Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | Unknown | PO / MO |
The patient took the third dose of the Vivotif vaccine six days after the first dose, and the fourth dose eight days after the first dose.; Case reference number US-BN-2025-000001 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-3417) on 31-Dec-2024 and concerns a 74-years-old male patient. The patient's medical history and concomitant medication details were not provided. On 21-Dec-2024, the patient took first dose of Vivotif (batch number: unknown), at unknown dose, orally for Typhoid immunization. On 23-Dec-2024, two days after first dose of Viviotif, the patient took second dose of Vivotif (batch number: unknown), at unknown dose, orally. On 27-Dec-2024, six days after first dose of Viviotif, the patient took third dose of Vivotif (batch number: unknown), at unknown dose, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). On 29-Dec-2024, eight days after first dose of Viviotif, the patient took fourth dose of Vivotif (batch number: unknown), at unknown dose, orally. As reported, the patient missed the middle dose and extended the last dose by another day (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. Additional information received from health care professional via Med Communications (reference number: USBAV24-3419) on 31-Dec-2024: Information included reference number, additional reporter and confirmation that the patient took Vivotif incorrectly.; Reporter's Comments: A 74-years-old male patient missed the middle dose and extended the last dose by another day which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 74-years-old male patient missed the middle dose and extended the last dose by another day which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None.