Analysis of Neurological Adverse Events Reported in VigiBase From COVID-19 Vaccines.

BACKGROUND: Fifteen COVID-19 vaccines have been granted emergency approval before the completion of conventional phases of clinical trials. The present study aimed to analyze the neurological adverse events (AEs) post-COVID-19 vaccination and focuses on determining the association of AEs with the vaccine. METHODOLOGY: The neurological AEs reported for COVID-19 vaccines in the WHO pharmacovigilance database (VigiBase) were extracted from the System Organ Classes - neurological disorders and investigations. Descriptive statistics are reported as percentage and frequency and the disproportionality analysis was also conducted. RESULTS:  For the neurological system, 19,529 AEs were reported. Of these, 15,638 events were reported from BNT162b2 vaccine, 2,751 from AZD1222 vaccine, 1,075 from mRNA-1273 vaccine, eight from Vero vaccine, two from Covaxin, and for 55 AEs, vaccine name was not mentioned. The reason for more AEs reported with BNT162b2 can be maximum vaccination with BNT162b2 vaccine in the study period. According to the disproportionality analysis based on IC025 value, ageusia, anosmia, burning sensation, dizziness, facial paralysis, headache, hypoaesthesia, lethargy, migraine, neuralgia, paresis, parosmia, poor sleep quality, seizure, transient ischemic attack, and tremor are some of the AEs that can be associated with the administration of the vaccine. CONCLUSION: The vaccines should be monitored for these AEs till the causality of these AEs with COVID-19 vaccines is established through further long-term follow-up studies. These neurological AEs reported in VigiBase should not be taken as conclusive and mass vaccination should be carried out to control the pandemic until a definite link of these adverse effects is established.

Hindi Translation and Validation of Childhood Asthma Control Test (C-ACT).

OBJECTIVE: Hindi translation and validation of the Childhood Asthma Control Test (C-ACT). METHODS: Children aged 5-11 years with newly diagnosed asthma were enrolled and followed every 4-weeks for 12 weeks. Asthma control was assessed with C-ACT and Global Initiative for Asthma (GINA) criteria. RESULTS: 60 children (34 boys, 56%) were enrolled. C-ACT showed a statistically significant correlation with GINA criteria at all visits. Cronbach's alpha to assess the internal consistency was 0.74, and the intraclass correlation coefficient to measure test-retest reliability was 0.83. The maximum area under the curve (AUC) for C-ACT was 0.95 (95% CI: 0.89-1.0; P<0.001). At a cutoff score of ≥20, the sensitivity, specificity, positive predictive value, and negative predictive value of C-ACT were 97.9%, 25%, 88.7%, and 87.5%, respectively. CONCLUSIONS: Hindi version of the C-ACT score is valid, reliable, and correlates well with the GINA criteria for asthma control in children. It has a high sensitivity at a cutoff score of ≥20, but the specificity was poor in differentiating asthma control.

Hyaline Vascular Type of Castleman Disease: Diagnostic Pitfalls on Cytology and Its Clinical Relevance.

Castleman disease (CD) is an uncommon cause of lymphadenopathy. The role of fine-needle aspiration cytology (FNAC) as a diagnostic modality in this disease is not well established. Cytological features of CD have a considerable overlap with many reactive conditions. It has subtle morphological features; which if overlooked, may miss the diagnosis. A two-year-old girl presented with cervical lymphadenopathy. FNAC of the cervical lymph node showed features of granulomatous lymphadenitis. Excision biopsy revealed the hyaline vascular type of CD. Cytological smears were reviewed carefully and revealed indicators of CD. These included capillary fragments with adherent reactive lymphoid cells, plump endothelial cells and pale pink material admixed with germinal center cells. The collections of plump endothelial cells had been misinterpreted as granulomas previously. This report highlights the subtle cytomorphological pointers of CD. Careful scrutiny for these features could aid the cytologist in differentiating CD from other reactive and neoplastic disorders, thus avoiding cytodiagnostic pitfalls. This case study reiterates an important fact that for a lymph node lesion, histopathology plays a crucial role in differentiating mimickers and renders an accurate diagnosis.

Clinical Profile and Risk Factors for Severe Disease in 402 Children Hospitalized with SARS-CoV-2 from India: Collaborative Indian Pediatric COVID Study Group.

INTRODUCTION: There is a lack of large multicentric studies in children with COVID-19 from developing countries. We aimed to describe the clinical profile and risk factors for severe disease in children hospitalized with COVID-19 from India. METHODS: In this multicentric retrospective study, we retrieved data related to demographic details, clinical features, including the severity of disease, laboratory investigations and outcome. RESULTS: We included 402 children with a median (IQR) age of 7 (2-11) years. Fever was the most common symptom, present in 38.2% of children. About 44% had underlying comorbidity. The majority were asymptomatic (144, 35.8%) or mildly symptomatic (219, 54.5%). There were 39 (9.7%) moderate-severe cases and 13 (3.2%) deaths. The laboratory abnormalities included lymphopenia 25.4%, thrombocytopenia 22.1%, transaminitis 26.4%, low total serum protein 34.7%, low serum albumin 37.9% and low alkaline phosphatase 40%. Out of those who were tested, raised inflammatory markers were ferritin 58.9% (56/95), c-reactive protein 33.3% (41/123), procalcitonin 53.5% (46/86) and interleukin-6 (IL-6) 76%. The presence of fever, rash, vomiting, underlying comorbidity, increased total leucocyte count, thrombocytopenia, high urea, low total serum protein and raised c-reactive protein was factors associated with moderate to severe disease. CONCLUSION: Fever was the commonest symptom. We identified additional laboratory abnormalities, namely lymphopenia, low total serum protein and albumin and low alkaline phosphatase. The majority of the children were asymptomatic or mildly symptomatic. We found high urea and low total serum protein as risk factors for moderate to severe disease for the first time.

Prevalence of Vitamin D Deficiency Among Infants in Northern India: A Hospital Based Prospective Study.

BACKGROUND: Vitamin D deficiency is one of the major nutritional deficiencies and an important contributor to nutritional and growth failure in infants, especially in those with low socioeconomic status. AIM: The primary objective of this study was to determine the proportion of vitamin D deficiency in infants, and the secondary objective was to assess the correlation between infant and maternal vitamin D levels. METHODS: This prospective, observational study was carried out at a tertiary care center, All India Institute of Medical Sciences in Rishikesh, Uttarakhand, India, in the Department of Pediatrics from January 2017 to December 2018. Children aged less than one year and their mothers were enrolled in the study. All the infants attending the Department of Pediatrics for well-child visits and sick-child visits were enrolled after obtaining written, informed consent. Infants with major congenital malformations and liver and kidney dysfunction were excluded. Serum vitamin D level of <20 ng/mL was defined as vitamin D deficiency. RESULTS: A total of 200 infants and 200 mothers were enrolled in the study. Among the study infants, 80% were neonates, and 20% were infants beyond the neonatal period. The prevalence of vitamin D deficiency was 74% in infants and 85.5% in mothers. Nearly half of the infants and mothers had severe vitamin D deficiency. Logistic regression analysis showed a positive correlation between maternal and infant vitamin D levels (r=0.074, p<0.001) and also with neonatal age group and low socioeconomic status. Hyperphosphatemia and hypocalcemia were predominant biochemical manifestations. CONCLUSION: The prevalence of vitamin D deficiency among the study infants was 74%. Neonatal age group, lower socioeconomic status, and maternal vitamin D deficiency were major determinants of vitamin D deficiency in infants.

Wilson's Disease Masquerading as Juvenile Idiopathic Arthritis in an Adolescent.

Wilson's disease (WD) is a rare autosomal-recessive inborn error of copper metabolism characterized by the toxic accumulation of copper in liver, brain, cornea, and other tissues. It has a variable clinical presentation. Musculoskeletal presentations are very unusual. We report a 17-year-old male who presented to us with juvenile idiopathic arthritis (JIA), which later proved to be a case of WD.

Pulmonary Hemosiderosis in a Child With Systemic Lupus Erythematosus: A Rare Presentation.

Pulmonary hemorrhage is an uncommon manifestation in children and is often associated with systemic lupus erythematosus. We report a case of an adolescent girl who presented to our hospital with recurrent episodes of fever, cough, and breathlessness. Later on, she was diagnosed with pulmonary hemosiderosis as a manifestation of systemic lupus erythematosus. She was started on immunosuppressive therapy initially with prednisolone and subsequently with azathioprine and hydroxychloroquine, which improved the clinical status of the child.

Prevalence of multidrug resistance tuberculosis in adult patients in India: A systematic review and meta-analysis.

BACKGROUND: Multidrug resistance tuberculosis (MDR-TB) is an important public health problem for India but there is a paucity of data related to the prevalence of MDR-TB in India. This systematic review and meta-analysis was designed to synthesize evidence regarding the prevalence of MDR-TB in adult patients in India. METHODS: PubMed and Google Scholar were searched to find different observational studies reporting MDR-TB prevalence in India. Data related to MDR-TB prevalence were pooled for the analysis. PubMed was searched by using different MeSH words. Prevalence was reported with 95% confidence interval (CI). A separate analysis was done for new cases and previously treated cases. Random effect model was used and heterogeneity was assessed by I2 and Cochran Q test. RESULTS: MDR-TB prevalence in new cases were 3% (95% CI 2%-5%, I2 = 95.3%). There was difference in prevalence between different methods of measurement of MDR-TB and study designs. MDR-TB prevalence in previously treated cases was found to be 35% (95% CI 29%-41%, I2 = 98.7%). Results vary with the method of measurement as well as the study design. CONCLUSION: MDR-TB prevalence in previously treated patients was found higher compared to the reported values in national surveys. There is a need for large scale cross-sectional study to verify the findings observed in this review.

Pulmonary Function Tests in Sickle Cell Disease.

OBJECTIVE: To determine pulmonary function abnormalities in children with Sickle Cell Disease (SCD) from Western India. METHODS: In this cross sectional study conducted at Surat, Gujarat, India; equal number of age and gender matched children i.e., 99 in the age group of 6-18 y was recruited in case (children with SCD) and control (non-SCD healthy children) groups respectively. Weight, height, body mass index (BMI) and hemoglobin (Hb) were assessed as baseline characteristics and spirometry was performed to assess the pulmonary function. RESULTS: The two groups of children were comparable in the baseline characteristics such as weight, height and BMI, however mean hemoglobin was significantly low in SCD as compared to healthy controls [9.1 ± 1.52 vs. 11.4 ± 1.04 (p=0.001)]. Mean (% predicted) Forced expiratory volume in 1 s (FEV1) (86.79 ± 11.6 vs. 94.3 ± 16.1) and FVC (84.4 ± 11.5 vs. 91.75 ± 15.2) values were significantly low (p < 0.001) in cases. CONCLUSIONS: The present study revealed that the difference of pulmonary function tests between sickle cell patients and normal age matched controls were statistically significant but this difference was not clinically significant.