Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | Unknown | PO / MO |
The patient took Vivotif vaccine, which had temperature excursion, the maximum temperature was around 72°F for five hours; The patient took Vivotif vaccine, which had temperature excursion, the maximum temperature was around 72°F for five hours; The patient took Vivotif vaccine, which had temperature excursion, the maximum temperature was around 72°F for five hours; Case reference number US-BN-2025-001592 is a spontaneous case initially received from a pharmacist via Communications (reference number: USBAV25-2371) on 24-Sep-2025 and concerns a 50-year-old female patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient left one box of Vivotif vaccine out of the fridge, the maximum temperature was around 72°F for five hours (explicitly coded as 'product temperature excursion issue' and 'product storage error temperature too high') On an unspecified date, the patient might have taken Vivotif vaccine (batch number: unknown) at an unknown dose, orally, for the 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 50-year-old female patient might have taken the affected Vivotif vaccine for the indication typhoid immunization, after the patient left one box of Vivotif vaccine out of the fridge, the maximum temperature was around 72°F for five hours, which is considered as product administration error, product temperature excursion issue and product storage error temperature too high. 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 50-year-old female patient might have taken the affected Vivotif vaccine for the indication typhoid immunization, after the patient left one box of Vivotif vaccine out of the fridge, the maximum temperature was around 72°F for five hours, which is considered as product administration error, product temperature excursion issue and product storage error temperature too high. 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