Sex: M
Vaccine: COVID19
Symptoms: Ejection fraction, Electrocardiogram, Magnetic resonance imaging heart, Myocarditis, SARS-CoV-2 test
Clinical narrative: myocarditis following SARS-CoV-2 vaccination; Cardiovascular imaging, 2021, pp 1-2, DOI 10.1016/j.jcmg.2021.06.003 entitled A Series of Patients With Myocarditis Following SARS-CoV-2 Vaccination With mRNA-1279 and BNT162b2. This author reported similar events for five patients. This is the fourth of five reports.  An adult male patient (age reported as 16-20) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single; and via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient developed Cardiac Magnetic Resonance Imaging (CMR)-proven myocarditis shortly after vaccination. The patient with no infectious prodrome developed severe chest pain and elevated troponin I within 2 days-4 days of second vaccination. The patient did not develop any other complications and was discharged home. Lag between vaccination and presentation was 4 days. There was no fever. The symptoms at presentation included pleuritic and positional chest pain; headache. The patient underwent lab tests and procedures which included ejection fraction: 46 % (normal > 55%), electrocardiogram: Sinus rhythm with non-specific T wave abnormalities, Cardiac Magnetic Resonance Imaging (CMR): revealed patchy midmyocardial increased T2 signal with corresponding late gadolinium enhancement consistent with the acute inflammation of myocarditis (4-chamber view demonstrating areas of increased T2 signal and LGE in the subepicardial apical and apical lateral segments), nasopharyngeal SARS-CoV-2 PCR testing: negative and troponin I: 5.21 ng/ml. The outcome of the event was unknown.  Large clinical trials of both BNT162b2 and mRNA1273 in more than 70,000 individuals showed good safety profiles for both of the mRNA-based vaccines and no reports of myocarditis. However, myocarditis has been described after other vaccinations, such as seasonal influenza and smallpox and regulatory agencies are evaluating the risk of COVID-19 vaccine-associated myocarditis based on reports. Findings in patients with suspected COVID-19 vaccine-associated myocarditis have not been well described in published reports, and the author's report tries to document some of these changes. Although the clinical presentation, Findings, and temporal association strongly suggest the possibility of vaccine associated myocarditis in the patient, the authors cannot conclude definitively that COVID-19 vaccine was causative or that other etiologies for myocarditis can be definitively excluded in the patient. Nevertheless, clinicians should be suspicious of myocarditis in recently vaccinated patients with symptoms consistent with this diagnosis.  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 currently available,The casual association between the reported event and suspected vaccine BNT162B2 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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202100999284 same article/drug/event, different patients