Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Diabetic ketoacidosis, Endotracheal intubation, Extubation, Hypervolaemia, Intensive care
Clinical narrative: ACUTE MYOCARDIAL INFARCTION; ACUTE RESPIRATORY FAILURE; COVID-19 PNEUMONIA; DIABETIC KETOACIDOSIS; CARDIAC ARREST; VENTRICULAR FIBRILLATION; ATRIAL FIBRILLATION; HYPERVOLAEMIA; POLYURIA; ENDOTRACHEAL INTUBATION; EXTUBATION; PERCUTANEOUS CORONARY INTERVENTION; SARS-COV-2 TEST POSITIVE; STENT PLACEMENT; INTENSIVE CARE; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS), concerned a 59 year old male of an unspecified race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total administered on 24-MAR-2021 for an unspecified indication. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 59 years old. No concomitant medications were reported. On 28-JAN-2022, the patient presented to hospital with inferior STEMI (ST-elevation myocardial infarction), acute myocardial infarction, percutaneous coronary intervention (PCI), diabetic ketoacidosis (DKA) and covid-19 pneumonia (Covid-PNA). Hospital course was complicated by acute hypoxic respiratory failure 2/2 PNA, volume overload (hypervolaemia) and experienced new onset of atrial fibrillation. On admission to critical care (intensive care), the patient was intubated (endotracheal intubation) and sedated and patient tested positive for COVID and patient was not on remdesivir because of being intubated. Laboratory data included: SARS-CoV-2 test which resulted positive. Patient was treated with steroids. For PNA (covid-19 pneumonia) he was started on antibiotics and diuresis (polyuria) for volume overload and was extubated. Patient was transferred to step down and started on remdesivir. The patient with inferior STEMI who underwent emergent percutaneous coronary intervention and drug-eluting stent (DES) to the RCA (Right coronary artery) then developed VF (Ventricular fibrillation) arrest with inability to achieve ROSC (Return of spontaneous circulation). The patient died on 01-FEB-2022. It was unspecified if an autopsy was performed. The number of days of hospitalization was not reported and it was unspecified if the patient was discharged from the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from an unknown cause of death on 01-FEB-2022, and the outcome of the events acute myocardial infarction, acute respiratory failure, atrial fibrillation, covid-19 pneumonia, cardiac arrest, diabetic ketoacidosis, ventricular fibrillation, endotracheal intubation, extubation, hypervolaemia, percutaneous coronary intervention, polyuria, sars-cov-2 test positive, stent placement and intensive care was reported as fatal. This report was serious (Death, and Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000235951. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information was received from central complaint vigilance department on 16-JUN-2022. The following information was updated and incorporated into case narrative: product quality complaint result.; Sender's Comments: V2: The follow up adds: product quality complaint result. This new information does not change prior causality assessment.   20220620773-covid-19 vaccine ad26.cov2.s-Acute myocardial infarction, Acute respiratory failure, Covid-19 pneumonia, Diabetic ketoacidosis,  Atrial fibrillation, Cardiac arrest,  Ventricular fibrillation, Endotracheal intubation, Extubation, Hypervolaemia, Percutaneous coronary intervention, Polyuria, Sars-cov-2 test positive, Stent placement ,Intensive care. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH