Adverse reactions : תופעות לוואי

ADVERSE REACTIONS
Body System As A Whole
In earlier studies with the vaccine grown in primary monkey kidney cells, transient local reactions at the site of injection were observed. Erythema, induration and pain occurred in 3.2%, 1% and 13%, respectively, of vaccinees within 48 hours post-vaccination. Temperatures of ≥39°C were reported in 38% of vaccinees. Other symptoms included irritability, sleepiness, fussiness, and crying. Because IPV was given in a different site but concurrently with Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (DTP), these systemic reactions could not be attributed to a specific vaccine. However, these systemic reactions were comparable in frequency and severity to that reported for DTP given alone without IPV. Although no causal relationship has been established, deaths have occurred in temporal association after vaccination of infants with IPV.
Four additional US studies using IMOVAX POLIO vaccine in more than 1,300 infants, between        2 to 18 months of age administered with DTP at the same time at separate sites or combined have demonstrated that local and systemic reactions were similar when DTP was given alone.

Table 2 : Percentage of Infants Presenting with Local or Systemic Reactions at 6, 24, and 48 Hours of Immunization with IMOVAX POLIO Vaccine Administered Intramuscularly Concomitantly at Separate Sites with Sanofi* Whole-Cell DTP Vaccine at 2 and 4 Months of Age and with Sanofi Acellular Pertussis Vaccine (Tripedia®) at 18 Months of Age 

AGE AT IMMUNIZATION
2 Months                             4 Months                      18 Months† 
REACTION                             (n=211)                              (n=206)                         (n=74) 
6 Hrs. 24 Hrs.     48 Hrs.           6 Hrs. 24 Hrs.     48 Hrs.   6 Hrs.     24 Hrs. 48 Hrs.

Local, IMOVAX POLIO vaccine alone‡
Erythema >1"                     0.5%      0.5%       0.5%            1.0%    0.0%        0.0%     1.4%        0.0%     0.0% 
Swelling                        11.4%      5.7%       0.9%           11.2%    4.9%        1.9%     2.7%        0.0%     0.0% 
Tenderness                      29.4%      8.5%       2.8%           22.8%    4.4%        1.0%    13.5%        4.1%     0.0% 
Systemic§

Fever >102.2°F                   1.0%      0.5%       0.5%            2.0%    0.5%        0.0%     0.0%        0.0%     4.2% 
Irritability                    64.5%     24.6%      17.5%           49.5%   25.7%       11.7%    14.7%        6.7%     8.0% 
Tiredness                       60.7%     31.8%       7.1%           38.8%   18.4%        6.3%     9.3%        5.3%     4.0% 
Anorexia                        16.6%      8.1%       4.3%            6.3%    4.4%        2.4%     2.7%        1.3%     2.7% 
Vomiting                         1.9%      2.8%       2.8%            1.9%    1.5%        1.0%     1.3%        1.3%     0.0% 

Persistent Crying                Percentage of infants within 72 hours after immunization was 0.0% after dose one, 1.4% after dose two, and 0.0% after dose three.


* Sanofi Pasteur Inc. formerly known as Aventis Pasteur Inc.
† Children who have been vaccinated with Tripedia vaccine.
‡ Data are from the IMOVAX POLIO vaccine administration site, given intramuscularly.
§ The adverse reaction profile includes the concomitant use of Sanofi whole-cell DTP vaccine or Tripedia vaccine with IMOVAX POLIO vaccine. Rates are comparable in frequency and severity to that reported for whole-cell DTP given alone.
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Digestive System
Anorexia and vomiting occurred with frequencies not significantly different as reported when DTP was given alone without IPV or OPV.

Nervous System
Although no causal relationship between IMOVAX POLIO vaccine and GBS has been established, GBS has been temporally related to administration of another inactivated poliovirus vaccine.

Post-marketing Experience

The following adverse events have been identified during postapproval use of IMOVAX POLIO vaccine. Because these events are reported voluntarily from a population of uncertain size, it may not be possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Adverse events were included based on one or more of the following factors: severity, frequency of reporting or strength of evidence for a causal relationship.
• Blood and lymphatic system disorders: lymphadenopathy
• General disorders and administration site conditions: agitation, injection site reaction including injection site rash and mass
• Immune system disorders: type I hypersensitivity including allergic reaction, anaphylactic reaction, and anaphylactic shock
• Musculoskeletal and connective tissue disorders: arthralgia, myalgia 
•   Nervous system disorders: convulsion, febrile convulsion, headache, paresthesia, and somnolence
•   Skin and subcutaneous tissue disorders: rash, urticarial

Reporting of Adverse Events
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