Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | 3004334 | PO / MO |
Patient took Vivioti vaccine which left it out of the fridge for about 48 hours, the maximum temperature was between 65 Fahrenheit to 72 Fahrenheit degrees; Patient took Vivioti vaccine which left it out of the fridge for about 48 hours, the maximum temperature was between 65 Fahrenheit to 72 Fahrenheit degrees; Patient took Vivioti vaccine which left it out of the fridge for about 48 hours, the maximum temperature was between 65 Fahrenheit to 72 Fahrenheit degrees; Case reference number US-BN-2025-001393 is a spontaneous case initially received from a consumer via Communications (reference number: USBAV25-2014) on 13-Aug-2025 and concerns a male patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient left Vivotif vaccine out of the fridge for about 48 hours, the maximum temperature was between 65 Fahrenheit to 72 Fahrenheit degrees (explicitly coded as 'product temperature excursion issue' and 'product storage error') On 11-Aug-2025, the patient received the first dose of Vivotif (batch number: 3004334) at an unknown dose, orally, for indication typhoid immunization (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 Vivotif vaccine. No additional information was provided.; Reporter's Comments: A male patient of unspecified age received the affected dose of Vivotif for indication typhoid immunization, which was out of the fridge for about 48 hours, the maximum temperature was between 65 Fahrenheit to 72 Fahrenheit degrees, which is considered as product administration error, product temperature excursion issue and product storage error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product temperature excursion issue, 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 temperature excursion issue, product storage error 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: A male patient of unspecified age received the affected dose of Vivotif for indication typhoid immunization, which was out of the fridge for about 48 hours, the maximum temperature was between 65 Fahrenheit to 72 Fahrenheit degrees, which is considered as product administration error, product temperature excursion issue and product storage error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product temperature excursion issue, 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 temperature excursion issue, product storage error 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