Pneumococcal conjugate vaccine (PCV13) - What you need to know

All content below is taken in its entirety from the CDC Information Statement (VIS): www.cdc.gov/vaccines/hcp/vis/vis-statements/pcv13.html

CDC review information for Pneumococcal Conjugate VIS:

• Page last reviewed: November 10, 2015
• Page last updated: November 10, 2015
• Issue date of VIS: November 5, 2015

Content source: National Center for Immunization and Respiratory Diseases

Information

1. Why get vaccinated?

Vaccination can protect both children and adults from pneumococcal disease.

Pneumococcal disease is caused by bacteria that can spread from person to person through close contact. It can cause ear infections, and it can also lead to more serious infections of the:

• Lungs (pneumonia),
• Blood (bacteremia), and
• Covering of the brain and spinal cord (meningitis).

Pneumococcal pneumonia is most common among adults. Pneumococcal meningitis can cause deafness and brain damage, and it kills about 1 child in 10 who get it.

Anyone can get pneumococcal disease, but children under 2 years of age and adults 65 years and older, people with certain medical conditions, and cigarette smokers are at the highest risk.

Before there was a vaccine, the United States saw:

• more than 700 cases of meningitis,
• about 13,000 blood infections,
• about 5 million ear infections, and
• about 200 deaths

in children under 5 each year from pneumococcal disease. Since vaccine became available, severe pneumococcal disease in these children has fallen by 88%.

About 18,000 older adults die of pneumococcal disease each year in the United States.

Treatment of pneumococcal infections with penicillin and other drugs is not as effective as it used to be, because some strains of the disease have become resistant to these drugs. This makes prevention of the disease, through vaccination, even more important.

2. PCV13 vaccine

Pneumococcal conjugate vaccine (called PCV13) protects against 13 types of pneumococcal bacteria.

PCV13 is routinely given to children at 2, 4, 6, and 12 to 15 months of age. It is also recommended for children and adults 2 to 64 years of age with certain health conditions, and for all adults 65 years of age and older. Your doctor can give you details.

3. Some people should not get this vaccine

Anyone who has ever had a life-threatening allergic reaction to a dose of this vaccine, to an earlier pneumococcal vaccine called PCV7, or to any vaccine containing diphtheria toxoid (for example, DTaP), should not get PCV13.

Anyone with a severe allergy to any component of PCV13 should not get the vaccine. Tell your doctor if the person being vaccinated has any severe allergies.

If the person scheduled for vaccination is not feeling well, your healthcare provider might decide to reschedule the shot on another day.

4. Risks of a vaccine reaction

With any medicine, including vaccines, there is a chance of reactions. These are usually mild and go away on their own, but serious reactions are also possible.

Problems reported following PCV13 varied by age and dose in the series. The most common problems reported among children were:

• About half became drowsy after the shot, had a temporary loss of appetite, or had redness or tenderness where the shot was given.
• About 1 out of 3 had swelling where the shot was given.
• About 1 out of 3 had a mild fever, and about 1 in 20 had a fever over 102.2°F.
• Up to about 8 out of 10 became fussy or irritable.

Adults have reported pain, redness, and swelling where the shot was given; also mild fever, fatigue, headache, chills, or muscle pain.

Young children who get PCV13 along with inactivated flu vaccine at the same time may be at increased risk for seizures caused by fever. Ask your doctor for more information.

Problems that could happen after any vaccine:

• People sometimes faint after a medical procedure, including vaccination. Sitting or lying down for about 15 minutes can help prevent fainting, and injuries caused by a fall. Tell your doctor if you feel dizzy, or have vision changes or ringing in the ears.
• Some older children and adults get severe pain in the shoulder and have difficulty moving the arm where a shot was given. This happens very rarely.
• Any medication can cause a severe allergic reaction. Such reactions from a vaccine are very rare, estimated at about 1 in a million doses, and would happen within a few minutes to a few hours after the vaccination.

As with any medicine, there is a very small chance of a vaccine causing a serious injury or death.

The safety of vaccines is always being monitored. For more information, visit: www.cdc.gov/vaccinesafety

5. What if there is a serious reaction?

What should I look for?

Look for anything that concerns you, such as signs of a severe allergic reaction, very high fever, or unusual behavior.

Signs of a severe allergic reaction can include hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, and weakness - usually within a few minutes to a few hours after the vaccination.

What should I do?

If you think it is a severe allergic reaction or other emergency that can't wait, call 9-1-1 or get the person to the nearest hospital. Otherwise, call your doctor.

Reactions should be reported to the Vaccine Adverse Event Reporting System (VAERS). Your doctor should file this report, or you can do it yourself through the VAERS web site at www.vaers.hhs.gov , or by calling 1-800-822-7967 .

VAERS does not give medical advice.

6. The National Vaccine Injury Compensation Program

The National Vaccine Injury Compensation Program (VICP) is a federal program that was created to compensate people who may have been injured by certain vaccines.

Persons who believe they may have been injured by a vaccine can learn about the program and about filing a claim by calling 1-800-338-2382 or visiting the VICP website at www.hrsa.gov/vaccinecompensation . There is a time limit to file a claim for compensation.

7. How can I learn more?

• Ask your healthcare provider. He or she can give you the vaccine package insert or suggest other sources of information.
• Contact your local or state health department.
• Contact the Centers for Disease Control and Prevention (CDC):
  • Call 1-800-232-4636 (1-800-CDC-INFO)
  • Visit CDC's website at www.cdc.gov/vaccines