Received Mar 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | PO / MO |
Patient received one dose of Vivotif capsule which was out of the refrigerator for 22 hours and the maximum temperature reached was 80 degrees Fahrenheit; Patient received one dose of Vivotif capsule which was out of the refrigerator for 22 hours and the maximum temperature reached was 80 degrees Fahrenheit; Case reference number US-BN-2024-002406 is a spontaneous case initially received from a pharmacist via agency (reference number: USBAV24-2114) on 26-Aug-2024 and concerns a 48-year-old female patient. 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, orally, for unknown indication. As reported, the administered Vivotif dose was out of the refrigerator for 22 hours and the maximum temperature reached was 80 degree 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. Non-significant follow-up was downloaded from VAERS on 09-May-2025 included new reference number. Administrative update performed within the case: Worldwide Unique Case Identification Number (WWID) updated from US-20240826-516361 to US-BAVARIAN NORDIC A/S-US-BN-2024-002406, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A 48-year-old female patient took a dose of Vivotif, which had been out of the refrigerator for 22 hours, reaching a maximum surrounding temperature of 80 deg F (equivalent to 26 deg C). This is considered product storage error and product administration error - listed as per company convention. No associated adverse events were reported. Medical history information was unavailable. The product storage and administration error are not related to Vivotif, but to human factors. The case is non-serious.; Sender's Comments: A 48-year-old female patient took a dose of Vivotif, which had been out of the refrigerator for 22 hours, reaching a maximum surrounding temperature of 80 deg F (equivalent to 26 deg C). This is considered product storage error and product administration error - listed as per company convention. No associated adverse events were reported. Medical history information was unavailable. The product storage and administration error are not related to Vivotif, but to human factors. The case is non-serious.
Comments: None.