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: Local Reactions at Injection Site: Induration; erythema; swelling.
Body as a Whole: Fever (>37.5°C). Nervous System: Headache; # dizziness. #
#Parent or guardian completed forms for children and neonates. Neonatal checklist did not include headache, fatigue, or dizziness.
Incidence <1% of Injections: Local Reactions at Injection Site: Pain; pruritus; ecchymosis.
Body as a Whole: Sweating; malaise; chills; weakness; flushing; tingling.
Cardiovascular System: Hypotension.
Respiratory System: Influenza-like symptoms; upper respiratory tract illnesses. Gastrointestinal System: Nausea; anorexia; abdominal pain/cramps; vomiting; constipation; diarrhea.
Lymphatic System: Lymphadenopathy.
Musculoskeletal System: Pain/stiffness in arm, shoulder, or neck; arthralgia; myalgia; back pain.
Skin and Appendages: Rash; urticaria; petechiae; pruritus; erythema.
Nervous System: Somnolence; insomnia; irritability; agitation. 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. Hypersensitivity: Anaphylaxis; erythema multiforme including Stevens-Johnson syndrome; angioedema; arthritis. 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).
Cardiovascular System: Tachycardia/palpitations. Respiratory System: Bronchospasm including asthma-like symptoms. Gastrointestinal System: Abnormal liver function tests; dyspepsia.
Nervous System: Migraine; syncope; paresis; neuropathy including hypoesthesia, paresthesia, Guillain-Barré syndrome and Bell's palsy, transverse myelitis; optic neuritis; multiple sclerosis; seizures. Hematologic: Thrombocytopenia.
Skin and Appendages: Eczema; purpura; herpes zoster; erythema nodosum; alopecia.
Special Senses: Conjunctivitis; keratitis; visual disturbances; vertigo; tinnitus; earache.
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. 18 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). 18, 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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