described as "not fell good". Therapeutic measures were taken as a result of headache, malaise including Tylenol for children.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Prior to vaccination,  the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Sudden hearing loss, Tinnitus, Vestibular function test, Vestibular migraine
Clinical narrative: sudden hearing loss; Vestibular migraines; Severe tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 09:00 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation, administered at pharmacy or drug store.  Relevant medical history included: "Severe Tree Nut Allergy - Lethal" (unspecified if ongoing). Prior to vaccination, the patient was  not diagnosed with COVID-19. Concomitant medication(s) included: INFLUENZA VACCINE, administration date 2021; OMEPRAZOLE; ATORVASTATIN; VIT D [COLECALCIFEROL]; SAMBUCOL. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), administration date: 23Mar2021, when the patient was 49 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), administration date: 14Apr2021, when the patient was 49 years old, for Covid-19 Immunization. The following information was reported: SUDDEN HEARING LOSS (disability) with onset 24Nov2021 04:00, outcome "not recovered", described as "sudden hearing loss"; VESTIBULAR MIGRAINE (disability) with onset 24Nov2021 04:00, outcome "not recovered", described as "Vestibular migraines"; TINNITUS (disability) with onset 24Nov2021 04:00, outcome "not recovered", described as "Severe tinnitus". The events "sudden hearing loss", "vestibular migraines" and "severe tinnitus" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: vestibular function test: (2021) unknown. Therapeutic measures were taken as a result of sudden hearing loss, vestibular migraine, tinnitus: hearing aids, audiogram, vestibular function test. Since the vaccination, the patient has not been tested for COVID-19. The lot number for bnt162b2 was not provided and will be requested during follow up.  Amendment: This follow-up report is being submitted to amend previous information. It was confirmed that the product was administered.
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Pericarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002191). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Single), for COVID-19 Immunization; Bnt162b2 (Dose 1, Single), for COVID-19 Immunization. The following information was reported: PERICARDITIS (medically significant), outcome "unknown", described as "Pericarditis". Clinical course: Patient took the Pfizer Covid-19 vaccine and booster and she stated that she developed pericarditis, and now she was asking if there was a coloration or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Hip arthroplasty, Irritable bowel syndrome, Nerve compression, Urticaria, Vaccination complication
Clinical narrative: Irritable bowel syndrome; Vaccination adverse reaction; Hives; Pinched nerve; Hip replacement; 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-163-4236033-00 (Abbvie).  A 55 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 08May2021 (Batch/Lot number: unknown) at the age of 54 years as dose 2, single and intramuscular, administration date 18Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HIP ARTHROPLASTY (medically significant) with onset 12Aug2021, outcome "recovering", described as "Hip replacement"; IRRITABLE BOWEL SYNDROME (medically significant), outcome "unknown", described as "Irritable bowel syndrome"; VACCINATION COMPLICATION (medically significant), outcome "recovering", described as "Vaccination adverse reaction"; URTICARIA (medically significant), outcome "unknown", described as "Hives"; NERVE COMPRESSION (medically significant), outcome "unknown", described as "Pinched nerve". The action taken for adalimumab was unknown.  The reporter considered "hip replacement", "irritable bowel syndrome", "vaccination adverse reaction", "hives" and "pinched nerve" related to bnt162b2.  Causality for Humira (Adalimumab):  The reporter's causality for the event(s) of left hip replaced, irritable bowel syndrome, side effects from covid shots and booster, hives off and on possibly caused heat and pinched nerve in back with Humira (Adalimumab) was no reasonable possibility. AbbVie's opinion is that there is no reasonable possibility that the events of left hip replaced, irritable bowel syndrome, side effects from covid shots and booster, hives off and on possibly caused heat and pinched nerve in back are related to humira (Adalimumab). Causality as per reporter for Pfizer BioNTech Covid-19 Vaccine (Tozinameran) for events hip replacement, Irritable bowel syndrome, Vaccination adverse reaction, Hives, Pinched nerve was not reported.  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 currently available,The casual association between the reported events and suspected vaccine BNT162B2 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: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Pain in extremity
Clinical narrative: Sore arm with the first dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Jan2021 07:30 (Lot number: P220395-0074L) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Muscular aches" (unspecified if ongoing), notes: He has muscular aches and his joints ache.; "joints ache" (unspecified if ongoing), notes: He has muscular aches and his joints ache.; "Flu" (unspecified if ongoing), notes: he had the flu previously maybe twice in his life; "whole body hurts" (unspecified if ongoing), notes: He has had no fever, but his whole body hurts.; "He can do no physical activity without straining himself" (unspecified if ongoing), notes: He can do no physical activity without straining himself; "He cant walk" (unspecified if ongoing), notes: He cant walk to the mailbox and back without stopping to rest. There were no concomitant medications. Vaccination history included: Flu shot, administration date: Nov2021. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jan2021, outcome "unknown", described as "Sore arm with the first dose". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: 2 years ago, he got involved with the pre-release Covid 19 study. Family Medical History Relevant to AE(s): None. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Prior Vaccinations (within 4 weeks): None. AE(s) following prior vaccinations: None.  No follow-up attempts are possible. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive COVID test result; Positive COVID test result; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 11 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Dec2021 (Lot number: FK5168) at the age of 11 years as dose 2 (tris), single and intramuscular, administered in arm left, administration date 16Nov2021 (Lot number: FK5168) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Patient received vaccine at Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior and other medications 2 weeks prior to the COVID vaccine. Patient had no known allergies. The patient was not tested positive for covid 19 prior to vaccination and had been tested post vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Jan2022, outcome "recovering" and all described as "Positive COVID test result". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive COVID test; Positive COVID test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 9 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Dec2021 (Lot number: FK5168) at the age of 9 years as dose 2 (tris), single and intramuscular, administered in arm left, administration date 16Nov2021 (Lot number: FK5168) as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Patient did not receive other medications in two weeks. Patient did not receive other vaccines within 4 weeks of COVID vaccine. Patient did not have Covid prior to vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jan2022, outcome "recovering" and all described as "Positive COVID test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Neoplasm malignant
Clinical narrative: for at-risk - cancer and congestive heart failure; for at-risk - cancer and congestive heart failure; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Congestive Heart Failure" (ongoing); "Cancer" (ongoing). The patient took concomitant medications. The following information was reported: CARDIAC FAILURE CONGESTIVE (medically significant), NEOPLASM MALIGNANT (medically significant), outcome "unknown" and all described as "for at-risk - cancer and congestive heart failure". Clinical course: Other medications in two weeks has at-risk conditions that may take medication. Unsure exact age but either adult or elderly probably 50s or 60s. Yesterday he had a dentist appointment to put a bridge in. They had to shave down a tooth, and his mouth was numb when he talked to us at around 17:45. Not sure when this procedure became necessary, but just an information. Believe he was likely at least fully vaccinated, but unsure which vaccine and when exactly got vaccinated. Probably sometime by 2021, may have had earlier access to vaccine due to pre-existing conditions. It was unknown if had covid prior vaccination and if had covid tested post vaccination. It was unknown if patient had any allergies.  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, UNK
Symptoms: Allergy to vaccine, Skin cancer
Clinical narrative: Skin cancer; Allergy to vaccine; MARKETING PROGRAME 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-163-4237721-00 (AbbVie).  A female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SKIN CANCER (medically significant), outcome "recovering", described as "Skin cancer"; ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Allergy to vaccine". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of skin cancer.  Clinical information: On unknown dates, the patient experienced skin cancer on face and leg and might be allergic to the covid-19 boosters. The patient developed skin cancer after starting on HUMIRA. In 2021, she had a surgery on her face to remove the area with cancer. On Jul2021, she had a second surgery on the skin on her leg. She suspected that she might be allergic to the ingredients of covid-19 boosters. It was unknown if she was enrolled in a COVID-19 Vaccine Trial.   The reporter's assessment of the causal relationship of the event skin cancer and allergy to vaccine with the suspect product BNT162B2 and adalimumab was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  As per Licensee opinion: The event of skin cancer on face and leg is not assessable for adalimumab. There is no reasonable possibility that the event of might be allergic to the covid-19 boosters 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 known safety profile and Limited information in the case report a casual association between the event skin cancer , allergy to vaccine with 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: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4236809-00 (Abbvie).  A 74 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date Aug2021 (Batch/Lot number: unknown) at the age of 73 years as dose 3 (booster), single, intramuscular, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: positive. The action taken for adalimumab was unknown.  Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and VACCINATION FAILURE,  COVID-19 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.