Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | Unknown | — |
The patient received RabAvert vaccine in the finger where the bite was, instead intramuscularly in the deltoid; Case reference number US-BN-2024-002818 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-3135) on 26-Nov-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient had rabies exposure, reported as a finger bite. On unspecified date, unknown amount of time after rabies exposure, the patient was vaccinated with the RabAvert along with device constituents prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, route, for indication post exposure vaccination. As reported, the patient received RabAvert vaccine in the finger (wound) where the animal was bitten, instead intramuscularly in the deltoid (explicitly coded as 'vaccine administered at inappropriate site'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccine. No further information was provided.; Reporter's Comments: A female patient of unknown age received RabAvert vaccine in the finger (bite wound), instead intramuscularly in the deltoid which is considered as vaccine administered at inappropriate site. Product administered at inappropriate site is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to RabAvert vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unknown age received RabAvert vaccine in the finger (bite wound), instead intramuscularly in the deltoid which is considered as vaccine administered at inappropriate site. Product administered at inappropriate site is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to RabAvert vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None