Analysis of Programmatic Adverse Events Occurring During the COVID-19 Immunisation Programme in Scotland
21 Pages Posted: 6 Sep 2022
Abstract
Introduction: The surveillance of adverse events following vaccination plays a key role in the success of a vaccination programme.Aim To identify the types and burden of programmatic adverse events (PAE) associated with the COVID-19 vaccination programme in Scotland, as well as their potential public health impact.
Method: Data relating to PAE were collected from the fourteen geographical health boards and special boards in Scotland for a one-year period from the start of the COVID-19 vaccination programme in Scotland (08 December 2020 to 07 December 2021). A descriptive analysis of the PAE was carried out to identify themes of adverse events that have occurred. An additional quantitative analysis was used to determine the frequency of PAE reports, quantify the number of PAE within each theme and compare PAEs by vaccine location.
Findings: A total of 979 PAE were reported in the context of over 10 million vaccine doses corresponding to a PAE reporting rate of 1/10,000 vaccine doses administered. Seven themes of PAE were identified. The most common theme identified was; “Issues With Pre-Vaccination Checks and Protocols Not Followed, Data Entry Errors and Errors Involving Use of Vaccine Management Tool (VMT)” (41.7%, n = 408). The second most frequently reported theme of PAE, accounting for 20.9% of all PAE (n=205) was; 'Vaccine Transport, Storage, Vials and Equipment, and Vaccine Wastage'. 53.6% (525) of errors occurred within the mass vaccination centres, reflecting the large proportion of vaccinations delivered in such settings.
Conclusion: This analysis provides a snapshot of adverse events during the COVID-19 vaccination programme in Scotland. This surveillance system has been extremely valuable in terms of learning and taking prompt mitigating actions during the COVID-19 vaccination programme in Scotland.
Note:
Funding Information: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Declaration of Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
Ethics Approval Statement: This study was performed within Public Health Scotland as part of its statutory duty to monitor and investigate public health problems. Under the UK Policy Framework for Health and Social Care Research set out by the NHS Health Research Authority, this does not fall within the definition of research and ethical review is not required. Individual consent is not required for Public Health Scotland staff to process personal data to perform specific tasks in the public interest that fall within its statutory role. The statutory basis for this is set out in Public Health Scotland’s privacy notice. A Data Protection Impact Assessment (DPIA) allows Public Health Scotland staff to link existing datasets.
Keywords: Vaccine safety, SARS-CoV-2, COVID-19 Vaccination, Adverse events, Programmatic adverse events, Vaccine surveillance
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