Health Topic

Vaccine Safety

Vaccines protect you and your family from disease. Learn about vaccine safety in the United States. It includes a thorough process of testing and evaluating vaccines before they can be approved.

Reviewed Reviewed by a registered pharmacistGeneral information

Important: This page is general information, not medical advice. It does not recommend or prescribe any treatment. Always consult your doctor or pharmacist before starting, stopping or changing any medicine.

About Vaccine Safety

Vaccines play an important role in keeping us healthy. They protect us from serious and sometimes deadly diseases. Vaccines are injections (shots), liquids, pills, or nasal sprays that you take to teach your body's immune system to recognize and defend against harmful germs. The germs could be viruses or bacteria.

Some types of vaccines contain germs that cause disease. But the germs have been killed or weakened enough that they won't make you sick. Some vaccines only contain a part of a germ. Other types of vaccines include instructions for your cells to make a protein of the germ.

These different vaccine types all spark an immune response, which helps your body fight off the germs. Your immune system will also remember the germ and attack it if that germ ever invades again. This protection against a certain disease is called immunity.

These diseases can be very serious. Because of this, getting immunity from a vaccine is safer than getting immunity by being sick with the disease. And for a few vaccines, getting vaccinated can actually give you a better immune response than getting the disease would.

As with medicines, any vaccine can cause side effects. Most of the time the side effects are minor, such as a sore arm, fatigue, or mild fever. They usually go away within a few days. These common side effects are often a sign that your body is starting to build immunity against a disease.

Serious side effects from vaccines can happen, but they are very rare. These side effects could include a severe allergic reaction. Other possible side effects are different for each vaccine. Talk with your health care provider if you're concerned about your health after getting vaccinated.

Some people worry that childhood vaccines could cause autism spectrum disorder (ASD). But many scientific studies have looked at this and have found no link between vaccines and ASD.

Every vaccine that is approved in the United States goes through extensive safety testing. It starts with testing and evaluation of the vaccine before it's approved by the Food and Drug Administration (FDA). This process can often take several years.:

  • First, the vaccine is tested in labs. Based on those tests, the FDA decides whether to test the vaccine with people.
  • Testing with people is done through clinical trials. In these trials, the vaccines are tested on volunteers. Clinical trials usually start with 20 to 100 volunteers, but eventually include thousands of volunteers.
  • The clinical trials have three phases. The trials are looking for the answer to important questions such as Is the vaccine safe?
  • What dose (amount) works best?
  • How does the immune system react to it?
  • How effective is it?

Testing and monitoring continue after the vaccine is approved:

  • The company making the vaccines tests every batch of vaccines for quality and safety. The FDA reviews the results of these tests. It also inspects the factories where the vaccine is made. These checks help make sure the vaccines meet standards for quality and safety.
  • The FDA, CDC, and other federal agencies continue to monitor its safety, to watch for possible side effects. They have systems to track any safety issues with the vaccines.

These high safety standards and testing help to make sure that vaccines in the United States are safe. Vaccines help protect against serious, even deadly, diseases. They not only protect you, but also help to keep these diseases from spreading to others.

It sits within Infections, Immune System and Safety Issues.

When to speak to someone. Reading about a topic cannot tell you whether it applies to you. Speak to a doctor or pharmacist if symptoms are severe, sudden, getting worse, or simply not going away — and seek emergency care immediately for chest pain, breathing difficulty, sudden weakness or confusion, or a serious allergic reaction.

Research on Vaccine Safety

5,390 studies areregistered for this condition on ClinicalTrials.gov, the U.S. National Library of Medicine's public registry. A selection is below — the links go straight to the registry entry, not to a summary of ours.

What a registered study does and does not mean. Registration means a study exists and has been declared publicly. It says nothing about whether the treatment being tested works, is safe, or is available to you. Many studies find no benefit — that is what research is for. Never seek out an experimental treatment on the strength of a registry entry alone.

Research currently under way

Research already completed

Study data from ClinicalTrials.gov, a service of the U.S. National Library of Medicine. Retrieved 2026-07-30. Registry entries are supplied by study sponsors and investigators; ClinicalTrials.gov does not verify their scientific validity. PocketsInfo is not affiliated with, and not endorsed by, the NLM or the NIH.

Where to read more

Rather than paraphrase, we point you to the primary sources. Every link below is to a government health agency, a national institute or a recognised medical body — grouped by what you are trying to find out.

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Related Issues

Clinical Trials

Medical subject headings

Clinicians and researchers index this subject under Vaccines, Vaccines, Vaccines. These are the terms to use when searching medical literature.

This page is built from the MedlinePlus health topic record for Vaccine Safety, a service of the U.S. National Library of Medicine (NLM), National Institutes of Health. Information is from MedlinePlus.gov. PocketsInfo is not affiliated with, and is not endorsed by, the NLM or the NIH. Retrieved 30 July 2026.