Although considered a rare event, vaccine injuries do happen all the time and when they do, it’s important that this information is properly reported and documented for the purposes of improving health and safety protocol related to vaccinations. In the United States, the way to report a vaccine injury experience is through a system co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). The reporting system is known by the acronym VAERS.
What is VAERS?
VAERS stands for the Vaccine Adverse Event Reporting System, which was established in 1990 an early warning system that enables the detection of possible safety issues with U.S. licensed vaccine products. It is a passive reporting system, which means that information is only collected when individuals submit reports of adverse reactions to vaccinations as they are experienced.
Since VAERS is only a reporting system, it is not designed to confirm whether or not a vaccine caused an adverse health event or condition. The information collected is useful for detecting patterns of concern that can inform investigation efforts to improve the overall safety of vaccines.
Primary objectives of VAERS include detecting new vaccine injuries, to observe increases in adverse events that are already known, to identify potential risk factors for certain types of heath incidents, to assess the safety of newly licensed vaccines, to identify and take action on incident patterns that are common to a specific space and time (clusters), to discover common safe-use issues and administration errors, and to serve the general public interest in the event of health emergencies such as large-scale vaccination programs in response to a pandemic.
Who is required to report vaccine injuries?
By law, U.S. healthcare providers are required to report any vaccine injuries they become aware of to VAERS if they are known adverse effects listed on the VAERS Table of Reportable Events Following Vaccination that occur within the specified time range criteria. They are also required to report any health outcome noted by the vaccine manufacturer as a contraindication (reason to deter additional doses).
Although not required, healthcare professionals are also highly encouraged to report to VAERS any adverse health condition or response to a vaccination even in circumstances where it is uncertain that the vaccine caused the adverse outcome. They are also encouraged to report any vaccine administration errors they identify.
Manufacturers of vaccine products must also report to VAERS all adverse health events brought to their attention.
You do not need to be a vaccine manufacturer or healthcare provider, however, to report a vaccine injury to VAERS. Anyone can submit a report, and should, if the event has not yet been reported.
What information is needed to file a report?
Information needed to file a VAERS report includes the patient’s age, date of birth and sex. You will also need to note the brand name of the vaccine and the dosage information. The report will also ask for the date, time, and location the vaccine was administered, when symptoms started, what symptoms occurred or are occurring, and the outcome of the adverse health event. Be prepared to also submit any test or laboratory results obtained and provide contact information of the physician who assisted with the diagnosis.
How to submit a report to VAERS
Once you’ve gathered the necessary date for the report, you have two options. You can report online by visiting the VAERS online reporting site. Or, you can download the VAERS writable PDF Form to a computer (see instructions on the lefthand side of the page at that link), complete the form via the computer file, save, and then upload the completed form to the same page (see instructions on the righthand side of the page at that link.
What happens after a report is submitted?
After your report is submitted, the VAERS system will assign a special identification number to the case that will be sent to you in a confirmation letter. This identification number will also allow you to provide any updates about the condition to VAERS to add new information to the submitted case, should an additional detail of relevance develop. The confirmation letter will arrive either by mail or be sent electronically depending on the communication preference you selected as part of your original report submission.
VAERS will only reach out by mail or electronic communication to the reporting individual to request any essential information that is missing on the original form.
Serious events reported may trigger direct request of the for medical records from the healthcare institution or public health authorities to better understand the adverse event. Any records collected in this way are added to the VAERS ID record, which is subject to compliance with privacy standards.
Both the identity of the person who received the vaccine and the identity of the person who filed the report remain protected (this information is not available to the public).
Should you have any additional questions about the submission process, you can call (800) 822-7967 or email to info@vaers.org. If you reach out by email, do not include any identifying information about the patient in your message.
Ensuring your experience, or your child’s experience, with a vaccine injury is included in VAERS reporting helps the effort to improve vaccine safety in the United States.
How to Pursue Vaccine Injury Compensation
If you or your child has experienced a vaccine injury from an immunization, and you’ve received a medical diagnosis to support this, you may also be eligible for compensation through the VICP: a taxpayer funded program created by Congress specifically for individuals who have been injured or killed by certain vaccines. The Vaccine Injury Lawyers can assist you with this application process at no cost to you.
Click here to share your vaccine injury experience with our team of experienced attorneys to see if we might be able to assist you in obtaining compensation through the VICP program. Reach out today to let us help you obtain the compensation you deserve.
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