Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | FDP00533 | IM |
The patient received a dose of RabAvert vaccine subcutaneously instead of intramuscularly by mistake; Case reference number US-BN-2024-002350 is a spontaneous case initially received from a other health professional via Med Communications (reference number USBAV24-1978) on 15-Aug-2024 and concerns a female patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, reported as last week, the patient was vaccinated with the first dose of RabAvert (batch number: FDP00533), at an unknown dose, intramuscularly for pre-exposure prophylaxis. On an unspecified date, unknown amount of time after first dose of RabAvert, reported as today, the patient was vaccinated with the second dose of RabAvert (batch number: FDP00533), at an unknown dose, subcutaneously (explicitly coded as 'Inappropriate route of vaccination'). As reported, the second dose of RabAvert was administered subcutaneously instead intramuscularly by mistake. At the time of the initial report, it was unknown if the patient experienced any adverse events due to RabAvert vaccine. Additional information received from pharmacist via Med Communication (reference number: USBAV24-1983) on 15-Aug-2024: included additional reporter, confirmation of patient's date of birth, confirmation that second dose of RabAvert was given subcutaneously, and reference number. Additional information received from Bavarian Nordic on 16-Aug-2024: Information included additional reference number (BN_2024_02939). Additional information received from pharmacist via Med Communication (reference number: USBAV24-1993) on 16-Aug-2024: included additional reported, confirmation of batch number and additional reference number.; Reporter's Comments: A female patient was vaccinated with the second dose of RabAvert for pre-exposure prophylaxis subcutaneously, which is considered as inappropriate route of vaccination. It was unknown if the patient experienced any adverse events due to RabAvert vaccine. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route 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 was vaccinated with the second dose of RabAvert for pre-exposure prophylaxis subcutaneously, which is considered as inappropriate route of vaccination. It was unknown if the patient experienced any adverse events due to RabAvert vaccine. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. USBAV24-1978: USBAV24-1983: USBAV24-1993:
Comments: None