vaers reporting 1

the .gov means it’s official.federal government websites often end in .gov or .mil. before sharing sensitive information, make sure you’re on a federal government site. the site is secure. the https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. this guidance for industry has been developed to clarify what information should be obtained before an individual case of an adverse experience after immunization should be submitted to the vaccine adverse event reporting system (vaers). the food and drug administration (fda) believes that the recommendations in this guidance document will improve the quality of postmarketing safety reports and clarify the industry’s current safety reporting responsibility to assure public health. 




federal government websites often end in .gov or .mil. the https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. background: underreporting is a limitation common to passive surveillance systems, including the vaccine adverse event reporting system (vaers) that monitors the safety of u.s.-licensed vaccines. objectives: to determine the sensitivity of vaers in capturing ae reports of anaphylaxis and guillain-barré syndrome (gbs) following vaccination and whether this is consistent with previous estimates for other severe aes.

we used data from vaers safety reviews as the numerator, and estimated incidence rates of anaphylaxis and gbs following vaccination from the vaccine safety datalink (vsd) studies as the denominator. results: vaers sensitivity for capturing anaphylaxis after seven different vaccines ranged from 13 to 76%; sensitivity for capturing gbs after three different vaccines ranged from 12 to 64%. for gbs, vaers captured 12% of cases after the 2012-13 inactivated seasonal influenza vaccine, 15-55% of cases after the 2009 h1n1 inactivated pandemic influenza vaccine, and 64% of cases after 4vhpv vaccine. conclusions: for anaphylaxis and gbs, vaers sensitivity is comparable to previous estimates for detecting important aes following vaccination.

important: if you are experiencing a medical emergency, seek immediate assistance from a healthcare provider or call 9-1-1. cdc and fda do not provide the information in this database contains reports received from 1990 to the present. data can be searched by the following: age, event category, gender, while very important in monitoring vaccine safety, vaers reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or, .

the food and drug administration (fda) believes that the recommendations in this guidance document will improve the quality of postmarketing the vaers database contains information on unverified reports of adverse events (illnesses, health problems, or symptoms) following immunization with us- reports for reactions to other vaccines are voluntary except when required as a condition of immunization grant awards. form vaers-1(fda)., .

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