Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | Unknown | — |
The patient received second dose of RabAvert in the gluteus; Case reference number US-BN-2024-002923 is a spontaneous case initially received from nurse via Med Communication (reference number: USBAV24-3371) on 23-Dec-2024 and concerns a female patient with unspecified age. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient took the first dose of RabAvert (batch number: unknown) along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at unknown dose, route or site of administration, for post exposure prophylaxis. On 23-Dec-2024, for unknown amount of time from the first dose, reported as day three, the patient took the second dose of RabAvert (batch number: unknown) along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at unknown dose, and route of administration in gluteus area (explicitly coded as 'Inappropriate site of vaccine administered'). At the time of the initial report, it was unknown if the patient experiences any adverse events due to RabAvert. No further information was provided.; Reporter's Comments: A female patient with unspecified age took the second dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution, at unknown dose, and route of administration in gluteus area which is considered as inappropriate site of vaccine administered. Product administered at inappropriate site is considered listed per company convention. At this point, it was unknown if the patient experiences any adverse events due to 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 female patient with unspecified age took the second dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution, at unknown dose, and route of administration in gluteus area which is considered as inappropriate site of vaccine administered. Product administered at inappropriate site is considered listed per company convention. At this point, it was unknown if the patient experiences any adverse events due to 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