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Write-up: ANAPHYLACTIC REACTION DESCRIBED AS SEVERE ALLERGIC REACTION, WITHIN 3 MINUTES OF GETTING THE VACCINE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 15:20 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine. Treatment medications (dates unspecified) included: epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine was not reported. The reporter provided causality between anaphylactic reaction and severe allergic reaction and covid-19 vaccine ad26.cov2.s was possible. Company causality between anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine and covid-19 vaccine ad26.cov2.s was possible. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 2021032606-covid-19 vaccine ad26.cov2.s-Anaphylactic reaction. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event.
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