VACCINE INFORMATION STATEMENT Hepatitis B Vaccine ManyVaccineInformationStatementsareavailableinSpanishandotherlanguages. Seewww.immunize.org/vis. HojasdeInformaciánSobreVacunasestándisponiblesenEspañolyen muchosotrosidiomas.Visitehttp://www.immunize.org/vis What You Need to Know 1 What is hepatitis B? Hepatitis B is a serious infection that affects the liver. It is caused by the hepatitis B virus. • In2009,about38,000peoplebecameinfectedwith hepatitis B. • Eachyearabout2,000to4,000peopledieinthe UnitedStatesfromcirrhosisorlivercancercausedby hepatitis B. Hepatitis B can cause: Acute (short-term) illness. This can lead to: •diarrheaandvomiting •lossofappetite •jaundice(yellowskinoreyes) •tiredness •paininmuscles,joints,andstomach Acuteillness,withsymptoms,ismorecommonamong adults.Childrenwhobecomeinfectedusuallydonot havesymptoms. Chronic (long-term) infection.Somepeoplegoonto developchronichepatitisBinfection.Mostofthemdo nothavesymptoms,buttheinfectionisstillveryserious, and can lead to: •liverdamage(cirrhosis)•livercancer•death Chronicinfectionismorecommonamonginfantsand childrenthanamongadults.Peoplewhoarechronically infectedcanspreadhepatitisBvirustoothers,evenif theydon’tlookorfeelsick.Upto1.4millionpeoplein theUnitedStatesmayhavechronichepatitisBinfection. HepatitisBvirusiseasilyspreadthroughcontactwith thebloodorotherbodyfluidsofaninfectedperson. Peoplecanalsobeinfectedfromcontactwithacontaminatedobject,wheretheviruscanliveforupto7days. • Ababywhosemotherisinfectedcanbeinfectedat birth; • Children,adolescents,andadultscanbecomeinfected by: - contactwithbloodandbodyfluidsthroughbreaksin theskinsuchasbites,cuts,orsores; - contactwithobjectsthathavebloodorbodyfluids onthemsuchastoothbrushes,razors,ormonitoring andtreatmentdevicesfordiabetes; - havingunprotectedsexwithaninfectedperson; - sharingneedleswheninjectingdrugs; - beingstuckwithausedneedle. 2 Hepatitis B vaccine: Why get vaccinated? HepatitisBvaccinecanpreventhepatitisB,andthe seriousconsequencesofhepatitisBinfection,including liver cancer and cirrhosis. HepatitisBvaccinemaybegivenbyitselforinthesame shotwithothervaccines. RoutinehepatitisBvaccinationwasrecommendedfor someU.S.adultsandchildrenbeginningin1982,andfor allchildrenin1991.Since1990,newhepatitisB infectionsamongchildrenandadolescentshavedropped bymorethan95%–andby75%inotheragegroups. Vaccinationgiveslong-termprotectionfromhepatitisB infection,possiblylifelong. 3 Who should get hepatitis B vaccine and when? Children and Adolescents • Babiesnormallyget3dosesofhepatitisBvaccine: 1stDose: Birth 2ndDose: 1-2monthsofage 3rdDose: 6-18monthsofage Somebabiesmightget4doses,forexample,ifa combinationvaccinecontaininghepatitisBisused. (Thisisasingleshotcontainingseveralvaccines.)The extradoseisnotharmful. • Anyonethrough18yearsofagewhodidn’tgetthe vaccinewhentheywereyoungershouldalsobe vaccinated. Adults • AllunvaccinatedadultsatriskforhepatitisBinfection should be vaccinated. This includes: - sexpartnersofpeopleinfectedwithhepatitisB, - menwhohavesexwithmen, - peoplewhoinjectstreetdrugs, - peoplewithmorethanonesexpartner, - peoplewithchronicliverorkidneydisease, - peopleunder60yearsofagewithdiabetes, - peoplewithjobsthatexposethemtohumanbloodor otherbodyfluids, - householdcontactsofpeopleinfectedwithhepatitisB, - residentsandstaffininstitutionsforthedevelopmen- tallydisabled, - kidneydialysispatients, - peoplewhotraveltocountrieswherehepatitisBis common, - peoplewithHIVinfection. • Otherpeoplemaybeencouragedbytheirdoctortoget hepatitisBvaccine;forexample,adults60andolder withdiabetes.Anyoneelsewhowantstobeprotected fromhepatitisBinfectionmaygetthevaccine. AdultsgettinghepatitisBvaccineshouldget3doses— withtheseconddosegiven4weeksafterthefirstandthe thirddose5monthsafterthesecond.Yourdoctorcantell youaboutotherdosingschedulesthatmightbeusedin certaincircumstances. Who should not get hepatitis B vaccine? • Anyonewithalife-threateningallergytoyeast,orto anyothercomponentofthevaccine,shouldnotget hepatitis B vaccine. Tell your doctor if you have any severeallergies. What should I look for? • Anyunusualcondition,suchasahighfeverorunusual behavior.Signsofaseriousallergicreactioncaninclude difficultybreathing,hoarsenessorwheezing,hives, paleness,weakness,afastheartbeatordizziness. What should I do? • Calladoctor,orgetthepersontoadoctorrightaway. • Tell yourdoctorwhathappened,thedateandtimeit happened,andwhenthevaccinationwasgiven. • Ask yourdoctor,nurse,orhealthdepartmenttoreport thereactionbyfilingaVaccineAdverseEvent ReportingSystem(VAERS)form.Oryoucanfilethis reportthroughtheVAERSwebsiteat www.vaers.hhs.gov,orbycalling1-800-822-7967. 7 • Anyonewhoismoderatelyorseverelyillwhenadose ofvaccineisscheduledshouldprobablywaituntil theyrecoverbeforegettingthevaccine. The National Vaccine Injury Compensation Program TheNationalVaccineInjuryCompensationProgram (VICP)wascreatedin1986. Personswhobelievetheymayhavebeeninjuredbya vaccinecanlearnabouttheprogramandaboutfilinga claimbycalling1-800-338-2382orvisitingtheVICP websiteatwww.hrsa.gov/vaccinecompensation. Yourdoctorcangiveyoumoreinformationaboutthese precautions. Note:Youmightbeaskedtowait28daysbeforedonating bloodaftergettinghepatitisBvaccine.Thisisbecausethe screeningtestcouldmistakevaccineinthebloodstream (whichisnotinfectious)forhepatitisBinfection. 8 What are the risks from hepatitis B vaccine? Hepatitis B is a very safe vaccine. Most people do not haveanyproblemswithit. Thevaccinecontainsnon-infectiousmaterial,andcannot cause hepatitis B infection. How can I learn more? • AskyourdoctorTheycangiveyouthevaccine packageinsertorsuggestothersourcesofinformation. • Callyourlocalorstatehealthdepartment. • ContacttheCentersforDiseaseControland Prevention(CDC): - Call 1-800-232-4636 (1-800-CDC-INFO) or -VisitCDC’swebsiteatwww.cdc.gov/vaccines Vaccine Information Statement (Interim) Somemildproblemshavebeenreported: • Sorenesswheretheshotwasgiven(uptoabout1 personin4). What if there is a moderate or severe reaction? VAERS does not provide medical advice. • Anyonewhohashadalife-threateningallergic reaction to a previous dose of hepatitis B vaccine shouldnotgetanotherdose. 5 Avaccine,likeanymedicine,couldcauseaserious reaction.Buttheriskofavaccinecausingseriousharm, ordeath,isextremelysmall.Morethan100million peopleintheUnitedStateshavebeenvaccinatedwith hepatitis B vaccine. 6 • Pregnantwomenwhoareatriskforoneofthereasons statedaboveshouldbevaccinated.Otherpregnant womenwhowantprotectionmaybevaccinated. 4 Severeproblemsareextremelyrare.Severeallergic reactionsarebelievedtooccuraboutoncein1.1million doses. • Temperatureof99.9°Forhigher(uptoabout1person in15). Hepatitis B Vaccine 2/2/2012 42 U.S.C. § 300aa-26 Office Use Only