Adverse reactions : תופעות לוואי

4.8       Undesirable effects

Summary of the safety profile

The safety profile presented below is based on a total of approximately 12,000 subjects administered PRIORIX in clinical trials.

Adverse reactions which might occur following the use of a combined mumps, measles, rubella vaccine correspond to those observed after administration of the monovalent vaccines alone or in combination.

In controlled clinical studies, signs and symptoms were actively monitored during a 42-day follow-up period. The vaccinees were also requested to report any clinical events during the study period.

The most common adverse reactions following PRIORIX administration were injection site redness and fever 38°C (rectal) or 37.5°C (axillary/oral).

Tabulated list of adverse reactions

Adverse reactions reported are listed according to the following 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)

Clinical trial data


System Organ Class             Frequency                  Adverse reactions Infections and infestations          Common             upper respiratory tract infection Uncommon          otitis media
Blood and lymphatic system Uncommon                  lymphadenopathy disorders
Immune system disorders            Rare              allergic reactions Metabolism       and    nutrition Uncommon           anorexia disorders
Psychiatric disorders              Uncommon          nervousness,         abnormal    crying, insomnia
Nervous system disorders           Rare              febrile convulsions Eye disorders                      Uncommon          conjunctivitis
Respiratory,    thoracic      and Uncommon           bronchitis, cough mediastinal disorders
Gastrointestinal disorders         Uncommon          parotid gland enlargement, diarrhoea, vomiting
Skin and subcutaneous tissue Common                  rash disorders
General      disorders       and Very common         redness at the injection site, fever administration site conditions                       38°C       (rectal)  or    37.5°C (axillary/oral)
Common            pain and swelling at the injection site,
fever >39.5°C (rectal) or >39°C
(axillary/oral)


In general, the frequency category for adverse reactions was similar for the first and second vaccine doses. The exception to this was pain at the injection site which was “Common” after the first vaccine dose and “Very common” after the second vaccine dose.

Post-marketing data

The following adverse reactions have been identified in rare occasions during post- marketing surveillance. Because they are reported voluntarily from a population of unknown size, a true estimate of frequency cannot be provided.

System Organ Class                            Adverse reactions
Infections and infestations                   Meningitis, measles-like syndrome, mumps- like syndrome (including orchitis,
epididymitis and parotitis)
Blood and lymphatic system disorders          Thrombocytopenia, thrombocytopenic purpura
Immune system disorders                       Anaphylactic reactions
Nervous system disorders                      Encephalitis*, cerebellitis, cerebellitis like symptoms (including transient gait disturbance and transient ataxia), Guillain-
Barré syndrome, transverse myelitis,
peripheral neuritis
Vascular disorders                            Vasculitis
Skin and subcutaneous tissue disorders        Erythema multiforme

Musculoskeletal and connective tissue           Arthralgia, arthritis disorders



* Encephalitis has been reported with a frequency below 1 per 10 million doses. The risk of encephalitis following administration of the vaccine is far below the risk of encephalitis caused by natural diseases (measles: 1 in 1,000 to 2,000 cases; mumps: 2-4 in 1,000 cases; rubella: approximately 1 in 6,000 cases).

Accidental intravascular administration may give rise to severe reactions or even shock.
Immediate measures depend on the severity of the reaction (see section 4.4).

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).