Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | 3004334 | PO / MO |
One box of Vivotif was outside of the fridge for a couple of periods, the maximum temperature was 77 °C, one occurrence it was out of range for 6h and in the other occurrence, it was out of range for under 12h; One box of Vivotif was outside of the fridge for a couple of periods, the maximum temperature was 77 °C, one occurrence it was out of range for 6h and in the other occurrence, it was out of range for under 12h; The patient took Vivotif vaccine which had couple of periods of temperature excursion; Case reference number US-BN-2025-001425 is a spontaneous case initially received from a nurse via Communications (reference number: USBAV25-2068) on 19-Aug-2025 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, as reported, the patient stored Vivotif in the fridge, but then patient had to travel so took it out of the fridge for six hours and then it was stored in the refrigerator (explicitly coded as 'product temperature excursion issue', 'product administration error' and 'product storage error temperature too high'). On an unspecified date, the Vivotif vaccine had a second temperature excursion for 12 hours, but the patient kept it intermittently in the cooler with an ice pack. The maximum temperature was 77 °C (explicitly coded as 'product temperature excursion issue', 'product administration error' and 'product storage error temperature too high'). On unspecified dates, the patient took the full course of four Vivotif capsules (batch number: 3004334) at an unknown dose, orally, for an unknown indication. At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif. No additional information was provided.; Reporter's Comments: A female patient of unspecified age stored Vivotif in the fridge, but then patient had to travel so took it out of the fridge for six hours and then it was stored in the refrigerator. On an unspecified date, the Vivotif vaccine had a second temperature excursion for 12 hours, but the patient kept it intermittently in the cooler with an ice pack. The maximum temperature was 77 °C. On unspecified dates, the patient took the full course of four affected Vivotif capsules for an unknown indication, which is considered as product temperature excursion issue, product administration error and product storage error. It was unknown if the patient experienced any adverse events due to Vivotif. Product temperature excursion issue, product administration error and product storage 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 administration error and product storage error are are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unspecified age stored Vivotif in the fridge, but then patient had to travel so took it out of the fridge for six hours and then it was stored in the refrigerator. On an unspecified date, the Vivotif vaccine had a second temperature excursion for 12 hours, but the patient kept it intermittently in the cooler with an ice pack. The maximum temperature was 77 °C. On unspecified dates, the patient took the full course of four affected Vivotif capsules for an unknown indication, which is considered as product temperature excursion issue, product administration error and product storage error. It was unknown if the patient experienced any adverse events due to Vivotif. Product temperature excursion issue, product administration error and product storage 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 administration error and product storage error are are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None