Received Mar 25, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | Unknown | PO / MO |
The patient had taken one out of four Vivotif capsule, and her daughter had taken three out of four Vivotif capsule after the meals, instead of one hour before the meals; Case reference number US-BN-2024-002758 is a spontaneous case initially received from consumer via Med Communications (reference number: USBAV24-2942) on 07-Nov-2024 and concerns two female patients of unknown age (mother and daughter). The patient's medical history and concomitant medication details were not provided. On unspecified dates, the patients took doses of Vivotif (batch number: unknown), at a dose of one capsule, orally, for indication reported as travel. As reported, the patient (mother) had taken one out of four Vivotif capsule and her daughter had taken three out of four Vivotif capsules after the meals, instead of one hour before the meals (explicitly coded as 'drug administration error'). At the time of the initial report, the patients did not experience any adverse event due to Vivotif, reported as did not feel anything bad. This case is linked to case US-BN-2024-002760 (same reporter). The reporter did not want to be contacted for a follow-up. Additional information received from consumer via Med Communications (reference number: USBAV24-2955) on 07-Nov-2024: included additional reference number. 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-20241107-70cafc to US-BAVARIAN NORDIC A/S-US-BN-2024-002758, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: Two female patients of unknown age took doses of Vivotif for indication reported as travel. As reported, the patient had taken one out of four Vivotif capsule and her daughter had taken three out of four Vivotif capsules after the meals, instead of one hour before the meals, which is considered as drug administration error. The patients did not experience any adverse event due to Vivotif. Product administration error is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: Two female patients of unknown age took doses of Vivotif for indication reported as travel. As reported, the patient had taken one out of four Vivotif capsule and her daughter had taken three out of four Vivotif capsules after the meals, instead of one hour before the meals, which is considered as drug administration error. The patients did not experience any adverse event due to Vivotif. Product administration error is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None