Vaccine Adverse Reaction
Conditions
Brief 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.
Interventions
DRUGSARS-CoV-2 vaccines
All patients treated at least with 1 SARS-CoV-2 vaccine
Sponsors
University Hospital, Caen
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TM reportes related to SARS-CoV-2 vaccine | date of the first AE related to a SARS-CoV-2 vaccine to December 10, 2021 |
Secondary
| Measure | Time frame |
|---|---|
| Description of the latency period since SARS-CoV-2 vaccine exposure. | date of the first AE related to a SARS-CoV-2 vaccine to December 10, 2021 |
| Description of the outcomes following TM | date of the first AE related to a SARS-CoV-2 vaccine to December 10, 2021 |
| Description of patients who experienced co-reported adverse events | date of the first AE related to a SARS-CoV-2 vaccine to December 10, 2021 |
Countries
France
Outcome results
None listed