Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | Unknown | PO / MO |
The patient took Vivotif vaccine which was left out looked like 14 hours, maximum temperature did not go above 77 degrees Fahrenheit; The patient took Vivotif vaccine which was left out looked like 14 hours, maximum temperature did not go above 77 degrees Fahrenheit; The patient took Vivotif vaccine which was left out looked like 14 hours, maximum temperature did not go above 77 degrees Fahrenheit; Case reference number US-BN-2025-000031 is a spontaneous case initially received from pharmacist via Communication (reference number: USBAV25-0060) on 08-Jan-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 had left out Vivotif looked like 14 hours and max temperature did not go above 77 degrees Fahrenheit (explicitly coded as 'product storage error' and 'product temperature excursion issue'). On an unspecified date, the patient took defected Vivotif vaccine (batch number: unknown) orally, at unknown dose, route or site of administration for indication pre-travel (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse events due Vivotif. No further information was provided.; Reporter's Comments: A 66-year-old female patient had left out Vivotif looked like 14 hours and max temperature did not go above 77 degrees Fahrenheit, which is considered as product storage error and product temperature excursion issue. On an unspecified date, the patient took defected Vivotif vaccine for indication pre-travel, which is considered as product administration error. It was unknown if the patient experienced any adverse events due 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 66-year-old female patient had left out Vivotif looked like 14 hours and max temperature did not go above 77 degrees Fahrenheit, which is considered as product storage error and product temperature excursion issue. On an unspecified date, the patient took defected Vivotif vaccine for indication pre-travel, which is considered as product administration error. It was unknown if the patient experienced any adverse events due 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