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Psychiatric adverse events reported after COVID-19 vaccination in the European Union (EU), the United States (US) and the United Kingdom (UK)

Published online by Cambridge University Press:  01 September 2022

D. Macias Saint-Gerons ,
P. Correa Ghisays  and
R. Tabarés-Seisdedos
D. Macias Saint-Gerons*
Affiliation:
CIBERSAM/ISCIII, Incliva/universidad De Valencia, Valencia, Spain
P. Correa Ghisays
Affiliation:
CIBERSAM/ISCIII, Incliva/universidad De Valencia, Valencia, Spain
R. Tabarés-Seisdedos
Affiliation:
CIBERSAM/ISCIII, Incliva/universidad De Valencia, Valencia, Spain
*
*Corresponding author.

Abstract

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Introduction

Several psychiatric adverse events can occur after vaccination. Passive surveillance reporting systems can support the identification of rare adverse events and contribute to hypothesis generation for potential causal associations.

Objectives

To describe the psychiatric adverse reactions associated with various COVID-19 vaccines reported in the WHO database (VigiBase®)

Methods

We for individual case reports (ICSRs) for “Psychiatric disorders” linked to COVID-19 vaccines authorized in the EU, the US and the UK. Reporting rates were calculated using the number of administered doses as a denominator. Disproportional reporting was investigated through frequentist and Bayesian approaches by the calculation the information component (IC) for adverse psychiatric adverse not included in the vaccine label.

Results

63322 ICSRs including 76,163 psychiatric adverse events were identified, 21878 (34.6 %) were serious events. Mean age in the reports was 48.8 years old (SD: 17.8) and involved 44441 (70.2%) female and 17975 (28.4%) women; sex was not specified in 906 (1.4%) reports. Rate of reported psychiatric adverse events per million administered doses were 52.0, 110.3, 164.8 and 170.8 for Tozinameran/Cominarty (Pfizer-BioNTech), Elasomeran (Moderna), Vaxzevria (AstraZeneca) and Ad26.COV2-S (Janssen) vaccines respectively. UK recorded the highest rates. The most frequently reported events were insomnia (21.6%), confusional state (13.6%) and anxiety (13.5%). Disproportionality was found for: habit cough (IC:3.6), clinomania (IC: 2.2), exploding head syndrome (IC: 2.2) and autoscopy (IC: 2.1).

Conclusions

Rates of reported psychiatric adverse events are very low. Doctors and patients should be aware of these potential adverse reactions. Continuing monitoring of emerging potential safety signals is advised.

Disclosure

No significant relationships.

Keywords

Covid-19vaccineadverse events
Type
Abstract
Information
European Psychiatry , Volume 65 , Special Issue S1: Abstracts of the 30th European Congress of Psychiatry , June 2022 , pp. S74
Creative Commons
Creative Common License - CCCreative Common License - BY
This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.
Copyright
© The Author(s), 2022. Published by Cambridge University Press on behalf of the European Psychiatric Association
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