Vaccination Information Statement

LYME DISEASE VACCINE

WHAT YOU NEED TO KNOW

1 What is Lyme disease?

Lyme disease is caused by infection with a bacteria. People get Lyme disease by being bitten by an infected tick.

You can not get Lyme disease from another person or from an infected animal.

A common sign of Lyme disease is a round, red, expanding rash 2 inches or more in diameter, which appears between 3 days and a month after the tick bite. People with Lyme disease might get chills and fever, headaches, or muscle and joint pain, and often feel tired.

If Lyme disease isn’t treated properly, other signs can appear weeks or months after the tick bite. These include:

• arthritis (pain and swelling in the joints, especially the knees)

• numbness or paralysis (often in the face muscles) • problems with the heart rhythm • problems with memory or concentration

Very few, if any, people die from Lyme disease.

About 12,000 - 15,000 cases of Lyme disease are reported each year in the United States, mainly in the Northeast and North Central parts of the country and in parts of California.

Lyme disease vaccine can help prevent Lyme disease.

2

Who should get Lyme disease vaccine and when

?

Lyme disease vaccine may be given to people between 15 and 70 years of age. The vaccine should be considered for people in this age range who live in areas where Lyme disease is a problem, and who work or spend leisure time in wooded, brushy, or overgrown areas where ticks live.

People who travel to areas where Lyme disease is common may consider the vaccine if they plan to spend time in wooded or overgrown areas.

The vaccine is not recommended for people with little or no exposure to wooded or overgrown areas that are infested by Lyme disease-bearing ticks.

The Lyme disease vaccine is given as an injection. Three doses are recommended:

!The 1st dose may be given at any time, but ideally should be given in January, February, or March.

!The 2nd dose should be given 1 month after the first

!The 3rd dose should be given 12 months after the first

It is not known yet how long protection lasts. But no schedule for booster doses has been determined at this time.

Effective Date: November 1, 1999

3

Some people should not get Lyme disease vaccine or should wait

• Children younger than 15 years of age should not get Lyme disease vaccine.

• Pregnant women should not get Lyme disease vaccine.

• Anyone with arthritis caused by a previous case of Lyme disease, which has not responded to antibiotic treatment, should not get Lyme disease vaccine. (Others who have had Lyme disease may get the vaccine.)

• Anyone who has had an allergic reaction to a previous dose of Lyme disease vaccine should not get another dose.

• Peoplewithimmunesystemproblemsshould check with their doctor before getting Lyme disease vaccine.

4

What are the risks from Lyme disease vaccine?

A vaccine, like any medicine, is capable of causing serious problems, such as severe allergic reactions. The risk of a vaccine causing serious harm, or death, is extremely small.

In clinical trials, Lyme disease vaccine has been associated only with mild problems, such as sore- ness where the shot is given.

Most people who get Lyme disease vaccine do not have any problems with it.

Mild problems

• soreness where the shot was given (about 1 person out of 4)

• redness or swelling where the shot was given (less than 1 person out of 50)

• muscleaches,jointpain,fever,chills(about1personout of 15 or less)

5 What if there is a moderate or severe reaction?

What should I look for?

Any unusual condition, such as a high fever or discomfort. Signs of a serious allergic reaction can include difficulty breathing, hoarseness or wheezing, hives, paleness, weakness, a fast heart beat or dizziness, occurring within a few minutes to a few hours after the vaccination. A high fever, should it occur, would be within a week after the vaccination.

What should I do?

• Call a doctor, or get the person to a doctor right away.

• Tell your doctor what happened, the date and time it happened, and when the vaccination was given.

• Ask your doctor, nurse, or health department to file a Vaccine Adverse Event Reporting System (VAERS) form, or call VAERS yourself at 1-800-822-7967.

6

How can I learn more?

• Ask your doctor or nurse. They can give you the vaccine package insert or suggest other sources of information.

• Call your local or state health department.

• Contact the Centers for Disease Control and Prevention (CDC):

- Call 1-800-232-2522 (English) - Call 1-800-232-0233 (Español) - VisittheNationalImmunizationProgram’s

website at http:/www.cdc.gov/nip

U

U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control and Prevention National Immunization Program

Lyme Disease Vaccine Information Statement