Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination failure
Clinical narrative: DEATH; COMPUTERISED TOMOGRAM ABDOMEN NORMAL; HAEMORRHAGE INTRACRANIAL; HYPOXIA; CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; CHEST PAIN; CYANOSIS; DYSPNOEA; HYPOTENSION; MENTAL STATUS CHANGES; ENDOTRACHEAL INTUBATION; ANGIOGRAM PULMONARY ABNORMAL; COMPUTERISED TOMOGRAM HEAD ABNORMAL; BLOOD GLUCOSE INCREASED; TROPONIN NORMAL; PLATELET COUNT NORMAL; INTENSIVE CARE; PULMONARY EMBOLISM; This spontaneous report received from a health care professional via Regulatory Authority VAERS (Vaccine Adverse Event Reporting System)(VAERS ID: 1337251); concerned a 67 year old male of unknown race and ethnic origin. Initial information was processed along with additional information on 07-JUN-2021 and on 08-JUN-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included anxiety, depression, and sleep apnea, and other pre-existing medical conditions included patient had no known allergies. Patient had no current illness.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980) .5 ml, 1 total, administered on 15-APR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen, lisdexamfetamine mesilate, naproxen, and vilazodone.  On 16-MAY-2021, the patient went to emergency department via ambulance for chest pain and shortness of breath (dyspnea). He was decompensated during transport, hypoxic, cyanotic, hypotensive, endotracheal Intubated in emergency department. Patient had computed tomography angiography of lungs (Angiogram pulmonary abnormal) showed saddle embolism extensive involvement of pulmonary artery branch all lobes, pulmonary emboli main right and left pulmonary arteries. Significant clot burden. Patient was admitted to Intensive care unit. He had change in mental status. Laboratory data included: Angiogram pulmonary (NR: not provided) Abnormal, Blood glucose (NR: not provided) 374 (increased), Computerized tomogram head (NR: not provided) Negative, Platelet count (NR: not provided) 248 (normal), and Troponin (NR: not provided) Negative. On 18-MAY-2021, patient had computerized tomogram of head showed intracranial hemorrhage (hemorrhagic conversion- large parenchymal hemorrhage 7cm range, midline shift with cerebral herniation). Patient had reportedly been sick about a week or 2 earlier, he was tested COVID positive after polymerase chain reaction on admission to hospital. The confirmed clinical vaccination failure was reported. Laboratory data included: Computerized tomogram abdomen (NR: not provided) Negative. Patient was hospitalized for 5 days. On 20-MAY-2021, patient died from pulmonary embolism, hemorrhage intracranial, hypoxia, hypotension, mental status changes, cyanosis, chest pain, confirmed covid-19 infection, dyspnea, and confirmed clinical vaccination failure. Treatment medications (dates unspecified) included: heparin, and 1/2 Tissue plasminogen activator (TPA) alteplase. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death, endotracheal intubation, angiogram pulmonary abnormal, computerized tomogram head abnormal, blood glucose increased, computerized tomogram abdomen normal, troponin normal, platelet count normal and intensive care on 20-MAY-2021. This report was serious (Death, Hospitalization Caused / Prolonged, Life Threatening, and Disability Or Permanent Damage). This report was associated with product quality complaint: 90000181970. 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 was received from complaint vigilance department 25-JUN-2021. The following information was updated and incorporated into case narrative: investigation results was reported as non voided.; Sender's Comments: V1;Follow up information received in the current version is regarding a product quality complaint number which is  added. This updated information does not change the prior causality assessment of reported events. :20210610311-JANSSENCOVID19VACCINEAd26.COV2.S- Death, pulmonary embolism, hemorrhage-intracranial, hypoxia, hypotension, cyanosis, chest pain, dyspnea, mental status changes, confirmed covid-19 infection, endotracheal intubation, angiogram pulmonary abnormal, computerized tomogram head abnormal, blood glucose increased, computerized tomogram abdomen normal, troponin normal, platelet count normal and intensive care- 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).  20210610311-JANSSEN COVID-19 VACCINE AD26.COV2.S- Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear 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: PULMONARY EMBOLISM; HAEMORRHAGE INTRACRANIAL; HYPOXIA; HYPOTENSION; MENTAL STATUS CHANGES; CYANOSIS; CHEST PAIN; CONFIRMED COVID-19 INFECTION; DYSPNOEA; CONFIRMED CLINICAL VACCINATION FAILURE