Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | Unknown | — |
The patient left Vivotif on counter over night ad than took one dose; The patient left Vivotif on counter over night ad than took one dose; The patient left Vivotif on counter over night ad than took one dose; Case reference number US-BN-2025-000969 is a spontaneous case initially received from consumer via Communication (reference number: USBAV25-1197) on 22-May-2025 and concerns a male patient with unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, as reported the patient left Vivotif on counter overnight. Then when patient got up the next morning to took patient saw a small print that says keep in refrigerator. (explicitly coded as 'product storage error' and 'product temperature excursion issue'). On unspecified date, the patient took dose of defected Vivotif (batch number: unknown) at unknown dose reported as one capsule, route or site of administration were unknown for unknown indication. (explicitly coded as 'product administration error'). At the time of initial report, it was unknown if patient experienced any of adverse events due to Vivotif. No further information was provided.; Reporter's Comments: A male patient of unspecified age left the Vivotif on counter overnight and did not refrigerate, which is considered as product storage error and product temperature excursion issue. As reported the patient took dose of defected Vivotif vaccine for unknown indication which is considered as product administration error. The patient's relevant medical history and concomitant medications were not provided. At the time of initial report, it was unknown if patient experienced any of adverse events due to Vivotif vaccine. Product administration error, product storage error, and product temperature excursion issue are considered as listed as per company convention. Product administration error, product storage error, and product temperature excursion issue are all assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient of unspecified age left the Vivotif on counter overnight and did not refrigerate, which is considered as product storage error and product temperature excursion issue. As reported the patient took dose of defected Vivotif vaccine for unknown indication which is considered as product administration error. The patient's relevant medical history and concomitant medications were not provided. At the time of initial report, it was unknown if patient experienced any of adverse events due to Vivotif vaccine. Product administration error, product storage error, and product temperature excursion issue are considered as listed as per company convention. Product administration error, product storage error, and product temperature excursion issue are all assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: NONE