Clinical Trial Data: In clinical studies, a total of approximately 45,000 doses of Cervarix were administered to approximately 16,000 female subjects aged 9-72 years and approximately 7,800 doses were administered to approximately 2,600 male subjects aged 10-18 years. These subjects were followed to assess the safety of the vaccine.
The most common reaction observed after vaccine administration was injection site pain, which occurred after 78% of all doses. The majority of these reactions were of mild to moderate severity and were not long lasting.
Adverse reactions considered as being at least possibly related to vaccination have been categorised by frequency.
Frequencies are reported as: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000).
Infections and infestations: Uncommon: upper respiratory tract infection.
Blood and lymphatic system disorders: Uncommon: lymphadenopathy.
Nervous system disorders: Very Common: headache.
Gastrointestinal disorders: Common: gastrointestinal including nausea, vomiting, diarrhoea and abdominal pain.
Skin and subcutaneous tissue disorders: Common: itching/pruritus, rash, urticaria.
Musculoskeletal and connective tissue and bone disorders: Very Common: myalgia. Common: arthralgia.
General disorders and administration site conditions: Very common: injection site reactions including pain, redness, swelling, fatigue.
Common: fever (≥38°C).
Uncommon: other injection site reactions such as induration, local paresthesia.
Post Marketing Data: Immune system disorders: Rare: allergic reactions (including anaphylactic and anaphylactoid reactions), angioedema.
Nervous system disorders: Rare: syncope or vasovagal responses to injection, sometimes accompanied by tonic-clonic movements.