Age: 53.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pericardial effusion, SARS-CoV-2 test
Clinical narrative: Bradycardia; Pericardial effusion; Carditis; Heart disorder; COVID-19; Intentional misuse in product use duration; MARKETING PROGRAM NAME IS NOT AVAILABLE  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): 21K-163-4191087-00 (Agency).  A 53 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 29Jul2021 (Batch/Lot number: unknown) at the age of 53 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Batch/Lot number: unknown) till 2020 at 40 mg (citrate free (40 mg,1 in 2 wk)) and second regimen subcutaneous (ongoing) (Batch/Lot number: unknown) at 40 mg (citrate free (40 mg,1 in 2 wk)) for rheumatoid arthritis. The patient's relevant medical history was not reported. Concomitant medication(s) included: ENBREL, start date: 1999. The following information was reported: COVID-19 (medically significant) with onset Jul2021, outcome "recovered" (2021), described as "COVID-19"; BRADYCARDIA (medically significant), outcome "unknown", described as "Bradycardia"; PERICARDIAL EFFUSION (medically significant), outcome "unknown", described as "Pericardial effusion"; CARDITIS (medically significant), outcome "unknown", described as "Carditis"; INTENTIONAL PRODUCT MISUSE (non-serious) with onset 2020, outcome "unknown", described as "Intentional misuse in product use duration"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "Heart disorder". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jul2021) positive. The action taken for adalimumab was dosage not changed.Clinical course: Patient had pacemaker installed Nov2021, The event of "pacemaker installed on heart" was amended to "Bradicardiya". It was unknown if patient was enrolled in a COVID-19 vaccine trial. The patient stopped taking Humira during the covid 19 pandemic that started around 16 Mar 2020. She had pacemaker installed Nov2021 and she had been on Humira for years. She reported having one dose of Pfizer vaccine on 29Jul2021 and 8 days later. She got covid eight days after her covid-19 vaccine. she reported that she had fluid around her heart, inflammation of her heart, and bradycardia and that's where her pacemaker came in.   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 the vaccine, [BNT162B2], was not provided and will be requested during follow-up.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the 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.