Reporte zur Charge F1808980

Symptomtext

OPTIC NEURITIS; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: F1808980, and expiry: UNKNOWN) with unspecified dose on left arm, on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, patient experienced loss of vision on the right eye that had not gotten better or worse since then. Patient went to ophthalmologist on 12-APR-2021 who diagnosed patient with optic neuritis and referred to neuro-ophthalmologist. On 13-APR-2021, patient went to emergency eye and ear. Patient was having upcoming appointments with primary doctor and neuro-ophthalmologist at the time of reporting. On 12-APR-2021, Laboratory data included: Dilated pupils (NR: not provided) diagnose with optic neuritis by eye doctor. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) normal findings, and CT scan (NR: not provided) normal findings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from optic neuritis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210429417-covid-19 vaccine ad26.cov2.s-Optic neuritis. 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).