Evidence map›Paper›PMID 36351861›Full record

Observational studyVaccine2023

Reactions following Pfizer-BioNTech COVID-19 mRNA vaccination and related healthcare encounters among 7,077 children aged 5-11 years within an integrated healthcare system.

Deborah E Malden, Julianne Gee, Sungching Glenn, Zhuoxin Li, Cheryl Mercado, Oluwaseye A Ogun, Sunhea Kim, Bruno J Lewin, Bradley K Ackerson, Amelia Jazwa and 3 more

Open access · hybridAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Vaccine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.4field-weighted citation impact, top 39% 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

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. 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

13 authors at 3 institutions in 1 country.

Deborah E MaldenEpidemic Intelligence Service, Centers for Disease Control and Prevention, Atlanta, GA, USA; Kaiser Permanente Southern California Department of Research & Evaluation, Pasadena, CA, USA. Electronic address: debbie.e.malden@kp.org.
Julianne GeeImmunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Sungching GlennKaiser Permanente Southern California Department of Research & Evaluation, Pasadena, CA, USA.
Zhuoxin LiKaiser Permanente Southern California Department of Research & Evaluation, Pasadena, CA, USA.
Cheryl MercadoKaiser Permanente Southern California Department of Research & Evaluation, Pasadena, CA, USA.
Oluwaseye A OgunKaiser Permanente Southern California Department of Research & Evaluation, Pasadena, CA, USA.
Sunhea KimKaiser Permanente Southern California Department of Research & Evaluation, Pasadena, CA, USA.
Bruno J LewinKaiser Permanente Southern California Department of Research & Evaluation, Pasadena, CA, USA; Kaiser Permanente Bernard J. Tyson School of Medicine, CA, USA.
Bradley K AckersonKaiser Permanente Southern California Department of Research & Evaluation, Pasadena, CA, USA.
Amelia JazwaImmunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Eric S WeintraubImmunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Michael M McNeilImmunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Sara Y TartofKaiser Permanente Southern California Department of Research & Evaluation, Pasadena, CA, USA; Kaiser Permanente Bernard J. Tyson School of Medicine, CA, USA.
Kaiser Permanente · USCenters for Disease Control and Prevention · USNational Center for Immunization and Respiratory Diseases · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundStudies combining data from digital surveys and electronic health records (EHR) can be used to conduct comprehensive assessments on COVID-19 vaccine safety.

methodsWe conducted an observational study using data from a digital survey and EHR of children aged 5-11 years vaccinated with Pfizer-BioNTech COVID-19 mRNA vaccine across Kaiser Permanente Southern California during November 4, 2021-February 28, 2022. Parents/guardians who enrolled their children were sent a 14-day survey on reactions. Survey results were combined with EHR, and medical encounters were described for children whose parents or guardians indicated seeking medical care for vaccine-related symptoms. This study describes self-reported reactions (local and systemic) and additional symptoms (chest pain, tachycardia, and pre-syncope).

resultsThe study recruited 7,077 participants aged 5-11 years who received the Pfizer-BioNTech COVID-19 mRNA vaccine. Of 6,247 participants with survey responses after dose 1, 2,176 (35 %) reported at least one systemic reaction, and 1,076 (32 %) of 3,401 respondents following dose 2 reported at least one systemic reaction. Local reactions were reported less frequently following dose 2 (1,113, 33 %) than dose 1 (3,140, 50 %). The most frequently reported reactions after dose 1 were pain at the injection site (48 %), fatigue (20 %), headache (12 %), myalgia (9 %) and fever (5 %). The most frequently reported symptoms after dose 2 were also pain at the injection site (30 %), fatigue (19 %), headache (13 %), myalgia (10 %) and fever (9 %). Post-vaccination reactions occurred most frequently-one day following vaccination. Chest pain or tachycardia were reported infrequently (1 %). EHR demonstrated that parents rarely sought care for post-vaccination symptoms, and among those seeking care, the most common symptoms documented in EHR were fever and nausea, comprising <0.5 % of children. No encounters were related to myocarditis.

conclusionWhile post-vaccination reactions to the Pfizer-BioNTech COVID-19 mRNA vaccine were common in children aged 5-11 years, our data showed that in most cases they were transient and did not require medical care.

Indexed as

COVID-19Delivery of Health Care, IntegratedBNT162 VaccineChest PainChildCOVID-19 VaccinesFatigueFeverHeadacheHumansMyalgiaRNA, MessengerVaccinationBNT162 VaccineCOVID-19 VaccinesRNA, MessengerAdverse eventsCOVID-19SurveillanceVaccinationVaccine safety

Identifiers

PMID36351861
PMCPMC9630154
OpenAlexW4308486179

What OpenQuestion holds

Textmetadata
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.