Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | 3004043 | PO / MO |
The patient took first dose of Vivotif but it had been out of refrigeration for a month; The patient took first dose of Vivotif but it had been out of refrigeration for a month; The patient took first dose of Vivotif but it had been out of refrigeration for a month; The patient took the first dose in 18-Jun-2024 and did not receive the second dose; Case reference number US-BN-2025-000882 is a spontaneous case initially received from a pharmacist via agency (reference number: USBAV25-0954) on 28-Apr-2025 and concerns a 19-year-old, male patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, as reported the Vivotif had been out of refrigeration for a month h (explicitly coded as 'product storage error' and 'product temperature excursion issue') On 18-Jun-2024, the patient took first dose of defected Vivotif (batch number: 3004043) orally, at unknown dose, for indication travel (explicitly coded as 'product administration error'. The patient took only first dose (explicitly coded as 'incomplete cource of vaccination'). At the time of the initial report, it was unknown if patient experienced any adverse events due to Vivotif. No further information was provided.; Reporter's Comments: A 19-year-old male patient took the first dose of defected Vivotif, which had been out of refrigeration for a month for indication travel, which is considered as product storage error, product temperature excursion issue and product administration error. The patient took only the first dose, which is considered as incomplete course of vaccination. It was unknown if patient experienced any adverse events due to Vivotif. Product administration error, product storage error, product temperature excursion issue and incomplete course of vaccination are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error, product storage error, product temperature excursion issue and incomplete course of vaccination are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 19-year-old male patient took the first dose of defected Vivotif, which had been out of refrigeration for a month for indication travel, which is considered as product storage error, product temperature excursion issue and product administration error. The patient took only the first dose, which is considered as incomplete course of vaccination. It was unknown if patient experienced any adverse events due to Vivotif. Product administration error, product storage error, product temperature excursion issue and incomplete course of vaccination are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error, product storage error, product temperature excursion issue and incomplete course of vaccination are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: NONE