Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | 3003830 | PO / MO |
The patient left Vivotif out of the refrigerator and took the second dose of Vivotif after the temperature excursion, maximum temperature was 70 degrees of Fahrenheit and it was left for two hours; The patient left Vivotif out of the refrigerator and took the second dose of Vivotif after the temperature excursion, maximum temperature was 70 degrees of Fahrenheit and it was left for two hours; Case reference number US-BN-2024-000036 is a spontaneous case report initially received from a nurse via Med Communication (reference number: USBAV24-0034) on 08-Jan-2024 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient took the first dose of Vivotif (batch number: 3003830 expiration date: 29-Feb-2024) at an unknown dose, orally for unknown indication. On an unspecified date, an unknown amount of time after the first dose of Vivotif, the patient took the second dose of Vivotif (batch number: 3003830 expiration date: 29-Feb-2024) at an unknown dose, orally. As reported, the patient left Vivotif out of the refrigerator and took the second dose (day three capsule) of Vivotif after the temperature excursion, maximum temperature was 70 degrees of Fahrenheit, and it was left for two hours (explicitly coded as 'product storage error' and 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information provided.; Reporter's Comments: A female patient of unspecified age took the second dose of Vivotif. As reported, the patient left Vivotif out of the refrigerator and took the second dose (day three capsule) of Vivotif after the temperature excursion, maximum temperature was 70 degrees of Fahrenheit and it was left for two hours, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error 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: A female patient of unspecified age took the second dose of Vivotif. As reported, the patient left Vivotif out of the refrigerator and took the second dose (day three capsule) of Vivotif after the temperature excursion, maximum temperature was 70 degrees of Fahrenheit and it was left for two hours, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error 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.