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----------------------WARNINGS AND PRECAUTIONS------------------------
• Myocarditis and/or pericarditis, ischemic heart disease and non-ischemic dilated cardiomyopathy. (5.1, 5.2)
• Encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia (vaccinia necrosum), generalized vaccinia, severe vaccinial skin infections, erythema multiforme major (including Stevens-Johnson syndrome), eczema vaccinatum, fetal vaccinia and fetal death. (5.1)
• Ocular vaccinia that may lead to blindness. (5.3)
• These risks, including risks of severe disability and/or death, are increased in vaccinees with:
• Cardiac disease. (5.2)
• Eye disease treated with topical steroids. (5.3)
• Congenital or acquired immune deficiency disorders. (5.4)
• History or presence of eczema and other skin conditions. (5.5)
• Infants < 12 months of age. (5.6)
• Pregnancy. (5.7)
• ACAM2000 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 stated for vaccinees. (5.10)
------------------------------ADVERSE REACTIONS-------------------------------
Common adverse reactions include inoculation site signs and symptoms, lymphadenitis, and constitutional symptoms, such as malaise, fatigue, fever, myalgia, and headache (6). These adverse reactions are less frequent in revaccinated persons than persons receiving the vaccine for the first time. Inadvertent inoculation at other sites is the most frequent complication of vaccinia vaccination. The most common sites involved are the face, nose, mouth, lips, genitalia and anus.
Self-limited skin rashes not associated with vaccinia replication in skin, including urticaria and folliculitis, may occur following vaccination.