chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Oxygen saturation, Vaccination failure
Clinical narrative: Highly suspect positive case; Highly suspect positive case; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 22Oct2021 (Lot number: FF2589) as dose 3 (booster ), single, administration date 17Feb2021 (Lot number: EL3247) as dose 2, single and administration date 27Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jan2022, outcome "recovering" and all described as "Highly suspect positive case". The event "highly suspect positive case" and "highly suspect positive case" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: oxygen saturation: 92-93 %. It was unknown if therapeutic measures were taken as a result of vaccination failure.  Clinical course: The reporter reported that the patient as exposed to sick daughter with Covid who is nonverbal, 10Jan, then she got sx 15Jan of coughing, headache, wheezing, low O2 (92-93%) by night starting last Saturday 15Jan2022, loss of smells for the last 3 days. PND PCR TEST tomorrow but highly suspect positive case. The information related to treatment, covid prior vaccination, and covid tested post vaccination was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events  and suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Nasopharyngitis, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Common cold/ Bad cold; 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): 22K-163-4240188-00 (AbbVie).  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 1, single and intramuscular (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free 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 flare up"; NASOPHARYNGITIS (non-serious), outcome "recovering", described as "Common cold/ Bad cold". The action taken for adalimumab was unknown. The reporter's causality for the event(s) of BAD COLD and rheumatoid arthritis flare with HUMIRA(ADALIMUMAB) was no reasonable possibility. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for the event rheumatoid arthritis flare up with BNT162B2 was possible. The reporter's assessment of the causal relationship of the bad cold with BNT162B2 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: booster; tested positive for COVID 19; tested positive for COVID 19; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "unknown" and all described as "tested positive for COVID 19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jan2022) positive.  The patient tested positive for COVID 19 on 09Jan2022 and stated "My symptoms were cold like, relatively light, and 10 days later, gone. I credit this positive experience to the vaccine you developed. I have three shots thus far."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Myelitis transverse, Paraplegia
Clinical narrative: near complete paraplegia; Transverse Myelitis; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 37 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Jan2022 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (unknown dose number; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PARAPLEGIA (hospitalization, medically significant) with onset 20Jan2022, outcome "unknown", described as "near complete paraplegia"; MYELITIS TRANSVERSE (hospitalization, medically significant) with onset 20Jan2022, outcome "unknown", described as "Transverse Myelitis". The patient was hospitalized for paraplegia, myelitis transverse (start date: 20Jan2022). The events "near complete paraplegia" and "transverse myelitis" were evaluated at the emergency room visit. The clinical course was reported as follows: the patient awoke with near complete paraplegia on morning of 20Jan2022. He ended up being seen at a local ER and was admitted to the hospital with diagnosis of Transverse Myelitis during the evening of 20Jan2022 by the reporting physician. Additional information: it was felt that the event may have been related to the Pfizer COMIRNATY booster shot given the previous day. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: A contributory role of suspect drug  in causing the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Eye swelling
Clinical narrative: Swollen his eyes; He can't breathe; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EYE SWELLING (non-serious), outcome "unknown", described as "Swollen his eyes"; DYSPNOEA (non-serious), outcome "unknown", described as "He can't breathe".  Additional information: Reporter just called because their grandson, he had a reaction to the Pfizer vaccine, and they asked for email to send some paper to let you know what happened with their grandson and they sent reporter some paper and they took it to the doctor but they lost the paper. So, they want to see if you can send the paper again. He had reaction, when they put the vaccine, he had swollen his eyes (voice not clear), he can't breathe, they told him, the doctor said that he cannot, they cannot put the vaccine again. The only thing reporter need is the paper they send them to take that paper to the doctor. They took that paper to the doctor, and they lost that. So, reporter calling to see if you can send back that paper. Reporter asked So, where they could get this, where they could send them.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP, for a Pfizer sponsored program. A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had COVID-19 (in less than 24 hours, tested positive for Omnicron), with outcome of unknown. Relevant laboratory tests and procedures available in the appropriate section. The lot number for BNT162B2 not provided and will be requested during follow-up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Osteonecrosis, SARS-CoV-2 test
Clinical narrative: Avascular necrosis; COVID-19; COVID-19;   This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4197207-00.  A 55 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 10May2021 (Batch/Lot number: unknown) at the age of 54 years as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at 40 mg (citrate free (40 mg,1 in 2 wk)) for rheumatoid arthritis. Relevant medical history included: "Ankle pain", start date: Apr2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 04Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 04Dec2021, outcome "recovered" (2021) and all described as "COVID-19"; OSTEONECROSIS (medically significant), outcome "unknown", described as "Avascular necrosis". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Nov2021) positive. The action taken for adalimumab was dosage permanently withdrawn. It was reported that, the solicited report from the PRIVACY by a consumer of a 55-year-old female patient with events of Avascular necrosis and non-serious COVID-19 Symptoms with HUMIRA (ADALIMUMAB). PFIZER BioNTech COVID-19 Vaccine (TOZINAMERAN) was also considered as suspect. She reported ankle pain which was prior to initiation of Humira and it was diagnosed as Avascular necrosis. It was unknown whether the patient was enrolled in a COVID-19 vaccine trial. Stated that, the primary reporter did not have the lot number information as the packaging was discarded.  Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of Avascular necrosis and COVID-19 symptoms was not reported. opinion was that there was no reasonable possibility that the events of Avascular Necrosis and COVID-19 symptoms are related to HUMIRA(ADALIMUMAB). The reporter's causality of PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) for the event(s) of Avascular necrosis and COVID-19 symptoms was reported as Possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; 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  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: 25.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Eye inflammation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Eye inflammation; Contact with individuals who tested positive for COVID with Humira; Contact with individuals who tested positive for COVID with Humira; 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): 22K-163-4237205-00 (AbbVie).  A 25 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 18Oct2021 (Batch/Lot number: unknown) at the age of 25 years as dose 3 (booster), single, intramuscular, administration date 13Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 23Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) as cf for rheumatoid arthritis. 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 2021, outcome "unknown" and all described as "Contact with individuals who tested positive for COVID with Humira"; EYE INFLAMMATION (non-serious), outcome "unknown", described as "Eye inflammation". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (13Jan2022) positive. The action taken for adalimumab was unknown.  Clinical information: Solicited report by a consumer of an adult female with events of non-serious Eye inflammation and contact with individuals who tested positive for covid with HUMIRA (ADALIMUMAB). On unknown dates, the patient experienced eye inflammation and contact with individuals who tested positive for covid. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 23Mar2021, the patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 13Apr2021, the patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech.   Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of Eye inflammation and contact with individuals who tested positive for covid with HUMIRA(ADALIMUMAB) was no reasonable possibility.  The reporter's assessment of the causal relationship of the events 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 assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19 test, vaccination failure and Eye inflammation
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He had his second dose of vaccine on May2021/tested positive for Covid; He had his second dose of vaccine on May2021/tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient in his 50's received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing), notes: diabetic patient in his mid 50s. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "He had his second dose of vaccine on May2021/tested positive for Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive; no negative, notes: after a second test he is no negative. Therapeutic measures were taken as a result of covid-19. Clinical course: Caller is a consumer who tested positive for Covid and he has already finished his course of Paxlovid treatment. and after a second test he is no negative (Wednesday) He had his second dose of vaccine on May2021 and He wants to know when he can get his booster for Pfizer BioNTech vaccine? The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac stress test, Cerebrovascular accident, Computerised tomogram, Investigation, Thrombosis
Clinical narrative: blood clot stroke\heart went into a fib; blood clot stroke; lost 20 pounds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergic to milk" (unspecified if ongoing), notes: allergic to milk. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number:01), for Covid-19 Immunization. The following information was reported: THROMBOSIS (hospitalization, medically significant) with onset 21Mar2021, outcome "recovering", described as "blood clot stroke\heart went into a fib"; CEREBROVASCULAR ACCIDENT (hospitalization, medically significant) with onset 21Mar2021, outcome "recovering", described as "blood clot stroke"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "lost 20 pounds". The patient was hospitalized for thrombosis, cerebrovascular accident (hospitalization duration: 2 day(s)). The events "blood clot stroke\heart went into a fib", "blood clot stroke" and "lost 20 pounds" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: cardiac stress test: passed; computerised tomogram: blood clot stroke, notes: blood clot stroke, The stroke was in the lower part of his brain.Head CT; investigation: results unknown. Therapeutic measures were taken as a result of thrombosis, cerebrovascular accident. Clinical course: The caller is calling about the Pfizer covid shot. 3 weeks after the shot the caller got a blood clot stroke, he had to go to the emergency room, and had an emergency procedure to get the clot out of his brain.The caller lost 20 pounds since this event.The caller feels better now and was healthy prior to taking the vaccine. The caller was in the hospital for 2 days. The caller was sitting on the couch and couldn't get up, he didn't look good. They called the EMS and took the caller to the hospital that handles strokes. They did a CAT scan on the callers head and saw that he was having a stroke. They went in through his penis for his procedure to get the clot. The stroke was in the lower part of his brain. The caller went to a neurologist and did tests and then the cardiologist had him do a test on the heart because his heart went into a fib, which he has never had before. This has settled down now. They made him do a nuclear stress test which the caller passed. Then because of the stroke the caller was put on meds that made all sorts of weird things happen to him. Patient did not have risk factors for TTS or other relevant medical history. He did not receive concomitant medications within 2 weeks of event onset. Patient received Blood clot retrieval in brain for TTS.    The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: blood clot stroke\heart went into a fib; blood clot stroke; lost 20 pounds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergic to milk" (unspecified if ongoing), notes: allergic to milk. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number:01), for Covid-19 Immunization. The following information was reported: THROMBOSIS (hospitalization, medically significant) with onset 21Mar2021, outcome "recovering", described as "blood clot stroke\heart went into a fib"; CEREBROVASCULAR ACCIDENT (hospitalization, medically significant) with onset 21Mar2021, outcome "recovering", described as "blood clot stroke"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "lost 20 pounds". The patient was hospitalized for thrombosis, cerebrovascular accident (hospitalization duration: 2 day(s)). The events "blood clot stroke\heart went into a fib", "blood clot stroke" and "lost 20 pounds" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: cardiac stress test: passed; computerised tomogram: blood clot stroke, notes: blood clot stroke, The stroke was in the lower part of his brain.Head CT; investigation: results unknown. Therapeutic measures were taken as a result of thrombosis, cerebrovascular accident. Clinical course: The caller is calling about the Pfizer covid shot. 3 weeks after the shot the caller got a blood clot stroke, he had to go to the emergency room, and had an emergency procedure to get the clot out of his brain.The caller lost 20 pounds since this event.The caller feels better now and was healthy prior to taking the vaccine. The caller was in the hospital for 2 days. The caller was sitting on the couch and couldn't get up, he didn't look good. They called the EMS and took the caller to the hospital that handles strokes. They did a CAT scan on the callers head and saw that he was having a stroke. They went in through his penis for his procedure to get the clot. The stroke was in the lower part of his brain. The caller went to a neurologist and did tests and then the cardiologist had him do a test on the heart because his heart went into a fib, which he has never had before. This has settled down now. They made him do a nuclear stress test which the caller passed. Then because of the stroke the caller was put on meds that made all sorts of weird things happen to him. Patient did not have risk factors for TTS or other relevant medical history. He did not receive concomitant medications within 2 weeks of event onset. Patient received Blood clot retrieval in brain for TTS.    The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram
Clinical narrative: blood clot stroke\heart went into a fib; blood clot stroke; lost 20 pounds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergic to milk" (unspecified if ongoing), notes: allergic to milk. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number:01), for Covid-19 Immunization. The following information was reported: THROMBOSIS (hospitalization, medically significant) with onset 21Mar2021, outcome "recovering", described as "blood clot stroke\heart went into a fib"; CEREBROVASCULAR ACCIDENT (hospitalization, medically significant) with onset 21Mar2021, outcome "recovering", described as "blood clot stroke"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "lost 20 pounds". The patient was hospitalized for thrombosis, cerebrovascular accident (hospitalization duration: 2 day(s)). The events "blood clot stroke\heart went into a fib", "blood clot stroke" and "lost 20 pounds" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: cardiac stress test: passed; computerised tomogram: blood clot stroke, notes: blood clot stroke, The stroke was in the lower part of his brain.Head CT; investigation: results unknown. Therapeutic measures were taken as a result of thrombosis, cerebrovascular accident. Clinical course: The caller is calling about the Pfizer covid shot. 3 weeks after the shot the caller got a blood clot stroke, he had to go to the emergency room, and had an emergency procedure to get the clot out of his brain.The caller lost 20 pounds since this event.The caller feels better now and was healthy prior to taking the vaccine. The caller was in the hospital for 2 days. The caller was sitting on the couch and couldn't get up, he didn't look good. They called the EMS and took the caller to the hospital that handles strokes. They did a CAT scan on the callers head and saw that he was having a stroke. They went in through his penis for his procedure to get the clot. The stroke was in the lower part of his brain. The caller went to a neurologist and did tests and then the cardiologist had him do a test on the heart because his heart went into a fib, which he has never had before. This has settled down now. They made him do a nuclear stress test which the caller passed. Then because of the stroke the caller was put on meds that made all sorts of weird things happen to him. Patient did not have risk factors for TTS or other relevant medical history. He did not receive concomitant medications within 2 weeks of event onset. Patient received Blood clot retrieval in brain for TTS.    The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Hypersensitivity, Rheumatoid arthritis, Vaccination site pain
Clinical narrative: covid/lung covid; covid/lung covid; Rheumatoid arthritis flare up; felt like allergies; sore arm;   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-163-4241673-00 (AbbVie Inc.).  A 37 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Jan2021 (Batch/Lot number: unknown) at the age of 37 years as dose 1, single and intramuscular, administration date 29Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "covid/lung covid"; RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "Rheumatoid arthritis flare up"; HYPERSENSITIVITY (non-serious), outcome "recovering", described as "felt like allergies"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "sore arm". The action taken for adalimumab was unknown.  Clinical course: The reporter's assessment of the causal relationship of the event with the suspect products 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. Causality for Humira (adalimumab) The reporter's causality for the event(s) of covid vaccine caused sore arm, covid/lung covid, rheumatoid arthritis flair up due to covid vaccine and felt like allergies was not provided.  Concomitant Drugs and dates of administration (Exclude those used to treat event) Concomitant Drugs Not Reported. Other Relevant History Not reported. event abate after stopping drug NA. . PFIZER BIONTECH COVID-19 VACCINE (tozinameran) was also considered suspect.  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 DRUG INEFFECTIVE, COVID-19 , RHEUMATOID ARTHRITIS ,  HYPERSENSITIVITY, VACCINATION SITE PAIN 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: 46.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: COVID-19 virus test positive; COVID-19 virus test positive; Booster; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. Other Case identifier(s): 22K-163-4241286-00.  A 46 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 04Oct2021 (Batch/Lot number: unknown) at the age of 46 years as dose 2 (booster), single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Humira for Moderate to severe rheumatoid arthritis. The following information was reported: IMMUNISATION (medically significant) with onset 04Oct2021, outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Jan2022, outcome "unknown" and all described as "COVID-19 virus test positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (unspecified date) unknown results, notes: had monochrome antibodies; sars-cov-2 test: (14Jan2022) positive, notes: Covid test. The action taken for adalimumab was unknown.  Clinical Course: It was unknown if patient was enrolled in a covid-19 vaccine trial.  Causality for Humira (adalimumab): The reporter's causality for the event(s) of tested positive for covid with Humira (adalimumab) was a Reasonable possibility.  Causality for Pfizer BioNTech covid-19 vaccine (tozinameran): The reporter's causality for the event(s) of tested positive for covid with Pfizer BioNTech covid-19 vaccine (tozinameran) was a possible.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided the lack of efficacy of the vaccine (LOE) cannot be excluded.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: has had all three doses and now he came back with a new variant of Covid; has had all three doses and now he came back with a new variant of Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DEXAMETHASONE; PAXLOVID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "has had all three doses and now he came back with a new variant of Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: he came back with a new variant of covid. Clinical course: Caller then states he has had all three doses and now he came back with a new variant of Covid, states his doctor put him on this stuff. Caller states he is also taking another pill with Paxlovid which is called Dexamethasone, 6mg.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200125084 Same patient/vaccine, different vaccine dose/event
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: has had all three doses and now he came back with a new variant of Covid; has had all three doses and now he came back with a new variant of Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DEXAMETHASONE; PAXLOVID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "has had all three doses and now he came back with a new variant of Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: he came back with a new variant of covid. Clinical course: Caller then states he has had all three doses and now he came back with a new variant of Covid, states his doctor put him on this stuff. Caller states he is also taking another pill with Paxlovid which is called Dexamethasone, 6mg.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200125084 Same patient/vaccine, different vaccine dose/event
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: My heart went into AFIB; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 56 year-old 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. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (hospitalization, medically significant), outcome "unknown", described as "My heart went into AFIB". I just want you to be aware of my reaction to the first two COVID vaccines. Patient heart went into AFIB, and patient was admitted to the hospital. Patient was 56 yoa, and had never experienced heart problems prior to the vaccines  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got covid; got covid; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An adult female patient (Believe likely age between 23-25) received bnt162b2 (BNT162B2) (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), COVID-19 (medically significant), outcome "unknown" and all described as "got covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  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, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hormone level abnormal
Clinical narrative: Severe hormonal side effects; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2022 (Lot number: 331308A) at the age of 31 years as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. 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: HORMONE LEVEL ABNORMAL (non-serious) with onset Jan2022, outcome "unknown", described as "Severe hormonal side effects". Therapeutic measures were taken as a result of hormone level abnormal.  Additional information: It was stated by the reporter that she called to report an adverse reaction to the Pfizer booster. Xanax used for treatment of event. Dose: 0.5mg. Formulation: Tablet. Frequency: 3 times a day. Xanax used for treatment of event. Dose: 0.5mg. Formulation: Tablet. Frequency: 3 times a day. No other medications.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Haemorrhage, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Bleeding; it's hurt to touch but it itches; it was like a golf ball afterwards and then it seems like that spread out and then in middle of it was all purple; it's hurt to touch but it itches/it was like a golf ball afterwards and then it seems like that spread out and then in middle of it was all purple; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 20Jan2022 (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:1st, Pfizer shot), administration date: 2021, for COVID-19 immunization; Bnt162b2 (Dose: 2nd, Pfizer shot), administration date: 2021, for COVID-19 immunization. The following information was reported: HAEMORRHAGE (medically significant) with onset Jan2022, outcome "unknown", described as "Bleeding"; VACCINATION SITE PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "it's hurt to touch but it itches"; VACCINATION SITE SWELLING (non-serious) with onset Jan2022, outcome "unknown", described as "it was like a golf ball afterwards and then it seems like that spread out and then in middle of it was all purple"; VACCINATION SITE PRURITUS (non-serious) with onset Jan2022, outcome "unknown", described as "it's hurt to touch but it itches/it was like a golf ball afterwards and then it seems like that spread out and then in middle of it was all purple". The patient had first two Pfizer shots last spring and then received the booster on Thursday the 20th and that got it was like a golf ball afterwards and then it seems like that spread out and then in middle of it was all purple, It was bleeding to before I took the bandage off but it didn't, means it's hurt to touch but it itches.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: potentially fatigue/fever; potentially fatigue/fever; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 24 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "motion sickness, hurt ankle (see previous AER for this), unsure if wears contact lenses" (unspecified if ongoing), notes: Known allergies: Unsure; "motion sickness, hurt ankle (see previous AER for this), unsure if wears contact lenses" (unspecified if ongoing), notes: Known allergies: Unsure. The patient took concomitant medications. The following information was reported: FATIGUE (non-serious), PYREXIA (non-serious), outcome "unknown" and all described as "potentially fatigue/fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19.In the attached report, you stated that you aware of (patient initial) first dose adverse event before you started at Pfizer. Per clarification email from colleagues, if the reporter was not a Pfizer colleague at the onset of the event, they would clarify the date of their first Pfizer awareness, Pfizer awareness date should be this reporter's  training completion date. Hence for the first dose adverse event, the awareness date should be the date you firstly completed training. Could you help to confirm when you firstly completed  training.The patient receive any other vaccines within four weeks prior to the vaccination was unknown reported. List of any other medications the patient received within 2 weeks of vaccination: unsure - potentially birth control but cannot confirm for sure  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Lymph node pain
Clinical narrative: Severe subaxillary pain in right lymph nodes; Dose number: 4; This is a spontaneous report from a contactable reporter (other healthcare professional). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 21Jan2022 at 13:45 (Lot number: FJ1614) at the age of 48 years as dose 4 (booster), single for COVID-19 immunisation. Relevant medical history included: "Latex allergy" (unspecified if ongoing), notes: Known allergies: Sensitivity to latex and TBD (not further specified) (unspecified if ongoing). Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN; Lot Number: Unknown; Route of Administration: Unspecified), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN; Lot Number: Unknown; Route of Administration: Unspecified), for COVID-19 immunisation and Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN; Lot Number: Unknown; Route of Administration: Unspecified), for COVID-19 immunisation.  The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 21Jan2022 at 13:45, outcome "unknown", described as "Dose number: 4"; LYMPH NODE PAIN (non-serious) with onset 22Jan2022 at 15:00, outcome "not recovered", described as "Severe sub axillary pain in right lymph nodes". Therapeutic measures were taken as a result of lymph node pain.  Additional Information: Therapeutic measures included treatment with elves and hot packs. The patient received unspecified concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; positive COVID-19 test with no symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 13 year-old 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), outcome "unknown", described as "tested positive for COVID"; ASYMPTOMATIC COVID-19 (medically significant), outcome "unknown", described as "positive COVID-19 test with no symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Clinical course: learned yesterday that my friend's daughter, 13, tested positive for COVID (she was exposed at school). She received 2 doses of Comirnaty and was recently boosted. She is symptom free. The lot number for bnt162b2 was not provided and will be requested during follow up.