Adverse Events Following Immunization with DTP Vaccine in Infants and Children in Kermanshah City: A Cohort Study

• Main Authors: M Karami, K Holakouie Naieni, A Rahimi, A Fotouhi, H Eftekhar Ardabili
• Format: Article
• Language: fas
• Published: Tehran University of Medical Sciences 2006-02-01
• Series: مجله اپیدمیولوژی ایران
• Subjects: DTP vaccine; Adverse Events Following Immunizations (AEFIs); Cumulative Incidence Rate
• Online Access: http://irje.tums.ac.ir/browse.php?a_code=A-10-25-195&slc_lang=en&sid=1
• ISSN: 1735-7489; 2228-7507

Background & Objectives: The DPT vaccine used in Iran is manufactured by the Razi Institute. So far, there have been no studies to determine the incidence and severity of adverse reactions to this vaccine. It was this lack of reliable information, plus concern for the unfavorable effects of such reactions on compliance with the vaccination schedule, that prompted the current study on DPT side effects.Methods: In this cohort study, 1910 children aged 0 to 6 were divided into different groups (cohorts) on the basis of factors such as injection site and then monitored for the appearance of adverse effects. Data for this study were gathered through questionnaires filled by telephone or house-to-house interviews. We interviewed parents of children attending the 46 urban health clinics in Kermanshah. These interviews produced the data needed to fill the first part of the study questionnaire. The investigators then gave each parent an "information sheet" containing the data necessary for the second part of the questionnaire. The interviewee was asked to record on this sheet any adverse effects occurring over the following 48 hours. At the end of this period, the parent was contacted via telephone to fill the second part of the questionnaire. Data thus gathered were analyzed using the Statistical Package for Social Sciences (SPSS), version 11.5. Results: In 1910 DTP immunizations given to children 0 to 6 years of age, followed for the development of adverse events occurring within 48 hours after immunization, the cumulative incidence rates were as follows: Swelling, 40.66% (38.43-42.89%); Redness, 43.08% (40.84-45.32%); Pain, 67.32% (65.20-69.40%); Fever (>38° C) 54.14% (51.89-56.40%); Fever (>40.5° C) 1.11% (0.64-1.59%); Drowsiness, 33.35% (31.21-35.48%); Persistent crying, 13.35% (11.81-14.88%); Local reactions, 75.79% (73.86-77.73%) and Systemic Reactions, 69.84% (67.76-71.97%). Only one child developed convulsion following immunization.Conclusions: Varying reaction rates in different studies, such as high rate of pain and persistent crying in this study, may reflect the different preparations that were used or differenced in the methods for vaccine evaluation. Moreover, because of the severity of systemic reactions, DTP vaccine should be administered in the thigh region