biology

Vaccine Adverse Event Reporting System

Vaccine Adverse Event Reporting System is a biology topic covered in the lgStudy science library. This page brings together a partial reference excerpt, illustrations, worked examples, real-world applications and a short study plan, so you can understand Vaccine Adverse Event Reporting System rather than just read about it. In short: The Vaccine Adverse Event Reporting System (VAERS) is a United States program for vaccine safety, co-managed by the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA).

Key takeaways

Vaccine Adverse Event Reporting System belongs to biology; place it in that map before memorising details.
Learn the definition first, then one example that makes the definition concrete.
Connect Vaccine Adverse Event Reporting System to a quantity you can measure, compute or draw — that is where exam questions come from.
Reproduce the core statement of Vaccine Adverse Event Reporting System from memory before moving on to harder problems.

Reference excerpt

The Vaccine Adverse Event Reporting System (VAERS) is a United States program for vaccine safety, co-managed by the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS is a postmarketing surveillance program, collecting information about adverse events (possible harmful side effects) that occur after administration of vaccines to ascertain whether the risk–benefit ratio is high enough to justify continued use of any particular vaccine. VAERS, the Vaccine Safety Datalink, and the Clinical Immunization Safety Assessment (CISA) Network are tools by which the CDC and FDA monitor vaccine safety to fulfill their duty as regulatory agencies charged with protecting the public. As it is based on submissions by the public, VAERS is susceptible to unverified reports, misattribution, underreporting, and inconsistent data quality. Raw, unverified data from VAERS has often been used by the anti-vaccine community to justify misinformation regarding the safety of vaccines; it is generally not possible to determine from VAERS data if a vaccine caused an adverse event, or how common the event might be.

Origins The program is an outgrowth of the 1986 National Childhood Vaccine Injury Act (NCVIA), which requires health care providers to report:

Any event listed by the vaccine manufacturer as a contraindication to subsequent doses of the vaccine. Any event listed in the Reportable Events Table that occurs within the specified time period after vaccination. The data are stored electronically by the CDC in the Vaccine Safety Datalink (VSD). VAERS was established in 1990 and is managed jointly by the FDA and the CDC. It is meant to act as a sort of "early warning system"—a way for physicians and researchers to identify possible unforeseen reactions or side effects of vaccination for further study.

Operation Higher-priority uses of the data include reports of death and other serious adverse events, recognizing and detecting adverse effects, and finding unexpected adverse events involving new vaccines. The VAERS data are also used to monitor known reactions to vaccines and for vaccine lot surveillance. Data mining techniques such as empirical Bayes methods can be used to improve the quality of data analysis. The system was used in 1999 to identify a rotavirus vaccine that had an increased risk of a bowel obstruction condition, and confirmatory research led to the vaccine's use being suspended.

Use in research and litigation Many medical researchers make use of VAERS to study the effects of vaccination. VAERS warns researchers using its database that the data should not be used in isolation to draw conclusions about cause and effect. Nonetheless, raw data from VAERS has been used in vaccine litigation to support the claim that vaccines cause autism. Litigation related to vaccines and autism has led to an increase in VAERS reports filed by plaintiff's attorneys. A 2006 article in Pediatrics found that most VAERS reports related to thimerosal, and many related to autism, were filed in connection with litigation, leading the authors to caution that inappropriate reliance on VAERS data may be a source of bias. The study's lead author stated: "Lawyers are manipulating this system to show increases [in vaccine-related adverse events] that are based on litigation, not health research." Paul Offit, chief of infectious disease at Children's Hospital of Philadelphia, wrote:

Public health officials were disappointed to learn that reports of autism to VAERS weren't coming from parents, doctors, nurses, or nurse practitioners; they were coming from personal-injury lawyers ... For the lawyers, VAERS reports hadn't been a self-fulfilling prophecy; they'd been a self-generated prophecy.

Limitations and abuse Like other spontaneous reporting systems, VAERS has several limitations, including underreporting, unverified reports, inconsistent data quality, and inadequate data about the number of people vaccinated. Due to the program's open and accessible design and its allowance of unverified reports, incomplete VAERS data is often used in false claims regarding vaccine safety. The Centers for Disease Control and Prevention (CDC) has warned that raw data from VAERS is not enough to determine whether a vaccine can cause a particular adverse event. For instance, noted anesthesiologist Jim Laidler once reported to VAERS that a vaccine had turned him into The Incredible Hulk. The report was accepted and entered into the database, but the dubious nature of the report prompted a VAERS representative to contact Laidler, who then gave his consent to delete it from the database. During the COVID-19 pandemic, raw VAERS data has often been disseminated by anti-vaccine groups in order to justify inaccurate safety claims related to COVID-19 vaccines, including adverse reactions and alleged fatalities claimed to have been caused by vaccines. Websites such as Medalerts (published by the anti-vaccine group National Vaccine Information Center) and OpenVAERS (which published a tally of vaccine adverse events and fatalities allegedly linked to COVID-19 vaccines based on VAERS data), have been linked to this misinformation. Comparative studies of VAERS, which look at relative reporting rates, have found that the data does not support these claims.

See also FDA Adverse Event Reporting System (FAERS) VigiBase (WHO) Yellow Card Scheme (UK reporting system)

References

External links vaers.hhs.gov – Vaccine Adverse Event Reporting System (official website). This also contains instructions for downloading the VAERS data. Vaccine Adverse Event Report System (VAERS) Overview, FDA VAERS request for searching the database Galindo, Belkys M., et al."Vaccine-Related Adverse Events in Cuban Children", 1999–2008. MEDICC Review. 2012;14(1):38–43.

Worked examples

Example 1 — a first encounter with Vaccine Adverse Event Reporting System

Start with the simplest possible case. Write down what Vaccine Adverse Event Reporting System claims or describes in one sentence, then invent the smallest concrete situation in which that sentence is true. In biology, the smallest case is usually a single object, a single equation or a single measurement. Check that every symbol or term in your sentence has a meaning in that case.

Example 2 — changing one variable

Take the situation from Example 1 and change exactly one quantity: double it, halve it, or set it to zero. Predict what should happen to Vaccine Adverse Event Reporting System before you calculate. Comparing your prediction with the result is the fastest way to find out whether you understand the idea or only the words.

Example 3 — an exam-style question

Typical questions about Vaccine Adverse Event Reporting System ask you to (a) state it precisely, (b) apply it to given data, and (c) explain a limitation. Practise writing all three answers in under five minutes; the third part is what separates a full-mark answer from an average one.

Applications of Vaccine Adverse Event Reporting System

In research: Vaccine Adverse Event Reporting System appears in biology research whenever the underlying quantities have to be modelled precisely. Papers usually cite it as a starting assumption and then explore where it breaks down.
In technology and industry: Engineering practice reuses Vaccine Adverse Event Reporting System in design rules, simulations and safety margins. Knowing the idea lets you read a specification sheet and understand why the numbers look the way they do.
In the classroom: Vaccine Adverse Event Reporting System is common in secondary-school and first-year university syllabi. It links to neighbouring topics Centers for Disease Control and Prevention, Drug safety, Food and Drug Administration, so understanding it makes those chapters shorter.
In everyday life: Look for Vaccine Adverse Event Reporting System outside the textbook — in sport, cooking, traffic, electronics or the sky above you. An example you found yourself is remembered far longer than one you were given.

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How to study Vaccine Adverse Event Reporting System in 20 minutes

Read the reference excerpt below once, without taking notes.
Close the page and write down what Vaccine Adverse Event Reporting System means in your own words.
Compare your version with the excerpt and mark what you missed.
Work through the three examples above with pen and paper.
Explain Vaccine Adverse Event Reporting System out loud to somebody else — or to Teacher Smith in the lgStudy chat.

Frequently asked questions

What is Vaccine Adverse Event Reporting System in simple terms?

Why does Vaccine Adverse Event Reporting System matter?

Because it connects several biology ideas at once: it gives you a definition you can apply, a quantity you can calculate, and a way to check whether a result is plausible.

How should I study Vaccine Adverse Event Reporting System?

Read the excerpt, restate it from memory, then work through the examples and applications listed on this page. The five-step study plan above takes about twenty minutes.

What does this page cover?

It gives you a compact reference excerpt plus original lgStudy explanations, examples, applications and study material on Vaccine Adverse Event Reporting System.