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 tigh; Case reference number US-BN-2025-000118 is a spontaneous case initially received from nurse via Med Communications (reference number: USBAV25-0093) on 13-Jan-2025 and concerns a 61-years-old male patient. The patient's medical history and concomitant medication details were not provided. On 13-Jan-2025, the patient received first dose of RabAvert along with device constituents prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at an unknown dose and route of administration, in thigh, for indication pre-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 event due to the RabAvert. No further information provided.; Reporter's Comments: A 61-years-old male patient received first dose of RabAvert along with device constituents prefilled syringe, needle for injection and needle for reconstitution, at an unknown dose and route of administration, in thigh, for indication pre-exposure prophylaxis 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 the RabAvert. 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 61-years-old male patient received first dose of RabAvert along with device constituents prefilled syringe, needle for injection and needle for reconstitution, at an unknown dose and route of administration, in thigh, for indication pre-exposure prophylaxis 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 the RabAvert. 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.