Age: 57.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Atrial fibrillation; COVID-19; COVID-19; Sugar blood level increased; Psoriasis/small spot of psoriasis; MARKETING PROGRAM NAME NOT APPLICABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4474267-00 (Agency).  A 58-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 12May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 57 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Lot number: 1163898), subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (hospitalization, medically significant) with onset Dec2021, outcome "recovering"; DRUG INEFFECTIVE (hospitalization, medically significant), SUSPECTED COVID-19 (hospitalization, medically significant) all with onset Dec2021, outcome "recovering" and all described as "COVID-19"; BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "Sugar blood level increased"; PSORIASIS (non-serious), outcome "recovering", described as "Psoriasis/small spot of psoriasis". The patient underwent the following laboratory tests and procedures: Blood glucose: HIgh-385, notes: Relevant Laboratory & Other Diagnostic Tests: Unknown date SUGAR LEVEL: High-385 no unit; SARS-CoV-2 test: Unknown results.  The action taken for adalimumab was dosage not changed. Clinical course: On unknown dates, the patient experienced HUMIRA was not working for first three months and then it started to work, high sugar level and small spot of psoriasis. In Dec2021, the patient experienced contracted covid and atrial fibrillation. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. Patient reported HUMIRA was not working for first three months and then it started to work. He had small spot. In Dec2022, patient contracted covid which caused atrial fibrillation. He had high sugar of 385. He was admitted twice into hospital due to covid. Also had similar reaction with the second Covid vaccination.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira: The reporter's causality for the event(s) of contracted covid, atrial fibrillation, humira was not working for first three months and then it started to work, high sugar level and small spot of psoriasis was not provided. (institute name withheld) opinion is that there is no reasonable possibility that the events of contracted covid, atrial  fibrillation, humira was not working for first three months and then it started to work, high sugar level and  small spot of psoriasis are related to HUMIRA(ADALIMUMAB). Causality as per reporter between Covid-19, Atrial fibrillation and Suspect vaccine was Possible. Causality as per reporter of Sugar blood level increased and Psoriasis with respect to Suspect vaccine was not reported.   The reporter's assessment of the causal relationship of "atrial fibrillation", "sugar blood level increased" and "psoriasis/small spot of psoriasis" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "covid-19" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally 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.