- The Vaccine Adverse Event Reporting System (VAERS) was created by Congress in 1986 as part of the National Childhood Vaccine Injury Act.
- Although health care providers are required by federal law to report specific vaccine reactions to VAERS, less than one percent of adverse events following vaccination are reported.
- Doctors, medical workers, adult patients and parents of minor children can report a vaccine reaction to VAERS.
The Vaccine Adverse Event Reporting System (VAERS) was created by Congress under the National Childhood Vaccine Injury Act of 1986 and became operational in 1990 in response to growing public concern about the safety of vaccines, particularly the DPT (diphtheria-pertussis-tetanus) vaccine.1
VAERS is jointly operated by the U.S. Food and Drug Administration (FDA) and U.S. Centers for Disease Control and Prevention (CDC).
Since VAERS began collecting reports in 1990, as of Nov. 14, 2019 there have been 8,087 vaccine-related deaths reported and about 47 percent of those death reports were for children under the age of three.2 There have been 17,394 reports of permanent disability following vaccinations, with about 30 percent occurring in children under age 17, while about 40 percent are in adults between 17 and 65 years old.3
Significant Under-Reporting to VAERS
A 2011 report by Harvard Pilgrim Health Care, Inc. for the U.S. Department of Health and Human Services (HHS) stated that fewer than one percent of all vaccine adverse events are reported to the government:4
Although 25% of ambulatory patients experience an adverse drug event, less than 0.3% of all adverse drug events and 1-13% of serious events are reported to the Food and Drug Administration (FDA). 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.
There have been 8,087 vaccine-related deaths reported to VAERS, but that number likely represents only one percent of the total number of deaths that have actually occurred and the real number may be 808,700 vaccine–related deaths. Similarly, 17,394 reports of permanent disabilities have been reported to VAERS, but that number likely is closer to 1,739,400 vaccine-related disabilities.
Although the 1986 Act legally requires doctors and other medical workers who administer vaccines in the U.S. to report vaccine reactions, Congress did not include legal penalties in the law for those who refuse to comply with the reporting requirement.5 Therefore, VAERS is really a “passive” reporting system because there is no mechanism to compel compliance and hold vaccine administrators accountable for failing to report serious health problems, hospitalizations, injuries and deaths that occur after vaccination to the government.
In addition, many vaccine reaction reports that are submitted to VAERS are incomplete, inaccurate or open to misinterpretation, especially those that are submitted by vaccine manufacturers. A 2009 study published in JAMA on “Postlicensure Safety Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine,” found that VAERS has data analysis limitations that include “underreporting, inconsistency in the quality and completeness of reported data, stimulated reporting due to extensive news coverage and reporting biases.” Researchers stated:
A further limitation of VAERS reports after qHPV [quadrivalent HPV vaccine] is that a large proportion (68%) come from the manufacturer and most of these reports (89%) do not include sufficient identifying information to allow medical review of the individual cases. For example, when additional clinical information was available for review, approximately one-half of the cases of GBS and transverse myelitis were not confirmed.6
Obstacles to Vaccine Reaction Reporting to VAERS
Several factors have been cited as potential barriers to accurate reporting of vaccine reactions to the government:
- Doctors, nurses and other vaccine providers are not aware it is a legal requirement to report health problems that occur after vaccination to VAERS;
- Vaccine providers either are unsure about what types of clinical symptoms need to be reported or dismiss serious health problems that follow vaccination as unrelated to the vaccine(s) recently given;
- The VAERS “Table of Reportable Events” is specific to each vaccine and requires vaccine providers to take the time to become familiar with the vaccine product insert to report “events described in manufacturer’s package insert as contraindications to additional doses of vaccine;”7
Also, there may be confusion about how to report a possible reaction, or an objection to spending the perceived time and effort it takes to report an event to VAERS.8 Reporting requirements also vary with the type of vaccine reaction, as well as by vaccine, and adverse events that occur after receipt of newer vaccines are more commonly reported than those that occur with vaccines that have been used for many years. One study reported,“68 percent of cases of vaccine-associated polio are reported to VAERS, but only four percent of MMR-associated thrombocytopenia are reported.”9
A proposed solution to underreporting of vaccine reactions has been to include a “proactive, spontaneous, automated adverse event reporting imbedded within EHRs [Electronic Health Records] and other computerized medical records and vaccine tracking systems.10
Anyone Can File A VAERS Report
If a doctor or medical worker, who has administered a vaccine, either does not recognize a vaccine reaction or refuses to make a report to VAERS, an adult patient or parent of a minor child who has developed a serious health problem after vaccination can make a report.
According to VAERS, the information needed to fill out the report includes:11
- Patient information (age, date of birth, sex)
- Vaccine information (brand name, dosage)
- Date, time, and location administered
- Date and time when adverse event(s) started
- Symptoms and outcome of the adverse event(s)
- Medical tests and laboratory results (if applicable)
- Physician’s contact information (if applicable)
Following is more information about identifying, reporting and preventing vaccine reactions:
- Do You Know How to Recognize a Vaccine Reaction?
- Learn How to Recognize the Signs and Symptoms of Vaccine Reactions
- If You Vaccinate, Ask 8 Questions
- Vaccine Reporting Systems – You Have Options
1 National Vaccine Information Center. National Childhood Vaccine Injury Act of 1986. NVIC.org.
2 MedAlerts. Search Results: Found 8,087 Cases Where Patient Died. Accessed Dec. 9, 2019.
3 MedAlerts. Search Results: Found 17,394 Cases where Disabled.
4 Harvard Pilgrim Health Care, Inc. Electronic System for Public Health Vaccine Adverse Event Reporting System. AHRQ 2011.
5 VAERS Vaccine Adverse Event Reporting System. Report an Adverse Event to VAERS. U.S. Department of Health and Human Services.
6 Slade BA, Leidel L, Vellozzi C, Woo EJ et al. Postlicensure Safety Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine. JAMA 2009; 302(7): 750-757.
7 VAERS. Table of Reportable Events Following Vaccination. Mar. 21, 2017.
8 Lazarus R. Electronic Support for Public Health-Vaccine Adverse Event Reporting System (ESP:VAERS). Harvard Pilgrim Health Care, Inc. 2011.
9 Braun M. Vaccine adverse event reporting system (VAERS): usefulness and limitations. Johns Hopkins Bloomberg School of Public Health.
10 VAERS. Report an Adverse Event to VAERS. U.S. Department of Health and Human Services.