Identification and Reporting of Adverse events following Immunization – A Prospective and Observational Study-Reference-Cited by-同舟云学术

Identification and Reporting of Adverse events following Immunization – A Prospective and Observational Study

Published:2024-07-24 Issue: Volume: Page:3409-3414
ISSN:0974-360X
Container-title:Research Journal of Pharmacy and Technology
language:en
Short-container-title:RJPT

Author:

Kumar A. Pramod¹,Boopathi Dharini²,Shaik Rahamthulla³,Naik Bhukya Srikanth³,goldstone Alladi Mighty³,Pravalika Mallavarapu Bala³,Mani Deepalakshmi⁴

Affiliation:

1. Department of Pharmacy Practice, Faculty of Pharmacy, MS Ramaiah College of Pharmacy Ramaiah University of Applied Sciences, Bangalore - 560054, Karnataka, India.

2. Senior Pharmacovigilance Associate - Adverse Reaction Monitoring Centre, Karpagam Faculty of Medical Science and Research, Coimbatore, India.

3. Department of Pharmacy Practice, Chebrolu Hanumaiah Institute of Pharmaceutical Sciences, Chowdavaram, Andhra Pradesh, India.

4. Department of Pharmacy Practice, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Ooty, Nilgiris, Tamil Nadu, India.

Abstract

Universal immunization programme monitors the efficacy and safety data related to vaccines via Adverse Events Following Immunization Secretariat and Immunization Technical Support Unit. Despite, there is a large data about AEFI; there exists a least data regarding the assessment of observed AEFIs. The objective of the study is to identify, report and assess the AEFIs for causality, severity, predictability and preventability. The prospective and observational study enrolled eligible subjects of age 0-14 weeks receiving vaccination from the immunization center at NRI general and multi-specialty hospital, Guntur, Andhra Pradesh. The study participants were monitored for 30 minutes post-vaccination and a telephonic survey was conducted after one week to identify AEFIs. All the AEFIs were assessed for causality, severity, predictability, preventability using appropriate scales. The incidence rate of observed AEFIs after Pentavalent-I dose was found to be 92.26. The most frequently observed AEFI was fever (26.62%) followed by Erythema (28.08%), swelling (25.21%), crying for 24 hrs (19.33%) and crying for 48 hr (3.33%). Upon causality assessment all the AEFIs were found to be consistent and vaccine product related reactions. 51.23% of AEFIs were found to be mild and rest was moderate in their severity. All the AEFIs were found to be predictable and 26.62% of AEFIs were preventable. Incidence rates of AEFIs were much higher than similar, previous studies. There existsno immunization-error related, vaccine-quality related, immunization-anxiety related reactions in our study. AEFI identification and reporting should be made mandatory at all clinics to know the incidence rates and severity among different population and to predict and prevent the severe AEFIs.

Publisher

A and V Publications

Reference20 articles.

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