• Clinical and Experimental Pediatrics
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• v.54 no.10
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• pp.422-424
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• 2011

Acute disseminated encephalomyelitis (ADEM) is an inflammatory demyelinating disease of the central nervous system that typically follows an infection or vaccination and has a favorable long-term prognosis. We describe the first reported case of ADEM after vaccination against novel influenza A (H1N1). A previously healthy 34-month-old boy who developed ADEM presented with a seizure and left-sided weakness 5 days after vaccination against novel influenza A (H1N1). Cerebrospinal fluid examination revealed elevated cell counts. T2-weighted images and fluid-attenuated inversion recovery images revealed multiple patchy hyperintense lesions in the frontal and parietal subcortical white matter and the left thalamus. After the administration of intravenous corticosteroid, the patient's clinical symptoms improved and he recovered completely without neurologic sequelae.

• Journal of Preventive Medicine and Public Health
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• v.56 no.2
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• pp.172-179
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• 2023

Objectives: Vaccination is an important intervention for preventing disease and reducing disease severity. Universal vaccination programs have significantly reduced the incidence of many dangerous diseases among children worldwide. This study investigated the side effects after immunization in infants under 1 year of age in Lorestan Province, western Iran. Methods: This descriptive analytical study included data from all children <1 year old in Lorestan Province, Iran who were vaccinated according to the national schedule in 2020 and had an adverse event following immunization (AEFI). Data were extracted from 1084 forms on age, sex, birth weight, type of birth, AEFI type, vaccine type, and time of vaccination. Descriptive statistics (frequency, percentage) were calculated, and the chi-square test and Fisher exact test were used to assess differences in AEFIs according to the abovelisted variables. Results: The most frequent AEFIs were high fever (n=386, 35.6%), mild local reaction (n=341, 31.5%), and swelling and pain (n=121, 11.2%). The least common AEFIs were encephalitis (n=1, 0.1%), convulsion (n=2, 0.2%), and nodules (n=3, 0.3%). Girls and boys only showed significant differences in mild local reactions (p=0.044) and skin allergies (p=0.002). The incidence of lymphadenitis (p<0.001), severe local reaction (p<0.001), mild local reaction (p=0.007), fainting (p=0.032), swelling and pain (p=0.006), high fever (p=0.005), and nodules (p<0.001) showed significant differences based on age at vaccination. Conclusions: Immunization is a fundamental public health policy for controlling vaccine-preventable infectious diseases. Although vaccines such as the Bacillus Calmette-Guérin vaccine, oral poliovirus vaccine, and pentavalent vaccine are well-researched and reliable, AEFIs are inevitable.

• Korean Journal of Clinical Pharmacy
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• v.30 no.1
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• pp.19-30
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• 2020

Objective: To describe patterns of spontaneous reporting on adverse events following immunization (AEFIs) using the human papilloma virus (HPV) vaccine according to the Brighton Collaboration (BC) criteria. Methods: We used the Korea Adverse Event Reporting System (KAERS) database including vaccinations between 2008 and 2017. To apply BC criteria, we classified 58 BC AEFIs into World Health Organization Adverse Reaction Terminology (WHO-ART) codes. We applied MedDRA standard medical queries that were pre-defined as five BC AEFIs. Terminology mapping between MedDRA and WHO-ART terms was performed by three researchers. Descriptive statistics of individual case safety reports were analyzed according to BC applicability. Disproportionality analyses were performed on each BC AEFI and each preferred AEFI term according to the case-noncase approach; reporting odds ratio (ROR) and 95% confidence intervals (CI) were calculated. Results: Among the 30,266 reports of vaccinations between 2008 and 2017, 2,845 reports included the HPV vaccine. Of these reports, 1,511 (53.1%) included at least one BC AEFI. Reports from physicians or manufacturers included more BC AEFIs than from other reporters. Injection site reactions and fever were frequently reported in BC AEFIs; spontaneous abortion and ectopic pregnancy (ROR, 14.29 [95% CI, 4.30-47.49]) and vasculitic peripheral neuropathy (ROR, 8.57 [95% CI, 2.61-28.10]) showed the highest ROR. Among non-BC AEFIs, dizziness or myalgia were frequently reported; exposure during pregnancy (ROR, 23.95 [95% CI, 16.27-35.25]) and inappropriate schedule of administration (ROR, 22.89 [95% CI, 16.74-31.31]) showed the highest ROR. Conclusion: BC criteria would be applicable for labeled AEFIs, whereas analyzing non-BC AEFIs would be useful for detecting unlabeled AEFIs.

• Pediatric Infection and Vaccine
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• v.8 no.2
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• pp.135-149
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• 2001

Purpose : To describe the characteristics of the claims for compensation and the methodology of investigations concerning adverse events following immunization(AEFI) and epidemiologic characteristics of the AEFI. From these results, to give a suggestion for improving AEFI surveillance system, consequently to stabilize National Immunization Program. Methods : Totally 61 cases were reported to the National Compensation Program and surveillance system of AEFI from 1995 to 2000. Documents from National Compensation Program, medical records and epidemiologic investigation reports of the cases were collected and analyzed. Results : The number of reported cases was 12 in 1995, 3 in 1996, 12 in 1998, 5 in 1999, and 29 in 2000, respectively. That of deaths was 24(39.3%) and 16 cases among them were autopsied(66.7%). That of claims for compensation was 36 and 17 cases among them were compensated(47.2%). The proportion of claim was lower in 1999~2000 than in 1995~1998, but proportion of compensation increased. Although proportion of investigation was lower in 1999~2000 than in 1995~1998, cases which were not epidemiologically investigated, decreased. The epidemiologic investigation launched within 24 hours after report increased from 25% in 1995~1998 to 48.3% in 1999~2000. Among reported cases, the number of boys was 31(50.8%), and 75.4% of subjects were from 2 months to 24 months old. 78.4% of adverse events occurred within one week after immunization. Conclusion : We can find that surveillance system of AEFI and quality of epidemiologic investigation has been somewhat improved. But, it seems that severe cases were more frequently reported than moderate or mild cases, and reporting rate was lower than that of other developed countries. We could not identify the detailed epidemiologic characteristics of AEFI due to these limitation of data. To achieve the stabilization of National Immunization Program, reporting rate and the quality of investigation should be improved.

• Pediatric Infection and Vaccine
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• v.16 no.2
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• pp.183-190
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• 2009

Purpose : To evaluate the number and severity of adverse reactions after Japanese Encephalitis (JE) vaccination in children using different vaccines (inactivated vaccine or live attenuated vaccine) and to determine the ability and safety of the vaccines to provide effective immunization for JE. Methods : From August 2006 to February 2007, we conducted a prospective cohort study of the adverse reactions associated with JE immunization in Korea. We investigated common adverse reactions during the 4 days following immunization using telephone collaborations with four public health centers and nine pediatric clinics. Results : The mean age of children receiving the inactivated vaccines and live attenuated vaccines, respectively, were 1.4 y (range: 1 to 8.5) and 1.7 y (range: 1 to 8.3). The number of children that received the inactivated vaccines was 425 (64.6%). A total of 233 (35.4%) received the live attenuated vaccines. Fourteen children (3.3%) had more than one localized adverse event with the inactivated vaccine, and six (2.6%) had more than one event with the live attenuated vaccine (P =0.607). Systemic adverse reactions occurred in 5.2% vs. 8.2%, respectively, of these groups (P =0.131). Fever was more common in the live attenuated vaccine group than in the inactivated vaccine group on the day of vaccination (P =0.026). Conclusions : The rate of adverse events in our study was even lower than that previously reported. No significant difference in outcomes between inactivated vaccine and live attenuated vaccine was found in JE-immunized children. Fever was more common in the live attenuated vaccine group than in the inactivated vaccine group on the day of vaccination.

• Journal of Preventive Medicine and Public Health
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• v.43 no.2
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• pp.99-104
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• 2010

The World Health Organization (WHO) announced the emergence of a novel influenza on April 24, 2009, and they declared pandemic on June 11. In Korea, the proportion of influenza-like illness and the consumption of antiviral agents peaked in early November. The government established the Central Headquarters for Influenza Control and operated the emergency response system. In the quarantine stations, we checked the body temperature and collected quarantine questionnaires from all the arrivals from infected countries. We also isolated the confirmed cases in the national isolation hospitals. However, as the community outbreaks were reported, we changed strategy from containment to mitigation. We changed the antiviral agent prescription guideline so that doctors could prescribe antiviral agents to all patients with acute febrile respiratory illness, without a laboratory diagnosis. Also the 470 designated hospitals were activated to enhance the efficacy of treatment. We vaccinated about 12 million people and manage the adverse event following the immunization management system. In 2010, we will establish additional national isolation wards and support hospitals to establish fever clinics and isolation intensive care unit (ICU) beds. We will also make a computer program for managing the national isolation hospitals and designated hospitals. We will establish isolation rooms and expand the laboratory in quarantine stations and we will construct a bio-safety level 3 laboratory in each province. In addition, we plan to construct a bio-safety level 4 laboratory at a new Korea Centers for Disease Control and Prevention (KCDC) facilities in Ossong.

• Clinical and Experimental Vaccine Research
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• v.11 no.1
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• pp.43-52
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• 2022

Purpose: Indonesia, a high populous and the second-highest country in epidemicity of hepatitis B in South-East Asia require maintaining its capacity of monovalent hepatitis B production to keep up with both the national immunization program and global needs. To keep the sustainability of the vaccine, a new bulk is needed to be made available. This study aims to evaluate the immunogenicity and safety of Bio Farma newly formulated recombinant hepatitis B vaccines, which came from different sources of bulk, compared to the already registered hepatitis B vaccine. Materials and Methods: An experimental, randomized, double-blind, cohort intervention phase II clinical trial was conducted on three recombinant hepatitis B vaccines from different bulk sources, with Bio Farma registered hepatitis B vaccine as the control group. A total of 536 participants around age 10 to 40 years old were thricely vaccinated with twice serological assessments. The subject's safety was monitored for 28 days after each vaccination. Results: Of 536 enrolled participants, 521 finished the vaccination and serology assessments. The investigational products were proven not to be inferior to the control. All vaccines were well tolerated. No differences in rates of local and systemic reactions were seen between the investigational products and control. No serious adverse event was found to be related to the investigational vaccines. Conclusion: Investigational vaccines are shown to be equally immunogenic and safe as the control vaccine.