Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Musculoskeletal stiffness, Rheumatoid arthritis
Clinical narrative: knuckle pain in left hand; Rheumatoid arthritis flare up; feeling bad; Limbs stiffness/left hand stiff; This is a Solicited report from a contactable consumer (patient) based on the information received by Pfizer from Regulatory Authority (Manufacturer Control No: 21K-163-4111174-00).   A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 1 and dose 2; both intramuscularly in 2021 as single dose for covid-19 immunisation; upadacitinib (RINVOQ), from an unspecified date to 2021, then from 2021 to 2021; both orally at unspecified dose for moderate to severe rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. The patient experienced rheumatoid arthritis flare up, feeling bad, and limbs stiffness in 2021, knuckle pain in left hand on an unspecified date. The case was serious per medically significant. Events details: Four months ago in Jun2021, the patient had a knuckle replacement surgery in left hand due to knuckle pain. The physician had advised her to stop upadacitinib for a week in order to evaluate how she did without upadacitinib. It was horrible after three days with her left hand stiff, but she no longer had the pain. She had a terrible feeling with rheumatoid arthritis flare ups with every single symptom after receiving the covid vaccine. She had stopped upadacitinib two days prior to the second injection. The action taken in response to the events for upadacitinib was unknown. The outcome of event knucle pain in left hand was resolved, outcome of other events was unknown.  Causality for upadacitinib: The reporter's causality for the event of knuckle pain in left hand with upadacitinib was a reasonable possibility. The reporter's causality for the events of feeling bad, limbs stiffness and rheumatoid arthritis flare up was not provided. Regulatory Authority opinion is that there is no reasonable possibility that the events of knuckle pain in left hand, feeling bad, limbs stiffness  and rheumatoid arthritis flare up are related to upadacitinib.  The reporter's assessment of the causal relationship of the events with the suspect product 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: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of knuckle pain in left hand, feeling bad, limbs stiffness  and rheumatoid arthritis flare up.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