ADVERSE REACTIONS
ENGERIX-B is generally well tolerated. As with any vaccine, however, it is possible that expanded commercial use of the vaccine could reveal rare adverse reactions.
Ten double-blind studies involving 2,252 subjects showed no significant difference in the frequency or severity of adverse experiences between ENGERIX-B and plasma-derived vaccines. 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 experiences tended to decrease with successive doses of ENGERIX-B. Using a symptom checklist,† the most frequently reported adverse reactions were injection site soreness (22%) and fatigue† (14%). Other reactions are listed below.
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.
†Parent or guardian completed forms for children and neonates. Neonatal checklist did not include headache, fatigue, or dizziness.
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.
Postmarketing Reports:
Additional adverse experiences have been reported with the commercial use of ENGERIX-B. Those listed below are to serve as alerting information to physicians.
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 (see CONTRAINDICATIONS).
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.
Reporting Adverse Events:
The National Childhood Vaccine Injury Act requires that the manufacturer and lot number of the vaccine administered be recorded by the healthcare provider in the vaccine recipient’s permanent medical record, along with the date of administration of the vaccine and the name, address, and title of the person administering the vaccine. The Act further requires the healthcare provider to report to the US Department of Health and Human Services via VAERS the occurrence following immunization of any event set forth in the Vaccine Injury Table including: Anaphylaxis or anaphylactic shock within 4 hours, encephalopathy or encephalitis within 72 hours, or any sequelae thereof (including death).,19 In addition, any event considered a contraindication to further doses should be reported. The VAERS toll-free number is 1-800-822-7967.
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