Adverse reactions : תופעות לוואי

4.8         Undesirable effects

Summary of the safety profile
The safety profile presented is based on analysis of over 16,000 subjects (aged 10 years and older) who have been vaccinated with at least 1 dose of Trumenba in completed clinical studies.


In over 16,000 subjects ≥ 10 years of age studied, the most common adverse reactions were headache, diarrhoea, nausea, muscle pain, joint pain, fatigue, chills, and injection site pain, swelling and redness.

Adverse reactions following booster vaccination in 301 subjects 15 to 23 years of age were similar to adverse reactions during the primary Trumenba vaccination series approximately 4 years earlier.

List of adverse reactions

Adverse reactions reported in clinical studies of subjects 10 years of age and older are listed in decreasing order of frequency and seriousness.

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 available data)

Immune system disorder
Not known:            Allergic reactions*
Nervous system disorders
Very Common: Headache

Gastrointestinal disorders
Very Common: Diarrhoea; nausea
Common:                  Vomiting

Musculoskeletal and connective tissue disorders
Very Common: Muscle pain (myalgia); joint pain (arthralgia)
General disorders and administration site conditions
Very Common: Chills; fatigue; redness (erythema), swelling (induration) and pain at injection site
Common:                 Fever ≥ 38 °C (pyrexia)

* Reported in the postmarketing experience. Because this reaction was derived from spontaneous reports, the frequency could not be determined and is thus considered as not known.


In clinical studies, fever (≥ 38°C) occurred more frequently as subject age decreased. Of subjects 10 to 18 years of age, 9.8% reported fever; and of subjects 18 to 25 years of age, 4.4% reported fever. Fever followed a predictable pattern after vaccination: onset occurred within 2 to 4 days, lasted 1 day, and was mild to moderate in severity. Fever rate and severity tended to decrease with subsequent Trumenba vaccinations.

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