Reporting Adverse Events Following Vaccination
Healthcare providers are required to report to VAERS the following adverse events after COVID-19 vaccination [under Emergency Use Authorization (EUA)], and other adverse events if later revised by FDA:
- Vaccine administration errors, whether or not associated with an adverse event (AE)
- Serious AEs regardless of causality. 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 if vaccination caused the event.
The Vaccine Adverse Event Reporting System (VAERS) is an early warning system that helps CDC and the Food and Drug Administration (FDA) monitor health problems that may occur following vaccination. VAERS is a passive surveillance system, and relies on people sending in reports of their experiences. As the frontline system for vaccine safety monitoring, VAERS depends on healthcare professionals to report any health problems of clinical significance that may occur after vaccination. Healthcare providers should report suspected adverse events following vaccination to VAERS for all vaccines currently licensed for use in the United States, and all COVID-19 vaccines authorized for emergency use.
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 vaccination
- Any adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine
Healthcare providers are encouraged to report:
- Any adverse event that occurs after the administration of a vaccine licensed in the United States, whether or not it is clear that a vaccine caused the adverse event
- Vaccine administration errors
Online reporting (i.e., electronic form) is strongly encouraged. Please report clinically important adverse events that occur after vaccination of adults or children, even if you are not sure whether the vaccine caused the adverse event.
VAERS accepts all reports, including reports of vaccination errors. Guidance on reporting vaccination errorsexternal icon is available if you have additional questions.
There are 2 ways to submit a report to VAERS:
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.
- Vaccine Adverse Event Reporting System (VAERS) - HHSexternal iconLearn more about the national monitoring system that serves as an early warning system to detect possible vaccine safety issues.
- Information for Healthcare Providers - VAERSexternal iconHealthcare providers can find guidance on what adverse events to report and answers to common questions about VAERS.
- Safety Information by VaccineGet the latest safety information from CDC on recommended U.S. vaccines.
- VAERS Print and Web MaterialSearch through education materials, including factsheets, brochures, graphics and web banners for healthcare professionals and the general public.