This is a post-marketing study to verify the clinical benefits of VIGIV [CNJ-016, Vaccinia Immune Globulin Intravenous (Human), sterile solution] in the resolution of complications resulting from smallpox vaccination in eligible patients treated with VIGIV.

This is an open-label Phase 4 study designed to collect additional data to assess the safety and efficacy of VIGIV [CNJ-016, Vaccinia Immune Globulin Intravenous (Human), sterile solution] in the first 100 consented patients treated with VIGIV.

Inclusion Criteria:

Subjects treated with VIGIV deployed from the US Strategic National Stockpile for any of the following conditions:

• Eczema vaccinatum.
• Progressive vaccinia.
• Severe generalized vaccinia.
• Vaccinia infections in individuals who have skin conditions such as burns, impetigo, varicella-zoster, or poison ivy, or in individuals who have eczematous skin lesions because of either the activity or extensiveness of such lesions.
• Aberrant infections induced by vaccinia virus that include its accidental implantation in eyes (except in cases of isolated keratitis), mouth, or other areas where vaccinia infection would constitute a special hazard.
• Informed consent voluntarily signed by subject, legal guardian or representative to participate in the study. For minors, the informed consent form must be signed by a legally acceptable representative and when appropriate, informed consent/assent must also be obtained from the minor.

Exclusion Criteria:

None.

Individuals who are administered VIGIV distributed from the US Strategic National Stockpile for the treatment of complications due to vaccinia vaccination or vaccinia infections.