Associations of neuralgic amyotrophy with COVID-19 vaccination: Disproportionality analysis using the World Health Organization pharmacovigilance database.

INTRODUCTION/AIMS: There are limited studies on the association of COVID-19 vaccination with neuralgic amyotrophy (NA). Therefore, we evaluated the association between COVID-19 vaccination and the occurrence of NA. METHODS: We explored unexpected safety signals for NA related to COVID-19 vaccination through disproportionality analysis using VigiBase, the World Health Organization's pharmacovigilance database. RESULTS: On October 15, 2021, 335 cases of NA were identified in the database. The median time to onset of NA after vaccination was around 2 weeks. A significant signal of disproportionality of NA was observed for the ChAdOx1 nCoV-19 vaccine (AstraZeneca) (information component [IC]025  = 0.33, reporting odds ratio [ROR]025  = 1.30) and two mRNA-based COVID-19 vaccines (BNT162b2 [Pfizer and BioNTech] and mRNA-1273 [Moderna]) (IC025  = 1.74, ROR025  = 3.82) compared with the entire database. However, when compared with influenza vaccines, we did not detect any signal of disproportionality of NA for both the ChAdOx1 nCoV-19 vaccine (IC025  = -2.71, ROR025  = 0.05) and mRNA-based COVID-19 vaccines (IC025  = -1.38, ROR025  = 0.13). DISCUSSION: A weak association was observed between NA and COVID-19 vaccines. However, the risk did not surpass that of influenza vaccines.

Associations of Guillain-Barré syndrome with coronavirus disease 2019 vaccination: Disproportionality analysis using the World Health Organization pharmacovigilance database.

Vaccinations against the severe acute respiratory syndrome coronavirus 2 which causes COVID-19 have been administered worldwide. We aimed to investigate associations of COVID-19 vaccination with the occurrence of Guillain-Barré syndrome (GBS). We explored potential safety signals regarding the development of GBS using disproportionality analyses to compare COVID-19 vaccination with all adverse drug reaction (ADR) reports and influenza vaccines reported to VigiBase. As of October 15, 2021, a total of 2163 cases (0.13%) of GBS and its variants (including 46 cases of Miller-Fisher syndrome and 13 cases of Bickerstaff's encephalitis) were identified in entire ADR database after vaccination with the ChAdOx1 nCoV-19 (AstraZeneca, Cambridge, UK) or the two messenger RNA-based COVID-19 (BNT162b2; Pfizer and BioNTech) or mRNA-1273; Moderna) vaccines. The median time to onset of GBS after vaccination was around 2 weeks. The ChAdOx1 nCoV-19 and two messenger RNA-based COVID-19 vaccines demonstrated a higher risk for GBS against entire database (information component [IC]025  = 1.73 reporting odds ratio [ROR]025  = 3.51; IC025  = 1.07, ROR025  = 2.22, respectively). When compared with influenza vaccines, neither the ChAdOx1 nCoV-19 nor mRNA-based vaccines were found to be associated with greater risks of GBS (IC025  = -1.84, ROR025  = 0.11; IC025  = -1.86, ROR025  = 0.06, respectively). Although potential safety signals associated with GBS COVID-19 vaccines have been identified, the risk of GBS from COVID-19 vaccines were low and did not surpass those of influenza vaccines; however, because of the heterogeneity of the sources of information in the WHO pharmacovigilance database, further epidemiological studies are warranted to confirm these observations.

Guillain-Barré Syndrome and Variants Following COVID-19 Vaccination: Report of 13 Cases.

BACKGROUND: Amidst growing concern about an increased risk of Guillain-Barré syndrome (GBS) following COVID-19 vaccination, clinical and electrodiagnostic features have not been fully characterized. METHODS: We retrospectively reviewed medical records of the patients diagnosed with GBS and its variants following COVID-19 vaccination at four referral hospitals during the period of the mass vaccination program in South Korea (February to October 2021). RESULTS: We identified 13 patients with GBS and variants post COVID-19 vaccination: AstraZeneca vaccine (Vaxzevria) in 8, and Pfizer-BioNTech vaccine (Comirnaty) in 5. The mean time interval from vaccination to symptom onset was 15.6 days (range 4-30 days). Electrodiagnostic classification was demyelinating in 7, axonal in 4 and normal in 2 cases. Clinical manifestations were diverse with varying severity: classical GBS in 8 cases, paraparetic variant in 3, Miller-Fisher syndrome in 1 and acute cervicobrachial weakness in 1. Four patients developed respiratory failure, and 2 of them showed treatment-related fluctuations. CONCLUSION: Our observations suggest that COVID-19 vaccines may be associated with GBS of distinctive clinical features characterized by severe quadriplegia, disproportionately frequent bilateral facial palsy or atypical incomplete variants. Continuous surveillance and further studies using robust study designs are warranted to fully assess the significance of the association.

Sensory Guillain-Barre syndrome following the ChAdOx1 nCov-19 vaccine: Report of two cases and review of literature.

Massive vaccination against COVID-19 has become a global priority. Simultaneously, concerns regarding the safety of vaccines are growing. We describe two patients who developed sensory Guillain-Barre syndrome (GBS) shortly after the first dose of the ChAdOx1 vaccine. We also summarize 12 published cases of GBS after ChAdOx1 vaccination, highlighting their unique clinical and paraclinical features. We propose a possible association between the risk of GBS and the ChAdOx1 vaccine and recommend surveillance for GBS following vaccination. Population-based studies are needed to determine causality and whether specific subpopulations are susceptible.