Facial palsy after administration of immune checkpoint inhibitors: case report, literature review and clinical care management.

Neurological immune-related adverse events (irAEs) due to immune checkpoint inhibitors (ICI) are rare complications of immunotherapy, particularly dreadful for patients and clinical teams. Indeed, neurological irAEs are potentially severe and their diagnosis require prompt recognition and treatment. Additionally, the spectrum of neurological irAEs is broad, affecting either neuromuscular junction, peripheral or central nervous system. Here, we described the case of a 55-year man with metastatic melanoma, facing a brutal right peripheral cerebral palsy after his third ipilimumab/nivolumab infusion. After the case presentation, we reviewed the literature about this rare complication of immunotherapy, and described its diagnosis work-up and clinical management.

Otolaryngologic Side Effects After COVID-19 Vaccination.

OBJECTIVES: With widespread vaccination against COVID-19, concerns regarding side effects have been raised. We aim to assess the frequency of otolaryngologic adverse events (AEs) following COVID-19 vaccination as compared with other vaccines in a national database. STUDY DESIGN: Retrospective analysis of national registry. METHODS: The Food and Drug Administration's Vaccine Adverse Event Reporting System (VAERS) database was queried from December 2020 to May 2021 for all COVID-19 vaccination AEs. Complaints were categorized as otolaryngologic and sub stratified into different anatomic components. Reporting odds ratios (ROR) and proportional reporting ratios (PRR) were determined for AEs of clinical significance. RESULTS: The total number of AEs reported from vaccination with the Moderna, Pfizer-BioNTech, and Janssen vaccines equaled 1,280,950. Of these, 62,660 (4.9%) were otolaryngologic in nature, with 32.6% associated with the oropharynx/larynx, 18.3% with the nasal cavity/sinuses, 17.1% with the ears/vestibular system, 10.0% with the oral cavity, and 21.9% miscellaneous. Signal ratios reached significance levels for dysgeusia (n = 2124, PRR: 17.33, ROR: 16.36), ageusia (n = 1376, PRR: 2.81, ROR: 2.81), anosmia (n = 983, PRR: 4.01, ROR: 4.01), rhinorrhea (n = 2203, PRR: 2.99, ROR: 3.00), throat tightness (n = 3666, PRR: 4.99, ROR: 5.00), throat irritation (n = 3313, PRR: 4.51, ROR: 4.52), dysphagia (n = 2538, PRR: 2.07, ROR: 2.07), tinnitus (n = 4377, PRR: 3.97, ROR: 3.98), and vertigo (n = 2887, PRR: 3.93, ROR: 3.93). Signal ratios were not significant for facial paralysis, Bell's palsy, anaphylaxis, sinusitis, hearing disability, and ear pain. CONCLUSIONS: Although several otolaryngologic symptoms were reported, few were found to be clinically significant. Of note, facial paralysis, Bell's palsy, and anaphylaxis did not meet signal thresholds to be determined significant. LEVEL OF EVIDENCE: 4 Laryngoscope, 134:1163-1168, 2024.

Peripheral facial palsy post SARS-CoV-2 vaccine: A regional pharmacovigilance cases series.

Peripheral facial palsy (PFP) is a rare adverse reaction identified from clinical trials of coronavirus disease 2019 (COVID-19) vaccines (messenger ribonucleic acid [mRNA] and viral vector). Few data are available on their onset patterns and risk of recurrence after re-injection of a COVID-19 vaccine; the objective of this study was to describe PFP cases attributed to COVID-19 vaccines. All cases of facial paralysis reported to the Regional Pharmacovigilance Center of Centre-Val de Loire area between January and October 2021, in which the role of a COVID-19 vaccine was suspected, were selected. Based on initial data and following additional information requested, each case was reviewed and analyzed to include only confirmed cases of PFP for which the role of the vaccine could be retained. From the 38 cases reported, 23 were included (15 excluded because of diagnosis not retained). They occurred in 12 men and 11 women (median age of 51 years). The first clinical manifestations occurred with a median time of 9 days after COVID-19 vaccine injection, and the paralysis was homolateral to the vaccinated arm in 70%. The etiological workup, always negative, included brain imaging (48%), infectious serologies (74%) and Covid-19 PCR (52%). Corticosteroid therapy was prescribed for 20 (87%) patients, combined with aciclovir in 12 (52%). At 4-month follow-up, clinical manifestations had regressed completely or partially in 20 (87%) of the 23 patients (median time of 30 days). From them 12 (60%) received another dose of COVID-19 vaccine and none had a recurrence and the PFP regressed despite the second dose in 2 of the 3 patients not fully recovered at 4 months. The potential mechanism of PFP after COVID-19 vaccine, which don't have a specific profile, is probably the interferon-γ. Moreover, the risk of recurrence after a new injection appears to be very low, which makes it possible to continue the vaccination.

Blastomyces Induced Otomastoiditis With Local Soft Tissue Invasion: A Case Report.

The aim of this report is to document a very rare case of Blastomycosis dermatitidis mastoiditis with extension into the retromastoid soft tissue and surrounding muscle. Blastomycosis dermatitidis is a dimorphic fungus of endemic areas which classically infiltrates the lungs; however, dissemination presenting as otomastoiditis is exceedingly rare. The patient was an immunocompetent 27-year-old male with no significant preexisting health conditions. He had significant work exposure to dust and soil and was referred to our department for evaluation of otalgia with headaches, hearing loss, and intermittent facial paralysis. Initially, the extent of the infection was unknown. Based on extensive disease on magnetic resonance imaging, the patient was scheduled for urgent tympanoplasty and mastoidectomy. Postoperative treatment with itraconazole resolved any further manifestations and halted further soft tissue invasion. It is important to consider uncommon fungal infections in the workup of persistent otalgia, especially when presenting with facial paralysis and a history of environmental exposure to soil and dust. This type of infection should be considered regardless of immunodeficiency status. Early detection may prevent hearing loss and local invasion into surrounding structures.

Facial Palsy Induced by Covaxin in Adolescent Female - A Rare Case Report.

BACKGROUND: The world has seen nearly 2 years of a pandemic caused by the SARS-CoV-2 virus, notoriously known as COVID-19. Several vaccines have been approved under Emergency Use Authorization (EUA) to combat the disease, one of which is Covaxin, an inactivated adjuvant SARSCoV- 2 vaccine that is generally well tolerated and has fewer side effects. However, we recently have seen a rare case of facial palsy (paralysis) following Covaxin vaccination in an adolescent girl. CASE PRESENTATION: A 16 years old adolescent girl presented with chief complaints of left side deviation of mouth with difficulty in closing right eye after 29 days of receiving the first dose of Covaxin, which was finally diagnosed as a "Covaxin induced facial palsy". Her symptoms were alleviated with some supportive measures, steroid and antiviral treatment, with full recovery. CONCLUSION: The case depicts facial nerve paralysis following Covaxin use, possibly the first of its kind. This case illustrates plausible explanation to Covaxin use and occurrence of facial palsy, however, further studies required to establish causal relationship.

Facial paralysis after intraoral anesthetic injection: A systematic review.

Many complications can occur after the injection of local intraoral anesthetics (ILIA) before dental intervention. Facial paralysis (FP) is one of these complications. The purpose of this study was to systematically analyze the association between ILIA and FP. A systematic review was carried out taking into account the methodology of the Cochrane Handbook for Systematic Reviews of Interventions and the PRISMA statement. The search strategy used "Palsy AND Facial" and "Paralysis AND Facial" as search terms. The ScienceDirect, PubMed and Scopus databases were searched using the "dentistry journal" filter. The inclusion criteria included studies describing FP after or during ILIA that were published in dental journals. The CAse REports (CARE) checklist was applied in evaluating the methodological quality of case reports. A total of 2,462 articles (algorithm) were identified. After reviewing titles and abstracts, 18 articles were deemed relevant taking into account the objectives of this study. Only 13 of them, after reading the full text, met the inclusion criteria and were analyzed. Case reports on 18 cases of FP were analyzed, 12 of which described the early development of FP (onset within 24 h) and 6 the late development (onset after 24 h). Acceptable compliance with CARE guidelines was observed in the included studies . Early FP CRs presented the effect of the administered anesthetic on the facial nerve, and the vascular effect of the vasoconstrictor included in the anesthetic formula, while more recent FP CRs focused on the reactivation of herpes simplex virus type 1 (HSV-1), human herpesvirus 6 (HHV-6) or varicella-zoster virus (VZV).

A case of Miller Fisher syndrome with delayed onset peripheral facial nerve palsy after COVID-19 vaccination: a case report.

BACKGROUND: To prevent the spread of the novel coronavirus disease 2019 (COVID-19) infection, various vaccines have been developed and used in a large number of people worldwide. One of the most commonly used vaccines is the mRNA vaccine developed by Moderna. Although several studies have shown this vaccine to be safe, the full extent of its side effects has not yet been known. Miller-Fisher syndrome (MFS) is a rare condition that manifests ophthalmoplegia, ataxia, and loss of tendon reflexes. It is a subtype of Guillain-Barré syndrome and an immune-mediated disease related to serum IgG anti-GQ1b antibodies. Several vaccines including those for COVID-19 have been reported to induce MFS. However, there have been no reports of MFS following Moderna COVID-19 vaccine administration. CASE PRESENTATION: A 70-year-old man was referred to our hospital due to diplopia that manifested 1 week after receiving the second Moderna vaccine dose. The patient presented with restricted abduction of both eyes, mild ataxia, and loss of tendon reflexes. He was diagnosed with MFS based on his neurological findings and detection of serum anti-GQ1b antibodies. The patient was administered intravenous immunoglobulin, and his symptoms gradually improved. Five days after admission, the patient showed peripheral facial paralysis on the right side. This symptom was suggested to be a delayed onset of peripheral facial nerve palsy following MFS that gradually improved by administration of steroids and antiviral drugs. CONCLUSION: There have been no previous reports of MFS after Moderna COVID-19 vaccination. This case may provide new information about the possible neurological side effects of COVID-19 vaccines.

[Bell's Palsy Secondary to COVID-19 Vaccine Pfizer: Case report]. / Parálisis de Bell secundaria a vacuna Pfizer para COVID-19: reporte de caso.

Background: BNT162b2 (Pfizer-BioNTech) is a nucleosidemodified mRNA vaccine formulated with lipid nanoparticles for the prevention of COVID-19 disease caused by SARSCoV-2 infection. In early December 2020, BNT162b2 received an emergency use authorization, initial efficacy and safety data have been released, consumer / patient information sheets for vaccines distributed in North America do not warn of Bell's palsy as a possible adverse effect. We reported the case of a patient who developed Bell's palsy on the right side in less than 3 hours after the application of the first dose of the Pfizer-BioNTech COVID-19 vaccine. Clinical case: 32-year-old latina woman who developed right facial paralysis after receiving the first dose of the BNT162b2 mRNA vaccine on April 7, 2021; with right facial paresis, absence of forehead wrinkles, lip-buccal sulcus and nasolabial fold; spasms of the facial and periorbital muscles, laterocervical pain; possible etiologies were ruled out, prednisone, gabapentin and topiramate. CT without alterations, achieving gradual improvement; until full functional recovery after 15 days. With benign evolution, congruent with the natural history of the disease, classifying it as idiopathic Bell's palsy. Conclusions: Although a causal relationship cannot be established, the time and mode of appearance of the paralysis suggested a relationship with the application of the BNT162b2 vaccine. Given the recommendation of the health authorities to monitor the cases of Bell's palsy, and the surveillance of events supposedly attributable to vaccination (ESAVI) and as it is the first case reported in the literature, in the mexican population, we believe that this case should be shared with the scientific community in a timely manner.

Introducción: la BNT162b2 (Pfizer-BioNTech) es una vacuna de ARNm modificado con nucleósidos y formulada con nanopartículas lipídicas para la prevención de la enfermedad covid-19 causada por la infección por SARS-CoV-2. A principios de diciembre del 2020, la BNT162b2 recibió una autorización para su uso de emergencia. Se han publicado datos iniciales de eficacia y seguridad, sin embargo las hojas de información para el consumidor/paciente para vacunas distribuidas en América del Norte no advierten sobre la parálisis de Bell como un posible efecto adverso. Informamos el caso de una mujer que desarrolló parálisis de Bell posterior a la aplicación de la primera dosis de la vacuna Pfizer-BioNTech. Caso clínico: mujer latina de 32 años que desarrolló parálisis facial derecha después de recibir la primera dosis de la vacuna ARNm BNT162b2 el 7 de abril de 2021; con paresia facial derecha, ausencia de arrugas en la frente, surco labio-bucal y pliegue nasolabial, así como espasmos de los músculos faciales y periorbitarios y dolor latero-cervical. Se descartaron posibles etiologías, se le indicó prednisona, gabapentina y topiramato, con TAC de cráneo simple sin alteraciones, logrando mejoría paulatina hasta la recuperación completa funcional a los 15 días, con evolución benigna, congruente con la evolución natural de la enfermedad, clasificándola como parálisis de Bell idiopática. Conclusiones: aunque no se puede establecer una relación causal, el momento y el modo de aparición de la parálisis sugieren fuertemente la relación con la aplicación de la vacuna BNT162b2. Dada la recomendación de las autoridades sanitarias de vigilar los casos de parálisis de Bell, y la vigilancia de eventos supuestamente atribuibles a la vacunación (ESAVI), se trata del primer caso reportado en la literatura en población mexicana, por lo que consideramos que debe compartirse con la comunidad científica de manera oportuna.

Safety of COVID-19 vaccination and acute neurological events: A self-controlled case series in England using the OpenSAFELY platform.

INTRODUCTION: We investigated the potential association of COVID-19 vaccination with three acute neurological events: Guillain-Barré syndrome (GBS), transverse myelitis and Bell's palsy. METHODS: With the approval of NHS England we analysed primary care data from >17 million patients in England linked to emergency care, hospital admission and mortality records in the OpenSAFELY platform. Separately for each vaccine brand, we used a self-controlled case series design to estimate the incidence rate ratio for each outcome in the period following vaccination (4-42 days for GBS, 4-28 days for transverse myelitis and Bell's palsy) compared to a within-person baseline, using conditional Poisson regression. RESULTS: Among 7,783,441 ChAdOx1 vaccinees, there was an increased rate of GBS (N = 517; incidence rate ratio 2·85; 95% CI2·33-3·47) and Bell's palsy (N = 5,350; 1·39; 1·27-1·53) following a first dose of ChAdOx1 vaccine, corresponding to 11.0 additional cases of GBS and 17.9 cases of Bell's palsy per 1 million vaccinees if causal. For GBS this applied to the first, but not the second, dose. There was no clear evidence of an association of ChAdOx1 vaccination with transverse myelitis (N = 199; 1·51; 0·96-2·37). Among 5,729,152 BNT162b2 vaccinees, there was no evidence of any association with GBS (N = 283; 1·09; 0·75-1·57), transverse myelitis (N = 109; 1·62; 0·86-3·03) or Bell's palsy (N = 3,609; 0·89; 0·76-1·03). Among 255,446 mRNA-1273 vaccine recipients there was no evidence of an association with Bell's palsy (N = 78; 0·88, 0·32-2·42). CONCLUSIONS: COVID-19 vaccines save lives, but it is important to understand rare adverse events. We observed a short-term increased rate of Guillain-Barré syndrome and Bell's palsy after first dose of ChAdOx1 vaccine. The absolute risk, assuming a causal effect attributable to vaccination, was low.

Sequential contralateral facial nerve palsies following COVID-19 vaccination first and second doses.

A 61-year-old man presented to the ENT emergency clinic with a history of unilateral facial nerve palsy occurring shortly after each dose of the Pfizer-BioNTech COVID-19 vaccine. The first episode developed 5 hours after administration of the first dose and the second 2 days after administration of the second dose. Investigations at initial presentation to the emergency department were unremarkable, and the patient was diagnosed with Bell's palsy on both occasions. We describe the first case of Bell's palsy occurring after each dose of any UK-approved COVID-19 vaccine. Single episodes of unilateral facial nerve palsies have been reported in clinical trials and in subsequent case reports. There has been no evidence, however, of an episode after each dose. We also describe the earliest onset of symptoms from timing of administration of the vaccine, further suggesting the Bell's palsy was associated with the vaccine.

[Acute facial paresis as a possible complication of vaccination against SARS-CoV-2]. / Eine akute Fazialisparese als mögliche Impfkomplikation bei einer Impfung gegen SARS-CoV-2.

Although acute facial nerve palsy (Bell's palsy) is explicitly mentioned in the information sheets for vaccines as a possible complication of vaccination against SARS-CoV-2, from our point of view the benefits of the vaccination clearly outweigh the possible risks. At most, if at all, a slightly increased risk can be derived from the previous case reports. In general, the risk of acute facial palsy is described in association with many vaccinations. The risk, if any, does not appear to be a specific risk of SARS-CoV-2 vaccines. On the other hand, cases of acute facial palsy as symptom of a COVID-19 disease have also been described, so that the theoretical question arises as to the extent to which the vaccination may prevent rather than promote the occurrence of facial palsy. Ultimately, if acted quickly, acute facial paralysis can be treated well and its severity and sequelae cannot be compared with the severity of a COVID-19 disease and its possible long-COVID sequelae.

Adverse Events Associated With New Injectable-Free Multidrug-Resistant Tuberculosis Drug Regimens / Efectos adversos asociados a los nuevos tratamientos farmacológicos sin inyectables contra la tuberculosis multirresistente

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Transient facial nerve palsy following dental local anaesthesia.

Facial nerve palsy is a rare but known complication of dental local anaesthesia and may be underreported. We describe a case of a transient facial nerve palsy following the administration of an inferior alveolar nerve block and discuss the immediate practical management. Knowing the likely transient nature of this complication means the patient can be reassured and unnecessary referral avoided. While the blink reflex is inhibited, steps are needed in order to protect the cornea and prevent secondary infection and scarring.

Facial Paralysis Following Influenza Vaccination: A Disproportionality Analysis Using the Vaccine Adverse Event Reporting System Database.

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.