Background incidence rates of adverse events of special interest related to COVID-19 vaccines in Ontario, Canada, 2015 to 2020, to inform COVID-19 vaccine safety surveillance

Background: Background incidence rates are critical in pharmacovigilance to facilitate identification of vaccine safety signals. We estimated background incidence rates of nine adverse events of special interest related to COVID-19 vaccines in Ontario, Canada. Methods: We conducted a population-based retrospective observational study using linked health administrative databases for hospitalizations and emergency department visits among Ontario residents. We estimated incidence rates of Bells palsy, idiopathic thrombocytopenia, febrile convulsions, acute disseminated encephalomyelitis, myocarditis, pericarditis, Kawasaki disease, Guillain-Barre syndrome, and transverse myelitis during five pre-pandemic years (2015-2019) and 2020. Results: The average annual population was 14 million across all age groups with 51% female. The pre-pandemic mean annual rates per 100,000 population during 2015-2019 were 43.9 for idiopathic thrombocytopenia, 27.8 for Bells palsy, 25.0 for febrile convulsions, 22.8 for acute disseminated encephalomyelitis, 11.3 for myocarditis/pericarditis, 8.6 for pericarditis, 2.9 for myocarditis, 1.9 for Guillain-Barre syndrome, 1.7 for transverse myelitis, and 1.6 for Kawasaki disease. Females had higher rates of acute disseminated encephalomyelitis and transverse myelitis while males had higher rates of myocarditis, pericarditis, and Guillain-Barre syndrome. Bells palsy, acute disseminated encephalomyelitis, and Guillain-Barre syndrome increased with age. The mean rates of myocarditis and/or pericarditis increased with age up to 79 years; males had higher rates than females: from 12-59 years for myocarditis and 12 years and older for pericarditis. Febrile convulsions and Kawasaki disease were predominantly childhood diseases and generally decreased with age. Conclusions: Our estimated background rates will permit estimating numbers of expected events for these conditions and facilitate detection of potential safety signals following COVID-19 vaccination.

Guillain barre syndrome and its association with covid-19 infection – A clinical case series

A novel coronavirus (COVID-19) pandemic is caused by severe acute respiratory syndrome coronavirus 2 (SARs-CoV-2). This pandemic has been globally alarming in the current period. Several neurological manifestations are reported occurring with the infection. Guillain barre syndrome (GBS) or acute onset inflammatory polyradiculoneuropathy has been among the frequent manifestations observed among them. To know the pattern and outcome of GBS in COVID-19 affected individuals. We have taken six individuals admitted with flaccid quadriparesis in the last two months. All were affected recently by COVID 19 infection, which RT PCR of the nasopharyngeal swab confirmed. The study participants have undergone nerve conduction studies and have been diagnosed with Guillain Barre syndrome using Brighton criteria. We did cerebrospinal fluid (CSF) analysis after admission. We initiated all patients on Intravenous immunoglobulin according to body weight (2g/kg divided over five days). We used the Barthel index score to assess the outcome of the individuals. We observed a mean duration of 18.25 days between the COVID-19 infection and the onset of symptoms. Apart from motor quadriparesis and sensory symptoms being in common, we also noticed cranial nerves and autonomic involvement. We made the diagnosis using the nerve conduction studies and Brighton criteria. After initiating intravenous immunoglobulin, all patients had a good outcome, and quality of life was better after two months of follow up. Guillain Barre syndrome is one of the neurological manifestations of COVID-19 and has a dramatic response with intravenous immunoglobulin and better outcome with treatment.

Guillain-Barré Syndrome with Rapid Onset and Autonomic Dysfunction Following First Dose of Pfizer-BioNTech COVID-19 Vaccine: A Case Report

Guillain-Barre syndrome (GBS) is an immune-mediated, often post-infectious illness manifesting as an acute, characteristically monophasic, polyradiculoneuropathy. We present a case of GBS with autonomic involvement following an mRNA-based vaccine against SARS-COV2 (Pfizer/BioNTech mRNA-BNT162b2). A 58-year-old woman presented with fatigue, distal extremity paresthesias, and severe back pain within 3 days after receiving her first vaccine dose. She developed worsening back pain and paresthesias in distal extremities which prompted her initial presentation to the hospital. By the third week post-vaccine, she developed increasing gait unsteadiness, progression of paresthesias, and new autonomic symptoms including presyncopal episodes and constipation. Neurological exam showed bilateral distal predominant lower extremity weakness, decreased sensation in a length-dependent pattern, and areflexia. EMG/NCS showed a diffuse sensorimotor polyneuropathy with mixed demyelinating and axonal features consistent with GBS. She was treated with 2 g/kg of IVIG over 3 days and also received prednisone 60 mg daily for 3 days for severe back pain, with improvement of symptoms. This possible association with mRNA-based vaccination expands the potential triggers for an autoimmune-based attack on the peripheral nervous system.

Treatment of Severe Japanese Encephalitis Complicated With Hashimoto’s Thyroiditis and Guillain-Barré Syndrome With Protein A Immunoadsorption: A Case Report

A severely comatose female patient was diagnosed with Japanese encephalitis (JE). Her condition was complicated by Hashimoto’s thyroiditis (HT) and Guillain-Barré syndrome (GBS). After antiviral, glucocorticoid, and immunoglobulin treatment, the patient’s consciousness was restored, and she could breathe spontaneously. Following this, new-onset, primarily demyelinating GBS developed, which progressed to demyelination combined with axonal injury. The patient was switched to protein A immunoadsorption (PAIA) therapy, and her Hughes score decreased rapidly, from 4 to 1 after 6 months. This patient is the first to receive PAIA combined with an antiviral-glucocorticoid-immunoglobulin regimen to treat encephalitis, meningitis, HT, and GBS caused by JE infection, thereby reflecting the importance of clinical application of PAIA in the treatment of immunological complications of JE.

Аcute transverse myelitis and Guillain – Barre overlap syndrome in a patient with СOVID-19

We report a case of transverse myelitis and Guillain–Barre syndrome (GBS) overlap in the 42-year-old patient with moderate course of Coronavirus disease 2019 (СOVID-19). Nasopharyngeal SARS-CoV 2 RT-PCR was positive. Severe neck pain developed in this patient on the 5-th day of СOVID-19. A few hours later weakness in the feet arised and then spread to the thighs and arms. Quadriparesis, arefl exia in all limbs, sensory loss below the level of T4 and bladder/bowel dysfunction were present. Pyramidal signs were negative. There was no increase of COVID-19 severity at the time of neurological signs development. Magnetic resonance imaging of the spinal cord showed the focal lesion in the C2-T1 segments, which was consistent with the features of longitudinally extensive transverse myelitis. Along with the myelitis, acute motor axonal polyneuropathy was diagnosed. This diagnosis of GBS was supported by ascending weakness with arefl exia, albumin-cytological dissociation in cerebrospinal fl uid and the data of neuroelectrophysiological examination. We proposed that both myelitis and GBS had disimmune nature associated with COVID-19. The other possible causes of damage to the spinal cord and peripheral nervous system were excluded.Immunotherapy with high dose of intravenous immunoglobulins was administered. Steroids also were used taking into account the myelitis. At the follow up in 4 months the motor functions were found to be improved nonsignifi cantly, the patient was still severe disabled.