Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; reaction to knees; 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-163-4353903-00 (Abbvie).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown) subcutaneous for rheumatoid arthritis. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up"; ARTHRALGIA (non-serious), outcome "unknown", described as "reaction to knees".  The reporter considered "rheumatoid arthritis flare up" related to BNT162b2. The reporter considered "reaction to knees" not related to BNT162b2.  DESCRIBE REACTION(S) (include relevant test/lab data): Rheumatoid arthritis flare up (Rheumatoid arthritis): Not recovered/not resolved. Vaccination adverse reaction (Vaccination complication): Unknown. Solicited report by a consumer of a female with event of non-serious rheumatoid arthritis flare up and reaction to knees after first dose of Pfizer vaccine with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced rheumatoid arthritis flare up and reaction to knees after first dose of Pfizer vaccine. 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 rheumatoid arthritis flare up with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of reaction to knees after first dose of Pfizer vaccine with Humira (Adalimumab) was no reasonable possibility. Suspect drug(s) (include generic name): HUMIRA (Solution for injection in pre-filled pen) (ADALIMUMAB). Route of administration: Subcutaneous. Indications for use: Moderate to severe rheumatoid arthritis. Therapy dates (From/To): Unk -Ongoing. Causality 1) Rheumatoid arthritis flare up (Rheumatoid arthritis). Action(s) taken with drug: Dose Not Changed. Causality as per reporter (Drug/Vaccine): Reasonable possibility. Dechallenge: N/A. 2) Vaccination adverse reaction (Vaccination complication). Action(s) taken with drug: Dose Not Changed. Causality as per reporter (Drug/Vaccine): No reasonable possibility. Dechallenge: N/A. Suspect drug(s) (include generic name): Pfizer Biontech Covid-19 Vaccine (Tozinameran) (Tozinameran), Unknown. Daily dose: 1st dose (1 in 1 Once). Route of administration: Intra-muscular. Indications for use: Covid-19 Vaccination. Therapy dates (From/To): UNK. Causality. 1) Rheumatoid arthritis flare up (Rheumatoid arthritis). Action(s) taken with drug: Dose Not Changed. Causality as per reporter (Drug/Vaccine): Reasonable possibility. Dechallenge: N/A. 2) Vaccination adverse reaction (Vaccination complication). Action(s) taken with drug: Dose Not Changed. Causality as per reporter (Drug/Vaccine): No reasonable possibility. Dechallenge: N/A. Did event abate after stopping drug? NA. CONCOMITANT DRUGS AND DATES OF ADMINISTRATION (Exclude those used to treat event).  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 in the case report and a plausible temporal relationship, a possible causal relationship between the 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.