ADVERSE REACTIONS
During clinical trials involving more than 31,000 individuals receiving doses ranging from 360 EL.U. to 1440 EL.U. and during extensive postmarketing experience in Europe, HAVRIX has been generally well tolerated. As with all pharmaceuticals, however, it is possible that expanded commercial use of the vaccine could reveal rare adverse events not observed in clinical studies.
The frequency of solicited adverse events tended to decrease with successive doses of HAVRIX. Most events reported were considered by the subjects as mild and did not last for more than 24 hours.
Of solicited adverse events in clinical trials, the most frequently reported by volunteers was injection-site soreness (56% of adults and 21% of children); however, less than 0.5% of soreness was reported as severe. Headache was reported by 14% of adults and less than 9% of children. Other solicited and unsolicited events occurring during clinical trials are listed below:
INCIDENCE 1% TO 10% OF INJECTIONS:
Local Reactions at Injection Site: Induration, redness, swelling.
Body as a Whole: Fatigue, fever (>37.5°C), malaise.
Gastrointestinal: Anorexia, nausea.
INCIDENCE <1% OF INJECTIONS:
Local Reaction at Injection Site: Hematoma.
Dermatologic: Pruritus, rash, urticaria.
Respiratory: Pharyngitis, other upper respiratory tract infections. Gastrointestinal: Abdominal pain, diarrhea, dysgeusia, vomiting.
Musculoskeletal: Arthralgia, elevation of creatine phosphokinase, myalgia.
Hematologic: Lymphadenopathy.
Central Nervous System: Hypertonic episode, insomnia, photophobia, vertigo.
Additional Safety Data: Safety data were obtained from 2 additional sources in which large populations were vaccinated. In an outbreak setting in which 4,930 individuals were immunized with a single dose of either 720 EL.U. or 1440 EL.U. of HAVRIX, the vaccine was well tolerated and no serious adverse events due to vaccination were reported. Overall, less than 10% of vaccinees reported solicited general adverse events following the vaccine. The most common solicited local adverse event was pain at the injection site, reported in 22.3% of subjects at 24 hours and decreasing to 2.4% by 72 hours. In a field efficacy trial, 19,037 children received the 360 EL.U. dose of HAVRIX. The most commonly reported adverse events following administration of HAVRIX were injection-site pain (9.5%) and tenderness (8.1%), which were reported following first doses of HAVRIX. Other adverse events were infrequent and comparable to the control vaccine ENGERIX-B. Additionally, no serious adverse events due to the vaccine were reported. The
large trial further allowed for analysis of rare adverse events, including hospitalization and death. No significant differences were found between the cohorts.
In subjects with chronic liver disease, HAVRIX was safe and well tolerated. Local injection site reactions were similar among all 4 groups, and no serious adverse reactions attributed to the vaccine were reported in subjects with chronic liver disease.
Postmarketing Reports: Rare voluntary reports of adverse events in people receiving HAVRIX that have been reported since market introduction of the vaccine include the following: Local: Localized edema.
While no causal relationship has been established, the following rare events have been reported: Body as a Whole: Anaphylaxis/anaphylactoid reactions, somnolence.
Cardiovascular: Syncope.
Hepatobiliary: Jaundice, hepatitis.
Dermatologic: Erythema multiforme, hyperhydrosis, angioedema.
Respiratory: Dyspnea.
Hematologic: Lymphadenopathy.
Central Nervous System: Convulsions, encephalopathy, dizziness, neuropathy, myelitis, paresthesia, Guillain-Barré syndrome, multiple sclerosis.
Other: Congenital abnormality.
Reporting of Adverse Events: The US Department of Health and Human Services has established the Vaccine Adverse Events Reporting System (VAERS) to accept reports of suspected adverse events after the administration of any vaccine, including, but not limited to, the reporting of events required by the National Childhood Vaccine Injury Act of 1986. The toll-free number for VAERS forms and information is 1-800-822-7967. 21
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