Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | Unknown | PO / MO |
The patient took two doses of Vivotif vaccine which left at room temperature for over 72 hours, maximum temperature reached was room temperature 70 Fahrenheit; The patient took two doses of Vivotif vaccine which left at room temperature for over 72 hours, maximum temperature reached was room temperature 70 Fahrenheit; Case reference number US-BN-2024-001756 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number USBAV24-0632) on 03-Apr-2024 and concerns a male patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, as reported on Saturday, the patient left one box of Vivotif vaccine at room temperature for 72 hours, maximum temperature was 70 Fahrenheit. On an unspecified dates, as reported the patient took two doses of Vivotif (batch number: unknown), at unknown dose, orally, for typhoid immunization (explicitly coded as 'Product administration error' and 'Product storage 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 was provided.; Reporter's Comments: A male patient of unknown age took two doses of Vivotif left at room temperature for 72 hours (maximum temperature was 70 Fahrenheit), which is considered product administration error and product storage error. Product administration error and product storage error are listed by convention. No associated adverse events were reported. Product administration error and product storage error are not related to the suspect product, but to a human action.; Sender's Comments: A male patient of unknown age took two doses of Vivotif left at room temperature for 72 hours (maximum temperature was 70 Fahrenheit), which is considered product administration error and product storage error. Product administration error and product storage error are listed by convention. No associated adverse events were reported. Product administration error and product storage error are not related to the suspect product, but to a human action.
Comments: None