Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fibromyalgia, Pain in extremity, Rheumatoid arthritis, Vaccination site pain
Clinical narrative: Rheumatoid arthritis flare up; sore arm; Fibromyalgia; vaccination site pain; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4379857-00.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 20Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years, on 20May2021 as dose 2, single (Batch/Lot number: unknown) and on 20Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Lot number: 1156743), subcutaneous for rheumatoid arthritis. The patient's relevant medical history was not reported. Concomitant medication(s) included: METHOTREXATE. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FIBROMYALGIA (non-serious), outcome "not recovered"; VACCINATION SITE PAIN (non-serious), outcome "unknown". The action taken for adalimumab was dosage not changed. The reporter's assessment of the causal relationship of "rheumatoid arthritis flare up", "sore arm" and "fibromyalgia" with the suspect product(s) 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. Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient had, non-serious Sore arm after all three Pfizer vaccine, Fibromyalgia and Rheumatoid arthritis flare up with HUMIRA (ADALIMUMAB). On unknown dates, the patient experienced Sore arm after all three Pfizer vaccine, Fibromyalgia and Rheumatoid arthritis flare up. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect. The reporter's causality for the event(s) of sore arm after all three Pfizer vaccines, and Fibromyalgia with Humira (ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of Rheumatoid arthritis flare up with Humira (ADALIMUMAB) was a reasonable possibility. Causality for HUMIRA(ADALIMUMAB) was reported as, the reporter's causality for the event(s) of sore arm after all three Pfizer vaccines, and Fibromyalgia with Humira (ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of Rheumatoid arthritis flare up with Humira (ADALIMUMAB) was a reasonable possibility. Causality was per reporter was, Vaccination site pain (Vaccination site pain) and Fibromyalgia (Fibromyalgia) was Not Related and Rheumatoid arthritis flare up; Causality as per reporter (Drug/Vaccine): Probable.  For Pfizer BioNTech COVID-19 Vaccine (Tozinameran) (Injection)(Tozinameran), Causality was reported for Vaccination site pain (Vaccination site pain) Causality as per reporter (Drug/Vaccine): Not Related and Fibromyalgia (Fibromyalgia) and Rheumatoid arthritis flare up, Causality as per reporter (Drug/Vaccine): Not reported. Vaccination site pain(Vaccination site pain): Causality as per reporter (Drug/Vaccine): Not Related. Fibromyalgia(Fibromyalgia): Causality as per reporter (Drug/Vaccine): Not reported. Rheumatoid arthritis flare up: Causality as per reporter (Drug/Vaccine): Not reported.  The reporter's assessment of the causal relationship of the event with the suspect product 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 available reported information, the causal association between the events rheumatoid arthritis, pain in extremity, fibromyalgia and vaccination site pain 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.