Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Joint swelling, Pain in extremity, Pharyngitis, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; knee swollen; little red; Throat infection; Pain in arm; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 03May2021 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, on 21May2021 as dose 2, single (Batch/Lot number: unknown) and on 20Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 21Sep2021 (ongoing) (Lot number: 1162124) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis flare up"; JOINT SWELLING (non-serious), outcome "recovering", described as "knee swollen"; ERYTHEMA (non-serious), outcome "recovering", described as "little red"; PHARYNGITIS (non-serious), outcome "unknown", described as "Throat infection"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in arm". The action taken for adalimumab was dosage not changed.  Clinical information: On unknown dates, the patient experienced knee swollen and a little red, throat infection, rheumatoid arthritis flare up and pain in arm. Pfizer BioNTech COVID-19 VACCINE (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira (Adalimumab). The reporter's causality for the event(s) of knee swollen and a little red unknown onset, knee swollen and a little red unknown onset, throat infection, rheumatoid arthritis flare up and pain in arm was not provided.  On 29Jun2022, received updates to event information, reporter opinion of causality, suspect drug information and narrative description. The events of "throat infection", "rheumatoid arthritis flare up" and "pain in arm" were added. The event of "knee pain" was removed. Causality of knee swelling, localized erythema, throat infection, Rheumatoid arthritis flare up, pain in arm was not reported with humira and causality of events of knee swelling, localized erythema, throat infection, Rheumatoid arthritis flare up was not reported by reporter with Pfizer BioNTech COVID-19 VACCINE and possible for event pain in arm.   The reporter's assessment of the causal relationship of "rheumatoid arthritis flare up", "knee swollen", "little red" and "throat infection" 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. The reporter considered "pain in arm" related to BNT162b2.  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, the causal relationship between the reported events and 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