Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Catheterisation cardiac, Echocardiogram, Stress cardiomyopathy, Troponin I
Clinical narrative: Myocardial infarction from nonobstructive coronary arteries (MINOCA); Takotsubo cardiomyopathy; This literature-non-study case was reported in a literature article.     No Medical History information was reported.  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 ACUTE MYOCARDIAL INFARCTION (Myocardial infarction from nonobstructive coronary arteries (MINOCA)) (seriousness criterion medically significant) and STRESS CARDIOMYOPATHY (Takotsubo cardiomyopathy) (seriousness criterion medically significant). At the time of the report, ACUTE MYOCARDIAL INFARCTION (Myocardial infarction from nonobstructive coronary arteries (MINOCA)) and STRESS CARDIOMYOPATHY (Takotsubo cardiomyopathy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Catheterisation cardiac: showed mild atherosclerosis. On an unknown date, Echocardiogram: revealed a left-ventricular ejection-fraction (LVEF) of 20-25% with a pattern consistent with Takotsubo cardiomyopathy. On an unknown date, Troponin I (0-0.039 ng/mL): 4.6 ng/mL.  For mRNA-1273 (Spikevax) (Unknown), the reporter considered ACUTE MYOCARDIAL INFARCTION (Myocardial infarction from nonobstructive coronary arteries (MINOCA)) and STRESS CARDIOMYOPATHY (Takotsubo cardiomyopathy) to be related.    No concomitant or treatment medications were reported.  Patient was presented with troponin elevation after receiving their COVID mRNA vaccine.  Author stated that two days after receiving moderna vaccine patient felt fatigue, chest pain, and pre-syncope.  Author concluded that the cardiac injury would be primarily caused by a hyperinflammatory response and might not be viral myocardial infiltration itself. The mRNA vaccines, like SARS-CoV-2 infection elicits an immune response that attacks the myocardium and author believed that Myocardial Infarction from Non-Obstructive Coronary Arteries (MINOCA) should be reported as an adverse reaction to the vaccine.  Company Comment: This literature non study case concerns 93-year-old elderly female patient with no prior medical history reported, who experienced the unexpected, serious (Medically significant) AESI events of Acute myocardial infarction (reported as Myocardial infarction from nonobstructive coronary arteries (MINOCA)) and Stress cardiomyopathy that occurred two days after second dose of mRNA-1273 vaccination. It was reported that patient felt fatigue, chest pain, and pre-syncope. Her troponin-I was significantly elevated to 4.6 ng/ml (ref. 0-0.039). Other causes of myocardial infarction were ruled out using echocardiography and cardiac catheterization. Echocardiogram revealed a left-ventricular ejection-fraction (LVEF) of 20-25% with a pattern consistent with Takotsubo cardiomyopathy. Cardiac catheterization showed mild atherosclerosis. No information on risk factors, co morbidities, detailed clinical course, management of the event and the outcome was available in the report. Author concludes that the cardiac injury could be primarily caused by a hyperinflammatory response and may not be viral myocardial infiltration itself. The mRNA vaccines, like SARS-CoV-2 infection elicits an immune response that attacks the myocardium. Advancing age of the patient remains as risk factor for the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-715572 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2023: Live follow up received by safety on 16-Mar-2023 has Email with information received and contains new updates. Reporter and literature information were updated.; Sender's Comments: This literature non study case concerns 93-year-old elderly female patient with no prior medical history reported, who experienced the unexpected, serious (Medically significant) AESI events of Acute myocardial infarction (reported as Myocardial infarction from nonobstructive coronary arteries (MINOCA)) and Stress cardiomyopathy that occurred two days after second dose of mRNA-1273 vaccination. It was reported that patient felt fatigue, chest pain, and pre-syncope. Her troponin-I was significantly elevated to 4.6 ng/ml (ref. 0-0.039). Other causes of myocardial infarction were ruled out using echocardiography and cardiac catheterization. Echocardiogram revealed a left-ventricular ejection-fraction (LVEF) of 20-25% with a pattern consistent with Takotsubo cardiomyopathy. Cardiac catheterization showed mild atherosclerosis. No information on risk factors, co morbidities, detailed clinical course, management of the event and the outcome was available in the report. Author concludes that the cardiac injury could be primarily caused by a hyperinflammatory response and may not be viral myocardial infiltration itself. The mRNA vaccines, like SARS-CoV-2 infection elicits an immune response that attacks the myocardium. Advancing age of the patient remains as risk factor for the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2023-715572:71 Year Old Female Case