Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 1 | FDP00552 | — |
Patient received first dose of RabAvert, however it was mistakenly stored in freezer and the minimum temperature reached -4.7 Fahrenheit degrees; Patient received first dose of RabAvert, however it was mistakenly stored in freezer and the minimum temperature reached -4.7 Fahrenheit degrees; The patient was scheduled to receive their second dose on 29-Sep-2024, but ended up not having the vaccine since pharmacist was unsure regarding dose scheduling; Case reference number US-BN-2024-002567 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-2548) on 30-Sep-2024 and concerns a 74-year-old female patient. The patient's medical history and concomitant medication details were not provided. On unspecified date, the RabAvert vaccine was mistakenly stored in freezer and the minimum temperature reached was negative 4.7 degrees Fahrenheit (explicitly coded as 'product storage error'). On 20-Sep-2024, the patient was vaccinated with the affected first dose of RabAvert (batch number: FDP00552) at an unknown dose, route and site of administration for pre-exposure prophylaxis (explicitly coded as 'product administration error'). As reported the second dose of RabAvert was scheduled on 29-Sep-2024 for the patient, but ended up not having the vaccine since pharmacist was unsure regarding dose scheduling (explicitly coded as 'inappropriate schedule of vaccine administered'). 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: A 74-year-old female patient was vaccinated with the affected first dose of RabAvert for pre-exposure prophylaxis, which was mistakenly stored in freezer and the minimum temperature reached was negative 4.7 degrees Fahrenheit, which is considered as product storage error and product administration error. As reported the second dose of RabAvert was scheduled on 29-Sep-2024 for the patient, but ended up not having the vaccine since pharmacist was unsure regarding dose scheduling, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due to RabAvert. Product storage error, product administration error and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product administration error and inappropriate schedule of product administration are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 74-year-old female patient was vaccinated with the affected first dose of RabAvert for pre-exposure prophylaxis, which was mistakenly stored in freezer and the minimum temperature reached was negative 4.7 degrees Fahrenheit, which is considered as product storage error and product administration error. As reported the second dose of RabAvert was scheduled on 29-Sep-2024 for the patient, but ended up not having the vaccine since pharmacist was unsure regarding dose scheduling, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due to RabAvert. Product storage error, product administration error and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product administration error and inappropriate schedule of product administration are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.