Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | Unknown | — |
The Rabavert was left outside of the refrigerator for approximately two hours on 75 Degrees Fahrenheit and the patient administered the vaccine; The Rabavert was left outside of the refrigerator for approximately two hours on 75 Degrees Fahrenheit and the patient administered the vaccine; The Rabavert was left outside of the refrigerator for approximately two hours on 75 Degrees Fahrenheit and the patient administered the vaccine; Case reference number US-BN-2025-001404 is a spontaneous case initially received from a pharmacist via agency (reference number: USBAV25-2037) on 15-Aug-2025 and concerns a patient of unspecified age and gender. The patient's medical history and concomitant medication details were not provided. On an unspecified date, RabAvert was left outside of the refrigerator for approximately two hours at 75 Degrees Fahrenheit (Explicitly coded as 'product storage error' and 'product temperature excursion issue'). On an unspecified date, the patient was vaccinated with the affected dose of RabAvert vaccine along with its reconstitution parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, unknown route and site of administration 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 event due to RabAvert. No further information was provided.; Reporter's Comments: This case concerns a patient of unspecified age and gender, who received RabAvert vaccine for unknown indication, which was left outside of the refrigerator for approximately two hours at 75 Degrees Fahrenheit, which is considered as 'product storage error', 'product temperature excursion issue' and 'product administration error'. At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccine. Product storage error, product temperature excursion issue and product administration error are considered as listed as 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: This case concerns a patient of unspecified age and gender, who received RabAvert vaccine for unknown indication, which was left outside of the refrigerator for approximately two hours at 75 Degrees Fahrenheit, which is considered as 'product storage error', 'product temperature excursion issue' and 'product administration error'. At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccine. Product storage error, product temperature excursion issue and product administration error are considered as listed as 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.