Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 1 | Unknown | — |
Itchy rash on the injection site; Case reference number US-BN-2025-002010 is a spontaneous case report initially received from consumer via Bavarian Nordic (reference number: unknown) on 24-Dec-2025 and concerns 69-year-old male patients. The patient's medical history and concomitant medication details were not provided. On 23-Dec-2025, the patient received the first dose of RabAvert vaccine along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, route or site of administration for unknown indication. On unspecified date, unknown amount of time after the vaccination the patient experienced itchy rash on the injection site rash. At the time of initial report, it was unknown if the patient recovered from the event of injection site rash. The reporter did not provide seriousness and causality assessment for the event of injection site rash. No further information was provided.; Reporter's Comments: A spontaneous case concerning, a 69 year old male received a first dose of RabAvert vaccine. Shortly after vaccination, he developed an itchy rash at the injection site. The event injuection site rash is expected as per CCDS V 6.0 and USPI. At the time of reporting, recovery status was unknown. Based on the temporal association, plausible biological mechanism, pattern of expected effects, and lack of alternative explanation, the events are considered related to vaccination. The event was assessed as non serious. For regulatory reporting purposes, this case is considered related.; Sender's Comments: A spontaneous case concerning, a 69 year old male received a first dose of RabAvert vaccine. Shortly after vaccination, he developed an itchy rash at the injection site. The event injuection site rash is expected as per CCDS V 6.0 and USPI. At the time of reporting, recovery status was unknown. Based on the temporal association, plausible biological mechanism, pattern of expected effects, and lack of alternative explanation, the events are considered related to vaccination. The event was assessed as non serious. For regulatory reporting purposes, this case is considered related.