Received Mar 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (JANSSEN)) | JANSSEN | UNK | — | — |
side effects for 4 years; injury; This spontaneous report received from a patient 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, intramuscular, 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. Company was unable to perform follow up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced side effects for 4 years and injury. (dose series 1) The patient took C19 Vaccine and have had all sorts of side effects for 4 years and was looking for help. The action taken with janssen covid-19 vaccine was not applicable. The outcome of side effects for 4 years and injury was not reported. This report was serious (disability/permanent damage).; Sender's Comments: V0-Adverse event, Injury. The event 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. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.