Evidence map›Paper›PMID 41871912›Full record

ArticleBMJ paediatrics open2026

Understanding adverse events following immunisation: evidence of vaccine safety and coincidental events from 3 years of surveillance.

Merrin Mathew, Savitha Rajapur Sanathan, Mandyam Dhati Ravi

Abstract read
In one paragraph

Article in BMJ paediatrics open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Review
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

3 authors.

Merrin MathewDepartment of Clinical Research, JSS Medical College, JSS Academy of Higher Education and Research, Mysuru, Karnataka, India rssavitha@jssuni.edu.in merrinmathew9@gmail.com.ORCID http://orcid.org/0000-0002-6354-2312
Savitha Rajapur SanathanDepartment of Clinical Pharmacy, JSS Academy of Higher Education & Research, Mysuru, Karnataka, India rssavitha@jssuni.edu.in merrinmathew9@gmail.com.
Mandyam Dhati RaviDepartment of Pediatrics, Hospital JSS Academy of Higher Education & Research, Mysuru, Karnataka, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPeriodic vaccine safety checks are a crucial component of any country's pharmacovigilance system. Unwanted reactions following childhood vaccination are unacceptable to the public, making rapid safety checks and alerts essential for maintaining public confidence.

objectivesThe study evaluates the safety of childhood vaccines in the paediatric population through active surveillance and explores various predictors for the development of adverse event following immunisation (AEFI) based on population characteristics. METHODOLOGY: A cohort event monitoring study was designed to identify AEFIs in children receiving at least one childhood vaccine under the Universal Immunisation Programme (UIP) at the study site. Both active surveillance (via telephone follow-up calls) and passive surveillance (from healthcare workers) were included. Potential predictors of AEFIs were evaluated using the χ

resultsThe study estimated an AEFI incidence rate of 10.37%, with 3.47% (1.27 events/1000 doses) being serious reactions requiring hospitalisation. The highest incidence was with the Pentavac vaccine (diphtheria, tetanus, pertussis, hepatitis B, Hib) at 19.21% (218 events/1000 doses), while the lowest incidence was observed with the oral polio vaccine at 0.13% (1.32 events/1000 doses). Most reported Adevrse Events were solicited (34.83 events/1000 doses), while unsolicited events accounted for 1.69/1000 doses. The most common reaction was fever (23.75 events/1000 doses), followed by pain at injection site (4.98 events/1000 doses). One death following Pentavac vaccination was reported but later deemed coincidental. Overall, 90.62% of the reactions were vaccine product-related, 4.76% coincidental, 2.70% immunisation error-related and 0.39% were indeterminate. Predictors of AEFIs included paediatric population, delayed immunisation, nutritional deficiencies and comorbid status of the child and children from affluent families.

conclusionChildhood vaccines included in the UIP have shown a favourable safety profile. Serious reactions are infrequent, emphasising the need for thorough investigation and clear communication to differentiate them from coincidental reactions, which can occur more frequently in this age group.

Indexed as

VaccinationVaccinesAdverse Drug Reaction Reporting SystemsChildChild, PreschoolFemaleHumansImmunization ProgramsIncidenceInfantMalePharmacovigilanceVaccinesChild HealthHealth PolicyTherapeutics

Identifiers

PMID41871912
PMCPMC13034279

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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.