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 took the first dose of Vivotif according to the schedule, but patient took a cup of coffee, ten minutes later after the dose; Case reference number US-BN-2024-002165 is a spontaneous case initially received from pharmacist via agency (reference number: USBAV24-1590) on 08-Jul-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication were not provided. 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, the patient took Vivotif according to the schedule, but the patient took a cup of coffee ten minutes later after the dose (explicitly coded as 'product administration error'). At the time of 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-20240708-e36bb9 to US-BAVARIAN NORDIC A/S-US-BN-2024-002165, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A female patient of unknown age took a cup of coffee ten minutes later after the dose of Vivotif which is considered as product administration error. Product administration error is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medications were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unknown age took a cup of coffee ten minutes later after the dose of Vivotif which is considered as product administration error. Product administration error is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medications were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None.