Does Hepatitis B Vaccine Have Side Effects?
Hepatitis B vaccine is considered as one of the safest and most effective vaccines ever made. Numerous studies were conducted by World Health Organization, U.S. Centers for Disease Control and Prevention, and many different medical societies.
No evidence shows that hepatitis B vaccine causes serious side effects, like autism and multiple sclerosis.
Common side effects from the hepatitis B vaccine may include soreness, swelling and redness at the injection site. The vaccine may not be recommended for those with documented yeast allergies or a history of an adverse reaction to the vaccine.
Keywords: hepatitis B vaccine; side effects; Centers for Disease Control and Prevention; soreness; yeast allergies
—————————————— edit 10/23/2018 ——————————————
Thanks to Mrs. Gomez.
The hepatitis B vaccine manufactured and available in U.S. are below:
- GlaxoSmithKline – Engerix-B®
- Merck – Recombivax HB®
The side effects disclosed in GlaxoSmithKline’s document are as below:
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared with rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. The most common solicited adverse events were injection site soreness (22%) and fatigue (14%).
In 36 clinical studies, a total of 13,495 doses of ENGERIX-B were administered to 5,071 healthy adults and children who were initially seronegative for hepatitis B markers, and healthy neonates. All subjects were monitored for 4 days post-administration. Frequency of adverse events tended to decrease with successive doses of ENGERIX-B. Using a symptom checklist, the most frequently reported adverse events were injection site soreness (22%) and fatigue (14%). Other events are listed below. Parent or guardian completed forms for children and neonates. Neonatal checklist did not include headache, fatigue, or dizziness. Incidence 1% to 10% of Injections Nervous System Disorders: Dizziness, headache. General Disorders and Administration Site Conditions: Fever (>37.5°C), injection site erythema, injection site induration, injection site swelling. Incidence <1% of Injections Infections and Infestations: Upper respiratory tract illnesses. Blood and Lymphatic System Disorders: Lymphadenopathy. Metabolism and Nutrition Disorders: Anorexia. Psychiatric Disorders: Agitation, insomnia. Nervous System Disorders: Somnolence, tingling. Vascular Disorders: Flushing, hypotension. Gastrointestinal Disorders: Abdominal pain/cramps, constipation, diarrhea, nausea, vomiting. Skin and Subcutaneous Tissue Disorders: Erythema, petechiae, pruritus, rash, sweating, urticaria. Musculoskeletal and Connective Tissue Disorders: Arthralgia, back pain, myalgia, pain/stiffness in arm, shoulder, or neck. General Disorders and Administration Site Conditions: Chills, influenza-like symptoms, injection site ecchymosis, injection site pain, injection site pruritus, irritability, malaise, weakness. In a clinical trial, 416 adults with type 2 diabetes and 258 control subjects without type 2 diabetes who were seronegative for hepatitis B markers received at least 1 dose of ENGERIX-B. Subjects were monitored for solicited adverse events for 4 days following each vaccination. The most frequently reported solicited adverse events in the entire study population were injection site pain (reported in 39% of diabetic subjects and 45% of control subjects) and fatigue (reported in 29% of diabetic subjects and 27% of control subjects). Serious adverse events were monitored through 30 days following the last vaccination. Serious adverse events (SAEs) occurred in 3.8% of diabetic subjects and 1.6% of controls. No SAEs were deemed related to ENGERIX-B.
6.2 Postmarketing Experience
In addition to reports in clinical trials, worldwide voluntary reports of adverse events received for ENGERIX-B since market introduction (1990) are listed below. This list includes SAEs or events that have a suspected causal connection to components of ENGERIX-B. Because these events are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine. Infections and Infestations Herpes zoster, meningitis. Blood and Lymphatic System Disorders Thrombocytopenia. Immune System Disorders Allergic reaction, anaphylactoid reaction, anaphylaxis. An apparent hypersensitivity syndrome (serum sickness-like) of delayed onset has been reported days to weeks after vaccination, including: arthralgia/arthritis (usually transient), fever, and dermatologic reactions such as urticaria, erythema multiforme, ecchymoses, and erythema nodosum. Nervous System Disorders Encephalitis; encephalopathy; migraine; multiple sclerosis; neuritis; neuropathy including hypoesthesia, paresthesia, Guillain-Barré syndrome and Bell’s palsy; optic neuritis; paralysis; paresis; seizures; syncope; transverse myelitis. Eye Disorders Conjunctivitis, keratitis, visual disturbances. Ear and Labyrinth Disorders Earache, tinnitus, vertigo. Cardiac Disorders Palpitations, tachycardia. Vascular Disorders Vasculitis. Respiratory, Thoracic, and Mediastinal Disorders Apnea, bronchospasm including asthma-like symptoms.
Gastrointestinal Disorders Dyspepsia. Skin and Subcutaneous Tissue Disorders Alopecia, angioedema, eczema, erythema multiforme including Stevens-Johnson syndrome, erythema nodosum, lichen planus, purpura. Musculoskeletal and Connective Tissue Disorders Arthritis, muscular weakness. General Disorders and Administration Site Conditions Injection site reaction. Investigations Abnormal liver function tests.
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The side effects disclosed in Merck’s document are as below:
6 ADVERSE REACTIONS
In healthy infants and children (up to 10 years of age), the most frequently reported systemic adverse reactions (>1% injections), in decreasing order of frequency, were irritability, fever, diarrhea, fatigue/weakness, diminished appetite, and rhinitis. In healthy adults, injection site reactions and systemic adverse reactions were reported following 17% and 15% of the injections, respectively.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. In three clinical studies, 434 doses of RECOMBIVAX HB, 5 mcg, were administered to 147 healthy infants and children (up to 10 years of age) who were monitored for 5 days after each dose. Injection site reactions and systemic adverse reactions were reported following 0.2% and 10.4% of the injections, respectively. The most frequently reported systemic adverse reactions (>1% injections), in decreasing order of frequency, were irritability, fever (101°F oral equivalent), diarrhea, fatigue/weakness, diminished appetite, and rhinitis. In a study that compared the three-dose regimen (5 mcg) with the two-dose regimen (10 mcg) of RECOMBIVAX HB in adolescents, the overall frequency of adverse reactions was generally similar. In a group of studies, 3258 doses of RECOMBIVAX HB, 10 mcg, were administered to 1252 healthy adults who were monitored for 5 days after each dose. Injection site reactions and systemic adverse reactions were reported following 17% and 15% of the injections, respectively. The following adverse reactions were reported: Incidence Equal To or Greater Than 1% of Injections GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site reactions consisting principally of soreness, and including pain, tenderness, pruritus, erythema, ecchymosis, swelling, warmth, nodule formation. The most frequent systemic complaints include fatigue/weakness; headache; fever (≥100°F); malaise. GASTROINTESTINAL DISORDERS Nausea; diarrhea RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Pharyngitis; upper respiratory infection Incidence Less Than 1% of Injections GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Sweating; achiness; sensation of warmth; lightheadedness; chills; flushing
GASTROINTESTINAL DISORDERS Vomiting; abdominal pains/cramps; dyspepsia; diminished appetite RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Rhinitis; influenza; cough NERVOUS SYSTEM DISORDERS Vertigo/dizziness; paresthesia SKIN AND SUBCUTANEOUS TISSUE DISORDERS Pruritus; rash (non-specified); angioedema; urticaria MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Arthralgia including monoarticular; myalgia; back pain; neck pain; shoulder pain; neck stiffness BLOOD AND LYMPHATIC DISORDERS Lymphadenopathy PSYCHIATRIC DISORDERS Insomnia/disturbed sleep EAR AND LABYRINTH DISORDERS Earache RENAL AND URINARY DISORDERS Dysuria CARDIAC DISORDERS Hypotension
6.2 Post-Marketing Experience The following additional adverse reactions have been reported with use of the marketed vaccine. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to a vaccine exposure. Immune System Disorders Hypersensitivity reactions including anaphylactic/anaphylactoid reactions, bronchospasm, and urticaria have been reported within the first few hours after vaccination. An apparent hypersensitivity syndrome (serum-sickness-like) of delayed onset has been reported days to weeks after vaccination, including: arthralgia/arthritis (usually transient), fever, and dermatologic reactions such as urticaria, erythema multiforme, ecchymoses and erythema nodosum [see Warnings and Precautions (5.1)]. Autoimmune diseases including systemic lupus erythematosus (SLE), lupus-like syndrome, vasculitis, and polyarteritis nodosa have also been reported. Gastrointestinal Disorders Elevation of liver enzymes; constipation Nervous System Disorders Guillain-Barré syndrome; multiple sclerosis; exacerbation of multiple sclerosis; myelitis including transverse myelitis; seizure; febrile seizure; peripheral neuropathy including Bell’s Palsy; radiculopathy; herpes zoster; migraine; muscle weakness; hypesthesia; encephalitis Skin and Subcutaneous Disorders Stevens-Johnson syndrome; alopecia; petechiae; eczema Musculoskeletal and Connective Tissue Disorders Arthritis Pain in extremity Blood and Lymphatic System Disorders Increased erythrocyte sedimentation rate; thrombocytopenia Psychiatric Disorders Irritability; agitation; somnolence Eye Disorders Optic neuritis; tinnitus; conjunctivitis; visual disturbances; uveitis Cardiac Disorders Syncope; tachycardia
The following adverse reaction has been reported with another Hepatitis B Vaccine (Recombinant) but not with RECOMBIVAX HB: keratitis.
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