Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | FDP00722 | — |
The second dose of RabAvert administered on day 33 instead of day 7; Case reference number US-BN-2025-001614 is a spontaneous case report initially received from a pharmacist via agency (reference number: USBAV25-2420) on 29-Sep-2025 and concerns an 18-year-old female patient. The patient's medical history and concomitant medication details were not reported. On 27-Aug-2025, 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: FDP00721; expiration date: Jan-2028), at an unknown dose, intramuscularly, at unknown site of administration, for indication reported as pre-exposure for Vet school. On 29-Sep-2025, 33 days after the first dose, the patient received the second dose RabAvert vaccine (batch number: FDP00721; expiration date: Jan-2028), at an unknown dose, intramuscularly, at 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 events due to RabAvert. No further information was provided.; Reporter's Comments: An 18-year-old female patient received the second dose of RabAvert vaccine for indication reported as pre-exposure for Vet school, 33 days after the first dose, 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 reported. 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: An 18-year-old female patient received the second dose of RabAvert vaccine for indication reported as pre-exposure for Vet school, 33 days after the first dose, 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 reported. 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.