Post-SARS-CoV-2-vaccination cerebral venous sinus thrombosis: an analysis of cases notified to the European Medicines Agency.
COVID-19 vaccine
CVST
EMA
thrombocytopenia
Journal
European journal of neurology
ISSN: 1468-1331
Titre abrégé: Eur J Neurol
Pays: England
ID NLM: 9506311
Informations de publication
Date de publication:
11 2021
11 2021
Historique:
revised:
13
07
2021
received:
15
06
2021
accepted:
15
07
2021
pubmed:
23
7
2021
medline:
27
10
2021
entrez:
22
7
2021
Statut:
ppublish
Résumé
Cerebral venous sinus thrombosis (CVST) has been described after vaccination against SARS-CoV-2. The clinical characteristics of 213 post-vaccination CVST cases notified to the European Medicines Agency are reported. Data on adverse drug reactions after SARS-CoV-2 vaccination notified until 8 April 2021 under the Medical Dictionary for Regulatory Activities Term 'Central nervous system vascular disorders' were obtained from the EudraVigilance database. Post-vaccination CVST was compared with 100 European patients with CVST from before the COVID-19 pandemic derived from the International CVST Consortium. In all, 213 CVST cases were identified: 187 after AstraZeneca/Oxford (ChAdOx1 nCov-19) vaccination and 26 after a messenger RNA (mRNA) vaccination (25 with Pfizer/BioNTech, BNT162b2, and one with Moderna, mRNA-1273). Thrombocytopenia was reported in 107/187 CVST cases (57%, 95% confidence interval [CI] 50%-64%) in the ChAdOx1 nCov-19 group, in none in the mRNA vaccine group (0%, 95% CI 0%-13%) and in 7/100 (7%, 95% CI 3%-14%) in the pre-COVID-19 group. In the ChAdOx1 nCov-19 group, 39 (21%) reported COVID-19 polymerase chain reaction tests were performed within 30 days of CVST symptom onset, and all were negative. Of the 117 patients with a reported outcome in the ChAdOx1 nCov-19 group, 44 (38%, 95% CI 29%-47%) had died, compared to 2/10 (20%, 95% CI 6%-51%) in the mRNA vaccine group and 3/100 (3%, 95% CI 1%-8%) in the pre-COVID-19 group. Mortality amongst patients with thrombocytopenia in the ChAdOx1 nCov-19 group was 49% (95% CI 39%-60%). Cerebral venous sinus thrombosis occurring after ChAdOx1 nCov-19 vaccination has a clinical profile distinct from CVST unrelated to vaccination. Only CVST after ChAdOx1 nCov-19 vaccination was associated with thrombocytopenia.
Sections du résumé
BACKGROUND AND PURPOSE
Cerebral venous sinus thrombosis (CVST) has been described after vaccination against SARS-CoV-2. The clinical characteristics of 213 post-vaccination CVST cases notified to the European Medicines Agency are reported.
METHODS
Data on adverse drug reactions after SARS-CoV-2 vaccination notified until 8 April 2021 under the Medical Dictionary for Regulatory Activities Term 'Central nervous system vascular disorders' were obtained from the EudraVigilance database. Post-vaccination CVST was compared with 100 European patients with CVST from before the COVID-19 pandemic derived from the International CVST Consortium.
RESULTS
In all, 213 CVST cases were identified: 187 after AstraZeneca/Oxford (ChAdOx1 nCov-19) vaccination and 26 after a messenger RNA (mRNA) vaccination (25 with Pfizer/BioNTech, BNT162b2, and one with Moderna, mRNA-1273). Thrombocytopenia was reported in 107/187 CVST cases (57%, 95% confidence interval [CI] 50%-64%) in the ChAdOx1 nCov-19 group, in none in the mRNA vaccine group (0%, 95% CI 0%-13%) and in 7/100 (7%, 95% CI 3%-14%) in the pre-COVID-19 group. In the ChAdOx1 nCov-19 group, 39 (21%) reported COVID-19 polymerase chain reaction tests were performed within 30 days of CVST symptom onset, and all were negative. Of the 117 patients with a reported outcome in the ChAdOx1 nCov-19 group, 44 (38%, 95% CI 29%-47%) had died, compared to 2/10 (20%, 95% CI 6%-51%) in the mRNA vaccine group and 3/100 (3%, 95% CI 1%-8%) in the pre-COVID-19 group. Mortality amongst patients with thrombocytopenia in the ChAdOx1 nCov-19 group was 49% (95% CI 39%-60%).
CONCLUSIONS
Cerebral venous sinus thrombosis occurring after ChAdOx1 nCov-19 vaccination has a clinical profile distinct from CVST unrelated to vaccination. Only CVST after ChAdOx1 nCov-19 vaccination was associated with thrombocytopenia.
Identifiants
pubmed: 34293217
doi: 10.1111/ene.15029
pmc: PMC8444640
doi:
Substances chimiques
COVID-19 Vaccines
0
ChAdOx1 nCoV-19
B5S3K2V0G8
BNT162 Vaccine
N38TVC63NU
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
3656-3662Commentaires et corrections
Type : CommentIn
Type : CommentIn
Informations de copyright
© 2021 The Authors. European Journal of Neurology published by John Wiley & Sons Ltd on behalf of European Academy of Neurology.
Références
JAMA Neurol. 2016 May 1;73(5):579-84
pubmed: 26974867
Eur J Neurol. 2021 Oct;28(10):3478-3490
pubmed: 33426733
Drug Saf. 2018 Jul;41(7):665-675
pubmed: 29520645
Eur J Neurol. 2021 Nov;28(11):3656-3662
pubmed: 34293217
N Engl J Med. 2021 Jun 10;384(23):2202-2211
pubmed: 33861525
N Engl J Med. 2021 Feb 18;384(7):643-649
pubmed: 33378605
EClinicalMedicine. 2021 Sep;39:101061
pubmed: 34368663
Neurology. 2020 Sep 22;95(12):e1706-e1715
pubmed: 32759191
N Engl J Med. 2021 Jun 3;384(22):2124-2130
pubmed: 33835768
Stroke. 2004 Mar;35(3):664-70
pubmed: 14976332
Ann Neurol. 2021 Oct;90(4):627-639
pubmed: 34288044
J Thromb Haemost. 2021 Jun;19(6):1585-1588
pubmed: 34018298
JAMA. 2021 Jun 22;325(24):2448-2456
pubmed: 33929487
Neurology. 2020 Sep 22;95(12):e1716-e1723
pubmed: 32759195
N Engl J Med. 2021 Jun 3;384(22):2092-2101
pubmed: 33835769