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VAERS: The 1990 Canary for Vaccine Safety

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  Published in Health and Fitness on Monday, December 22nd 2025 at 17:31 GMT by Time

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VAERS Explained: How the Vaccine Adverse Event Reporting System Works and Why It Matters

When a vaccine causes a reaction—whether it’s a simple fever or something rarer like a blood clot—anyone who experiences it can file a report. That data is pooled into the Vaccine Adverse Event Reporting System (VAERS), the U.S. federal database that sits at the intersection of public health, vaccine safety, and the media’s fascination with “adverse events.” A recent Time.com article, What is VAERS? The Vaccine Adverse Event Reporting System (and why it matters), dives deep into the history, mechanics, and limits of VAERS, while also unpacking the way the system is often misused by anti‑vaccine groups. Below is a thorough summary of its key points—complete with context from the linked CDC pages the article cites.

1. The Origins and Purpose of VAERS

VAERS was launched in 1990 by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) as a passive reporting system. The goal was simple: to provide an early warning mechanism that would flag potential safety signals in newly licensed or already marketed vaccines. Think of it as the “canary in the coal mine” for vaccine safety. Because it is passive, any observer—healthcare professionals, parents, or patients—can submit a report. This broad net helps capture a wide range of events, from mild reactions to rare but serious complications.

The Time article stresses that VAERS is not a diagnostic tool or a definitive source of causality. It only records reports; the CDC and FDA then perform more rigorous investigations—often through the Vaccine Safety Datalink (VSD) or the CDC’s Sentinel Initiative—to determine whether a genuine safety problem exists.

2. How VAERS Works – From Submission to Public Data

Submission
- Who can report? Anyone can, but health professionals are encouraged because they can provide more detailed medical information.
- What gets reported? A wide spectrum: immediate reactions, delayed events, or even events occurring weeks later that a patient believes are linked to a vaccine.

Processing
- Initial review checks for completeness and potential duplicates.
- Signal detection uses statistical algorithms to flag clusters of reports that might indicate a real problem.

Public Release
- VAERS data are publicly available in real time. The Time piece points readers to the CDC’s VAERS website, where the raw dataset can be downloaded as a CSV file.
- Accessibility is a core principle: the public, journalists, researchers, and policy makers can examine the data directly.

Interpretation
- The CDC’s own guidance—also linked in the Time article—emphasizes that a VAERS report does not prove causation. A reported event might coincide with vaccination purely by chance.
- Contextual benchmarks (like background incidence rates for a condition) are essential before making conclusions.

3. The Public Perception Problem

The Time article spends considerable space on how VAERS is often weaponized by anti‑vaccine narratives. In the era of COVID‑19, the sheer volume of reports spurred conspiracy theories that “everyone who got the vaccine had an adverse event.” Critics of the system often ignore the following safeguards:

• Passive vs. active: Because VAERS is passive, it is prone to both over‑reporting (due to heightened vigilance) and under‑reporting (due to lack of awareness).
• Data quality: Reports can contain inaccuracies, incomplete medical histories, or even intentional misinformation.
• Statistical noise: Random coincidences are inevitable, especially for rare conditions. The CDC’s own analysis shows that the rate of events reported to VAERS often aligns with expected background rates.

The Time piece cites a 2022 study from JAMA Network Open (linked in the article) that found the proportion of serious adverse events in VAERS for COVID‑19 vaccines was no higher than that for other licensed vaccines, reinforcing that the data do not indicate a new safety signal.

4. Real‑World Examples: What VAERS Has Taught Us

Myocarditis After mRNA COVID‑19 Vaccines
VAERS flagged a cluster of myocarditis cases in adolescent males after the second dose. Subsequent investigations by the CDC and the Office of the National Coordinator for Health Information Technology confirmed a higher incidence than in unvaccinated peers. However, the cases were generally mild and resolved quickly, underscoring the need for nuance.

Thrombosis With Thrombocytopenia Syndrome (TTS)
Reports of TTS after Johnson & Johnson’s Janssen vaccine led the CDC to issue a temporary pause and eventually a label change. VAERS was instrumental in spotting this signal early.

Rare but Real Events
VAERS has also documented very rare events such as Guillain‑Barré syndrome after influenza vaccination and anaphylaxis after the first dose of mRNA COVID‑19 vaccines. These examples illustrate how the system can surface genuine safety concerns—provided the data are followed up with deeper analysis.

5. Complementary Systems: VAERS Is Just the First Step

The article underscores that VAERS is one layer in a multi‑tiered vaccine safety monitoring framework. The CDC and FDA also run:

• Vaccine Safety Datalink (VSD): A network of health plans that collect detailed electronic health data, enabling case‑control studies.
• Sentinel Initiative: An active surveillance system that monitors millions of people across the U.S. for vaccine‑related safety signals.
• Adverse Event Reporting System (AERS): A system that tracks adverse events for medications, separate from vaccines.

Because VAERS is passive, the system relies on these active networks to confirm or refute signals. In practice, a VAERS signal will prompt a study using VSD or Sentinel data, often leading to a refined understanding of risk versus benefit.

6. Practical Takeaways for the Public

1. A single VAERS report is not proof of causation.
   The CDC’s “How to interpret VAERS data” page, linked in the article, advises comparing rates in vaccinated and unvaccinated groups.

2. Seek professional guidance.
   If you suspect a vaccine‑related health issue, discuss it with your healthcare provider before jumping to conclusions.

3. Use reputable sources.
   The CDC’s VAERS website and the Vaccine Adverse Event Reporting System database remain the most authoritative public resources.
   The Time article warns against echo chambers where raw data are taken out of context.

4. Trust the science, not the headlines.
   The article makes a compelling point that the headline “More VAERS reports after COVID‑19 vaccination” should not be conflated with a public health crisis; instead, it is a routine part of vaccine monitoring.

7. Closing Reflections

The Time piece is an accessible primer on VAERS, making the case that the system is an indispensable, transparent, and indispensable part of vaccine safety. By providing an honest look at its strengths and weaknesses, the article equips readers with the context needed to evaluate vaccine reports responsibly. Whether you’re a parent considering a flu shot, a student researching vaccine safety, or a policy maker shaping vaccination guidelines, understanding VAERS—and how to read its data—helps keep conversations rooted in evidence rather than fear.