Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | Unknown | PO / MO |
The patients did not get second dose of Vivotif as instructed and took it 77 hours after first dose; Case reference number US-BN-2025-000207 is a spontaneous case report initially received from a consumer via Communication (reference number: USBAV25-0292) on 10-Feb-2025 and concerns two patients one male patient and one of unspecified gender and both of unspecified age (MULTI 2) . The patient's relevant medical history and concomitant medications were not provided. On 06-Feb-2025, on Thursday at 06:30 am in the morning, the patients took first dose of Vivotif vaccine (batch number: unknown) at an unknown dose, orally for indication reported as pre-travel. On 09-Feb-2025 at 11:30 am in the morning, reported as 77 hours after first dose, the patients took second dose of Vivotif vaccine (batch number: unknown) at an unknown dose, orally. As reported through a combination of errors, patients did not take the second dose as instructed until yesterday morning until 77 hours after the first dose, the maximum time frame was 72 hours (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 vaccine. Additional information received from a health care professional via Communications (reference number: USBAV25-0295) on 10-Feb-2025 included: the initial for the second patient and additional reference number. Additional information received from a health care professional via Communications (reference number: USBAV25-0294) on 10-Feb-2025 included: an additional reporter and reference number.; Reporter's Comments: Two patients (one male patient and one of unspecified gender and both of unspecified age) took the second dose of Vivotif vaccine for indication reported as pre-travel, reported as 77 hours after first dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patients experienced any adverse events due to Vivotif vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patients' relevant medical history and concomitant medications were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: Two patients (one male patient and one of unspecified gender and both of unspecified age) took the second dose of Vivotif vaccine for indication reported as pre-travel, reported as 77 hours after first dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patients experienced any adverse events due to Vivotif vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patients' relevant medical history and concomitant medications were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.