Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pain, Rheumatoid arthritis, SARS-CoV-1 test
Clinical narrative: Rheumatoid arthritis flare; Body Aches; COVID; COVID; This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 47 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1160838) at unk (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "Rheumatoid arthritis" (ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jul2022, outcome "unknown" and all described as "COVID"; RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis flare"; PAIN (non-serious), outcome "unknown", described as "Body Aches". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: (01Jul2022) positive. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "covid" and "rheumatoid arthritis flare" 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 "body aches" related to BNT162b2.  Product-Reaction level: Drug: Humira (Solution for injection in pre-filled pen) (Adalimumab)  Causality:  1) Rheumatoid arthritis flare up (Rheumatoid arthritis). Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A  2) COVID-19 (COVID-19). Action(s) taken with drug: Unknown , Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A  3) Generalized aching (Pain). Action(s) taken with drug: Unknown , Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A  Drug: Pfizer-BioNTech Covid-19 Vaccine (Tozinameran) (Injection) (Tozinameran) (Daily Dose: 1) First dose (1 in 1 Once), 2) Second dose (1 in 1 Once) Causality:  1) Rheumatoid arthritis flare up (Rheumatoid arthritis) Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A  2) COVID-19 (COVID-19) Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A  3) Generalized aching (Pain) Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Possible Dechallenge: N/A   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association 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.