Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | 3004337 | — |
The patient took one capsule of Vivotif while it was unrefrigerated; The patient took one capsule of Vivotif while it was unrefrigerated; The patient took one capsule of Vivotif while it was unrefrigerated; Case reference number US-BN-2025-001938 is a spontaneous case initially received from other health professional via Bavarian Nordic (reference number: CASE-001105) on 09-Dec-2025 and concerns a 36-year-old male patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient took a dose of Vivotif (batch number: 3004337) at an unknown dose and route of administration for an unknown indication. As reported, the patient took one capsule while it was unrefrigerated. (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 the Vivotif vaccine. No further information was provided.; Reporter's Comments: A 36-year-old male patient took a dose of Vivotif for an unknown indication. As reported, the patient took one capsule while it was unrefrigerated, which is considered as product temperature excursion issue, product storage error, and product administration error. It was unknown if the patient 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 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 36-year-old male patient took a dose of Vivotif for an unknown indication. As reported, the patient took one capsule while it was unrefrigerated, which is considered as product temperature excursion issue, product storage error, and product administration error. It was unknown if the patient 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 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.