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Note: This document contains side effect information about hepatitis b pediatric vaccine. Some of the dosage forms listed on this page may not apply to the brand name Recombivax HB Pediatric / Adolescent.For the Consumer
Applies to hepatitis b pediatric vaccine: intramuscular suspension
Hepatitis B pediatric vaccine should not be given to a child who is allergic to baker's yeast.
This vaccine will not protect against hepatitis B if your child is already infected with the virus, even if he or she does not yet show symptoms.
Get emergency medical help if your child has signs of an allergic reaction: hives; difficulty breathing; swelling of the face, lips, tongue, or throat.
Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.
Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shot caused any side effects.
Becoming infected with hepatitis B is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.
Call your doctor at once if your child has:
high fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
fussiness, irritability, crying for an hour or longer;
unusual muscle weakness;
changes in behavior; or
severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Common side effects include:
diarrhea, loss of appetite;
feeling weak or tired;
mild fussiness or crying;
low fever; or
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.For Healthcare Professionals
Applies to hepatitis b pediatric vaccine: intramuscular suspensionGeneral
The most common adverse events were injection site reactions, headache, and fatigue.Local
Very common (10% or more): Injection site pain (33.8%), injection site soreness (22%), injection site redness (15.6%), injection site swelling (11.7%)
Common (1% to 10%): Injection site induration
Uncommon (0.1% to 1%): Injection site ecchymosis, injection site pruritus
Postmarketing reports: Injection site reactionNervous system
Very common (10% or more): Headache (23.4%)
Common (1% to 10%): Dizziness, drowsiness
Uncommon (0.1% to 1%): Somnolence, tingling, paresthesia
Postmarketing reports: Encephalitis, encephalopathy, migraine, multiple sclerosis, neuritis, neuropathy including hypoesthesia, Guillain-Barre syndrome and Bell's palsy, optic neuritis, paralysis, paresis, seizures, syncope, transverse myelitis, vertigo, demyelinating disease of the central nervous system, exacerbation of multiple sclerosisOther
Very common (10% or more): Fatigue (33.8%)
Common (1% to 10%): Fever, malaise
Uncommon (0.1% to 1%): Chills, influenza-like symptoms, sweating, achiness, sensation of warmth, lightheadedness, flushing, earache
Postmarketing reports: TinnitusHypersensitivity
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, ecchymosis, and erythema nodosum.
Postmarketing reports: Allergic reaction, anaphylactoid reaction, anaphylaxis, apparent hypersensitivity syndromeMetabolic
Common (1% to 10%): Appetite lost
Uncommon (0.1% to 1%): AnorexiaPsychiatric
Very common (10% or more): Irritability
Uncommon (0.1% to 1%): Agitation, insomniaRespiratory
Common (1% to 10%): Pharyngitis, upper respiratory infection
Uncommon (0.1% to 1%): Upper respiratory tract illnesses, rhinitis, cough, influenza
Frequency not reported: Pharyngitis
Postmarketing reports: Apnea, bronchospasm including asthma-like symptomsMusculoskeletal
Uncommon (0.1% to 1%): Arthralgia, back pain, myalgia, pain/stiffness in arm, shoulder, or neck
Postmarketing reports: Arthritis, muscular weaknessGastrointestinal
Common (1% to 10%): Gastrointestinal symptoms
Uncommon (0.1% to 1%): Abdominal pain/cramps, constipation, diarrhea, nausea, vomiting
Postmarketing reports: DyspepsiaHematologic
Uncommon (0.1% to 1%): Lymphadenopathy
Postmarketing reports: Thrombocytopenia, increased erythrocyte sedimentation rateDermatologic
Uncommon (0.1% to 1%): Erythema, petechiae, pruritus, rash, sweating, urticaria
Postmarketing reports: Alopecia, angioedema, eczema, erythema multiforme including Stevens-Johnson syndrome, erythema nodosum, lichen planus, purpuraCardiovascular
Uncommon (0.1% to 1%): Flushing, hypotension
Postmarketing reports: Palpitations, tachycardia, vasculitis, syncopeOcular
Very rare (less than 0.01%): Uveitis
Postmarketing reports: Conjunctivitis, keratitis, visual disturbances, optic neuritisGenitourinary
Uncommon (0.1% to 1%): DysuriaHepatic
Postmarketing reports: Abnormal liver function testsImmunologic
Postmarketing reports: Herpes zoster, meningitis
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Recombivax Hb (www.drugs.com/mtm/recombivax-hb-pediatric-adolescent.html).
December 16, 2020
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