Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | #3004007 | PO / MO |
The patient took the first dose of Vivotif vaccine which did not refrigerate; The patient took the first dose of Vivotif vaccine which did not refrigerate; The patient took only first dose and did not take the second, third and fourth dose of Vivotif; Case reference number US-BN-2024-001891 is a spontaneous case report initially received from a other health care professional via Med Communication (reference number: USBAV24-0966) on 08-May-2024 and concerns a 29-years-old female patient. The patient's medical history and concomitant medication was not provided. On an unspecified date, the patient left Vivotif vaccine at room temperature for a week (explicitly coded as 'Product storage error'). On 07-May-2024, the patient took the first dose of Vivotif (batch number: #3004007), orally, at an unknown dose, for unknown indication reported as pre travel (explicitly coded as 'Product administration error'). As reported the patient did not take the second, third and fourth doses of Vivotif (explicitly coded as 'Incomplete course of vaccination'). At the time of the 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 29-year-old female patient left Vivotif vaccine at room temperature for a week, which is considered as product storage error. Reportedly, the patient took the first dose of Vivotif for unknown indication reported as pre travel, which is considered as product administration error. As reported the patient did not take the second, third and the fourth dose of Vivotif, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product storage error, product administration error and incomplete course of vaccination are considered as listed per company convention. The patient's medical history and concomitant medication was not provided. Product storage error, product administration error and incomplete course of vaccination 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: A 29-year-old female patient left Vivotif vaccine at room temperature for a week, which is considered as product storage error. Reportedly, the patient took the first dose of Vivotif for unknown indication reported as pre travel, which is considered as product administration error. As reported the patient did not take the second, third and the fourth dose of Vivotif, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product storage error, product administration error and incomplete course of vaccination are considered as listed per company convention. The patient's medical history and concomitant medication was not provided. Product storage error, product administration error and incomplete course of vaccination have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None