Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 3 | Unknown | — |
The patient received the three doses of RabAvert for post exposure prophylaxis and the doses were administered over 30 days or more; Case reference number US-BN-2025-001600 is a spontaneous case initially reported by a pharmacist via Communications (reference number: USBAV25-2380) on 24-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 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 the indication of post exposure prophylaxis. On an unspecified date, an unknown amount of time after the first dose, the patient received the second dose of RabAvert 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. On an unspecified date, an unknown amount of time after the first dose, the patient received the third dose of RabAvert 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. As reported, the patient had three doses of RabAvert for post exposure prophylaxis, but they did not receive them correctly according to the schedule - the doses were administered over 30 days or more (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: This case concerns a patient of unspecified age and gender. As reported, the patient had three doses of RabAvert for post exposure prophylaxis, but they did not receive them correctly according to the schedule - the doses were administered over 30 days or more, which is considered as 'inappropriate schedule of product administered'. Inappropriate schedule of product administered is considered as listed per company convention. At the time of the initial report, it was unknown if the patient experienced any adverse events due to RabAvert. The patient's relevant medical history and concomitant medication details were not provided. Inappropriate schedule of product administered is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: This case concerns a patient of unspecified age and gender. As reported, the patient had three doses of RabAvert for post exposure prophylaxis, but they did not receive them correctly according to the schedule - the doses were administered over 30 days or more, which is considered as 'inappropriate schedule of product administered'. Inappropriate schedule of product administered is considered as listed per company convention. At the time of the initial report, it was unknown if the patient experienced any adverse events due to RabAvert. The patient's relevant medical history and concomitant medication details were not provided. Inappropriate schedule of product administered is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: none