Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | — |
The patient received one dose of Vivotif, which was left out of the refrigerator for two hours, reached a maximum temperature of 70 degrees Fahrenheit; The patient received one dose of Vivotif, which was left out of the refrigerator for two hours, reached a maximum temperature of 70 degrees Fahrenheit; Case reference number US-BN-2024-002309 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-1868) on 05-Aug-2024 and concerns a patient of unknown age or gender. 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: unknown), at an unknown dose, route for unknown indication. As reported the patient took one dose of Vivotif, which was left out of the refrigerator for two hours and reached a maximum temperature of 70 degrees Fahrenheit (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 demographics received a dose of Vivotif, which had been stored outside of a fridge for two hours, reaching a maximum temperature of 70 deg F (equivalent to 21 deg C). This is considered product storage error and product administration error, which are listed situations as per company convention. No associated adverse events were reported at this time. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to Vivotif, but to human error. The case is non-serious.; Sender's Comments: A patient of unknown demographics received a dose of Vivotif, which had been stored outside of a fridge for two hours, reaching a maximum temperature of 70 deg F (equivalent to 21 deg C). This is considered product storage error and product administration error, which are listed situations as per company convention. No associated adverse events were reported at this time. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to Vivotif, but to human error. The case is non-serious.
Comments: None.