Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | 3004333 | — |
The patients received Vivotif vaccine which had nine temperature excursions, minimum temperature was from 34.3°F to 30.2°F; The patients received Vivotif vaccine which had nine temperature excursions, minimum temperature was from 34.3°F to 30.2°F; The patients received Vivotif vaccine which had nine temperature excursions, minimum temperature was from 34.3°F to 30.2°F; Case reference number US-BN-2025-001163 is a spontaneous case initially received from a nurse via Communication (reference number: USBAV25-1632) on 07-Jul-2025 and concerns patients of unspecified age and gender (MULTI 20). The patients' medical history and concomitant medication details were not provided. On 12-Jun-2025, eight units of Vivotif vaccine (batch number: 3004333) had temperature excursion, with a recorded minimum temperature of 34.3°F that lasted for 1 hour and 23 minutes (explicitly coded as 'product temperature excursion issue' and 'product storage error temperature too low'). On 14-Jun-2025, eight units of Vivotif vaccine (batch number: 3004333) had temperature excursion, the temperature dropped to 30.2°F and remained out of range for 5 hours and 58 minutes (explicitly coded as 'product temperature excursion issue' and 'product storage error temperature too low'). On 15-Jun-2025, eight units of Vivotif vaccine (batch number: 3004333) had temperature excursion, the minimum temperature again reached 30.2°F and stayed at that level for 7 hours and 25 minutes (explicitly coded as 'product temperature excursion issue' and 'product storage error temperature too low'). On 16-Jun-2025, eight units of Vivotif vaccine (batch number: 3004333) had temperature excursion, the temperature was recorded at 30.6°F for a total of 5 hours and 7 minutes (explicitly coded as 'product temperature excursion issue' and 'product storage error temperature too low'). On 17-Jun-2025, eight units of Vivotif vaccine (batch number: 3004333) had temperature excursion, the minimum temperature fell to 33.8°F and lasted for 2 hours and 50 minutes (explicitly coded as 'product temperature excursion issue' and 'product storage error temperature too low'). On 20-Jun-2025, eight units of Vivotif vaccine (batch number: 3004333) had temperature excursion, a temperature deviation occurred with a recorded minimum of 32.9°F lasting 3 hours (explicitly coded as 'product temperature excursion issue' and 'product storage error temperature too low'). On 21-Jun-2025 ,eight units of Vivotif vaccine (batch number: 3004333) had temperature excursion the temperature dropped to 32.2°F for a duration of 5 hours and 8 minutes (explicitly coded as 'product temperature excursion issue' and 'product storage error temperature too low'). On 22-Jun-2025, eight units of Vivotif vaccine (batch number: 3004333) had temperature excursion, the recorded minimum temperature was 32.5°F over a period of 4 hours and 25 minutes (explicitly coded as 'product temperature excursion issue' and 'product storage error temperature too low'). On 23-Jun-2025, eight units of Vivotif vaccine (batch number: 3004333) had temperature excursion, the final recorded excursion occurred with a minimum temperature of 32.7°F for 2 hours and 14 minutes (explicitly coded as 'product temperature excursion issue' and 'product storage error temperature too low'). On an unspecified date, 20 patients took the Vivotif (batch number: 3004333) at an unknown dose, route, or site of administration, for an unknown indication (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patients experienced any adverse events due to Vivotif. No further information was provided.; Reporter's Comments: The patients of unspecified age and gender received Vivotif vaccine for unknown indication, which had nine temperature excursions, minimum temperature was from 34.3°F to 30.2°F. it was unknown if the patients experienced any adverse events due to Vivotif. Product temperature excursion issue, product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product temperature excursion issue, product storage error 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: The patients of unspecified age and gender received Vivotif vaccine for unknown indication, which had nine temperature excursions, minimum temperature was from 34.3°F to 30.2°F. it was unknown if the patients experienced any adverse events due to Vivotif. Product temperature excursion issue, product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product temperature excursion issue, product storage error 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