Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: DEATH; INTERNAL BLEEDING; HEMATOMA; LOW BLOOD OXYGEN; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID -19 INFECTION; This spontaneous report received from a consumer concerned a 69 year old white non- hispanic or latino male. Initial information was processed along with the additional information received on 30-AUG-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure and was on CPAP (Continuous positive airway pressure ) machine, non-alcohol user, and non-smoker. The patient had no known allergies and no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 21-SEP-2021) dose was not reported, 1 in total administered to left arm on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-JUL-2021, the patient developed shortness of breath and fever (Suspected covid -19 infection) and was taken to emergency room. There patient tested positive for covid-19 infection (suspected clinical vaccination failure). The patient was transferred to other hospital and was on CPAP machine along with Bi-PAP. The patient had low blood oxygen. The patient was put on oxgyen. On unspecified date the patient become negative for covid-19 infection. The patient had internal bleeding and was on blood thinner. The patient had hematoma and could not breath. On 19-AUG-2021 the patient was again transferred to another hospital and was intubated which made him worse. On 27-AUG-2021 the patient passed away. The number of days hospitalized was 32. It was unknown whether the cause of death was due to covid-19 infection or due to vaccine. It was unknown whether an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on 27-AUG-2021, recovered from suspected covid -19 infection, had not recovered from hematoma, internal bleeding, and low blood oxygen, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Life Threatening). This report was associated with a product quality complaint 90000191347.; Sender's Comments: V0: 20210857346-covid-19 vaccine ad26.cov2.s-Death, internal bleeding, suspected covid -19 infection, hematoma and low blood oxygen. 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). 20210857346-covid-19 vaccine ad26.cov2.s- suspected 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: UNKNOWN CAUSE OF DEATH