Table 1.

Major and minor criteria for the case definition of viscerotropic disease

Major criteria	Laboratory or clinical data
Hepatic	Total bilirubin ≥1.5× ULN or ≥1.5× patient’s BV or ALT or AST ≥3× ULN or ≥3× patient’s BV
Renal	Creatinine ≥1.5× ULN or ≥1.5× patient’s BV
Musculoskeletal	CPK ≥5× ULN
Respiratory	Oxygen saturation ≤88% on room air or requirement for mechanical ventilation
Platelet disorder	Platelets <100,000/μL
Hypotension	Requirement for vasopressor drugs to maintain systolic BP
Coagulopathy	INR ≥1.5 or prothrombin time ≥1.5× ULN or activated partial thromboplastin time ≥1.5× ULN or elevated fibrin degradation products or hemorrhage from more than one site
Minor criteria
Hepatic	Jaundice
Renal	Urine output <500 mL urine/24 hours for adults; <0.5 mL/kg/h for children
Musculoskeletal	Positive urine dipstick test for blood with a negative urine microscopy examination for red blood cells
Respiratory	Increased respiratory rate for age
Platelet disorder	Petechiae or purpura present
Hypotension	Systolic BP <90 mmHg for adults; <fifth percentile for age in children <16 years
Coagulopathy	Clinically evident hemorrhage (one of): epistaxis, hematemesis, melena, hematochezia, hemoptysis, metrorrhagia or menorrhagia, gingival hemorrhage, persistent bleeding from needle puncture sites

Notes: Symptoms and physical signs are indicated in bold. Adapted from Vaccine, 30(33), Gershman MD, Staples JE, Bentsi-Enchill AD, et al, Viscerotropic dis ease: case definition and guidelines for collection, analysis, and presentation of immunization safety data, 5038–5058, Copyright 2012, with permission from Elsevier.13

Abbreviations: ULN, upper limit of normal; BV, baseline value; h, hour; BP, blood pressure; ALT, alanine aminotransferase; AST, aspartate aminotransferase; INR, International Normalized Ratio; CPK, creatinine phosphokinase.