Investigating the association of receipt of seasonal influenza vaccine with occurrence of anesthesia/paresthesia and severe headaches, Canada 2012/13-2016/17, the Canadian Vaccine Safety Network

Background: Concern about adverse events following immunization is frequently cited by both those who receive or decline vaccines. Neurological adverse events are especially concerning. Objectives: Our aim was to detect associations between seasonal influenza vaccination and the occurrence of severe anesthesia/paresthesia or severe headaches. Methods: Data were analyzed from the Canadian National Vaccine Safety network. Events occuring on days 0-7 were self-reported and prevented daily activity, led to school or work absenteeism, or required medical attention. Controls were the previous year's vaccinees; events in controls were collected prior to the start of the influenza vaccination program of each year (2012/13 through 2016/17). Multivariable logistic regression was used to determine the association between seasonal influenza vaccination and the occurrence of anesthesia/paresthesia or severe headaches. Results: The total sample was 107,565 for investigating anesthesia/paresthesia and 97,420 for investigating severe headaches. Anesthesia/paresthesia was reported by 104/107,565 (0.10%) participants; 63/69,129 (0.09%) vaccinees and 41/38,436 (0.11%) controls (adjusted odds ratio (aOR) = 0.89; 95% CI = 0.60, 1.32). Severe headaches were reported by 1361/97,420 (1.40%) participants; 907/61,463 (1.48%) vaccinees and 454/35,957 (1.26%) controls (aOR = 1.21; 95% CI = 1.08, 1.36). No specific vaccine product was associated with severe headaches. Conclusions: Our study found no association between severe anesthesia/paresthesia and seasonal influenza vaccination. While there was an association with severe headaches as an adverse event following influenza vaccination, the rates of these events are similar to rates reported from clinical trials and are not a cause for additional concern. (C) 2020 The Authors. Published by Elsevier Ltd.