Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | — |
The patient took one dose of Vivotif vaccine which left out at room temperature about 68 Fahrenheit degree to 72 Fahrenheit degree; The patient took one dose of Vivotif vaccine which left out at room temperature about 68 Fahrenheit degree to 72 Fahrenheit degree; The patient took one dose of Vivotif vaccine which left out at room temperature about 68 Fahrenheit degree to 72 Fahrenheit degree; Case reference number US-BN-2025-000936 is a spontaneous case report initially received from a pharmacist via Communication (reference number: USBAV25-1090) on 12-May-2025 and concerns a female patient of unspecified age. The patient's relevant medical history and concomitant medications were not provided. On an unspecified date, the patient left vaccine out instead of putting in the fridge. The box was left outside of the fridge since Friday, Saturday and Sunday (three days) in room temperature, the room temperature was about 68 degrees Fahrenheit to 72 degrees Fahrenheit (explicitly coded as 'product storage error' and 'product temperature excursion issue'). On an unspecified date, on Friday, the patient took first dose of affected Vivotif vaccine (batch number: unknown) at an unknown dose, unknown route for unknown indication. As reported, as second dose has not taken yet (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A female patient of unspecified age left vaccine box outside of the fridge (for three days) in room temperature, the room temperature was about 68 degrees Fahrenheit to 72 degrees Fahrenheit which is considered as product storage error and product temperature excursion issue. The patient took first dose of affected Vivotif vaccine at an unknown dose, unknown route for unknown indication. Reportedly, the second dose has not been taken yet which is currently considered as product administration error. Product administration error, product storage error and product temperature excursion issue are all considered as listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. The patient's relevant medical history and concomitant medications were not provided. Product administration error, product storage error and product temperature excursion issue are all assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unspecified age left vaccine box outside of the fridge (for three days) in room temperature, the room temperature was about 68 degrees Fahrenheit to 72 degrees Fahrenheit which is considered as product storage error and product temperature excursion issue. The patient took first dose of affected Vivotif vaccine at an unknown dose, unknown route for unknown indication. Reportedly, the second dose has not been taken yet which is currently considered as product administration error. Product administration error, product storage error and product temperature excursion issue are all considered as listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. The patient's relevant medical history and concomitant medications were not provided. Product administration error, product storage error and product temperature excursion issue are all assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None.