Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | FDP00595 | — |
| RAB | RABIES (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | Unknown | — |
The patient was bitten by a puppy; Case reference number US-BN-2025-001505 is a spontaneous case initially received from a consumer via Med Communication (reference number: USBAV25-2207) on 04-Sep-2025 and concerns a female patient of an unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified day in 2022, the patient received a rabies vaccine (brand name: unknown) (batch number: unknown) an at an unknown dose, site, or route of administration for an unknown indication. On 06-Feb-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: FDP00595) at an unknown dose, site, or route of administration as a booster (also reported as post exposure prophylaxis'). On 09-Feb-2025, three 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: FDP00595) at an unknown dose, site, or route of administration as a booster. On an unspecified date, last Friday/last week, also reported as six months after vaccination with RabAvert, the patient was bitten by a puppy. On an unspecified date, reported as almost a week after exposure, the patient enquired whether she was still covered by previous RabAvert doses or whether she should receive additional doses. At the time of the initial report, the outcome of the event dog bite' was unknown. The reporter assessed the event dog bite' as non-serious and did not provide causality assessment. Additional information was received from a nurse via Bavarian Nordic (reference number: USBAV25-2211) on 04-Sep-2025 and included: event verbatim, additional reporter, event description and additional reference number.; Reporter's Comments: The spontaneous case concerning , a female patient of unspecified age received a rabies vaccine in 2022 (details unknown). About six months later, she was bitten by a puppy, and nearly a week after exposure she enquired if prior RabAvert doses provided coverage or if additional doses were needed. On Day 0, she was given the first dose of RabAvert (batch FDP00595) as booster/post exposure prophylaxis, followed by a second dose on Day 3. The event dog bite is not expected of RabAvert. However, the animal bite, is assessed as not related to suspect vaccine but to human factor. The case is assessed as non-serious. For regulatory reporting purposes, this case is considered not related.; Sender's Comments: The spontaneous case concerning , a female patient of unspecified age received a rabies vaccine in 2022 (details unknown). About six months later, she was bitten by a puppy, and nearly a week after exposure she enquired if prior RabAvert doses provided coverage or if additional doses were needed. On Day 0, she was given the first dose of RabAvert (batch FDP00595) as booster/post exposure prophylaxis, followed by a second dose on Day 3. The event dog bite is not expected of RabAvert. However, the animal bite, is assessed as not related to suspect vaccine but to human factor. The case is assessed as non-serious. For regulatory reporting purposes, this case is considered not related.
Comments: None.