Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Vena cava thrombosis
Clinical narrative: DEATH; ACUTE RESPIRATORY FAILURE; PULMONARY EMBOLISM; SEPTIC SHOCK; VENA CAVA THROMBOSIS; ACUTE KIDNEY INJURY; COVID-19 PNEUMONIA; COVID-19; DIZZINESS; COUGH; ENDOTRACHEAL INTUBATION; RENAL REPLACEMENT THERAPY; SARS-COV-2 TEST POSITIVE; CONFIRMED CLINICAL VACCINATION FAILURE; DYSPNOEA; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System)(VAERS ID 1655956),concerned a 68 year old male. Initial information was processed with additional information received on 13-SEP-2021. The patient's height, and weight were not reported. The patient's past medical history included: Sorin Perceval S (S/P) aortic valve replacement, and concurrent conditions included: hypertension, congestive heart failure, and hyperlipidemia. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A and expiry: Unknown) dose was not reported, 1 in total, administered on 27-APR-2021 for prophylactic vaccination. Concomitant medications included lorazepam, atorvastatin, and carvedilol. On 13-AUG-2021, the patient arrived at the emergency room (ER) due to shortness of breath (dyspnoea) which he had since 1 week ago. Associated symptoms include dry cough and dizziness. The patient was intubated (endotracheal intubation) in the emergency room(ER). On the same day, Laboratory data included: COVID-19 PCR (polymerase chain reaction) test (NR: not provided) positive. Finally, the patient was diagnosed with acute hypoxic respiratory failure, covid-19 (confirmed clinical vaccination failure), covid-19 pneumonia, septic shock, oliguric acute kidney injury (AKI) which required continuous renal replacement therapy (CRRT). The patient was also diagnosed with partial proximal inferior vena cava (IVC) thrombosis and emboli in the lingual (pulmonary embolism) and due to these events the patient was hospitalized (dates unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome for the event confirmed clinical vaccination failure was not reported. On 30-AUG-2021, the patient died from acute kidney injury, acute respiratory failure, covid-19, covid-19 pneumonia, cough, dizziness, dyspnoea, pulmonary embolism, septic shock, vena cava thrombosis, renal replacement therapy, endotracheal intubation, death, sars-cov-2 test positive. It was unspecified if an autopsy was performed. This report was serious (Death, and Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000193188. 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 Central Complaint Vigilance department on 22-OCT-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1:This follow up adds- Product quality complaint investigation result. This new information does not alter prior causality assessment. 20210920491-covid-19 vaccine ad26.cov2.s- Death, acute kidney injury, acute respiratory failure, covid-19, covid-19 pneumonia, cough, dizziness, dyspnoea, pulmonary embolism, septic shock, vena cava thrombosis, renal replacement therapy, endotracheal intubation, sars-cov-2 test positive. This event 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. 20210920491-covid-19 vaccine ad26.cov2.s- confirmed clinical vaccination failure.This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: ACUTE KIDNEY INJURY; ACUTE RESPIRATORY FAILURE; COVID-19; COVID-19 PNEUMONIA; COUGH; DIZZINESS; DYSPNOEA; PULMONARY EMBOLISM; SEPTIC SHOCK; VENA CAVA THROMBOSIS; RENAL REPLACEMENT THERAPY; ENDOTRACHEAL INTUBATION; DEATH