Pentacel (as a combination product containing Diphtheria, Tetanus Toxoids, Acellular Pertussis, Haemophilus influenzae type b, Polio Vaccine)

Name: Pentacel (as a combination product containing Diphtheria, Tetanus Toxoids, Acellular Pertussis, Haemophilus influenzae type b, Polio Vaccine)

Who should not get Hib vaccine or should wait?

Hib vaccine should not be given to infants younger than 6 weeks of age.

A person who has ever had a life-threatening allergic reaction after a previous dose of Hib vaccine, OR has a severe allergy to any part of this vaccine, should not get Hib vaccine. Tell the person giving the vaccine about any severe allergies.

People who are mildly ill can get Hib vaccine. People who are moderately or severely ill should probably wait until they recover. Talk to your healthcare provider if the person getting the vaccine isn't feeling well on the day the shot is scheduled.

What are the risks of a vaccine reaction?

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

Most people who get Hib vaccine do not have any problems with it.

Mild problems following Hib vaccine

  • redness, warmth, or swelling where the shot was given
  • fever

These problems are uncommon. If they occur, they usually begin soon after the shot and last 2 or 3 days.

Problems that could happen after any vaccine

Any medication can cause a severe allergic reaction. Such reactions from a vaccine are very rare, estimated at fewer than 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 remote chance of a vaccine causing a serious injury or death.

Older children, adolescents, and adults might also experience these problems 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 people get severe pain in the shoulder and have difficulty moving the arm where a shot was given. This happens very rarely.

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

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. These would usually start 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 and get the person to the nearest hospital. Otherwise, call your doctor.
  • Afterward, the reaction should be reported to the Vaccine Adverse Event Reporting System (VAERS). Your doctor might file this report, or you can do it yourself through the VAERS web site at http://www.vaers.hhs.gov, or by calling 1-800-822-7967.

VAERS does not give medical advice.

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 http://www.hrsa.gov/vaccinecompensation. There is a time limit to file a claim for compensation.

Brand names

  • ActHIB®
  • Hiberix®
  • Liquid Pedvax HIB®

Brand names of combination products

  • Comvax® (containing Haemophilus influenzae type b, Hepatitis B)
  • MenHibrix® (containing Haemophilus influenzae type b, Meningococcal Vaccine)
  • Pentacel® (containing Diphtheria, Tetanus Toxoids, Acellular Pertussis, Haemophilus influenzae type b, Polio Vaccine)

What are the risks from DTaP vaccine?

Getting diphtheria, tetanus, or pertussis disease is much riskier than getting DTaP vaccine.

However, a vaccine, like any medicine, is capable of causing serious problems, such as severe allergic reactions. The risk of DTaP vaccine causing serious harm, or death, is extremely small.

  • Fever (up to about 1 child in 4)
  • Redness or swelling where the shot was given (up to about 1 child in 4)
  • Soreness or tenderness where the shot was given (up to about 1 child in 4)
  • These problems occur more often after the 4th and 5th doses of the DTaP series than after earlier doses. Sometimes the 4th or 5th dose of DTaP vaccine is followed by swelling of the entire arm or leg in which the shot was given, lasting 1 to 7 days (up to about 1 child in 30).
  • Other mild problems include: fussiness (up to about 1 child in 3), tiredness or poor appetite (up to about 1 child in 10), vomiting (up to about 1 child in 50).
  • Seizure (jerking or staring) (about 1 child out of 14,000)
  • Non-stop crying, for 3 hours or more (up to about 1 child out of 1,000)
  • High fever, over 105°F (about 1 child out of 16,000)
  • Serious allergic reaction (less than 1 out of a million doses)
  • Several other severe problems have been reported after DTaP vaccine. These include: long-term seizures, coma, or lowered consciousness; permanent brain damage. These are so rare it is hard to tell if they are caused by the vaccine.

Controlling fever is especially important for children who have had seizures, for any reason. It is also important if another family member has had seizures. You can reduce fever and pain by giving your child an aspirin-free pain reliever (such as acetaminophen) when the shot is given, and for the next 24 hours, following the package instructions.

Other names

  • DTaP
  • DTaP-HepB-IPV
  • DTaP-IPV
  • DTaP-IPV/Hib
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