Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19, Cardio-respiratory arrest, Central venous catheterisation, Death
Clinical narrative: DEATH; PULSELESS ELECTRICAL ACTIVITY; RHABDOMYOLYSIS; INTENSIVE CARE; ACUTE RESPIRATORY FAILURE; DEATH; MULTIPLE ORGAN DYSFUNCTION SYNDROME; DYSPNOEA; PULSELESS ELECTRICAL ACTIVITY; ENDOTRACHEAL INTUBATION; CARDIO-RESPIRATORY ARREST; ACUTE RESPIRATORY FAILURE; COVID-19; RHABDOMYOLYSIS; CENTRAL VENOUS CATHETERISATION; MULTIPLE ORGAN DYSFUNCTION SYNDROME; DIARRHOEA; CARDIO-RESPIRATORY ARREST; DYSPNOEA; COVID-19; ENDOTRACHEAL INTUBATION; CENTRAL VENOUS CATHETERISATION; INTENSIVE CARE; DIARRHOEA; SARS-COV-2 TEST POSITIVE; This spontaneous report received from a health care professional by a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) and concerned a 79 year old male of an unspecified race and ethnicity. Initial information was processed with the additional information received on 23-AUG-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol abuse, COPD (Chronic Obstructive Pulmonary Disease), pneumothorax, carotid stenosis, BPH (Benign prostatic hyperplasia), and DVT (Deep vein thrombosis).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: unknown) dose was not reported, 1 total administered on 15-MAR-2021 for an unspecified indication. Age at time of vaccination 79 years old. Drug start period was 170 days. No concomitant medications were reported.  On 01-SEP-2021, the EMS (emergency medical services) brought patient to ED (emergency department) with increasing SOB (shortness of breath) (dyspnoea), O2 (oxygen) saturation in 70 percent was found on the floor in house by EMS might had been there 2 days placed on NRB (non-rebreather mask). On the same day, the patient had rhabdomyolysis and diarrhea. The patient found to be positive for COVID-19 (SARSCoV-2 test positive) intubated in ED (endotracheal intubation). Then the patient was placed for vasopressor treatment Decadron AHRF (acute hypoxemic respiratory failure). Patient had acute respiratory failure, cardio-respiratory arrest and multiple organ dysfunction syndrome, transferred to ICU (intensive care unit), suffered PEA (pulseless electrical activity) arrest code called ROSC (delayed return of spontaneous circulation) achieved family transitioned patient to DNR (do not resuscitate). On the same day, patient also had central venous catheterization. The patient was hospitalized for 1 day. On 09-SEP-2021, the patient died from acute respiratory failure, covid-19, cardio-respiratory arrest, central venous catheterisation, diarrhoea, dyspnoea, multiple organ dysfunction syndrome, pulseless electrical activity, intensive care unit, rhabdomyolysis, endotracheal intubation, SARSCoV-2 test positive.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused/Prolonged). This report was associated with product quality complaint 90000247576. 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 was received from Complaint Department on 03-OCT-2022. The following information was updated and incorporated into case narrative: Product quality complaint result was added.; Sender's Comments: V1: The follow up adds- Product quality complaint investigation result. This new information does not change prior causality assessment.  20220844625-covid-19 vaccine ad26.cov2.s -Rhabdomyolysis. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related. (Also concurrent event of Covid-19 is major risk factor for event of Rhabdomyolysis.)  20220844625-covid-19 vaccine ad26.cov2.s -Covid-19,  SARS cov 2 test positive, diarrhea. 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  20220844625-covid-19 vaccine ad26.cov2.s Death, Acute respiratory failure, multiple organ dysfunction syndrome, cardio-respiratory arrest, pulseless electrical activity, central venous catheterisation , dyspnoea, intensive care unit, endotracheal intubation. The case causality is considered NOT RELATED. Rationale: Patient's age, co-morbidities, concurrent severe viral illness provides a more possible explanation.; Reported Cause(s) of Death: ACUTE RESPIRATORY FAILURE; COVID-19; CARDIO-RESPIRATORY ARREST; CENTRAL VENOUS CATHETERISATION; DIARRHOEA; DYSPNOEA; MULTIPLE ORGAN DYSFUNCTION SYNDROME; PULSELESS ELECTRICAL ACTIVITY; RHABDOMYOLYSIS; INTENSIVE CARE UNIT; ENDOTRACHEAL INTUBATION; SAR