By Barbara Loe Fisher
As COVID-19 vaccines are being rolled out and given to millions of Americans in every state, it is critical that doctors and other medical workers, who are administering the vaccines, actively report every serious health problem, injury and death that happens after vaccination to the federal Vaccine Adverse Event Reporting System. Known as VAERS, the centralized vaccine reaction reporting system was created under the National Childhood Vaccine Injury Act of 1986. 1 2
If you get a vaccine, including a COVID-19 vaccine, and your health deteriorates within hours, days or weeks of being vaccinated, the person who gave you the shot is required by federal law to file a report with VAERS. 3 If he or she refuses to file a vaccine reaction report, you can do it yourself.
Parents of DPT Vaccine Injured Children Got VAERS Into 1986 Act
In 1982, when Kathi Williams and I joined with other parents of DPT vaccine injured children and founded the educational charity known today as the National Vaccine Information Center, 4 we discovered there was no centralized vaccine reaction reporting system in the U.S. and no requirement for doctors to report vaccine reactions. Back then, the government’s Monitoring System for Adverse Events Following Vaccination 5 was split into two parts: doctors vaccinating children in public health clinics were supposed to report serious vaccine reactions, injuries and deaths to the Centers for Disease Control and doctors in private practice and vaccine manufacturers could choose to report to the Food and Drug Administration, 6 7 but there was no requirement to report vaccine reactions.
As parents who had watched our children have serious reactions and regress into chronic poor health after DPT shots, 8 9 we argued that every vaccine provider and every vaccine manufacturer should be required to report vaccine reactions, injuries and deaths to the government. To ensure transparency, we wanted those vaccine reaction reports to be accessible to the public and to independent researchers investigating vaccine safety issues. We also wanted a way for individuals who had experienced a vaccine reaction to be able to file a vaccine reaction report themselves if a vaccine provider refused to do it.
That is why we worked with Congress in the early 1980s to secure vaccine safety informing, recording, reporting and research provisions in the 1986 Act. 10 11 12 We insisted that the government publish written information describing vaccine reactions and disease risks to be given to parents before children are vaccinated; 13 and that doctors and other vaccine providers be required to keep a permanent record of all vaccines given and the manufacturer’s name and lot number; 14 and that serious health problems following vaccination be recorded in the child’s permanent medical record, along with the requirement that vaccine providers and manufacturers be required to report adverse events to a centralized vaccine reaction reporting database monitored by health agencies and open to the public. 15
Ultimately, Congress agreed with parents that federal health agencies should create a new centralized Vaccine Adverse Event Reporting System. VAERS was finally launched in 1990 – four years after the 1986 Act was passed. 16
VAERS A Post-Marketing Vaccine Safety Surveillance Tool
VAERS records the timing of the vaccination and onset of the adverse event; the age and current illnesses or medications taken by the person who reacted; past history of vaccine reactions; the name of the state where the person lives and other important information to help record and evaluate reported vaccine reactions. 17 18
CDC officials say that, “about 85 to 90 percent of the reports [to VAERS] describe mild side effects such as fever, arm soreness, and crying or mild irritability. The remaining reports are classified as serious, which means that the adverse event resulted in permanent disability, hospitalization, life-threatening illness, or death.” 19
The reality is that federal health agencies are unable to follow up every vaccine reaction, so the system remains a broad post-marketing surveillance tool for picking up red flags that signal unusual or frequent vaccine complications, which may not have been identified in pre-licensing clinical trials 23 or – in the case of COVID-19 vaccines – were not identified prior to the FDA granting vaccine manufacturers an Emergency Use Authorization to distribute experimental COVID-19 vaccines. 24
You can search the VAERS database of vaccine reaction reports filed since 1990 by going to NVIC.org and accessing the user-friendly MedAlerts search engine.
No Legal Sanctions for Doctors Failing to Report Vaccine Adverse Events to VAERS
Sadly, even though it has been a federal law for vaccine providers and vaccine manufacturers to report to VAERS for more than three decades, there are no legal consequences for failing to report. A 2011 federally funded study found that less than one percent of vaccine reactions that happen in the US are ever reported to VAERS. 29 That’s because Congress made it a federal requirement in the 1986 Act to report, but did not include legal penalties when vaccine companies or vaccine providers fail to report.
The result is that 99 percent of vaccine reactions, including injuries and deaths, which are taking place every day among the highly vaccinated US population, go unreported.
Reaction Reporting to VAERS Should Be A Priority for New COVID-19 Vaccines
Today, the US is operating under a public health emergency declaration 30 and there is an even greater need to step up efforts to report vaccine reactions to VAERS, especially injuries and deaths, that occur after vaccination. COVID-19 vaccines were fast tracked to market in record breaking time. 31 32 33 34 Most of the participants in clinical trials where healthy people between 17 and 55 years old. 35 36
This means that while COVID-19 vaccines are being given to millions of Americans, VAERS becomes an extremely important mechanism for detecting a pattern of vaccine-related serious health problems that may not have been detected in clinical trials that only included thousands of subjects and did not include certain high risk categories of people – like those over age 85 37 38 or pregnant women 39 40 or people with certain underlying health problems. 41 42
During this time when there is a national COVID-19 vaccination campaign underway, you can help by reminding medical workers giving COVID-19 vaccines to file reaction reports with VAERS. Vaccine administrators are not supposed to be making their own judgments about whether an adverse event following vaccination was or was not caused by the vaccine. They are simply supposed to file a VAERS report as required under the 1986 National Childhood Vaccine Injury Act whenever a person suffers a serious deterioration in health after vaccination, especially if it results in a permanent injury or death.
If A Vaccine Provider Fails to Report a COVID-19 Reaction to VAERS – DIY
Remember, if you or your minor child have gotten a COVID-19 shot and have suffered a reaction 43 44 45 46 47 48 49 50 51 52 53 but the person who gave the vaccine refuses to make a report to VAERS, you can file a report yourself.
It’s your health. Your family. Your choice.
NVIC VAERS Update: On May 21, 2021, the CDC released COVID-19 vaccine-related data through May 14, 2021 reported to VAERS. As of May 14, 2021, there had been 227,805 adverse events reported to VAERS following COVID-19 vaccinations. Of those, 153,710 adverse events were reported after the first dose of COVID-19 vaccine and 64,193 were reported after the second dose. There have been 4,406 reports of COVID-19 vaccine related deaths, which includes 142 death reports from other countries. See MedAlerts.org.
2 U.S. Centers for Disease Control and Prevention (CDC). Fact Sheet for Vaccine Adverse Event Reporting System (VAERS): A National Program for Monitoring Vaccine Safety.
3 42 U.S.C. United States Code, 2016 edition. Title 42 – The Public Health and Welfare Chapter 6A – Public Health Service. Subchapter XIX – Vaccines. Part 2 – National Vaccine Injury Compensation Program. Subpart c – ASSURING A SAFER CHILDHOOD VACCINATION PROGRAM IN THE UNITED STATED STATES Sec. 300aa-25. Recording and reporting of information.
4 Institute of Medicine Vaccine Safety Committee. Adverse Effects of Pertussis and Rubella Vaccines. Appendix B: Pertussis and Rubella Vaccines: A Brief Chronology. Pertussis Vaccines 1982, 1985. Pp. 323-324. Washington, DC. The National Academy Press 1991.
5 Stetler HC, Mulen JR et al. Monitoring System for adverse events following immunization. Vaccine 1987; 5(3): 169-174.
6 Ellenberg SS, Chen RT. The Complicated Task of Monitoring Vaccine Safety. Pub Health Rep 1997; 112. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1381831/pdf/pubhealthrep00042-0012.pdf
8 Fisher BL. The Moral Right to Conscientious, Philosophical and Personal Belief Exemption to Vaccination. Oral Presentation for National Vaccine Advisory Committee May 2, 1997.
10 Fisher BL. Statement of National Vaccine Information Center: Compensating Vaccine Injuries: Are Reforms Needed? U.S. House Subcommittee on Criminal Justice, Drug Policy and Human Resources Hearing Sept. 28, 1999.
11 Fisher BL, Williams K, Wrangham TK. NVIC Response to Government Accountability Office (GAO) inquiry on History and Implementation of the National Childhood Vaccine Injury Act. July 11, 2014.
12 National Vaccine Information Center. NVIC Position Statement on the 1986 National Childhood Vaccine Injury Act May 2018.
13 42 U.S.C. United States Code, 2016 edition. Title 42 – The Public Health and Welfare Chapter 6A – Public Health Service. Subchapter XIX – Vaccines. Part 2 – National Vaccine Injury Compensation Program. Subpart c – ASSURING A SAFER CHILDHOOD VACCINATION PROGRAM IN THE UNITED STATES. Sec. 300aa-26. Vaccine information. (Vaccine Information Statements were substantively weakened by amendments to the 1986 Act in H.R. 2022 Preventive Health Amendments of 1993 – Sponsor Rep. Henry Waxman (D-CA). Section 708: Simplification of Vaccine Information Materials.)
16 CDC. Current Trends Vaccine Adverse Event Reporting System – United States. MMWR Oct. 29, 1990; 39(41): 730-733.
18 CDC. Vaccine Adverse Event Reporting System (VAERS): Information Collected from Reports. Apr. 8, 2021.
20 Zhou W, Pool V et al. Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS) – United States, 1991-2001. MMWR Jan. 24, 2003; 52(1): 1-24.
21 CDC. Making the Vaccine Decision: Addressing Common Concerns. Mild Side Effects Are Expected. “Severe, long lasting side effects are extremely rare.” National Center for Immunization and Respiratory Diseases Aug. 5, 2019.
22 CDC. Vaccine Recommendations and Guidelines of the Advisory Committee on Immunization Practices (ACIP): Preventing and Managing Adverse Reactions. National Center for Immunization and Respiratory Diseases Feb. 4, 2021.
24 Shimabukuro T. CDC COVID-19 vaccine safety monitoring by COVID-19 Vaccine Planning Unit (VPU) Vaccine Safety Team. National Center for Immunization and Respiratory Diseases Aug. 26, 2020.
25 Chen RT, Rastogi SC et al. The Vaccine Adverse Event Reporting System (VAERS). Vaccine 1994; 12(6): 542-550.
26 Singleton DA, Lloyd SC et al. An overview of the vaccine adverse event reporting system (VAERS) as a surveillance system: VAERS Working Group. Vaccine 1999; 17(22): 2908-2917.
27 Pellegrino P, Carnovale C, Perrone V et al. Acute Disseminated Encephalomyelitis Onset: Evaluation Based on Vaccine Adverse Events Reporting System. PLOS One Oct. 18, 2013.
28 Ren JJ, Sun Y et al. A statistical analysis of vaccine adverse event data. BMC Med Inform Decis Mak 2019; 101.
29 Harvard Pilgrim Health Care, Inc. Electronic System for Public Health Vaccine Adverse Event Reporting System. AHRQ 2011.
30 U.S. Department of Health and Human Services. Renewal of Determination That A Public Health Emergency Exists. Office of the Assistant Secretary for Preparedness and Response Apr. 15, 2021.
31 Lanese N. Researchers fast-track coronavirus vaccine by skipping key animal testing first. Live Science Mar. 13, 2020.
33 The Vaccine Reaction. Poll: 69 Percent of Americans Worried Fast-Tracked COVID-19 Vaccines Won’t Be Safe. Aug. 10, 2020.
34 FDA. Emergency Use Authorization for Vaccines Explained. Nov. 20, 2020.
37 Helfand BKI, Webb M, Gartaganis SL. The Exclusion of Older Persons from Vaccine and Treatment Trials for Coronavirus Disease 2019 – Missing the Target. JAMA Int Med 2020; 180(11): 1546-1549.
38 Span P. Older Adults May Be Left Out of Some COVID-19 Trials. New York Times June 19, 2020.
39 Rozsa M. WHO says Moderna, Pfizer coronavirus vaccines should not be given to pregnant women. Here’s why. Salon Jan. 28, 2021.
40 Gillian H, Van Spall C. Exclusion of pregnant and lactating women from COVID-19 vaccine trials: a missed opportunity. Eur Heart J Mar. 4, 2021.
41 Radcliffe S. Here’s What We Know About the Demographics of the COVID-19 Vaccine Trials. Healthline Aug. 9, 2020.
42 Odell J. Messenger RNA (nRNA) SARS Coronavirus ‘Vaccines’ and their Potential Autoimmunity Part 2. Bioregulatory Medicine Institute Feb. 24, 2021.
43 Fisher BL. Over 3,000 “Health Impact Events” After COVID-19 mRNA Vaccinations. The Vaccine Reaction Dec. 22, 2020.
44 Fisher BL. Miami Obstetrician Develops Bleeding Disorder, Dies After Getting COVID-19 Vaccine. The Vaccine Reaction Jan. 11, 2021.
46 Hendler C. Severe Reactions to COVID-19 Vaccine Close Schools in Michigan, Ohio and New York. The Vaccine Reaction Mar. 8, 2021.
47 Fisher BL. Healthy Mom, 39, in Utah Dies of Organ Failure Four Days After Moderna COVID Vaccination. The Vaccine Reaction Mar. 15, 2021.
48 Saudaga V, Patil S et al. Vigilance regarding immune thrombocytopenic purpura after COVID-19 vaccine. Ir J Med Sci Mar. 31, 2021; 1-2.
49 Guenot M. The rare clots people get after taking COVID-19 vaccines are different from other clots and require special treatment. Business Insider Apr. 20, 2021.
50 British Medical Journal. First reported cases of clots in large arteries causing stroke following COVID-19 vaccination. EurekAlert May 25, 2021.
51 Crist C. CDC Looks Into Post-COVID Vaccine Heart Inflammation. WebMD May 24, 2021.
52 The Vaccine Reaction. CDC Investigating Cases of Heart Inflammation After COVID-19 Vaccination. May 31, 2021.
53 CDC. Possible Side Effects After Getting COVID-19 Vaccine. May 25, 2021.