Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | Unknown | PO / MO |
The patient left Vivotif out of refrigeration since 29-May-2025 and took three out of four doses; The patient left Vivotif out of refrigeration since 29-May-2025 and took three out of four doses; The patient left Vivotif out of refrigeration since 29-May-2025 and took three out of four doses; Case reference number US-BN-2025-001033 is a spontaneous case report initially received from a nurse via Communication (reference number: USBAV25-1356) on 09-Jun-2025 and a female patient of unspecified age. The patient's relevant medical history and concomitant medications were not provided. On 29-May-2025 the patient left Vivotif out of refrigeration (explicitly coded as 'product storage error' and 'product temperature excursion issue'). On 03-Jun-2025, the patient took first dose of affected Vivotif vaccine (batch number: unknown), at unknown dose reported as capsule, orally for unknown indication (explicitly coded as 'product administration error'). On 05-Jun-2025, two days after first dose, the patient took second dose of affected Vivotif vaccine (batch number: unknown), at unknown dose reported as capsule, orally (explicitly coded as 'product administration error'). On 07-Jun-2025, four days after first dose, the patient took third dose of affected Vivotif vaccine (batch number: unknown), at unknown dose reported as capsule, orally (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A female patient of unspecified age left Vivotif out of refrigeration, which is considered as product storage error and product temperature excursion issue. Reportedly, the patient took three doses of affected Vivotif vaccine for unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product storage error, product administration error and product temperature excursion issue are considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Product storage error, product administration error and product temperature excursion issue are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unspecified age left Vivotif out of refrigeration, which is considered as product storage error and product temperature excursion issue. Reportedly, the patient took three doses of affected Vivotif vaccine for unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product storage error, product administration error and product temperature excursion issue are considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Product storage error, product administration error and product temperature excursion issue are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.