Severe allergic reactions: Anaphylactic, anaphylactoid reactions, including shock which can include one or several of the following symptoms: urticaria, skin rash, swelling of face and/or neck, breathing difficulties, bluish discoloration of the tongue or lips, low blood pressure, rapid heart rate and weak pulse, skin coldness, dizziness and potentially fainting.
When these signs or symptoms appear, it is usually very soon after the injection, while the person affected is still at the medical centre or at the doctor's surgery. If one of these symptoms occurs after the patient has left the place where the vaccine was administered, the patient must consult a doctor immediately.
Other side effects: Most side effects occurred within 3 days after vaccination. Most effects resolved spontaneously within 1 to 3 days after onset.
They were reported with the following frequencies: Very common (may affect more than 1 in 10 people): Injection site pain, injection site redness (erythema)(1), injection site swelling/oedema(1), injection site hardening (induration)(1); headache (cephalalgia)(1); muscle pain (myalgia); generally feeling unwell; fatigue, unusual weakness (asthenia)(2).
Common (may affect up to one in 10 people): Fever(3).
Uncommon (may affect up to one in 100 people): Injection site itching (injection site pruritus)(4).
Not known (cannot be estimated from available data): serum sickness disease: joint pain, skin rash, swelling of lymph nodes and generally feeling unwell. When these symptoms appear, it is generally 2-4 weeks after vaccination; fainting in response to an injection (vasovagal syncope); cough, wheezing, respiratory discomfort (asthma); nausea, vomiting, diarrhoea, stomach pain (abdominal pain); rash, sometimes swollen and itchy (pruritus, skin rash, urticaria); joint pain (arthralgia).
(1)Common in adults, (2)Common in children and adolescents (from 2 to 17 years of age), (3)Not reported in adults, (4)Not reported in children and adolescents (from 2 to 17 years of age).
Reporting of side effects: If the patient gets any side effects, talk to a doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects, patient can help provide more information on the safety of this medicine.
View ADR Reporting Link