Evidence map›Paper›PMID 41138438›Full record

ArticleVaccine2025

Near real-time surveillance and tree-based data mining to assess the safety of respiratory syncytial virus vaccines in older adults in the vaccine safety datalink.

James G Donahue, Noelle M Cocoros, Burney A Kieke, Kayla E Hanson, Eric S Weintraub, W Katherine Yih, Erica Scotty, David L McClure, Bruce Fireman, Thomas G Boyce and 19 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Vaccine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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

2 citing papers in PubMed.

  1. AS01Drug safety · 2026
    Article
  2. Article
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

29 authors.

James G DonahueMarshfield Clinic Research Institute, Marshfield, WI, USA.
Noelle M CocorosHarvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA, USA.
Burney A KiekeMarshfield Clinic Research Institute, Marshfield, WI, USA.
Kayla E HansonMarshfield Clinic Research Institute, Marshfield, WI, USA.
Eric S WeintraubCenters for Disease Control and Prevention, Immunization Safety Office, Atlanta, GA, USA.
W Katherine YihHarvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA, USA.
Erica ScottyMarshfield Clinic Research Institute, Marshfield, WI, USA.
David L McClureMarshfield Clinic Research Institute, Marshfield, WI, USA.
Bruce FiremanKaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California Division of Research, Oakland, CA, USA.
Thomas G BoyceMarshfield Clinic Research Institute, Marshfield, WI, USA.
Judith C MaroHarvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA, USA.
Joan BartlettKaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California Division of Research, Oakland, CA, USA.
Jason M GlanzKaiser Permanente Colorado, Aurora, CO, USA.
Jacob L HaapalaHealthPartners Institute, Minneapolis, MN, USA.
Michael HorbergKaiser Permanente Mid-Atlantic Permanente Research Institute, Washington, DC, USA.
Laura HurleyDenver Health, Denver, CO, USA.
Stephanie A IrvingKaiser Permanente Center for Health Research, Portland, OR, USA.
Lisa A JacksonKaiser Permanente Washington, Seattle, WA, USA.
Seohyun KimKaiser Permanente Mid-Atlantic Permanente Research Institute, Washington, DC, USA.
Nicola P KleinKaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California Division of Research, Oakland, CA, USA.
Michael M McNeilCenters for Disease Control and Prevention, Immunization Safety Office, Atlanta, GA, USA.
Tanya R MyersCenters for Disease Control and Prevention, Immunization Safety Office, Atlanta, GA, USA.
Lei QianKaiser Permanente Southern California, Pasadena, CA, USA.
Ning SmithKaiser Permanente Center for Health Research, Portland, OR, USA.
Maria E SundaramMarshfield Clinic Research Institute, Marshfield, WI, USA. Electronic address: sundaram.maria@marshfieldresearch.org.
Sara TartofKaiser Permanente Southern California, Pasadena, CA, USA.
Lily WangCenters for Disease Control and Prevention, Immunization Safety Office, Atlanta, GA, USA.
Stanley XuKaiser Permanente Southern California, Pasadena, CA, USA.
Edward A BelongiaMarshfield Clinic Research Institute, Marshfield, WI, USA.

Funding

Intramural CDC HHS CC999999
6 · The paper itself

Abstract

backgroundTwo respiratory syncytial virus (RSV) vaccines, Pfizer's Abrysvo and GSK's Arexvy, were licensed in 2023 in the U.S. However, population-based assessments of their safety in adults ≥60 years have not been widely published. We provide results from two complementary investigations of vaccinated adults in the Vaccine Safety Datalink (VSD).

methodsThe rapid cycle analysis (RCA) used a sequential cohort design and biweekly analyses of near real-time data to compare the incidence of 12 pre-specified outcomes in two post-vaccination risk intervals (1-21, 1-42 days) with the incidence in comparison intervals. The surveillance period was August 1, 2023, through September 28, 2024; nine of 13 VSD sites participated. Statistically significant signals were investigated by medical record review with re-analysis of confirmed outcomes. The self-controlled tree-based data mining analysis was designed to identify temporal clustering of ICD-10 diagnosis codes in the inpatient or emergency department settings 1-56 days post-vaccination, without pre-specifying outcomes or risk intervals. The study period was July 1, 2023, through December 31, 2023; 10 sites participated.

resultsThe RCA analysis included 436,823 persons who received an RSV vaccine. No statistical signal was identified for 11 of 12 adverse events. A signal was detected for immune thrombocytopenic purpura following Arexvy, but re-analysis following medical record review did not confirm an association. The tree-based data mining analysis included 248,056 vaccinees, identified 53,734 counts of 3429 diagnosis codes, and identified no statistically significant clusters for either vaccine.

conclusionsThese post-licensure safety assessments provide evidence supporting the safety of RSV vaccines in older adults. As more data accrue, additional monitoring is warranted for rare adverse events.

Indexed as

Data MiningRespiratory Syncytial Virus InfectionsRespiratory Syncytial Virus VaccinesAdverse Drug Reaction Reporting SystemsAgedAged, 80 and overCohort StudiesFemaleHumansMaleMiddle AgedProduct Surveillance, PostmarketingRespiratory Syncytial Virus, HumanUnited StatesVaccinationRespiratory Syncytial Virus Vaccines

Identifiers

PMID41138438
PMCPMC12704511

What OpenQuestion holds

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Registered trials

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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.