Disproportionality analysis of adverse neurological and psychiatric reactions with the ChAdOx1 (Oxford-AstraZeneca) and BNT162b2 (Pfizer-BioNTech) COVID-19 vaccines in the United Kingdom

References

• Baden LR, Sahly HM, Essink B, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. The New England Journal of Medicine. 2020;384:403–416.
   PubMed Web of Science ®Google Scholar
• Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. The New England Journal of Medicine. 2020;383:2603–2615.
   PubMed Web of Science ®Google Scholar
• al KN, Zhang Y, Xia S, et al. Effect of 2 inactivated SARS-CoV-2 vaccines on symptomatic COVID-19 infection in adults: a randomized clinical trial. JAMA. 2021;326:35–45.
   PubMed Web of Science ®Google Scholar
• Voysey M, Costa Clemens SA, Madhi SA, et al. Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: a pooled analysis of four randomised trials. Lancet. 2021;397:881–891.
   PubMed Web of Science ®Google Scholar
• Ling Y, Zhong J, Luo J. Safety and effectiveness of SARS‐CoV‐2 vaccines: a systematic review and meta‐analysis. J Med Virol. 2021;93(12):6486–6495.
   PubMed Web of Science ®Google Scholar
• Motamedi H, Ari MM, Dashtbin S, et al. An update review of globally reported SARS-CoV-2 vaccines in preclinical and clinical stages. Int Immunopharmacol. 2021;96:107763.
   PubMed Web of Science ®Google Scholar
• Montastruc JL, Sommet A, Lacroix I, et al. Pharmacovigilance for evaluating adverse drug reactions: value, organization, and methods. Joint Bone Spine. 2006;73:629–632.
   PubMed Web of Science ®Google Scholar
• Härmark L, van Grootheest AC. Pharmacovigilance: methods, recent developments and future perspectives. Eur J Clin Pharmacol. 2008;64:743–752.
   PubMed Web of Science ®Google Scholar
• Stratton K, Alamario DA, Wizemann T, et al. Committee I of M (US) ISR. Immunization safety review: influenza vaccines and neurological complications. 2004. DOI: 10.17226/10822.
   Google Scholar
• Fenichel GM. Assessment: neurologic risk of immunization: report of the therapeutics and technology assessment subcommittee of the American academy of neurology. Neurology. 1999;52:1546–1552.
   PubMed Web of Science ®Google Scholar
• Dodd CN, Romio SA, Black S, et al. International collaboration to assess the risk of Guillain Barré syndrome following influenza A (H1N1) 2009 monovalent vaccines. Vaccine. 2013;31:4448–4458.
   PubMed Web of Science ®Google Scholar
• Schonberger LB, Bregman DJ, Sullivan-bolyai JZ, et al. Guillain-Barre syndrome following vaccination in the national influenza immunization program, United States, 1976–1977. Am J Epidemiol. 1979;110:105–123.
   PubMed Web of Science ®Google Scholar
• Moro E, Priori A, Beghi E, et al., The international European academy of neurology survey on neurological symptoms in patients with COVID‐19 infection. Eur J Neurol. 2020;27(9): 1727–1737.
   PubMed Web of Science ®Google Scholar
• Safety platform for emergency vACcines. D2.3 priority list of adverse events of special interest: COVID-19. https://brightoncollaboration.us/wp-content/uploads/2020/06/SPEAC_D2.3_V2.0_COVID-19_20200525_public.pdf. cited 2022 June 11.
   Google Scholar
• Li X, Ostropolets A, Makadia R, et al. Characterising the background incidence rates of adverse events of special interest for covid-19 vaccines in eight countries: multinational network cohort study. BMJ. 2021;373(1435)
   Google Scholar
• Montastruc JL, Sommet A, Bagheri H, et al. Benefits and strengths of the disproportionality analysis for identification of adverse drug reactions in a pharmacovigilance database. Br J Clin Pharmacol. 2011;72:905–908.
   PubMed Web of Science ®Google Scholar
• Gordon SF, Clothier HJ, Morgan H, et al. Immune thrombocytopenia following immunisation with vaxzevria ChadOx1-S (AstraZeneca) vaccine, Victoria, Australia. Vaccine. 2021;39:7052–7057.
   PubMed Web of Science ®Google Scholar
• Medicines & Healthcare products Regulatory Agency. Coronavirus vaccine - weekly summary of yellow card reporting - GOV.UK. 2021. https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting. cited 2021 July 11.
   Google Scholar
• Brown E. Medical dictionary for regulatory activities (MedDRA®), Pharmacovigilance, 2007; Second Edition
   Google Scholar
• Wilson AM, Thabane L, Holbrook A. Application of data mining techniques in pharmacovigilance. Br J Clin Pharmacol. 2004;57(2):127–134
   PubMed Web of Science ®Google Scholar
• Menni C, Klaser K, May A, et al. Vaccine side-effects and SARS-CoV-2 infection after vaccination in users of the COVID symptom study app in the UK: a prospective observational study. Lancet Infect Dis. 2021;21:939–949.
   PubMed Web of Science ®Google Scholar
• Alami A, Krewski D, Mattison D, et al. Risk of myocarditis and pericarditis among young adults following mRNA COVID-19 vaccinations. Vaccines (Basel). 2022;10(5):722.
   PubMed Web of Science ®Google Scholar
• Varricchio F, Iskander J, Destefano F, et al. Understanding vaccine safety information from the vaccine adverse event reporting system. Pediatr Infect Dis J. 2004;23:287–294.
   PubMed Web of Science ®Google Scholar
• Pariente A, Gregoire F, Fourrier-Reglat A, et al. Impact of safety alerts on measures of disproportionality in spontaneous reporting databases: the notoriety bias. Drug Saf. 2007;30:891–898.
   PubMed Web of Science ®Google Scholar
• Ozonoff A, Nanishi E, Levy O. Bell’s palsy and SARS-CoV-2 vaccines. Lancet Infect Dis. 2021;21:450–452.
   PubMed Web of Science ®Google Scholar
• Tamaki A, Cabrera CI, Li S, et al. Incidence of bell palsy in patients with COVID-19. JAMA Otolaryngol Head Neck Surg. 2021;147(8):767–768.
   PubMed Web of Science ®Google Scholar
• Meidaninikjeh S, Sabouni N, Taheri M, et al. SARS-CoV-2 and Guillain-Barré Syndrome: lessons from Viral Infections. Viral Immunol. 2022;35(6):404–417.
   PubMedGoogle Scholar
• Trimboli M, Zoleo P, Arabia G, et al. Guillain-Barré syndrome following BNT162b2 COVID-19 vaccine. Neurol Sci. 2021;42(11):4401–4402.
   PubMed Web of Science ®Google Scholar
• Scendoni R, Petrelli C, Scaloni G, et al. Electromyoneurography and laboratory findings in a case of Guillain-Barré syndrome after second dose of Pfizer COVID-19 vaccine. Hum Vaccin Immunother. 2021;17(11):4093–4096.
   PubMed Web of Science ®Google Scholar
• Bonifacio GB, Patel D, Cook S, et al. Bilateral facial weakness with paraesthesia variant of Guillain-Barré syndrome following Vaxzevria COVID-19 vaccine. J Neurol Neurosurg Psychiatry. 2022;93(3):341–342.
   PubMed Web of Science ®Google Scholar
• Nasuelli NA, de Marchi F, Cecchin M, et al. A case of acute demyelinating polyradiculoneuropathy with bilateral facial palsy after ChAdOx1 nCoV-19 vaccine. Neurol Sci. 2021;42(11):4747–4749.
   PubMed Web of Science ®Google Scholar
• Rosenblum HG, Hadler SC, Moulia D, et al. Use of COVID-19 vaccines after reports of adverse events among adult recipients of Janssen (johnson & johnson) and mRNA covid-19 vaccines (pfizer-biontech and moderna): update from the advisory committee on immunization practices - United States, July 202. MMWR Morb Mortal Wkly Rep. 2021;70:1094–1099.
   PubMed Web of Science ®Google Scholar
• Osowicki J, Morgan H, Harris A, et al. Guillain-Barré syndrome in an Australian State using both mRNA and adenovirus-vector SARS-CoV-2 vaccines. Ann Neurol. 2021;90:856–858.
   PubMed Web of Science ®Google Scholar
• Patone M, Handunnetthi L, Saatci D, et al. Neurological complications after first dose of COVID-19 vaccines and SARS-CoV-2 infection. Nat Med. 2021;27:2144–2153.
   PubMed Web of Science ®Google Scholar
• Haber P, Sejvar J, Mikaeloff Y, et al. Vaccines and Guillain-Barré syndrome. Drug Saf. 2009;32:309–323.
   PubMed Web of Science ®Google Scholar
• Burrows A, Bartholomew T, Rudd J, et al. Sequential contralateral facial nerve palsies following COVID-19 vaccination first and second doses. BMJ Case Rep. 2021;14(7):e243829.
   PubMedGoogle Scholar
• Iftikhar H, Noor SMU, Masood M, et al. Bell’s palsy after 24 hours of mRNA-1273 SARS-CoV-2 vaccine. Cureus. 2021;13(6):e15935.
   PubMed Web of Science ®Google Scholar
• Fuller G, Morgan C. Bell’s palsy syndrome: mimics and chameleons. Pract Neurol. 2016;16:439–444.
   PubMedGoogle Scholar
• Shemer A, Pras E, Einan-Lifshitz A, et al. Association of COVID-19 vaccination and facial nerve Palsy: a case-control study. JAMA Otolaryngol Head Neck Surg. 2021;147(8):739–743.
   PubMed Web of Science ®Google Scholar
• Wan EYF, Chui CSL, Lai FTT, et al. Bell’s palsy following vaccination with mRNA (BNT162b2) and inactivated (CoronaVac) SARS-CoV-2 vaccines: a case series and nested case-control study. Lancet Infect Dis. 2021;3099:1–9.
   Google Scholar
• Salinas MR, Dieppa M. Transient akathisia after the SARS-Cov-2 vaccine. Clin Park Relat Disord. 2021;4:100098.
   PubMedGoogle Scholar
• Alves RSC, Barbosa ER, Scaff M. Postvaccinal parkinsonism. Mov Dis. 1992;7:178–180.
   PubMed Web of Science ®Google Scholar
• Reijneveld JC, Taphoorn MJB, Hoogenraad TU, et al. Severe but transient parkinsonism after tetanus vaccination. J Neurol Neurosurg Psychiatry. 1997;63(2):258.
   PubMed Web of Science ®Google Scholar
• Kim DD, Kung CS, Perez DL. Helping the public understand adverse events associated with COVID-19 vaccinations: lessons learned from functional neurological disorder. JAMA Neurol. 2021;78:789–790.
   PubMed Web of Science ®Google Scholar
• Brandão PRP, Grippe TC, Pereira DA, et al. New-onset movement disorders associated with covid-19. Tremor Other Hyperkinet Mov (N Y). 2021;11:26.
   PubMed Web of Science ®Google Scholar
• Bohmwald K, Gálvez NMS, Ríos M, et al. Neurologic alterations due to respiratory virus infections. Front Cell Neurosci. 2018;12:386.
   PubMed Web of Science ®Google Scholar
• Otero-Losada M, Kobiec T, Udovin L, et al. Parkinson’s disease in the era of a novel respiratory virus pandemic. Front Neurol. 2020;11:18–21.
   PubMed Web of Science ®Google Scholar
• Espay AJ, Aybek S, Carson A, et al. Current concepts in diagnosis and treatment of functional neurological disorders. JAMA Neurol. 2018;75:1132–1141.
   PubMed Web of Science ®Google Scholar
• Fasano A, Daniele A. Functional disorders after COVID-19 vaccine fuel vaccination hesitancy. J Neurol Neurosurg Psychiatry. 2022;93:339–340.
   PubMed Web of Science ®Google Scholar
• Hatmal MM, Al-Hatamleh MAI, Olaimat AN, et al. Side effects and perceptions following covid-19 vaccination in Jordan: a randomized, cross-sectional study implementing machine learning for predicting severity of side effects. Vaccines (Basel). 2021;9(6):556.
   PubMed Web of Science ®Google Scholar
• Cari L, Fiore P, Naghavi Alhosseini M, et al. Blood clots and bleeding events following BNT162b2 and ChAdOx1 nCoV-19 vaccine: an analysis of European data. J Autoimmun. 2021;122:102685.
   PubMed Web of Science ®Google Scholar
• Sessa M, Kragholm K, Hviid A, et al. Thromboembolic events in younger women exposed to Pfizer-BioNTech or moderna COVID-19 vaccines. Expert Opin Drug Saf. 2021;20:1451–1453.
   PubMed Web of Science ®Google Scholar
• Krzywicka K, Heldner MR, Sánchez van Kammen M, et al. Post‐SARS‐CoV‐2‐vaccination cerebral venous sinus thrombosis: an analysis of cases notified to the European medicines agency. Eur J Neurol. 2021;28(11):3656–3662.
   PubMed Web of Science ®Google Scholar