Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cardiac failure, Diabetes mellitus, Psoriatic arthropathy, Vaccination site pain
Clinical narrative: Heart failure; Diabetes; Psoriatic arthritis aggravated; Site of vaccination painful; MARKETING PROGRAM 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): 22K-163-4327104-00 (AbbVie).  A 60 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 31Mar2021 (Batch/Lot number: unknown) at the age of 60 years as dose 1, single and intramuscular, administration date 21Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1158968) for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC FAILURE (medically significant), outcome "not recovered", described as "Heart failure"; DIABETES MELLITUS (medically significant), outcome "not recovered", described as "Diabetes"; PSORIATIC ARTHROPATHY (medically significant), outcome "not recovered", described as "Psoriatic arthritis aggravated"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Site of vaccination painful". The action taken for adalimumab was unknown.  The reporter's causality for the event(s) of heart failure, diabetes, Pfizer BioNTech COVID-19 vaccine caused sore arm, right before taking Humira injection got psoriatic arthritis flare up unknown onset and right before taking Humira injection got psoriatic arthritis flare up unknown onset was not provided. AbbVie's opinion is that the event of heart failure is not assessable. AbbVie's opinion is that there is no reasonable possibility that the events of diabetes, Pfizer BioNTech COVID-19 vaccine caused sore arm, right before taking Humira injection got psoriatic arthritis flare up unknown onset and right before taking Humira injection got psoriatic arthritis flare up unknown onset are related to Humira (Adalimumab).  The reporter's assessment of the causal relationship of the (Heart failure , Diabetes , Site of vaccination painful , Psoriatic arthritis aggravated) with the suspect product 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.