PMID- 30828025 OWN - NLM STAT- MEDLINE DCOM- 20190320 LR - 20190320 IS - 1347-5231 (Electronic) IS - 0031-6903 (Linking) VI - 139 IP - 3 DP - 2019 TI - [Adverse Events after the Introduction of Quadrivalent Influenza Vaccine in Comparison with AH1pdm Vaccine (2009) in Japan]. PG - 469-474 LID - 10.1248/yakushi.18-00160 [doi] AB - Inactivated quadrivalent influenza vaccine (IIV4) has been used as seasonal influenza vaccine since 2016 in Japan. This study examined the safety of IIV4 in comparison with the AH1pdm monovalent vaccine used for novel influenza in 2009. Questionnaire surveillance associated with adverse events (AEs) was conducted at Chiba University Hospital, Japan. After being vaccinated, all health care workers (HCWs) were given a daily AEs check sheet on which they recorded solicited events, the same surveillance program used after AH1pdm vaccination in 2009. The frequency of injection site AEs with IIV4 was significantly higher than with the monovalent vaccine, but there was no significant difference with systemic AEs. Injection site and systemic AEs were reported as 83.7% and 25.5%, respectively, with IIV4. The grades of AE, mild, moderate and severe, were 67.2%, 16.4% and 0.1% with IIV4, respectively, indicating that almost all of the AEs reported with IIV4 were mild or moderate. Systemic AEs with IIV4 and monovalent vaccine were reported to be 25.5% and 23.1%, respectively, with the difference not being significant. The grade of AEs with IIV4, mild, moderate and severe, was 19.1%, 5.6% and 0.9%, respectively. The ratio of HCWs reporting AEs peaked at around 80% on day 1, then decreasing to less than 5% by day 7. AEs with IIV4 were reported more frequently compared with the AH1pdm monovalent vaccine. However, in consideration of the grade and duration of AEs, IIV4 was a well-tolerated, safe vaccine. FAU - Yamazaki, Shingo AU - Yamazaki S AD - Division of Pharmacy, Chiba University Hospital. FAU - Fujiwara, Mariko AU - Fujiwara M AD - Division of Infection Control, Chiba University Hospital. FAU - Inoue, Chikako AU - Inoue C AD - Division of Infection Control, Chiba University Hospital. FAU - Watanabe, Masaharu AU - Watanabe M AD - Division of Clinical Laboratory, Chiba University Hospital. FAU - Takayanagi, Shin AU - Takayanagi S AD - Division of Infection Control, Chiba University Hospital. FAU - Taniguchi, Toshibumi AU - Taniguchi T AD - Division of Infection Control, Chiba University Hospital. FAU - Watanabe, Akira AU - Watanabe A AD - Medical Mycology Research Center, Chiba University. FAU - Ishiwada, Naruhiko AU - Ishiwada N AD - Medical Mycology Research Center, Chiba University. FAU - Igari, Hidetoshi AU - Igari H AD - Division of Infection Control, Chiba University Hospital. LA - jpn PT - Comparative Study PT - Journal Article PL - Japan TA - Yakugaku Zasshi JT - Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan JID - 0413613 RN - 0 (Influenza Vaccines) SB - IM MH - Adult MH - Aged MH - Anaphylaxis/epidemiology/etiology MH - Chills/epidemiology/etiology MH - Female MH - Fever/epidemiology/etiology MH - Headache/epidemiology/etiology MH - Hospitals, University/statistics & numerical data MH - Humans MH - Influenza Vaccines/*adverse effects MH - Injection Site Reaction/*epidemiology/*etiology MH - Japan/epidemiology MH - Male MH - Middle Aged MH - Myalgia/epidemiology MH - Nausea/epidemiology/etiology MH - Severity of Illness Index MH - Surveys and Questionnaires MH - Time Factors MH - Young Adult OTO - NOTNLM OT - AH1pdm vaccine OT - adverse event OT - quadrivalent influenza vaccine EDAT- 2019/03/05 06:00 MHDA- 2019/03/21 06:00 CRDT- 2019/03/05 06:00 PHST- 2019/03/05 06:00 [entrez] PHST- 2019/03/05 06:00 [pubmed] PHST- 2019/03/21 06:00 [medline] AID - 10.1248/yakushi.18-00160 [doi] PST - ppublish SO - Yakugaku Zasshi. 2019;139(3):469-474. doi: 10.1248/yakushi.18-00160.