Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | Unknown | — |
The Vivotif vaccine was left out in the room temperature for a month and male patient took all four capsules of Vivotif and female patient took unspecified number of Vivotif without refrigerated; The Vivotif vaccine was left out in the room temperature for a month and male patient took all four capsules of Vivotif and female patient took unspecified number of Vivotif without refrigerated; The Vivotif vaccine was left out in the room temperature for a month and male patient took all four capsules of Vivotif and female patient took unspecified number of Vivotif without refrigerated; Case reference number US-BN-2025-000839 is a spontaneous case initially received from physician via Communication (reference number: USBAV25-0841) on 15-Apr-2025 and concerns one male and female patient of unspecified ages (MULTI 2). The patients' medical history and concomitant medication details were not provided. On an unspecified date, almost a month ago, Vivotif vaccine was picked up and left out in the room temperature for a month (explicitly coded as 'product storage error' and 'product temperature excursion issue') On unspecified dates, the male patient took four doses of defected Vivotif vaccine (batch number: unknown) at a dose of one capsule, unknown route for unknown indication (explicitly coded as 'product administration error'). On unspecified date, female patient took unspecified number of defected Vivotif vaccines (batch number: unknown) at a dose of one capsule, unknown route for unknown indication (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patients experienced any of adverse events due Vivotif. Additional information received from physician via Med Communication (reference number: USBAV25-0842) on 15-Apr-2025: New information included patient details for second patient and reference number.; Reporter's Comments: This case concerns one male and female patients of unspecified age/age group. On an unspecified date, almost a month ago, Vivotif vaccine was picked up and left out in the room temperature for a month which is considered as product temperature excursion issue' and 'product storage error'. On unspecified dates, the male patient took four doses of defected Vivotif vaccine for unknown indication and on unspecified date, female patient took unspecified number of defected Vivotif for unknown indication, which is considered as 'product administration error '. At the time of the initial report, it was unknown if the patients experienced any of adverse events due Vivotif. 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 one male and female patients of unspecified age/age group. On an unspecified date, almost a month ago, Vivotif vaccine was picked up and left out in the room temperature for a month which is considered as product temperature excursion issue' and 'product storage error'. On unspecified dates, the male patient took four doses of defected Vivotif vaccine for unknown indication and on unspecified date, female patient took unspecified number of defected Vivotif for unknown indication, which is considered as 'product administration error '. At the time of the initial report, it was unknown if the patients experienced any of adverse events due Vivotif. 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