Legend Tool 3 Morbidity and Mortality Clinical Evaluation Tool for Vaccine Adverse Reactions Risk based on clinical presentation. Dermatologic Reactions/Toxic Appearance, Distant from Site (or in a Close Contact)

Low www.bt.cdc.gov/agent/smallpox/vaccination/clineval (03-12-2003 Version)

Moderate Consult with state/ local health department and CDC to obtain clinical guidance and to report inadvertent High exposure to contained in smallpox vaccine. Management of the adverse reactions discussed in this tool may be different when risk factor(s) are present. See Consultation and Reporting Information. History of known risk Vaccine recipients or close contacts with risk factor(s) should be reported, whether or not an adverse event develops. Vaccine Recipient Yes Yes factors for smallpox Risk Factor Adverse Reaction (Potential/ Reported Historically) or Close Contact? Atopic Dermatitis/Eczema vaccine adverse reactions? Acute Exfoliative Dermatitis Inadvertent Immunocompromised including HIV+/AIDS Progressive Vaccinia Immunocompromised including HIV+/AIDS (Severe form) Allergy to vaccine component Allergic Reaction No Pregnancy Fetal Vaccinia and potential unknown risks to fetus

Widespread, extensive bullae and Large contiguous patches of skin with Generalized papular, vesicular or Rapid, progressive, and painless erosions with involvement of two or vesicles and pustules (may be pustular eruption with varying extension of central vaccination more mucosal surfaces. umbilicated and coalescing) that are degrees of erythema (typical lesion lesion or progression without Systemic symptoms present. suspicious for vaccinial lesions. size > 5 mm). Lesions typically apparent healing after 15 days. Predilection for sites typical for eczema/ appear within 6-9 days of Lesion often necrotic. Initially little vaccination, evolve through normal to no inflammation, +/- distant Erythema multiforme major atopic dermatitis eruptions. Lesions vaccination stages and are in the metastatic lesions to skin, bones, (Stevens-Johnson Syndrome) often erupt over intact skin and are same stage of development. Severe and viscera. - NOT recommended usually seen in vaccine recipients or systemic symptoms present. VIG (first line agent) or contacts (especially young children) (second line agent). with history of atopic dermatitis/ - Hospitalize and provide eczema, irrespective of disease activity Progressive vaccinia (Vaccinia supportive care. or severity. Systemic toxicity with necrosum, Vaccinia gangrenosum). - Role of steroids unclear; consult with worsening disease may occur. Generalized vaccinia (severe form) - Request release of VIG (first line dermatologist as indicated. - Request release of VIG (first line agent) or Cidofovir (second line agent) or Cidofovir (second line agent). agent). - Contact state health department for See Consultation and Eczema vaccinatum - Contact state health department guidance. Reporting Information - Request release of VIG (first line for guidance. - Hospitalize and provide supportive agent) or Cidofovir (second line agent). Consultation and Reporting Information - Hospitalize and provide care with attention to secondary - Contact state health department Civilian health care providers who need clinical consultation supportive care. infections. for guidance. with or without release of Vaccinia Immune Globulin (VIG) - Conduct immunologic work-up. - Conduct immunologic work-up. - Hospitalize and provide supportive (first line agent) or Cidofovir (second line agent) for - Use infection control precautions. - Use infection control precautions. care with attention to hemodynamic potential smallpox vaccine adverse reactions should support, secondary infections and contact their state/ local health department or the CDC meticulous skin care (severe cases Clinician Information Line at (877) 554-4625. Military health See Consultation and See Consultation and may require burn unit). care providers (or civilian providers treating a DoD Reporting Information. Reporting Information. - Use infection control precautions. healthcare beneficiary) requesting clinical consultation should call (866) 210-6469, and if requesting VIG release should call (888) USA-RIID or (301) 619-2257. Health care providers should report smallpox vaccine See Consultation and adverse events to their state/ local health department and to Reporting Information. for smallpox vaccine adverse reactions distant from the Vaccine Adverse Event Reporting System (VAERS) at vaccination site (or in a close contact) http://www.vaers.org/ or (800) 822-7967. Consider conditions not related to smallpox vaccine such as: Please call (888) 246-2675 (Español (888) 246-2857, TTY Laboratory testing - Varicella - Kawasaki syndrome (866) 874-2646) or visit http://www.bt.cdc.gov/agent/ Consider use of licensed diagnostic - Disseminated herpes zoster - Sweet’s syndrome smallpox/index.asp for general public information about tests to rule out etiologies not - Disseminated virus (HSV) (Acute febrile neutrophilic dermatosis) smallpox vaccination. Persons experiencing urgent or life- related to vaccina virus contained in - Meningococcemia - Leukocytoclastic vasculitis threatening medical events should seek immediate medical smallpox vaccine. (e.g. Henoch-Schonlein purpura) assistance. Disclaimer The CDC and its partners in the Clinical Immunization Safety Assessment (CISA) network have developed Clinical Evaluation Tools to help health care providers manage patients with potential adverse reactions from smallpox vaccination in the absence of circulating smallpox virus (pre-event setting). These Tools are based on studies conducted before routine US childhood smallpox vaccination was discontinued in 1972 and on expert opinion; they are not entirely evidence-based. The Tools may not apply to all patients with smallpox vaccine adverse reactions and are not intended to substitute for evaluation by a trained clinician. This Tool was last updated on 3-12-03. Please direct feedback on these Tools to [email protected]. Page 6.63