Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Rheumatoid arthritis, Vaccination site inflammation, Vaccination site pain
Clinical narrative: Rheumatoid arthritis flare up; Sacroiliac joints inflammation; Pain after pfizer covid-19 vaccine; Inflamation after pfizer covid-19 vaccine; This is a solicited report based on the information received by Pfizer from Regulatory Authority (MFR Control No. 21K-163-4114790-00) from the marketing program facilitated collect received from a contactable consumer (patient).  A 47-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular on 06Aug2021 (Batch/Lot number was not reported) age at vaccination of 47-years-old, as single dose, dose 2 intramuscular on 27Aug2021 (Batch/Lot number was not reported) at vaccination of 47-years-old, as single dose, for covid-19 immunisation; upadacitinib (RINVOQ), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for rheumatoid arthritis.  The patient medical history and concomitant medications were not reported.   On unknown dates in 2021 (after pfizer covid-19 vaccine), the patient experienced non-serious sacroiliac joints inflammation, rheumatoid arthritis flare up, vaccination site pain and vaccination site inflammation. The patient was experienced inflammation in her sacroiliac joints every now and then. She had a flare up when she stopped to get the covid-19 vaccine with pain and inflammation. She received a steroid shot on her elbow and two week later in her shoulder. It was unknown if patient was enrolled in a covid-19 vaccine trial.  On an unknown date, rheumatoid arthritis flare up resolved, outcome of the event Joint inflammation was resolving while outcome of the events vaccination site pain and vaccination site inflammation was unknown.  Causality for Rinvoq (upadacitinib): The reporter's causality for the events of sacroiliac joints inflammation and rheumatoid arthritis flare up with Rinvoq (upadacitinib) was no reasonable possibility. The reporter's causality for the events of vaccination site pain and vaccination site inflammation with Rinvoq (upadacitinib) was not provided.  The reporter's assessment of the causal relationship of all the events with the 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.  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 event (sacroiliac joints inflammation, rheumatoid arthritis flare up, vaccination site pain and vaccination site inflammation and the 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."