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Life Threatening? No
Write-up: MOTOR RESTLESSNESS; INNER RESTLESSNESS; RAFT PRODUCTION; FEVER; This spontaneous report received from a consumer via a Regulatory Authority [ ES-AEMPS-902043] concerned a 62-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, and batch number were not reported) dose was not reported, frequency 1 total, administered on 17-MAY-2021 for covid-19 vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included pitavastatin 25 mg, ursodeoxycholic acid 300 mg, and edoxaban used for unknown indication. On 17-MAY-2021, the patient experienced raft production and fever. On 18-MAY-2021, he experienced inner restlessness. On 20-MAY-2021, the patient experienced motor restlessness. On an unspecified date, the patient died. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of inner restlessness, raft production, motor restlessness and fever on an unspecified date. This report was serious (Death).; Sender''s Comments: V0:20210641756-covid-19 vaccine ad26.cov2.s-raft production,fever,inner restlessness,motor restlessness. 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: INNER RESTLESSNESS; RAFT PRODUCTION; MOTOR RESTLESSNESS; FEVER
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