Pentacel 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.