Diphtheria, Tetanus, and Pertussis Vaccine Safety

Overview

Vaccines are available that can help prevent diphtheria, tetanus, and pertussis (whooping cough). All infants and children, adolescents, and adults should get vaccinated.

Available vaccines & manufacturer package inserts

DTaP (diphtheria, tetanus, and acellular pertussis) vaccines and package inserts

For infants and children up to 7 years of age

• The FDA approved Daptacel in 2002. It is approved for use in children who are 6 weeks through 6 years of age to protect against diphtheria, tetanus, and pertussis.
• FDA approved Infanrix in 1997. It is approved for use in children who are 6 weeks through 6 years of age to protect against diphtheria, tetanus, and pertussis.
• FDA approved Kinrix in 2008. It is approved for use in children who are 4 to 6 years of age to protect against diphtheria, tetanus, pertussis, and polio.
• FDA approved Pediarix in 2002. It is approved for use in children who are 6 weeks through 6 years of age to protect against diphtheria, tetanus, pertussis, polio, and hepatitis B.
• FDA approved Pentacel in 2008. It is approved for use in children who are 6 weeks through 4 years of age to protect against diphtheria, tetanus, pertussis, Haemophilus Influenzae type B (Hib), and polio.
• FDA approved Quadracel in 2015. It is approved for use in children who are 4 through 6 years of age to protect against diphtheria, tetanus, pertussis, and polio.
• FDA approved Vaxelis in 2018. It is approved for use in children aged 6 weeks through 4 years of age to protect against diphtheria, tetanus, pertussis, Hib, hepatitis B, and polio.

Tdap (tetanus, diphtheria, and acellular pertussis) vaccines and package inserts

For preteens, teens and adults

• FDA approved Boostrix in 2005. It is approved for use in people 10 years of age and older to protect against diphtheria, tetanus, and pertussis.
  • FDA approved the use of the Boostrix vaccine in people who are pregnant to prevent infant pertussis in 2022.
• FDA approved Adacel in 2005. It is approved for use in people 10 to 64 years of age to protect against diphtheria, tetanus, and pertussis.
  • FDA approved the use of the Adacel vaccine in people who are pregnant to prevent infant pertussis in 2023.

Td (tetanus and diphtheria) vaccines and package inserts

For preteens, teens and adults

• FDA approved TDVax, a generic vaccine, in 1967. It is approved for use in people 7 years of age and older to protect against tetanus and diphtheria.
• FDA approved Tenivac in 2003. It is approved for use in people 7 years of age and older to protect against tetanus and diphtheria.

Who should & should not get the vaccine

CDC recommends diphtheria, tetanus, and whooping cough (pertussis) vaccination for everyone.

Common side effects

DTaP

• Soreness or swelling where the shot was given.
• Fever.
• Fussiness.
• Feeling tired.
• Loss of appetite.
• Vomiting.

Most side effects are mild to moderate and can last from 1 to 3 days.

Tdap

• Pain, redness, or swelling where the shot was given.
• Mild fever.
• Headache.
• Feeling tired.
• Nausea, vomiting, diarrhea, stomachache.

Td

• Pain, redness, or swelling where the shot was given.
• Mild fever.
• Headache.
• Feeling tired.
• Nauseas, vomiting, diarrhea, or stomachache.

DTaP and Tdap vaccine are safe and effective at preventing diphtheria, tetanus, and pertussis. Vaccines, like any medicine, can have side effects. The most common side effects are usually mild and go away on their own.

A closer look at the safety data

DTaP

• DTaP safety reviews of VAERS reports found no unexpected health concerns related to the vaccine.
  • Several studies of DTaP vaccine safety have looked for neurologic problems or seizures after children were vaccinated and found that there is no increased risk for these concerns with the DTaP vaccine.
  • There is a small increased risk for febrile seizures when inactivated influenza vaccine (flu shot) is given during the same doctor's visit as a DTaP vaccine.
• DTaP may cause mild injection site reactions. However, severe injection site reactions are rare, and may be less frequent when the vaccine is injected into the leg rather than into the arm. Reactions happen about as often when DTaP is combined with other vaccines.

Tdap

• Tdap safety reviews of VAERS reports have found no unexpected safety concerns for the general population, for people who are pregnant, or for adults over age 65.
• In the Vaccine Safety Datalink (VSD), studies have found no association between Tdap vaccination and Guillain-Barré Syndrome or other neurologic disorders. Other studies have found that there is no increased risk for other types of health problems, such as allergies, blood disorders, and chronic illnesses.
• Although injection site reactions are common, studies have found a low rate of severe injection site reactions. These local reactions are unusual even when the vaccine is given at the same time as Menactra, a meningococcal vaccine, or when a person receives several doses of Tdap vaccine over a short time period.

How CDC monitors vaccine safety

CDC and the Food and Drug Administration (FDA) are committed to ensuring that vaccines provided to the public are safe and effective. Once vaccines are licensed or authorized for emergency use in the United States, CDC and FDA continuously monitor them through several safety systems.

Resources