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Appendix

Introduction

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IMPORTANT WARNING:

Smallpox and mpox (vaccinia) vaccine, live may cause damage to the heart. Tell whoever will be giving the vaccine if you have or have ever had a heart attack, heart failure, a stroke or transient ischemic attack (TIA; mini stroke), or other heart problems. If you experience any of the following symptoms, call your doctor immediately: chest pain, shortness of breath, difficulty breathing, or changes in heartbeat.

Smallpox and mpox (vaccinia) vaccine, live may cause damage to the brain or spinal cord. If you experience any of the following symptoms, call your doctor immediately: stiff neck, confusion, agitation, trouble moving body parts, muscle weakness, loss of consciousness, or seizures.

Smallpox and mpox (vaccinia) vaccine, live may cause skin disorders. Tell whoever will be giving the vaccine if you have or have ever had eczema or other skin conditions. If you experience any of the following symptoms, call your doctor immediately: rash, particularly around the site of injection, a sore that will not heal.

Smallpox and mpox (vaccinia) vaccine, live may cause damage to the eye(s) that may lead to blindness if the vaccine is accidentally spread to the eye. If you experience any of the following symptoms, call your doctor immediately: watery, painful eyes, blurred vision, or changes in vision.

Smallpox and mpox (vaccinia) vaccine, live may be passed along to other people that you have close contact with you for up to 6 weeks after vaccination. Avoid close contact (skin or objects that touch the skin) with those who are immunocompromised, have or have ever had eczema. Also avoid contact with those who are pregnant or infants who are less than 12 months of age.

You should not receive Smallpox and mpox (vaccinia) vaccine, live if you are pregnant or plan to become pregnant. You or your partner should not become pregnant for 6 weeks after vaccination or until the site of vaccination has healed.

Talk to your doctor about the risk(s) of receiving smallpox vaccine, live.

Why get vaccinated?

Smallpox and mpox (vaccinia) vaccine, live may prevent smallpox or mpox that may occur with infection due to orthopoxviruses.

Infection with these viruses can cause the following: skin rashes and lesions, fever, muscle aches, swollen lymph nodes that may be life-threatening.

Smallpox and mpox (vaccinia) vaccine, live contains a live virus that has been weakened so it does not cause disease but can still stimulate the body to make antibodies against the virus to provide a defense against potential infection.

How is the vaccine given?

Smallpox and mpox (vaccinia) vaccine, live comes as a suspension (liquid) to be given by a puncture device into the skin of your upper arm by a healthcare provider. Keep the injection site on your arm bandaged until the vaccination site is fully healed. Follow all directions for changing this bandage and caring for the site of injection to prevent spread of the virus.

Smallpox vaccine, live is given as a single dose. It may be given again at a later time as recommended by your doctor.

What should you tell the person who is giving the vaccine?

Tell your vaccine provider if you: