Boostrix Adverse Reactions

Clinical Trial Data: The safety profile as follows is based on data from clinical trials where Boostrix was administered to 839 children (from 4 to 9 years of age) and 1931 adults, adolescents and children (above 10 years of age).
Adverse reactions reported are listed according to the following frequency: Very common ≥1/10; Common ≥1/100 and <1/10; Uncommon ≥1/1,000 and <1/100; Rare ≥1/10,000 and <1/1,000; Very rare <1/10,000.
Children from 4 to 9 years of age: Infections and infestations: Uncommon: upper respiratory tract infection.
Metabolism and nutrition disorders: Common: anorexia.
Psychiatric disorders: Very common: irritability.
Nervous system disorders: Very common: somnolence.
Common: headache.
Uncommon: disturbances in attention.
Eye disorders: Uncommon: conjunctivitis.
Gastrointestinal disorders: Common: diarrhoea, vomiting, gastrointestinal disorders.
Skin and subcutaneous tissue disorders: Uncommon: rash.
General disorders and administration site conditions: Very common: injection site reactions (including pain, redness and swelling), fatigue.
Common: fever ≥37.5°C (including fever >39°C).
Uncommon: other injection site reactions (such as induration), pain.
Adults, adolescents and children from the age of 10 years onwards: Infections and infestations: Uncommon: upper respiratory tract infection, pharyngitis.
Blood and lymphatic system disorders: Uncommon: lymphadenopathy.
Nervous system disorders: Very common: headache.
Common: dizziness.
Uncommon: syncope.
Respiratory, thoracic and mediastinal disorders: Uncommon: cough.
Gastrointestinal disorders: Common: nausea, gastrointestinal disorders.
Uncommon: diarrhoea, vomiting.
Skin and subcutaneous tissue disorders: Uncommon: hyperhidrosis, pruritus, rash.
Musculoskeletal and connective tissue disorders: Uncommon: arthralgia, myalgia, joint stiffness, musculoskeletal stiffness.
General disorders and administration site conditions: Very common: injection site reactions (including pain, redness and swelling), fatigue, malaise.
Common: fever ≥37.5°C, injection site reactions (such as injection site mass and injection site abscess sterile).
Uncommon: fever >39°C, influenza like illness, pain.
Reactogenicity after repeat dose of Boostrix: Data on 146 subjects suggest a small increase in local reactogenicity (pain, redness, swelling) with repeated vaccination according to a 0, 1, 6 months schedule in adults (>40 years of age).
Subjects fully primed with 4 doses of DTPw followed by a Boostrix dose around 10 years of age show an increase of local reactogenicity after an additional Boostrix dose administered 10 years later.
Safety in women vaccinated with dTpa during pregnancy: In a randomized controlled clinical trial where women were vaccinated between 27 and 36 weeks of pregnancy, the safety profile observed was similar in the dTpa-vaccinated group as compared to the control group. The types and rates of solicited/unsolicited adverse events are in line with the observations available for the general population.
The following adverse events of interest were reported during the randomized controlled clinical trial: No pregnancy/neonate-related adverse events of interest were considered related to Boostrix vaccination during the study.
Pregnancy/neonate-related adverse events of interest were reported at similar rates (below 5%) in both study groups, the most common being premature labor (3.8% of women who received Boostrix vs 3.2% who received placebo during pregnancy) and premature rupture of membranes (3.8% of women who received Boostrix vs 4.3% who received placebo during pregnancy).
There were no maternal or neonatal deaths.
Congenital anomaly of infants born to vaccinated mothers was reported for 2.6% and 2.3% of women who received Boostrix vs those who received placebo during pregnancy, respectively. No safety concern was identified.
Post-Marketing Data: Blood and lymphatic system disorders: Rare: angioedema.
Immune system disorders: Very rare: allergic reactions, including anaphylactic and anaphylactoid reactions.
Nervous system disorders: Rare: convulsions (with or without fever).
Skin and subcutaneous tissue disorders: Rare: urticaria.
General disorders and administration site conditions: Rare: extensive swelling of the vaccinated limb, asthenia.