VAERS
Vulnerabilities and Validity of Our Vaccine Reporting Tools
The pod page must receive a dozen messages (at least) every week from people who are nervous about getting vaccinated because of a post they saw about vaccine adverse events.
Last week, an article was published in JAMA titled, “Misinformation and the Vaccine Adverse Event Reporting System.” In it, the authors do a great job of explaining the strengths and weaknesses of the Vaccine Adverse Event Reporting System (VAERS), and how it has, unfortunately, been weaponized to spread fear and misinformation.
As a reminder, VAERS is a passive reporting system, meaning anyone can submit a report without verification. This can lead to misleading information, as reports do not necessarily mean the vaccine caused the event. (Correlation does NOT equal causation!) For example, people may mistakenly conclude that a vaccine caused a serious illness or death because these events are reported after vaccination, even if they are not caused by the vaccine.
Interestingly, the authors recommend renaming VAERS to something that more accurately reflects its purpose, such as the “Vaccine Safety Sentinel”. They also suggest providing more information to the public about VAERS and how to interpret its data.
Here is a direct quote that is quite powerful.
“As scholars have noted, language does our thinking for us. Terming an early-warning and monitoring system the Vaccine Adverse Event Reporting System and allowing full access to unvetted language increases public susceptibility to misconceptions about vaccine safety. Those seeking to discredit vaccination exploit that susceptibility. It may be time for the CDC and FDA to couple transparent access to this passive surveillance system with language, in the form of a more accurate name, well-defined guidance about VAERS’ nature and use, and comprehensible information about an event’s verification status.”
Source:
Jamieson KH, Johnson KB, Cappola AR. Misinformation and the Vaccine Adverse Event Reporting System. JAMA. Published online February 26, 2024. doi:10.1001/jama.2024.1757
Here are the key takeaways from the article:
VAERS is a passive reporting system, meaning anyone can submit a report without verification.
This can lead to misleading information, as reports do not necessarily mean the vaccine caused the event.
The authors recommend renaming VAERS to something that more accurately reflects its purpose, such as the “Vaccine Safety Sentinel”.
They also suggest providing more information to the public about VAERS and how to interpret its data.
So, all this being said, what is the utility of VAERS?
When VAERS is utilized in the right way, by the right people, it is a useful early warning system. It can detect adverse reactions, especially those that were too rare to be detected in clinical trials. However, the system can be misused. Filing a false report is a violation of Federal Law, punishable by fine and imprisonment. VAERS functions as an early public health warning system in the following ways:
It casts a wide surveillance net.
VAERS casts a broad net, accepting reports from healthcare providers, manufacturers, and the public on any suspected adverse events after vaccination.
The bar for submitting a report is intentionally low. This encourages reporting even for potential side effects that might not be definitively linked to the vaccine.
It detects rare signals.
Its primary purpose is spotting patterns or unusually high rates of specific reactions that might not surface in smaller clinical trials. These signal potential problems needing further investigation.
When rare signals are detected, it triggers rigorous follow-up.
Scientists analyze VAERS data alongside other sources:
Controlled clinical trials
Epidemiological studies
Medical records
This is how they determine if a signal in VAERS represents a real safety risk or just coincidental events.
If initial analysis suggests a potential safety issue, it sparks deeper investigation. This can lead to:
Changes in vaccine formulation
Updated recommendations on vaccine usage
Targeted studies to confirm or disprove the risk.
Real-World Example:
The rotavirus vaccine is a good example. Early VAERS data suggested a possible link to a rare bowel condition. This triggered further investigation, confirming a slight risk. The vaccine remains in use but with updated guidance to balance the risk against the benefits.
Key Points and Takeaways:
VAERS is one piece of the puzzle: It's crucial for public health, but it's not infallible. Understanding its limitations is vital and we need to do a better job of communicating this to the public.
The early warning system function of VAERS allows for quickly identifying potential concerns, giving public health officials a head start in protecting public safety.
How has VAERS been misused to push an anti-vax agenda? Let’s discuss…
Misrepresenting Cause & Effect:
Correlation ≠ Causation: An event occurring after vaccination doesn't mean the vaccine caused it. Anti-vaxxers often highlight VAERS reports of deaths or serious side effects, implying the vaccine is to blame without any investigation of the underlying causes.
Ignoring Reporting Biases:
Anyone Can Report: VAERS is designed for flagging potential concerns, not proving causation. Reports can be from anyone, including individuals with anti-vaccine agendas.
Unverified Data: Reports often lack medical confirmation or investigation into whether the event was caused by the vaccine.
Exaggerating Numbers:
Focus on Scary Stats: Anti-vaxxers focus on the raw number of reports without context. They ignore that VAERS expects reports even of coincidental events and that rates of serious side effects are incredibly low when analyzed scientifically.
Ignoring Background Rates:
Normal Illness Gets Blamed: Deaths and illnesses occur all the time, regardless of vaccination. Misusing VAERS ignores that a certain number of adverse events would happen coincidentally after vaccination even if the vaccine were completely harmless.
Selective Reporting:
Cherry-picking: Anti-vaxxers highlight specific VAERS reports that fit their narrative while ignoring the vast majority that don't show severe vaccine reactions.
Again: reports of adverse events do not mean that the event was caused by a vaccine; in fact, most VAERS reports have been deemed to be unrelated to vaccinations. Many reports on VAERS are false or coincidental. If you broke your arm after getting vaccinated, that is not evidence the two are linked in any way.
VAERS is a double-edged sword. While useful for monitoring large populations to detect rare events, reports in VAERS are frequently misrepresented and taken out of context by people aiming to elicit vaccine hesitancy and refusal.