Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | Unknown | PO / MO |
GI bug; The patient took the following two doses of Vivotif after skipping a week; Case reference number US-BN-2025-000931 is a spontaneous case initially received from pharmacist via Communications (reference number: USBAV25-1088) on 12-May-2025 and concerns a male patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified dates, as reported the patient, two weeks ago and they took two doses on alternate days of Vivotif vaccine (batch number: unknown) at dose of capsule, orally for unknown indication. On an unspecified date, unknown of time after took the Vivotif vaccine, as reported, the patient had to skip a week with taking Vivotif because of Gastrointestinal infection (GI) bug. On an unspecified dates, as reported; after skipping a week, the patient took the following two doses of Vivotif (batch number: unknown) at dose of capsule, orally (explicitly codes as 'inappropriate schedule of vaccine administered') At the time of the initial report, it was unknown if the patient recovered from the event of 'gastrointestinal infection NOS'. The reporter assessed the event of 'gastrointestinal infection NOS' as non-serous and possibly related to the product of Vivotif. No further information was provided.; Reporter's Comments: This case concerns a male patient of unspecified age who started taking Vivotif vaccine. Patient had taken 2 doses of the vaccine on alternate days and experienced non-serious event of gastrointestinal infection on the unknown date and time after Vivotif vaccine for unknown indication. As reported, the patient skipped vaccine for a week and received the following 2 doses, which is considered as inappropriate schedule product administrated. Gastrointestinal infection is not listed per CCDS V8 and not expected per USPI. Inappropriate schedule product administrated is considered as listed as per company convention. Patient's medical history and concomitant medications was not reported. Outcome is unknown. Based on the limited information provided regarding this case, the causal role of the suspect vaccine cannot be excluded in the occurrence of the events, hence the events are considered related to the suspect vaccine. Inappropriate schedule product administrated is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: This case concerns a male patient of unspecified age who started taking Vivotif vaccine. Patient had taken 2 doses of the vaccine on alternate days and experienced non-serious event of gastrointestinal infection on the unknown date and time after Vivotif vaccine for unknown indication. As reported, the patient skipped vaccine for a week and received the following 2 doses, which is considered as inappropriate schedule product administrated. Gastrointestinal infection is not listed per CCDS V8 and not expected per USPI. Inappropriate schedule product administrated is considered as listed as per company convention. Patient's medical history and concomitant medications was not reported. Outcome is unknown. Based on the limited information provided regarding this case, the causal role of the suspect vaccine cannot be excluded in the occurrence of the events, hence the events are considered related to the suspect vaccine. Inappropriate schedule product administrated is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.