Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | Unknown | — |
Patient took Vivotif vaccine which stored outside of the approved temperature, maximum temperature that the product was exposed to was 71°F.; Patient took Vivotif vaccine which stored outside of the approved temperature, maximum temperature that the product was exposed to was 71°F.; Patient took Vivotif vaccine which stored outside of the approved temperature, maximum temperature that the product was exposed to was 71°F.; Case reference number US-BN-2025-001763 is a spontaneous case initially received from a physician via Bavarian Nordic (reference number: CASE-000588) on 04-Nov-2025 and concerns a female patient of an unknown age. The patient's medical history and concomitant medications details were provided. On 29-Oct-2025, the patient picked up Vivotif and left it out of the fridge, that the maximum temperature that the product was exposed to was 71°F (explicitly coded as 'product storage error temperature too high' and 'product temperature excursion issue') On 30-Oct-2025, the patient took the first capsule of Vivotif which was stored outside of the approved temperature (batch number: not reported), at unknown dose, site or route of administration for an unknown indication (explicitly coded as 'product administration error'). On 01-Nov-2025, two days after the first dose, the patient took second capsule of Vivotif which was stored outside of the approved temperature (batch number: not reported), at unknown dose, site or route of administration (explicitly coded as 'product administration error'). On 03-Nov-2025, two days after the second dose, the patient took third capsule of Vivotif which was stored outside of the approved temperature (batch number: not reported), at unknown dose, site or 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 Vivotif. No further information was provided.; Reporter's Comments: This case concerns a female patient of an unknown age. As reported, patient took 3 doses of Vivotif vaccine for unknown indication, which was left out of the fridge that the product was exposed to was 71°F, which is considered 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. 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: This case concerns a female patient of an unknown age. As reported, patient took 3 doses of Vivotif vaccine for unknown indication, which was left out of the fridge that the product was exposed to was 71°F, which is considered 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. 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