Evidence map›Paper›PMID 38130887›Full record

ArticleVaccine: X2023

Nationwide safety surveillance of COVID-19 mRNA vaccines following primary series and first booster vaccination in Singapore.

Sreemanee Raaj Dorajoo, Hui Xing Tan, Chun Hwee Desmond Teo, Jing Wei Neo, Yen Ling Koon, Jing Jing Amelia Ng, Mun Yee Tham, Pei Qin Belinda Foo, Li Fung Peck, Pei San Ang and 6 more

Open access · goldAbstract read
In one paragraph

Article in Vaccine: X, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.7field-weighted citation impact, top 15% 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

7 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
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  7. Neurovascular Adverse Effects of Sars-Cov-2 Vaccination.Drug design, development and therapy · 2024
    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

16 authors at 2 institutions in 2 countries.

Sreemanee Raaj DorajooVigilance & Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Singapore.
Hui Xing TanVigilance & Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Singapore.
Chun Hwee Desmond TeoVigilance & Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Singapore.
Jing Wei NeoVigilance & Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Singapore.
Yen Ling KoonVigilance & Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Singapore.
Jing Jing Amelia NgVigilance & Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Singapore.
Mun Yee ThamVigilance & Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Singapore.
Pei Qin Belinda FooVigilance & Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Singapore.
Li Fung PeckVigilance & Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Singapore.
Pei San AngVigilance & Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Singapore.
Theen Adena LimVigilance & Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Singapore.
Wang Woon Jalene PohVigilance & Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Singapore.
Su Lin Dorothy TohHealth Products Regulation Group, Health Sciences Authority, Singapore.
Cheng Leng ChanHealth Products Regulation Group, Health Sciences Authority, Singapore.
Ian DouglasFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical, Medicine, London, United Kingdom.
Bee Leng Sally SohVigilance & Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Singapore.
Health Sciences Authority · SGLondon School of Hygiene & Tropical Medicine · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The real-world safety profile of COVID-19 mRNA vaccines remains incompletely elucidated. Methods: We performed a nationwide post-market safety surveillance analysis in Singapore, on vacinees aged 5 years and older, through mid-September 2022. Observed-over-expected (O/E) analyses were performed to identify potential safety signals among eight shortlisted adverse events of special interest (AESIs): strokes, cerebral venous thrombosis (CVT), acute myocardial infarction, myocarditis/pericarditis, pulmonary embolism, immune thrombocytopenia, convulsions and appendicitis. Self-controlled case series analyses (SCCS) were performed to validate signals of concern, occurring within 42 days of vaccination. Findings: Elevated risks were observed on O/E analyses for the following AESIs: myocarditis/pericarditis, [rate ratio (RR): 3.66, 95 % confidence interval (95 % CI): 2.71 to 4.94], appendicitis [RR: 1.14 (1.02 to 1.27)] and CVT [RR: 2.11 (1.18 to 3.77)]. SCCS analyses generated corroborative findings: myocarditis/pericarditis, [relative incidence (RI): 6.96 (3.95 to 12.27) at 1 to 7 days post-dose 2], CVT [RI: 4.30 (1.30 to 14.20) at 22 to 42 days post-dose 1] and appendicitis [RI: 1.31 (1.03 to 1.67) at 1 to 7 days post-dose 1]. Booster dose 1 continued to be associated with higher rates of myocarditis/pericarditis on O/E analysis [RR: 2.30, (1.39 to 3.80) and 1.69, (1.11 to 2.59)] at 21- and 42-days post-booster dose 1, respectively. Males aged 12 to 17 exhibited highest risks of both myocarditis/pericarditis [RI: 6.31 (1.36 to 29.3)] and appendicitis [RI: 2.01 (1.12 to 3.64)] after primary vaccination. Similarly, CVT was also predominantly observed in males aged above 50 (11 out of 16 cases), within 42-days of vaccination. Interpretation: Our data suggest that myocarditis/pericarditis, appendicitis and CVT are associated with primary vaccination using COVID-19 mRNA vaccines. Males at specific ages exhibit higher risks for all three AEs identified. The risk of myocarditis/pericarditis continues to be elevated after booster dose 1.

Indexed as

Active surveillanceCovid-19 mRNA vaccinesPharmacovigilanceSignal detectionSignal validationVaccine safety

Identifiers

PMID38130887
PMCPMC10733694
OpenAlexW4389273925

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.