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ACAM2000 Side Effects

Generic name: smallpox vaccine

Note: This document contains side effect information about smallpox vaccine. Some of the dosage forms listed on this page may not apply to the brand name ACAM2000.

Applies to smallpox vaccine: percutaneous powder for injection

Local

Very common (10% or more): Injection site pruritus (92%), injection site erythema (74%), injection site pain (67%), injection site swelling (48%)[Ref]

Nervous system

Very common (10% or more): Headache (50%)

Frequency not reported: Encephalitis, encephalomyelitis, encephalopathy[Ref]

Other

Very common (10% or more): Fatigue (48%), malaise (37%), feeling hot (32%), rigors (21%), exercise tolerance decreased (11%)[Ref]

Cardiovascular

Frequency not reported: Myocarditis, pericarditis, ischemic heart disease, non-ischemic dilated cardiomyopathy[Ref]

Dermatologic

Very common (10% or more): Erythema (22%), rash (11%)

Frequency not reported: Erythema multiforme major (including Stevens-Johnson syndrome)[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (46%)[Ref]

Hematologic

Very common (10% or more): Lymph node pain (57%)

Common (1% to 10%): Lymphadenopathy[Ref]

Ocular

Frequency not reported: Ocular complications, blindness[Ref]

Immunologic

Frequency not reported: Generalized vaccinia, severe vaccinial skin infections, eczema vaccinatum[Ref]

Gastrointestinal

Very common (10% or more): Nausea (19%), diarrhea (16%)

Common (1% to 10%): Constipation, vomiting[Ref]

Respiratory

Common (1% to 10%): Dyspnea[Ref]

References

1. "Product Information. ACAM2000 (smallpox vaccine)." Emergent BioSolutions Inc., Lansing, MI.

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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.