Sex: M
Vaccine: COVID19
Symptoms: Disease recurrence, Ejection fraction, Electrocardiogram, Electrocardiogram ST segment, Laboratory test
Clinical narrative: Recurrent MRI-documented myocarditis following Pfizer-BioNTech SARS-CoV-2 vaccination; Recurrent MRI-documented myocarditis following Pfizer-BioNTech SARS-CoV-2 vaccination; This is a literature report for the following literature source(s):   A 23-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "sharp, substernal chest pain" (unspecified if ongoing), notes: Four years later, he re-presented complaining of a 2-day history; "myocarditis", start date: 2017 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (medically significant), 3 days after the suspect product(s) administration, outcome "unknown", DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "Recurrent MRI-documented myocarditis following Pfizer-BioNTech SARS-CoV-2 vaccination". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: (unspecified date) normal; Angiocardiogram: (unspecified date) revealed no significant disease; Antinuclear antibody: (unspecified date) negative; Aspartate aminotransferase: (unspecified date) 62 IU/l; C-reactive protein: (unspecified date) 4.845 mg/dl; Ejection fraction: (2017) 56%; (2017) 64%; Electrocardiogram: (unspecified date) revealed ST segment, notes: elevations in V2- V3 with concave T-waves and no PR segment depression; (unspecified date) demonstrated preserved left, notes: ventricle (LV) systolic function, normal LV cavity size and wall thickness, normal wall motion, and no pericardial effusion; Electrocardiogram ST segment: (unspecified date) less pronounced, notes: compared to an EKG from outside hospital several hours before; Work-up for viral etiology: (unspecified date) negative; Magnetic resonance imaging heart: (unspecified date) revealed a new area of late, notes: gadolinium enhancement of the basal anterolateral wall restricted to the epicardium (arrow) seen on short axis and 4-chamber views; (unspecified date) showed an ejection fraction of 64%, notes: However, the LV had new hypokinesis of the mid-inferior and inferolateral segmen; (2017) showing inferior/inferolateral, notes: scar in the epicardium  history of myocarditis; (2017) LV ejection fraction on cardiac MRI was 56%; Troponin I: (unspecified date) 6.795 ng/ml; White blood cell count: (unspecified date) within normal limits.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between the suspect drug and the events 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.