Tom: Hi, I'm Dr. Tom Shimabukuro from CDC,
the Centers for Disease Control and Prevention.
Adamma: And I'm Dr. Adamma Mba-Jonas from FDA,
the US Food and Drug Administration.
Tom: The Vaccine Adverse Event Reporting System, or VAERS,
is the national vaccine safety monitoring system
run by the CDC and the FDA.
We depend on people like you to send us reports of adverse events,
or health problems, occurring after vaccination.
Adamma: Anyone can submit a report including healthcare professionals,
patients, parents, and caregivers.
We encourage you to report anything
you think is a medically important health event.
There is additional reporting guidance
for healthcare professionals on the VAERS website.
Tom: It's important to understand that VAERS is not designed
to determine if a vaccine caused an adverse event.
VAERS reports alone generally cannot tell us
if there is a safety problem with a vaccine.
Rather, VAERS is an early warning system to detect possible
safety problems that require further evaluation.
Adamma: We welcome all reports regardless of seriousness
and regardless of how likely the vaccine was
to have caused the adverse event.
We'll analyze reports for any unusual or unexpected patterns.
The information you provide helps us monitor the safety of vaccines.
We appreciate your participation.
We also want you to know that personal information in VAERS reports
will remain confidential as required by law.
Tom: We encourage you to submit your report
using the VAERS online reporting tool.
Once you start filling out the form you must finish.
You cannot save your work and return later.
Take a moment to look at the checklist on the VAERS website
before you start so you'll know what information you need.
Adamma: There's also the option of reporting through a writeable PDF form.
We'll talk about that more in a minute.
Although there are two options for reporting,
you only need to submit one report.
Choose the option that works best for you.
Let's walk through the online reporting tool first.
To use the secure online reporting tool,
go to the VAERS website
at vaers.hhs.gov.
This is the VAERS homepage.
Click on the tab that says Report an Adverse Event.
Before you begin the report, review the checklist in the blue box
to make sure you have the necessary information.
If you're inactive on the reporting page for 20 minutes,
it will time out and you'll have to
start the report over from the beginning.
Click on Option 1-Report Online to VAERS.
Fill in all the requested information to the best of your ability.
Questions with a red asterisk are very important and should be completed.
Use the Next button to advance through all the sections of the form.
Do not use your browser's back or
forward arrow or you will lose your information.
There are five sections.
The first section - Patient Information - asks for details about the patient,
such as name, address, and date of birth.
It also asks for the date of vaccination and medical history.
Complete this information and click
Next to move on to the next section.
If you've left essential items blank,
you will get a pop-up notification
for each item where information is still needed.
You can choose Yes, fix now or Continue to next page.
Even if you don't have the information to answer
essential items you can still move forward
by selecting "Continue to next page."
As you advance through each section, you'll see check marks
in the left-hand column next to Completion Status.
The second section - Reporter Information - asks for information
about the person completing the form.
The third section - Facility Information - asks for information
about the facility or place where the vaccine was given.
The fourth section - Vaccine Information - asks for information
about the vaccines given and the patient's adverse event.
There are drop down arrows to choose the vaccine, manufacturer,
vaccine route, site, and dose number.
If you don't see the vaccine listed, choose Other Vaccine
from near the bottom of the list and type the
vaccine name in the box.
If more than one vaccine was given,
click the green button that says Add One More.
The next set of questions asks you to describe the adverse event.
The final section asks for additional information,
including other recent vaccines given, previous adverse
events, race, ethnicity, and U.S. military status.
When you have completed the form, click the Submit box.
You will receive a confirmation message asking
if you are sure you want to submit the form.
After you click Submit form, you will receive the message Success!
Your VAERS form was submitted.
You will also be given an E-report number.
Save this number in case you have questions about your report.
If you want the E-report number emailed to you,
enter your email address in the box.
If you scroll down, you will see your completed VAERS report
which you can print. Remember, if you're inactive on the
reporting page site for 20 minutes, it will time out
and you will have to start over from the beginning.
Tom: If the online reporting tool doesn't work for you,
you can report the information using a writable PDF form.
Let's move on to the description of how to
send a report using the writable PDF form.
On the VAERS website, click on the tab that says
Report an Adverse Event.
Click on Option 2-Report using a Writable PDF form.
Here you will find instructions for downloading the writable PDF form.
You will need Adobe Acrobat version 5.0 or later
to fill out the form.
Click on Download the Writable PDF form.
Open the VAERS form and save it to your computer.
Fill out the form as completely as you can.
Essential items are highlighted in yellow.
The drop down menu on questions 17 and 22 will allow you to select a response.
Be sure to click the Save button when you are finished
and before closing the form.
If you left essential questions blank,
you will get a reminder that the form is not complete.
However, if you don't have all the information,
you can still save and submit the form.
When you're ready to submit the form, go back to the VAERS website
at vaers.hhs.gov.
Click on Report an Adverse Event.
Scroll down and click on Option 2-Report
using a Writable PDF form.
Click on Step 2 -
Enter your name and email address.
Under the PDF file, click the Browse button.
A new window will allow you to go to the folder
where you have saved the completed form.
Select the finished form to upload.
Complete the word verification by typing the characters
shown in the box and click Upload the Writable PDF Form.
You will receive the message Success!
Your VAERS form was submitted.
You will also be given an E-report number.
Save this number in case you have questions about your report.
If you want the E-report number emailed to you,
enter your email address in the box.
Tom: Thank you for doing your part to help
CDC and FDA monitor the safety of vaccines.
Adamma: If you have questions or need more information
you can contact VAERS by email
at info@VAERS.org,
or call 1-800-822-7967.