VACCINE INFORMATION STATEMENT Td or Tdap (Tetanus-Diphtheria or Tetanus-Diphtheria-Pertussis) What You Need to Know 1 Why get vaccinated? Tetanus, diphtheria and pertussis can be very serious diseases. TETANUS (Lockjaw) causes painful muscle spasms and stiffness, usually all over the body. • Itcanleadtotighteningofmusclesintheheadandneckso the victim cannot open his mouth or swallow, or sometimes even breathe. Tetanus kills about 1 out of 5 people who are infected. DIPHTHERIA can cause a thick membrane to cover the back of the throat. • Itcanleadtobreathingproblems,paralysis,heartfailure,and even death. PERTUSSIS(WhoopingCough)causesseverecoughing spellswhichcanleadtodifficultybreathing,vomiting,and disturbed sleep. • Itcanleadtoweightloss,incontinence,ribfracturesand passingoutfromviolentcoughing.Upto2in100adolescents and5in100adultswithpertussisarehospitalizedorhave complications,includingpneumoniaanddeath. These three diseases are all caused by bacteria. Diphtheria and pertussis are spread from person to person. Tetanus enters the bodythroughcuts,scratches,orwounds. TheUnitedStatessawasmanyas200,000casesayearof diphtheria and pertussis before vaccines were available, and hundredsofcasesoftetanus.Sincethen,tetanusand diphtheria cases have dropped by about 99% and pertussis casesbyabout92%. Children6yearsofageandyoungergetDTaP vaccine to protect them from these three diseases. But older children, adolescents, and adults need protection too. 2 Vaccines for adolescents and adults: Td and Tdap Twovaccinesareavailabletoprotectpeople7yearsofageand older from these diseases: • Td vaccinehasbeenusedformanyyears.Itprotects againsttetanusanddiphtheria. • Tdap vaccinewaslicensedin2005.Itisthefirst vaccineforadolescentsandadultsthatprotectsagainst pertussis as well as tetanus and diphtheria. ATdboosterdoseisrecommendedevery10years.Tdapis givenonlyonce. 3 Which vaccine, and when? Ages 7 through 18 years • AdoseofTdapisrecommendedatage11or12.Thisdose couldbegivenasearlyasage7forchildrenwhomissedone or more childhood doses of DTaP. Vaccine ManyVaccineInformationStatementsareavailableinSpanishandotherlanguages.Seewww.immunize.org/vis. HojasdeInformaciánSobreVacunasestándisponiblesenEspañolyenmuchosotrosidiomas. Visitehttp://www.immunize.org/vis • Childrenandadolescentswhodidnotgetacompleteseries ofDTaPshotsbyage7shouldcompletetheseriesusinga combination of Td and Tdap. Age 19 years and Older • AlladultsshouldgetaboosterdoseofTdevery10years. Adultsunder65whohavenevergottenTdapshouldgeta doseofTdapastheirnextboosterdose.Adults65andolder maygetoneboosterdoseofTdap. • Adults(includingwomenwhomaybecomepregnantand adults65andolder)whoexpecttohaveclosecontactwith ababyyoungerthan12monthsofageshouldgetadoseof Tdap to help protect the baby from pertussis. • Healthcareprofessionalswhohavedirectpatientcontactin hospitalsorclinicsshouldgetonedoseofTdap. Protection After a Wound • Apersonwhogetsaseverecutorburnmightneedadoseof Td or Tdap to prevent tetanus infection. Tdap should be used for anyone who has never had a dose previously. Td should be used if Tdap is not available, or for: - anybody who has already had a dose of Tdap, - children7through9yearsofagewhocompletedthe childhood DTaP series, or - adults65andolder. Pregnant Women • PregnantwomenwhohaveneverhadadoseofTdapshould getone,afterthe20thweekofgestationandpreferably duringthe3rdtrimester.IftheydonotgetTdapduringtheir pregnancytheyshouldgetadoseassoonaspossibleafter delivery.Pregnantwomenwhohavepreviouslyreceived Tdapandneedtetanusordiphtheriavaccinewhilepregnant shouldgetTd. TdaporTdmaybegivenatthesametimeasothervaccines. 4 Some people should not be vaccinated or should wait • Anyonewhohashadalife-threateningallergicreactionafter adoseofanytetanus,diphtheria,orpertussiscontaining vaccineshouldnotgetTdorTdap. • Anyonewhohasasevereallergytoanycomponentofa vaccineshouldnotgetthatvaccine.Tellyourdoctorifthe persongettingthevaccinehasanysevereallergies. • Anyonewhohadacoma,orlongormultipleseizureswithin 7daysafteradoseofDTPorDTaPshouldnotgetTdap, unless a cause other than the vaccine was found. These peoplemaygetTd. • Talktoyourdoctorifthepersongettingeithervaccine: - has epilepsy or another nervous system problem, - hadsevereswellingorseverepainafterapreviousdoseof DTP, DTaP, DT, Td, or Tdap vaccine, or - hashadGuillainBarréSyndrome(GBS). Td • Feverover102°F(rare) Tdap or Td • Extensiveswellingofthearmwheretheshotwasgiven(up toabout3in100). Anyone who has a moderate or severe illness on the day the shot is scheduled should usually wait until they recover before gettingTdaporTdvaccine.Apersonwithamildillnessor low fever can usually be vaccinated. Severe Problems 5 What are the risks from Tdap and Td vaccines? With a vaccine, as with any medicine, there is always a small riskofalife-threateningallergicreactionorotherserious problem. Brieffaintingspellsandrelatedsymptoms(suchasjerking movements) can happen after any medical procedure, includingvaccination.Sittingorlyingdownforabout15minutes afteravaccinationcanhelppreventfaintingandinjuries causedbyfalls.Tellyourdoctorifthepatientfeelsdizzyor light-headed,orhasvisionchangesorringingintheears. Gettingtetanus,diphtheriaorpertussisdiseasewouldbemuch morelikelytoleadtosevereproblemsthangettingeitherTd or Tdap vaccine. Problems reported after Td and Tdap vaccines are listed below. Mild Problems (Noticeable, but did not interfere with activities) Tdap • Pain(about3in4adolescentsand2in3adults) • Rednessorswellingattheinjectionsite(about1in5) • Mildfeverofatleast100.4°F(uptoabout1in25 adolescentsand1in100adults) • Headache(about4in10adolescentsand3in10adults) • Tiredness(about1in3adolescentsand1in4adults) • Nausea,vomiting,diarrhea,stomachache(upto1in4 adolescentsand1in10adults) • Chills,bodyaches,sorejoints,rash,swollenglands (uncommon) Td • Pain(uptoabout8in10) • Rednessorswellingattheinjectionsite(uptoabout1in3) • Mildfever(uptoabout1in15) • Headacheortiredness(uncommon) Moderate Problems (Interfered with activities, but did not require medical attention) Tdap • Painattheinjectionsite(about1in20adolescentsand1in 100adults) • Rednessorswellingattheinjectionsite(uptoabout1in16 adolescentsand1in25adults) • Feverover102°F(about1in100adolescentsand1in250 adults) • Headache(1in300) • Nausea,vomiting,diarrhea,stomachache(upto3in100 adolescentsand1in100adults) (Unable to perform usual activities; required medical attention) Tdap or Td • Swelling,severepain,bleedingandrednessinthearm wheretheshotwasgiven(rare). Asevereallergicreactioncouldoccurafteranyvaccine.They are estimated to occur less than once in a million doses. 6 What if there is a severe reaction? What should I look for? Anyunusualcondition,suchasasevereallergicreactionor ahighfever.Ifasevereallergicreactionoccurred,itwould bewithinafewminutestoanhouraftertheshot.Signsof aseriousallergicreactioncanincludedifficulty breathing, weakness, hoarseness or wheezing, a fast heart beat, hives, dizziness, paleness, or swelling of the throat. What should I do? • Calladoctor,orgetthepersontoadoctorrightaway. • Tellyourdoctorwhathappened,thedateandtimeithappened, andwhenthevaccinationwasgiven. • AskyourprovidertoreportthereactionbyfilingaVaccine AdverseEventReportingSystem(VAERS)form.Oryoucan filethisreportthroughtheVAERSwebsiteat www.vaers.hhs.gov,orbycalling1-800-822-7967. VAERS does not provide medical advice. 7 The National Vaccine Injury Compensation Program TheNationalVaccineInjuryCompensationProgram(VICP) wascreatedin1986. Persons who believe they may have been injured by a vaccine canlearnabouttheprogramandaboutfilingaclaimbycalling 1-800-338-2382orvisitingtheVICPwebsiteat www.hrsa.gov/vaccinecompensation. 8 How can I learn more? • Yourdoctorcangiveyouthevaccinepackageinsertor suggestothersourcesofinformation. • Callyourlocalorstatehealthdepartment. • ContacttheCentersforDiseaseControlandPrevention(CDC): - Call1-800-232-4636 (1-800-CDC-INFO) or -VisitCDC’swebsiteatwww.cdc.gov/vaccines Vaccine Information Statement (Interim) Td & Tdap Vaccines 1/24/2012 42 U.S.C. § 300aa-26 Office Use Only