Researchers can get lazy and start to use acronyms and initializations to save time and keystrokes. Apparently I have been guilty of using such abbreviations, without proper explanation.

Recently a reader sent an email asking me just what is VAERS anyway, who runs it, what information are they tracking, how do the get it and from whom. Rather that give my Inconvenient Woman readers a two second summary, back to saving keystrokes again, I ‘m using the VAERS description copy directly from the CDC site. That way I wont miss any of the important stuff, trying to save keystrokes. (Editorial note: I’m not a touch typist. Typing class was taught at the same time as Latin, and for reasons that escape me now, I chose conjugation of Latin verbs over a useful life skill.)

Vaccine Adverse Event Reporting System (VAERS)

Vaccines are developed in accordance with the highest standards of safety. However, as with any medical procedure, vaccination has some risks. Individuals react differently to vaccines, and there is no way to predict the reaction of a specific individual to a particular vaccine.

The National Childhood Vaccine Injury Act (NCVIA) requires health care providers to report adverse events (possible side effects) that occur following vaccination, so the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) established the Vaccine Adverse Event Reporting System (VAERS) in 1990. VAERS is a national passive reporting system that accepts reports from the public on adverse events associated with vaccines licensed in the United States. VAERS data are monitored to—

• Detect new, unusual, or rare vaccine adverse events
• Monitor increases in known adverse events
• Identify potential patient risk factors for particular types of adverse events
• Identify vaccine lots with increased numbers or types of reported adverse events
• Assess the safety of newly licensed vaccines

Approximately 30,000 VAERS reports are filed annually, with 10–15% classified as serious (causing disability, hospitalization, life-threatening illness or death). Anyone can file a VAERS report, including health care providers, manufacturers, and vaccine recipients or their parents or guardians. The VAERS form requests the following information: the type of vaccine received, the timing of vaccination, the onset of the adverse event, current illnesses or medication, past history of adverse events following vaccination, and demographic information about the recipient. VAERS forms can be completed online, or you can complete a paper form and mail or fax it to VAERS. To request a paper VAERS form to be faxed to you, or if you need assistance in filling it out, call (800) 822-7967.

A contractor, under the supervision of FDA and CDC, enters the information from VAERS forms into a database. Those reporting an adverse event to VAERS receive a confirmation letter containing a VAERS identification number. Additional information may be submitted to VAERS using the assigned identification number. Selected cases of serious adverse reactions are followed up at 60 days and one year post-vaccination to check the recovery status of the patient. The FDA and CDC use VAERS data to monitor vaccine safety and conduct research studies. VAERS data (without identifying personal information) are also available to the public.

While VAERS provides useful information on vaccine safety, the data are somewhat limited. Specifically, judgments about causality (whether the vaccine was truly responsible for an adverse event) cannot be made from VAERS reports because of incomplete information. As a result, researchers have turned more recently to large-linked databases (LLDB) to study vaccine safety. LLDB provide scientists with access to the complete medical records of millions of individuals receiving vaccines (all identifying information is deleted to protect the confidentiality of the patient). One example of a LLDB is the Vaccine Safety Datalink (VSD) Project.

Reporting Vaccine Adverse Events

• VAERS online reporting form
• VAERS paper reporting form (PDF)

Everyone is encouraged to report any clinically significant or unexpected event (even if uncertain that the vaccine caused the event) for any vaccine. The Reportable Events Table (RET) lists and explains injuries and conditions that are presumed to be caused by vaccines, and time periods in which the first symptom must occur after receiving the vaccine. It is used by the Vaccine Injury Compensation Program, which is operated by the U.S. Health Resources and Services Administration. Health care providers are required by law to report to VAERS any conditions on the RET, vaccine adverse events that are listed in the manufacturer’s insert, and clinically significant or unexpected events following vaccination.

National Surveillance Data for Vaccine Adverse Events

VAERS Data: When evaluating data from VAERS, it is important to note that for any reported event, no cause-and-effect relationship has been established. VAERS receives reports on all potential associations between vaccines and adverse events. Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. The report of an adverse event to VAERS is not documentation that a vaccine caused the event.

Recent Research

In 2006, FDA licensed RotaTeq, a new rotavirus vaccine. The same year, CDC implemented a post-licensure vaccine safety study of the RotaTeq vaccine.

Other Resources

2008 VAERS brochure: full color (PDF-3.8MB) or text only (TXT-5KB) Gardasil vaccine reports to VAERS Scientific articles published by members of the VAERS Team VAERS Annual Letter to Health Care Providers (PDF-636KB)

Scientific Articles

1. Varricchio F, Iskander J, Destefano F, Ball R, Pless R, Braun MM, Chen RT. Understanding vaccine safety information from the Vaccine Adverse Event Reporting System. Pediatric Infectious Disease Journal 2004;23(4):287–294.
2. Zhou W, Pool V, Iskander JK, English-Bullard R, Ball R, Wise RP, Haber P, Pless RP, Mootrey G, Ellenberg SS, Braun MM, Chen RT. Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)—United States, 1991–2001. MMWR 2003;52(1):1–24.
3. Chen RT, Rastogi SC, Mullen JR, Hayes SW, Cochi SL, Donlon JA, Wassilak SG. The Vaccine Adverse Event Reporting System (VAERS). Vaccine 1994;12(6):542–550.

Please note: Some of these publications are available for download only as Portable Document Format (PDF) files, which require Adobe^® Acrobat^® Reader to view. Please review the information on downloading and using Acrobat Reader software.

To download a PDF of VAERS report: Quadrivalent Human Papillomavirus Vaccine (HPV4): Post-licensure Safety Update, Vaccine Adverse Event Reporting System (VAERS), United States Advisory Committee on Immunization Practices, 10-22-08,
Click here

Page last modified: May 12, 2008
Content source: Immunization Safety Office

©2012 An Inconvenient Woman. All Rights Reserved.

What is FDA posting?

The following reports list any potential signals of serious risks/new safety information that were identified using the AERS database during the indicated quarter. The appearance of a drug on this list does not mean that FDA has concluded that the drug has this listed risk. It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk. If after further evaluation the FDA determines that the drug is associated with the risk, it may take a variety of actions including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.

FDA wants to emphasize that the listing of a drug and a potential signal of a serious risk/new safety information on this Web site does not mean that FDA is suggesting that healthcare providers should not prescribe the drug or that patients taking the drug should stop taking the medication. Patients who have questions about their use of the identified drug should contact their health care provider.

FDA will complete its evaluation of each potential safety issue and may issue additional public communications as appropriate.

Why is FDA posting this information?

FDA is posting these reports in accordance with Title IX, Section 921 of the Food and Drug Administration Amendments Act of 2007 (FDAAA; see insert). FDA will publish a new list of potential signals of serious risks/new safety information identified each quarter.

How was the list generated?

FDA staff in the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) regularly examine the AERS database as part of routine safety monitoring. When a potential signal of a serious risk is identified from AERS data, it is entered as a safety issue into CDER’s Document Archiving, Reporting, and Regulatory Tracking System (DARRTS) or into CBER’s Therapeutics and Blood Safety Branch Safety Signal Tracking (SST) system. Potential signals of serious risks are normally based upon groups of AERS reports, although a single AERS report could lead to further evaluation of a potential safety issue.

What information is provided?

The table in each report lists the names of products and potential safety issues that were entered into the above CDER or CBER tracking systems where the AERS database identified (or contributed to identification of) the potential safety issues.

A new report will be made available each quarter showing newly identified potential signals of serious risks/new safety information identified from the AERS database during the previous quarter. Information from previous quarters will remain available on the website.

Quarterly Reports

• January 2008 to March 2008

Back to Top Back to AERS

Date created: September 5, 2008

©2012 An Inconvenient Woman. All Rights Reserved.

By JARED A. FAVOLE

WSJ.com, September 5, 2008 8:07 p.m.

WASHINGTON — The Food and Drug Administration on Friday unveiled a report listing 20 drugs that the agency is investigating for potential side effects, as part of a new policy to warn patients and health-care professionals as early as possible.

The list includes a wide array of drugs, from Eli Lilly & Co.’s antidepressant Cymbalta to Purdue Pharma LP’s painkiller Oxycontin. It also addresses a range of adverse reactions, including cardiac arrest, cancer and Purple Glove Syndrome, which can result in patients having their arms amputated. (See the FDA’s list of drugs that are under investigation.)

The FDA has already sent out warnings about a handful of the drugs on the list. The report lists TNF blockers — such as Johnson & Johnson’s Remicade — as being potentially associated with cancer in children. In June, the FDA said it was investigating the possible link. TNF blockers target a compound known as tumor necrosis factor, which is overproduced in many patients with inflammatory diseases like arthritis and Crohn’s.

But there appear to be new ones, too. The report lists Biogen Idec Inc. and Elan Corp.’s multiple-sclerosis treatment Tysabri as potentially being associated with skin cancer. Medical journals have reported cases of melanoma in patients taking Tysabri, but the FDA hasn’t previously said it was investigating the drug for this side effect.

The list, which the FDA will start issuing quarterly, is aimed at giving consumers and health-care professionals early indications of what the FDA is investigating, but it might end up creating more confusion. Indeed, the agency is concerned “that people will stop taking a drug inappropriately” because it is on the list, said Paul Seligman, associate director of safety policy at the agency.

The FDA said it alerted companies whose drugs appeared on the list prior to it being made public — several companies said they received word late Thursday — and intends to give drug makers a heads-up in the future as well.

Drug makers said they support the FDA’s additional efforts to be transparent about drug safety, but some expressed concern that the information was being communicated to patients without context and wondered about what patients might do with the information.

“It is very, very important that patients and their physicians understand the benefits and the risks of the drug. To speak about one without the other could have an impact on patient perception of their medications,” said Tony Jewell, a spokesman for AstraZeneca PLC, whose psychiatric medication Seroquel made the list for the possible safety concern of overdose due to confusing sample-pack labeling.

Companies also cautioned that just because a drug is posted on the site doesn’t mean a causal relationship has been identified, and it is also risky if patients go off their medications without consulting a physician.

The FDA’s intention is for patients and doctors to use the list to be aware of potential adverse events and to encourage them to report any problems. The list doesn’t represent a comprehensive list of drugs the FDA is investigating, the FDA’s Mr. Seligman said.

The report is generated from the agency’s adverse-event-reporting database. That compilation consists of voluntary reports from patients and health-care professionals, and is widely considered to capture only a fraction of the actual adverse events associated with any given drug.

Mr. Seligman said the FDA is hopeful the quarterly reports will encourage people to report adverse events.

Write to Jared A. Favole at jared.favole@dowjones.com

©2012 An Inconvenient Woman. All Rights Reserved.