Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | Unknown | IM |
The patient only received the diluent and not the vial that contained the actual vaccine; The patient only received the diluent and not the vial that contained the actual vaccine; Case reference number US-BN-2024-002293 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-1865) on 02-Aug-2024 and concerns a male patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient had contact with an animal. On an unspecified date, the patient was vaccinated with the first dose of RabAvert (batch number: unknown), at an unknown dose and site, intramuscularly, for post-exposure rabies prophylaxis. On the same date, the patient received a dose of immunoglobulin human anti-rabies (HRI), at an unknown dose, route, or site of administration. On 02-Aug-2024, an unknown amount of time after the first dose, the patient was vaccinated with the second dose of RabAvert (batch number: unknown), at an unknown dose or site, administered intramuscularly. As reported, the patient only received the diluent and not the vial that contained the actual vaccine (explicitly coded as 'active ingredient not added to diluent' and 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to the RabAvert vaccine. No further information was provided.; Reporter's Comments: A male patient of unspecified age was vaccinated with the second dose of RabAvert, at an unknown dose or site, administered intramuscularly. Reportedly, the patient only received the diluent and not the vial that contained the actual vaccine which is considered as active ingredient not added to diluent 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 the 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 male patient of unspecified age was vaccinated with the second dose of RabAvert, at an unknown dose or site, administered intramuscularly. Reportedly, the patient only received the diluent and not the vial that contained the actual vaccine which is considered as active ingredient not added to diluent 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 the 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
HRIG