Age: 54.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Bursitis, Osteoarthritis, Rheumatoid arthritis, Vaccination site inflammation
Clinical narrative: Bursitis; Osteoarthritis; Inflammation with COVID booster; Rheumatoid arthritis symptoms increased; 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-163-4342179-00 (Agency).  A 54 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 21Oct2021 (Batch/Lot number: unknown) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01, Route of Admin: Intramuscular), administration date: 31Mar2021, when the patient was 54 years old, for COVID-19 immunization, reaction(s): "Increase in her rheumatoid arthritis symptoms", "She probably felt things with the first two doses but just did not relate it to the vaccine"; Bnt162b2 (Dose: 02, Route of Admin: Intramuscular), administration date: 21Apr2021, when the patient was 54 years old, for COVID-19 immunization, reaction(s): "Increase in her rheumatoid arthritis symptoms", "She probably felt things with the first two doses but just did not relate it to the vaccine". The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "Rheumatoid arthritis symptoms increased"; BURSITIS (non-serious), outcome "unknown", described as "Bursitis"; VACCINATION SITE INFLAMMATION (non-serious) with onset 2021, outcome "unknown", described as "Inflammation with COVID booster"; OSTEOARTHRITIS (non-serious), outcome "recovering", described as "Osteoarthritis". The action taken for upadacitinib was unknown.  Clinical course: The patient experienced inflammation with the COVID booster and it also caused an increase in her rheumatoid arthritis symptoms which lasted for about eight weeks. She thought she probably felt things with the first two doses but just did not relate it to the vaccine. She had Osteoarthritis that affects many areas. She had been doing very well for about a week. 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 bursitis, inflammation with COVID booster, osteoarthritis and rheumatoid arthritis symptoms increased was not provided.  Causality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran): The reporter's causality for the event(s) of Bursitis and Osteoarthritis was not reported. The reporter's causality for the event(s) of inflammation with COVID booster and rheumatoid arthritis symptoms increased was Probable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case , a possible causal association between  all the reported  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