Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Extubation, Hypoxia, Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: SEPTIC PULMONARY EMBOLISM; COVID-19 PNEUMONIA; HYPOXIA; SEPTIC SHOCK; COVID-19; DYSPNOEA; ENDOTRACHEAL INTUBATION; EXTUBATION; PYREXIA; SARS-COV-2 TEST POSITIVE; DEATH; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System concerned a 38 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: unknown) dose was not reported, 01 total was administered on 14-MAY-2021 for an unknown indication. No concomitant medications were reported. On 28-AUG-2021, patient was admitted to hospital (date unspecified), number of days hospitalized was 2 days and discharge information was not reported with shortness of breath (dyspnoea), fever (pyrexia), and hypoxia. Patient tested positive for COVID-19 (severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) which was tested positive) (Confirmed clinical vaccination failure) Patient's condition worsened and required intubation (endotracheal intubation) and comfort measures. Then extubation occurred patient expired in the hospital from an unknown cause. Patient was diagnosed with Covid-19, Covid-19 pneumonia, septic shock, and septic pulmonary embolism (PE). It was unspecified whether an autopsy was performed or not. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of covid-19 pneumonia, hypoxia, septic pulmonary embolism, septic shock, covid-19, dyspnoea, endotracheal intubation, extubation, pyrexia and sars-cov-2 test positive on 30-AUG-2021, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with a product quality complaint: 90000200304 The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information received from Complaint department on 08-NOV-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1: Follow up information received in the current version is regarding product quality complaint investigation result. This updated information does not change the prior causality assessment of reported events.   20211061549- COVID-19 VACCINE AD26.COV2.S- Death, Septic pulmonary embolism, Covid-19 pneumonia, Hypoxia, Septic shock, Covid-19, Dyspnoea, Endotracheal intubation, Extubation, Pyrexia, 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). 20211061549- COVID-19 VACCINE AD26.COV2.S- Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: CAUSE OF DEATH UNKNOWN