title: Post-marketing surveillance of adverse events following immunization with inactivated quadrivalent and trivalent influenza vaccine in health care providers in Western Australia.
abstract: In 2015, inactivated quadrivalent influenza vaccine (QIV) was first introduced into the Australian market. A routine vaccine safety surveillance system in Western Australia was used to conduct post-licensure surveillance of adverse events following immunization with inactivated QIV and trivalent influenza vaccines (TIV) in a sample of 1685 healthcare providers (HCPs). A similar percentage of HCPs who received QIV reported having any reaction seven days post-vaccination as HCPs who received TIV (13.6 vs. 12.8%, respectively; p=0.66). However, a slightly higher percentage of HCPs who received QIV reported pain or swelling at the injection site as compared to HCPs who received TIV (6.9% vs. 4.2%, respectively; p=0.02). No serious vaccine-associated adverse events were detected during follow-up of either vaccine. Acknowledging the study limitations, the results of this post-marketing surveillance support the safety of QIV, suggesting there is little difference in the reactogenicity of QIV as compared to TIV.
authors.affiliation: School of Pathology and Laboratory Medicine, University of Western Australia, Australia; Communicable Disease Control Directorate, Western Australia Department of Health, Australia. Electronic address: Annette.Regan@health.wa.gov.au.
authors.forename: Annette K
authors.initials: AK
authors.lastname: Regan
authors.affiliation: Communicable Disease Control Directorate, Western Australia Department of Health, Australia.
authors.forename: Lauren
authors.initials: L
authors.lastname: Tracey
authors.affiliation: Communicable Disease Control Directorate, Western Australia Department of Health, Australia.
authors.forename: Robyn
authors.initials: R
authors.lastname: Gibbs
mesh_terms: D000328:Adult; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000473:pathology*; D004487:Edema / Q000453:epidemiology; D005260:Female; D006282:Health Personnel; D006801:Humans; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000453:epidemiology; D011358:Product Surveillance, Postmarketing; D012871:Skin Diseases / Q000453:epidemiology / Q000473:pathology; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects; D014904:Western Australia
chemical_list: D007252:Influenza Vaccines; D015164:Vaccines, Inactivated
keywords: Inactivated quadrivalent influenza vaccine; Influenza vaccine; Public health surveillance; Vaccination; Vaccine safety