chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Thinking abnormal
Clinical narrative: Extreme brain fog; Extreme confusion; short-term memory delays and losses; thinking issues; no concentration; Extremely exhausted; Anxiety over effects; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Jan2022 11:00 (Lot number: FJ1614) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DEXTROAMPHETAMINE HYDROCHLORIDE. Vaccination history included: Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer , prev dose brand unknown=False, prev dose lot number=EW0176,, prev dose lot unknown=False, prev dose administration date=08May2021,, prev dose administration time: 12:00 PM, prev dose dose number=2,, prev dose vaccine location=Left arm), administration date: 08May2021, when the patient was 42 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=EW0158,, prev dose lot unknown=False, prev dose administration date=08Apr2021,, prev dose administration time: 12:00 PM,, prev dose dose number=1,, prev dose vaccine location=Left arm), administration date: 08Apr2021, when the patient was 42 years old, for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 22Jan2022 14:00, outcome "not recovered", described as "Extreme brain fog"; CONFUSIONAL STATE (non-serious) with onset 22Jan2022 14:00, outcome "not recovered", described as "Extreme confusion"; AMNESIA (non-serious) with onset 22Jan2022 14:00, outcome "not recovered", described as "short-term memory delays and losses"; THINKING ABNORMAL (non-serious) with onset 22Jan2022 14:00, outcome "not recovered", described as "thinking issues"; DISTURBANCE IN ATTENTION (non-serious) with onset 22Jan2022 14:00, outcome "not recovered", described as "no concentration"; FATIGUE (non-serious) with onset 22Jan2022 14:00, outcome "not recovered", described as "Extremely exhausted"; ANXIETY (non-serious) with onset 22Jan2022 14:00, outcome "not recovered", described as "Anxiety over effects". Therapeutic measures were not taken as a result of feeling abnormal, confusional state, amnesia, thinking abnormal, disturbance in attention, fatigue, anxiety.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Sandoz dextroampamphetamin 30 mg tab received in two weeks prior vaccination. Patient not diagnosed with covid-19 prior to vaccination since vaccination patient not tested for covid-19. Patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Chills, Intermenstrual bleeding, Lip swelling
Clinical narrative: Fever; chills; enlarged lymph nodes in armpit; extreme soreness/pain in armpit; full body heat rash; hives; swelling of lips; tingly fingers; period/spotting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Jan2022 17:00 (Lot number: 33130ba) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hypothyroidism" (unspecified if ongoing); "skin cancer" (unspecified if ongoing); "Tree nuts" (unspecified if ongoing), notes: known allergies: Tree nuts. Concomitant medication(s) included: SERTRALINE; GIANVI; LYSINE; BUSPIRONE; SYNTHROID. Vaccination history included: Bnt162b2 (Dose 2, Product: COVID 19, Brand: Pfizer, Lot number: ew0158, Vaccine location: Left arm), administration date: 12Apr2021, when the patient was 33 years old, for Covid-19 immunization; Bnt162b2 (Dose: 1, Product: COVID 19 , Brand: Pfizer, Lot number: en6205, Dose administration time: 03:00 PM , Vaccine location: Left arm), administration date: 22Mar2021, when the patient was 33 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "Fever"; CHILLS (non-serious), outcome "recovered", described as "chills"; LYMPHADENOPATHY (non-serious), outcome "recovered", described as "enlarged lymph nodes in armpit"; AXILLARY PAIN (non-serious), outcome "recovered", described as "extreme soreness/pain in armpit"; MILIARIA (non-serious), outcome "recovered", described as "full body heat rash"; URTICARIA (non-serious), outcome "recovered", described as "hives"; LIP SWELLING (non-serious), outcome "recovered", described as "swelling of lips"; PARAESTHESIA (non-serious), outcome "recovered", described as "tingly fingers"; INTERMENSTRUAL BLEEDING (non-serious), outcome "recovered", described as "period/spotting". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, lymphadenopathy, axillary pain, miliaria, urticaria, lip swelling, paraesthesia, intermenstrual bleeding.  Additional Information: The patient had not received other vaccine in 4 weeks and covid prior vaccination. The patient had covid tested post vaccination. Covid test result was negative.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Miliaria, Paraesthesia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; chills; enlarged lymph nodes in armpit; extreme soreness/pain in armpit; full body heat rash; hives; swelling of lips; tingly fingers; period/spotting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Jan2022 17:00 (Lot number: 33130ba) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hypothyroidism" (unspecified if ongoing); "skin cancer" (unspecified if ongoing); "Tree nuts" (unspecified if ongoing), notes: known allergies: Tree nuts. Concomitant medication(s) included: SERTRALINE; GIANVI; LYSINE; BUSPIRONE; SYNTHROID. Vaccination history included: Bnt162b2 (Dose 2, Product: COVID 19, Brand: Pfizer, Lot number: ew0158, Vaccine location: Left arm), administration date: 12Apr2021, when the patient was 33 years old, for Covid-19 immunization; Bnt162b2 (Dose: 1, Product: COVID 19 , Brand: Pfizer, Lot number: en6205, Dose administration time: 03:00 PM , Vaccine location: Left arm), administration date: 22Mar2021, when the patient was 33 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "Fever"; CHILLS (non-serious), outcome "recovered", described as "chills"; LYMPHADENOPATHY (non-serious), outcome "recovered", described as "enlarged lymph nodes in armpit"; AXILLARY PAIN (non-serious), outcome "recovered", described as "extreme soreness/pain in armpit"; MILIARIA (non-serious), outcome "recovered", described as "full body heat rash"; URTICARIA (non-serious), outcome "recovered", described as "hives"; LIP SWELLING (non-serious), outcome "recovered", described as "swelling of lips"; PARAESTHESIA (non-serious), outcome "recovered", described as "tingly fingers"; INTERMENSTRUAL BLEEDING (non-serious), outcome "recovered", described as "period/spotting". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, lymphadenopathy, axillary pain, miliaria, urticaria, lip swelling, paraesthesia, intermenstrual bleeding.  Additional Information: The patient had not received other vaccine in 4 weeks and covid prior vaccination. The patient had covid tested post vaccination. Covid test result was negative.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Fever; chills; enlarged lymph nodes in armpit; extreme soreness/pain in armpit; full body heat rash; hives; swelling of lips; tingly fingers; period/spotting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Jan2022 17:00 (Lot number: 33130ba) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hypothyroidism" (unspecified if ongoing); "skin cancer" (unspecified if ongoing); "Tree nuts" (unspecified if ongoing), notes: known allergies: Tree nuts. Concomitant medication(s) included: SERTRALINE; GIANVI; LYSINE; BUSPIRONE; SYNTHROID. Vaccination history included: Bnt162b2 (Dose 2, Product: COVID 19, Brand: Pfizer, Lot number: ew0158, Vaccine location: Left arm), administration date: 12Apr2021, when the patient was 33 years old, for Covid-19 immunization; Bnt162b2 (Dose: 1, Product: COVID 19 , Brand: Pfizer, Lot number: en6205, Dose administration time: 03:00 PM , Vaccine location: Left arm), administration date: 22Mar2021, when the patient was 33 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "Fever"; CHILLS (non-serious), outcome "recovered", described as "chills"; LYMPHADENOPATHY (non-serious), outcome "recovered", described as "enlarged lymph nodes in armpit"; AXILLARY PAIN (non-serious), outcome "recovered", described as "extreme soreness/pain in armpit"; MILIARIA (non-serious), outcome "recovered", described as "full body heat rash"; URTICARIA (non-serious), outcome "recovered", described as "hives"; LIP SWELLING (non-serious), outcome "recovered", described as "swelling of lips"; PARAESTHESIA (non-serious), outcome "recovered", described as "tingly fingers"; INTERMENSTRUAL BLEEDING (non-serious), outcome "recovered", described as "period/spotting". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, lymphadenopathy, axillary pain, miliaria, urticaria, lip swelling, paraesthesia, intermenstrual bleeding.  Additional Information: The patient had not received other vaccine in 4 weeks and covid prior vaccination. The patient had covid tested post vaccination. Covid test result was negative.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: pfizer shot killed his 17 year old son; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). A 17 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "pfizer shot killed his 17 year old son". The patient date of death was unknown. The reported cause of death was "pfizer shot killed his 17 year old son". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: pfizer shot killed his 17 year old son
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Breakthrough COVID infections; Breakthrough COVID infections; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 13Oct2021 (Batch/Lot number: unknown) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date 29Sep2021; LEVOXYL; VITAMIN D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6199), administration date: 16Mar2021, when the patient was 59 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN5318), administration date: 23Feb2021, when the patient was 59 years old, for COVID-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 17Jan2022, outcome "recovering" and all described as "Breakthrough COVID infections". The event "breakthrough covid infections" and "breakthrough covid infections" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: covid-19: (24Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19, drug ineffective.  Clinical course: The patient took other vaccine in four weeks. No COVID prior vaccination. The patient tested COVID post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pericardial effusion, Pericarditis, SARS-CoV-2 test
Clinical narrative: Pericarditis; large pericardial effusion; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 16:00 (Lot number: EW0191) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: ADVIL 12 HOUR. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 24Jan2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL1284), administration date: 03Jan2021, for Covid-19 immunization. The following information was reported: PERICARDITIS (hospitalization, life threatening) with onset 03Jan2022, outcome "recovering", described as "Pericarditis"; PERICARDIAL EFFUSION (hospitalization, life threatening) with onset 03Jan2022, outcome "recovering", described as "large pericardial effusion". The patient was hospitalized for pericarditis, pericardial effusion (hospitalization duration: 3 days). The events "pericarditis" and "large pericardial effusion" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) negative, notes: Nasal Swab.  Therapeutic measures were taken as a result of pericarditis, pericardial effusion including NSAIDs.  Course of the event Pericarditis with large pericardial effusion, requiring surgical window procedure. 700-800 ml of bloody fluid drained from pericardium. AE Treatment: Surgery for drainage of pericardial fluid. Nsaids.  Follow up information has been requested; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and PERICARDITIS and PERICARDIAL EFFUSION cannot be completely excluded.
Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Alanine aminotransferase, Alanine aminotransferase increased, Vertigo
Clinical narrative: Vertigo; raised alt liver numbers; 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-163-4244517-00 (AbbVie).  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 02Aug2021 (Batch/Lot number: unknown) as dose 1, single, intramuscular, administration date 23Aug2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 29Dec2021 (Batch/Lot number: unknown) as dose 3, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriatic arthropathy, uveitis. The patient's relevant medical history was not reported. Concomitant medication(s) included: REPATHA. The following information was reported: VERTIGO (hospitalization) with onset Dec2021, outcome "unknown", described as "Vertigo"; ALANINE AMINOTRANSFERASE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "raised alt liver numbers". The patient was hospitalized for vertigo (start date: Dec2021). The event "vertigo" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: alanine aminotransferase: raised. The action taken for adalimumab was unknown.  Additional Information: The patient reported that she had Raised alt liver numbers began increasing. She also taking Repatha. She was hospitalized in Dec2021 for vertigo. Patient agreed to have MD contacted. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of Vertigo, Alanine aminotransferase increased but also consider possible contributory effects from patient's medical history and/or concomitant medications. 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Alanine aminotransferase increased, Vertigo
Clinical narrative: Vertigo; raised alt liver numbers; 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-163-4244517-00 (AbbVie).  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1154341) for psoriatic arthropathy, uveitis. The patient's relevant medical history was not reported. Concomitant medication(s) included: REPATHA. Vaccination history included: Bnt162b2 (Dose 2, Route of administration: Intramuscular), administration date: 23Aug2021, when the patient was 58 years old, for Covid-19 immunization, reaction(s): "Vertigo", "Raised alt liver numbers"; Bnt162b2 (Dose 1, Route of administration: Intramuscular), administration date: 02Aug2021, when the patient was 58 years old, for Covid-19 immunization, reaction(s): "Vertigo", "Raised alt liver numbers". The following information was reported: VERTIGO (hospitalization) with onset Dec2021, outcome "unknown", described as "Vertigo"; ALANINE AMINOTRANSFERASE INCREASED (non-serious), outcome "unknown", described as "raised alt liver numbers". The patient was hospitalized for vertigo (start date: Dec2021). The event "vertigo" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: alanine aminotransferase: raised, notes: increasing. The action taken for adalimumab was unknown.  The reporters causality for the events vertigo and raised ALT liver numbers with BNT162B2 was not reported. The reporters causality for the events vertigo and raised ALT liver numbers with Humira (Adalimumab) was reasonable 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 temporal relationship the possibility of causal association between the reported events and the suspect drug BNT162B2 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. Other Case identifier(s): US-PFIZER INC-202200142905 (Pfizer).  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 14:00 (Lot number: FE3594) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "episode of Bell's palsy" (unspecified if ongoing), notes: lasted for a couple of weeks., probably 25 years ago. There were no concomitant medications. Vaccination history included: Flu vaccine (this was probably 25 years ago.). The following information was reported: COVID-19 (non-serious) with onset 19Jan2022, outcome "recovering", described as "COVID-19". The event "covid-19" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19. Pfizer-BioNTech Covid-19 Vaccine: NDC/Expiry: Unknown, this information is not on the CDC vaccine record card. Second dose is scheduled to be administered on 30Jan2022; caller does not know if that will be changed relative to this event and Paxlovid therapy yet. NDC: Caller no longer had the outer packaging for this product, he only had the individual blister pack which did not have NDC listed on it. Lot/Expiry: Caller no longer had the outer packaging for this product, he only had the individual blister pack which he had to get a magnifying glass to read Lot/Expiry on because they are pretty small numbers.   Additional information: The patient is pretty much out of danger at this time, just about all of her symptoms are gone at this time; but caller mentioned patient is still going to test positive for a while he would assume. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) is None. Additional Vaccines Administered on Same Date of the Pfizer Suspect-If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect s none. The patient did not any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient visited Emergency Room just to verify if she could take a certain stomach medication with Paxlovid for medication referral and they were able to verify it was fine; patient was not admitted to the hospital or seen in the emergency room for any other reason. Physician Office Clinic visit only for testing only. Patient just completed Paxlovid therapy today for the treatment of COVID-19.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage urinary tract, Inappropriate schedule of product administration
Clinical narrative: Blood clot in urine; On 01Apr2021, he received first dose/On 01Aug2021, he received second 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-163-4242343-00.  A 78 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Aug2021 (Batch/Lot number: unknown) at the age of 77 years as dose 2, single for covid-19 immunisation; leuprorelin acetate (LUPRON DEPOT) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. It was unknown if he was enrolled in a COVID-19 vaccine trial. Vaccination history included: Bnt162b2 (Dose 1, Route of administration: Intramuscular), administration date: 01Apr2021, when the patient was 77 years old, for COVID-19 Immunization. The following information was reported: HAEMORRHAGE URINARY TRACT (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "Blood clot in urine"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 01Aug2021, outcome "unknown", described as "On 01Apr2021, he received first dose/On 01Aug2021, he received second dose". The action taken for leuprorelin acetate was unknown. The patient had blood clots in urine and was hospitalized several times since end of last year 2021. Pfizer Biontech COVID-19 Vaccine (TOZINAMERAN) was also considered suspect. Adverse event information provided by the patient was related to COVID-19 vaccine.   Causality for LUPRON DEPOT (LEUPROLIDE ACETATE DEPOT)  The reporter's causality for the event(s) of blood clots in urine was not provided. opinion is that the event of blood clots in urine is not assessable.  Causality:  LUPRON DEPOT (LEUPROLIDE ACETATE DEPOT)  1) Blood clot in urine (Haemorrhage urinary tract) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr.(Drug/Vaccine): Not assessable Dechallenge : N/A  Pfizer Biontech COVID-19 Vaccine (TOZINAMERAN)  1) Blood clot in urine (Haemorrhage urinary tract) Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A Did event abate after stopping drug? NA  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal association between the event and suspect drug BNT162B2 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: 27.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthritis reactive, Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19 symptoms; COVID-19 symptoms; Reactive arthritis;   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-163-4241110-00 (AbbVie).  A 27 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 11Aug2021 (Batch/Lot number: unknown) at the age of 27 years as dose 2, single and intramuscular, administration date 20Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free. 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 "COVID-19 symptoms"; ARTHRITIS REACTIVE (medically significant), outcome "recovering", described as "Reactive arthritis". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for HUMIRA the event(s) of REACTIVE ARTHRITIS with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of COVID-19 SYMPTOMS was not provided. The causality of Reactive arthritis, Suspected COVID-19 with respect to Drug PFIZER BIONTECH COVID-19 was Probable.   The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on limited information in the case , a possible causal association between all the reported  events Drug ineffective , suspected Covid 19 infection , Arthritis Reactive and the suspect drug BNT162B2 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Confusional state, Feeling abnormal
Clinical narrative: confusion; did not feel right; Cellulitis; 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-163-4241744-00 (AbbVie).  A 54 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Feb2021 (Batch/Lot number: unknown) at the age of 54 years as dose 2, single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous since Sep2021 (ongoing) (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01, Route of Admin: Intra-muscular), administration date: Feb2021, when the patient was 54 years old, for COVID-19 Vaccination. The following information was reported: CONFUSIONAL STATE (hospitalization) with onset 2021, outcome "unknown", described as "confusion"; FEELING ABNORMAL (hospitalization) with onset 2021, outcome "unknown", described as "did not feel right"; CELLULITIS (medically significant) with onset 2021, outcome "unknown", described as "Cellulitis". The patient was hospitalized for confusional state, feeling abnormal (start date: Mar2021). The action taken for risankizumab was dosage not changed.  The reporter considered "cellulitis" related to bnt162b2. Reporter's causality assessment for events confusional state and feeling abnormal due to bnt162b2 was not provided. The reporters causality for the events and Skyrizi (Risankizumab) were not provided. AbbVies opinion is that there is a reasonable possibility that the event of cellulitis is related to Skyrizi (Risankizumab).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As per available information , the causal association between the reported event and the suspect drug cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Cataract
Clinical narrative: Cataracts; 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-163-4244415-00 (RA).  A 75 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for product used for unknown indication. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CATARACT (hospitalization, medically significant), outcome "unknown", described as "Cataracts". The action taken for adalimumab was unknown. Clinical course: On unknown dates, the patient experienced cataracts and hospitalized after receiving pfizer covid-19 vaccination. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. The patient was hospitalized after receiving pfizer covid vaccine. He was scheduled for cataracts surgery. He did not agreed to have physician contacted. It was unknown if patient was enrolled in a covid-19 vaccine trial. He received dose of covid-19 vaccine manufactured by pfizer/biontech.  Causality for humira (adalimumab)The reporter's causality for the event(s) of cataracts and hospitalized after receiving pfizer covid-19 vaccination was not provided. (withheld) opinion is that there is no reasonable possibility that the events of cataracts and hospitalized after receiving pfizer covid-19 vaccination are related to humira (adalimumab).  The reporter's assessment of the causal relationship of the cataracts  with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between event cataract and suspect drug 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
Sex: F
Vaccine: COVID19
Symptoms: Fear of injection, Head injury
Clinical narrative: head trauma; phobia of needles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HEAD INJURY (medically significant), outcome "unknown", described as "head trauma"; FEAR OF INJECTION (non-serious), outcome "unknown", described as "phobia of needles".  clinical course:Caller states she is calling regarding the pill that they had advertised on TV. She states that she works in (Hospital Name withheld) and she had asked them about if they have a pill out for taking the vaccine, a pill for the booster. She states that she wants to find out because she has a phobia of needles. She has a phobia that she will start flailing and screaming and running. She took the 2 shots and had to have Xanax to try and calm down, it was still not enough. She wants to know if she could probably take the pill so that she can do her third shot. Was unable to clarify the name of the pill the caller was referring to. Caller states she did not know the name of the pill. She states there is a pill for the Pfizer that she wanted to take for the booster shot. Clarified that the booster shot the caller was referring to was the Pfizer booster shot for Covid. She is really wanting to know because she would rather take pill then the shot. She states that she has had head trauma. She would rather take the pill than go to a public place and go to the store. They are telling them they have to go to (Facility name withheld) to take the shot. Caller states she does not really have anybody there or somebody to hold her down.  She wanted to know where she could go to take the pill. Caller was advised to check with her state or local health department regarding vaccine locations and to consult with her primary care provider. Caller states she will try to see her primary care doctor. She states she is really anxious to take the shot and she just wants to get this over with.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Hypoaesthesia oral, Throat tightness, Vaccination site erythema
Clinical narrative: throat felt like it was closing up; her lips started to get numb; hard to swallow; hard to breath; she got a little red dot at the injection site, in the left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jan2022 (Lot number: FJ5683) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation; diphenhydramine hydrochloride (BENADRYL), since 21Jan2022 (Batch/Lot number: unknown) at pill. Relevant medical history included: "allergy to corn" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Second dose, EW0183), administration date: 15May2021, when the patient was 60 years old, for Covid-19 immunization, reaction(s): "allergic reaction"; Bnt162b2 (First dose, LOT-EW0151), administration date: 02Apr2021, when the patient was 60 years old, for Covid-19 immunization, reaction(s): "allergic reaction". The following information was reported: THROAT TIGHTNESS (non-serious) with onset 21Jan2022, outcome "unknown", described as "throat felt like it was closing up"; HYPOAESTHESIA ORAL (non-serious) with onset 21Jan2022, outcome "unknown", described as "her lips started to get numb"; DYSPHAGIA (non-serious) with onset 21Jan2022, outcome "unknown", described as "hard to swallow"; DYSPNOEA (non-serious) with onset 21Jan2022, outcome "unknown", described as "hard to breath"; VACCINATION SITE ERYTHEMA (non-serious) with onset Jan2022, outcome "unknown", described as "she got a little red dot at the injection site, in the left arm". The event "hard to breath" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of dyspnoea.  Additional information: This report is not related to a study or programme. Other products was not provided. The patient taking Benadryl  pre treatment for vaccine. Reporter seriousness for given Benadryl 30 minutes prior to vaccine and it did not work was unspecified. On 21Jan2022 nurse there gave her a pill of the Benadryl, waited 30 minutes and it did not work. Caller states the nurse got it from the pharmacy there, states the bottle had not been opened. Lot and Expiration was unknown. Patient history was not provided. Investigation assessment not provided. It was reported hard to breathe, states they immediately wheeled her to the urgent care and was there for 2.5 hours, states she treated with a breathing treatment in urgent care, did not give her prednisone because the doctor said that would interfere with the vaccine. Her eyes are brown.  No follow-up attempts are possible. No further information is expected.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: experienced COVID-19; experienced COVID-19; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. Other Case identifier(s): 22K-163-4245431-00.  A 8 year-old male patient received PFIZER BION-TECH COVID-19 VACCINE (BNT162B2), intramuscular, administration date Dec2021 (Batch/Lot number: unknown) at the age of 8 years as dose 2 (tris), single and intramuscular, administration date 30Nov2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at cf pen for arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Dec2021, outcome "unknown", COVID-19 (medically significant) with onset Dec2021, outcome "recovered" and all described as "experienced COVID-19". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.The reporter stated that there is a possible causal relationship with the events and suspect PFIZER BION-TECH COVID-19 VACCINE (TOZINAMERAN). The reporter stated that there is no reasonable possibility of causal relationship with the events and suspect drug HUMIRA (ADALIMUMAB).   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, a possible causal relationship between reported events and suspect product BNT162B2 cannot be exlcuded
Sex: U
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Exposure via breast milk
Clinical narrative: Patient has breastfed infant since receipt of primary series, unknown if pregnant at time of receipt of first dose; tested positive for COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  An infant patient was exposed to bnt162b2 (BNT162B2), transmammary, administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single, transmammary, administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and transmammary, administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The mother of the patient was 32 year-old. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPOSURE VIA BREAST MILK (non-serious), outcome "unknown", described as "Patient has breastfed infant since receipt of primary series, unknown if pregnant at time of receipt of first dose"; EXPOSURE TO SARS-COV-2 (non-serious), outcome "unknown", described as "tested positive for COVID-19".  Additional information: Patient has breastfed infant since receipt of primary series, unknown if pregnant at time of receipt of first dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200144949 Mom case
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive COVID test; Positive COVID test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 42 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 16Dec2021 (Lot number: FL3197) at the age of 42 years as dose 3 (booster), single, intramuscular, administration date 12May2021 (Lot number: EW0176) as dose 2, single and intramuscular, administration date 21Apr2021 (Lot number: ER8731) as dose 1, single for covid-19 immunization at Workplace clinic.The patient had no relevant medical history.The patient took concomitant medications included other medications the patient received within 2 weeks of vaccination: Centrum Men's Multivitamin. Patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: Yes. The following information was reported: VACCINATION FAILURE (medically significant) with onset 25Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 25Jan2022, outcome "not recovered" and all described as "Positive COVID test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Jan2022) positive, notes: covid test name post vaccination: self test covid test type post vaccination: Nasal Swab; (25Jan2022) pending, notes: covid test name post vaccination: PCR covid test type post vaccination: Nasal Swab. It was unknown if therapeutic measures were taken as a result of covid-19.
Age: 23.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID; COVID; 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-163-4245037-00.  A 23 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 15Mar2021 (Batch/Lot number: unknown) at the age of 23 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "recovering" and all described as "COVID". The action taken for adalimumab was unknown.  The reporter considered "covid" related to bnt162b2. 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  and the administration of the vaccine cannot be excluded.