Adverse Events Following COVID-19 Immunization Reported Through Hotlines, February-August 2021, Bangladesh: Descriptive Study (Preprint)

Abstract

BACKGROUND For COVID-19 vaccine safety, the vaccination program of Bangladesh started facility-based passive surveillance to address adverse events following immunization (AEFIs) of COVID-19 vaccination. Institute of Epidemiology, Disease Control and Research (IEDCR), Bangladesh has been using emergency hotlines for outbreak reporting since 2008. During the COVID-19 pandemic, these hotlines are used for pandemic-related information and reporting. Thus, COVID-19 vaccinees also use these hotlines to report AEFIs. OBJECTIVE We analyzed the documented AEFIs records of IEDCR to characterize the vaccinees who reported AEFIs through IEDCR hotlines. METHODS We performed descriptive analysis of COVID-19 vaccinees who reported AEFIs through IEDCR hotlines from February to August 2021. We defined AEFIs as untoward medical occurrences which follow immunization and which do not necessarily have a causal relationship with the usage of the vaccines. We analyzed the vaccinees who reported AEFIs through IEDCR hotlines by age, gender, occupation, the severity of AEFIs, and time intervals of reporting. RESULTS Among 819 vaccinees who reported AEFIs through IEDCR hotlines, 68% (555/819) were male and their median age was 41 years (interquartile range: 32-51 years). Of them, 89% reported AEFIs following 1st dose of vaccination. Among females, 71% (186/264) were housewives. Among males, 45% (249/555) were service holders, 16% (90/555) were businessmen, 8% (46/555) were students. About 78% (638/819) of vaccinees were from urban vaccination centers. Vaccinees who had mild AEFIs like fever (62%), injection-site pain (41%), headache (25%) were reported through IEDCR hotlines. Although 65% (534/819) vaccinees who reported AEFIs through IEDCR hotlines developed symptoms within 24 hours of vaccination, only 24% (196/819) vaccinees reported them within 24 hours. CONCLUSIONS Middle-aged, males, and urban vaccinees who developed mild AEFIs commonly reported AEFIs through IEDCR hotlines. We recommended that AEFIs data generated from different reporting systems including hotline numbers should be incorporated together for an efficient COVID-19 vaccine safety surveillance system.