Received Feb 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (JANSSEN)) | JANSSEN | UNK | — | — |
disabled; chronic ear ringing attacks; food and med allergies; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up. No concomitant medications were reported. On an unspecified date, the patient experienced disabled, chronic ear ringing attacks, and food and med allergies. (dose series 1). The action taken with janssen covid-19 vaccine was not applicable. The outcome of disabled, chronic ear ringing attacks and food and med allergies was not reported. This report was serious (other medically important condition).; Sender's Comments: V0;Disability; The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.