Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | 3004089 | PO / MO |
The patient took one dose of Vivotif vaccine and then the refrigerator went out of range overnight, vaccine reached 56 Fahrenheits for up to 12 hours, after the excursion the patient took second dose; The patient took one dose of Vivotif vaccine and then the refrigerator went out of range overnight, vaccine reached 56 Fahrenheits for up to 12 hours, after the excursion the patient took second dose; The patient took one dose of Vivotif vaccine and then the refrigerator went out of range overnight, vaccine reached 56 Fahrenheits for up to 12 hours, after the excursion the patient took second dose; Case reference number US-BN-2025-00253 is a spontaneous case initially received from a pharmacist via Communication (reference number: USBAV25-0358) on 17-Feb-2025 and concerns a patient with unspecified age and gender. The patient's medical history and concomitant medication details were not provided. On unspecified dates, the patient took the first dose of Vivotif (batch number: 3004089), the dose was unknown, orally, for indication against typhoid fever. On an unspecified date, as reported the refrigerator went out of range overnight, Vivotif vaccine reached 56 Fahrenheits up to 12 hours (explicitly coded as 'product storage error temperature too high' and 'product temperature excursion issue'). On 17-Feb-2024, unknown of time after first dose of VIvotif, the patient took the second dose of defected Vivotif vaccine (batch number: 3004089), the dose was unknown, orally (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any of adverse event due Vivotif. No further information was provided.; Reporter's Comments: A patient with unspecified age and gender took the dose of defected Vivotif vaccine, namely the refrigerator went out of range overnight, Vivotif vaccine reached 56 Fahrenheits up to 12 hours, which is considered as product storage error temperature too high, product temperature excursion issue and product administration error. It was unknown if the patient experienced any adverse event due Vivotif. Product storage error, product temperature excursion issue and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product temperature excursion issue 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 patient with unspecified age and gender took the dose of defected Vivotif vaccine, namely the refrigerator went out of range overnight, Vivotif vaccine reached 56 Fahrenheits up to 12 hours, which is considered as product storage error temperature too high, product temperature excursion issue and product administration error. It was unknown if the patient experienced any adverse event due Vivotif. Product storage error, product temperature excursion issue and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product temperature excursion issue 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