Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Alopecia, Atrial fibrillation, Blood test, Hepatic enzyme abnormal, Immunisation reaction
Clinical narrative: AFib; Vaccination adverse reaction; Liver enzyme abnormal; Hair loss; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4145931-00.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 15Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 57 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Lot number: 1152962) and second regimen (Lot number: 1164825) at unk (citrate free), all subcutaneous for psoriatic arthropathy, psoriasis. The patient's relevant medical history and concomitant medications were not reported. No Known Allergies.  The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "AFib"; IMMUNISATION REACTION (non-serious), outcome "recovered", described as "Vaccination adverse reaction"; HEPATIC ENZYME ABNORMAL (non-serious), outcome "unknown", described as "Liver enzyme abnormal"; ALOPECIA (non-serious), outcome "not recovered", described as "Hair loss". The patient underwent the following laboratory tests and procedures: Blood test: Liver enzymes changed, notes: Her blood test showed change in liver enzyme from last blood test; Lipids: Enzymes are up. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of atrial fibrillation.  Clinical course: Patient with events of AFIB and non-serious covid vaccine reaction, enzymes up/liver enzymes changed and hair loss/more in crown of head with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced afib, covid vaccine reaction, enzymes up/liver enzymes changed and hair loss/more in crown of head. On an unknown date, covid vaccine reaction resolved. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. The patient was better but losing hair loss more in the crown of head significant. The patient hair loss that was not getting worse but also was not getting better. She had Atrial fibrillation and laser heart surgery but that was a benefit to her. The patient enzymes were up. Her blood test showed change in liver enzyme from last blood test. She reported mild covid vaccine reaction and still had hair loss. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of afib, covid vaccine reaction, enzymes up/liver enzymes changed and hair loss/more in crown of head was not provided. AbbVie's opinion is that the events of Afib and enzymes up/liver enzymes changed are not assessable. Abbvie's opinion is that there is no reasonable possibility that the events of covid vaccine reaction and hair loss/more in crown of head are related to Humira (Adalimumab). Causality for event AFib: Causality as per reporter (Drug/Vaccine): Not Reported; Causality as per Mfr. (Drug/Vaccine): Not accessible. Causality for event Vaccination adverse reaction: Causality as per reporter (Drug/Vaccine): Not Reported; Causality as per Mfr. (Drug/Vaccine): Not reasonable possibility. Causality for event Liver enzyme abnormal: Causality as per reporter (Drug/Vaccine): Not Reported; Causality as per Mfr. (Drug/Vaccine): Not accessible. Causality for event Hair loss: Causality as per reporter (Drug/Vaccine): Not Reported; Causality as per Mfr. (Drug/Vaccine): Not reasonable possibility. Causality for BNT162B2 (Vaccine): Causality for event AFib: Causality as per reporter (Drug/Vaccine): Not Reported. Causality for event Vaccination adverse reaction: Causality as per reporter (Drug/Vaccine): Possible. Causality for event Liver enzyme abnormal: Causality as per reporter (Drug/Vaccine): Not Reported. Causality for event Hair loss: Causality as per reporter (Drug/Vaccine): Not Reported. The reporter's assessment of the causal relationship of "afib", "vaccination adverse reaction", "liver enzyme abnormal" and "hair loss" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.