Searching the Vaccine Adverse Event Reporting System (VAERS) Database


Uploaded by CDCStreamingHealth on 25.01.2013

Transcript:
Data Searching VAERS WONDER. Data from the Vaccine Adverse Event Reporting System, or VAERS, is available to the public. This presentation will show you how to search data from this system.
In searching VAERS data, you will be able to learn about symptoms, illnesses and adverse events that have been reported after vaccination. You will also learn about the strengths and weaknesses of the VAERS surveillance system.
VAERS is a national system that accepts reports of adverse events or health problems that occur after vaccines licensed for use in the United States are administered. VAERS receives approximately 30,000 reports per year and will accept reports from anyone including doctors, nurses, pharmacists and other healthcare providers, vaccine manufacturers and patients or parents.
When a report is received, the illness signs and symptoms or adverse event is assigned a code and entered into a database. VAERS data are searched based on the assigned codes.
VAERS is managed by the Centers for Disease Control and Prevention, CDC, and the Food and Drug Administration, FDA. It was created as a result of the National Childhood Vaccine Injury Act of 1986.
The purpose of VAERS is to detect new, unusual or rare health problems that occur after vaccination. We refer to these as vaccine adverse events. VAERS is also used to detect potential risk factors in people who have received vaccines for particular types of health problems, and to monitor trends in known adverse events.
VAERS can also be used to identify vaccine lots with increased adverse events. Additionally, VAERS is used to respond to vaccine safety concerns and public health emergencies.
It’s important to understand the limitations of the VAERS data so that you have a clear understanding of what the data means.
VAERS is a passive reporting system, meaning that reports about adverse events can be submitted voluntarily by anyone, including healthcare providers, patients, or family members. Because of this, VAERS data may and often does include incorrect and incomplete information.
Underreporting, or failure to report events, is one of the main limitations of VAERS. However, we do know that serious medical events are more likely to be reported than minor ones.
VAERS cannot determine cause-and-effect. The report of an adverse event to VAERS does not indicate that a vaccine caused the event. It only indicates that the event occurred sometime after vaccine was given. No proof that the event was caused by the vaccine is required in order for VAERS to accept the report.
VAERS accepts all reports without judging whether or not the event was caused by the vaccine. More information on the limits of VAERS data can be found on the VAERS website at www.vaers.hhs.gov.
Remember, the report of an adverse event to VAERS does not indicate that a vaccine caused the event. It only indicates that the adverse event or health problem occurred sometime after the vaccine was received.
Why would you want to search the VAERS database? If you have a patient or a family member who became sick a few days after getting a vaccine and you want to see how often that illness has been reported and the circumstances surrounding it to see if it is similar to your patient or your family member. Let’s take a look at how to search the VAERS database.
There are 2 ways to obtain VAERS data. Use CDC WONDER which is a search engine or download raw files from the VAERS website. This presentation will walk you through the 8 steps to search WONDER. It will not cover downloading of the raw data files from the VAERS website.
Keep in mind, VAERS data change regularly as new reports are received by the system, so your search results may change if you repeat the same search on a later date. VAERS data on WONDER are regularly updated about every month to reflect new reports that come in each day to VAERS.
Now that you have some information about what VAERS is and the limitations of the data, you are ready to start searching the VAERS data on WONDER.
Go to the CDC WONDER site at http://www.wonder.cdc.gov/vaers.html to begin your search. After you have viewed the general information about VAERS, click on the gray button that says “VAERS DATA SEARCH”.
The screen will look like this.
There are 8 steps in VAERS WONDER. This page lists each step.
Step 1 is “organize table layout”. This allows you to group results by different variables including the age of the patients, event category, and many others. In this step, choose what variables you want to see in your results.
Click on the down arrow to the right of any list box to drop the box down and show you the options for the selected field. For example, the “Group Results By” box shows “Age” as the default value, but you can click the down arrow to open the list box and select another option. Your results table will show a row for every variable you select.
If you want to view the written description of the adverse event exactly as it was reported, versus just the symptoms of the event, you must select “VAERS ID” in the first box under “Group Results By". Also, in the “Optional Measures” section, you must check the box entitled “Adverse Event Description.”
Any other variables picked from the “Group Results By” list need to appear in the order listed in the dropdown menu. If you want the output to have a title, insert it in the title box. In this example, we’ll be searching for reports of fever after influenza vaccine in young children. So, we enter the title “Fever or Febrile Seizures after influenza vaccine in kids ages 5 and under.”
In Step 2, select the symptoms you are interested in. The only fever code is “fever neonatal”, but we’re not interested in neonatal cases of fever since neonates do not get influenza vaccine. We are, however, interested in fever among young children, so we need to find symptoms that indicate fever or febrile seizure.
Click on the “search” tab and type in the symptom or illness you are interested in. We typed in “fever.” Then, click the gray search button.
A list of search terms for fever will appear in the symptoms box.
Select terms for your search. When you highlight a term, it will move to the “currently selected” box on the right side of the screen. If you want to select more than one term, hold down the control button on your keyboard. If you want to select a range of terms, hold down the shift key. The terms that we’re selecting are “febrile convulsion” and “pyrexia.”
Now, scroll down to section 3 and select the vaccine or vaccines that you are interested in. When you highlight it, it will be move to the “currently selected” box on the right side of the screen.
If you would like to search more than one vaccine, use the control key when you highlight them. If there is just one specific brand of flu vaccine that you want to search, click on the gray box that says open at the bottom of the form and then highlight the specific brand that you are interested in searching.
Scroll down to step 4. This step allows you to select event characteristics that you are interested in searching. If you do not select anything, it will default to all events. Onset interval means the timeframe from vaccine to adverse event. Manufacturer refer to the manufacturer of the vaccine product.
VAERS ID is the ID number assigned to a VAERS report. Use this if you have a specific VAERS ID number and you want information about that specific VAERS report. Event category allows you to limit your search to specific serious events such as deaths, life threatening illnesses, permanent disability, hospitalizations, or prolonged hospitalization.
You can also search for reports that resulted in emergency rooms visits or you can search other non-serious reports. The Recovered variable allows you to limit your search to reports for persons who did not recover, who did recover, who had unknown recovery status, or who did not have a response to the recovery status question --in other words it was missing information.
Finally, the serious category allows you to limit your search to serious or non-serious reports. A serious report is one in which one of the following was checked on the VAERS report: Death, life threatening illness, hospitalization, prolongation of an existing hospitalization, or permanent disability. If none are checked, the report is listed as non-serious.
Scroll down to step 5. This step allows you to select specific states, U-S territories, or foreign reports, as well as ages and genders you are interested in searching.
If you don’t select anything, it will default to all U-S states and territories and all ages and genders. For our example, we want to search all of the U-S for ages 5 and under for both genders.
Scroll down to step 6. This step allows you to select specific vaccination dates that you are interested in searching. If you don’t select anything in this section, it will default to all dates.
If you want to select a specific time frame within year instead of an entire year, highlight the year that you are interested in, click on the gray “open” button and select the months you want to search.
Scroll down to step 7. This step allows you to select specific report dates you are interested in searching. If you don’t select, it will default to all dates. If want to select a specific time frame within a year instead of the entire year, highlight the year, click the gray “open” button and then select the months you want to search.
Keep in mind that VAERS accepts reports at any time regardless of when the vaccination date was, so there may be reports received in this year for patients vaccinated in previous years.
Scroll down to step 8. This step allows you to select other options including showing totals and the number of decimal places the results will include. In our example, results will go to 2 decimal places. If you don’t select anything, it will default to show totals and 2 decimal places.
The final step is to press any of the gray “send” buttons on the page.
Your requested results will appear on the screen. Use the scroll bar on the right side of the screen to scroll down and view the results.
If you need assistance in using CDC WONDER to search the VAERS data, click on the “contact us” button listed at the top of the results page.
For more information on vaccine safety or VAERS, see the websites listed on this slide. If you have general immunization questions, call 1-800-CDC-INFO.
The best way to learn how to use VAERS WONDER is to practice. Thank you for participating in the VAERS WONDER training presentation.