Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 1 | Unknown | — |
The patient had an encounter with a bat; The patient received RabAvert vaccine on day eight instead of day zero; Case reference number US-BN-2025-001615 is a spontaneous case report initially received from a consumer via agency (reference number: USBAV25-2412) on 29-Sep-2025 and concerns a male patient of unknown age. On an unspecified dates in 2005 the patient received three doses of RabAvert vaccine along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number unknown; expiration date unknown), at an unknown dose, at an unknown route of administration, for indication reported as international travel to a country where there were some rabid dogs. On an unspecified date, as reported, the patient encountered a bat. On unknown date in 2025, eight days after exposure to the bat, 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 unknown), at an unknown dose, at an unknown route of administration, at unknown site of administration for postexposure prophylaxis (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient recovered from 'animal starch' The reporter did not provide a seriousness and causality assessment for the event of 'animal starch'. No further information was provided.; Reporter's Comments: A male patient of unknown age received three doses of RabAvert vaccine for indication reported as international travel to a country where there were some rabid dogs. Reportedly, on an unspecified date, the patient encountered a bat. Eight days after exposure to the bat, the patient received the first dose of RabAvert vaccine for post-exposure prophylaxis, which is considered as inappropriate schedule of vaccine administered. Animal scratch is unlisted and unexpected for RabAvert per CCDS v6 and USPI, whilst inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering the nature of the event, causality for animal scratch is not related to RabAvert. 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: A male patient of unknown age received three doses of RabAvert vaccine for indication reported as international travel to a country where there were some rabid dogs. Reportedly, on an unspecified date, the patient encountered a bat. Eight days after exposure to the bat, the patient received the first dose of RabAvert vaccine for post-exposure prophylaxis, which is considered as inappropriate schedule of vaccine administered. Animal scratch is unlisted and unexpected for RabAvert per CCDS v6 and USPI, whilst inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering the nature of the event, causality for animal scratch is not related to RabAvert. 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.