Myocarditis/Pericarditis

• Suspected cases of myocarditis and/or pericarditis have been observed in healthy adult primary vaccinees (at an approximate rate of 5.7 per 1000, 95% CI: 1.9 to 13.3) receiving this vaccine [See WARNINGS AND PRECAUTIONS (5.1)]

Other Reactions

• Encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia, generalized vaccinia, severe vaccinial skin infections, and erythema multiforme major (including STEVENS JOHNSON SYNDROME) and eczema vaccinatum resulting in permanent sequelae or death, ocular complications, blindness, and fetal death have occurred following either primary vaccination or revaccination with smallpox vaccines [See WARNINGS and Precautions (5)].

These risks are increased in vaccinees with the following conditions and may result in severe disability, permanent neurological sequelae and/or death:

• Cardiac disease or a history of cardiac disease
• Eye disease treated with topical steroids
• Congenital or acquired immune deficiency disorders, including those taking immunosuppressive medications
• Eczema and persons with a history of eczema or other acute or chronic exfoliative skin conditions
• Infants less than 12 months of age
• Pregnancy

Live Vaccine

• This is a live vaccinia virus that can be transmitted to persons who have close contact with the vaccinee and the risks in contacts are the same as those for the vaccinee.

Benefit/Risk

• The risk for experiencing serious vaccination complications must be weighed against the risks for experiencing a potentially fatal smallpox infection.