Internet-Based Reporting to the Vaccine Adverse Event Reporting System: A More Timely and Complete Way for Providers to Support Vaccine Safety

Haber, Penina; Iskander, John K.; Walton, Katherine; Campbell, Scott R.; Kohl, Katrin

doi:10.1542/peds.2010-1722g

Cited by 18 publications

(9 citation statements)

References 16 publications

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“…In the USA, 80 % of drug [1], 35 % of vaccine [2], and 98 % of device [3] AE reports received by the US FDA come from the biopharmaceutical industry. In the clinical context, while the true extent of under-reporting is unknown, a recent study of Medicare enrollees in a hospital found that 86 % of AEs went unreported [4].…”

Section: Introductionmentioning

confidence: 99%

Digital Drug Safety Surveillance: Monitoring Pharmaceutical Products in Twitter

et al. 2014

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BackgroundTraditional adverse event (AE) reporting systems have been slow in adapting to online AE reporting from patients, relying instead on gatekeepers, such as clinicians and drug safety groups, to verify each potential event. In the meantime, increasing numbers of patients have turned to social media to share their experiences with drugs, medical devices, and vaccines.ObjectiveThe aim of the study was to evaluate the level of concordance between Twitter posts mentioning AE-like reactions and spontaneous reports received by a regulatory agency.MethodsWe collected public English-language Twitter posts mentioning 23 medical products from 1 November 2012 through 31 May 2013. Data were filtered using a semi-automated process to identify posts with resemblance to AEs (Proto-AEs). A dictionary was developed to translate Internet vernacular to a standardized regulatory ontology for analysis (MedDRA®). Aggregated frequency of identified product-event pairs was then compared with data from the public FDA Adverse Event Reporting System (FAERS) by System Organ Class (SOC).ResultsOf the 6.9 million Twitter posts collected, 4,401 Proto-AEs were identified out of 60,000 examined. Automated, dictionary-based symptom classification had 72 % recall and 86 % precision. Similar overall distribution profiles were observed, with Spearman rank correlation rho of 0.75 (p < 0.0001) between Proto-AEs reported in Twitter and FAERS by SOC.ConclusionPatients reporting AEs on Twitter showed a range of sophistication when describing their experience. Despite the public availability of these data, their appropriate role in pharmacovigilance has not been established. Additional work is needed to improve data acquisition and automation.

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Section: Introductionmentioning

confidence: 99%

Digital Drug Safety Surveillance: Monitoring Pharmaceutical Products in Twitter

et al. 2014

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“…13 Studies that use passive surveillance, such as the U.S. Vaccine Adverse Event Reporting System, 16 are crucial in identifying signals regarding AEs postlicensure. However, because by definition they do not consider the rate of such events in nonvaccinated populations, they are not designed to assess a statistical association between a vaccine and an adverse event, so such studies were excluded from this project.…”

Section: Methodsmentioning

confidence: 99%

Safety of Vaccines Used for Routine Immunization in the United States

Maglione¹,

Gidengil²,

Das³

et al. 2014

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There is evidence that some vaccines are associated with serious adverse events; however, these events are extremely rare and must be weighed against the protective benefits that vaccines provide. Careful consideration should be given to the investigation of research gaps, including patient risk factors that may be associated with AEs; however, important factors must be taken into account when determining whether studies are warranted, including the severity and frequency of the AE being studied and the challenges of conducting sufficiently powered studies when investigating rare events.

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“…The self-controlled case series was developed specifically to assess the safety of vaccines; this method eliminates confounding by all timeindependent variables by using cases as their own controls and predefined "time windows" before and after vaccination. This design has been used to study purpura, febrile seizures, intussusception, and autism 97 are crucial in identifying signals regarding AEs post licensure, but they are not designed to assess a statistical association, so they were excluded as sources of data.…”

Section: Studies Controlling For Multiple Vaccinations During Childhoodmentioning

confidence: 99%

Safety of Vaccines Used for Routine Immunization of US Children: A Systematic Review

et al. 2014

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BACKGROUND: Concerns about vaccine safety have led some parents to decline recommended vaccination of their children, leading to the resurgence of diseases. Reassurance of vaccine safety remains critical for population health. This study systematically reviewed the literature on the safety of routine vaccines recommended for children in the United States. METHODS: Data sources included PubMed, Advisory Committee on Immunization Practices statements, package inserts, existing reviews, manufacturer information packets, and the 2011 Institute of Medicine consensus report on vaccine safety. We augmented the Institute of Medicine report with more recent studies and increased the scope to include more vaccines. Only studies that used active surveillance and had a control mechanism were included. Formulations not used in the United States were excluded. Adverse events and patient and vaccine characteristics were abstracted. Adverse event collection and reporting was evaluated by using the McHarm scale. We were unable to pool results. Strength of evidence was rated as high, moderate, low, or insufficient. RESULTS: Of 20 478 titles identified, 67 were included. Strength of evidence was high for measles/mumps/rubella (MMR) vaccine and febrile seizures; the varicella vaccine was associated with complications in immunodeficient individuals. There is strong evidence that MMR vaccine is not associated with autism. There is moderate evidence that rotavirus vaccines are associated with intussusception. Limitations of the study include that the majority of studies did not investigate or identify risk factors for AEs; and the severity of AEs was inconsistently reported. CONCLUSIONS: We found evidence that some vaccines are associated with serious AEs; however, these events are extremely rare and must be weighed against the protective benefits that vaccines provide.

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Internet-Based Reporting to the Vaccine Adverse Event Reporting System: A More Timely and Complete Way for Providers to Support Vaccine Safety

Cited by 18 publications

References 16 publications

Digital Drug Safety Surveillance: Monitoring Pharmaceutical Products in Twitter

Digital Drug Safety Surveillance: Monitoring Pharmaceutical Products in Twitter

Safety of Vaccines Used for Routine Immunization in the United States

Safety of Vaccines Used for Routine Immunization of US Children: A Systematic Review

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