Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction, Productive cough, SARS-CoV-2 test
Clinical narrative: Two heart attacks/Leg stents failed after hearth attacks; Cardiogenic shock; Acute renal failure; ischemic cardiomyopathy; Phlegm/Cough; Lack of drug effect; tested positive for Covid 19; This spontaneous case was reported by a consumer and describes the occurrence of CARDIOGENIC SHOCK (Cardiogenic shock), ACUTE KIDNEY INJURY (Acute renal failure), ISCHAEMIC CARDIOMYOPATHY (ischemic cardiomyopathy), MYOCARDIAL INFARCTION (Two heart attacks/Leg stents failed after hearth attacks) and COVID-19 (tested positive for Covid 19) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052C21A and 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stent placement (stent put in her leg) on 16-Jun-2021, Stent placement (she also had stents put in her legs and because suffered the 2 heart attacks) in July 2021, Bypass surgery (leg bypass surgery) in September 2021 and Amputation above knee on 24-Dec-2021. Concurrent medical conditions included Penicillin allergy, Allergy to antibiotic (Amoxicillin), Allergy (Aspirin) and Diabetes. Concomitant products included INSULIN for Diabetes.   On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDIAL INFARCTION (Two heart attacks/Leg stents failed after hearth attacks) (seriousness criteria hospitalization and medically significant). On 31-Dec-2021, the patient experienced COVID-19 (tested positive for Covid 19) (seriousness criterion medically significant). On an unknown date, the patient experienced CARDIOGENIC SHOCK (Cardiogenic shock) (seriousness criteria death and medically significant), ACUTE KIDNEY INJURY (Acute renal failure) (seriousness criteria death and medically significant), ISCHAEMIC CARDIOMYOPATHY (ischemic cardiomyopathy) (seriousness criteria death and medically significant), PRODUCTIVE COUGH (Phlegm/Cough) and DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with SACUBITRIL, VALSARTAN (ENTRESTO) at an unspecified dose and frequency; RANOLAZINE at an unspecified dose and frequency; METOPROLOL at an unspecified dose and frequency; CLOPIDOGREL at an unspecified dose and frequency and ATORVASTATIN at an unspecified dose and frequency. The patient died on 23-Feb-2022. The reported cause of death was Ischemic cardiomyopathy, Cardiogenic shock and Acute renal failure. An autopsy was not performed. At the time of death, MYOCARDIAL INFARCTION (Two heart attacks/Leg stents failed after hearth attacks), COVID-19 (tested positive for Covid 19), PRODUCTIVE COUGH (Phlegm/Cough) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, SARS-CoV-2 test: positive (Positive) positive.         This case was linked to MOD-2022-566930 (Patient Link).  Company Comment: This spontaneous case concerns a 69-year-old old female patient with relevant concurrent condition of diabetes mellitus and medical history of stent placement for unspecified peripheral condition who experienced the fatal, unexpected, serious (medically significant) adverse events of special interest of Cardiogenic shock, Ischaemic cardiomyopathy and Acute kidney injury and twice reported unexpected, serious (hospitalization, medically significant) adverse event of special interest of Myocardial infarction and unexpected, serious (medically significant) adverse event of special interest of COVID-19 which occurred after receiving the second dose of mRNA-1273 vaccine. Patient developed chest pain a day after the second dose of vaccination. She was admitted in a hospital and diagnosed to have two episodes of Myocardial infarction. She was discharged and prescribed with Entresto, Ranolazine, Metoprolol, Clopidogrel and Atorvastatin. Her leg stents failed on the same month of vaccination thus she underwent peripheral vascular bypass surgery two months after. Approximately 5 months after vaccination, she underwent above the knee leg amputation for unknown indication. She was started on physical rehabilitation since then. Patient developed COVID-19 (with a positive SARS-CoV-2 test) approximately five months after the second dose of mRNA-1273 vaccine. Drug ineffective was also considered (COVID-19 occurred approximately five months post-completion of primary vaccination of mRNA-1273 and within the recommended dosing interval). It was mentioned that COVID-19 is contributory to the patient demise however the clinical presentation, diagnostic evaluation and treatment details was not reported in this case. Death occurred approximately seven months after second dose of mRNA-1273 vaccine. The cause of death was reported as Cardiogenic shock, Ischemic cardiomyopathy, and Acute renal failure. It is unknown if an autopsy was performed. Patient´s advanced age and concurrent condition remain as confounders for the events Myocardial infarction, Cardiogenic shock, Ischaemic cardiomyopathy and Acute kidney injury and the fatal outcome. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69-year-old old female patient with relevant concurrent condition of diabetes mellitus and medical history of stent placement for unspecified peripheral condition who experienced the fatal, unexpected, serious (medically significant) adverse events of special interest of Cardiogenic shock, Ischaemic cardiomyopathy and Acute kidney injury and twice reported unexpected, serious (hospitalization, medically significant) adverse event of special interest of Myocardial infarction and unexpected, serious (medically significant) adverse event of special interest of COVID-19 which occurred after receiving the second dose of mRNA-1273 vaccine. Patient developed chest pain a day after the second dose of vaccination. She was admitted in a hospital and diagnosed to have two episodes of Myocardial infarction. She was discharged and prescribed with Entresto, Ranolazine, Metoprolol, Clopidogrel and Atorvastatin. Her leg stents failed on the same month of vaccination thus she underwent peripheral vascular bypass surgery two months after. Approximately 5 months after vaccination, she underwent above the knee leg amputation for unknown indication. She was started on physical rehabilitation since then. Patient developed COVID-19 (with a positive SARS-CoV-2 test) approximately five months after the second dose of mRNA-1273 vaccine. Drug ineffective was also considered (COVID-19 occurred approximately five months post-completion of primary vaccination of mRNA-1273 and within the recommended dosing interval). It was mentioned that COVID-19 is contributory to the patient demise however the clinical presentation, diagnostic evaluation and treatment details was not reported in this case. Death occurred approximately seven months after second dose of mRNA-1273 vaccine. The cause of death was reported as Cardiogenic shock, Ischemic cardiomyopathy, and Acute renal failure. It is unknown if an autopsy was performed. Patient´s advanced age and concurrent condition remain as confounders for the events Myocardial infarction, Cardiogenic shock, Ischaemic cardiomyopathy and Acute kidney injury and the fatal outcome. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: ischemic cardiomyopathy; cardiogenic shock; acute renal failure