Tdap vaccine is safe and well tolerated. See reported adverse events below:
Table 1: Adverse reactions reported in clinical trials with Boostrix
System Organ Class
|
Frequency
|
Adverse Reactions
|
Subjects aged 4 – 8 years (N=839)
|
Subjects aged 10 – 76 years (N=1931)
|
Infections and infestations
|
Uncommon
|
upper respiratory tract infection
|
upper respiratory tract infection pharyngitis
|
Blood and lymphatic system disorders
|
Uncommon
|
|
lymphadenopathy
|
Metabolism and nutrition disorders
|
Common
|
anorexia
|
|
Psychiatric disorders
|
Very common
|
irritability
|
|
Nervous system disorders
|
Very common
Common
Uncommon
|
somnolence headache disturbances in attention
|
headache
dizziness
syncope
|
Eye disorders
|
Uncommon
|
Conjunctivitis
|
|
Respiratory, thoracic and mediastinal disorders
|
Uncommon
|
|
Cough
|
Gastrointestinal disorders
|
Common
|
diarrhoea, vomiting, gastrointestinal disorders
|
nausea
gastrointestinal disorders
|
|
Uncommon
|
|
diarrhoea
vomiting
|
Skin and
subcutaneous tissue disorders
|
Uncommon
|
|
rash hyperhidrosis
pruritus
rash
|
Musculoskeletal and connective tissue disorders
|
Uncommon
|
|
arthralgia
myalgia
joint stiffness
musculoskeletal stiffness
|
General disorders and administration site conditions
|
Very common Common Uncommon
|
injection site reactions (such as redness and/or swelling), injection site, pain, fatigue
|
injection site reactions (such as redness and/or swelling), malaise, fatigue, injection site pain
|
|
|
pyrexia (fever ≥ 37.5°C including fever > 39.0°C), extensive swelling of vaccinated limb (sometimes involving the
adjacent joint)
|
pyrexia (fever ≥ 37.5°C), injection site reactions (such as injection site mass and injection site abscess sterile)
|
|
|
|
pyrexia (fever > 39.0°C), influenza like illness, pain
|
|
|
other injection site reactions (such as induration), pain
|
|
See information at http://www.hpra.ie/img/uploaded/vaccines/SPC_PA1077020001.pdf
Very common (>1 in 10): Local injection site reactions (pain, redness and swelling). Common (> 1 in 100 to <1 in 10): Pyrexia, malaise, fatigue
Serious side effects are very rare