Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21B and 031M20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN for Blood pressure.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Dec-2021, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria hospitalization, medically significant and life threatening). The patient was hospitalized for 2 days due to MYOCARDIAL INFARCTION. The patient was treated with CLOPIDOGREL for Adverse event, at an unspecified dose and frequency; METOPROLOL for Adverse event, at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of 81 milligram. At the time of the report, MYOCARDIAL INFARCTION (heart attack) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concurrent condition included blood pressure. Patient reported he has had an adverse reaction after Moderna booster dose: A blood clot and heart attack. This happened on 13Dec2021. Patient went to ER and was  hospitalized or 2 days.   Company comment: This  spontaneous case concerns a 71-year-old male patient with a relevant medical history Hypertension, who experienced the unexpected serious (life threatening, medically significant and hospitalization) event of Myocardial infarction (AESI) after mRNA- 1273 vaccine. The event occurred approximately 17 days after the booster dose of mRNA- 1273 vaccine. Patient was hospitalized for 2 days. Dual antiplatelet therapy with aspirin and clopidogrel and metoprolol were given as treatments. Very limited information is available regarding clinical course. Underlying hypertension remains a confounder. The event was reported as life-threatening and was retained as such in line with EMA guideline on good pharmacovigilance practices. However, no evidence was reported to support an immediate risk of death. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This  spontaneous case concerns a 71-year-old male patient with a relevant medical history Hypertension, who experienced the unexpected serious (life threatening, medically significant and hospitalization) event of Myocardial infarction (AESI) after mRNA- 1273 vaccine. The event occurred approximately 17 days after the booster dose of mRNA- 1273 vaccine. Patient was hospitalized for 2 days. Dual antiplatelet therapy with aspirin and clopidogrel and metoprolol were given as treatments. Very limited information is available regarding clinical course. Underlying hypertension remains a confounder. The event was reported as life-threatening and was retained as such in line with EMA guideline on good pharmacovigilance practices. However, no evidence was reported to support an immediate risk of death. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.