Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | Unknown | PO / MO |
The patient took two doses of Vivotif capsules which was left out at room temperature whole the time for almost a month; The patient took two doses of Vivotif capsules which was left out at room temperature whole the time for almost a month; The patient took two doses of Vivotif capsules which was left out at room temperature whole the time for almost a month; Case reference number US-BN-2024-002894 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-3307) on 16-Dec-2024 and concerns a 21-year-old female patient. The patient's past medical history and concomitant medication details were not provided. The patient's current conditions included anxiety. On unspecified date, the patient left out the Vivotif vaccine at room temperature whole the time for almost a month (explicitly coded as 'product storage error temperature too high' and 'product temperature excursion issue'). On 13-Dec-2024, patient took the first dose of defected Vivotif vaccine (batch number: unknown), at a dose of one capsule, orally, for indication reported as pretravel (explicitly coded as 'product administration error'). On 15-Dec-2024, two days after the first dose, the patient took the second dose of defected Vivotif vaccine (batch number: unknown), at a dose of one capsule, orally, (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 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-20241216-3e9dce to US-BAVARIAN NORDIC A/S-US-BN-2024-002894, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A 21-year-old female patient left out the Vivotif vaccine at room temperature whole the time for almost a month, which is considered as product storage error temperature too high and product temperature excursion issue. Reportedly, the patient took the first dose of defected Vivotif vaccine for indication reported as pretravel, which is considered as product administration error. Two days after the first dose, the patient took the second dose of defected Vivotif vaccine, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product storage error, product temperature excursion issue and product administration error are considered as listed per company convention. The patient's past medical history and concomitant medication details were not provided, and current conditions included anxiety. Product storage error, product temperature excursion issue and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 21-year-old female patient left out the Vivotif vaccine at room temperature whole the time for almost a month, which is considered as product storage error temperature too high and product temperature excursion issue. Reportedly, the patient took the first dose of defected Vivotif vaccine for indication reported as pretravel, which is considered as product administration error. Two days after the first dose, the patient took the second dose of defected Vivotif vaccine, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product storage error, product temperature excursion issue and product administration error are considered as listed per company convention. The patient's past medical history and concomitant medication details were not provided, and current conditions included anxiety. Product storage error, product temperature excursion issue and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Anxiety