Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive, Sepsis, Tachypnoea, Vascular occlusion
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SARS-COV-2 TEST POSITIVE; INTENSIVE CARE; COVID-19; TACHYPNOEA; PYREXIA; ACUTE KIDNEY INJURY; EMBOLIC STROKE; DIABETIC KETOACIDOSIS; HEMIPARESIS; HYPOXIA; PNEUMONIA; SEPSIS; HYPERCOAGULATION; VASCULAR OCCLUSION; PERIPHERAL EMBOLISM; This spontaneous report received from a patient via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1685968) concerned a 64 year old male. The patient's height, and weight were not reported. The patient's past medical history included: bypass surgery, and concurrent conditions included: diabetes mellitus type 2, and coronary artery disease. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980 expiry: unknown) dose was not reported, 1 total, administered at right arm on 05-APR-2021 for an unspecified indication. Concomitant medications included atorvastatin, glipizide, levothyroxine, metformin, metoprolol succinate, and paracetamol for unknown indication. On 27-AUG-2021, the patient was admitted to the hospital directly from the airport after he arrived in a flight from another country. During that time, the patient was noted to have pyrexia (febrile), tachypnea, and hypoxia. The patient was also thought to have had sepsis secondary to multifocal pneumonia and diabetic ketoacidosis. The patient experienced covid-19 and on 30-AUG-2021, the patient underwent SARS-CoV-2 test which was found positive (suspected clinical vaccination failure). The patient was admitted to the cardiac care unit (intensive care) from 28-AUG-2021 to 05-SEP-2021. During hospitalization, patient had acute kidney injury (acute renal failure) and cardioembolism (peripheral embolism) in setting of COVID-19 hypercoagulable state (hypercoagulation) with embolic CVA (embolic stroke), with L-sided weakness (hemiparesis), embolic LLE acute occlusion (vascular occlusion) without tissue loss. As of 09-SEP-2021, the patient was still admitted in the medical surgery setting. The patient was hospitalized for a duration of 13 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from intensive care on 05-SEP-2021, and the outcome of acute kidney injury, covid-19, diabetic ketoacidosis, embolic stroke, hemiparesis, hypercoagulation, hypoxia, peripheral embolism, pneumonia, pyrexia, SARS-cov-2 test positive, sepsis, tachypnoea, vascular occlusion and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000195228. 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 Regulatory Authority on 05-NOV-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V3: The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.This added information does not alter the causality of previous reported events. 20210949888-COVID-19 VACCINE AD26.COV2.S- Suspected clinical vaccine failure. This event is considered not related. The event has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: SPECIAL SITUATIONS  20210949888-COVID-19 VACCINE AD26.COV2.S- DIABETIC KETOACIDOSIS. 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: MEDICAL HISTORY (TII DM)  20210949888-COVID-19 VACCINE AD26.COV2.S.- ACUTE KIDNEY INJURY, EMBOLIC STROKE, HEMIPARESIS, HYPOXIA, PNEUMONIA, SEPSIS, HYPERCOAGULATION, VASCULAR OCCLUSION, PERIPHERAL EMBOLISM, INTENSIVE CARE, COVID-19, SARS-COV-2 TEST POSITIVE, TACHYPNOEA, PYREXIA. This event is considered unassessable. The events 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 events.