chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis, Pericarditis
Clinical narrative: A 14 year old and An 18 year old were hospitalized for myocarditis/pericarditis; A 14 year old and An 18 year old were hospitalized for myocarditis/pericarditis; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  An 18-year-old 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: PERICARDITIS (hospitalization, medically significant), MYOCARDITIS (hospitalization, medically significant), outcome "recovered" and all described as "A 14 year old and An 18 year old were hospitalized for myocarditis/pericarditis".  Additional information: Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Pneumonia, Suspected COVID-19
Clinical narrative: stayed in the hospital over a month with Covid; stayed in the hospital over a month with Covid; started on with pneumonia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A 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: Covid-19 vaccine (Primary series of immunization completed, Manufacturer name unknown), for COVID-19 immunization. The following information was reported: SUSPECTED COVID-19 (hospitalization, medically significant), DRUG INEFFECTIVE (hospitalization, medically significant), outcome "unknown" and all described as "stayed in the hospital over a month with Covid"; PNEUMONIA (medically significant), outcome "unknown", described as "started on with pneumonia". Therapeutic measures were taken as a result of suspected covid-19, drug ineffective.  Clinical course: When caller was reporting about her own experience with the Pfizer Covid vaccine booster, she mentions that  her cousin had all three and she knows it don't keep you from getting the virus. She knows it is supposed to keep from going in the hospital but her cousin stayed in the hospital over a month with Covid and had to go home on oxygen. She states they can't tell her the vaccines are perfect. she does not have any further details to provide regarding her cousin's experience. She states he started on with pneumonia, that is all she knows. He just had his booster shot too. No further details were provided. description of product complaint: got all three vaccines and got the Covid.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Type 2 diabetes mellitus
Clinical narrative: Diabetes type 2 after receiving my second dose of Covid vaccine; This is a spontaneous report received from a contactable Consumer (patient) for a Pfizer sponsored program.   A patient (no qualifiers provided) received 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: COVID-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: TYPE 2 DIABETES MELLITUS (medically significant), outcome "unknown", described as "Diabetes type 2 after receiving my second dose of Covid vaccine".  The Lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. A male patient received bnt162b2 (BNT162B2) (Lot number: FA6780) as dose number unknown (booster), single for Covid-19 immunisation; Covid-19 vaccine (COVID-19 VACCINE) (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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Had Covid after receiving the Covid-19 vaccine". Clinical Course: Her husband's brother and his wife also got Covid after being boosted. No further details, she doesn't know if they would want to report. Declines to complete a report for her husband's brother and his wife. Follow-up (28Mar2022): Follow-up attempts are completed. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202200469651 same reporter/drug/AE, different patient.
Sex: M
Vaccine: COVID19
Symptoms: Bradycardia, Dizziness, Renal surgery, Syncope
Clinical narrative: severe bradycardia; continual syncope; constant dizziness; kidney surgery; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient. A 68-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: Covid-19 vaccine (Manufacturer: Unknown, Dose Number: 1), for COVID-19 immunization. Clinical course: since 2 days after receiving his second Covid vaccine, the patient experienced continual syncope events and constant dizziness from then on. The patient had kidney surgery the end of Dec (as reported) and a pacemaker installed two weeks before the report to correct a severe bradycardia (heart would stop often up to 7 seconds. The patient was in excellent health before and he ran a 10K every day. It was obvious the vaccine was the cause The following information was reported: BRADYCARDIA (medically significant), outcome "unknown", described as "severe bradycardia"; SYNCOPE (medically significant), outcome "unknown", described as "continual syncope"; RENAL SURGERY (medically significant) with onset Dec2021, outcome "unknown", described as "kidney surgery"; DIZZINESS (non-serious), outcome "unknown", described as "constant dizziness". Therapeutic measures were taken as a result of bradycardia, renal surgery. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Autoimmune hepatitis, Hepatic enzyme, Hepatic enzyme increased, Laboratory test
Clinical narrative: Autoimmune Hepatitis; severe abdominal pain; liver enzymes were very high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for Covid-19 immunisation. The following information was reported: AUTOIMMUNE HEPATITIS (medically significant), outcome "unknown", described as "Autoimmune Hepatitis"; ABDOMINAL PAIN (non-serious), outcome "unknown", described as "severe abdominal pain"; HEPATIC ENZYME INCREASED (non-serious), outcome "unknown", described as "liver enzymes were very high". Patient had taken the first two Covid vaccines, and had since contracted Autoimmune Hepatitis, clearly triggered by the vaccines. Patient's liver enzymes were great just one month prior to the vaccines in a regular annual check-up. Then patient developed severe abdominal pain, and when finally tested again, the liver enzymes were very high. Further tests revealed Autoimmune hepatitis (AIH). Patient will live with this the rest of his/ her now-shortened life, wanted to know if there are any suggestions. The patient underwent the following laboratory tests and procedures: hepatic enzyme: great just one month prior to vaccines; ver high; laboratory test: aih. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Investigation, Pain in extremity
Clinical narrative: severe shortness of breath; postural tachycardia; dizziness; chronic fatigue; pins and needles in my feet; left leg calf pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 28-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 (Lot number: EN6205) at the age of 28 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies: almonds" (unspecified if ongoing); "Allergies: cashews" (unspecified if ongoing). Concomitant medication(s) included: LAMICTAL; WELLBUTRIN; LUVOX [FLUVOXAMINE MALEATE]; TRAZODONE; SINGULAIR. Past drug history included: Amoxicillin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6207, Location of injection: Arm Left), administration date: 01Mar2021, when the patient was 28 years old, for covid- 19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Four months after vaccination (12Jul2021), the patient developed severe shortness of breath, postural tachycardia, dizziness, chronic fatigue, pins and needles in feet, and left leg calf pain. Full cardiac and neurological workup could not find definitive cause. Symptoms continued and the patient was currently on disability. The following information was reported: DYSPNOEA (disability) with onset 12Jul2021, outcome "not recovered", described as "severe shortness of breath"; TACHYCARDIA (disability) with onset 12Jul2021, outcome "not recovered", described as "postural tachycardia"; DIZZINESS (disability) with onset 12Jul2021, outcome "not recovered", described as "dizziness"; FATIGUE (disability) with onset 12Jul2021, outcome "not recovered", described as "chronic fatigue"; PARAESTHESIA (disability) with onset 12Jul2021, outcome "not recovered", described as "pins and needles in my feet"; PAIN IN EXTREMITY (disability) with onset 12Jul2021, outcome "not recovered", described as "left leg calf pain". The adverse events resulted in emergency room/department or urgent care. The patient underwent the following laboratory tests and procedures: investigation: (unspecified date) could not find definitive cause; sars-cov-2 test: (Jul2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of dyspnoea, tachycardia, dizziness, fatigue, paraesthesia, pain in extremity. Since the vaccination, the patient has been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test, Tachycardia
Clinical narrative: severe shortness of breath; postural tachycardia; dizziness; chronic fatigue; pins and needles in my feet; left leg calf pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 28-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 (Lot number: EN6205) at the age of 28 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies: almonds" (unspecified if ongoing); "Allergies: cashews" (unspecified if ongoing). Concomitant medication(s) included: LAMICTAL; WELLBUTRIN; LUVOX [FLUVOXAMINE MALEATE]; TRAZODONE; SINGULAIR. Past drug history included: Amoxicillin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6207, Location of injection: Arm Left), administration date: 01Mar2021, when the patient was 28 years old, for covid- 19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Four months after vaccination (12Jul2021), the patient developed severe shortness of breath, postural tachycardia, dizziness, chronic fatigue, pins and needles in feet, and left leg calf pain. Full cardiac and neurological workup could not find definitive cause. Symptoms continued and the patient was currently on disability. The following information was reported: DYSPNOEA (disability) with onset 12Jul2021, outcome "not recovered", described as "severe shortness of breath"; TACHYCARDIA (disability) with onset 12Jul2021, outcome "not recovered", described as "postural tachycardia"; DIZZINESS (disability) with onset 12Jul2021, outcome "not recovered", described as "dizziness"; FATIGUE (disability) with onset 12Jul2021, outcome "not recovered", described as "chronic fatigue"; PARAESTHESIA (disability) with onset 12Jul2021, outcome "not recovered", described as "pins and needles in my feet"; PAIN IN EXTREMITY (disability) with onset 12Jul2021, outcome "not recovered", described as "left leg calf pain". The adverse events resulted in emergency room/department or urgent care. The patient underwent the following laboratory tests and procedures: investigation: (unspecified date) could not find definitive cause; sars-cov-2 test: (Jul2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of dyspnoea, tachycardia, dizziness, fatigue, paraesthesia, pain in extremity. Since the vaccination, the patient has been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Paraesthesia
Clinical narrative: full arm pins and needles every day; got the shot almost a year later; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 56-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Feb2022 administration time AM (Lot number: FK9895) as dose 2, single for COVID-19 immunisation. Vaccine was not administered at military facility. Relevant medical history included: "thyroid hypo", start date: 1991 (ongoing). Concomitant medication included: SYNTHROID taken for hypothyroidism, start date: 1991 (ongoing). Vaccination history included: BNT162b2 (dose 1, single, administration time AM, right upper arm, intramuscular, lot no: ER8371), administration date: 18Apr2021, for COVID-19 immunisation, reactions: "that I had nerve damage", "pins and needles from my shoulder 2 finger tip". The patient did not receive prior vaccinations within 4 weeks. The following information was reported: PARAESTHESIA (disability, medically significant), outcome "not recovered", described as "full arm pins and needles every day"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 03Feb2022, outcome "unknown", described as "got the shot almost a year later". The event "full arm pins and needles every day" was evaluated at the physician office visit. The patient did not undergo any relevant tests.  Clinical course: Patient only got the shot (almost a year later) because she had to. She would lose her job if she did not. Her doctor said she did not qualify for a medical exemption. While the second dose did not make it worse. She still had full arm pins and needles every day. Frequency and intensity change but she never skipped a day.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200175812 same reporter/patient/drug/different dose/event
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Sharp Stabbing pain in neck and arm; Sharp Stabbing pain in neck and arm; This is a spontaneous report received from contactable reporter (Pharmacist).  A 34-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Mar2022 (Batch/Lot number: unknown) at the age of 33 years as dose 3 (booster), 0.3 ml single for COVID-19 immunisation. Vaccination facility type was reported as pharmacy. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, single, lot FA7484 , expiration Sep2021, Intramuscular injection in left arm), administration date: 06Aug2021, when the patient was 34 years old, for COVID-19 Immunization, reaction: "She was fine with the first two doses"; BNT162b2 (dose 2, single, lot FF2588 , expiration Dec2021, intramuscular injection in left arm), administration date: 27Aug2021, when the patient was 34 years old, for COVID-19 immunization, reaction: "She was fine with the first two doses". The pharmacist said that first two doses were the ones that had to be reconstituted. The patient did not experience adverse event following previous vaccinations. It was unknown if patient received prior vaccinations within four weeks prior to the first administration date of the suspect vaccine. The following information was reported: NECK PAIN (medically significant), PAIN IN EXTREMITY (medically significant) all with onset 13Mar2022, outcome "not recovered" and all described as "Sharp Stabbing pain in neck and arm". The patient did not undergo relevant tests.  Clinical course: Patient told her that this was debilitating.  She was a law official and had to move constantly. Every time she had to use her arm, she could feel the pain. Sharp stabbing neck and arm pain unknown time. She just said it happened after she got it and she did not specify if same day or next day (as reported). Patient will probably go to the doctor. At the time of this report the event did not result in emergency room or physician office visit.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Considering the plausible drug-event temporal association, there is a reasonable possibility that reported events were related to BNT162B2 vaccine administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, Exposure to SARS-CoV-2, Headache
Clinical narrative: Unclear exposure then fevers 102; Unclear exposure then fevers 102; Myalgia; HA moderate symptoms; Test: Home Ag, Result: Positive; Test: Home Ag, Result: Positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 28 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 25Mar2022, outcome "unknown", COVID-19 (medically significant) with onset 25Mar2022, outcome "not recovered" and all described as "Test: Home Ag, Result: Positive"; EXPOSURE TO SARS-COV-2 (non-serious), PYREXIA (non-serious) all with onset 25Mar2022 02:00, outcome "not recovered" and all described as "Unclear exposure then fevers 102"; MYALGIA (non-serious) with onset 25Mar2022 02:00, outcome "not recovered", described as "Myalgia"; HEADACHE (non-serious) with onset 25Mar2022 02:00, outcome "not recovered", described as "HA moderate symptoms". The patient underwent the following laboratory tests and procedures: body temperature: (25Mar2022) 102; sars-cov-2 test: (25Mar2022) positive, notes: Covid test type post vaccination=Unknown. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19, exposure to sars-cov-2, pyrexia, myalgia, headache. Reporter assessed the case as non-serious. There was no covid prior to vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events  drug ineffective and covid-19 cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Unclear exposure then fevers 102; Unclear exposure then fevers 102; Myalgia; HA moderate symptoms; Test: Home Ag, Result: Positive; Test: Home Ag, Result: Positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 28 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 25Mar2022, outcome "unknown", COVID-19 (medically significant) with onset 25Mar2022, outcome "not recovered" and all described as "Test: Home Ag, Result: Positive"; EXPOSURE TO SARS-COV-2 (non-serious), PYREXIA (non-serious) all with onset 25Mar2022 02:00, outcome "not recovered" and all described as "Unclear exposure then fevers 102"; MYALGIA (non-serious) with onset 25Mar2022 02:00, outcome "not recovered", described as "Myalgia"; HEADACHE (non-serious) with onset 25Mar2022 02:00, outcome "not recovered", described as "HA moderate symptoms". The patient underwent the following laboratory tests and procedures: body temperature: (25Mar2022) 102; sars-cov-2 test: (25Mar2022) positive, notes: Covid test type post vaccination=Unknown. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19, exposure to sars-cov-2, pyrexia, myalgia, headache. Reporter assessed the case as non-serious. There was no covid prior to vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events  drug ineffective and covid-19 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Rash
Clinical narrative: Affects her mother's ability to sleep; She developed rashes on the wrists around her body, then her ankle, then her back/had it all over her body at various times; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program.  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer"), for Covid-19 immunization. The following information was reported: RASH (non-serious) with onset 2021, outcome "not recovered", described as "She developed rashes on the wrists around her body, then her ankle, then her back/had it all over her body at various times"; INSOMNIA (non-serious), outcome "unknown", described as "Affects her mother's ability to sleep". Therapeutic measures were taken as a result of rash.  Additional information: Pt received booster dose of the Pfizer-BioNTech Covid vaccine on Oct2021 and a week after, she developed rashes on the wrists around her body, then her ankle, then her back. Reporter mentioned those are just examples and that her mother had it all over her body at various times. Reporter states she never noticed where and when it started. She added that this affects her mother's ability to sleep. Patient had also tried antihistamine but that work and was also prescribed prednisone 3 days ago where she had some relief but was also told it could come back. Reporter wanted to know if there are any reports like this after taking the booster dose and if there are any recommendations from Pfizer. Reporter said she can understand rash is a side effect but generally everything, but the rash was either or localized to site of injection but she haven't seen anything the type of rash her mom has. Reporter wanted to know If something hasn't published yet. if there are other incidents, hopefully there will be more information or not and reporter don't know if its related to the vaccine but because of the timing it seems to be helping for now.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Colitis ulcerative, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Colitis ulcerative aggravated; COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4331384-00.  A 41 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 23Nov2021 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single, intramuscular, administration date 20Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 30Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "COVID-19"; COLITIS ULCERATIVE (medically significant), outcome "not recovered", described as "Colitis ulcerative aggravated". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive. The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira (adalimumab): The reporter causality for the event(s) of Ulcerative Colitis Flare Up and Covid was not provided. Causality: 1) Colitis ulcerative aggravated (Colitis ulcerative): Causality as per reporter (Drug/Vaccine): Not reported, 2) COVID-19 (COVID-19): Causality as per reporter (Drug/Vaccine): Not reported. Causality: 1) Colitis ulcerative aggravated (Colitis ulcerative): Causality as per reporter (Drug/Vaccine): Probable, 2) COVID-19 (COVID-19): Causality as per reporter (Drug/Vaccine): Probable.  The reporter considered "covid-19" and "colitis ulcerative aggravated" related to bnt162b2.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the Limited information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event. The case will be reassessed once new information is available
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: I don't have my menstrual period; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient (not pregnant) 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: Covid-19 vaccine (Dose Number: 2, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose Number: 1, Manufacturer: Unknown), for Covid-19 Immunization. The following information was reported: MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "I don't have my menstrual period".  Additional Information: Forwarded as an Adverse Event by the team on 28Mar2022 Reporter provided verification of contact address on 26Mar2022.Patient reported that she received her three doses of covid 19. After her third dose she did not have her menstrual period. And she was not pregnant. Her daughter received the third dose and she has the same problem and she was not sexual active. She was not pregnant she was virgin.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 59.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Pneumonia, Suspected COVID-19
Clinical narrative: COVID-19; Suspected COVID-19; Pneumonia; 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-163-4330897-00.  A 59 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 59 years as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID-19"; SUSPECTED COVID-19 (medically significant), outcome "recovering", described as "Suspected COVID-19"; PNEUMONIA (medically significant), outcome "recovering", described as "Pneumonia". The action taken for adalimumab was unknown.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of pneumonia and COVID with Humira (Adalimumab) was no reasonable possibility.  The reporter's assessment of the causal relationship of the DRUG INEFFECTIVE, Suspected COVID-19, PNEUMONIA 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 available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of Suspected COVID-19, Drug ineffective and Pneumonia 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: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chest pain, Fatigue, Joint warmth, Pain, Psoriatic arthropathy
Clinical narrative: psoriatic arthritis flare up; right ankles hot; chest throbbing; humira wore off three or four days; Achy; fatigued; MARKETING PROGRAM NAME NOT AVAILIBLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4334407-00.  A 48 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Mar2021 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single, intramuscular, administration date 20Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) at unk (citrate free) for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "not recovered", described as "psoriatic arthritis flare up"; JOINT WARMTH (non-serious), outcome "not recovered", described as "right ankles hot"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigued"; CHEST PAIN (non-serious), outcome "not recovered", described as "chest throbbing"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Achy"; THERAPEUTIC RESPONSE SHORTENED (non-serious), outcome "not recovered", described as "humira wore off three or four days". The action taken for adalimumab was dosage not changed.  Additional information- It was reported that the reporter's causality for the events of right ankles hot, fatigued, psoriatic arthritis flare up, chest throbbing and HUMIRA wore off three or four days before next HUMIRA injection with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the events of fatigued and achy with HUMIRA (ADALIMUMAB) was no reasonable possibility.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Therapeutic response shortened
Clinical narrative: psoriatic arthritis flare up; right ankles hot; chest throbbing; humira wore off three or four days; Achy; fatigued; MARKETING PROGRAM NAME NOT AVAILIBLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4334407-00.  A 48 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Mar2021 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single, intramuscular, administration date 20Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) at unk (citrate free) for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "not recovered", described as "psoriatic arthritis flare up"; JOINT WARMTH (non-serious), outcome "not recovered", described as "right ankles hot"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigued"; CHEST PAIN (non-serious), outcome "not recovered", described as "chest throbbing"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Achy"; THERAPEUTIC RESPONSE SHORTENED (non-serious), outcome "not recovered", described as "humira wore off three or four days". The action taken for adalimumab was dosage not changed.  Additional information- It was reported that the reporter's causality for the events of right ankles hot, fatigued, psoriatic arthritis flare up, chest throbbing and HUMIRA wore off three or four days before next HUMIRA injection with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the events of fatigued and achy with HUMIRA (ADALIMUMAB) was no reasonable possibility.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Actinic keratosis, SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: actinic keratosis removed from head back; tested positive for COVID-19; tested positive for COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4336958-00.  A 68 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) (at the age of 68 years), as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1155990) at unk (citrate free) for psoriasis. Relevant medical history included: "Actinic keratosis removed form head back" (ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset Feb2022, outcome "unknown", SARS-COV-2 TEST POSITIVE (medically significant) with onset Feb2022, outcome "recovered" (2022) and all described as "tested positive for COVID-19"; ACTINIC KERATOSIS (medically significant), outcome "not recovered", described as "actinic keratosis removed from head back". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Feb2022) positive. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of actinic keratosis.  The reporter's causality for the event Actinic keratosis with Comirnaty and COVID-19 virus test positive was not reported. The reporter's causality for the event of actinic keratosis removed form head back with Humira(Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of tested positive for covid-19 was not provided. Agency's opinion is that there was no reasonable possibility that the events of actinic keratosis removed form head back and tested positive for covid-19 are related to Humira(Adalimumab).   Clinical Course: It was reported that the patient was tested positive for covid-19. In Mar2022, he had actinic keratosis removed form head back and had some more in march. He was not sure if this was related to Humira or not. He had these removed over the years before starting Humira. It was unknown if patient was enrolled in a covid-19 vaccine trial.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Drug interaction, Pain, Rheumatoid arthritis, Swelling
Clinical narrative: Rheumatoid arthritis flare up; had worse rheumatoid arthritis flare up and lack of effect with Rinvoq (Upadacitinib).; Lack of drug effect; having swelling and pain, flare ups.; having swelling and pain, flare ups.; 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-163-4336601-00 (Agency).  A 33 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up"; DRUG INTERACTION (non-serious), outcome "unknown", described as "had worse rheumatoid arthritis flare up and lack of effect with Rinvoq (Upadacitinib)."; THERAPEUTIC PRODUCT EFFECT DELAYED (non-serious), outcome "unknown", described as "Lack of drug effect"; SWELLING (non-serious), PAIN (non-serious), outcome "unknown" and all described as "having swelling and pain, flare ups.". The action taken for upadacitinib was dosage permanently withdrawn.  The reporter considered "rheumatoid arthritis flare up" related to bnt162b2.  Clinical course: The patient stopped Rinvoq because he was having swelling and pain, flare ups. Around the COVID-19 vaccinations, he was having worse flare ups.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic product effect delayed
Clinical narrative: Rheumatoid arthritis flare up; had worse rheumatoid arthritis flare up and lack of effect with Rinvoq (Upadacitinib).; Lack of drug effect; having swelling and pain, flare ups.; having swelling and pain, flare ups.; 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-163-4336601-00 (Agency).  A 33 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up"; DRUG INTERACTION (non-serious), outcome "unknown", described as "had worse rheumatoid arthritis flare up and lack of effect with Rinvoq (Upadacitinib)."; THERAPEUTIC PRODUCT EFFECT DELAYED (non-serious), outcome "unknown", described as "Lack of drug effect"; SWELLING (non-serious), PAIN (non-serious), outcome "unknown" and all described as "having swelling and pain, flare ups.". The action taken for upadacitinib was dosage permanently withdrawn.  The reporter considered "rheumatoid arthritis flare up" related to bnt162b2.  Clinical course: The patient stopped Rinvoq because he was having swelling and pain, flare ups. Around the COVID-19 vaccinations, he was having worse flare ups.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.