Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Fatigue; 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-163-4508869-00.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Batch/Lot number: unknown), on 19Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 04Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), on 24Feb2022 (ongoing) as unk (citrate free) (Batch/Lot number: unknown) subcutaneous 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 2022, outcome "unknown"; RHEUMATOID ARTHRITIS (medically significant) with onset 2022, outcome "not recovered", described as "Rheumatoid arthritis flare up". The action taken for adalimumab was dosage not changed.  Describe reaction(s): Fatigue (10016256) (Fatigue (10016256))- Unknown, Rheumatoid arthritis flare up (10060732) (Rheumatoid arthritis (10039073))- Not recovered/not resolved. Seq. No.: 1 Reaction: Fatigue (10016256) (Fatigue (10016256)), Start Date: ??-??-2022. Seq. No.: 2, Reaction: Rheumatoid arthritis flare up (10060732) (Rheumatoid arthritis (10039073)) , Start Date: ??-??-2022. Solicited report from the country by a consumer of a 62-year-old female with events of non-serious fatigue and rheumatoid arthritis flare up with Humira (Adalimumab). There was no reported medical history. In 2022, the patient experienced fatigue and rheumatoid arthritis flare up. 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 fatigue with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of rheumatoid arthritis flare up with Humira (Adalimumab) was a reasonable possibility. Suspect drug(s): Humira (Solution for injection in pre-filled pen) (Adalimumab),1160836, Daily dose: Citrate free, Route of administration: Subcutaneous, Indications for use: Moderate to severe rheumatoid arthritis, Therapy dates: 24Feb2022. Causality: Fatigue (10016256) (Fatigue (10016256)), Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Not Related, Dechallenge: N/A. Rheumatoid arthritis flare up (10060732) (Rheumatoid arthritis (10039073)), Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Probable, Dechallenge: N/A. Suspect drug(s): Pfizer BioNTech COVID-19 vaccine (tozinameran) (tozinameran), unknown, unknown, unknown. Daily dose: 1st dose (1 in 1 Once), 2nd dose (1 in 1 Once), 3rd dose (1 in 1 Once). Therapy dates: 29Mar2021 - 29Mar2021, 19Apr2021 - 19Apr2021, 04Nov2021 - 04Nov2021. Causality: Fatigue (10016256) (Fatigue (10016256)), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Probable, Dechallenge: N/A. Rheumatoid arthritis flare up (10060732) (Rheumatoid arthritis (10039073)) , Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A. Did event abate after stopping drug; NA.  The reporter considered "rheumatoid arthritis flare up" and "fatigue" 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 available information, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of "rheumatoid arthritis flare up" and "fatigue" . The impact of this report on the benefit/risk profile of the Pfizer drug 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.