Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | FDP0055 | IM |
Patient received second dose of preexposure prophylaxis with Rabavert on day 10, instead of day seven; Case reference number US-BN-2024-002289 is a spontaneous case initially received from a health care professional via Med Communications (reference number: USBAV24-1849) on 01-Aug-2024 and concerns a 40-year-old male patient. The patient's medical history and concomitant medication details were not provided. On 22-Jul-2024, the patient was vaccinated with the first dose of RabAvert (batch number: FDP0055), at an unknown dose, via intramuscular use in unknown site of administration, for pre-exposure prophylaxis. On 01-Aug-2024, ten days after the first dose, the patient was vaccinated with the second dose of RabAvert (batch number: FDP0055), at an unknown dose, via intramuscular use in unknown site of administration (explicitly coded as 'inappropriate schedule of drug 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 40-year-old male patient was vaccinated with the second dose of RabAvert for pre-exposure prophylaxis, as reported ten days after the first dose, which is considered as inappropriate schedule of drug 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 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 40-year-old male patient was vaccinated with the second dose of RabAvert for pre-exposure prophylaxis, as reported ten days after the first dose, which is considered as inappropriate schedule of drug 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 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.