Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Summary of the safety profile

The safety profile presented below is based on a placebo-controlled Phase III clinical study (conducted in Europe, North America, Asia and Southern hemisphere) in adults ≥ 60 years of age in which more than 12 000 adults received one dose of Arexvy and more than 12 000 received placebo with a follow- up period of approximately 12 months.

In study participants 60 years of age and older, the most commonly reported adverse reactions were injection site pain (61%), fatigue (34%), myalgia (29%), headache (28%), and arthralgia (18%). These adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination.
Most other adverse reactions were uncommon and similarly reported between the study groups.

Tabulated list of adverse reactions

Adverse reactions are listed below by MedDRA system organ class and 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)


Table 1. Adverse reactions
System Organ Class                   Frequency                  Adverse reactions 
Blood and lymphatic system
Uncommon                    lymphadenopathy disorders
 hypersensitivity reactions (such
Immune system disorders                Uncommon as rash)
Nervous system disorders              Very common                      headache  nausea, abdominal pain,
Gastrointestinal disorders             Uncommon vomiting

Musculoskeletal and connective
Very common                 myalgia, arthralgia tissue disorders
Very common             injection site pain, fatigue
 injection site erythema, injection
Common
General disorders and                                         site swelling, fever, chills administration site conditions
Uncommon                  injection site pruritus
 pain, malaise

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).