Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myocardial infarction, Peripheral swelling, Vaccination site pain
Clinical narrative: had another heart attack¨; ¨Had 2 heart attacks¨; ¨Swollen feet¨; ¨Was very fatigued with little walking¨; ¨A lot of pain in the arm of the injection ¨( left arm); This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (¨Had 2 heart attacks¨) and MYOCARDIAL INFARCTION (had another heart attack¨) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Automated external defibrillator user (HOSPITALISED (07-MAY-2021 - 13-MAY-2021)), Coronary artery bypass graft (HOSPITALISED (07-MAY-2021 - 13-MAY-2021)) and Catheterization cardiac (HOSPITALISED (07-MAY-2021 - 13-MAY-2021)). Concurrent medical conditions included Diabetes, Blood pressure high and Hypertension (not adequately controlled "has high blood pressure levels but it is not constant so he doesn´t take medication for that".). Concomitant products included METFORMIN for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced VACCINATION SITE PAIN (¨A lot of pain in the arm of the injection ¨( left arm)). On 07-May-2021, the patient experienced MYOCARDIAL INFARCTION (¨Had 2 heart attacks¨) (seriousness criteria hospitalization and medically significant). On 13-May-2021, the patient experienced PERIPHERAL SWELLING (¨Swollen feet¨) and FATIGUE (¨Was very fatigued with little walking¨). On 20-May-2021, the patient experienced MYOCARDIAL INFARCTION (had another heart attack¨) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 07-May-2021 to 13-May-2021 due to MYOCARDIAL INFARCTIONThe patient was hospitalized from 07-May-2021 to 13-May-2021 due to MYOCARDIAL INFARCTION The patient was treated with TICAGRELOR (BRILINTA) from 07-May-2021 to 13-May-2021 at an unspecified dose and frequency; ATORVASTATIN CALCIUM (LIPITOL) from 07-May-2021 to 13-May-2021 at an unspecified dose and frequency; BROMAZEPAM (LAXYL [BROMAZEPAM]) from 13-May-2021 to 20-May-2021 at an unspecified dose and frequency; CARVEDILOL from 13-May-2021 to 20-May-2021 at an unspecified dose and frequency; CLOPIDOGREL from 13-May-2021 to 20-May-2021 at an unspecified dose and frequency; ACETYLSALICYLIC ACID (ASPRIN) from 13-May-2021 to 20-May-2021 at an unspecified dose and frequency; VALSARTAN from 13-May-2021 to 20-May-2021 at an unspecified dose and frequency and SPIRONOLACTONE from 13-May-2021 to 20-May-2021 at an unspecified dose and frequency. On 07-May-2021, VACCINATION SITE PAIN (¨A lot of pain in the arm of the injection ¨( left arm)) had resolved. On 20-May-2021, FATIGUE (¨Was very fatigued with little walking¨) had resolved. At the time of the report, MYOCARDIAL INFARCTION (¨Had 2 heart attacks¨) and MYOCARDIAL INFARCTION (had another heart attack¨) had resolved and PERIPHERAL SWELLING (¨Swollen feet¨) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took the 1st dose of the vaccine on 28apr2021 and referred a lot of pain in the arm of the injection. On 07may2021 he was diagnosed with myocardial infarction and was hospitalized. On 13may2021 the patient got discharged to home with oral medication and an external defibrillator. During this period he had swollen feet and extreme fatigue. On 20may2021 the patient had another myocardial infarction, is currently hospitalized receiving Tridil as treatment and is requires a heart transplant.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However the patient's comorbidities (diabetes and hypertension) are risk factors for myocardial infarction and pose as confounders of this event. Since the most recent event of myocardial infarction is life-threatening further information was requested regarding the event outcome.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However the patient's comorbidities (diabetes and hypertension) are risk factors for myocardial infarction and pose as confounders of this event. Since the most recent event of myocardial infarction is life-threatening further information was requested regarding the event outcome.