Age: 62.0
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): US-ABBVIE-4177742.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 29Jul2021 as dose 1, single (Batch/Lot number: unknown) and on 19Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1168552) at 40 mg daily (40 mg, daily (40 mg/0.4 ml)), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid Arthritis Flare Up". The action taken for adalimumab was unknown.  The reporter considered "rheumatoid arthritis flare up" related to BNT162b2.  Clinical course: Solicited report by a consumer of an adult female with an event of and non-serious Rheumatoid Arthritis Flare Up with Adalimumab Solution for Injection, Single Dose Pen. There was no reported medical history. On unknown date(s), the patient experienced Rheumatoid Arthritis Flare Up. Pfizer/BioNTech Covid-19 Vaccine was also considered suspect. Causalities: The reporter's causality for the event(s) of Rheumatoid Arthritis Flare Up with Adalimumab Solution for Injection was No Reasonable Possibility. The reporter's causality for the event(s) of Rheumatoid Arthritis Flare Up with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility. Agency's opinion was that the causality for the event(s) of Rheumatoid Arthritis Flare Up with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. Agency's opinion was that the causality for the event(s) of Rheumatoid Arthritis Flare Up with Adalimumab Solution for Injection was Not Provided. Medical History: Not reported. Assessment Results: Humira 40 mg/0.4 ml:  Rheumatoid arthritis flare up, Non-Health Care Professional, Global Introspection, Not Related. Humira 40 mg/0.4 ml: Rheumatoid arthritis flare up, Agency. Assessment Results: Pfizer/BioNTech Covid-19 Vaccine: Rheumatoid arthritis flare up, Agency. Pfizer/BioNTech Covid-19 Vaccine: Rheumatoid arthritis flare up, Non-Health Care Professional, Global Introspection, Possible. Did Reaction Abate After Stopping Drug? N/A. Did Reaction Reappear After Reintroduction? N/A.  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 in the case, the causal association between the events    and the suspect drug BNT162B2 cannot be 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.