Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Rheumatoid arthritis flare up; Vaccination site pain; Difficulty in standing; Back pain aggravated; Muscle pain; Hand swelling; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown), on 21Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 16Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64-year-old, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (ongoing) (Batch/Lot number: unknown), second regimen (ongoing) (Batch/Lot number: unknown) and third regimen (ongoing) (Batch/Lot number: unknown), all subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "Moderate to severe rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up"; VACCINATION SITE PAIN (non-serious), outcome "unknown"; DYSSTASIA (non-serious), outcome "unknown", described as "Difficulty in standing"; BACK PAIN (non-serious), outcome "unknown", described as "Back pain aggravated"; MYALGIA (non-serious), outcome "not recovered", described as "Muscle pain"; PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "Hand swelling". The action taken for adalimumab was dosage not changed. Clinical course: Pfizer booster vaccine caused sore arm, hard to stand from sitting position, back pain from arthritis was flaring up, rheumatoid arthritis flare up, muscle pain and hand swelling with humira (adalimumab). It was unknown if patient was enrolled in a covid-19 vaccine trial. The patient was treated with meloxicam.  The reporter's causality for bnt162b2 with respect to the events Vaccination site pain was possible, Difficulty in standing, Rheumatoid arthritis flare up, Back pain aggravated, Muscle pain and Hand swelling was not provided. The reporter's causality for co-suspect Humira with respect to the events Vaccination site pain was no reasonable possibility, Difficulty in standing was not reported, Rheumatoid arthritis flare up, Back pain aggravated, Muscle pain and Hand swelling was 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, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event Rheumatoid arthritis which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes 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.