Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | Unknown | — |
The patient finished all four capsules of Vivotif, which had not been stored properly in the refrigerator during the course of treatment; The patient finished all four capsules of Vivotif, which had not been stored properly in the refrigerator during the course of treatment.; The patient finished all four capsules of Vivotif, which had not been stored properly in the refrigerator during the course of treatment.; Case reference number US-BN-2025-001083 is a spontaneous case initially received from a pharmacist via agency (reference number: USBAV25-1437) on 17-Jun-2025 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, also reported as on Day 1, the patient took the first dose of Vivotif (batch number: unknown) one capsule, at an unknown route or site of administration for an unknown indication. On an unspecified date, also reported as on Day 3, two days after the patient took the first dose, the patient took the second dose of Vivotif (batch number: unknown) one capsule, at an unknown route or site of administration. On an unspecified date, also reported as on Day 5, four days after the patient took the first dose, the patient took the third dose of Vivotif (batch number: unknown) one capsule, at an unknown route or site of administration. On an unspecified date, also reported as on Day 7, six days after the patient took the first dose, the patient took the fourth dose of Vivotif (batch number: unknown) one capsule, at an unknown route or site of administration. As reported, all four capsules had not been stored properly in the refrigerator (explicitly coded as 'product administration error', 'product temperature excursion issue' and 'product storage error'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif. No further information was provided.; Reporter's Comments: A female patient of unspecified age finished all four capsules of Vivotif, which had not been stored properly in the refrigerator during the course of treatment, which is considered as product administration error, product storage error and product temperature excursion issue. It was unknown if the patient experienced any adverse events due to Vivotif. Product administration error, product storage error and product temperature excursion issue 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 and product temperature excursion issue are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unspecified age finished all four capsules of Vivotif, which had not been stored properly in the refrigerator during the course of treatment, which is considered as product administration error, product storage error and product temperature excursion issue. It was unknown if the patient experienced any adverse events due to Vivotif. Product administration error, product storage error and product temperature excursion issue 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 and product temperature excursion issue are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: NONE