Introduction

Class Name(s):

• 80:12 Vaccines

Brand Name(s):

• Pediarix^®

Why get vaccinated?

Diphtheria, tetanus, pertussis, hepatitis B, and inactivated polio vaccine may prevent diphtheria, tetanus, pertussis, and poliomyelitis (polio) that may occur with infection due to C. diphtheriae (diphtheria), C. tetani (tetanus), B. pertussis (pertussis), hepatitis B virus, and polioviruses.

Infection with C. diphtheriae can cause diphtheria (difficulty breathing and life-threatening heart failure and paralysis), infection with C. tetani can cause tetanus (painful stiffening of the muscles), infection with B. pertussis can cause whooping cough (a respiratory disease with severe coughing episodes), hepatitis B virus can cause liver disease, and polioviruses can cause polio (illness with sore throat and fever that may progress to a brain infection and cause paralysis).

Diphtheria, tetanus, pertussis, hepatitis B, and inactivated polio vaccine does not contain active bacteria or virus. The vaccine works by triggering the body to make antibodies against viruses and the toxins produced by these bacteria to provide a defense against potential infection.

How is the vaccine given?

Diphtheria, tetanus, pertussis, hepatitis B, and inactivated polio vaccine comes as a suspension (liquid) to be given intramuscularly (into a muscle) by a healthcare provider.

Diphtheria, tetanus, pertussis, hepatitis B, and inactivated polio vaccine is given as 3 doses given at 2, 4, and 6 months of age. Doses should be given at least 6 weeks apart.

What should you tell the person who is giving the vaccine?

Tell your vaccine provider if you:

• have had an allergic reaction to this vaccine, any part of this vaccine, any other vaccine or any drug, food or substance. Tell your vaccine provider about the allergy and what symptoms you had.
• had encephalopathy (decreased consciousness, seizures, coma) within 7 days to a previous dose of pertussis containing vaccine, had a nervous system condition (spams or seizures), or are at risk for seizures. Your doctor will likely tell you that you can not receive another pertussis-containing vaccine.
• are immunocompromised or are receiving immunosuppressive medications, had Guillain-Barre syndrome (a nervous system disorder) within six weeks of a previous dose of tetanus containing vaccine, or have had a history of any of the following occurring after receiving a pertussis-containing vaccine: fever, persistent, inconsolable crying for 3 hours or more, seizures, collapse or loss of consciousness.

In some cases, your health care provider may decide to postpone vaccination to a future visit.

What are the risks from vaccination?

Side effects that have been reported with Diphtheria, tetanus, pertussis, hepatitis B, and inactivated polio vaccine include:

• pain, redness, swelling at the site of injection
• fever
• drowsiness
• irritability, fussiness
• loss of appetite

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• rash, hives, difficulty breathing or swallowing
• seizures or other nervous system changes

People sometimes faint after medical procedures, including vaccination. Tell your provider if you feel dizzy or have vision changes or ringing in the ears.

Adverse reactions should be reported to the Vaccine Adverse Event Reporting System (VAERS). Your health care provider will usually file this report, or you can do it yourself. Visit http://vaers.hhs.gov or call 1-800-822-7967. VAERS is only for reporting reactions, and VAERS staff members do not give medical advice.

How can I learn more?

• Read the Vaccine Information Sheet (VIS) that your vaccine provider will give you or you can obtain it at http://www.cdc.gov/vaccines/hcp/current-vis/index.html
• Ask your healthcare provider.
• Call your local or state health department.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™ Copyright, 2026. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: July 15, 2026.