Smallpox Vaccine, Live

What is this medication?

SMALLPOX VACCINE (smol paks vak SEEN) is a vaccine used to reduce the risk of getting smallpox virus infection.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): ACAM2000

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Diabetes (high blood sugar)
• Heart disease
• High cholesterol
• High blood pressure
• Immune system problems
• Skin conditions or disease
• Stroke
• An unusual or allergic reaction to smallpox vaccine, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This vaccine is injected under the skin. It is given by your care team.

A special MedGuide will be given before each vaccination. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While it may be given to children as young as 16 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medication is not for regular use.

What may interact with this medication?

Interactions are not expected.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team regularly.

Cases of inflammation of the heart have been reported after receiving this vaccine. It is not known whether the vaccine causes the heart inflammation. Talk to your care team right away if you are unusually weak or tired; have trouble breathing; chest pain; dizziness; fast, irregular heartbeat; fever; joint pain; swelling of the ankles, feet, hands or other unusual swelling. Adolescents or young adult males at an increased risk of inflammation of the heart may consider waiting 4 weeks after smallpox vaccination before getting an mRNA COVID-19 vaccine.

Women should inform their care team if they wish to become pregnant or think they might be pregnant. There is potential for serious harm to an unborn child. Talk to your care team for more information.

After getting this vaccine, it may be possible to give smallpox to others. Until scabbing occurs (usually between Days 14 to 21 after primary vaccination), avoid people with low immune systems, past or present eczema, pregnant women, and infants less than 12 months of age. Talk to your care team if you have questions.

This vaccine, like all vaccines, may not fully protect everyone. Continue to follow all guidelines to prevent exposure.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Dizziness, loss of balance or coordination, confusion or trouble speaking
• Inflammation of the heart—unusually weak or tired, trouble breathing, chest pain, dizziness, fast or irregular heartbeat, fever, joint pain, swelling of the ankles, feet, hands or other unusual swelling
• New or worsening eye pain, redness, irritation, or discharge
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Skin infection—skin redness, swelling, warmth, or pain
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Fever
• General discomfort and fatigue
• Headache
• Muscle pain
• Pain, redness, or irritation at injection site
• Swollen lymph nodes in the neck, groin, chest, or underarm area

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This vaccine is only given by your care team. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.