As part of our commitment to preventing medication harm with education, we are providing COVID-19 specific and general vaccine safety-related information as made available from the U.S. Food & Drug Administration (FDA) and the Centers for Disease Control & Prevention (CDC).
Fact Sheets to Read Before Your COVID-19 Vaccine
Before being vaccinated, you should be informed about certain information. In fact, per the FDA, vaccination providers are required to provide a Fact Sheet to all patients and parents/guardians for anyone receiving the available COVID-19 vaccine options. So, know the facts in advance. Download the Pfizer-BioNTech COVID-19 vaccine Fact Sheet HERE. Download the Moderna COVID-19 vaccine Fact Sheet HERE.
Report a Vaccine Safety Issue or Injury
According to the CDC and FDA, “you should report any adverse event that happens after getting a vaccine, even if you’re not sure the vaccine caused the adverse event”. Any events that resulted in hospitalization, disability, or death are especially important to report. Report a vaccine adverse event online HERE or by downloading a paper reporting form HERE.
The FDA Approval Documentation for the COVID-19 Vaccines
On December 11, 2020, the FDA approved the Pfizer-BioNTech vaccine under an Emergency Use Authorization (EUA). Read the full approval Letter of Authorization HERE. To read the full Pfizer-BioNTech Briefing Document: HERE. On December 18, 2020, the FDA also approved Moderna’s vaccine under an EUA. Read the full approval Letter of Authorization HERE. To read the full Briefing Document for the Moderna vaccine: HERE.
Fact Sheet & Brochure: Reporting Vaccine Adverse Events
The Vaccine Adverse Event Reporting System (VAERS) is government-managed and used by both the FDA and CDC to monitor vaccine safety. Learn more about this vital program and why it is important for both healthcare providers and patients to participate. Download the “Report to VAERS” brochure HERE or download the VAERS Fact Sheet HERE.