Objectives The aim of this study was to disseminate information about the safety of bivalent coronavirus disease 2019 (COVID-19) mRNA booster vaccines administered to adults in the Republic of Korea.
Methods Two databases were used to assess the safety of COVID-19 booster doses of Pfizer BA.1, Pfizer BA.4/5, Moderna BA.1, and Moderna BA.4/5 vaccines for adults aged 18 years and older. Adverse events (AEs) were analyzed using data reported to the web-based COVID-19 vaccination management system (CVMS) and a self-reported text-message survey.
Results Between October 11, 2022 and March 30, 2023, the CVMS received reports of 2,369 (93.7%) non-serious AEs from vaccinated adults, along with 158 (6.3%) serious AEs, which included 5 cases of anaphylaxis and 33 deaths. From October 11, 2022 to January 27, 2023, 40,022 people aged 18 and older responded to a survey conducted via text message. The booster doses were associated with fewer local and systemic AEs compared to the original vaccines. After receiving the bivalent vaccine, the most commonly reported AEs were pain at the injection site, headache, fatigue, and myalgia.
Conclusion Overall, bivalent vaccines exhibited fewer AEs compared to the original vaccines. The majority of AEs were non-serious, and serious AEs were rare among adults aged 18 years and older following vaccination with the Pfizer and Moderna bivalent vaccines.
Objectives With the recent global mpox outbreak, the JYNNEOS vaccine (Modified Vaccinia Ankara-Bavarian Nordic) was developed as a third-generation smallpox vaccine and initially favored for mpox immunization. Vaccine-associated side effects contribute to vaccine hesitancy. Consequently, tracking adverse events post-immunization is crucial for safety management. This study used data from the national active vaccine safety surveillance conducted in Korea from August 25 to November 24, 2022 to detect potential safety signals and adverse events. Methods: Data on health conditions following vaccination were gathered from web-based surveys and reported via active surveillance through the Immunization Registry Information System. This follow-up system functioned via a text message link, surveying adverse events and health conditions beginning on the second day post-vaccination. Information about specific adverse events, including both local and systemic reactions, was collected. Results: The study included 86 healthcare workers who had received at least 1 dose of the JYNNEOS vaccine. Among the respondents, 79.1% reported experiencing at least 1 adverse event, with the majority being local reactions at the injection site. The incidence of adverse events was higher following the first dose (67.9%) than after the second dose (34.4%). The most frequently reported adverse event for both doses was mild pain at the injection site. Conclusion: The study provides crucial information on the safety of the JYNNEOS vaccine, demonstrating that most adverse events were manageable and predominantly localized to the injection site. Nonetheless, additional research is needed on the safety of various vaccine administration techniques and the vaccine’s effects on broader demographics.
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Objectives This study aimed to examine the prevalence and pattern of adverse events following childhood immunization and the responses of mothers in Ile-Ife, South West Nigeria.
Methods This descriptive cross-sectional study was conducted among 422 mothers of children aged 0 to 24 months attending any of the 3 leading immunization clinics in Ile-Ife, Nigeria. The respondents were selected using the multi-stage sampling technique. Data were collected using a pretested structured interviewer-administered questionnaire and analyzed using IBM SPSS ver. 26.0. The chi-square test was used to test associations, while binary logistic regression was used to determine the predictors of mothers’ responses to adverse events following immunization (AEFIs). A p-value of <0.05 was considered statistically significant.
Results The mean age of the respondents was 29.99±5.74 years. About 38% of the children had experienced an AEFI. Most mothers believed that the pentavalent vaccine was the most common cause of AEFIs (67.5%). Fever (88.0%) and pain and swelling (76.0%) were the most common AEFIs. More than half of the mothers (53.7%) administered home treatment following an AEFI. Younger mothers (odds ratio [OR], 2.43; 95% confidence interval [CI], 1.20–5.01), mothers who delivered their children at a healthcare facility (OR, 3.24; 95% CI, 1.08–9.69), and mothers who were knowledgeable about reporting AEFIs (OR, 2.53; 95% CI, 1.04–7.70) were most likely to respond appropriately to AEFIs.
Conclusion The proportion of mothers who responded poorly to AEFIs experienced by their children was significant. Therefore, strategies should be implemented to improve mothers’ knowledge about AEFIs to improve their responses.
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Objectives Age-specific information regarding myocarditis/pericarditis in adolescents following mRNA-based coronavirus disease 2019 (COVID-19) vaccination in Asia remains insufficient. This study investigated the incidence and clinical characteristics of myocarditis/pericarditis in Republic of Korea adolescents after mRNA-based COVID-19 vaccination.
Methods This retrospective descriptive study utilized patient data from the Korea Immunization Management System. Incidence rates were calculated according to age and sex. Clinical characteristics (symptoms/signs, laboratory values, and imaging results) were compared between mild and severe cases.
Results Between July 19, 2021 and September 30, 2022, 3,728,224 individuals aged 12 to 19 years received 6,484,165 mRNA-based COVID-19 vaccines, and 173 cases met the case definition for myocarditis/pericarditis: 151 mild (87.3%) and 22 severe (12.7%). The incidence was 3.8-fold higher in males than in females. Troponin I/ troponin T was elevated in 96% of myocarditis cases, demonstrating higher sensitivity than creatine kinase-myocardial band (67.6%) or C-reactive protein (75.2%). ST-segment or Twave on electrography abnormalities were found in 60.3% (85/141). Paroxysmal/sustained atrial/ventricular arrhythmias were more common in severe than in mild cases (45.5% vs. 16.8%, p=0.008). Edema on T2-weighted magnetic imaging occurred in 21.6% (8/37) and 62.5% (5/8) of mild and severe cases, respectively (p=0.03). Abnormal pericardial fluid collection or pericardial inflammation was found in 75.4% of pericarditis cases (49/65).
Conclusion Myocarditis/pericarditis occurred in rare cases following mRNA-based COVID-19 vaccination. Most cases were mild, but the incidence was higher in adolescent males and after the second dose. As bivalent severe acute respiratory syndrome coronavirus 2 mRNA vaccination started in Republic of Korea in October 2022, the post-vaccination incidence of myocarditis/pericarditis should be closely monitored, considering clinical characteristics.
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Objectives On February 26, 2021, coronavirus disease 2019 (COVID-19) vaccination was started for high-priority groups based on the recommendation of the Advisory Committee on Immunization Practices with 2 available COVID-19 vaccines (AstraZeneca and Pfizer-BioNTech) in Korea. This report provides a summary of adverse events following COVID-19 vaccination as of April 30, 2021.
Methods Adverse events following immunization are notifiable by medical doctors to the Korea Immunization Management System (KIMS) under the national surveillance system. We analyzed all adverse events reports following COVID-19 vaccination to the KIMS from February 26 to April 30, 2021.
Results In total, 16,196 adverse events following 3,586,814 administered doses of COVID-19 vaccines were reported in approximately 2 months (February 26 to April 30, 2021). Of these, 15,658 (96.7%) were non-serious adverse events, and 538 (3.3%) were serious adverse events, including 73 (0.5%) deaths. The majority of adverse events (n=13,063, 80.7%) were observed in women, and the most frequently reported adverse events were myalgia (52.2%), fever (44.9%), and headache (34.9%). Of the 73 deaths following the COVID-19 vaccination, none were related to the vaccines.
Conclusion By April 30, 3.6 million doses of the COVID 19 vaccine had been given in Korea, and the overwhelming majority of reports were for non-serious events. The Korea Disease Control and Prevention Agency continues to monitor the safety of COVID-19 vaccination.
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Objectives
The purpose of this study was to investigate the correlation between nursing workload and nurse-perceived patient adverse events. Methods
A total of 1,816 nurses working in general inpatient units of 23 tertiary general hospitals in South Korea were surveyed, and collected data were analyzed through multilevel logistic regression analysis. Results
Among variables related to nursing workload, the non-nursing task experience had an influence on all four types of patient adverse events. Nurses with non-nursing tasks experienced patient adverse events—falls [odds ratio (OR) = 1.31], nosocomial infections (OR = 1.23), pressure sores (OR = 1.16), and medication errors (OR = 1.23)—more often than occasionally. In addition, when the bed to nurse ratio was higher, nurses experienced cases of pressure sores more often (OR = 1.35). By contrast, nurses who said the nursing workforce is sufficient were less likely than others to experience cases of pressure sores (OR = 0.78). Hospitals with a relatively high proportion of nurses who perceived the nursing workforce to be sufficient showed a low rate of medication error (OR = 0.28). Conclusion
The study suggested that the high level of nursing workload in South Korea increases the possibility of patient adverse events.
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