Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Atrial fibrillation; stiffness; hard time getting up; This is a solicited report received from a contactable reporter (consumer). The reporter is the patient. Other case identifier: US-ABBVIE-4134422 (Agency). A 61-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 04Mar2022 as dose 1, single (lot number unknown) and on 05Apr2022 as dose 2, single (lot number unknown) at the age of 61 years, all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (lot number unknown), subcutaneous for psoriasis; adalimumab (HUMIRA), (lot number unknown), subcutaneous. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (hospitalization, medically significant) with onset Apr2022, outcome "not recovered"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "not recovered", described as "stiffness"; MOBILITY DECREASED (non-serious), outcome "not recovered", described as "hard time getting up". The patient was hospitalized for atrial fibrillation (start date: 2022). The action taken for risankizumab and adalimumab was unknown.  The reporter considered "atrial fibrillation" related to BNT162b2. The reporter's assessment of the causal relationship of events "stiffness" and "hard time getting up" with the suspect product 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.  Agency company narrative: Solicited report from a consumer of a 61.000-years-old male with events of Atrial fibrillation, and non-serious Stiffness, Humira stopped working and Hard time getting up with Single Dose Pen, Adalimumab Solution for Injection, Single-Dose Prefilled Syringe with Needle Guard, Risankizumab Solution for Injection. There was no reported medical history. On Apr2022, the patient experienced Atrial fibrillation. On unknown date(s), the patient experienced Hard time getting up, Humira stopped working, Stiffness. Pfizer/BioNTech was also considered suspect. It was unknown if patient was enrolled in COVID-19-Vaccine Trial. Patient had stiffness and hard time getting up. He was on HUMIRA but it stopped working for him. He had second covid 19 vaccine and ended up in the hospital due to atrial fibrillation. Causalities: The reporter's causality for the event(s) of hard time getting up, stiffness, Humira stopped working and atrial fibrillation with Risankizumab solution for injection was not provided. The reporter's causality for the event(s) of hard time getting up, stiffness and Humira stopped working with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was not provided. The reporter's causality for the event(s) of atrial fibrillation with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was reasonable possibility. The reporter's causality for the event(s) of hard time getting up, stiffness, Humira stopped working and atrial fibrillation with Adalimumab solution for injection was not provided. Agency's opinion was that the causality for the event(s) of hard time getting up, stiffness, Humira stopped working and atrial fibrillation with Risankizumab solution for injection was no reasonable possibility. Agency's opinion was that the causality for the event(s) of hard time getting up, stiffness, Humira stopped working and atrial fibrillation with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was not provided. Agency's opinion was that the causality for the event(s) of hard time getting up, stiffness, Humira stopped working and atrial fibrillation with Adalimumab solution for injection was no reasonable possibility. Agency's alternative etiology for stiffness with Risankizumab solution for injection: More likely related to underlying condition of psoriasis associated complications/comorbidities possibly confounded by lack of drug effect from Humira. Agency's Alternative Etiology for atrial fibrillation with Risankizumab solution for injection: Event likely related to COVID vaccine. Agency's Alternative Etiology for Humira stopped working with risankizumab solution for injection: Desired beneficial effect not observed with Humira. Agency's Alternative Etiology for stiffness with Adalimumab solution for injection: More likely related to underlying condition of psoriasis associated complications/comorbidities possibly confounded by lack of drug effect from Humira. Agency's Alternative Etiology for Humira stopped working with Adalimumab solution for injection: Desired beneficial effect not observed. Agency's Alternative Etiology for hard time getting up with Adalimumab solution for injection: More likely related to underlying condition of psoriasis associated complications/comorbidities possibly confounded by lack of drug effect from Humira. Agency's Alternative Etiology for hard time getting up with Risankizumab solution for injection: More likely related to underlying condition of psoriasis associated complications/comorbidities possibly confounded by lack of drug effect from Humira. Medical History: Not reported. Primary reporter did not have the lot number information because the information was not available in the patient's file for Skyrizi. Check all appropriate to adverse reaction: Involved or prolonged inpatient hospitalization.  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 in the case, the causal association between the events atrial fibrillation, musculoskeletal stiffness, mobility decreased and the suspect drug cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.