Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Blood pressure measurement, Coronary artery disease, Echocardiogram, Electrocardiogram
Clinical narrative: Myocarditis; CAD; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 69-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.   Concurrent medical conditions included Hypertension (mild).    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant) and CORONARY ARTERY DISEASE (CAD). The patient was treated with SACUBITRIL;VALSARTAN at an unspecified dose and frequency; SPIRONOLACTONE at an unspecified dose and frequency; FUROSEMIDE at an unspecified dose and frequency and CARVEDILOL at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (Myocarditis) had resolved and CORONARY ARTERY DISEASE (CAD) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiogram: showed minimal CAD.. On an unknown date, Blood pressure measurement: 125/79. On an unknown date, Echocardiogram: revealed severely reduced left ventricle systolic function with an ejection fraction (LVEF) 20-25%, normal right ventricle, and unremarkable valvular structures. and showed improvement in LVEF to 40%.. On an unknown date, Electrocardiogram: showed sinus rhythm with frequent premature complexes.. On an unknown date, Heart rate: 80. On an unknown date, Magnetic resonance imaging: Imaging sequences included black blood single-shot fast spin echo, bright blood balanced steady-state free precession gradient echo, T1 weighted inversion recovery early gadolinium enhanced (EGE) and late gadolinium enhanced (LGE) imaging. EGE and LGE were obtained 3 minutes and 7-10 minutes after single dose (0.1 mM/kg) of gadobenate  dimeglumine    intravenous contrast, respectively. LGE short axis image demonstrates mid LV anteroseptal, inferoseptal mid wall and inferior, inferolateral wall sub epicardial enhancement. EGE short axis image demonstrates mid LV anteroseptal, inferoseptal mid wall and inferior, inferolateral wall sub epicardial enhancement sub epicardial enhancement suggesting hyperemia. T2-weighted black-blood short axis image demonstrates mid LV anteroseptal, inferoseptal, inferior and inferolateral wall edema.. On an unknown date, Magnetic resonance imaging heart: showed LVEF of 38% and myocardial edema involving the basal and mid inferoseptal, inferior and inferolateral walls in a pattern consistent with myocarditis.. On an unknown date, N-terminal prohormone brain natriuretic peptide: elevated at 1586. On an unknown date, Oxygen saturation: 96 % on room air. On an unknown date, Physical examination: lungs are clear to auscultation, no murmurs or rubs, with no lower extremity swelling.. On an unknown date, Respiratory rate: 15.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered MYOCARDITIS (Myocarditis) and CORONARY ARTERY DISEASE (CAD) to be related.    No concomitant medications were reported. It was reported that the patien presented to the office after developing acute shortness of breath a few days after receiving second dose. The patient was active and exercises daily. His presentation was gradual worsening dyspnea on exertion over a few days combined with orthopnea and paroxysmal nocturnal dyspnea (PND). The patient was started on goal-directed medical therapy. It was stated that his symptoms resolved with medical therapy. At the time of report he was pending a repeat echocardiogram to reevaluate his left ventricular systolic function. At 5 weeks outpatient follow-up, he did well, able to do daily activities without any discomfort.  This literature non-study case concerns a 69-year-old active male patient, with past medical history of mild hypertension, who experienced the expected and serious (due to medically significant) AESI of Myocarditis. He presented to the office after developing acute shortness of breath a few days after receiving mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. His presentation was gradual worsening dyspnea on exertion over a few days combined with orthopnea and paroxysmal nocturnal dyspnea. On physical exam, lungs were clear to auscultation, no murmurs or rubs, with no lower extremity swelling. He was normotensive with blood pressure of 125/79, respiratory rate of 15, heart rate of 80, and oxygen saturation of 96% on room air. Electrocardiography (ECG) showed sinus rhythm with frequent premature complexes. His Pro B-natriuretic peptide was elevated at 1586. His echocardiogram (ECHO) revealed severely reduced left ventricle systolic function with an ejection fraction (LVEF) of 20-25%, normal right ventricle, and unremarkable valvular structures. His workup included a CT angiogram of the chest with minimal coronary artery disease. A cardiac magnetic resonance imaging showed LVEF of 38% and myocardial edema involving the basal and mid inferoseptal, inferior and inferolateral walls in a pattern consistent with myocarditis. He was started on goal-directed medical therapy with sacubitril-valsartan, spironolactone, furosemide, and carvedilol. His symptoms resolved with medical therapy. At 5 weeks outpatient follow-up, he did well, able to do daily activities without any discomfort. Repeat ECHO showed improvement in LVEF to 40%. Mild hypertension could be a contributory factor for coronary artery disease. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2022: Live follow up received by safety on 02-DEC-2022 has Email with FTA received contains significant information: Reporter information, Patient details, medical history, lab details, clinical course details updated.; Sender's Comments: This literature non-study case concerns a 69-year-old active male patient, with past medical history of mild hypertension, who experienced the expected and serious (due to medically significant) AESI of Myocarditis. He presented to the office after developing acute shortness of breath a few days after receiving mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. His presentation was gradual worsening dyspnea on exertion over a few days combined with orthopnea and paroxysmal nocturnal dyspnea. On physical exam, lungs were clear to auscultation, no murmurs or rubs, with no lower extremity swelling. He was normotensive with blood pressure of 125/79, respiratory rate of 15, heart rate of 80, and oxygen saturation of 96% on room air. Electrocardiography (ECG) showed sinus rhythm with frequent premature complexes. His Pro B-natriuretic peptide was elevated at 1586. His echocardiogram (ECHO) revealed severely reduced left ventricle systolic function with an ejection fraction (LVEF) of 20-25%, normal right ventricle, and unremarkable valvular structures. His workup included a CT angiogram of the chest with minimal coronary artery disease. A cardiac magnetic resonance imaging showed LVEF of 38% and myocardial edema involving the basal and mid inferoseptal, inferior and inferolateral walls in a pattern consistent with myocarditis. He was started on goal-directed medical therapy with sacubitril-valsartan, spironolactone, furosemide, and carvedilol. His symptoms resolved with medical therapy. At 5 weeks outpatient follow-up, he did well, able to do daily activities without any discomfort. Repeat ECHO showed improvement in LVEF to 40%. Mild hypertension could be a contributory factor for coronary artery disease. The benefit-risk relationship of mRNA-1273 is not affected by this report.