Adverse reactions : תופעות לוואי

4.8.        Undesirable effects
Summary of the tolerability profile
More than 13,000 subjects, including approximately 1,000 children and adolescents under 18 years of age, have received at least one dose of Verorab in clinical studies.
The undesirable effects were generally moderate in intensity and occurred within 3 days of vaccination. Most of the effects resolved spontaneously within 1 to 3 days of their appearance.

The most common undesirable effects in all age groups (except infants/young children less than 24 months of age) were headaches, malaise, myalgia and injection site pain. Pain was the most common reaction at the injection site.
Tabulated list of the undesirable effects
The undesirable effects listed below are those from clinical studies and post-marketing surveillance worldwide. Within each system organ class, the adverse events are classified by frequency according to the following convention:
• 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);
• Not known (cannot be estimated from the available data).


Paediatric
Adults population
Undesirable effects                         ≥ 18 years less than 18 years
Frequency            Frequency
Blood and lymphatic system disorders
Lymphadenopathy                                                  Common              Common Immune system disorders
Allergic reactions (e.g., rash, urticaria, pruritus)            Uncommon            Uncommon Anaphylactic reactions and angio-oedema                         Not known           Not known Metabolism and nutrition disorders
Decreased appetite                                              Uncommon            Uncommon Nervous system disorders
Headache                                                       Very common         Very common Dizziness / Vertigo                                             Uncommon                 - Irritability (in infants / young children)                           -             Very common Somnolence (in infants / young children)                             -             Very common Insomnia (in infants / young children)                               -               Common Ear and labyrinth disorders
Sudden loss of hearing which may persist                        Not known            Not known Respiratory, thoracic and mediastinal disorders
Dyspnoea                                                           Rare                   - Gastrointestinal disorders
Nausea                                                          Uncommon                - Abdominal pain                                                  Uncommon            Uncommon Diarrhoea                                                       Uncommon                - Vomiting                                                            -               Uncommon Musculoskeletal and connective tissue disorders
Myalgia                                                        Very common         Very common Arthralgia                                                      Uncommon                 - General disorders and administration site conditions
Injection site pain                                            Very common         Very common Injection site erythema                                          Common              Common Injection site pruritus                                          Common                  - Injection site swelling                                          Common              Common Injection site induration                                        Common                  - Malaise                                                        Very common         Very common Flu-like syndrome                                                Common Fever                                                            Common              Common Asthenia                                                        Uncommon                 - Chills                                                          Uncommon            Uncommon Inconsolable crying (in infants / young children)                    -             Very common 

Reporting of suspected adverse reactions
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/