Evidence map›Paper›PMID 36793715›Full record

ReviewFrontiers in immunology2023

Sex-disaggregated outcomes of adverse events after COVID-19 vaccination: A Dutch cohort study and review of the literature.

Janneke W Duijster, Thomas Lieber, Silvia Pacelli, Leontine Van Balveren, Loes S Ruijs, Monika Raethke, Agnes Kant, Florence Van Hunsel

Abstract readReview
In one paragraph

Review in Frontiers in immunology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing 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

26 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Observational
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Nuvaxovid NVX-CoV2373 vaccine safety profile: real-world data evidence after 100,000 doses, Australia, 2022 to 2023.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2024
    Observational
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Observational
  19. Article
  20. 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

8 authors.

Janneke W DuijsterNetherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, Netherlands.
Thomas LieberNetherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, Netherlands.
Silvia PacelliNetherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, Netherlands.
Leontine Van BalverenNetherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, Netherlands.
Loes S RuijsNetherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, Netherlands.
Monika RaethkeNetherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, Netherlands.
Agnes KantNetherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, Netherlands.
Florence Van HunselNetherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Albeit the need for sex-disaggregated results of adverse events after immunization (AEFIs) is gaining attention since the COVID-19 pandemic, studies with emphasis on sexual dimorphism in response to COVID-19 vaccination are relatively scarce. This prospective cohort study aimed to assess differences in the incidence and course of reported AEFIs after COVID-19 vaccination between males and females in the Netherlands and provides a summary of sex-disaggregated outcomes in published literature. Methods: Patient reported outcomes of AEFIs over a six month period following the first vaccination with BioNTech-Pfizer, AstraZeneca, Moderna or the Johnson&Johnson vaccine were collected in a Cohort Event Monitoring study. Logistic regression was used to assess differences in incidence of 'any AEFI', local reactions and the top ten most reported AEFIs between the sexes. Effects of age, vaccine brand, comorbidities, prior COVID-19 infection and the use of antipyretic drugs were analyzed as well. Also, time-to-onset, time-to-recovery and perceived burden of AEFIs was compared between the sexes. Third, a literature review was done to retrieve sex-disaggregated outcomes of COVID-19 vaccination. Results: The cohort included 27,540 vaccinees (38.5% males). Females showed around two-fold higher odds of having any AEFI as compared to males with most pronounced differences after the first dose and for nausea and injection site inflammation. Age was inversely associated with AEFI incidence, whereas a prior COVID-19 infection, the use of antipyretic drugs and several comorbidities were positively associated. The perceived burden of AEFIs and time-to-recovery were slightly higher in females. Discussion: The results of this large cohort study correspond to existing evidence and contribute to the knowledge gain necessary to disentangle the magnitude of the effect sex in response to vaccination. Whilst females have a significant higher probability of experiencing an AEFI than males, we observed that the course and burden is only to a minor extent different between the sexes.

Indexed as

AntipyreticsCOVID-19COVID-19 VaccinesAdverse Drug Reaction Reporting SystemsCohort StudiesComorbidityFemaleHumansMaleNetherlandsProspective StudiesVaccinationAntipyreticsCOVID-19 Vaccinesadverse event after vaccinationCOVID-19 vaccinelongitudinal cohort designpatient reported outcomepharmacovigilancesex

Identifiers

PMID36793715
PMCPMC9922710

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.