Publication related to RSI or an RSI staff member
Disproportionality analysis of adverse neurological and psychiatric reactions with the ChAdOx1 (Oxford-AstraZeneca) and BNT162b2 (Pfizer-BioNTech) COVID-19 vaccines in the United Kingdom.
BACKGROUND: Information on neurological and psychiatric adverse events following immunization (AEFIs) with COVID-19 vaccines is limited. RESEARCH DESIGN & METHODS: We examined and compared neurological and psychiatric AEFIS reports related to BNT162b2 (Pfizer-BioNTech) and ChAdOx1 (Oxford-AstraZeneca) COVID-19 vaccines and recorded in the United Kingdom Medicines and Healthcare products Regulatory Agency between 9 December 2020 and 30 June 2021. RESULTS: As of 30 June 2021, 46.1 million doses of ChAdOx1 and 30.3 million doses of BNT162b2 had been administered. The most frequently reported AEFI was headache with 1,686 and 575 cases per million doses of ChAdOx1 and BNT162b2, respectively. AEFIs more frequently reported after CHAdOx1 compared with BNT162b2 vaccination were Guillain-Barre syndrome (OR, 95% CI = 2.53, 1.82-3.51), freezing (6.66, 3.12-14.22), cluster headache (1.53, 1.28-1.84), migraine (1.23,1.17-1.30), postural dizziness (1.24,1.13-1.37), tremor (2.86, 2.68-3.05), headache (1.40, 1.38-1.43), paresthesia (1.11, 1.06-1.16), delirium (1.85, 1.45-2.36), hallucination (2.20, 1.82-2.66), poor quality sleep (1.53, 1.26-1.85), and nervousness (1.54, 1.26-1.89) Reactions less frequently reported with ChAdOx1 than with BNT162b2 were Bell’s palsy (0.47, 0.41-0.55), anosmia (0.58, 0.47-0.71), facial paralysis (0.35, 0.29-0.41), dysgeusia (0.68, 0.62-0.73), presyncope (0.48, 0.42-0.55), syncope (0.63, 0.58-0.67), and anxiety (0.75 (0.67-0.85). CONCLUSION: Neurological and psychiatric AEFIs were relatively infrequent, but each vaccine was associated with a distinctive toxic profile.
Authors
- Otero-Losada, Matilde, Otero-Losada M, Consejo Nacional de Investigaciones Científicas y Técnicas, Universidad Abierta Interamericana-Centro de Altos Estudios en Ciencias Humanas y de La Salud, UAI-CAECIHS CONICET, Buenos Aires, Argentina.
- Petrovsky, Nikolai, Petrovsky N, Flinders University, Bedford Park, Australia.; Vaxine, Bedford Park, Australia.
- Alami, Abdallah, Alami A, Faculty of Medicine University of Ottawa, McLaughlin Centre for Population Health Risk Assessment, Ottawa, Ontario, Canada.; Risk Sciences International, Ottawa, Ontario, Canada.
- Crispo, James A, Crispo JA, School of Mathematics and Statistics, Carleton University, Ottawa, Ontario, Canada.; Human Sciences Division, Northern Ontario School of Medicine, Sudbury, Ontario, Canada.; Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, Ontario, Canada.
- Mattison, Donald, Mattison D, Faculty of Medicine University of Ottawa, McLaughlin Centre for Population Health Risk Assessment, Ottawa, Ontario, Canada.; Risk Sciences International, Ottawa, Ontario, Canada.; Arnold School of Public Health, University of South Carolina, Columbia, Ontario, USA.; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.
- Capani, Francisco, Capani F, Consejo Nacional de Investigaciones Científicas y Técnicas, Universidad Abierta Interamericana-Centro de Altos Estudios en Ciencias Humanas y de La Salud, UAI-CAECIHS CONICET, Buenos Aires, Argentina.; Facultad de Ciencias de la Salud, Universidad Autónoma de Chile, Santiago de Chile, Chile.
- Goetz, Christopher, Goetz C, Department of Neurological Sciences, Rush University Medical Center, Chicago, Illinois, USA.
- Krewski, Daniel, Krewski D, Faculty of Medicine University of Ottawa, McLaughlin Centre for Population Health Risk Assessment, Ottawa, Ontario, Canada.; Risk Sciences International, Ottawa, Ontario, Canada.; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.
- Perez-Lloret, Santiago, Perez-Lloret S, Observatorio de Salud Pública, Pontificia Universidad Católica Argentina, Buenos Aires, Argentina.; Department of Physiology, Faculty of Medicine, University of Buenos Aires, Buenos Aires, Argentina.
BACKGROUND: Information on neurological and psychiatric adverse events following immunization (AEFIs) with COVID-19 vaccines is limited. RESEARCH DESIGN & METHODS: We examined and compared neurological and psychiatric AEFIS reports related to BNT162b2 (Pfizer-BioNTech) and ChAdOx1 (Oxford-AstraZeneca) COVID-19 vaccines and recorded in the United Kingdom Medicines and Healthcare products Regulatory Agency between 9 December 2020 and 30 June 2021. RESULTS: As of 30 June 2021, 46.1 million doses of ChAdOx1 and 30.3 million doses of BNT162b2 had been administered. The most frequently reported AEFI was headache with 1,686 and 575 cases per million doses of ChAdOx1 and BNT162b2, respectively. AEFIs more frequently reported after CHAdOx1 compared with BNT162b2 vaccination were Guillain-Barre syndrome (OR, 95% CI = 2.53, 1.82-3.51), freezing (6.66, 3.12-14.22), cluster headache (1.53, 1.28-1.84), migraine (1.23,1.17-1.30), postural dizziness (1.24,1.13-1.37), tremor (2.86, 2.68-3.05), headache (1.40, 1.38-1.43), paresthesia (1.11, 1.06-1.16), delirium (1.85, 1.45-2.36), hallucination (2.20, 1.82-2.66), poor quality sleep (1.53, 1.26-1.85), and nervousness (1.54, 1.26-1.89) Reactions less frequently reported with ChAdOx1 than with BNT162b2 were Bell's palsy (0.47, 0.41-0.55), anosmia (0.58, 0.47-0.71), facial paralysis (0.35, 0.29-0.41), dysgeusia (0.68, 0.62-0.73), presyncope (0.48, 0.42-0.55), syncope (0.63, 0.58-0.67), and anxiety (0.75 (0.67-0.85). CONCLUSION: Neurological and psychiatric AEFIs were relatively infrequent, but each vaccine was associated with a distinctive toxic profile.
