Evidence map›Paper›PMID 36371366›Full record

ArticleVaccine2022

A post-marketing safety assessment of COVID-19 mRNA vaccination for serious adverse outcomes using administrative claims data linked with vaccination registry in a city of Japan.

Yoshinori Takeuchi, Masao Iwagami, Sachiko Ono, Nobuaki Michihata, Kohei Uemura, Hideo Yasunaga

Open access · greenAbstract read
In one paragraph

Article in Vaccine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.4field-weighted citation impact, top 9% 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

13 citing papers in PubMed, 25 citations in OpenAlex.

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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

6 authors at 2 institutions in 2 countries.

Yoshinori TakeuchiDivision of Medical Statistics, Department of Social Medicine, Faculty of Medicine, Toho University, Tokyo, Japan; Department of Biostatistics, School of Public Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. Electronic address: ytake-tky@umin.ac.jp.
Masao IwagamiDepartment of Health Services Research, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan; Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
Sachiko OnoDepartment of Eat-loss Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Nobuaki MichihataDepartment of Health Services Research, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Kohei UemuraInterfaculty Initiative in Information Studies, The University of Tokyo, Tokyo, Japan.
Hideo YasunagaDepartment of Clinical Epidemiology & Health Economics, School of Public Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
The University of Tokyo · JPUniversity of Tsukuba · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe safety profiles of COVID-19 vaccines are incompletely evaluated in Japan.

objectivesTo examine the risk of serious adverse effects after COVID-19 mRNA vaccination (BNT162b2 and mRNA-1273) in cohort studies and self-controlled case series (SCCS).

methodsUsing an administrative claims database linked with the COVID-19 vaccination registry in a city in Japan between September 2020 and September 2021, we identified health insurance enrolees aged ≥ 18 years. We evaluated the risk of acute myocardial infarction, appendicitis, Bell's palsy, convulsions/seizures, disseminated intravascular coagulation, immune thrombocytopenia, pulmonary embolism, haemorrhagic or ischemic stroke, venous thromboembolism, and all-cause mortality, 21 days following any COVID-19 mRNA vaccination, compared with non-vaccination periods. For the cohort studies, we estimated incidence rate ratios (IRRs) by Poisson regression and rate differences (IRDs) by weighted least-squares regression, adjusting for sex, age, and Charlson comorbidity index. We applied a modified SCCS design to appropriately treat outcome-dependent exposures. For the modified SCCS, we estimated within-subject IRRs by weighted conditional Poisson regression. Subgroup analyses stratified by sex and age were also conducted.

resultsWe identified 184,491 enrolees [male: 87,218; mean (standard deviation) age: 64.2 (19.5) years] with 136,667 first and 127,322 s dose vaccinations. The risks of any outcomes did not increase in any analyses, except for the fact that the modified SCCS indicated an increased risk of pulmonary embolism after the first dose in women (within-subject IRR [95%CI]: 3.97 [1.18-13.32]).

conclusionThe findings suggested that the COVID-19 mRNA vaccine was generally safe, whilst a signal of pulmonary embolism following the first dose of the COVID-19 mRNA vaccine was observed.

Indexed as

COVID-19Pulmonary EmbolismAgedBNT162 VaccineCOVID-19 VaccinesFemaleHumansJapanMaleMarketingMiddle AgedmRNA VaccinesRegistriesRNA, MessengerBNT162 VaccineCOVID-19 VaccinesmRNA VaccinesRNA, MessengerCohort studyMedical information databaseObservational studyPharmacoepidemiologySelf-controlled case series

Identifiers

PMID36371366
PMCPMC9637511
OpenAlexW4308739635

What OpenQuestion holds

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Registered trials

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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.