Vaccines are essential to getting children off to a healthy start in life and keeping them healthy as they grow up.
Because immunization programs of the 20th and 21st centuries have been so successful, many parents today have never seen the many vaccine-preventable diseases that were once common. They may not realize that those infectious diseases could reemerge. If individuals choose not to vaccinate themselves or their children, some diseases that are now rare or nonexistent in the U.S. may resurface.
Infectious diseases that used to be common in children in the U.S. – including polio, diphtheria, pertussis (whooping cough), rubella (German measles), and chickenpox – are preventable with vaccines approved by the U.S. Food and Drug Administration. Vaccines can prevent contagious diseases that once killed or harmed many infants, children, and adults. The FDA ensures that the vaccines that we approve or authorize for emergency use in the U.S. meet our safety and effectiveness standards.
From babies to teenagers, people need vaccines throughout childhood to protect them from potentially dangerous infectious diseases. Without vaccines, children would be at risk for serious illness and even disability, or death, from diseases such as meningitis due to Haemophilus influenzae type b (Hib), measles, and whooping cough, among others.
A vaccine is a medical product. Like any medicine, vaccines can cause side effects, but most are minor and short-lived, such as a low-grade fever, or pain and redness at the injection site.
Severe, long-lasting side effects of vaccines are rare.
The risk of being harmed by vaccines is much smaller than the risk of serious illness from the diseases they prevent. Ensuring the safety and effectiveness of vaccines is one of the FDA’s top priorities.
The FDA ensures that the vaccines we approve or authorize have undergone a rigorous and extensive development program. This includes studies conducted by the manufacturers to show that the vaccines meet FDA standards for safety and effectiveness in the target population. The FDA has extensive expertise in clinical trial design and methods, and manufacturers conduct clinical trials according to plans that have been evaluated by the FDA. The FDA approves or authorizes a vaccine only if it determines that the vaccine’s benefits outweigh its risks.
If you have questions about vaccines, visit the FDA’s guide for parents and caregivers. It describes in more detail the routinely administered vaccines for children and provides answers to commonly asked questions. Also, a health care provider is the best resource for information about vaccines.
In the meantime, here are some tips to keep in mind when your child is vaccinated.
Review the vaccine information sheets.
These sheets explain both the benefits and risks of a vaccine. The health care provider administering the vaccine is required by law to provide them to you.
Talk to a health care provider about the benefits and risks of vaccines.
Learn the facts about the benefits and risks of vaccines, along with the potential consequences of not vaccinating against diseases. Some people are surprised to learn that children can be harmed by or even die of measles, diphtheria, whooping cough, and other infectious diseases that can be prevented by vaccines.
Before vaccination, tell the health care provider about certain conditions and allergies.
The health care provider administering the vaccine should be informed if your child is sick, or if they have a history of certain allergic or other bad side effects to previous vaccinations or their components. For example, eggs are used to produce some influenza (flu) vaccines. Tell the health care provider if your child has a severe allergy to eggs.
Some vaccines are supplied in vials or prefilled syringes that may contain natural rubber latex, which can cause allergic reactions in people who are sensitive to latex. Let the health care provider know about an allergy to latex.
It is also important to discuss with the health care provider which vaccines should or should not be given to children who have a weakened immune system.
Report problems and side effects.
Vaccines are very safe, and severe side effects are rare. But if you have any concerns after receiving a vaccine, contact a health care provider.
The FDA also closely monitors the safety of vaccines after they are approved. One way we accomplish this is by collecting reports of possible side effects (also known as adverse events). Side effects should be reported to the Vaccine Adverse Event Reporting System (VAERS). This is a national vaccine safety surveillance program co-monitored by the FDA and the Centers for Disease Control and Prevention (CDC).
VAERS is a system to detect possible safety problems with vaccines approved or authorized in the U.S. VAERS encourages you to report any medically important adverse event occurring after the administration of vaccines. An adverse event can be reported even if it is uncertain or unlikely that the vaccine caused it. A health care provider can file this report, or you can do it yourself.
VAERS does not give medical advice. Reporting to VAERS is unlikely to answer the question of why an individual experienced an adverse event after vaccination, or whether the vaccine caused the adverse event. But it helps FDA doctors and scientists identify potential safety concerns promptly for further study. If it is determined that additional studies are needed, the results of the studies help the FDA assess if the vaccine causes the adverse event. The FDA and CDC do not contact every individual who reports an adverse event to VAERS, but some individuals may be contacted if follow-up information is needed.
Visit the VAERS website at www.vaers.hhs.gov to report possible side effects or other problems related to vaccines. You can report a problem online, download a form, or call 1-800-822-7967 for more information.