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2. Utilising accessible and reproducible neurological assessments in clinical studies: Insights from use of the Neurological Impairment Scale in the multi-centre COVID-CNS study

Author

Alam, Ali M., Webb, Glynn W., Collie, Ceryce, Mariathasan, Sashini, Huang, Yun, Hilton, Orla, Shil, Rajish, Dodd, Katherine C., Lilleker, James B., Smith, Craig J., Easton, Ava, Tamborska, Arina, Thomas, Rhys H., Davies, Nicholas W.S., Jenkins, Thomas M., Zandi, Michael, Benjamin, Laura, Ellul, Mark A., Solomon, Tom, Pollak, Thomas A., Nicholson, Tim, Breen, Gerome, van Wamelen, Daniel J., Wood, Nicholas W., and Michael, Benedict D.

Published
2024
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4. Cerebral venous thrombosis after vaccination against COVID-19 in the UK: a multicentre cohort study

Author

Al-izzi, Sara, Baheerathan, Aravindhan, Banerjee, Soma, Benson, Gary, Boshier, Claudia, Buddha, Sandeep, Burley, Nathan, Cameron Smail, Ruaridh, Chandratheva, Arvind, Chudakou, Pavel, Clatworthy, Philip, Coles, Alasdair, Cox, Thomas, Dasgupta, Ranjit, Davenport, Richard, Devine, Darrell, Fenlon, Stephen, Gabriel, Carolyn, Ghatala, Rita, Hall, Claire, Hargovan, Milan, Harkness, Kirsty, Harvey, Ian, Hicken, Lucy, Howaniec, Laura, Ibnouf, Abubaker, Idrovo, Luis, Ingle, Gordon, Kyan Lee, Yong, Lang, Ailidh, McBride, Simon, McLeod, Malcolm, Medlock, Ruth, Mehta, Puja, Morrison, Ian, Muddegowda, Girish, Muzerengi, Sharon, Pang, Donald, Periyasamy, Gopinath, Preston, Gavin, Priestley, Naomi, Revicka, Lydia, Saber, Sadia, Smith, Elliott, Sorour, Youssef, Spooner, Oliver, Stone, Jon, Sztriha, Laszlo, Thambirajah, Narmathey, Thomas, Rhys, Veale, David, Wall, Jasmine, White, Sarah, White, James, Yusoff, Syarah, Zambreanu, Laura, Perry, Richard J, Tamborska, Arina, Singh, Bhagteshwar, Craven, Brian, Marigold, Richard, Arthur-Farraj, Peter, Yeo, Jing Ming, Zhang, Liqun, Hassan-Smith, Ghaniah, Jones, Matthew, Hutchcroft, Christopher, Hobson, Esther, Warcel, Dana, White, Daniel, Ferdinand, Phillip, Webb, Alastair, Solomon, Tom, Scully, Marie, Werring, David J, and Roffe, Christine

Published
2021
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5. Clinical review of cerebral venous thrombosis in the context of COVID-19 vaccinations: Evaluation, management, and scientific questions

Author

Thakur, Kiran T., Tamborska, Arina, Wood, Greta K., McNeill, Emily, Roh, David, Akpan, Imo J., Miller, Eliza C., Bautista, Alyssa, Claassen, Jan, Kim, Carla Y., Guekht, Alla, Pardo, Carlos A., Williams, Olajide, García-Azorín, David, Prasad, Kameshwar, Schmutzhard, Erich, Michael, Benedict D., Chou, Sherry H.-Y., Winkler, Andrea S., Solomon, Tom, and Elkind, Mitchell S.

Published
2021
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8. Anosmia: Brighton Collaboration case definition and guidelines for data collection, analysis, and presentation of immunization safety data

Author

Yi-Chun, Carol Liu, Munoz, Flor M., Izurieta, Hector S, Tamborska, Arina A, Solomon, Tom, Law, Barbara, and Chhabra, Nipun

Subjects
Infectious Diseases, General Veterinary, General Immunology and Microbiology, SPEAC, Anosmia, CEPI, adverse event, Public Health, Environmental and Occupational Health, Molecular Medicine, guidelines, immunization, case definition
Abstract

This is a Brighton Collaboration case definition of anosmia to be used in the evaluation of adverse events following immunization, and for epidemiologic studies for the assessment of background incidence or hypothesis testing. The case definition was developed by a group of experts convened by the Coalition for Epidemic Preparedness Innovations (CEPI) in the context of active development of SARS-CoV-2 vaccines. The case definition format of the Brighton Collaboration was followed to develop a consensus definition and defined levels of certainty, after an exhaustive review of the literature and expert consultation. The document underwent peer review by the Brighton Collaboration Network and by two expert reviewers prior to submission., The SPEAC Project is funded in whole by CEPI.

Published
2023
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11. Anosmia: Brighton Collaboration case definition and guidelines for data collection, analysis, and presentation of immunization safety data (Manuscript draft)

Author

Yi-Chun, Carol Liu, Munoz, Flor M., Izurieta, Hector S, Tamborska, Arina A, Solomon, Tom, Law, Barbara, and Chhabra, Nipun

Subjects
SPEAC, Anosmia, CEPI, adverse event, guidelines, immunization, case definition
Abstract

This is a Brighton Collaboration case definition of anosmia to be used in the evaluation of adverse events following immunization, and for epidemiologic studies for the assessment of background incidence or hypothesis testing. The case definition was developed by a group of experts convened by the Coalition for Epidemic Preparedness Innovations (CEPI) in the context of active development of SARS-CoV-2 vaccines. The case definition format of the Brighton Collaboration was followed to develop a consensus definition and defined levels of certainty, after an exhaustive review of the literature and expert consultation. The document underwent peer review by the Brighton Collaboration Network and by two expert reviewers prior to submission.

Published
2022
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12. Consensus Clinical Guidance for Diagnosis and Management of Adult COVID-19 Encephalopathy Patients

Author

Michael, Benedict D, Walton, Dean, Westenberg, Erica, García-Azorín, David, Singh, Bhagteshwar, Tamborska, Arina A, Netravathi, M, Chomba, Mashina, Wood, Greta K, Easton, Ava, Siddiqi, Omar K, Jackson, Thomas A, Pollak, Thomas A, Nicholson, Timothy R, Nair, Shalini, Breen, Gerome, Prasad, Kameshwar, Thakur, Kiran T, Chou, Sherry H-Y, Schmutzhard, Erich, Frontera, Jennifer A, Helbok, Raimund, Padovani, Alessandro, Menon, David K, Solomon, Tom, Winkler, Andrea S, and Global COVID-19 Neuro Research Coalition

Subjects
Psychiatry and Mental health, Neurology (clinical)
Abstract

Encephalopathy, a common condition among patients hospitalized with COVID-19, can be a challenge to manage and negatively affect prognosis. While encephalopathy may present clinically as delirium, subsyndromal delirium, or coma and may be a result of systemic causes such as hypoxia, COVID-19 has also been associated with more prolonged encephalopathy due to less common but nevertheless severe complications, such as inflammation of the brain parenchyma (with or without cerebrovascular involvement), demyelination, or seizures, which may be disproportionate to COVID-19 severity and require specific management. Given the large number of patients hospitalized with severe acute respiratory syndrome coronavirus-2 infection, even these relatively unlikely complications are increasingly recognized and are particularly important because they require specific management. Therefore, the aim of this review is to provide pragmatic guidance on the management of COVID-19 encephalopathy through consensus agreement of the Global COVID-19 Neuro Research Coalition. A systematic literature search of MEDLINE, medRxiv, and bioRxiv was conducted between January 1, 2020, and June 21, 2021, with additional review of references cited within the identified bibliographies. A modified Delphi approach was then undertaken to develop recommendations, along with a parallel approach to score the strength of both the recommendations and the supporting evidence. This review presents analysis of contemporaneous evidence for the definition, epidemiology, and pathophysiology of COVID-19 encephalopathy and practical guidance for clinical assessment, investigation, and both acute and long-term management.

Published
2022

13. Guillain-Barré syndrome following SARS-CoV-2 vaccination in the UK: a prospective surveillance study

Author

Tamborska, Arina A, Singh, Bhagteshwar, Leonhard, Sonja E, Hodel, Eva Maria, Stowe, Julia, Watson-Fargie, Taylor, Fernandes, Peter M, Themistocleous, Andreas C, Roelofs, Jacob, Brennan, Kathryn, Morrice, Caroline, Michael, Benedict D, Jacobs, Bart C, McDonald, Helen, Solomon, Tom, and UK Covid Vaccine GBS Study Group

Abstract

Objective: To investigate features of Guillain-Barré syndrome (GBS) following SARS-CoV-2 vaccines and evaluate for a causal link between the two. Methods: We captured cases of GBS after SARS-CoV-2 vaccination through a national, open-access, online surveillance system. For each case, the certainty of GBS was graded using the Brighton criteria, and the relationship to the vaccine was examined using modified WHO Causality Assessment criteria. We compared age distribution of cases with that of prepandemic GBS cases and clinical features with the International GBS Outcome Study (IGOS). Results: Between 1 January and 30 June 2021, we received 67 reports of GBS following the ChAdOx1 vaccine (65 first doses) and three reports following the BNT162b2 vaccine (all first doses). The causal association with the vaccine was classified as probable for 56 (80%, all ChAdOx1), possible for 12 (17%, 10 ChAdOx1) and unlikely for two (3%, 1 ChAdOx1). A greater proportion of cases occurred in the 50-59 age group in comparison with prepandemic GBS. Most common clinical variants were sensorimotor GBS (n=55; 79%) and facial diplegia with paraesthesias (n=10; 14%). 10% (n=7/69) of patients reported an antecedent infection, compared with 77% (n=502/652) of the IGOS cohort (p

Published
2022

14. Safety of COVID-19 vaccination and acute neurological events: A self-controlled case series in England using the OpenSAFELY platform

Author

Walker, Jemma L, primary, Schultze, Anna, additional, Tazare, John, additional, Tamborska, Arina, additional, Singh, Bhagteshwar, additional, Donegan, Katherine, additional, Stowe, Julia, additional, Morton, Caroline E, additional, Hulme, William J, additional, Curtis, Helen J, additional, Williamson, Elizabeth J, additional, Mehrkar, Amir, additional, Eggo, Rosalind M, additional, Rentsch, Christopher T, additional, Mathur, Rohini, additional, Bacon, Sebastian, additional, Walker, Alex J, additional, Davy, Simon, additional, Evans, David, additional, Inglesby, Peter, additional, Hickman, George, additional, MacKenna, Brian, additional, Tomlinson, Laurie, additional, CA Green, Amelia, additional, Fisher, Louis, additional, Cockburn, Jonathan, additional, Parry, John, additional, Hester, Frank, additional, Harper, Sam, additional, Bates, Christopher, additional, Evans, Stephen JW, additional, Solomon, Tom, additional, Andrews, Nick J, additional, Douglas, Ian J, additional, Goldacre, Ben, additional, Smeeth, Liam, additional, and McDonald, Helen I, additional

Published
2022
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15. Neurological events reported after COVID-19 vaccines: an analysis of vaccine adverse event reporting system

Author

Frontera, Jennifer A., Tamborska, Arina A., Doheim, Mohamed F., Garcia-Azorin, David, Gezegen, Hasim, Guekht, Alla, Yusof Khan, Abdul Hanif Khan, Santacatterina, Michele, Sejvar, James, Thakur, Kiran T., Westenberg, Erica, Winkler, Andrea S., Beghi, Ettore, Frontera, Jennifer A., Tamborska, Arina A., Doheim, Mohamed F., Garcia-Azorin, David, Gezegen, Hasim, Guekht, Alla, Yusof Khan, Abdul Hanif Khan, Santacatterina, Michele, Sejvar, James, Thakur, Kiran T., Westenberg, Erica, Winkler, Andrea S., and Beghi, Ettore

Abstract

Objective: To identify the rates of neurological events following administration of mRNA (Pfizer, Moderna) or adenovirus vector (Janssen) vaccines in the U.S. Methods: We used publicly available data from the U.S. Vaccine Adverse Event Reporting System (VAERS) collected between January 1, 2021 and June 14, 2021. All free text symptoms that were reported within 42 days of vaccine administration were manually reviewed and grouped into 36 individual neurological diagnostic categories. Post-vaccination neurological event rates were compared between vaccine types and to age-matched baseline incidence rates in the U.S. and rates of neurological events following COVID. Results: Of 306,907,697 COVID vaccine doses administered during the study timeframe, 314,610 (0.1%) people reported any adverse event and 105,214 (0.03%) reported neurological adverse events in a median of 1 day (IQR0-3) from inoculation. Guillain-Barre Syndrome (GBS), and cerebral venous thrombosis (CVT) occurred in fewer than 1 per 1,000,000 doses. Significantly more neurological adverse events were reported following Janssen (Ad26.COV2.S) vaccination compared to either Pfizer-BioNtech (BNT162b2) or Moderna (mRNA-1,273; 0.15% vs 0.03% vs 0.03% of doses, respectively, p < 0.0001). The observed-to-expected ratios for GBS, CVT and seizure following Janssen vaccination were ≥1.5-fold higher than background rates. However, the rate of neurological events after acute SARS-CoV-2 infection was up to 617-fold higher than after COVID vaccination. Interpretation: Reports of serious neurological events following COVID vaccination are rare. GBS, CVT and seizure may occur at higher than background rates following Janssen vaccination. Despite this, rates of neurological complications following acute SARS-CoV-2 infection are up to 617-fold higher than after COVID vaccination. ANN NEUROL 2022;91:756–771.

Published
2022

16. Characterization and analysis of neurologic adverse events associated with COVID-19 vaccination (S12.006)

Author

Boruah, Abhilasha, Westenberg, Erica, Khan, Abdul Hanif, Fan, Kee Hoo, Guekht, Alla, Spatola, Marianna, Calandri, Ismael, Netravathi, M, Wijeratne, Tissa, Warburton, Elyce, Doheim, Mohamed Fahmy, Pulickal, Carolin, Chen, Jakin, Thakur, Kiran, Mulchan, Nicholas, Ssonko, Vivian, Tetreault, Lindsay, Sejvar, Jim, Faissner, Simon, James, Jeyanthan Charles, Hunter, Jessica, Garcia-Azorin, David, Tamborska, Arina, Bresjanac, Maja, Delgado-Garcia, Guillermo, Singh, Nina, Baykan, Betül, Gezegen, Hasim, Kyei-Frimpong, Nana, Winkler, Andrea, Frontera, Jennifer, Boruah, Abhilasha, Westenberg, Erica, Khan, Abdul Hanif, Fan, Kee Hoo, Guekht, Alla, Spatola, Marianna, Calandri, Ismael, Netravathi, M, Wijeratne, Tissa, Warburton, Elyce, Doheim, Mohamed Fahmy, Pulickal, Carolin, Chen, Jakin, Thakur, Kiran, Mulchan, Nicholas, Ssonko, Vivian, Tetreault, Lindsay, Sejvar, Jim, Faissner, Simon, James, Jeyanthan Charles, Hunter, Jessica, Garcia-Azorin, David, Tamborska, Arina, Bresjanac, Maja, Delgado-Garcia, Guillermo, Singh, Nina, Baykan, Betül, Gezegen, Hasim, Kyei-Frimpong, Nana, Winkler, Andrea, and Frontera, Jennifer

Abstract

Objective: To characterize the incidence and spectrum of neurological adverse events (AE) after COVID-19 vaccination. Background: The devastating COVID-19 pandemic has led to 230 million people diagnosed and greater than 4.8 million deaths worldwide. Widespread vaccination efforts have resulted in administration of over 6 million vaccine doses to curb the significant health and socioeconomic impacts of the disease. While there are numerous reports of adverse events following COVID-19 vaccine, there is limited characterization of the spectrum of neurological AEs post-vaccination. Design/Methods: Data was gathered from the publicly available Vaccine Adverse Event Reporting System (VAERS), a passive reporting system not implying causality. Among individuals who received the J&J, Moderna, and Pfizer vaccines from 1/1/2021–6/14/2021, 314,610 adverse events were reported and these were reviewed by Neurology trained clinicians to determine the presence of various neurological AEs (40 conditions coded). Results: 306,473,169 COVID vaccine dose were administered in the USA during the study period with 314,610 total AEs (0.10%) and 105,930 neurological AEs (0.03%) reported. J&J vaccine was associated with the most AEs (17,670, 0.15%), followed by Moderna (42656, 0.03%) and Pfizer (42267, 0.03%). On average more events were reported in women (71%) and a majority occurred after the first dose (54%). < 1 events were reported per million vaccine doses for serious neurological conditions such as Bell’s palsy (0.0007%), Guillain-Barre syndrome (0.00009%), cerebral venous thrombosis (0.00005%), transverse myelitis (0.00003%), and acute disseminated encephalomyelitis (0.00006%). Overall neurological complications following vaccine were drastically lower than complications post-COVID infection (14–80%). Conclusions: Adverse neurological events following COVID-19 vaccination are extremely rare and significantly less common than adverse neurological effects following SARS-CoV-2 infection

Published
2022

17. Prognostic indicators and outcomes of hospitalised COVID-19 patients with neurological disease: An individual patient data meta-analysis

Author

Singh, Bhagteshwar, Lant, Suzannah, Cividini, Sofia, Cattrall, Jonathan W S, Goodwin, Lynsey C, Benjamin, Laura, Michael, Benedict D, Khawaja, Ayaz, Matos, Aline de Moura Brasil, Alkeridy, Walid, Pilotto, Andrea, Lahiri, Durjoy, Rawlinson, Rebecca, Mhlanga, Sithembinkosi, Lopez, Evelyn C, Sargent, Brendan F, Somasundaran, Anushri, Tamborska, Arina, Webb, Glynn, Younas, Komal, Al Sami, Yaqub, Babu, Heavenna, Banks, Tristan, Cavallieri, Francesco, Cohen, Matthew, Davies, Emma, Dhar, Shalley, Fajardo Modol, Anna, Farooq, Hamzah, Harte, Jeffrey, Hey, Samuel, Joseph, Albert, Karthikappallil, Dileep, Kassahun, Daniel, Lipunga, Gareth, Mason, Rachel, Minton, Thoma, Mond, Gabrielle, Poxon, Joseph, Rabas, Sophie, Soothill, Germander, Zedde, Marialuisa, Yenkoyan, Konstantin, Brew, Bruce, Contini, Erika, Cysique, Lucette, Zhang, Xin, Maggi, Pietro, van Pesch, Vincent, Lechien, Jérome, Saussez, Sven, Heyse, Alex, Brito Ferreira, Maria Lúcia, Soares, Cristiane N, Elicer, Isabel, Eugenín-von Bernhardi, Laura, Ñancupil Reyes, Waleng, Yin, Rong, Azab, Mohammed A, Abd-Allah, Foad, Elkady, Ahmed, Escalard, Simon, Corvol, Jean-Christophe, Delorme, Cécile, Tattevin, Pierre, Bigaut, Kévin, Lorenz, Norbert, Hornuss, Daniel, Hosp, Jona, Rieg, Siegbert, Wagner, Dirk, Knier, Benjamin, Lingor, Paul, Winkler, Andrea Sylvia, Sharifi-Razavi, Athena, Moein, Shima T, Seyedalinaghi, Seyedahmad, Jamalimoghadamsiahkali, Saeidreza, Morassi, Mauro, Padovani, Alessandro, Giunta, Marcello, Libri, Ilenia, Beretta, Simone, Ravaglia, Sabrina, Foschi, Matteo, Calabresi, Paolo, Primiano, Guido Alessandro, Servidei, Serenella, Biagio Mercuri, Nicola, Liguori, Claudio, Pierantozzi, Mariangela, Sarmati, Loredana, Boso, Federica, Garazzino, Silvia, Mariotto, Sara, Patrick, Kimani N, Costache, Oana, Pincherle, Alexander, Klok, Frederikus A, Meza, Roger, Cabreira, Verónica, Valdoleiros, Sofia R, Oliveira, Vanessa, Kaimovsky, Igor, Guekht, Alla, Koh, Jasmine, Fernández Díaz, Eva, Barrios-López, José María, Guijarro-Castro, Cristina, Beltrán-Corbellini, Álvaro, Martínez-Poles, Javier, Diezma-Martín, Alba María, Morales-Casado, Maria Isabel, García García, Sergio, Breville, Gautier, Coen, Matteo, Uginet, Marjolaine, Bernard-Valnet, Raphaël, Du Pasquier, Renaud, Kaya, Yildiz, Abdelnour, Loay H, Rice, Claire, Morrison, Hamish, Defres, Sylviane, Huda, Saif, Enright, Noelle, Hassell, Jane, D'Anna, Lucio, Benger, Matthew, Sztriha, Laszlo, Raith, Eamon, Chinthapalli, Krishna, Nortley, Ro, Paterson, Ro, Chandratheva, Arvind, Werring, David J, Dervisevic, Samir, Harkness, Kirsty, Pinto, Ashwin, Jillella, Dinesh, Beach, Scott, Gunasekaran, Kulothungan, Rocha Ferreira Da Silva, Ivan, Nalleballe, Krishna, Santoro, Jonathan, Scullen, Tyler, Kahn, Lora, Kim, Carla Y, Thakur, Kiran T, Jain, Rajan, Umapathi, Thirugnanam, Nicholson, Timothy R, Sejvar, James J, Hodel, Eva Maria, Tudur Smith, Catrin, Solomon, Tom, Calabresi, Paolo (ORCID:0000-0003-0326-5509), Primiano, Guido, Servidei, Serenella (ORCID:0000-0001-8478-2799), Singh, Bhagteshwar, Lant, Suzannah, Cividini, Sofia, Cattrall, Jonathan W S, Goodwin, Lynsey C, Benjamin, Laura, Michael, Benedict D, Khawaja, Ayaz, Matos, Aline de Moura Brasil, Alkeridy, Walid, Pilotto, Andrea, Lahiri, Durjoy, Rawlinson, Rebecca, Mhlanga, Sithembinkosi, Lopez, Evelyn C, Sargent, Brendan F, Somasundaran, Anushri, Tamborska, Arina, Webb, Glynn, Younas, Komal, Al Sami, Yaqub, Babu, Heavenna, Banks, Tristan, Cavallieri, Francesco, Cohen, Matthew, Davies, Emma, Dhar, Shalley, Fajardo Modol, Anna, Farooq, Hamzah, Harte, Jeffrey, Hey, Samuel, Joseph, Albert, Karthikappallil, Dileep, Kassahun, Daniel, Lipunga, Gareth, Mason, Rachel, Minton, Thoma, Mond, Gabrielle, Poxon, Joseph, Rabas, Sophie, Soothill, Germander, Zedde, Marialuisa, Yenkoyan, Konstantin, Brew, Bruce, Contini, Erika, Cysique, Lucette, Zhang, Xin, Maggi, Pietro, van Pesch, Vincent, Lechien, Jérome, Saussez, Sven, Heyse, Alex, Brito Ferreira, Maria Lúcia, Soares, Cristiane N, Elicer, Isabel, Eugenín-von Bernhardi, Laura, Ñancupil Reyes, Waleng, Yin, Rong, Azab, Mohammed A, Abd-Allah, Foad, Elkady, Ahmed, Escalard, Simon, Corvol, Jean-Christophe, Delorme, Cécile, Tattevin, Pierre, Bigaut, Kévin, Lorenz, Norbert, Hornuss, Daniel, Hosp, Jona, Rieg, Siegbert, Wagner, Dirk, Knier, Benjamin, Lingor, Paul, Winkler, Andrea Sylvia, Sharifi-Razavi, Athena, Moein, Shima T, Seyedalinaghi, Seyedahmad, Jamalimoghadamsiahkali, Saeidreza, Morassi, Mauro, Padovani, Alessandro, Giunta, Marcello, Libri, Ilenia, Beretta, Simone, Ravaglia, Sabrina, Foschi, Matteo, Calabresi, Paolo, Primiano, Guido Alessandro, Servidei, Serenella, Biagio Mercuri, Nicola, Liguori, Claudio, Pierantozzi, Mariangela, Sarmati, Loredana, Boso, Federica, Garazzino, Silvia, Mariotto, Sara, Patrick, Kimani N, Costache, Oana, Pincherle, Alexander, Klok, Frederikus A, Meza, Roger, Cabreira, Verónica, Valdoleiros, Sofia R, Oliveira, Vanessa, Kaimovsky, Igor, Guekht, Alla, Koh, Jasmine, Fernández Díaz, Eva, Barrios-López, José María, Guijarro-Castro, Cristina, Beltrán-Corbellini, Álvaro, Martínez-Poles, Javier, Diezma-Martín, Alba María, Morales-Casado, Maria Isabel, García García, Sergio, Breville, Gautier, Coen, Matteo, Uginet, Marjolaine, Bernard-Valnet, Raphaël, Du Pasquier, Renaud, Kaya, Yildiz, Abdelnour, Loay H, Rice, Claire, Morrison, Hamish, Defres, Sylviane, Huda, Saif, Enright, Noelle, Hassell, Jane, D'Anna, Lucio, Benger, Matthew, Sztriha, Laszlo, Raith, Eamon, Chinthapalli, Krishna, Nortley, Ro, Paterson, Ro, Chandratheva, Arvind, Werring, David J, Dervisevic, Samir, Harkness, Kirsty, Pinto, Ashwin, Jillella, Dinesh, Beach, Scott, Gunasekaran, Kulothungan, Rocha Ferreira Da Silva, Ivan, Nalleballe, Krishna, Santoro, Jonathan, Scullen, Tyler, Kahn, Lora, Kim, Carla Y, Thakur, Kiran T, Jain, Rajan, Umapathi, Thirugnanam, Nicholson, Timothy R, Sejvar, James J, Hodel, Eva Maria, Tudur Smith, Catrin, Solomon, Tom, Calabresi, Paolo (ORCID:0000-0003-0326-5509), Primiano, Guido, and Servidei, Serenella (ORCID:0000-0001-8478-2799)

Abstract

BackgroundNeurological COVID-19 disease has been reported widely, but published studies often lack information on neurological outcomes and prognostic risk factors. We aimed to describe the spectrum of neurological disease in hospitalised COVID-19 patients; characterise clinical outcomes; and investigate factors associated with a poor outcome.MethodsWe conducted an individual patient data (IPD) meta-analysis of hospitalised patients with neurological COVID-19 disease, using standard case definitions. We invited authors of studies from the first pandemic wave, plus clinicians in the Global COVID-Neuro Network with unpublished data, to contribute. We analysed features associated with poor outcome (moderate to severe disability or death, 3 to 6 on the modified Rankin Scale) using multivariable models.ResultsWe included 83 studies (31 unpublished) providing IPD for 1979 patients with COVID-19 and acute new-onset neurological disease. Encephalopathy (978 [49%] patients) and cerebrovascular events (506 [26%]) were the most common diagnoses. Respiratory and systemic symptoms preceded neurological features in 93% of patients; one third developed neurological disease after hospital admission. A poor outcome was more common in patients with cerebrovascular events (76% [95% CI 67-82]), than encephalopathy (54% [42-65]). Intensive care use was high (38% [35-41]) overall, and also greater in the cerebrovascular patients. In the cerebrovascular, but not encephalopathic patients, risk factors for poor outcome included breathlessness on admission and elevated D-dimer. Overall, 30-day mortality was 30% [27-32]. The hazard of death was comparatively lower for patients in the WHO European region.InterpretationNeurological COVID-19 disease poses a considerable burden in terms of disease outcomes and use of hospital resources from prolonged intensive care and inpatient admission; preliminary data suggest these may differ according to WHO regions and country income levels. The different

Published
2022

18. Guillain-Barré syndrome following SARS-CoV-2 vaccination in the UK:A prospective surveillance study

Author

Tamborska, Arina A., Singh, Bhagteshwar, Leonhard, Sonja E., Hodel, Eva Maria, Stowe, Julia, Watson-Fargie, Taylor, Fernandes, Peter M., Themistocleous, Andreas C., Roelofs, Jacob, Brennan, Kathryn, Morrice, Caroline, Michael, Benedict D., Jacobs, Bart C., McDonald, Helen, Solomon, Tom, Tamborska, Arina A., Singh, Bhagteshwar, Leonhard, Sonja E., Hodel, Eva Maria, Stowe, Julia, Watson-Fargie, Taylor, Fernandes, Peter M., Themistocleous, Andreas C., Roelofs, Jacob, Brennan, Kathryn, Morrice, Caroline, Michael, Benedict D., Jacobs, Bart C., McDonald, Helen, and Solomon, Tom

Abstract

Objective To investigate features of Guillain-Barré syndrome (GBS) following SARS-CoV-2 vaccines and evaluate for a causal link between the two. Methods We captured cases of GBS after SARS-CoV-2 vaccination through a national, open-access, online surveillance system. For each case, the certainty of GBS was graded using the Brighton criteria, and the relationship to the vaccine was examined using modified WHO Causality Assessment criteria. We compared age distribution of cases with that of prepandemic GBS cases and clinical features with the International GBS Outcome Study (IGOS). Results Between 1 January and 30 June 2021, we received 67 reports of GBS following the ChAdOx1 vaccine (65 first doses) and three reports following the BNT162b2 vaccine (all first doses). The causal association with the vaccine was classified as probable for 56 (80%, all ChAdOx1), possible for 12 (17%, 10 ChAdOx1) and unlikely for two (3%, 1 ChAdOx1). A greater proportion of cases occurred in the 50-59 age group in comparison with prepandemic GBS. Most common clinical variants were sensorimotor GBS (n=55; 79%) and facial diplegia with paraesthesias (n=10; 14%). 10% (n=7/69) of patients reported an antecedent infection, compared with 77% (n=502/652) of the IGOS cohort (p<0.00001). Facial weakness (63% (n=44/70) vs 36% (n=220/620); p<0.00001) and sensory dysfunction (93% (n=63/68) vs 69% (n=408/588); p=0.00005) were more common but disease severity and outcomes were similar to the IGOS study. Interpretation Most reports of GBS followed the first dose of ChAdOx1 vaccine. While our study cannot confirm or refute causation, this observation, together with the absence of alternative aetiologies, different than expected age distribution and the presence of unusual clinical features support a causal link. Clinicians and surveillance bodies should remain vigilant to the possibility of this very rare adverse event and its atypical variants.

Published
2022

20. Characterization and Analysis of Neurologic Adverse Events Associated with COVID-19 Vaccination (S12.006)

Author

Boruah, Abhilasha, primary, Westenberg, Erica, additional, Khan, Abdul Hanif, additional, Hoo, Fan Kee, additional, Guekht, Alla, additional, Spatola, Marianna, additional, Calandri, Ismael, additional, Netravathi, M, additional, Wijeratne, Tissa, additional, Warburton, Elyce, additional, Doheim, Mohamed Fahmy, additional, Pulickal, Carolin, additional, Chen, Jakin, additional, Thakur, Kiran, additional, Mulchan, Nicholas, additional, Ssonko, Vivian, additional, Tetreault, Lindsay, additional, Sejvar, Jim, additional, Faissner, Simon, additional, James, Jeyanthan Charles, additional, Hunter, Jessica, additional, García-Azorín, David, additional, Tamborska, Arina, additional, Bresjanac, Maja, additional, Delgado-Garcia, Guillermo, additional, Singh, Nina, additional, Baykan, Betül, additional, Gezegen, Hasim, additional, Kyei-Frimpong, Nana, additional, Winkler, Andrea, additional, and Frontera, Jennifer, additional

Published
2022
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21. sj-pdf-1-cep-10.1177_03331024221099231 - Supplemental material for Timing of headache after COVID-19 vaccines and its association with cerebrovascular events: An analysis of 41,700 VAERS reports

Author

Garcia-Azorin, David, Baykan, Betül, Beghi, Ettore, Doheim, Mohamed F, Fernandez-de-las-Penas, Cesar, Gezegen, Hasim, Guekht, Alla, Hoo, Fan Kee, Santacatterina, Michele, Sejvar, James, Tamborska, Arina A, Thakur, Kiran T, Westenberg, Erica, Winkler, Andrea S, and Frontera, Jennifer A

Subjects
FOS: Psychology, FOS: Clinical medicine, 170199 Psychology not elsewhere classified, 110319 Psychiatry (incl. Psychotherapy), 110306 Endocrinology, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified, 110904 Neurology and Neuromuscular Diseases, Neuroscience
Abstract

Supplemental material, sj-pdf-1-cep-10.1177_03331024221099231 for Timing of headache after COVID-19 vaccines and its association with cerebrovascular events: An analysis of 41,700 VAERS reports by David Garcia-Azorin, Betül Baykan, Ettore Beghi, Mohamed F Doheim, Cesar Fernandez-de-las-Penas, Hasim Gezegen, Alla Guekht, Fan Kee Hoo, Michele Santacatterina, James Sejvar, Arina A Tamborska, Kiran T Thakur, Erica Westenberg, Andrea S Winkler, Jennifer A Frontera and Contributors from the Global COVID-19 Neuro Research Coalition in Cephalalgia

Published
2022
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22. Cerebral venous thrombosis after vaccination against COVID-19 in the UK: a multicentre cohort study

Author

Perry, Richard J, primary, Tamborska, Arina, additional, Singh, Bhagteshwar, additional, Craven, Brian, additional, Marigold, Richard, additional, Arthur-Farraj, Peter, additional, Yeo, Jing Ming, additional, Zhang, Liqun, additional, Hassan-Smith, Ghaniah, additional, Jones, Matthew, additional, Hutchcroft, Christopher, additional, Hobson, Esther, additional, Warcel, Dana, additional, White, Daniel, additional, Ferdinand, Phillip, additional, Webb, Alastair, additional, Solomon, Tom, additional, Scully, Marie, additional, Werring, David J, additional, Roffe, Christine, additional, Al-izzi, Sara, additional, Baheerathan, Aravindhan, additional, Banerjee, Soma, additional, Benson, Gary, additional, Boshier, Claudia, additional, Buddha, Sandeep, additional, Burley, Nathan, additional, Cameron Smail, Ruaridh, additional, Chandratheva, Arvind, additional, Chudakou, Pavel, additional, Clatworthy, Philip, additional, Coles, Alasdair, additional, Cox, Thomas, additional, Dasgupta, Ranjit, additional, Davenport, Richard, additional, Devine, Darrell, additional, Fenlon, Stephen, additional, Gabriel, Carolyn, additional, Ghatala, Rita, additional, Hall, Claire, additional, Hargovan, Milan, additional, Harkness, Kirsty, additional, Harvey, Ian, additional, Hicken, Lucy, additional, Howaniec, Laura, additional, Ibnouf, Abubaker, additional, Idrovo, Luis, additional, Ingle, Gordon, additional, Kyan Lee, Yong, additional, Lang, Ailidh, additional, McBride, Simon, additional, McLeod, Malcolm, additional, Medlock, Ruth, additional, Mehta, Puja, additional, Morrison, Ian, additional, Muddegowda, Girish, additional, Muzerengi, Sharon, additional, Pang, Donald, additional, Periyasamy, Gopinath, additional, Preston, Gavin, additional, Priestley, Naomi, additional, Revicka, Lydia, additional, Saber, Sadia, additional, Smith, Elliott, additional, Sorour, Youssef, additional, Spooner, Oliver, additional, Stone, Jon, additional, Sztriha, Laszlo, additional, Thambirajah, Narmathey, additional, Thomas, Rhys, additional, Veale, David, additional, Wall, Jasmine, additional, White, Sarah, additional, White, James, additional, Yusoff, Syarah, additional, and Zambreanu, Laura, additional

Published
2021
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23. Considerations for Causality Assessment of Neurological and Neuropsychiatric Complications of SARS-CoV-2 Vaccines: from Cerebral Venous Sinus Thrombosis to Functional Neurological Disorder

Author

Butler, Matthew, Tamborska, Arina, Wood, Greta, Ellul, Mark, Thomas, Rhys, Galea, Ian, Pett, Sarah, Solomon, Tom, Pollak, Tom, Michael, Benedict, and Nicholson, Timothy

Abstract

Worldwide SARS-CoV-2 vaccination campaigns for prevention of COVID-19 are currently underway. In clinical trials and in open-label monitoring the vaccines have shown efficacy against COVID-19 and there have been limited and transient side effects. Previous vaccination campaigns have taught us that neurological adverse events to vaccinations can occur. In this review, we summarise what is already known about neurological and neuropsychiatric adverse events of COVID-19 vaccinations, and place this in the context of historical vaccination campaigns. There have been a number of neurological and neuropsychiatric adverse events following immunisation (AEFI) in association with SARS-CoV-2 vaccinations, however in each case there is either no definitive evidence currently to support causality or recognised adverse events are extremely rare. Causality assessment aids such as the Causality Assessment of an Adverse Event Following Immunization from the World Health Organisation and the Bradford Hill criteria may help us better understand potential neurological and neuropsychiatric adverse events to COVID-19 vaccinations. Functional neurological disorder (FND) can be precipitated by the process of vaccination and has previously been noted to potentially spread between individuals, particularly in younger communities. Importantly FND does not implicate the vaccine constituents and therefore should not hamper ongoing vaccination campaigns. Although neurological and neuropsychiatric AEFI may occur after SARS-CoV-2 vaccinations, at present there are no common causally associated neurological adverse events. It is likely that some patients will develop FND in response to vaccination, although this does not implicate vaccine constituents. In cases of future serious neurological or neuropsychiatric AEFIs, judicious and rapid assessment of causality must occur. In general, the benefits of ARS-CoV-2 vaccination at present outweigh the risks from a neurological standpoint, although in specific situations the risk-benefit ratio will vary depending on geographic and demographic factors as well as population risk factors. Ensuring as minimal disruption as possible to ongoing swift worldwide vaccination campaigns is essential to establish the herd immunity required to end the COVID-19 pandemic.

Published
2021

24. Considerations for causality assessment of neurological and neuropsychiatric complications of SARS-CoV-2 vaccines: from cerebral venous sinus thrombosis to functional neurological disorder

Author

Butler, Matt, primary, Tamborska, Arina, additional, Wood, Greta K, additional, Ellul, Mark, additional, Thomas, Rhys H, additional, Galea, Ian, additional, Pett, Sarah, additional, Singh, Bhagteshwar, additional, Solomon, Tom, additional, Pollak, Thomas Arthur, additional, Michael, Benedict D, additional, and Nicholson, Timothy R, additional

Published
2021
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25. Diagnosis and management of adult patients with COVID-19 encephalopathy; consensus guidance from the Global COVID-19 Neuro Research Coalition

Author

Michael, Benedict, primary, Walton, Dean, additional, Westenberg, Erica, additional, Garcia-Azorin, David, additional, Singh, Bhagteshwar, additional, Tamborska, Arina, additional, Netravathi, M, additional, Chomba, Maschina, additional, Wood, Greta, additional, Easton, Ava, additional, Siddiqi, Omar, additional, Jackson, Thomas, additional, Nicholson, Timothy, additional, Nair, Shalini, additional, Breen, Gerome, additional, Prasad, Kameshwar, additional, Thakur, Kiran, additional, Chou, Sherry Hsiang-Yi, additional, Schmutzhard, Erich, additional, Frontera, Jennifer, additional, Helbok, Raimund, additional, Padovani, Alessandro, additional, Menon, David, additional, Solomon, Tom, additional, and Winkler, Andrea, additional

Published
2021
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26. Clinical Review of Cerebral Venous Thrombosis in the Context of COVID-19 Vaccinations: Evaluation, Management, and Scientific Questions

Author

Thakur, Kiran, primary, Tamborska, Arina, additional, Wood, Greta K., additional, N. McNeill, Emily, additional, Roh, David, additional, Akpan, Imo, additional, C. Miler, Eliza, additional, Bautista, Alyssa, additional, Claassen, Jan, additional, Y. Kim, Carla, additional, Guekht, Alla, additional, A. Pardo-Villamizar, Carlos, additional, Williams, Olajide, additional, García-Azorín, David, additional, Prasad, Kameshwar, additional, Schmutzhard, Erich, additional, Michael, Benedict D., additional, Chou, Sherry Hsiang-Yi, additional, Winkler, Andrea S., additional, Solomon, Tom, additional, and Elkind, Mitchell S.V., additional

Published
2021
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27. Defining Causality in Neurological &amp; Neuropsychiatric COVID-19 Vaccine Complications: What Have We Learnt from Current and Previous Vaccination Campaigns?

Author

Butler, Matthew, primary, Tamborska, Arina, additional, Wood, Greta, additional, Ellul, Mark, additional, Thomas, Rhys H, additional, Galea, Ian, additional, Pett, Sarah, additional, Solomon, Tom, additional, Pollak, Tom, additional, Michael, Benedict, additional, and Nicholson, Timothy, additional

Published
2021
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29. Non-invasive measurement of fasciculation frequency demonstrates diagnostic accuracy in amyotrophic lateral sclerosis

Author

Tamborska, Arina, primary, Bashford, James, additional, Wickham, Aidan, additional, Iniesta, Raquel, additional, Masood, Urooba, additional, Cabassi, Cristina, additional, Planinc, Domen, additional, Hodson-Tole, Emma, additional, Drakakis, Emmanuel, additional, Boutelle, Martyn, additional, Mills, Kerry, additional, and Shaw, Chris, additional

Published
2020
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30. Mitochondrial DNA Is a Pro-Inflammatory Damage-Associated Molecular Pattern Released During Active IBD

Author

Boyapati, Ray K, primary, Dorward, David A, additional, Tamborska, Arina, additional, Kalla, Rahul, additional, Ventham, Nicholas T, additional, Doherty, Mary K, additional, Whitfield, Philip D, additional, Gray, Mohini, additional, Loane, Joseph, additional, Rossi, Adriano G, additional, Satsangi, Jack, additional, and Ho, Gwo-tzer, additional

Published
2018
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35. Timing of headache after COVID-19 vaccines and its association with cerebrovascular events: An analysis of 41,700 VAERS reports.

Author

Garcia-Azorin, David, Baykan, Betül, Beghi, Ettore, Doheim, Mohamed F, Fernandez-de-las-Penas, Cesar, Gezegen, Hasim, Guekht, Alla, Hoo, Fan Kee, Santacatterina, Michele, Sejvar, James, Tamborska, Arina A, Thakur, Kiran T, Westenberg, Erica, Winkler, Andrea S, and Frontera, Jennifer A

Abstract

Background: Delayed-onset of headache seems a specific feature of cerebrovascular events after COVID-19 vaccines. Methods: All consecutive events reported to the United States Vaccine Adverse Reporting System following COVID-19 vaccines (1 January to 24 June 2021), were assessed. The timing of headache onset post-vaccination in subjects with and without concomitant cerebrovascular events, including cerebral venous thrombosis, ischemic stroke, and intracranial haemorrhage was analysed. The diagnostic accuracy in predicting concurrent cerebrovascular events of the guideline- proposed threshold of three-days from vaccination to headache onset was evaluated. Results: There were 314,610 events following 306,907,697 COVID-19 vaccine doses, including 41,700 headaches, and 178/41,700 (0.4%) cerebrovascular events. The median time between the vaccination and the headache onset was shorter in isolated headache (1 day vs. 4 (in cerebral venous thrombosis), 3 (in ischemic stroke), or 10 (in intracranial hemorrhage) days, all P < 0.001). Delayed onset of headache had an area under the curve of 0.83 (95% CI: 0.75–0.97) for cerebral venous thrombosis, 0.70 (95% CI: 0.63–76) for ischemic stroke and 0.76 (95% CI: 0.67–84) for intracranial hemorrhage, and >99% negative predictive value. Conclusion: Headache following COVID-19 vaccination occurs within 1 day and is rarely associated with cerebrovascular events. Delayed onset of headache 3 days post-vaccination was an accurate diagnostic biomarker for the occurrence of a concomitant cerebrovascular events. [ABSTRACT FROM AUTHOR]

Published
2022
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36. Re: Shahim et al., 2024 "Cholinesterase inhibitors are associated with reduced mortality in patients with Alzheimer's disease and previous myocardial infarction".

Author

Tamborska AA, Bray CF, and Kurth T

Subjects
Humans, Treatment Outcome, Risk Assessment, Risk Factors, Alzheimer Disease mortality, Alzheimer Disease drug therapy, Alzheimer Disease diagnosis, Myocardial Infarction mortality, Myocardial Infarction drug therapy, Cholinesterase Inhibitors therapeutic use, Cholinesterase Inhibitors adverse effects
Published
2024
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37. Consensus Clinical Guidance for Diagnosis and Management of Adult COVID-19 Encephalopathy Patients.

Author

Michael BD, Walton D, Westenberg E, García-Azorín D, Singh B, Tamborska AA, Netravathi M, Chomba M, Wood GK, Easton A, Siddiqi OK, Jackson TA, Pollak TA, Nicholson TR, Nair S, Breen G, Prasad K, Thakur KT, Chou SH, Schmutzhard E, Frontera JA, Helbok R, Padovani A, Menon DK, Solomon T, and Winkler AS

Subjects
Humans, Adult, Consensus, Prognosis, COVID-19 Testing, COVID-19 complications, Brain Diseases diagnosis, Brain Diseases etiology, Brain Diseases therapy, Delirium diagnosis, Delirium etiology, Delirium therapy
Abstract

Encephalopathy, a common condition among patients hospitalized with COVID-19, can be a challenge to manage and negatively affect prognosis. While encephalopathy may present clinically as delirium, subsyndromal delirium, or coma and may be a result of systemic causes such as hypoxia, COVID-19 has also been associated with more prolonged encephalopathy due to less common but nevertheless severe complications, such as inflammation of the brain parenchyma (with or without cerebrovascular involvement), demyelination, or seizures, which may be disproportionate to COVID-19 severity and require specific management. Given the large number of patients hospitalized with severe acute respiratory syndrome coronavirus-2 infection, even these relatively unlikely complications are increasingly recognized and are particularly important because they require specific management. Therefore, the aim of this review is to provide pragmatic guidance on the management of COVID-19 encephalopathy through consensus agreement of the Global COVID-19 Neuro Research Coalition. A systematic literature search of MEDLINE, medRxiv, and bioRxiv was conducted between January 1, 2020, and June 21, 2021, with additional review of references cited within the identified bibliographies. A modified Delphi approach was then undertaken to develop recommendations, along with a parallel approach to score the strength of both the recommendations and the supporting evidence. This review presents analysis of contemporaneous evidence for the definition, epidemiology, and pathophysiology of COVID-19 encephalopathy and practical guidance for clinical assessment, investigation, and both acute and long-term management.

Published
2023
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38. Guillain-Barré syndrome following SARS-CoV-2 vaccination in the UK: a prospective surveillance study.

Author

Tamborska AA, Singh B, Leonhard SE, Hodel EM, Stowe J, Watson-Fargie T, Fernandes PM, Themistocleous AC, Roelofs J, Brennan K, Morrice C, Michael BD, Jacobs BC, McDonald H, and Solomon T

Abstract

Objective: To investigate features of Guillain-Barré syndrome (GBS) following SARS-CoV-2 vaccines and evaluate for a causal link between the two., Methods: We captured cases of GBS after SARS-CoV-2 vaccination through a national, open-access, online surveillance system. For each case, the certainty of GBS was graded using the Brighton criteria, and the relationship to the vaccine was examined using modified WHO Causality Assessment criteria. We compared age distribution of cases with that of prepandemic GBS cases and clinical features with the International GBS Outcome Study (IGOS)., Results: Between 1 January and 30 June 2021, we received 67 reports of GBS following the ChAdOx1 vaccine (65 first doses) and three reports following the BNT162b2 vaccine (all first doses). The causal association with the vaccine was classified as probable for 56 (80%, all ChAdOx1), possible for 12 (17%, 10 ChAdOx1) and unlikely for two (3%, 1 ChAdOx1). A greater proportion of cases occurred in the 50-59 age group in comparison with prepandemic GBS. Most common clinical variants were sensorimotor GBS (n=55; 79%) and facial diplegia with paraesthesias (n=10; 14%). 10% (n=7/69) of patients reported an antecedent infection, compared with 77% (n=502/652) of the IGOS cohort (p<0.00001). Facial weakness (63% (n=44/70) vs 36% (n=220/620); p<0.00001) and sensory dysfunction (93% (n=63/68) vs 69% (n=408/588); p=0.00005) were more common but disease severity and outcomes were similar to the IGOS study., Interpretation: Most reports of GBS followed the first dose of ChAdOx1 vaccine. While our study cannot confirm or refute causation, this observation, together with the absence of alternative aetiologies, different than expected age distribution and the presence of unusual clinical features support a causal link. Clinicians and surveillance bodies should remain vigilant to the possibility of this very rare adverse event and its atypical variants., Competing Interests: Competing interests: TS was chair/cochair of the UK Research and Innovation/National Institute for Health Research COVID-19 Rapid Response and Rolling Funding Initiatives, was an Advisor to the UK COVID-19 Therapeutics Advisory Panel and is a member of the UK Medicines and Healthcare Products Regulatory Agency COVID-19 Vaccines Benefit Risk Expert Working Group. BCJ is a chair of Steering Committee of IGOS. HM is an invited expert for the Commission on Human Medicines COVID-19 Vaccines Safety Surveillance Methodologies Expert Working Group. The remaining authors have no relevant conflict of interest to declare., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Published
2022
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