Post-licensure surveillance of quadrivalent inactivated influenza (IIV4) vaccine in the United States, Vaccine Adverse Event Reporting System (VAERS), July 1, 2013−May 31, 2015

Abstract

BackgroundQuadrivalent inactivated influenza vaccines (IIV4) were first available for use during 2013−14 influenza season for individuals aged ≥6 months. IIV4 is designed to protect against four different flu viruses; two influenza A viruses and two influenza B viruses.MethodsWe searched the Vaccine Adverse Event Reporting System (VAERS) for US reports after IIV4 and trivalent inactivated influenza vaccine (IIV3) from 7/1/2013–5/31/2015. Medical records were requested for non-manufacturer reports classified as serious (i.e. death, hospitalization, prolonged hospitalization, life-threatening illness, permanent disability). The review included automated data analysis, clinical review of all serious reports, reports of special interest, and empirical Bayesian data mining.ResultsVAERS received 1,838 IIV4 reports; 512 (28%) in persons aged 6 months–17 years of which 42 (8.2%) were serious reports; 1,265 (69%) in persons aged >18 years of which 84 (6.6%) were serious reports; two in children <6 months and 59 in persons of unknown age. Injection site erythema (24%), fever (14%) and injection site swelling (17%) were the most frequent adverse events among persons aged 6 months–17 years, while injection site pain (16%), pain (15%) and pain in extremity (13%) were the most frequent among persons aged 18−64 years given the vaccine alone. Among non-death serious reports, injection site reactions, constitutional symptoms, Guillain-Barré syndrome, seizures, and anaphylaxis were the most frequently reported adverse events. Data mining detected disproportional reporting for incorrect vaccine administration with no associated adverse events. Adverse events following IIV4 reported to VAERS were similar to those following IIV3.ConclusionsIn our review of VAERS reports, IIV4 had a similar safety profile to IIV3. Most of the reported AEs were non-serious. Our findings are consistent with data from pre-licensure studies of IIV4.

Enhanced Safety Surveillance of Seasonal Quadrivalent Influenza Vaccines in English Primary Care: Interim Analysis

“…The level of detection of AEIs in our pilot study is comparable to that found in other observation systems [ 33 , 34 ]. This seems to suggest that use of ADR cards together with EHR system weekly data extractions is an appropriate tool for adverse event surveillance.…”

Safety of the 9-Valent Human Papillomavirus Vaccine

“…The safety profile observed for 9vHPV is consistent with data from the vaccine's prelicensure clinical trials and is similar to postlicensure safety monitoring data for 4vHPV and bivalent HPV vaccine and for other vaccines administered in this age group (eg, tetanus, diphtheria, and acellular pertussis; meningococcal conjugate; and influenza vaccines). 7,[36][37][38][39] For 9vHPV, 97.4% of reports to the VAERS were classified as nonserious (versus 94.2% for 4vHPV); crude AE reporting rates for all reports and serious reports were 259 and 7 reports per million doses distributed, respectively (versus 327 and 19 reports per million, respectively, for 4vHPV); and the most frequently reported AEs (dizziness, syncope, headache, nausea, and injection site reactions) were similar to those observed for 4vHPV. 7 VAERS is a critical early warning system to detect possible safety problems in US-licensed vaccines and is a key component of the US vaccine safety monitoring infrastructure.…”

Influenza vaccines: Evaluation of the safety profile

“…An investigation on the VAERS reports following vaccination with IIV4 and trivalent IIV3 from 7/1/2013 to 5/31/2015 was conducted by Haber et al., 40 who reported similar safety profiles between the two vaccines. This observation was in agreement with the data obtained from pre-licensure studies of IIV4.…”