Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | Unknown | PO / MO |
Patient took three doses of Vivotif as prescribed, but did not take fourth dose as scheduled; Last dose of Vivotif left out of the refrigerator at room temperature for days or a week; Case reference number US-BN-2024-002628 is a spontaneous case initially received from pharmacist via Med Communications (reference number USBAV24-2635) on 07-Oct-2024 and concerns a 31-year-old female patient. The patient's medical history and concomitant medication details were not provided. On unspecified dates, reported as per prescribed, the patient took the first, second and third dose of Vivotif vaccine (batch number: unknown), at unknown dose, orally for an unknown indication. On unspecified date, the patient left out of the fridge one capsule of Vivotif vaccine at room temperature for days or maybe a week (explicitly coded as 'product storage error'). On 01-Oct-2024, as reported was due date for the last dose, but the patient never took the fourth dose of Vivotif on that day (explicitly coded as 'Inappropriate schedule of product administration'). At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif. Additional information received from pharmacist on 09-Oct-2024 included: information about reporter and conformation that the patient did not take fourth dose of Vivotif on 10-Oct-2024. 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-20241007-cc42c9 to US-BAVARIAN NORDIC A/S-US-BN-2024-002628, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A 31-year-old female patient left out of the fridge one capsule of Vivotif vaccine at room temperature for days or maybe a week which is considered as product storage error. Reportedly, the patient never took the fourth dose of Vivotif the scheduled day which is considered as inappropriate schedule of product administration. Inappropriate schedule of product administration and product storage 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 details were not provided. Inappropriate schedule of product administration and product storage error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 31-year-old female patient left out of the fridge one capsule of Vivotif vaccine at room temperature for days or maybe a week which is considered as product storage error. Reportedly, the patient never took the fourth dose of Vivotif the scheduled day which is considered as inappropriate schedule of product administration. Inappropriate schedule of product administration and product storage 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 details were not provided. Inappropriate schedule of product administration and product storage error are both assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None