Read and report vaccine reactions, harassment and failures.
Mild side effects such as redness, warmth, or swelling at the injection site where the shot was given have been reported in connection with administration of hepatitis B vaccines. Systemic reactions include fever, headache, and pain. However, more severe reactions have also been reported in both clinical trials with all of the vaccines as well as to the Vaccine Adverse Events Reporting System (VAERS). See Hepatitis B Quick Facts for current reports of hepatitis B containing vaccine reactions, hospitalizations, injuries and deaths made to VAERS and links to the manufacturers package inserts.
Some of the events reported during pre-licensure clinical trials by the manufacturers included:
Recombivax HB – tenderness, swelling, nodule formation, pharyngitis, upper respiratory infection, sweating, lightheadedness, chills, dyspepsia, vomiting, influenza, vertigo, paresthesia, myalgia, back, shoulder and neck pain, insomnia, earache, dysuria and hypotension.
In the clinical trials conducted by the manufacturer prior to vaccine licensure, Recombivax-HB hepatitis B vaccine was only evaluated for safety in 147 healthy infants and children for a total of 5 days after each vaccine dose was administered. No long-term safety data was reported for individuals who participated in the clinical trials conducted by the manufacturer before the FDA approved the vaccine for use in all newborn infants.
Engerix B – Dizziness, headache, upper respiratory infections, agitation, lymphadenopathy, agitation, insomnia, hypotension, diarrhea, nausea, vomiting, rash, sweating, back pain, myalgia, chills, influenza-like symptoms, irritability, malaise and weakness.
Clinical trials of Engerix B conducted by the manufacturer prior to FDA approval involved 5,071 healthy newborns, children, and adults without evidence of past hepatitis B infection. Adverse events in trial participants were monitored for only 4 days following each vaccine dose, and no long-term safety studies of trial participants were reportedly conducted by the vaccine manufacturer.
Twinrix - Upper respiratory tract infections, agitation, insomnia, dizziness, migraine, paresthesia, somnolence, syncope, vertigo, abdominal pain, vomiting, rash, sweating, urticaria, back pain, myalgia, influenza-like symptoms, irritability, weakness, lymphadenopathy, hypotension, hypertonia, tingling and photophobia.
Clinical trials of Twinrix conducted in the US involved 773 adults between 18 and 70 years of age who received either Twinrix, or Engerix-B hepatitis B vaccine and Havrix hepatitis A vaccine. No placebo-controlled study was conducted and trial participants were monitored for specific pre-determined adverse events for a total of 4 days post vaccination, and up to 31 days for unsolicited adverse events. No long-term safety studies were reportedly completed by the vaccine manufacturer.
Pediarix – fever, drowsiness, irritability, loss of appetite, pyrexia, gastroenteritis, culture-negative clinical sepsis, bronchiolitis, asthma, diabetes mellitus, chronic neutropenia, febrile and afebrile seizures, and death.
Clinical trials of Pediarix conducted in the US involved 673 infants who received the vaccine and 335 infants who were given separate doses of Infanrix (DTaP) vaccine, Engerix-B hepatitis B vaccine, and IPV (inactivated polio vaccine). Infants in both groups were also given the 7-valent pneumococcal conjugate vaccine (PCV7) and a Hib conjugate vaccine, both of which are no longer available in the US. Participants were monitored for specific adverse reactions for a total of 4 days after each dose administered at 2, 4, and 6 months, and a telephone follow-up was conducted at 1 month and 6 months after the third vaccine dose to solicit information on adverse events. No additional long-term studies for safety were reportedly conducted by the manufacturer after six months following completion of the 3-dose series clinical trial.
HEPLISAV-B – Fatigue, headache, malaise, fever, myalgia, Guillain-Barré syndrome (GBS), Grave’s disease, myocardial infarction (heart attack), hypothyroidism, vitiligo, herpes zoster (shingles), and death.
Clinical trials of HEPLISAV-B hepatitis B vaccine involved a total of 9,597 adults between 18 and 70 years of age involved in five separate studies, however, data from only three of the five studies was made available for review in the package insert. Participants in these three clinical studies received either 2 doses of HEPLISAV-B vaccine and a third dose of saline placebo, or 3 doses of ENGERIX-B hepatitis B vaccine. No placebo-controlled studies were completed.
In Study 1, participants were monitored for specific pre-determined adverse events for seven days and unsolicited adverse events for 28 days following each dose. No additional adverse event data was collected on participants involved in this study after seven months following receipt of the first vaccine dose (one month after receipt of the third dose). Study 2 and Study 3 participants were also monitored for specific pre-determined adverse events for seven days and unsolicited adverse events for 28 days following each vaccine dose, however, Study 2 participants were monitored for 12 months following the first dose (5 months after dose 3), and Study 3 participants were monitored up to 13 months (6 months after dose 3). No long-term safety studies on clinical trial participants were reportedly conducted by the manufacturer past six months following completion of the 3-dose series clinical trials.
VAXELIS - fever, irritability, decreased appetite, pyrexia, respiratory syncytial virus bronchiolitis, bronchiolitis, bronchospasm, hypotonia, GI disorder, colitis, myoclonus, failure to thrive, hydrocephalus, constipation, injection site redness, pain, and swelling, dehydration, diarrhea, intussusception, Group A streptococcus bacteremia, Idiopathic thrombocytopenic purpura (ITP), febrile convulsion, and death.
Clinical trials of VAXELIS involved a total of 5,251 infants between the ages of 43 and 99 days at enrollment over a total of six studies. Two of the six studies were completed in the US and involved 3,392 infants who received VAXELIS, and 889 infants who were controls.
In one US study (Study 005), participants received either VAXELIS at 2, 4, and 6 months and DAPTACEL (DTaP) + PedvaxHIB (HIB) at 15 months, or PENTACEL (5 in one vaccine containing DTaP, HIB, and IPV) at 2, 4, and 6 months, RECOMBIVAX-HB hepatitis B vaccine at 2 and 6 months, and DAPTACEL + ActHIB (HIB) at 15 months. Additionally, all study participants in both groups received RotaTeq vaccine (rotavirus) at 2, 4, and 6 months and Prevnar 13 (pneumococcal conjugate vaccine) at 2, 4, 6, and 15 months.
In the second US study (Study 006), participants received either VAXELIS at 2, 4, and 6 months and PENTACEL at 15 months or PENTACEL at 2, 4, 6, and 15 months and RECOMBIVAX-HB hepatitis B vaccine at 2 and 6 months. As with Study 005, all clinical trial participants also received RotaTeq vaccine at 2, 4, and 6 months and Prevnar 13 at 2, 4, 6, and 15 months.
No placebo-controlled studies of VAXELIS were conducted, and study participants were evaluated for specific pre-determined adverse events by their parent/guardian for five days following receipt of a vaccine dose at 2, 4, and 6 months. Unsolicited adverse events following any vaccine dose were monitored for only 30 days after each administered dose. No long-term safety studies of clinical trial participants were reportedly conducted by the manufacturer after one month following completion of the vaccine clinical trial.
PREHEVBRIO – injection site pain and tenderness, myalgia, fatigue, headache, nausea, vomiting, diarrhea, fever, dizziness/vertigo, generalized itching, joint pain, hives, lymphadenopathy, and lymph node pain.
Clinical trials of PREHEVBRIO hepatitis B vaccine involved two studies of 4,443 participants who received at least one hepatitis B dose. Study participants received either 3 doses of PREHEVRIO hepatitis B vaccine or 3 doses of Engerix-B hepatitis B vaccine. No placebo-controlled studies were conducted. In both studies, participants were monitored for specific pre-determined adverse events for 7 days, and unsolicited adverse events for 28 days following each vaccine dose. Monitoring for serious adverse event continued until six months following receipt of the third vaccine dose. No long-term safety studies past six months following completion of the 3 dose vaccine series was reportedly completed by the manufacturer.
During the past three decades, there have been many published reports and studies linking hepatitis B vaccination to numerous chronic immune and neurological diseases in children and adults. These include lupus, arthritis, including polyarthritis and rheumatoid arthritis Guillain Barre Syndrome, demyelinating disorders such as optic neuritis, Bell’s palsy, transverse myelitis, demyelinating neuropathy and multiple sclerosis along with diabetes mellitus, chronic fatigue, vascular disorders and more.
In the comprehensive report evaluating scientific evidence, Adverse Effects of Vaccines: Evidence and Causality, published in 2012 by the Institute of Medicine, 27 reported vaccine adverse events following the hepatitis B vaccine were evaluated by a physician committee. These adverse events included multiple sclerosis, arthritis, Guillain Barre Syndrome, diabetes mellitus, optic neuritis, transverse myelitis and more. In 26 of the 27 hepatitis B vaccine-related adverse events evaluated, the IOM committee concluded that there was inadequate evidence to support or reject a causal relationship between the hepatitis B vaccine and the reported adverse event, primarily because there was either an absence of methodologically sound published studies or too few quality studies to make a determination. The IOM committee, however, concluded that the scientific evidence “convincingly supports” a causal relationship between anaphylaxis and hepatitis B in yeast-sensitive individuals.
A 2010 study published in the Journal of Toxicology and Environmental Health found that male neonates had a threefold greater chance of being diagnosed with autism compared to boys never vaccinated or vaccinated after the first month of life.
A 2015 study, which reviewed case studies and research on numerous autoimmune disorders following the hepatitis B vaccine, concluded that there is a link between hepatitis B vaccine and development of vasculitis, chronic arthritis, lupus, MS, myelitis, and thrombocytopenia/pancytopenia. While the study examined a relationship between hepatitis B vaccine and other conditions, such as neuropathy, myasthenia gravis, chronic fatigue syndrome, autoimmune skin conditions and more, study authors determined that further research was required before conclusions could be drawn.
Using the MedAlerts search engine, as of June 30, 2023, there have been more than 104,109 adverse events reported to the federal Vaccine Adverse Events Reporting System (VAERS) in connection with Hepatitis B and Hepatitis B containing vaccines. Nearly 56 percent (57,705) of serious Hepatitis B vaccine-related adverse events occurred in children under three years old, with over 70 percent (1,716) of deaths occurring in children under three years of age. Of the vaccine-related adverse events reported to VAERS there were 2,344 related deaths, 16,008 hospitalizations, and 3,707 related disabilities. 73,816 of the adverse events were associated with Hepatitis B vaccine alone (not combined with other vaccines).
Even though the National Childhood Vaccine Injury Act of 1986 legally required pediatricians and other vaccine providers to report serious health problems following vaccination to federal health agencies (VAERS), many doctors and other medical workers giving vaccines to children and adults fail to report vaccine-related health problem to VAERS. There is evidence that only between 1 and 10 percent of serious health problems that occur after use of prescription drugs or vaccines in the U.S. are ever reported to federal health officials who are responsible for regulating the safety of drugs and vaccines and issue national vaccine policy recommendations.
As of August 1, 2023, there have been 1,014 claims filed so far in the federal Vaccine Injury Compensation Program (VICP) for 102 deaths and 912 injuries that occurred after hepatitis B vaccination. Of that number, the U.S. Court of Claims administering the VICP has compensated 382 children and adults, who have filed vaccine injury claims following vaccination with a hepatitis B or hepatitis B combination vaccine.
IMPORTANT NOTE: NVIC encourages you to become fully informed about Hepatitis B and the Hepatitis B vaccine by reading all sections in the Table of Contents , which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.