Adverse reactions to vaccinia vaccination range from mild and self-limited to severe and life-threatening, including inoculation site signs and symptoms, constitutional symptoms, generalized vaccinia, eczema vaccinatum, and progressive vaccinia
However, its use increases the risk for development of progressive vaccinia
or eczema vaccinatum; these adverse events would then need to be treated with ST-246.
There were no severe adverse events such as autoinoculation/contact inoculation, eczema vaccinatum, progressive vaccinia
, generalized vaccinia, encephalitis, or the myopericarditis that has been "a major concern" in the U.S.
An immunoglobulin containing antivaccinia antibody for the treatment and/or modification of serious complications of smallpox vaccination, including eczema vaccinatum, progressive vaccinia
, severe generalized vaccinia, and vaccinia infections in people who have skin conditions, such as burns, impetigo, or varicella zoster.
Smallpox vaccine administration can trigger a wide range of dermatologic reactions, from severe conditions such as eczema vaccinatum and progressive vaccinia
, to milder reactions such as generalized vaccinia and erythema multiforme.
* Progressive vaccinia
. This is the rapid, progressive, and painless extension of the central vaccination lesion without apparent healing for 15 days.
Other common adverse reactions likely to result in either ambulatory visits or time lost from work or school include a robust primary reaction (4% to 18%); generalized vaccinia (240 out of 1 million primary vaccinations) with vesicles/pustules distant from vaccine site and mild systemic illness; inadvertent inoculation to other places on the body (529 out of 1 million); eczema vaccinia (1 out of 25,000) generally occurring among persons with a history of eczema; progressive vaccinia
(1 out of 600,000) seen among persons with impaired T-cell function with necrosis at the vaccine site, with severe and potentially fatal systemic illness.
. This disorder involves the spread of vaccinial lesions from the inoculation site throughout the body.
Other complications include autoinoculation, in which traces of the vaccine can be transmitted by a health worker's hands to the eyes, for example; progressive vaccinia
(also called vaccinia gangrenosa); and eczema vaccinatum, a widespread skin reaction in patients with atopic dermatitis.
Immunocompromised individuals can develop progressive vaccinia
, an often fatal condition in which the vaccinia sores spread over the body.
Safety data from ACAM2000 clinical trials indicate a similar safety profile to Dryvax, including a risk for serious adverse events (e.g., progressive vaccinia
, postvaccinial encephalitis, and eczema vaccinatum) (5,6).
The FDA approved VIGIV with the condition that postmarketing studies be conducted, including assessing clinical benefits, such as increased survival in patients with progressive vaccinia
and eczema vaccinatum.