Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 5 | Unknown | — |
The patient received second dose of RabAvert two days after the first dose for post exposure prophylaxis; Case reference number US-BN-2025-001446 is a spontaneous case initially received from other healthcare professional via Bavarian Nordic (reference number: QE-017945) on 21-Aug-2025 and concerns a 25-year-old male patient. The patient's medical history and concomitant medication details were not provided. On 30-Jul-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: FDP00595, expiration date: 31-Jul-2027) at 1 ml, intramuscularly, in deltoid muscle, for post exposure prophylaxis. On 01-Aug-2025, two days after the first dose of RabAvert, 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: FDP00595, expiration date: 31-Jul-2027) at 1 ml, intramuscularly, in deltoid muscle, for post exposure prophylaxis (explicitly coded as 'inappropriate schedule of vaccine administered'). On 06-Aug-2025, seven days after the first dose of RabAvert, the patient received the third dose of RabAvert vaccine along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00595, expiration date: 31-Jul-2027) at 1 ml, intramuscularly, in deltoid muscle. On 13-Aug-2025, 14 days after the first dose of RabAvert, the patient received the fourth dose of RabAvert vaccine along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00595, expiration date: 31-Jul-2027) at 1 ml, intramuscularly, in deltoid muscle. On an unspecified date, unknown amount of time after the first dose RabAvert, the patient received the fifth dose RabAvert vaccine along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at an unknown dose, site or route of administration. On an unspecified date, the syringe malfunction occurred while reconstituting the product. It was reported that no harm was caused to the patient. The malfunctioning product was not used, and a new box of vaccine was opened (batch number: FDP00595), reconstituted and administered to the patient instead. While attempting to draw the reconstituted product back into the syringe, the plunger pulled all the way out and the product (batch number: FDP00595) was lost. None of that vaccine was administered to the patient. The RabAvert, plunger stopper and subsequently plunger rod fell out causing leakage. The sample was not provided, hence no investigation of the specific sample could be performed. The product quality complaint number was (QE-017945). At the time of the follow-up report, *the patient did not experience any of adverse events due to RabAvert*. Additional information received from other healthcare professional via Bavarian Nordic on 26-Aug-2025: Information included missed dose confirmation. All updated information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow-up information was received from other healthcare professional on 16-Sep-2025: New information included added patient details, RabAvert dosing information details, event details and confirmation that none of the malfunctioned vaccine was administered to the patient. Additional information received from Bavarian Nordic on 07-Nov-2025: Information included confirmation that no investigation performed since sample not provided. Follow-up information was received from other healthcare professional on 16-Jan-2026: New information included confirmation that the patient received all required doses. Hence, event incomplete course of vaccination was removed. Follow-up information was received from other healthcare professional on 10-Feb-2026: New information included confirmation that the patient did not experience any adverse events.; Reporter's Comments: A 25-year-old male patient received the second dose of RabAvert two days after the first dose for post exposure prophylaxis, which is considered as inappropriate schedule of product administration. It was unknown if the patient experienced any of adverse events due RabAvert. Inappropriate schedule of product administration is considered listed per company convention. At the time of the follow-up report, the patient did not experience any of adverse events due to RabAvert. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to suspect vaccine, but to human factor. The case is non-serious.; Sender's Comments: A 25-year-old male patient received the second dose of RabAvert two days after the first dose for post exposure prophylaxis, which is considered as inappropriate schedule of product administration. It was unknown if the patient experienced any of adverse events due RabAvert. Inappropriate schedule of product administration is considered listed per company convention. At the time of the follow-up report, the patient did not experience any of adverse events due to RabAvert. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to suspect vaccine, but to human factor. The case is non-serious.
Comments: None.