Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Her hands and feet were swollen and painful; Her hands and feet were swollen and painful; Her hands and feet were swollen and painful; Her hands and feet were swollen and painful; flu like symptoms; Total knee replacement; MARKETING PROGRAMME NAME NOT AVAILABLE.  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): 22K-163-4296942-00.  A 62 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 62 years as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) as unk, daily and subcutaneous, administration date 28Feb2022 (ongoing) (Batch/Lot number: unknown) as unk, daily for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (medically significant), outcome "recovered", described as "flu like symptoms"; KNEE ARTHROPLASTY (medically significant) with onset 26Feb2022, outcome "not recovered", described as "Total knee replacement"; RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up"; PERIPHERAL SWELLING (non-serious), JOINT SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Her hands and feet were swollen and painful". The reporter's causality for the event(s) of Knee replacement surgery, flu like symptoms and rheumatoid arthritis flare with Humira(Adalimumab) was no reasonable possibility. Causality for Pfizer Biontech Covid-19 Vaccine (TOZINAMERAN) as per reporter for Total knee replacement (Knee arthroplasty), Rheumatoid arthritis flare up (Rheumatoid arthritis) is Not reported and causality for Flu like symptoms (Influenza like illness) is possible. The causality Peripheral swelling, Joint swelling and Pain in extremity for Humira and Pfizer Biontech Covid-19 Vaccine (TOZINAMERAN) was unknown.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. The action taken for adalimumab was unknown. The reporter considered "flu like symptoms" related to bnt162b2.  Clinical course: The patient stated that it was in the middle of an arthritis flare and possibly it was the result of stopping therapy. She was getting back on therapy just now as of 28Feb2022. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of  Influenza like illness, Knee Arthroplasty, Rheumatoid arthritis, Peripheral swelling, Joint swelling, Pain in extremity. 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.