Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Rheumatoid arthritis flare up; Allergic Reaction Every Time Used Humira /Allergy Symptoms on Hands/Feet/Arms and Knees; General body pain; Mobility decreased; Loss of Hair and Condition Became Worst After Had The Second Dose of Covid-19 Vaccine with HUMIRA; Psoriasis; Had Symptoms Like Covid 19 But Never Tested Positive; 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-163-4394011-00 (Company).  A 52-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2,  single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (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: HYPERSENSITIVITY (non-serious) with onset 2022, outcome "not recovered", described as "Allergic Reaction Every Time Used Humira /Allergy Symptoms on Hands/Feet/Arms and Knees"; PAIN (non-serious) with onset 2022, outcome "not recovered", described as "General body pain"; SUSPECTED COVID-19 (non-serious) with onset 2022, outcome "unknown", described as "Had Symptoms Like Covid 19 But Never Tested Positive"; ALOPECIA (non-serious) with onset 2022, outcome "unknown", described as "Loss of Hair and Condition Became Worst After Had The Second Dose of Covid-19 Vaccine with HUMIRA"; MOBILITY DECREASED (non-serious) with onset 2022, outcome "not recovered"; PSORIASIS (non-serious) with onset 2022, outcome "not recovered"; RHEUMATOID ARTHRITIS (medically significant) with onset 2022, outcome "not recovered", described as "Rheumatoid arthritis flare up". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. The action taken for adalimumab was unknown.  Clinical Course: On unknown dates, the patient experienced Sort of Allergic Reaction Every Time Used Humira/Allergy Symptoms on Hands/Feet/Arms And Knees/Physician Believe Possible Symptoms off Psoriasis, Had Symptoms Like Covid 19 But Never Tested Positive, Loss Of Hair and Condition Became Worst After Had the Second Dose of Covid-19 Vaccine with HUMIRA (ADALIMUMAB). In 2022, the patient experienced Rheumatoid Arthritis Flare Up and Pain On Body That Made Patient Difficult to Move. 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, Sort of Allergic Reaction Every Time Used Humira/Allergy Symptoms on Hands/Feet/Arms And Knees/Physician Believe Possible Symptoms off Psoriasis unknown onset, Had Symptoms Like Covid 19 But Never Tested Positive, Pain on Body That Made Patient Difficult To Move Onset in 2022, Pain On Body That Made Patient Difficult To Move onset in 2022, Loss Of Hair, Condition Became Worst After Had The Second Dose Of Covid-19 Vaccine and Sort Of Allergic Reaction Every Time Used Humira/Allergy Symptoms On Hands/ Feet/'Arms And Knees/Physician Believe Possible Symptoms Off Psoriasis unknown onset was not provided.  The reporter's assessment of the causal relationship of "rheumatoid arthritis flare up", "allergic reaction every time used humira /allergy symptoms on hands/feet/arms and knees", "general body pain", "mobility decreased", "loss of hair and condition became worst after had the second dose of covid-19 vaccine with humira ", "psoriasis" and "had symptoms like covid 19 but never tested positive" 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 if and when received.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event,  "rheumatoid arthritis flare up", Hypersensitivity, pain, suspected COVID-19, alopecia, mobility decreased, psoriasis cannot be completely ruled out. 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.