Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | 3004342 | — |
The Vivotif was not refrigerated for 12 hours, the maximum temperature was not above 77 degrees Fahrenheit and it was taken by the patient.; The Vivotif was not refrigerated for 12 hours, the maximum temperature was not above 77 degrees Fahrenheit and it was taken by the patient.; The Vivotif was not refrigerated for 12 hours, the maximum temperature was not above 77 degrees Fahrenheit and it was taken by the patient.; Case reference number US-BN-2025-001636 is a spontaneous case initially received from pharmacist via Bavarian-Nordic (reference number: CASE-000082) on 03-Oct-2025 and concerns a 27-years-old female patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient did not refrigerate Vivotif (batch number: 3004342) for 12 hours, and maximum temperature was not above 77 degrees Fahrenheit (explicitly coded as 'product temperature excursion issue' and 'product storage error temperature too high'). On an unspecified date, the patient took a dose of affected Vivotif vaccine (batch number: 3004342), at unknown dose, route or site of administration for an unknown indication (explicitly coded as 'product administration error'). At the time of initial report, it was unknown if the patient experienced any adverse events due to Vivotif. No further information was provided.; Reporter's Comments: This case concerns a 27-years-old female patient. As reported, the patient took the dose of Vivotif vaccine for an unknown indication, which was affected as the patient did not refrigerate the vaccine for 12 hours, and maximum temperature was not above 77 degrees Fahrenheit, which is considered as 'product storage error', 'product temperature excursion issue' and 'product administration error'. At the time of initial report, it was unknown if the patient experienced any adverse events due to Vivotif. Product storage error, product temperature excursion issue and product administration error are considered as listed as 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: This case concerns a 27-years-old female patient. As reported, the patient took the dose of Vivotif vaccine for an unknown indication, which was affected as the patient did not refrigerate the vaccine for 12 hours, and maximum temperature was not above 77 degrees Fahrenheit, which is considered as 'product storage error', 'product temperature excursion issue' and 'product administration error'. At the time of initial report, it was unknown if the patient experienced any adverse events due to Vivotif. Product storage error, product temperature excursion issue and product administration error are considered as listed as 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.