Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | Unknown | — |
Adult patient received RabAvert dose into the anterolateral thigh instead of deltoid area; Case reference number US-BN-2024-002768 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-2978) on 11-Nov-2024 and concerns an adult patient of unknown age and gender. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient was vaccinated with the dose of RabAvert (batch number: unknown) along with device constituents prefilled syringe, needle for injection and needle for reconstitution at an unknown dose, route in anterolateral thigh for post exposure prophylaxis (explicitly coded as 'vaccine administered at inappropriate site'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to Rabavert. No further information was provided.; Reporter's Comments: An adult patient of unknown age and gender was vaccinated with the dose of RabAvert, along with device constituents prefilled syringe, needle for injection and needle for reconstitution at an unknown dose, route in anterolateral thigh for post exposure prophylaxis, which is considered as vaccine administered at inappropriate site. It was unknown if the patient experienced any adverse events due to RabAvert. Product administered at inappropriate site is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: An adult patient of unknown age and gender was vaccinated with the dose of RabAvert, along with device constituents prefilled syringe, needle for injection and needle for reconstitution at an unknown dose, route in anterolateral thigh for post exposure prophylaxis, which is considered as vaccine administered at inappropriate site. It was unknown if the patient experienced any adverse events due to RabAvert. Product administered at inappropriate site is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.