Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Joint range of motion decreased, Nervous system disorder, Paraesthesia
Clinical narrative: Rheumatoid arthritis flare up; left ring finger locking; angry nerves on feet, ankles, arms; Tingling sensation; Left ring finger buckling and had bump on it; Left ring finger buckling and had bump on it; sensation of Burning; fatigue; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer from Regulatory Authority (MFR Control No. #21K-163-4016399-00).   A 63-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 20Apr2021 (Batch/Lot number was not reported) at the age of 62-year-old as single dose for COVID-19 vaccination; Upadacitinib (RINVOQ), from an unspecified date, then from an unspecified date then from an unspecified date and ongoing, all via an unspecified route of administration (Batch/Lot number was not reported) at unspecified dose for moderate to severe rheumatoid arthritis. The patient medical history was not reported. It was unknown if she was enrolled in a COVID-19 vaccine trial. Concomitant medication included methotrexate. On unknown dates in 2021, the patient experienced left ring finger locking, angry nerves on feet, ankles, arms, tingling sensation, left ring finger buckling and had bump on it, sensation of burning and rheumatoid arthritis flare up. The patient had fatigue and left ring finger locking. The physician prescribed methotrexate to use with upadacitinib. Her left ring finger was buckling, sensation of burning and had bump on it. She had nerve issues, angry nerves as doctor described it, on feet, ankles, arms and tingling sensation. She got Covid 19 Pfizer brand and second shot she felt achy. The action taken in response to the events for upadacitinib was unknown.  Therapeutic measures were taken as a result of left ring finger locking, angry nerves on feet, ankles, arms, tingling sensation, left ring finger buckling and had bump on it, sensation of burning and fatigue. Outcome of rheumatoid arthritis flare up was not recovered, of other events was unknown.  The reporter's assessment of the causal relationship of 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.  Causality for upadacitinib: The reporter's causality for the events of left ring finger locking, felt achy with second shot of Covid-19 vaccine, angry nerves on feet, ankles, arms, tingling sensation, left ring finger buckling and had bump on it and sensation of burning was not provided. The reporter's causality for the event of rheumatoid arthritis flare up with upadacitinib was a reasonable possibility.  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 available information in the case, the causal association between the events rheumatoid arthritis, joint range of motion decreased, nervous system disorder, paraesthesia, skin disorder, trigger finger, burning sensation, fatigue and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.