Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | 3003908 | PO / MO |
Patient took a dose of Vivotif stored for 12 hours at maximum temperature of 55 degrees Fahrenheit; Patient took a dose of Vivotif stored for 12 hours at maximum temperature of 55 degrees Fahrenheit; Case reference number US-BN-2024-000144 is a spontaneous case report initially received from a consumer via Med Communication (reference number: USBAV24-0252) on 05-Feb-2024 and concerns female patient of unspecified age. The patient's relevant medical history and concomitant medications were not provided. On 03-Feb-2024, reported as on Saturday night at 09:00 pm, the patient took the first dose of Vivotif (batch number: 3003908), at an unknown dose, orally, for typhoid immunization. After administration of first dose, the patient put Vivotif on a calendar outside of the refrigerator for 12 hours, at maximum temperature of 55 degrees Fahrenheit (explicitly coded as 'product storage error'). As reported, on the next morning the patient put Vivotif to the refrigerator and this was the first temperature excursion. On 05-Feb-2024, two days after taking the first dose of Vivotif, the patient took the second dose of Vivotif (batch number: 3003908), at unknown dose, orally (explicitly coded as 'product administration error'). As reported that patient did not have any effects due to excursion. No further information provided.; Reporter's Comments: A female patient of unspecified age put Vivotif outside of the refrigerator for 12 hours, at maximum temperature of 55 degrees Fahrenheit, which is considered as product storage error. As reported, on the next morning the patient put Vivotif to the refrigerator and this was the first temperature excursion. Reportedly, two days after taking the first dose of Vivotif, the patient took the second dose of Vivotif which had temperature excursion, which is considered as product administration error. The patient did not have any effects due to excursion. Product storage error and product administration error are considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Product storage error and product administration error 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 female patient of unspecified age put Vivotif outside of the refrigerator for 12 hours, at maximum temperature of 55 degrees Fahrenheit, which is considered as product storage error. As reported, on the next morning the patient put Vivotif to the refrigerator and this was the first temperature excursion. Reportedly, two days after taking the first dose of Vivotif, the patient took the second dose of Vivotif which had temperature excursion, which is considered as product administration error. The patient did not have any effects due to excursion. Product storage error and product administration error are considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Product storage error and product administration error has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.