Adverse reactions : תופעות לוואי

4.8    Undesirable effects
a. Summary of the safety profile
More than 6200 children aged from 12 months to 15 years were vaccinated with AVAXIM 80 U PEDIATRIC during clinical trials.
Most undesirable effects were moderate and limited to the first few days following vaccination with spontaneous recovery. Reactions were more rarely reported after the booster dose than after the first dose.
However, as with all pharmaceuticals, expanded commercial use of the vaccine might reveal rarer undesirable effects.
b. Tabulated list of adverse reactions
The undesirable effects are derived from clinical studies and worldwide post-marketing experience.
In each System Organ Class, the undesirable effects are ranked under headings of frequency, the most common reactions coming first, using the following convention:
Very common      (≥1/10)
Common           (≥1/100, <1/10)
Uncommon         (≥1/1 000, <1/100)
Rare             (≥1/10 000, <1/1000)
Very rare        (<1/10 000)
Not known: cannot be estimated from the available data.
The table below summarize the frequencies of the adverse reactions that were recorded after the first dose, after the booster dose or after any dose of AVAXIM 80 U PEDIATRIC.

Adverse reactions                                Frequency        Frequency after        Frequency after the        the booster        after any dose
primary dose           dose
Immune system disorders
Anaphylactic reaction                             Not known          Not known           Not known Metabolism and nutrition disorders
Appetite decrease                                  Common             Common              Common Psychiatric disorders
Abnormal crying                                 Very common          Uncommon          Very common Irritability                                      Common              Common             Common Insomnia                                          Common              Common             Common Nervous system disorders
Cephalalgia                                       Common             Common            Very common Vasovagal syncope in response to injection        Not known          Not known          Not known Seizures with or without fever                    Not known          Not known          Not known Gastrointestinal disorders
Adverse reactions                               Frequency        Frequency after       Frequency after the        the booster       after any dose
primary dose           dose
Abdominal pain                                  Common              Common             Common Diarrhoea                                       Common              Common             Common Nausea                                          Common              Common             Common Vomiting                                        Common              Common             Common Skin and subcutaneous tissue disorders
Rash                                               NR*             Uncommon           Uncommon Urticaria                                       Uncommon              NR*             Uncommon Musculoskeletal and connective tissue
disorders
Arthralgia                                       Common            Uncommon            Common Myalgia                                          Common             Common             Common General disorders and administration
site conditions
Local reactions
Pain at the injection site                    Very common           Common           Very common Redness at the injection site                   Common              Common             Common Induration or oedema at the injection site      Common              Common             Common Haematoma at the injection site                 Common             Uncommon            Common Systemic reactions
Malaise                                          Common             Common           Very common Fever                                            Common             Common             Common Asthenia or somnolence                           Common             Common             Common * Not reported during clinical studies
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 (www.health.gov.il) according to the National Regulation by using an online form https://sideeffects.health.gov.il