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.

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.

[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.

Risk of serious adverse events after the BNT162b2, CoronaVac, and ChAdOx1 vaccines in Malaysia: A self-controlled case series study.

BACKGROUND: Rapid deployment of COVID-19 vaccines is challenging for safety surveillance, especially on adverse events of special interest (AESIs) that were not identified during the pre-licensure studies. This study evaluated the risk of hospitalisations for predefined diagnoses among the vaccinated population in Malaysia. METHODS: Hospital admissions for selected diagnoses between 1 February 2021 and 30 September 2021 were linked to the national COVID-19 immunisation register. We conducted self-controlled case-series study by identifying individuals who received COVID-19 vaccine and diagnosis of thrombocytopenia, venous thromboembolism, myocardial infarction, myocarditis/pericarditis, arrhythmia, stroke, Bell's Palsy, and convulsion/seizure. The incidence of events was assessed in risk period of 21 days postvaccination relative to the control period. We used conditional Poisson regression to calculate the incidence rate ratio (IRR) and 95% confidence interval (CI) with adjustment for calendar period. RESULTS: There was no increase in the risk for myocarditis/pericarditis, Bell's Palsy, stroke, and myocardial infarction in the 21 days following either dose of BNT162b2, CoronaVac, and ChAdOx1 vaccines. A small increased risk of venous thromboembolism (IRR 1.24; 95% CI 1.02, 1.49), arrhythmia (IRR 1.16, 95% CI 1.07, 1.26), and convulsion/seizure (IRR 1.26; 95% CI 1.07, 1.48) was observed among BNT162b2 recipients. No association between CoronaVac vaccine was found with all events except arrhythmia (IRR 1.15; 95% CI 1.01, 1.30). ChAdOx1 vaccine was associated with an increased risk of thrombocytopenia (IRR 2.67; 95% CI 1.21, 5.89) and venous thromboembolism (IRR 2.22; 95% CI 1.17, 4.21). CONCLUSION: This study shows acceptable safety profiles of COVID-19 vaccines among recipients of BNT162b2, CoronaVac, and ChAdOx1 vaccines. This information can be used together with effectiveness data for risk-benefit analysis of the vaccination program. Further surveillance with more data is required to assess AESIs following COVID-19 vaccination in short- and long-term.

Background incidence rates of adverse events of special interest related to COVID-19 vaccines in Ontario, Canada, 2015 to 2020, to inform COVID-19 vaccine safety surveillance.

BACKGROUND: Background incidence rates are critical in pharmacovigilance to facilitate identification of vaccine safety signals. We estimated background incidence rates of 11 adverse events of special interest related to COVID-19 vaccines in Ontario, Canada. METHODS: We conducted a population-based retrospective observational study using linked health administrative databases for hospitalizations and emergency department visits among Ontario residents. We estimated incidence rates of Bell's palsy, idiopathic thrombocytopenia, febrile convulsions, acute disseminated encephalomyelitis, myocarditis, pericarditis, Kawasaki disease, Guillain-Barré syndrome, transverse myelitis, acute myocardial infarction, and anaphylaxis during five pre-pandemic years (2015-2019) and 2020. RESULTS: The average annual population was 14 million across all age groups with 51% female. The pre-pandemic mean annual rates per 100,000 population during 2015-2019 were 191 for acute myocardial infarction, 43.9 for idiopathic thrombocytopenia, 28.8 for anaphylaxis, 27.8 for Bell's palsy, 25.0 for febrile convulsions, 22.8 for acute disseminated encephalomyelitis, 11.3 for myocarditis/pericarditis, 8.7 for pericarditis, 2.9 for myocarditis, 2.0 for Kawasaki disease, 1.9 for Guillain-Barré syndrome, and 1.7 for transverse myelitis. Females had higher rates of acute disseminated encephalomyelitis, transverse myelitis and anaphylaxis while males had higher rates of myocarditis, pericarditis, and Guillain-Barré syndrome. Bell's palsy, acute disseminated encephalomyelitis, and Guillain-Barré syndrome increased with age. The mean rates of myocarditis and/or pericarditis increased with age up to 79 years; males had higher rates than females: from 12 to 59 years for myocarditis and ≥12 years for pericarditis. Febrile convulsions and Kawasaki disease were predominantly childhood diseases and generally decreased with age. CONCLUSIONS: Our estimated background rates will permit estimating numbers of expected events for these conditions and facilitate detection of potential safety signals following COVID-19 vaccination.

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

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 ecomendación de las autoridades sanitarias de vigilar los casos de parálisis de Bell, y la vigilancia de eventos upuestamente 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.

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 upposedly 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.

Left Bell's palsy following the first dose of mRNA-1273 SARS-CoV-2 vaccine: A case report.

Even though no definitive link has been established, Bell's palsy has been described as a potential side effect of SARS-CoV-2 mRNA vaccines in a few reports, and the US Food and Drug Administration has recommended strict surveillance of its occurrence in the vaccinated general population. We present the case of a previously healthy 35-year-old female patient who developed Bell's palsy 12 h after receiving the first dose of the mRNA-1273 vaccine. Her general practitioner performed the diagnosis, and corticosteroid treatment was initiated, with slow symptoms improvement. The neurologist's evaluation and a contrast-enhanced brain Magnetic Resonance Imaging revealed a subtle enhancement of the left facial nerve, confirming the diagnosis of Bell's palsy.

Real-world safety data for the Pfizer BNT162b2 SARS-CoV-2 vaccine: historical cohort study.

OBJECTIVE: The Pfizer BNT162b2 vaccine showed a reassuring safety profile in clinical trials, but real-world data are scarce. Bell's palsy, herpes zoster, Guillain-Barré syndrome (GBS) and other neurological complaints in proximity to vaccination have received special public attention. We compared their rates among vaccinated and unvaccinated individuals. METHODS: Individuals ≥16 years vaccinated with at least one dose of BNT162b2 were eligible for this historical cohort study in a health maintenance organization insuring 1.2 million citizens. Each vaccinee was matched to a non-vaccinated control by sex, age, population sector (general Jewish, Arab, ultra-orthodox Jewish) and comorbidities. Diagnosis of Covid-19 before or after vaccination was an exclusion criterion. The outcome was a diagnosis of Bell's palsy, GBS, herpes zoster or symptoms of numbness or tingling, coded in the visit diagnosis field using ICD-9 codes. Diagnoses of Bell's palsy and GBS were verified by individual file review. RESULTS: Of 406 148 individuals vaccinated during the study period, 394 609 (97.2%) were eligible (11 539 excluded). A total of 233 159 (59.1%) were matched with unvaccinated controls. Mean follow was 43 ± 15.14 days. In vaccinated and unvaccinated individuals there were 23 versus 24 cases of Bell's palsy (RR 0.96, CI 0.54-1.70), one versus zero cases of GBS, 151 versus 141 cases of herpes zoster (RR 1.07, CI 0.85-1.35) and 605 versus 497 cases of numbness or tingling (RR 1.22, CI 1.08-1.37), respectively. DISCUSSION: No association was found between vaccination, Bell's palsy, herpes zoster or GBS. Symptoms of numbness or tingling were more common among vaccinees. This study adds reassuring data regarding the safety of the BNT162b2 vaccine.

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.

Immune-related Bell's palsy in melanoma patients treated with immune checkpoint inhibitors.

Immune-checkpoint inhibitors (ICIs) exposed the oncology community to novel immune-related adverse events (irAEs). Here, we report on a retrospective analysis of patients with melanoma who developed an ICI-related, unilateral, acute and peripheral facial nerve paralysis (Bell's palsy).We retrospectively reviewed all the cases of ICI-related Bell's palsy in patients with melanoma treated at our institution from January 2015 to January 2020. A total of five cases of ICI-related Bell's palsy were identified. Median age was 63 years. Median time-to-onset of Bell's palsy from ICIs initiation was 15 weeks. Four patients were treated with prednisone alone, whereas one patient was treated with prednisone plus valaciclovir. All the patients completely recovered from Bell's palsy without neurological sequelae. In melanoma patients treated with ICIs, Bell's palsy is a rare, neurologic irAE with a favorable outcome following administration of oral corticosteroids.

Atezolizumab-Induced Bell's Palsy in a Patient With Small Cell Lung Cancer.

Immune checkpoint inhibitors are rapidly becoming popular therapeutic options for patients suffering from a number of malignancies. Atezolizumab is a programmed cell death ligand-1 inhibitor, and binding to this ligand decreases the ability of tumor cells to evade the immune system, resulting in self-tolerance. While inhibition of these molecules leads to increased T-cell destruction of tumor cells, it also may lead to autoimmune destruction of healthy cells. Neurotoxicity is a rare complication of immune checkpoint inhibitor therapy, and facial palsy as a complication of atezolizumab therapy has only been reported in one additional study. We present the case of a 68-year-old female with a history of small cell carcinoma of the lung presenting with sudden-onset facial palsy and numbness of the distal extremities in the setting of receiving atezolizumab immunotherapy. Our patient was managed with temporary cessation of her immunotherapy, oral prednisone, and supportive measures. Within 4 weeks, the patient had complete resolution of her facial palsy and was able to resume immunotherapy without further complication. Clinicians should be aware of this rare adverse effect in order to enact early management including temporary cessation of therapy to prevent morbidity in patients undergoing immunotherapy.

Current safety issues with quadrivalent meningococcal conjugate vaccines.

Invasive meningococcal disease, although rare, can present as sudden, life-threatening disease with high risk of mortality or severe long-term sequelae. The main prevention strategy for invasive meningococcal disease in the United States is the routine vaccination of adolescents and other persons at increased risk of meningococcal disease with quadrivalent meningococcal conjugate vaccines. Two such vaccines are currently licensed and available in the United States, Menactra® (Sanofi Pasteur) and Menveo® (GlaxoSmithKline), and usage in the adolescent population has steadily increased since their introduction. Although early reports raised concerns about a possible association of Menactra with Guillain-Barré syndrome, a comprehensive safety review determined that if such risk existed it was no more than 0.66 cases per 1 million vaccinations. More recently, a study found an elevated risk of Bell's palsy when Menveo was administered concomitantly with other vaccines but no association was found when the vaccine was administered alone. In this commentary, we describe the current state of knowledge with respect to the safety of quadrivalent meningococcal conjugate vaccines, and we identify potential areas for safety research for these vaccines.

Immunization and Bell's palsy in children: a case-centered analysis.

Bell's palsy (BP) is an acute and idiopathic paralysis of the facial nerve, with an estimated incidence ranging from 11.5 per 100,000 person-years to 53.3 per 100,000 person-years in different populations. BP has been reported following immunization with inactivated trivalent influenza vaccine (TIV) and hepatitis B virus (HBV) vaccine. Epidemiologic studies examining this association among children are lacking. From 2001 through 2006, all children aged ≤18 years diagnosed with BP within the Kaiser Permanente Northern California population were identified using International Classification of Diseases, Ninth Revision, code 351.0. All electronically identified cases were reviewed and adjudicated by an otolaryngologist (n = 233). Using a case-centered approach, the authors examined the risk of BP during 3 risk intervals. Immunization with TIV (odds ratio (OR) = 0.7, 95% confidence interval (CI): 0.2, 2.8), HBV vaccine (OR = 0.8, 95% CI: 0.2, 2.4), or any vaccine (treating all vaccines combined; OR = 0.9, 95% CI: 0.6, 1.4) was not associated with increased risk of BP 1-28 days after immunization. Similarly, no association was found between vaccines and BP during the periods 1-14 and 29-56 days following immunization. Results of this study suggest that there is no association between immunization and BP in children.