Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | PO / MO |
The patient took the first dose of Vivotif on 06-Dec-2025, which was not refrigerate since 03-Dec-2025; The patient took the first dose of Vivotif on 06-Dec-2025, which was not refrigerate since 03-Dec-2025; The patient took the first dose of Vivotif on 06-Dec-2025, which was not refrigerate since 03-Dec-2025; Case reference number US-BN-2025-001923 is a spontaneous case initially received from other health professional via Bavarian Nordic (reference number: CASE-001081) on 08-Dec-2025 and concerns a 21-year-old female patient. The patient's medical history and concomitant medication details were not provided. On 03-Dec-2025, the patient picked up Vivotif but did not refrigerate and left outside (explicitly coded as 'product temperature excursion issue', and 'product storage error'). On 06-Dec-2025, the patient took the first dose of affected Vivotif (batch number: unknown) *at a dose of one capsule orally for immunization* (explicitly coded as 'product administration error'). *The reporter did not know the batch number and expiration date. * *It was an error of human factor as the patient did not read the prescription carefully. * At the time of the *follow-up* report, the patient *did not* experience any adverse events due to the Vivotif vaccine. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up received from other health professional via on 06-Jan-2026: New information included patient demographic details, product dosing details and confirmation that the patient did not experience any adverse events. The contributing factor for the error was provided.; Reporter's Comments: A 21-year-old female patient took the first dose of Vivotif for immunization. As reported the Vivotif was not refrigerated, which is considered as product temperature excursion issue, product storage error, and product administration error. The patient did not experience any adverse events due to the Vivotif vaccine. Product temperature excursion issue, product storage error and product administration error are considered as listed per company convention. The patient's 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: A 21-year-old female patient took the first dose of Vivotif for immunization. As reported the Vivotif was not refrigerated, which is considered as product temperature excursion issue, product storage error, and product administration error. The patient did not experience any adverse events due to the Vivotif vaccine. Product temperature excursion issue, product storage error and product administration error are considered as listed per company convention. The patient's 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.