V-safe active surveillance for COVID-19 vaccine safety. Version 6, October 21, 2022

Details

• Corporate Authors:
  Centers for Disease Control and Prevention (U.S.)
• Description:
  V-safe is an active surveillance program to monitor the safety of COVID-19 vaccines during the period when the vaccines are authorized for use under Food and Drug Administration (FDA) Emergency Use Authorization (EUA) and possibly early after vaccine licensure. V-safe is a new smartphone-based system that uses text messaging to initiate web-based survey monitoring in the form of periodic health check-ins to assess for potential adverse events following vaccination. CDC will use the follow-up capability of the existing Vaccine Adverse Event Reporting System (VAERS) call center to conduct active telephone follow-up on recipients reporting significant, medically attended health impacts during v-safe health check-ins. The purpose of v-safe surveillance is to rapidly characterize the safety profile of COVID-19 vaccines when given outside a clinical trial setting and to detect and evaluate clinically important adverse events and safety issues that might impact policy or regulatory decisions.
  
  v-safe-protocol-v6-508.pdf
  
  
• Subjects:
  Coronavirus Infections/prevention & Control COVID-19 Vaccines/adverse Effects COVID-19/prevention & Control Mobile Applications Pandemics/prevention & Control Patient Safety Pneumonia, Viral/prevention & Control Vaccination/adverse Effects Viral Vaccines
• Document Type:
  Book
• Name as Subject:
  v-safe
• Pages in Document:
  87 numbered pages
• Collection(s):
  Stephen B. Thacker CDC Library
• Main Document Checksum:
  urn:sha256:a207d61668c50c3782f27757b5c45a0f3b6d49b9775c5273f4e03a1a586a91e7
• Download URL:
  https://stacks.cdc.gov/view/cdc/158502/cdc_158502_DS1.pdf
• File Type:
  [PDF - 776.09 KB ]