Received Mar 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | 3004085 | PO / MO |
The patient took one dose of Vivotif vaccine which package was left out of the fridge for less than 12 hours; The patient took one dose of Vivotif vaccine which package was left out of the fridge for less than 12 hours; The patient took one dose of Vivotif vaccine which package was left out of the fridge for less than 12 hours; The patient took one dose of Vivotif vaccine and had not taken other doses yet; Case reference number US-BN-2024-002917 is a spontaneous case initially received from a nurse via Communications (reference number: USBAV24-3297) on 13-Dec-2024 and concerns a 71-years-old male patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient left package of Vivotif vaccine out of the fridge for less than 12 hours and once realized, put back in the fridge (explicitly coded as 'product storage error' and 'product temperature excursion issue'). On 06-Dec-2024, the patient took first dose of defected Vivotif vaccine (batch number: 3004085 and expiration date: 31-Mar-2025), at a dose of one capsule, orally for indication reported as travel Immunization and patient had not taken the other doses yet.* As reported, the patient took one pill as instructed on the package leaflet and did not take the other three pills in the package* (explicitly coded as 'incomplete course of vaccination' and 'product administration error'). At the time of the follow-up report, patient did not experience any adverse event due to Vivotif. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up information received from a nurse on 27-Dec-2024: New information included added patient initials, Vivotif dosing details and confirmed that patient did not experience any adverse effects. Follow up information received from a nurse on 07-Jan-2025: New information included Vivotif dosing details. 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-20241213-8bf9d0 to US-BAVARIAN NORDIC A/S-US-BN-2024-002917, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A 71-year-old male patient left package of Vivotif vaccine out of the fridge for less than 12 hours and once realized, put back in the fridge which is considered as product storage error and product temperature excursion issue. Reportedly, the patient took the first dose of defected Vivotif vaccine, at unknown dose, orally for indication typhoid immunization and had not taken the other doses yet which is considered as incomplete course of vaccination and product administration error. Product temperature excursion issue, product storage error, product administration error and incomplete course of vaccination are all considered listed according to company conventions. The patient did not experience any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Product temperature excursion issue, product storage error, product administration and incomplete course of vaccination are all assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 71-year-old male patient left package of Vivotif vaccine out of the fridge for less than 12 hours and once realized, put back in the fridge which is considered as product storage error and product temperature excursion issue. Reportedly, the patient took the first dose of defected Vivotif vaccine, at unknown dose, orally for indication typhoid immunization and had not taken the other doses yet which is considered as incomplete course of vaccination and product administration error. Product temperature excursion issue, product storage error, product administration error and incomplete course of vaccination are all considered listed according to company conventions. The patient did not experience any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Product temperature excursion issue, product storage error, product administration and incomplete course of vaccination are all assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None