Received Dec 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | FDP00613 | IM / LA |
patient received rabies vaccine and did not respond, vaccination failure; Case reference number US-BN-2025-001976 is a spontaneous case initially received from a physician via Bavarian Nordic (reference number: BN_2025_00369) on 12-Dec-2025 and concerns a patient of an unknown age and gender. The patient's medical history and concomitant medications details were not provided. On an unspecified date, the patient received a dose of Rabies vaccine along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00613), at dose of 1 ml, in left deltoid via intramuscular route for unknown indication. On an unspecified date, the patient received the rabies vaccine and did not respond, vaccination failure. At the time of this report, it was unknown if the patient recovered from 'vaccination failure'. The reporter did not provide a seriousness assessment for the event of 'vaccination failure', However, the event of 'vaccination failure' was assessed as serious due to the seriousness criteria of medical significance. The reporter did not provide causality for the event of 'vaccination failure'. No further information was provided.; Reporter's Comments: A patient of an unknown age and gender did not respond after the patient received a dose of Rabies vaccine for unknown indication, which is considered as vaccination failure (medical significance). Vaccination failure is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. The causality is assessed as not related. This case is considered as serious due to medical significance. For regulatory reporting purposes, this case is considered related.; Sender's Comments: A patient of an unknown age and gender did not respond after the patient received a dose of Rabies vaccine for unknown indication, which is considered as vaccination failure (medical significance). Vaccination failure is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. The causality is assessed as not related. This case is considered as serious due to medical significance. For regulatory reporting purposes, this case is considered related.
Comments: None.