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Life Threatening? No
Write-up: PASSING OUT/FAINTING; LOW HEART RATE (30 BEATS PER MINUTE); DECREASED BLOOD PRESSURE (60/50); SHAKING; This spontaneous report received from a patient concerned a 42 year old white, not Hispanic or Latino male. The patient''s height and weight were not reported. The patient''s concurrent conditions included seasonal allergy, non alcoholic and non smoker. The patient did not had drug abuse or illicit drug use. The patient did not had reactions before with any other vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 12-APR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021 after vaccination, the patient immediately experienced low heart rate (30 beats per minute), decreased blood pressure (60/50), profuse sweating and shaking and as the result he passed out immediately. The patient reported that he was under care of the medical staff at the facility and both his heart rate and blood pressure were reassessed multiple times within the hour of observation. The patient reported that vaccination provider advised him that his reaction was not related to the Janssen Covid-19 vaccine and that he fainted only because he was afraid of the needle but the patient denied and stated that he was not afraid of the needle. Laboratory data included: Blood pressure (NR: not provided) 60/50 mmHg and heart rate (NR: not provided) 30 beats per minute. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passing out/fainting on 12-APR-2021, and low heart rate (30 beats per minute), decreased blood pressure (60/50) and shaking on unspecified date APR-2021. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210428755 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Passing out/fainted, low heart rate, Decreased blood pressure. 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).
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