Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Septic shock, Spontaneous haemorrhage
Clinical narrative: DEATH; RESUSCITATION; SARS-COV-2 TEST POSITIVE; MECHANICAL VENTILATION; PYREXIA; CARDIAC ARREST; ACUTE RESPIRATORY FAILURE; ACUTE MYOCARDIAL INFARCTION; COVID-19 PNEUMONIA; HYPOXIA; PULSELESS ELECTRICAL ACTIVITY; RETROPERITONEAL HAEMORRHAGE; SEPTIC SHOCK; SPONTANEOUS HAEMORRHAGE; COVID-19; CHEST PAIN; COUGH; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAERS ID 2051154) concerned a 76 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: Benign prostatic hyperplasia (BPH), diabetes, Gastroesophageal reflux disease (GERD), and hypertension and other pre-existing medical conditions included: The patient had no known drug allergies.. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022 expiry: unknown) dose was not reported, dose number in series was 01, 01 total was administered on 16-MAR-2021 for an unspecified indication to the left arm. Concomitant medications included famotidine, fluticasone nasal, metformin, methocarbamol, pantoprazole, Acetaminophen (paracetamol), tamsulosin hydrochloride, and tramadol used for an unspecified indication.  On 26-DEC-2021, the patient experienced cough. On 03-JAN-2022, the patient presented to emergency department (ED) with worsening cough, fever and 'CP' (sic) with cough, he had no alleviating factors. Laboratory data on the same day included: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test (COVID-19 test) using the system, was positive. Patient was admitted for acute hypoxic respiratory failure from Coronavirus disease (COVID-19) pneumonia on the same day on 03-JAN-2022. The course was complicated by septic shock, spontaneous retroperitoneal bleed and acute myocardial infarction/Non-ST-Elevation Myocardial Infarction (NSTEMI) and required multiple pressors and had worsening hypoxia despite maximum ventilation (mechanical ventilation) support. He also had retroperitoneal haemorrhage, spontaneous haemorrhage and chest pain. He had pulseless electrical activity arrest (PEA), cardiac arrest. On 15-JAN-2022 patient expired despite of prolonged Cardiopulmonary resuscitation (CPR). The patient died from unknown cause of death (dose number in series was 01). It was unknown if an autopsy was performed. Patient was hospitalized for 12 days, and discharge date was 15-JAN-2022. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of death, cardiac arrest, acute respiratory failure, acute myocardial infarction, COVID-19 pneumonia, hypoxia, pulseless electrical activity, retroperitoneal haemorrhage, septic shock, spontaneous haemorrhage, COVID-19, chest pain, cough, mechanical ventilation, pyrexia, resuscitation and SARS-CoV-2 test positive was fatal. This report was serious (Death, and Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000214994. The suspected product quality complaint has been confirmed to be the reported allegation was not confirmed and the root cause was determined to be not manufacturing related based on the PQC evaluation/investigation performed.  Additional information received on 03-FEB-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V2: This follow up version was created to update following information: Product quality complaint investigation result. This added information does not alter the causality of previous reported event.  20220156917 -COVID-19 VACCINE AD26.COV2.S-death, cardiac arrest, acute respiratory failure, acute myocardial infarction, COVID-19 pneumonia, hypoxia, pulseless electrical activity, retroperitoneal haemorrhage, septic shock, spontaneous haemorrhage, COVID-19, chest pain, cough, mechanical ventilation, pyrexia, resuscitation and SARS-CoV-2 test positive. This event(s) is considered unassessable. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH