Adverse reactions : תופעות לוואי

4.8         Undesirable effects
Summary of safety profile

In clinical studies that enrolled girls and women aged from 10 up to 72 years (of which 79.2% were aged 10-25 years at the time of enrolment), Cervarix was administered to 16,142 subjects whilst 13,811 subjects received control. These subjects were followed for serious adverse events over the entire study period. In a pre-defined subset of subjects (Cervarix = 8,130 versus control = 5,786), adverse events were followed for 30 days after each injection.

The most common adverse reaction observed after vaccine administration was injection site pain which occurred after 78% of all doses. The majority of these reactions were of mild to moderate severity and were not long lasting.

List of adverse reactions
Adverse reactions considered as being at least possibly related to vaccination have been categorised by frequency.

Frequencies are reported as:
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)

• Clinical trial data

Infections and infestations:
Uncommon: upper respiratory tract infection
Nervous system disorders:
Very common: headache
Uncommon: dizziness

Gastrointestinal disorders:
Common: gastrointestinal symptoms including nausea, vomiting, diarrhoea and abdominal pain 
Skin and subcutaneous tissue disorders:
Common: itching/pruritus, rash, urticaria

Musculoskeletal and connective tissue disorders:
Very common: myalgia
Common: arthralgia
General disorders and administration site conditions:
Very common: injection site reactions including pain, redness, swelling; fatigue Common: fever (≥38°C)
Uncommon: other injection site reactions such as induration, local paraesthesia 
A similar safety profile has been observed in subjects with prior or current HPV infection as compared to subjects negative for oncogenic HPV DNA or seronegative for HPV-16 and HPV-18 antibodies.

•   Post marketing data

Because these events were reported spontaneously, it is not possible to reliably estimate their frequency.

Blood and lymphatic system disorders
Lymphadenopathy

Immune system disorders
Allergic reactions (including anaphylactic and anaphylactoid reactions), angioedema 
Nervous system disorders
Syncope or vasovagal responses to injection, sometimes accompanied by tonic-clonic movements (see section 4.4)

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. Healthcare professionals are asked to report any suspected adverse reactions to the Ministry of Health according to the National Regulation by using an online form

(http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.h ealth.gov.il) or by email (adr@MOH.HEALTH.GOV.IL).
Additionally, you should also report to GSK Israel (il.safety@gsk.com).