Neurological complications after first dose of COVID-19 vaccines and SARS-CoV-2 infection.
Martina Patone,Lahiru Handunnetthi,Defne Saatci,Jiafeng Pan,Srinivasa Vittal Katikireddi,Saif Razvi,David M. Hunt,Xue W Mei,Sharon Dixon,Francesco Zaccardi,Kamlesh Khunti,Peter J. Watkinson,Carol Coupland,Carol Coupland,James Doidge,David A Harrison,Rommel Ravanan,Aziz Sheikh,Aziz Sheikh,Chris Robertson,Julia Hippisley-Cox +20 more
TLDR
In this article, a self-controlled case series study was conducted to investigate hospital admissions from neurological complications in the 28 days after a first dose of ChAdOx1nCoV-19 (n = 20,417,752) or BNT162b2 (n= 12,134,782), and after a SARS-coV-2-positive test.Abstract:
Emerging reports of rare neurological complications associated with COVID-19 infection and vaccinations are leading to regulatory, clinical and public health concerns. We undertook a self-controlled case series study to investigate hospital admissions from neurological complications in the 28 days after a first dose of ChAdOx1nCoV-19 (n = 20,417,752) or BNT162b2 (n = 12,134,782), and after a SARS-CoV-2-positive test (n = 2,005,280). There was an increased risk of Guillain–Barre syndrome (incidence rate ratio (IRR), 2.90; 95% confidence interval (CI): 2.15–3.92 at 15–21 days after vaccination) and Bell’s palsy (IRR, 1.29; 95% CI: 1.08–1.56 at 15–21 days) with ChAdOx1nCoV-19. There was an increased risk of hemorrhagic stroke (IRR, 1.38; 95% CI: 1.12–1.71 at 15–21 days) with BNT162b2. An independent Scottish cohort provided further support for the association between ChAdOx1nCoV and Guillain–Barre syndrome (IRR, 2.32; 95% CI: 1.08–5.02 at 1–28 days). There was a substantially higher risk of all neurological outcomes in the 28 days after a positive SARS-CoV-2 test including Guillain–Barre syndrome (IRR, 5.25; 95% CI: 3.00–9.18). Overall, we estimated 38 excess cases of Guillain–Barre syndrome per 10 million people receiving ChAdOx1nCoV-19 and 145 excess cases per 10 million people after a positive SARS-CoV-2 test. In summary, although we find an increased risk of neurological complications in those who received COVID-19 vaccines, the risk of these complications is greater following a positive SARS-CoV-2 test.read more
Citations
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Neurological Events Reported after COVID-19 Vaccines: An Analysis of VAERS.
Jennifer A. Frontera,Arina Tamborska,Mohamed Fahmy Doheim,David García-Azorín,Haşim Gezegen,Alla Guekht,Abdul Hanif Khan Yusof Khan,Michele Santacatterina,James J. Sejvar,Kiran T. Thakur,Erica Westenberg,Andrea Sylvia Winkler,Ettore Beghi +12 more
TL;DR: Significantly more neurological adverse events were reported following Janssen (Ad26.COV2.S) vaccination compared to either Pfizer-BioNtech (BNT162b2) or Moderna (mRNA-1273; 0.15% versus 0.03% of doses, respectively), but the rate of neurological events after acute SARS-CoV-2 infection was up to 617-fold higher than after COVID vaccination.
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Adverse effects of COVID-19 mRNA vaccines: the spike hypothesis
Ioannis P. Trougakos,Evangelos Terpos,Harry Alexopoulos,Marianna Politou,Dimitrios Paraskevis,Andreas Scorilas,Efstathios Kastritis,Evangelos Andreakos,Meletios A. Dimopoulos +8 more
TL;DR: O'Driscoll et al. as mentioned in this paper showed that COVID-19 mRNA vaccines induce robust immune responses against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), yet their cellular/molecular mode of action and the etiology of the induced adverse events (AEs) remain elusive.
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Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults
Joseph B. Fraiman,Juan Erviti,Mark Jones,Sander Greenland,Patrick J. Whelan,Robert S. Kaplan,Peter Doshi +6 more
TL;DR: In this paper , serious adverse events reported in the placebo-controlled, phase III randomized clinical trials of Pfizer and Moderna mRNA COVID-19 vaccines in adults (NCT04368728 and NCT04470427), focusing analysis on Brighton Collaboration adverse events of special interest.
Journal ArticleDOI
Neurological Events Reported after COVID‐19 Vaccines: An Analysis of Vaccine Adverse Event Reporting System
Jennifer A. Frontera,Arina Tamborska,Mohamed Fahmy Doheim,David García-Azorín,Haşim Gezegen,Alla Guekht,Abdul Hanif Khan Yusof Khan,Michele Santacatterina,James J. Sejvar,Kiran T. Thakur,Erica Westenberg,Andrea Sylvia Winkler,Ettore Beghi,Ricardo F. Allegri,Betül Baykan,Lana Blinc,Abhilasha P Boruah,Maja Bresjanac,Yuliya Bryzgalova,Ismael Calandri,Guillermo Delgado-García,Rashmi Devaraj,Simon Faissner,Fan Kee Hoo,Jessica Hunter,Jeyanthan Charles James,Nana Yaa Kyei‐Frimpong,Suzannah Lant,Nicholas Mulchan,Manjunath Netravathi,Svetlana Pikovskaya,Nihara Abdul Rasheed,Ahmed S. Safwat,Parthasarathy Satishchandra,Ali S. Shalash,Nina Singh,Marianna Spatola,Vivian Ssonko,Lindsay G. Tetreault,Gaja Cvejić Vidali,J Weng,Elyce Warburton,T. Welte,Tissa Wijeratne,Doris Yan Xia,D. Zhuravlev,M S Zinchuk +46 more
TL;DR: To identify the rates of neurological events following administration of mRNA (Pfizer, Moderna) or adenovirus vector (Janssen) vaccines in the U.S.
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COVID-19 vaccination and Guillain-Barré syndrome: analyses using the National Immunoglobulin Database
TL;DR: In this article , the authors performed a population-based study of National Health Service data in England and a multicentre surveillance study from UK hospitals to investigate the relationship between COVID-19 vaccination and Guillain-Barré syndrome (GBS).
References
More filters
Journal ArticleDOI
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine.
Fernando P. Polack,Stephen J. Thomas,Nicholas Kitchin,Judith Absalon,Alejandra Gurtman,Stephen Lockhart,John L. Perez,Gonzalo Pérez Marc,Edson D. Moreira,Cristiano Zerbini,Ruth Bailey,Kena A. Swanson,Satrajit Roychoudhury,Kenneth Koury,Ping Li,Warren Kalina,David A. Cooper,Robert W. Frenck,Laura L. Hammitt,Özlem Türeci,Haylene Nell,Axel Schaefer,Serhat Ünal,Dina B. Tresnan,Susan Mather,Philip R. Dormitzer,Ugur Sahin,Kathrin U. Jansen,William C. Gruber +28 more
TL;DR: A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older and safety over a median of 2 months was similar to that of other viral vaccines.
Journal ArticleDOI
BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting.
Noa Dagan,Noam Barda,Noam Barda,Noam Barda,Eldad Kepten,Oren Miron,Oren Miron,Shay Perchik,Mark A. Katz,Mark A. Katz,Mark A. Katz,Miguel A. Hernán,Marc Lipsitch,Ben Y. Reis,Ran D. Balicer,Ran D. Balicer +15 more
TL;DR: This study in a nationwide mass vaccination setting suggests that the BNT162b2 mRNA vaccine is effective for a wide range of Covid-19–related outcomes, a finding consistent with that of the randomized trial.
Journal ArticleDOI
Neurological and neuropsychiatric complications of COVID-19 in 153 patients: a UK-wide surveillance study.
Aravinthan Varatharaj,Aravinthan Varatharaj,Naomi Thomas,Mark Ellul,Mark Ellul,Mark Ellul,Nicholas W. S. Davies,Thomas A Pollak,Elizabeth L Tenorio,Mustafa Sultan,Ava Easton,Gerome Breen,Michael S. Zandi,Jonathan P. Coles,Hadi Manji,Rustam Al-Shahi Salman,David K. Menon,Timothy R Nicholson,Laura A Benjamin,Laura A Benjamin,Alan Carson,Craig J. Smith,Martin R Turner,Tom Solomon,Tom Solomon,Tom Solomon,Rachel Kneen,Rachel Kneen,Sarah Pett,Ian Galea,Ian Galea,Rhys H. Thomas,Rhys H. Thomas,Benedict D Michael,Benedict D Michael,Benedict D Michael,Claire Allen,Neil Archibald,James Arkell,Peter Arthur-Farraj,Mark R. Baker,Harriet A. Ball,Verity Bradley-Barker,Zoe Brown,Stefania Bruno,Lois Carey,Christopher Carswell,Annie Chakrabarti,James Choulerton,Mazen Daher,Ruth Davies,Rafael Di Marco Barros,Sofia Dima,Rachel Dunley,Dipankar Dutta,Richard James Booth Ellis,Alex Everitt,Joseph Fady,Patricia Fearon,Leonora Fisniku,Ivie Gbinigie,Alan Gemski,Emma Gillies,Effrossyni Gkrania-Klotsas,Julie Grigg,Hisham Hamdalla,Jack Hubbett,Neil Hunter,Anne-Catherine Huys,Ihmoda Ihmoda,Sissi Ispoglou,Ashwani Jha,Ramzi Joussi,Dheeraj Kalladka,Hind Khalifeh,Sander Kooij,Guru Kumar,Sandar Kyaw,Lucia Li,Edward Littleton,Malcolm R. Macleod,Mary Joan MacLeod,Barbara Madigan,Vikram Mahadasa,Manonmani Manoharan,Richard Marigold,Isaac Marks,Paul M. Matthews,Michael Mccormick,Caroline Mcinnes,Antonio Metastasio,Philip Milburn-McNulty,Clinton Mitchell,Duncan Mitchell,Clare Morgans,Huw R. Morris,Jasper M. Morrow,Ahmed Mubarak Mohamed,Paula Mulvenna,Louis Murphy,Robert Namushi,Edward J Newman,Wendy Phillips,Ashwin Pinto,David A Price,Harald Proschel,Terry Quinn,Deborah Ramsey,Christine Roffe,Amy L Ross Russell,Neshika Samarasekera,Stephen Sawcer,Walee Sayed,Lakshmanan Sekaran,Jordi Serra-Mestres,Victoria K. Snowdon,Gayle Strike,James Sun,Christina Tang,Mark Vrana,Ryckie G. Wade,Chris Wharton,Lou Wiblin,Iryna Boubriak,Katie Herman,Gordon T. Plant +125 more
TL;DR: This is the first nationwide, cross-specialty surveillance study of acute neurological and psychiatric complications of COVID-19 and provides valuable and timely data that are urgently needed by clinicians, researchers, and funders.
Journal ArticleDOI
Negative controls: a tool for detecting confounding and bias in observational studies.
TL;DR: It is argued that negative controls should be more commonly employed in observational studies, and that additional work is needed to specify the conditions under which negative controls will be sensitive detectors of other sources of error in observational Studies.
Journal ArticleDOI
The emerging spectrum of COVID-19 neurology: clinical, radiological and laboratory findings.
Ross W. Paterson,Ross W. Paterson,Rachel Brown,Laura A Benjamin,Laura A Benjamin,Ross Nortley,Ross Nortley,Sarah Wiethoff,Sarah Wiethoff,Tehmina Bharucha,Tehmina Bharucha,Tehmina Bharucha,Dipa L Jayaseelan,Dipa L Jayaseelan,Guru Kumar,Rhian E Raftopoulos,Laura Zambreanu,Laura Zambreanu,Vinojini Vivekanandam,Anthony Khoo,Ruth Geraldes,Ruth Geraldes,Krishna Chinthapalli,Krishna Chinthapalli,Elena Boyd,Hatice Tuzlali,Gary Price,Gerry Christofi,Jasper M. Morrow,Jasper M. Morrow,Patricia McNamara,Benjamin C Mcloughlin,Soon Tjin Lim,Puja Mehta,Viva Levee,Stephen Keddie,Wisdom Yong,S Anand Trip,S Anand Trip,Alexander J.M. Foulkes,Alexander J.M. Foulkes,Gary Hotton,Thomas D. Miller,Alex Everitt,Christopher Carswell,Nicholas W. S. Davies,Michael Yoong,David Attwell,Jemeen Sreedharan,Eli Silber,Jonathan M. Schott,Arvind Chandratheva,Richard J. Perry,Robert Simister,Anna M. Checkley,Nicky Longley,Simon F. Farmer,Francesco Carletti,Catherine F Houlihan,Maria Thom,Michael P. Lunn,Jennifer Spillane,Jennifer Spillane,Robin Howard,Robin Howard,Angela Vincent,Angela Vincent,David J. Werring,Chandrashekar Hoskote,Hans Rolf Jäger,Hans Rolf Jäger,Hadi Manji,Hadi Manji,Michael S. Zandi,Michael S. Zandi +74 more
TL;DR: A case series of 43 patients with neurological complications of SARS-CoV-2 infection includes encephalopathies, encephalitis, acute disseminated encephalomyelitis with haemorrhagic change, transverse myelitis, ischaemic stroke, and Guillain-Barré syndrome.