What Is VAERS?
The Vaccine Adverse EventReporting System (VAERS)is a national program thatmonitors the safety of vaccines after they arelicensed.VAERS is managedby the U.S.Centers for Disease Control andPrevention (CDC) and the U.S.Food and DrugAdministration (FDA).VAERS is part of a larger system that makessure that vaccines are safe and work asintended.Steps to make sure that vaccinesare safe begin before a vaccine is licensed andcontinue afterward.Before a vaccine islicensed,FDA requires that it go throughextensive safety testing.After a vaccine islicensed,VAERS is used to watch for any problems,or “adverse events,”that happenafter vaccination.Even though careful andcomplete studies are done before a vaccine islicensed,rare side effects may not be founduntil a vaccine is given to millions of peoplewith different backgrounds and medicalhistories.VAERS helps to make sure that thebenefits of vaccines continue to be far greater than the risks.There are things that VAERS cannot do.VAERScannot prove that a vaccine either did cause or did not cause a problem.In fact,vaccines arenot the cause of many of the problemsreported to VAERS.Sometimes people whoget vaccinated coincidentally will get sick fromsome other cause—they get a stomachache,cold,or flu—and it has nothing to do with thevaccine.Rarely,people who have beenvaccinated will get unexpected reactions thatare serious and should be reported to VAERS.Even though VAERS cannot prove that avaccine caused a problem,it can give FDA andCDC important information that might signal aproblem.If it looks as though a vaccine mightbe causing a problem,FDA and CDC willinvestigate further.
Does VAERS Provide Medical Advice?
No,VAERS does not provide medical advice.For medical advice,please contact your healthcare provider or state health department.
Who Can Report toVAERS?
Anyone can report toVAERS.FDA and CDCencourage patients,parents,and others toreport any significant problems experiencedafter vaccination,even if they are not certain that a vaccine caused them.To report a possibleproblem after vaccination,visit the VAERS web siteatwww.vaers.hhs.gov.Alsosee the section in thisbrochure on “How Do IReport?”
Why Should I Reportto VAERS?
Better reporting helpskeep vaccines safe for youand your family,and for everyone who receivesvaccinations.Each VAERS report providesvaluable information that helps FDA and CDCmake sure that vaccines are safe.The moreaccurate and complete the VAERS reports,thebetter the system works.Remember,novaccine (or any medicine) is completely free of risk and some side effects are possible.
What Types of Events Should BeReported?
You should report any serious problem thathappens after getting a vaccine,even if you arenot sure that the vaccine caused the problem.It is especially important to report any problem that resulted in hospitalization,disability,or death.Health careproviders are requiredby law to report certainproblems.To get a listof these,please call800-822-7967 or go towww.vaers.hhs.gov/reportable.htmor www.hr
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