Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Myocarditis, Oropharyngeal pain, Pain, Poor quality sleep, Sleep disorder
Clinical narrative: myocarditis following SARS-CoV-2 vaccination; This is a literature report from the Regulatory Authority. 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 first of five reports.  An adult male patient (age reported as 35-40 years) 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 on an unspecified date. The patient with no infectious prodrome developed severe chest pain and elevated troponin I, 4 days after 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 positional and pleuritic chest and neck pain; chills; and myalgias. The patient underwent lab tests and procedures which included ejection fraction: 45 %  (normal > 55%), electrocardiogram: sinus rhythm with inferolateral ST elevation, Cardiac Magnetic Resonance Imaging (CMR): revealed patchy midmyocardial increased t2 signal (In each panel, T2-weighted sequences are on the left and late gadolinium (LGE) sequences are on the right. Short-axis and 4-chamber views demonstrating areas of increased T2 signal and LGE in the mid wall of the lateral segments (arrowheads) in a patient who received their second SARS-CoV-2 vaccination 5 days earlier.), nasopharyngeal SARS-CoV-2 PCR testing: negative and troponin I: 5.41 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 post-Emergency Use Authorization reports. Findings in the patient with suspected COVID-19 vaccine-associated myocarditis have not been well described in published reports, and the author's report tried 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, 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: A contributory role of BNT162B2 to the event myocarditis cannot be fully excluded based on temporal relationship and since it is part of the product safety profile. This case will be reassessed if additional information becomes available. Linked Report(s): US-PFIZER INC-202101048345 same article/drug/event, different patients; US-PFIZER INC-202101048365 same article/drug/event, different patients; US-PFIZER INC-202101048389 same article/drug/event, different patients; US-PFIZER INC-202101048410 same article/drug/event, different patients.