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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-CoV-2 vaccines | Drug | All patients treated at least with 1 SARS-CoV-2 vaccine |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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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:
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All patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandre Joachim | Caen | Basse Normandie | 14000 | France |
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| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| D000090982 | BNT162 Vaccine |
| D000090983 | 2019-nCoV Vaccine mRNA-1273 |
| D000090984 | Ad26COVS1 |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| 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 |
| D000087503 |
| mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000941 | Antigens |
| D001685 | Biological Factors |