Age: 49.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Hepatic enzyme increased, Liver function test, Pain
Clinical narrative: rheumatoid arthritis flare from the waist down with both vaccinations; pain; Elevated liver panels; COVID-19; COVID-19; 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-163-4524024-00.  A 49-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) at the age of 49 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "Dry eyes" (unspecified if ongoing); "Eye Redness" (unspecified if ongoing); "Vision decreased" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "recovered" (2022) and all described as "COVID-19"; RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "rheumatoid arthritis flare from the waist down with both vaccinations"; PAIN (non-serious), outcome "unknown"; HEPATIC ENZYME INCREASED (non-serious), outcome "recovering", described as "Elevated liver panels". The patient underwent the following laboratory tests and procedures: Liver function test: (unspecified date) Elevated, notes: LABORATORY TEST: Elevated; SARS-CoV-2 test: (Apr2022) patient experienced COVID-19. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of rheumatoid arthritis, pain.  Clinical course: On unknown dates, the patient experienced pain, rheumatoid arthritis flare from waist down with both vaccinations and elevated liver panels. In Apr2022, the patient experienced COVID-19. In 2022, the COVID-19 resolved. On an unknown date, rheumatoid arthritis flare from the waist down with both vaccinations resolved. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient was treated with ADVIL. Test name: Laboratory test, Test date: Unknown  Causality for BioNTech COVID-19 Vaccine as per reporter: Causality for event pain, Elevated liver enzymes, COVID-19 as per reporter (Drug/Vaccine) Not Reported. Causality for event pain, Rheumatoid arthritis flare up as per reporter (Drug/Vaccine) Possible  Causality for Humira (Adalimumab) The reporter's causality for the event(s) of Pain and Elevated liver panels was not provided. The reporter's causality for the event(s) of rheumatoid arthritis flare from the waist down with both vaccinations and COVID-19 with Humira (Adalimumab) was no reasonable possibility.   Causality for Humira (Adalimumab) as per reporter: Causality for event pain, Elevated liver enzymes as per reporter (Drug/Vaccine) Not Reported. Causality for event Rheumatoid arthritis flare up, COVID-19 as per reporter (Drug/Vaccine) Not Related.  The reporter considered "rheumatoid arthritis flare from the waist down with both vaccinations" related to BNT162b2. The reporter's assessment of the causal relationship of "covid-19", "pain" and "elevated liver panels" 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 information on the batch/lot number for BNT162b2 has been requested and will be submitted when received.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between reported Serious events like LOE events, Rheumatoid arthritis and non serious events like pain, hepatic enzyme increased with the suspect drug 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