Received Mar 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | Unknown | — |
The patient did not refrigerate Vivotif vaccine and took four doses; The patient did not refrigerate Vivotif vaccine and took four doses; The patient did not refrigerate Vivotif vaccine and took four doses; Case reference number US-BN-2025-000317 is a spontaneous case initially received from a pharmacist via Communications (reference number: USBAV25-0501) on 05-Mar-2025 and concerns a 71-years-old female patient. The patient's medical history and concomitant medication details were not provided. On 14-Feb-2025, the patient picked up the vaccine. On 21-Feb-2025, the patient administered first dose of Vivotif vaccine, without knowing it needs to be refrigerated even after instructed (batch number: unknown), at unknown dose, route or site of administration for unknown indication (explicitly coded as 'product storage error', 'product temperature excursion issue' and 'product administration error'). On an unspecified date, the patient took the second dose of Vivotif (batch number: unknown), at unknown dose, route, site of administration. On an unspecified date, the patient took the third dose of Vivotif (batch number: unknown), at unknown dose, route or site of administration. On 27-Feb-2025, the patient took the fourth dose of Vivotif (batch number: unknown), at unknown dose, route or site of administration. At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A 71-year-old female patient received the first dose of Vivotif vaccine for unknown indication, without knowing it needs to be refrigerated even after instructed, which is considered as product storage error, product temperature excursion issue and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif. Product storage error, product temperature excursion 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 storage error, product temperature excursion 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: A 71-year-old female patient received the first dose of Vivotif vaccine for unknown indication, without knowing it needs to be refrigerated even after instructed, which is considered as product storage error, product temperature excursion issue and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif. Product storage error, product temperature excursion 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 storage error, product temperature excursion 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.