Abstract
Introduction: On June 2023, more that 400 million vaccine doses have been administered in Indonesia. [1] Adverse Events Following Immunization (AEFI) can be perceived by some recipients of the COVID-19 vaccine. Several studies about AEFI of COVID-19 vaccine has been done in some countries [2-5], but in Indonesia the data is still limited. Aim: To analyse the adverse effects of COVID-19 vaccination and factors correlated to the incident. Methods: We developed an online validated self-administered questionnaire based on previous study. [6] This study used crosssectional method with adult vaccinated respondents at one of primary health centre in Indonesia by using consecutive and snowball sampling. Patients included in this study had received COVID-19 vaccine between January 2021 and April 2022. Descriptive and inferential statistics using SPSS 25.0 were done to analyse the data. Results: A total of 200 respondents were included in this study with 526 vaccine doses consists of 307 (58.4%) Sinovac, 117 (22.2%) Moderna, 51 (9.7%) AstraZeneca, and 51 (9.7%) Pfizer-BioNTech COVID-19 vaccine. Most of the respondents 127 (63.5%) experienced AEFIs after receiving the COVID-19 vaccine. The most commonly reported adverse events were pain/soreness at the injection site (19.29%), increased drowsiness (12.89%), fatigue/lethargy/lack of energy (10.22%), fever (9, 51%), and joint/muscle pain (7.73%). AEFI was experience mostly with onset of 4-12 hours after administration (44.9%) with duration of 1-3 days (58.3%). Vaccine type and doses significantly affected the incidence of fever, local, neuromuscular-skeletal, and nervous system events (p < 0.05). Female patient (p < 0.05, OR = 1.836) and patient with comorbidities (p < 0.05, OR = 2.02) tend to have more local events. Younger age complaint more about the incidence of nervous system events (p < 0.05, OR = 0.433), while different Body Mass Index (BMI) showed no correlation with any observed adverse events following COVID-19 vaccination. Conclusions: This study emphasized that most of COVID-19 vaccine adult recipients in Indonesia experienced AEFI with some factors contribute including type and dose of vaccine, gender, having comorbid, and age.
Original language | English |
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Publication status | Published - Nov 2023 |
Event | The 22nd Annual Meeting of the International Society of Pharmacovigilance (ISoP 2023) - Bali, Indonesia Duration: 6 Nov 2023 → 9 Nov 2023 |
Conference
Conference | The 22nd Annual Meeting of the International Society of Pharmacovigilance (ISoP 2023) |
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Country/Territory | Indonesia |
City | Bali |
Period | 6/11/23 → 9/11/23 |