Like all medicines, Focetria can cause side effects, although not everybody gets them. Allergic reactions may occur following vaccination, in rare cases leading to shock. Doctors are aware of this possibility and have emergency treatment available for use in such cases.
In the clinical studies with the vaccine, most side effects were mild in nature and short term. The side-effects are generally similar to those related to the seasonal flu vaccine.
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)
The side effects listed below have occurred with Focetria in clinical studies in adults, including the elderly:
Pain, hardening of the skin at the injection site, injection site redness, injection site swelling, pain at the site of injection, aching muscles, headache, sweating, fatigue, generally feeling unwell and shivering
Bruising of the skin at the injection site, fever and nausea
Flu like symptoms
Convulsion, eye swelling and anaphylaxis
These side effects usually disappear within 1-2 days without treatment. If they persist, CONSULT YOUR DOCTOR.
Side effects from clinical studies in children
A clinical study was conducted with the same vaccine in children. General side effects reported very commonly in the 6 months-35 months of age group per dose were irritability, unusual crying, sleepiness, diarrhoea and change in eating habits. Among the adolescents the very common events were: sweating, nausea and chills. Very commonly reported reactions in both children and adolescents were pain, hardening of the skin at the injection site, injection site redness, generally feeling unwell, muscle ache, headache and fatigue.
Other side effects
The side effects listed below have occurred in the days or weeks after vaccination with Focetria.
Generalised skin reactions including itching, urticaria (hives), rash or swelling of the skin and mucous membranes.
Disorders of the gut such as nausea, vomiting, abdominal pain and diarrhoea.
Headache, dizziness, drowsiness, fainting.
Neurological disorders such as severe stabbing or throbbing pain along one or more nerves, tingling, fits, and neuritis (inflammation of nerves).
Swollen lymph nodes, palpitations, weakness, pain in the extremities and cough.
Allergic reactions possibly with shortness of breath, wheezing, swelling of the throat, or leading to a dangerous decrease of blood pressure, which, if untreated, may lead to shock. Doctors are aware of this possibility and have emergency treatment available for use in such cases.
Data in children and adolescents suggest a slight decrease in reactogenicity after the second dose of the vaccine, with no increase in rates of fever.
In addition, the side effects listed below have occurred in the days or weeks after vaccination with adjuvanted and non-adjuvanted vaccines given routinely every year to prevent flu. These side effects may occur with Focetria.
Low blood platelet count which can result in bleeding or bruising.
Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems), exudative erythema multiforme.
Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), and a type of paralysis known as Guillain-Barré Syndrome.
If any of these side effects occur, please tell your doctor or nurse immediately.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.