Consumer reporting of adverse events following immunization

Clothier, Hazel J; Selvaraj, Gowri; Easton, Marion; Lewis, Georgina; Crawford, Nigel; Buttery, James Peter

doi:10.4161/hv.34369

Cited by 36 publications

(31 citation statements)

References 17 publications

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“…Patients generally give an adequate description of the course of clinical symptoms and they seem more likely to report on the impact of ADRs on their daily life compared to healthcare professionals 6, 7. Some studies found that patients are likely to report more serious ADRs compared to healthcare professionals, while others demonstrate the opposite 8, 9, 10, 11, 12. There are also studies that demonstrated no difference in seriousness between both groups 6, 7, 13, 14.…”

Section: Introductionmentioning

confidence: 99%

Does patient reporting lead to earlier detection of drug safety signals? A retrospective comparison of time to reporting between patients and healthcare professionals in a global database

Rolfes

Hunsel

Caster

et al. 2018

Brit J Clinical Pharma

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AimsTo explore if there is a difference between patients and healthcare professionals (HCPs) in time to reporting drug–adverse drug reaction (ADR) associations that led to drug safety signals.MethodsThis was a retrospective comparison of time to reporting selected drug–ADR associations which led to drug safety signals between patients and HCPs. ADR reports were selected from the World Health Organization Global database of individual case safety reports, VigiBase. Reports were selected based on drug–ADR associations of actual drug safety signals. Primary outcome was the difference in time to reporting between patients and HCPs. The date of the first report for each individual signal was used as time zero. The difference in time between the date of the reports and time zero was calculated. Statistical differences in timing were analysed on the corresponding survival curves using a Mann–Whitney U test.ResultsIn total, 2822 reports were included, of which 52.7% were patient reports, with a median of 25% for all included signals. For all signals, median time to signal detection was 10.4 years. Overall, HCPs reported earlier than patients: median 7.0 vs. 8.3 years (P < 0.001).ConclusionsPatients contributed a large proportion of reports on drug–ADR pairs that eventually became signals. HCPs reported 1.3 year earlier than patients. These findings strengthen the evidence on the value of patient reporting in signal detection and highlight an opportunity to encourage patients to report suspected ADRs even earlier in the future.

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Section: Introductionmentioning

confidence: 99%

Does patient reporting lead to earlier detection of drug safety signals? A retrospective comparison of time to reporting between patients and healthcare professionals in a global database

Rolfes

Hunsel

Caster

et al. 2018

Brit J Clinical Pharma

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“…[16][17][18][19][20] Mobile AEFI reporting using apps could also leverage other functionality in smartphones. Assessment of local reactions or rash could be facilitated if individuals are able to photograph lesions and transmit them with their reports.…”

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confidence: 99%

“…However, one study of consumer reporting of AEFI's demonstrated a higher rate of serious events being reported by vaccines than by health care providers, although more research is needed to explain why this occurs. 23,17 The impact of an app that facilitates mobile AEFI reporting on vaccine hesitancy also needs to be studied. Mobile AEFI reporting permitting direct reporting by individuals would resemble the United States Vaccine Adverse Event Reporting System (VAERS) in several ways and may reflect the advantages and disadvantages of this system.…”

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confidence: 99%

An evaluation of the feasibility and usability of a proof of concept mobile app for adverse event reporting post influenza vaccination

Wilson

Atkinson

Westeinde

et al. 2016

Human Vaccines & Immunotherapeutics

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The Canadian National Vaccine Safety network (CANVAS) gathers and analyzes safety data on individuals receiving the influenza vaccine during the early stages of annual influenza vaccination campaigns with data collected via participant surveys through the Internet. We sought to examine whether it was feasible to use a mobile application (app) to facilitate AEFI reporting for the CANVAS network. To explore this, we developed a novel smartphone app, recruited participants from a hospital influenza immunization clinic and by word of mouth and instructed them to download and utilize the app. The app reminded participants to complete the CANVAS AEFI surveillance surveys ("AEFI surveys") on day 8 and 30, a survey capturing app usability metrics at day 30 ("usability survey") and provided a mechanism to report AEFI events spontaneously throughout the whole study period. All survey results and spontaneous reports were recorded on a privacy compliant, cloud server. A software plug-in, Lookback, was used to record the on-screen experience of the app sessions. Of the 76 participants who consented to participate, 48(63%) successfully downloaded the app and created a profile. In total, 38 unique participants completed all of the required surveillance surveys; transmitting 1104 data points (survey question responses and spontaneous reports) from 83 completed surveys, including 21 usability surveys and one spontaneous report. In total, we received information on new or worsening health conditions after receiving the influenza vaccine from 11(28%) participants. Of the usability survey responses, 86% agreed or strongly agreed that they would prefer to use a mobile app based reporting system instead of a web-based system. The single spontaneous report received was from a participant who had also reported using the Day 8 survey. Of Lookback observable sessions, an accurate transmission proportion of 100% (nD290) was reported for data points. We demonstrated that a mobile app can be used for AEFI reporting, although download and survey completion proportions suggest potential barriers to adoption. Future studies should examine implementation of mobile reporting in a broader audience and impact on the quality of reporting of adverse events following immunization.

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“…Despite these shortcomings, passive AEFI data especially from the public is important to collect in order for them to feel included in vaccine safety monitoring. Moreover, since the public is more likely to report unexpected AEFIs than HCPs their reports could lead to the discovery of rare AEFIs (Clothier et al, 2014;Parrella et al, 2013). Due to this, several studies have suggested that vaccinees and their caretakers (in case of children) must be well equipped to actively partake in AEFI reporting (Hazell, Cornelius, Hannaford, Shakir, & Avery, 2013;Inch, Watson, & Anakwe-Umeh, 2012).…”

Section: Introductionmentioning

confidence: 99%

An Assessment of the Reporting Pattern of Adverse Events Following Immunizations in VigiAccess

Yamoah¹,

Oosthuizen²

2018

GJHS

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PURPOSE: Globally, adverse events following immunization (AEFI) reporting continues to be a challenge. It is estimated that about 95% of AEFIs never get reported after vaccinations necessitating strategies to improve it. The introduction of databases such as VigiAccess in which AEFI data from Pharmacovigilance centres around the world can be assessed is an important step towards improving AEFI reporting and enhancing vaccine safety. This study assessed the reporting pattern of AEFIs from the various continents of the world in VigiAccess, an open-access pharmacovigilance database. METHODS: VigiAccess was thoroughly searched on the 5th of February 2018 for the categories of reported AEFIs and number and types of AEFIs reported for measles vaccine, oral polio vaccine, yellow fever vaccine, pneumococcal vaccine, rotavirus vaccine, meningococcal vaccine, tetanus vaccine and BCG vaccine. RESULTS: After a thorough search through VigiAccess, 27 categories of reported AEFIs were retrieved. The total number of AEFIs for the 8 vaccines was 813,973. General disorders and administration site conditions were the highest number of AEFIs (251,405 representing 30.9%) followed by skin and subcutaneous tissue disorders (93,011 representing 11.4%) and nervous system disorders (89,077 representing 10.9%). With the continental data, the Americas recorded the highest number of AEFIs followed by Europe, Oceania, Asia and Africa. CONCLUSION: General and vaccine administration site conditions were the highest number of AEFIs. The Americas recorded the highest number of AEFIs whereas Africa recorded the least. VigiAccess needs improvement in data synchronization to enhance its reliability.

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Consumer reporting of adverse events following immunization

Cited by 36 publications

References 17 publications

Does patient reporting lead to earlier detection of drug safety signals? A retrospective comparison of time to reporting between patients and healthcare professionals in a global database

Does patient reporting lead to earlier detection of drug safety signals? A retrospective comparison of time to reporting between patients and healthcare professionals in a global database

An evaluation of the feasibility and usability of a proof of concept mobile app for adverse event reporting post influenza vaccination

An Assessment of the Reporting Pattern of Adverse Events Following Immunizations in VigiAccess

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