Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Fatigue, Limb deformity, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Fatigue; Arm deformity; Eczema; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4210232-00 (Abbvie).  A 69 year-old female patient received BNT162B2 (BNT162B2), intramuscular, administration date 06Mar2021 (Batch/Lot number: unknown) at the age of 69 years as dose 1, single for covid-19 immunization; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "recovered", described as "Fatigue"; LIMB DEFORMITY (non-serious) with onset Mar2021, outcome "not recovered", described as "Arm deformity"; ECZEMA (non-serious) with onset Mar2021, outcome "not recovered", described as "Eczema"; RHEUMATOID ARTHRITIS (medically significant) with onset Mar2021, outcome "not recovered", described as "Rheumatoid arthritis flare up". The action taken for adalimumab was unknown. Clinical course: a 69-year-old female with events of non-serious COVID vaccine made fatigued, left arm fused together, eczema and rheumatoid arthritis flare up with HUMIRA (adalimumab). There was no reported medical history. On unknown dates, the patient experienced left arm fused together, eczema and rheumatoid arthritis flare up. In Mar2021, the patient experienced COVID vaccine made fatigued. In 2021, the COVID vaccine made fatigued resolved. PFIZER BIONTECH COVID-19 vaccine (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 06Mar2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 06Apr2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech.  Causality for HUMIRA (ADALIMUMAB) and PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN): The reporter's causality for the event(s) of COVID vaccine made fatigued, left arm fused together, eczema and rheumatoid arthritis flare up was not provided.  The reporter's assessment of the casual relationship of the events 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 and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   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.