This vaccine is used to help prevent smallpox or monkeypox infection. Smallpox and monkeypox are caused by a certain type of virus (orthopox virus). This vaccine contains live viruses that have been weakened. It works by increasing the body's natural defense (immunity) against the viruses.

This vaccine is recommended for people at high risk for the infection. Those at high risk include certain lab, health care, or public health workers, and people who have been exposed to someone infected with an orthopox virus.

Vaccines may not fully protect everyone who receives them.

Read all vaccine information available from your health care professional before receiving the vaccine. If you have any questions, ask your health care professional.

This vaccine is given by injection under the skin by a health care professional, usually as 2 doses (4 weeks apart). It is given in the upper arm.

Vaccines are usually given in a series of doses to provide the best protection. Closely follow the vaccination schedule provided by your health care professional. To help you remember, mark your calendar with a reminder.

This vaccine may be given at the same time as other vaccines.

Redness/soreness/swelling/itching at the injection site, tiredness, headache, and muscle pain may occur. If any of these effects last or get worse, tell your health care professional promptly.

Rarely, some people have symptoms such as fainting, dizziness, vision changes, or ringing in the ears just after getting a vaccine injection. Tell your health care professional right away if you have any of these symptoms. Sitting or lying down may help, since these symptoms usually don't last long.

Remember that this vaccine has been prescribed because your health care professional has judged that the benefit to you is greater than the risk of side effects. Many people using this vaccine do not have serious side effects.

A very serious allergic reaction to this vaccine is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your health care professional.

Contact the doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may call the Vaccine Safety Section at Public Health Agency of Canada at 1-866-844-0018.

Before you receive this vaccine, tell the health care professional if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving this vaccine, tell your health care professional your medical history, especially of:

• current fever/illness
• immune system disorders (such as due to HIV infection, certain cancers such as leukemia/lymphoma, cancer or radiation treatment)
• certain heart problems (such as myocarditis, pericarditis)
• vaccination history (including previous reactions to any vaccines)

During pregnancy, this vaccine should be received only when clearly needed. Discuss the risks and benefits with your health care professional.

It is unknown if this vaccine passes into breast milk. Consult your health care professional before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your health care professional. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• drugs that weaken the immune system (including cyclosporine, tacrolimus, cancer chemotherapy, corticosteroids such as prednisone)

Not applicable.

Keep all medical and lab appointments.

Keep vaccine records for yourself and your children and provide them to the health care professionals to prevent unnecessary re-vaccinations.

It is important that you get each vaccination as scheduled. Ask when you should get each dose and mark your calendar with a reminder. If you miss a dose, call the health care professional to reschedule.

Not applicable. This vaccine is given in a hospital or clinic and will not be stored at home.