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 Vivotif three days after the first dose and the fourth dose of Vivotif six days after the first dose; Case reference number US-BN-2024-000051 is a spontaneous case report initially received from a nurse via Med Communication (reference number: USBAV24-0071) on 11-Jan-2024 and concerns a 37-year-old female patient. The patient's medical history and concomitant medication details were not provided. On 05-Jan-2024, the patient took the first dose of Vivotif (batch number: unknown) at an unknown dose, orally for typhoid fever prophylaxis. On 07-Jan-2024, two days after the first dose of Vivotif, the patient took the second dose of Vivotif (batch number: unknown) at an unknown dose, orally. On 08-Jan-2024, three days after the first dose of Vivotif, the patient took the third dose of Vivotif (batch number: unknown) at an unknown dose, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). On 11-Jan-2024, six days after the first dose of Vivotif, the patient took the fourth dose of Vivotif (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. No further information was provided.; Reporter's Comments: A 37-year-old female patient took the third dose of Vivotif on the day 3 after the first dose, which is considered as inappropriate schedule of vaccine administered. Reportedly, on the day 6 after the first dose, the patient took the fourth 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 is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 37-year-old female patient took the third dose of Vivotif on the day 3 after the first dose, which is considered as inappropriate schedule of vaccine administered. Reportedly, on the day 6 after the first dose, the patient took the fourth 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 is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.