Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 3 | FDP00529 | IM / LA |
The patient received second dose of Rabavert vaccine nine days after first dose and third dose 19 days after the first dose; Case reference number US-BN-2025-001154 is a spontaneous case initially received from a nurse via agency (reference number: USBAV25-1629) on 07-Jul-2025 and concerns a 23-year-old, female patient. The patient's medical history and concomitant medication details were not provided. On 18-Jun-2025, the patient received the first dose of RabAvert along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: *FDP00529 and expiration date: 30-Nov-2027), 0.5 milliliter* intramuscularly, *on the left deltoid* for the indication of pre-exposure. *On 27-Jun-2025, nine days after the first dose, the patient received the second dose of RabAvert along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00529 and expiration date: 30-Nov-2027), 0.5 milliliter, intramuscularly on deltoid. (Explicitly coded as: 'inappropriate schedule of product administration')*. *On 07-Jul-2025, 19 days after the first dose, the patient received the third dose of RabAvert along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00529 and expiration date: 30-Nov-2027), 0.5 milliliter, intramuscularly on deltoid. (Explicitly coded as: 'inappropriate schedule of product administration')*. At the time of the *follow-up report, the patient did not experience any adverse events 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 19-Sep-2025: New information included patient details, updated suspect product details.; Reporter's Comments: The spontaneous case concerns, a 23-year-old female received her first RabAvert dose for pre-exposure on Day 0 (left deltoid). She received the second dose on Day 9 and the third dose on Day 19, both coded as inappropriate schedule of product administration. Inappropriate schedule of product administration is considered as listed per company convention. The patient did not experienced any adverse events due to RabAvert. The patient's relevant 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: The spontaneous case concerns, a 23-year-old female received her first RabAvert dose for pre-exposure on Day 0 (left deltoid). She received the second dose on Day 9 and the third dose on Day 19, both coded as inappropriate schedule of product administration. Inappropriate schedule of product administration is considered as listed per company convention. The patient did not experienced any adverse events due to RabAvert. The patient's relevant 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