Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | 3004171 | PO / MO |
The patient ate 20 minutes after taking the Vivotif; The patient took third capsule of Vivotif vaccine one day late; Case reference number US-BN-2025-001067 is a spontaneous case initially received from a healthcare professional via agency (reference number: USBAV25-1387) on 13-Jun-2025 and concerns a 33-year-old, female patient. The patient's medical history and concomitant medication details were not provided. On 07-Jun-2025, the patient took the first dose of Vivotif (batch number: 3004171) orally, at an unknown dose, for travel. On 09-Jun-2025, two days after the patient took the first dose and 20 minutes after eating, the patient took the second dose of Vivotif (batch number: 3004171) orally, at an unknown dose (explicitly coded as: 'product administration error'). On 12-Jun-2025, five days after the patient took the first dose and also reported as one day late, the patient took the third dose of Vivotif (batch number: 3004171) orally, at an unknown dose (explicitly coded as 'inappropriate schedule of vaccine administered'). 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 33-year-old female patient took the second dose of Vivotif orally, at an unknown dose, two days after the patient took the first dose and 20 minutes after eating which is considered as product administration error. Five days after the patient took the first dose and also reported as one day late, the patient took the third dose of Vivotif orally, at an unknown dose which is considered as inappropriate schedule of vaccine administered. Product administration error and inappropriate schedule of product administration are considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif. The patient's medical history and concomitant medication details were not provided. Product administration error and inappropriate schedule of product administration are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 33-year-old female patient took the second dose of Vivotif orally, at an unknown dose, two days after the patient took the first dose and 20 minutes after eating which is considered as product administration error. Five days after the patient took the first dose and also reported as one day late, the patient took the third dose of Vivotif orally, at an unknown dose which is considered as inappropriate schedule of vaccine administered. Product administration error and inappropriate schedule of product administration are considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif. The patient's medical history and concomitant medication details were not provided. Product administration error and inappropriate schedule of product administration are both assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: NONE