Surveillance on Adverse Events Following COVISHIELD (ChAdOx1 nCoV-19) vaccination in Goa, India: An observational study.

BACKGROUND: COVISHIELD, ChAdOx1 nCoV- 19 Corona Virus Vaccine was granted emergency use authorization (EUA) as the first vaccine in India in January 2021. Knowing what to anticipate after vaccination will reduce vaccine hesitancy in the public. This study aimed to identify and measure the adverse events following COVID-19 vaccination. MATERIALS AND METHODS: A cross-sectional observational study was conducted at Goa Medical College, starting on February 21 till May 23, 2021. A total of 418 people were enrolled. We collected the data using the Microsoft Form and analyzed using Microsoft Excel and R-program. RESULTS: Of the 418 vaccine recipients, the incidence rate of AEFI (Adverse Events Following Immunization) was 54.31%. Fever, fatigue, and headache were the most commonly reported systemic AEFIs. Among these, 54.7% of AEFI were mild, 42.38% were of the moderate category, and only 2.96% were of grade 3 severity. None of the AEFIs were severe enough for hospitalization. Most of them developed symptoms within 24 hours of the first dose. Complete recovery from AEFIs took a median time of 24 hours. CONCLUSION: Most of our study findings were consistent with the phase 1, 2/3 trials findings of Oxford-AstraZeneca's ChAdOx1 vaccine. The AEFI symptoms were considered immune reactions to the vaccine. The AEFIs were more common among younger individuals and females. The chance of missing a serious adverse event like a thromboembolic phenomenon cannot be ruled out. We observed low AEFI rates with COVISHIELD in the Indian population compared to Oxford-AstraZeneca's ChAdOx1 vaccine in the UK-based population, which can be explained by pre-existing immunity against adenovirus in the Indian population. However, based on the study findings, we may interpret that the COVISHIELD, Serum Institute of India, carries a good safety profile overall.

COVID-19 Mimicking Classic Hemolytic Syndrome in a Toddler

Introduction: Coronavirus disease 2019 (COVID-19) is a heterogenous, predominantly pulmonary disease, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Thrombotic microangiopathy (TMA), a triad of hemolytic anemia, thrombocytopenia and end organ damage, is present in severe COVID-19 and Hemolytic uremic syndrome (HUS). Classic HUS is commonly caused by Shiga toxin (ST) producing Escherichia coli 0157:H7 (ST-HUS). We report a toddler with features of classic HUS with positive PCR testing for SARS-CoV-2. Case Description: A 2-year healthy girl presented with diarrhea of 7 days that turned bloody 2 days prior to admission. Previously, several family members with respiratory symptoms tested positive for COVID-19. On admission, she appeared jaundiced with generalized swelling, BP was 137/85 mm Hg (>99%). By day 2, her diarrhea subsided, she was oliguric, fatigued and listless. She was treated symptomatically and BP was controlled with labetalol. Pertinent laboratory data: Hemoglobin 5.1g/dL, reticulocyte 8.4%, platelets 51 K/muL lactate dehydrogenase 833 U/L and haptoglobin < 8 mg/dl. Serum creatinine (SCr) was 0.71 mg/dl with eGFR of 67 ml/min/1.73m2 and Urine showed +3 protein and blood. Random sample (RS) urine protein to Cr ratio was 5.1 (<0.2). Stool culture was negative for E. coli 0157:H7 and other enteropathogens. Shiga toxin 1 and 2 were negative by enzyme immune assay. Nasal swab was positive for SARS-CoV-2 by PCR. Genetic renal panel v8 for aHUS was negative. Complement, Coombs and ANA negative. ADAMSTS13 level >100%. By day 5, symptoms subsided and kidney function improved significantly with SCr at 0.55 mg/dl (eGFR 81ml/min/1.73m2). She was discharged on Lisinopril. Four months later, BP was 107/73 mm Hg and SCr 0.32 mg/dl (eGFR 127ml/min/1.73m2). Urine had trace protein with RS urine protein to Cr ratio of 0.32. Discussion(s): Both COVID-19 and HUS cause severe endothelial dysfunction resulting in release of inflammatory cytokines, complement dysregulation, and development of TMA. COVID-19 has been reported as a potential trigger of aHUS in patients with kidney involvement wherein genetic testing revealed complement defect. Our patient had features of classic HUS, was negative for ST-HUS and ST, but positive for SARS-CoV-2. COVID-19 may be considered in children with bloody diarrhea followed by hemolytic anemia, thrombocytopenia and acute kidney injury.

Transverse myelitis in a pediatric patient with COVID-19

Case Report Transverse myelitis is the segmental inflammation of the spinal cord with motor and sensory abnormalities at and below the level of the lesion. Often, the etiology is unknown but may be attributed to autoimmune conditions or viruses. Here we describe a rare case of transverse myelitis secondary to severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2]/coronavirus disease (COVID-19). Case A 5-year-old male with a history of asthma presented for vomiting and altered mental status. The patient was noted to be altered, lethargic, and in respiratory distress. Intubation was performed. After family collateral was obtained, it was revealed that patient possibly ingested Sertraline and/or Risperidone at an unknown time prior to arrival. History also revealed that he had slurred speech, ataxia, and a fall with trauma to forehead 1 day prior to arrival. He tested positive for COVID-19 via PCR and chest x-ray revealed RLL consolidation. Dexamethasone was started. When sedation was weaned in hopes of extubation, patient was noted to be alert, but not moving extremities and had minimal gag and cough reflex. MRI of Brain and Spine were conducted and revealed findings suggestive of long segment transverse myelitis involving C2 to C3. LP was performed with unremarkable CSF studies and IV Solumedrol was started. In light of active COVID-19 infection, and worsening respiratory status, patient started on 5 days Remdesivir. Further, patient underwent ten sessions of plasmapheresis. Repeat MRI was consistent with previous. Physical and occupational therapy initiated at the onset of illness in hopes of achieving musculoskeletal improvement. Patient had some minimal musculoskeletal improvement, however, given his condition, decision was made for patient to undergo placement of gastrostomy and tracheostomy tubes. Patient was weaned off of sedatives and withdrawal was treated with a clonidine taper. Once stabilized, patient was transferred to neurological inpatient rehabilitation center. Discussion Neurological manifestations in children affected by SARS-CoV-2 are relatively common but are often non-specific. Worldwide data reports only 1% of children with COVID-19 present with severe symptoms of encephalopathy, seizures, and meningeal signs. Pathophysiology is multifactorial, including direct invasion of the CNS, vascular insufficiency, immune dysregulation and autoimmunity. Imaging is paramount in the diagnosis of transverse myelitis. Treatments are emerging and may include steroids, immunoglobulin, plasmapheresis, and monoclonal antibodies. Conclusion Much is unknown about COVID-19. Information is emerging and evolving daily. Cases of transverse myelitis in COVID-19 have been reported in few adult patients and minimal pediatric patients. Practitioners should keep transverse myelitis on their list of differentials for neurological complications of SARS-CoV-2 infections and initiate aggressive treatment with a multidisciplinary approach.