Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; felt like she was having a heart attack and the pain persisted for one week; 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-163-4496759-00.  A 69-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (hospitalization) with onset 28Jun2022, outcome "recovered" (2022), described as "Rheumatoid arthritis flare up"; MYOCARDIAL INFARCTION (medically significant) with onset 28Jun2022, outcome "unknown", described as "felt like she was having a heart attack and the pain persisted for one week". The patient was hospitalized for rheumatoid arthritis (start date: 28Jun2022). The action taken for adalimumab was dosage not changed. Clinical course: On 28Jun2022, the patient experienced terrible rheumatoid arthritis flare in right shoulder going down the right arm with Humira (ADALIMUMAB). In 2022, the terrible rheumatoid arthritis flare in right shoulder going down the right arm resolved. Pfizer BioNTech covid-19 vaccine was also considered suspect. In 28Jun2022, the patient had terrible rheumatoid arthritis flare in right shoulder going down the right arm and had to go to hospital. She felt like she was having a heart attack and the pain persisted for one week. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event of "terrible rheumatoid arthritis flare in right shoulder going down the right arm" with Humira (ADALIMUMAB) was no reasonable possibility (also reported as 'not related'). The company's opinion is that there is no reasonable possibility that the event of "terrible rheumatoid arthritis flare in right shoulder going down the right arm" is related to Humira (ADALIMUMAB). The reporter's causality for the event "terrible rheumatoid arthritis flare in right shoulder going down the right arm" with Pfizer BioNTech covid-19 vaccine was possible.  The reporter considered "rheumatoid arthritis flare up" related to BNT162b2. The reporter's assessment of the causal relationship of "felt like she was having a heart attack and the pain persisted for one week" 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: 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.