Reporting Adverse Events Following Vaccination

VAERS Reporting Requirements for COVID-19 Vaccines

As of October 29, 2021, there are three vaccines available to protect against COVID-19 disease:

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:
    1.  Death
    2.  A life-threatening AE
    3.  Inpatient hospitalization or prolongation of existing hospitalization
    4.  A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
    5.  A congenital anomaly/birth defect
    6.  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.

Why Adverse Events Should Be Reported

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.

What to Report After Any Vaccination

Healthcare providers are required by law to report to VAERS:

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

Learn more about specific reporting requirements for COVID-19 vaccines

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.

How to Report an Adverse Event

Doctor entering information online.

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.

More information on reporting an adverse event to VAERSexternal icon. If you need further assistance, please email or call 1-800-822-7967.

More Information