is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis, 𝗽𝗼𝗹𝗶𝗼𝗺𝘆𝗲𝗹𝗶𝘁𝗶𝘀 and invasive disease due to Haemophilus influenzae type b. Pentacel is approved for use as a four dose series in children 6 weeks through 4 years of age (prior to 5th birthday).
The following adverse events were included based on one or more of the following factors: severity, frequency of reporting, or strength of evidence for a causal relationship to Pentacel. • Cardiac disorders • Cyanosis • Gastrointestinal disorders • Vomiting, diarrhea • General disorders and administration site conditions • Injection site reactions (including inflammation, mass, abscess and sterile abscess), extensive swelling of the injected limb (including swelling that involved adjacent joints), vaccination failure/therapeutic response decreased (invasive H. influenzae type b disease) • Immune system disorders •Anaphylaxis/anaphylactic reaction, hypersensitivity (such as rash and urticaria) • Infections and infestations • Meningitis, rhinitis, viral infection • Metabolism and nutrition disorder • If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain-Barré syndrome may be increased following Pentacel.