Received Mar 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (JANSSEN)) | JANSSEN | UNK | — | — |
Severe Brachial neuritis; This spontaneous report received from a patient concerned a patient of unspecified age and sex. Received via J and J managed social media. 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 and frequency not reported, administered on 09-Oct-2021, additional dosage information included: dose number in 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. The patient left arm/ hand remained at 50 percent function since 5 days post Janssen covid vaccine. On an unspecified date, the patient experienced severe brachial neuritis. (dose series 1). The action taken with janssen covid-19 vaccine was not applicable. The outcome of severe brachial neuritis was not reported. This report was serious (other medically important condition).; Sender's Comments: V0; brachial neuritis; The event has an 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.