![]() Healthcare providers are required by law to report to VAERS: Healthcare providers should report suspected adverse events following vaccination to VAERS for all vaccines currently licensed for use in the United States, and all COVID-19 vaccines authorized for emergency use. As the frontline system for vaccine safety monitoring, VAERS depends on healthcare professionals to report any health problems of clinical significance that may occur after vaccination. VAERS is a passive surveillance system, and relies on people sending in reports of their experiences. The Vaccine Adverse Event Reporting System (VAERS) is an early warning system that helps CDC and the Food and Drug Administration (FDA) monitor health problems that may occur following vaccination. When submitting a VAERS report, ensure that you document the Route in Section 17 of the VAERS form, by choosing “intradermal” or “subcutaneous” from the selection menu. These are considered routes of vaccination. Subcutaneously (under the skin) in the upper arm above the elbow.Intradermally (between the layers of the skin) on the inner aspect of the forearm, and.It authorizes the vaccine to be administered in one of two ways: Providers are encouraged to also report to VAERS any additional clinically significant AEs following vaccination, even if they are not sure if vaccination caused the event.Īs of August 9, 2022, FDA issued an Emergency Use Authorization (EUA) for JYNNEOS monkeypox vaccine. Cases of thromboembolic events and neurovascular events.Cases of cardiac events, including myocarditis and pericarditis.Serious* adverse events (irrespective of attribution to vaccination).Vaccine administration errors, whether or not associated with an adverse event.The vaccination provider is responsible for mandatory reporting of the following listed events following JYNNEOS or ACAM2000 vaccination to VAERS: The vaccination provider must report all serious* adverse events following administration of JYNNEOS or ACAM2000 vaccine and vaccine administration errors to the Vaccine Adverse Event Reporting System (VAERS) by submitting online at. Healthcare providers are encouraged to report to VAERS any additional clinically significant AEs following vaccination, even if they are not sure whether the vaccine caused the event.Īlso, healthcare providers must report any additional selected AEs and/or any revised safety reporting requirements per FDA’s conditions of authorized use of vaccine(s) throughout the duration of any COVID-19 vaccine’s Emergency Use Authorization (EUA) or any approved COVID-19 vaccine as outlined in the Fact Sheet for Healthcare Providers. Cases of COVID-19 that result in hospitalization or death.Cases of Multisystem Inflammatory Syndrome in children and adults.Cases of pericarditis after a Pfizer-BioNTech, Moderna, or Novavax vaccine.Cases of myocarditis after a Pfizer-BioNTech, Moderna, or Novavax vaccine.An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above.A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions.Inpatient hospitalization or prolongation of existing hospitalization.Serious AEs regardless of whether the reporter thinks the vaccine caused the AE. ![]() ![]() Mixing and matching of booster doses intentionally (as of October 21, 2021, mixing and matching of booster doses is allowed).If a mixed series is given intentionally (e.g., due to hypersensitivity to a vaccine ingredient).VAERS reporting is not required for the following situations:.If a different product from the primary series is inadvertently administered for the additional or booster (third dose), VAERS reporting is required.If the incorrect mRNA COVID-19 vaccine product was inadvertently administered for a second dose in a 2-dose series, VAERS reporting is required.Vaccine administration errors, whether or not associated with an adverse event (AE).Healthcare providers who administer COVID-19 vaccines are required by FDA, and under the provider agreements for the CDC COVID-19 Vaccination Program, to report the following to VAERS: The reporting requirements for COVID-19 vaccines are the same for those authorized under emergency use (EUA) or approved under a Biologics License Application (BLA). Johnson & Johnson’s Janssen COVID-19 Vaccine.Pfizer-BioNTech COVID-19 Vaccine (Comirnaty®).As of August, 2022, there are four vaccines available to protect against COVID-19 disease:
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