Adenocarcinoma histology, higher LN SUVmax, and higher LN risk category independently correlate with nodal involvement with malignancy and may be used in a model to accurately predict the risk of a node's involvement with malignancy.
Background
Vaccinations are a cornerstone of preventative medicine in the USA. However, growing concerns regarding facial nerve palsy following vaccination exist.
Objective
This study aims to assess the occurrence of facial palsy as reported by the Vaccine Adverse Event Reporting System (VAERS) database.
Methods
A retrospective analysis of the VAERS database was performed for cases of ‘Facial Palsy’, ‘Bell’s Palsy’, ‘Facial Paralysis’ and ‘Ramsay Hunt Syndrome’ between 2009 and 2018. Subgroup analysis was performed to determine gender, age, history of facial palsy, type of vaccine used, number of days until onset of symptoms and overall facial palsy rate.
Results
Nine hundred and forty-four entries met our inclusion criteria with 961 vaccine administrations resulting in facial paralysis. Facial palsy following vaccinations was evenly distributed across all age cohorts with two peaks between 60 and 74 years old and between 0 and 14 years old. Most patients were female (N = 526, 55.7%) without a reported history of facial palsy (N = 923, 97.8%). In 2009, reported incidence rate was 0.53%, as compared with 0.23% in 2018. The influenza vaccine had the greatest number of cases (N = 166, 17.3%), followed by the varicella (N = 87, 9.1%) and human papillomavirus vaccines (N = 47, 4.9%).
Conclusions
With the SARS-CoV-2 pandemic and recent approvals of the vaccinations, there is growing concern of facial palsy following vaccination. Although it is a known adverse event following vaccination, the likelihood of facial palsy following vaccination is low, with only 0.26% of overall reported cases over a 10-year span.
Background: Intranasal sprays (INSs) are commonly used medications for the treatment of many rhinologic conditions. Despite their popularity, an analysis of a nationwide reporting database and comparison to the available literature has never been performed. Methods: The Food and Drug Administration Adverse Event Reporting System (FAERS) database was accessed to obtain adverse event (AE) records from 2014 to 2019 for varying INSs, including: 10 corticosteroids, 1 alpha adrenergic, and 3 antihistamines. The Proportional Reporting Ratios (PRR) and Reporting Odds Ratios (ROR) were calculated for dyspnea, anosmia, ageusia/dysgeusia, epistaxis, and headache. A PRR ≥ 2 or ROR ≥ 1 was considered significant. Results: Corticosteroids had 98 864 total reported AEs to the database, followed by antihistamines (7011) and alpha adrenergics (2071). In total, dyspnea was reported 5843 times, followed by headache (4230), epistaxis (1205), ageusia/dysgeusia (920), and anosmia (312). Overall, PRR and ROR values for dyspnea ranged from 0.51 to 4.25 and 0.51 to 4.49; for dysgeusia/ageusia from 0.56 to 6.09 and 0.56 to 6.12; and for epistaxis from 1.03 to 27.24 and 1.03 to 30.76, respectively. All medications which listed anosmia within the top AEs had PRR and ROR values exceeding 2 and 1, respectively. The PRR for headache exceeded 2 for 1 medication and the ROR exceeded 1 in 7 medications. Conclusion: The AEs of dyspnea, anosmia, ageusia/dysgeusia, epistaxis, and headache are reported within the FAERS database for commonly prescribed INSs. When compared against the existing scientific literature, the clinical significance of this reporting tool from the FDA for these classes of medications remains unvalidated.
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