chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 52-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6204), in left arm, on 29Mar2021 as dose 2, single (Lot number: ER8732), in left arm, on 21Oct2021 as dose 3 (booster), single (Lot number: FF2P88) and on 07Apr2022 as dose 4 (booster), single (Lot number: F54989) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Codeine and codeine derivatives, reaction(s): "known allergies: Codeine and codeine derivatives", notes: known allergies: Codeine and codeine derivatives. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jul2022) Positive, notes: I tested positive for Covid at noon on 25Jul2022; (01Aug2022) Positive, notes: I tested during the morning of 01Aug2022, prior to going to work, and I had a positive result. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient tested positive for Covid at noon on 25Jul2022; the test was the result of a recent exposure. He began feeling tired and achy around 3pm on 25Jul2022. He began Paxlovid around 6pm on 25Jul2022. He awoke on 26Jul2022 with no symptoms. He tested during the morning of 01Aug2022, prior to going to work, and he had a positive result. He felt well until late afternoon on 01Aug2022, which is when more significant symptoms began to occur. As of 03Aug2022, he had significant fatigue and aches, a headache, significant sinus inflammation, and a scratchy throat. He was experiencing Paxlovid rebound with worse symptoms. He was questioning if the rebound is due to both my body not mounting a significant enough defense and the Paxlovid dose being insufficient to drop the viral load below its pathogenic level. The patient did not receive any other medication within 2 weeks prior to Covid vaccination.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient received a vaccine and did not received other medication in 2 weeks. He had no known allergies. Anti-viral details: Product: COVID 19 Treatment, Brand: Pfizer, Treatment start date: 25Jul2022, Treatment stop date: 29Jul2022, Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 20Feb2021 at 12:00 as dose 1, single (Lot number: EL9267), in right arm, on 13Mar2021 at 12:00 as dose 2, single (Lot number: EN6206), in left arm and on 27Sep2021 at 16:00 as dose 3 (booster), single (Lot number: EL9267) at the age of 71 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Apr2022 at 16:00 as dose 4 (booster), single (Lot number: 002m21a), in right arm for covid-19 immunisation. The patient's relevant medical history included: "autoimmune" (unspecified if ongoing). Concomitant medication(s) included: CELEBREX, start date: Jan2016. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Jul2022 at 18:00, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Received treatment with Paxlovid  from 16Jul2022 to 19Jul2022.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jan2021 as dose1, single (Lot number: EL3247), in left arm, on 19Feb2021 as dose 2, single (Lot number: EM9810), in left arm, on 04Oct2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 26Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Negative test following completion of tx with Paxlovid; (04Aug2022) Positive, notes: Tested positive again, 7 days after completion of tx with Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Lumbar spinal stenosis, Magnetic resonance imaging, Neuropathy peripheral
Clinical narrative: neuropathy symptoms; Burning in bilateral ischial tuberosities and hip pain; Lumbar discomfort/ Hip pain; have an MRI which should some stenosis L4/L5/S1 level; Left shoulder tendonitis sever to point of non-use/Right Shoulder tendonitis used arm but difficult; The initial case was missing the following minimum criteria hence considered as invalid as Unspecified product and Unspecified AE. Upon receipt of follow-up information on (01Aug2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP), Program ID: (003110). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: EL9267) and on 03Mar2021 as dose 2, single (Lot number: EN6204) at the age of 70 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: TENDONITIS (non-serious) with onset Apr2021, outcome "not recovered", described as "Left shoulder tendonitis sever to point of non-use/Right Shoulder tendonitis used arm but difficult"; NEUROPATHY PERIPHERAL (hospitalization, medically significant), outcome "unknown", described as "neuropathy symptoms"; BURNING SENSATION (hospitalization), outcome "not recovered", described as "Burning in bilateral ischial tuberosities and hip pain"; ARTHRALGIA (hospitalization), outcome "not recovered", described as "Lumbar discomfort/ Hip pain"; LUMBAR SPINAL STENOSIS (hospitalization), outcome "unknown", described as "have an MRI which should some stenosis L4/L5/S1 level". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: showed some stenosis. Therapeutic measures were taken as a result of burning sensation, tendonitis.  Clinical course: The patient received the suspect vaccination on left and right deltoid. She received P.T (physical therapy) for burning and hips in Aug2021. Provided W/stretch her bilateral tendonitis and burning and lumber discomfort. The patient never root injections had no improvement either time. The patient did had a MRI which should some stenosis L4/L5/S1 level, where she saw neurologist, took advised she was not currently a candidate for surgery. So she tried nerve root block injections for and only temporary (24hrs) relief. Hip pain continued as well as burning sensation-attributed to stenosis but not experienced prior to vaccine injections. Her belief was that vaccinations contributed to tendonitis and neuropathy sysmptoms. At least stirred things up to the point where she noticed changes in how she walk and move in general - hip pain was intermittent but burning sensation was 24/7 for past 16 months. The patient had no AE following prior vaccinations.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tendonitis
Clinical narrative: neuropathy symptoms; Burning in bilateral ischial tuberosities and hip pain; Lumbar discomfort/ Hip pain; have an MRI which should some stenosis L4/L5/S1 level; Left shoulder tendonitis sever to point of non-use/Right Shoulder tendonitis used arm but difficult; The initial case was missing the following minimum criteria hence considered as invalid as Unspecified product and Unspecified AE. Upon receipt of follow-up information on (01Aug2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP), Program ID: (003110). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: EL9267) and on 03Mar2021 as dose 2, single (Lot number: EN6204) at the age of 70 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: TENDONITIS (non-serious) with onset Apr2021, outcome "not recovered", described as "Left shoulder tendonitis sever to point of non-use/Right Shoulder tendonitis used arm but difficult"; NEUROPATHY PERIPHERAL (hospitalization, medically significant), outcome "unknown", described as "neuropathy symptoms"; BURNING SENSATION (hospitalization), outcome "not recovered", described as "Burning in bilateral ischial tuberosities and hip pain"; ARTHRALGIA (hospitalization), outcome "not recovered", described as "Lumbar discomfort/ Hip pain"; LUMBAR SPINAL STENOSIS (hospitalization), outcome "unknown", described as "have an MRI which should some stenosis L4/L5/S1 level". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: showed some stenosis. Therapeutic measures were taken as a result of burning sensation, tendonitis.  Clinical course: The patient received the suspect vaccination on left and right deltoid. She received P.T (physical therapy) for burning and hips in Aug2021. Provided W/stretch her bilateral tendonitis and burning and lumber discomfort. The patient never root injections had no improvement either time. The patient did had a MRI which should some stenosis L4/L5/S1 level, where she saw neurologist, took advised she was not currently a candidate for surgery. So she tried nerve root block injections for and only temporary (24hrs) relief. Hip pain continued as well as burning sensation-attributed to stenosis but not experienced prior to vaccine injections. Her belief was that vaccinations contributed to tendonitis and neuropathy sysmptoms. At least stirred things up to the point where she noticed changes in how she walk and move in general - hip pain was intermittent but burning sensation was 24/7 for past 16 months. The patient had no AE following prior vaccinations.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I also caught COVID on Christmas of 2021; I also caught COVID on Christmas of 2021; 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), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "I also caught COVID on Christmas of 2021". Clinical course: Description of Potential AE: would like to take pay in study SBXSN25C. Wondering if there was any studies around me that could use me for research.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Second Pfizer vaccine caused achiness and soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4454382-00.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 58 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Route of administration: Intramuscular), administration date: 25Feb2021, when the patient was 58-year-old, for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Second Pfizer vaccine caused achiness and soreness".  Additional information: In Mar2021, the patient experienced second Pfizer vaccine caused achiness and soreness. In Mar2021, the second Pfizer vaccine caused achiness and soreness resolved. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Optic ischaemic neuropathy, Optical coherence tomography, Visual acuity tests, Visual field tests
Clinical narrative: Nonarteritic Anterior Ischemic Optic Neuropathy; This is a literature report for the following literature source(s).  A 64-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "developed acute, unilateral vision loss", "superior sectoral optic disc edema".  The following information was reported: OPTIC ISCHAEMIC NEUROPATHY (medically significant), outcome "recovered", described as "Nonarteritic Anterior Ischemic Optic Neuropathy". The patient underwent the following laboratory tests and procedures: All examination findings: normal OD; revealed superior sectoral optic disc edema; revealed peripapillary splinter hemorrhages in the, notes: optic nerve OS; Optical coherence tomography: showed diffuse thickening of the retinal nerve fib, notes: fiber layer OS; Visual acuity tests: 20/80; 20/100, notes: OS; Visual field tests: revealed dense constriction OS. Therapeutic measures were taken as a result of optic ischaemic neuropathy.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events 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.,Linked Report(s) : US-PFIZER INC-202201024250 Same patient/drug, events occcured in different time;US-PFIZER INC-PV202200035839 Master article.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Product preparation issue, Vaccination site pain
Clinical narrative: extremely sore arm; received an incorrectly diluted Covid-19 vaccine on 7/19/22. The nurse feels he got over twice the dose strength for his age; received an incorrectly diluted Covid-19 vaccine on 7/19/22. The nurse feels he got over twice the dose strength for his age; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5-year-old male patient received BNT162b2 (BNT162B2), on 19Jul2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT PREPARATION ISSUE (non-serious), ACCIDENTAL OVERDOSE (non-serious) all with onset 19Jul2022, outcome "unknown" and all described as "received an incorrectly diluted Covid-19 vaccine on 7/19/22. The nurse feels he got over twice the dose strength for his age"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "extremely sore arm".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4486513-00.  A 61-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "recovered", described as "Stroke". The action taken for adalimumab was dosage permanently withdrawn. The event abated after stopping the drug Humira (Adalimumab). The patient experienced an event of stroke like symptoms with Humira (Adalimumab). On an unknown date, the patient experienced stroke like symptoms. On an unknown date, stroke like symptoms resolved. Pfizer Biontech COVID-19 Vaccine (Tozinameran) was also considered suspect. The patient was on Humira but had to be removed because it caused him stroke like symptoms. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter considered "stroke" related to BNT162b2.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of stroke like symptoms with Humira (Adalimumab) was a reasonable possibility.  Causality for Humira (Adalimumab)  1) Stroke (Cerebrovascular accident) Action(s) taken with drug: Drug discontinued Causality as per reporter (Drug/Vaccine): Probable Dechallenge: Yes  Causality for Pfizer Biontech COVID-19 Vaccine (Tozinameran)  1) Stroke (Cerebrovascular accident) Causality as per reporter (Drug/Vaccine): Possible  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event stroke and the use of suspect product BNT162b2 cannot be fully excluded. The case will be reassessed once further 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive for Covid; positive for Covid; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4486960-00.   A 44-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk, citrate free, subcutaneous for psoriatic arthropathy. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Jul2022, outcome "not recovered" and all described as "positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jul2022) Positive. The action taken for adalimumab was unknown. Clinical course: On unknown dates, the patient experienced positive for COVID and got sick after first COVID Vaccine booster dose. On an unknown date, got sick after first COVID Vaccine booster dose resolved. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's assessment of the causal relationship of "positive for covid" with the suspect product(s) 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.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriatic arthropathy
Clinical narrative: Psoriatic arthritis; This is a report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4486835-00.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Batch/Lot number: unknown), on 03Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 06Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years, all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Lot number: 1159488), oral for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "unknown", described as "Psoriatic arthritis". The action taken for upadacitinib was unknown.  Clinical course: It was reported that on an unknown date, the patient experienced psoriatic arthritis was not improving. Patient felt that her psoriatic arthritis should be more improved but physician stated to give Rinvoq more time. Unknown if patient was enrolled in a covid-19 vaccine trial.   The reporter's causality for the event of psoriatic arthritis with BNT162b2 was Possible.   The reporter's causality for the event of psoriatic arthritis not improving with Rinvoq (Upadacitinib) 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: Based on limited information in the case , a possible causal association between   the reported   event and the suspect drug cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: After my 2nd shot I got covid19 for the 2nd time; After my 2nd shot I got covid19 for the 2nd time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "After my 2nd shot I got covid19 for the 2nd time".  Clinical course: Patient reported covid-19 vaccine don't work very well just over 2 years since patient had covid-19. A year later patient got vaccine. Within 6 or 8 months after patient's 2nd shot patient got covid19 for the 2nd time. Not really happy about it.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: diagnosed with covid-19; diagnosed with covid-19; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  An 82-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) 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), outcome "unknown" and all described as "diagnosed with covid-19". The patient underwent laboratory test: SARS-CoV-2 test: Positive, notes: Diagnosed with Covid-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: patient has taken BNT162b2 vaccines and boosters.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4487105-00. A 56-year-old female patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Batch/Lot number: unknown), on 03Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 06Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years, all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (ongoing) (Batch/Lot number: unknown), oral. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 11Jul2022, outcome "unknown", COVID-19 (medically significant) with onset 11Jul2022, outcome "recovering" and all described as "COVID-19". The action taken for upadacitinib was dosage not changed. Clinical course: On 11Jul2022, the patient experienced COVID-19. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. On 11Jul2022, the patient had COVID-19. She was recovering from COVID-19 and felt better just had congestion. Physician advised to keep taking Rinvoq. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter considered "covid-19" related to BNT162b2. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
Sex: U
Vaccine: COVID19
Symptoms: Anti-neutrophil cytoplasmic antibody positive vasculitis, Antineutrophil cytoplasmic antibody, Autoimmune disorder, Haemoglobin, Haemoglobin decreased
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed., Manufacturer unknown), for covid-19 immunization. The following information was reported: ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS (hospitalization, medically significant), outcome "unknown", described as "ANCA associated Vasculitis"; AUTOIMMUNE DISORDER (hospitalization, medically significant), outcome "unknown", described as "autoimmune disease"; HAEMOGLOBIN DECREASED (hospitalization), outcome "unknown", described as "9 blood transfusions as hemoglobin level frequently drops below 7.0". The patient was hospitalized for anti-neutrophil cytoplasmic antibody positive vasculitis, autoimmune disorder, haemoglobin decreased (hospitalization duration: 32 day(s)). The patient underwent the following laboratory tests and procedures: Antineutrophil cytoplasmic antibody: ANCA associated Vasculitis and autoimmune disease, notes: My diagnosis is ANCA associated Vasculitis and autoimmune disease; Haemoglobin: 7.0, notes: frequently drops below 7.0; Transfusion: 9 blood transfusions, notes: I have received 9 blood transfusions as hemoglobin level frequently drops below 7.0. Clinical course: It was reported that patient was in the hospital for 32 days and diagnosis was ANCA associated Vasculitis and autoimmune disease. Patient received 9 blood transfusions as hemoglobin level frequently drops below 7.0. It was also reported that patient was without any health problems until received Pfizer booster. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Transfusion
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed., Manufacturer unknown), for covid-19 immunization. The following information was reported: ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS (hospitalization, medically significant), outcome "unknown", described as "ANCA associated Vasculitis"; AUTOIMMUNE DISORDER (hospitalization, medically significant), outcome "unknown", described as "autoimmune disease"; HAEMOGLOBIN DECREASED (hospitalization), outcome "unknown", described as "9 blood transfusions as hemoglobin level frequently drops below 7.0". The patient was hospitalized for anti-neutrophil cytoplasmic antibody positive vasculitis, autoimmune disorder, haemoglobin decreased (hospitalization duration: 32 day(s)). The patient underwent the following laboratory tests and procedures: Antineutrophil cytoplasmic antibody: ANCA associated Vasculitis and autoimmune disease, notes: My diagnosis is ANCA associated Vasculitis and autoimmune disease; Haemoglobin: 7.0, notes: frequently drops below 7.0; Transfusion: 9 blood transfusions, notes: I have received 9 blood transfusions as hemoglobin level frequently drops below 7.0. Clinical course: It was reported that patient was in the hospital for 32 days and diagnosis was ANCA associated Vasculitis and autoimmune disease. Patient received 9 blood transfusions as hemoglobin level frequently drops below 7.0. It was also reported that patient was without any health problems until received Pfizer booster. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I still got infected after being vaccinated/Got COVID after receiving vaccine; I still got infected after being vaccinated/Got COVID after receiving vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. 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 "I still got infected after being vaccinated/Got COVID after receiving vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site inflammation
Clinical narrative: Inflammation and redness around injection site from COVID booster received; redness around injection site from COVID booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 9-year-old male patient received BNT162b2 (BNT162B2), on 28Jul2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 9 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose:1st, Time: 16:45, Site and Route of injection:, Anatomical site of injection: Left arm, Batch/Lot number: FK5127), administration date: 18Nov2021, for COVID-19 immunization; BNT162b2 (Dose:2nd , Time: 14:15, Anatomical site of injection: Left arm, Batch/Lot number: FK5127), administration date: 28Dec2021, for COVID-19 immunization, reaction(s): "hyperactivity", "increased appetite/ Voracious appetite". The following information was reported: VACCINATION SITE INFLAMMATION (non-serious) with onset Jul2022, outcome "unknown", described as "Inflammation and redness around injection site from COVID booster received"; VACCINATION SITE ERYTHEMA (non-serious) with onset Jul2022, outcome "unknown", described as "redness around injection site from COVID booster".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Crohn's disease, Temporomandibular joint syndrome
Clinical narrative: Crohn's disease flare; Temporomandibular joint issues; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4485286-00 (RA).  A 62-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and in 2022 as dose 3 (booster),single (Batch/Lot number: unknown) at the age of 60 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for crohn's disease. The patient's relevant medical history included: "Crohn's Disease", start date: Jan2020, stop date: Jan2020. The patient's concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (medically significant), outcome "unknown", described as "Crohn's disease flare"; TEMPOROMANDIBULAR JOINT SYNDROME (non-serious), outcome "unknown", described as "Temporomandibular joint issues". The action taken for adalimumab was unknown.  Clinical course included on an unknown date, the patient experienced TEMPOROMANDIBULAR JOINT ISSUES. In Jan2020, the patient experienced CROHN'S DISEASE FLARE. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter contact for lot number information was unsuccessful.   The reporter's assessment of the causal relationship of "crohn's disease flare" and "temporomandibular joint issues" with the suspect product(s) BNT162b2 was provided as possible. The reporter's assessment of the causal relationship of "crohn's disease flare" and "temporomandibular joint issues" with the suspect product(s) adalimumab (HUMIRA) was not provided 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 known safety profile and Limited information in the case report a casual association between reported events and the suspect drug BNT162B2 cannot be excluded.
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Dizziness, Peripheral artery thrombosis
Clinical narrative: Left radial artery left arm blood clot; Dizzy; This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4485445-00.  A 50-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for hidradenitis. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: PERIPHERAL ARTERY THROMBOSIS (medically significant), outcome "recovering", described as "Left radial artery left arm blood clot"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy". The action taken for adalimumab was unknown.  Clinical course: on unknown dates, the patient experienced left radial artery left arm blood clot and dizzy. Moderna covid-19 vaccine (Elasomeran) and pfizer biontech covid-19 vaccine (Tozinameran) were also considered suspect. Patient was waking up in mornings and dizzy. it was unknown if patient was enrolled in a covid-19 vaccine trial. Primary reporter did not have the lot number information, because the packaging was discarded. It was reported that the non-serious dizzy with Humira (Adalimumab). there was no reported medical history.   Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of left radial artery left arm blood clot and dizzy was not provided. Agency's opinion is that the events of left radial artery left arm blood clot and dizzy are not assessable.  The reporter's assessment of the causal relationship of "left radial artery left arm blood clot" and "dizzy" with the suspect product(s) 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: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.  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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram head, Dizziness, Drug ineffective, Fall
Clinical narrative: COVID-19; COVID-19; Urinary tract infection; Vertigo; Tinnitus; Feeling unwell; Fall; Dizzy; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (not provided).  A 50-year-old female patient received BNT162b2 (BNT162B2), on 30Jul2021 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Lot number: 1159928) at citrate free and second regimen (Lot number: 1160838) at citrate free, all subcutaneous for hidradenitis; hydrochlorothiazide, triamterene (TRIAMTERENE AND HYDROCHLOROTHIAZID), (Batch/Lot number: unknown) at (1 in 1 d), oral; venlafaxine (VENLAFAXINE), (Batch/Lot number: unknown), oral. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxycillin, reaction(s): "Allergy: amoxycillin". The following information was reported: DIZZINESS (non-serious) with onset Dec2021, outcome "not recovered", described as "Dizzy"; FALL (non-serious) with onset Feb2022, outcome "recovering"; MALAISE (non-serious) with onset 06May2022, outcome "unknown", described as "Feeling unwell"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19"; URINARY TRACT INFECTION (non-serious), outcome "recovering"; VERTIGO (non-serious), outcome "not recovered"; TINNITUS (non-serious), outcome "not recovered". The patient underwent the following laboratory tests and procedures: Computerised tomogram head: (Feb2022) unknown results, notes: okay. The action taken for adalimumab, hydrochlorothiazide, triamterene and venlafaxine was unknown. Therapeutic measures were taken as a result of vertigo, dizziness.  The reporter's causality for the event(s) of Dizzy, Vertigo, Tinnitus, COVID, fell after going to bathroom/due to vertigo and urinary tract infection with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of feeling unwell was not provided.The reporter's assessment of the causal relationship of "covid-19", "urinary tract infection", "vertigo", "dizzy", "tinnitus", "fall" and "feeling unwell" with the suspect product(s) 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.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Tinnitus, Urinary tract infection, Vertigo
Clinical narrative: COVID-19; COVID-19; Urinary tract infection; Vertigo; Tinnitus; Feeling unwell; Fall; Dizzy; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (not provided).  A 50-year-old female patient received BNT162b2 (BNT162B2), on 30Jul2021 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Lot number: 1159928) at citrate free and second regimen (Lot number: 1160838) at citrate free, all subcutaneous for hidradenitis; hydrochlorothiazide, triamterene (TRIAMTERENE AND HYDROCHLOROTHIAZID), (Batch/Lot number: unknown) at (1 in 1 d), oral; venlafaxine (VENLAFAXINE), (Batch/Lot number: unknown), oral. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxycillin, reaction(s): "Allergy: amoxycillin". The following information was reported: DIZZINESS (non-serious) with onset Dec2021, outcome "not recovered", described as "Dizzy"; FALL (non-serious) with onset Feb2022, outcome "recovering"; MALAISE (non-serious) with onset 06May2022, outcome "unknown", described as "Feeling unwell"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19"; URINARY TRACT INFECTION (non-serious), outcome "recovering"; VERTIGO (non-serious), outcome "not recovered"; TINNITUS (non-serious), outcome "not recovered". The patient underwent the following laboratory tests and procedures: Computerised tomogram head: (Feb2022) unknown results, notes: okay. The action taken for adalimumab, hydrochlorothiazide, triamterene and venlafaxine was unknown. Therapeutic measures were taken as a result of vertigo, dizziness.  The reporter's causality for the event(s) of Dizzy, Vertigo, Tinnitus, COVID, fell after going to bathroom/due to vertigo and urinary tract infection with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of feeling unwell was not provided.The reporter's assessment of the causal relationship of "covid-19", "urinary tract infection", "vertigo", "dizzy", "tinnitus", "fall" and "feeling unwell" with the suspect product(s) 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.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 61-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FASLODEX. Vaccination history included: Covid-19 vaccine (PRIMARY IMMUNIZATION SERIES COMPLETED;, MANUFACTURER UNKNOWN, LOT UNKNOWN), for Covid-19 Immunization.  The following information was reported: FATIGUE (non-serious), outcome "unknown".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.