Background and Objective Several cases of facial paralysis have been reported following influenza vaccination; however, recent surveillance studies have not shown an increased risk. In this study, we analyzed the vaccine adverse event reporting system (VAERS) data to determine whether the facial paralysis reporting rate is higher in those who received influenza vaccination compared with those who received other vaccines. Methods We evaluated reports of facial paralysis in people who received influenza vaccination during January 2015 to October 2019 using Medical Dictionary for Regulatory Activities Preferred Terms. A disproportionality analysis was performed to determine the proportional reporting ratio (PRR), Chi-square statistic, and reporting odds ratio (ROR) with 95% confidence interval (CI). The demographic and clinical characteristics of the cases were also analyzed. Results Two hundred fifty cases of facial paralysis following influenza vaccination were reported during the study period. The median age of the patients was 45 (interquartile range, 30-57) years; 132 (52.8%) patients were females. The majority of the patients received the injected trivalent or quadrivalent seasonal influenza vaccine by intramuscular route. The PRR, Chi-square statistic, and ROR (95% CI) was 2.44, 122.32, and 2.44 (2.08-2.88), respectively; on excluding cases involving concomitant paresis/paralysis of limbs or Guillain-Barre syndrome, the disproportionality statistics were 2.30, 89.37, and 2.30 (1.93-2.75), respectively. Conclusions Our study shows increased reporting of facial paralysis following influenza vaccination as compared with other vaccines. Considering the inherent limitations of the VAERS database analysis, and the fact that disproportionality measures only indicate the presence of a signal, our study findings need to be explored in well-designed prospective pharmacoepidemiologic studies.
Background:
Drug-resistant tuberculosis (DR-TB) is a significant public health problem, especially in the developing and
underdeveloped countries; its treatment is relatively expensive, of longer duration, and associated with more
adverse effects.
Objective:
The objective of this study was to report the treatment outcomes in patients with DR-TB and determine if a few
selected clinico-demographic parameters and baseline laboratory values, done as part of the pre-treatment
evaluation, have any impact on sputum culture conversion and outcomes. The aim was to identify the potential
factors associated with unfavourable outcomes prior to starting treatment.
Methods:
A retrospective analysis of data of patients diagnosed with DR-TB admitted at our centre from January 2015 to
May 2016 was done. Of the 114 patients included, culture reports were available in 85 and 72 patients at the end
of the third and sixth month, respectively. The clinico-demographic and laboratory parameters were compared
with the sputum culture report at the end of the third and sixth month and final treatment outcomes.
Results:
Favorable outcome (cured) was seen in 33.3% (38/114) patients. Female gender was associated with delayed
sputum culture conversion at three months (P = 0.020). A positive culture at the end of the sixth month was
significantly associated with unfavourable outcomes (P = 0.002). A low body mass index (BMI) (15.86 [IQR,
14.10−18.11]) and a higher platelet count (358 × 109
/L [IQR, 282−4.85]) at the initiation of treatment were
independently and significantly associated with unfavourable outcomes.
Conclusion:
Patients with a low BMI and high platelet count are more likely to have unfavourable treatment outcomes.
Identifying patients with these risk factors during the pre-treatment phase and more intensive follow-up during
the treatment course could be advocated.
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