Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | — |
The whole family (3 males and 1 female) took the first dose of Vivotif which was left at room temperature probably 68-70 F.; The whole family (3 males and 1 female) took the first dose of Vivotif which was left at room temperature probably 68-70 F.; The whole family (3 males and 1 female) took the first dose of Vivotif which was left at room temperature probably 68-70 F.; Case reference number US-BN-2025-001877 is a spontaneous case initially received from a pharmacist via Bavarian Nordic (reference number: CASE-000937) on 26-Nov-2025 and concerns four patients: 51-year-old male patient, 17-year-old male patient, 43-year-old female patient, and one male patient of unknown age (MULTI 4). The patient's medical history and concomitant medication details were not provided. On 25-Nov-2025, reported as yesterday, around 5, the Vivotif vaccine was left out like 16 hours at room temperature probably 68-70 F (explicitly coded as 'Product temperature excursion issue' and 'product storage error temperature too high'). On 25-Nov-2025, all four patients (three males and one female) took the first dose of Vivotif (batch number: unknown) at an unknown dose and route of administration for the unknown indication (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patients experienced any adverse events due to Vivotif vaccine. Additional information received from a pharmacist via Bavarian Nordic (reference number: CASE-000937) on 26-Nov-2025 included: confirmation demographic information for second patient. Additional information received from a pharmacist via Bavarian Nordic (reference number: CASE-000937) on 26-Nov-2025 included: confirmation demographic information for third patient. Additional information received from a pharmacist via Bavarian Nordic (reference number: CASE-000937) on 26-Nov-2025 included: confirmation demographic information for fourth patient.; Reporter's Comments: Four patients: 51-year-old male patient, 17-year-old male patient, 43-year-old female patient, and one male patient of unknown age took the first dose of affected Vivotif for the unknown indication, which was left out like 16 hours at room temperature probably 68-70 F, which is considered as product temperature excursion issue, product storage error temperature too high and product administration error. It was unknown if the patients experienced any adverse events due to Vivotif vaccine. Product temperature excursion issue, product storage error and product administration error are considered as listed per company convention. The patients' 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: Four patients: 51-year-old male patient, 17-year-old male patient, 43-year-old female patient, and one male patient of unknown age took the first dose of affected Vivotif for the unknown indication, which was left out like 16 hours at room temperature probably 68-70 F, which is considered as product temperature excursion issue, product storage error temperature too high and product administration error. It was unknown if the patients experienced any adverse events due to Vivotif vaccine. Product temperature excursion issue, product storage error and product administration error are considered as listed per company convention. The patients' 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.