Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | 3004337 | PO / MO |
The patient did not refrigerate the Vivotif vaccine for about three days (was at room temperature) and took maybe one or two doses; did not refrigerate the vaccine for about three days; The patient did not refrigerate the Vivotif vaccine for about three days (was at room temperature) and took maybe one or two doses; Case reference number US-BN-2025-001415 is a spontaneous case initially received from a pharmacist via Communications (reference number: USBAV25-2050) on 18-Aug-2025 and concerns an adult male patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient did not refrigerate the vaccine for about three days and kept it at room temperature (explicitly coded 'product storage error temperature too high' and 'product temperature excursion issue'). On unspecified dates, the patient took one or two doses Vivotif (batch number: 3004337) at unknown doses, orally, for indication travelling to an area endemic for typhoid ('product administration error'). At the time of the initial report, it was unknown if the patients experienced any adverse events due to Vivotif. No additional information was provided.; Reporter's Comments: An adult male patient did not refrigerate the Vivotif vaccine for about three days and kept it at room temperature, which is considered as product storage error temperature too high and product temperature excursion issue. On unspecified dates, the patient took one or two doses Vivotif for indication travelling to an area endemic for typhoid, which is considered as product administration error. It was unknown if the patient experienced any adverse events due to Vivotif. Product administration error, product temperature excursion issue and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error, product temperature excursion issue and product storage error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: An adult male patient did not refrigerate the Vivotif vaccine for about three days and kept it at room temperature, which is considered as product storage error temperature too high and product temperature excursion issue. On unspecified dates, the patient took one or two doses Vivotif for indication travelling to an area endemic for typhoid, which is considered as product administration error. It was unknown if the patient experienced any adverse events due to Vivotif. Product administration error, product temperature excursion issue and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error, product temperature excursion issue and product storage error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None