Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Somnolence, Vaccination failure
Clinical narrative: Heart disease/heart is not pumping as it should; No energy/hard time trying to be awake and coherent; hard time trying to be awake and coherent; hard time trying to be awake and coherent; Tested positive for COVID on 26-Jul-2022 after 2nd shot of Moderna Vaccine on 12-Jun-2021; COVID-19; Massive heart attack; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL INFARCTION (Massive heart attack) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient had no allergies.  The patient's past medical history included Umbilical hernia and Neck surgery (2 neck surgeries) in 2009. Concomitant products included LISINOPRIL and CARVEDILOL for an unknown indication.   On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced MYOCARDIAL INFARCTION (Massive heart attack) (seriousness criterion medically significant). On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19) and VACCINATION FAILURE (Tested positive for COVID on 26-Jul-2022 after 2nd shot of Moderna Vaccine on 12-Jun-2021). On an unknown date, the patient experienced CARDIAC DISORDER (Heart disease/heart is not pumping as it should), ASTHENIA (No energy/hard time trying to be awake and coherent), INCOHERENT (hard time trying to be awake and coherent) and SOMNOLENCE (hard time trying to be awake and coherent). At the time of the report, MYOCARDIAL INFARCTION (Massive heart attack), CARDIAC DISORDER (Heart disease/heart is not pumping as it should) and ASTHENIA (No energy/hard time trying to be awake and coherent) had not resolved and COVID-19 (COVID-19), VACCINATION FAILURE (Tested positive for COVID on 26-Jul-2022 after 2nd shot of Moderna Vaccine on 12-Jun-2021), INCOHERENT (hard time trying to be awake and coherent) and SOMNOLENCE (hard time trying to be awake and coherent) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jul-2022, SARS-CoV-2 test: (Positive) Positive.         The patient do not experienced any similar event in the past. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The patient had to go to another city for two days of testing (sonogram) and to find what was the issue. He now had heart disease and was on medication for the rest of his life. The patient explains that if he gets an infection, it can cause another heart attack. He states that he doesn't think the vaccines were safe.  The symptoms were neither, maintained.  Company comment: This is a spontaneous case concerning a 36 year-old, male patient with no relevant medical history, who experienced the serious (due to medically important condition) unexpected, AESI of Myocardial infarction and the non-serious unexpected event of COVID-19. The event Myocardial infarction occurred approximately 5 months after the second dose of mRNA-1273 vaccine and the event COIVD-19 occurred approximately 1 year 1 month after the second dose. The patient sought medical care in the emergency department. An ultrasound was performed, no results were provided. It was reported he had a hard time trying to be awake and coherent, he has no energy and now has heart disease and is on medication for life. Additionally, vaccination failure was considered in the case since the primary vaccination with 2 doses of mRNA-1273 vaccine was administered. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-656994 (E2B Linked Report).; Sender's Comments: Company Comment: This is a spontaneous case concerning a 36 year-old, male patient with no relevant medical history, who experienced the serious (due to medically important condition) unexpected, AESI of Myocardial infarction and the non-serious unexpected event of COVID-19. The event Myocardial infarction occurred approximately 5 months after the second dose of mRNA-1273 vaccine and the event COIVD-19 occurred approximately 1 year 1 month after the second dose. The patient sought medical care in the emergency department. An ultrasound was performed, no results were provided. It was reported he had a hard time trying to be awake and coherent, he has no energy and now has heart disease and is on medication for life. Additionally, vaccination failure was considered in the case since the primary vaccination with 2 doses of mRNA-1273 vaccine was administered. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-656994:other patients case