Adverse reactions : תופעות לוואי

4.8   Undesirable effects
Very rarely, vaccine-associated paralysis has been observed with trivalent oral poliomyelitis vaccines (less than one case per 1 million doses administered). The majority of cases of vaccine-associated paralytic poliomyelitis (VAPP) occurred after the administration of the first dose.

Fever, vomiting and diarrhoea have been observed after immunization with Polio Sabin One and Three (oral).
Allergic/anaphylactoid reactions have been described after immunization with GlaxoSmithKline Biologicals' trivalent oral poliomyelitis vaccine.

The frequencies by dose are defined as follows:
Very rare: (<1/10,000)

Organ system classes                         Frequency                          Undesirable effects General disorders and                                Very rare1                 Fever2 administration site condition
Gastro-intestinal disorders                          Very rare1                 Diarrhoea2, vomiting2 Immune system disorders                              Very rare1                 Allergic/anaphylactoid reactions3 1
Infections and infestations                          Very rare                  Vaccine-associated paralysis3 1
Frequency based on post-marketing surveillance data on trivalent poliomyelitis vaccines 2
Undesirable effects reported in the context of a clinical trial conducted in Bangladesh 3
Undesirable effects based on post-marketing surveillance data on trivalent poliomyelitis vaccines 
Reporting suspected undesirable effects
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 (http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.gov.il).
Additionally, you should also report to GSK Israel (il.safety@gsk.com).