Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | Unknown | — |
The patient received RabAvert first dose on day one after exposure and second dose was administered 36 hours early; RabAvert was administered in the same arm as human rabies immune globulin (HRIG) dose; Case reference number US-BN-2024-001929 is a spontaneous case report initially received from a pharmacist via Med Communication (reference number: USBAV24-1079) on 20-May-2024 and concerns a female patient. The patient's medical history and concomitant medication details were not provided. On 14-May-2024, the patient was vaccinated with the first dose of RabAvert (batch number: unknown) at an unknown dose, via unknown route and site of administration for post exposure prophylaxis and with human rabies immune globulin (HRIG) dose (brand name: unknown) in the same arm, at an unknown dose, route, for post-exposure. As reported, instead of using day zero, it was used on day one (explicitly coded as 'inappropriate schedule of vaccine administered', 'lack of vaccination site rotation'). On an unspecified date, the patient was vaccinated with the second dose of RabAvert (batch number: unknown) at an unknown dose, via unknown route and site of administration. As reported, the second dose was administered 36 hours early (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert. Additional information received from a pharmacist via Med Communication (reference number: USBAV24-1089) on 21-May-2024: included added co-suspect (HRIG), event (lack of vaccine site rotation) and reference number (USBAV24-1089).; Reporter's Comments: A female patient was vaccinated with the first dose of RabAvert for post exposure prophylaxis and with human rabies immune globulin (HRIG) dose in the same arm, for post-exposure. As reported, instead of using day zero, it was used on day one, which is considered as inappropriate schedule of vaccine administered and lack of vaccination site rotation. The patient was vaccinated with the second dose of RabAvert. As reported, the second dose was administered 36 hours early, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert. Inappropriate schedule of product administration and lack of vaccination site rotation are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and lack of vaccination site rotation have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient was vaccinated with the first dose of RabAvert for post exposure prophylaxis and with human rabies immune globulin (HRIG) dose in the same arm, for post-exposure. As reported, instead of using day zero, it was used on day one, which is considered as inappropriate schedule of vaccine administered and lack of vaccination site rotation. The patient was vaccinated with the second dose of RabAvert. As reported, the second dose was administered 36 hours early, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert. Inappropriate schedule of product administration and lack of vaccination site rotation are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and lack of vaccination site rotation have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.
HRIG