Evidence map›Paper›PMID 36863611›Full record

ArticleIndian heart journal

Serious adverse event following immunization and thromboembolic events associated with COVID19 vaccination: An analysis of nationwide causality assessment from India.

Aravind P Gandhi, U Venkatesh, Naveen Murali

Open access · goldAbstract read
In one paragraph

Article in Indian heart journal. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.9field-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

3 citing papers in PubMed, 6 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

3 authors at 3 institutions in 1 country.

Aravind P GandhiDepartment of Community Medicine, ESIC Medical College & Hospital, Hyderabad, India. Electronic address: aravindsocialdoc@gmail.com.
U VenkateshDepartment of Community Medicine & Family Medicine, All India Institute of Medical Sciences, Gorakhpur, India. Electronic address: venkatesh2007mbbs@gmail.com.
Naveen MuraliDepartment of Pharmacology, PGIMER, Chandigarh, India.
All India Institute of Medical Sciences · INESIC Hospital · INPost Graduate Institute of Medical Education and Research · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVaccines against the COVID-19 pandemic were introduced in late 2020. The present study has been conducted to study the serious Adverse Events Following Immunization (AEFIs) reported for COVID-19 vaccines from India.

methodsSecondary data analysis of the causality assessment reports for the 1112 serious AEFIs published by the Ministry of Health & Family Welfare, Government of India, was conducted. For the current analysis, all the reports published till 29.03.2022 were included. The primary outcome variables analyzed were the consistent causal association and the thromboembolic events.

resultsThe majority of the serious AEFIs assessed were either coincidental (578, 52%) or vaccine product related (218, 19.6%). All the serious AEFIs were reported among the Covishield (992, 89.2%) and COVAXIN (120, 10.8%) vaccines. Among these, 401 (36.1%) were deaths, and 711 (63.9%) were hospitalized and recovered. On adjusted analysis, females, the younger age group and non-fatal AEFIs showed a statistically significant consistent causal association with COVID-19 vaccination. Thromboembolic events were reported among 209 (18.8%) of the analyzed participants, with a significant association with higher age and case fatality rate.

conclusionDeaths reported under serious AEFIs were found to have a relatively lower consistent causal relationship with the COVID-19 vaccines than the recovered hospitalizations in India. No consistent causal association was found between the thromboembolic events and the type of COVID-19 vaccine administered in India.

Indexed as

COVID-19COVID-19 VaccinesImmunizationAdverse Drug Reaction Reporting SystemsChAdOx1 nCoV-19FemaleHumansIndiaPandemicsVaccinationVaccinesVaccines, InactivatedBBV152 COVID-19 vaccineChAdOx1 nCoV-19COVID-19 VaccinesVaccinesVaccines, InactivatedAdverse events following immunizationCOVID-19 vaccineDeathsIndiaThromboembolic events

Identifiers

PMID36863611
PMCPMC9970920
OpenAlexW4323037118

What OpenQuestion holds

Textmetadata
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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.