Infanrix (DTaP) Preservative Free

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

Diphtheria can lead to breathing problems, paralysis, heart failure, or death.

Tetanus (lockjaw) causes painful tightening of the muscles that can lead to "locking" of the jaw, making it impossible to open the mouth, swallow, or breathe. Tetanus can lead to death.

Pertussis (whooping cough) causes severe, long-lasting coughing episodes that can interfere with eating, drinking, or breathing. Pertussis can lead to pneumonia, seizures, brain damage, and death.

Diphtheria and pertussis spread from person to person. Tetanus enters the body through a cut or wound.

The diphtheria, tetanus, acellular pertussis pediatric vaccine (also called DTaP) helps prevent these diseases in children. This vaccine helps your body develop immunity to the disease but will not treat an already active infection.

DTaP vaccine is for use in children between the ages of 6 weeks and 6 years old (before the child has reached his or her 7th birthday).

Like any vaccine, the DTaP vaccine may not provide protection from disease in every person.

This vaccine is given as an injection (shot) into a muscle.

This vaccine is given as a series of 5 doses. It is usually given at 2, 4, and 6 months of age, followed by one dose at 15 to 20 months of age and another dose at 4 to 6 years of age.

The timing of this vaccination is very important for it to work well. Your child's individual booster schedule may be different from these guidelines. Follow your child's doctor's instructions or the schedule recommended by your local health department.

Your child may receive other vaccines at the same time as this vaccine.

Your child may be given other medications to help prevent certain serious side effects or allergic reactions. Keep taking these medicines for as long as your doctor has prescribed.

Getting diphtheria, pertussis, or tetanus is far more harmful to your child's health than getting this vaccine.

Your child should not receive this vaccine if he or she has ever had a similar vaccine that caused any of the following:

• a severe allergic reaction to Infanrix (DTaP) Preservative Free or any ingredient in the vaccine;
• nervous system problems or brain disorders (such as infantile spasms or uncontrolled epilepsy); or
• decreased consciousness, seizures, or coma within 7 days after receiving a pertussis vaccine.

Your child may not be able to receive this vaccine if he or she has ever had a pertussis vaccine that caused:

• within 48 hours after the vaccine--a very high fever (105°F (40.5°C) or higher), excessive crying for 3 hours or longer, fainting or going into shock; or
• within 3 days after the vaccine--a seizure.

Tell your vaccination provider if your child has or has ever had:

• seizures;
• Guillain-Barré syndrome (within 6 weeks after receiving a tetanus vaccine); or
• a weak immune system caused by disease or by taking certain medicines or receiving cancer treatments.

Tell the vaccination provider if your child was born prematurely or has a seizure disorder.

The pediatric version of this vaccine (Daptacel, Infanrix) should not be given to a child who is 7 years or older.

Get emergency medical help if your child shows signs of an allergic reaction: hives, trouble breathing, swelling of the face, lips, tongue, or throat.

Your child should not get the second shot if they had a life-threatening allergic reaction after the first shot.

Keep track of all side effects your child experiences. If the child gets a booster dose, inform the vaccination provider if any side effects occurred after the previous shot.

Getting diphtheria, pertussis, or tetanus can be more harmful to your child's health than getting the vaccine that protects against these diseases. Like any medicine, this vaccine can cause side effects, but the chance of serious side effects is very low.

Call your child's doctor immediately if your child has a fever of 105°F (40.5°C) or higher, collapses or has a shock-like episode, or cries nonstop for 3 hours or more within 48 hours after getting a DTaP vaccine, or if your child has a seizure within 3 days after receiving the vaccine.

Also contact your doctor right away if your child experiences:

• fainting; or
• nervous system issues—numbness, pain, tingling, weakness, a burning or prickly feeling, vision or hearing problems, or trouble breathing.

Common side effects include:

• pain, redness, tenderness, or swelling at the injection site;
• fussiness or unusual crying;
• fever;
• drowsiness or tiredness; or
• loss of appetite.

This is not a complete list of side effects and others may happen. Call your child's doctor for medical advice about side effects. You can report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Contact your vaccination provider if your child misses a dose or falls behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Make sure your child receives all recommended doses of this vaccine, or the child may not be fully protected against disease.

An overdose of this vaccine is not likely to happen.

Follow the vaccination provider's instructions regarding any limits on food, drinks, or activities.

Before getting this vaccine, inform the vaccination provider about all other vaccines your child has had recently.

Also, inform the vaccination provider if your child has recently taken drugs or treatments that can weaken the immune system, including:

• steroid medicine;
• cancer treatments;
• medicine for psoriasis, rheumatoid arthritis, or other autoimmune disorders; or
• medicines to treat or prevent organ transplant rejection.

This list is not complete. Other drugs may affect this vaccine, including prescription and over-the-counter medicines, vitamins, and Herbal products. Not all possible drug interactions are listed here.