Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer, Myocarditis
Clinical narrative: Myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 60-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.       No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). The patient was treated with DOPAMINE for Myocarditis, at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiogram: unremarkable for pulmonary embolism Unremarkable for pulmonary embolism. On an unknown date, C-reactive protein: elevated (High) Elevated CRP. On an unknown date, Computerised tomogram coronary artery: unremarkable for coronary artery disease Unremarkable for coronary artery disease. On an unknown date, Echocardiogram: marked global hypokinesis, severe dilatation, an e Marked global hypokinesis, severe dilatation, an ejection fraction of less than 15% and grade 3 diastolic dysfunction of the left ventricle. On an unknown date, Ejection fraction: 35-40% with marked improvement 35-40% with marked improvement. On an unknown date, Fibrin D dimer: elevated (High) Elevated D-Dimer level.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered MYOCARDITIS (Myocarditis) to be related.    No concomitant medication was provided by reporter. Patient presented with new onset heart failure (NHYA class 4) symptoms.Viral panel for common virus causing myocarditis was negative.The patient was symptomatically treated initially with dopamine drip and intravenous diuretics and later transitioned to oral diuretics and beta-blockers on discharge. On follow up 2-3 months later, significant increase in the ejection fraction to 35-40% with marked improvement and reduction in left ventricular chamber size was noted.Patient did not meet the criteria for Multisystem inflammatory syndrome in Adults and immunoglobulin therapy was not used.  Company Comment: This literature non-study case concerns a 60-year-old, male patient with reported no medical history who experienced the expected, serious (hospitalized, medically significant) adverse event of special interest of Myocarditis which occurred four weeks after receiving the first dose of mRNA-1273 vaccine. It has been reported that patient had symptoms of heart failure four weeks after receiving the first dose of mRNA-1274 vaccine. He was admitted in a hospital. Laboratory workup revealed elevated CRP and D-Dimer levels. The 2-D echocardiogram showed marked global hypokinesia, severe dilatation, grade 3 diastolic dysfunction of the left ventricle and an ejection fraction of less than 15%. CT coronary scoring and CT Angiography of pulmonary vasculature were unremarkable. Viral panel was negative. He was managed as a case of myocarditis and was symptomatically treated with dopamine drip and intravenous diuretics. On discharge, he was prescribed with oral diuretics and beta-blockers. Two to three months after hospital admission, there was a significant increase in the ejection fraction to 35-40% with marked improvement and reduction in left ventricular chamber size was noted. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This literature non-study case concerns a 60-year-old, male patient with reported no medical history who experienced the expected, serious (hospitalized, medically significant) adverse event of special interest of Myocarditis which occurred four weeks after receiving the first dose of mRNA-1273 vaccine. It has been reported that patient had symptoms of heart failure four weeks after receiving the first dose of mRNA-1274 vaccine. He was admitted in a hospital. Laboratory workup revealed elevated CRP and D-Dimer levels. The 2-D echocardiogram showed marked global hypokinesia, severe dilatation, grade 3 diastolic dysfunction of the left ventricle and an ejection fraction of less than 15%. CT coronary scoring and CT Angiography of pulmonary vasculature were unremarkable. Viral panel was negative. He was managed as a case of myocarditis and was symptomatically treated with dopamine drip and intravenous diuretics. On discharge, he was prescribed with oral diuretics and beta-blockers. Two to three months after hospital admission, there was a significant increase in the ejection fraction to 35-40% with marked improvement and reduction in left ventricular chamber size was noted. The benefit-risk relationship of mRNA-1273 is not affected by this report.