When We Confuse the Smoke Alarm with the Fire
Description
Our Tempest in a Teapot
My daughter Sophia (or 'Zosia' as I call her, using the Polish version) is seven and a half going on seventeen. This morning, like most Saturday mornings, she's orchestrating chaos: trying to convince her brother Dylan to put a bag of frozen peaches in the oven to make a peach pie. I love the ambition, but the execution? Not so much.
During weekday mornings, I turn into a pole vaulter, leaping over the piles of outfits she's tried on and discarded, as I frantically shuffle around in my mother's rainbow fuzzy robe from the 1980s with coffee breath and frizzy hair, desperately trying to get us out the door before another tardy slip. My husband lovingly calls her "a tempest in a teapot"—bold, fierce, knows exactly what she wants, and lets the world know.
This tenacity can be, shall we say, challenging. But I know this fire will serve her well. She's going to need that determination in this world, and I would never want to suppress it.
Her fierce independence reminds me of another double-edged sword: VAERS, the Vaccine Adverse Event Reporting System. Like Sophia's boldness, VAERS serves a critical purpose, but it can also create chaos when misunderstood or misused.
Let's discuss...
What VAERS Actually Is
Of all the systems we have in place to monitor vaccine safety, VAERS is definitely the most well-known—and unfortunately, the most misunderstood. At its core, VAERS is an early warning system, established jointly by the CDC and FDA in 1990. Think of it as a giant suggestion box where anyone (doctors, patients, concerned family members) can report health issues that occur after vaccination.
[Note: Unbiased Science created an entire post on how safety signals are investigated, but, for some reason, Meta flagged it as “mature content” for people 18 years and older. I am looking into it, but can’t embed it here. You should be able to view it if you click here and are logged into Instagram.]
Healthcare providers are legally required to report certain events to VAERS, including serious adverse events and deaths following vaccination, that occur within a specified time period after vaccination. They are also strongly encouraged to report other adverse events, regardless of whether they think the vaccine caused them. This requirement ensures comprehensive reporting, but also means many unrelated events end up in the database.
When patterns emerge in these reports, they trigger an investigation. This is how the system is supposed to work, and it has worked remarkably well over the decades:
In 1997, VAERS data helped doctors identify cases of vaccine-associated paralytic poliomyelitis (VAPP) from the oral polio vaccine. This led to a switch from OPV to the inactivated polio vaccine (IPV), which greatly reduced these rare side effects.
VAERS detected cases of cerebral venous sinus thrombosis (CVST) with the J&J COVID-19 vaccine. After approximately 6.8 million doses, the system captured reports of this rare blood clot combined with low platelet levels. Authorities paused the vaccine, thoroughly investigated, and identified 15 cases of thrombosis with thrombocytopenia syndrome (TTS) among nearly 8 million doses, as reported by the FDA and CDC.
In 2021, Israeli health officials first flagged cases of myocarditis occurring mainly in young men shortly after the second dose of the Pfizer-BioNTech COVID-19 vaccine. This early clinical alert prompted researchers in the U.S. to closely examine VAERS reports. VAERS proved valuable by rapidly confirming this unusual pattern that had not been apparent in clinical trials because it was so rare. After extensive investigation, scientists determined that while there is an increased risk of myocarditis (primarily in males aged 12-29) following mRNA COVID-19 vaccination, the benefits of vaccination far outweigh the risks. (As a reminder, myocarditis is more common and typically more severe following viral infection than after vaccination.)
This is VAERS at its best: catching rare safety signals that might not appear in clinical trials, triggering investigations that lead to evidence-based policy changes.
What VAERS Isn't
VAERS is emphatically NOT a system for determining whether vaccines cause specific problems. It's a collection of unverified reports that can include literally anything that happens after vaccination.
In what has become a legendary example in public health circles, anesthesiologist Dr. James Laidler once submitted a report to VAERS claiming that a flu vaccine had turned him into the Incredible Hulk. The report was accepted into the database. Only after VAERS officials noticed this rather unusual submission and contacted him did he agree to have it removed.
If someone dies in a car crash after vaccination, that must be reported to VAERS. Lightning strikes? Those, too, could end up in the database. As the VAERS website itself states in bold letters: "VAERS reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable."
The Spurious Correlation Problem
This brings us to a fundamental problem in data interpretation: confusing correlation with causation. Just because two things happen around the same time doesn't mean one caused the other. This logical error is so common that economist Tyler Vigen created an entire website devoted to ridiculous correlations at tylervigen.com/spurious-correlations (it is brilliant, check it out).
Shark attacks correlate with ice cream sales. Both increase in summer, but ice cream doesn't cause shark attacks. The divorce rate in Maine correlates with margarine consumption. Nicolas Cage movie releases correlate with pool drownings. These are real statistical correlations, but they're meaningless in terms of causation.
Using VAERS reports to claim vaccines cause deaths is the same logical fallacy.
Someone might push back: "Well, these examples are absurd. Isn't it much more reasonable to expect that something being injected into a child's body and then them dying shortly thereafter is a little suspect?"
It definitely warrants investigating, which is exactly what VAERS is designed to trigger. But the reality is that children, unfortunately, do die of various causes. And because kids receive a regular schedule of vaccines throughout childhood, it's statistically expected that some unrelated deaths will occur after vaccination purely by chance. That's why we need proper investigation, not raw VAERS reports, to determine causation.
Understanding Vaccine Safety Systems
One common misconception is thinking VAERS is the only vaccine safety monitoring system. In fact, it's just the first line of defense—a passive surveillance system that casts a wide net. When VAERS detects a potential signal, that's when the real detective work begins.
The Vaccine Safety Datalink (VSD), established in 1990 as a collaboration between the CDC and large healthcare organizations, uses actual medical records from over 9 million people annually. It links vaccination records with medical outcomes, allowing researchers to conduct controlled studies comparing vaccinated and unvacci