A Nationwide Survey of mRNA COVID-19 Vaccinee's Experiences on Adverse Events and Its Associated Factors.

BACKGROUND: Although coronavirus disease 2019 (COVID-19) vaccines have been distributed worldwide under emergency use authorization, the real-world safety profiles of mRNA vaccines still need to be clearly defined. We aimed to identify the overall incidence and factors associated with adverse events (AEs) following mRNA COVID-19 vaccination. METHODS: We conducted web-based survey from December 2 to 10 in 2021 with a 2,849 nationwide sampled panel. Study participants were individuals who had elapsed at least two-weeks after completing two dosing schedules of COVID-19 vaccination aged between 18-49 years. We weighted the participants to represent the Korean population. The outcome was the overall incidence of AEs following mRNA COVID-19 vaccination and associated factors. We estimated the weighted odds ratios (ORs) using multivariable logistic regression models to identify the factors associated with AEs. RESULTS: Of the 2,849 participants (median [interquartile range] age, 35 [27-42] years; 51.6% male), 90.8% (n = 2,582) for the first dose and 88.7% (n = 2,849) for the second dose reported AEs, and 3.3% and 4.3% reported severe AEs, respectively. Occurrence of AEs was more prevalent in mRNA-1273 (OR, 2.06; 95% confidence interval [CI], 1.59-2.67 vs. BNT162b2), female sex (1.88; 1.52-2.32), and those with dermatologic diseases (2.51; 1.32-4.77). History of serious allergic reactions (1.96; 1.06-3.64) and anticoagulant medication use (4.72; 1.92-11.6) were associated with severe AEs. CONCLUSION: Approximately 90% of participants reported AEs following mRNA COVID-19 vaccination. Substantial factors, including vaccine type (mRNA-1273), female sex, and dermatologic diseases were associated with AEs. Our findings could aid policymakers in establishing vaccination strategies tailored to those potentially susceptible to AEs.

Barriers to COVID-19 vaccine surveillance: the issue of under-reporting adverse events.

Objectives: This study investigated the reporting rates of adverse events following immunization (AEFIs) to the spontaneous reporting system (SRS) and its predictors among individuals with AEFIs after coronavirus disease 2019 (COVID-19) vaccination. Methods: A cross-sectional, web-based survey was conducted from December 2 to 20, 2021, recruiting participants >14 days after completion of a primary COVID-19 vaccination series. Reporting rates were calculated by dividing the number of participants who reported AEFIs to the SRS by the total number of participants who experienced AEFIs. We estimated adjusted odds ratios (AORs) using multivariate logistic regression to determine factors associated with spontaneous AEFI reporting. Results: Among 2,993 participants, 90.9% and 88.7% experienced AEFIs after the first and second vaccine doses, respectively (reporting rates, 11.6% and 12.7%). Furthermore, 3.3% and 4.2% suffered moderate to severe AEFIs, respectively (reporting rates, 50.5% and 50.0%). Spontaneous reporting was more prevalent in women (AOR=1.54; 95% CI, 1.31-1.81); those with moderate to severe AEFIs (AOR=5.47; 95% CI, 4.45-6.73), comorbidities (AOR=1.31; 95% CI, 1.09-1.57), a history of severe allergic reactions (AOR=2.02; 95% CI, 1.47-2.77); and those who had received mRNA-1273 (AOR=1.25; 95% CI, 1.05-1.49) or ChAdOx1 (AOR=1.62; 95% CI, 1.15-2.30) vaccines versus BNT162b2. Reporting was less likely in older individuals (AOR=0.98; 95% CI, 0.98-0.99 per 1-year age increment). Conclusion: Spontaneous reporting of AEFIs after COVID-19 vaccination was associated with younger age, female sex, moderate to severe AEFIs, comorbidities, history of allergic reactions, and vaccine type. AEFI under-reporting should be considered when delivering information to the community and in public health decision-making.

Predictors of COVID-19 booster vaccine hesitancy among fully vaccinated adults in South Korea: a nationwide cross-sectional survey.

Objectives: To explore predictors of COVID-19 booster hesitancy among fully vaccinated young adults and parental factors on COVID-19 vaccine hesitancy for their children. Methods: A cross-sectional study was conducted via an online survey from December 2 to 20, 2021. We enrolled participants aged 18-49 years and elapsed ≥2 weeks after completing a primary series of COVID-19 vaccination. We estimated odds ratios (ORs) with 95% confidence intervals (CIs) using multivariate logistic regressions to evaluate factors associated with booster/vaccine hesitancy. Results: Among 2,993 participants, 48.8% indicated hesitancy (wait and see: 40.2%; definitely not: 8.7%). The booster hesitancy was more in females (OR 1.25, 95% CI 1.05-1.50), younger age group (1.44 [1.17-1.77] at 18-29 years vs. 40-49 years), lower education level (2.05 [1.10-3.82] in no high school vs. graduate degree), mRNA-1273 (2.01, 1.65-2.45 vs. BNT162b2), and those with serious adverse events following previous COVID-19 vaccination (2.03, 1.47-2.80). The main reasons for booster hesitancy were concerns about its safety (54.1%), followed by doubt about the efficacy (29.8%). Among 1,020 respondents who had children aged <18 years, 65.8% indicated COVID-19 vaccine hesitancy for their children; the hesitancy for children was higher at the younger age, and lower at lower education level, ChAdOx1 (vs. BNT162b2), and those with history of COVID-19 infection. Conclusion: Concerns on the efficacy and safety of COVID-19 vaccines were the major barrier to booster hesitancy. The initial COVID-19 vaccine type, younger age, women, lower education level, and adverse events following COVID-19 vaccine were the key predictors of booster hesitancy.