Received Mar 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | 3004337 | — |
The patient took the first dose of Vivotif which was not refrigerated; The patient took the first dose of Vivotif which was not refrigerated; The patient took the first dose of Vivotif which was not refrigerated; Case reference number US-BN-2025-001633 is a spontaneous case initially received from consumer via Bavarian Nordic (reference number: CASE-000051) on 02-Oct-2025 and concerns 51-years-old and 52-years-old female patients. The patient's relevant medical history and concomitant medications were not provided. On 01-Oct-2025 the patients took first dose of Vivotif vaccine (batch number: 3004337) at an unknown dose, unknown route of administration, for unknown indication. As reported the Vivotif vaccine was not refrigerated. (explicitly coded as product temperature excursion issue', product storage error' and product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. Additional information was received from health care professional via Bavarian Nordic on 02-Oct-2025 included new reference number CASE-000051, date of first dose and new reporter added. Additional information was received from health care professional via Bavarian Nordic on 06-Oct-2025 included new reference numbers CASE-000100 and country of occurrence confirmed as United States.; Reporter's Comments: A 51-year-old and 52-year-old female patient took first dose of Vivotif vaccine for unknown indication. As reported the Vivotif vaccine was not refrigerated, which is considered as product temperature excursion issue, product storage error, and product administration error. It was unknown if the patients experienced 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 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: A 51-year-old and 52-year-old female patient took first dose of Vivotif vaccine for unknown indication. As reported the Vivotif vaccine was not refrigerated, which is considered as product temperature excursion issue, product storage error, and product administration error. It was unknown if the patients experienced 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 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.