CDC: Hib, Varicella - New Info Materials, Immunization Schedules

CDC: Hib, Varicella - New Info Materials, Immunization Schedules

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Quick Summary: Effective June 1, 1999, each health care provider who administers any vaccine that contains hepatitis B, Haemophilus influenzae type b (Hib), varicella (chickenpox), measles, mumps, or rubella vaccines shall, prior to administration of each dose of the vaccine, provide a copy of the relevant vaccine information materials contained in this notice to the parent or legal representative of any child to whom such provider intends to administer the vaccine and to any adult to whom such provider intends to administer the vaccine.

Recordkeeping

Health care providers shall make a notation in each patient’s permanent medical record at the time vaccine information materials are provided indicating

(1) the edition date of the materials distributed and

(2) the date these materials were provided.

This recordkeeping requirement supplements the requirement of 42 U.S.C. Sec. 300aa-25 that all health care providers administering these vaccines must record in the patient’s permanent medical record (or in a permanent office log) the name, address and title of the individual who administers the vaccine, the date of administration and the vaccine manufacturer and lot number of the vaccine used.

Applicability of State Law

Health care providers should consult their legal counsel to determine additional State requirements pertaining to immunization. The Federal requirement to provide the vaccine information materials supplements any applicable State law.

VACCINE INFORMATION

STATEMENT – Hib

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. If the germs stay in the child’s nose and throat, the child probably will not get 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 and deafness. Hib disease can also cause:

pneumonia

severe swelling in the throat, making it hard to breathe

infections of the blood, joints, bones, and covering of the heart

death

Before Hib vaccine, about 20,000 children in the United States under 5 years old got severe Hib disease each year, and nearly 1,000 died.

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 life-threatening 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 serious problems, such as severe allergic reactions. The risk of Hib vaccine causing serious harm or death is extremely small.

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 1/4 of 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 problem?

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 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.

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's immunization program.

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 (12/16/98) Vaccine Information Statement 42 U.S.C. Sec. 300aa-26.

VACCINE INFORMATION

STATEMENT – Varicella

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.

Most people who get chickenpox vaccine will not get chickenpox. But if someone who has been vaccinated does get chickenpox, it is usually very mild. They will have fewer spots, are less likely to have a fever, and will recover faster.

2. Who should get chickenpox vaccine and when?

Children should get 1 dose of chickenpox vaccine between 12 and 18 months of age, or at any age after that if they have never had chickenpox.

People who do not get the vaccine until 13 years of age or older should get 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.

3. Some people should not get chickenpox vaccine or should wait.

People should not get chickenpox vaccine if they have ever had a life-threatening allergic reaction to gelatin, the antibiotic neomycin, or (for those needing a second dose) a previous dose of chickenpox 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.

Women should not get pregnant for 1 month after getting chickenpox vaccine.

Some people should check with their doctor about whether they should get chickenpox vaccine, including 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.

Ask your doctor or nurse for more information.

4. What are the risks from chickenpox vaccine?

A vaccine, like any medicine, is capable of causing serious 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 person out of 10, or less)

Mild rash, up to a month after vaccination (1 person out of 20, or less). It is possible for these people to infect other members of their household, but this is extremely rare.

Moderate Problems

Seizure (jerking or staring) caused by fever (less than 1 person out of 1,000)

Severe Problems

Pneumonia (very rare)

Other serious problems, including severe brain reactions and 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.

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 within a few minutes to a few hours after the shot.

A high fever or seizure, if it occurs, would happen 1 to 6 weeks after the shot.