Pentacel is a vaccine indicated for active immunization against
diphtheria, tetanus, pertussis, ๐ฝ๐ผ๐น๐ถ๐ผ๐บ๐๐ฒ๐น๐ถ๐๐ถ๐ 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.
โข Cardiac disorders
Cyanosis
โข Gastrointestinal disorders
Vomiting, diarrhea
โข 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)
โข Immune system disorders
Anaphylaxis/anaphylactic reaction, hypersensitivity (such as rash and urticaria)
โข Infections and infestations
Meningitis, rhinitis, viral infection
โข Metabolism and nutrition disorder
โข If Guillain-Barrรฉ syndrome occurred within 6 weeks of receipt of a
prior vaccine containing tetanus toxoid, the risk for Guillain-Barrรฉ
syndrome may be increased following Pentacel.