The Effect of Sex on the Incidence, Latency, Duration and Perceived Burden of Adverse Events Following Seasonal Influenza Vaccination in the Netherlands

P. Slingerland, Florence P. A. M. Hunsel (), T. Lieber, L. Balveren and J. W. Duijster
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P. Slingerland: Netherlands Pharmacovigilance Centre Lareb
Florence P. A. M. Hunsel: Netherlands Pharmacovigilance Centre Lareb
T. Lieber: Netherlands Pharmacovigilance Centre Lareb
L. Balveren: Netherlands Pharmacovigilance Centre Lareb
J. W. Duijster: Netherlands Pharmacovigilance Centre Lareb

Drug Safety, 2023, vol. 46, issue 12, No 5, 1323-1334

Abstract: Abstract Introduction The annual reformulation of the seasonal influenza vaccine results in fluctuating frequencies and severity of adverse effects following immunization (AEFIs), which stresses the importance of pharmacovigilance. Also, sex-related factors are known to influence the development of AEFIs. This study aims to describe the difference in incidence and course (i.e., time-to-onset, time-to-recovery, and perceived burden) of AEFIs between males and females after seasonal influenza vaccination. Methods We assessed data from cohort event monitoring studies, which were performed over nine consecutive years (2013–2021), each covering several months during the seasonal influenza campaign in the Netherlands. Participants reported information about AEFIs over a 30-day period in three questionnaires. The effect of sex, age, body mass index, study year, and comorbidities on the incidence of any AEFI, local reactions, fever and the five most reported AEFIs was analyzed using logistic regression. The difference in time-to-onset, time-to-recovery, and perceived burden between males and females was analyzed by the Kruskal–Wallis test. Results The cohort included 7789 participants (53.0% females). Females had around 2.5-fold (p

Date: 2023
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DOI: 10.1007/s40264-023-01356-7

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