Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Arteriovenous malformation, Atrial fibrillation, Gastrointestinal arteriovenous malformation, Vaccination site pain
Clinical narrative: sore arm  following the covid 19 vaccine; Atrial fibrillation; garteriovenous malformation in the duodenum; arteriovenous malformation in the duodenum; MARKETING PROGRAM NAME NOT AVAILABL  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-163-4387006-00.  An 81-year-old male patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Batch/Lot number: unknown), on 11Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 80 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1159098) at citrate free, subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 01, Intramuscular), administration date: 16Feb2021, when the patient was 79-year-old, for COVID-19 Immunization; BNT162b2 (Dose 02, Intramuscular), administration date: 11Mar2021, when the patient was 80-year-old, for COVID-19 Immunization. The following information was reported: ARTERIOVENOUS MALFORMATION (medically significant) with onset 29Mar2022, outcome "unknown", described as "arteriovenous malformation in the duodenum"; GASTROINTESTINAL ARTERIOVENOUS MALFORMATION (medically significant) with onset 29Mar2022, outcome "unknown", described as "garteriovenous malformation in the duodenum"; ATRIAL FIBRILLATION (medically significant) with onset Apr2022, outcome "unknown"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore arm  following the covid 19 vaccine". The action taken for adalimumab was unknown. clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira (ADALIMUMAB) and PFIZER BIONTECH COVID-19 VACCINE. The reporter's causality for the event(s) of Arteriovenous  malformation in the duo-denum, sore arm following The COVID 19 VACCINE and atrial fibrillation with Humira and Comirnaty was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Arteriovenous malformation, Gastrointestinal arteriovenous malformation and atrial fibrillation which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes 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.