Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | Unknown | PO / MO |
The female patient took four doses and male two doses of Vivotif which was unrefrigerated for two weeks and then refrigerated for some time; The female patient took four doses and male two doses of Vivotif which was unrefrigerated for two weeks and then refrigerated for some time; The female patient took four doses and male two doses of Vivotif which was unrefrigerated for two weeks and then refrigerated for some time; Case reference number US-BN-2025-000892 is a spontaneous case report initially received from a consumer via agency (reference number: USBAV25-0984) on 30-Apr-2025 and concerns a 69-years-old female and male patients. The patients relevant medical history and concomitant medications were not provided. On 01-Apr-2025, the Vivotif vaccine was unrefrigerated for two weeks (explicitly coded as 'product storage error' and product temperature excursion issue) On 15-Apr-2025, the Vivotif vaccine then refrigerated for some time. On an unspecified date, as reported every other day, the female patient took four doses of affected Vivotif (batch number: unknown) at unknown dose, orally for typhoid immunization (explicitly coded as 'product administration error'). On an unspecified date, as reported every other day, the male patient took two doses of affected Vivotif vaccine (batch number: unknown) at unknown dose, orally for typhoid immunization (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patients experienced any adverse events due to Vivotif vaccine. Additional informations received from pharmacist via agency (reference number: USBAV25-0988, USBAV25-0987 and USBAV25-0991) on 30-Ape-2025: Information included reference number, demographic information for the patients and additional reporter.; Reporter's Comments: This case concerns a 69-year-old elderly male and female patients. As reported Vivotif vaccine was unrefrigerated for two weeks, which is considered as 'product temperature excursion issue', and 'product storage error'. On unspecified date, as reported every other day, the female patient took four doses of affected Vivotif, and the male patient took two doses of affected Vivotif vaccine which is considered 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. Product temperature excursion issue, product storage error and product administration error are considered as listed as per company convention. The patients' 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: This case concerns a 69-year-old elderly male and female patients. As reported Vivotif vaccine was unrefrigerated for two weeks, which is considered as 'product temperature excursion issue', and 'product storage error'. On unspecified date, as reported every other day, the female patient took four doses of affected Vivotif, and the male patient took two doses of affected Vivotif vaccine which is considered 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. Product temperature excursion issue, product storage error and product administration error are considered as listed as per company convention. The patients' 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.