Proposed Vaccine Information Materials for Hepatitis B, Haemophilus influenzae type b (Hib), Varicella (Chickenpox), and Measles, Mumps, Rubella (MMR) Vaccines

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Proposed Vaccine Information Materials for Hepatitis B,

Haemophilus influenzae type b (Hib), Varicella (Chickenpox), and

Measles, Mumps, Rubella (MMR) Vaccines

AGENCY: Centers for Disease Control and Prevention (CDC), Department of

Health and Human Services (HHS).

ACTION: Notice with comment period.

-----------------------------------------------------------------------

SUMMARY: Under the National Childhood Vaccine Injury Act (42 U.S.C.

Sec. 300aa-26), CDC must develop vaccine information materials that

health care providers are required to give to patients/parents prior to

administration of specific vaccines. CDC seeks written comment on

proposed new vaccine information materials for hepatitis B, Haemophilus

influenzae ype b, and Varicella vaccines, and revised vaccine

information materials for measles, mumps, rubella (MMR) vaccines.

DATES: Written comments are invited and must be received on or before

November 2, 1998.

ADDRESSES: Written comments should be addressed to Walter A. Orenstein,

M.D., Director, National Immunization Program, Centers for Disease

Control and Prevention, Mailstop E-05, 1600 Clifton Road, N.E.,

Atlanta, Georgia 30333.

FOR FURTHER INFORMATION CONTACT: Walter A. Orenstein, M.D., Director,

National Immunization Program, Centers for Disease Control and

Prevention, Mailstop E-05, 1600 Clifton Road, N.E., Atlanta, Georgia

30333, telephone (404) 639-8200.

SUPPLEMENTARY INFORMATION: The National Childhood Vaccine Injury Act of

1986 (Public Law 99-660), as amended by Section 708 of Public Law 103-

183, added Section 2126 to the Public Health Service Act. Section 2126,

codified at 42 U.S.C. Sec. 300aa-26, requires the Secretary of Health

and Human Services to develop and disseminate vaccine information

materials for distribution by health care providers to any patient (or

to the parent or legal representative in the case of a child) receiving

vaccines covered under the National Vaccine Injury Compensation

Program.

Development and revision of the vaccine information materials have

been delegated by the Secretary to the Centers for Disease Control and

Prevention (CDC). Section 2126 requires that the materials be

developed, or revised, after notice to the public, with a 60-day

comment period, and in consultation with the Advisory Commission on

Childhood Vaccines, appropriate health care provider and parent

organizations, and the Food and Drug Administration. The law also

requires that the information contained in the materials be based on

available data and information, be presented in understandable terms,

and include:

(1) A concise description of the benefits of the vaccine,

(2) A concise description of the risks associated with the vaccine,

(3) A statement of the availability of the National Vaccine Injury

Compensation Program, and

(4) Such other relevant information as may be determined by the

Secretary.

The vaccines initially covered under the National Vaccine Injury

Compensation Program were diphtheria, tetanus, pertussis, measles,

mumps, rubella, and poliomyelitis vaccines. Since April 15, 1992, any

health care provider who intends to administer one of the covered

vaccines is required to provide copies of the relevant vaccine

information materials prior to administration of any of these vaccines.

(The materials currently in use for measles, mumps, and rubella

vaccines and the tetanus diphtheria [Td] vaccine, were published in a

Federal Register notice on June 20, 1994 (59 FR 31888). The current

materials for polio vaccine were published in a Federal Register notice

on February 6, 1997 (62 FR 5696), and, the current materials for

diphtheria, tetanus, and pertussis containing vaccines, other than Td

vaccine, were published in a Federal Register notice on January 9, 1998

(63 FR 1730). Instructions for use of the vaccine information materials

and a list of contacts for obtaining copies of these materials are

included in the January 9, 1998 Federal Register notice (63 FR 1730).)

Newly Covered Vaccines

With passage of Public Law 105-34, Congress expanded coverage of

the National Vaccine Injury Compensation Program, effective August 6,

1997, to include the following additional vaccines: hepatitis B,

Haemophilus influenzae type b (Hib), and Varicella (chickenpox)

vaccines. (See 63 FR 25777, May 11, 1998, for information regarding

coverage of these vaccines under the Vaccine Injury Compensation

Program.) Therefore, as required under 42 U.S.C. 300aa-26, CDC must

develop vaccine information materials covering these vaccines.

Included in this notice are proposed vaccine information materials

covering hepatitis B, Haemophilus influenzae type b (Hib), and

Varicella vaccines. In addition to proposed materials for these newly

covered vaccines, this notice also includes proposed revised vaccine

information materials for measles, mumps, rubella (MMR) vaccines. The

MMR materials are being revised to follow the format of the materials

published since 1997.

The proposed vaccine information materials included in this notice

were drafted in consultation with the Advisory Commission on Childhood

Vaccines, the Food and Drug Administration, American Academy of

Pediatrics, American Nurses Association, Dissatisfied Parents Together,

Healthy Start, Immunization Action Coalition, Immunization Education

and Action Committee: Healthy Mothers/Healthy Babies Coalition,

National Association of Pediatric Nurse Associates and Practitioners,

National Association of County Health Officials, National Coalition for

Adult Immunization, National Coalition of Hispanic Health and Human

Services Organizations (COSSMHO), National Council of La Raza, National

Vaccine Advisory Committee, and the National Vaccine Injury

Compensation Program. Also, CDC provided copies of the draft materials

to other organizations and sought their consultation; however, those

organizations did not provide comments. In addition to consultation

with these groups, the CDC presented drafts of these vaccine

information materials to parents gathered in 18 ethnically and

geographically diverse

[[Page 47027]]

focus groups. Comments provided by the consultants and focus groups

were considered in drafting the proposed vaccine information materials

included in this notice.

We invite written comment on the proposed vaccine information

materials that follow, entitled ``Hepatitis B Vaccine: What You Need to

Know,'' ``Haemophilus influenzae type b (Hib) Vaccine: What You Need to

Know,'' ``Chickenpox Vaccine: What You Need to Know,'' and ``Measles,

Mumps and Rubella Vaccines: What You Need to Know.'' Comments submitted

will be considered in finalizing these materials. When the final

materials are published in the Federal Register, the notice will

include an effective date for their use.

* * * * *

Hepatitis B Vaccine--What You Need to Know

1. Why Get Vaccinated?

Hepatitis B is a Serious Disease

The hepatitis B virus can cause short-term (acute) illness that

leads to:

Loss of appetite.

Tiredness.

Pain in muscles, joints, and stomach.

Diarrhea and vomiting.

Jaundice (yellow skin or eyes).

It can also cause long-term (chronic) illness that leads to:

Liver damage (cirrhosis).

Liver cancer.

Death.

Each year in the United States it is estimated that,

64,000 people--mostly young adults--get hepatitis B.

More than 11,000 people have to stay in the hospital

because of hepatitis B.

About 1.25 million people have chronic hepatitis B

infection.

4,000-5,000 people die from chronic hepatitis B.

Hepatitis B vaccine can prevent hepatitis B. Hepatitis B vaccine is

the first anti-cancer vaccine because it can prevent a form of liver

cancer.

2. How is Hepatitis B Virus Spread?

Hepatitis B virus is spread through contact with the blood or body

fluids of an infected person. A person can get infected in several

ways, such as:

During birth when the virus passes from an infected mother

to her baby.

By having sex with an infected person.

By injecting illegal drugs.

By being stuck with a used needle.

By sharing personal items, such as a razor or toothbrush,

with an infected person.

People can get hepatitis B infection without knowing how they got

it. About one third of hepatitis B cases in the United States have an

unknown source.

3. Who Should Get Hepatitis B Vaccine and When?

(1) Everyone 18 years of age and younger.

(2) Adults over 18 who are at risk.

Adults at risk for hepatitis B infection include:

Men or women who have sex with more than one steady

partner.

Men or women who have recently gotten a sexually

transmitted disease.

Injection drug users.

Men who have sex with other men.

Household contacts and sex partners of persons with long-

term hepatitis B.

People whose job involves contact with human blood.

People who live or travel for more than 6 months in

countries where hepatitis B is common.

Clients and staff in institutions for the developmentally

disabled.

Hemodialysis patients.

Recipients of certain blood products.

Prisoners in long-term correctional facilities.

If you are not sure whether you are at risk, ask your doctor or

nurse.

People should get 3 doses of hepatitis B vaccine, according to the

following schedule. If you miss a dose or get behind schedule, get the

next dose as soon as you can. There is no need to start over.

Hepatitis B Vaccination Schedule

----------------------------------------------------------------------------------------------------------------

WHO?

---------------------------------------------------------------------------------

Infant whose Infant whose

WHEN? mother is mother is not

infected with infected with Older child, adolescent, or adult

hepatitis B hepatitis B

----------------------------------------------------------------------------------------------------------------

First Dose.................... Within 12 hours Birth-2 months of Any time.

of birth. age.

Second Dose................... 1-2 months of age 1-4 months of age 1-2 months after first dose.

(At least 1

month after

first dose).

Third Dose.................... 6 months of age.. 6-18 months of 4-6 months after first dose.

age.

----------------------------------------------------------------------------------------------------------------

The second dose must be given at least 1 month after the first

dose, and the third dose must be given at least 2 months after the

second and at least 4 months after the first. The third dose should not

be given to infants younger than 6 months of age.

All three doses are needed for full and lasting immunity.

Ask your doctor or nurse for more information.

Hepatitis B vaccine may be given at the same time as other

vaccines.

4. Some People Should Not Get Hepatitis B Vaccine or Should Wait

People should not get hepatitis B vaccine if they have ever had a

serious allergic reaction to:

--A previous dose of hepatitis B vaccine, or

--Baker's yeast (the kind used for making bread)

People who are moderately or severely ill at the time the shot is

scheduled should usually wait until they recover before getting

hepatitis B vaccine.

Ask your doctor or nurse for more information.

5. What Are the Risks From Hepatitis B Vaccine?

A vaccine, like any medicine, is capable of causing life-

threatening problems, such as severe allergic reactions. The risk of

hepatitis B vaccine causing serious harm, or death, is extremely small.

Getting hepatitis B vaccine is much safer than getting

hepatitis B disease.

Most people who get hepatitis B vaccine do not have any

problems with it.

Mild Problems

Soreness where the shot was given, lasting a day or two

(up to 1 out of 11 children and adolescents, and about 1 out of 4

adults).

Mild to moderate fever (up to 1 out of 14 children and

adolescents, and 1 out of 100 adults).

Severe Problems

Serious allergic reaction (very rare).

[[Page 47028]]

6. What if There is a Moderate or Severe Reaction?

What Should I Look For?

Any unusual condition, such as a serious allergic

reaction, high fever or behavior changes. Signs of a serious allergic

reaction can include difficulty breathing, hoarseness or wheezing,

hives, paleness, weakness, a fast heart beat or dizziness. If such a

reaction were to occur, it would be within a few minutes to a few hours

after the shot.

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.

7. The National Vaccine Injury Compensation Program

In the rare event that you or your child has a serious reaction to

a vaccine, a Federal program has been created to help you pay for the

care of those who have been harmed.

For details about the National Vaccine Injury Compensation program,

call 1-800-338-2382 or visit the program's website at http://

www.hrsa.dhhs.gov/bhpr/vicp

8. 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. They can give

you the Parents Guide to Childhood Immunization, Immunization of

Adults: A Call to Action, or other information.

Contact the Centers for Disease Control and Prevention

(CDC):

--Call 1-800-232-2522 (English)

--Call 1-888-443-7232 (English)

--Call 1-800-232-0233 (Espanol)

--Visit the National Immunization Program's website at http://

www.cdc.gov/nip

_Visit the Hepatitis Branch's website at http://www.cdc.gov/ncidod/

diseases/hepatitis/hepatitis.htm

U.S. Department of Health & Human Services

Centers for Disease Control and Prevention

National Immunization Program

Hepatitis B (00/00/00) (Proposed)

Vaccine Information Statement

42 U.S.C. Sec. 300aa-26

* * * * *

Haemophilus Influenzae Type B (HIB) Vaccine--What You Need to Know

1. What is Hib Disease?

Haemophilus influenzae type b (Hib) disease is a serious disease

caused by a bacteria. It usually strikes children under 5 years old.

Your child can get Hib disease by being around other children or

adults who may have the bacteria and not know it. The germs spread from

person to person through the air. If the germs stay in the child's nose

and throat, the child probably will not become sick. But sometimes the

germs spread into the lungs or the bloodstream, and then Hib can cause

serious problems.

Before Hib vaccine, Hib disease was the leading cause of bacterial

meningitis among children under 5 years old in the United States.

Meningitis is an infection of the brain and spinal cord coverings which

can lead to lasting brain damage.

In addition to meningitis, Hib disease can cause:

Hearing loss.

Pneumonia.

Severe swelling in the throat, making it hard to breathe.

Infections of the blood, joints, bones, and covering of

the heart.

Death.

Hib Vaccine Can Prevent Hib Disease

Many more children would get Hib disease if we stopped vaccinating.

2. Who Should Get Hib Vaccine and When?

Children Should Get Hib Vaccine At:

2 months of age

4 months of age

6 months of age*

12-15 months of age

*Depending on what brand of Hib vaccine is used, your child might

not need the dose at 6 months of age. Your doctor or nurse will tell

you if this dose is needed.

If you miss a dose or get behind schedule, get the next dose as

soon as you can. There is no need to start over.

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

Older Children and Adults

Children over 5 years old usually do not need Hib vaccine. But some

older children or adults with special health conditions should get it.

These conditions include sickle cell disease, HIV/AIDS, removal of the

spleen, bone marrow transplant, or cancer treatment with drugs. Ask

your doctor or nurse for details.

3. Some People Should Not Get Hib Vaccine or Should Wait

People who have ever had a serious allergic reaction to a previous

dose of Hib vaccine should not get another dose.

Children less than 6 weeks of age should not get Hib vaccine.

People who are moderately or severely ill at the time the shot is

scheduled should usually wait until they recover before getting Hib

vaccine.

Ask your doctor or nurse for more information.

4. What Are the Risks From Hib Vaccine?

A vaccine, like any medicine, is capable of causing life-

threatening problems, such as severe allergic reactions. The risk of

Hib vaccine causing serious harm, or death, is extremely small.

Getting Hib vaccine is much safer than getting Hib

disease.

Most people who get Hib vaccine do not have any problems

with it.

Mild Problems

Redness, warmth, or swelling where the shot was given (up

to 1 out of 25 children).

Fever over 101 deg.F (up to 1 out of 20 children).

If these problems happen, they usually start within a day of

vaccination. They may last 2-3 days.

5. What if There is a Moderate or Severe Reaction?

What Should I Look For?

Any unusual condition, such as a serious allergic

reaction, high fever or behavior changes. Signs of a serious allergic

reaction can include difficulty breathing, hoarseness or wheezing,

hives, paleness, weakness, a fast heart beat or dizziness.

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. The National Vaccine Injury Compensation Program

In the rare event that you or your child has a serious reaction to

a vaccine, a Federal program has been created to help you pay for the

care of those who have been harmed.

[[Page 47029]]

For details about the National Vaccine Injury Compensation program,

call 1-800-338-2382 or visit the program's website at http://

www.hrsa.dhhs.gov/bhpr/vicp

7. 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. They can give

you the Parents Guide to Childhood Immunization or other information.

Contact the Centers for Disease Control and Prevention

(CDC):

--Call 1-800-232-2522 (English)

--Call 1-800-232-0233 (Espanol)

--Visit the National Immunization Program's website at http://

www.cdc.gov/nip

U.S. Department of Health & Human Services

Centers for Disease Control and Prevention

National Immunization Program

Hib (00/00/00) (Proposed)

Vaccine Information Statement

42 U.S.C. 300aa-26

* * * * *

Chickenpox Vaccine--What You Need to Know

1. Why Get Vaccinated?

Chickenpox (also called Varicella) is a Common Childhood Disease

It is usually mild, but it can be serious, especially in young

infants and adults.

The chickenpox virus can be spread from person to person

through the air, or by contact with fluid from chickenpox blisters.

It causes a rash, itching, fever, and tiredness.

It can lead to severe skin infection, scars, pneumonia,

brain damage, or death.

A person who has had chickenpox can get a painful rash

called shingles years later.

About 12,000 people are hospitalized for chickenpox each

year in the United States.

About 100 people die each year in the United States as a

result of chickenpox.

Chickenpox Vaccine Can Prevent Chickenpox

2. Chickenpox Vaccine

If someone who has been vaccinated does get chickenpox, it

is usually very mild. They have fewer spots, are less likely to have a

fever, and will recover faster.

3. Who Should Get Chickenpox Vaccine and When?

Children should get chickenpox vaccine between 12 and 18

months of age.

Older children, or adults, who have never had chickenpox

or chickenpox vaccine should get the vaccine. It can be given at any

age.

Dosage:

Children 1-12 years of age: 1 dose

Anyone 13 years of age or older: 2 doses, 4-8 weeks apart

Ask your doctor or nurse for details.

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

4. Some People Should Not Get Chickenpox Vaccine or Should Wait

People who have ever had a serious allergic reaction to

gelatin, the antibiotic neomycin, or a previous dose of chickenpox

vaccine should not get the vaccine.

People who are moderately or severely ill at the time the

shot is scheduled should usually wait until they recover before getting

chickenpox vaccine.

Pregnant women should wait to get chickenpox vaccine until

after they have given birth.

Some people should check with their doctor about whether

they should get chickenpox vaccine. These people include anyone who:

--Has HIV/AIDS, or another disease that affects the immune system

--Is being treated with drugs that affect the immune system, such as

steroids, for 2 weeks or longer

--Has any kind of cancer

--Is taking cancer treatment with x-rays or drugs

People who recently had a transfusion or were given other

blood products should ask their doctor when they may get chickenpox

vaccine.

If you are not sure, ask your doctor or nurse.

5. What Are the Risks From Chickenpox Vaccine?

A vaccine, like any medicine, is capable of causing life-

threatening problems, such as severe allergic reactions. The risk of

chickenpox vaccine causing serious harm, or death, is extremely small.

Getting chickenpox vaccine is much safer than getting

chickenpox disease.

Most people who get chickenpox vaccine do not have any

problems with it.

Mild Problems

Soreness or swelling where the shot was given (about 1 out

of 5 children and up to 1 out of 3 adolescents and adults).

Fever (1 out of 6 children, 1 out of 10 adolescents or

adults).

Mild rash, up to a month after vaccination (up to 1 out of

16 people getting the vaccine). These people can, rarely, spread the

vaccine virus to other members of their household.

Moderate Problems

Seizure (jerking or staring) caused by fever (less than 1

out of 1,000 people getting the vaccine).

Severe Problems

Some severe problems, including pneumonia, brain damage, or low

blood count, have been reported after chickenpox vaccination. These

happen so rarely experts cannot tell whether they are caused by the

vaccine or not. If they are, it is extremely rare.

6. What if There is a Moderate or Severe Reaction?

What Should I Look For?

Any unusual condition, such as a serious allergic reaction, high

fever or behavior changes. Signs of a serious allergic reaction can

include difficulty breathing, hoarseness or wheezing, hives, paleness,

weakness, a fast heart beat or dizziness. If it occurs, a high fever or

seizure would occur one to six weeks after the shot.

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.

7. The National Vaccine Injury Compensation Program

In the rare event that you or your child has a serious reaction to

a vaccine, a Federal program has been created to help you pay for the

care of those who have been harmed.

For details about the National Vaccine Injury Compensation program,

call 1-800-338-2382 or visit the program's website at http://

www.hrsa.dhhs.gov/bhpr/vicp

8. 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. They can give

you the Parents Guide to Childhood Immunization, Immunization of

Adults: A Call to Action, or other information.

[[Page 47030]]

Contact the Centers for Disease Control and Prevention

(CDC):

--Call 1-800-232-2522 (English)

--Call 1-800-232-0233 (Espanol)

--Visit the National Immunization Program's website at http://

www.cdc.gov/nip

U.S. Department of Health & Human Services

Centers for Disease Control and Prevention

National Immunization Program

Varicella (00/00/00) (Proposed)

Vaccine Information Statement

42 U.S.C. Sec. 300aa-26

* * * * *

Measles, Mumps and Rubella Vaccines--What You Need To Know

1. Why Get Vaccinated?

Measles, Mumps, and Rubella Are Serious Diseases

Measles

Measles virus causes rash, cough, runny nose, eye

irritation, and fever.

It can lead to ear infection, pneumonia, seizures (jerking

and staring), brain damage, and death.

Mumps

Mumps virus causes fever, headache, and swollen glands.

It can lead to deafness, meningitis (infection of the

brain and spinal cord covering), painful swelling of the testicles,

and, rarely, death.

Rubella (German Measles)

Rubella virus causes rash, mild fever, swollen glands, and

arthritis (mostly in women).

If a woman gets rubella while she is pregnant, she could

have a miscarriage or her baby could be born with serious birth

defects.

You or your child could catch these diseases by being around

someone who has them. They spread from person to person through the

air.

Measles, Mumps, and Rubella (MMR) Vaccine Can Prevent These Diseases

Most children who get their MMR shots will not get these diseases.

Many more children would get them if we stopped vaccinating.

2. Who Should Get MMR Vaccine and When?

Children should get 2 doses of MMR vaccine, the first at:

12-15 months of age

And the second at:

4-6 years of age

These are the recommended ages. But children can get the second

dose of MMR vaccine at any age, as long as it is at least 28 days after

the first dose.

Some Adults Should Also Get MMR Vaccine

Generally, anyone 18 years of age or older, who was born after

1957, should get at least one dose of MMR vaccine unless they:

Have documentation of at least one dose each of measles,

mumps, and rubella vaccines,

Have other acceptable evidence of immunity to these three

diseases, or

Have a medical reason why they should not get the vaccines

(see #3, below).

Ask your doctor or nurse for more information.

Adults with a special need for these three vaccines include:

College students, trade school students, and other

students beyond high school.

People working in hospitals and other medical facilities.

International travelers and passengers on cruise ships.

Women of childbearing age (who are not pregnant).

People who move to the US from countries that do not have

routine rubella vaccination.

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

Immunity from MMR vaccine probably lasts for life.

3. Some People Should Not Get MMR Vaccine or Should Wait

People who have ever had a serious allergic reaction to

gelatin, the antibiotic neomycin, or a previous dose of MMR vaccine

should not get the vaccine.

People who are moderately or severely ill at the time the

shot is scheduled should usually wait until they recover before getting

MMR vaccine.

Pregnant women should wait to get MMR vaccine until after

they have given birth. Women should not get pregnant for 3 months after

getting MMR vaccine.

Some people should check with their doctor about whether

they should get MMR vaccine. These people include anyone who:

--Has HIV/AIDS, or another disease that affects the immune system.

--Is being treated with drugs that affect the immune system, such as

steroids, for 2 weeks or longer.

--Has any kind of cancer.

--Is taking cancer treatment with x-rays or drugs.

--Has ever had a low platelet count (a blood disorder).

People who recently had a transfusion or were given other

blood products should ask their doctor when they may get MMR vaccine.

If you are not sure, ask your doctor or nurse.

4. What Are the Risks From MMR Vaccine?

A vaccine, like any medicine, is capable of causing life-

threatening problems, such as severe allergic reactions. The risk of

MMR vaccine causing serious harm, or death, is extremely small.

Getting MMR vaccine is much safer than getting any of

these three diseases.

Most people who get MMR vaccine do not have any problems

with it.

Mild Problems

Fever (up to 1 person out of 6).

Mild rash (about 1 person out of 20).

Swelling of glands in the cheeks, neck, or under the jaw

(rare).

If these problems occur, it is usually within 7-12 days after the

shot. They occur less often after the second dose.

Moderate Problems

Seizure (jerking or staring) caused by fever (about 1 out

of 3,000 doses).

Temporary pain and stiffness in the joints, mostly in

teenage or adult women (up to 1 out of 4).

Low platelet count, which can cause a bleeding disorder

(about 1 out of 30,000 doses).

Severe Problems (Very Rare)

Serious allergic reaction (less than 1 out of a million

doses).

Several other severe problems have been known to occur after a

child gets MMR vaccine. But this happens so rarely, experts cannot be

sure whether they are caused by the vaccine or not. These include:

Deafness.

Long seizures, coma, or lowered consciousness.

Permanent brain damage.

5. What if There is a Moderate or Severe Reaction?

What Should I Look For?

Any unusual condition, such as a serious allergic

reaction, high fever or behavior changes. Signs of a serious allergic

reaction can include difficulty breathing, hoarseness or wheezing,

hives, paleness, weakness, a fast heart beat or dizziness. If it

occurs, a high fever or seizure would occur 1 to 2 weeks after the

shot.

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.

[[Page 47031]]

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. The National Vaccine Injury Compensation Program

In the rare event that you or your child has a serious reaction to

a vaccine, a Federal program has been created to help you pay for the

care of those who have been harmed.

For details about the National Vaccine Injury Compensation program,

call 1-800-338-2382 or visit the program's website at http://

www.hrsa.dhhs.gov/bhpr/vicp

7. 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. They can give

you the Parents Guide to Childhood Immunization, Immunization of

Adults: A Call to Action, or other information.

Contact the Centers for Disease Control and Prevention

(CDC):

--Call 1-800-232-2522 (English)

--Call 1-800-232-0233 (Espanol)

--Visit the National Immunization Program's website at http://

www.cdc.gov/nip

U.S. Department of Health & Human Services

Centers for Disease Control and Prevention

National Immunization Program

MMR (00/00/00) (Proposed)

Vaccine Information Statement

42 U.S.C. 300aa-26

Dated: August 28, 1998.

Thena M. Durham,

Acting Associate Director for Management and Operations, Centers for

Disease Control and Prevention (CDC).

[FR Doc. 98-23736 Filed 9-2-98; 8:45 am]

BILLING CODE 4163-18-P