Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 1 | Unknown | — |
The patient missed first dose of RabAvert due to temperature excursion; Case reference number US-BN-2025-001281 is a spontaneous case initially received from a pharmacist via agency (reference number: USBAV25-1756) on 18-Jul-2025 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient had exposure to the animal. On an unknown date, the RabAvert vaccine, along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) had a temperature excursion for 2 hours at a maximum temperature of 75 degrees Fahrenheit. The patient was scheduled to receive the first dose for post exposure but eloped or went against medical leave and the vaccine was not used, as reported the patient missed first dose. (explicitly coded as 'missed dose'). At the time of this report, it was unknown if the patient experienced an adverse event. No further information was received.; Reporter's Comments: This case concerns a female patient of unspecified age. As reported the patient was scheduled to receive the first dose of RabAvert vaccine, for an indication of post exposure but eloped or went against medical leave and the vaccine was not used, as reported the patient missed first dose, which is considered as 'product dose omission issue'. Product dose omission issue is considered as listed per company convention. At the time of this report, it was unknown if the patient experienced an adverse event. The patient's relevant medical history and concomitant medication details were not provided. Product dose omission issue is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: This case concerns a female patient of unspecified age. As reported the patient was scheduled to receive the first dose of RabAvert vaccine, for an indication of post exposure but eloped or went against medical leave and the vaccine was not used, as reported the patient missed first dose, which is considered as 'product dose omission issue'. Product dose omission issue is considered as listed per company convention. At the time of this report, it was unknown if the patient experienced an adverse event. The patient's relevant medical history and concomitant medication details were not provided. Product dose omission issue is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.