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Administered by: Other Purchased by: ?
Life Threatening? No
Write-up: PASSED AWAY; HIGH BLOOD PRESSURE; DIZZINESS; THROWING UP; HEADACHE; This spontaneous report received from a consumer concerned a 73 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included high blood pressure, no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: unknown) dose was not reported, 1 total administered on 16-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. It was reported that the patient received covid-19 vaccine ad26.cov2.s on 16-MAR-2021. On 17-MAR-2021, the patient''s only complaint was that she experienced headache. On 14-APR-2021, she complained about dizziness and throwing up that was getting worse and high blood pressure on same day the reporter called the patient''s doctor''s office at 14:30 p.m. and doctor saw the patient''s blood pressure was returned to normal and she underwent laboratory data included: systolic blood pressure (NR: not provided) 113 mmHg, 170 mmHg, 190 mmHg. After few hours, 7 or 10 hours she passed away in her sleep, no pain at the time of death between 12:00 a.m. or 15:00 p.m. on 15-APR-2021. It was unspecified if an autopsy was performed. The reporter was unsure about the true time of death. The reporter did not complaint for a lawsuit as the doctor of the patient did not know if the death was correlated with the vaccine. The patient did not had no other disease, except high blood pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient passed away on 15-APR-2021, recovered from high blood pressure on 14-APR-2021, and headache on an unspecified date in 2021, and the outcome of dizziness and throwing up was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: - covid-19 vaccine ad26.cov2.s-Death. 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). covid-19 vaccine ad26.cov2.s-High Blood pressure . 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: UNDERLYING DISEASE; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
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