Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | Unknown | — |
The patient was vaccinated with two doses of RabAvert for possible exposure and they were administered in the upper buttock; Case reference number US-BN-2025-001186 is a spontaneous case initially received from a consumer via agency (reference number: USBAV25-1678) on 10-Jul-2025 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient was vaccinated with two RabAvert shots along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) in the upper buttock area, at an unknown dose, route of administration, for indication post exposure prophylaxis (explicitly coded as 'vaccine administered at inappropriate site'). 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 female patient of unspecified age, who received the two doses of RabAvert vaccine for post exposure prophylaxis. As reported, patient received the both the doses of RabAvert, in the upper buttock area, which is considered as 'product administered at inappropriate site'. Product administered at inappropriate site 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. Product administered at inappropriate site 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 female patient of unspecified age, who received the two doses of RabAvert vaccine for post exposure prophylaxis. As reported, patient received the both the doses of RabAvert, in the upper buttock area, which is considered as 'product administered at inappropriate site'. Product administered at inappropriate site 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. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: NONE