Received Mar 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | 3004009 | PO / MO |
The patient took two doses of Vivotif vaccine which were left out of the refrigerator for 48 hours; The patient took two doses of Vivotif vaccine which were left out of the refrigerator for 48 hours; Case reference number US-BN-2024-002268 is a spontaneous case report initially received from a consumer via agency (reference number USBAV24-1792) on 26-Jul-2024 and concerns a female patient of unknown age. The patient had no relevant medical history, reported as no health issues, and the patient was not pregnant. The patient's concomitant medication details were not provided. On unspecified date, the doses of Vivotif were left out of the refrigerator for 48 hours (explicitly coded as 'product storage error'). On 24-Jul-2024, the patient took the affected first dose of Vivotif (batch number: 33004009), at an unknown dose, orally, for indication reported as pre travel. On 26-Jul-2024, two days after first dose of Vivotif, the patient took the affected second dose of Vivotif (batch number: unknown), at an unknown dose, orally (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. 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-20240726-a47ed0 to US-BAVARIAN NORDIC A/S-US-BN-2024-002268, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A female patient received her second Vivotif dose, after the capsule had been stored for 48 hours outside of the refrigerator, which is considered product storage error and product administration error. No associated adverse events were reported. Product storage and administration error are considered listed per company convention. The patient had no relevant medical history. 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 female patient received her second Vivotif dose, after the capsule had been stored for 48 hours outside of the refrigerator, which is considered product storage error and product administration error. No associated adverse events were reported. Product storage and administration error are considered listed per company convention. The patient had no relevant medical history. Product storage error and product administration error are not related to Vivotif, but to human error. The case is non-serious.
Comments: None