Received Mar 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | Unknown | — |
The patient received two capsules of Vivotif during the first round, and had CBC abnormal; The patient received two capsules of Vivotif during the first round, then patient had CBC abnormal, all immunizations were stopped, subsequently, the patient began a second round of Vivotif.; Case reference number US-BN-2024-002381 is a spontaneous case initially received from a consumer via agency (reference number: USBAV24-2053) on 21-Aug-2024 and concerns a patient of unknown age and gender. The patient's medical history and concomitant medication details were not provided. On unspecified dates, the patient took the first and second doses of the first round of Vivotif (batch number: unknown), at an unknown dose and route of administration for unknown indication. As reported, all immunizations were stopped due to CBC abnormal, subsequently, the patient began a second round of Vivotif (explicitly coded as 'inappropriate schedule of vaccine administered'). On an unspecified date, as reported the patient received the first dose of the second round of Vivotif (batch number: unknown), at an unknown dose and route of administration. At the time of the initial report, it was unknown if the patient recovered from the event CBC abnormal. The reporter assessed the event CBC abnormal as non-serious and causality was assessed as possible for the event CBC abnormal. 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-20240821-0f1f26 to US-BAVARIAN NORDIC A/S-US-BN-2024-002381, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A patient of unknown demographics developed abnormal full blood count, an unspecified amount of time after receiving two doses of Vivotif. As a results, the patient's immunizations were put on hold, until eventually a new vaccination round of Vivotif was started on an unknown date (which is considered inappropriate schedule of vaccine administered). Full blood count abnormal is unlisted and unexpected per CCDS v8.0 and USPI for Vivotif. Inappropriate schedule of vaccination is listed per company convention. Medical history was unknown. It was unknown whether there was an increase or decrease to a single or multiple lines of peripheral blood cells. More information about the patient's underlying conditions would be helpful to put the case into context. The event is assessed as related, because contributory role of Vivotif cannot be ruled out, due to the suggestive temporal sequence. Inappropriate schedule of vaccine administration is not related to Vivotif, but to human factors. The case is non-serious.; Sender's Comments: A patient of unknown demographics developed abnormal full blood count, an unspecified amount of time after receiving two doses of Vivotif. As a results, the patient's immunizations were put on hold, until eventually a new vaccination round of Vivotif was started on an unknown date (which is considered inappropriate schedule of vaccine administered). Full blood count abnormal is unlisted and unexpected per CCDS v8.0 and USPI for Vivotif. Inappropriate schedule of vaccination is listed per company convention. Medical history was unknown. It was unknown whether there was an increase or decrease to a single or multiple lines of peripheral blood cells. More information about the patient's underlying conditions would be helpful to put the case into context. The event is assessed as related, because contributory role of Vivotif cannot be ruled out, due to the suggestive temporal sequence. Inappropriate schedule of vaccine administration is not related to Vivotif, but to human factors. The case is non-serious.
Comments: None.
Test Name: CBC; Result Unstructured Data: abnormal