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Public Health & Policy

A scoping review of active, participant centred, digital adverse events following immunization (AEFI) surveillance of WHO approved COVID-19 vaccines: A Canadian immunization Research Network study

Mohamed Serhana Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada
,
Athanasios Psihogiosa Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada
,
Nooh Kabira Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada
,
A. Brianne Botaa Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada
,
Salima S. Mithania Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada
,
David P. Smithb Department of Cellular and Molecular Medicine, University of Ottawa, Ottawa, Canada;c Institute of Mental Health Research, University of Ottawa, Ottawa, Canada
,
David T. Zhua Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada;e Yale School of Public Health, Yale University, New Haven, CT, USA
,
Devon Greysonf School of Population and Public Health, University of British Columbia, Vancouver, Canada
,
Sarah Wilsong Health Protection, Public Health Ontario, Toronto, ON, Canada;h Dalla Lana School of Public Health, University of Toronto, Toronto, Canada;i Populations & Public Health Research Program, ICES, Toronto, ON, Canada
,
Deshayne Felld Department of Pediatrics, Children’s Hospital of Eastern Ontario (CHEO) Research Institute, Ottawa, Canada;j School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada
,
Karina A. Topk Department of Pediatrics, University of Alberta, Edmonton, AB, Canada;l Departments of Pediatrics and Community Health & Epidemiology, Dalhousie University, Halifax, Nova Scotia, Canada
,
Julie A. Bettingerm Vaccine Evaluation Center, Department of Pediatrics, BC Children’s Hospital Research Institute, University of British Columbia, Vancouver, Canada
&
Kumanan Wilsona Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada;j School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada;n Department of Medicine, University of Ottawa, Ottawa, Canada;o O’Neill Institute for National and Global Health Law, Georgetown University;p Bruyère Research Institute, Ottawa, CanadaCorrespondence[email protected]
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Article: 2293550 | Received 21 Jul 2023, Accepted 08 Dec 2023, Published online: 19 Feb 2024

ABSTRACT

This scoping review examines the role of digital solutions in active, participant-centered surveillance of adverse events following initial release of COVID-19 vaccines. The goals of this paper were to examine the existing literature surrounding digital solutions and technology used for active, participant centered, AEFI surveillance of novel COVID-19 vaccines approved by WHO. This paper also aimed to identify gaps in literature surrounding digital, active, participant centered AEFI surveillance systems and to identify and describe the core components of active, participant centered, digital surveillance systems being used for post-market AEFI surveillance of WHO approved COVID-19 vaccines, with a focus on the digital solutions and technology being used, the type of AEFI detected, and the populations under surveillance. The findings highlight the need for customized surveillance systems based on local contexts and the lessons learned to improve future vaccine monitoring and pandemic preparedness.

Introduction

Post-market surveillance for adverse events following immunization (AEFI) from COVID-19 vaccines is a key priority amongst public health stakeholders and policy makers, with emphasis placed on the necessity for adequate, comprehensive, and adaptable population level safety monitoring.Citation1–3 Broadly speaking, AEFI surveillance can either be passive (unprompted, spontaneous reporting of events)Citation4,Citation5 or active (deliberate prompting of participants and/or active case seeking to solicit event reporting),Citation6 with data typically sourced from either healthcare providers, vaccinees, or both to monitor a population for safety signals.Citation4 An increasingly recognized and emerging form of AEFI monitoring is active, participant-centered surveillance, which collects solicited health and/or reactogenicity information from vaccinees.Citation5 In addition to classic analog approaches to active, participant-centered AEFI surveillance, such as health diary cards and interviews, a number of systems are employing digital solutions and technology, such as e-mail and short-message-system (SMS).Citation5

Digital solutions have been utilized in many facets of public health measures one of which is pandemic planning and responses.Citation7–10 The technology has been implemented for some AEFI surveillance for monitoring the safety of vaccines, for example the CDC’s V-Safe app.Citation11 As the COVID-19 pandemic subsides there is an opportunity to learn from the implementation of the various digital solutions implemented in multiple jurisdictions. This information can be valuable for future pandemic as well as non-pandemic settings. Digital systems have various advantages. The major advantage is that they facilitate more real time AEFI surveillance which allows for more rapid detection of AEFI signals. Another advantage is that digital systems can be more easily standardized, which is key in implementing a “gold-standard” that is translatable across the international community, and they can capture large volumes of data and information.Citation12 A disadvantage surrounding digital systems is data privacy concerns. Patients may have concerns regarding how their health information is digitally handled which could hinder patient trust in the system.Citation13 Digital systems also exclude individuals who may not be fluent with technology, such as older adults in long-term care. Finally, they are more expensive to implement and require more maintenance.Citation13–15

To assist in this regard, we conducted a scoping review to better understand the role of different technological and digital approaches to active, participant-centered, AEFI surveillance of COVID-19 vaccines during the early stages of the pandemic.

Methods

Our objectives were

  1. To identify the published research (describe the extent, range, and nature of research activity)Citation12–14 of digital solutions and technology used for active, participant centered, AEFI surveillance of novel COVID-19 vaccines approved by the World Health Organization (WHO).Citation15

  2. To identify gaps in literature surrounding digital, active, participant centered AEFI surveillance systems

  3. To identify and describe the core components of active, participant centered, digital surveillance systems being used for post-market AEFI surveillance of WHO approved COVID-19 vaccines, with a focus on the digital solutions and technology being used, the type of AEFI detected, and the populations under surveillance.

For the purpose of this review, “digital” was defined as any tool that used electronic technology for capturing and processing data through digital signals. “Active, participant-centered, AEFI surveillance” was defined as an approach which proactively searched for AEFIs and included purposeful solicitation of health events and/or symptom information specifically from vaccinees following immunization, where clear prompting for and elicitation of data occurred, with cases actively sought out.

Methodological approach

This scoping review followed a detailed and structured approach, informed by PRISMA Extension for Scoping Review (PRISMA-ScR) guidelines to identify, plot, and describe the peer-reviewed literature landscape within the area of active, participant centered, digital AEFI surveillance for WHO approved COVID-19 vaccines.Citation14

Information sources

Three bibliographic databases (Embase Classic + Embase, OVID-Medline, and EBM Review – Cochrane Central Register of Controlled Trials) were searched for published, peer-reviewed literature ranging from January 1st, 1946 to December 15th, 2022. The search strategy was created in collaboration with, and executed by, an experienced medical librarian. A detailed description of the search strategy, including the specific search terms selected and conventions applied, is found in Appendix 1. The final search result records were uploaded to Covidence, where additional deduplication automatically occurred. Screening was conducted by four independent investigators (DS, DZ, MS, and NK). Grey literature was searched for and accessed in order to provide additional contextual information for the identified digital solutions extracted from included records.

Selection of sources of evidence

Pre-determined inclusion and exclusion criteria () were first applied to all titles and abstracts by two independent investigators (DZ, DS, NK, and MS) followed by full text screening completed independently in duplicate, with a third-party (BB and KW) resolving decision conflicts. Studies that were included in the scoping review underwent data extraction by one investigator (NK), with a second performing verification (MS).

Table 1. Applied inclusion and exclusion criteria.

Data charting process & items

Data was collected from included records and inputted into tables with prespecified categories. Extraction endpoints included reference details (authorship and publication year), study design, surveillance approach details (period of data collection, population(s) under surveillance, technology and digital solutions used for AEFI data collection, and reporting schedule, any formal system name (e.g., V-Safe etc.), the type of COVID-19 vaccine(s) under surveillance, types of adverse events reported (local, systemic, serious, or severe), and management approach(es) for serious events.

Synthesis and presentation of results

Characteristics of included studies (authorship, publication year, country, study design, data collection period, and sample size), characteristics and components of the digital surveillance (population(s) monitored, vaccine(s) covered, response rate(s), participant communication methods, data collection methods, and AEFI surveillance timing) and human resources required to carry out surveillance (human follow-up approaches, operating costs, and associated public health agencies) were summarized in table format.

Results

Selection of sources of evidence and included studies

The applied search strategy, after initial deduplication by the medical librarian using referencing software, identified 3796 records. After additional automatic deduplication by Covidence (n = 1),Citation16 title and abstract screening excluded 3443 records, from which an additional 296 were subsequently excluded after full-text review. A detailed description of the screening process is presented in a PRISMA flow-chart (). 56 studies were included in the present scoping review (). Two of these publications, one by Zhang et al. (2021) and the other by Zhu et al. (2021), performed their analyses using the same dataset; accordingly, we included 56 papers from 55 unique studies.

Figure 1. PRISMA chart.

PRISMA Flow-Chart (COVID-19 Vaccine Active, Participant Centered, Digital AEFI Surveillance)
Figure 1. PRISMA chart.

Table 2. Study characteristics.

Characteristics of studies

The studies included came from 19 unique countries. 7 of the studies were conducted in Italy, 7 in Israel, 6 in the United States, 6 in South Korea, 6 in Japan, and 3 from Canada.

There were various study designs implemented. As expected, all studies were observational in nature and can be further classified as cross sectional or cohort in nature. It was found that 22 studies were classified as cross-sectional, and 33 studies were classified as cohort.

Populations examined included healthcare workers which accounted for 55.3% of all studies (N = 31/56), the general population at 33.9% (N = 19/56), patients with various illnesses at 5.4% (N = 3/56), and pregnant people at 3.6% (N = 2/56).

Multiple different COVID-19 vaccines were examined in these studies and some studies had multiple vaccines. The most common was the Pfizer-BioNTech (BNT162b2) vaccine, which was found in 39 studies, followed by the Oxford-AstraZeneca (AZD1222) vaccine, which was found in 20 studies, the third most common was the Moderna (mRNA-1273) vaccine which was found in 9 different studies. Other vaccines that were included in these studies were the Sinovac (CoronaVac) vaccine, the Johnson & Johnson (Ad26.COV2.S) vaccine, and the Sinopharm (BBIBP-CorV) vaccine.

Digital AEFI surveillance solutions

There were two broad categories of digital solutions identified. A small percentage of publications (N = 5.6%; N = 3/56) employed specifically designed AEFI digital surveillance systems (either purpose built or adapted from publicly available software) such as CANVAS, CANIM, Voxiva, TeleWatch, or SmartVax. However, most of the papers reported using publicly available software for data capture. The most frequently used software platforms were Google Forms (21.4%; N = 12/56) and REDCap (N = 7.1%; N = 4/56). These two categories overlap as the first set of solutions may leverage publicly available software. A comprehensive list of digital technologies used for surveillance, and their attributes, can be seen in . Crucially, many studies that were excluded from our review did not provide necessary details concerning their digital surveillance tool (N = 54) to determine what was used.

Table 3. Response rates.

A variety of communication mediums were used when reaching out to individuals within the various studies. Email was the most frequent (26.8%; N = 15/56), followed by SMS (23.2%; N = 13/56), cell-phone app notification (7.1%; N = 4/56), web-portal notification (1.7%; N = 1/56, or a combination of methods (8.9%; N = 3/56). 17 studies did not clearly specify how participants were communicated with (27.1%; N = 17/56), although it appears that prospective instructions were given to participants in person in some instances.

Response rates

There was a wide range of the response rates in the studies reflecting the heterogeneity of the technologies and study designs (See . for more information). In some instances, there is a higher response rate reported for specific genders or age groups. For example, in Vigezzi et al, females had a higher response rate (66.3%, N = 1286/1939) (p < .01) compared to males (52.2%, N = 376/720) (p < .01).

Discussion

This scoping review provides an overview of published research on the digital technologies used for active, participant-centered AEFI surveillance of COVID-19 vaccines approved by the World Health Organization (WHO) during the early stages of the pandemic. Our review provides a sample of the breadth of programs that were utilized during the pandemic. We observed a diversity of programs, with some appearing to be more specifically built for AEFI surveillance and others identifying existing software that could facilitate this function. There was a diversity in data collected among programs, methods of communicating with participants and participant response rates. We limited the search to this time period as we wanted to examine AEFI reporting in the context of the COVID-19 pandemic which was a highly unusual event and atypical situation for standard AEFI reporting. Future studies could expand this review to examine AEFI reporting of COVID-19 vaccines beyond the initial pandemic release of vaccines.

We also noted variability on the level of detail reported on these systems, particularly with respect to evaluation criteria and a substantial difference in response rates. Future research would benefit from further exploration of the best strategies to ensure optimal reporting of AEFI’s. Ultimately, however, surveillance systems need to be custom built for the local environment in which they will be implemented. Federal jurisdictions face challenges with respect to the collection of public health data from regional governments which unitary states do not.Citation72 There is also a diversity of challenges for high income countries versus low- and middle-income countries.Citation73 In many low- and middle-income countries (LIMCs), there is a lack of a formal vaccine safety monitoring system. Vaccines are often used without extensive post-licensure experience.Citation74 For example, vaccines that target novel threats such as Lassa and Nipah viruses are employed in such environments. In response, sentinel sites, which are designed healthcare facilities, are provided the tools and resources to collect data from individuals who experience an adverse event post-vaccination.Citation74 This approach has been successful in Mali and Niger when evaluating a new meningococcal vaccine.

The difference between females and males regarding AEFI response rate is still to be understood fully. This could be due to selection bias or behavior in terms of who response to online surveys or biological differences that may influence AEFI occurrence.Citation75 The COVID-19 pandemic and subsequent vaccine roll-out demonstrated the need for AEFI surveillance systems and the value of digital technologies in supporting these systems. The rapid roll-out of a multitude of new vaccines, some using novel platforms, required post-market surveillance systems to ensure both the safety and effectiveness of these vaccines. COVID vaccines approve for use on an emergency basis further emphasized the need for robust post-market surveillance. AEFI surveillance systems were critical as they identified the risk of vaccine-induced immune thrombotic thrombocytopenia (VITT) with the ChAdOx1 CoV-19 vaccine and the risk of myocarditis from mRNA vaccines, quantified these risks and guided vaccine recommendations.Citation76,Citation77

This review can guide public health AEFI surveillance. Robust AEFI surveillance systems need to be in place in anticipation of future pandemic vaccines as well as to enhance monitoring of existing vaccine programs and the roll-out of novel vaccines.Citation74 Standardization of AEFI surveillance and reporting of these systems is a priority of the WHO.Citation78 For example, we observed that many studies found within this review would have benefitted from having a comparison group to serve as a control. Having a comparison group that is representative of the vaccinated population would allow the studies examined to have a more accurate assessment of AEFI risks and benefits.

The international community should prioritize the adoption of standardized definitions for events, using established frameworks such as those provided by the Brighton Collaboration.Citation79 To ensure global consistency and facilitate seamless integration across digital systems, it is imperative to implement a WHO standard. This involves the development of an Adverse Events Following Immunization (AEFI) reporting framework that incorporates standardized forms or templates for comprehensive data collection, covering essential information such as patient demographics, vaccination details, and a detailed description of AEFI.Citation79,Citation80

In collaboration with the World Health Organization (WHO), the international community could further enhance this framework by developing a recognized system for coding AEFI events, akin to established medical coding systems like the International Classification of Diseases (ICD) or the Diagnostic and Statistical Manual of Mental Disorders (DSM).Citation78 This holistic approach, combining standardized definitions, digital system integration, and a universally accepted coding system, would significantly contribute to the global effort in ensuring the safety of vaccines and streamlining the reporting and analysis of vaccine safety data.

AEFI data extracted through digital surveillance technologies

The studies included in this scoping review clearly defined the type of AEFI being detected in their respective participant populations. All studies reported local and systemic events (N = 56), although there was less consistency with respect to defining and reporting severe events, serious adverse events (SAEs) and medically attended adverse events (MAEs). Twenty-two studies report medically attended events and seven of the twenty-two studies report that participants experienced ‘severe’ events, although the term is not defined. Further information is provided in . including follow-up protocols for SAE surveillance where applicable.

Limitations

The protocol that was generated internally and used to conduct this scoping review was not registered. This scoping review did not conduct an environmental scan, thus it only included peer reviewed published articles and did not search the gray literature which encompasses non-published materials, such as newspaper articles, policy documents, conference abstracts, reports and any other forms of unpublished research. Due to investigator language proficiency, only records that were available in English could be included, which presents an issue due to the global scope of our study. Further, this scoping review only included articles up to December 31st, 2022, therefore, limiting our study inclusion and analyses to approximately the first two waves of the COVID-19 pandemic which encompassed the vaccine rollout of the primary vaccine and a 2nd booster in Canada. Our intent, however, was to examine AEFI systems for the release of the emerging vaccines during the pandemic period which would largely have occurred by this time period. AEFI reporting during the post-pandemic phase of COVID-19 would be similar to other AEFI reporting which we have previously reported on.Citation81 Due to the rapidly evolving nature of the pandemic, newly emerging, COVID-19 vaccines, and changing landscape of active, participant-centered AEFI surveillance systems in response to these innovations, future studies should incorporate longer-term follow-up and continued evaluation of these surveillance systems as the pandemic progresses.

Conclusion and future directions

The scoping review has explored the different approaches and digital solutions for AEFI surveillance during the early stages of the COVID-19 pandemic. The rapid creation or repurposing of AEFI surveillance systems was a major challenge for public health systems during the pandemic. Learnings from each other experience can allow these systems to be better prepared for future pandemics as well as further augment their existing AEFI surveillance systems.

Financial support

This work was supported by the Public Health Agency of Canada and Canadian Institute of Health Research through the Canadian Immunization Research Network (FRN#151944).

Disclosure statement

KW is Chief Scientists of CANImmunize Inc and has served as a member of the independent data safety advisory board for Medicago and Moderna. KAT receives research support from the Coalition of Epidemic Preparedness Innovations for vaccine safety studies. During the conduct of this work, D. B. F. worked for the University of Ottawa and had academic appointments at the Children’s Hospital of Eastern Ontario Research Institute and ICES; she is currently employed by Pfizer.

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Appendix 1.

Search Strategies

Embase Classic+Embase <1947 to 2022 December 15>

Ovid MEDLINE(R) ALL < 1946 to December 15, 2022>

EBM Reviews - Cochrane Central Register of Controlled Trials <November 2022>

  1. COVID-19 Vaccines/36188

  2. ((coronavirus or 2019 ncov or 2019-ncov or covid or COVID-19 or COVID-19 virus or COVID-19 or COVID-19 virus or COVID-19 or COVID-19 virus or coronavirus disease 19 or coronavirus disease 2019 or coronavirus disease 2019 virus or coronavirus disease-19 or sars cov 2 or sars coronavirus 2 or sars-cov-2 or sars2) adj3 (vaccin* or immuni*)).tw,kf.63512

  3. ((mRNA or messenger RNA) adj3 vaccin*).tw,kf.14674

  4. (BNT162b2 or BNT 162b2).tw,kf.8949

  5. pfizer vaccin×.tw,kf.660

  6. moderna vaccin×.tw,kf.773

  7. astra zeneca vaccin×.tw,kf.46

  8. (AZD1222 or azd 1222).tw,kf.1310

  9. (mRNA-1273 or mRNA1273).tw,kf.3897

  10. johnson vaccin×.tw,kf.154

  11. Vaxzevria.tw,kf.638

  12. astrazenica.tw,kf.70

  13. Covishield.tw,kf.680

  14. Spikevax.tw,kf.510

  15. BNT162b1.tw,kf.63

  16. ChAdOx1-S.tw,kf.367

  17. or/1-16 76,261

  18. (adverse event* or side effect*).tw,kf.1493402

  19. Adverse Drug Reaction×.tw,kf.56363

  20. exp “Drug-Related Side Effects and Adverse Reactions”/752180

  21. ((local or systemic) adj2 reaction*).tw,kf.36448

  22. reactogenicity.tw,kf. or ae.fs. or aefi.tw,kf.3505587

  23. risk/or risk factors/or patient safety/or “drug-related side effects and adverse reactions”/2873320

  24. or/18-23 7,147,377

  25. 17 and 2419156

  26. Vaccines, Synthetic/ae and COVID-19/95

  27. 25 or 26 19,156

  28. product surveillance, postmarketing/or pharmacovigilance/27593

  29. Adverse Drug Reaction Reporting Systems/13099

  30. (pharmacovigilance or monitor* or drug evaluation*).tw,kf.2412654

  31. Adverse Drug Reaction Reporting Systems/13099

  32. Drug Evaluation/247384

  33. surveillance.mp.650989

  34. Self Report/190401

  35. ((self or patient) adj2 report*).tw,kf.728881

  36. survey×.mp.3025822

  37. questionnaire×.mp.2282175

  38. or/28–37 7,685,377

  39. or/28–38 7,685,377

  40. 27 and 395422

  41. 40 use medall1920

  42. limit 41 to dt = 20211209–202212161196

  43. exp SARS-CoV-2 vaccine/46143

  44. ((coronavirus or 2019 ncov or 2019-ncov or covid or COVID-19 or COVID-19 virus or COVID-19 or COVID-19 virus or COVID-19 or COVID-19 virus or coronavirus disease 19 or coronavirus disease 2019 or coronavirus disease 2019 virus or coronavirus disease-19 or sars cov 2 or sars coronavirus 2 or sars-cov-2 or sars2) adj3 (vaccin* or immuni*)).tw.62869

  45. ((mRNA or messenger RNA) adj3 vaccin*).tw.14094

  46. (BNT162b2 or BNT 162b2).tw.8752

  47. pfizer vaccin×.tw.627

  48. moderna vaccin×.tw.737

  49. astra zeneca vaccin×.tw.44

  50. (AZD1222 or azd 1222).tw.1271

  51. (mRNA-1273 or mRNA1273).tw.3784

  52. johnson vaccin×.tw.147

  53. Vaxzevria.tw.615

  54. astrazenica.tw.70

  55. Covishield.tw.640

  56. Spikevax.tw.471

  57. BNT162b1.tw.61

  58. ChAdOx1-S.tw.359

  59. or/43–58 77,013

  60. vaccination reaction/or exp adverse drug reaction/752180

  61. (adverse event* or side effect*).tw.1475630

  62. AEFI.tw.1385

  63. ((local or systemic) adj2 reaction*).tw.36238

  64. reactogenicity.tw.7637

  65. or/60–64 2,100,903

  66. 59 and 65 11,633

  67. exp SARS-CoV-2 vaccine/ae7833

  68. exp SARS-CoV-2 vaccine/and (risk/or risk factor/or patient safety/)2331

  69. 66 or 67 or 68 17,452

  70. postmarketing surveillance/or drug surveillance program/or active surveillance/46398

  71. pharmacovigilance/7477

  72. (surveillance or pharmacovigilance or monitor* or drug evaluation*).tw.2844349

  73. drug screening/254360

  74. self report/190401

  75. ((self or patient) adj2 report*).tw.720219

  76. (survey* or questionnaire*).mp.4344459

  77. or/70–76 7,600,425

  78. 69 and 774992

  79. 78 use emczd3113

  80. limit 79 to dc = 20211209–202212162439

  81. COVID-19 Vaccines/36188

  82. ((coronavirus or 2019 ncov or 2019-ncov or covid or COVID-19 or COVID-19 virus or COVID-19 or COVID-19 virus or COVID-19 or COVID-19 virus or coronavirus disease 19 or coronavirus disease 2019 or coronavirus disease 2019 virus or coronavirus disease-19 or sars cov 2 or sars coronavirus 2 or sars-cov-2 or sars2) adj3 (vaccin* or immuni*)).tw,kw.68854

  83. ((mRNA or messenger RNA) adj3 vaccin*).tw,kw.14268

  84. (BNT162b2 or BNT 162b2).tw,kw.8874

  85. pfizer vaccin×.tw,kw.655

  86. moderna vaccin×.tw,kw.771

  87. astra zeneca vaccin×.tw,kw.46

  88. (AZD1222 or azd 1222).tw,kw.1306

  89. (mRNA-1273 or mRNA1273).tw,kw.3866

  90. johnson vaccin×.tw,kw.147

  91. Vaxzevria.tw,kw.634

  92. astrazenica.tw,kw.70

  93. Covishield.tw,kw.673

  94. Spikevax.tw,kw.508

  95. BNT162b1.tw,kw.63

  96. ChAdOx1-S.tw,kw.367

  97. or/81–96 80,358

  98. (adverse event* or side effect*).tw,kw.1515106

  99. Adverse Drug Reaction×.tw,kw.82184

  100. 100exp “Drug-Related Side Effects and Adverse Reactions”/752180

  101. 101((local or systemic) adj2 reaction*).tw,kw.36275

  102. 102reactogenicity.tw,kw. or ae.fs. or aefi.tw,kw.3505562

  103. 103risk/or risk factors/or patient safety/or “drug-related side effects and adverse reactions”/2873320

  104. 104or/98–103 7,175,226

  105. 10597 and 104 19,496

  106. 106Vaccines, Synthetic/ae and COVID-19/95

  107. 107105 or 106 19,496

  108. 108product surveillance, postmarketing/or pharmacovigilance/27593

  109. 109Adverse Drug Reaction Reporting Systems/13099

  110. 110(pharmacovigilance or monitor* or drug evaluation*).tw,kw.2396986

  111. 111Adverse Drug Reaction Reporting Systems/13099

  112. 112Drug Evaluation/247384

  113. 113surveillance.mp.650989

  114. 114Self Report/190401

  115. 115((self or patient) adj2 report*).tw,kw.722922

  116. 116survey×.mp.3025822

  117. 117questionnaire×.mp.2282175

  118. 118or/108–117 7,670,074

  119. 119107 and 1185458

  120. 120119 use cctr141

  121. 121limit 120 to yr=“2022”66

  122. 12242 or 80 or 1213701

  123. 123remove duplicates from 1222717

Ovid MEDLINE(R) ALL <1946 to December 15, 2022>

  1. COVID-19 Vaccines/16941

  2. ((coronavirus or 2019 ncov or 2019-ncov or covid or COVID-19 or COVID-19 virus or COVID-19 or COVID-19 virus or COVID-19 or COVID-19 virus or coronavirus disease 19 or coronavirus disease 2019 or coronavirus disease 2019 virus or coronavirus disease-19 or sars cov 2 or sars coronavirus 2 or sars-cov-2 or sars2) adj3 (vaccin* or immuni*)).tw,kf.29013

  3. ((mRNA or messenger RNA) adj3 vaccin*).tw,kf.6420

  4. (BNT162b2 or BNT 162b2).tw,kf.3648

  5. pfizer vaccin×.tw,kf.234

  6. moderna vaccin×.tw,kf.314

  7. astra zeneca vaccin×.tw,kf.14

  8. (AZD1222 or azd 1222).tw,kf.369

  9. (mRNA-1273 or mRNA1273).tw,kf.1358

  10. johnson vaccin×.tw,kf.59

  11. Vaxzevria.tw,kf.177

  12. astrazenica.tw,kf.3

  13. Covishield.tw,kf.214

  14. Spikevax.tw,kf.130

  15. BNT162b1.tw,kf.18

  16. ChAdOx1-S.tw,kf.139

  17. or/1-16 33,413

  18. (adverse event* or side effect*).tw,kf.493062

  19. Adverse Drug Reaction×.tw,kf.19521

  20. exp “Drug-Related Side Effects and Adverse Reactions”/129577

  21. ((local or systemic) adj2 reaction*).tw,kf.12741

  22. reactogenicity.tw,kf. or ae.fs. or aefi.tw,kf.1954820

  23. risk/or risk factors/or patient safety/or “drug-related side effects and adverse reactions”/1117659

  24. or/18-23 3,175,642

  25. 17 and 247348

  26. Vaccines, Synthetic/ae and COVID-19/94

  27. 25 or 267348

  28. product surveillance, postmarketing/or pharmacovigilance/10588

  29. Adverse Drug Reaction Reporting Systems/8665

  30. (pharmacovigilance or monitor* or drug evaluation*).tw,kf.966031

  31. Adverse Drug Reaction Reporting Systems/8665

  32. Drug Evaluation/42048

  33. surveillance.mp.277616

  34. Self Report/41786

  35. ((self or patient) adj2 report*).tw,kf.279327

  36. survey×.mp.1217430

  37. questionnaire×.mp.913528

  38. or/28–37 2,803,321

  39. or/28–38 2,803,321

  40. 27 and 391920

Embase Classic+Embase <1947 to 2022 December 15>

  1. exp SARS-CoV-2 vaccine/27938

  2. ((coronavirus or 2019 ncov or 2019-ncov or covid or COVID-19 or COVID-19 virus or COVID-19 or COVID-19 virus or COVID-19 or COVID-19 virus or coronavirus disease 19 or coronavirus disease 2019 or coronavirus disease 2019 virus or coronavirus disease-19 or sars cov 2 or sars coronavirus 2 or sars-cov-2 or sars2) adj3 (vaccin* or immuni*)).tw.32738

  3. ((mRNA or messenger RNA) adj3 vaccin*).tw.7628

  4. (BNT162b2 or BNT 162b2).tw.5040

  5. pfizer vaccin×.tw.399

  6. moderna vaccin×.tw.434

  7. astra zeneca vaccin×.tw.30

  8. (AZD1222 or azd 1222).tw.867

  9. (mRNA-1273 or mRNA1273).tw.2376

  10. johnson vaccin×.tw.91

  11. Vaxzevria.tw.431

  12. astrazenica.tw.53

  13. Covishield.tw.424

  14. Spikevax.tw.354

  15. BNT162b1.tw.38

  16. ChAdOx1-S.tw.204

  17. or/1-16 42,179

  18. vaccination reaction/or exp adverse drug reaction/618761

  19. (adverse event* or side effect*).tw.792306

  20. AEFI.tw.776

  21. ((local or systemic) adj2 reaction*).tw.20492

  22. reactogenicity.tw.2959

  23. or/18-22 1,286,882

  24. 17 and 237196

  25. exp SARS-CoV-2 vaccine/ae4332

  26. exp SARS-CoV-2 vaccine/and (risk/or risk factor/or patient safety/)1940

  27. 24 or 25 or 26 10,427

  28. postmarketing surveillance/or drug surveillance program/or active surveillance/41029

  29. pharmacovigilance/4339

  30. (surveillance or pharmacovigilance or monitor* or drug evaluation*).tw.1590371

  31. drug screening/199586

  32. self report/145953

  33. ((self or patient) adj2 report*).tw.390578

  34. (survey* or questionnaire*).mp.2650343

  35. or/28–34 4,521,044

  36. 27 and 353113

EBM Reviews – Cochrane Central Register of Controlled Trials <November 2022>

  1. COVID-19 Vaccines/210

  2. ((coronavirus or 2019 ncov or 2019-ncov or covid or COVID-19 or COVID-19 virus or COVID-19 or COVID-19 virus or COVID-19 or COVID-19 virus or coronavirus disease 19 or coronavirus disease 2019 or coronavirus disease 2019 virus or coronavirus disease-19 or sars cov 2 or sars coronavirus 2 or sars-cov-2 or sars2) adj3 (vaccin* or immuni*)).tw,kw.1462

  3. ((mRNA or messenger RNA) adj3 vaccin*).tw,kw.342

  4. (BNT162b2 or BNT 162b2).tw,kw.165

  5. pfizer vaccin×.tw,kw.13

  6. moderna vaccin×.tw,kw.13

  7. astra zeneca vaccin×.tw,kw.1

  8. (AZD1222 or azd 1222).tw,kw.58

  9. (mRNA-1273 or mRNA1273).tw,kw.109

  10. johnson vaccin×.tw,kw.3

  11. Vaxzevria.tw,kw.20

  12. astrazenica.tw,kw.14

  13. Covishield.tw,kw.25

  14. Spikevax.tw,kw.11

  15. BNT162b1.tw,kw.6

  16. ChAdOx1-S.tw,kw.20

  17. or/1–161627

  18. (adverse event* or side effect*).tw,kw.229879

  19. Adverse Drug Reaction×.tw,kw.29100

  20. exp “Drug-Related Side Effects and Adverse Reactions”/3842

  21. ((local or systemic) adj2 reaction*).tw,kw.3114

  22. reactogenicity.tw,kw. or ae.fs. or aefi.tw,kw.140676

  23. risk/or risk factors/or patient safety/or “drug-related side effects and adverse reactions”/31571

  24. or/18–23 356,402

  25. 17 and 24664

  26. Vaccines, Synthetic/ae and COVID-19/0

  27. 25 or 26664

  28. product surveillance, postmarketing/or pharmacovigilance/123

  29. Adverse Drug Reaction Reporting Systems/95

  30. (pharmacovigilance or monitor* or drug evaluation*).tw,kw.108677

  31. Adverse Drug Reaction Reporting Systems/95

  32. Drug Evaluation/5750

  33. surveillance.mp.9469

  34. Self Report/2662

  35. ((self or patient) adj2 report*).tw,kw.56917

  36. survey×.mp.70305

  37. questionnaire×.mp.163449

  38. or/28–37 329,913

  39. 27 and 38141

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