Transverse Myelitis Related to SARS-CoV-2 Vaccines

Caen University Hospital

Status: Completed

Conditions: Vaccine Adverse Reaction

Treatments: Drug: SARS-CoV-2 vaccines

Study type: Observational

Funder types: Other

Identifiers

NCT05178264

Pharmaco 20211210

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 580 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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)