General Discussion
In reply to the discussion: You hear antivaxers use "VAERS" a lot [View all]womanofthehills
(11,040 posts)Possible Outcomes of Reporting to VAERS
How are VAERS reports analyzed?
Analyzing VAERS reports is a complex task. Both FDA and CDC review data reported to VAERS. FDA reviews reports to assess whether a reported event is adequately reflected in the Emergency Use Authorization prescribing information, or product labeling for licensed (approved) vaccines. In addition, FDA closely monitors reporting trends for individual vaccine lots.
Can information reported to VAERS lead to FDA actions?
Based on information reported to VAERS and/or other systems in place to monitor vaccine safety, FDA may undertake a number of regulatory actions. These could include changes to the vaccine labeling, Fact Sheets, communications to the public and healthcare providers, or requiring the manufacturer to conduct additional studies.
Will I be contacted by VAERS after submitting a report?
You will be contacted by VAERS if follow-up information (e.g., medical records or other medical documentation) is needed. Please be aware that not everyone who submits a report is contacted and there may be a delay of when someone is contacted.
https://www.fda.gov/vaccines-blood-biologics/vaccine-adverse-events/vaccine-adverse-event-reporting-system-vaers-questions-and-answers