When We Confuse the Smoke Alarm with the Fire
How Unverified VAERS Reports Are Being Used to Scare Parents About 25 Child Deaths
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 unvaccinated populations.
The CDC also runs the Clinical Immunization Safety Assessment (CISA) Project, which provides expert consultation on complex vaccine safety issues and conducts clinical research on vaccine safety questions.
While VAERS accepts any report from anyone, VSD uses verified medical data to answer the critical question: "Is this adverse event actually happening more often in vaccinated people than in unvaccinated people?" This is how we move from correlation to understanding causation.
Of course, VSD isn't perfect either and has its own limitations. It can only study outcomes that come to medical attention, it's limited to insured populations, and extremely rare events might still be hard to detect, even with millions of people. But unlike VAERS, VSD uses medical records, making it far more reliable for determining whether vaccines actually cause specific health problems.
When Misunderstanding Becomes Dangerous
A pediatrician recently shared their own VAERS experience as a comment on a recent Instagram post: "My patient developed sudden onset shock and had to be hospitalized in the ICU. They didn't find a bacterial infection and she had the COVID vaccine days before, so I reported it. We then learned that she had started a medication to treat latent tuberculosis and that was the cause of all of her symptoms. My report is still in there, but the vaccine had nothing to do with her shock or hospitalization."
This physician added: "Physicians should be encouraged to report like this—any concern, any time even if it's wrong. Using the data maliciously to scare people is so awful and will decrease reporting."
This is exactly how the system should work; physicians report potential issues even when uncertain, creating a comprehensive database for pattern detection. But that same openness makes VAERS vulnerable to misuse.
The Current Situation
The Washington Post broke news yesterday about Trump administration health officials who plan to claim that COVID vaccines killed 25 children, based on VAERS reports. They're planning to present this at next week's Advisory Committee on Immunization Practices (ACIP) meeting (the very committee that makes official vaccine recommendations for the entire country).
This represents a catastrophic misuse of VAERS data for two reasons:
VAERS cannot determine causation. Those 25 reports could include car accidents, drownings, or any death that happened to occur after vaccination. The FDA commissioner himself said that investigations into these cases could take months, yet they're announcing conclusions before investigations are complete.
The timing couldn't be worse. The ACIP meeting will set national vaccine policy. These unverified claims will generate headlines and social media posts about a "government coverup" of vaccine deaths in children, fueling vaccine hesitancy at a critical moment and also likely impacting recommendations as many parents wait for news about whether their child can receive a COVID-19 vaccine.
Look to the Data
At the June ACIP meeting, CDC staff presented data showing that at least 25 children died who had COVID-associated hospitalizations since July 2023. Of the 16 who were old enough for vaccination, none were up-to-date on vaccines according to the Washington Post.
The virus is killing unvaccinated kids, not the other way around.
Research on excess mortality provides helpful context. A comprehensive study found statistically significant excess mortality among U.S. children ages 0-17 during the Delta wave of 2021, with 1,532 excess deaths occurring primarily in the South, where vaccine uptake was lower. The deaths were concentrated in areas with fewer public health protections and lower vaccination rates.
Let's zoom out for a second. The US has experienced an estimated 14.7 million excess deaths compared to other wealthy nations from 1980-2023, with the trend continuing even after the pandemic, according to a 2025 JAMA Health Forum study. In 2023 alone, there were 705,331 excess U.S. deaths compared to peer nations, driven by drug overdoses, firearm injuries, and cardiometabolic disease. Not vaccines.
While politicians weaponize unverified VAERS reports about vaccines, we're ignoring the actual documented causes of why American children and adults are dying at higher rates than in any other wealthy nation.
The Stakes
As one skeptical commenter noted, "Considered a key system for understanding danger signals in jabs until the signals were terribly inconvenient. Fascinating."
I can understand why someone might feel this way; it can seem suspicious when officials appear to dismiss concerning data, but that's not what is happening here. VAERS remains very useful as an early warning system, triggering further investigation. It successfully identified the J&J vaccine blood clotting issue, polio vaccine complications, and myocarditis signals—proving the system works. When those signals appeared, scientists didn't dismiss them; they investigated thoroughly and took action. But VAERS was never designed to determine causation; that requires controlled studies, medical record reviews through systems like VSD, and proper epidemiological investigation.
The real tragedy here is that weaponizing VAERS data undermines the entire vaccine safety monitoring system. When politicians misuse safety data to score political points, they erode public trust in the very systems designed to protect us.
The Bottom Line
VAERS is like my daughter's fierce independence; powerful when properly channeled, chaotic when misunderstood. It's an essential tool for vaccine safety monitoring, successfully catching rare side effects that might otherwise go unnoticed. But VAERS reports alone cannot prove causation.
As public health professionals scramble to address this latest misuse of VAERS data, parents are left confused and frightened. The headlines write themselves: "Government Data Shows Vaccines Kill Children." But that's not what VAERS shows at all. It shows unverified reports that require investigation, nothing more.
Meanwhile, verified data from proper surveillance systems shows COVID itself has killed dozens of unvaccinated children. Those aren't unverified reports or spurious correlations; those are confirmed deaths that proper vaccination could have prevented.
If properly conducted studies using verified data ever showed that a vaccine caused a child's death, every scientist, doctor, and public health official I know would demand immediate action. We all want to protect children. That's precisely why we have multiple layers of safety monitoring. But our findings are only as valid as the data we use—and VAERS, by design, is not the tool for determining causation. It's the alarm bell, not the investigation.
We need VAERS. We need robust vaccine safety monitoring. But we also need leaders who understand the difference between an early warning system and proof of causation. The difference between smoke signals and true fire. Our children's lives depend on getting this right.
Stay Curious,
Unbiased Science
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Much better to have the context and facts when discussing these issues rather than simply dismissing people espousing misinformation. Thanks. Every issue of this substack is fabulous.
Nice post - great job with the correlation vs causation discussion. Thank you 🙏