Received Jul 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
cardiac arrest secondary to ventricular fibrillation/cardiac arrest secondary to myocarditis following the first dose of Pfizer-BioNTech mRNA COVID-19 vaccination.; cardiac arrest secondary to ventricular fibrillation/cardiac arrest secondary to myocarditis following the first dose of Pfizer-BioNTech mRNA COVID-19 vaccination.; cardiac arrest secondary to ventricular fibrillation/cardiac arrest secondary to myocarditis following the first dose of Pfizer-BioNTech mRNA COVID-19 vaccination.; This is a literature report for the following literature source(s). A 23-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC ARREST (hospitalization, medically significant, life threatening), VENTRICULAR FIBRILLATION (hospitalization, medically significant, life threatening), MYOCARDITIS (hospitalization, medically significant, life threatening), all with latency 3 weeks after the suspect product(s) administration, outcome "recovered" and all described as "cardiac arrest secondary to ventricular fibrillation/cardiac arrest secondary to myocarditis following the first dose of Pfizer-BioNTech mRNA COVID-19 vaccination.". The patient underwent the following laboratory tests and procedures: Cardiac electrophysiologic study: Negative, notes: for inducible ventricular arrhythmias; Echocardiogram: Normal ejection fraction, notes: with no other abnormalities; Ejection fraction: normal; Electrocardiogram: showed normal sinus rhythm.; Testing for Drug-induced and infectious causes of myocarditis: Negative; Magnetic resonance imaging heart: subepicardial enhancement, notes: along the lateral wall of left ventricular consistent with focal myocarditis; SARS-CoV-2 test: Negative, notes: on nasopharyngeal swab testing on admission; Troponin I (0.0-0.04): 0.5 ng/ml, notes: elevated. Clinical course: Myocarditis is a known adverse event associated with COVID-19 vaccination. We report the index case of cardiac arrest secondary to myocarditis following the first dose of Pfizer-BioNTech mRNA COVID-19 vaccination. case details included A 23-year-old male with no significant medical history presented after a resuscitated cardiac arrest secondary to ventricular fibrillation. He had received the first dose of COVID-19 vaccine (Pfizer-BioNTech mRNA vaccine) 3 weeks before. He had no known COVID-19 exposure and SARS-CoV-2 PCR was negative on nasopharyngeal swab testing on admission. EKG showed normal sinus rhythm and troponin I was elevated at 0.5 ng/ml (reference range 0.0-0.04 ng/ml). Echocardiogram showed normal ejection fraction with no other abnormalities. Cardiac MRI showed subepicardial enhancement along the lateral wall of left ventricular consistent with focal myocarditis. Electrophysiological study was negative for inducible ventricular arrhythmias. Testing for drug-induced and infectious causes of myocarditis yielded negative results. No arrhythmias or recurrence of symptoms were observed during the hospital stay and the patient was discharged in a stable condition with advice to refrain from second dose of vaccine. Discussion included a diagnosis of focal myocarditis temporally associated with the vaccine was established. Clinical course was mild, and he continued to do well at follow-up without additional clinical sequelae. Recent literature shows an association of myocarditis with mRNA-COVID-19 vaccination, with a prevalence of 0.03%. It is mostly seen in young healthy males after the second dose. Cardiac arrest secondary to COVID vaccine-induced myocarditis is an unusual presentation and no similar cases have been reported to date. Such presentation after the first vaccine dose is also rare in the reported cases. Conclusion included a high clinical suspicion of COVID-19 vaccine-associated myocarditis should be maintained in young healthy males with a mild disease course. Cardiac arrest is a possible catastrophic presentation of such vaccine-induced myocarditis.; Sender's Comments: Based on drug safety and plausible temporal association, there is reasonable possibility of causal association between the reported events CARDIAC ARREST, VENTRICULAR FIBRILLATION, MYOCARDITIS and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Test Name: Electrophysiological study; Test Result: Negative ; Comments: for inducible ventricular arrhythmias.; Test Name: Echocardiogram; Result Unstructured Data: Test Result:Normal ejection fraction; Comments: with no other abnormalities.; Test Name: ejection fraction; Result Unstructured Data: Test Result:normal; Test Name: EKG; Result Unstructured Data: Test Result:showed normal sinus rhythm.; Test Name: Testing for Drug-induced and infectious causes of myocarditis; Test Result: Negative ; Test Name: Cardiac MRI; Result Unstructured Data: Test Result:subepicardial enhancement; Comments: along the lateral wall of left ventricular consistent with focal myocarditis.; Test Name: SARS-CoV-2 PCR; Test Result: Negative ; Comments: on nasopharyngeal swab testing on admission.; Test Name: Troponin I; Result Unstructured Data: Test Result:0.5 ng/ml; Comments: elevated