Ocular complications in the Department of Defense Smallpox Vaccination Program

Abstract

Objective: The purpose of this case series was to present an overview of the nature and frequency of ocular complications in the Department of Defense (DoD) Smallpox Vaccination Program.

Design: Retrospective, noncomparative case series.

Participants: The authors retrospectively evaluated data collected on individuals with an ophthalmologic complaint after receiving smallpox vaccination or after contact with a recently immunized individual. The vaccinee and contact cases occurred secondary to inoculations given between December 13, 2002 and May 28, 2003 as part of the DoD Smallpox Vaccination Program.

Methods: Data were collected primarily from reports to military headquarters or to the Vaccine Adverse Event Reporting System and individual medical records.

Main outcome measures: The incidence, types, and timing of ocular complications were evaluated. Diagnostic and treatment considerations also were reviewed.

Results: Between December 13, 2002 and May 28, 2003, 450,293 smallpox vaccinations were given. We identified 16 confirmed or probable cases of ocular vaccinia, with an incidence of 3.6 per 100,000 inoculations. Of these cases, 12 (75%) were seen in the vaccinees, and 4 (25%) in close contacts. Of the 12 self-inoculation cases, 7 (58.3%) were seen in individuals receiving the vaccine for the first time (primary vaccination), and 3 (25.0%) were seen in individuals previously vaccinated (revaccination); the vaccination status in 2 cases was unknown. Clinical manifestations included lid pustules, blepharitis, periorbital cellulitis, conjunctivitis, conjunctival ulcers, conjunctival membranes, limbal pustules, corneal infiltrates, and iritis, with onset of symptoms 3 to 24 days after inoculation or contact. Five of 9 tested cases were culture or polymerase chain reaction positive for vaccinia. Treatment for most cases was topical trifluridine 1% (Viroptic; King Pharmaceuticals, Inc., Bristol, TN). Vaccinia immune globulin was used in 1 case. In all patients, recovery occurred without significant visual sequelae.

Conclusions: When compared with historical data on the ocular complications of smallpox vaccination, the incidence of ocular complications during the DoD Smallpox Vaccination program has been low. In addition, the severity of disease seems to be less than during other vaccination periods. These findings perhaps are the result of improved screening of vaccinees, prevaccination counseling, postvaccination wound care, and the suggested efficacy of trifluridine in the treatment of ocular vaccinia.