Surveillance of adverse events following immunization of 13-valent pneumococcal conjugate vaccine among infants, in Zhejiang province, China

References

• Rodgers G, Klugman K. The future of pneumococcal disease prevention. Vaccine. 2011;29:43–7. doi:10.1016/j.vaccine.2011.07.047.
   Google Scholar
• O’Brien KL, Wolfson LJ, Watt JP, Henkle E, Deloria-Knoll M, McCall N, Lee E, Mulholland K, Levine OS, Cherian T, et al. Burden of disease caused by Streptococcus pneumoniae in children younger than 5 years: global estimates. Lancet. 2009;374(9693):893–902. doi:10.1016/S0140-6736(09)61204-6.
   PubMed Web of Science ®Google Scholar
• Pittet LF, Posfay-Barbe KM. Pneumococcal vaccines for children: a global public health priority. Clin Microbiol Infect. 2012;18(Suppl 5):25–36. doi:10.1111/j.1469-0691.2012.03938.x.
   PubMed Web of Science ®Google Scholar
• World Health Organization. Pneumococcal vaccines-WHO position paper 2012. Weekly Epidemiol Record 2012;87:129–44.
   PubMedGoogle Scholar
• Hausdorff WP. The roles of pneumococcal serotypes 1 and 5 in paediatric invasive disease. Vaccine. 2007;25(13):2406–12. doi:10.1016/j.vaccine.2006.09.009.
   PubMed Web of Science ®Google Scholar
• Hausdorff WP, Feikin DR, Klugman KP. Epidemiological differences among pneumococcal serotypes. Lancet Infect Dis. 2005;5(2):83–93. doi:10.1016/S1473-3099(05)70083-9.
   PubMed Web of Science ®Google Scholar
• Barry C, Krause VL, Cook HM, Menzies RI. Invasive pneumococcal disease in Australia, 2007 and 2008. Commun Dis Intelligence Annu Rep. 2012;36:151–65.
   Google Scholar
• Nuorti JP, Whitney CG. Prevention of pneumococcal disease among infants and children-use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine-recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2010;59:1–18.
   PubMedGoogle Scholar
• Chilson E, Scott DA, Schmoele-Thoma B, Watson W, Moran MM, Isturiz R. Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine in patients with immunocompromising conditions: a review of available evidence. Hum Vaccin Immunother. 2020;16(11):2758–72. doi:10.1080/21645515.2020.1735224.
   PubMed Web of Science ®Google Scholar
• Huang L-M, Lin T-Y, Juergens C. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccines in Taiwan. Vaccine. 2012;30(12):2054–59. doi:10.1016/j.vaccine.2011.12.054.
   PubMed Web of Science ®Google Scholar
• Zhang T, Zhang J, Shao X, Feng S, Xu X, Zheng B, Liu C, Dai Z, Jiang Q, Gessner BD, et al. Effectiveness of 13-valent pneumococcal conjugate vaccine against community acquired pneumonia among children in China, an observational cohort study. Vaccine. 2021;39(33):4620–27. doi:10.1016/j.vaccine.2021.06.075.
   PubMed Web of Science ®Google Scholar
• Soo Kim D, Hee Shin S, Jong Lee H, Jin Hong Y, Young Lee S, Min Choi K, Chi Eun O, Hwan Kim K, Juergens C, Patterson S, et al. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine given to Korean children receiving routine pediatric vaccines. Pediatr Infect Dis J. 2013;32(3):266–73. doi:10.1097/INF.0b013e3182748bb6.
   PubMed Web of Science ®Google Scholar
• Liu D, Wendi W, Keli L, Disha X, Jiakai Y, Li L, Wang H. Surveillance of adverse events following immunization in China: past, present, and future. Vaccine. 2015;33:4041–46. doi:10.1016/j.vaccine.2015.04.060.
   PubMed Web of Science ®Google Scholar
• Pan X, Huakun L, Chen F, Wang Y, Liang H, Shen L, Chen Y, Hu Y. Analysis of adverse events following immunization in Zhejiang, China, 2019: a retrospective cross-sectional study based on the passive surveillance system. Hum Vaccin Immunother. 2021;17(10):3823–30. doi:10.1080/21645515.2021.1939621.
   PubMed Web of Science ®Google Scholar
• Rust J. Updating the international classification of diseases and related health problems, tenth revision (ICD-10). Health Inf Manag. 2010;39:40.
   PubMedGoogle Scholar
• Hu Y, Li Q, Lin L, Chen E, Chen Y, Qi X. Surveillance for adverse events following immunization from 2008 to 2011 in Zhejiang Province, China. Clin Vaccine Immunol. 2013;20:211–17. doi:10.1128/CVI.00541-12.
   PubMed Web of Science ®Google Scholar
• Li Q, Hu Y, Zhong Y, Chen Y, Tang X, Guo J, Shen L. Using the immunization information system to determine vaccination coverage rates among children aged 1–7 years: a report from Zhejiang Province, China. Int J Environ Res Public Health. 2014;11:2713–28. doi:10.3390/ijerph110302713.
   PubMed Web of Science ®Google Scholar
• Kim S, Park K, Kim MS, Yang BR, Choi HJ, Park BJ. Data-mining for detecting signals of adverse drug reactions of fluoxetine using the Korea Adverse Event Reporting System (KAERS) database. Psychiatry Res. 2017;256:237–42. doi:10.1016/j.psychres.2017.06.038.
   PubMed Web of Science ®Google Scholar
• Destefano F, Pfeifer D, Nohynek H. Safety profile of pneumococcal conjugate vaccines: systematic review of pre- and post-licensure data. Bull World Health Organ. 2008;86(5):373–80. doi:10.2471/BLT.07.048025.
   PubMed Web of Science ®Google Scholar
• Mahajan D, Cook J, Dey A, Macartney K, Menzies RI. Annual report: surveillance of adverse events following immunisation in Australia, 2011. Commun Dis Intel. 2012;36:315–32.
   Google Scholar
• Weber JCP. Epidemiology of adverse reactions to non-steroidal anti-inflammatory drugs. Adv Inflam Res. 1984;6:1–7.
   Google Scholar
• Fu Tseng H Sy LS, Amy Liu I-L, Lei Qian, SM Marcy, Weintraub E, Yih K, Baxter R, Glanz JM, Donahue J., et al. Post-licensure surveillance for pre-specified adverse events following the 13-valent pneumococcal conjugate vaccine in children. Vaccine. 2013;31(22):2578–83. doi:10.1016/j.vaccine.2013.03.040.
   PubMed Web of Science ®Google Scholar
• White C, Halperin SA, Scheifele DW. Pediatric combined formulation DTaP-IPV/Hib vaccine. Expert Rev Vaccines. 2009;8:831–40. doi:10.1586/erv.09.59.
   PubMed Web of Science ®Google Scholar
• Littlejohn ES, Clothier HJ, Perrett KP, Danchin M. Surveillance of adverse events following the introduction of 13-valent pneumococcal conjugate vaccine in infants, and comparison with adverse events following 7-valent pneumococcal conjugate vaccine, in Victoria, Australia. Hum Vaccin Immunother. 2015;11:1828–35.
   PubMed Web of Science ®Google Scholar
• Plosker GL. 13-valent pneumococcal conjugate vaccine: a review of its use in infants, children, and adolescents. Paediatr Drugs. 2013;15(5):403–23. doi:10.1007/s40272-013-0047-z.
   PubMed Web of Science ®Google Scholar
• Isaacs D, Lawrence G, Boyd I, Ronaldson K, McEwen J. Reporting of adverse events following immunization in Australia. J Paediatr Child Health. 2005;41(4):163–66. doi:10.1111/j.1440-1754.2005.00580.x.
   PubMed Web of Science ®Google Scholar
• Michael Marcy S, Kohl KS, Dagan R, Nalin D, Blum M, Connell Jones M, Hansen J, Labadie J, Lee L, Martin BL, et al. Fever as an adverse event following immunization: case definition and guidelines of data collection, analysis, and presentation. Vaccine. 2004;22(5–6):551–56. doi:10.1016/j.vaccine.2003.09.007.
   PubMed Web of Science ®Google Scholar
• Gidudua JF, Walcob GA, Taddioc A, Zempskyd WT, Halperine SA, Calugara A, Gibbsf NA, Hennigg R, Jovancevich M, Netterlidi E, et al. Immunization site pain: case definition and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine. 2012;30(30):4558–77.
   PubMed Web of Science ®Google Scholar
• Clarke E, Bashorun A, Adigweme I, Badjie Hydara M, Umesi A, Futa A, Ochoge M, Obayemi D, Edem B, Saidy-Jah E, et al. Immunogenicity and safety of a novel ten-valent pneumococcal conjugate vaccine in healthy infants in The Gambia: a phase 3, randomised, double-blind, non-inferiority trial. Lancet Infect Dis. 2021;21(6):834–46. doi:10.1016/S1473-3099(20)30735-0.
   PubMed Web of Science ®Google Scholar
• DuVernoy TS, Braun MM. Hypotonic-hyporesponsive episodes reported to the Vaccine Adverse Event Reporting System (VAERS), 1996-1998. Paediatrics. 2000;106:E52.
   PubMed Web of Science ®Google Scholar
• Heijbel H, Ciofi Degli Atti MC, and Harzer E, Liese J，Tozzi AE. Hypotonic hyporesponsive episodes in eight pertussis vaccine studies. Dev Biol Standard. 1997;89:101–03.
   PubMedGoogle Scholar
• Gold MS, Kempe A, Osbourn M. A comparison of serious adverse reactions to whole cell and acellular pertussis vaccines in South Australia. Med J Aust. 1999;171:331–32. doi:10.5694/j.1326-5377.1999.tb123677.x.
   PubMed Web of Science ®Google Scholar
• Miller E. Overview of recent trials of acellular pertussis vaccine. Biologicals. 1999;27:79–86. doi:10.1006/biol.1999.0184.
   PubMed Web of Science ®Google Scholar
• Bonhoeffer J, Menkes J, Gold MS, de Souza-brito G, Fisher MC, Halsey N, Vermeer P; The Brighton Collaboration Seizure Working Group. Generalized convulsive seizure as an adverse event following immunization: case definition and guidelines for data collection, analysis, and presentation. Vaccine. 2004;22(5–6):557–62. doi:10.1016/j.vaccine.2003.09.008.
   PubMed Web of Science ®Google Scholar
• Tse A, Tseng HF, Greene SK, Vellozzi C, Lee GM. Signal identification and evaluation for risk of febrile seizures in children following trivalent inactivated influenza vaccine in the Vaccine Safety Datalink Project, 2010–2011. Vaccine. 2012;30(11):2024–31. doi:10.1016/j.vaccine.2012.01.027.
   PubMed Web of Science ®Google Scholar
• Yeh SH, Gurtman A, Hurley DC, Block SL, Schwartz RH, Patterson S, Jansen KU, Love J, Gruber WC, Emini EA, et al. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers. Pediatrics. 2010;126(3):e493–505. doi:10.1542/peds.2009-3027.
   PubMed Web of Science ®Google Scholar
• Vanderkooi OG, Scheifele DW, Girgenti D, Halperin SA, Patterson SD, Gruber WC, Emini EA, Scott DA, Kellner JD; Canadian PCV13 Study Group. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine in healthy infants and toddlers given with routine pediatric vaccinations in Canada. Pediatr Infect Dis J. 2012;31(1):72–77. doi:10.1097/INF.0b013e318233049d.
   PubMed Web of Science ®Google Scholar
• Hirtz DG, Nelson KB, Ellenberg JH. Seizures following childhood immunization. J Pediatr. 1983;102:14–18. doi:10.1016/S0022-3476(83)80278-9.
   PubMed Web of Science ®Google Scholar