Pediarix (DTaP-HepB IPV)

Diphtheria, pertussis (whooping cough), and tetanus are serious diseases caused by bacteria. Hepatitis B and polio are serious diseases caused by viruses.

Diphtheria leads to a thick coating in the nose, throat, and airway. This can cause breathing problems, paralysis, heart problems, or even death.

Hepatitis B causes inflammation of the liver, vomiting, and jaundice (yellowing of the skin or eyes). Hepatitis can result in liver cancer, cirrhosis, or death.

Pertussis (whooping cough) causes severe, long-lasting coughing episodes that can make it hard to eat, drink, or breathe. Pertussis can lead to pneumonia, seizures, brain damage, and death.

Polio is a life-threatening condition that affects the brain and spinal cord, causing muscle weakness and paralysis. Polio can be fatal if it affects the muscles that help you breathe.

Tetanus (lockjaw) causes painful muscle tightening that can result in the jaw "locking," preventing the person from opening their mouth, swallowing, or breathing. Tetanus can lead to death.

Diphtheria, hepatitis B, pertussis, and polio are spread from person to person. Tetanus enters the body through a cut or wound.

The diphtheria, hepatitis B, acellular pertussis, polio, and tetanus vaccine is used to help prevent these diseases in children who are 6 weeks through 6 years of age (before their seventh birthday) and who were born to mothers who are hepatitis B surface antigen (HBsAg)-negative.

This vaccine helps your child's body build immunity to these diseases, but will not treat an active infection that your child already has.

Like any vaccine, the diphtheria, hepatitis B, pertussis acellular, polio, and tetanus vaccine may not protect every person from disease.

Getting infected with diphtheria, hepatitis B, pertussis, polio, or tetanus may be much 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 a vaccine containing diphtheria, hepatitis B, pertussis, polio, or tetanus, or to any ingredient in this vaccine, including yeast, neomycin, or polymyxin B;
• decreased consciousness, seizures, or coma within 7 days after getting a pertussis vaccine; or
• nervous system problems or brain disorders (such as infantile spasms or uncontrolled epilepsy).

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

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

Tell the vaccination provider if your child was born prematurely.

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 another shot if he or she had a life-threatening allergic reaction after the first shot.

Keep a record of all side effects your child experiences. If the child receives another dose, inform the vaccination provider if the previous shot caused any side effects.

Getting infected with diphtheria, hepatitis B, pertussis, polio, or tetanus may pose a greater risk to your child's health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the chance of serious side effects is very low.

Contact 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 continuously for 3 hours or longer within 48 hours after receiving the DTaP-HepB-IPV vaccine, or if your child has a seizure within 3 days after getting the vaccine.

Also call your doctor right away if the child has:

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

Common side effects of Pediarix (DTaP-HepB IPV) may include:

• redness, pain, or swelling where the shot was given;
• fever of 100.4°F or higher;
• fussiness, crying more than usual;
• drowsiness; or
• loss of appetite.

This is not a complete list of side effects, and others may happen. Call your 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.

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

This vaccine is given as a series of 3 doses, usually given at 2, 4, and 6 months of age. The first dose may be given as early as 6 weeks of age.

Your child's individual schedule may be different from these guidelines, especially if the child was born prematurely. Follow your doctor's instructions or the schedule recommended by your local health department.

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 unlikely to happen.

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

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

Also, let the vaccination provider know if your child has recently taken any 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 for preventing organ transplant rejection.

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