Sudden or Otherwise, Providers Have a Mandatory Duty to Report Adverse Events
"Irrespective of Attribution to Vaccination"
There has been much conjecture about whether or not seemingly notable illnesses and deaths are related to covid vaccination. My intention with this article is not to speculate but to draw awareness to the MANDATORY DUTY of those providing covid vaccines to report serious adverse events following covid vaccination to the Vaccine Adverse Events Reporting System (VAERS), as is required by the FDA and the terms of the Emergency Use Authorization.
Many, if not most, vaccine providers are unaware of the MANDATORY requirement to report serious adverse events (SAEs) following vaccination. Equally important is the distinction that they must report serious adverse events even if they do not think the events are related to vaccination. As noted in the terms of the EUA, in the Fact Sheet for Providers, in the Fact Sheet for Patients, and on the CDC website, serious adverse events following administration of a covid vaccine MUST be reported “irrespective of attribution to vaccination.”
Physicians do not get to make a determination of causation in place of reporting to the Vaccine Adverse Event Reporting System (VAERS).
The CDC emphasizes that:
“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…”
Serious adverse events MUST be reported to VAERS “regardless of whether the reporter thinks the vaccine caused the AE.”
Vaccine providers are MANDATORY reporters and have been from day one of covid vaccine roll out. They are required to report, among other things, serious adverse events including death irrespective of attribution to vaccination.
What are some examples of serious adverse events?
Serious adverse events are defined as:
Death;
A life-threatening adverse event;
Inpatient hospitalization or prolongation of existing hospitalization;
A persistent or significant incapacity or substantial disruption of the ability to
conduct normal life functions;
A congenital anomaly/birth defect;
An important medical event that based on appropriate medical judgement
may jeopardize the individual and may require medical or surgical intervention to prevent 1 of the outcomes listed above.
When the EUA’s were initially issued, there was a time frame given - ex: within 15 days - to look for adverse events, but at some point that time frame was removed. Because these are experimental drugs with no long term safety studies, reporting is vital to help identify safety signals. * Reports to VAERS do not imply causation - VAERS is a tool used to identify post marketing safety signals.
Deaths, especially, must be reported - including those that appear accidental or intentional, meaning suicides.
Medical events with known possible AEs, including myocarditis and blood clots, could result in a catastrophic accident.
Tragically, in Louisiana there is a VAERS report for a “completed suicide” because of vaccine injury.
Health Freedom Louisiana supported legislation introduced by Representative Raymond Crews in 2022 that would require coroners to file a VAERS report if an individual died within a certain number of days of vaccination, but heavy opposition from the coroner association defeated the bill. As it stands, coroners are not “providers” and therefore not required to report to VAERS, leaving a huge gap in the reporting system. As noted by a local coroner:
The deceased do not report.
VAERS is notoriously underreported. A study commissioned by the CDC and performed by Harvard Pilgrim HMO found that less than 1% of adverse events following vaccination are reported. In the case of EUA covid vaccines, I have found that medical professionals are unaware of the mandatory nature of reporting of serious adverse events.
If you are a medical professional and want to learn more about VAERS and how to make effective reports, go to The VAERS Project. As noted in the graphic below, most employers do not provide education on how to file a report. The VAERS Project can help!
Have YOU experienced a life threatening or important medical event - ex: new cancer diagnosis, aneurism, autoimmune disorder - following covid vaccination and no VAERS report was filed? You can file a VAERS report too! There is no time limit on when a VAERS report has to be filed.
Find more information on our website, HealthFreedomLA.org.