The United States currently has the safest vaccine supply in its history. The nation’s long-standing vaccine safety system ensures that vaccines are as safe as possible.
Vaccine Safety is a vital part of the nation’s response to the COVID-19 pandemic. As vaccines are developed and become available, the public’s knowledge of their safety, both initially and during extended use, is an important part of a successful national vaccination effort.
CDC’s Immunization Safety Office works to communicate timely and transparent information about the safety of vaccines to public health officials, healthcare providers, and the public. The office conducts vaccine safety monitoring and clinical research to help keep vaccines safe.
Report a Possible Health Problem following
Vaccination to VAERS
Everyone is encouraged to report possible health problems (adverse events) after vaccination to the Vaccine Adverse Event Reporting System (VAERS). Healthcare providers and vaccine manufacturers are required to report certain health events.
Healthcare providers or health departments in the United States can request a consultation for complex COVID-19 vaccine safety questions from CISA COVIDvax.
Vaccine Safety is a top priority while CDC and federal partners work to make COVID-19 vaccines available.
The Vaccine Adverse Event Reporting System (VAERS) serves as the nation’s early warning system to monitor for potential vaccine safety problems. Anyone can report possible health problems to VAERS.
The Vaccine Safety Datalink (VSD) is a collaboration between CDC and 9 health care organizations that conducts active vaccine safety monitoring and research.
The Clinical Immunization Safety Assessment (CISA) Project is a partnership between CDC and 7 medical research centers that provides expert consultation and conducts clinical research on vaccine-associated health risks.
COVID-19 Vaccine Product Information
Key information for each specific COVID-19 vaccine including administration, storage and handling, safety, and reporting.
COVID-19 Vaccine Information Overview
Overview of what everyone should know about the different COVID-19 vaccines.
COVID-19 Vaccine Emergency Use Authorization (EUA) Fact Sheets for Recipients and Caregivers
Fact sheets for each COVID-19 vaccine authorized under the Emergency Use Authorization (EUA).
For the COVID-19 response, CDC’s vaccine safety experts have developed protocols and standard operating procedures to guide COVID-19 vaccine safety monitoring efforts.
V-safe Protocol – version 5 [PDF – 87 Pages]
V-safe Pregnancy Registry Protocol (amendment) version 2 [PDF – 11 Pages]
VAERS SOP version 4 [PDF – 37 pages]
CISA COVIDvax Work Plan [PDF – 29 pages]
Myocarditis Outcomes Study Protocol version 2 [PDF – 5 pages]
VSD Protocol version 1.4 [PDF – 33 pages]
VMED Study Protocol version 1.8 [PDF – 18 pages]
Tree-Based Data Mining Protocol version 1.8 [PDF – 13 Pages]
SAB and Stillbirth Monthly Surveillance Protocol version 2.0 [PDF – 28 pages]
COVID-19 KAB Survey Protocol [PDF – 22 Pages]
Mortality and Vaccination with COVID-19 Vaccines Protocol [PDF – 12 Pages]
COVID-19 Vaccine Safety and Maternal Outcomes version 1.7 [PDF – 42 pages]
Smartphone COVID-19 Vaccine Monitoring in KP: Pilot Program [PDF – 38 Pages]
Changes in Healthcare Use Following COVID-19 Infection [PDF – 11 pages]
COVID-19 Vaccine Safety Monitoring in Underserved Populations [PDF-16 Pages]
SAB and Stillbirth Case-Control Studies version 1.0 [PDF- 34 Pages]
Menstrual Irregularities Working Group Protocol [PDF- 10 Pages]
Infant Infections and Maternal COVID-19 Vaccination version 1.2 [PDF- 18 Pages]
Simultaneous vaccine administration and co-administration with COVID-19 vaccine [PDF- 22 Pages]