Abstract Title:

Smallpox vaccination and adverse reactions. Guidance for clinicians.

Abstract Source:

MMWR Recomm Rep. 2003 Feb 21;52(RR-4):1-28. PMID: 12617510

Abstract Author(s):

Joanne Cono, Christine G Casey, David M Bell,

Article Affiliation:

Bioterrorism Preparedness and Response Program, National Center for Infectious Diseases, USA.


The guidance in this report is for evaluation and treatment of patients with complications from smallpox vaccination in the preoutbreak setting. Information is also included related to reporting adverse events and seeking specialized consultation and therapies for these events. The frequencies of smallpox vaccine-associated adverse events were identified in studies of the 1960s. Because of the unknown prevalence of risk factors among today's population, precise predictions of adverse reaction rates after smallpox vaccination are unavailable. The majority of adverse events are minor, but the less-frequent serious adverse reactions require immediate evaluation for diagnosis and treatment. Agents for treatment of certain vaccine-associated severe adverse reactions are vaccinia immune globulin (VIG), the first-line therapy, and cidofovir, the second-line therapy. These agents will be available under Investigational New Drug (IND) protocols from CDC and the U.S. Department of Defense (DoD). Smallpox vaccination in the preoutbreak setting is contraindicated for persons who have the following conditions or have a close contact with the following conditions: 1) a history of atopic dermatitis (commonly referred to as eczema), irrespective of disease severity or activity; 2) active acute, chronic, or exfoliative skin conditions that disrupt the epidermis; 3) pregnant women or women who desire to become pregnant in the 28 days after vaccination; and 4) persons who are immunocompromised as a result of human immunodeficiency virus or acquired immunodeficiency syndrome, autoimmune conditions, cancer, radiation treatment, immunosuppressive medications, or other immunodeficiencies. Additional contraindications that apply only to vaccination candidates but do not include their close contacts are persons with smallpox vaccine-component allergies, women who are breastfeeding, those taking topical ocular steroid medications, those with moderate-to-severe intercurrent illness, and persons aged<18 years. in addition, history of darier disease is a contraindication potential vaccinee and if household contact has active disease. the event smallpox outbreak, outbreak-specific guidance will be disseminated by cdc regarding populations to vaccinated specific contraindications vaccination. vaccinia can transmitted from vaccinee's unhealed vaccination site other persons close lead same adverse events as vaccinee. avoid transmission virus (found vaccine) vaccinees their contacts, should wash hands with warm soapy water or hand rubs containing>or = 60% alcohol immediately after they touch their vaccination site or change their vaccination site bandages. Used bandages should be placed in sealed plastic bags and can be disposed of in household trash. Smallpox vaccine adverse reactions are diagnosed on the basis of clinical examination and history, and certain reactions can be managed by observation and supportive care. Adverse reactions that are usually self-limited include fever, headache, fatigue, myalgia, chills, local skin reactions, nonspecific rashes, erythema multiforme, lymphadenopathy, and pain at the vaccination site. Other reactions are most often diagnosed through a complete history and physical and might require additional therapies (e.g., VIG, a first-line therapy and cidofovir, a second-line therapy). Adverse reactions that might require further evaluation or therapy include inadvertent inoculation, generalized vaccinia (GV), eczema vaccinatum (EV), progressive vaccinia (PV), postvaccinial central nervous system disease, and fetal vaccinia. Inadvertent inoculation occurs when vaccinia virus is transferred from a vaccination site to a second location on the vaccinee or to a close contact. Usually, this condition is self-limited and no additional care is needed. Inoculations of the eye and eyelid require evaluation by an ophthalmologist and might require therapy with topical antiviral or antibacterial medications, VIG, or topical steroids. GV is characterized by a disseminated maculopapular or vesicular rash, frequently on an erythematous base, which usually occurs 6-9 days after first-time vaccination. This condition is usually self-limited and benign, although treatment with VIG might be required when the patient is systemically ill or found to have an underlying immunocompromising condition. Infection-control precautions should be used to prevent secondary transmission and nosocomial infection. EV occurs among persons with a history of atopic dermatitis (eczema), irrespective of disease severity or activity, and is a localized or generalized papular, vesicular, or pustular rash, which can occur anywhere on the body, with a predilection for areas of previous atopic dermatitis lesions. Patients with EV are often systemically ill and usually require VIG. Infection-control precautions should be used to prevent secondary transmission and nosocomial infection. PV is a rare, severe, and often fatal complication among persons with immunodeficiencies, characterized by painless progressive necrosis at the vaccination site with or without metastases to distant sites (e.g., skin, bones, and other viscera). This disease carries a high mortality rate, and management of PV should include aggressive therapy with VIG, intensive monitoring, and tertiary-level supportive care. Anecdotal experience suggests that, despite treatment with VIG, persons with cell-mediated immune deficits have a poorer prognosis than those with humoral deficits. Infection-control precautions should be used to prevent secondary transmission and nosocomial infection. Central nervous system disease, which includes postvaccinial encephalopathy (PVE) and postvaccinial encephalomyelitis (or encephalitis) (PVEM), occur after smallpox vaccination. PVE is most common among infants aged<12 months. clinical symptoms of central nervous system disease indicate cerebral or cerebellar dysfunction with headache, fever, vomiting, altered mental status, lethargy, seizures, and coma. pve pvem are not believed to be a result replicating vaccinia virus diagnoses exclusion. although no specific therapy exists for pvem, supportive care, anticonvulsants, intensive care might required. fetal vaccinia, resulting from vaccinial transmission mother fetus, is rare, but serious, complication smallpox vaccination during pregnancy shortly before conception. it manifested by skin lesions organ involvement, often results in neonatal death. known reliable intrauterine diagnostic test available confirm infection. given the rarity congenital among live-born infants, should ordinarily reason consider termination pregnancy. indication routine, prophylactic use vig an unintentionally vaccinated pregnant woman; however, withheld if woman develops condition where needed. other less-common adverse events after have been reported occur temporal association vaccination, causality has established. treatment recommended persons close contacts contraindications who inadvertently inoculated exposed. these followed closely early recognition reactions that develop, clinicians encouraged enroll cdc registry calling clinician information line at 877-554-4625. request consultation ind therapies vaccinia-related civilians, contact your state health department cdc's (877-554-4625). evaluation tools http.>

Study Type : Review

Print Options


Login to Comment

Commenting is limited to Members only. If you are already a member, please login to post a comment. If you do not have a member account and would like to become a member, please click here to begin the process to become a member.