Like all medicines, Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics 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 trials 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 Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics 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.
Brusing of the skin at the injection site, fever and nausea, generally feeling unwell and shivering.
Flu like symptoms.
Convulsions, 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 study in children (6 months to 17 years of age)
A clinical study was conducted with the same vaccine in children. General side effects reported very commonly in the 6 months to 35 months of age group were injection site redness, muscle ache, irritability and unusual crying. Very commonly reported reactions in the 36 months to 17 years of age group were pain, headache and fatigue.
Other rare side effects observed after routine use:
The side effects listed below have occurred in the days or weeks after vaccination with Focetria H1N1v vaccine.
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 side effects 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 vaccines given routinely every year to prevent flu. These side effects may occur with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
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), and exudative erythema multiforme (type of allergic skin reaction that occurs in response to medications, infections, or illness).
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.