May A Ahmed1, Monika Naus2, Joel Singer2, Louis Valiquette3, Brenda L Coleman4, Gaston De Serres5, Otto G Vanderkooi6, Karina A Top7, Jennifer E Isenor8, James D Kellner9, Anne E McCarthy10, Julie A Bettinger11. 1. Vaccine Evaluation Center, BC Children's Hospital, University of British Columbia, Vancouver, British Columbia, Canada. 2. School of Public and Population Health, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada. 3. Department of Microbiology and Infectious Diseases, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Canada. 4. Sinai Health System and University of Toronto, Toronto, Ontario, Canada. 5. CHU de Québec-Université Laval, Québec, Canada. 6. Alberta Children's Hospital, University of Calgary, Calgary, Alberta, Canada. 7. Department of Pediatrics, Dalhousie University and Canadian Center for Vaccinology, IWK Health Centre, Halifax, Nova Scotia, Canada. 8. College of Pharmacy and Canadian Center for Vaccinology, Halifax, Nova Scotia, Canada. 9. Department of Pediatrics, University of Calgary and Alberta Health Services, Alberta Children's Hospital Research Institute, Calgary, Canada. 10. Department of Medicine, The Ottawa Hospital, University of Ottawa and the Ottawa Health Research Institute, Ottawa, Ontario, Canada. 11. Vaccine Evaluation Center, BC Children's Hospital, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: jbettinger@cfri.ca.
Abstract
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.
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.
Authors: Miguel García-Grimshaw; Santa Elizabeth Ceballos-Liceaga; Anaclara Michel-Chávez; Mario García-Alanis; Arturo Cadena-Fernández; Javier Andrés Galnares-Olalde; Guillermo Carbajal-Sandoval; Daniel Amado Carrillo-García; Noé Hernández-Valdivia; Laura E Hernández-Vanegas; María Del Mar Saniger-Alba; Alonso Gutierrez-Romero; José Luis Díaz-Ortega; Gustavo Reyes-Terán; Hugo López-Gatell; Fernando Daniel Flores-Silva; Carlos Cantú-Brito; Erwin Chiquete; Antonio Arauz; Sergio Iván Valdés-Ferrer Journal: Vaccine Date: 2021-10-29 Impact factor: 3.641
Authors: Julie A Bettinger; Manish Sadarangani; Gaston De Serres; Louis Valiquette; Otto G Vanderkooi; James D Kellner; Matthew P Muller; Karina A Top; Jennifer E Isenor; Allison McGeer; Kimberly Marty Journal: BMJ Open Date: 2022-01-20 Impact factor: 2.692