Evidence map›Paper›PMID 32040350›Full record

ArticleHuman vaccines & immunotherapeutics2020

Post-marketing surveillance of adverse events following measles, mumps, rubella and varicella (MMRV) vaccine: retrospecive study in apulia region (ITALY), 2009-2017.

Pasquale Stefanizzi, Sara De Nitto, Francesco Patano, Francesco Paolo Bianchi, Davide Ferorelli, Paolo Stella, Domenica Ancona, Vito Bavaro, Silvio Tafuri

Open access · bronzeAbstract read
In one paragraph

Article in Human vaccines & immunotherapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
3.2field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 34 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Pasquale StefanizziBiomedical Science and Human Oncology, Universita degli Studi di Bari Aldo Moro , Bari, Italy.
Sara De NittoBiomedical Science and Human Oncology, Universita degli Studi di Bari Aldo Moro , Bari, Italy.
Francesco PatanoBiomedical Science and Human Oncology, Universita degli Studi di Bari Aldo Moro , Bari, Italy.
Francesco Paolo BianchiBiomedical Science and Human Oncology, Universita degli Studi di Bari Aldo Moro , Bari, Italy.
Davide FerorelliInterdisciplinary Department of Medicine, Aldo Moro University of Bari , Bari, Italy.
Paolo StellaApulian Regional Health Department, Bari, Italy.
Domenica AnconaApulian Regional Health Department, Bari, Italy.
Vito BavaroBiomedical Science and Human Oncology, Universita degli Studi di Bari Aldo Moro , Bari, Italy.
Silvio TafuriBiomedical Science and Human Oncology, Aldo Moro University of Bari , Bari, Italy.
University of Bari Aldo Moro · ITAgenzia Regionale Sanitaria della Puglia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Since 2006, some Italian Regions introduced the active offer of measles, mumps, rubella, and varicella (MMRV) vaccine for all newborns during the second years of life. In 2011, Italian Drug Authority (AIFA) recommended the discontinuation of the MMRV use for an increased risk of febrile seizures following vaccination; furthermore, some Regions (such as Apulia, that introduced MMRV offer in 2009) chose to continue the use of MMRV and Ministry of Health recommended to guarantee supplemental monitoring of safety of the vaccine. In Italy, the surveillance of Adverse Events following immunization (AEFIs) is currently carried out by AIFA and Regional Health Authorities; this paper aims to summarize the results of MMRV-vaccine surveillance of AEFIs program carried out in Apulia. From the AIFA database, we selected MMRV AEFIs that occurred in Apulia (about 4,000,000 inhabitants) from 2009 to 2017. For serious AEFIs, we applied the WHO causality assessment algorithm, using for cases hospitalized information from individual medical records. In the 8 years of observation, 155 MMRV-AEFIs (reporting rate: 37.9×100,000 doses) occurred of which 26 were classified as serious (6.3×100,000 doses) and 22 led to hospitalization. Performing causality assessment, for 10 the classification was "consistent causal association to immunization" (reporting rate: 2.4×100000 doses), for 2 indeterminate, for 13 "inconsistent causal association to immunization" and for 1 not-classifiable. No case of febrile seizure resulted consistent to vaccination. All consistent serious AEFIs were completely resolved at subsequent follow-up.

Indexed as

ChickenpoxMeaslesMumpsRubellaChickenpox VaccineHumansInfantInfant, NewbornItalyMeasles-Mumps-Rubella VaccineProduct Surveillance, PostmarketingVaccines, CombinedChickenpox VaccineMeasles-Mumps-Rubella VaccineVaccines, Combinedadverse events following immunizationcausality assessmentfebrile seizurespharmacovigilanceVaccine safety

Identifiers

PMID32040350
PMCPMC7482746
OpenAlexW3004540104

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.