Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | 3004043 | PO / MO |
Patient took first dose of Vivotif on 30-Sep-2024, second dose on 02-Oct-2024, third dose on 07-Oct-2024 (seven days after the first dose), and fourth dose on 09-Oct-2024 (nine days after the first dose).; Case reference number US-BN-2024-002622 is a spontaneous case initially received from a nurse via Med Communications (reference number: USBAV24-2645) on 07-Oct-2024 and concerns a 45-year-old female patient. The patient's medical history and concomitant medication details were not provided. On 30-Sep-2024, the patient took the first dose of Vivotif (batch number: 3004043; expiration date: 30-Nov-2024), at a dose of one capsule, orally for pre travel. On 02-Oct-2024, two days after the first dose, the patient took the second dose of Vivotif (batch number: 3004043; expiration date: 30-Nov-2024), at a dose of one capsule, orally. On 07-Oct-2024, seven days after the first dose, the patient took the third dose of Vivotif (batch number: 3004043; expiration date: 30-Nov-2024), at a dose of one capsule, orally. As reported the patient initially lost the doses in the refrigerator, and once found took the third dose (explicitly coded as 'inappropriate schedule of vaccine administered'). *On 09-Oct-2024, nine days after the first dose, the patient took the fourth dose of Vivotif (batch number: 3004043; expiration date: 30-Nov-2024), at a dose of one capsule, orally. As reported the patient initially lost the doses in the refrigerator, and once found took the fourth dose (explicitly coded as 'inappropriate schedule of vaccine administered').* *At the time of this follow-up report, the 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 14-Nov-2024: New information included Vivotif dosing details added and confirmation of absence of adverse events. 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-20241007-1af8cb to US-BAVARIAN NORDIC A/S-US-BN-2024-002622, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A 45-year-old female patient took the third dose of Vivotif, seven days after the first dose, at a dose of one capsule, orally. Reportedly, the patient initially lost the doses in the refrigerator, and once found took the third dose which is considered as inappropriate schedule of vaccine administered. Also, nine days after the first dose, the patient took the fourth dose of Vivotif, at a dose of one capsule, orally. As reported the patient initially lost the doses in the refrigerator, and once found took the fourth dose, which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per 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. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 45-year-old female patient took the third dose of Vivotif, seven days after the first dose, at a dose of one capsule, orally. Reportedly, the patient initially lost the doses in the refrigerator, and once found took the third dose which is considered as inappropriate schedule of vaccine administered. Also, nine days after the first dose, the patient took the fourth dose of Vivotif, at a dose of one capsule, orally. As reported the patient initially lost the doses in the refrigerator, and once found took the fourth dose, which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per 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. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None.