Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | Unknown | PO / MO |
The patient took first dose and second of Vivotif vaccine on two consecutive days; The patient took the first dose of Vivotif vaccine with food; Case reference number US-BN-2024-001817 is a spontaneous case report initially received from a consumer (self-report) via Med Communications (reference number: USBAV24-0773) on 18-Apr-2024 and concerns an elderly female patient. The patient's medical history and concomitant medications were not provided. On 16-Apr-2024, reported as on Tuesday, the patient took the first dose of Vivotif vaccine (batch number: unknown), at an unknown dose, orally, for unknown indication. As reported, the patient took the first dose of Vivotif with food (explicitly coded as 'product administration error'). On 17-Apr-2024, reported as on Wednesday, one day after the first dose of Vivotif, the patient took the second dose of Vivotif vaccine (batch number: unknown), at an unknown dose, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. Additional information received from Med Communications on 18-Apr-2024 included additional reference number, dates and route of Vivotif administration.; Reporter's Comments: An elderly female patient took the first dose of Vivotif with food, which is considered as product administration error. Reportedly, the patient took the second dose of Vivotif vaccine on the day 1 after the first dose of Vivotif, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Inappropriate schedule of product administration and product administration error are considered as listed per company convention. The patient's medical history and concomitant medications were not provided. Inappropriate schedule of product administration and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: An elderly female patient took the first dose of Vivotif with food, which is considered as product administration error. Reportedly, the patient took the second dose of Vivotif vaccine on the day 1 after the first dose of Vivotif, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Inappropriate schedule of product administration and product administration error are considered as listed per company convention. The patient's medical history and concomitant medications were not provided. Inappropriate schedule of product administration and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None