Monitoring Vaccine Safety: How to Report Injuries and Adverse Reactions

By Janey Bibolet Ward

SUMMARY: Is vaccination safe, and if not… is it worth the risk to offset the illness you’re trying to avoid? Does getting vaccinated provide relief from fear and anxiety that feel too hard to live with? Or are you a “hard NO!”—never, no way, not a chance; not for me? These questions only you can answer for yourself, and rightly so. The research can be hard to untangle, and knowing who to trust… overwhelming. Increasing your awareness about vaccine injury, and knowing how to report adverse events (AEs) for a loved one or yourself, is a step you can take toward bodily autonomy and personal accountability.

The United States Federal Government employs several vaccine safety monitoring systems to track, report, and study the effects on the population from Food and Drug Administration (FDA) and Emergency Use Authorization (EUA) licensed, approved, and authorized biologic agents. 

The COVID-19 pandemic has challenged and tested these systems' capacity to provide timely and accurate reporting. This article will identify these tools and explore how they function, what’s lacking, and where improvements are needed.

What Is the Vaccine Adverse Event Reporting System (VAERS)?

The CDC’s Manual for the Surveillance of Vaccine-Preventable Diseases defines the function and purpose of the federal public health surveillance tool, the Vaccine Adverse Event Reporting System (VAERS).  

VAERS is an “early warning system used to monitor adverse events (AEs) that occur after vaccination. VAERS is the frontline system of a comprehensive vaccine safety monitoring program in the United States.” 

The Centers for Disease Control and Prevention (CDC) co-manages the program with the Food and Drug Administration, (FDA) and uses it for post-marketing surveillance. The FDA states:

“The purpose of VAERS is to detect possible signals of adverse events that occur after the administration of U.S. licensed or authorized vaccines.” 

Healthcare practitioners are required by law to report adverse events regardless of proof of causation. It is a federal crime to submit falsified reports.

How To Report an Adverse Event to VAERS

If you’re ready to jump right in, the process to report an injury to VAERS can be done online, or via a printable PDF form. It’s important to report adverse reactions as soon as possible. Claims expire two years after the injury, and are not recognized in court past this time.

The History of VAERS

The VAERS reporting system was established to provide a portal for consumers and practitioners to submit vaccine injury reports in lieu of filing malpractice or medical indemnity lawsuits against pharmaceutical and biologics companies that produce vaccines. 

The vaccine injury compensation court, as it’s commonly known, was voted into law in November 1986 under the direction of the American Academy of Pediatrics (AAP). 

This system was placed into effect as a direct result of the Cutter Incident, where the manufacturer of an early polio vaccine, Cutter Industries, released a contaminated product that resulted in several deaths and hundreds of incidents of paralysis in young children. 

The government created VAERS and this special court in order to protect pharmaceutical companies from liability claims and lawsuits if their products harmed, maimed, permanently injured, or killed persons who received them. 

It was touted as the first line of safety monitoring for licensed and approved vaccines, and a tracking system to detect adverse events during post-marketing surveillance (after patients have received the vaccine). 

Vaccine manufacturers threatened to stop making vaccines because they were getting sued. A deal was made for the government to pass this law in order to continue the production and existing supply chain.

The National Vaccine Injury Compensation Program

The National Vaccine Injury Compensation Program (VICP) is a federal program that was created to compensate families whose children may have been injured by certain vaccines. 

Adults can file for vaccines which are given to children too, but any vaccine given only to adults is not free from liability, and can go to regular court. 

Claims regarding alleged injury or death due to vaccination have a time limit for filing in VAERS, and moving to the VICP courts, which may be as short as two years.

How to File a Claim in the VICP

Visit the VICP website, or call 1-800-338-2382 to learn about the program and file a claim. Instructions on how to file a claim/petition can be found here.

The National Vaccine Injury Compensation Program Data Report, updated September 1, 2022, provides detailed information on negotiated settlements and paid compensations. 

As stated by the health equity organization, Health Resources & Services Administration (HRSA):

“According to the CDC, from 2006 to 2021 over 4 billion doses of covered vaccines were distributed in the U.S. For petitions filed in this time period, 9,806 were adjudicated by the Court, and of those, 6,994 were compensated. This means for every 1 million doses of vaccines distributed, approximately 1 individual was compensated.

Since 1988, over 25,308 petitions have been filed with the VICP. Over that 30-year time period, 21,427 petitions have been adjudicated, with 9,219 of those determined to be compensable, while 12,208 were dismissed. 

Total compensation paid over the life of the program is approximately $4.8 billion.”

Payouts on these settlements legally acknowledge evidence of harm and/or death as a result of vaccination.

Safety Signals: Adverse Events and Determining Causation

If a pattern of adverse events is detected, the agencies are directed to proceed with continued safety monitoring and further studies. The VAERS overview on the FDA site notes: 

“VAERS reports generally cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. Some events may occur coincidentally after the administration of a vaccine while others may in fact be caused by a vaccine. 

If a safety signal is found in VAERS, further studies can be conducted in safety systems such as the CDC's Vaccine Safety Datalink (VSD), or the Clinical Immunization Safety Assessment (CISA) project.

These systems do not have the same limitations as VAERS, and can better assess health risks and possible connections between adverse events and a vaccine.” 

What Qualifies as an Adverse Event?

The VAERS Table of Reportable Events Following Vaccination lists known potential adverse events for routine vaccination. For COVID-19, The Biologics Effectiveness and Safety (BEST) Initiative and Center for Biologics Evaluation and Research (CBER) will monitor 15 adverse events to see if they are causally related to the Emergency Use Authorization (EUA) vaccines and boosters (COVID-19 Vaccine Safety Surveillance: Active Monitoring Master Protocol, page 13). 

It’s important to differentiate: These 15 adverse events were decided upon upfront, and not from post-marketing signals. Therefore, some or none may apply, and there may be others which are relevant, yet not monitored.

Vaccine Information Statements (VISs)

The CDC publishes Vaccine Information Statements (VISs) with known side effects and adverse reactions for each licensed vaccine currently in use. 

Refer to the Childhood Vaccination Schedule (required by state laws to attend daycare and schools) and Adult Vaccination Schedule (recommended). Instructions on how to report AEs to VAERS are included on each statement.

Read the Package Insert

Read the package insert for the known AEs associated with the particular vaccine. The most common potential side effects are listed. Take note: The least common, most severe effects are buried in the fine print. 

For fully informed consent, be sure to read the package insert in its entirety. The risks of the “disease” must be considered against the risks of the vaccination.

COVID-19 Vaccine Safety Surveillance in Addition to VAERS

The Center for Biologics Evaluation and Research (CBER) monitors the safety of authorized COVID-19 vaccines through both passive and active safety surveillance systems. 

CBER does so in collaboration with the Centers for Disease Control and Prevention (CDC), the Centers for Medicare & Medicaid Services (CMS), the U.S.Department of Veterans Affairs (VA), and other academic and large non-government healthcare data systems. 

In addition, CBER participates actively in ongoing international pharmacovigilance (monitoring the effects of medical drugs) efforts, including those organized by the International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO). 

These efforts are in addition to the pharmacovigilance efforts being undertaken by the individual manufacturers for authorized vaccines. A coordinated and overlapping approach using state-of-the-art technologies has been implemented. Additional systems include v-safe and Vaccine Safety Datalink (VSD).

Passive Versus Active Surveillance

As stated by the U.S. Food & Drug Administration:

“Passive surveillance is defined as unsolicited reports of adverse events that are sent to a central database or health authority.” 

VAERS is a passive system that relies on those affected to make reports. By law, doctors are required to do so for their patients. 

“Active surveillance involves proactively obtaining and rapidly analyzing information occurring in millions of individuals recorded in large healthcare data systems to verify safety signals identified through passive surveillance or to detect additional safety signals that may not have been reported as adverse events to passive surveillance systems. The FDA is conducting active surveillance using the Sentinel BEST (Biologics Effectiveness and Safety) System and the CMS system.”

V-safe for COVID-19 Vaccine Post-Marketing Surveillance

The CDC launched v-safe “after vaccination self checker” to track Covid-19 vaccine uptake and compliance, and is intended to be used as a voluntary tool to report adverse events through your smartphone. 

V-safe is currently gaining media attention, as it’s being used to track adverse events from the Emergency Use Authorized (EUA) COVID-19 vaccines and boosters. The Informed Consent Action Network (ICAN) filed suit in federal court to demand the release of AEs reported via v-safe. 

As a result of a lawsuit filed by the Informed Consent Action Network (ICAN), the CDC released data from December 14, 2020 through July 31, 2022. ICAN created a dashboard to share the information the CDC refused to make public. 

This begs the question of why this data was not available to consumers in real time. Hundreds of millions of people were being vaccinated when EUA biologics were rushed to market, and sweeping mandates were instituted.

A Separate Court for COVID-19 Under the PREP Act

COVID-19 vaccine injury claims are submitted to VAERS but adjudicated in a special court funded under the PREP Act. 

H.R. 98 was passed in March 2021 to provide a separate compensation court specific to COVID-19, and is funded by the Countermeasures Injury Compensation Program (CICP). 

Countermeasures Injury Compensation Program (CICP)

A separate fund from the VICP was established in 2005 under the PREP Act to provide immunity from liability to drug manufacturers and all entities involved in providing countermeasures during a public health emergency.  

This is the fund used to compensate COVID-19 countermeasures, and/or vaccine injury or death claims. CICP defines: “Covered Countermeasures must be ‘''qualified pandemic or epidemic products,''’ or ‘''security countermeasures,''’ or drugs, biological products, or devices authorized for investigational or emergency use.”

As of September 2022 the U.S. Department of Health and Human Services reports: 

“Of the 9,888 COVID-19 countermeasure claims, 7,084 allege injuries/deaths from COVID-19 vaccines and 2,804 allege injuries/deaths from other COVID-19 countermeasures.”

How to File a Claim With CICP

Follow instructions to submit your claim. This must be filed within one year of the adverse event or in the case of death.

Proving Causation Is Difficult in the Vaccine Courts

Most vaccines used today are made from combinations of several different ingredients and multiple virus strains. The composition of these agents complicates verification of specific allergic, systemic, or fatal reactions, and identification of the particular active component. 

This is a red flag system used to identify harmful trends, as AEs are required by law to be reported by health care providers regardless of causation.

How to Access Data From CDC’s VAERS System

Read instructions on how to view the VAERS data. Alternatively, watch the video tutorial on how to access the data.

Significant Issue With Underreporting Adverse Events

Few people are aware of this system, and most are not given instructions on how to report adverse events during clinical visits. 

Practitioners are not routinely trained to provide information on reporting, and parents are not likely to report at home. Sadly, many cases slip through the cracks; unreported. 

Historically, this has been a passive reporting system, relying on practitioners to direct patients to submit claims. The accuracy of the data has been called into question. 

In 2011, the U.S. Department of Health & Humans Services (HHS) grant-funded a million-dollar study by Harvard Pilgrim Health Care, Inc. (HPHC) that estimated only 1% of adverse events are reported. 

From Harvard Pilgrim Health Care, Inc.:

“Adverse events from drugs and vaccines are common, but underreported. […] Likewise, fewer than 1% of vaccine adverse events are reported. Low reporting rates preclude or slow the identification of ‘problem’ drugs and vaccines that endanger public health. New surveillance methods for drug and vaccine adverse effects are needed.”

The Guide to Interpreting VAERS Data states:

"Underreporting" is one of the main limitations of passive surveillance systems, including VAERS. The term, underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. The degree of underreporting varies widely. As an example, a great many of the millions of vaccinations administered each year by injection cause soreness, but relatively few of these episodes lead to a VAERS report. 

Physicians and patients understand that minor side effects of vaccinations often include this kind of discomfort, as well as low fevers. On the other hand, more serious and unexpected medical events are probably more likely to be reported than minor ones, especially when they occur soon after vaccination, even if they may be coincidental and related to other causes.”

The Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP: VAERS) final report from the HPHC noted the results indicated that the CDC was not willing or able to implement an active surveillance system that would prove to be more accurate in tracking AEs from routine vaccinations. 

The changes suggested would have been particularly helpful for active surveillance in an EUA vaccination program such as COVID-19.

“Results: Restructuring at CDC and consequent delays in terms of decision making have made it challenging despite best efforts to move forward with discussions regarding the evaluation of ESP:VAERS performance in a randomized trial and comparison of ESP:VAERS performance to existing VAERS and Vaccine Safety Datalink data. However, Preliminary data were collected and analyzed and this initiative has been presented at a number of national symposia.”

An independent media article, “Why Did the CDC Silence the Million Dollar Harvard Project Charged With Upgrading Our Vaccine Safety Surveillance System?” published by Truth Snitch in October 2017 posits the reason for the alleged suppression of the Harvard Pilgrim Study by the CDC was due to the automated test system working all too well. It identified far more incidents of AEs than the passive reporting system, VAERS, ever would.

Sentinel Initiative and CBER

From the U.S. Food & Drug Administration:

“FDA’s Sentinel Initiative was launched in 2008 in response to a mandate in the FDA Amendments Act (FDAAA) of 2007 to establish a national risk identification and analysis system using electronic healthcare data to monitor the safety of drugs, biologics, and devices. 

In line with these goals, CBER has launched several projects within Sentinel to improve post-licensure safety surveillance of vaccines and other biologics.”

Significant Underreporting of Myocarditis After COVID-19 Vaccination

A Journal of the American Medical Association (JAMA) study published in January 2022, Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021, funded and supported by contracts with the Boston Medical Center, Cincinnati Children’s Hospital Medical Center, Duke University, and Vanderbilt University Medical Center, with the U.S. Centers for Disease Control and Prevention (CDC) and Clinical Immunization Safety Assessment Project (CISA) concluded:

“As a passive system, VAERS data are subject to reporting biases in that both underreporting and overreporting are possible. Given the high verification rate of reports of myocarditis to VAERS after mRNA-based COVID-19 vaccination, underreporting is more likely.

Therefore, the actual rates of myocarditis per million doses of vaccine are likely higher than estimated.”

Emergency Use Authorization (EUA) Fact Sheets for COVID-19

Centers for Disease Control and Prevention states:

“For each COVID-19 vaccine authorized under an Emergency Use Authorization (EUA), the Food and Drug Administration (FDA) requires that vaccine recipients or their caregivers are provided with certain vaccine-specific EUA information to help make an informed decision about vaccination.

This is accomplished by providing an EUA Fact Sheet for Recipients and Caregivers. The Fact Sheet is similar in purpose and content to vaccine information statements (VISs) for licensed vaccines but differs in that the EUA Fact Sheet is specific to each authorized COVID-19 vaccine, is developed by the manufacturer of the vaccine, and is authorized by the FDA.”

COVID-19 Vaccine Consent Forms

In this section you’ll find resources, and responses to frequently asked questions about COVID-19 medical consent forms:

• U.S. Covid-19 Screening and Consent Form. 

• FAQs About Medical Consent & Pfizer-BioNTech Booster Doses for Long-term Care Residents.

OpenVAERS

The OpenVAERS website lists real time data for AEs from COVID-19 through September 16, 2022.

Allegations of Data Fraud

On March 4, 2022, Dr. Henry Ealy, III, Dennis Linthicum, Kim Thatcher, Senator Dennis Linthicum, and Senator Kim Thatcher filed a Petition to Impanel Special Grand Jury to Investigate Allegations of Federal Crimes against Robert Redfield, Rochelle Walensky, Alex Azar, Xavier Becerra, Brian Moyer, and Does 1-25 (additional defendants). 

Watch the Interview With Dr. Naomi Wolf and the Plaintiffs. 

The suit alleges data fraud and corruption by government officials to deceive the public with regards to the COVID-19 pandemic and EUA Vaccines, and for willfully withholding data on AEs and the accuracy of safety reports. 

“According to the CMS data file, specifically in the state of Oregon, hospitals have been receiving upwards to $220,000 dollars for every hospital death listed as a COVID death. The incentives being used to justify the inflation in the number of diagnoses and implementation of suboptimal treatment for certain patients can only be described, as Dr. Wolf suggests, as a “biofacist approach to medicine.”

Further, Dr. Ealy discusses the irregularities in timeline between when the CARES Act was enacted, in January of 2019, and when the pandemic surfaced. The timeline for these and other important events throughout the pandemic suggests premeditated planning and continued fraud within the public health sector. The combination of civil and criminal offenses that make up this growing scandal are dissected throughout this interview.” 

In Conclusion

No vaccine is 100% effective, and with regards to COVID-19, if you’ve been vaccinated you can still test positive and become ill. The truth is that all of us will be infected over time, and the vaccine does not stop transmission.

At best, it may protect some people from severe adverse events and hospitalization or death, but the waning protection from antibodies lasts only a short time, thus requiring multiple doses and subsequent boosters, potentially on an annual basis. 

Everyone has a right to informed consent using real-time reports that reveal accurate adverse events (AEs). Vaccination (and therefore the decision not to vaccinate) should always be a personal choice, after determining the risk-benefit analysis of a particular biologic agent with associated toxins. 

Educate yourself by digging into the research, listening to your intuition, and talking to people whose wisdom you trust. Be generous in sharing what you’ve learned, with others who seek guidance and support.

~

Originally published by A Voice For Choice Advocacy on October 06, 2022.

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