COVID-19 Vaccine Safety Monitoring Systems

• CDC and FDA’s Vaccine Adverse Event Reporting System (VAERS) — A national system that accepts reports from healthcare professionals, vaccine manufacturers, and the public about adverse events that happen after vaccination. Reports of adverse events that are unexpected, appear to happen more often than expected, or have unusual patterns are further assessed.
  • The majority of reports to VAERS after COVID-19 vaccination have been non-serious adverse events.
  • There are two ways to report an adverse event to VAERS: report online or report using a writable pdf form. If you need further assistance reporting to VAERS, please email info@VAERS.org or call 1-800-822-7967.
  • For healthcare providers: Under Emergency Use Authorization, FDA requires healthcare professionals to report to VAERS certain adverse events that occur after COVID-19 vaccination. CDC also encourages reporting of any medically important adverse event even if it isn’t clear that the vaccine caused the health problem.
  • Learn more: How VAERS helps to monitor vaccine safety
  • Watch video: VAERS and Vaccine Safety: How It Works [00:02:04]

• The Vaccine Safety Datalink (VSD) — A network of 13 integrated healthcare organizations and networks across the United States that conducts active surveillance and research using electronic health records.
• CDC’s Clinical Immunization Safety Assessment (CISA) Project — A collaboration between CDC and medical research centers that serves as a vaccine safety resource for U.S. healthcare providers with complex vaccine safety questions about their patients, provides technical assistance for vaccine safety issues, and conducts clinical research studies about vaccine safety.
• The Centers for Medicare and Medicaid Services (CMS) — The U.S. Food and Drug Administration (FDA) actively monitors vaccine safety through the CMS Medicare Claims database. This system looks for any vaccine-related claims among Medicare participants aged 65 years and older. FDA then shares this information with CDC.
• FDA’s Biologics Effectiveness and Safety (BEST) System — A system of claims-based data used for active surveillance and research.

CDC and FDA have multiple safety monitoring systems in place to capture information about COVID-19 vaccination during pregnancy.

• CDC and FDA’s Vaccine Adverse Event Reporting System (VAERS) — VAERS is a national system to which healthcare professionals, vaccine manufacturers, and the public can report possible side effects or health problems that happen after vaccination. Scientists investigate reports of events that are unexpected, appear to happen more often than expected, or have unusual patterns. The VAERS reporting form has a question to identify pregnant people (question 8). CDC clinicians review all pregnancy reports related to COVID-19 vaccinations.
• The Vaccine Safety Datalink (VSD) — VSD is a network of thirteen integrated healthcare organizations across the United States that monitor and evaluate the safety of vaccines. The system is also used to help determine whether possible side effects identified using VAERS are related to vaccination. Through VSD, CDC monitors in-season weekly counts and rates of COVID-19 vaccination in pregnant people.
• CDC’s Clinical Immunization Safety Assessment (CISA) Project — The CISA Project is a collaboration between CDC and medical research centers that serve as a vaccine safety resource for U.S. healthcare providers with complex vaccine safety questions about their patients, provide technical assistance for vaccine safety issues, and conduct clinical research studies about vaccine safety. CISA is currently conducting a clinical research study to learn more about the safety of COVID-19 vaccines in pregnant people and their babies (CISA Project Clinical Research Studies | Vaccine Safety | CDC) and is planning an additional clinical research study on COVID-19 vaccine safety among pregnant people.
• CDC’s Birth Defects Study to Evaluate Pregnancy Exposures (BD-STEPS) — BD-STEPS is an ongoing study that collects information, including COVID-19 vaccination information, from people who have recently been pregnant to understand the potential causes of birth defects and how to prevent them.

• Department of Defense’s (DOD’s) VAERS data— Spontaneous adverse event reporting to VAERS for the DOD population.
• DOD’s Vaccine Adverse Event Clinical System (VAECS) — A system for case tracking and evaluation of adverse events following immunization in DOD and DOD-affiliated populations.
• DOD’s Electronic Health Record and Defense Medical Surveillance System — Large, linked electronic health records (AHLTA/MHS GENESIS) and administrative data systems for near real-time safety monitoring and research.

• Department of Veterans Affairs (VA) Adverse Drug Event Reporting System (VA ADERS) — A national reporting system for adverse events following receipt of drugs and immunizations.
• VA Electronic Health Record — A system of electronic health record and administrative data for active surveillance and research.

Indian Health Service (IHS) vaccine safety monitoring systems:
Passive surveillance

• Vaccine Adverse Event Reporting System (VAERS)
  • VAERS functionality permits analysis of adverse events in IHS system of care

• IHS Safety Tracking & Response System
  • Federal and participating tribal sites
  • Worker-related adverse events and vaccine administration errors

Active surveillance

• IHS Sentinel Survey
  • Biweekly survey of adverse events, including vaccine administration errors
  • 58 federal and tribal sites representing IHS Areas
  • Supports reporting to VAERS