Received Mar 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | Unknown | PO / MO |
The patient took the second and fourth dose of Vivotif vaccine a day later then it was supposed to; Case reference number US-BN-2024-002210 is a spontaneous case initially received from a consumer via agency (reference number: USBAV24-1708) on 18-Jul-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient took the first dose of Vivotif vaccine (batch number: unknown), at a dose of a pill, orally for typhoid immunization. On unspecified date, reported as a day later than it was supposed to, the patient took the second dose of Vivotif vaccine (batch number: unknown), at a dose reported as pill, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). On unspecified date, unknown amount of time after the second dose of Vivotif, the patient took the third dose of Vivotif vaccine (batch number: unknown), at a dose reported as pill, orally. On unspecified date, reported as a day later than it was supposed to, the patient took the fourth dose of Vivotif vaccine (batch number: unknown), at a dose reported as pill, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. Additional information received from consumer via agency (USBAV24-1711) on 19-Jul-2024: New information included confirmation that reporter did not provide consent to disclose personal details and not be contacted for further follow-up, new reference number, and dosage information. 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-20240718-5d45dd to US-BAVARIAN NORDIC A/S-US-BN-2024-002210, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A female patient of unknown age took the second dose of Vivotif vaccine, at a dose reported as pill, orally which is considered as inappropriate schedule of vaccine administered. A day later than it was supposed to, the patient took the fourth dose of Vivotif vaccine, at a dose reported as pill, orally which is also considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. 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 female patient of unknown age took the second dose of Vivotif vaccine, at a dose reported as pill, orally which is considered as inappropriate schedule of vaccine administered. A day later than it was supposed to, the patient took the fourth dose of Vivotif vaccine, at a dose reported as pill, orally which is also considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. 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