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. Pneumococcal disease

Infection with Streptococcus pneumoniae bacteria can make children very sick.

It causes blood infections, pneumonia, and bacterial meningitis, mostly in young children. (Meningitis is an infection of the covering of the brain.) Pneumococcal meningitis kills about 3 people in 10 who get it.

Pneumococcal meningitis can also lead to other health problems, including deafness and brain damage.

Before there was a vaccine, pneumococcal infection caused:
• over 700 cases of meningitis,
• 13,000 blood infections,
• about 5 million ear infections, and
• about 200 deaths
every year in the United States in children under five.

Children younger than 2 years of age are at highest
risk for serious disease.

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

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

2. Pneumococcal conjugate vaccine (PCV)

There are 91 strains of pneumococcal bacteria. Pneumococcal conjugate vaccine (PCV) protects against 7 of them. These 7 strains are responsible for most severe pneumococcal infections among children. Since PCV came into use, severe pneumococcal disease has dropped by nearly 80% among children under 5.

PCV can also prevent some cases of pneumonia and some ear infections. But pneumonia and ear infections have many causes, and PCV only works against those caused by pneumococcal bacteria.

PCV is given to infants and toddlers . . . to protect them when they are at greatest risk for serious diseases caused by pneumococcal bacteria.

Older children and adults with certain chronic illnesses may get a different vaccine called pneumococcal polysaccharide vaccine. There is a separate Vaccine Information Statement for that vaccine.

3. Who should get the vaccine and when?

Infants and Children under 2 years of age:

PCV is routinely given as a series of 4 doses, one dose at each of these ages:
- 2 months
- 4 months
- 6 months
- 12-15 months

Children who miss their shots at these ages should still get the vaccine. The number of doses and the intervals between doses will depend on the child’s age. Ask your health care provider for details.

Children 2 through 4 years of age:

• Healthy children between their 2nd and 5th birthdays who have not completed the PCV series should get 1 dose.

• Children with medical conditions such as:
- sickle cell disease,
- a damaged spleen or no spleen,
- cochlear implants,
- HIV/AIDS or other diseases that affect the immune system (such as diabetes, cancer, or liver disease), or
- chronic heart or lung disease . . .

or children who take medications that affect the immune system, such as chemotherapy or steroids . . .

should get 1 or 2 doses of PCV, if they have not already completed the 4-dose series. Ask your health care provider for 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 if they have a severe allergy to any 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?

Any medicine, including a vaccine, could possibly cause a serious problem, such as a severe allergic reaction. However, the risk of any vaccine causing serious harm, or death, is extremely small.

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 greater than 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.

No serious reactions have been associated with this vaccine.

6. 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 severe 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 the doctor what happened, the date and time it happened, and when the vaccination was given.

Ask your provider 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.

7. 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.

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 (Interim)
Pneumococcal Conjugate Vaccine
12/9/08
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, experts believe that using oral polio vaccine is no longer worth the slight risk, except in limited circumstances which your doctor can describe. The polio shot (IPV) does not cause polio. If you or your child will be getting OPV, ask for a copy of the OPV supplemental Vaccine Information Statement.

4. Some people should not get IPV or should, wait.

These people should not get IPV:

• Anyone who has ever had a life-threatening allergic reaction to the antibiotics neomycin, streptomycin or polymyxin B should not get the polio shot.

• Anyone who has a severe allergic reaction to a polio shot should not get another one.

These people should wait:

• Anyone who is moderately or severely ill at the time the shot is scheduled should usually wait until they recover before getting polio vaccine. People with minor illnesses, such as a cold, may be vaccinated.

Ask your health care provider for more information.

5.What are the risks from IPV?

Some people who get IPV get a sore spot where the shot was given. The vaccine used today has never been known to cause any serious problems, and most people don't have any problems at all with it.

However, a vaccine, like any medicine, could cause serious problems, such as a severe allergic reaction. The risk of a polio shot 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.

. 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
Polio
1/1/2000
42 U.S.C. Section 300aa-26

Rabies

Rabies 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 Rabies?

Rabies is a serious disease. It is caused by a virus.

Rabies is mainly a disease of animals. Humans get rabies when they are bitten by infected animals.

At first there might not be any symptoms. But weeks, or even years after a bite, rabies can cause pain, fatigue, headaches, fever, and irritability. These are followed by seizures, hallucinations, and paralysis. Rabies is almost always fatal.

Wild animals - especially bats - are the most common source of human rabies infection in the United States.

Skunks, raccoons, dogs, and cats can also transmit the disease.

Human rabies is rare in the United States. There have been only 39 cases diagnosed since 1990. However, between 16,000 and 39,000 people are treated each year for possible exposure to rabies after animal bites. Also, rabies is far more common in other parts of the world, with about 40,000 - 70,000 rabies-related deaths each year. Bites from unvaccinated dogs cause most of these cases.

Rabies vaccine can prevent rabies.

2. Rabies vaccine

Rabies vaccine is given to people at high risk of rabies to protect them if they are exposed. It can also prevent the disease if it is given to a person after they have been exposed.

Rabies vaccine is made from killed rabies virus. It cannot cause rabies.

3. Who should get rabies vaccine and when?

Preventive Vaccination (No Exposure)

People at high risk of exposure to rabies, such as veterinarians, animal handlers, rabies laboratory workers, spelunkers, and rabies biologics production workers should be offered rabies vaccine.

The vaccine should also be considered for:

People whose activities bring them into frequent contact with rabies virus or with possibly rabid animals.

International travelers who are likely to come in contact with animals in parts of the world where rabies is common.

The pre-exposure schedule for rabies vaccination is 3 doses, given at the following times:
Dose 1: As appropriate
Dose 2: 7 days after Dose 1
Dose 3: 21 days or 28 days after Dose 1

For laboratory workers and others who may be repeatedly exposed to rabies virus, periodic testing for immunity is recommended, and booster doses should be given as needed. (Testing or booster doses are not recommended for travelers.) Ask your doctor for details.

Vaccination After an Exposure

Anyone who has been bitten by an animal, or who otherwise may have been exposed to rabies, should see a doctor immediately.

A person who is exposed and has never been vaccinated against rabies should get 5 doses of rabies vaccine - one dose right away, and additional doses on the 3rd, 7th, 14th, and 28th days. They should also get a shot of Rabies Immune Globulin at the same time as the first dose. This gives immediate protection.

A person who has been previously vaccinated should get 2 doses of rabies vaccine - one right away and another on the 3rd day. Rabies Immune Globulin is not needed.

4. Tell your doctor if . . .

Talk with a doctor before getting rabies vaccine if you:

1) ever had a serious (life-threatening) allergic reaction to a previous dose of rabies vaccine, or to any component of the vaccine,

2) have a weakened immune system because of:
- HIV/AIDS or another disease that affects the immune system,
- treatment with drugs that affect the immune system, such as steroids,
- cancer, or cancer treatment with radiation or drugs.

If you have a minor illnesses, such as a cold, you can be vaccinated. If you are moderately or severely ill, you should probably wait until you recover before getting a routine (non-exposure) dose of rabies vaccine.

If you have been exposed to rabies virus, you should get the vaccine regardless of any other illnesses you may have.

5. What are the risks from rabies 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. Serious problems from rabies vaccine are very rare.

Mild problems:
• soreness, redness, swelling, or itching where the shot was given (30% - 74%)
• headache, nausea, abdominal pain, muscle aches, dizziness (5% - 40%)

Moderate problems:
• hives, pain in the joints, fever (about 6% of booster doses)
• illness resembling Guillain-Barré Syndrome (GBS), with complete recovery (very rare)

Other nervous system disorders have been reported after rabies vaccine, but this happens so rarely that it is not known whether they are related to the vaccine.

NOTE: Several brands of rabies vaccine are available in the United States, and reactions may vary between brands. Your provider can give you more information about a particular brand.

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 rabies website at www.cdc.gov/ncidod/dvrd/rabies

U.S. Department of Health & Human Services
Centers for Disease Control and Prevention
Vaccine Information Statement
Rabies Vaccine
1/12/06

Rotavirus

Rotavirus 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 rotavirus?

Rotavirus is a virus that causes severe diarrhea, mostly in babies and young children. It is often accompanied by vomiting and fever.

Rotavirus is not the only cause of severe diarrhea, but it is one of the most serious. Each year in the United States rotavirus is responsible for:
• more than 400,000 doctor visits
• more than 200,000 emergency room visits
• 55,000 to 70,000 hospitalizations
• 20-60 deaths

Almost all children in the U.S. are infected with rotavirus before their 5th birthday.

Children are most likely to get rotavirus disease between November and May, depending on the part of the country.

Your baby can become infected by being around other children who have rotavirus diarrhea.

2. Rotavirus vaccine.

Better hygiene and sanitation have not reduced rotavirus diarrhea very much in the United States. The best way to protect your baby is with rotavirus vaccine.

Rotavirus vaccine is an oral (swallowed) vaccine; not a shot.

Rotavirus vaccine will not prevent diarrhea or vomiting caused by other germs, but it is very good at preventing diarrhea and vomiting caused by rotavirus. Most babies who get the vaccine will not get rotavirus diarrhea at all, and almost all of them will be protected from severe rotavirus diarrhea.

Babies who get the vaccine are also much less likely to be hospitalized or to see a doctor because of rotavirus infection.

3. Who should get rotavirus vaccine and when?

There are two brands of rotavirus vaccine. A baby should get either 2 or 3 doses, depending on which brand is used. The doses are recommended at these ages:
First Dose: 2 months of age
Second Dose: 4 months of age
Third Dose: 6 months of age (if needed)

The first dose may be given as early as 6 weeks of age, and should be given by age 14 weeks 6 days. The last dose should be given by 8 months of age.

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

Babies who get the vaccine may be fed normally afterward.

4. Some children should not get rotavirus vaccine or should wait.

A child who has had a severe (life-threatening) allergic reaction to a dose of rotavirus vaccine should not get another dose. A child who has a severe (life threatening) allergy to any component of rotavirus vaccine should not get the vaccine. Tell your doctor if your child has any severe allergies that you know of.

Children who are moderately or severely ill at the time the vaccination is scheduled should probably wait until they recover. This includes children who have diarrhea or vomiting. Ask your doctor or nurse. Children with mild illnesses should usually get the vaccine.

Check with your doctor if your child has any ongoing digestive problems.

Check with your doctor if your child’s immune system is weakened because of:
- HIV/AIDS, or any other disease that affects the immune system
- treatment with drugs such as long-term steroids
- cancer, or cancer treatment with x-rays or drugs

Check with your doctor if your child recently had a blood transfusion or received any other blood product (such as immune globulin).

In the late 1990s a different type of rotavirus vaccine was used. This vaccine was found to be associated with an uncommon type of bowel obstruction called “intussusception,” and was taken off the market.

The new rotavirus vaccines have not been associated with intussusception.

However, babies who have had intussusception, from any cause, they are at higher risk for getting it again. If your baby has ever had intussusception, discuss this with your doctor.

5. What are the risks from rotavirus vaccine?

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

Most babies who get rotavirus vaccine do not have any problems with it.

Mild problems

Babies may be slightly more likely to be irritable, or to have mild, temporary diarrhea or vomiting after getting a dose of rotavirus vaccine than babies who did not get the vaccine.

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

If rare reactions occur with any new product, they may not be identified until thousands, or millions, of people have used it. Like all vaccines, rotavirus 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. 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 (Interim)
Rotavirus
8/28/08
42 U.S.C. Section 300aa-26

Shingles

Shingles 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 shingles?

Shingles is a painful skin rash, often with blisters. It is also called Herpes Zoster.

A shingles rash usually appears on one side of the face or body and lasts a week to 10 days. Its main symptom is pain, which can be quite severe. Other symptoms of shingles can include fever, headache, chills and upset stomach. Very rarely, a shingles infection can lead to pneumonia, hearing problems, blindness, brain inflammation (encephalitis) or death.

For about 1 person in 5, severe pain can continue even after the rash clears up. This is called post-herpetic neuralgia.

Shingles is caused by the Varicella Zoster virus, the same virus that causes chickenpox. Only someone who has had a case of chickenpox – or gotten chickenpox vaccine – can get shingles. The virus stays in your body. It can reappear many years later to cause a case of shingles.

You can’t catch shingles from another person with shingles. However, a person who has never had chickenpox (or chickenpox vaccine) could get chickenpox from someone with shingles. This is not very common.

Shingles is far more common in people 60 and older than in younger people. It is also more common in people whose immune systems are weakened because of a disease such as cancer, or drugs such as steroids or chemotherapy. At least 500,000 people a year in the United States get shingles.

2. Shingles vaccine

A vaccine for shingles was licensed in 2006. In clinical trials, the vaccine prevented shingles in about half of people 60 years of age and older. It can also reduce the pain associated with shingles.

A single dose of shingles vaccine is indicated for adults 60 years of age and older.

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

A person should not get shingles vaccine who:

has ever had a life-threatening allergic reaction to gelatin, the antibiotic neomycin, or any other component of shingles vaccine. Tell your doctor if you have any severe allergies.

has a weakened immune system because of

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

- treatment with drugs that affect the immune system, such as steroids,

- cancer treatment such as radiation or chemotherapy,

- a history of cancer affecting the bone marrow or lymphatic system, such as leukemia or lymphoma.

has active, untreated tuberculosis.

is pregnant, or might be pregnant. Women should not become pregnant until at least three months after getting shingles vaccine.

Someone with a minor illness, such as a cold, may be vaccinated. But anyone who is

moderately or severely ill should usually wait until they recover before getting the vaccine. This includes anyone with a temperature of 101.3° F or higher.

4. What are the risks from shingles vaccine?

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

No serious problems have been identified with shingles vaccine.

Mild Problems

Redness, soreness, swelling, or itching at the site of the injection (about 1 person in 3).

Headache (about 1 person in 70).

Like all vaccines, shingles vaccine is being closely monitored for unusual or severe problems.

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. How can I learn more?

Your provider 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)
Shingles
9/11/06

Td/Tdap

Tetanus, Diphtheria (Td) or Tetanus, Diphtheria, Pertussis (Tdap) 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?

Children 6 years of age and younger are routinely vaccinated against tetanus, diphtheria and pertussis. But older children, adolescents, and adults need protection from these diseases too. Td (Tetanus, Diphtheria) and Tdap (Tetanus, Diphtheria, Pertussis) vaccines provide that protection.

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 kills about 1 out of 5 people who are infected.

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

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

PERTUSSIS (Whooping Cough) causes severe coughing spells, vomiting, and disturbed sleep.

These three diseases are all caused by bacteria. Diphtheria and pertussis are spread from person to person. Tetanus enters the body through cuts, scratches, or wounds.

The United States averaged more than 1,300 cases of tetanus and 175,000 cases of diphtheria each year before vaccines. Since vaccines have been available, tetanus cases have fallen by over 96% and diphtheria cases by over 99.9%.

Before 2005, only children younger than than 7 years of age could get pertussis vaccine. In 2004 there were more than 8,000 cases of pertussis in the U.S. among adolescents and more than 7,000 cases among adults.

2. Td and Tdap vaccines.

Td vaccine has been used for many years. It protects against tetanus and diphtheria.

Tdap was licensed in 2005. It is the first vaccine for ado- lescents and adults that protects against all three diseases.

Note: At this time, Tdap is licensed for only one lifetime dose per person. Td is given every 10 years, and more often if needed.

These vaccines can be used in three ways: 1) as catch-up for people who did not get all their doses of DTaP or DTP when they were children, 2) as a booster dose every 10 years, and 3) for protection against tetanus infection after a wound.

3. Which vaccine, and when?

Routine: Adolescents 11 through 18
A dose of Tdap is recommended for adolescents who got DTaP or DTP as children and have not yet gotten a booster dose of Td. The preferred age is 11-12.

Adolescents who have already gotten a booster dose of Td are encouraged to get a dose of Tdap as well, for
protection against pertussis. Waiting at least 5 years between Td and Tdap is encouraged, but not required.

Adolescents who did not get all their scheduled doses of DTaP or DTP as children should complete the series using a combination of Td and Tdap.

Routine: Adults 19 and Older
All adults should get a booster dose of Td every 10 years. Adults under 65 who have never gotten Tdap should
substitute it for the next booster dose.

Adults under 65 who expect to have close contact with an infant younger than 12 months of age (including women who may become pregnant) should get a dose of Tdap. Waiting at least 2 years since the last dose of Td is suggested, but not required.

Healthcare workers under 65 who have direct patient contact in hospitals or clinics should get a dose of Tdap. A 2-year interval since the last Td is suggested, but not required.

New mothers who have never gotten Tdap should get a dose as soon as possible after delivery. If vaccination is needed during pregnancy, Td is usually preferred over Tdap.

Protection After a Wound
A person who gets a severe cut or burn might need a dose of Td or Tdap to prevent tetanus infection. Tdap may be used for people who have never had a dose. But Td should be used if Tdap is not available, or for:
- anybody who has already had a dose of Tdap,
- children 7 through 9 years of age, or
- adults 65 and older.

Tdap and Td may be given at the same time as other vaccines.

4. Some people should not be vaccinated or should wait.

Anyone who has had a life-threatening allergic reaction after a dose of DTP, DTaP, DT, or Td should not get Td or Tdap.

Anyone who has a severe allergy to any component of a vaccine should not get that vaccine. Tell your provider if the person getting the vaccine has any severe allergies.

Anyone who had a coma, or long or multiple seizures within 7 days after a dose of DTP or DTaP should not get Tdap, unless a cause other than the vaccine was found (these people can get Td).

Talk to your provider if the person getting either vaccine:
- has epilepsy or another nervous system problem,
- had severe swelling or severe pain after a previous dose of DTP, DTaP, DT, Td, or Tdap vaccine, or
- has had Guillain Barré Syndrome (GBS).

Anyone who has a moderate or severe illness on the day
the shot is scheduled should usually wait until they recover before getting Tdap or Td vaccine. A person with a mild illness or low fever can usually be vaccinated.

5. What are the risks from Tdap and Td vaccines?

With a vaccine (as with any medicine) there is always a small risk of a life-threatening allergic reaction or other serious problem.

Getting tetanus, diphtheria or pertussis would be much more likely to lead to severe problems than getting either vaccine.

Problems reported after Td and Tdap vaccines are listed below.

Mild Problems
(Noticeable, but did not interfere with activities)

Tdap
- Pain (about 3 in 4 adolescents and 2 in 3 adults)
- Redness or swelling (about 1 in 5)
- Mild fever of at least 100.4°F (up to about 1 in 25
adolescents and 1 in 100 adults)
- Headache (about 4 in 10 adolescents and 3 in 10 adults)
- Tiredness (about 1 in 3 adolescents and 1 in 4 adults)
- Nausea, vomiting, diarrhea, stomach ache (up to 1 in 4 adolescents and 1 in 10 adults)
- Chills, body aches, sore joints, rash, swollen glands (uncommon)

Td
- Pain (up to about 8 in 10)
- Redness or swelling (up to about 1 in 3)
- Mild fever (up to about 1 in 15)
- Headache or tiredness (uncommon)

Moderate Problems
(Interfered with activities, but did not require medical attention)

Tdap
- Pain at the injection site (about 1 in 20 adolescents and 1 in 100 adults)
- Redness or swelling (up to about 1 in 16 adolescents and 1 in 25 adults)
- Fever over 102°F (about 1 in 100 adolescents and 1 in 250 adults)
- Headache (1 in 300)
- Nausea, vomiting, diarrhea, stomach ache (up to 3 in 100 adolescents and 1 in 100 adults)

Td
- Fever over 102°F (rare)

Tdap or Td
- Extensive swelling of the arm where the shot was given (up to about 3 in 100).

Severe Problems
(Unable to perform usual activities; required medical attention)

Tdap
- Two adults had nervous system problems after getting the vaccine during clinical trials. These may or may not have been caused by the vaccine. These problems went away on their own and did not cause any permanent harm.

Tdap or Td
- Swelling, severe pain, and redness in the arm where the shot was given (rare).

A severe allergic reaction could occur after any vaccine. They are estimated to occur less than once in a million doses.

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 (Interim)
Td and Tdap Vaccines
11/18/08
42 U.S.C. Section 300aa-26

Typhoid

Typhoid 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 typhoid?

Typhoid (typhoid fever) is a serious disease. It is caused by bacteria called Salmonella Typhi.

Typhoid causes a high fever, weakness, stomach pains, headache, loss of appetite, and sometimes a rash. If it is not treated, it can kill up to 30% of people who get it.

Some people who get typhoid become “carriers,” who can spread the disease to others.

Generally, people get typhoid from contaminated food or water. Typhoid is not common in the U.S., and most U.S. citizens who get the disease get it while traveling. Typhoid strikes about 21 million people a year around the world and kills about 200,000.

Typhoid vaccine can prevent typhoid.

2. Typhoid vaccines

There are two vaccines to prevent typhoid. One is an inactivated (killed) vaccine gotten as a shot, and the other is live, attenuated (weakened) vaccine which is taken orally (by mouth).

3. Who should get typhoid vaccine and when?

Routine typhoid vaccination is not recommended in the United States, but typhoid vaccine is recommended for:

• Travelers to parts of the world where typhoid is common. (NOTE: typhoid vaccine is not 100% effective and is not a substitute for being careful about what you eat or drink.)

• People in close contact with a typhoid carrier.

• Laboratory workers who work with Salmonella Typhi bacteria.

Inactivated Typhoid Vaccine (Shot)

• Should not be given to children younger than 2 years of age.

• One dose provides protection. It should be given at least 2 weeks before travel to allow the vaccine time to work.

• A booster dose is needed every 2 years for people who remain at risk.

Live Typhoid Vaccine (Oral)

• Should not be given to children younger than 6 years of age.

• Four doses, given 2 days apart, are needed for protection. The last dose should be given at least 1 week before travel to allow the vaccine time to work.

• A booster dose is needed every 5 years for people who remain at risk.

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

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

Inactivated Typhoid Vaccine (Shot)

• Anyone who has had a severe reaction to a previous dose of this vaccine should not get another dose.

Live Typhoid Vaccine (Oral)

• Anyone who has had a severe reaction to a previous dose of this vaccine should not get another dose.

• Anyone whose immune system is weakened should not get this vaccine. They should get the inactivated typhoid vaccine instead. These people include anyone who:
- Has HIV/AIDS or another disease that affects the immune system.
- Is being treated with drugs that affect the immune system, such as steroids, for 2
weeks or longer.
- Has any kind of cancer.
- Is taking cancer treatment with x-rays or drugs.

• Oral typhoid vaccine should not be given within 24 hours of certain antibiotics.

Ask your doctor or nurse for more information.

5. What are the risks from typhoid 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 either of the two typhoid vaccines are very rare.

Inactivated Typhoid Vaccine (Shot)

Mild Reactions:
• Fever (up to about 1 person per 100).
• Headache (up to about 3 people per 100).
• Redness or swelling at the site of the injection (up to 7 people per 100).

Live Typhoid Vaccine (Oral)

Mild Reactions:
• Fever or headache (up to about 5 people per 100).
• Abdominal discomfort, nausea, vomiting, or rash (rare).

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):

- Visit the CDC’s typhoid website at www.cdc.gov/ncidod/dbmd/diseaseinfo/typhoidfever_g.htm

U.S. Department of Health & Human Services
Centers for Disease Control and Prevention
Vaccine Information Statement
Typhoid Vaccine
5/19/04

Varicella (Chickenpox)

Chickenpox 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?

Chickenpox (also called varicella) is a common childhood disease. It is usually mild, but it can be serious, especially in young infants and adults.

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

• It can lead to severe skin infection, scars, pneumonia, brain damage, or death.

• The chickenpox virus can be spread from person to person through the air, or by contact with fluid from chickenpox blisters.

• A person who has had chickenpox can get a painful rash called shingles years later.

• Before the vaccine, about 11,000 people were hospitalized for chickenpox each year in the United States.

• Before the vaccine, about 100 people died each year in the United States as a result of chickenpox.

Chickenpox vaccine can prevent chickenpox.

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

2. Who should get chickenpox vaccine and when?

Routine

Children who have never had chickenpox should get 2 doses of chickenpox vaccine at these ages:
- First dose: 12 through 15 months of age
- Second dose: 4 through 6 years of age (may be given earlier if at least 3 months after the first dose)

People 13 years of age and older (who have never had chickenpox or received chickenpox vaccine) should get two doses at least 28 days apart.

Catch-Up

Children or adolescents who are not fully vaccinated should receive one or two doses of chickenpox vaccine. The timing of these doses depends on the person's age. Ask your provider.

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

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

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

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

• People who are moderately or severely ill at the time the shot is scheduled should usually wait until they recover before getting chickenpox vaccine.

• Pregnant women should wait to get chickenpox vaccine until after they have given birth. Women should not get pregnant for 1 month after getting chickenpox vaccine.

• Some people should check with their doctor about whether they should get chickenpox vaccine, including anyone who:
- Has HIV/AIDS or another disease that affects the immune system
- Is being treated with drugs that affect the immune system, such as steroids, for 2 weeks or longer
- Has any kind of cancer
- Is getting cancer treatment with radiation or drugs

• People who recently had a transfusion or were given other blood products should ask their doctor when they may get chickenpox vaccine.

Ask your provider for more information.

4. What are the risks from chickenpox vaccine?

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

Getting chickenpox vaccine is much safer than getting chickenpox disease. Most people who get chickenpox vaccine do not have any problems with it.

Mild Problems
• Soreness or swelling where the shot was given (about 1 out of 5 children and up to 1 out of 3 adolescents and adults)
• Fever (1 person out of 10, or less)
• Mild rash, up to a month after vaccination (1 person out of 25). It is possible for these people to infect other members of their household, but this is extremely rare.

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

Severe Problems
• Pneumonia (very rare)

Other serious problems, including severe brain reactions and low blood count, have been reported after chickenpox vaccination. These happen so rarely experts cannot tell whether they are caused by the vaccine or not. If they are, it is extremely rare.

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)
Varicella Vaccine
3/13/08
42 U.S.C. Section 300aa-26

Yellow Fever

Yellow Fever 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 Yellow Fever?

Yellow fever is a serious disease caused by the yellow fever virus. It is spread through the bite of an infected mosquito and cannot be spread directly from person to person. It is found in certain parts of Africa and South America.

Yellow fever can cause:
- fever and flu-like illness
- jaundice (yellow skin or eyes)
- liver, kidney, respiratory and other organ system failure
- vomiting blood
- death

People with yellow fever disease usually have to be hospitalized.

2. How can I prevent Yellow Fever?

Yellow Fever Vaccine

Yellow fever vaccine can prevent yellow fever.

Yellow fever vaccine is given only at approved vaccination centers.

After receiving the vaccine, you should receive an International Certificate of Vaccination (yellow card) that has been validated by the vaccination center. This Certificate becomes valid 10 days after vaccination and lasts for 10 years. You will need this card as proof of vaccination to enter certain countries. Consult your health department or visit CDC’s travel information website at www.cdc.gov/travel to learn the travel requirements for different countries or to find the nearest approved vaccination center.

Please make sure you discuss your travel itinerary with your doctor or nurse before you receive your yellow fever vaccination.

Other Preventive Measures

As with any disease transmitted by mosquitoes, precautions and insect repellent are also recommended to prevent exposure to yellow fever virus. These precautions include remaining in well-screened areas, wearing clothes that cover most of the body, and using effective insect repellent (i.e., containing up to 50% N,N-diethylmetatoluamide [DEET]) on skin and clothing.

3. Who should get Yellow Fever vaccine?

- Persons 9 months of age or older traveling to or living in a country that requires yellow fever vaccination for certain travelers. Check with your health-care provider.

- Persons 9 months of age or older traveling to a country that does not require yellow fever vaccination but is located in an area where the risk of yellow fever is known to exist. Check with your health-care provider.

Infor mation about known or probable infected areas is available from the World Health Organization ( www.who.int), the Pan American Health Organization (www.paho.org), and CDC ( www.cdc.gov/travel).

If you continue to live or travel in yellow fever-endemic areas, you should receive a booster dose of yellow fever vaccine after 10 years.

Yellow fever vaccine may be given at the same time as most other vaccines.

4. Who should not get Yellow Fever vaccine?

Persons who have ever had a life-threatening allergic reaction to eggs, chicken, gelatin or to a previous yellow fever vaccine.

Infants younger than 9 months of age. For infants 6 to 8 months of age who cannot avoid travel to a yellow fever area, discuss vaccination with their doctor. Under no circumstances should infants younger than 6 months of age be vaccinated.

Pregnant women and nursing mothers should avoid or postpone travel to a yellow fever area. If travel cannot be avoided, discuss vaccination with your doctor.

Check with your doctor before getting yellow fever vaccine if you:
- Have a history of allergy to eggs, chicken, or gelatin
- Have HIV/AIDS or another disease that affects the immune system
- Have been under treatment for 2 weeks or longer with drugs that affect the immune system, such as steroids
- Have any kind of cancer
- Are taking cancer treatment with X-rays or drugs
- Your thymus gland has been removed, or if you have a history of problems with your thymus, such as myasthenia gravis, DiGeorge syndrome, or thymoma.

If you are 65 or older, discuss with your physician the risks and benefits of vaccination in the context of your risk for exposure to yellow fever virus based on your destination.

If you cannot get the vaccine because of a medical reason and proof of yellow fever vaccination is required for your travel, your doctor can give you a waiver letter. When planning to use a waiver letter, you should also obtain specific advice from the embassy of the country or countries you plan to visit.

If you cannot get the vaccine, discuss with your doctor other ways to prevent yellow fever.

5. What are the risks from Yellow Fever 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.

Reactions are less likely to occur after a booster dose of yellow fever vaccine than after the first dose.

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 for 5 to 10 days. In studies, they occurred in as many as 25 percent of vaccine recipients.

Severe problems(estimates based on passive reporting):
• Life-threatening allergic reaction (approximately 1 reported per 131,000 doses).
• Severe nervous system reactions (approximately 1 reported per 150,000 to 250,000 doses).
• Life-threatening severe illness with major organ system failure (approximately 1 per 200,000 to 300,000 doses, or per 40,000 to 50,000 doses in people 60 years of age and older). More than half of the people who suffer these side effects die.

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, behavior changes, or flu-like symptoms that occur 1-30 days after vaccination. Signs of an allergic reaction 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 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 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):

- Visit the CDC’s Travelers’ Health website at www.cdc.gov/travel/diseases/yellowfever.htm or other CDC websites at www.cdc.gov/ncidod/dvbid/yellowfever/ or www.cdc.gov/mmwr/preview/mmwrhtml/00031094.htm.

U.S. Department of Health & Human Services
Centers for Disease Control and Prevention
Vaccine Information Statement
Yellow Fever
11/9/04

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This page last modified on December 9, 2008
Content last reviewed on September 17, 2008
Content Source: National Center for Immunization and Respiratory Diseases

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