Age: 66.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Myalgia, Pain in extremity, Rheumatoid arthritis
Clinical narrative: Flare of rheumatoid arthritis in hands and elbows; Muscle pain/muscle hurted in arm; Hand pain; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer from company manufacture number (21K-163-4140354-00).   A 67-year-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular on Mar2021 (Batch/Lot number was not reported) as dose 1, single, dose 2 intramuscular on Mar2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation, age at vaccination was 66 years; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date at Citrate Free for moderate to severe rheumatoid arthritis.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced flare of rheumatoid arthritis in hands and elbows, muscle pain/muscle hurted in arm, hand pain. Clinical course: Solicited report by a consumer of an elderly male with events of non-serious Muscle pain/muscle hurted in arms, flare of rheumatoid arthritis in hands and elbows and hand pain with HUMIRA (ADALIMUMAB). There was no reported medical history. On unknown dates, the patient experienced Muscle pain/muscle hurted in arms, flare of rheumatoid arthritis in hands and elbows and hand pain. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In Mar2021, he received first dose COVID-19 Vaccine manufactured by Pfizer. In Mar2021, Received second dose COVID-19 Vaccine manufactured by Pfizer. Causality for HUMIRA (adalimumab) The reporter's causality for the events of Muscle pain/muscle hurted in arms with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of flare of rheumatoid arthritis in hands and elbows and hand pain was not provided. The action taken in response to the events for adalimumab was unknown. The outcome of event rheumatoid arthritis in hands and elbows was not recovered, of other events was unknown. Causality between Pfizer Biontech Covid-19 Vaccine (Tozinameran) and events flare of rheumatoid arthritis in hands and elbows, muscle pain/muscle hurted in arm, hand pain as per reporter was possible.  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 events Rheumatoid arthritis, Myalgia, Pain in extremity 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.