Age: 50.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Myocardial infarction
Clinical narrative: Condition aggravated; Heart attack; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4272159-00 (AbbVie).  A 50-year-old male patient received BNT162b2 (BNT162B2), in Jun2021 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years and in Jul2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for psoriatic arthropathy, psoriasis. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset Apr2021, outcome "recovering", described as "Heart attack"; CONDITION AGGRAVATED (non-serious), outcome "unknown". Solicited report from the by a consumer of a 50 year old male with events of Heart Attack and non-serious Flare up of Unknown indication Humira (Adalimumab). There was no reported medical history. On an  unknown date, the patient experienced Flare up of Unknown Indication. In Apr2021, the patient experienced Heart Attack. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. In Apr2021, the patient has heart attack. On 21Apr2021 he had open heart surgery, coronary artery bypass graft surgery. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Heart Attack and Flare up of unknown Indication with Humira (Adalimumab) was no reasonable possibility. AbbVie's opinion is that there is no reasonable possibility that the event of Heart Attack is related to Humira (Adalimumab). AbbVie's opinion is that the event of Flare up of Unknown Indication is not assessable. On 07Apr2022, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information and narrative description. The event of "flare up of unknown indication" was added. The event of "Open heart surgery/coronary artery bypass surgery" was amended to "heart attack". Suspect drug(s) information: Humira (Solution for injection in pre-filled pen) (Adalimumab), Unknown, Route of administration: Subcutaneous, Indications for use: Psoriatic Arthritis, Moderate to Severe Chronic Plaque Psoriasis. Pfizer Biontech Covid-19 Vaccine (Tozinameran) (Tozinameran), Unknown, Unknown, Daily Dose: 1st dose (1 in 1 once), Route of Administration: Intramuscular, Indications for Use: Covid-19 Vaccination, Therapy dates (From/To): Jun2021. Product-Reaction level: Seq.No.: 1. Drug: Humira (Solution for injection in pre-filled pen) (Adalimumab): Causality: Heart attack (Myocardial infarction), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): No reasonable possibility, Causality as per Mfr.(Drug/Vaccine): No reasonable possibility, Dechallenge: N/A. Condition aggravated (Condition aggravated), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): No reasonable possibility, Causality as per Mfr.(Drug/Vaccine): Not assessable, Dechallenge: N/A. Seq.No.: 2: Drug: Pfizer Biontech Covid-19 Vaccine (Tozinameran) (Tozinameran), Unknown, Unknown, Daily Dose: 1) 1st dose (1 in 1 Once). 2nd dose (1 in 1 Once), Route of Admin: 1) Intramuscular. Intramuscular, Therapy Dates/Duration: 1) Jun2021 - Jun2021; Jul2021 - Jul2021. Causality: Heart attack (Myocardial infarction), Causality as per reporter (Drug/Vaccine): Possible, Dechallenge: N/A. Condition aggravated (Condition aggravated), Causality as per reporter (Drug/Vaccine): Possible, Dechallenge: N/A. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of myocardial infarction.  The reporter's assessment of the causal relationship of "heart attack" and "condition aggravated" 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.  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 information provided in the narrative, a causal association between the suspect drug and the events cannot be completely 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.