Received Mar 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | PO / MO |
Patient left Vivotif outside of the fridge for approximately one week, reaching a maximum temperature of 67 degrees Fahrenheit, and patient took one dose today while it was not refrigerated; Patient left Vivotif outside of the fridge for approximately one week, reaching a maximum temperature of 67 degrees Fahrenheit, and patient took one dose today while it was not refrigerated; Patient left Vivotif outside of the fridge for approximately one week, reaching a maximum temperature of 67 degrees Fahrenheit, and patient took one dose today while it was not refrigerated; Case reference number US-BN-2025-000265 is a spontaneous case initially received from consumer via Communications (reference number: USBAV25-0379) on 19-Feb-2025 and concerns a 66-year-old female patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, as reported, the patient was not aware that Vivotif needs to be refrigerated (explicitly coded as 'product storage error' and 'product temperature excursion issue'). On 19-Feb-2025, the patient took the first dose of Vivotif (batch number: unknown) at unknown dose, orally for typhoid immunization. As reported, the patient left Vivotif outside of the fridge for approximately one week, reaching a maximum temperature of 67 degrees Fahrenheit. The HCP states that the patient took one dose while it was not refrigerated (explicitly coded as 'product administration error'). At the time of initial report, it was unknown if the patient experienced any adverse event. No further information was provided.; Reporter's Comments: A 66-year-old female patient was not aware that Vivotif needs to be refrigerated which is considered as product storage error and product temperature excursion issue. The patient took the first dose of Vivotif, at unknown dose, orally for typhoid immunization. Reportedly, the patient left Vivotif outside of the fridge for approximately one week, reaching a maximum temperature of 67 degrees Fahrenheit and the patient took one dose while it was not refrigerated which is considered as product administration error. Product temperature excursion issue, product storage error and product administration error are all considered listed per company conventions. The patient's medical history and concomitant medication details were not provided. At this point, it was unknown if the patient experienced any adverse event. Product temperature excursion issue, product storage error and product administration error are all assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 66-year-old female patient was not aware that Vivotif needs to be refrigerated which is considered as product storage error and product temperature excursion issue. The patient took the first dose of Vivotif, at unknown dose, orally for typhoid immunization. Reportedly, the patient left Vivotif outside of the fridge for approximately one week, reaching a maximum temperature of 67 degrees Fahrenheit and the patient took one dose while it was not refrigerated which is considered as product administration error. Product temperature excursion issue, product storage error and product administration error are all considered listed per company conventions. The patient's medical history and concomitant medication details were not provided. At this point, it was unknown if the patient experienced any adverse event. Product temperature excursion issue, product storage error and product administration error are all assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None.