Safety Information for Hepatitis B Vaccines | Vaccine Safety (2024)

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• Pain, soreness, redness, or swelling in the arm where the shot was given
• Headache
• Fever
• Fatigue
• Irritability, diarrhea, loss of appetite in healthy infants and children who received (Recombivax, Vaxelis, Pediarix)
• Vomiting, crying, drowsiness in children (Vaxelis, Pediarix)

Who Should Not Get Hepatitis B Vaccine

Tell your vaccine provider if the person getting the vaccine:

• Has had a severe allergic reaction, such as anaphylaxis, after a previous dose or any component of the vaccine they are getting
• Has a yeast allergy
• Has had an allergic reaction to neomycin (if they are getting Twinrix)

Note: PREHEVBRIO vaccine is the only hepatitis B vaccine that does not contain yeast, making it safe for people who are allergic to yeast.
Note: Until safety data are available, providers should not vaccinate pregnant women needing hepatitis B vaccination with Heplisav-B.

Women who might have received 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.

More information about contraindications and precautions.

• Hepatitis B Questions and Answers for the Public
  Learn more about the hepatitis B virus and the vaccines that provide protection.
• Who Should Not Get Vaccinated
  Some people should not get certain vaccines or should wait before getting them. Read the CDC guidelines for each vaccine
• Hepatitis B Vaccine – ACIP Recommendations and Guidance
  Official guidance on hepatitis B vaccine from the Advisory Committee on Immunization Practices (ACIP).
• Hepatitis B Questions and Answers for Health Professionals
  Information for clinicians on hepatitis B virus, vaccination, and treatment.

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 Vaccine Safety Datalink (VSD) study compared deaths among newborns vaccinated with hepatitis B and unvaccinated newborns. The study found no differences between vaccinated and unvaccinated newborns.

  Source: Lack of association between hepatitis B birth immunization and neonatal death: a population based study from the Vaccine Safety Datalink project [Pediatric Infect Dis J. 2004]

• CDC reviewed Vaccine Adverse Event Reporting System (VAERS) reports of adverse events following hepatitis B vaccination from 2005 through 2015. During that time, 20,231 reports following hepatitis B or hepatitis B-containing vaccines, were submitted to VAERS. Over half of reports were in persons younger than 2 years of age; the majority of reports (78%) were following hepatitis B-containing vaccines in combination with other vaccines at the same visit. The most frequently reported adverse events for vaccines given in combination were fever, injection site redness, and vomiting. This review of the hepatitis B vaccine did not detect any new or unexpected safety concerns. These findings are consistent with pre-licensure clinical trials and other post-licensure monitoring and research.

  Source: Safety of currently licensed hepatitis B surface antigen vaccines in the United Stated, Vaccine Adverse Event Reporting System (VAERS), 2005-2015 [Vaccine. 2018]

• A separate review of VAERS studied reports made following the administration of hepatitis A (inactivated) and hepatitis B (recombinant) vaccines combined from May 2001 to September 2003. There were no unexpected health problems.

  Source: Adverse events after hepatitis A B combination vaccine [Vaccine. 2006]

• In the early 1990s, CDC conducted a study of healthy full-term newborns to determine whether hepatitis B vaccination of newborns increases the risk of fever and/or suspected sepsis. The study found no evidence of increased fevers, sepsis evaluations, allergy or brain problems or medical procedures after to newborn hepatitis B vaccination.

  Source: Safety of Neonatal hepatitis B vaccine administration [Pediatr Infect Dis J. 2001]

• In a 4-year case series review of hepatitis B vaccine reports among newborns, there were no serious health problems linked to the hepatitis B vaccine. This was the largest case series review of hepatitis B vaccination reports among newborn babies and infants. Several studies have evaluated a possible link between hepatitis B vaccination and multiple sclerosis or optic neuritis. The studies did not show any link.

  Source: Safety of Neonatal Hepatitis B Vaccine Administration [Pediatr Infect Dis J. 2001]

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 followingoutcomes:

• 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.