Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | Unknown | — |
three patients were received The Rabavert which temperature was unmonitored without the data loggers for two weekends; three patients were received The Rabavert which temperature was unmonitored without the data loggers for two weekends; three patients were received The Rabavert which temperature was unmonitored without the data loggers for two weekends; Case reference number US-BN-2025-001127 is a spontaneous case report initially received from a nurse via agency (reference number: USBAV25-1554) on 26-Jun-2025 and concerns three patients of unspecified age and gender (MULTI 3). The patient's relevant medical history and concomitant medications were not provided. On an unspecified date, at 03:00 pm, Rabavert temperature was checked then only checked the temperature again on Monday 07:00 am and it happen over a period of two weekends. On an unspecified date, the Rabavert temperature was unmonitored without the data loggers for two weekends (explicitly coded as 'product storage error' and 'product temperature excursion issue'). On an unspecified date, three patients received of defected Rabavert vaccine along with pre-filled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, orally, for unknown indication (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to Rabavert vaccine. No further information was provided.; Reporter's Comments: Three patients of unspecified age and gender received defected Rabavert vaccine for unknown indication, which temperature was unmonitored without the data loggers for two weekends, which is considered as product storage error, product temperature excursion issue and product administration error. It was unknown if the patient experienced any adverse events due to Rabavert vaccine. Product storage error, product temperature excursion issue and product administration error are considered as listed per company convention. The patient's relevant medical history and concomitant medications 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: Three patients of unspecified age and gender received defected Rabavert vaccine for unknown indication, which temperature was unmonitored without the data loggers for two weekends, which is considered as product storage error, product temperature excursion issue and product administration error. It was unknown if the patient experienced any adverse events due to Rabavert vaccine. Product storage error, product temperature excursion issue and product administration error are considered as listed per company convention. The patient's relevant medical history and concomitant medications 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.