Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, COVID-19, Cardiac failure congestive, Drug ineffective, Illness
Clinical narrative: congestive heart failure; atrial fibrillation; pneumonia; COVID; COVID; sick; broke out; This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4715018.  A 55-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for psoriasis; guselkumab (TREMFYA), since 2023 (Batch/Lot number: unknown). The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (prolonged hospitalization, medically significant), COVID-19 (prolonged hospitalization, medically significant) all with onset 2022, outcome "unknown" and all described as "COVID"; ATRIAL FIBRILLATION (prolonged hospitalization, medically significant) with onset 2022, outcome "unknown"; RASH (non-serious) with onset 2022, outcome "unknown", described as "broke out"; CARDIAC FAILURE CONGESTIVE (prolonged hospitalization, medically significant) with onset 2022, outcome "unknown", described as "congestive heart failure"; PNEUMONIA (prolonged hospitalization, medically significant) with onset 2022, outcome "unknown"; ILLNESS (non-serious) with onset 2022, outcome "unknown", described as "sick". The action taken for adalimumab and guselkumab was dosage permanently withdrawn.  The reporter's assessment of the causal relationship of "congestive heart failure", "atrial fibrillation", "pneumonia", "covid", "sick" and "broke out" 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.  Clinical course: Solicited report from the country by a consumer of a 55 year old male with events of atrial fibrillation, pneumonia, congestive heart failure, and COVID, and non-serious sick and broke out with Adalimumab Solution for Injection, Single Dose Pen. There was no reported medical history. Tremfya, Pfizer COVID vaccine were also considered suspect. The patient reported that he was unsure if the medication was meeting the treatment expectations and was new to the medication. The patient received samples from his physician and has been on Tremfya for the last 5 weeks and denied any side effects. Patient was previously on Humira and Skyrizi and discontinued medication-patient broke out while on medication. Patient stated that he took the Pfizer COVID vaccine and has been sick ever since getting the covid vaccines and hospitalized with COVID and pneumonia. Last year a patient was hospitalized again with pneumonia, and then was hospitalized again with congestive heart failure and atrial fibrillation. Patient discontinued Humira, Skyrizi or Tremfya at that time. Causalities: The reporter's causality for the event(s) of broke out with Adalimumab Solution for Injection was Reasonable Possibility. The reporter's causality for the event(s) of COVID, atrial fibrillation, congestive heart failure, pneumonia and sick with Adalimumab Solution for Injection was Not Provided. The reporter's causality for the event(s) of COVID, atrial fibrillation, broke out, congestive heart failure, pneumonia and sick with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. The reporter's causality for the event(s) of COVID, atrial fibrillation, broke out, congestive heart failure, pneumonia and sick with Tremfya (Guselkumab) was Not Provided. Assessment Results: HUMIRA- Sickness, Non-Health Care Professional, Global Introspection, Not Reported; Authority, Global Introspection, No Reasonable Possibility. HUMIRA- Congestive heart failure, Non-Health Care Professional, Global Introspection, Not Reported; Authority, Global Introspection, Not assessable. Pfizer COVID vaccine- Skin breakout, Non-Health Care Professional, Global Introspection, Not Reported; Authority. HUMIRA-Drug effect incomplete, Non-Health Care Professional, Global Introspection, Not Reported; Authority, Global Introspection, No Reasonable Possibility. HUMIRA- COVID-19, Non-Health Care Professional, Global Introspection, Not Reported; Authority, Global Introspection, No Reasonable Possibility. Pfizer COVID vaccine- Sickness, Non-Health Care Professional, Global Introspection, Not Reported; Authority. Tremfya- Atrial fibrillation, Non-Health Care Professional, Global Introspection, Not Reported; Authority. Tremfya- Pneumonia, Non-Health Care Professional, Global Introspection, Not Reported; Authority. HUMIRA- Pneumonia, Non-Health Care Professional, Global Introspection, Not Reported; Authority, Global Introspection, Not assessable. HUMIRA- Skin breakout, Non-Health Care Professional, Global Introspection, Probable; Authority, Global Introspection, No Reasonable Possibility. HUMIRA- Atrial fibrillation, Non-Health Care Professional, Global Introspection, Not Reported; Authority, Global Introspection, Not assessable. Pfizer COVID vaccine- Drug effect incomplete, Non-Health Care Professional, Global Introspection, Not Reported; Authority. Pfizer COVID vaccine- Atrial fibrillation, Non-Health Care Professional, Global Introspection, Not Reported; Authority. Tremfya- Drug effect incomplete, Non-Health Care Professional, Global Introspection, Not Reported; Authority. Tremfya- Congestive heart failure, Non-Health Care Professional, Global Introspection, Not Reported; Authority. Tremfya- COVID-19, Non-Health Care Professional, Global Introspection, Not Reported; Authority. Pfizer COVID vaccine- Pneumonia, Non-Health Care Professional, Global Introspection, Not Reported; Authority. Tremfya- Skin breakout, Non-Health Care Professional, Global Introspection, Not Reported; Authority. Pfizer COVID vaccine- Congestive heart failure, Non-Health Care Professional, Global Introspection, Not Reported; Authority. Pfizer COVID vaccine- COVID-19, Non-Health Care Professional, Global Introspection, Not Reported; Authority. Tremfya- Sickness, Non-Health Care Professional, Global Introspection, Not Reported; Authority.  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 the available information in the case, the causal association between the events and the suspect drug BNT162B2 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.