Reporte zur Charge J&J 1808982

Symptomtext

CONVULSIONS; FLU LIKE SYMPTOMS; FEELING YUCKY; This spontaneous report received from a parent concerned an 18 year old white non Hispanic or Latino male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no change in lifestyle and had no allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 16-SEP-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 16-SEP-2021, about an hour or two, patient started to feel yucky. On the same day, patient had convulsions and flu like symptoms throughout the day with a fever brought to the emergency room (ER) at 12:45 AM on 17-SEP-2021 with a temperature 102.4 Degrees Fahrenheit at the triage with severe back pain, vomiting and convulsing. The patient was administered Motrin, Phenergren and IV fluids. The blood works were performed, fast covid-19 screening, CPK and comprehensive metabolic panel. The patient was discharged at 3 AM and returned home. It was reported that flu like symptoms body ache, fever, back ache, nausea, vomiting and convulsing which got progressively worse as the day wore on. The temperature was fluctuating between 99 and 100 Degrees Fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from convulsions, and flu like symptoms, and the outcome of feeling yucky was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210935140- covid-19 vaccine ad26.cov2.s-Convulsion & flu like symptoms. 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).