Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Myocardial infarction, Myocarditis
Clinical narrative: admitted because of heart attack and pain to the chest on MAY2021; Caregiver called to inform us that her husband, age 75 years is suffering from Myocarditis; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYOCARDITIS (Caregiver called to inform us that her husband, age 75 years is suffering from Myocarditis) and MYOCARDIAL INFARCTION (admitted because of heart attack and pain to the chest on MAY2021) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In May 2021, the patient experienced MYOCARDIAL INFARCTION (admitted because of heart attack and pain to the chest on MAY2021) (seriousness criteria hospitalization and medically significant). In September 2021, the patient experienced MYOCARDITIS (Caregiver called to inform us that her husband, age 75 years is suffering from Myocarditis) (seriousness criterion medically significant). The patient was hospitalized on sometime in May 2021 due to MYOCARDIAL INFARCTION. The patient was treated with SACUBITRIL, VALSARTAN (ENTRESTO) at an unspecified dose and frequency; APIXABAN (ELIQUIS) at an unspecified dose and frequency; ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency and ATORVASTATIN CALCIUM (LIPITOR) at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (Caregiver called to inform us that her husband, age 75 years is suffering from Myocarditis) had not resolved and MYOCARDIAL INFARCTION (admitted because of heart attack and pain to the chest on MAY2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: He had something called injection rate (How your heart outputs blood; His went down to 30 % for the normal capacity, his puls was erratic. Myocarditis..         It was unknown if the patient receives any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient was extremely fit, having been a swimmer in his youth. Patient did not had history of covid-19 infection and did not had history of myocarditis or pericarditis.  Concomitant product use was not provided by the reporter.  On May-2021, patient was admitted to hospital because of heart attack and pain to the chest. Patient was shifted to another hospital for an unspecified procedure.  On Sep-2021, the patient developed cardiac issues including fatigue, shortness of breath. This prompted them to visit a cardiologist. After completing some tests, the myocarditis diagnosis was made. Patient had some chest pain not a lot, mostly tired. sometimes short of breath, dizzy, dyspnea (Difficult/labored breathing). Patient also had dyspnea exertional, he had sensation of running out of the air and of not being able to breathe fast or deeply enough during physical activity. He pushes himself. Also had palpitations. Physician made him wear a monitor, his heartbeat was very low, Painful respiration. Patient started experiencing shortness of breath, fatigue, heart related issues noticed it was 6 months after receiving the Moderna COVID-19.  Patient was treated with Entresto for heart medicine used in adults with chronic (long-term) heart failure, Eliquis to prevent serious blood clots, Aspirin and Lipitor.   This case was linked to US-MODERNATX, INC.-MOD-2024-759814 (E2B Linked Report).  Company Comment: This spontaneous case concerns a 75-year-old male patient, with no reported medical history, who experienced the unexpected and serious (Medically significant and Hospitalization) AESI of MYOCARDIAL INFARCTION approximately 2 months after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine), and the expected and serious (Medically significant) event of MYOCARDITIS that occurred approximately 6 months after vaccination. He experienced fatigue, shortness of breath, chest pain, palpitations, dizzy, dyspnea exertional, and sensation of running out of the air during physical activity. An echocardiogram the injection rate went down to 30 % for the normal capacity and his pulse was erratic. On a monitor, his heartbeat was very low. He was admitted because of heart attack and chest pain and was treated with Entresto, Eliquis, Aspirin and Lipitor. He was shifted to another hospital for an unspecified procedure. No further clinical information was available for medical review. Patient´s age remains as a confounder for MYOCARDIAL INFARCTION. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-759814:Invalid case