Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | Unknown | IM |
The patient was administered a dose of Rabavert, but it appears that the freeze-dried component of the vaccine was not properly diluted; The patient was administered a dose of Rabavert, but it appears that the freeze-dried component of the vaccine was not properly diluted; Case reference number US-BN-2024-002377 is a spontaneous case initially received from health care professional via Med Communication (reference number: USBAV24-2035) on 19-Aug-2024 and concerns a 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 a dose of RabAavert (batch number: unknown), at an unknown dose, via intramuscular use at unknown site of administration for pre-exposure prophylaxis. As reported, the freeze-dried component of the vaccine was not properly diluted (explicitly coded as 'product concentrate not diluted' and 'product administration error'). At the time of initial report, it was unknown if the patient experienced any adverse event due to RabAvert. Additional information received from health care professional via Med Communication (reference number: USBAV24-2061) on 21-Aug-2024: included reference number (USBAV24-2061).; Reporter's Comments: A patient of unknown age and gender was vaccinated with a dose of RabAavert, at an unknown dose, via intramuscular use at unknown site of administration for pre-exposure prophylaxis. Reportedly, the freeze-dried component of the vaccine was not properly diluted which is considered as product concentrate not diluted and product administration error. Product preparation error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event 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 for both reported events. The case is non-serious.; Sender's Comments: A patient of unknown age and gender was vaccinated with a dose of RabAavert, at an unknown dose, via intramuscular use at unknown site of administration for pre-exposure prophylaxis. Reportedly, the freeze-dried component of the vaccine was not properly diluted which is considered as product concentrate not diluted and product administration error. Product preparation error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event 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 for both reported events. The case is non-serious.
Comments: None.