chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Booster; COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program (172086). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Manufacturer unknown), for COVID-19 immunisation; Bnt162b2 (Dose 2, Manufacturer unknown), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Jan2022, outcome "unknown" and all described as "COVID-19"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive. Additional information: Patient had underlying health issues. Patient presented COVID-19 symptoms at time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Immunisation, Respiratory tract congestion, Suspected COVID-19
Clinical narrative: Covid-19; Respiratory tract congestion; Covid-19; Booster dose; 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-163-4224252-00.  A 40 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Dec2021 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation; risankizumab rzaa (SKYRIZI [RISANKIZUMAB RZAA]), subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose=1, Route of Admin: Intramuscular), for COVID-19 immunization; Bnt162b2 (Dose=2, Route of Admin: Intramuscular), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 20Dec2021, outcome "unknown", described as "Booster dose"; DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 01Jan2022, outcome "not recovered" and all described as "Covid-19"; RESPIRATORY TRACT CONGESTION (non-serious), outcome "unknown", described as "Respiratory tract congestion". The action taken for risankizumab rzaa was unknown. The patient had booster dose of COVID one and half weeks prior to 01Jan2022 and reports ended up with COVID on 01Jan2022, physician was aware and Skyrizi will be delayed a week due to continued cough, chest congestion. It was reported that it was unknown if the patient was enrolled in a COVID-19 Vaccine Trial, also the reporter's causality for the events of COVID and CHEST CONGESTION with SKYRIZI(RISANKIZUMAB) had no reasonable possibility, and the reporter's causality for the event(s) of COVID and CHEST CONGESTION with Pfizer Biontech Covid-19 Vaccine was reported as probable. It was not available whether the event abated after stopping the drug.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and the possible contributory role of suspect product BNT162B2 to the development of events drug ineffective, suspected covid19, respiratory tract congestion cannot be totally excluded.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: booster; Positive Covid diagnosis; Positive Covid diagnosis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from regulatory authority. The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 03Nov2021 (Lot number: EW0217) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: CLARITIN-D; FEBUXOSTAT; ALBUTEROL HFA. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 15Feb2021, when the patient was 38 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 25Jan2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jan2022, outcome "recovering" and all described as "Positive Covid diagnosis"; IMMUNISATION (medically significant) with onset 11Jan2022, outcome "recovering", described as "booster". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, immunisation.  Clinical course: No any other vaccine in four weeks. Patient had no Covid prior vaccination. Covid tested positive post vaccination. Patient had no known allergies.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, SARS-CoV-2 test, Swelling
Clinical narrative: Swelling; rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 42 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid prior vaccination: Yes" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), when the patient was 42 years old, for COVID-19 immunization. The following information was reported: SWELLING (hospitalization) with onset 05Jan2022, outcome "unknown", described as "Swelling"; RASH (hospitalization) with onset 05Jan2022, outcome "unknown", described as "rash". The patient was hospitalized for swelling, rash (hospitalization duration: 3 day(s)). The events "swelling" and "rash" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Therapeutic measures were taken as a result of swelling, rash. Clinical course: It was unknown if the patient received any other vaccine in four weeks and any other medication in 2 weeks.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Rash, SARS-CoV-2 test, Swelling
Clinical narrative: Swelling; rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 42 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid prior vaccination: Yes" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), when the patient was 42 years old, for COVID-19 immunization. The following information was reported: SWELLING (hospitalization) with onset 05Jan2022, outcome "unknown", described as "Swelling"; RASH (hospitalization) with onset 05Jan2022, outcome "unknown", described as "rash". The patient was hospitalized for swelling, rash (hospitalization duration: 3 day(s)). The events "swelling" and "rash" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Therapeutic measures were taken as a result of swelling, rash. Clinical course: It was unknown if the patient received any other vaccine in four weeks and any other medication in 2 weeks.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, SARS-CoV-2 test, Swelling
Clinical narrative: rash; Swelling; covid test result=Positive; covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 42 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE:1), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid test result=Positive"; RASH (hospitalization) with onset 05Jan2022, outcome "unknown", described as "rash"; SWELLING (hospitalization) with onset 05Jan2021, outcome "unknown", described as "Swelling". The patient was hospitalized for rash, swelling (hospitalization duration: 3 day(s)). The events "rash" and "swelling" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Therapeutic measures were taken as a result of rash, swelling. Additional information: If other vaccine in four weeks: Unknown. Other medications in two weeks: Unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Rash, SARS-CoV-2 test, Swelling
Clinical narrative: rash; Swelling; covid test result=Positive; covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 42 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE:1), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid test result=Positive"; RASH (hospitalization) with onset 05Jan2022, outcome "unknown", described as "rash"; SWELLING (hospitalization) with onset 05Jan2021, outcome "unknown", described as "Swelling". The patient was hospitalized for rash, swelling (hospitalization duration: 3 day(s)). The events "rash" and "swelling" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Therapeutic measures were taken as a result of rash, swelling. Additional information: If other vaccine in four weeks: Unknown. Other medications in two weeks: Unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, Product use issue, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Got covid; Got covid; Immunisation (Dose 3); FLU and BNT162B2 were taken on same date (04Nov2021); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Nov2021 (Lot number: ew0217) as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administration date 04Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 ([{prev_dose_product=COVID 19,, prev_dose_brand=pfizer,, prev_dose_brand_unknown=False,, prev_dose_lot_number=el3247,, prev_dose_lot_unknown=False,, prev_dose_administration_date=16Fe, b2021, prev_dose_dose_number=2,, prev_dose_vaccine_location=Left, arm},), administration date: 16Feb2021, when the patient was 51 years old, for COVID-19 immunization; Bnt162b2 ({prev_dose_product=COVID 19,, prev_dose_brand=pfizer,, prev_dose_brand_unknown=False,, prev_dose_lot_number=el3247,, prev_dose_lot_unknown=False,, prev_dose_administration_date=27Ja, n2021, prev_dose_dose_number=1,, prev_dose_vaccine_location=Left, arm}]), administration date: 27Jan2021, when the patient was 51 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 04Nov2021, outcome "unknown", described as "Immunisation (Dose 3)"; PRODUCT USE ISSUE (medically significant) with onset 04Nov2021, outcome "unknown", described as "FLU and BNT162B2 were taken on same date (04Nov2021)"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jan2022, outcome "recovering" and all described as "Got covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jan2022) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Gait disturbance, Suspected COVID-19
Clinical narrative: had Covid  after receiving the covid vaccine; had Covid  after receiving the covid vaccine; hard time walking; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4223964-00.  A 74 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 02Mar2021 (Batch/Lot number: unknown) at the age of 73 years as dose 2, single and intramuscular, administration date 09Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "had Covid  after receiving the covid vaccine"; GAIT DISTURBANCE (medically significant), outcome "unknown", described as "hard time walking". The action taken for adalimumab was unknown. The reporter's assessment of the causal relationship of the events with the suspect product was not related. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the events Drug ineffective, Suspected Covid-19, Gait disturbance and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis; Injection site itching; Injection site redness; 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-163-4223121-00 (Abbvie).  A 51 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 15Jun2021 (Batch/Lot number: unknown) at the age of 51 years as dose 2, single and intramuscular, administration date 15May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown). 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 "unknown", described as "Rheumatoid arthritis"; INJECTION SITE PRURITUS (non-serious) with onset 2021, outcome "recovered", described as "Injection site itching"; INJECTION SITE ERYTHEMA (non-serious) with onset 2021, outcome "recovered", described as "Injection site redness". The action taken for adalimumab was dosage not changed.  Causality for Humira (ADALIMUMAB): Causality for the events Injection site itching, Injection site redness was not reported by the reporter. Causality for the event Rheumatoid Arthritis was not related as per reporter.  Causality for Pfizer BioNTech COVID-19 Vaccine: Causality for the events Injection site itching, Injection site redness was not reported by the reporter. Causality for the event Rheumatoid Arthritis was reported as possible by the reporter.  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 and the possible contributory role of suspect product BNT162B2 to the development of events rheumatoid arthritis, injection site pruritus, injection site redness cannot be totally excluded. The case will be reassessed when additional information available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Nasopharyngitis, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Positive Covid test on 07Jan2022; Positive Covid test on 07Jan2022; Light Runny nose; Little cold one night; Tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Feb2021 (Lot number: EL3247) at the age of 42 years as dose 2, single and administered in arm left, administration date 03Feb2021 (Lot number: EL3247) 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 07Jan2022, outcome "recovered" (2022) and all described as "Positive Covid test on 07Jan2022"; RHINORRHOEA (non-serious) with onset 07Jan2022, outcome "recovered" (09Jan2022), described as "Light Runny nose"; NASOPHARYNGITIS (non-serious) with onset 07Jan2022, outcome "recovered" (09Jan2022), described as "Little cold one night"; FATIGUE (non-serious) with onset 07Jan2022, outcome "recovered" (09Jan2022), described as "Tired". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, rhinorrhoea, nasopharyngitis, fatigue. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, no medications within 2 weeks of vaccination and was not diagnosed with Covid-19, prior to vaccination. Positive Covid test on 07Jan2022 and he was told to report. Symptoms were very little, light runny nose, little cold one night, tired. Lasted for 2 days, and then felt good. Device date was reported as 11Jan2022.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Positive Covid test on 07Jan2022; Positive Covid test on 07Jan2022; Light Runny nose; Little cold one night; Tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Feb2021 (Lot number: EL3247) at the age of 42 years as dose 2, single and administered in arm left, administration date 03Feb2021 (Lot number: EL3247) 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 07Jan2022, outcome "recovered" (2022) and all described as "Positive Covid test on 07Jan2022"; RHINORRHOEA (non-serious) with onset 07Jan2022, outcome "recovered" (09Jan2022), described as "Light Runny nose"; NASOPHARYNGITIS (non-serious) with onset 07Jan2022, outcome "recovered" (09Jan2022), described as "Little cold one night"; FATIGUE (non-serious) with onset 07Jan2022, outcome "recovered" (09Jan2022), described as "Tired". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, rhinorrhoea, nasopharyngitis, fatigue. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, no medications within 2 weeks of vaccination and was not diagnosed with Covid-19, prior to vaccination. Positive Covid test on 07Jan2022 and he was told to report. Symptoms were very little, light runny nose, little cold one night, tired. Lasted for 2 days, and then felt good. Device date was reported as 11Jan2022.
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2021SA407150 (Manufacturer report number).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Guillain-Barre syndrome". This case involved an adult male patient who experienced guillan-barre (Guillain-Barre syndrome) while being treated with product nos and Tozinameran (Pfizer BioNTech covid-19 vaccine). On an unknown date, the patient started treatment with product nos (not otherwise specified) of unknown formulation at dosage unknown (with an unknown batch number and expiry date) and Pfizer BioNTech covid-19 vaccine (Tozinameran) of unknown formulation at dosage unknown (with an unknown batch number and expiry date) for Prophylactic vaccination. On an unknown date and unknown latency after initiation of suspect drug the patient developed guillan-barre (Guillain-Barre syndrome). This event Guillain-Barre syndrome was assessed as medically significant as per reporter. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was unknown for the event. No further information was reported.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid test result=Positive / covid test date=10Jan2022; covid test result=Positive / covid test date=10Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 09Jan2022 12:00 (Lot number: FL3198) at the age of 34 years as dose 2, single and administered in arm left, administration date 19Dec2021 12:00 (Lot number: FE3594) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; AMITRIPTYLINE; TYLENOL; OMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Jan2022 04:00, outcome "unknown" and all described as "covid test result=Positive / covid test date=10Jan2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Swelling, Vaccination site swelling
Clinical narrative: covid test result=Positive / covid test date=10Jan2022; covid test result=Positive / covid test date=10Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 09Jan2022 12:00 (Lot number: FL3198) at the age of 34 years as dose 2, single and administered in arm left, administration date 19Dec2021 12:00 (Lot number: FE3594) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; AMITRIPTYLINE; TYLENOL; OMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Jan2022 04:00, outcome "unknown" and all described as "covid test result=Positive / covid test date=10Jan2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Asthenopia, Decreased appetite, Ear congestion, Eye disorder
Clinical narrative: vision was diminished in left eye; extreme eye strain; feels like my eyes are not working together; sensitive to light; facial pain; congestion; congested in ear mostly left side; floaters in both eyes; Anxiety; unable to sleep; loss of appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 19Apr2021 08:00 (Lot number: EW0151) at the age of 45 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). There was no other medical history, no prior COVID. There were no concomitant medications. There were no other vaccine in four weeks; no other medications in two weeks. Vaccination history included: Bnt162b2 (DOSE 1; Batch/Lot No: ER8730;Location of injection: Arm Left), administration date: 29Mar2021, when the patient was 44 years old, for COVID-19 immunization. The following information was reported: VISUAL IMPAIRMENT, described as "vision was diminished in left eye"; ASTHENOPIA, described as "extreme eye strain"; EYE DISORDER, described as "feels like my eyes are not working together"; PHOTOPHOBIA, described as "sensitive to light"; FACIAL PAIN, described as "facial pain"; NASAL CONGESTION, described as "congestion"; EAR CONGESTION, described as "congested in ear mostly left side"; VITREOUS FLOATERS, described as "floaters in both eyes"; ANXIETY, described as "Anxiety"; INSOMNIA, described as "unable to sleep"; DECREASED APPETITE, described as "loss of appetite". Two weeks after the second vaccine vision was diminished in left eye, extreme eye strain, the patient felt like his eyes were not working together, sensitive to light. He felt facial pain and congestion, also congested in ear mostly left side as well; floaters in both eyes, anxiety, unable to sleep, loss of appetite. He was unable to work on a computer. These events were all reported with onset 29Apr2021 08:00, outcome "not recovered", seriousness "Disability or permanent damage". These events were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) negative. Therapeutic measures were taken as a result of visual impairment, asthenopia, eye disorder, photophobia, facial pain, nasal congestion, ear congestion, vitreous floaters, anxiety, insomnia, decreased appetite. AE treatment: eye drops, steroids, laser treatments  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Facial pain, Insomnia, Nasal congestion, Photophobia, SARS-CoV-2 test
Clinical narrative: vision was diminished in left eye; extreme eye strain; feels like my eyes are not working together; sensitive to light; facial pain; congestion; congested in ear mostly left side; floaters in both eyes; Anxiety; unable to sleep; loss of appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 19Apr2021 08:00 (Lot number: EW0151) at the age of 45 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). There was no other medical history, no prior COVID. There were no concomitant medications. There were no other vaccine in four weeks; no other medications in two weeks. Vaccination history included: Bnt162b2 (DOSE 1; Batch/Lot No: ER8730;Location of injection: Arm Left), administration date: 29Mar2021, when the patient was 44 years old, for COVID-19 immunization. The following information was reported: VISUAL IMPAIRMENT, described as "vision was diminished in left eye"; ASTHENOPIA, described as "extreme eye strain"; EYE DISORDER, described as "feels like my eyes are not working together"; PHOTOPHOBIA, described as "sensitive to light"; FACIAL PAIN, described as "facial pain"; NASAL CONGESTION, described as "congestion"; EAR CONGESTION, described as "congested in ear mostly left side"; VITREOUS FLOATERS, described as "floaters in both eyes"; ANXIETY, described as "Anxiety"; INSOMNIA, described as "unable to sleep"; DECREASED APPETITE, described as "loss of appetite". Two weeks after the second vaccine vision was diminished in left eye, extreme eye strain, the patient felt like his eyes were not working together, sensitive to light. He felt facial pain and congestion, also congested in ear mostly left side as well; floaters in both eyes, anxiety, unable to sleep, loss of appetite. He was unable to work on a computer. These events were all reported with onset 29Apr2021 08:00, outcome "not recovered", seriousness "Disability or permanent damage". These events were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) negative. Therapeutic measures were taken as a result of visual impairment, asthenopia, eye disorder, photophobia, facial pain, nasal congestion, ear congestion, vitreous floaters, anxiety, insomnia, decreased appetite. AE treatment: eye drops, steroids, laser treatments  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment, Vitreous floaters
Clinical narrative: vision was diminished in left eye; extreme eye strain; feels like my eyes are not working together; sensitive to light; facial pain; congestion; congested in ear mostly left side; floaters in both eyes; Anxiety; unable to sleep; loss of appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 19Apr2021 08:00 (Lot number: EW0151) at the age of 45 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). There was no other medical history, no prior COVID. There were no concomitant medications. There were no other vaccine in four weeks; no other medications in two weeks. Vaccination history included: Bnt162b2 (DOSE 1; Batch/Lot No: ER8730;Location of injection: Arm Left), administration date: 29Mar2021, when the patient was 44 years old, for COVID-19 immunization. The following information was reported: VISUAL IMPAIRMENT, described as "vision was diminished in left eye"; ASTHENOPIA, described as "extreme eye strain"; EYE DISORDER, described as "feels like my eyes are not working together"; PHOTOPHOBIA, described as "sensitive to light"; FACIAL PAIN, described as "facial pain"; NASAL CONGESTION, described as "congestion"; EAR CONGESTION, described as "congested in ear mostly left side"; VITREOUS FLOATERS, described as "floaters in both eyes"; ANXIETY, described as "Anxiety"; INSOMNIA, described as "unable to sleep"; DECREASED APPETITE, described as "loss of appetite". Two weeks after the second vaccine vision was diminished in left eye, extreme eye strain, the patient felt like his eyes were not working together, sensitive to light. He felt facial pain and congestion, also congested in ear mostly left side as well; floaters in both eyes, anxiety, unable to sleep, loss of appetite. He was unable to work on a computer. These events were all reported with onset 29Apr2021 08:00, outcome "not recovered", seriousness "Disability or permanent damage". These events were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) negative. Therapeutic measures were taken as a result of visual impairment, asthenopia, eye disorder, photophobia, facial pain, nasal congestion, ear congestion, vitreous floaters, anxiety, insomnia, decreased appetite. AE treatment: eye drops, steroids, laser treatments  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: He passed away 14 days after receiving the 1st dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 47 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 19Mar2021 17:30 (Lot number: EP7534) at the age of 47 years as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Known allergies: any type of cillins" (unspecified if ongoing). No covid prior vaccination. No other vaccine in four weeks. Other medications in two weeks included blood pressure medications. The patient took concomitant medications. The following information was reported: DEATH (death) with onset 03Apr2021 02:30, outcome "fatal", described as "He passed away 14 days after receiving the 1st dose.". Therapeutic measures were not taken as a result of death. The patient date of death was 03Apr2021. The reported cause of death was "He passed away 14 days after receiving the 1st dose.". No treatment for AE. No covid tested post vaccination. It was also reported that patient did not Recovered. It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: He passed away 14 days after receiving the 1st dose.
Sex: U
Vaccine: PNC13
Symptoms: Product container seal issue
Clinical narrative: the seal of a Prevnar 13 syringe is broke at the top and that it "came that way"; the seal of a Prevnar 13 syringe is broke at the top and that it "came that way"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) and all described as "the seal of a Prevnar 13 syringe is broke at the top and that it "came that way"". Additional information: Caller is a Pfizer Territory Manager. Caller shared that that a HCP reported to him the seal of a Prevnar 13 syringe is broke at the top and that it "came that way". Caller reports the HCP is seeking a replacement.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Drug ineffective, Fatigue, Immunisation, Incorrect route of product administration
Clinical narrative: 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-163-4222859-00 (RA), US-PFIZER INC-202200047448 (Pfizer). A 45 year-old female patient received bnt162b2 (BNT162B2), subcutaneous, administration date 27Aug2021 (Batch/Lot number: unknown) at the age of 45 years as dose 3 (booster), single, subcutaneous, administration date 16Apr2021 (Batch/Lot number: unknown) as dose 2, single and subcutaneous, administration date 25Mar2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis; methotrexate (METHOTREXATE) (Batch/Lot number: unknown). The patient's relevant medical history was not reported. Concomitant medication(s) included: FOLIC ACID. The following information was reported: IMMUNISATION (medically significant) with onset 27Aug2021, outcome "unknown", described as "Booster"; SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 27Nov2021, outcome "unknown" and all described as "COVID-19"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm"; ALOPECIA (non-serious), outcome "unknown", described as "hair loss"; STOMATITIS (non-serious), outcome "unknown", described as "sores mouth"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "bnt162b2 via subcutaneous". The action taken for adalimumab was unknown. Additional information: Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Hair Loss, Covid-19, Sore Arm And Fatigue After All Covid Vaccine onset in 2021, Mouth Sores and Sore Arm And Fatigue After All Covid Vaccine onset in 2021 was not provided. The reporter causality for event Fatigue, Sores mouth, Sore arm was not reported and for hair loss and COVID-19 reported as not related with suspect BNT162B2. The reporter causality for event Fatigue, Sore arm was not reported, Sores mouth hair loss was reported as probable and COVID-19 it was not related with suspect Methotrexate. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Stomatitis, Suspected COVID-19
Clinical narrative: 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-163-4222859-00 (RA), US-PFIZER INC-202200047448 (Pfizer). A 45 year-old female patient received bnt162b2 (BNT162B2), subcutaneous, administration date 27Aug2021 (Batch/Lot number: unknown) at the age of 45 years as dose 3 (booster), single, subcutaneous, administration date 16Apr2021 (Batch/Lot number: unknown) as dose 2, single and subcutaneous, administration date 25Mar2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis; methotrexate (METHOTREXATE) (Batch/Lot number: unknown). The patient's relevant medical history was not reported. Concomitant medication(s) included: FOLIC ACID. The following information was reported: IMMUNISATION (medically significant) with onset 27Aug2021, outcome "unknown", described as "Booster"; SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 27Nov2021, outcome "unknown" and all described as "COVID-19"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm"; ALOPECIA (non-serious), outcome "unknown", described as "hair loss"; STOMATITIS (non-serious), outcome "unknown", described as "sores mouth"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "bnt162b2 via subcutaneous". The action taken for adalimumab was unknown. Additional information: Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Hair Loss, Covid-19, Sore Arm And Fatigue After All Covid Vaccine onset in 2021, Mouth Sores and Sore Arm And Fatigue After All Covid Vaccine onset in 2021 was not provided. The reporter causality for event Fatigue, Sores mouth, Sore arm was not reported and for hair loss and COVID-19 reported as not related with suspect BNT162B2. The reporter causality for event Fatigue, Sore arm was not reported, Sores mouth hair loss was reported as probable and COVID-19 it was not related with suspect Methotrexate. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 25.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Back pain, Immunisation, Psoriasis, Psoriatic arthropathy
Clinical narrative: booster; Psoriasis on back of head, back pain and Psoriatic Arthritis; Psoriasis on back of head, back pain and Psoriatic Arthritis; Psoriasis on back of head, back pain and Psoriatic Arthritis; 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-163-4219534-00 (Agency).  A 25 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 25 years as dose 3 (booster), single, intramuscular, administration date 27Mar2021 (Batch/Lot number: unknown) as dose 1, single and intramuscular, administration date 17Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; PSORIATIC ARTHROPATHY (medically significant), PSORIASIS (non-serious), BACK PAIN (non-serious), outcome "not recovered" and all described as "Psoriasis on back of head, back pain and Psoriatic Arthritis". 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 Psoriasis on back of head, back pain and psoriatic arthritis flare up was not provided. The causality of the events psoriasis and back pain was not reported with bnt162b2 and causality of the event psoriatic arthritis aggravated was not related with 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 the reported  events  may be not related to suspect drug BNT162B2. case can be reassess once additional information becomes available.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: feeling unwell and got tested for Covid positive; feeling unwell and got tested for Covid positive; booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a sponsored program (172086). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 26Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "oncology patient" (unspecified if ongoing), notes: She was an oncology patient; "had one lung" (unspecified if ongoing), notes: only had one lung. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 26Oct2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jan2022, outcome "unknown" and all described as "feeling unwell and got tested for Covid positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Jan2022) positive, notes: got tested for Covid on 10Jan2022 afternoon and got her results back on 11Jan2022. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Immunisation, Vaccination failure, covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.