PMID- 32709434 OWN - NLM STAT- MEDLINE DCOM- 20210427 LR - 20210427 IS - 1873-2518 (Electronic) IS - 0264-410X (Linking) VI - 38 IP - 37 DP - 2020 Aug 18 TI - Monitoring the safety of high-dose, trivalent inactivated influenza vaccine in the vaccine adverse event reporting system (VAERS), 2011 - 2019. PG - 5923-5926 LID - S0264-410X(20)30907-5 [pii] LID - 10.1016/j.vaccine.2020.07.007 [doi] AB - BACKGROUND: On 12/23/2009 a new high-dose trivalent inactivated influenza vaccine (IIV3-HD) was licensed for adults aged >/=65 years. We assessed the post-licensure safety data for IIV3-HD in the Vaccine Adverse Event Reporting System (VAERS) during 2011-2019. METHODS: We searched VAERS for reports after IIV3-HD during 1/1/2011-06/30/2019 in persons aged >/=65 years. Medical records were reviewed for all death reports and for certain pre-specified conditions (e.g. Guillain Barre Syndrome [GBS], anaphylaxis). We also reviewed certain groups who received IIV3-HD erroneously (e.g. pregnant women, children). Empirical Bayesian data mining was used to identify disproportional reporting. RESULTS: VAERS received 12,320 reports after IIV3-HD;723 reports (5.9%) were serious. The most common adverse events (AEs) among serious reports were pyrexia (30.2%), asthenia (28.9%), and dyspnea (24.9%), and among non-serious reports were injection site erythema (16.8%), pain in extremity (15.8%), and injection site pain (14.2%). Among 55 death reports, the most common causes of death were diseases of the circulatory system (n = 23;41.8%). Based on medical record review, there were 61 reports of GBS and 13 of anaphylaxis. There were 13 reports of pregnant-women who inadvertently received IIV3-HD; three reports described arm pain or local reactions, and 10 did not report any AE. Among 59 reports of children who erroneously received IIV3-HD, 31 experienced an AE (most commonly injection site or constitutional reactions) and the remaining 28 reports did not describe any AE. CONCLUSIONS: Post-licensure safety data of IIV3-HD during 9 influenza seasons revealed no new or unexpected safety concerns among individuals >/=65 years. Inadvertent administration of IIV3-HD to children or pregnant women was observed, although with no serious AEs reported. Training and education of providers in vaccine recommendations and groups for whom the vaccine is indicated may help in preventing these vaccine administration errors. This review provides baseline information for future monitoring of the quadrivalent-high-dose influenza vaccine. CI - Published by Elsevier Ltd. FAU - Moro, Pedro L AU - Moro PL AD - Immunization Safety Office, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, GA, United States. Electronic address: pmoro@cdc.gov. FAU - Woo, Emily Jane AU - Woo EJ AD - Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States. FAU - Marquez, Paige AU - Marquez P AD - Immunization Safety Office, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, GA, United States. FAU - Cano, Maria AU - Cano M AD - Immunization Safety Office, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, GA, United States. LA - eng PT - Journal Article PT - Review DEP - 20200721 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (Influenza Vaccines) SB - IM MH - Adult MH - Adverse Drug Reaction Reporting Systems MH - Aged MH - Bayes Theorem MH - Child MH - Female MH - *Guillain-Barre Syndrome/epidemiology MH - Humans MH - *Influenza Vaccines/adverse effects MH - *Influenza, Human/prevention & control MH - Pregnancy MH - Product Surveillance, Postmarketing OTO - NOTNLM OT - Epidemiology OT - High-dose inactivated influenza vaccine OT - Post-licensure surveillance OT - Vaccine safety COIS- Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. EDAT- 2020/07/28 06:00 MHDA- 2021/04/28 06:00 CRDT- 2020/07/26 06:00 PHST- 2020/04/26 00:00 [received] PHST- 2020/07/02 00:00 [revised] PHST- 2020/07/05 00:00 [accepted] PHST- 2020/07/28 06:00 [pubmed] PHST- 2021/04/28 06:00 [medline] PHST- 2020/07/26 06:00 [entrez] AID - S0264-410X(20)30907-5 [pii] AID - 10.1016/j.vaccine.2020.07.007 [doi] PST - ppublish SO - Vaccine. 2020 Aug 18;38(37):5923-5926. doi: 10.1016/j.vaccine.2020.07.007. Epub 2020 Jul 21.