Adverse reactions observed from clinical trialsThe safety of trivalent inactivated influenza vaccines is assessed in open label, uncontrolled clinical trials performed as annual update requirement, including at least 50 adults aged 18 60 years and at least 50 elderly aged 61years or older. Safety evaluation is performed during the first 3 days following vaccination.The following undesirable effects have been observed during clinical trials with the following frequencies:very common (≥1/10), common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100)Tabulated list of adverse reactions.
*These reactions usually disappear within 1-2 days without treatment.Paediatric populationIn three clinical studies healthy children 6 months to 17 years of age were administered Fluarix (more than 3500 children).The following adverse reactions have also been reported in this age population.
|Organ class||Very common≥1/10||Common≥1/100, <1/10 ||Uncommon≥1/1,000, <1/100 |
|Nervous system disorders|| ||Headache*
|Skin and subcutaneous tissue disorders || ||Sweating*
|Musculoskeletal and connective tissue disorders|| ||Myalgia, arthralgia*
|General disorders and administration site conditions|| ||Fever, malaise, shivering, fatigue.
Local reactions: redness, swelling, pain, ecchymosis, induration*
1reported in children aged from 6 months to 17 years
2reported in children aged from 6 months to <6 years
3reported in children aged from 6 years to 17 years
|Organ class||Very common ≥1/10||Common ≥1/100, <1/10||Uncommon ≥1/1,000, <1/100|
|Metabolism and nutrition disorders||Loss of appetite2|| || |
|Psychiatric disorders||Irritability2|| || |
|Nervous system disorders||Drowsiness2, headache3|| || |
|Gastrointestinal disorders|| ||Gastrointestinal symptoms3|| |
|Musculoskeletal, connective tissue and bone disorders||Joint pain3, muscle aches3|| || |
|General disorders and administration site conditions||Fever2, fatigue3. Local reactions: redness1, swelling1, pain1||Fever3 , shivering3|| |
Adverse reactions reported from post-marketing surveillanceAdverse reactions reported from post-marketing surveillance are, next to the reactions which have also been observed during the clinical trials, the following:
Blood and lymphatic system disorders:Transient thrombocytopenia, transient lymphadenopathy
Immune system disorders:Allergic reactions (symptoms including conjunctivitis), in rare cases leading to shock, angioedema
Nervous system disorders:Neuralgia, paraesthesia, febrile convulsions, neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome
Vascular disorders:Vasculitis associated in very rare cases with transient renal involvement
Skin and subcutaneous tissue disorders: Generalised skin reactions including pruritus, urticaria or non-specific rash