Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | 3004342 | PO / MO |
The patient took vaccine of Viviotif which left out of refrigeration for approximately 23 hours/The maximum temperature that the product was exposed to would have been about 70 degrees F; The patient took vaccine of Viviotif which left out of refrigeration for approximately 23 hours/The maximum temperature that the product was exposed to would have been about 70 degrees F; The patient took vaccine of Viviotif which left out of refrigeration for approximately 23 hours/The maximum temperature that the product was exposed to would have been about 70 degrees F; Case reference number US-BN-2025-001999 is a spontaneous case initially received from a pharmacist via Bavarian Nordic (reference number: CASE-001326) on 22-Dec-2025 and concerns a *40-year-old* male patient. The patient's medical history and concomitant medications details were not provided. On an unspecified date, the patient left Vivotif out of refrigeration for approximately 23 hours. The maximum temperature that the product was exposed to would have been about 70 degrees F (explicitly coded as 'product temperature excursion issue', product storage error'). Once the patient realized it was supposed to be cold, it was placed in the fridge. Total quantity of Vivotif exposed was four capsules. On 21-Dec-2025, the patient took first dose of defected Vivotif (batch number: 3004342, expiration date: Sep-2026) *one capsule orally, route for prior to travel* (explicitly coded as 'product administration error'). *On 23-Dec-2025, the patient took second dose of Vivotif vaccine (batch number: 3004342, expiration date: Sep-2026) one capsule orally, route for prior to travel. On 25-Dec-2025, the patient took third dose of Vivotif vaccine (batch number: 3004342, expiration date: Sep-2026) one capsule orally, route for prior to travel. On 27-Dec-2025, the patient took fourth dose of Vivotif vaccine (batch number: 3004342, expiration date: Sep-2026) one capsule orally, route for prior to travel.* At the time of the *follow-up* report, the patient *did not* experience any adverse events due to the Vivotif vaccine. Additional information received from pharmacist on 23-Dec-2025 included: dosing information and reporter's information. Additional information received from pharmacist on 23-Dec-2025: included that; the patient began treatment with the product because he figured it was likely better than not starting treatment. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up received from pharmacist via on 12-Jan-2026 via Bavarian Nordic: New information included patient demographic details, product dosing details and confirmation that the patient did not experience any adverse events.; Reporter's Comments: A 40-year-old male patient took the first dose of defected Vivotif for unknown indication, after the patient left Vivotif out of refrigeration for approximately 23 hours. The maximum temperature that the product was exposed to would have been about 70 degrees F, which is considered as product temperature excursion issue, product storage error and product administration error. The patient did not experience any adverse events due to the Vivotif vaccine. Product temperature excursion issue, product storage error and product administration error are considered as listed per company convention. No medical history was provided, and concomitant medications details were provided. Product temperature excursion issue, product storage error 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 40-year-old male patient took the first dose of defected Vivotif for unknown indication, after the patient left Vivotif out of refrigeration for approximately 23 hours. The maximum temperature that the product was exposed to would have been about 70 degrees F, which is considered as product temperature excursion issue, product storage error and product administration error. The patient did not experience any adverse events due to the Vivotif vaccine. Product temperature excursion issue, product storage error and product administration error are considered as listed per company convention. No medical history was provided, and concomitant medications details were provided. Product temperature excursion issue, product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.