[Federal Register Volume 63, Number 171 (Thursday, September 3, 1998)]
[Notices]
[Pages 47026-47031]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-23736]
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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.
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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?
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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
