VACCINE SAFETY
Information for Health Care Providers

Providers Play an Important Role in Vaccine Safety
The United States currently has the safest, most effective vaccines in its history. Federal regulations require that vaccines undergo years of testing before they can be licensed. Once in use, vaccines are monitored continually for safety and efficacy. As an immunization provider, you play a key role in helping to ensure the safety and efficacy of vaccines through proper vaccine storage and handling, vaccine administration, timing and spacing of vaccine doses, observation of precautions and  contraindications, management of vaccine side effects, reporting of suspected side effects, and communication about vaccine benefits and risks.

Vaccine Storage, Handling and Administration
To achieve the best possible results from vaccines, carefully follow recommendations for storage, handling, and administration found in each vaccine’s package insert. Here are other steps you can take to help ensure vaccine safety: 
* Inspect vaccines upon delivery and monitor refrigerator and freezer temperatures to assure maintenance of the cold chain.
* Rotate vaccine stock so the oldest vaccines are used first.
* Never administer a vaccine later than the expiration date.
* Administer vaccines within the prescribed time periods following reconstitution.
* Wait to draw vaccines into syringes until immediately prior to administration.
* Never mix vaccines in the same syringe unless they are specifically approved for mixing by the Food and Drug Administration (FDA).
* Record vaccine and administration information, including lot numbers and injection sites, in the patient's record.
* If errors in vaccine storage and administration occur, take corrective action immediately to prevent them from happening again and notify public health authorities.

Timing and Spacing
The timing and spacing of vaccine doses are two of the most important issues in the appropriate use of vaccines. To ensure optimal results from each immunization, follow the currently recommended immunization schedules for children, adolescents and adults. The recommended childhood immunization schedule and influenza immunization recommendations are updated each year and can be found at http://www.cdc.gov/nip
These points also should be remembered: 
* Administering all needed vaccines during the same visit is important because it increases the likelihood that children and adults will be fully immunized as recommended. Studies have shown that vaccines are as effective given simultaneously as they are individually, and carry no greater risk for adverse side effects.
* There is no medical basis for giving combination vaccines separately. Administration of separated combination vaccines results in more discomfort. 
* Some vaccines, like pediatric diphtheria and tetanus, produce increased rates of mild side effects when given too frequently. Good record keeping, maintaining careful patient histories, and adherence to recommended schedules can decrease the chances that patients receive extra doses of vaccines.

Observe Valid Contraindications.
Contraindications and precautions to vaccination indicate when vaccines should not be given. A contraindication is a condition in a patient that increases the chance of a serious, adverse reaction. In general, a vaccine should not be administered when a contraindication is present. A precaution is a condition in a patient that may increase the chance of a serious side effect or render the vaccine ineffective. Normally, vaccination is deferred when a precaution is present. However, situations may arise when the benefits of vaccination outweigh the risk of a side effect, and the provider may decide to vaccinate the patient. Most contraindications and precautions are temporary and the vaccine may be given at a later time. The Centers for Disease Control and Prevention’s (CDC) Guide to Contraindications to Childhood Vaccinations can be obtained on-line at www.cdc.gov/nip
One key to preventing serious adverse reactions to vaccines is screening for contraindications and precautions. Every provider who administers vaccines should screen every patient before giving a vaccine dose. Sample screening questionnaires are available from the Immunization Action Coalition at www.immunize.org
Many conditions are often inappropriately regarded as contraindications to vaccination. In most cases, the following are contraindications:
* Mild acute illness (e.g., diarrhea and minor upper respiratory tract illnesses, including otitis media) with or without low grade fever
* Mild to moderate local reactions and/or low grade or moderate fever following a prior dose of the vaccine
* Current antimicrobial therapy
* Convalescent phase of illness
* Recent exposure to an infectious disease
* Premature birth
* Breastfeeding

Be Prepared to Manage Vaccine Side Effects
Most people experience no side effects, or only mild ones, following immunization. Mild side effects may include soreness, swelling, or redness at the injection site, or mild fever. Severe side effects, such as severe allergic reactions, following vaccination are extremely rare. However, any provider who administers vaccines should have procedures in place for the emergency care of a person who experiences an anaphylactic reaction. Epinephrine and equipment for maintaining an airway should be available for immediate use. All vaccine providers should be familiar with the office emergency plan and should be certified in cardiopulmonary resuscitation.

Communicate About Vaccine Benefits and Risks
While you can do a number of things to help make vaccines as safe and effective as possible, providing patients or parents/guardians with information about vaccines and immunization is equally important.
Before you administer each dose of certain vaccines, you are required by law to provide a copy of the most current Vaccine Information Statement (VIS) to either the adult vaccinee or to the child’s parent/legal guardian. VIS are developed by the CDC and discuss the benefits and risks associated with specific vaccines. You must also record in the patient’s chart the date that the VIS was given and the publication date of the VIS. Current VIS are available at www.cdc.gov/nip. Translations in over 20 languages are available at www.immunize.org
Materials such as brochures, videos and resource kits can assist you in communicating with patients or parents about vaccine benefits and risks. Visit www.cdc.gov/nip for more information about communication resources.
Finally, parents can be referred to credible Internet and hotline resources including:
	CDC's National Immunization Information Hotline:
	ENGLISH: 1-800-232-2522  ESPAÑOL: 1-800-232-0233
	CDC's National Immunization Program web site: www.cdc.gov/nip

Report Suspected Side Effects to VAERS
The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety monitoring program. VAERS collects information about adverse events (possible side effects) that occur after administration of U.S. licensed vaccines.

The National Childhood Vaccine Injury Act requires health care providers to report selected events occurring after vaccination to VAERS. However, VAERS encourages reporting of any clinically significant adverse event that occurs after administration of any vaccine licensed in the United States, even if it is not certain that the vaccine caused the event. 

By reporting possible vaccine side effects to VAERS, you provide valuable information that is needed for the ongoing evaluation of vaccine safety. The CDC and FDA use VAERS information to ensure the safest strategies of vaccine use and to further reduce the rare risks associated with vaccines.

More information about VAERS, including reporting forms, can be obtained from: VAERS info line:  800-822-7967 and the VAERS website:  www.vaers.org

For more information about the topics covered in this brochure, see the General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP) at www.cdc.gov/nip