Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | FDP00553 | IM / LA |
The patient received second dose of Rabavert vaccine ten days after first dose; Case reference number US-BN-2025-001593 is a spontaneous case initially received from a nurse via agency (reference number: USBAV25-2372) on 24-Sep-2025 and concerns a *45-year-old* female patient. The patient's medical history and concomitant medication details were not provided. On *15-Sep-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: *FDP00553, expiration date: 31-Dec-2027) 1 milliliter, intramuscularly on left deltoid* for indication of pre-exposure. On *25-Sep-2025, 10 days after the first dose, the patient received the second dose of RabAvert vaccine along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00553, expiration date: 31-Dec-2027) 1 milliliter, intramuscularly on right deltoid (explicitly coded as 'inappropriate schedule of product administration').* At the time of the *follow-up report, the patient did not experience any 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 information received from a nurse via Bavarian Nordic on 02-Oct-2025. New information included: patient details, updated suspect product details.; Reporter's Comments: A 45-year-old female patient received the second dose of RabAvert vaccine 10 days after the first dose, which is considered as inappropriate schedule of product administration. 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 details 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 45-year-old female patient received the second dose of RabAvert vaccine 10 days after the first dose, which is considered as inappropriate schedule of product administration. 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 details 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.