science

Vaccine Information Statement

Vaccine Information Statement is a science 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 Information Statement rather than just read about it. In short: A Vaccine Information Statement (VIS) is a document designed by the Centers for Disease Control and Prevention (CDC) to provide information to a patient receiving a vaccine in the United States. The National Childhood Vaccine Injury Act requires that medical professionals provide a VIS to patients before receiving certain vaccinations.

Key takeaways

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

Reference excerpt

A Vaccine Information Statement (VIS) is a document designed by the Centers for Disease Control and Prevention (CDC) to provide information to a patient receiving a vaccine in the United States. The National Childhood Vaccine Injury Act requires that medical professionals provide a VIS to patients before receiving certain vaccinations. The VIS includes information about the vaccine's benefits and risks, a description of the vaccine, indications and contraindications, instructions for patients experiencing an adverse reaction, and additional resources.

History In the 1974 case of Reyes v. Wyeth Laboratories, the US Fifth Circuit Court of Appeals decided that vaccine manufacturers were responsible for warning patients of the risks associated with their vaccine. This created concern among manufacturers, since they were reliant on the healthcare professionals administering their vaccines to convey these risks, and the companies could be liable for mistakes made by healthcare providers. Consequently, vaccine prices increased to cover the costs of litigation. In response, the CDC added "duty to warn" clauses in their contracts, which required either the individualized judgement of a physician or "meaningful warnings related to the risks and benefits of vaccination" for all publicly purchased vaccines. This gave way to an early version of the VIS known as the "Important Information Statement" (IIS), the first of which was developed for "Swine and Victoria Influenza" vaccine in 1976. Over the following decade, more than 50 IISs were created for various vaccines. An increase in vaccine-related lawsuits and fear of manufacturers withdrawing vaccines from the market led to the 1986 National Childhood Vaccine Injury Act (NCVIA). The act established the National Vaccine Injury Compensation Program (VICP) and the Vaccine Adverse Event Reporting System (VAERS) to take liability for adverse reactions off vaccine manufacturers. The act also required the development of written information about all vaccines included in the VICP, which were primarily routine childhood vaccinations. The act required that all patients, or their parents/legal representatives, be given this information before vaccination. The secretary of the Department of Health and Human Services gave the responsibility of developing these materials to the CDC. By 1991, the CDC developed four 12-page "Vaccine Information Pamphlets" (VIPs) for DTP, MMR, polio, and tetanus-diphtheria (Td) vaccines. These pamphlets fulfilled the requirements of the NCVIA, but were criticized for their length and the amount of time they took to develop. Concerns were raised that patients could not read the entire forms during their visit, and could be less informed due to a less thorough review of the information. A 1993 amendment to the NCVIA simplified the requirements for the document and simplified the process through which it was created. It removed the requirement for a public hearing in the development of the document and reduced the time period for public comment to 60 days. The simplified requirements led to the single sheet (two-sided) Vaccine Information Statements (VISs) that are still used. By 1997 VISs were available for all vaccines that required them under NCVIA and the CDC began creating VISs for additional vaccines. In 2008, the Pediatric Multi-Vaccine VIS was developed, which included information on the vaccines for diphtheria, tetanus, and pertussis(DTaP), polio, hepatitis B, pneumococcal conjugate, and Haemophilus influenzae type B (Hib). This allows caregivers to read one document during their visit instead of an individual document for each vaccine. In 2013, a "provider information document" was developed to include information that was relevant to medical providers but not to patients, reducing the need to frequently update VISs. By 2016, the provider information was made available through a links to the CDC website. VISs are now available on the CDC website and can be provided in hard copies or electronically. The Immunization Action Coalition (IAC), a partner organization to the CDC, also provides translations of VISs in over 40 languages.

Contents

According to the 1993 amended National Childhood Vaccine Injury Act (NCVIA), a VIS must contain at least the following four components: (1) a description of the benefits of the given vaccine, (2) a description of its risks, (3) information about the National Vaccine Injury Compensation Program (VICP), and (4) other relevant information as determined by the Secretary of Health and Human Services. Current VISs typically include the following sections:

"Why get vaccinated?" - This section includes a description of the benefits of the vaccine and the risks of the illness that it protects from. "[Name of vaccine]" - This section is a description of the specific vaccine, including information about who it's recommended for, its administration, the number and timing of doses, and any other pertinent information. "Talk with your health care provider" - This section includes factors that may affect someone's decision to receive the given vaccine. It includes information about allergies, illnesses, or other contraindications that may increase the risks associated with the vaccine. The section recommends a discussion with the patient's health care provider over any concerns. "Risks of a vaccine reaction" - This section includes potential side effects and adverse reactions. "What if there is a serious problem?" - This section contains instructions for patients experiencing an adverse reaction. It includes instructions to contact either their health care provider or 9-1-1, depending on the level of severity, and contact information for the Vaccine Adverse Event Reporting System (VAERS). "The National Vaccine Injury Compensation Program" - This section is only included in VISs for vaccines covered by the VICP, as set forth in the NCVIA. It includes the website and phone number for the VICP. "How can I learn more?" - This section includes additional resources and contact information for the CDC. The Multi-Vaccine VIS (DTaP, Hib, hepatitis B, polio, and pneumococcal conjugate) includes the same sections listed above, with sub-headings in the first four sections for each of the vaccines included, as needed.

… excerpt ends here. Continue reading the full article.

Worked examples

Example 1 — a first encounter with Vaccine Information Statement

Start with the simplest possible case. Write down what Vaccine Information Statement claims or describes in one sentence, then invent the smallest concrete situation in which that sentence is true. In science, 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 Information Statement 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 Information Statement 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 Information Statement

In research: Vaccine Information Statement appears in science 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 Information Statement 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 Information Statement is common in secondary-school and first-year university syllabi. It links to neighbouring topics 1986 in American law, Drug safety, Federal sovereign immunity in the United States, so understanding it makes those chapters shorter.
In everyday life: Look for Vaccine Information Statement 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 Information Statement in 20 minutes

Read the reference excerpt below once, without taking notes.
Close the page and write down what Vaccine Information Statement 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 Information Statement out loud to somebody else — or to Teacher Smith in the lgStudy chat.

Frequently asked questions

What is Vaccine Information Statement in simple terms?

Why does Vaccine Information Statement matter?

Because it connects several science 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 Information Statement?

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 Information Statement.