Pentacel Side Effects

Generic name: diphtheria toxoid / haemophilus b conjugate (prp-t) vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid

Medically reviewed by Drugs.com. Last updated on Sep 13, 2024.

Note: This document provides detailed information about Pentacel.

Applies to diphtheria toxoid / haemophilus b conjugate (prp-t) vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid: intramuscular powder for suspension, intramuscular suspension Side Effects associated with diphtheria toxoid / haemophilus b conjugate (prp-t) vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid. Some dosage forms listed on this page may not apply specifically to the brand name Pentacel.

Applies to diphtheria toxoid / haemophilus b conjugate (prp-t) vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid: intramuscular powder for suspension, intramuscular suspension.

Precautions

It is very important that you call the doctor right away if you or your child have any unwanted effects after receiving the vaccine. This may include fainting, seizures, a high fever, crying that will not stop, or severe redness or swelling where the shot was given.

This vaccine may cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, swelling of the tongue and throat, or trouble breathing after you get the injection.

Tell your child’s doctor about all other vaccines your child has had, especially if those vaccines were part of a series. This vaccine might be used to finish a series of vaccines.

This vaccine will not treat an active infection. If your child has an infection due to diphtheria, tetanus, pertussis, polio, or Haemophilus influenzae type b, your child will need medicines to treat these infections. .

Fainting may occur after you receive this vaccine. You may also have vision changes, numbness or tingling in your arms, hands, or feet, or jerky movements of the arms and legs. Call the doctor right away if you or your child have any of these symptoms.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Pentacel

Along with its needed effects, diphtheria toxoid/haemophilus b conjugate (prp-t) vaccine/pertussis, acellular/poliovirus vaccine, inactivated/tetanus toxoid may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking diphtheria toxoid / haemophilus b conjugate (prp-t) vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid:

Other side effects of Pentacel

Some side effects of diphtheria toxoid / haemophilus b conjugate (prp-t) vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to diphtheria toxoid / haemophilus b conjugate (prp-t) vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid: intramuscular kit.

Psychiatric adverse events

• Very common (10% or more): Fussiness/irritability (76.9%)
• Postmarketing reports: Screaming

Other

• Very common (10% or more): Inconsolable crying (59.3%), fever (16.3%)
• Rare (less than 0.1%): Death
• Postmarketing reports: Vaccination failure/therapeutic response decreased^[Ref]

Four deaths occurred in the clinical trials. Causes of death were asphyxia due to suffocation, head trauma, Sudden Infant Death Syndrome, and neuroblastoma which occurred at 8, 23, 52, and 256 days post-vaccination respectively.^[Ref]

Nervous system

• Very common (10% or more): Decreased activity/lethargy (45.8%)
• Rare (less than 0.1%): Seizures, encephalopathy
• Frequency not reported: Hypotonia^[Ref]

Four patients experienced a seizure within 7 days of vaccination. One case of encephalopathy occurred 30 days post-vaccination and was secondary to cardiac arrest after cardiac surgery.^[Ref]

Local

• Very common (10% or more): Injection site tenderness (56.1%), increase in arm circumference (33.6%), injection site redness (17.3%)
• Common (1% to 10%): Injection site swelling
• Postmarketing reports: Injection site reactions (including inflammation, mass, abscess, sterile abscess), extensive swelling of the injected limb (including swelling involving adjacent joints)^[Ref]

Hypersensitivity

• Postmarketing reports: Anaphylaxis/anaphylactic reaction, hypersensitivity (such as rash and urticaria)^[Ref]

Respiratory

• Frequency not reported: Asthma
• Postmarketing reports: Apnea, cough^[Ref]

Asthma was a serious adverse event that occurred within 30 days following the 4th dose of vaccine.^[Ref]

Immunologic

• Frequency not reported: Bronchiolitis, gastroenteritis, pneumonia
• Postmarketing reports: Meningitis, rhinitis, viral infection^[Ref]

Bronchiolitis, gastroenteritis, and pneumonia were serious adverse events that occurred within 30 days following the 4th dose of vaccine.^[Ref]

Cardiovascular

• Postmarketing reports: Cyanosis, pallor^[Ref]

Dermatologic

• Postmarketing reports: Erythema, skin discoloration^[Ref]

Metabolic

• Postmarketing reports: Decreased appetite^[Ref]

Gastrointestinal

• Postmarketing reports: Vomiting, diarrhea^[Ref]

See also:

Further information

Pentacel side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer