Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | — |
The patient picked up the Vivotif vaccine and left it unrefrigerated for four hours at the maximum temperature 72 Fahrenheits and had at least one dose; The patient picked up the Vivotif vaccine and left it unrefrigerated for four hours at the maximum temperature 72 Fahrenheits and had at least one dose; The patient picked up the Vivotif vaccine and left it unrefrigerated for four hours at the maximum temperature 72 Fahrenheits and had at least one dose; Case reference number US-BN-2025-001436 is a spontaneous case report initially received from a pharmacist via Communication (reference number: USBAV25-2094) on 21-Aug-2025 and concerns a 47-years-old female patient. The patient's relevant medical history and concomitant medications were not provided. On an unspecified date, the patient picked up the Vivotif vaccine (batch number: unknown) and left it unrefrigerated at 72 degrees Fahrenheit for four hours (explicitly coded as 'product storage error temperature too high' and 'product temperature excursion issue'). On an unspecified date, the patient took the first dose of affected Vivotif vaccine (batch number: unknown) at an unknown dose and route for an unknown indication (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 47-year-old female patient took the dose of affected Vivotif vaccine for an unknown indication, after the patient left it unrefrigerated at 72 degrees Fahrenheit for four hours, 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 47-year-old female patient took the dose of affected Vivotif vaccine for an unknown indication, after the patient left it unrefrigerated at 72 degrees Fahrenheit for four hours, 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.