Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | Unknown | PO / MO |
Patient took second dose of Vivotif, 61 days after the first dose; Nausea experienced about 4 hours after the first dose; Vomiting experienced about 4 hours after the first dose; Nausea experienced about 4 hours after the second dose; Vomiting experienced about 4 hours after the second dose; Case reference number US-BN-2025-001946 is a spontaneous case initially received from a pharmacist via Bavarian Nordic (reference number: CASE-001144) on 11-Dec-2025 and concerns a 68-year-old female patient. No medical history was provided. No concomitant medications details were provided. On 12-Aug-2025, the patient was administered with the first dose of Vivotif vaccine (batch number: unknown), one capsule orally for prevention of typhoid illness. On an unknown date, approximately four hours after taking the first dose, the patient experienced *moderate* nausea and vomiting. *On an unspecified date, the patient recovered from events of nausea and vomiting, as reported nausea with duration of four hours and vomiting with duration of one hour. * On 12-Oct-2025, 61 days after administration of first dose of Vivotif, the patient received with the second dose of Vivotif vaccine (batch number: unknown), one capsule orally for prevention of typhoid illness. (explicitly coded as 'inappropriate schedule of vaccine administration') On an unknown date, approximately four hours after taking the second dose, the patient experienced *moderate* nausea and vomiting. *On an unspecified date, the patient recovered from events of nausea and vomiting, as reported nausea with duration of four hours and vomiting with duration of one hour. *. At the time of the follow-up report, the patient *recovered* from the events of nausea and vomiting *experienced after the first dose, recovered from the event of nausea after the second dose, and resolved but resulting in complication/condition from the event of vomiting after the second dose*. The reporter *assessed the events of nausea and vomiting after the first and the second dose as non-serious. The reporter assessed the events of nausea and vomiting after the first dose as probably related and nausea and vomiting after the second dose as certainly related to the product Vivotif.* All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*) Follow-up information was received from the pharmacist on 06-Jan-2026. New information included Vivotif dosing information for the first two doses, patient's demographic information and reported adverse events. Follow-up information was received from the pharmacist on 16-Jan-2026. New information included seriousness, severity, duration, outcome and causality assessment of the events. Additional information received from the pharmacist on 16-Jan-2026 included confirmation for the outcome of the events nausea and vomiting.; Reporter's Comments: A 68-year-old female patient experienced non-serious events of nausea and vomiting on an unknown date, approximately 4 hours after the patient was administered with the first dose of Vivotif vaccine for prevention of typhoid illness. Reportedly, 61 days after administration of first dose of Vivotif, the patient received the second dose of Vivotif vaccine, which is considered as inappropriate schedule of vaccine administered. On an unknown date, approximately 4 hours after taking the second dose, the patient experienced non-serious events of nausea and vomiting. Nausea and vomiting are listed and expected for Vivotif per CCDS v9 and USPI. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was recovered. Considering compatible temporal relationship, known vaccine safety profile and insufficient information regarding presence of confounding factors or alternative explanations, the causality is assessed as related to the suspect vaccine. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. For regulatory reporting purposes, this case is considered related.; Sender's Comments: A 68-year-old female patient experienced non-serious events of nausea and vomiting on an unknown date, approximately 4 hours after the patient was administered with the first dose of Vivotif vaccine for prevention of typhoid illness. Reportedly, 61 days after administration of first dose of Vivotif, the patient received the second dose of Vivotif vaccine, which is considered as inappropriate schedule of vaccine administered. On an unknown date, approximately 4 hours after taking the second dose, the patient experienced non-serious events of nausea and vomiting. Nausea and vomiting are listed and expected for Vivotif per CCDS v9 and USPI. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was recovered. Considering compatible temporal relationship, known vaccine safety profile and insufficient information regarding presence of confounding factors or alternative explanations, the causality is assessed as related to the suspect vaccine. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. For regulatory reporting purposes, this case is considered related.
Comments: None.