Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | Unknown | — |
The patient took two doses of Vivotif vaccine which did not store in the fridge reaching at maximum room temperature; The patient took two doses of Vivotif vaccine which did not store in the fridge reaching at maximum room temperature; The patient took two doses of Vivotif vaccine which did not store in the fridge reaching at maximum room temperature; Case reference number US-BN-2025-000831 is a spontaneous case initially received from a pharmacist via agency (reference number: USBAV25-0822) on 11-Apr-2025 and concerns a male patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On 08-Apr-2025, reported as a couple days ago, the patient picked up the Vivotif vaccine, but did not store in the fridge reaching at maximum room temperature (explicitly coded as 'product temperature excursion issue' and 'product storage error). On the same day, the patient took first dose of Vivotif (batch number: unknown) at an unknown dose, route or site administration for unknown indication (explicitly coded as 'product administration error'). On 10-Apr-2025, two days after the first dose, the patient took second dose of Vivotif (batch number: unknown) at an unknown dose, route or site administration (explicitly coded as 'product administration error'). At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: This case concerned a male patient of unspecified age/age group, who took first dose of Vivotif vaccine at an unknown dose, for unknown indication. As reported, the patient picked up the Vivotif vaccine, but did not store in the fridge reaching at maximum room temperature 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 Vivotif. Product temperature excursion issue, product storage error and product administration error are considered as listed as 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 concerned a male patient of unspecified age/age group, who took first dose of Vivotif vaccine at an unknown dose, for unknown indication. As reported, the patient picked up the Vivotif vaccine, but did not store in the fridge reaching at maximum room temperature 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 Vivotif. Product temperature excursion issue, product storage error and product administration error are considered as listed as 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