Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Rheumatoid arthritis, Vaccination site cellulitis
Clinical narrative: Rheumatoid arthritis flare up; Cold; Vaccination site cellulitis; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. Other Case identifier(s): 22K-163-4241170-00.  A 47 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Aug2021 (Batch/Lot number: unknown) at the age of 46 years as dose 1, single and intramuscular, administration date 15Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; upadacitinib (RINVOQ), first regimen oral (Batch/Lot number: unknown) till 2021 and second regimen oral since 2021 (Batch/Lot number: unknown) 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 "not recovered", described as "Rheumatoid arthritis flare up"; VACCINATION SITE CELLULITIS (non-serious) with onset Aug2021, outcome "recovering", described as "Vaccination site cellulitis"; NASOPHARYNGITIS (non-serious), outcome "not recovered", described as "Cold". The action taken for upadacitinib was unknown. In Aug2021, the patient had second dose of Covid-19 Vaccine and for which was also off of Rinvoq during that time to accommodate the vaccine. Cellulitis appeared after the second dose of Covid-19 vaccine at injection site. The reaction she had needed antibiotics after for cellulitis. She had been having flares due to weather in new area and climate. For the ongoing flares, she recently was off of steroids and was just dealing with the pain and severe cold. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Rinvoq(Upadacitinib) : The reporter's causality for the event(s) of covid second shot reaction/cellulitis at injection site, cold and rheumatoid arthritis flares with Rinvoq(Upadacitinib) was no reasonable possibility.The reporter's causality for the event(s) of covid second shot reaction/cellulitis at injection site was with bnt162b2 (BNT162B2) was possible. The reporter's assessment of the causal relationship of the events cold and rheumatoid arthritis flares with the suspect product 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 current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events rheumatoid arthritis cannot be totally 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.