NCT05178264

Transverse Myelitis Related to SARS-CoV-2 Vaccines

Transverse Myelitis Related to SARS-CoV-2 Vaccines in Patients: an Observational and Retrospective Study Using the WHO's Pharmacovigilance Database

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 580 (actual)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Vaccine Adverse Reaction

Interventions

Type	Name	Description
DRUG	SARS-CoV-2 vaccines	All patients treated at least with 1 SARS-CoV-2 vaccine

Timeline

• Start date: 2021-12-10
• Primary completion: 2021-12-10
• Completion: 2021-12-10
• First posted: 2022-01-05
• Last updated: 2022-01-05

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated drug study