chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Obstructive airways disorder, SARS-CoV-2 test
Clinical narrative: feeling very nauseous; weak; unable to breathe; muscles around my vital organs had swollen up so much; airways were blocked; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  An 18 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Sep2021 15:00 (Batch/Lot number: unknown) at the age of 18 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. No known allergies. There were no concomitant medications. The following information was reported: NAUSEA (hospitalization) with onset 02Sep2021 06:00, outcome "recovered", described as "feeling very nauseous"; ASTHENIA (hospitalization) with onset 02Sep2021 06:00, outcome "recovered", described as "weak"; DYSPNOEA (hospitalization) with onset 02Sep2021, outcome "recovered", described as "unable to breathe"; MUSCLE SWELLING (hospitalization) with onset 02Sep2021, outcome "recovered", described as "muscles around my vital organs had swollen up so much"; OBSTRUCTIVE AIRWAYS DISORDER (hospitalization) with onset 02Sep2021, outcome "recovered", described as "airways were blocked". The patient was hospitalized for nausea, asthenia, dyspnoea, muscle swelling, obstructive airways disorder (hospitalization duration: 1 day(s)). The events "feeling very nauseous", "weak", "unable to breathe", "muscles around my vital organs had swollen up so much" and "airways were blocked" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: chest x-ray: (unspecified date) unknown results; sars-cov-2 test: (06Jan2022) negative, notes: Covid test type post vaccination: Nasal swab. Therapeutic measures were taken as a result of nausea, asthenia, dyspnoea, muscle swelling, obstructive airways disorder. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. Reported Event: I woke up about 15 hours after receiving the first dose of the vaccine, feeling very nauseous and weak. I went back to sleep, unable to attend school and then woke up about 2 hours later unable to breathe. I was taken to the ER where they determined that the muscles around my vital organs had swollen up so much that my airways were blocked and that it was a bad reaction to the vaccine. I was given oxygen and medication to relax my muscles and then instructed not to receive any further COVID vaccinations by various medical professionals. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included: Oxygen, Medication.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Investigation
Clinical narrative: I suffered a cryptogenic stroke; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (Lot number: EW0196) at the age of 58 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ENALAPRIL taken for hypertension; LIPITOR taken for blood cholesterol abnormal. Vaccination history included: Covid-19 vaccine (Dose number unknown; Manufacturer unknown), for COVID-19 Immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant) with onset 20Oct2021, outcome "recovered", described as "I suffered a cryptogenic stroke". The patient was hospitalized for cerebrovascular accident (start date: 20Oct2021, discharge date: 23Oct2021, hospitalization duration: 3 day(s)). The patient underwent the following laboratory tests and procedures: investigation: (Oct2021) negative; (Oct2021) negative; (Oct2021) negative. Therapeutic measures were taken as a result of cerebrovascular accident. The patient reported that 20 days after he had my COVID booster, patient suffered a cryptogenic stroke and all subsequent testing was negative for any other cause of the stroke. Patient had four lab work up including anticoagulation, coagulopathy work up, complete screening at the time of the stroke. Patient was in the hospital for three days. Patient stated that he was no longer experiencing the problem and he received the "tPA" (not further clarified) at the hospital, with resolution of the symptoms.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram, Electrocardiogram abnormal, Myocarditis, SARS-CoV-2 test
Clinical narrative: Abnormal EKG; high troponin; Hospitalized at (with held) with Myocarditis; Chest pain began overnight Monday heading into Day 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 15-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Feb2022 15:00 (Lot number: FK9729) at the age of 15 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0185, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM, Route of Administration: Intramuscular), administration date: 05Jun2021, when the patient was 14 years old, for COVID-19 immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0176, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM, Route of Administration: Intramuscular), administration date: 15May2021, when the patient was 14 years old, for COVID-19 immunisation. The following information was reported: MYOCARDITIS (hospitalization) with onset 28Feb2022, outcome "not recovered", described as "Hospitalized at (with held) with Myocarditis"; CHEST PAIN (hospitalization) with onset 28Feb2022, outcome "not recovered", described as "Chest pain began overnight Monday heading into Day 3"; ELECTROCARDIOGRAM ABNORMAL (hospitalization) with onset 01Mar2022, outcome "not recovered", described as "Abnormal EKG"; TROPONIN INCREASED (hospitalization) with onset 01Mar2022, outcome "not recovered", described as "high troponin". The patient was hospitalized for myocarditis, chest pain, electrocardiogram abnormal, troponin increased (start date: 02Mar2022, discharge date: 04Mar2022, hospitalization duration: 2 day(s)). The events "hospitalized at (with held) with myocarditis", "chest pain began overnight monday heading into day 3", "abnormal ekg" and "high troponin" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test (Blood test for COVID): (02Mar2022) negative, notes: covid test type post vaccination (blood test); electrocardiogram (EKG): (01Mar2022) abnormal; troponin: (01Mar2022) high. Therapeutic measures (ibuprofen) were taken as a result of myocarditis, chest pain, electrocardiogram abnormal, troponin increased. Additional information: The patient received the most recent COVID-19 vaccine in a pharmacy or drug store. The patient was under monitoring and was scheduled for MRI and repeat EKGs.   No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin, Troponin increased
Clinical narrative: Abnormal EKG; high troponin; Hospitalized at (with held) with Myocarditis; Chest pain began overnight Monday heading into Day 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 15-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Feb2022 15:00 (Lot number: FK9729) at the age of 15 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0185, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM, Route of Administration: Intramuscular), administration date: 05Jun2021, when the patient was 14 years old, for COVID-19 immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0176, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM, Route of Administration: Intramuscular), administration date: 15May2021, when the patient was 14 years old, for COVID-19 immunisation. The following information was reported: MYOCARDITIS (hospitalization) with onset 28Feb2022, outcome "not recovered", described as "Hospitalized at (with held) with Myocarditis"; CHEST PAIN (hospitalization) with onset 28Feb2022, outcome "not recovered", described as "Chest pain began overnight Monday heading into Day 3"; ELECTROCARDIOGRAM ABNORMAL (hospitalization) with onset 01Mar2022, outcome "not recovered", described as "Abnormal EKG"; TROPONIN INCREASED (hospitalization) with onset 01Mar2022, outcome "not recovered", described as "high troponin". The patient was hospitalized for myocarditis, chest pain, electrocardiogram abnormal, troponin increased (start date: 02Mar2022, discharge date: 04Mar2022, hospitalization duration: 2 day(s)). The events "hospitalized at (with held) with myocarditis", "chest pain began overnight monday heading into day 3", "abnormal ekg" and "high troponin" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test (Blood test for COVID): (02Mar2022) negative, notes: covid test type post vaccination (blood test); electrocardiogram (EKG): (01Mar2022) abnormal; troponin: (01Mar2022) high. Therapeutic measures (ibuprofen) were taken as a result of myocarditis, chest pain, electrocardiogram abnormal, troponin increased. Additional information: The patient received the most recent COVID-19 vaccine in a pharmacy or drug store. The patient was under monitoring and was scheduled for MRI and repeat EKGs.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Malaise
Clinical narrative: strokes; feel sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 54 year-old male patient received bnt162b2 (BNT162B2), administration date 18Jan2022 (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: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant) with onset 2022, outcome "unknown", described as "strokes"; MALAISE (hospitalization, medically significant) with onset 2022, outcome "unknown", described as "feel sick". The patient was hospitalized for cerebrovascular accident, malaise (start date: 2022).  Clinical course details: The patient is turning 55. Recently, he was admitted to the hospital for two undiagnosed strokes. He began to feel sick a week or two after the third dose with no history in his family, ever, of strokes. He began to feel sick after he got the third dose, which was why he was rushed to the hospital.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I had Covid diagnosed with Covid/I have the Pfizer vaccines which I have all 3 of them; I had Covid diagnosed with Covid/I have the Pfizer vaccines which I have all 3 of them; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 79 years as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: BREO ELLIPTA taken for asthma. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had Covid diagnosed with Covid/I have the Pfizer vaccines which I have all 3 of them". Clinical course: It was reported that, he had Covid diagnosed with Covid and when he diagnosed he called his doctor, doctor told because as patient have asthma your age and you got Covid recommend to try this new drug of Pfizer. Patient have the Pfizer vaccines which he have all 3 of them, as he said because you have asthma would recommend this drug (Paxlovid) and patient should go off everything he was taking, vitamins or anything longer taking be safe go off all of them.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Pancreatitis acute
Clinical narrative: Acute pancreatitis; 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 parent.  A 15 year-old 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: PANCREATITIS ACUTE (hospitalization, medically significant), outcome "unknown", described as "Acute pancreatitis". The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid Arthritis Breakthrough Symptoms; MARKETING PROGRAM NAME NOT AVAILBALE  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-163-4300089-00.  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) 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 "recovering", described as "Rheumatoid Arthritis Breakthrough Symptoms". The action taken for adalimumab was unknown. Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.The event abated after stopping drug.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of Rheumatoid arthritis breakthrough symptoms with HUMIRA(ADALIMUMAB) was no reasonable possibility.  Causality for Pfizer biontech covid-19 vaccine(tozinameran): The reporter's causality for the event of Rheumatoid arthritis breakthrough symptoms was not related.  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 reported event rheumatoid arthritis with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Impaired healing, Mouth haemorrhage, Stomatitis
Clinical narrative: suspected auto immune reaction exacerbated with Covid vaccination; sores developed in the mouth/were not healing; sores developed in the mouth/were not healing; mouth bleeding; 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-163-4163210-00.  A 45 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Batch/Lot number: unknown) at 40 mg (40 mg (citrate free, 1 in 2 wk)), second regimen subcutaneous (Batch/Lot number: unknown) at 40 mg (40 mg (citrate free, 1 in 1 wk)) and third regimen subcutaneous (Batch/Lot number: unknown) at 40 mg (40 mg (citrate free, 1 in 2 wk)) for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "not recovered", described as "suspected auto immune reaction exacerbated with Covid vaccination"; STOMATITIS (non-serious), outcome "recovering", IMPAIRED HEALING (non-serious), outcome "not recovered" and all described as "sores developed in the mouth/were not healing"; MOUTH HAEMORRHAGE (non-serious), outcome "recovering", described as "mouth bleeding". The action taken for adalimumab was dosage permanently withdrawn. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of sores developed in the mouth/were not healing unknown onset and mouth bleeding with Humira (adalimumab) was a reasonable possibility. The reporter's causality for the event of suspected auto immune reaction exacerbated with COVID vaccination with Humira (adalimumab) was no reasonable possibility. The reporter's causality for the event of sores developed in the mouth/were not healing unknown onset was not provided. The reporter's assessment of the causal relationship of the events with the suspect product bnt162b2 was possible at the time of this report.  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 available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event Autoimmune disorder which cannot be fully assessed/excluded. The case will be reassessed if additional 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriatic arthropathy
Clinical narrative: Psoriatic arthritis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4303430-00.  A 53 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Dec2021 (Batch/Lot number: unknown) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1157581) at citrate free for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1, Route of Admin: Intramuscular), administration date: 01Apr2021, when the patient was 52 years old, for COVID-19 Vaccination; Bnt162b2 (DOSE: 2, Route of Admin: Intramuscular), administration date: 01May2021, when the patient was 52 years old, for COVID-19 Vaccination. The following information was reported: PSORIATIC ARTHROPATHY (medically significant) with onset Feb2022, outcome "recovering", described as "Psoriatic arthritis flare up". The action taken for adalimumab was unknown.  The reporter considered "psoriatic arthritis flare up" related to bnt162b2.  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 available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Psoriatic arthropathy  which cannot be fully assessed/excluded. The case will be reassessed if additional 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: M
Vaccine: COVID19, UNK
Symptoms: Joint range of motion decreased, Rheumatoid arthritis, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: could not move neck, arms; covid vaccine had left arm sore; rheumatoid arthritis flare; MARKETING PROGRAM NAME NOT AVAILIBLE  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-163-4296985-00.  A 52 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), intramuscular (Batch/Lot number: unknown) till Oct2021 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) with onset 2021, outcome "not recovered", described as "rheumatoid arthritis flare"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "could not move neck, arms"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "covid vaccine had left arm sore". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive; (Feb2022) positive. 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 covid vaccine had left arm sore with Humira (adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of rheumatoid arthritis flare with Humira (adalimumab) was a reasonable possibility. the reporter's causality for the event(s) of could not move neck, arms was not provided.   Causality for Pfizer BioNTech Covid-19 Vaccine: The reporter's causality for the event of covid vaccine had left arm sore was possible, the reporter's causality for the event Rheumatoid arthritis flare up and Joint range of motion decreased was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event Rheumatoid arthritis which cannot be fully assessed/excluded. The case will be reassessed if additional 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: a persistent rash on my head and parts of my upper body; 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) (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. The mother's vaccination history included: Covid 19 vaccine (Dose 1), for covid-19 immunisation; Covid-19 vaccine (Dose 2), for covid-19 immunisation. The following information was reported: RASH (non-serious), outcome "unknown", described as "a persistent rash on my head and parts of my upper body". The event "a persistent rash on my head and parts of my upper body" was evaluated at the physician office visit. Therapeutic measures were taken as a result of rash.  Additional information included Receiving the covid 19 Vaccine (2 plus the booster) Patient had a persistent rash on my head and parts of my upper body. I have to been to two dermatologist and my primary care physician, none of whom has been able to determine the cause. Patient  have taken two rounds of steroids and have used Zyrtec, an over the counter antihistamine as recommended by the CDC, to try to eliminate this, but to no avail. Perhaps you can help me determine what in the vaccine could possibly have caused my problem so patient can finally eliminate the rashes.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test date: 11Feb2022 / covid test result: Positive; covid test date: 11Feb2022 / covid test result: Positive; 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 left, administration date 27Dec2021 (Lot number: Fl3198) at the age of 35 years as dose 3 (booster), single, administered in arm right, administration date 30Apr2021 (Lot number: Ew0176) as dose 2, single and administration date 09Apr2021 (Lot number: Er8734) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Corn" (unspecified if ongoing); "Known allergies: lamb" (unspecified if ongoing). Concomitant medication(s) included: LAMICTAL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Feb2022, outcome "unknown" and all described as "covid test date: 11Feb2022 / covid test result: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Feb2022) positive.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-1 test, Swelling face, Urticaria
Clinical narrative: covid test date: 11Feb2022 / covid test result: Positive; covid test date: 11Feb2022 / covid test result: Positive; 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 left, administration date 27Dec2021 (Lot number: Fl3198) at the age of 35 years as dose 3 (booster), single, administered in arm right, administration date 30Apr2021 (Lot number: Ew0176) as dose 2, single and administration date 09Apr2021 (Lot number: Er8734) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Corn" (unspecified if ongoing); "Known allergies: lamb" (unspecified if ongoing). Concomitant medication(s) included: LAMICTAL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Feb2022, outcome "unknown" and all described as "covid test date: 11Feb2022 / covid test result: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Feb2022) positive.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Neck pain, Pain in extremity, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Throbbing pain in neck; Throbbing pain in back; Pain in fingers; Joint pain; MARKETING PROGRAM NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4304307-00.  A 60 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Oct2021 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single and intramuscular, administration date 01Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (ongoing) (Lot number: 1155125) 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 "not recovered", described as "Rheumatoid arthritis flare up"; NECK PAIN (non-serious), outcome "not recovered", described as "Throbbing pain in neck"; BACK PAIN (non-serious), outcome "not recovered", described as "Throbbing pain in back"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Pain in fingers"; ARTHRALGIA (non-serious) with onset 01Oct2021, outcome "unknown", described as "Joint pain". The action taken for upadacitinib was dosage not changed.  Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine trial. The reporter's causality for the events of rheumatoid arthritis flare up, throbbing pain in neck, throbbing pain in back and pain in fingers with Rinvoq (Upadacitinib) was a reasonable possibility. The reporter's causality for the events of joint pain with Rinvoq (Upadacitinib) was no reasonable possibility. The reporter's assessment of the causal relationship of the events (rheumatoid arthritis, neck pain, back pain and pain in extremity) with the suspect product bnt162b2 was not provided while the causal relationship of the event arthralgia with the suspect product bnt162b2 was reported as possible (the reporter considered "joint pain" related to bnt162b2).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Lab Notes: Nasal Swab/Positive; Lab Notes: Nasal Swab/Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Sep2021 (Lot number: Fe3592) at the age of 51 years as dose 2, single and administered in arm left, administration date 25Aug2021 (Lot number: Ew0187) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Jan2022, outcome "unknown" and all described as "Lab Notes: Nasal Swab/Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Jan2022) positive, notes: Nasal Swab.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose of Adacel with no reported adverse event; Initial information received on 09-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (healthcare professional).  This case involves a 22-years-old male patient who received an expired dose of adacel with no reported adverse event while receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Mar-2022, the patient received a dose of 0.5 mL of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection once  (lot U5872AA/:06984AA; 02-Feb-2022 and 18-Mar-2023) via intramuscular route in the right deltoid as prophylactic vaccination.  On 09-MAR-2022 the patient developed a non-serious event "patient received an expired dose of adacel with no reported adverse event" (expired product administered) (latency: same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken: Not applicable.  Corrective treatment: Not reported  Outcome: Unknown for expired product administered.  Additional information was received on 09-Mar-2022 from consumer/non-hcp: Case updated to non-serious case from non-case.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: An expired dose of TENIVAC was inadvertently administered, with no reported adverse event; Initial information received on 07-Mar-2022 regarding an unsolicited valid non-serious case received from the health care professional.  This case involves a 57 years old female patient who was inadvertently administered with an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids (Tenivac), with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided. No other vaccines administered.    On 07-Mar-2022, the patient was inadvertently administered with an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids (dosage: 0.5 ml once; strength and formulation: not provided) (lot number: U6603AA, expiration date: 05-March-2022) via intramuscular route in the left deltoid for immunization (expired product administered) (latency: same day). The reporter asked whether dose needed repeating. No adverse event was reported.   Action taken with diphtheria-2/tetanus-5 adsorbed toxoids was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: patient received IPOL, that was no longer suitable for use due to a temperature excursion, with no reported adverse event; Initial information received  on 09-Mar-2022 regarding an unsolicited valid non-serious case received from another health professional.  This case involves a 3-year-old child, male patient who experienced patient received ipol, that was no longer suitable for use due to a temperature excursion, with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation.  On 08-Mar-2022, the patient received a  dose of suspect IPV (VERO) suspension for injection, 1.5 ml, dose 5, lot U1C51M via subcutaneous route expiry date 17-June-2023 via subcutaneous route in the left thigh for Immunization. Patient has taken the vaccine previously.  On 08-MAR-2022 the patient developed a non-serious event "patient received ipol, that was no longer suitable for use due to a temperature excursion, with no reported adverse event" (product storage error) following the administration of IPV (VERO) latency 1 day.  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient received IPOL, that was no longer suitable for use due to a temperature excursion, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event patient received ipol, that was no longer suitable for use due to a temperature excursion, with no reported adverse event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Cough, Injection site swelling
Clinical narrative: cough; swelling from the injection site on his left arm through his hand; Initial information received on 09-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old male patient who had cough and swelling from the injection site on his left arm through his hand while receiving vaccine diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Feb-2022, the patient received a  dose of suspect Quadracel dosage: 0.5 ml, formulation: injection, (strength: unknown) expiration date: 23-Feb-2024, lot: C5970AA via intramuscular route in the left arm for prophylactic vaccination.  On 24-Feb-2022 the patient developed a non-serious event "cough", "swelling from the injection site on his left arm through his hand" (vaccination site swelling) (latency: same day).   No lab data was reported.  Action taken with Quadracel was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At the time of reporting, the outcome was Recovered / Resolved on an unknown date for the event swelling from the injection site on his left arm through his hand and was Recovered / Resolved on 09-Mar-2022 for the event cough.
Age: 12.0
Sex: M
Vaccine: HEP, IPV, MMR, TD, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired dose of TENIVAC to a patient with no adverse event; Initial information received on 10-Mar-2022 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 12 years old male patient who was administered an expired dose of tenivac with no adverse event while receiving vaccine Diphtheria-2/Tetanus-5 adsorbed toxoids no preservative adult [Tenivac].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Varicella zoster vaccine (Varicella vaccine); Hepatitis B vaccine; Polio vaccine and Measles, Mumps, Rubella vaccine (MMR)for Immunization.  On 09-Mar-2022, the patient received a 0.25 mL to 2 mL dose of suspect Diphtheria-2/Tetanus-5 adsorbed toxoids no preservative adult suspension for injection (lot number: U6603AA; expiry date: 05-Mar-2022) via intramuscular route in the right arm for immunization.  On 09-MAR-2022, the patient was administered an expired dose of tenivac with no adverse event (expired product administered) (latency: same day) following the administration of Diphtheria-2/Tetanus-5 adsorbed toxoids no preservative adult.  Action taken was not applicable.   At time of reporting, the outcome was Unknown for the event expired product administered.
Sex: M
Vaccine: MMR
Symptoms: Condition aggravated, Discomfort, Ear infection, Immunisation reaction, Pain
Clinical narrative: Developed hives on his torso and chest; rash was likely normal reaction to his MMR vaccine/ it could be an allergic reaction to the MMR vaccine; developed a rash on his stomach; Ear infection; Great discomfort; Pain; This spontaneous report was received from a consumer and refers to a 13 month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-JAN-2022, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, dose, lot number, expiry date, formulation and route of administration were not provided; frequency was reported as routine 12 month dosage) for routine vaccination.  On 07-FEB-2022, the patient developed a rash on his stomach (rash). In February 2022, he was diagnosed with ear infection, treatment was given for it by prescribing amoxicillin. The consumer reported that the pediatrician also noted the rash was likely a normal reaction to his MMR vaccine and expressed no concerns. On 13-FEB-2022, the patient developed hives on his torso and chest (urticaria). Amoxicillin was discontinued on approximately 13-FEB-2022 at 19:00. On 14-FEB-2022, the rash and hives began to spread and became worse. In February 2022, it was reported that the ear infection had healed. Furthermore, on 14-FEB-2022, the rash continued to get worse. It was reported that it could be an allergic reaction to the MMR Vaccine (allergy to vaccine) (on 07-FEB-2022). In February 2022, the patient was in great discomfort (discomfort) and pain. Treatment was given for discomfort and pain by giving diphenhydramine hydrochloride (BENADRYL) and cetirizine hydrochloride (ZYRTEC); it was reported that they were not addressing it. On 15-FEB-2022, the rash was even worse than before. In February 2022, the patient was administered steroids and he will continue to receive steroids for the next 13 days.  The outcome of rash and allergy to vaccine were reported as not recovered. The outcome of ear infection was reported as recovered. The outcome of the adverse events of urticaria, discomfort and pain were not reported. The relatedness between Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and the adverse events of rash and allergy to vaccine was reported to be as related. The relatedness between Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and the adverse events of ear infection, urticaria, discomfort and pain was not reported.
Sex: M
Vaccine: MMR
Symptoms: Rash, Urticaria
Clinical narrative: Developed hives on his torso and chest; rash was likely normal reaction to his MMR vaccine/ it could be an allergic reaction to the MMR vaccine; developed a rash on his stomach; Ear infection; Great discomfort; Pain; This spontaneous report was received from a consumer and refers to a 13 month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-JAN-2022, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, dose, lot number, expiry date, formulation and route of administration were not provided; frequency was reported as routine 12 month dosage) for routine vaccination.  On 07-FEB-2022, the patient developed a rash on his stomach (rash). In February 2022, he was diagnosed with ear infection, treatment was given for it by prescribing amoxicillin. The consumer reported that the pediatrician also noted the rash was likely a normal reaction to his MMR vaccine and expressed no concerns. On 13-FEB-2022, the patient developed hives on his torso and chest (urticaria). Amoxicillin was discontinued on approximately 13-FEB-2022 at 19:00. On 14-FEB-2022, the rash and hives began to spread and became worse. In February 2022, it was reported that the ear infection had healed. Furthermore, on 14-FEB-2022, the rash continued to get worse. It was reported that it could be an allergic reaction to the MMR Vaccine (allergy to vaccine) (on 07-FEB-2022). In February 2022, the patient was in great discomfort (discomfort) and pain. Treatment was given for discomfort and pain by giving diphenhydramine hydrochloride (BENADRYL) and cetirizine hydrochloride (ZYRTEC); it was reported that they were not addressing it. On 15-FEB-2022, the rash was even worse than before. In February 2022, the patient was administered steroids and he will continue to receive steroids for the next 13 days.  The outcome of rash and allergy to vaccine were reported as not recovered. The outcome of ear infection was reported as recovered. The outcome of the adverse events of urticaria, discomfort and pain were not reported. The relatedness between Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and the adverse events of rash and allergy to vaccine was reported to be as related. The relatedness between Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and the adverse events of ear infection, urticaria, discomfort and pain was not reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 03-JAN-2022, the patient was vaccinated with improperly stored hepatitis aAvaccine, inactivated (VAQTA), (once, lot # U024094,was confirmed as formulation vial, expiration date 10-MAY-2023 (route of administration and anatomical location were not reported) for prophylaxis (product storage error). Temperature 35.9 Fahrenheit degrees for 20 minutes on 29-DEC-2021. There was no previous temperature excursions. No additional adverse event was reported (No adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA007167: