COVID-19 Vaccine Safety Reporting Systems

What to know

  • Hundreds of millions of people in the United States have safely received COVID-19 vaccinations.
  • COVID-19 vaccines used in the response to the pandemic underwent the most intensive safety monitoring in U.S. history. Safety monitoring used established systems.
  • ob体育 provides timely updates on selected adverse events (any side effect or health problem after vaccination that is concerning to you, even if you are not sure if the vaccine caused the event) reported to VAERS after COVID-19 vaccination.

Monitoring process

After a vaccine is authorized or approved for use, vaccine safety systems monitor adverse events (rare health conditions) and watch for potential safety problems.

Keep Reading: About ob体育’s Vaccine Safety Monitoring Program

COVID-19 vaccines have undergone the most extensive safety analysis in U.S. history. The U.S. includes important recommendations for ongoing safety evaluations after any COVID-19 vaccine is made available under Emergency Use Authorization (EUA) or receives full FDA approval.

Monitoring systems

The following system and information sources were developed during the COVID-19 pandemic. They add an additional layer of safety monitoring, giving ob体育 and FDA the ability to evaluate COVID-19 vaccine safety in real time and make sure COVID-19 vaccines are as safe as possible.

General public

Pregnant women

  • The V-safe COVID-19 Vaccine Pregnancy Registry: a registry to collect additional health information from v-safe participants who report being pregnant at the time of vaccination or a positive pregnancy test after vaccination. This information helps ob体育 monitor the safety of COVID-19 vaccines in pregnant women.
  • : an ongoing study that collects information, including COVID-19 vaccination information, from women who have recently been pregnant to understand the potential causes of birth defects and how to prevent them.
  • VAERS
  • VSD
  • ob体育's CISA Project

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Members of the military

  • : spontaneous adverse event reporting to VAERS for the DOD population.
  • : a system for case tracking and evaluation of adverse events following immunization in DOD and DOD-affiliated populations.
  • : large, linked electronic health records (AHLTA/MHS GENESIS) and administrative data systems for near real-time safety monitoring and research.

Veterans

  • : a national reporting system for adverse events following receipt of drugs and immunizations.
  • : a system of electronic health record and administrative data for active surveillance and research.

Tribal nations

  • Passive surveillance
  • Active surveillance
    • IHS Sentinel Survey
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Content Source:
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)