Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile

The most common local undesirable effects, both in children and adults, are pain and redness at the injection site.
The most common general undesirable effects are, in children, irritability and in adults, fatigue and headache.

Tabulated list of adverse reactions

Clinical trial data
The safety profile presented in the table below is based on data from 5 331 subjects including 1 664 children (up to 18 years of age) vaccinated with Havrix 720 Junior and 3 667 adults (from 16 years of age) vaccinated with Havrix 1440 Adult, in clinical trials (total vaccinated cohort). A total of 3 193 doses of Havrix 720 Junior and 7 131 doses of Havrix 1440 Adult were administered during clinical trials. A total number of 3 971 doses of Havrix 1440 Adult were administered concomitantly with Engerix-B in 2 064 adult subjects.

Adverse reactions reported are listed according to the following frequency: 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)

Within each frequency grouping the adverse reactions are presented in the order of decreasing seriousness.

System organ class                        Frequency          Adverse reactions Upper respiratory tract infection (2),
Infections and infestations               Uncommon rhinitis
Metabolism and nutrition disorders        Common             Appetite lost Psychiatric disorders                     Very common        Irritability (1) Very common        Headache (3)
Common             Drowsiness (1)
Nervous system disorders
Uncommon           Dizziness (2)
Rare               Hypoaesthesia (2), paraesthesia (2)
Gastrointestinal signs and symptoms (2) (5),
Common
Gastrointestinal disorders                                   diarrhoea (4), nausea Uncommon              Vomiting
Uncommon              Rash (1)
Skin and subcutaneous tissue disorders
Rare                  Pruritus (2)
Musculoskeletal and connective tissue
Uncommon              Myalgia (2), musculoskeletal stiffness (2) disorders
Injection site pain and injection site
Very common erythema, fatigue (2)
General disorders and administration                         Malaise, fever (≥37.5 C), injection site site conditions                           Common             reaction (such as injection site induration (4) and injection site swelling)
Uncommon           Influenza like illness (2)

Rare               Chills (2)
(1) only with Havrix 720 Junior
(2) only with Havrix 1440 Adult
(3) reported with a frequency of common with Havrix 720 Junior
(4) reported with a frequency of uncommon with Havrix 720 Junior
(5) gastrointestinal = including nausea, vomiting, diarrhoea (symptoms not separately recorded) 
Post-marketing data

The following additional adverse reactions have been identified during post-marketing surveillance with both Havrix 720 Junior and Havrix 1440 Adult.

System organ class                       Frequency           Adverse reactions Anaphylaxis, allergic reactions including
Immune system disorders                  Rare                anaphylactoid reactions and serum sickness-like reaction
Nervous system disorders                 Rare                Convulsions Vascular disorders                       Rare                Vasculitis Angioneurotic oedema, erythema
Skin and subcutaneous tissue disorders   Rare multiforme, urticaria
Musculoskeletal and connective tissue
Rare                Arthralgia disorders

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).