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Administered by: Other Purchased by: ?
Life Threatening? No
Write-up: COLLAPSED; HEADACHE; This spontaneous report received from a consumer concerned a 70 year old male. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the patient experienced headache, was clammy to the touch. On same day at 14:00, checked blood pressure (BP) and it was 145/75 and his oxygen level read in the 90''s. At 18:00, he collapsed while getting up out of his chair and emergency medical services (EMS) was called performed cardiopulmonary resuscitation (CPR) but never got him back. On 10-MAR-2021, the patient died from cause unknown. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of collapsed on 10-MAR-2021, and the outcome of headache was not reported. This report was serious (Death, and Other Medically Important Condition). The suspected product quality complaint has been confirmed to be no product quality complaint identified within the reported. Complaint is approved for void, based on the PQC evaluation/investigation performed. This report was associated with product quality complaint :90000173895.; Sender''s Comments: V0: 20210341940-COVID-19 VACCINE AD26.COV2.S- COLLAPSED. This event is considered Unassessable. The event 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.; Reported Cause(s) of Death: Cause unknown
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