Report #2889687

Overview

Sex

Unknown

Age

Age unknown

State

AZ

Recovered

Recovered

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (6)

Symptom narrative

Cramping; Nausea; Vomiting; Diarrhea; Headache; patient inadvertently taking Vivotif, took all four tablets at once; patient inadvertently taking Vivotif, took all four tablets at once; Case reference number US-BN-2025-001835 is a spontaneous case initially received from other health care professional via Bavarian Nordic (reference number: CASE-000878) on 21-Nov-2025 and concerns a 27-years-old male patient. The patients' medical history and concomitant medication details were not provided. On an unspecified date, the patient inadvertently took Vivotif (batch number: *3004298*), all four tablets *orally* at once *for indication reported as oral typhoid* (explicitly coded as 'overdose and inappropriate schedule of vaccine administration). On *27-Nov-2025*, patient experienced nausea, vomiting, diarrhoea, headache, cramping as side effects from taking all doses at once. *On 28-Nov-2025*, the patient *recovered* from the events nausea, vomiting, diarrhoea, headache, cramping. The reporter *assessed the events nausea, vomiting, diarrhoea, headache, cramping as non-serious and probably related to Vivotif.* Additional information was received from health care professional via Bavarian Nordic on 24-Nov-2025 included new reference numbers (CASE-000892, BN_2025_00347; 036700068) and additional events nausea, vomiting, diarrhoea, headache, cramping. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*) Follow-up information was received from other health care professional on 06-Feb-2026. New information included Vivotif dosing information, patient's demographic information, event start and stop date, seriousness, outcome and causality assessment of the events of nausea, vomiting, diarrhoea, headache and cramping.; Reporter's Comments: A spontaneous case, concerning a 27-year-old male patient reported non-serious events of nausea, vomiting, diarrhoea, headache, and cramping, which occurred following an overdose and inappropriate schedule of vaccine administration with Vivotif (batch number unknown). The patient had inadvertently ingested all four tablets at once (coded as overdose). The events nausea, vomiting, diarrhoea, headache are excepted whereas cramping are unexpected as per CCDS V6.0 and SmPC of Vivotif. The event inappropriate schedule of product administration and ovredose are listed as per company convention. The outcome of these events was unknown at the time of initial report. A temporal association exists between suspect drug and the reported events; however, without further historical, clinical, and pharmacological information, a definitive causal link cannot be established. Inappropriate schedule of product administration and overdose assessed as not related to suspect vaccine but to human factor. The case assessed as non-serious. For regulatory reporting purposes, this case is considered related.Based on the follow up information, there is no change in company's assessment.; Sender's Comments: A spontaneous case, concerning a 27-year-old male patient reported non-serious events of nausea, vomiting, diarrhoea, headache, and cramping, which occurred following an overdose and inappropriate schedule of vaccine administration with Vivotif (batch number unknown). The patient had inadvertently ingested all four tablets at once (coded as overdose). The events nausea, vomiting, diarrhoea, headache are excepted whereas cramping are unexpected as per CCDS V6.0 and SmPC of Vivotif. The event inappropriate schedule of product administration and ovredose are listed as per company convention. The outcome of these events was unknown at the time of initial report. A temporal association exists between suspect drug and the reported events; however, without further historical, clinical, and pharmacological information, a definitive causal link cannot be established. Inappropriate schedule of product administration and overdose assessed as not related to suspect vaccine but to human factor. The case assessed as non-serious. For regulatory reporting purposes, this case is considered related.Based on the follow up information, there is no change in company's assessment.