Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | Unknown | PO / MO |
The patient kept Vivotif at room temperature for about a day and a half and took three doses; The patient kept Vivotif at room temperature for about a day and a half and took three doses; The patient kept Vivotif at room temperature for about a day and a half and took three doses; Case reference number US-BN-2025-000943 is a spontaneous case report initially received from a consumer via Communication (reference number: USBAV25-1111) on 14-May-2025 and concerns a female patient of unspecified age. The patient's relevant medical history and concomitant medications were not provided. On an unspecified date, as reported the patient did not read the instructions of Vivotif vaccine until about to took them, about a day and a half later. So, the medications were at room temperature for about a day and a half (explicitly coded as 'product storage error' and 'product temperature excursion issue'). On an unspecified date, the patient took the first dose of defective Vivotif vaccine (batch number: unknown) at an unknown dose, orally for unknown indication (explicitly coded as 'product administration error'). On an unspecified date, unknown time after the first dose of Vivotif, the patient took the second dose of defective Vivotif vaccine (batch number: unknown) at an unknown dose, orally (explicitly coded as 'product administration error'). On an unspecified date, the patient took the third dose of defective Vivotif vaccine (batch number: unknown) at an unknown dose, orally (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A female patient of unspecified age left Vivotif vaccine at room temperature for about a day and a half which is considered as product storage error and product temperature excursion issue. The patient took the first dose of defective Vivotif vaccine, at an unknown dose, orally for unknown indication which is considered as product administration error. Unknown time after the first dose of Vivotif, the patient took the second dose of defective Vivotif vaccine, at an unknown dose, orally which is also considered as product administration error. On an unspecified date, the patient took the third dose of defective Vivotif vaccine, at an unknown dose, orally which is also considered as product administration error. Product storage error, product administration error and product temperature excursion issue are all considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. The patient's relevant medical history and concomitant medications were not provided. Product storage error, product administration 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 female patient of unspecified age left Vivotif vaccine at room temperature for about a day and a half which is considered as product storage error and product temperature excursion issue. The patient took the first dose of defective Vivotif vaccine, at an unknown dose, orally for unknown indication which is considered as product administration error. Unknown time after the first dose of Vivotif, the patient took the second dose of defective Vivotif vaccine, at an unknown dose, orally which is also considered as product administration error. On an unspecified date, the patient took the third dose of defective Vivotif vaccine, at an unknown dose, orally which is also considered as product administration error. Product storage error, product administration error and product temperature excursion issue are all considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. The patient's relevant medical history and concomitant medications were not provided. Product storage error, product administration 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.