VAERS Frequently Asked Questions

**This taken from the VAERS site.

What is VAERS?
The National Childhood Vaccine Injury Act (NCVIA) of 1986 mandated the reporting of certain adverse events following vaccination to help ensure the safety of vaccines distributed in the United States. This Act led to the establishment of the Vaccine Adverse Event Reporting System (VAERS) in November 1990 by the Department of Health and Human Services. VAERS provides a database management system for the collection and analysis of datafrom reports of adverse events following vaccination. VAERS is operated jointly by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS currently receives approximately 800-1000 reports each month.

Who can report to VAERS?
Any one can report to VAERS. VAERS reports are usually submitted by health care providers, vaccine manufacturers,and vaccine recipients (or their parents/guardians). Patients, parents, and guardians are encouraged to seek the help of a health-care professional in reporting to VAERS.

Why should I report to VAERS?
Registries of disease or injury work best when reporting is complete. Complete reporting of post-vaccination events supplies public health professionals with the information they need to ensure the safest strategies of vaccine administration.

Does my reporting injuries (or deaths) to VAERS affect personal liability?
No. The National Childhood Vaccine Injury Act of 1986 provides liability protection through the Vaccine Injury Compensation Program. In light of this protection, practitioner liability is unaffected by the VAERS reporting requirement.

What events should be reported to VAERS?
Although NCVIA only requires reporting of the post-vaccination adverse events mentioned in the Reportable Events Table, VAERS encourages all reporting of any clinically significant adverse event occurring after the administration of any vaccine licensed in the United States. On average, about 17% of the reports reflect adverse events resulting in life-threatening illness, hospitalization, permanent disability, extended hospital stay or death. The remaining 83% of the reports primarily describe events such as fever, local reactions transient crying or mild irritability, and other less serious experiences.

The Reportable Events Table specifically outlines the reportable post-vaccination events and the time frames in whichthey must occur in order to qualify as being reportable. A copy of the Table can be obtained by calling 1-800-822-7967.

The NCVIA requires the following events be reported:

    Any event set forth in the Reportable Events Table that occurs within the time period specified.
    Any event listed in the manufacturer's package insert as a contraindication to subsequent doses of the vaccine.

How are VAERS reports analyzed?
Both the CDC and the FDA review data reported to VAERS. The CDC focuses on collective reports, attempting to detect unusual epidemiologic trends and associations. The FDA reviews individual reports, assessing whether are ported event is adequately reflected in product labeling, and also closely monitors reporting trends for individual vaccine manufacturers and vaccine lots.

Safety surveillance includes the analysis of reports by individual epidemiologists, and weekly review meetings of serious VAERS reports to detect potential risks which require further investigation.

Can information reported to VAERS cause a recall of a vaccine?
The FDA has the authority to recall a vaccine from use in the United States if they feel it represents a risk to the American public. VAERS reports may signal that there is the potential for a safety risk, which would prompt a wider evaluation of the safety of the vaccine lot. If the evaluation confirms a risk, the batch can be recalled.

Over the last 10 years, there have been only three vaccine recalls. One batch of vaccine was recalled after the FDA detected impurities in the vaccine; another was mislabeled. The third batch was recalled because an FDA inspection found substandard conditions at the production plant which had the potential to produce a substandard batch.

In the winter of 1996-97, a pharmaceutical company voluntarily withdrew a vaccine from distribution because it did not retain its protective effect long enough after manufacture to meet Federal standards. This vaccine was not a safety threat, but did not work well enough to protect people from getting the disease it was designed to protect them from.

Are all events reported to VAERS caused by vaccinations?
Again, VAERS accepts all reports of adverse events following vaccination, so not all events reported to VAERS arecaused by vaccines. In fact, limitations such as differential reporting rates, simultaneous administration of different vaccine antigens, temporal reporting bias and lack of background vaccination rate data generally prevent the determination of vaccine-event causal associations using VAERS data. Without fully understanding its limitations, results from VAERS can easily be misinterpreted.

Understanding Rhabdomyolysis

This is very important information if you are using statins or other drugs as mentioned in this article - YODA   Unusual Kidney Injury Can Be Caused By Hazing, Medication Interaction And Anesthetics 27 Apr 2011   A muscle condition that injures the kidneys is well-known to football experts -- diagnosed recently in a professional player and 13 college athletes. Yet new studies are finding some surprising sources of rhabdomyolysis, the potentially deadly condition, according to research being presented at the National Kidney Foundation's Spring Clinical Meetings, held here this week.  This condition causes muscles to break down, releasing their fibers and enzymes into the body. These enter the bloodstream and plug up the kidney, resulting in potentially fatal damage. Recently, the condition was diagnosed in Washington Redskins player Albert Haynesworth and 13 players on an Iowa college team, as well as two dozen high school football players in Oregon. In these cases, the condition - often called simply "rhabdo" - is attributed to intense workouts, injury, or heat exhaustion. But there are less obvious causes that can put even non-athletes at risk.  One group of researchers presented findings from a 19-year-old man who developed rhabdo after being hazed by his fraternity. As part of the hazing, he was struck in the back and buttock areas up to 1,000 times with wooden paddles, injuring the muscles and triggering rhabdomyolysis.  "This is yet another reason why hazing can be deadly," said study author Dr. Khalid Bashir of the Morehouse School of Medicine. Thankfully, with treatment, the man survived. "The strange thing is that the patient entered a fraternity thinking his brothers would protect him from other people," said Dr. Bashir. "When, in fact, it was the other way around."  In another study, Dr. Gaurav Alreja at Baystate Medical Center and his colleagues describe a man who developed rhabdo after taking the combination of a cholesterol-lowering drug and an antibiotic.  Previous research has shown that these cholesterol-lowering drugs, known as statins, can increase the risk of rhabdo, explained Dr. Alreja. In this instance, a 73-year-old man on a relatively high dose of simvastatin developed rhabdo after he added the antibiotic azithromycin - a common drug thought to be very safe, he explained.  "This patient likely had some predisposition to developing rhabdomyolysis, and the high dose of the statin increased that risk - adding this antibiotic likely tipped the balance," said Dr. Alreja. "Hopefully, doctors and patients will keep this interaction in mind when offering antibiotics to patients receiving statins."  Thankfully, the patient recovered, and was able to continue taking high-doses of statins without the antibiotic, and the rhabdo did not return.  In another less fortunate report, doctors describe a 24-year-old man who died after developing rhabdomyolysis as a complication from anesthesia. The man had been under anesthesia for days following a car accident, and patients in this situation are sometimes at risk of developing propofol infusion syndrome (PRIS), a series of complications resulting from the anesthetic propofol.  In this instance, the patient developed rhabdomyolysis as well, and died.  Many people - even doctors - may not be aware that PRIS can cause rhabdomyolysis, and hopefully this man's tragedy will help change that, said study author Dr. Tamim H. Naber of the Hofstra North Shore-LIJ School of Medicine. "Knowledge of this rare condition is important to help diagnose the condition early, and potentially stop the course of the disease," said Dr. Naber.  "These studies illustrate the importance of overall awareness of the many uncommon causes of rhabdomyolysis, which can have devastating effects on athletes and non-athletes alike," said Dr. Lynda Szczech, National Kidney Foundation President.  Source:  National Kidney Foundation Article URL: http://www.medicalnewstoday.com/releases/223517.php Main News Category: Urology / Nephrology Also Appears In:  Sports Medicine / Fitness,   Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms and conditions. Save time! Get the latest medical news headlines for your specialist area, in a weekly newsletter e-mail. See http://www.medicalnewstoday.com/newsletters.php for details.

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