Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | Unknown | — |
Patient took third dose of Vivotif which was exposed to 55-60 degree Fahrenheit for 16 hours; Patient took third dose of Vivotif which was exposed to 55-60 degree Fahrenheit for 16 hours; Case reference number US-BN-2024-001913 is a spontaneous case report initially received from a health care professional via Med Communications (reference number: USBAV24-1045) on 14-May-2024 and concerns a patient of unknown age and gender. The patient's medical history and concomitant medication details were not provided. On unspecified dates, the patient took the first, second and third dose of Vivotif (batch number: unknown) at an unknown dose, via an unknown route for unknown indication. As reported, the patient took third dose of Vivotif which was exposed to 55-60 degree Fahrenheit for 16 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. No further information was provided.; Reporter's Comments: A patient of unknown age and gender took the first, second and the third dose of Vivotif for unknown indication. As reported, the patient took the third dose of Vivotif which was exposed to 5560-degree Fahrenheit for 16 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. Product administration error and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage 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 patient of unknown age and gender took the first, second and the third dose of Vivotif for unknown indication. As reported, the patient took the third dose of Vivotif which was exposed to 5560-degree Fahrenheit for 16 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. Product administration error and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage 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.