Take a second and think back to when you or your child received a medical treatment or product at the doctor's office. For drugs, you most likely received a multiple-paged sheet with all the directions, contraindications, and possible side effects. For surgery, you've had to sign some kind of disclosure that you're aware of possible negative outcomes. But what about immunizations? Did you receive anything?
It's required by law that doctor's provide Vaccine Information Statements (VIS) prior to providing these products. The VIS typically given lists only injection site reactions. However, more recently these statements have been updated to include more serious reactions listed by the manufacturers. It's imperative patients are given the full disclosure on possible adverse reactions because this awareness directly relates to the success of a passive surveillance system called VAERS.
Vaccine Adverse Event Reporting System (VAERS) was established in 1990 and is co-managed by the CDC and FDA. It is a system put in place to report adverse reactions to vaccinations. Anyone can report to VAERS, however medical professionals are required to report all adverse events that come to their attention. It's a passive reporting system, meaning it relies on individuals to send in their reports.
As a passive system, it relies heavily on medical professionals to inform us on what the possible adverse reactions could be and then follow through with reporting. In a CDC study, it was stated that "Passive surveillance systems (e.g., VAERS) are subject to multiple limitations, including underreporting, reporting of temporal associations or unconfirmed diagnoses, and lack of denominator data and unbiased comparison groups" (emphasis added).
Additionally, the Congressional Committee on Government Reform discussed in a report titled "The Vaccine Injury Compensation Program: Addressing Needs and Improving Practices" that VAERS, "may be lauded as the 'front line' of vaccine safety, [however] the lack of enforcement provisions and effective monitoring of reporting practices preclude accurate assessments of the extent to which adverse events are actually reported." Also stated in the text, "Former DFA Commissioner David A. Kessler has estimated that VAERS reports currently represent only a fraction of the serious adverse events" (emphasis added).
This congressional committee also discussed another challenge for this system. "Assessment is further complicated by the administration of multiple vaccines at the same time, following currently recommended vaccine schedules, because there may be no conclusive way to determine which vaccine or combination of vaccines caused the specific adverse event." If you've read manufacturer inserts, there are a slew of adverse reactions that can occur. The flu product itself has over 40 reactions depending which brand is used. If the flu was administered during a well-baby visit when many other products are given at the same time, how can a medical professional know which product caused a reaction? And how can the parent know if they weren't granted informed consent?
Most notable in this discussion is the CDC-funded Harvard study conducted about VAER's effectiveness and reliability. The final report stated, "Adverse events from drugs and vaccines are common, but underreported. ...Likewise, fewer than 1% of vaccine adverse events are reported." In other words, for every 100 adverse reactions that occur, only 1 of them is actually reported to VAERS. This is a broken and failing reporting system. It is routinely said that adverse reactions are rare when in fact, based on this study, it is the opposite.
Why does it matter that reactions are underreported? The Harvard researchers stated it perfectly.
In addition to these alarming findings, the researchers also stated in the final report that "there was never an opportunity to perform system performance assessments because the necessary CDC contacts were no longer available and the CDC consultants responsible for receiving data were no longer responsive to our multiple requests to proceed with testing and evaluation." Meaning, once the CDC heard the researchers findings, they severed communications. There was no action taken with the information provided.
The question isn't if adverse reactions and injuries are common, but why they remain to be underreported even though the CDC and Congress have both stated they are underreported.