Transverse Myelitis Related to SARS-CoV-2 Vaccines

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

580 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-10

Study Completion Date

2021-12-10

Brief Summary

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Few patients receiving SARS-CoV-2 vaccines may experience rare but serious adverse events such as transverse myelitis (TM). Today, data about TM are scarce.

The objective was to investigate reports of TM adverse events related to SARS-CoV-2 vaccines labelled by FDA and EMA, including ChAdOx1nCov-19 (Oxford-AstraZeneca), BNT162b2 (Pfizer/BioNTech), mRNA-1273 (Moderna) and Ad26.COV2.S (Janssen/Johnson \& Johnson) and using the World Health Organization's (WHO) pharmacovigilance database: VigiBase.

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Detailed Description

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Here, investigators use the World Health Organization's (WHO) database of individual safety case reports, to identify cases of TM related to SARS-CoV-2 vaccines.

Conditions

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Vaccine Adverse Reaction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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SARS-CoV-2 vaccines

All patients treated at least with 1 SARS-CoV-2 vaccine

Intervention Type DRUG

Other Intervention Names

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(ChAdOx1nCov-19 (Oxford-AstraZeneca), BNT162b2 (Pfizer/BioNTech), mRNA-1273 (Moderna) and Ad26.COV2.S (Janssen/Johnson & Johnson))

Eligibility Criteria

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Inclusion Criteria

\- case reported in the World Health Organization (WHO) database (VigiBase) of individual safety case reports at the time of the extraction,

Exclusion Criteria

* chronology not compatible between the SARS-CoV-2 vaccine adminisration and onset of TM.
* vaccines non-labelled by FDA/EMA (data cutoff december 10, 2021)

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes