Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | PO / MO |
The patient picked up Vivotif and left it out of the fridge at room temperature for around 18 hours, reaching a maximum temperature of around 65 degrees Fahrenheit; The patient picked up Vivotif and left it out of the fridge at room temperature for around 18 hours, reaching a maximum temperature of around 65 degrees Fahrenheit; The patient took one capsule of Vivotif on Saturday at lunch time after 18 hours being kept unrefrigerated; Case reference number US-BN-2025-000254 is a spontaneous case initially received from a pharmacist via Communication (reference number: USBAV25-0352) on 17-Feb-2025 and concerns 83-years-old male patient. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient picked up Vivotif and left it out in the fridge at room temperature for around 18 hours, reaching a maximum temperature of around 65 degrees Fahrenheit (explicitly coded as 'product storage error temperature too high' and 'product temperature excursion issue'). On 15-Feb-2025, reported as on Saturday, the patient took one capsule of Vivotif vaccine after 18 hours being kept unrefrigerated (batch number: unknown), at a dose of one capsule, orally, for typhoid immunization (explicitly coded as 'product administration error'). As reported, the vaccine was put back in the fridge. 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: An 83-years-old male patient picked up Vivotif and left it out in the fridge at room temperature for around 18 hours, reaching a maximum temperature of around 65 degrees Fahrenheit which is considered as product storage error temperature too high and product temperature excursion issue. The patient took one capsule of Vivotif vaccine after 18 hours being kept unrefrigerated, at a dose of one capsule, orally, for typhoid immunization 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. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. 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: An 83-years-old male patient picked up Vivotif and left it out in the fridge at room temperature for around 18 hours, reaching a maximum temperature of around 65 degrees Fahrenheit which is considered as product storage error temperature too high and product temperature excursion issue. The patient took one capsule of Vivotif vaccine after 18 hours being kept unrefrigerated, at a dose of one capsule, orally, for typhoid immunization 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. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. 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