Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain assessment, Psoriatic arthropathy
Clinical narrative: Psoriatic arthritis; Feeling unwell; MARKETING PROGRAM NAME IS NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4195727-00.  A 56 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 55 years as dose 1, single and intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous since 09May2021 (ongoing) (Batch/Lot number: unknown) at 40 mg (40 mg,1 in 14 d) for psoriatic arthropathy. Relevant medical history included: "Joint pain" (unspecified if ongoing), notes: 2021 Pain Scale: joint pain at 30/100. The patient's concomitant medications were not reported. The following information was reported: PSORIATIC ARTHROPATHY (medically significant) with onset 2021, outcome "recovering", described as "Psoriatic arthritis"; MALAISE (non-serious) with onset 2021, outcome "recovering", described as "Feeling unwell". The patient underwent the following laboratory tests and procedures: pain assessment: (2021) joint pain at 30/100. The action taken for adalimumab was unknown. Clinical course was reported as, the events of non-serious PSORIATIC ARTHRITIS SYMPTOMS and NOT FEELING WELL with HUMIRA 40MG/0.4ML (ADALIMUMAB). In 2021, the patient experienced Psoriatic Arthritis Symptoms and Not Feeling Well. 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) 40MG/0.4ML(Adalimumab) reported as, the reporter's causality for the event(s) of Psoriatic Arthritis Symptoms with HUMIRA 40MG/0.4ML(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of Not Feeling Well was not provided. The reporter's causality for the event(s) of Psoriatic Arthritis Symptoms  with BNT162B2  was not reported . The reporter's causality for the event(s) of Feeling unwell was possible. The reporter's causality for the event(s) of Psoriatic Arthritis Symptoms  with HUMIRA 40MG/0.4ML(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of Feeling unwell was not provided. Changed History reported as, On 30Dec2021, received updates to event information, reporter opinion of causality, suspect drug information, laboratory/diagnostic procedures and narrative description. The event of "PLAQUES" was removed.  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 available information and the possible contributory role of suspect product BNT162B2 to the development of events psoriatic arthritis symptoms, malaise cannot be totally excluded. The case will be reassessed when additional information available. 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 RAs, Ethics Committees, and Investigators, as appropriate.