Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; 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-163-4428047-00 (Company).  A 24-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen since 04Oct2021 (Batch/Lot number: unknown) at weekly (unk, weekly (cf (1 in 1 wk))) and second regimen since Mar2022 (ongoing) (Batch/Lot number: unknown) at weekly (unk, weekly (citrate free (1 in 1 wk))), all subcutaneous for rheumatoid arthritis. The patient's relevant medical history was not reported. Concomitant medication(s) included: METHOTREXATE, stop date: Mar2022. Concomitant drugs and dates of administration (excluding those used to treat event) included METHOTREXATE from an unspecified date to Mar2022.  The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "Rheumatoid arthritis flare up". The action taken for adalimumab was dosage not changed. An adult female with an event of non-serious rheumatoid arthritis flare up here and there/after took PFIZER vaccine each time had rheumatoid arthritis flare with HUMIRA (ADALIMUMAB). On an unknown date, the patient experienced rheumatoid arthritis flare up here and there/after took PFIZER vaccine each time had rheumatoid arthritis flare on an unknown date, RHEUMATOID ARTHRITIS flare up here and there/after took PFIZER vaccine each time had rheumatoid arthritis flare resolved. PFIZER BIONTECH COVID-19 VACCINE (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA (ADALIMUMAB) was The reporter's causality for the event (s) of Rheumatoid Arthritis Flare up Here and Thereafter Took Pfizer Vaccine Each Time Had Rheumatoid Arthritis Flare with HUMIRA (ADALIMUMAB) was no reasonable possibility. Patient took HUMIRA (Solution for injection in pre-filled pen) (ADALIMUMAB) at a daily dose of citrate free daily/weekly via subcutaneous route of administration for moderate to severe rheumatoid arthritis from 04Oct2021 to 2022 (Mar2022 to ongoing). Whether event abate after stopping drug was NA. For PFIZER BIONTECH COVID-19 mRNA VACCINE (TOZINAMERAN) the causality details included for the event rheumatoid arthritis flare up (Rheumatoid arthritis) with action taken with drug was dose not changed and causality as per reporter between (Drug/Vaccine) was not related with dechallenge being NA. Rheumatoid arthritis flare up (Rheumatoid arthritis) with actions taken with drug was unknown and causality as per reporter between (Drug/Vaccine) was possible and dechallenge was NA.   The reporter's assessment of the causal relationship of "rheumatoid arthritis flare up" 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.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event "rheumatoid arthritis" and 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.