Evidence map›Paper›PMID 36851085›Full record

ArticleVaccines2023

A Cross-Sectional Study to Assess mRNA-COVID-19 Vaccine Safety among Indian Children (5-17 Years) Living in Saudi Arabia.

Marya Ahsan, Riyaz Ahamed Shaik, Ayaz K Mallick, Saeed S Banawas, Thamer A M Alruwaili, Yousef Abud Alanazi, Hayat Saleh Alzahrani, Ritu Kumar Ahmad, Mohammad Shakil Ahmad, Faisal Holil AlAnazi and 6 more

Abstract read
In one paragraph

Article in Vaccines, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
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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

16 authors.

Marya AhsanDepartment of Pharmacology, College of Medicine, Imam Mohammad Ibn Saud Islamic University (IMSIU), Riyadh 13317, Saudi Arabia.
Riyaz Ahamed ShaikDepartment of Family & Community Medicine, College of Medicine, Majmaah University, Al Majmaah 11952, Saudi Arabia.ORCID 0000-0003-1322-9210
Ayaz K MallickDepartment of Clinical Biochemistry, College of Medicine, King Khalid University, Abha 61421, Saudi Arabia.
Saeed S BanawasDepartment of Medical Laboratories, College of Applied Medical Science, and Health and Basic Sciences Research Center, Majmaah University, Majmaah 11952, Saudi Arabia.ORCID 0000-0002-4423-8892
Thamer A M AlruwailiDepartment of Pediatrics, College of Medicine, Jouf University, Aljouf 72388, Saudi Arabia.ORCID 0000-0001-8965-4120
Yousef Abud AlanaziDepartment of Pediatrics, College of Medicine, Majmaah University, Majmaah 11952, Saudi Arabia.
Hayat Saleh AlzahraniDepartment of Clinical Science, College of Medicine, Princess Nourah bint Abdulrahman University, Riyadh 11671, Saudi Arabia.
Ritu Kumar AhmadDepartment of Physiotherapy, College of Applied Medical Science, Buraydah Private Colleges, Buraydah 51418, Saudi Arabia.
Mohammad Shakil AhmadDepartment of Family & Community Medicine, College of Medicine, Majmaah University, Al Majmaah 11952, Saudi Arabia.ORCID 0000-0003-3941-7121
Faisal Holil AlAnaziDepartment of Medicine, College of Medicine, Majmaah University, Majmaah 11952, Saudi Arabia.
Fahad AlfhaidDepartment of Family & Community Medicine, College of Medicine, Majmaah University, Al Majmaah 11952, Saudi Arabia.
Mohammed Zaid AljulifiDepartment of Family & Community Medicine, College of Medicine, Majmaah University, Al Majmaah 11952, Saudi Arabia.ORCID 0000-0002-1401-5305
Vini MehtaDepartment of Public Health Dentistry, Dr.D.Y.Patil Dental College and Hospital, Dr.D.Y.Patil Vidyapeeth, Pune 411018, India.ORCID 0000-0003-4174-907X
Abdalah Emad AlmhmdCollege of Medicine, Majmaah University, Majmaah 11952, Saudi Arabia.ORCID 0000-0003-1884-1660
Abdulaziz S D Al DahamCollege of Medicine, Jouf University, Aljouf 72388, Saudi Arabia.
Mutlaq M M AlruwailiCollege of Medicine, Jouf University, Aljouf 72388, Saudi Arabia.ORCID 0000-0002-4082-3250

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The objective of this study is to assess the frequency and severity of adverse events following immunization (AEFI) in Indian children aged 5-17 years who received the Pfizer-BioNTech mRNA COVID-19 vaccine, as well as to investigate for predictors of AEFI. To examine AEFI following the first and second doses of Pfizer's vaccine, semi-structured questionnaires were distributed as Google forms at Indian schools in Saudi Arabia. The 385 responses included 48.1% male and 51.9% female children, with 136 responses of children aged 5-11 years (group A) and 249 responses from children aged 12-17 years (group B). Overall, 84.4% of children had two shots. The frequency of AEFI was reported to be higher after the first dose than after the second (OR = 2.12, 95% CI = 1.57-2.86). The reported AEFIs included myalgia, rhinitis, local reaction with fever, a temperature of 102 °F or higher, and mild to moderate injection site reactions. While group B frequently reported multiple AEFIs, group A typically reported just one. Local reaction with low grade fever was more frequently reported in group B after the first dose (24.1%) and second dose (15.4%), while local reaction without low grade fever was most frequently observed in group A after the first (36.8%) and second dose (30%). Only prior COVID-19 infection (OR = 2.98, 95% CI = 1.44-6.2) was associated with AEFI after the second dose in the study sample, whereas male gender (OR = 1.71, 95% CI = 1.13-2.6) and prior COVID-19 infection (OR = 2.95, 95% CI = 1.38-6.3) were predictors of AEFI after the first dose. Non-serious myocarditis was reported by only one child. According to the analysis conducted, the Pfizer's mRNA COVID-19 vaccination was found to be safe in Indian children.

Indexed as

adverse events following immunization (AEFI)adverse events of special interest (AESI)COVID-19mRNA vaccinemyocarditis

Identifiers

PMID36851085
PMCPMC9961071

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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.