Vaccines: Pubs/VIS/text-files

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Vaccine Information Statements: Text Files

This page offers text-only versions of all Vaccine Information Statements, appropriate for screen-reader devices.

Multi-Vaccine VIS

YOUR BABY’S FIRST VACCINES: What you need to know.

Babies get six vaccines between birth and 6 months of age.

These vaccines protect your baby from 8 serious diseases (see the next page).

Your baby will get vaccines today that prevent these diseases:
o Hepatitis B
o Polio
o Pneumococcal Disease
o Diphtheria, Tetanus & Pertussis
o Rotavirus
o Hib
(Provider: Check appropriate boxes.)

These vaccines may be given separately, or some might be given together in the same shot (for example, Hepatitis B and Hib can be given together, and so can DTaP, Polio and Hepatitis B).

These “combination vaccines” are as safe and effective as the individual vaccines, and mean fewer shots for your baby.

These vaccines may all be given at the same visit.

Getting several vaccines at the same time will not harm your baby.

This Vaccine Information Statement (VIS) tells you about the benefits and risks of these vaccines. It also contains information about reporting an adverse reaction, the National Vaccine Injury Compensation Program, and how to get more information about childhood diseases and vaccines.

Please read this VIS before your child gets his or her immunizations, and take it home with you afterward. Ask your doctor, nurse, or other healthcare provider if you have questions.

Individual Vaccine Information Statements are also available for these vaccines.

Many Vaccine Information Statements are available in Spanish and other languages. See www.immunize.org/vis.

Vaccine Benefits: Why get vaccinated?

Your children’s first vaccines protect them from 8 serious diseases, caused by viruses and bacteria. These diseases have injured and killed many children (and adults) over the years. Polio paralyzed about 37,000 people and killed about 1,700 each year in the 1950s before there was a vaccine. In the 1980s, Hib disease was the leading cause of bacterial meningitis in children under 5 years of age. About 15,000 people a year died from diphtheria before there was a vaccine. Most children have had at least one rotavirus infection by their 5th birthday.

None of these diseases has completely disappeared. Without vaccination, they will come back. This has happened in other parts of the world.

8 Diseases Prevented by Childhood Vaccines

Diphtheria: Bacteria

You can get it from contact with an infected person.

Signs and symptoms include a thick covering in the back of the throat that can make it hard to breathe.

It can lead to breathing problems, heart failure, and death.

Tetanus (Lockjaw): Bacteria

You can get it from a cut or wound. It does not spread from person to person.

Signs and symptoms include painful tightening of the muscles, usually all over the body.

It can lead to stiffness of the jaw, so the victim can’t open his mouth or swallow. It leads to death in about 1 case out of 5.

Pertussis (Whooping Cough): Bacteria

You can get it from contact with an infected person.

Signs and symptoms include violent coughing spells that can make it hard for an infant to eat, drink, or breathe. These spells can last for weeks.

It can lead to pneumonia, seizures (jerking and staring spells), brain damage, and death.

Hib (Haemophilus influenzae type b): Bacteria

You can get it from contact with an infected person.

Signs and symptoms. There may be no signs or symptoms in mild cases.

It can lead to meningitis (infection of the brain and spinal cord coverings); pneumonia; infections of the blood, joints, bones, and covering of the heart; brain damage; deafness; and death.

Hepatitis B: Virus

You can get it from contact with blood or body fluids of an infected person. Babies can get it at birth if the mother is infected, or through a cut or wound. Adults can get it from unprotected sex, sharing needles, or other exposures to blood.

Signs and symptoms include tiredness, diarrhea and vomiting, jaundice (yellow skin or eyes), and pain in muscles, joints and stomach.

It can lead to liver damage, liver cancer, and death.

Polio: Virus

You can get it from close contact with an infected person. It enters the body through the mouth.

Signs and symptoms can include a cold-like illness, or there may be no signs or symptoms at all.

It can lead to paralysis (can't move arm or leg), or death (by paralyzing breathing muscles).

Pneumococcal: Bacteria

You can get it from contact with an infected person.

Signs and symptoms include fever, chills, cough, and chest pain.

It can lead to meningitis (infection of the brain and spinal cord coverings), blood infections, ear infections, pneumonia, deafness, brain damage, and death.

Rotavirus: Virus

You can get it from contact with other children who are infected.

Signs and symptoms include severe diarrhea, vomiting and fever.

It can lead to dehydration, hospitalization (up to about 70,000 a year), and death.

How Vaccines Work

Immunity from Disease: When a child gets sick with one of these diseases, her immune system produces immunity, which keeps her from getting the same disease again. But getting sick is unpleasant, and can be dangerous.

Immunity from Vaccines: Vaccines are made with the same bacteria or viruses that cause a disease, but they have been weakened or killed to make them safe. A child’s immune system responds to a vaccine the same way it would if the child had the disease. This means he will develop immunity without having to get sick first.

Routine Childhood Vaccines

Six vaccines are recommended for children between birth and 6 months of age. They can prevent the 8 diseases described on the previous page. Children will also get at least one “booster” dose of most of these vaccines when they are older.

• DTaP (Diphtheria, Tetanus & Pertussis) Vaccine: 5 doses – 2 months, 4 months, 6 months, 15-18 months, 4-6 years. Some children should not get pertussis vaccine. These children can get a vaccine called DT, which does not contain pertussis.

• Hepatitis B Vaccine: 3 doses – Birth, 1-2 months, 6-18 months.

• Polio Vaccine: 4 doses – 2 months, 4 months, 6-18 months, 4-6 years.

• Hib (Haemophilus influenzae type b) Vaccine: 3 or 4 doses – 2 months, 4 months, 6 months, 12-15 months. Several Hib vaccines are available. With one type, the 6-month dose is not needed.

• Pneumococcal Vaccine: 4 doses – 2 months, 4 months, 6 months, 12-15 months. Older children with certain diseases may also need this vaccine.

• Rotavirus Vaccine: 2 or 3 doses – 2 months, 4 months, 6 months. Rotavirus is an oral (swallowed) vaccine, not a shot. Two rotavirus vaccines are available. With one type, the 6 month dose is not needed.

Vaccine Risks

Vaccines can cause side effects, like any other medicine. Mostly these are mild “local” reactions such as tenderness, redness or swelling where the shot is given, or a mild fever. They happen in up to 1 child out of 4 with most childhood vaccines. They appear soon after the shot is given and go away within a day or two.

More severe reactions can also occur, but this happens much less often. Some of these reactions are so uncommon that experts can’t tell whether they are caused by vaccines or not.

Among the most serious reactions to vaccines are severe allergic reactions to a substance in a vaccine. These reactions happen very rarely – less than once in a million shots. They usually happen very soon after the shot is given. Doctor’s office or clinic staff are trained to deal with them.

The risk of any vaccine causing serious harm, or death, is extremely small. Getting a disease is much more likely to harm a child than getting a vaccine.

Other Reactions

The following conditions have been associated with routine childhood vaccines. By “associated” we mean that they appear more often in children who have been recently vaccinated than in those who have not. An association doesn’t prove that a vaccine caused a reaction, but does mean it is probable.

DTaP Vaccine

Mild Problems: Fussiness (up to 1 child in 3); tiredness or poor appetite (up to 1 child in 10); vomiting (up to 1 child in 50); swelling of the entire arm or leg for 1-7 days (up to 1 child in 30) – usually after the 4th or 5th dose.

Moderate Problems: Seizure (jerking or staring)(1 child in 14,000); non-stop crying for 3 hours or more (up to 1 child in 1,000); fever over 105 degrees Fahrenheit (1 child in 16,000).

Serious Problems: Long-term seizures, coma, lowered consciousness, and permanent brain damage have been reported very rarely after D.T.a.P. vaccine. They are so rare we can’t be sure they are caused by the vaccine.

Polio Vaccine / Hepatitis B Vaccine / Hib Vaccine

These vaccines have not been associated with mild problems other than local reactions, or with moderate or serious problems.

Pneumococcal Vaccine

Mild Problems: During studies of the vaccine, some children became fussy or drowsy or lost their appetite.

Rotavirus Vaccine

Mild Problems: Children who get rotavirus vaccine are slightly more likely than other children to be irritable or have mild, temporary diarrhea or vomiting. This happens within the first week after getting a dose of vaccine. Rotavirus vaccine does not appear to cause any serious side effects.

Precautions

If your child is sick on the date vaccinations are scheduled, your provider may want to put them off until she recovers. A child with a mild cold or a low fever can usually be vaccinated that day. But for a more serious illness, it may be better to wait.

Some children should not get certain vaccines. Talk with your provider if your child had a serious reaction after a previous dose of a vaccine, or has any life-threatening allergies. (These reactions and allergies are rare.)

If your child had any of these reactions to a previous dose of DTaP:
- A brain or nervous system disease within 7 days
- Non-stop crying for 3 or more hours
- A seizure or collapse
- A fever over 105° Fahrenheit
Talk to your provider before getting DTaP Vaccine.

If your child has:
- A life-threatening allergy to the antibiotics neomycin, streptomycin, or polymyxin B
Talk to your provider before getting Polio Vaccine.

If your child has:
- A life-threatening allergy to yeast
Talk to your provider before getting Hepatitis B Vaccine.

If your child has:
- A weakened immune system
- Ongoing digestive problems
- Recently gotten a blood transfusion or other blood product
- Ever had intussusception (an uncommon type of intestinal obstruction)
Talk to your provider before getting Rotavirus Vaccine.

What if my child has a moderate or severe reaction?

What should I look for?

Look for any unusual condition, such as a serious allergic reaction, high fever, weakness, or unusual behavior.

Serious allergic reactions are extremely rare with any vaccine. If one were to happen, it would most likely come within a few minutes to a few hours after the shot.

Signs of a serious allergic reaction can include:
- difficulty breathing
- weakness
- hives
- hoarseness or wheezing
- dizziness
- paleness
- swelling of the throat
- fast heart beat

What should I do?

Call a doctor, or get the child to a doctor right away.

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

Ask your healthcare provider to report the reaction by filing a Vaccine Adverse Event Reporting System (VAERS) form. Or you can file this report yourself through the VAERS website at www.vaers.hhs.gov, or by calling 1-800-822-7967.

AERS does not provide medical advice.

The National Vaccine Injury Compensation Program

A federal program exists to help pay for the care of anyone who has a serious reaction to a vaccine.

For information about the National Vaccine Injury Compensation Program, call 1-800-338-2382 or visit their website at www.hrsa.gov/vaccinecompensation.

For More Information

Ask your healthcare provider. They can show 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) at 1-800-232-4636 (1-800-CDC-INFO).

Visit CDC websites at www.cdc.gov/vaccines and www.cdc.gov/ncidod/diseases/hepatitis.

Department of Health and Human Services
Centers for Disease Control and Prevention
Vaccine Information Statement (Interim)
42 USC section 300aa-26
9/18/2008

Anthrax

Anthrax Vaccine: What You Need to Know

1. What is anthrax?

Anthrax is a serious disease that can affect both animals and humans. It is caused by bacteria called Bacillus anthracis. People can get anthrax from contact with infected animals, wool, meat, or hides. In its most common form, anthrax is a skin disease that causes skin ulcers and usually fever and fatigue. Up to 20% of these cases are fatal if untreated.

When B. anthracis is inhaled, as when used as a biological weapon, it is much more serious. The first symptoms may include a sore throat, mild fever and muscle aches. But within several days these symptoms are followed by severe breathing problems, shock, and often meningitis (inflammation of the brain and spinal cord covering). Once symptoms appear, this form of anthrax is almost always fatal, despite treatment with antibiotics.

2. What is anthrax vaccine?

Anthrax vaccine protects against anthrax disease. The U.S. vaccine does not contain actual B. anthracis cells and it does not cause anthrax disease. Anthrax vaccine was licensed in 1970.

Based on limited but convincing evidence, the vaccine protects against both cutaneous (skin) and inhalational anthrax.

3. Who should get anthrax vaccine and when?

People 18 to 65 years of age potentially exposed to large amounts of B. anthracis bacteria on the job, such as laboratory workers.

Military personnel who may be at risk of anthrax exposure from weapons.

The basic vaccine series consists of 6 doses.

* The first three doses are given at two-week intervals.

* Three additional doses are given, at 6, 12, and 18 months after the first dose.

Annual booster doses are needed for ongoing protection.

If a dose is not given at the scheduled time, the series does not have to be started over. Resume the series as soon as practical.

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

4. Some people should not get anthrax vaccine or should wait

Anyone who has had a serious allergic reaction to a previous dose of anthrax vaccine should not get another dose.

Anyone who has recovered from cutaneous (skin) anthrax should not get the vaccine.

Pregnant women should not be routinely vaccinated with anthrax vaccine. This is merely a precaution. There is no evidence that the vaccine is harmful to either a pregnant woman or her unborn baby. Vaccination may be recommended for pregnant women who have been exposed, or are likely to be exposed, to anthrax.

There is no reason to delay childbearing after either the man or the woman gets anthrax vaccine.

Vaccines, including anthrax vaccine, are safe to give to breast-feeding women.

5. What are the risks from anthrax vaccine?

Getting anthrax disease is much more dangerous than any risk from the vaccine.

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

Mild Problems

* Soreness, redness, or itching where the shot was given (about 1 out of 10 men, about 1 out of 6 women)

* A lump where the shot was given (about 1 person out of 2)

* Muscle aches or joint aches (about 1 person out of 5)

* Headaches (about 1 person out of 5)

* Fatigue (about 1 out of 15 men, about 1 out of 6 women)

* Chills or fever (about 1 person out of 20)

* Nausea (about 1 person out of 20).

Moderate Problems

* Large areas of redness where the shot was given (up to 1 person out of 20).

Severe Problems

* Serious allergic reaction (very rare - less than once in 100,000 doses).

As with any vaccine, other severe problems have been reported. But these events appear to occur no more often among anthrax vaccine recipients than among unvaccinated people.

There is no evidence that anthrax vaccine causes sterility, birth defects, or long-term health problems.

Independent civilian committees have not found anthrax vaccination to be a factor in unexplained illnesses among Gulf War veterans.

6. What if there is a moderate or severe reaction?

What should I look for?

Any unusual condition, such as a severe allergic reaction or a high fever. If a severe allergic reaction occurred, it would happen within a few minutes to an hour after the shot. Signs of a serious allergic reaction can include difficulty breathing, weakness, hoarseness or wheezing, a fast heart beat, hives, dizziness, paleness, or swelling of the throat.

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 health care provider to file a Vaccine Adverse Event Reporting System (VAERS) form if you have any reaction to the vaccine. Or call VAERS yourself at 1-800-822-7967 or visit their website at www.hhs.vaers.gov

How can I learn more?

* Ask your doctor or other health care provider. They can give you the vaccine package insert or suggest other sources of information.

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

- Call 1-800-232-4636 (1-800-CDC-INFO)

- Visit the CDC's website at http://www.cdc.gov/ncidod/dbmd/diseaseinfo/anthrax_g.htm

* Contact the U.S Department of Defense (DoD):

- Call 1-877-438-8222

- Visit the DoD website at www.anthrax.osd.mil

U.S. Department of Health and Human Services
Centers for Disease Control and Prevention
Vaccine Information Statement
Anthrax
4/24/03

DTaP

Diphtheria, Tetanus, and Pertussis Vaccines: What You Need to Know

Many Vaccine Information Statements are available in Spanish and other languages. See www.immunize.org/vis.

1. Why get vaccinated?

Diphtheria, tetanus, and pertussis are serious diseases caused by bacteria.

Diphtheria and pertussis are spread from person to person. Tetanus enters the body through cuts or wounds.

DIPHTHERIA causes a thick covering in the back of the throat.

It can lead to breathing problems, paralysis, heart failure, and even death.

TETANUS (Lockjaw) causes painful tightening of the muscles, usually all over the body.

It can lead to "locking" of the jaw so the victim cannot open his mouth or swallow. Tetanus leads to death in about 2 out of 10 cases.

PERTUSSIS (Whooping Cough) causes coughing spells so bad that it is hard for infants to eat, drink, or breathe. These spells can last for weeks.

It can lead to pneumonia, seizures (jerking and staring spells), brain damage, and death.

Diphtheria, tetanus, and pertussis vaccine (DTaP) can help preventthese diseases. Most children who are vaccinated with DTaP will be protected throughout childhood. Many more children would get these diseases if we stopped vaccinating.

DTaP is a safer version of an older vaccine called DTP. DTP is no longer used in the United States.

2. Who should get DTaP vaccine and when?

Children should get 5 doses of DTaP vaccine, one dose at each of the following ages:
2 months
4 months
6 months
15 to 18 months
4 to 6 years

DTaP may be given at the same time as other vaccines.

3. Some children should not get DTaP vaccine or should wait

Children with minor illnesses, such as a cold, may be vaccinated. But children who are moderately or severely ill should usually wait until they recover before getting DTaP vaccine.

Any child who had a life-threatening allergic reaction after a dose of DTaP should not get another dose.

Any child who suffered a brain or nervous system disease within 6 days after a dose of DTaP should not get another dose

Talk with your doctor if your child:
- had a seizure or collapsed after a dose of DTaP
- cried non-stop for 3 hours or more after a dose of DTaP
- had a fever over 105° Fahrenheit after a dose of DTaP.

Ask your health care provider for more information. Some of these children should not get another dose of pertussis, but may get a vaccine without pertussis, called DT.

4. Older children and adults

DTaP should not be given to anyone 7 years of age or older because pertussis vaccine is only licensed for children under 7.

But older people still need protection. A vaccine called Tdap is similar to DTaP. A single dose of Tdap is recommended for people 11 through 64 years of age. Another vaccine, called Td,

protects against tetanus and diphtheria, but not pertussis. It is recommended every 10 years. There are separate Vaccine Information Statements for these vaccines.

5. What are the risks from DTaP vaccine?

Getting diphtheria, tetanus or pertussis disease is much riskier than getting DTaP vaccine.

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

Mild Problems (Common)
- Fever (up to about 1 child in 4)
- Redness or swelling where the shot was given (up to about 1 child in 4)
- Soreness or tenderness where the shot was given (up to about 1 child in 4)

These problems occur more often after the 4th and 5th doses of the DTaP series than after earlier doses.

Sometimes the 4th or 5th dose of DTaP vaccine is followed by swelling of the entire arm or leg in which the shot was given, for 1 to 7 days (up to about 1 child in 30).

Other mild problems include:
- Fussiness (up to about 1 child in 3)
- Tiredness or poor appetite (up to about 1 child in 10)
- Vomiting (up to about 1 child in 50)

These problems generally occur 1 to 3 days after the shot.

Moderate Problems (Uncommon)
- Seizure (jerking or staring) (about 1 child out of 14,000)
- Non-stop crying, for 3 hours or more (up to about 1 child out of 1,000)
- High fever, over 105 degrees Fahrenheit (about 1 child out of 16,000)

Severe Problems (Very Rare)
- Serious allergic reaction (less than 1 out of a million doses)

Several other severe problems have been reported after DTaP vaccine. These include: - Long-term seizures, coma, or lowered consciousness
- Permanent brain damage.

These are so rare it is hard to tell if they are caused by the vaccine.

Controlling fever is especially important for children who have had seizures, for any reason. It is also important if another family member has had seizures.

You can reduce fever and pain by giving your child an aspirin-free pain reliever when the shot is given, and for the next 24 hours, following the package instructions.

6. What if there is a moderate or severe reaction?

What should I look for?

Any unusual conditions, such as a serious allergic reaction, high fever or unusual behavior. Serious allergic reactions are extremely rare with any vaccine. If one were to occur, it would most likely be within a few minutes to a few hours after the shot. Signs can include difficulty breathing, hoarseness or wheezing, hives, paleness, weakness, a fast heart beat or dizziness. If a high fever or seizure were to occur, it would usually be within a week 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 you can file this report through the VAERS web site at www.vaers.hhs.gov, or by calling 1-800-822-7967.

VAERS does not provide medical advice.

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 www.hrsa.gov/vaccinecompensation.

8. How can I learn more?

Ask your health care provider. 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 1-800-232-4636 (1-800-CDC-INFO)

- Visit the CDC immunization program's website at www.cdc.gov/vaccines

U.S. Department of Health & Human Services
Centers for Disease Control and Prevention
Vaccine Information Statement
DTaP
5/17/07
42 U.S.C. Section 300aa-26

Haemophilus influenzae type b (Hib)

Haemophilus Influenzae Type b (Hib) Vaccine: What you Need to Know

Many Vaccine Information Statements are available in Spanish and other languages. See www.immunize.org/vis.

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 people 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 to 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 one fourth of children)
- Fever over 101° F (up to 1 out of 20 children)

If these problems happen, the usually start within a day of vaccination. They may last 2 to 3 days.

5. What if there is a moderate or severe reaction?

What should I look for?

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.

VAERS does not provide medical advice.

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 www.hrsa.gov/vaccinecompensation.

7. How can I learn more?

Ask your health care provider. 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 1-800-232-4636 (1-800-CDC-INFO)

- Visit the CDC's website at www.cdc.gov/vaccines

U.S. Department of Health & Human Services
Centers for Disease Control and Prevention
Vaccine Information Statement
Hib
12/16/98
42 U.S.C. Section 300aa-26

Hepatitis A

Hepatitis A Vaccine: What You Need to Know

Many Vaccine Information Statements are available in Spanish and other languages. See www.immunize.org/vis.

1. What is hepatitis A?

Hepatitis A is a serious liver disease caused by the hepatitis A virus (HAV). HAV is found in the stool of persons with hepatitis A. It is usually spread by close personal contact and sometimes by eating food or drinking water containing HAV

Hepatitis A can cause:
- mild “flu-like” illness,
- jaundice (yellow skin or eyes),
- severe stomach pains and diarrhea.

People with hepatitis A often have to be hospitalized (up to about 1 person in 5).

Sometimes, people die as a result of hepatitis A (about 3 to 5 deaths per 1,000 cases).

A person who has hepatitis A can easily pass the disease to others within the same household.

Hepatitis A vaccine can prevent hepatitis A.

2. Who should get hepatitis A vaccine and when?

WHO?

Some people should be routinely vaccinated with hepatitis A vaccine:

• All children 1 year (12 through 23 months) of age.

• Persons 1 year of age and older traveling to or working in countries with high or intermediate prevalence of hepatitis A, such as those located in Central or South America, Mexico, Asia (except Japan), Africa, and eastern Europe. For more information see www.cdc.gov/travel.

• Children and adolescents through 18 years of age who live in states or communities where routine vaccination has been implemented because of high disease incidence.

• Men who have sex with men.

• Persons who use street drugs.

• Persons with chronic liver disease.

• Persons who are treated with clotting factor concentrates.

• Persons who work with HAV-infected primates or who work with HAV in research laboratories.

Other people might get hepatitis A vaccine in special situations:

• Hepatitis A vaccine might be recommended for children or adolescents in communities where outbreaks of hepatitis A are occurring.

Hepatitis A vaccine is not licensed for children younger than 1 year of age.

WHEN?

For children, the first dose should be given at 12 through 23 months of age. Children who are not vaccinated by 2 years of age can be vaccinated at later visits.

For travelers, the vaccine series should be started at least one month before traveling to provide the best protection.

Persons who get the vaccine less than one month before traveling can also get a shot called immune globulin (IG). IG gives immediate, temporary protection.

For others, the hepatitis A vaccine series may be started whenever a person is at risk of infection.

Two doses of the vaccine are needed for lasting protection. These doses should be given at least 6 months apart.

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

3. Some people should not get hepatitis A vaccine or should wait.

• Anyone who has ever had a severe (life-threatening) allergic reaction to a previous dose of hepatitis A vaccine should not get another dose.

• Anyone who has a severe (life threatening) allergy to any vaccine component should not get the vaccine. Tell your doctor if you have any severe allergies. All hepatitis A vaccines contain alum and some hepatitis A vaccines contain 2-phenoxyethanol.

• Anyone who is moderately or severely ill at the time the shot is scheduled should probably wait until they recover. Ask your doctor or nurse. People with a mild illness can usually get the vaccine.

• Tell your doctor if you are pregnant. The safety of hepatitis A vaccine for pregnant women has not been determined. But there is no evidence that it is harmful to either pregnant women or their unborn babies. The risk, if any, is thought to be very low.

4. What are the risks from hepatitis A vaccine?

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

Getting hepatitis A vaccine is much safer than getting the disease.

Mild problems
• soreness where the shot was given (about 1 out of 2 adults, and up to 1 out of 6 children)
• headache (about 1 out of 6 adults and 1 out of 25 children)
• loss of appetite (about 1 out of 12 children)
• tiredness (about 1 out of 14 adults)

If these problems occur, they usually last 1 or 2 days.

Severe problems
• serious allergic reaction, within a few minutes to a few hours of the shot (very rare)

5. What if there is a moderate or severe reaction?

What should I look for?

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.

VAERS does not provide medical advice.

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 www.hrsa.gov/vaccinecompensation.

7. How can I learn more?

Ask your health care provider. 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 1-800-232-4636 (1-800-CDC-INFO)

- Visit CDC websites at: www.cdc.gov/hepatitis or www.cdc.gov/vaccines

U.S. Department of Health & Human Services
Centers for Disease Control and Prevention
Vaccine Information Statement
Hepatitis A
3/21/06
42 U.S.C. Section 300aa-26

Hepatitis B

Hepatitis B Vaccine: What You Need to Know

Many Vaccine Information Statements are available in Spanish and other languages. See www.immunize.org/vis.

1. What is hepatitis B?

Hepatitis B is a serious disease that affects the liver. It is caused by the hepatitis B virus (HBV). HBV can cause:

Acute (short-term) illness. This can lead to:
• loss of appetite
• diarrhea and vomiting
• tiredness
• jaundice (yellow skin or eyes)
• pain in muscles, joints, and stomach

Acute illness is more common among adults. Children who become infected usually do not have acute illness.

Chronic (long-term) infection. Some people go on to develop chronic HBV infection. This can be very serious, and often leads to:
• liver damage (cirrhosis)
• liver cancer
• death

Chronic infection is more common among infants and children than among adults. People who are infected can spread HBV to others, even if they don’t appear sick.

• In 2005, about 51,000 people became infected with hepatitis B.

• About 1.25 million people in the United States have chronic HBV infection.

• Each year about 3,000 to 5,000 people die from cirrhosis or liver cancer caused by HBV.

Hepatitis B virus is spread through contact with the blood or other body fluids of an infected person. A person can become infected by:

- contact with a mother’s blood and body fluids at the time of birth;

- contact with blood and body fluids through breaks in the skin such as bites, cuts, or sores;

- contact with objects that could have blood or body fluids on them such as toothbrushes or razors;

- having unprotected sex with an infected person;

- sharing needles when injecting drugs;

- being stuck with a used needle on the job.

2. Hepatitis B vaccine: Why get vaccinated?

Hepatitis B vaccine can prevent hepatitis B, and the serious consequences of HBV infection, including liver cancer and cirrhosis.

Routine hepatitis B vaccination of U.S. children began in 1991. Since then, the reported incidence of acute hepatitis B among children and adolescents has dropped by more than 95% – and by 75% in all age groups.

Hepatitis B vaccine is made from a part of the hepatitis B virus. It cannot cause HBV infection.

Hepatitis B vaccine is usually given as a series of 3 or 4 shots. This vaccine series gives long-term protection from HBV infection, possibly lifelong.

3. Who should get hepatitis B vaccine and when?

Children and Adolescents

• All children should get their first dose of hepatitis B vaccine at birth and should have completed the vaccine series by 6 through 18 months of age.

• Children and adolescents through 18 years of age who did not get the vaccine when they were younger should also be vaccinated.

Adults

• All unvaccinated adults at risk for HBV infection should be vaccinated. This includes:
- sex partners of people infected with HBV,
- men who have sex with men,
- people who inject street drugs,
- people with more than one sex partner,
- people with chronic liver or kidney disease,
- people with jobs that expose them to human blood,
- household contacts of people infected with HBV,
- residents and staff in institutions for the developmentally disabled,
- kidney dialysis patients,
- people who travel to countries where hepatitis B is common,
- people with HIV infection.

• Anyone else who wants to be protected from HBV infection may be vaccinated.

4. Who should not get hepatitis B vaccine?

• Anyone with a life-threatening allergy to yeast, or to any other component of the vaccine, should not get hepatitis B vaccine. Tell your provider if you have any severe allergies.

• Anyone who has had a life-threatening allergic reaction to a previous dose of hepatitis B vaccine should not get another dose.

• Anyone who is moderately or severely ill when a dose of vaccine is scheduled should probably wait until they recover before getting the vaccine.

Your provider can give you more information about these precautions.

Pregnant women who need protection from HBV infection may be vaccinated.

5. Hepatitis B vaccine risks

Hepatitis B is a very safe vaccine. Most people do not have any problems with it.

The following mild problems have been reported:
• Soreness where the shot was given (up to about 1 person in 4).
•Temperature of 99.9° F or higher (up to about 1 person in 15).

Severe problems are extremely rare. Severe allergic reactions are believed to occur about once in 1.1 million doses.

A vaccine, like any medicine, could cause a serious reaction. But the risk of a vaccine causing serious harm, or death, is extremely small. More than 100 million people have gotten hepatitis B vaccine in the United States.

6. What if there is a moderate or severe reaction?

What should I look for?

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.

VAERS does not provide medical advice.

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 www.hrsa.gov/vaccinecompensation.

8. How can I learn more?

Ask your health care provider. They can give you the vaccine package insert or suggest other sources of information.

Call your local or state health department's immunization program.

ontact the Centers for Disease Control and Prevention (CDC):

- Call 1-800-232-4636 (1-800-CDC-INFO)

- Visit CDC websites at: www.cdc.gov/hepatitis, www.cdc.gov/vaccines, or www.cdc.gov/travel

U.S. Department of Health & Human Services
Centers for Disease Control and Prevention
Vaccine Information Statement (Interim)
Hepatitis B
7/18/07
42 U.S.C. Section 300aa-26

Human Papillomavirus (HPV)

Human Papillomavirus (HPV) Vaccine: What you need to know

Many Vaccine Information Statements are available in Spanish and other languages. See www.immunize.org/vis.

1. What is HPV?

Genital human papillomavirus (HPV) is the most common sexually transmitted virus in the United States.

There are about 40 types of HPV. About 20 million people in the U.S. are infected, and about 6.2 million more get infected each year. HPV is spread through sexual contact.

Most HPV infections don’t cause any symptoms, and go away on their own. But HPV is important mainly because it can cause cervical cancer in women. Every year in the U.S. about 10,000 women get cervical cancer and 3,700 die from it. It is the 2nd leading cause of cancer deaths among women around the world.

HPV is also associated with several less common types of cancer in both men and women. It can also cause genital warts and warts in the upper respiratory tract.

More than 50 percent of sexually active men and women are infected with HPV at sometime in their lives.

There is no treatment for HPV infection, but the conditions it causes can be treated.

2. HPV vaccine. Why get vaccinated?

HPV vaccine is an inactivated (not live) vaccine which protects against 4 major types of HPV.

These include 2 types that cause about 70 percent of cervical cancer and 2 types that cause about 90 percent of genital warts. HPV vaccine can prevent most genital warts and most cases of cervical cancer.

Protection from HPV vaccine is expected to be long-lasting. But vaccinated women still need cervical cancer screening because the vaccine does not protect against all HPV types that cause cervical cancer.

3. Who should get HPV vaccine and when?

Routine Vaccination

• HPV vaccine is routinely recommended for girls 11 and 12 years of age. Doctors may give it to girls as young as 9 years

Why is HPV vaccine given to girls at this age?

It is important for girls to get HPV vaccine before their first sexual contact – because they have not been exposed to HPV. For these girls, the vaccine can prevent almost 100% of disease caused by the 4 types of HPV targeted by the vaccine.

However, if a girl or woman is already infected with a type of HPV, the vaccine will not prevent disease from that type.

Catch-Up Vaccination

• The vaccine is also recommended for girls and women 13 through 26 years of age who did not receive it when they were younger.

HPV vaccine is given as a 3-dose series:
- 1st Dose: Now
- 2nd Dose: 2 months after Dose 1
- 3rd Dose: 6 months after Dose 1

Additional (booster) doses are not recommended.

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

4. Some girls or women should not get HPV vaccine or should wait.

• Anyone who has ever had a life-threatening allergic reaction to yeast, to any other component of HPV vaccine, or to a previous dose of HPV vaccine should not get the vaccine. Tell your doctor if the person getting the vaccine has any severe allergies.

• Pregnant women should not get the vaccine. The vaccine appears to be safe for both the mother and the unborn baby, but it is still being studied. Receiving HPV vaccine when pregnant is not a reason to consider terminating the pregnancy. Women who are breast feeding may safely get the vaccine.

Any woman who learns that she was pregnant when she got HPV vaccine is encouraged to call the HPV vaccine in pregnancy registry at 800-986-8999.

Information from this registry will help us learn how pregnant women respond to the vaccine.

• People who are mildly ill when the shot is scheduled can still get HPV vaccine. People with moderate or severe illnesses should wait until they recover.

5. What are the risks from HPV vaccine?

HPV vaccine does not appear to cause any serious side effects.

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

Several mild problems may occur with HPV vaccine:
• Pain at the injection site (about 8 people in 10)
• Redness or swelling at the injection site (about 1 person in 4)
• Mild fever (100° F) (about 1 person in 10)
• Itching at the injection site (about 1 person in 30)
• Moderate fever (102° F) (about 1 person in 65)

These symptoms do not last long and go away on their own.

Life-threatening allergic reactions from vaccines are very rare. If they do occur, it would be within a few minutes to a few hours after the vaccination.

Like all vaccines, HPV vaccine will continue to be monitored for unusual or severe problems.

6. What if there is a moderate or severe reaction?

What should I look for?

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.

VAERS does not provide medical advice.

7. How can I learn more?

Ask your health care provider. 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 1-800-232-4636 (1-800-CDC-INFO)

- Visit the CDC's website at www.cdc.gov/vaccines

U.S. Department of Health & Human Services
Centers for Disease Control and Prevention
Vaccine Information Statement (Interim)
Human Papillomavirus (HPV) Vaccine
2/2//07

Influenza: TIV

Inactivated Influenza Vaccine: What You Need to Know

2008-2009

Many Vaccine Information Statements are available in Spanish and other languages. See www.immunize.org/vis.

1. Why get vaccinated?

Influenza (“flu”) is a contagious disease.

It is caused by the influenza virus, which can be spread by coughing, sneezing, or nasal secretions.

Other illnesses can have the same symptoms and are often mistaken for influenza. But only an illness caused by the influenza virus is really influenza.

Anyone can get influenza, but rates of infection are highest among children. For most people, it lasts only a few days.

It can cause:
· fever
· sore throat
· chills
· fatigue
· cough
· headache
· muscle aches

Some people get much sicker. Influenza can lead to pneumonia and can be dangerous for people with heart or breathing conditions. It can cause high fever, diarrhea and seizures in children. On average, 226,000 people are hospitalized every year because of influenza and 36,000 die – mostly elderly.

Influenza vaccine can prevent influenza.

2. Inactivated influenza vaccine.

There are two types of influenza vaccine:

1. Inactivated (killed) vaccine, or the “flu shot” is given by injection into the muscle. 2. Live, attenuated (weakened) influenza vaccine is sprayed into the nostrils. This vaccine is described in a separate Vaccine Information Statement.

Influenza viruses are always changing. Because of this, influenza vaccines are updated every year, and an annual vaccination is recommended.

Each year scientists try to match the viruses in the vaccine to those most likely to cause flu that year. When there is a close match the vaccine protects most people from serious influenza-related illness. But even when there is not a close match, the vaccine provides some protection. Influenza vaccine will not prevent “influenza-like” illnesses caused by other viruses.

It takes up to 2 weeks for protection to develop after the shot. Protection lasts up to a year.

Some inactivated influenza vaccine contains a preservative called thimerosal. Some people have suggested that thimerosal may be related to developmental problems in children. In 2004 the Institute of Medicine reviewed many studies looking into this theory and concluded that there is no evidence of such a relationship. Thimerosal-free influenza vaccine is available.

3. Who should get inactivated influenza vaccine?

All children 6 months and older and all older adults:

• All children from 6 months through 18 years of age.

• Anyone 50 years of age or older.

Anyone who is at risk of complications from influenza, or more likely to require medical care:

• Women who will be pregnant during influenza season.

• Anyone with long-term health problems with:
- heart disease
- kidney disease
- liver disease
- lung disease
- metabolic disease, such as diabetes
- asthma
- anemia, and other blood disorders

• Anyone with a weakened immune system due to:
- HIV/AIDS or other diseases affecting the immune system
- long-term treatment with drugs such as steroids
- cancer treatment with x-rays or drugs

• Anyone with certain muscle or nerve disorders (such as seizure disorders or cerebral palsy) that can lead to breathing or swallowing problems.

• Anyone 6 months through 18 years of age on long-term aspirin treatment (they could develop Reye Syndrome if they got influenza).

• Residents of nursing homes and other chronic-care facilities.

Anyone who lives with or cares for people at high risk for influenza-related complications:

• Health care providers.

• Household contacts and caregivers of children from birth up to 5 years of age.

• Household contacts and caregivers of
- people 50 years and older, or
- anyone with medical conditions that put them at higher risk for severe complications from influenza.

Health care providers may also recommend a yearly influenza vaccination for:

• People who provide essential community services.

• People living in dormitories, correctional facilities, or under other crowded conditions, to prevent outbreaks.

• People at high risk of influenza complications who travel to the Southern hemisphere between April and September, or to the tropics or in organized tourist groups at any time.

Influenza vaccine is also recommended for anyone who wants to reduce the likelihood of becoming ill with influenza or spreading influenza to others.

4. When should I get influenza vaccine?

Plan to get influenza vaccine in October or November if you can. But getting vaccinated in December, or even later, will still be beneficial in most years. You can get the vaccine as soon as it is available, and for as long as illness is occurring in your community. Influenza can occur any time from November through May, but it most often peaks in January or February.

Most people need one dose of influenza vaccine each year. Children younger than 9 years of age getting influenza vaccine for the first time – or who got influenza vaccine for the first time last season but got only one dose – should get 2 doses, at least 4 weeks apart, to be protected.

Influenza vaccine may be given at the same time as other vaccines, including pneumococcal vaccine.

5. Some people should talk with a doctor before getting influenza vaccine.

Some people should not get inactivated influenza vaccine or should wait before getting it.

• Tell your doctor if you have any severe (life-threatening) allergies. Allergic reactions to influenza vaccine are rare.

- Influenza vaccine virus is grown in eggs. People with a severe egg allergy should not get the vaccine.

- A severe allergy to any vaccine component is also a reason to not get the vaccine.

- If you have had a severe reaction after a previous dose of influenza vaccine, tell your doctor.

• Tell your doctor if you ever had Guillain-Barré Syndrome (a severe paralytic illness, also called GBS). You may be able to get the vaccine, but your doctor should help you make the decision.

• People who are moderately or severely ill should usually wait until they recover before getting flu vaccine. If you are ill, talk to your doctor or nurse about whether to reschedule the vaccination. People with a mild illness can usually get the vaccine.

6. What are the risks from inactivated influenza vaccine?

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

Serious problems from influenza vaccine are very rare. The viruses in inactivated influenza vaccine have been killed, so you cannot get influenza from the vaccine.

Mild problems:
• soreness, redness, or swelling where the shot was given
• fever
• aches

If these problems occur, they usually begin soon after the shot and last 1-2 days.

Severe problems:

• Life-threatening allergic reactions from vaccines are very rare. If they do occur, it is usually within a few minutes to a few hours after the shot.

• In 1976, a type of influenza (swine flu) vaccine was associated with Guillain-Barré Syndrome (GBS). Since then, flu vaccines have not been clearly linked to GBS. However, if there is a risk of GBS from current flu vaccines, it would be no more than 1 or 2 cases per million people vaccinated. This is much lower than the risk of severe influenza, which can be prevented by vaccination.

7. What if there is a severe reaction?

What should I look for?

• Any unusual condition, such as a 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 report the reaction by filing a Vaccine Adverse Event Reporting System (VAERS) form.

Or you can file this report through the VAERS web site at www.vaers.hhs.gov, or by calling 1-800-822-7967.

VAERS does not provide medical advice.

8. The National Vaccine Injury Compensation Program

A federal program exists to help pay for the care of anyone who has a serious reaction to a vaccine.

For more information about the National Vaccine Injury Compensation Program, call 1-800-338-2382 or visit their website at www.hrsa.gov/vaccinecompensation.

9. How can I learn more?

• Ask your immunization provider. 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 1-800-232-4636 (1-800-CDC-INFO)

- Visit CDC’s website at www.cdc.gov/flu

Department of Health and Human Services
Centers for Disease Control and Prevention
Vaccine Information Statement
Inactivated Influenza Vaccine
7/24/08
42 U.S.C. section 300aa-26

Influenza: LAIV

Live, Intranasal Influenza Vaccine: What You Need to Know

2008-2009

Many Vaccine Information Statements are available in Spanish and other languages. See www.immunize.org/vis.

1. Why get vaccinated?

Influenza (“flu”) is a contagious disease.

It is caused by the influenza virus, which can be spread by coughing, sneezing, or nasal secretions.

Other illnesses can have the same symptoms and are often mistaken for influenza. But only an illness caused by the influenza virus is really influenza.

Anyone can get influenza, but rates of infection are highest among children. For most people, it lasts only a few days.

It can cause:
· fever
· sore throat
· chills
· fatigue
· cough
· headache
· muscle aches

Influenza vaccine can prevent influenza.

2. Live, attenuated influenza vaccine (LAIV) – Nasal spray

There are two types of influenza vaccine:

1. Live, attenuated influenza vaccine (LAIV) contains live but attenuated (weakened) influenza virus. It is sprayed into the nostrils. 2. Inactivated influenza vaccine, sometimes called the “flu shot,” is given by injection. Inactivated influenza vaccine is described in a separate Vaccine Information Statement.

Influenza viruses are always changing. Because of this, influenza vaccines are updated every year, and an annual vaccination is recommended.

Each year scientists try to match the viruses in the vaccine to those most likely to cause flu that year. When there is a close match the vaccine protects most people from serious influenza-related illness. But even when the there is not a close match, the vaccine provides some protection. Influenza vaccine will not prevent “influenza-like” illnesses caused by other viruses.

It takes up to 2 weeks for protection to develop after the vaccination. Protection lasts up to a year.

LAIV does not contain thimerosal or other preservatives.

3. Who can get LAIV?

LAIV is approved for people from 2 through 49 years of age, who are not pregnant and do not have certain health conditions (see #4, below). Influenza vaccination is recommended for people who can spread influenza to others at high risk, such as:

• Household contacts and out-of-home caregivers of children up to 5 years of age, and people 50 and older.

• Physicians and nurses, and family members or anyone else in close contact with people at risk of serious influenza.

Health care providers may also recommend a yearly influenza vaccination for:

• People who provide essential community services.

• People living in dormitories, correctional facilities, or under other crowded conditions, to prevent outbreaks.

Influenza vaccine is also recommended for anyone who wants to reduce the likelihood of becoming ill with influenza or spreading influenza to others.

4. Some people should not get LAIV.

LAIV is not licensed for everyone. The following people should get the inactivated vaccine (flu shot) instead:

• Adults 50 years of age and older or children between 6 months and 2 years of age. (Children younger than 6 months should not get either influenza vaccine.)

• Children younger than 5 with asthma or one or more episodes of wheezing within the past year.

• People who have long-term health problems with:
- heart disease
- kidney or liver disease
- lung disease
- metabolic disease, such as diabetes
- asthma
- anemia, and other blood disorders

• Anyone with certain muscle or nerve disorders (such as seizure disorders or cerebral palsy) that can lead to breathing or swallowing problems.

• Anyone with a weakened immune system.

• Children or adolescents on long-term aspirin treatment.

• Pregnant women.

Tell your doctor if you ever had Guillain-Barré syndrome (a severe paralytic illness also called GBS). You may be able to get the vaccine, but your doctor should help you make the decision.

The flu shot is preferred for people (including health-care workers, and family members) in close contact with anyone who has a severely weakened immune system (requiring care in a protected environment, such as a bone marrow transplant unit). People in close contact with those whose immune systems are less severely weakened (including those with HIV) may get LAIV.

Anyone with a nasal condition serious enough to make breathing difficult, such as a very stuffy nose, should get the flu shot instead.

Some people should talk with a doctor before getting either influenza vaccine:

• Anyone who has ever had a serious allergic reaction to eggs or another vaccine component, or to a previous dose of influenza vaccine. LAIV also contains MSG, arginine, gentamicin, and gelatin.

5. When should I get influenza vaccine?

Plan to get influenza vaccine in October or November if you can. But getting it in December, or even later, will still be beneficial most years. You can get the vaccine as soon as it is available, and for as long as illness is occurring in your community. Influenza can occur from November through May, but it most often peaks in January or February.

LAIV may be given at the same time as other vaccines.

6. What are the risks from LAIV?

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

Live influenza vaccine viruses rarely spread from person to person. Even if they do, they are not likely to cause illness.

LAIV is made from weakened virus and does not cause influenza. The vaccine can cause mild symptoms in people who get it (see below).

Mild problems:

Some children and adolescents 2-17 years of age have reported mild reactions, including:
• runny nose, nasal congestion or cough
• fever
• headache and muscle aches
• wheezing
• abdominal pain or occasional vomiting or diarrhea

Some adults 18-49 years of age have reported:
• runny nose or nasal congestion
• sore throat
• cough, chills, tiredness/weakness
• headache

These symptoms did not last long and went away on their own. Although they can occur after vaccination, they may not have been caused by the vaccine.

Severe problems:

• Life-threatening allergic reactions from vaccines are very rare. If they do occur, it is usually within a few minutes to a few hours after the vaccination.

• If rare reactions occur with any product, they may not be identified until thousands, or millions, of people have used it. Millions of doses of LAIV have been distributed since it was licensed, and no serious problems have been identified. Like all vaccines, LAIV will continue to be monitored for unusual or severe problems.

7. What if there is a severe reaction?

What should I look for?

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 report the reaction by filing a Vaccine Adverse Event Reporting System (VAERS) form.

Or you can file this report through the VAERS website at www.vaers.hhs.gov, or by calling 1-800-822-7967.

VAERS does not provide medical advice.

8. The National Vaccine Injury Compensation Program

A federal program exists to help pay for the care of anyone who has a serious reaction to a vaccine.

For more information about the National Vaccine Injury Compensation Program, call 1-800-338-2382 or visit their website at www.hrsa.gov/vaccinecompensation.

9. How can I learn more?

• Ask your immunization provider. 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 1-800-232-4636 (1-800-CDC-INFO)

- Visit CDC’s website at www.cdc.gov/flu

Department of Health and Human Services
Centers for Disease Control and Prevention
Vaccine Information Statement
Live, Attenuated Influenza Vaccine
7/24/08
42 U.S.C. section 300aa-26

Japanese Encephalitis

Japanese Encephalitis Vaccine: What you need to know

Many Vaccine Information Statements are available in Spanish and other languages. See www.immunize.org/vis.

1. What is Japanese encephalitis?

Japanese encephalitis (JE) is a serious infection caused by a virus. It occurs in certain rural parts of Asia.

Encephalitis means swelling of the brain. JE spreads through the bite of infected mosquitoes. It cannot spread directly from one person to another.

Japanese encephalitis can cause:

Mild infections with fever and headache.

Severe infections with encephalitis. About 1 in 4 of such cases results in death. Symptoms of more severe infection are headache, high fever, neck stiffness, stupor, disorientation, abnormal movements, occasional convulsions (especially in infants), coma, and paralysis.

2. How can I prevent Japanese encephalitis?

Protection from Mosquitoes

As with any disease transmitted by mosquitoes, you can prevent exposure to JE virus by:

- Remaining in well-screened areas,

- wearing clothes that cover most of the body, and

- using an effective insect repellent, such as those containing up to 30 percent N.N. diethylmetatoluamide (DEET) on skin and clothing. Use of permethrin on clothing will also help prevent mosquito bites.

Japanese encephalitis Vaccine

Japanese encephalitis vaccine can prevent JE.

(NOTE: JE vaccine is not 100% effective and is not a substitute for mosquito precautions.)

3. Who should get Japanese encephalitis vaccine and when?

Who?

People who live or travel in certain rural parts of Asia should get the vaccine.

Laboratory workers at risk of exposure to JE virus should also be vaccinated.

When?

Three doses of vaccine are given, with the second dose given 7 days after the 1st and the third dose given 30 days after the first.

The third dose should be given at least 10 days before travel, to be sure the vaccine begins to protect and to allow for medical care if there are delayed side effects.

A booster dose may be needed after 2 years.

Children 1 to 3 years of age get a smaller dose than older children and adults. Children younger than 1 year of age should not normally get the vaccine.

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

4. Who should not get Japanese encephalitis vaccine?

Anyone who has ever had a life-threatening reaction to mouse protein, thimerosal, or to a previous dose of JE vaccine.

Tell your doctor if you:
- have severe allergies, especially a history of allergic rash (hives) or wheezing after a wasp sting or taking medications,
- are pregnant, or are a nursing mother,
- will be traveling for fewer than 30 days, especially if you will be in major urban areas. (You may be at lower risk for Japanese encephalitis and not need the vaccine.)

5. What are the risks from Japanese encephalitis 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.

Mild Problems
- soreness, redness, or swelling where the shot was given (about 1 person in 5)
- fever, headache, muscle pain, abdominal pain, rash, chills, nausea, vomiting, or dizziness (about 1 person in 10)
- If these problems occur, they usually begin soon after the shot and last for a couple of days.

Moderate or Severe Problems

Serious allergic reactions including rash; swelling of the hands and feet, face, or lips; and breathing difficulty. These have occurred within minutes to as long as 10 to 17 days after receiving the vaccine, usually about 48 hours after the vaccination. (About 60 per 10,000 people vaccinated have had allergic reactions to JE vaccine.)

Other severe problems, such as seizures or nervous system problems, have been reported. These are rare (probably less than 1 per 50,000 people vaccinated).

6. What if there is a moderate or severe reaction?

What should I look for?

Look for any unusual conditions, such as high fever, allergic symptoms or neurologic problems that occur 1 to 30 days after vaccination. Serious allergic reactions are extremely rare with any vaccine. If one were to occur, it would most likely be within a few minutes to a few hours after the shot. Signs can include difficulty breathing, hoarseness or wheezing, hives, paleness, weakness, a fast heart beat or dizziness within a few minutes up to two 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 the clinic where you received the vaccine to save any left over vaccine and the vaccine vial, and record the lot number.

VAERS does not provide medical advice.

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.

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

- Visit the CDC travelers health website at www.cdc.gov/travel

- Or other CDC websites at www.cdc.gov/ncidod/dvbid/jencephalitis/index.htm or ftp.cdc.gov/pub/Publications/mmwr/rr/rr4201.pdf

U.S. Department of Health & Human Services
Centers for Disease Control and Prevention
Vaccine Information Statement
Japanese Encephalitis Vaccine
5/11/05

Meningococcal

Meningococcal Vaccines: What you need to know

Many Vaccine Information Statements are available in Spanish and other languages. See www.immunize.org/vis.

1. What is meningococcal disease?

Meningococcal disease is a serious bacterial illness. It is a leading cause of bacterial meningitis in children 2 through 18 years old in the United States.

Meningitis is an infection of fluid surrounding the brain and the spinal cord. Meningococcal disease also causes blood infections.

About 1,000 - 2,600 people get meningococcal disease each year in the U.S. Even when they are treated with antibiotics, 10-15% of these people die. Of those who live, another 11-19% lose their arms or legs, become deaf, have problems with their nervous systems, become mentally retarded, or suffer seizures or strokes.

Anyone can get meningococcal disease. But it is most common in infants less than one year of age and people with certain medical conditions, such as lack of a spleen. College freshmen who live in dormitories, and teenagers 15-19 have an increased risk of getting meningococcal disease.

Meningococcal infections can be treated with drugs such as penicillin. Still, about 1 out of every ten people who get the disease dies from it, and many others are affected for life. This is why preventing the disease through use of meningococcal vaccine is important for people at highest risk.

2. Meningococcal vaccine

There are two kinds of meningococcal vaccine in the U.S.:

- Meningococcal conjugate vaccine (MCV4) was licensed in 2005. It is the preferred vaccine for people 2 through 55 years of age.

- Meningococcal polysaccharide vaccine (MPSV4) has been available since the 1970s. It may be used if MCV4 is not available, and is the only meningococcal vaccine licensed for people older than 55.

Both vaccines can prevent 4 types of meningococcal disease, including 2 of the 3 types most common in the United States and a type that causes epidemics in Africa. Meningococcal vaccines cannot prevent all types of the disease. But they do protect many people who might become sick if they didn’t get the vaccine.

Both vaccines work well, and protect about 90% of people who get them. MCV4 is expected to give better, longer-lasting protection.

MCV4 should also be better at preventing the disease from spreading from person to person.

. Who should get meningococcal vaccine and when?

A dose of MCV4 is recommended for children and adolescents 11 through 18 years of age.

This dose is normally given during the routine preadolescent immunization visit (at 11 to 12 years of age). But those who did not get the vaccine during this visit should get it at the earliest opportunity.

Meningococcal vaccine is also recommended for other people at increased risk for meningococcal disease:

College freshmen living in dormitories.

Microbiologists who are routinely exposed to meningococcal bacteria.

U.S. military recruits.

Anyone traveling to, or living in, a part of the world where meningococcal disease is common, such as parts of Africa.

Anyone who has a damaged spleen, or whose spleen has been removed.

Anyone who has terminal complement component deficiency (an immune system disorder).

People who might have been exposed to meningitis during an outbreak.

MCV4 is the preferred vaccine for people 2 through 55 years of age in these risk groups.

MPSV4 can be used if MCV4 is not available and for adults over 55.

How Many Doses?

People 2 years of age and older should get 1 dose. Sometimes an additional dose is recommended for people who remain at high risk. Ask your provider.

MPSV4 may be recommended for children 3 months to 2 years of age under special circumstances. These children should get 2 doses, 3 months apart.

4. Some people should not get meningococcal vaccine or should wait.

Anyone who has ever had a severe (life-threatening) allergic reaction to a previous dose of either meningococcal vaccine should not get another dose.

Anyone who has a severe (life threatening) allergy to any vaccine component should not get the vaccine. Tell your doctor if you have any severe allergies.

Anyone who is moderately or severely ill at the time the shot is scheduled should probably wait until they recover. Ask your provider. People with a mild illness can usually get the vaccine.

Anyone who has ever had Guillain-Barré Syndrome should talk with their provider before getting MCV4.

Meningococcal vaccines may be given to pregnant women. However, MCV4 is a new vaccine and has not been studied in pregnant women as much as MPSV4 has. It should be used only if clearly needed.

Meningococcal vaccines may be given at the same time as other vaccines.

5. What are the risks from meningococcal vaccine?

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

Mild problems

As many as half the people who get meningococcal vaccines have mild side effects, such as redness or pain where the shot was given.

If these problems occur, they usually last for 1 or 2 days. They are more common after MCV4 than after MPSV4.

A small percentage of people who receive the vaccine develop a fever.

Severe problems

Serious allergic reactions, within a few minutes to a few hours of the shot, are very rare.

A serious nervous system disorder called Guillain-Barré Syndrome (or GBS) has been reported among some people who received MCV4. This happens so rarely that it is currently not possible to tell if the vaccine might be a factor. Even if it is, the risk is very small.

6. What if there is a moderate or severe reaction?

What should I look for?

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.

VAERS does not provide medical advice.

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 www.hrsa.gov/vaccinecompensation.

8. How can I learn more?

Ask your health care provider. 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 1-800-232-4636 (1-800-CDC-INFO)

- Visit the CDC’s website at www.cdc.gov/vaccines

- Visit CDC’s meningococcal disease website at www.cdc.gov/ncidod/dbmd/diseseinfo/meningococcal_g.htm

- Visit CDC’s Travelers’ Health website at wwwn.cdc.gov/travel

U.S. Department of Health & Human Services
Centers for Disease Control and Prevention
Vaccine Information Statement (Interim)
Meningococcal
1/28/08
42 U.S.C. Section 300aa-26

MMR

Measles, Mumps, and Rubella (MMR) Vaccines: What You Need to Know

Many Vaccine Information Statements are available in Spanish and other languages. See www.immunize.org/vis.

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 or ovaries, and, rarely, death.

Rubella (German Measles)

• Rubella virus causes rash, mild fever, 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 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 1956, should get at least one dose of MMR vaccine, unless they can show that they have had either the vaccines or the diseases.

Ask your provider for more information.

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

Note: A “combination” vaccine called MMRV, which contains both MMR and Varicella (chickenpox) vaccines, may be given instead of the two individual vaccines to people 12 years of age and younger.

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

* People should not get MMR vaccine who have ever had a life-threatening allergic reaction to gelatin, the antibiotic neomycin, or to a previous dose of MMR 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 avoid getting pregnant for 4 weeks after getting MMR vaccine.

* Some people should check with their doctor about whether they should get MMR 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
- 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

Ask your provider for more information.

4. What are the risks from MMR vaccine?

A vaccine, like any medicine, is capable of causing serious 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 or neck (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)

• Temporary 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-term seizures, coma, or lowered consciousness
- Permanent brain damage

Note: The first dose of MMRV vaccine has been associated with rash and higher rates of fever than MMR and Varicella vaccines given separately. Rash has been reported in about 1 person in 20 and fever in about 1 person in 5.

Seizures caused by a fever are also reported more often after MMRV. These usually occur 5-12 days after the first dose.

5. What if there is a moderate or severe reaction?

What should I look for?

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.

VAERS does not provide medical advice.

6. The National Vaccine Injury Compensation Program

A federal program has been created to help people who may have been harmed by a vaccine.

For details about the National Vaccine Injury Compensation Program, call 1-800-338-2382 or visit the program's website at www.hrsa.gov/vaccinecompensation.

7. How can I learn more?

Ask your health care provider. 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 1-800-232-4636 (1-800-CDC-INFO)

- Visit the CDC’s website at www.cdc.gov/vaccines

U.S. Department of Health & Human Services
Centers for Disease Control and Prevention
Vaccine Information Statement (Interim)
MMR Vaccine
3/13/08
42 U.S.C. Section 300aa-26

Pneumococcal Conjugate

Pneumococcal Conjugate Vaccine: What You Need to Know

Many Vaccine Information Statements are available in Spanish and other languages. See www.immunize.org/vis.

1. Why get vaccinated?

Infection with Streptococcus pneumoniae bacteria can cause serious illness and death. Invasive pneumococcal disease is responsible for about 200 deaths each year among children under 5 years old. It is the leading cause of bacterial meningitis in the United States. (Meningitis is an infection of the covering of the brain).

Each year pneumococcal infection causes severe disease in children under five years old, Before a vaccine was available, pneumococcal infection each year caused:
- over 700 cases of meningitis
- 13,000 blood infections, and
- about 5 million ear infections

It can also lead to other health problems, including:
- pneumonia,
- deafness,
- brain damage.

Children under 2 years old are at highest risk for serious disease.

Pneumococcus bacteria are spread from person to person through close contact.

Pneumococcal infections can be hard to treat because the bacteria have become resistant to some of the drugs that have been used to treat them. This makes prevention of pneumococcal infections even more important.

Pneumococcal conjugate vaccine can help prevent serious pneumococcal disease, such as meningitis and blood infections. It can also prevent some ear infections. But ear infections have many causes, and pneumococcal vaccine is effective against only some of them.

2. Pneumococcal conjugate vaccine

Pneumococcal conjugate vaccine is approved for infants and toddlers. Children who are vaccinated when they are infants will be protected when they are at greatest risk for serious disease.

Some older children and adults may get a different vaccine called pneumococcal polysaccharide vaccine. There is a separate Vaccine Information Statement for people getting this vaccine.

3. Who should get the vaccine and when?

Children under 2 years of age:
- 2 months
- 4 months
- 6 months
- 12 to 15 months

Children who weren't vaccinated at these ages can still get the vaccine. The number of doses needed depends on the child's age. Ask your health care provider for details.

Children between 2 and 5 years of age:

Pneumococcal conjugate vaccine is also recommended for children between 2 and 5 years old who have not already gotten the vaccine and are at high risk of serious pneumococcal disease. This includes children who:
- have sickle cell disease,
- have a damaged spleen or no spleen,
- have HIV/AIDS,
- have other diseases that affect the immune system, such as diabetes, cancer, or liver disease, or who
- take medications that affect the immune system, such as chemotherapy or steroids, or
- have chronic heart or lung disease.

The vaccine should be considered for all other children under age 5 years, especially those at higher risk of serious pneumococcal disease. This includes children who:
- are under 3 years of age,
- are of Alaska Native, American Indian or African American descent, or
- attend group day care.

The number of doses needed depends on the child's age. Ask your health care provider for more details.

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

4. Some children should not get pneumococcal conjugate vaccine or should wait.

Children should not get pneumococcal conjugate vaccine if they had a severe (life-threatening) allergic reaction to a previous dose of this vaccine, or have a severe allergy to a vaccine component. Tell your health-care provider if your child has ever had a severe reaction to any vaccine, or has any severe allergies.

Children with minor illnesses, such as a cold, may be vaccinated. But children who are moderately or severely ill should usually wait until they recover before getting the vaccine.

5. What are the risks from pneumococcal conjugate vaccine?

In studies (nearly 60,000 doses), pneumococcal conjugate vaccine was associated with only mild reactions:

Up to about 1 infant out of 4 had redness, tenderness, or swelling where the shot was given.

Up to about 1 out of 3 had a fever of over 100.4° F, and up to about 1 in 50 had a higher fever (over 102.2° F).

Some children also became fussy or drowsy, or had a loss of appetite.

So far, no moderate or severe reactions have been associated with this vaccine. However, a vaccine, like any medicine, could cause serious problems, such as a severe allergic reaction. The risk of this vaccine causing serious harm, or death, is extremely small.

6. What if there is a moderate or severe reaction?

What should I look for?

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.

VAERS does not provide medical advice.

7. The National Vaccine Injury Compensation Program

A federal program has been created to help people who may have been harmed by a vaccine.

For details about the National Vaccine Injury Compensation Program, call 1-800-338-2382 or visit the program's website at www.hrsa.gov/vaccinecompensation.

8. How can I learn more?

Ask your health care provider. 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 1-800-232-4636 (1-800-CDC-INFO)

- Visit the CDC’s website at www.cdc.gov/vaccines

U.S. Department of Health & Human Services
Centers for Disease Control and Prevention
Vaccine Information Statement
Pneumococcal Conjugate Vaccine
9/30/02
42 U.S.C. Section 300aa-26

Pneumococcal Polysaccharide

Pneumococcal Polysaccharide Vaccine: What You Need to Know

Many Vaccine Information Statements are available in Spanish and other languages. See www.immunize.org/vis.

1. Why get vaccinated?

Pneumococcal disease is a serious disease that causes much sickness and death. In fact, Pneumococcal disease kills more people in the United States each year than all other vaccine-preventable diseases combined. Anyone can get pneumococcal disease. However, some

people are at greater risk from the disease. These include people 65 and older, the very young, and people with special health problems such as alcoholism, heart or lung disease, kidney failure, diabetes, HIV infection, or certain types of cancer.

Pneumococcal disease can lead to serious infections of the lungs (pneumonia), the blood bacteremia), and the covering of the brain (meningitis). About 1 out of every 20 people who get pneumococcal pneumonia dies from it, as do about 2 people out of 10 who get bacteremia and 3 people out of 10 who get meningitis. People with the special health problems mentioned above are even more likely to die from the disease.

Drugs such as penicillin were once effective in treating, these infections; but the disease has become more resistant to these drugs, making treatment of pneumococcal infections more difficult. This makes prevention of the disease through vaccination even more important.

2. Pneumococcal polysaccharide vaccine (PPV)

The pneumococcal polysaccharide vaccine (PPV) protects against 23 types of pneumococcal bacteria. Most healthy adults who get the vaccine develop protection to most or all of these types within 2 to 3 weeks of getting the shot. Very old people, children under 2 years of age, and people with some long-term illnesses might not respond as well or at all.

3. Who should get PPV?

• All adults 65 years of age or older.

• Anyone over 2 years of age who has a long-term health problem such as:
- heart disease
- lung disease
- sickle cell disease
- diabetes
- alcoholism
- cirrhosis
- leaks of cerebrospinal fluid

• Anyone over 2 years of age who has a disease or condition that lowers the body's resistance to infection, such as:
- lymphoma, leukemia
- Hodgkin's disease
- kidney failure
- nephrotic syndrome
- damaged spleen, or no spleen
- organ transplant
- multiple myeloma
- HIV infection or AIDS

• Anyone over 2 years of age who is taking any drug or treatment that lowers the body's resistance to infection, such as:
- long-term steroids
- radiation therapy
- certain cancer drugs

• Alaskan Natives and certain Native American populations.

4. How many doses of PPV are needed?

Usually one dose of PPV is all that is needed.

However, under some circumstances a second dose may be given.

• A second dose is recommended for those people aged 65 and older who got their first dose when they were under 65, if 5 or more years have passed since that dose.

• A second dose is also recommended for people who:
- have a damaged spleen or no spleen
- have sickle-cell disease
- have HIV infection or AIDS
- have cancer, leukemia, lymphoma, multiple myeloma
- have kidney failure
- have nephrotic syndrome
- have had an organ or bone marrow transplant
- are taking medication that lowers immunity (such as chemotherapy or long-term steroids)

Children 10 years old and younger may get this second dose 3 years after the first dose. Those older than 10 should get it 5 years after the first dose.

5. Other facts about getting the vaccine

* Otherwise healthy children who often get ear infections, sinus infections, or other upper respiratory diseases do not need to get PPV because of these conditions.

* PPV may be less effective in some people, especially those with lower resistance to infection. But these people should still be vaccinated, because they are more likely to get seriously ill from Pneumococcal disease.

* Pregnancy: The safety of PPV for pregnant women has not yet been studied. There is no evidence that the vaccine is harmful to either the mother or the fetus, but pregnant women should consult with their doctor before being vaccinated. Women who are at high risk of pneumococcal disease should be vaccinated before becoming pregnant, if possible.

6. What are the risks from PPV?

PPV is a very safe vaccine.

About half of those who get the vaccine have very mild side effects, such as redness or pain where the shot is given.

Less than 1% develop a fever, muscle aches, or more severe local reactions.

Severe allergic reactions have been reported very rarely.

As with any medicine, there is a very small risk that serious problems, even death, could occur after getting a vaccine.

Getting the disease is much more likely to cause serious problems than getting the vaccine.

7. What if there is a moderate or severe reaction?

What should I look for?

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.

VAERS does not provide medical advice.

8. How can I learn more?

Ask your health care provider. 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 1-800-232-4636 (1-800-CDC-INFO)

- Visit the CDC’s website at www.cdc.gov/vaccines

U.S. Department of Health & Human Services
Centers for Disease Control and Prevention
Vaccine Information Statement
Pneumococcal
7/29/97

Polio

Polio Vaccine: What You Need to Know

Many Vaccine Information Statements are available in Spanish and other languages. See www.immunize.org/vis.

1. What is polio?

Polio is a disease caused by a virus. It enters a child's (or adult's) body through the mouth. Sometimes it does not cause serious illness. But sometimes it causes paralysis (can't move arm or leg). It can kill people who get it, usually by paralyzing the muscles that help them breathe.

Polio used to be very common in the United States. It paralyzed and killed thousands of people a year before we had a vaccine for it.

2. Why get vaccinated?

Inactivated Polio Vaccine (IPV) can prevent polio.

History: A 1916 polio epidemic in the United States killed 6,000 people and paralyzed 27,000 more. In the early 1950's there were more than 20,000 cases of polio each year. Polio vaccination was begun in 1955. By 1960 the number of cases had dropped to about 3,000, and by 1979 there were only about 10. The success of polio vaccination in the U.S. and other countries sparked a world-wide effort to eliminate polio.

Today: No wild polio has been reported in the United States for over 20 years. But the disease is still common in some parts of the world. It would only take one case of polio from another country to bring the disease back if we were not protected by vaccine. If the effort to eliminate

the disease from the world is successful, some day we won't need polio vaccine. Until then, we need to keep getting our children vaccinated.

3. Who should get polio vaccine and when?

IPV is a shot, given in the leg or arm, depending on age. Polio vaccine may be given at the same time as other vaccines.

Children

Most people should get polio vaccine when they are children. Children get 4 doses of IPV, at these ages:
- A dose at 2 months
- A dose at 4 months
- A dose at 6-18 months
- A booster dose at 4-6 years

Adults

Most adults do not need polio vaccine because they were already vaccinated as children. But three groups of adults are at higher risk and should consider polio vaccination:

(1) people traveling to areas of the world where polio is common,

(2) laboratory workers who might handle polio virus, and

(3) healthcare workers treating patients who could have polio.

Adults in these three groups who have never been vaccinated against polio should get 3 doses of IPV:
- The first dose at any time,
- The second dose 1 to 2 months later,
- The third dose 6 to 12 months after the second.

Adults in these three groups who have had 1 or 2 doses of polio vaccine in the past should get the remaining 1 or 2 doses. It doesn't matter how long it has been since the earlier dose(s).

Adults in these three groups who have had 3 or more doses of polio vaccine (either IPV or OPV) in the past may get a booster dose of IPV.

Ask your health care provider for more information.

Oral Polio Vaccine: No longer recommended

There are two kinds of polio vaccine: IPV, which is the shot recommended in the United States today, and a live, oral polio vaccine (OPV), which is drops that are swallowed.

Until recently OPV was recommended for most children in the United States. OPV helped us rid the country of polio, and it is still used in many parts of the world.

Both vaccines give immunity to polio, but OPV is better at keeping the disease from spreading to other people. However, for a few people (about one in 2.4 million), OPV actually causes polio. Since the risk of getting polio in the United States is now extremely low,