Postmarketing Safety Surveillance of a Hexavalent Vaccine in the Vaccine Adverse Event Reporting System.

Pedro L Moro, Bicheng Zhang, Paige Marquez, Jonathan Reich

Open access · greenAbstract read

In one paragraph

Article in The Journal of pediatrics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it

0cells of the map it votes in

0citing papers in PubMed

–field-weighted citation impact, top 85% 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

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

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

4 authors at 2 institutions in 1 country.

Pedro L MoroImmunization Safety Office, Division of Healthcare Quality Promotion CDC, Silver Spring, MD. Electronic address: pmoro@cdc.gov.

Bicheng ZhangImmunization Safety Office, Division of Healthcare Quality Promotion CDC, Silver Spring, MD.

Paige MarquezImmunization Safety Office, Division of Healthcare Quality Promotion CDC, Silver Spring, MD.

Jonathan ReichCenter for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD.

Center for Biologics Evaluation and Research · USOffice of Science · US

Funding

Intramural CDC HHS CC999999

6 · The paper itself

Abstract

We assessed the safety of hexavalent vaccine diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, hepatitis b, and haemophilus influenzae b conjugate vaccine in the Vaccine Adverse Event Reporting System. Five hundred-one reports of adverse events (AEs) were identified; 21 (4.2%) were serious. Most frequently reported AEs were fever (10.2%) and injection site erythema (5.4%). AEs reported were consistent with findings from prelicensure studies.

Indexed as

Diphtheria-Tetanus-Pertussis VaccineHaemophilus VaccinesHepatitis B VaccinesHumansPoliovirus Vaccine, InactivatedVaccines, CombinedVaccines, ConjugateDiphtheria-Tetanus-Pertussis VaccineHaemophilus VaccinesHepatitis B VaccinesPoliovirus Vaccine, InactivatedVaccines, CombinedVaccines, Conjugateepidemiologyhexavalent vaccinesurveillancevaccine safety

Identifiers

PMID37517652

DOI10.1016/j.jpeds.2023.113643

PMCPMC11758478

OpenAlexW4385336868

What OpenQuestion holds

Textmetadata

LicenceTDM

Read underepoch 390

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.