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.
Original language | English |
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Pages (from-to) | 3582-3590 |
Number of pages | 9 |
Journal | Vaccine |
Volume | 38 |
Issue number | 19 |
DOIs | |
Publication status | Published - Apr 23 2020 |
Bibliographical note
Funding Information:JDK has received investigator initiated funding for epidemiologic research from Pfizer and contract clinical trial funding from Merck outside the submitted work.
Funding Information:
KAT has received grants from GSK and consultancy fees from Pfizer outside the submitted work.
Funding Information:
The Canadian National Vaccine Safety Network as part of the Canadian Immunization Research Network is funded by a research grant from the Canadian Institutes of Health Research and the Public Health Agency of Canada grants: #124309 (1 June 2012 – 31 May 2014) , #137470 (1 June 2014 – 31 May 2017) , and #151944 (1 June 2017 – 31 December 2022) .
Publisher Copyright:
© 2020 The Authors
ASJC Scopus Subject Areas
- Molecular Medicine
- General Immunology and Microbiology
- General Veterinary
- Public Health, Environmental and Occupational Health
- Infectious Diseases
PubMed: MeSH publication types
- Journal Article
- Research Support, Non-U.S. Gov't