ABSTRACT
Objective@#To investigate the incidence of adverse event following immunization (AEFI) with 13-valent pneumococcal polysaccharide conjugate vaccine (PCV13) in Jiaxing City, Zhejiang Province, so as to provide insights into safety monitoring and evaluation of PCV13.@*Methods@#Surveillance data of AEFI with PCV13 in Jiaxing City from 2020 to 2022 were collected from the AEFI Monitoring Information Management System of the Immunization Planning System of Chinese Disease Prevention and Control Information System, including demographic information, vaccination time, time of AEFI occurrence and clinical symptoms, and the reported incidence, population and district distribution, and clinical symptoms of AEFI with PCV13 were descriptively analyzed.@*Results@#Totally 455 cases of AEFI with PCV13 were reported in Jiaxing City from 2020 to 2022, with a reported incidence rate of 232.33/105 doses. There were 431, 21 and 3 cases of general, abnormal, coincidence and psychogenic reactions, with reported incidence rates of 220.07/105 doses, 10.72/105 doses and 1.53/105 doses, respectively, and no reports of causal reaction, vaccine quality accident and vaccination accident. The AEFI cases included 258 boys and 197 girls, with a boy/girl ratio of 1.31∶1, and 288 children at ages of less than a year (63.30%). The largest number of AEFI was reported in Haining City (87 cases, 19.12%), and there were 349 AEFI cases (76.70%) within 24 hours following vaccination. The clinical symptoms mainly included redness and swelling, fever and induration, with reported incidence rates of 132.76/105 doses (260 cases), 109.27/105 doses (214 cases), and 55.66/105 doses (109 cases), respectively. There were 450 cases cured and 5 cases improved in 455 cases of AEFI.@*Conclusions@#General reaction is the predominant AEFI in Jiaxing City from 2020 to 2022, with mild symptoms. Most AEFI occurs within 24 hours following vaccination, and has a good prognosis.
ABSTRACT
Objective @#To investigate the incidence of suspected adverse events following immunization(AEFI) in Chongchuan District, Nantong City, Jiangsu Province from 2008 to 2022, so as to provide insights into safety assessment of vaccines. @*Methods@#The data on AEFI surveillance in Chongchuan District from 2008 to 2022 were collected through the National Immunization Program Information Management System of China, including demographics, history of vaccination, laboratory tests, incidence of AEFI and clinical characteristics. The epidemiological, clinical characteristics and reported incidence of AEFI were analyzed in Chongchuan District from 2008 to 2022 using a descriptive epidemiological method. @*Results@#The reported incidence of AEFI in Chongchuan District from 2008 to 2022 appeared a tendency towards a decline (P<0.05), and the annual average reported incidence was 50.85/105. The incidence of AEFI associated with vaccines included in the national immunization program was significantly higher than that caused by vaccines that were not included in the national immunization program (74.67/105 vs. 20.35/105, P<0.05). General reaction was the predominant type of AEFI (1 937 cases, 44.21/105), and there were 274 cases with abnormal reactions (6.25/105) and 17 cases with coincident syndromes (0.39/105); however, no vaccine quality or vaccination accidents occurred. A high incidence rate was seen in AEFI associated with vaccines administered by subcutaneous (75.05/105) and intramuscular injection (47.40/105), and a low incidence rate was found in AEFI associated with vaccines administered orally (16.41/105). The five highest reported incidence rates of AEFI were found for the combined diphtheria, tetanus, acellular pertussis, poliovirus and Haemophilus influenzae type b vaccine (312.01/105), 7-valent pneumococcal polysaccharide-protein conjugate vaccine (292.14/105), inactivated Japanese encephalitis vaccine (248.37/105), Group ACYW135 meningococcal polysaccharide vaccine (240.67/105) and combined live vaccine for measles and rubella (229.31/105). The general reactions mainly included fever, redness and swelling and induration (1 878 cases, 96.95%), and abnormal reactions mainly included allergic skin rash (241 cases, 87.96%). In addition, 91.34% of AEFI occurred within 24 hours after vaccination, and 99.73% of cases with AEFI were cured during the 3-month follow-up.@*Conclusions@#The reported incidence of AEFI appeared a tendency towards a decline in Chongchuan District from 2008 to 2022. General reaction was the predominant type of AEFI, and all AEFI showed a good prognosis. The safety of vaccines was high in Chongchuan District from 2008 to 2022.