Evidence map›Paper›PMID 42430326›Full record

ArticlePloS one2026

Adverse events following immunization during COVID-19 mass vaccination campaigns in the Democratic Republic of Congo: Findings from active safety surveillance.

Kizito Kayumba, Alemayehu Duga, Mosoka Papa Fallah, Claire Tshidibi, Nicky Lubaki, Barnabas Coulibaly, Benjamin Djoudalbaye, Efire Nora Sylvana, Senga Lucy Sembuche, Tedi Tilahun and 8 more

Abstract read
In one paragraph

Article in PloS one, 2026. 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
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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.

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

18 authors.

Kizito KayumbaAfrica Centres for Disease Control and Prevention (Africa CDC), Addis Ababa, Ethiopia.ORCID https://orcid.org/0009-0001-7877-9478
Alemayehu DugaAfrica Centres for Disease Control and Prevention (Africa CDC), Addis Ababa, Ethiopia.
Mosoka Papa FallahAfrica Centres for Disease Control and Prevention (Africa CDC), Addis Ababa, Ethiopia.
Claire TshidibiMinistry of Health, Kinshasa, Democratic Republic of Congo.
Nicky LubakiMinistry of Health, Kinshasa, Democratic Republic of Congo.
Barnabas CoulibalyAfrica Centres for Disease Control and Prevention (Africa CDC), Addis Ababa, Ethiopia.
Benjamin DjoudalbayeAfrica Centres for Disease Control and Prevention (Africa CDC), Addis Ababa, Ethiopia.
Efire Nora SylvanaAfrica Centres for Disease Control and Prevention (Africa CDC), Addis Ababa, Ethiopia.
Senga Lucy SembucheAfrica Centres for Disease Control and Prevention (Africa CDC), Addis Ababa, Ethiopia.
Tedi TilahunAfrica Centres for Disease Control and Prevention (Africa CDC), Addis Ababa, Ethiopia.
Murtala JibrilAfrica Centres for Disease Control and Prevention (Africa CDC), Addis Ababa, Ethiopia.
Carlos KiloweAfrica Centres for Disease Control and Prevention (Africa CDC), Addis Ababa, Ethiopia.
Aminu KubaAfrica Centres for Disease Control and Prevention (Africa CDC), Addis Ababa, Ethiopia.
Antoine Mafwila LusalaAfrica Centres for Disease Control and Prevention (Africa CDC), Addis Ababa, Ethiopia.
Nebiyu DerejeAfrica Centres for Disease Control and Prevention (Africa CDC), Addis Ababa, Ethiopia.
Nicaise NdembiAfrica Centres for Disease Control and Prevention (Africa CDC), Addis Ababa, Ethiopia.ORCID https://orcid.org/0000-0001-5131-3136
Tajudeen RajiAfrica Centres for Disease Control and Prevention (Africa CDC), Addis Ababa, Ethiopia.
Ngashi NgongoAfrica Centres for Disease Control and Prevention (Africa CDC), Addis Ababa, Ethiopia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPost-marketing safety surveillance is essential for ensuring vaccine safety and maintaining public trust, particularly in African settings where evidence on the safety of COVID-19 vaccines remains limited. This study aimed to determine the overall incidence and types of AEFIs, as well as the factors associated with their occurrence, during COVI-19 mass vaccination campaigns in Democratic Republic of Congo.

methodsFrom December 1-29, 2023, a prospective safety surveillance study was conducted in Kinshasa Province. Participants were surveyed through phone calls from day 1-28 following COVID-19 vaccine administration. AEFI incidence rates were calculated by type of vaccine, sex, number of dose and age group. Factors associated with AEFIs were identified using multivariable logistic regression models, expressed by adjusted odds ratio and its 95% confidence interval.

resultsThe study included 4766 participants. Their median [IQR] age was 36 [27-48] years and 2503 (53%) were males, 94.63% received the J&J vaccine while 256 (5.37%) received the BNT162b2 vaccine. Incidence of AEFIs was 23.75% (95%CI: 22.54%-24.99%). AEFIs mostly reported were fever (9.61%, 95%CI: 8.88%-10.48%), injection site pain (9.00%, 95%CI: 8.20%-9.85%), headache (4.11%, 95%CI: 3.57%-4.72%), stiffness (1.51%, 95%CI: 1.18%-1.89%) and myalgia (1.15%, 95%CI: 0.87%-1.49%). The incidence of AEFIs was higher for the BNT162b2 vaccine at 34.48% (95% CI: 28.57%-40.54%) vs. 23.15% (95% CI: 21.92%-24.41%) for the J&J vaccine. Compared to participants aged 18-59 years, those under 18 years old were associated with decreased odds of reporting any AEFI (aOR= 0.26, 95%CI: 0.13-0.88) and injection site pain (aOR=0.18, 95%CI: 0.05-0.75). Those aged 60 years and older were associated with decreased odds of reporting any AEFI (aOR= 0.78, 95%CI: 0.62-0.99) and fever (aOR=0. 63, 95%CI: 0.43-0.92).

conclusionsApproximately one-quarter of participants reported AEFI. The observed association with vaccine type and age underscores the need for systematic vaccine safety monitoring in the population. This is critical for guiding future vaccination strategies tailored to individuals who may be more susceptible to AEFIs.

Indexed as

COVID-19COVID-19 VaccinesMass VaccinationAdolescentAdultBNT162 VaccineDemocratic Republic of the CongoFemaleHumansIncidenceMaleMiddle AgedProspective StudiesSARS-CoV-2BNT162 VaccineCOVID-19 Vaccines

Identifiers

PMID42430326
PMCPMC13353984

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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.