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Administered by: Unknown Purchased by: ?
Life Threatening? Yes
Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION and BACK PAIN in a 71-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 626761A) for COVID-19 vaccination. The patient''s past medical history included Myocardial infarct (bypasses used) from 2002 to 2016 and Myocardial infarct (stents used) in 2002. Concomitant products included CLOPIDOGREL BISULFATE (TROMBEX) for Anticoagulant therapy, ACETYLSALICYLIC ACID (ANOPYRIN) for Antiplatelet therapy, RAMIPRIL (TRITACE) for Arterial hypertension, ALLOPURINOL (MILURIT) for Gout, ATORVASTATIN CALCIUM (SORTIS) for Hypercholesterolaemia, EZETIMIBE (EZEN) for Hyperlipidemia, CARVEDILOL (CORYOL [CARVEDILOL]) for an unknown indication. On 29-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 01-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced BACK PAIN (seriousness criterion life threatening). On 09-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (seriousness criteria death, medically significant and life threatening). The patient died on 09-Apr-2021. The reported cause of death was myocardial infarction. An autopsy was performed, but no results were provided. At the time of death, BACK PAIN had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. No treatment information was provided by the reporter. The patient consulted Cardiologist and was observed as everything was normal. Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. However patient?s medical history could be a confounder.; Sender''s Comments: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. However patient?s medical history could be a confounder.; Reported Cause(s) of Death: myocardial infarction
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