Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Ejection fraction, Electrocardiogram, Magnetic resonance imaging, Myocarditis
Clinical narrative: acute myocarditis 3 days after 2nd dose; This is a literature report from License Party for the following literature source(s).  A 56-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: "SARS-CoV-2 infection" (unspecified if ongoing), notes: without need for hospitalization. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant), 3 days after the suspect product(s) administration, outcome "recovered", described as "acute myocarditis 3 days after 2nd dose". The patient underwent the following laboratory tests and procedures: C-reactive protein: 5.8; Ejection fraction: 60 %, notes: inferolateral hypokinesia; Electrocardiogram: results below, notes: Diffuse peaked T waves; Magnetic resonance imaging: results below, notes: Edema delayed enhancement; SARS-CoV-2 test: negative; Troponin: 21; 37. Therapeutic measures were not taken as a result of myocarditis.  Clinical course: The article describes 8 patients who were hospitalized with chest pain and who were diagnosed with myocarditis by laboratory and cardiac magnetic resonance imaging within 2 to 4 days of receiving either the BNT162b2 or mRNA-1273 vaccine. Patients provided written informed consent, and the collection of clinical cases followed local Institutional Review Board requirements. The data that support the findings of this study are available from the corresponding author on reasonable request. Two of the patients (patients 3 and 4) had previously been infected by SARS-CoV-2 without need for hospitalization. All individuals were otherwise healthy males between the ages of 21 and 56 years. All but 1 patient developed symptoms after their second dose. Systemic symptoms began within 24 hours after vaccine administration in 5 out of 8 patients, with chest pain presenting between 48 and 96 hours later. Chest pain was most commonly described as constant. Troponin values were elevated in all individuals and appeared to peak the day after admission, whereas no patient had eosinophilia. All patients were tested and were negative for SARS-CoV-2. Left ventricular ejection fraction was reduced (<50%) in 2 of 8 (25%) patients with a median left ventricular ejection fraction of 51.5% (first to third quartile, 48% to 59%). Five patients demonstrated regional wall motion abnormalities with inferior and inferolateral walls involved, and the remaining 3 cases had generalized hypokinesis. Some patients were tachycardic at presentation, but no patients required inotropes or mechanical circulatory support. On average, our patients presented with symptoms of acute myocarditis 3 days after the second injection. Hemodynamically stable.  SUSPECT PRODUCT is under agreement with BIONTECH SE.; Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported event myocarditis  and suspect BNT162B2 cannot be excluded. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.