Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | Unknown | — |
Vivotif vaccine was stored at 72 Fahrenheit degrees for one week; The patients did the entire course of vaccination after temperature excursion; Vivotif vaccine was stored at 72 Fahrenheit degrees for one week; The patients did the entire course of vaccination after temperature excursion; Case reference number US-BN-2024-000617 is a spontaneous case received from a pharmacist initially received from Med Communications (reference number: USBAV24-0485) on 11-Mar-2024 and concerns two child patients. The patients' medical history and concomitant medications were not provided. On an unspecified date, the Vivotif vaccine was exposed to the first temperature excursion reaching a temperature of 72 Fahrenheit degrees for one week (explicitly coded as 'product storage error'). As reported, mother of patients did not put vaccine in refrigerator. On an unspecified date, an unknown amount of time after the first temperature excursion, patients were vaccinated with Vivotif vaccine (batch number: unknown), at an unknown dose and route of administration for an unknown indication (explicitly coded as 'product administration error'). As reported, patients did the entire course of vaccination. At the time of the initial report, it was unknown if any of the patients experienced any adverse event due to Vivotif vaccine. Additional information received on 11-Mar-2024 from a pharmacist via Med Communications: included confirmation about initials and date of birth for second patient and additional reference number (USBAV24-0484).; Reporter's Comments: Two child patients were vaccinated with Vivotif vaccine for an unknown indication, which was exposed to the first temperature excursion reaching a temperature of 72 Fahrenheit degrees for one week, which is considered as product storage error and product administration error. It was unknown if any of the patients experienced any adverse event due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patients' medical history and concomitant medications 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: Two child patients were vaccinated with Vivotif vaccine for an unknown indication, which was exposed to the first temperature excursion reaching a temperature of 72 Fahrenheit degrees for one week, which is considered as product storage error and product administration error. It was unknown if any of the patients experienced any adverse event due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patients' medical history and concomitant medications 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.