Causality assessment of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS)

Loughlin, Anita M.; Marchant, Colin D.; Adams, William; Barnett, Elizabeth D.; Baxter, Roger; Black, Steve; Casey, Christine; Dekker, Cornelia L.; Edwards, Katherine M.; Klein, Jerold; Klein, Nicola P.; LaRussa, Philip; Sparks, Robert; Jakob, Kathleen

doi:10.1016/j.vaccine.2012.09.074

Cited by 31 publications

(35 citation statements)

References 8 publications

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“…11 The reporting rate of Green Channel Centre was greater than the mean Italian reporting rate in the same period and, interestingly, also superior to the reporting rate of Vaccine Adverse Event Reporting System (VAERS), the largest database of AEFI reports established in the United States, that received annually nearly 28 000 reports of AEFI, corresponding to a AEFI reporting rate of 12.7 for 100 000 administered doses. 5,12 In conclusion, preliminary results of the twoyears' experience of the Liguria Region in post marketing surveillance of vaccine safety and in improving the signal of AEFI, by education of healthcare personnel and involvement of patients, seems to confirm the satisfactory results obtained by similar projects.…”

Section: Resultsmentioning

confidence: 62%

Routine surveillance of adverse events following immunization as an important tool to monitor vaccine safety

Alicino

Merlano²,

Zappettini³

et al. 2014

Human Vaccines & Immunotherapeutics

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Post licensure surveillance of adverse events following immunization (AEFI) is a fundamental activity to improve safety and maintain public confidence in vaccines. Since 2011, the Liguria Region has been involved in the inter-regional project of post-marketing surveillance of AEFI, coordinated by the Italian Medicine Agency and the Veneto region. The main objectives of the project are: (1) to coordinate the surveillance activities in the 8 Italian Regions included in the project; (2) to encourage the signal of AEFI by healthcare workers and patients; (3) to organize education activities addressed to health care workers, and, finally; (4) to establish vaccination counseling services in each Region. In particular, the Ligurian multidisciplinary team, composed by physicians expert in the field of vaccination and pharmacists, is involved in the causality assessment between vaccines and all adverse events signaled within the Liguria Region and in the analysis of all adverse events signaled in Italy as possibly related to influenza vaccines. During 2013, the team has organized 4 courses, addressed to healthcare personnel of vaccination outpatient clinics, focused on European and Italian legislation on pharmaco-vigilance and vaccine-vigilance and aimed at promoting signal of AEFI. Since October 2013, the Liguria Region has been participating to the inter-regional project of active surveillance of adverse events aimed at promoting the signal of AEFI by parents of vaccinated infants. After two years of implementation of the project both the number of reported AEFI and the reporting rate per 100 000 administered doses of vaccine increased. The activities need to be consolidated in the next years in order to guarantee high standard of vaccine safety, maintain the confidence in current immunization programs and reach optimal vaccination coverage rate.

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Section: Resultsmentioning

confidence: 62%

Routine surveillance of adverse events following immunization as an important tool to monitor vaccine safety

Alicino

Merlano²,

Zappettini³

et al. 2014

Human Vaccines & Immunotherapeutics

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“…The primary purpose of VAERS is to detect possible vaccine safety problems that might require further evaluation [25,26]. VAERS accepts all reports, including reports of vaccination errors, regardless of whether an AHE is documented.…”

Section: Methodsmentioning

confidence: 99%

Vaccination errors reported to the Vaccine Adverse Event Reporting System, (VAERS) United States, 2000–2013

Hibbs

Moro

Lewis

et al. 2015

Vaccine

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“…The causal relationships between live vaccination and rash or pneumonia, 2 commonly described complications of live vaccination in immunocompromised patients, [13][14][15] were assessed by using World Health Organization (WHO) criteria modified by CISA investigators 20 and a novel algorithm developed by the CISA Network. 18 If a subject died, cause of death provided in the medical record was accepted; previous live vaccine-preventable illnesses and vaccinations were reviewed.…”

Section: Methodsmentioning

confidence: 99%

“…A comprehensive investigation of live vaccine safety, including more recently introduced vaccines (ie, rotavirus), among patients with DGS is also warranted and may be enhanced using new causality assessment algorithms. [18][19][20] This study from the Clinical Immunization Safety Assessment (CISA) Network describes live vaccine-preventable illnesses, vaccination patterns, and adverse events following live immunization (AEFLIs) among 194 individuals with a documented chromosome 22q11.2 microdeletion.…”

mentioning

confidence: 99%

Live Vaccine Use and Safety in DiGeorge Syndrome

et al. 2014

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WHAT'S KNOWN ON THIS SUBJECT: Individuals with DiGeorge syndrome (DGS) have varying degrees of immunodeficiency. All are susceptible to vaccine-preventable infections with serious complications. Although live vaccines are generally contraindicated in this population, limited evidence suggests that they may be effective and safe for select individuals.WHAT THIS STUDY ADDS: Many individuals with DGS received live vaccines despite having a known diagnosis. Adverse events following live immunizations were typically minor and self-limited, suggesting that live vaccines may be considered for patients with DGS who exhibit mild-to-moderate immunosuppression. abstract OBJECTIVE: Live vaccines are generally contraindicated in patients with DiGeorge syndrome (DGS), a congenital disorder characterized by cellular immune deficiency. Vaccine utilization and safety in this population are not well described. This study examined vaccination patterns and adverse events following live immunization (AEFLI) in these individuals. METHODS:A multicenter retrospective cohort study was conducted in subjects with DGS confirmed by fluorescence in situ hybridization assay (chromosome 22q11.2 microdeletion). Live vaccine-preventable illnesses, vaccination coverage and timeliness, and AEFLIs in the 56-day window after live vaccination were examined. Bivariate and multivariable analyses assessed the impact of demographics medical history, timing of diagnostic confirmation, and preceding immune function on vaccination patterns and AEFLIs.RESULTS: Of 194 subjects, 77% and 75% received measles-mumps-rubella (MMR) and varicella vaccines, respectively; 58% completed recommended vaccinations by age 19 to 35 months. Adverse events occurred after 14% and 20% of MMR and varicella vaccine doses, respectively. Most events were minor, few were serious, and no deaths were reported in post-live vaccination windows. Although early diagnostic confirmation negatively affected live vaccination coverage and timeliness (P , .001), baseline CD4% did not differ between subjects who did or did not receive live vaccines by 12 to 18 months. Among varicella vaccine recipients, those with a subsequent adverse event had a lower preceding CD4% (24.8% 6 7.3%) than those without (35.5% 6 11.7%) (P , .05); no CD4% differences were observed with MMR vaccination. Fourteen unvaccinated subjects experienced live vaccine-preventable illnesses.CONCLUSIONS: Live vaccines were frequently given and generally welltolerated among patients with DGS with mild-to-moderate immunosuppression.

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Causality assessment of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS)

Cited by 31 publications

References 8 publications

Routine surveillance of adverse events following immunization as an important tool to monitor vaccine safety

Routine surveillance of adverse events following immunization as an important tool to monitor vaccine safety

Vaccination errors reported to the Vaccine Adverse Event Reporting System, (VAERS) United States, 2000–2013

Live Vaccine Use and Safety in DiGeorge Syndrome

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