Age: 69.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Feeling abnormal, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis symptoms worsening; felt rotten before that and felt more rotten; This is a report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4375778-00.  A 69-year-old female patient received BNT162b2 (BNT162B2), in Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years intramuscular for covid-19 immunization; upadacitinib (RINVOQ), (Batch/Lot number: unknown), oral for rheumatoid arthritis. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE, start date: 14Jul2022; METHOTREXATE. Vaccination history included: BNT162b2 (Dose 3 (BOOSTER), SINGLE, Route of Admin : Intramuscular), administration date: 23Aug2021, when the patient was 68-year-old, for Covid-19 immunization, reaction(s): "the patient experienced pain", "Feels bad", "Exhaustion"; BNT162b2 (Dose 2, SINGLE, Route of Admin : Intramuscular), administration date: 26Mar2021, when the patient was 68-year-old, for Covid-19 immunization; BNT162b2 (Dose 1, SINGLE, Route of Admin : Intramuscular), administration date: 26Feb2021, when the patient was 68-year-old, for Covid-19 immunization, reaction(s): "Vaccination site pain", "arm sore after first covid shot". The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2022, outcome "unknown", described as "Rheumatoid arthritis symptoms worsening"; FEELING ABNORMAL (non-serious) with onset 2022, outcome "not recovered", described as "felt rotten before that and felt more rotten". The action taken for upadacitinib was unknown.  The reporter considered "rheumatoid arthritis symptoms worsening" and "felt rotten before that and felt more rotten" related to BNT162b2.  Causality for RINVOQ (upadacitinib): The reporter's causality for the event(s) of felt bad/more rotten not sure if rinvoq working and rheumatoid arthritis symptoms worsening was not provided.   Clinical course: She had covid 19 vaccination booster number two in 23Aug2021 and Apr2022 of Pfizer manufacturer. In 2022, the patient experienced felt bad/more rotten. She started physical therapy about two weeks ago, felt rotten before that and felt more rotten. The cut down to 11 milligram of prednisone and lessened that dose and she took 50 milligram dose and also took methotrexate injections. She was unsure if medication Rinvoq was not working or if her condition was worsening, physician did not know what to do and was using methotrexate with it. It was unknown if patient was enrolled in a Covid-19 vaccine Trial.   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 information provided in the narrative , a possible contributory role of the suspect vaccine  to reported event s of Rheumatoid arthritis and fleeing abnormal 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.