Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiomegaly, Chest X-ray, Chest pain, Chronic left ventricular failure, Condition aggravated
Clinical narrative: Sudden cardiac death; Acute kidney injury; Atrial fibrillation; Cardiac arrest; Cardio-respiratory arrest; Cardiomegaly; Chest pain; Chronic left ventricular failure; Condition aggravated; Decreased appetite; Dehydration; Diastolic dysfunction; Dyspnoea; Fall; Fatigue; Feeding disorder; Fluid intake reduced; Hypokalaemia; Hypotension; Hypovolaemia; Malaise; Palpitations; Renal impairment; Renal tubular necrosis; Sleep apnoea syndrome; Tachycardia; This case was received via DA VAERS (Reference number: 1391483) on 22-Jun-2021 and was forwarded to Moderna on 22-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of SUDDEN CARDIAC DEATH (Sudden cardiac death), ACUTE KIDNEY INJURY (Acute kidney injury), ATRIAL FIBRILLATION (Atrial fibrillation), CARDIAC ARREST (Cardiac arrest), CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest), CARDIOMEGALY (Cardiomegaly), CHEST PAIN (Chest pain), CHRONIC LEFT VENTRICULAR FAILURE (Chronic left ventricular failure), CONDITION AGGRAVATED (Condition aggravated), DECREASED APPETITE (Decreased appetite), DEHYDRATION (Dehydration), DIASTOLIC DYSFUNCTION (Diastolic dysfunction), DYSPNOEA (Dyspnoea), FALL (Fall), FATIGUE (Fatigue), FEEDING DISORDER (Feeding disorder), FLUID INTAKE REDUCED (Fluid intake reduced), HYPOKALAEMIA (Hypokalaemia), HYPOTENSION (Hypotension), HYPOVOLAEMIA (Hypovolaemia), MALAISE (Malaise), PALPITATIONS (Palpitations), RENAL IMPAIRMENT (Renal impairment), RENAL TUBULAR NECROSIS (Renal tubular necrosis), SLEEP APNOEA SYNDROME (Sleep apnoea syndrome) and TACHYCARDIA (Tachycardia) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Coronary artery disease, Congestive heart failure, Hypertension, Atrial fibrillation (Chronic Afib), Pulmonary hypertension, Cholecystectomy, Hernia repair, Tonsillectomy and Anticoagulant therapy on 02-Apr-2021. Concomitant products included CHLORTHALIDONE, LOSARTAN POTASSIUM (LOSARTAN POTASSIUM ACCORD), MELOXICAM and METOPROLOL SUCCINATE for an unknown indication.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced ACUTE KIDNEY INJURY (Acute kidney injury) (seriousness criteria hospitalization, medically significant and life threatening), ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criteria hospitalization, medically significant and life threatening), CARDIAC ARREST (Cardiac arrest) (seriousness criteria hospitalization, medically significant and life threatening), CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) (seriousness criteria hospitalization, medically significant and life threatening), CARDIOMEGALY (Cardiomegaly) (seriousness criteria hospitalization and life threatening), CHEST PAIN (Chest pain) (seriousness criteria hospitalization and life threatening), CHRONIC LEFT VENTRICULAR FAILURE (Chronic left ventricular failure) (seriousness criteria hospitalization and life threatening), CONDITION AGGRAVATED (Condition aggravated) (seriousness criteria hospitalization and life threatening), DECREASED APPETITE (Decreased appetite) (seriousness criteria hospitalization and life threatening), DEHYDRATION (Dehydration) (seriousness criteria hospitalization and life threatening), DIASTOLIC DYSFUNCTION (Diastolic dysfunction) (seriousness criteria hospitalization and life threatening), DYSPNOEA (Dyspnoea) (seriousness criteria hospitalization and life threatening), FALL (Fall) (seriousness criteria hospitalization and life threatening), FATIGUE (Fatigue) (seriousness criteria hospitalization and life threatening), FEEDING DISORDER (Feeding disorder) (seriousness criteria hospitalization and life threatening), FLUID INTAKE REDUCED (Fluid intake reduced) (seriousness criteria hospitalization and life threatening), HYPOKALAEMIA (Hypokalaemia) (seriousness criteria hospitalization, medically significant and life threatening), HYPOTENSION (Hypotension) (seriousness criteria hospitalization and life threatening), HYPOVOLAEMIA (Hypovolaemia) (seriousness criteria hospitalization and life threatening), MALAISE (Malaise) (seriousness criteria hospitalization and life threatening), PALPITATIONS (Palpitations) (seriousness criteria hospitalization and life threatening), RENAL IMPAIRMENT (Renal impairment) (seriousness criteria hospitalization, medically significant and life threatening), RENAL TUBULAR NECROSIS (Renal tubular necrosis) (seriousness criteria hospitalization, medically significant and life threatening), SLEEP APNOEA SYNDROME (Sleep apnoea syndrome) (seriousness criteria hospitalization and life threatening) and TACHYCARDIA (Tachycardia) (seriousness criteria hospitalization and life threatening). The patient died on 10-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ACUTE KIDNEY INJURY (Acute kidney injury), ATRIAL FIBRILLATION (Atrial fibrillation), CARDIAC ARREST (Cardiac arrest), CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest), CARDIOMEGALY (Cardiomegaly), CHEST PAIN (Chest pain), CHRONIC LEFT VENTRICULAR FAILURE (Chronic left ventricular failure), CONDITION AGGRAVATED (Condition aggravated), DECREASED APPETITE (Decreased appetite), DEHYDRATION (Dehydration), DIASTOLIC DYSFUNCTION (Diastolic dysfunction), DYSPNOEA (Dyspnoea), FALL (Fall), FATIGUE (Fatigue), FEEDING DISORDER (Feeding disorder), FLUID INTAKE REDUCED (Fluid intake reduced), HYPOKALAEMIA (Hypokalaemia), HYPOTENSION (Hypotension), HYPOVOLAEMIA (Hypovolaemia), MALAISE (Malaise), PALPITATIONS (Palpitations), RENAL IMPAIRMENT (Renal impairment), RENAL TUBULAR NECROSIS (Renal tubular necrosis), SLEEP APNOEA SYNDROME (Sleep apnoea syndrome) and TACHYCARDIA (Tachycardia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood creatinine: increased (Inconclusive) increased. On 02-Apr-2021, Chest X-ray: abnormal (abnormal) CXR showed enlarged cardiac silhouette.. On 02-Apr-2021, Echocardiogram: normal (normal) normal. On 02-Apr-2021, Ejection fraction: normal (normal) 55-60% with Grade 1 diastolic dysfunction. On 02-Apr-2021, Electrocardiogram: abnormal (abnormal) atrial fibrillation. On 02-Apr-2021, Myocardial necrosis marker: normal (Negative) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Advanced Cardiovascular Life Support (ACLS) was performed and despite maximal effort, the patient subsequently expired at 0737.  Company Comment : This is a case of death in a 66-year-old male patient with medical history of Coronary artery disease, Congestive heart failure, Hypertension, Chronic Atrial fibrillation and Pulmonary hypertension, that occurred 10 days after receiving second dose of vaccine (Lot number unknown). The patient experienced sudden cardiac death during hospitalization for worsening dyspnea in the past weeks prior to hospitalization. No further information is expected.; Sender's Comments: This is a case of death in a 66-year-old male patient with medical history of Coronary artery disease, Congestive heart failure, Hypertension, Chronic Atrial fibrillation and Pulmonary hypertension, that occurred 10 days after receiving second dose of vaccine (Lot number unknown). The patient experienced sudden cardiac death during hospitalization for worsening dyspnea in the past weeks prior to hospitalization. No further information is expected.; Reported Cause(s) of Death: unknown cause of death