Received Mar 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | Unknown | — |
The Vivotif vaccine envelope was left out on the counter on Sunday and not discovered until Tuesday. Two patients had taken two doses each, and one patient had taken one dose.; The Vivotif vaccine envelope was left out on the counter on Sunday and not discovered until Tuesday. Two patients had taken two doses each, and one patient had taken one dose.; The Vivotif vaccine envelope was left out on the counter on Sunday and not discovered until Tuesday. Two patients had taken two doses each, and one patient had taken one dose.; Case reference number US-BN-2025-000928 is a spontaneous case report initially received from a nurse via Communication (reference number: USBAV25-1074) on 09-May-2025 and concerns two male patients and three female patients (to be confirmed who of them received the vaccine). The patient's relevant medical history and concomitant medications were not provided. As reported, the family of five educate very diligently the need for refrigeration, started the medication which was took home and put it in the fridge. All the patients were on different schedules. As reported two of them have not started. On an unspecified date, reported as on Sunday, one of the family members left the envelop out on the counter and it was not discovered until Tuesday (explicitly coded as 'product temperature excursion issue' and 'product storage error'). On an unspecified dates, two patients took two doses of Vivotif vaccine (batch number: unknown) at an unknown dose, route, or site of administration for unknown indication (explicitly coded as 'product administration error'). On an unspecified dates, one patient took three doses of Vivotif vaccine (batch number: unknown) at an unknown dose, route, or site of administration for unknown indication (explicitly coded as 'product administration error'). At the time of initial report, it was unknown if the patients experienced any adverse events due to Vivotif vaccine. Additional information received from a nurse via Med Communications on 09-May-2025 (USBAV25-1077) included additional reference number and confirmation demographic information for second patient Additional information received from a nurse via Med Communications on 09-May-2025 (USBAV25-1078) included additional reference number and confirmation demographic information for third patient Additional information received from a nurse via Med Communications on 09-May-2025 (USBAV25-1079) included additional reference number and confirmation demographic information for fourth patient. Additional information received from a nurse via Med Communications on 09-May-2025 (USBAV25-1080) included additional reference number and confirmation demographic information for fifth patient. Non-significant follow up was received from Med communications on 13-Jun-2025 included new reference number; Reporter's Comments: This case concerns a family of 5 patients (two male patients and three female patients). On unspecified date, one of the family members left out Vivotif vaccine on the counter (unrefrigerated), which is considered as product temperature excursion issue', and 'product storage error'. On unspecified dates, as reported, two patients took two doses of Vivotif vaccine. Later, on an unspecified date, one patient took three doses of Vivotif vaccine which is considered as 'product administration error'. At the time of initial report, it was unknown if the patients 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 family of 5 patients (two male patients and three female patients). On unspecified date, one of the family members left out Vivotif vaccine on the counter (unrefrigerated), which is considered as product temperature excursion issue', and 'product storage error'. On unspecified dates, as reported, two patients took two doses of Vivotif vaccine. Later, on an unspecified dates, one patient took three doses of Vivotif vaccine which is considered as 'product administration error'. At the time of initial report, it was unknown if the patients 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