Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Mental status changes, Oxygen saturation, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: DEATH; EMBOLIC STROKE; ACUTE RESPIRATORY FAILURE; COVID-19; COVID-19 PNEUMONIA; ACUTE RESPIRATORY FAILURE; EMBOLIC STROKE; ENDOTRACHEAL INTUBATION; BACTERIAL INFECTION; DEATH; COVID-19; HYPERCOAGULATION; HYPERCOAGULATION; MENTAL STATUS CHANGES; MENTAL STATUS CHANGES; COVID-19 PNEUMONIA; ENDOTRACHEAL INTUBATION; BODY TEMPERATURE INCREASED; BODY TEMPERATURE INCREASED; BACTERIAL INFECTION; SARS-COV-2 TEST POSITIVE; This spontaneous report received from a health care professional by a Regulatory Authority, Vaccine Adverse Event Reporting System (VAERS} concerned a 66 year old female of an unspecified race and ethnicity. Initial information was processed along with additional information received on 07-FEB-2023. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, ESRD (end-stage renal disease), obesity, and atrial fibrillation. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 26-JAN-2022 for an unspecified indication.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 2) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date 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 66 years old. No concomitant medications were reported.  On 01-NOV-2022, the patient had COVID-19 virus test which was positive. On 08-NOV-2022, the patient was brought to emergency department (ED) after exhibiting an altered mental status at her nursing home and her temperature was 102 F (coded as body temperature increased) and oxygen saturation was 75-80 percentage. The patient had another COVID PCR (polymerase chain reaction) test done in the emergency department which was positive (dose number in series 2). The patient was admitted on 08-NOV-2022 and was eventually diagnosed with secondary bacterial infection and COVID pneumonitis (covid-19 pneumonia). The patient was intubated (coded as endotracheal intubation) for acute respiratory failure. During admission she was found to have suffered bilateral embolic strokes. This was thought to be secondary to hypercoagulable state (coded as hypercoagulation) from covid (dose number in series 2) as well as pre-existing atrial fibrillation. The patient was hospitalized and the number of days of hospitalization was not reported. Ultimately patient was discussed with the family and the decision was made to proceed with compassionate extubation on 07-DEC-2022, and shortly after that on the same day the patient died from acute respiratory failure, bacterial infection, body temperature increased, covid-19, covid-19 pneumonia, death, embolic stroke, endotracheal intubation, hypercoagulation, mental status changes, and sars-cov-2 test positive. It was unknown if an autopsy was performed. 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.  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 received from department on 16-FEB-2023. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V2: The follow up adds- Product quality complaint investigation result. This new information does not change prior causality assessment.  20230212428-covid-19, covid-19 pneumonia, sars-cov-2 test positive. The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine administration.  20230212428-Death, acute respiratory failure, bacterial infection, body temperature increased, , endotracheal intubation, mental status changes . The event 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. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.  20230212428-embolic stroke, hypercoagulation.. The event has an compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event. Specifically: MEDICAL HISTORY. Therefore, this event is considered inconsistent with vaccine administration.; Reported Cause(s) of Death: ACUTE RESPIRATORY FAILURE; BACTERIAL INFECTION; BODY TEMPERATURE INCREASED; COVID-19; COVID-19 PNEUMONIA; DEATH; EMBOLIC STROKE; ENDOTRACHEAL INTUBATION; HYPERCOAGULATION; MENTAL STATUS CHANGES; SARS-COV-2 TEST POSITIVE