Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Rheumatoid arthritis
Clinical narrative: after third covid vaccine booster rheumatoid arthritis flare ups seem to be more frequent with Rinvoq (Upadacitinib); There was burning and pain in her joints; She was also experienced fatigue; 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-163-4377575-00 (Company).  A 65-year-old female patient received BNT162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown), oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed but unknown manufacturer.), for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "after third covid vaccine booster rheumatoid arthritis flare ups seem to be more frequent with Rinvoq (Upadacitinib)"; ARTHRALGIA (non-serious), outcome "unknown", described as "There was burning and pain in her joints"; FATIGUE (non-serious), outcome "unknown", described as "She was also experienced fatigue". The action taken for upadacitinib was unknown.  The reporter considered "after third covid vaccine booster rheumatoid arthritis flare ups seem to be more frequent with rinvoq (upadacitinib)" related to BNT162b2. The reporter's assessment of the causal relationship of "there was burning and pain in her joints" and "she was also experienced fatigue" 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.  Clinical Course: The reporter considered after third covid vaccine booster rheumatoid arthritis flare ups seem to be more frequent with rinvoq (upadacitinib)" related to BNT162b2. It was reported that the patient had issue with her joints. There was burning and pain in her joints and she was also experienced fatigue. This started after third covid vaccine booster. The flare ups seem to be more frequent since taking the booster. Her doctor was aware and calls them long term covid symptoms. The reporter's causality for the event of after third Covid vaccine booster Rheumatoid Arthritis flare ups seem to be more frequent with Rinvoq (Upadacitinib) there was no reasonable possibility. The reporter's causality for the event of after third Covid vaccine booster Rheumatoid Arthritis flare-ups seem to be more frequent with Rinvoq (Upadacitinib) was Possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided,  the causal association between the events  rheumatoid arthritis, arthralgia, fatigue and the suspect drug 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 drug 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.