Received Mar 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | — |
Patient took their first Vivotif dose on Tuesday, but the product was not refrigerated, and it's been for more than 24 hours out of refrigeration; Patient took their first Vivotif dose on Tuesday, but the product was not refrigerated, and it's been for more than 24 hours out of refrigeration; Case reference number US-BN-2024-002001 is a spontaneous case initially received from a pharmacist via Communication (reference number: USBAV24-1292) on 06-Jun-2024 and concerns a patient of unknown age and gender. The patient's medical history and concomitant medication was not reported. On an unspecified date, the patient took the first dose of Vivotif (batch number: unknown) at an unknown dose, via oral use for unknown indication. As reported, patient took their first Vivotif dose on Tuesday, but the product was not refrigerated, and it's been for more than 24 hours out of refrigeration (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-20240606-87a1f3 to US-BAVARIAN NORDIC A/S-US-BN-2024-002001, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A patient of unknown age and gender took the first dose of Vivotif, at an unknown dose, via oral use for unknown indication. Reportedly, patient took their first Vivotif dose which has been for more than 24 hours out of refrigeration which is considered as product storage error and product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication was not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown age and gender took the first dose of Vivotif, at an unknown dose, via oral use for unknown indication. Reportedly, patient took their first Vivotif dose which has been for more than 24 hours out of refrigeration which is considered as product storage error and product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication was not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None.