Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | 3004368 | — |
The patient took a dose of Vivotif that was out of refrigerator for three days; The patient took a dose of Vivotif that was out of refrigerator for three days; The patient took a dose of Vivotif that was out of refrigerator for three days; Case reference number US-BN-2025-001925 is a spontaneous case initially received from consumer via Bavarian Nordic (reference number: CASE-001079) 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 06-Dec-2025, the patient took the dose of Vivotif (batch number: 3004368) at an unknown dose and route of administration for an unknown indication. As reported that the patient took the Vivotif dose that was out of refrigerator for three days (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 21-year-old female patient took the dose of Vivotif for an unknown indication. As reported that the patient took the Vivotif dose that was out of refrigerator for three days, 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 21-year-old female patient took the dose of Vivotif for an unknown indication. As reported that the patient took the Vivotif dose that was out of refrigerator for three days, 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.