Assessment of sex-specific differences in adverse events following immunization reporting in Ontario, 2012–15

Harris, Tara; Nair, Jyotsna; Fediurek, J; Deeks, Shelley L.

doi:10.1016/j.vaccine.2017.03.035

Cited by 59 publications

(51 citation statements)

References 16 publications

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“…Sex-specific differences were significant (p<0.05) in those seven years of age and older, with a higher AEFI reporting rate seen in females compared with males. This is similar to results found in other studies that have studied sex-specific differences in AEFI reporting rates (29,31,32). There were more male than female AEFI reports submitted for those under seven years of age; however, this difference was not significant.…”

Section: Discussionsupporting

confidence: 92%

“…A greater proportion (63%) of reports involved females. This is similar to other findings where females in the adult population were found to consistently report more adverse effects (7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)29). The reported sex differences by age can also be explained in part by higher vaccine coverage in female adults (30).…”

Section: Discussionsupporting

confidence: 87%

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Vaccine safety surveillance in Canada: Reports to CAEFISS, 2013–2016

Ahmadipour

Watkins

Fréchette

et al. 2018

CCDR

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Background: Canada has one of the strongest vaccine safety surveillance systems in the world. This system includes both passive surveillance of all vaccines administered and active surveillance of all childhood vaccines. Objectives: To provide 1) a descriptive analysis of the adverse events following immunization (AEFI) reports for vaccines administered in Canada, 2) an analysis of serious adverse events (SAEs) and 3) a list of the top ten groups of vaccines with the highest reporting rates. Methods: Descriptive analyses were conducted of AEFI reports received by the Public Health Agency of Canada (PHAC) by August 14, 2017, for vaccines marketed in Canada and administered from January 1, 2013 to December 31, 2016. Data elements in this analysis include: type of surveillance program, AEFIs, demographics, health care utilization, outcome, seriousness of adverse events and type of vaccine. Results: Over the four year period, 11,079 AEFI reports were received from across Canada. The average annual AEFI reporting rate was 13.4/100,000 doses distributed in Canada for vaccines administered during 2013-2016 and was found to be inversely proportional to age. The majority of reports (92%) were non-serious events, involving vaccination site reactions rash, and allergic events. Overall, there were 892 SAE reports, for a reporting rate of 1.1/100,000 doses distributed during 2013-2016. Of the SAE reports, the most common primary AEFIs were anaphylaxis followed by seizure. Meningococcal serogroup C conjugate vaccines (given concomitantly) were responsible for the highest rates of AEFIs, at 91.6 per 100,000 doses distributed. There were no unexpected vaccine safety issues identified or increases in frequency or severity of expected adverse events. Conclusion: Canada's continuous monitoring of the safety of marketed vaccines during 2013-2016 did not identify any increase in the frequency or severity of AEFIs, previously unknown AEFIs, or areas that required further investigation or research. Vaccines marketed in Canada continue to have an excellent safety profile.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionsupporting

confidence: 87%

Vaccine safety surveillance in Canada: Reports to CAEFISS, 2013–2016

Ahmadipour

Watkins

Fréchette

et al. 2018

CCDR

View full text Add to dashboard Cite

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“…Male predominance was observed for children under seven years of age and female predominance was observed among those seven years and older. The results of a greater proportion of reports involving females is similar to other findings where females in the adult population were found to consistently report more adverse events (3,4,17). The reported sex differences by age may also be explained in part by higher vaccine coverage in female adults (18).…”

Section: Surveillancesupporting

confidence: 84%

Vaccine safety surveillance in Canada: Reports to CAEFISS, 2017

Johnson

Anyoti

Coulby

2018

CCDR

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Background: Canada has a comprehensive vaccine safety surveillance system that includes both passive and active surveillance of vaccines administered in Canada. Objectives: To provide 1) a descriptive analysis of the adverse events following immunization (AEFI) reports for vaccines administered in Canada, 2) a descriptive review of health care utilization and outcome following an AEFI and 3) an analysis of serious adverse events (SAEs). Methods: Data was obtained from the Canadian Adverse Events Following Immunization Surveillance System (CAEFISS), which includes both passive and active surveillance. Descriptive analyses were conducted of AEFI reports arising from vaccines administered from January 1, 2017 to December 31, 2017 and received by April 30, 2018. Data elements included AEFIs, demographics, health care utilization, outcome, and seriousness of adverse events. Results: There were 2,960 AEFI reports submitted to CAEFISS from across Canada for vaccines administered in 2017. The AEFI reporting rate was 12.6/100,000 doses distributed (8.1/100,000 population) in Canada for vaccines administered in 2017 and was found to be inversely proportional to age. The majority of reports (91%) were non-serious events, primarily involving vaccination site reactions such as rash, and allergic events. Overall, there were 253 SAE reports, for a reporting rate of 1.1/100,000 doses distributed in 2017. Of the SAE reports, the most common primary AEFIs were seizure (n=58, 23%) followed by anaphylaxis (n=33, 13%). There were no unexpected vaccine safety issues identified or increases in frequency or severity of expected adverse events. Conclusion: Canada's continuous monitoring of the safety of marketed vaccines in 2017 did not identify any increase in the frequency or severity of AEFIs, previously unknown AEFIs or areas that required further investigation or research. Vaccines marketed in Canada continue to have an excellent safety profile.

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“…The observed female predominance in AEFI reporting has been previously noted in Ontario (21,22) and in other passive AEFI surveillance systems (23)(24)(25) although it appears particularly striking in this current assessment (93.3 and 86.5 percent in 18-49 and 50-64 year olds, respectively). The reasons for this phenomenon are likely multi-factorial.…”

Section: Discussionsupporting

confidence: 50%