Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | FDP00447 | IM |
The second dose of RabAvert delayed one day; Case reference number US-BN-2024-002276 is a spontaneous case initially received from a nurse via Med Communication (reference number USBAV24-1827) on 31-Jul-2024 and concerns a *43-year-old female patient*. The patient's medical history and concomitant medication were not reported. *On 24-Jul-2024, reported as week ago, the patient received the first dose of RabAvert (batch number: FDP00447, expiry date: 30-Apr-2027), at a dose of 1.00, intramuscularly*, at an unknown site of administration, for pre-exposure vaccination. *On 01-Aug-2024, reported as delayed one day, eight days after the first dose, the patient received the second dose of RabAvert (batch number: FDP00555, expiry date: 30-Sep-2027), at a dose of 1.00, intramuscularly, * at an unknown site of administration (explicitly coded as 'inappropriate schedule of vaccine administered'). *As reported, the second dose was delayed one day to match with the patient's son schedule* (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of this follow up report, the patient did not experience fever, and the patient *did not experience any other adverse event due to RabAvert*. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up report received from a nurse on 14-Aug-2024 included: confirmation that the patient did not experience fever, and that the second dose was delayed for one day. The case is linked to case ID US-BN-2024-002277 due to the same report and family member. Follow up information received from a nurse on 12-Sep-2024: New information included patient's details, Rabavert dosing information, and confirmation that patient did not experience any adverse event due to RabAvert vaccine.; Reporter's Comments: A 43-year-old female patient received the second dose of RabAvert for pre-exposure vaccination, as reported with one day delay, which is considered as inappropriate schedule of vaccine administered. The patient did not experience 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 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: A 43-year-old female patient received the second dose of RabAvert for pre-exposure vaccination, as reported with one day delay, which is considered as inappropriate schedule of vaccine administered. The patient did not experience 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 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