Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | Unknown | — |
Encountered a bat that may have wounded patient's right leg; Case reference number US-BN-2025-001315 is a spontaneous case initially received from a consumer via agency (reference number: USBAV25-1812) on 25-Jul-2025 and concerns a 25-year-old male patient. The patient's medical history and concomitant medication details were not provided. On an unspecified day in Jul-2023, the patient had a bat wound. On an unspecified dates, unknown time after bat wound the patient was vaccinated four times with RabAvert vaccine along with its constituent parts: prefilled syringe, needle for injection, and needle for reconstitution (batch number: unknown) at an unknown dose, route of administration, or site of administration, for indication the bat wound. On 22-Jul-2025, Tuesday at 9 pm, the patient encountered a bat that may have wounded right leg. On 23-Jul-2025, Wednesday at 1 am at the emergency room (ER), the patient had a RabAvert vaccine booster along with its constituent parts: prefilled syringe, needle for injection, and needle for reconstitution (batch number: unknown) at an unknown dose, route of administration, or site of administration, four hours for indication post-exposure to bat wound. The outcome of the event 'animal bite' was unknown. The reporter did not provide a seriousness assessment. The reporter assessed the event of 'animal bite' as possibly related to the RabAvert product. No additional information was provided.; Reporter's Comments: A spontaneous case concerning a 25 year old male following a prior bat wound, the patient received four doses of RabAvert with reconstitution components at unknown dose, route, and site. After a later possible bat bite to the right leg, the patient received a RabAvert booster for post exposure prophylaxis. The event animal bite is unexpected as per unexpected as per the current CCDS v 6.0 and USPI. Outcome was unknown. The medical history, concomitant medications, and batch numbers were not provided. The evaluation did not find enough evidence to suggest a reasonable possibility of a causal nor plausible biological mechanism of action between the reported event and suspect vaccine, therefore the causality is assessed as not related. The case is non serious.; Sender's Comments: A spontaneous case concerning a 25 year old male following a prior bat wound, the patient received four doses of RabAvert with reconstitution components at unknown dose, route, and site. After a later possible bat bite to the right leg, the patient received a RabAvert booster for post exposure prophylaxis. The event animal bite is unexpected as per unexpected as per the current CCDS v 6.0 and USPI. Outcome was unknown. The medical history, concomitant medications, and batch numbers were not provided. The evaluation did not find enough evidence to suggest a reasonable possibility of a causal nor plausible biological mechanism of action between the reported event and suspect vaccine, therefore the causality is assessed as not related. The case is non serious.
Comments: NONE