Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 3 | Unknown | IM |
Patient was vaccinated with three doses of Rabavert at the same time; Patient was vaccinated with three doses of Rabavert at the same time; Case reference number US-BN-2024-002556 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-2522) on 26-Sep-2024 and concerns a 7-year-old male patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient experienced dog bite. On 25-Sep-2024, unknown amount of time after the animal exposure, reported around 10:00 pm, the patient was vaccinated with three doses of Rabavert (batch number: unknown) one milliliter, intramuscularly in unknown site of administration for post exposure prophylaxis (explicitly coded as 'vaccine overdose' and '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 7-year-old male patient was vaccinated with three doses of Rabavert for post exposure prophylaxis, which is considered as vaccine overdose and inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Rabavert. Inappropriate schedule of product administration and overdose are considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration and overdose are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 7-year-old male patient was vaccinated with three doses of Rabavert for post exposure prophylaxis, which is considered as vaccine overdose and inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Rabavert. Inappropriate schedule of product administration and overdose are considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration and overdose are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.