Received Mar 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | 3004044;3004043 | PO / MO |
The patients took first doses of Vivotif vaccines which were out of refrigerate five days, maximum temperature was 75 Fahrenheit degrees; The patients took first doses of Vivotif vaccines which were out of refrigerate five days, maximum temperature was 75 Fahrenheit degrees; Case reference number US-BN-2024-002085 is a spontaneous case initially received from a consumer via Communications (reference number USBAV24-1451) on 24-Jun-2024 and concerns two patients, 14-years-old and 18-years-old male patients. The patient's medical history and concomitant medication details were not provided. On 23-Jun-2024, reported as yesterday, the patients took first dose of Vivotif (batch number: 3004044; 3004043), at unknown dose, orally, for typhoid fever immunisation. As reported, two boxes of Vivotif vaccine were out of the fridge for five days and maximum temperature was 75 Fahrenheit degrees (explicitly coded as 'Product storage error' and 'Product administration error'). At the time of the initial report, it was unknown if any of the patients experienced any adverse event due to Vivotif vaccine. Additional information received from consumer on 24-Jun-2024 via Communications included age of second patient and additional reference number USBAV24-1449. Non-significant follow up was downloaded from VAERS on 09-May-2025 included new reference number Administrative update performed within the case: Worldwide Unique Case Identification Number (WWID) updated from US-20240624-c318dd to US-BAVARIAN NORDIC A/S-US-BN-2024-002085, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: Two patients, 14-year-old and 18-year-old male patients took the first dose of Vivotif for typhoid fever immunisation. As reported, two boxes of Vivotif vaccine were out of the fridge for five days and maximum temperature was 75 Fahrenheit degrees, which is considered as product storage error and product administration error. It was unknown if any of the patients experienced any adverse event due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: Two patients, 14-year-old and 18-year-old male patients took the first dose of Vivotif for typhoid fever immunisation. As reported, two boxes of Vivotif vaccine were out of the fridge for five days and maximum temperature was 75 Fahrenheit degrees, which is considered as product storage error and product administration error. It was unknown if any of the patients experienced any adverse event due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. USBAV24-1451:
Comments: None