Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Clinical trial data
Healthy individuals
More than 7,900 individuals have participated in clinical trials evaluating the reactogenicity profile of the vaccine administered subcutaneously either alone or concomitantly with other vaccines.

The safety profile presented below is based on a total of 5,369 doses of Varilrix administered alone to infants, children, adolescents and adults.

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 Infections and infestations               Uncommon               upper respiratory tract infection, pharyngitis Blood and lymphatic system
Uncommon               lymphadenopathy disorders
Psychiatric disorders                     Uncommon               irritability Nervous system disorders                  Uncommon               headache, somnolence Eye disorders                             Rare                   conjunctivitis Respiratory, thoracic and mediastinal
Uncommon               cough, rhinitis disorders
Uncommon               vomiting, nausea
Gastrointestinal disorders
Rare                   diarrhoea, abdominal pain
Common                 rash
Skin and subcutaneous tissue
Uncommon               viral rash, pruritus disorders
Rare                   urticaria
Musculoskeletal and connective
Uncommon               arthralgia, myalgia tissue disorders
Very common         pain, erythema pyrexia (oral/axillary temperature  37.5°C or
General disorders and administration Common                   rectal temperature  38.0°C)†, injection site site conditions                                               swelling† pyrexia (oral/axillary temperature > 39.0°C or
Uncommon rectal temperature > 39.5°C), fatigue, malaise
 According to MedDRA (Medical Dictionary for Regulatory Activities) terminology † Injection site swelling and pyrexia were reported very commonly in studies conducted in adolescents and adults. Injection site swelling was also reported very commonly after the second dose in children under 13 years of age.

A trend for higher incidence of pain, erythema and injection site swelling after the second dose was observed as compared to the first dose.

No differences were seen in the reactogenicity profile between initially seropositive and initially seronegative subjects.
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Individuals at high risk of severe varicella
There are limited data from clinical trials available in subjects at high risk of severe varicella. However, vaccine-associated reactions (mainly papulo-vesicular eruptions and pyrexia) are usually mild. As in healthy subjects, erythema, swelling and pain at the site of injection are mild and transient.

Post-marketing data

The following additional adverse reactions have been identified in rare occasions during post-marketing surveillance. Because they are reported voluntarily from a population of unknown size, a true estimate of frequency cannot be provided.

System organ class                      Adverse reactions
Infections and infestations              herpes zoster
Blood and lymphatic system thrombocytopenia disorders
Immune system disorders                  anaphylactic reaction, hypersensitivity encephalitis, cerebrovascular accident, seizure, cerebellitis, cerebellitis- Nervous system disorders like symptoms (including transient gait disturbance and transient ataxia) vasculitis (including Henoch Schonlein purpura and Kawasaki
Vascular disorders syndrome)
Skin and subcutaneous tissue erythema multiforme disorders
 According to MedDRA (Medical Dictionary for Regulatory Activities) terminology 

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).