PMID- 26518405 OWN - NLM STAT- MEDLINE DCOM- 20161005 LR - 20200225 IS - 1873-2518 (Electronic) IS - 0264-410X (Print) IS - 0264-410X (Linking) VI - 33 IP - 48 DP - 2015 Nov 27 TI - Surveillance of adverse events after the first trivalent inactivated influenza vaccine produced in mammalian cell culture (Flucelvax((R))) reported to the Vaccine Adverse Event Reporting System (VAERS), United States, 2013-2015. PG - 6684-8 LID - S0264-410X(15)01527-3 [pii] LID - 10.1016/j.vaccine.2015.10.084 [doi] AB - BACKGROUND: In November 2012, the first cell cultured influenza vaccine, a trivalent subunit inactivated influenza vaccine (Flucelvax((R)), ccIIV3), was approved in the US for adults aged >/= 18 years. OBJECTIVE: To assess adverse events (AEs) after ccIIV3 reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. METHODS: We searched VAERS for US reports after ccIIV3 among persons vaccinated from July 1, 2013-March 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barre syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category using MedDRA system organ classes (SOC) to each report. Empirical Bayesian data mining was used to identify disproportional AE reporting following ccIIV3. RESULTS: VAERS received 629 reports following ccIIV3 of which 313 were for administration of vaccine to persons <18 years. Among 309 reports with an AE documented, 19 (6.1%) were serious and the most common categories were 152 (49.2%) general disorders and administration site conditions (mostly injection site and systemic reactions) and 73 (23.6%) immune system disorders with two reports of anaphylaxis. Four reports of GBS were submitted. Disproportional reporting was identified for 'drug administered to patient of inappropriate age.' CONCLUSIONS: Review of VAERS reports did not identify any concerning pattern of AEs after ccIIV3. Injection site and systemic reactions were the most commonly reported AEs, similar to the pre-licensure clinical trials. Reports following ccIIV3 in persons <18 years highlight the need for education of healthcare providers regarding approved ccIIV3 use. CI - Published by Elsevier Ltd. FAU - Moro, Pedro L AU - Moro PL AD - Immunization Safety Office, Centers for Disease Control and Prevention, United States. Electronic address: pmoro@cdc.gov. FAU - Winiecki, Scott AU - Winiecki S AD - Center for Biologics Evaluation and Research, Food and Drug Administration, United States. FAU - Lewis, Paige AU - Lewis P AD - Immunization Safety Office, Centers for Disease Control and Prevention, United States. FAU - Shimabukuro, Tom T AU - Shimabukuro TT AD - Immunization Safety Office, Centers for Disease Control and Prevention, United States. FAU - Cano, Maria AU - Cano M AD - Immunization Safety Office, Centers for Disease Control and Prevention, United States. LA - eng GR - CC999999/Intramural CDC HHS/United States PT - Journal Article DEP - 20151027 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (Influenza Vaccines) RN - 0 (Vaccines, Inactivated) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Cell Culture Techniques/methods MH - Child MH - Child, Preschool MH - Drug-Related Side Effects and Adverse Reactions/*epidemiology/*pathology MH - Female MH - Humans MH - Infant MH - Influenza Vaccines/*administration & dosage/*adverse effects MH - Male MH - Middle Aged MH - *Product Surveillance, Postmarketing MH - Technology, Pharmaceutical/methods MH - United States/epidemiology MH - Vaccines, Inactivated/administration & dosage/adverse effects MH - Young Adult PMC - PMC6500456 MID - NIHMS1025241 OTO - NOTNLM OT - Adverse event OT - Cell culture OT - Surveillance OT - Trivalent inactivated influenza vaccine OT - Vaccine safety COIS- Conflict of interest: None of the authors have a conflict of interest. EDAT- 2015/11/01 06:00 MHDA- 2016/10/07 06:00 PMCR- 2019/05/04 CRDT- 2015/11/01 06:00 PHST- 2015/08/12 00:00 [received] PHST- 2015/10/09 00:00 [revised] PHST- 2015/10/18 00:00 [accepted] PHST- 2015/11/01 06:00 [entrez] PHST- 2015/11/01 06:00 [pubmed] PHST- 2016/10/07 06:00 [medline] PHST- 2019/05/04 00:00 [pmc-release] AID - S0264-410X(15)01527-3 [pii] AID - 10.1016/j.vaccine.2015.10.084 [doi] PST - ppublish SO - Vaccine. 2015 Nov 27;33(48):6684-8. doi: 10.1016/j.vaccine.2015.10.084. Epub 2015 Oct 27.