Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | Unknown | — |
The second dose was administered two hours after being left at the hospital room temperature at 72 Degrees Fahrenheit to 74 Degrees Fahrenheit; The second dose was administered two hours after being left at the hospital room temperature at 72 Degrees Fahrenheit to 74 Degrees Fahrenheit; The second dose was administered two hours after being left at the hospital room temperature at 72 Degrees Fahrenheit to 74 Degrees Fahrenheit; Case reference number US-BN-2025-001402 is a spontaneous case initially received from a consumer via agency (reference number: USBAV25-2033) on 15-Aug-2025 and concerns a 25-year-old female patient. The patient's medical history and concomitant medication details were not provided. On unspecified date, patient experienced cat bite. On 11-Aug-2025, the patient was vaccinated with the first 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, route and site of administration for post-exposure prophylaxis. As reported, the RabAvert vaccine was left out of the fridge for two hours, reaching a maximum temperature of around 72ºF to 74ºF hospital room temperature (explicitly coded as 'product storage error' and 'product temperature excursion issue'). On 14-Aug-2025, three days after first dose, the patient was vaccinated with the second dose of affected RabAvert vaccine along with its reconstitution parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, route and site of administration. (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 25-year-old female patient, who received RabAvert vaccine for post-exposure prophylaxis. As reported after first dose, vaccine was left out of the fridge for two hours, reaching a maximum temperature of around 72ºF to 74ºF. Patient also received second dose of RabAvert vaccine 3 days after the first dose, 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 25-year-old female patient, who received RabAvert vaccine for post-exposure prophylaxis. As reported after first dose, vaccine was left out of the fridge for two hours, reaching a maximum temperature of around 72ºF to 74ºF. Patient also received second dose of RabAvert vaccine 3 days after the first dose, 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.