Behind the scenes in public health: Adverse events following immunization (AEFI) signal investigation in British Columbia

MacDonald, Lauren E.; Naus, Monika

doi:10.14745/ccdr.v40is3a03

Cited by 4 publications

(4 citation statements)

References 8 publications

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“…Second is the improvement of public health response with the establishment of a clinical assessment/referral system to assess and follow up with individuals who have suspected AEFIs (7). Third is the noticeable improvement of the investigative capacity both for clusters of adverse events and for vaccine safety issues that may emerge from surveillance signals through the various clinical and research networks (7,8). Finally, another positive development is the use of the Brighton Collaboration definitions and harmonization of tools with international standards that not only facilitate international collaboration but also represent the best standard of practice in vaccine vigilance (6,13,14).…”

Section: Progress To Datementioning

confidence: 99%

“…The six papers presented in this supplement on vaccine safety (3,4,5,6,7,8) have been specially selected to collectively represent a series of complementary aspects of what goes into vaccine vigilance: monitoring, signal generation, investigation and response, together with the role of research networks that allow for quick implementation of vaccine research and clinical trials. They highlight the best assets of Canadian vaccine vigilance and provide examples of provincial/territorial resources, activities and capacity.…”

Section: Introductionmentioning

confidence: 99%

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Vaccine vigilance in Canada: Is it as robust as it could be?

Duclos

2014

CCDR

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Canada has been known to have one of the better vaccine safety surveillance capacities in the world, but in the early 2000s, it was noted there was still room for improvement. How has Canada done over the last decade and is there more to be done? Canada has done well. First, there has been significant progress made by the Vaccine Vigilance Working Group to enhance the passive vaccine safety monitoring system and address potential issues arising from the review of surveillance data and cases or clusters of concern. Second, there has been an increased investigative capacity for clusters of adverse events and other vaccine safety issues, including an assessment and referral system for individuals with adverse events following immunizations (AEFIs). Third, the use of the Brighton Collaboration definitions and other international standards has facilitated international collaboration and represents the best standard of practice. Despite all these improvements, however, there is more that could be done. The sensitivity of Canada's passive surveillance system still varies from one province and territory to another. The timeliness of the data exchange flow could improve. The AEFI Signal Response Protocol, which identifies the processes and required actions for timely management of any newly detected or emerging vaccine safety signals, is a critical piece of a robust vaccine safety system but it is still in the making. It is commendable that Canada has decided to expand its focus on evaluation research from influenza vaccines to vaccine-preventable diseases more broadly, with the establishment of the Canadian Immunization Research Network (CIRN). CIRN's newly developed Provincial Collaborative Network and the move toward record linkages is excellent. These new investments are welcome in light of the rich vaccine development pipeline, the increased pool of available vaccines, and the growing set of technologies for vaccines production, delivery, and safety monitoring. What would round this all out would be a stronger capacity to monitor the implementation of vaccination programs and vaccine coverage, and better documentation of the reduction of the disease burden attributable to vaccination programs. Canada's investment in vaccines for the health of all deserves no less.

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Section: Progress To Datementioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Vaccine vigilance in Canada: Is it as robust as it could be?

Duclos

2014

CCDR

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“…So, the vaccine safety is important and is rising in global concern [ 3 11 12 13 ]. The effects of post-vaccination events are very minimally known and the assessment, documentation of that AEs are minimum in the Indian population.…”

Section: Introductionmentioning

confidence: 99%

Adverse events following pediatric immunization in an Indian city

Paramkusham

Palakurthy

Gurram

et al. 2021

Clin Exp Vaccine Res

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Purpose Adverse effects are noticeable immediately after vaccination, especially when vaccinated to healthy people at the time of vaccination. The vaccine may cause adverse events which are very rare but adverse event following immunization surveillance becomes correspondingly more important in a less studied population like India. Hence, there is a need for carrying out a study pertaining to vaccine safety in the pediatric population of age 0–12 years and assessing the events occurring post-vaccination. Materials and Methods A prospective observational study was conducted in three primary healthcare centers and two tertiary care hospitals for 6 months from April 2016 to September 2016 with a total of 826 children enrolled. Detected adverse events for suspected vaccines were analyzed for causality by the World Health Organization causality assessment instrument. Sex-specific differences in incidences of adverse events were assessed. Results The cumulative adverse events were found highest in pentavalent vaccines (510 incidences, 62.04%) followed by the bacillus Calmette-Guérin vaccine (189 incidences, 22.99%). The study didn’t reveal any significant association in incidences of adverse events following immunization and sex of the children. Conclusion Vaccine safety surveillance studies are need of the hour in developing countries to maintain public trust in vaccines, the ultimate objective being to have vaccines with the most favorable benefit-risk profile. The present study discussed the various adverse events following immunization and suggested the absence of any sex-specific difference in incidences of adverse events in children.

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“…In 2017, SIRVA As opposed to routine intramuscular vaccine administration, SIRVA appears to be a complication of intracapsular inoculation of vaccine antigens or adjuvants triggering an inflammatory response and injuring the shoulder joint (Atanasoff et al, 2010;Barnes, Ledford, & Hogan, 2012;Bodor & Montalvo, 2007). Onset of symptoms commonly occurs within 48 hours of injection into the upper arm, characterized by intense shoulder pain with limited range of motion (Atanasoff et al, 2010;Cross, Moghaddas, Bittery, Ayoub, & Korman, 2016;Degreef & Debeer, 2012;Macdonald & Naus, 2014;Okur, Chaney, & Lomasney, 2014). There are no neurological deficits associated with SIRVA, and nerve conduction abnormalities are not present (Arias et al, 2017;Atanasoff et al, 2010;Bancsi et al, 2019;Cook, 2013).…”

Section: Introductionmentioning

confidence: 99%

Shoulder Injury Related to Vaccine Administration (SIRVA): An Occupational Case Report

Shahbaz

Blanc

Domeracki

et al. 2019

Workplace Health Saf

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Transient shoulder pain is a common complaint following intramuscular vaccine administration into the deltoid. More severe vaccination-associated shoulder complications comprising of weakness and decreased range of motion are categorized under the construct “shoulder injury related to vaccine administration” (SIRVA) that subsumes both subjective and objective findings consistent with injury. We describe the presentation and management of a case of SIRVA in a health care worker following seasonal influenza vaccine administration as part of a hospital-based employee health program and review the relevant biomedical literature. We present a case from a single medical center. All data were collected by professionals in occupational health by interviewing, performing physical examinations, and reviewing medical records associated with the injured worker. Severe pain and limited range of shoulder motion developed following an influenza vaccination that was administered using a poorly positioned, larger than recommended needle. Magnetic resonance imaging (MRI) demonstrated moderate glenohumeral joint effusion and synovitis, with fluid accumulating in the subscapularis recess within 1 week of injury. At 8 months after initial injury, MRI showed persistent mild tenosynovitis of the long head of the biceps tendon, interval accumulation of a large glenohumeral joint effusion, and infraspinatus tendinitis with subjacent reactive bone marrow edema. The affected worker experienced work restrictions but had no complete lost workdays to date due to the injury. Occupationally related SIRVA is a preventable adverse event that should be considered in workplace vaccine administration programs, and appropriate education and training provided to vaccine administrators to address this.

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Behind the scenes in public health: Adverse events following immunization (AEFI) signal investigation in British Columbia

Cited by 4 publications

References 8 publications

Vaccine vigilance in Canada: Is it as robust as it could be?

Vaccine vigilance in Canada: Is it as robust as it could be?

Adverse events following pediatric immunization in an Indian city

Shoulder Injury Related to Vaccine Administration (SIRVA): An Occupational Case Report

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