Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Clinical trials
Summary of the safety profile


In all age groups the most frequently reported local adverse reaction after vaccination was injection site pain ( 15.6% to 40.9%).

In adults 18 years of age and above, the most frequently reported general adverse reactions after vaccination were fatigue (11.1%), headache (9.2%) and myalgia (11.8%).

In subjects aged 6 to 17 years, the most frequently reported general adverse reactions after vaccination were fatigue (12.6%), myalgia (10.9%) and headache (8.0%).

In subjects aged 3 to 5 years, the most frequently reported general adverse reactions after vaccination were drowsiness (9.8%) and irritability (11.3%).

In subjects aged 6 months to 3 years, the most frequently reported general adverse reactions after vaccination were irritability/fussiness (14.9%) and loss of appetite (12.9%).

Tabulated list of adverse reactions
Adverse reactions reported for Fluarix Tetra in the different age groups are listed per dose according to the following frequency categories:

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)
Very rare (<1/10,000)

Adults

A clinical study with Fluarix Tetra in adults has evaluated the incidence of adverse reactions in subjects ≥18 years who received one dose of Fluarix Tetra (N = 3,036) or Fluarix (trivalent influenza vaccine) (N = 1,010).



The following adverse reactions per dose have been reported:

System Organ Class                      Frequency                     Adverse Reactions Nervous system disorders               Common              Headache
Uncommon            Dizziness1
Gastrointestinal disorders             Common              Gastrointestinal symptoms (including nausea, vomiting, diarrhoea and/or abdominal pain)
Skin and subcutaneous tissue           Common              Sweating2 disorders
Musculoskeletal and connective         Very common         Myalgia tissue disorders                       Common              Arthralgia General disorders and                  Very common         Injection site pain, fatigue administration site conditions         Common              Injection site redness, injection site swelling, shivering, fever, injection site induration2
Uncommon            Injection site haematoma1, injection site pruritus1
1
Reported as unsolicited adverse reaction
2
Reported in previous Fluarix trials



Children aged 6 months to <18 years

Two clinical studies evaluated the reactogenicity and safety of Fluarix Tetra in children who received at least one dose of Fluarix Tetra or a control vaccine.

One study enrolled children 3 to <18 years of age who received Fluarix Tetra (N = 915) or Fluarix (N = 912). The second study enrolled children 6 to <36 months of age who received Fluarix Tetra (N = 6,006) or a non-influenza vaccine control (N = 6,012) (see section 5.1).

The following adverse reactions per dose have been reported:

Adverse reactions                             Frequency
System Organ                                           6 to <36           3 to <6          6 to <18 Class                                                 (months)            (years)          (years) 
Metabolism and        Loss of appetite             Very common        Common            N/A nutrition disorders
Psychiatric           Irritability/Fussiness       Very common        Very common       N/A disorders
Nervous system        Drowsiness                   Very common        Common            N/A disorders             Headache                     N/A                N/A               Common Gastrointestinal      Gastrointestinal             N/A                N/A               Common disorders             symptoms (including nausea, diarrhoea,
vomiting and/or abdominal pain)
Skin and              Rash1                        N/R                Uncommon          Uncommon subcutaneous tissue disorders
Musculoskeletal       Myalgia                      N/A                N/A               Very common and connective        Arthralgia                   N/A                N/A               Common tissue disorders
General disorders     Fever (≥38.0°C)              Common             Common            Common and administration    Fatigue                      N/A                N/A               Very common site conditions       Injection site pain          Very common        Very common       Very common Injection site redness       Very common        Very common       Very common Injection site swelling      Common             Very common       Very common Shivering                    N/A                N/A               Common Injection site pruritus1     N/R                Uncommon          Uncommon Injection site               N/A                Common            Common induration2
N/A=Not solicited in this age group
N/R=Not reported
1
Reported as unsolicited adverse reaction
2
Reported in previous Fluarix trials



Post-marketing data

The following adverse reactions have been observed for Fluarix and/or Fluarix Tetra during post- marketing surveillance1

System Organ Class             Frequency                          Adverse events Blood and lymphatic            Rare              Transient lymphadenopathy system disorders
Immune system disorders        Rare              Allergic reactions (including anaphylactic reactions) Nervous system disorders       Rare              Neuritis, acute disseminated encephalomyelitis, Guillain-Barré syndrome2
Skin and subcutaneous          Rare              Urticaria, pruritus, erythema, angioedema tissue disorders
General disorders and          Rare              Influenza-like illness, malaise administration site conditions
1
Three of the influenza strains contained in Fluarix are included in Fluarix Tetra.
2
Spontaneous reports of Guillain-Barré syndrome have been received following vaccination with Fluarix and Fluarix Tetra; however, a causal association between vaccination and Guillain-Barré syndrome has not been established.


Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/
Additionally, you should also report to GSK Israel (il.safety@gsk.com)