Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac failure congestive, Drug ineffective, Illness, Psoriasis
Clinical narrative: Patient was unsure if the Tremfya was meeting treatment expectations; Psoriasis broke out; Sick; Atrial fibrillation; Congestive heart failure; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4714204.  A 55-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; risankizumab rzaa (SKYRIZI [RISANKIZUMAB RZAA]), (Batch/Lot number: unknown), subcutaneous for psoriasis; guselkumab (TREMFYA), since Feb2023 (Batch/Lot number: unknown). The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (prolonged hospitalization, medically significant) with onset 2022, outcome "unknown"; CARDIAC FAILURE CONGESTIVE (prolonged hospitalization, medically significant) with onset 2022, outcome "unknown", described as "Congestive heart failure"; PSORIASIS (non-serious) with onset 2022, outcome "unknown", described as "Psoriasis broke out"; ILLNESS (non-serious) with onset 2022, outcome "unknown", described as "Sick"; DRUG INEFFECTIVE (non-serious), outcome "unknown", described as "Patient was unsure if the Tremfya was meeting treatment expectations". The action taken for guselkumab was unknown. The action taken for risankizumab rzaa was dosage permanently withdrawn.  The reporter's assessment of the causal relationship of "pneumonia", "atrial fibrillation", "congestive heart failure", "covid", "patient was unsure if the tremfya was meeting treatment expectations", "psoriasis broke out" and "sick" 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 Information: Solicited report from the country by a consumer of a 55 year old male with events of Covid, Congestive heart failure, Pneumonia and Atrial fibrillation and non-serious Psoriasis broke out, Sick and patient was unsure if the Tremfya was meeting treatment expectations with Risankizumab Solution for Injection, Single-Dose Prefilled Syringe with Needle Guard. There was no reported medical history. In 2022, the patient experienced Covid, Congestive heart failure, Pneumonia and Atrial fibrillation. On unknown date(s), the patient experienced Sick, Psoriasis broke out. Patient was unsure if the Tremfya was meeting treatment expectations. Pfizer BioNTech COVID-19 vaccine, Tremfya were also considered suspect. In 2022, patient was hospitalized with Covid and hospitalized with pneumonia a second time, and then was hospitalized again with congestive heart failure and atrial fibrillation, all in 2022 and patient was not on Humira, Skyrizi or Tremfya at the time. Patient stated that he was unsure if the medication Tremfya was meeting his treatment expectations. He stated that he was new to medication. He received samples from his physician and has been on Tremfya from Feb2023. He denied any side effects. He was previously on Humira and Skyrizi and discontinued medication, he broke out while on medication. He stated that he took the Pfizer Covid vaccine and had been sick ever since getting the covid vaccines.  Causalities: The reporter's causality for the event(s) of Psoriasis broke out with Risankizumab Solution for Injection was Reasonable Possibility. The reporter's causality for the event(s) of Sick with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility. The reporter's causality for the event(s) of Atrial fibrillation, Congestive heart failure, Covid, Patient was unsure if the Tremfya was meeting treatment expectations, Pneumonia and Sick with Risankizumab Solution for Injection was Not Provided. The reporter's causality for the event(s) of Atrial fibrillation, Congestive heart failure, Covid, Patient was unsure if the Tremfya was meeting treatment expectations, Pneumonia and Psoriasis broke out with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. The reporter's causality for the event(s) of Atrial fibrillation, Congestive heart failure, Covid, Patient was unsure if the Tremfya was meeting treatment expectations, Pneumonia, Psoriasis broke out and Sick with Tremfya (Guselkumab) was Not Provided. Agency's opinion was that the causality for the event(s) of Atrial fibrillation, Congestive heart failure, Covid, Patient was unsure if the Tremfya was meeting treatment expectations, Pneumonia, Psoriasis broke out and Sick with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. Agency's opinion was that the causality for the event(s) of Atrial fibrillation, Congestive heart failure, Covid, Patient was unsure if the Tremfya was meeting treatment expectations, Pneumonia, Psoriasis broke out and Sick with Tremfya (Guselkumab) was Not Provided. Agency's opinion was that the causality for the event(s) of Atrial fibrillation, Congestive heart failure, Covid, Patient was unsure if the Tremfya was meeting treatment expectations, Pneumonia and Psoriasis broke out with Risankizumab Solution for Injection was No Reasonable Possibility. Agency's Alternative Etiology for Psoriasis broke out with Risankizumab Solution for Injection: More likely related to natural progression of underlying Psoriasis. Agency's Alternative Etiology for Congestive heart failure with Risankizumab Solution for Injection: More likely related to increased risk from concurrent COVID - 19 infection in this advanced patient with underlying Psoriasis. Agency's Alternative Etiology for Pneumonia with Risankizumab Solution for Injection: More likely related to increased risk from concurrent COVID - 19 infection in this advanced patient with underlying Psoriasis. Agency's Alternative Etiology for Covid with Risankizumab Solution for Injection: More likely related to SARS CoV-2 pandemic outbreak in general population in this advanced patient with underlying Psoriasis. Agency's Alternative Etiology for Atrial fibrillation with Risankizumab Solution for Injection: More likely related to increased risk from concurrent COVID - 19 infection in with congestive heart failure in This advanced patient with underlying Psoriasis. Assessment Results: SKYRIZI - Psoriasis flare-up, Agency, Global Introspection, No Reasonable Possibility. SKYRIZI - Psoriasis flare-up, Non-Health Care Professional, Global Introspection, Probable. Pfizer BioNTech COVID-19 vaccine - Pneumonia, Agency. Pfizer BioNTech COVID-19 vaccine - Pneumonia, Non-Health Care Professional, Global Introspection, Not Reported. Pfizer BioNTech COVID-19 vaccine - Sickness, Agency. Pfizer BioNTech COVID-19 vaccine - Sickness, Non-Health Care Professional, Global Introspection, Probable. SKYRIZI - Sickness, Agency, Global Introspection. SKYRIZI - Sickness, Non-Health Care Professional, Global Introspection, Not Reported. SKYRIZI - Congestive heart failure, COVID-19 and Pneumonia, Agency, Global Introspection, No Reasonable Possibility. SKYRIZI - Congestive heart failure, COVID-19 and Pneumonia, Non-Health Care Professional, Global Introspection, Not Reported. Pfizer BioNTech COVID-19 vaccine - Congestive heart failure and Psoriasis flare-up, Agency. Pfizer BioNTech COVID-19 vaccine - Congestive heart failure and Psoriasis flare-up, Non-Health Care Professional, Global Introspection, Not Reported. Pfizer BioNTech COVID-19 vaccine - COVID-19, Agency. Pfizer BioNTech COVID-19 vaccine - COVID-19, Non-Health Care Professional, Global Introspection, Not Reported. Tremfya - Lack of drug effect, Agency. Tremfya - Lack of drug effect, Non-Health Care Professional, Global Introspection, Not Reported. SKYRIZI - Lack of drug effect, Agency, Global Introspection, No Reasonable Possibility. SKYRIZI - Lack of drug effect, Non-Health Care Professional, Global Introspection, Not Reported. Tremfya - COVID-19 and Congestive heart failure, Agency. Tremfya - COVID-19 and Congestive heart failure, Non-Health Care Professional, Global Introspection, Not Reported. Tremfya - Pneumonia and Atrial fibrillation, Agency. Tremfya - Pneumonia and Atrial fibrillation, Non-Health Care Professional, Global Introspection, Not Reported. Pfizer BioNTech COVID-19 vaccine - Atrial fibrillation, Agency. Pfizer BioNTech COVID-19 vaccine - Atrial fibrillation, Non-Health Care Professional, Global Introspection, Not Reported. SKYRIZI - Atrial fibrillation, Agency, Global Introspection, No Reasonable Possibility. SKYRIZI - Atrial fibrillation, Non-Health Care Professional, Global Introspection, Not Reported. Pfizer BioNTech COVID-19 vaccine - Lack of drug effect, Agency. Pfizer BioNTech COVID-19 vaccine - Lack of drug effect, Non-Health Care Professional, Global Introspection, Not Reported. Tremfya - Sickness and Psoriasis flare-up, Agency. Tremfya - Sickness and Psoriasis flare-up, Non-Health Care Professional, Global Introspection, Not Reported.  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.