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1.
Expert Opin Drug Saf ; 22(4): 343-349, 2023 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-36043937

RESUMEN

BACKGROUND: Information on neurological and psychiatric adverse events following immunization (AEFIs) with COVID-19 vaccines is limited. RESEARCH DESIGN & METHODS: We examined and compared neurological and psychiatric AEFIS reports related to BNT162b2 (Pfizer-BioNTech) and ChAdOx1 (Oxford-AstraZeneca) COVID-19 vaccines and recorded in the United Kingdom Medicines and Healthcare products Regulatory Agency between 9 December 2020 and 30 June 2021. RESULTS: As of 30 June 2021, 46.1 million doses of ChAdOx1 and 30.3 million doses of BNT162b2 had been administered. The most frequently reported AEFI was headache with 1,686 and 575 cases per million doses of ChAdOx1 and BNT162b2, respectively. AEFIs more frequently reported after CHAdOx1 compared with BNT162b2 vaccination were Guillain-Barré syndrome (OR, 95% CI = 2.53, 1.82-3.51), freezing (6.66, 3.12-14.22), cluster headache (1.53, 1.28-1.84), migraine (1.23,1.17-1.30), postural dizziness (1.24,1.13-1.37), tremor (2.86, 2.68-3.05), headache (1.40, 1.38-1.43), paresthesia (1.11, 1.06-1.16), delirium (1.85, 1.45-2.36), hallucination (2.20, 1.82-2.66), poor quality sleep (1.53, 1.26-1.85), and nervousness (1.54, 1.26-1.89) Reactions less frequently reported with ChAdOx1 than with BNT162b2 were Bell's palsy (0.47, 0.41-0.55), anosmia (0.58, 0.47-0.71), facial paralysis (0.35, 0.29-0.41), dysgeusia (0.68, 0.62-0.73), presyncope (0.48, 0.42-0.55), syncope (0.63, 0.58-0.67), and anxiety (0.75 (0.67-0.85). CONCLUSION: Neurological and psychiatric AEFIs were relatively infrequent, but each vaccine was associated with a distinctive toxic profile.


We examined reports on adverse neurological and psychiatric effects following immunization with BNT162b2 (Pfizer-BioNTech) and ChAdOx1 (Oxford-AstraZeneca) for COVID-19 to the United Kingdom Medicines and Healthcare products Regulatory Agency between 9 December 2020 and 30 June 2021. Adverse effects following immunization (AEFIs) were relatively infrequent. Compared to BNT162b2, Guillain-Barré syndrome, freezing phenomenon, cluster headache, migraine, postural dizziness, tremor, headache, paresthesia, delirium, hallucination, poor quality sleep, and nervousness were more frequently reported for ChAdOx1. Reactions less frequently reported for ChAdOx1 than for BNT162b2 were Bell's palsy, anosmia, facial paralysis, dysgeusia, presyncope, syncope, and anxiety.


Asunto(s)
Vacunas contra la COVID-19 , COVID-19 , Humanos , Vacunas contra la COVID-19/efectos adversos , Vacuna BNT162 , COVID-19/prevención & control , Inmunización , Vacunación/efectos adversos , Cefalea/inducido químicamente , Cefalea/epidemiología
2.
Surgery ; 165(2): 423-430, 2019 02.
Artículo en Inglés | MEDLINE | ID: mdl-30545657

RESUMEN

BACKGROUND: The 30-day readmission rate is increasingly utilized as a metric of quality that impacts reimbursement. To date, there are no nationally representative data on readmission rates after thyroid surgery. We aimed to determine national readmission rates after inpatient thyroidectomy operations and whether select clinical factors were associated with increased odds of postthyroidectomy readmission. METHODS: Using the 2014 Nationwide Readmissions Database, we identified patients undergoing inpatient thyroid surgery as defined by the International Classification of Diseases, Ninth Revision, procedure codes for thyroid lobectomy, partial thyroidectomy, complete thyroidectomy, and substernal thyroidectomy. Descriptive statistics were used to report readmission rates, most common diagnosis and causes of readmission, and timing of presentation after discharge. Multivariable logistic regression models controlling for potential confounders were used to determine whether select factors were associated with 30-day readmission. RESULTS: A total of 22,654 patients underwent inpatient thyroid surgery during the study period, 990 of whom (4.4%) were readmitted within 30 days. Among these, the most common diagnoses during readmission were disorders of mineral metabolism and hypocalcemia, accounting for 36.0% and 26.6% of readmissions, respectively. This held true regardless of the apparent indication for thyroid surgery (goiter, cancer, or thyroid function disorder) or timing of readmission after discharge. Calcium-related abnormalities were the top diagnoses at readmissions (22.1%). Most readmissions (54.6%) occurred within 7 days of discharge, with 24.6% within the first 2 days Factors associated with an increased odds of readmission included having Medicare (adjusted odds ratio [AOR] 1.47 and 95% confidence interval [CI] 1.03-2.11) or Medicaid insurance (AOR 1.44 [CI 1.04-1.99]), being discharged to inpatient post acute care (AOR 2.31 [CI 1.48-3.62]) or to home health care (AOR 1.78 [CI 1.21-2.63]), having an Elixhauser comorbidity score ≥ 4 (AOR 2.04 [CI 1.27-3.26]), and a duration of stay ≥2 days after the thyroid surgery (AOR 2.7 [CI 1.9-3.82]). The only complication during index admission associated with increased odds of readmission was hypocalcemia (AOR 1.5 [CI 1.1-2.06]. Indications for thyroid surgery were not associated with increased odds of readmission. CONCLUSION: Readmissions after thyroid surgery are relatively low and occur early after surgery. The most common diagnoses identified on readmission were calcium and mineral metabolism disorders, which also were the most common cause of readmission. Socioeconomic factors, comorbidities, and complications during the index admissions were found to be associated with nonelective, postthyroidectomy readmissions. Recognition of these risk factors may guide the development of interventions and protocols to decrease readmissions.


Asunto(s)
Readmisión del Paciente/estadística & datos numéricos , Tiroidectomía , Factores de Edad , Anciano , Comorbilidad , Bases de Datos Factuales , Femenino , Servicios de Atención a Domicilio Provisto por Hospital/estadística & datos numéricos , Humanos , Hipocalcemia/epidemiología , Tiempo de Internación/estadística & datos numéricos , Masculino , Medicaid/estadística & datos numéricos , Medicare/estadística & datos numéricos , Enfermedades Metabólicas/epidemiología , Persona de Mediana Edad , Atención Subaguda/estadística & datos numéricos , Estados Unidos/epidemiología
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