Can Hepatitis B Vaccine Cause Injury and Death?
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. Fever over 99.9 degrees F may occur, and can last one to two days. Systemic reactions include irritability, diarrhea, fatigue, weakness, diminished appetite and rhinitis.1 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.
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.2
- 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.3
- 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.4
- 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.5
- 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.6
- 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.7
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,8 arthritis, including polyarthritis and rheumatoid arthritis9,10,11 Guillain Barre Syndrome,12 demyelinating disorders such as optic neuritis, Bell’s palsy, transverse myelitis, demyelinating neuropathy and multiple sclerosis13,14,15,16,17 along with diabetes mellitus,18 chronic fatigue,19 vascular disorders and more.20,21
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. 22 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.23 The IOM committee, however, concluded that the scientific evidence “convincingly supports” a causal relationship between anaphylaxis and hepatitis B in yeast-sensitive individuals.24
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.25
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. 26
As of January 2, 2019, there have been 908 claims filed so far in the federal Vaccine Injury Compensation Program (VICP) for 96 deaths and 812 injuries that occurred after hepatitis B vaccination. Of that number, the U.S. Court of Claims administering the VICP has compensated 330 children and adults, who have filed vaccine injury claims following vaccination with a hepatitis B or hepatitis B combination vaccine.27
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.
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1 CDC.gov Hepatitis B Vaccine Information Sheet Jul 20, 2016
2 FDA. Recombivax-HB Package Insert. May 20, 2014
3 FDA. Engerix-B - Package Insert Apr. 28, 2016
4 FDA. TwinRix - Package Insert. Apr. 25, 2016
5 FDA. Pediarix Product Insert. Apr. 25,2016
6 FDA. HEPLISAV-B – Package Insert.
7 FDA Clinical Review – VAXELIS
8 Agmon-Levin, N., Zafrir, Y., Paz, Z, Shilton, T, Zandman-Goddard, G., Shoenfeld, Y, Ten cases of systemic lupus erythematosus related to hepatitis B vaccine. Lupus. Nov. 2009 vol. 18 no. 13;1192-1197.
9 Maillefert, JF, Sibilia J, Toussirot E, et al. Rheumatic disorders developed after hepatitis B vaccination Rheumatology (Oxford). 1999 Oct;38(10):978-83.
10 Hachulla E, Houvenagel E, Mingui A, et al. Reactive arthritis after hepatitis B vaccination. J Rheumatol. 1990 Sep;17(9):1250–1251
11 Maillefert J., Sibilia, J Vaccination and rheumatoid arthritis. Ann Rheum Dis. 2002 Jul; 61(7): 575–576.
12 Khamaisi M, Shoenfeld Y, Orbach H. Guillain-Barré syndrome following hepatitis B vaccination. Clin Exp Rheumatol. 2004 Nov-Dec;22(6):767-70.
13 Shaw FE JR, Graham DJ, Guess HA et al.: Postmarketing surveillance for neurologic adverse events reported after hepatitis B vaccination. Experience of the first three years. Am J Epidemiol. 1988 Feb;127(2):337-52.
14 Herroelen L, de Keyser J, Ebinger G. Central-nervous-system demyelination after immunisation with recombinant hepatitis B vaccine. Lancet. 1991 Nov 9;338(8776):1174-5.
15 Nadler, JP, Multiple sclerosis and hepatitis B vaccination. Clin Infect Dis. 1993 Nov;17(5):928-9.
16 Kaplanski G, Retornaz F, Durand J, Central nervous system demyelination after vaccination against hepatitis B and HLA haplotype. J Neurol Neurosurg Psychiatry 1995 Jun; 58(6): 758–759.
17 Alp H, Tan H, Orbak Z, Bell's Palsy as a Possible Complication of Hepatitis B Vaccination in A Child. J Health Popul Nutr. 2009 Oct; 27(5): 707–708
18 Classen, JB, Clustering of Cases of IDDM 2 to 4 Years after Hepatitis B Immunization is Consistent with Clustering after Infections and Progression to IDDM in Autoantibody Positive Individuals The Open Pediatric Medicine Journal, 2008, 2: 1-6
19 Agmon-Levin N, Zafrir Y, Kivity S et al. Chronic fatigue syndrome and fibromyalgia following immunization with the hepatitis B vaccine: another angle of the 'autoimmune (auto-inflammatory) syndrome induced by adjuvants' (ASIA) Immunol Res. 2014 Dec;60(2-3):376-83
20 Goolsby PL., Erythema nodosum after Recombivax HB Hepatitis B vaccine. N Engl J Med. 1989 Oct 26;321(17):1198-9.
21 Cockwell, P., Allen, MB., Page, R., Vasculitis related to hepatitis B vaccine. BMJ. 1990 Dec 1; 301(6763): 1281.
22 Institute of Medicine Committee to Review Adverse Effects of Vaccines. Adverse Effects of Vaccines: Evidence and Causality. (Evaluating Biological Mechanisms for Adverse Events: Increased Susceptibility). Washington, DC: The National Academies Press. 2012.Chap. 8 (453-503)
25 Gallagher CM, Goodman MS, Hepatitis B vaccination of male neonates and autism diagnosis NHIS 1997-2002. J Toxicol Environ Health A. 2010;73(24):1665-77.
26 Smyk, D. S., Sakkas, L. I., Shoenfeld, Y., & Bogdanos, D. P. (2015). Hepatitis B Vaccination and Autoimmunity. In Vaccines & Autoimmunity (pp. 147-161). John Wiley & Sons.
27 U.S. Department of Health and Human Services. Statistics Reports. Claims Filed and Compensated or Dismissed by Vaccine — National Vaccine Injury Compensation Program. Jan 2. 2019