Smallpox and Mpox (Vaccinia) Vaccine Injection, Live

SMALLPOX and MPOX (VACCINIA) VACCINE (smol poks and EM poks [vuh CHEE nee uh] vak SEEN) reduces the risk of smallpox and monkeypox (mpox). It does not treat smallpox or mpox. It is still possible to get smallpox or mpox after receiving this vaccine, but the symptoms may be less severe or not last as long. It works by helping your immune system learn how to fight off a future infection.

This vaccine is given through the skin. It is given by your care team. They will make shallow pokes in the skin of your upper arm with a needle holding a small drop of the vaccine.

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

Talk to your care team to see which vaccines are right for you. Some vaccines should not be used in all age groups.

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
• Eye pain, redness, irritation, or discharge with blurry or decreased vision
• Heart muscle inflammation—unusual weakness or fatigue, shortness of breath, chest pain, fast or irregular heartbeat, dizziness, swelling of the ankles, feet, or hands
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Skin infection—skin redness, swelling, warmth, or pain

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
• Nausea
• Pain, redness, or irritation at injection site
• Swollen lymph nodes in the neck, groin, chest, or underarm area

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

Interactions are not expected.

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

Visit your care team for regular health checks.

This is a live virus vaccine. It uses a weakened form of the virus that causes a disease. It is possible to transfer the virus to people who are near you for up to 6 weeks after your dose and until the vaccination site has healed. It is important to care for your vaccination site as instructed so that the virus doesn't spread to other parts of your body or to other people. Avoid close contact with people at increased risk of serious side effects. This includes infants, people who have heart or skin conditions, take steroid eye medications, have a weakened immune system, or are pregnant. Avoid touching your eyes, genitals, and other body parts to avoid spreading the virus.

To care for your vaccination site, cover it with gauze and first-aid tape. The bandage should allow air to pass but not fluids. You should also wear a shirt with sleeves that cover the site. Keep the site dry and covered until the scab falls off on its own. Do not scratch or pick at the scab. Change the bandage when fluid begins to soak through, at least every 1 to 3 days. Wash your hands with soap and warm water after contact with the site or any bandage, clothes, towels, or sheets that may have touched the site. Throw away gloves and bandages in a sealed plastic bag. Add a small amount of bleach to kill the virus. Place items that may have come into contact with the site in a separate wash. Use hot water with detergent and bleach. When the scab falls off, throw it away in a sealed plastic bag and wash your hands.

Cases of heart muscle inflammation have been reported after receiving this vaccine. It is not known whether the vaccine causes the inflammation. Talk to your care team right away if you have unusual weakness or fatigue, shortness of breath, chest pain, fast or irregular heartbeat, dizziness, or swelling of the ankles, feet, or hands. People at an increased risk of heart muscle inflammation may consider waiting 4 weeks after smallpox vaccination before getting an mRNA COVID-19 vaccine.

Talk to your care team if you or your partner may be or could become pregnant. Serious fetal side effects may occur if this vaccine is given during pregnancy. Avoid pregnancy for 6 weeks after vaccination and until the vaccination site has healed.

Do not breastfeed for 6 weeks after vaccination and until the vaccination site has healed.

Do not donate blood, organs, tissues, or cells for 6 weeks after vaccination and until the vaccination site has healed.

Report any side effects to your care team or to the Vaccine Adverse Event Reporting System (VAERS) website at https://vaers.hhs.gov. This is only for reporting side effects; VAERS staff do not give medical advice.