Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | 3004343 | — |
Patient stored Vivotif at home at 65 to 68 degrees and Vivotif was out of the fridge for 5 days and patient took two doses; Patient stored Vivotif at home at 65 to 68 degrees and Vivotif was out of the fridge for 5 days and patient took two doses; Patient stored Vivotif at home at 65 to 68 degrees and Vivotif was out of the fridge for 5 days and patient took two doses; Missed dose - Due for dose yesterday; Case reference number US-BN-2025-001843 is a spontaneous case initially received from a pharmacist via Bavarian Nordic (reference number: CASE-000899) on 24-Nov-2025 and concerns a female patient. The patients' medical history and concomitant medication details were not provided. On an unspecified date, patient stored Vivotif at home at 65 to 68 degrees and Vivotif was out of the fridge for 5 days. (explicitly coded as 'product storage error' and 'product temperature excursion issue'). On unspecified date, the patient was vaccinated with first dose of Vivotif (batch number: 3004343) at an unknown dose, route and site of administration for an unknown indication. (explicitly coded as 'product administration error'). On unspecified date, the patient was vaccinated with second dose of Vivotif (batch number: 3004343) at an unknown dose, route and site of administration for an unknown indication. (explicitly coded as 'product administration error') On unspecified date, reported as yesterday patient was due for dose, and patient did not take the dose of Vivotif. (explicitly coded as 'Product dose omission issue') At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. Additional information received on 24-Nov-2025 from Bavarian Nordic included new reference number and reporter information. (CASE-000898); Reporter's Comments: This case concerns a female patient. As reported patient was vaccinated with 2 doses of Vivotif vaccine, which was out of fridge for 5 days, for unknown indication, which is considered as product temperature excursion issue, product storage error and product administration error. Patient also missed the dose which is considered as product dose omission issue. At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. Product temperature excursion issue, product storage error, product dose omission issue 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, product dose omission issue 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. As reported patient was vaccinated with 2 doses of Vivotif vaccine, which was out of fridge for 5 days, for unknown indication, which is considered as product temperature excursion issue, product storage error and product administration error. Patient also missed the dose which is considered as product dose omission issue. At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. Product temperature excursion issue, product storage error, product dose omission issue 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, product dose omission issue 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.