Hepatitis B Vaccines

Safety Information

About Hepatitis B

Hepatitis B is a liver infection caused by the hepatitis B virus. It is spread when infected blood, semen, or other body fluids enters the body of a person who is not infected. This can happen through sexual contact, sharing needles or other drug-injection equipment, or from mother to baby at birth. The virus can spread from an infected individual even if they do not look or feel sick.

For some people, hepatitis B is a short-term illness with symptoms that can include fever, tiredness, loss of appetite, nausea, vomiting, jaundice, abdominal pain, dark urine, clay-colored bowel movements, joint pain, and jaundice (yellow color in the skin or eyes). But for others, it can become a long-term, chronic infection that might not have symptoms. Risk for chronic infection is related to age at infection: approximately 90% of infected infants become chronically infected, compared with 2%–6% of adults. Chronic hepatitis B can lead to serious health issues, like cirrhosis or liver cancer.

Learn more about hepatitis B.

There are safe and effective vaccines that can protect against hepatitis B.

Vaccine Information Statements

Vaccine Information Statements (VISs) are information sheets produced by CDC that explain both the benefits and risks of a vaccine.

Available Vaccines

There are 5 licensed hepatitis B vaccines currently available in the United States: 3 single antigen vaccines and 2 combination vaccines.

Who Should Get Hepatitis B Vaccine

Hepatitis B vaccine is given as a series of 2, 3, or 4 shots, depending on the vaccine formula and health needs of the person getting vaccinated. CDC recommends hepatitis B vaccine for:

  • All infants within 24 hours of birth (usually 3 doses completed over a 6-month period)
  • Children and adolescents younger than 19 years of age who have not yet gotten the vaccine

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  • People who are at increased risk of hepatitis B due to travel to certain countries, work exposure to blood, high-risk sexual behavior, injectable drug use, living situations, and certain medical conditions.
  • Anyone who wants protection against hepatitis B

For more information, see Who should get vaccinated against hepatitis B.

Child and Adult Immunization Schedules
Get CDC’s official recommended immunization schedules for children, adolescents, and adults.

Manufacturer Package Inserts

Common Side Effects

Hepatitis B vaccine is safe and effective at preventing hepatitis B infections. Vaccines, like any medicine, can have side effects. Many people who get hepatitis B vaccine have no side effects at all. The most common side effects are usually mild and last 1-2 days.


Severe allergic reactions following vaccination are rare, but can be life threatening.
Symptoms of a severe allergic reaction can include hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, and weakness.

If such reactions occur, call 9-1-1 and get the person to the nearest hospital.

Hepatitis B vaccine
Common Side Effects
  • Soreness, redness, or swelling in the arm where the shot was given
  • Headache
  • Fever

Who Should Not Get Hepatitis B Vaccine

Tell your vaccine provider if the person getting the vaccine:

  • Has had an allergic reaction after a previous dose or any component of a hepatitis B vaccine
  • Has had an allergic reaction to yeast
  • Has had an allergic reaction to neomycin (contraindication for Twinrix)

Note: Until safety data are available, providers should not vaccinate pregnant women needing hepatitis B vaccination with Heplisav-B.

Women who might receive Heplisav-B during pregnancy (usually before knowing they are pregnant) are encouraged to enroll in the Heplisav-B pregnancy registry. Contact Dynavax Technologies Corporation, phone: 1-844-443-7734.

People with minor illnesses, such as a cold, may be vaccinated. People who are moderately or severely ill should usually wait until they recover before getting hepatitis B vaccine.

People getting a combination shot should talk to their doctor about contraindications to other vaccines.

More information about contraindications and precautions.

More Information
Report Possible Adverse Events To VAERS

The Vaccine Adverse Event Reporting System (VAERS) is an early warning system, co-managed by CDC and FDA, that monitors for potential vaccine safety problems.

Healthcare providers and vaccine manufacturers are required by law to report certain adverse events following vaccination to VAERS; patients and caregivers can also submit reports.

For more information, see Report an Adverse Event to VAERS.

A Closer Look at the Safety Data

Which adverse events are considered “serious?”

By the Code of Federal Regulations (CFR) Title 21, an adverse event is defined as serious if it involves any of the following outcomes:

  • Death
  • A life-threatening adverse event
  • A persistent or significant disability or incapacity
  • A congenital anomaly or birth defect
  • Hospitalization, or prolongation of existing hospitalization

Learn more about adverse events.

How CDC Monitors Vaccine Safety

CDC and FDA monitor the safety of vaccines after they are approved or authorized. If a problem is found with a vaccine, CDC and FDA will inform health officials, health care providers, and the public.

CDC uses 3 systems to monitor vaccine safety:

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