In the 1980’s cases of severe brain injury following DTP (diptheria, tetanus, pertussis) vaccination were increasing and parents began suing vaccine manufacturers. In fact, there were so many cases that the “lawsuits against vaccine companies and health care providers threatened to cause vaccine shortages and reduce U.S. vaccination rates“. Congress, in their wisdom, instead of holding manufacturers accountable and demanding safer vaccines, passed legislation at the behest of the pharmaceutical industry which provided legal protections and restricted product liability for the vaccine manufacturers – The National Childhood Vaccine Injury Act of 1986. As is the case with many laws, the name makes you think it’s doing something good when in reality it’s making things worse. And worse it was.
- removed product liability from vaccine manufacturers – you can’t sue them for injury or death from vaccines;
- established the National Vaccine Injury Compensation Program – vaccine injury claims against vaccine manufacturers cannot be filed in state or federal civil courts, but instead must be heard in the U.S. Court of Federal Claims, sitting without a jury, also known as “vaccine court”; and
- required healthcare providers who administer vaccines to report certain vaccine injuries.
The Vaccine Adverse Event Reporting System (VAERS)
Established in 1990 and co-managed by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), VAERS is a national early warning system to detect possible safety problems in U.S. licensed vaccines. In fact, it is the only post-market surveillance system healthcare providers are required to report to, but it is a passive reporting system, meaning it relies on individuals to send in reports of their experiences. Anyone can report to VAERS – patients, parents, caregivers and healthcare providers. But if someone doesn’t report the event, it never gets captured or reported. So while VAERS is not designed to determine if a vaccine caused a health problem and therefore one can not automatically infer causation from reports in VAERS, we know that injuries are underreported. In 2007, CDC awarded a grant to Harvard Pilgrim Health Care, Inc. to study and evaluate VAERS performance. They found that “adverse events from vaccines are common but underreported, with less than one percent reported“.
Adverse events from vaccines are common but underreported, with less than one percent reported.Grant Final Report: Electronic Support for Public Health-Vaccine Adverse Event Reporting System (ESP:VAERS) by Harvard Pilgrim Health Care, Inc.
Reporting Vaccine Adverse Reactions
(Except reactions to the COVID-19 vaccines – for those see below)
Healthcare providers are required by law to report to VAERS:
- Any adverse event listed in the VAERS Table of Reportable Events Following Vaccination that occurs within the specified time period after vaccination
- An adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine
Healthcare providers are strongly encouraged to report:
- Any adverse event that occurs after the administration of a vaccine licensed in the United States, whether or not it is clear that a vaccine caused the adverse event
- Vaccine administration errors
*Vaccine manufacturers are required to report to VAERS all adverse events that come to their attention.*
Reporting COVID-19 Vaccine Adverse Reactions
The reporting requirements for COVID-19 vaccines are the same for those authorized under emergency use or fully approved. That means for all COVID-19 vaccines healthcare providers are required by law to report to VAERS:
- vaccine administration errors, whether or not associated with an adverse event,
- serious adverse events irrespective of attribution to vaccination
- Per the FDA, serious adverse events are defined as:
- 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 one of the outcomes listed above.
- Per the FDA, serious adverse events are defined as:
- cases of Multisystem Inflammatory Syndrome
- cases of COVID-19 that result in hospitalization or death
Healthcare providers are encouraged to report to VAERS any additional clinically significant AEs following vaccination, even if they are not sure if vaccination caused the event.
Patients, Parents, Caregivers
As noted above, you don’t have to be a healthcare provider to report an adverse reaction. Anyone can submit a report, including patients, parents, and caregivers.
Unfortunately, besides not being trained in recognizing vaccine reactions, especially with experimental COVID-19 vaccines, doctors sometimes fail to submit reports because they refuse to.
It is critical for people to empower themselves with knowing what is legally required of healthcare workers as well as being aware of the option to submit reports themselves.
Here at Health Freedom Louisiana we take medical ethics extremely seriously. Therefore, if your doctor is refusing to submit a VAERS report for a serious adverse reaction to a COVID-19 vaccine, for which they are required BY LAW to report WITHOUT DETERMINING CAUSALITY, report them by filing a complaint with the Louisiana State Medical Board.
They must be held accountable.
Countermeasures Injury Compensation Program (CICP)
CICP is a federal program that may help pay for costs of medical care and other specific expenses of certain people who have been seriously injured by certain medicines or vaccines, including the COVID-19 vaccines. Generally, a claim must be submitted to the CICP within one year from the date of receiving the vaccine. To learn more about this program, visit injurycompensation.hrsa.gov/DICPSubmit/ or call 1-855-266-2427.