Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | 3003901 | PO / MO |
Patient could not tolerate the Vivotif, vomited and was nauseated all day; Patient could not tolerate the Vivotif, vomited and was nauseated all day; Patient could not tolerate the Vivotif, vomited and was nauseated all day; Case reference number US-BN-2024-001740 is a spontaneous case report initially received from a nurse via Med Communication (reference number: USBAV24-0614) on 01-Apr-2024 and concerns a *16-year-old* male patient. *The patient had no medical history*. The patient's concomitant medication details were not provided. *On 03-Sep-2024, the patient took a first dose of Vivotif (batch number: 3003901, expiry date: 30-Jun-2024) orally, at an unknown dose, for typhoid. As reported the patient had not taken any other medications at the time of the events and no laboratory tests were performed*. *On the same day, eight hours from the first dose, the patient severely could not tolerate the Vivotif. Additionally, the patient severely vomited and felt moderately nauseated all day*. *On the same day, the patient recovered from the events drug intolerance, nauseated and vomited*. The reporter assessed the events drug intolerance, nauseated and vomited as non-serious and causality was assessed for the events drug intolerance, nauseated and vomited as possible. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up report received from a nurse via manufacturer on 23-Apr-2024: New information included added patient demographic details (initials, age and date of birth), dosage details of Vivotif, events start date, stop date, outcome, intensity and confirmation on the medical history, laboratory tests and other medications administered at the time of Vivotif.; Reporter's Comments: A 16-year-old male patient could not tolerate the Vivotif (eight hours from the first dose), vomited and was nauseated all day. Nausea and vomiting are listed/expected for Vivotif according to CCDS version 8.0 and USPI, whilst drug intolerance is listed per company convention as a non-specific event. The outcome was resolved. The patient had no medical history and concomitant medication details were not provided. Due to plausible temporal relationship and product known safety profile, the causality for all reported events is assessed as related to Vivotif. The case is non-serious.; Sender's Comments: A 16-year-old male patient could not tolerate the Vivotif (eight hours from the first dose), vomited and was nauseated all day. Nausea and vomiting are listed/expected for Vivotif according to CCDS version 8.0 and USPI, whilst drug intolerance is listed per company convention as a non-specific event. The outcome was resolved. The patient had no medical history and concomitant medication details were not provided. Due to plausible temporal relationship and product known safety profile, the causality for all reported events is assessed as related to Vivotif. The case is non-serious.
Comments: None.