Adverse reactions : תופעות לוואי

4.8 Undesirable effects
a. Summary of the safety profile
During clinical development, more than 15,000 people received TYPHIM Vi (first or second injection).
The most common adverse reactions, in all age groups, were injection site pain. In adults from 18 years of age, myalgia and fatigue were the most frequently reported systemic reactions. In children and adolescents (from 2 to 17 years of age), myalgia and headache were the most frequently reported systemic reactions.
Most adverse reactions appeared within 3 days after vaccination. Most reactions resolved spontaneously within 1 to 3 days after onset.
b. Tabulated list of adverse reactions
The adverse reactions come from clinical studies (pooled analysis) and worldwide post-marketing experience. The pooled analysis has been performed on 6 recent studies sharing the same safety standard integrating data from 1532 subjects (97 children and adolescents from 2 to 17 years of age and 1435 adults).
In each System Organ Class, the adverse reactions are ranked under headings of frequency, the most common reactions coming first, using the following convention: Very common (≥1/10) Common (≥1/100 to <1/10)
Uncommon (≥1/1000 to <1/100) Rare (≥1/10 000 to <1/1000) Very rare (<1/10 000) including isolated cases
Not known (cannot be estimated from the available data).

The table below summarizes the frequencies of the adverse reactions that were recorded after any dose of TYPHIM Vi in children and adolescents from 2 to 17 years of age and adults.

Adverse Reactions Experienced             Children and Adolescents    Adults 2-17 years                  ≥ 18 years
Frequency                   Frequency
Immune system disorders
Anaphylactic, anaphylactoid reactions, Not known*
including shock
Serum sickness disease                    Not known*
Nervous system disorders
Vasovagal syncope in response to Not known*
injection
Headache                                  Very common                 Common Respiratory, thoracic and mediastinal disorders
Asthma                                    Not known*
Gastrointestinal disorders
Nausea                                    Not known*
Vomiting                                  Not known*
Diarrhoea                                 Not known*
Abdominal pain                            Not known*
Skin and subcutaneous tissue disorders
Allergic type reactions such as pruritus, Not known*
rash, urticaria
Musculoskeletal and connective tissue disorders
Arthralgia                                Not known*
Myalgia                                   Very common                 Very common General disorders and administration site condition
Injection site pain                       Very common
Injection site erythema                   Very common                 Common Injection site pruritus                   -                           Uncommon Injection     site        swelling/oedema/ Very common                Common induration
Malaise                                   Common                      Very common Fever                                     Common                                      - Fatigue/asthenia                          Common                      Very common 
* reported during postmarketing surveillance

The most frequently reported adverse reactions in children and adolescents (from 2 to17 years of age) were injection site reactions: pain (52.6%), swelling/oedema/ induration (16.5%) and erythema (14.4%). The most frequently reported systemic reactions were myalgia (14.6%) and headache (13.5%).

In adults from 18 years of age, the most frequently reported adverse reaction were injection site pain (75.6%), myalgia (47.1%) and fatigue/asthenia (25.0%).

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