Age: 68.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis, Vaccination complication
Clinical narrative: Rheumatoid Arthritis Flare Affecting Right Knee and Right Leg and Bilateral Hips; Received Covid Vaccine and Having Some Issues; 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): 22K-163-4235285-00 (AbbVie).  A 68 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 13Dec2021 (Batch/Lot number: unknown) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Humira for Rheumatoid Arthritis. Vaccination history included: Bnt162b2 (Dose 1, Single, Route of Admin: Intramuscular), administration date: 05Apr2021, when the patient was 67 years old, for covid-19 immunization; Bnt162b2 (Dose 2, Single, Route of Admin: Intramuscular), administration date: 26Apr2021, when the patient was 67 years old, for COVID-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid Arthritis Flare Affecting Right Knee and Right Leg and Bilateral Hips"; VACCINATION COMPLICATION (medically significant) with onset Dec2021, outcome "not recovered", described as "Received Covid Vaccine and Having Some Issues". The action taken for adalimumab was unknown. It was reported that on an unknown date, the patient experienced Rheumatoid Arthritis Flare Affecting Right Knee and Right Leg and Bilateral Hips. In Dec2021, the patient experienced Received Covid Vaccine and Having Some Issues. Pfizer Biontech Covid-19 Vaccine (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter considered "received covid vaccine and having some issues" related to bnt162b2.  Causality for Pfizer Biontech Covid-19 Vaccine (TOZINAMERAN): The reporter's causality for the event(s) of Rheumatoid Arthritis Flare Affecting Right Knee and Right Leg and Bilateral Hips was not reported and for event received Covid Vaccine and Having Some Issues was reported as possible.  Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of Rheumatoid Arthritis Flare Affecting Right Knee and Right Leg and Bilateral Hips and Received Covid Vaccine and Having Some Issues 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 known safety profile and Limited information in the case report a casual association between the events Rheumatoid arthritis, vaccination complication  with 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