Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 4 | Unknown | — |
The fifth dose of RabAvert vaccine was delayed in administration about a week after the recommended 28-day schedule; Case reference number US-BN-2025-001547 is a spontaneous case initially received from a consumer via agency (reference number: USBAV25-2303) on 16-Sep-2025 and concerns a patient of unspecified age and gender. The patient's medical history and concomitant medication details were not provided. On an unspecified date, 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, expiration date: unknown) at an unknown dose, route or site of administration for an unknown indication. On an unspecified date, an unknown amount of time after the vaccination with the first dose, the patient received the second dose of RabAvert vaccine along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown, expiration date: unknown) at an unknown dose, route or site of administration. On an unspecified date, an unknown amount of time after the vaccination with the first dose, the patient received the third dose of RabAvert vaccine along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown, expiration date: unknown) at an unknown dose, route or site of administration. On an unspecified date, an unknown amount of time after the vaccination with the first dose, the patient received the fourth dose of RabAvert vaccine along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown, expiration date: unknown) at an unknown dose, route or site of administration for an unknown indication. On an unspecified date, the patient laboratory examination test included antibody titer test. On an unspecified date, a week after the 28th day after the vaccination, the fifth dose of RabAvert vaccine was delayed in administration about a week after the recommended 28-day schedule. (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to RabAvert. No further information was provided.; Reporter's Comments: A patient of unspecified age and gender received four doses of RabAvert vaccine for an unknown indication. Reportedly, the fifth dose of RabAvert vaccine was delayed in administration about a week after the recommended 28-day schedule, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due to RabAvert. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unspecified age and gender received four doses of RabAvert vaccine for an unknown indication. Reportedly, the fifth dose of RabAvert vaccine was delayed in administration about a week after the recommended 28-day schedule, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due to RabAvert. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: NONE