Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 3 | Unknown | — |
The patient received three doses of RabAvert that were stored at 48 Fahrenheit, the earliest dose had been stored at same temperature for three days; The patient received three doses of RabAvert that were stored at 48 Fahrenheit, the earliest dose had been stored at same temperature for three days; The patient received three doses of RabAvert that were stored at 48 Fahrenheit, the earliest dose had been stored at same temperature for three days; Case reference number US-BN-2025-000215 is a spontaneous case initially received from a physician via Med Communication (reference number: USBAV25-0321) on 24-Feb-2025 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 an encounter with a dog. On an unspecified date, the RabAvert vaccine was stored at 48 Fahrenheit, the earliest dose was stored at same temperature for three days (explicitly coded as 'product storage error temperature too high' and 'product temperature excursion issue' ) On 30-Jan-2025, unknown time of encounter with the dog, the patient received the first dose of RabAvert 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 indication post exposure (explicitly coded as 'product administration error'). On 03-Feb-2025, unknown time of encounter with the dog the patient received the second dose of RabAvert 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 (explicitly coded as 'product administration error'). On 06-Feb-2025, unknown time of encounter with the dog the patient took the third dose of RabAvert 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 (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any of adverse events due RabAvert. No further information was provided.; Reporter's Comments: A male patient of unspecified age received the first, second and the third dose of RabAvert for indication post exposure, after the RabAvert vaccine was stored at 48 Fahrenheit, the earliest dose was stored at same temperature for three days, which is considered as product storage error temperature too high, product temperature excursion issue and product administration error. It was unknown if the patient experienced any of adverse events due RabAvert. Product storage error, product temperature excursion issue and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product temperature excursion issue and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unspecified age received the first, second and the third dose of RabAvert for indication post exposure, after the RabAvert vaccine was stored at 48 Fahrenheit, the earliest dose was stored at same temperature for three days, which is considered as product storage error temperature too high, product temperature excursion issue and product administration error. It was unknown if the patient experienced any of adverse events due RabAvert. Product storage error, product temperature excursion issue and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product temperature excursion issue and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: NONE