Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Streptococcus test, Unresponsive to stimuli
Clinical narrative: DEATH; UNRESPONSIVE; DIAPHORETIC; LOW BLOOD PRESSURE; FEVER; This spontaneous report received from a health care professional concerned a 69-year-old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: right femur fracture, and concurrent conditions included: pneumonia, anxiety, hypertension (HTN), constipation, vitamin D deficiency, unspecified intellectual disorder, major depressive disorder, obsessive-compulsive disorder (OCD), parkinsons disease, impaired walking/mobility, seizure disorder, dry eye syndrome, urinary incontinence, benign prostatic hyperplasia (BPH), osteoarthritis, and psychotic disorder. The patient previously received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, batch number were not reported, expiry: unknown) dose was not reported, (dose number in series was 1), 01 in total was administered on 26-MAR-2021 for prophylactic vaccination. Batch number not reported: The batch number was not reported and has been requested. No adverse events were reported following vaccination with covid-19 vaccine ad26.cov2.s. (dose number in series 1) On 22-DEC-2021, the patient was admitted to facility for nursing care due to pneumonia, right femur fracture, anxiety, HTN, constipation, vitamin D deficiency, unspecified intellectual disorder, major depressive disorder, OCD, Parkinson's Disease. Impaired walking/mobility, seizure disorder, dry eye syndrome, urinary incontinence, BPH, osteoarthritis, and psychotic disorder. Outbreak COVID 19 testing revealed negative tests throughout course of stay. On 23-DEC-2021, a consent to administer the booster was obtained and signed. The patient additionally received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213D21A, expiry: 11-APR-2022) 0.5 ml, (dose number in series was 2), 01 in total was administered on 29-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. Following vaccination with the covid-19 vaccine ad26.cov2.s, the reporter reported that, vital signs remained stable with the patient being afebrile throughout the process. On 30-DEC-2021, at approximately 21:30 hours, licensed practical nurse (LPN) noted that the patient had temperature of 100.7 degree Fahrenheit and medical service was also notified. An order to obtain a rapid strep test was obtained and was found to be negative. At approximately 21:40 hours, LPN noted that he was unresponsive, diaphoretic with fever and low blood pressure. Medical services were notified again and an order was received to send to emergency room (ER) for evaluation. ER reported to facility LPN that resident had passed away while in ER. (dose number in series was 2)  On 30-DEC-2021, the patient died from unknown cause. It was not reported whether autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of death was reported as fatal and outcome of unresponsive, diaphoretic, fever, low blood pressure was not reported (dose number in series was 2). This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20220124221 and 20220130332.; Sender's Comments: V0: 20220124404-Covid-19 vaccine ad26.cov2.s-Death and unresponsive. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH