How to Report Adverse Events to VAERS
Reporting adverse events to VAERS helps scientist at CDC and FDA keep vaccines safe.
Option 1: Submit a VAERS Report onlineexternal icon (Preferred)
The online VAERS Report must be completed and submitted in the same session; it cannot be saved and edited at a later time. Note: sessions time out after 20 minutes of inactivity; no information is saved.
Option 2: Download a Writable PDF Form and upload when readyexternal icon
The Writable PDF Form can be downloaded and completed electronically on your own time. When ready, return to the VAERS Writable PDF web page (use link above) and follow Step 2 instructions to upload the form.
Reporting possible health problems (adverse events) after vaccination to VAERS provides valuable information. These reports help CDC and FDA detect new or unusual adverse events that could indicate a problem with a vaccine. If it looks as though a vaccine might be causing a problem, FDA and CDC will investigate further and take action if needed.
Everyone is encouraged to report possible adverse events after vaccination to VAERS, even if they are not sure whether the vaccine caused the problem. In general, you should report any side effect or health problem after vaccination that is concerning to you.
Under the National Childhood Vaccine Injury Act (NCVIA), healthcare providers are required by law to report to VAERS:
- Any adverse event listed in the VAERS Table of Reportable Events Following Vaccination pdf icon[PDF – 5 Pages]external icon that occurs within the specified time period after vaccinations
- An adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine
Healthcare providers are strongly encouraged to report to VAERS:
- Any adverse event that occurs after the administration of a vaccine licensed in the United States, whether it is or is not clear that a vaccine caused the adverse event
- Vaccine administration errors
Vaccine manufacturers are required to report to VAERS all adverse events that come to their attention.
The VICP compensates people whose injuries may have been caused by certain vaccines. The program is separate from VAERS, and administered by the Health Resources and Service Administration.
Reporting an adverse event to VAERS does not create a claim for compensation with the VICP. Claims must be filed separately with the VICP.
To learn more about filing a claim, visit the National Vaccine Injury Compensation Programexternal icon.
As of October 29, 2021, there are three vaccines available to protect against COVID-19 disease:
- Pfizer-BioNTech COVID-19 Vaccine (Comirnaty®)external icon is FDA-approved for people ages 16 years and older; it is authorized for emergency use in people 5 years and older.
- Moderna COVID-19 Vaccineexternal icon is authorized for emergency use in people ages 18 years and older.
- Johnson & Johnson’s Janssen COVID-19 Vaccineexternal icon is authorized for emergency use in people ages 18 years and older.
The reporting requirements for COVID-19 vaccines are the same for those authorized under emergency use or fully approved. Healthcare providers who administer COVID-19 vaccines are required by law to report the following to VAERS:
- Vaccine administration errors, whether or not associated with an adverse event (AE).
- If the incorrect mRNA COVID-19 vaccine product was inadvertently administered for a second dose in a 2-dose series, VAERS reporting is required.
- If a different product from the primary series is inadvertently administered for the additional or booster (third dose), VAERS reporting is required.
- VAERS reporting is not required for the following situations:
- If a mixed series is given intentionally (e.g., due to hypersensitivity to a vaccine ingredient)
- Mixing and matching of booster doses (as of October 21, 2021, mixing and matching of booster doses is allowed)
- Serious AEs regardless of whether the reporter thinks the vaccine caused the AE. Serious AEs per FDA are defined as:
- A life-threatening AE
- Inpatient hospitalization or prolongation of existing hospitalization
- A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
- A congenital anomaly/birth defect
- An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above
- Cases of Multisystem Inflammatory Syndrome
- Cases of COVID-19 that result in hospitalization or death
Healthcare providers are encouraged to report to VAERS any additional clinically significant AEs following vaccination, even if they are not sure whether the vaccine caused the event.
Also, healthcare providers should report any additional selected AEs and/or any revised safety reporting requirements per FDA’s conditions of authorized use of vaccine(s) throughout the duration of any COVID-19 vaccine’s Emergency Use Authorization (EUA) or any approved COVID-19 vaccine as outlined in the Fact Sheet for Healthcare Providersexternal icon.
CDC and FDA encourage anyone who experiences (or is made aware) of an adverse event after vaccination to report it to VAERS, even if they are not sure the vaccine caused the problem:
- Parents/family member
- Those who administer vaccines
- Healthcare providers
- Vaccine manufacturers
Reporting to VAERS helps CDC and FDA scientists keep vaccines safe.
Which adverse events are considered “serious”?
By the Code of Federal Regulations (CFR) Title 21external icon, an adverse event is defined as serious if it involves any of the following outcomes:
- A life-threatening adverse event
- A persistent or significant disability or incapacity
- A congenital anomaly or birth defect
- Hospitalization, or prolongation of existing hospitalization
Learn more about adverse events.
Each VAERS report is assigned a VAERS identification number. This number can be used to provide additional information about the report to VAERS, if necessary. VAERS will send the identification number to the reporting individual in a confirmation letter (electronically or by mail, depending on communications preferences listed on the original report).
Other than the confirmation letter, VAERS will only reach out to the reporting individual for additional information if “essential fields” of the VAERS form are not filled out. VAERS will not contact the reporting individual by phone for follow-up. Additional information requests are sent electronically or by mail, and will explain what information is missing from the report and how the reporter can update it.
CDC or FDA scientists follow up on reports identified as serious adverse events immediately by obtaining medical records to better understand the event. These requests for medical records are made directly to health institutions or public health authorities that create and maintain medical records. The medical records are added to the permanent record under the VAERS ID, compliant with privacy standards.
- Vaccine Adverse Event Reporting System (VAERS) - HHSexternal iconThe official website for VAERS. Learn more about this national vaccine safety monitoring system, including what to report, how to report, FAQs, and more.
- VAERS Frequently Asked Questions (FAQs) - HHSexternal iconGet answers to the most common questions about VAERS.
- Access VAERS Data Through VAERS WONDER SystemLearn how to search and interpret the data reported to VAERS.
- Video: Vaccine Adverse Event Reporting System (VAERS) Website and Ways to ReportLearn how to report an adverse event using VAERS and how CDC and FDA monitor the safety of vaccines.