Serious Complications

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: 1.9-13.3) receiving ACAM2000 [see Warnings and Precautions (5.1)].

Encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia, generalized vaccinia, severe vaccinial skin infections, erythema multiforme major (including STEVENS-JOHNSON SYNDROME), eczema vaccinatum resulting in permanent sequelae or death, and fetal death have occurred following either primary vaccination or revaccination with ACAM2000 or other live vaccinia virus vaccines that were used historically [see Warnings and Precautions (5)].

Accidental eye infection (ocular vaccinia) may result in ocular complications including keratitis and corneal scarring that may lead to blindness [see Warning and Precautions (5.3)].

These risks may result in severe disability, permanent neurological sequelae and/or death and are increased in individuals who: 

• Have cardiac disease or a history of cardiac disease
• Have eye disease treated with topical steroids
• Have congenital or acquired immune deficiency disorders, including individuals taking immunosuppressive medications
• Have eczema or a history of eczema or other acute or chronic exfoliative skin conditions
• Are less than 12 months of age
• Are pregnant

ACAM2000 contains 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 vaccine.

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