Post-SARS-CoV-2-vaccination Cerebral Venous Sinus Thrombosis: an analysis of cases notified to the European Medicines Agency.

Krzywicka, Katarzyna; Heldner, Mirjam R.; Sánchez van Kammen, Mayte; van Haaps, Thijs; Hiltunen, Sini; Silvis, Suzanne M; Levi, Marcel; Kremer Hovinga, Johanna A.; Jood, Katarina; Lindgren, Erik; Tatlisumak, Turgut; Putaala, Jukka; Aguiar de Sousa, Diana; Middeldorp, Saskia; Arnold, Marcel; Coutinho, Jonathan M; Ferro, José M (2021). Post-SARS-CoV-2-vaccination Cerebral Venous Sinus Thrombosis: an analysis of cases notified to the European Medicines Agency. European journal of neurology, 28(11), pp. 3656-3662. Wiley 10.1111/ene.15029

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BACKGROUND

Cerebral venous sinus thrombosis (CVST) has been described after vaccination against SARS-CoV-2. We report clinical characteristics of 213 post-vaccination CVST cases notified to the European Medicines Agency (EMA).

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. We compared post-vaccination CVST to 100 European patients with CVST from before the COVID-19 pandemic derived from the International CVST Consortium.

RESULTS

We identified 213 CVST cases: 187 after AstraZeneca/Oxford (ChAdOx1 nCov-19), vaccination and 26 after a mRNA vaccine (25 Pfizer/BioNTech, BNT162b2 and 1 Moderna, mRNA-1273). Thrombocytopenia was reported in 107/187 CVST cases (57%, 95%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, there were 39 (21%) reported COVID-19 PCR tests 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 among patients with thrombocytopenia in the ChAdOx1 nCov-19 group was 49% (95%CI 39-60%).

CONCLUSIONS

CVST occurring after ChAdOx1 nCov-19 vaccination has a clinical profile distinct from CVST unrelated to vaccination. Only CVST after ChAdOx1 nCov-19 was associated with thrombocytopenia.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Neurology
04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Clinic of Haematology and Central Haematological Laboratory
04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > DCR Unit Sahli Building > Forschungsgruppe Neurologie
04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > Unit Childrens Hospital > Forschungsgruppe Hämatologie (Erwachsene)

UniBE Contributor:

Heldner, Mirjam Rachel; Kremer Hovinga, Johanna Anna and Arnold, Marcel

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

1468-1331

Publisher:

Wiley

Language:

English

Submitter:

Pierrette Durand Lüthi

Date Deposited:

10 Aug 2021 15:46

Last Modified:

18 Oct 2021 01:32

Publisher DOI:

10.1111/ene.15029

PubMed ID:

34293217

Uncontrolled Keywords:

COVID-19 vaccine CVST EMA thrombocytopenia

BORIS DOI:

10.48350/157810

URI:

https://boris.unibe.ch/id/eprint/157810

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