Short-term adverse events after COVAXIN vaccination in adolescents (15–18 Years) in Northern India: Frequency, predictors, and reporting behavior
Background: India initiated COVID-19 vaccination for adolescents (aged 15–18 years) on January 3, 2022, exclusively using COVAXIN. Adolescent-specific safety data remain limited, and adverse event following immunization (AEFI) reporting is notably low. This study evaluated the frequency, characteris...
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Elsevier
2025-07-01
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| Series: | Clinical Epidemiology and Global Health |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S221339842500171X |
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| author | Sujoy Bose Arpita Bhriguvanshi Mehul Saxena |
| author_facet | Sujoy Bose Arpita Bhriguvanshi Mehul Saxena |
| author_sort | Sujoy Bose |
| collection | DOAJ |
| description | Background: India initiated COVID-19 vaccination for adolescents (aged 15–18 years) on January 3, 2022, exclusively using COVAXIN. Adolescent-specific safety data remain limited, and adverse event following immunization (AEFI) reporting is notably low. This study evaluated the frequency, characteristics, and predictors of adolescents' short-term, self-reported AEFI post-COVAXIN vaccination and assessed their awareness and practices regarding official AEFI reporting mechanisms. Methods: A retrospective cohort study was conducted between May and September 2022 among 411 adolescents vaccinated with at least one dose of COVAXIN across schools in urban and rural Lucknow, Northern India. Data on demographics, vaccine doses, AEFI symptoms, onset, duration, management, prior SARS-CoV-2 infection, and awareness and reporting behaviors were collected via a validated questionnaire through face-to-face interviews. Results: 65.45 % reported AEFI after the first dose and 56 % after the second. The most common reactions included injection-site pain, fever, and headache, predominantly occurring within 12 h and resolving within three days. Females reported significantly higher AEFI frequency (Adjusted OR = 3.0; 95 %CI:1.23–7.37), and the first dose was associated with greater reactogenicity (Adjusted OR = 1.55; 95 %CI:1.14–2.09). Prior SARS-CoV-2 infections significantly influenced AEFI occurrence. Despite frequent mild, self-limiting symptoms, awareness of official AEFI reporting mechanisms was low (18 %), with only 1.2 % formally reporting their symptoms. Conclusion: COVAXIN vaccination in adolescents demonstrated a favorable short-term safety profile with predominantly mild, transient reactions. However, critically low awareness and negligible formal reporting highlight an urgent need to strengthen vaccine safety monitoring and public education on reporting practices. |
| format | Article |
| id | doaj-art-71dfd6b58f474815b3b3cf2d86ec2c99 |
| institution | Matheson Library |
| issn | 2213-3984 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Clinical Epidemiology and Global Health |
| spelling | doaj-art-71dfd6b58f474815b3b3cf2d86ec2c992025-07-26T05:23:12ZengElsevierClinical Epidemiology and Global Health2213-39842025-07-0134102082Short-term adverse events after COVAXIN vaccination in adolescents (15–18 Years) in Northern India: Frequency, predictors, and reporting behaviorSujoy Bose0Arpita Bhriguvanshi1Mehul Saxena2Faculty of Medical Sciences, King George's Medical University, Shah Mina Road, Chowk, Lucknow, 226003, Uttar Pradesh, IndiaDepartment of Pediatrics, King George's Medical University, Shah Mina Road, Chowk, Lucknow, 226003, Uttar Pradesh, IndiaFaculty of Medical Sciences, King George's Medical University, Shah Mina Road, Chowk, Lucknow, 226003, Uttar Pradesh, India; Corresponding author.Background: India initiated COVID-19 vaccination for adolescents (aged 15–18 years) on January 3, 2022, exclusively using COVAXIN. Adolescent-specific safety data remain limited, and adverse event following immunization (AEFI) reporting is notably low. This study evaluated the frequency, characteristics, and predictors of adolescents' short-term, self-reported AEFI post-COVAXIN vaccination and assessed their awareness and practices regarding official AEFI reporting mechanisms. Methods: A retrospective cohort study was conducted between May and September 2022 among 411 adolescents vaccinated with at least one dose of COVAXIN across schools in urban and rural Lucknow, Northern India. Data on demographics, vaccine doses, AEFI symptoms, onset, duration, management, prior SARS-CoV-2 infection, and awareness and reporting behaviors were collected via a validated questionnaire through face-to-face interviews. Results: 65.45 % reported AEFI after the first dose and 56 % after the second. The most common reactions included injection-site pain, fever, and headache, predominantly occurring within 12 h and resolving within three days. Females reported significantly higher AEFI frequency (Adjusted OR = 3.0; 95 %CI:1.23–7.37), and the first dose was associated with greater reactogenicity (Adjusted OR = 1.55; 95 %CI:1.14–2.09). Prior SARS-CoV-2 infections significantly influenced AEFI occurrence. Despite frequent mild, self-limiting symptoms, awareness of official AEFI reporting mechanisms was low (18 %), with only 1.2 % formally reporting their symptoms. Conclusion: COVAXIN vaccination in adolescents demonstrated a favorable short-term safety profile with predominantly mild, transient reactions. However, critically low awareness and negligible formal reporting highlight an urgent need to strengthen vaccine safety monitoring and public education on reporting practices.http://www.sciencedirect.com/science/article/pii/S221339842500171XAdverse events following immunization (AEFI)COVAXINAdolescentsVaccine safetyIndia |
| spellingShingle | Sujoy Bose Arpita Bhriguvanshi Mehul Saxena Short-term adverse events after COVAXIN vaccination in adolescents (15–18 Years) in Northern India: Frequency, predictors, and reporting behavior Clinical Epidemiology and Global Health Adverse events following immunization (AEFI) COVAXIN Adolescents Vaccine safety India |
| title | Short-term adverse events after COVAXIN vaccination in adolescents (15–18 Years) in Northern India: Frequency, predictors, and reporting behavior |
| title_full | Short-term adverse events after COVAXIN vaccination in adolescents (15–18 Years) in Northern India: Frequency, predictors, and reporting behavior |
| title_fullStr | Short-term adverse events after COVAXIN vaccination in adolescents (15–18 Years) in Northern India: Frequency, predictors, and reporting behavior |
| title_full_unstemmed | Short-term adverse events after COVAXIN vaccination in adolescents (15–18 Years) in Northern India: Frequency, predictors, and reporting behavior |
| title_short | Short-term adverse events after COVAXIN vaccination in adolescents (15–18 Years) in Northern India: Frequency, predictors, and reporting behavior |
| title_sort | short term adverse events after covaxin vaccination in adolescents 15 18 years in northern india frequency predictors and reporting behavior |
| topic | Adverse events following immunization (AEFI) COVAXIN Adolescents Vaccine safety India |
| url | http://www.sciencedirect.com/science/article/pii/S221339842500171X |
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