Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | 3004338 | — |
The patient missed the last and final dose of Vivotif as the capsule was found broken in the package; Case reference number US-BN-2025-001649 is a spontaneous case initially received from a pharmacist via Bavarian Nordic (reference number: CASE-000103) on 06-Oct-2025 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient took the first dose of Vivotif (batch number: 3004338, expiration date: Aug-2026), at an unknown dose, route or site of administration for an unknown indication. On an unspecified date, an unknown amount of time from the first dose, the patient took the second dose of Vivotif batch number: 3004338, expiration date: Aug-2026), at an unknown dose, route or site of administration. On an unspecified date, an unknown amount of time from the first dose, the patient took the third dose of Vivotif batch number: 3004338, expiration date: Aug-2026), at an unknown dose, route or site of administration. On an unspecified date, an unknown amount of time from the first dose, the patient did not take the fourth dose of Vivotif (batch number: 3004338, expiration date: Aug-2026), as the capsule was found broken in the package. (explicitly coded as 'missed dose'). On 16-Oct-2025, a review of quality events for lot 3004338 was conducted, and only one change control was identified, related to the quarantine of the product in the (withheld) while awaiting FDA release. The complaint rating was calculated as 0.005% (100/19235). On 30-Oct-2025, the Batch Records for Vivotif Lot 3004338 were reviewed, and no deviations occurred during manufacturing. Capsule breakage for Vivotif is a known phenomenon, which can occur during the coating step following storage or transfer to the hopper. According to BN0081292 when a complaint is received for defective capsules, the complaint rate is calculated. For Vivotif lot 3004292, 19'235 final packages were produced, and the complaint rate was 0.005% (100/19235). As the complaint rate is smaller than 0,01% no deviation was opened. Concerning the manufacturing process, it is planned to implement a capsule weighing system, a machine for fully automatic 100% gross control weight inspection and counting of hard gelatine capsules and HPMC capsules, suitable for both empty and filled (coated and uncoated) capsules. All defective capsules and capsules with over- or underweight will be sorted into a bad parts bin, while confirming capsules will be discharged into a good parts container. Change control QE-015838 ("Vivotif: Implementation Accura 100% capsule scale (coated / uncoated capsule)") is currently in pre-implementation phase to introduce the capsule weighing system. Since document revisions did not reveal any issues during production, the sample investigation did not identify any defective capsules, and the complaint rate remains below 0.01%. As no pictures nor sample were submitted by the reporter, no further investigation can be conducted regarding this complaint. At the time of the initial report, the patient did not experience any adverse event due to Vivotif. Bavarian Nordic product quality complaint number for this case is QE-018749. Additional information received from pharmacist via Bavarian Nordic on 07-Oct-2025 included quality complaint number, confirmation that the patient missed the last and final dose of Vivotif. Additional information received from pharmacist via Bavarian Nordic on 12-Nov-2025 included investigation summary results.; Reporter's Comments: This case concerns a female patient of unspecified age, who received three doses of Vivotif vaccine for an unknown indication. As reported patient did not receive the fourth dose, which is considered as product dose omission issue. Product dose omission issue is considered listed per company convention. Patient's medical history and concomitant medication details were not provided. Patient did not experience any adverse event due to Vivotif. Product dose omission issue is assessed as not related to suspect vaccine, but to human factor. The case is non-serious.; Sender's Comments: This case concerns a female patient of unspecified age, who received three doses of Vivotif vaccine for an unknown indication. As reported patient did not receive the fourth dose, which is considered as product dose omission issue. Product dose omission issue is considered listed per company convention. Patient's medical history and concomitant medication details were not provided. Patient did not experience any adverse event due to Vivotif. Product dose omission issue is assessed as not related to suspect vaccine, but to human factor. The case is non-serious.
Comments: NONE