Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | — |
The patient took the first capsule of Vivotif, which was left out of refrigerator; The patient took the first capsule of Vivotif, which was left out of refrigerator; The patient took the first capsule of Vivotif, which was left out of refrigerator; Case reference number US-BN-2025-001937 is a spontaneous case initially received from consumer via Bavarian Nordic (reference number: CASE-001099) on 09-Dec-2025 and concerns a male patient of unknown age. The patient's medical history and concomitant medication details were not provided. On an unknown date, the patient took a dose of Vivotif (batch number: unknown) at an unknown dose and route of administration for the indication prophylactic vaccination. As reported that the patient took the first capsule of Vivotif, which was left out of refrigerator (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 male patient of unknown age took a dose of Vivotif for the indication prophylactic vaccination. As reported that the patient took the first capsule of Vivotif, which was left out of refrigerator, 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 male patient of unknown age took a dose of Vivotif for the indication prophylactic vaccination. As reported that the patient took the first capsule of Vivotif, which was left out of refrigerator, 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.