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

Applies to smallpox vaccine: injection powder for solution.

Serious side effects of ACAM2000

Along with its needed effects, smallpox vaccine (the active ingredient contained in ACAM2000) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking smallpox vaccine:

More common

• Feeling unusually cold
• shivering
• swollen, painful, or tender lymph glands in the neck, armpit, or groin

Less common

• Agitation
• anxiety
• back pain
• blindness
• blistering, peeling, or loosening of skin
• blue or pale skin
• blurred vision
• changes in vision
• chest discomfort
• chest pain, possibly moving to the left arm, neck, or shoulder
• confusion
• convulsions (seizures)
• cough
• diarrhea
• difficult or labored breathing
• dizziness
• drowsiness
• fast heartbeat
• fever and chills
• hallucinations
• headache
• irritability
• itching
• joint or muscle pain
• loss of consciousness
• mood or mental changes
• red skin lesions, often with a purple center
• red, irritated eyes
• shortness of breath
• skin rash that is encrusted, scaly, and oozing
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stiff neck
• tightness in the chest
• trouble breathing
• unusual tiredness or weakness
• vomiting
• wheezing

Other side effects of ACAM2000

Some side effects of smallpox vaccine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Decreased ability to exercise
• difficulty having a bowel movement (stool)
• difficulty with moving
• flushing or redness of the skin
• general feeling of discomfort or illness
• itching, pain, redness, or swelling at the vaccine site
• muscle aching or cramping
• muscle stiffness
• nausea
• rash
• swollen joints
• unusually warm skin

For Healthcare Professionals

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]