Abstract :
Objectives: As the COVID-19 pandemic is an emerging healthcare concern, there has been swift vaccine development with minimal clinical trials questioning its protective efficacy outside of clinical trial conditions. The study aims to analyze the adverse events following immunization (AEFI) with COVID-19 vaccines among the domestic Indian population. It also aimed to evaluate the association between AEFI and demographic characteristics, comorbidities, and type of vaccine.
Materials and Methods: This cross-sectional survey included participants ? 18 years of Indian origin for passive reporting of AEFI with COVID-19 vaccination using a questionnaire. The incidence of AEFI was calculated in percentage; the Chi-square test was used to determine associations between AEFI and independent variables.
Results: The incidence of reported AEFI was 76.4%. The most frequently reported AEFI was redness [74.38% (n?=?328)], followed by pain [52.83% (n?=?233)], swelling [52.83% (n?=?233)], and fever [50.34% (n?=?222)]. The majority of AEFIs were mild to moderate and resolved spontaneously. Females had significantly more AEFI with longer duration than males. The type of vaccine received had no significant effect on the number or duration of AEFI; 3.63% tested positive for COVID-19 after the first dose and 3.11% after the second dose of the vaccine, with no significant correlation between comorbidities and the presence of AEFI.
Conclusion: More than three-fourths of the vaccines resulted in one or more forms of adverse events, but most events were self-limiting. Females were more prone to develop AEFI. Knowledge about what to expect after vaccination will help educate the public, allay misconceptions and reduce vaccine hesitancy.
Keyword :
Aefi, COVID19, India, Vaccine, Vaccine development