Monday, October 24, 2011

The Incredible Hulk Vaccine Side Effect: Or, Understanding VAERS

By Karen Ernst

Inevitably, in the course of speaking with someone who wants to support her decision not to vaccinate her child, you will be asked to read the VAERS (Vaccine Adverse Events Reporting System) database. Reading VAERS is not inherently wrong or bad. However, before reading VAERS, you should understand what it is and what you will find there.

VAERS is the place where doctors, patients, and really anyone else can report what they suspect to be side effect of a vaccination. The CDC and the FDA co-sponsor this data base, and they use it to monitor possible vaccine side effects. When certain patterns or clusters of similar reports appear, public health officials investigate these events and make appropriate recommendations. For example, in 1999, VAERS caught a higher than expected incidence of intussusception—a bowel disorder—following adminstration of RotaShield, a rotovirus vaccine.  Epidemiological studies confirmed the heightened risk of this side effect, and the vaccine was pulled from the market.

In this sense, VAERS is invaluable. It gives public health officials the information they need in order to keep our immunization program as safe as possible. As a parent, I take comfort in the fact that VAERS exists and that people who know how to analyze the data are on top of it.

However, VAERS is a passive reporting system. This means that anyone can report anything to it. There is no go-between. It’s almost like an online forum or message board; anyone can post and no one vets the claims. As such, a report in VAERS does not prove that any adverse event was actually caused by vaccines.  In fact, it doesn't even prove that any reported adverse event actually existed. One of the more well-known examples of how any report makes it into VAERS was Dr. James Laidler’s report that the influenza vaccine turned him into the Incredible Hulk. He inspired Kevin Leitch from Left Brain Right Brain to report a similar Wonder Woman adverse event. 

Of course, those examples are a bit tongue-in-cheek. There are other events people submit, however, which can be taken no more seriously.  For example, here is one reported event, taken word for word from the VAERS data base:

“Information has been received from a nurse practitioner concerning a patient’s nephew, a 17-year-old male consumer who she "thought" was vaccinated with a dose of GARDASIL (lot number not provided) in November 2010. The nurse practitioner stated that two weeks after the patient received the dose of GARDASIL, approximately November 2010 (also reported as "two weeks ago" on approximately 01-APR-2011), the patient died of sudden cardiac death on the lacrosse field. Unspecified medical treatment was given. It was unspecified if any lab diagnostic test were performed. The cause of death was sudden cardiac death. Sudden cardiac death was considered to be immediately life-threatening and disabling by the reporting nurse practitioner. Additional information has been requested.”

In this third-hand report (a nurse practitioner reporting about the nephew of a patient), VAERS cannot even confirm whether or not the deceased ever received the vaccine in question. In another very sad report, suicide (following a history of suicidal ideation) is blamed on a vaccine: “Known chronic depression, she elected to stop her medications when she turned 18. Committed suicide 04/28/11. Hung herself.”

Other similar reports are made here at the well-known anti-vaccine site National Vaccine Information Center. Included in this one page of the VAERS data base are people who read something on the internet and made a VAERS report.  Sometimes the same person made multiple, similar, vague reports. That bereaved parents and concerned others make reports to VAERS is not troublesome, even when these reports may be dubious or even fraudulent.  Epidemiologists and public health experts know how to wade through the overwhelming amount of information in order to determine the safety of our vaccines.
But the anti-vaccine movement relies heavily on the VAERS data base to frighten parents away from vaccines, and this is extremely troublesome. 

VAERS does not prove causation, or even correlation, when it comes to side effects and vaccines. Parents would be far better off trusting their doctors who have examined the studies done to ensure the safety of the vaccines we use to protect our children. As parents, it’s easy to be scared off vaccines by reports of “vaccine injury.” However, when making a decision as crucial as this one, we must know where our information comes from and the truth behind the way it is presented.

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