chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Nasopharyngitis, Pyrexia, SARS-CoV-2 test
Clinical narrative: Tested positive exactly 5 months post 2nd vaccine dose; Tested positive exactly 5 months post 2nd vaccine dose; fever; chills; cold symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Aug2021 (Lot number: FA7484) at the age of 49 years as dose 2, single and intramuscular, administered in arm left, administration date 21Jul2021 (Lot number: FA7484) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "in remission for prior breast cancer treatment" (unspecified if ongoing), notes: in remission for prior breast cancer treatment; "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "If Covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; OLMESARTAN; AROMASIN; XOPENEX; CLARITIN [CLARITHROMYCIN]. Past drug history included: Clindamycin, reaction(s): "Known allergies: Clindamycin".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jan2022 15:45, outcome "recovering" and all described as "Tested positive exactly 5 months post 2nd vaccine dose"; PYREXIA (non-serious) with onset 11Jan2022 15:45, outcome "recovering", described as "fever"; CHILLS (non-serious) with onset 11Jan2022 15:45, outcome "recovering", described as "chills"; NASOPHARYNGITIS (non-serious) with onset 11Jan2022 15:45, outcome "recovering", described as "cold symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, pyrexia, chills, nasopharyngitis.  Clinical course: Facility type was Pharmacy or Drug Store. If Covid prior vaccination was yes. If covid tested post vaccination was yes. The patient did not receive any other vaccines within four weeks prior to the vaccination.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Tested positive exactly 5 months post 2nd vaccine dose; Tested positive exactly 5 months post 2nd vaccine dose; fever; chills; cold symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Aug2021 (Lot number: FA7484) at the age of 49 years as dose 2, single and intramuscular, administered in arm left, administration date 21Jul2021 (Lot number: FA7484) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "in remission for prior breast cancer treatment" (unspecified if ongoing), notes: in remission for prior breast cancer treatment; "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "If Covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; OLMESARTAN; AROMASIN; XOPENEX; CLARITIN [CLARITHROMYCIN]. Past drug history included: Clindamycin, reaction(s): "Known allergies: Clindamycin".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jan2022 15:45, outcome "recovering" and all described as "Tested positive exactly 5 months post 2nd vaccine dose"; PYREXIA (non-serious) with onset 11Jan2022 15:45, outcome "recovering", described as "fever"; CHILLS (non-serious) with onset 11Jan2022 15:45, outcome "recovering", described as "chills"; NASOPHARYNGITIS (non-serious) with onset 11Jan2022 15:45, outcome "recovering", described as "cold symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, pyrexia, chills, nasopharyngitis.  Clinical course: Facility type was Pharmacy or Drug Store. If Covid prior vaccination was yes. If covid tested post vaccination was yes. The patient did not receive any other vaccines within four weeks prior to the vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, Suspected COVID-19
Clinical narrative: Booster; has Covid; has Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "has Covid"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster". The event "has covid" was evaluated at the emergency room visit. Reported that she had the primary series vaccination and the booster. Her sister recently visited her at her home and stayed there for about ten or fifteen minutes and now her sister had Covid. Her sister had also had her complete vaccination series. Sister went to the emergency room, and they told her that taking antibiotics wouldn't help and to keep taking ibuprofen. She was concerned that she can get infected by her sister. Asked if she should get a fourth dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Oct2021 12:00 (Lot number: FF2590) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE SODIUM; SPIRONOLACTONE; TRELEGY; OMEPRAZOLE. The following information was reported: COVID-19 (medically significant) with onset 06Nov2021, outcome "unknown", described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Nov2021) positive, notes: Rapid antigen, nasal swab. Additional information: patient had no known allergies. Patient did not have COVID-19 prior to vaccination. It was unknown if patient received other vaccine in four weeks.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200047534 Same reporter/patient/drug, different dose/events
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID symptoms; COVID symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program (159558). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: Before the vaccines, she had a hard case of Covid. The patient's 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 "COVID symptoms". Clinical comment: The patient was asking about the Booster shot. She said that she already had the 2 doses of the Pfizer vaccine and on each vaccine she had COVID symptoms.     The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Myelitis transverse
Clinical narrative: Acute transverse myelitis; This is a literature report.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYELITIS TRANSVERSE (medically significant), outcome "unknown", described as "Acute transverse myelitis".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis bad flare up; 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-163-4218689-00 (Agency).  A 51 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single and intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "Rheumatoid arthritis bad flare up". The action taken for upadacitinib was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for RINVOQ(UPADACITINIB): The reporters causality for the event(s) of rheumatoid arthritis bad flare up was not provided.  PFIZER BIONTECH COVID-19 vaccine: Causality: 1) Rheumatoid arthritis flare up: (Rheumatoid arthritis)  Causality as per reporter (Drug/Vaccine) : Possible  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is no reasonable possibility of causal association between the event rheumatoid arthritis and the suspect drug BNT162B2.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Illness, Systemic lupus erythematosus
Clinical narrative: lupus; she was so sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date May2021 (Batch/Lot number: unknown) at the age of 20 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Diagnosed about 4 years ago. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the vaccine.  The following information was reported: LUPUS SYNDROME (medically significant), outcome "unknown", described as "Lupus"; ILLNESS (non-serious), outcome "unknown", described as "she was so sick". The events "Lupus" and "she was so sick" were evaluated at the physician office visit. The patient didn't have Lupus before she got the vaccine and now (as of Jan2022) she had been diagnosed with it. She was diagnosed with Lupus 2 weeks ago (as of 11Jan2022), which was about 1 week after getting the 2nd dose of the vaccine. She started getting symptoms after she received the 1st dose of the vaccine in May2021, but she wasn't diagnosed with Lupus until just recently. She waited all that time to get the 2nd dose because she was so sick. She decided to finally get the 2nd dose due to the Omicron strain, but she was still sick and going to doctors to try to figure out what was wrong, so she doesn't know if it was the 1st dose that did it or the 2nd dose. The doctors don't want to link this to the vaccine, but she felt that it was related. The patient underwent the following laboratory tests and procedures: blood test: unknown results. She had done a lot of bloodwork.  The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200049289 Same patient/ vaccine, different dose/AE
Age: 50.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (Not Available). The reporter is the patient. Other Case identifier(s): 21K-163-4218801-00 (Agency).  A 51 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 08Aug2021 (Batch/Lot number: unknown) at the age of 50 years as dose 2, single and intramuscular, administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for psoriatic arthropathy. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID". The action taken for adalimumab was dosage permanently withdrawn. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No known allergies. Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of COVID was not provided. The reporter's assessment of the causal relationship of the events vaccination failure and COVID-19 with the suspect product was possible at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Home AG: positive; Home AG: positive; HA; booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 07Dec2021 (Lot number: FF2589) at the age of 50 years as dose 3 (booster), single, administration date 15Mar2021 (Lot number: EL3247) as dose 2, single and administration date 22Feb2021 (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: IMMUNISATION (medically significant) with onset 07Dec2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant) with onset 10Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 10Jan2022, outcome "recovering" and all described as "Home AG: positive"; HEADACHE (non-serious) with onset 10Jan2022, outcome "recovering", described as "HA". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of covid-19, headache.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Immunisation, Vaccination failure, Covid 19, Headache and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid Positive on 11Jan2022; Covid Positive on 11Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (Lot number: EL3247) as dose 2, single and administration date 22Feb2021 (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 11Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 11Jan2022, outcome "recovering" and all described as "Covid Positive on 11Jan2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Jan2022) positive. Therapeutic measures were not taken as a result of covid-19. Clinical course:   Prior to vaccination, patient was not diagnosed with COVID-19. No prolonged hospitalization reported.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Pain in extremity, Rheumatoid arthritis
Clinical narrative: rheumatoid arthritis flare up; hands started hurting/Hand pain; 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-163-4218960-00 (Agency).  A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 26Feb2021 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single and intramuscular, administration date 26Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; prednisone (PREDNISONE) (Batch/Lot number: unknown); adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a covid-19 vaccine trial. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "rheumatoid arthritis flare up"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "hands started hurting/Hand pain". The action taken for prednisone and adalimumab was unknown.  The reporter's assessment of the causal relationship of the events (Hand pain, Rheumatoid arthritis flare up) with the suspect products Humira (Adalimumab) and Prednisone was Not Reported.  The reporter's assessment of the causal relationship of the events (Hand pain, Rheumatoid arthritis flare up) with the suspect product PFIZER BIONTECH COVID-19 VACCINE was Probable.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Rheumatoid arthritis, Pain in extremity and the suspect drug BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Dose number 3; Reports + covid today I do not have any other details; Reports + covid today I do not have any other details; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from regulatory authority.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: FF2589) as dose 3 (booster), single, administration date 24Mar2021 at the age of 51 years (Lot number: EL3247) as dose 2, single and administration date 03Mar2021 at the age of 51 years (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine and it was unknown if the patient was diagnosed with COVID-19 The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Dose number 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jan2022, outcome "unknown" and all described as "Reports + covid today I do not have any other details". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Jan2022) positive. It was unknown if therapeutic measures were taken as a result of covid-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events vaccination failure, Booster, covid19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Death, Immunisation, Movement disorder, Myelitis transverse
Clinical narrative: Booster; He stated the female patient died; Transverse myelitis; Unable to move her arms and legs; This is a spontaneous report received from contactable reporter (Physician) from a sales representative.  A female patient received bnt162b2 (Pfizer-BioNTech COVID-19) (Batch/Lot number: unknown) 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 (Manufacturer Unknown, Dose number unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (death), outcome "fatal", described as "Booster"; DEATH (death), outcome "fatal", described as "He stated the female patient died"; MYELITIS TRANSVERSE (medically significant) after vaccination three days, outcome "unknown", described as "Transverse myelitis"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "Unable to move her arms and legs". The event "unable to move her arms and legs" was evaluated at the emergency room visit. The patient date of death was unknown. The reported cause of death was "He stated the female patient died". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: He stated the female patient died
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient tested positive for Covid infection; Patient tested positive for Covid infection; Booster Dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Dec2021 16:45 (Lot number: FF2589) at the age of 16 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (previous dose product=COVID 19, previous dose brand=Pfizer, previous dose lot number=EU0180, previous dose administrator route=Intramuscular, previous dose administration date=06Jun2021 , previous dose dose number=2, previous dose vaccine location=Left arm), administration date: 06Jun2021, when the patient was 16 years old, for COVID-19 immunization; Bnt162b2 (previous dose product=COVID 19, previous dose brand=Pfizer, previous dose lot number=EW0177, previous dose administrator route=Intramuscular, previous dose administration date=16May2021 , previous dose dose number=1, previous dose vaccine location=Left arm), administration date: 16May2021, when the patient was 15 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 16Dec2021 16:45, outcome "unknown", described as "Booster Dose"; VACCINATION FAILURE (medically significant) with onset 11Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 11Jan2022, outcome "recovering" and all described as "Patient tested positive for Covid infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) negative; (11Jan2022) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The patient took other medication Multivitamins and birth control pill with in two weeks. Patient did not have any Known allergies.The patient did not receive any other vaccines within four weeks prior to the vaccination.COVID prior vaccination was none reported.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient. A 63 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Patient had a hard case of covid" (unspecified if ongoing) and getting the vaccines threw her back into those symptoms. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunization, reaction(s): "COVID symptoms". The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "passed off 3 times". Patient asked for advice if ever she can get the booster shot. She said that she had strong reactions to the two (2) vaccines unable to transfer to Covid19 line because there was a long wait time. Patient did not report until she called yesterday (as per report), stated that she was put through and passed off 3 times. She complained that didn't get to speak with anyone regarding this but only heard recordings about the Pfizer covid vaccine. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid-19; Covid-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (NOT AVAILABLE). The reporter is the patient. Other Case identifier(s): 22K-163-4220902-00.  A 38 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 15May2020 (Batch/Lot number: unknown) at the age of 38 years as dose 2, single and intramuscular, administration date 15Apr2020 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Covid-19". The action taken for adalimumab was unknown.   The reporters assessment of the causal relationship of the events with the suspect product  bnt162b2 was reported as possible  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is no reasonable possibility of causal association between the events DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) and the suspect drug BNT162B2
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Fatigue, General physical condition abnormal, Illness
Clinical narrative: BOOSTER; passed out; Sickness; Dizzy; Tiredness; General body appearance abnormal/bad shape; Confused; 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-163-4220680-00.  A 60 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at 40 mg (40 mg (cf (40 mg,1 in 2 week). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Drug :PFIZER BIONTECH COVID-19 VACCINE, Route of Admin: Intramuscular, Indication for use : COVID-19 VACCINATION), for covid-19 immunization; Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "BOOSTER"; LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "passed out"; ILLNESS (non-serious), outcome "unknown", described as "Sickness"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; GENERAL PHYSICAL CONDITION ABNORMAL (non-serious), outcome "unknown", described as "General body appearance abnormal/bad shape"; CONFUSIONAL STATE (non-serious), outcome "unknown", described as "Confused". The action taken for adalimumab was unknown. The patient had been in bad shape, she got really really sick with her covid booster shot. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of passing out, patient had been in bad shape/got sick with covid booster shot unknown onset, dizzy, tired, patient had been in bad shape/got sick with covid booster shot unknown onset and confused was not provided. The events of passing out, patient had been in bad shape/got sick with covid booster shot unknown onset, dizzy, tired, patient had been in bad shape/got sick with covid booster shot unknown onset and confused are not assessable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Immunisation, Booster, Loss of consciousness, Illness, dizziness, Fatigue, General physical condition abnormal, confusional state and the suspect drug BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Loss of consciousness
Clinical narrative: BOOSTER; passed out; Sickness; Dizzy; Tiredness; General body appearance abnormal/bad shape; Confused; 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-163-4220680-00.  A 60 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at 40 mg (40 mg (cf (40 mg,1 in 2 week). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Drug :PFIZER BIONTECH COVID-19 VACCINE, Route of Admin: Intramuscular, Indication for use : COVID-19 VACCINATION), for covid-19 immunization; Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "BOOSTER"; LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "passed out"; ILLNESS (non-serious), outcome "unknown", described as "Sickness"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; GENERAL PHYSICAL CONDITION ABNORMAL (non-serious), outcome "unknown", described as "General body appearance abnormal/bad shape"; CONFUSIONAL STATE (non-serious), outcome "unknown", described as "Confused". The action taken for adalimumab was unknown. The patient had been in bad shape, she got really really sick with her covid booster shot. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of passing out, patient had been in bad shape/got sick with covid booster shot unknown onset, dizzy, tired, patient had been in bad shape/got sick with covid booster shot unknown onset and confused was not provided. The events of passing out, patient had been in bad shape/got sick with covid booster shot unknown onset, dizzy, tired, patient had been in bad shape/got sick with covid booster shot unknown onset and confused are not assessable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Immunisation, Booster, Loss of consciousness, Illness, dizziness, Fatigue, General physical condition abnormal, confusional state and the suspect drug BNT162B2.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dysarthria, Heart rate, Heart rate increased, Hypertension
Clinical narrative: BP at (+245/+105); Tremors; High heartbeat; Slurred words; 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. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 29Jun2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "High BP" (unspecified if ongoing), notes: Prior to the vac, an episode lasted approx. 20 minutes up to an hour. Concomitant medication(s) included: METOPROLOL SUCCINATE. The following information was reported: HYPERTENSION (medically significant) with onset Jun2021, outcome "recovered" (2021), described as "BP at (+245/+105)"; TREMOR (non-serious) with onset Jun2021, outcome "unknown", described as "Tremors"; HEART RATE INCREASED (non-serious) with onset Jun2021, outcome "unknown", described as "High heartbeat"; DYSARTHRIA (non-serious) with onset Jun2021, outcome "unknown", described as "Slurred words". Patient questioned can Metoprolol Succ. ER (taken 2 hrs prior to vaccine) cause a bad interaction with the Covid vac. Pfizer had my report, last year. Pfizer Vac: 29Jun2021: 1st dose. Within moments of vac, Side Effect included BP at (+245/+105), tremors, high heartbeat, slurred words. EMT was called. Patient decided no hospital. Effects lasted Months after the vac: each High BP episode lasted up to 2-4 hours. Prior to the vac, an episode lasted approx. 20 minutes up to an hour. Doctors, etc. said not to take additional vaccines. The patient underwent the following laboratory tests and procedures: BP: (Jun2021) +245/+105; (Jun2021) high; Heartbeat: (Jun2021) high.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: BP at (+245/+105); Tremors; High heartbeat; Slurred words; 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. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 29Jun2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "High BP" (unspecified if ongoing), notes: Prior to the vac, an episode lasted approx. 20 minutes up to an hour. Concomitant medication(s) included: METOPROLOL SUCCINATE. The following information was reported: HYPERTENSION (medically significant) with onset Jun2021, outcome "recovered" (2021), described as "BP at (+245/+105)"; TREMOR (non-serious) with onset Jun2021, outcome "unknown", described as "Tremors"; HEART RATE INCREASED (non-serious) with onset Jun2021, outcome "unknown", described as "High heartbeat"; DYSARTHRIA (non-serious) with onset Jun2021, outcome "unknown", described as "Slurred words". Patient questioned can Metoprolol Succ. ER (taken 2 hrs prior to vaccine) cause a bad interaction with the Covid vac. Pfizer had my report, last year. Pfizer Vac: 29Jun2021: 1st dose. Within moments of vac, Side Effect included BP at (+245/+105), tremors, high heartbeat, slurred words. EMT was called. Patient decided no hospital. Effects lasted Months after the vac: each High BP episode lasted up to 2-4 hours. Prior to the vac, an episode lasted approx. 20 minutes up to an hour. Doctors, etc. said not to take additional vaccines. The patient underwent the following laboratory tests and procedures: BP: (Jun2021) +245/+105; (Jun2021) high; Heartbeat: (Jun2021) high.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Drug ineffective, Illness, Immunisation, Pyrexia
Clinical narrative: booster; Was diagnosed with COVID-19 on 1/6/2022.; contracted COVID-19; Fever (103.50F); very sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Relevant medical history included: "lung tissue scarring" (unspecified if ongoing); "underlying genetic condition" (unspecified if ongoing). The patient's concomitant medications were not reported. It was reported that patient was at high risk due to an underlying genetic condition and lung tissue scarring. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; SUSPECTED COVID-19 (medically significant) with onset 06Jan2022, outcome "unknown", described as "Was diagnosed with COVID-19 on 1/6/2022."; DRUG INEFFECTIVE (medically significant) with onset 06Jan2022, outcome "unknown", described as "contracted COVID-19"; PYREXIA (non-serious) with onset 05Jan2022, outcome "unknown", described as "Fever (103.50F)"; ILLNESS (non-serious) with onset 05Jan2022, outcome "unknown", described as "very sick". The patient underwent the following laboratory tests and procedures: body temperature: (05Jan2022) 103.5 Fahrenheit.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: booster; Was diagnosed with COVID-19 on 1/6/2022.; contracted COVID-19; Fever (103.50F); very sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Relevant medical history included: "lung tissue scarring" (unspecified if ongoing); "underlying genetic condition" (unspecified if ongoing). The patient's concomitant medications were not reported. It was reported that patient was at high risk due to an underlying genetic condition and lung tissue scarring. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; SUSPECTED COVID-19 (medically significant) with onset 06Jan2022, outcome "unknown", described as "Was diagnosed with COVID-19 on 1/6/2022."; DRUG INEFFECTIVE (medically significant) with onset 06Jan2022, outcome "unknown", described as "contracted COVID-19"; PYREXIA (non-serious) with onset 05Jan2022, outcome "unknown", described as "Fever (103.50F)"; ILLNESS (non-serious) with onset 05Jan2022, outcome "unknown", described as "very sick". The patient underwent the following laboratory tests and procedures: body temperature: (05Jan2022) 103.5 Fahrenheit.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Electrocardiogram, Heart rate, Heart rate increased, Hypertension
Clinical narrative: volatile BP; rapid heart rate; Severe insomnia; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP).  A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm right, administration date 17Mar2021 (Lot number: ER2613) at the age of 69 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Help for sleep" (unspecified if ongoing); "Low cholesterol" (unspecified if ongoing); "HTV" (unspecified if ongoing). Concomitant medications included: LOSARTAN taken for tidal volume increased, stop date: Jun2021; ATORVASTATIN taken for blood cholesterol decreased (ongoing); MIRTAZAPINE taken for sleep disorder (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Time: 13:30, Anatomical Site of injection:  Arm, Route of administration: Intramuscular, Batch/Lot number: EN6203), administration date: 23Feb2021, for Covid-19 Immunization. The following information was reported: INSOMNIA (medically significant) with onset 17Mar2021, outcome "recovered" (Aug2021), described as "Severe insomnia"; HYPERTENSION (medically significant) with onset 18Mar2021, outcome "recovered" (05Jan2022), described as "volatile BP"; HEART RATE INCREASED (medically significant) with onset 17Mar2021, outcome "recovered" (Aug2021), described as "rapid heart rate". The events "severe insomnia", "volatile bp" and "rapid heart rate" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (18Mar2021) volatile bp, notes: extremely high bp; electrocardiogram: (May2021) normal; heart rate: (17Mar2021) rapid. Therapeutic measures were taken as a result of insomnia included lorazepam (ATIVAN), hypertension included new BP medication, heart rate increased included propanalol.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: volatile BP; rapid heart rate; Severe insomnia; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP).  A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm right, administration date 17Mar2021 (Lot number: ER2613) at the age of 69 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Help for sleep" (unspecified if ongoing); "Low cholesterol" (unspecified if ongoing); "HTV" (unspecified if ongoing). Concomitant medications included: LOSARTAN taken for tidal volume increased, stop date: Jun2021; ATORVASTATIN taken for blood cholesterol decreased (ongoing); MIRTAZAPINE taken for sleep disorder (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Time: 13:30, Anatomical Site of injection:  Arm, Route of administration: Intramuscular, Batch/Lot number: EN6203), administration date: 23Feb2021, for Covid-19 Immunization. The following information was reported: INSOMNIA (medically significant) with onset 17Mar2021, outcome "recovered" (Aug2021), described as "Severe insomnia"; HYPERTENSION (medically significant) with onset 18Mar2021, outcome "recovered" (05Jan2022), described as "volatile BP"; HEART RATE INCREASED (medically significant) with onset 17Mar2021, outcome "recovered" (Aug2021), described as "rapid heart rate". The events "severe insomnia", "volatile bp" and "rapid heart rate" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (18Mar2021) volatile bp, notes: extremely high bp; electrocardiogram: (May2021) normal; heart rate: (17Mar2021) rapid. Therapeutic measures were taken as a result of insomnia included lorazepam (ATIVAN), hypertension included new BP medication, heart rate increased included propanalol.  No follow-up attempts are possible. No further information is expected.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: SARs-COV2- PCR test via saliva obtained on 10Jan2022 was positive; SARs-COV2- PCR test via saliva obtained on 10Jan2022 was positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the parent.  A 11 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Dec2021 12:00 (Lot number: FL0007) at the age of 11 years as dose 2, single and intramuscular, administered in arm left, administration date 10Nov2021 09:00 (Lot number: FK5618) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jan2022, outcome "unknown" and all described as "SARs-COV2- PCR test via saliva obtained on 10Jan2022 was positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive, notes: Other; (22Sep2021) negative, notes: Other. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Facility type vaccine was Pharmacy or Drug Store. SARs-COV2 PCR testing via saliva done weekly since Sep2021 all negative until SARs-COV2- PCR test via saliva obtained on 10Jan2022 was positive. Patient did not receive other vaccine in four weeks. Patient did not receive other medication in two weeks. The patient did not have covid prior vaccination. The patient was covid tested post vaccination. No known drug allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and a possible contributory role of the suspect product BNT162B2 to the development of events vaccination failure, covid19 cannot be totally excluded.