Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | Unknown | — |
The RabAvert was left out of the fridge for around two hours reaching maximum temperature of 68 to 70 Degrees Fahrenheit and administered immediately to the patient; The RabAvert was left out of the fridge for around two hours reaching maximum temperature of 68 to 70 Degrees Fahrenheit and administered immediately to the patient; The RabAvert was left out of the fridge for around two hours reaching maximum temperature of 68 to 70 Degrees Fahrenheit and administered immediately to the patient; Case reference number US-BN-2025-001374 is a spontaneous case initially received from a pharmacist via agency (reference number: USBAV25-1944) on 07-Aug-2025 and concerns adult female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the RabAvert was left out of the fridge for around two hours reaching maximum temperature of 68 to 70 Degrees Fahrenheit and administered immediately to the patient (Explicitly coded as 'product storage error' and 'product temperature excursion issue'). On 06-Aug-2025, 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 events due to RabAvert. No further information was provided.; Reporter's Comments: An adult female patient of unspecified age was vaccinated with the affected dose (which was left out of the fridge for around two hours reaching maximum temperature of 68 to 70 Degrees Fahrenheit) of RabAvert vaccine along with its reconstitution parts: prefilled syringe, needle for injection and needle for reconstitution, at an unknown dose, unknown route and site of administration for unknown indication, and administered immediately to the patient, which is considered as product administration error, product storage error and product temperature excursion issue. Product administration error, product storage error and product temperature excursion issue are all considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to RabAvert. The patient's medical history and concomitant medication details were not provided. Causality is not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: An adult female patient of unspecified age was vaccinated with the affected dose (which was left out of the fridge for around two hours reaching maximum temperature of 68 to 70 Degrees Fahrenheit) of RabAvert vaccine along with its reconstitution parts: prefilled syringe, needle for injection and needle for reconstitution, at an unknown dose, unknown route and site of administration for unknown indication, and administered immediately to the patient, which is considered as product administration error, product storage error and product temperature excursion issue. Product administration error, product storage error and product temperature excursion issue are all considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to RabAvert. The patient's medical history and concomitant medication details were not provided. Causality is not related to suspect product but to human factor. The case is non-serious.
Comments: None.