Received Mar 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | Unknown | — |
The patient took second dose of Vivitof which was left out of fridge over night; The patient took second dose of Vivitof which was left out of fridge over night; The patient took second dose of Vivitof which was left out of fridge over night; Case reference number US-BN-2025-001994 is a spontaneous case initially received from consumer via Bavarian Nordic (reference number: CASE-001328) on 22-Dec-2025 and concerns a male patient of unknown age. The patient's medical history and concomitant medication details were not provided. On 20-Dec-2025, the patient took the first dose of Vivotif (batch number: unknown) at an unknown dose and route of administration, for an unknown indication. On an unspecified date, the patient stated that left the Vivotif capsules out of refrigerator overnight (explicitly coded as 'product temperature excursion issue', and 'product storage error', On 22-Dec-2025, two days after first dose, the patient took defected the second dose of Vivotif (batch number: unknown) at an unknown dose and route of administration (explicitly coded as '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 defected dose of Vivotif for an unknown indication, after the patient stated that left the Vivotif capsules out of refrigerator overnight, which is considered as product temperature excursion issue, product storage error and product administration error. It was unknown if the patient experienced any adverse event due to 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 defected dose of Vivotif for an unknown indication, after the patient stated that left the Vivotif capsules out of refrigerator overnight, which is considered as product temperature excursion issue, product storage error and product administration error. It was unknown if the patient experienced any adverse event due to 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.