Received Mar 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | 3004008 | PO / MO |
Patient taken first three doses of Vivotif sequentially; Case reference number US-BN-2024-001984 is a spontaneous case initially received from a nurse via Communication (reference number: USBAV24-1240) on 03-Jun-2024 and concerns a 76-year-old female patient. The patient did not have no notable medical history and other medications. The patient's concomitant medications included TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid). On 28-May-2024, the patient took first dose of Vivotif (batch number: 3004008, expiry date: 31 Oct 2024) one capsule, via oral use for pre travel. On 29-May-2024, one day after the first dose, the patient took second dose of Vivotif (batch number: 3004008, expiry date: 31 Oct 2024) one capsule, via oral use (explicitly coded as 'inappropriate schedule of vaccine administered'). On 30-May-2024, two days after the first dose, the patient took third dose of Vivotif (batch number: 3004008, expiry date: 31 Oct 2024) one capsule, via oral use (explicitly coded as 'inappropriate schedule of vaccine administered'). On 01-Jun-2024, four days after the first dose, the patient took fourth dose of Vivotif (batch number: 3004008, expiry date: 31 Oct 2024) one capsule, via oral use (explicitly coded as 'inappropriate schedule of vaccine administered'). As reported medication error occurred during the administration, it happened at home as the patient did not read the instructions after taking medication at home. On 31 May 2024 the patient went to take fourth dose and observed that the directions said every other day. *At the time of 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 (*). Additional information received from a nurse via Communication on 04-Jun-2024: included additional reference number (USBAV24-1257). Additional information received from Communication on 06-Jun-2024: included confirmation that the suspect product is Vivotif. Follow up information received from a nurse on 18-Jun-2024: New information included added patient demographic details (patient initials and age), concomitant product TDAP, Vivotif dosage information and confirmation on patient medical history, medication error, contributing factors that led to the event during the administration of Vivotif. Follow up information received from a nurse on 08-Jul-2024: New information included confirmation that the patient did not experience any 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-20240603-208694 to US-BAVARIAN NORDIC A/S-US-BN-2024-001984, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A 76-year-old female patient took the second dose of Vivotif one day after the first dose, at a dose reported as four capsules, via oral use which is considered as inappropriate schedule of vaccine administered. Two days after the first dose, the patient took third dose of Vivotif, which is also considered as inappropriate schedule of vaccine administered. On the day four after the first dose, the patient took the fourth dose of Vivotif, which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. The patient did not experience any adverse event due to Vivotif. The patient did not have notable medical history and other medications, and concomitant medications included TDAP. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 76-year-old female patient took the second dose of Vivotif one day after the first dose, at a dose reported as four capsules, via oral use which is considered as inappropriate schedule of vaccine administered. Two days after the first dose, the patient took third dose of Vivotif, which is also considered as inappropriate schedule of vaccine administered. On the day four after the first dose, the patient took the fourth dose of Vivotif, which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. The patient did not experience any adverse event due to Vivotif. The patient did not have notable medical history and other medications, and concomitant medications included TDAP. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None.
TDAP