Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | FDP00543 | IM |
Patient received two doses of RabAvert for pre-exposure on 13-Aug-2024 and 23-Aug-2024; Case reference number US-BN-2024-002390 is a spontaneous case initially received from a nurse via Med Communication (reference number: USBAV24-2096) on 23-Aug-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On 13-Aug-2024, the patient was vaccinated with the first dose of RabAvert (batch number: FDP00543), at an unknown dose, administered intramuscularly in unknown site of administration, for pre-exposure. On 23-Aug-2024, 10 days after the first dose, the patient was vaccinated with the second dose of RabAvert (batch number: FDP00543), at an unknown dose, administered intramuscularly in unknown site of administration (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert. No further information was provided.; Reporter's Comments: A female patient of unknown age was vaccinated with the second dose of RabAvert for pre-exposure, on the day 10 after the first dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event 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 female patient of unknown age was vaccinated with the second dose of RabAvert for pre-exposure, on the day 10 after the first dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event 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.