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3.
J Korean Med Sci ; 38(22): e170, 2023 Jun 05.
Artigo em Inglês | MEDLINE | ID: covidwho-20245085

RESUMO

BACKGROUND: Although coronavirus disease 2019 (COVID-19) vaccines have been distributed worldwide under emergency use authorization, the real-world safety profiles of mRNA vaccines still need to be clearly defined. We aimed to identify the overall incidence and factors associated with adverse events (AEs) following mRNA COVID-19 vaccination. METHODS: We conducted web-based survey from December 2 to 10 in 2021 with a 2,849 nationwide sampled panel. Study participants were individuals who had elapsed at least two-weeks after completing two dosing schedules of COVID-19 vaccination aged between 18-49 years. We weighted the participants to represent the Korean population. The outcome was the overall incidence of AEs following mRNA COVID-19 vaccination and associated factors. We estimated the weighted odds ratios (ORs) using multivariable logistic regression models to identify the factors associated with AEs. RESULTS: Of the 2,849 participants (median [interquartile range] age, 35 [27-42] years; 51.6% male), 90.8% (n = 2,582) for the first dose and 88.7% (n = 2,849) for the second dose reported AEs, and 3.3% and 4.3% reported severe AEs, respectively. Occurrence of AEs was more prevalent in mRNA-1273 (OR, 2.06; 95% confidence interval [CI], 1.59-2.67 vs. BNT162b2), female sex (1.88; 1.52-2.32), and those with dermatologic diseases (2.51; 1.32-4.77). History of serious allergic reactions (1.96; 1.06-3.64) and anticoagulant medication use (4.72; 1.92-11.6) were associated with severe AEs. CONCLUSION: Approximately 90% of participants reported AEs following mRNA COVID-19 vaccination. Substantial factors, including vaccine type (mRNA-1273), female sex, and dermatologic diseases were associated with AEs. Our findings could aid policymakers in establishing vaccination strategies tailored to those potentially susceptible to AEs.


Assuntos
COVID-19 , Humanos , Feminino , Masculino , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , COVID-19/epidemiologia , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Vacina de mRNA-1273 contra 2019-nCoV , Vacina BNT162 , RNA Mensageiro , Vacinação/efeitos adversos
4.
Medicine (Baltimore) ; 102(20): e33824, 2023 May 19.
Artigo em Inglês | MEDLINE | ID: covidwho-20245062

RESUMO

To search whether or not the severe acute respiratory syndrome corona virus-2 (SARS-CoV-2) messenger ribonucleic acid (mRNA) vaccine affects the fertility of women at the 6th months by using AMH, which is an ovarian reserve test. Our study, designed as a prospective case-control study, included 104 women who presented to the GOP EAH obstetrics and gynecology outpatient clinic in January and February 2022. The study group included 74 women who presented to the outpatient clinic and planned to be vaccinated and 30 women who refused to be vaccinated as the control group. Anti-COVID-19 antibody levels in all participants were checked before participation in the study, and participants who were positive were excluded from the study. Blood was taken from the participants in both control and study groups to evaluate their AMH levels before the 2 doses of vaccination. After 2 doses of the vaccine, they were called for follow-up, and serological tests were performed to check whether they were positive for anti-COVID-19 antibodies. Participants in both groups were referred for follow-up after 6 months, samples were taken again for AMH, and the data were recorded. The mean age of the study group was 27.6 ±â€…5.3 years, and the mean age of the control group was 28.65 ±â€…5.25 years (P = .298). There was no statistically significant difference between the vaccinated and nonvaccinated groups in terms of AMH levels measured at the 6th month (P = .970). When the vaccinated group was compared in terms of AMH values at the first visit before vaccination and at the 6th month after vaccination, no statistically significant difference was found between them (p:0.127) mRNA vaccination to protect against SARS-CoV-2 does not adversely affect ovarian reserve, which is an indirect indicator of fertility. mRNA vaccines continue to be the most important method of protection against epidemics. Carefully and accurately informing women who are hesitant to get vaccinated is of great importance for the success of the fight against the epidemic.


Assuntos
COVID-19 , Reserva Ovariana , Gravidez , Feminino , Humanos , Adulto Jovem , Adulto , Vacinas contra COVID-19/efeitos adversos , SARS-CoV-2 , COVID-19/prevenção & controle , Estudos de Casos e Controles , Vacinação , RNA Mensageiro , Vacinas de mRNA , Anticorpos Antivirais
5.
Hum Vaccin Immunother ; 19(2): 2220630, 2023 08 01.
Artigo em Inglês | MEDLINE | ID: covidwho-20244911

RESUMO

Vogt-Koyanagi-Harada (VKH) disease is a rare and serious ocular adverse reaction following COVID-19 vaccination. This study aimed to evaluate the clinical features, diagnosis and management of COVID-19 vaccine-associated VKH disease. Case reports of VKH disease after COVID-19 vaccination were collected up to February 11, 2023 for retrospective analysis. Twenty-one patients (9 males and 12 females) were included, with a median age of 45 years (range 19-78), from three main regions, Asia (12/21), the Mediterranean region (4/21), and South America (5/21). Fourteen patients developed symptoms after the first dose of the vaccine, and 8 after the second dose. Vaccines included mRNA vaccine (10 cases), virus vector vaccine (6 cases), and inactivated vaccine (5 cases). The average time interval from vaccination to onset of symptoms was 7.5 days (range 12 hours to 4 weeks). All 21 patients experienced visual impairment after vaccination, with 20 cases involving both eyes. Sixteen patients showed symptoms of meningitis. Serous retinal detachment was observed in 16 patients, choroidal thickening was observed in 14, aqueous cell in 9, and subretinal fluid in 6. CSF pleocytosis was detected in 7 patients and skin symptoms were found in 3 patients. All patients received corticosteroid therapy, and 8 also received immunosuppressive agents. All patients recovered well, with a mean recovery time of 2 months. Early diagnosis and early treatment are crucial to the prognosis of patients with VKH after vaccination with COVID-19 vaccine. The risk of vaccination against COVID-19 in patients with a history of VKH disease should be evaluated clinically.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Síndrome Uveomeningoencefálica , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem , COVID-19/prevenção & controle , COVID-19/complicações , Teste para COVID-19 , Vacinas contra COVID-19/efeitos adversos , Prognóstico , Estudos Retrospectivos , Síndrome Uveomeningoencefálica/induzido quimicamente , Síndrome Uveomeningoencefálica/complicações , Síndrome Uveomeningoencefálica/diagnóstico
6.
Clin Nucl Med ; 48(8): e396-e397, 2023 Aug 01.
Artigo em Inglês | MEDLINE | ID: covidwho-20244849

RESUMO

ABSTRACT: A 13-year-old boy was suspected with pericarditis after a second booster dose of bivalent mRNA COVID-19 vaccine. After specific preparation for cardiac inflammation with carbohydrate-free, high-fat diet, the 18 F-FDG PET/CT successfully demonstrated simultaneous presentation of vaccination-related axillary lymphadenopathy and pericarditis without the interference of physiological myocardial uptake.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Pericardite , Adolescente , Humanos , Masculino , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Fluordesoxiglucose F18 , Pericardite/diagnóstico por imagem , Pericardite/etiologia , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada , RNA Mensageiro , Vacinação
7.
Vaccine ; 41(30): 4422-4430, 2023 Jul 05.
Artigo em Inglês | MEDLINE | ID: covidwho-20244793

RESUMO

BACKGROUND: On 2/27/2021, FDA authorized Janssen COVID-19 Vaccine (Ad.26.COV2.S) for use in individuals 18 years of age and older. Vaccine safety was monitored using the Vaccine Adverse Event Reporting System (VAERS), a national passive surveillance system, and v-safe, a smartphone-based surveillance system. METHODS: VAERS and v-safe data from 2/27/2021 to 2/28/2022 were analyzed. Descriptive analyses included sex, age, race/ethnicity, seriousness, AEs of special interest (AESIs), and cause of death. For prespecified AESIs, reporting rates were calculated using the total number of doses of Ad26.COV2.S administered. For myopericarditis, observed-to-expected (O/E) analysis was performed based on the number verified cases, vaccine administration data, and published background rates. Proportions of v-safe participants reporting local and systemic reactions, as well as health impacts, were calculated. RESULTS: During the analytic period, 17,018,042 doses of Ad26.COV2.S were administered in the United States, and VAERS received 67,995 reports of AEs after Ad26.COV2.S vaccination. Most AEs (59,750; 87.9 %) were non-serious and were similar to those observed during clinical trials. Serious AEs included COVID-19 disease, coagulopathy (including thrombosis with thrombocytopenia syndrome; TTS), myocardial infarction, Bell's Palsy, and Guillain-Barré syndrome (GBS). Among AESIs, reporting rates per million doses of Ad26.COV2.S administered ranged from 0.06 for multisystem inflammatory syndrome in children to 263.43 for COVID-19 disease. O/E analysis revealed elevated reporting rate ratios (RRs) for myopericarditis; among adults ages 18-64 years, the RR was 3.19 (95 % CI 2.00, 4.83) within 7 days and 1.79 (95 % CI 1.26, 2.46) within 21 days of vaccination. Of 416,384 Ad26.COV2.S recipients enrolled into v-safe, 60.9 % reported local symptoms (e.g. injection site pain) and 75.9 % reported systemic symptoms (e.g., fatigue, headache). One-third of participants (141,334; 33.9 %) reported a health impact, but only 1.4 % sought medical care. CONCLUSION: Our review confirmed previously established safety risks for TTS and GBS and identified a potential safety concern for myocarditis.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Síndrome de Guillain-Barré , Adolescente , Adulto , Criança , Humanos , Ad26COVS1 , Sistemas de Notificação de Reações Adversas a Medicamentos , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Estados Unidos/epidemiologia , Vacinas
9.
Thromb Res ; 228: 121-127, 2023 Aug.
Artigo em Inglês | MEDLINE | ID: covidwho-20244318

RESUMO

INTRODUCTION: The European Medicine Agency has authorized COVID-19 vaccination in adolescents and young adults (AYAs) from 12 years onwards. In elderly vitamin K antagonist (VKA) users, COVID-19 vaccination has been associated with an increased risk of supra- and subtherapeutic INRs. Whether this association is also observed in AYAs using VKA is unknown. Our aim was to describe the stability of anticoagulation after COVID-19 vaccination in AYA VKA users. MATERIALS AND METHODS: A case-crossover study was performed in a cohort of AYAs (12-30 years) using VKAs. The most recent INR results before vaccination, the reference period, were compared with the most recent INR after the first and, if applicable, second vaccination. Several sensitivity analyses were performed in which we restricted our analysis to stable patients and patients without interacting events. RESULTS: 101 AYAs were included, with a median age [IQR] of 25 [7] years, of whom 51.5 % were male and 68.3 % used acenocoumarol. We observed a decrease of 20.8 % in INRs within range after the first vaccination, due to an increase of 16.8 % in supratherapeutic INRs. These results were verified in our sensitivity analyses. No differences were observed after the second vaccination compared to before and after the first vaccination. Complications after vaccination occurred less often than before vaccination (9.0 vs 3.0 bleedings) and were non-severe. CONCLUSIONS: the stability of anticoagulation after COVID-19 vaccination was decreased in AYA VKA users. However, the decrease might not be clinically relevant as no increase of complications nor significant dose adjustments were observed.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Humanos , Masculino , Adulto Jovem , Adolescente , Idoso , Adulto , Feminino , Vacinas contra COVID-19/efeitos adversos , Estudos Cross-Over , COVID-19/prevenção & controle , Anticoagulantes/uso terapêutico , Coeficiente Internacional Normatizado/métodos , Vitamina K
10.
Rev Neurol ; 76(12): 399-402, 2023 06 16.
Artigo em Espanhol | MEDLINE | ID: covidwho-20244285

RESUMO

INTRODUCTION: New-onset super-refractory status epilepticus (NOSRSE) is a neurological emergency characterised by the development of status epilepticus in a patient without epilepsy or any known prior neurological disease and with no clear structural, toxic or metabolic cause, which recurs after 24 hours of induced coma. The most common identifiable cause is inflammatory-autoimmune. Consequently, we present a case of NOSRSE related to SARS-CoV-2 vaccination as an opportunity to investigate the dysimmune origin of this pathology. CASE REPORT: We report the case of a 40-year-old male who presented at the emergency department with fever and headache with no clear source of infection. His personal history included bacterial meningitis in childhood without any sequelae and protein S deficiency without treatment at the time, as well as vaccination with ChAdOx1 nCoV-19 21 days earlier. He was initially diagnosed with a urinary tract infection and treated with cefuroxime. Two days later, he was taken back to the emergency department with confusional symptoms and tonic-clonic seizures. He did not respond to midazolam and finally required sedation and orotracheal intubation for refractory status epilepticus. While in hospital, he required a number of lines of antiepileptic drugs, ketamine, a ketogenic diet, immunotherapy and plasmapheresis in order to successfully limit NOSRSE. The aetiological study offered normal results for serology, antineuronal antibodies in serum and cerebrospinal fluid, transthoracic echocardiography, testicular ultrasound and computed tomographic angiography. Only the control MRI scan showed a diffuse and bilateral alteration of the right hemispheric cortex and thalamic pulvinar as the only finding. CONCLUSION: It is crucial to report suspected adverse reactions associated with SARS-CoV-2 vaccination, thereby allowing continued monitoring of the risk/benefit ratio of vaccination.


TITLE: Estado epiléptico superrefractario de nueva aparición criptógeno tras vacunación contra el SARS-CoV-2. A propósito de un caso.Introducción. El estado epiléptico superrefractario de nueva aparición (NOSRSE) es una emergencia neurológica caracterizada por el desarrollo de estado epiléptico en un paciente sin epilepsia ni enfermedad neurológica previa conocida y sin clara causa estructural, tóxica o metabólica, que recurre tras 24 horas del coma inducido. La causa identificable más frecuente es la inflamatoria-autoinmune. En consecuencia, planteamos un caso de NOSRSE relacionado con la vacunación para el SARS-CoV-2 como una oportunidad de indagar el origen disinmune de esta patología. Caso clínico. Varón de 40 años que acude al servicio de urgencias refiriendo fiebre y cefalea sin claro foco infeccioso. Entre sus antecedentes personales destacamos una meningitis bacteriana en la infancia sin secuelas y un déficit de proteína S sin tratamiento en ese momento, así como vacunación con ChAdOx1 nCoV-19 21 días antes. Fue inicialmente diagnosticado de infección del tracto urinario y tratado con cefuroxima. Dos días después, se le llevó de nuevo a urgencias con cuadro confusional y crisis tonicoclónicas, sin respuesta al midazolam, y requirió finalmente sedación e intubación orotraqueal por estado epiléptico refractario. Durante su ingreso requirió múltiples líneas de antiepilépticos, quetamina, dieta cetógena, inmunoterapia y plasmaféresis para conseguir limitar el NOSRSE. El estudio etiológico ofrecía normalidad de los resultados de serología, anticuerpos antineuronales en el suero y líquido cefalorraquídeo, ecocardiografía transtorácica, ecografía testicular y angiotomografía computarizada. Únicamente la resonancia magnética de control mostró una alteración difusa y bilateral de la corteza hemisférica y pulvinar talámica derecha como único hallazgo. Conclusión. Es crucial notificar las sospechas de reacciones adversas asociadas a la vacunación frente al SARS-CoV-2, permitiendo así una supervisión continuada de la relación riesgo/beneficio de ésta.


Assuntos
COVID-19 , Estado Epiléptico , Masculino , Humanos , Adulto , Vacinas contra COVID-19/efeitos adversos , SARS-CoV-2 , ChAdOx1 nCoV-19 , COVID-19/complicações , Estado Epiléptico/etiologia , Vacinação/efeitos adversos
11.
Expert Rev Vaccines ; 22(1): 501-517, 2023.
Artigo em Inglês | MEDLINE | ID: covidwho-20244063

RESUMO

INTRODUCTION: The coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has resulted in significant morbidity and mortality worldwide. As SARS-CoV-2 moves into endemic status, vaccination remains a key element in protecting the health of individuals, societies, and economies worldwide. AREAS COVERED: NVX-CoV2373 (Novavax, Gaithersburg, MD) is a recombinant protein vaccine composed of SARS-CoV-2 spike trimer nanoparticles formulated with saponin-based Matrix-M™ adjuvant (Novavax, Gaithersburg, MD). NVX-CoV2373 is authorized for emergency use in adults and adolescents aged ≥12 years in the United States and numerous other countries. EXPERT OPINION: In clinical trials, NVX-CoV2373 showed tolerable reactogenicity and favorable safety profiles characterized by mostly mild-to-moderate adverse events of short duration and by low rates of severe and serious adverse events comparable to those seen with placebo. The two-dose primary vaccination series resulted in robust increases in anti-spike protein immunoglobulin G, neutralizing antibody titers, and cellular immune responses. NVX-CoV2373 vaccination was associated with complete protection against severe disease and a high (90%) rate of protection against symptomatic disease in adults, including symptomatic disease caused by SARS-CoV-2 variants. Additionally, the NVX-CoV2373 adjuvanted recombinant protein platform offers a means to address issues of COVID-19 vaccination hesitancy and global vaccine equity.


Assuntos
COVID-19 , Vacinas , Adolescente , Adulto , Humanos , Anticorpos Neutralizantes , Anticorpos Antivirais , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Imunogenicidade da Vacina , SARS-CoV-2 , Criança
13.
Rev Soc Bras Med Trop ; 56: e0007, 2023.
Artigo em Inglês | MEDLINE | ID: covidwho-20243659

RESUMO

The Cogan's sign is indicative of myasthenia gravis. This is the first report of neurological signs in a patient with post-COVID-19 vaccine-associated myasthenia gravis in Brazil. In this case, a previously healthy 68-year-old woman presented with proximal limb weakness, left ptosis, and diplopia 1 month after receiving her fourth dose of the COVID-19 vaccine. Neurological examination revealed the presence of Cogan's sign, and she recovered rapidly after treatment. To our knowledge, this is the first reported case of myasthenia gravis associated with the COVID-19 vaccine in Brazil.


Assuntos
Blefaroptose , COVID-19 , Miastenia Gravis , Humanos , Feminino , Idoso , Vacinas contra COVID-19/efeitos adversos , COVID-19/complicações , Miastenia Gravis/induzido quimicamente , Miastenia Gravis/diagnóstico , Miastenia Gravis/complicações , Blefaroptose/complicações , Blefaroptose/diagnóstico , Blefaroptose/tratamento farmacológico , Diplopia/complicações , Diplopia/tratamento farmacológico
14.
Nihon Shokakibyo Gakkai Zasshi ; 120(4): 325-329, 2023.
Artigo em Japonês | MEDLINE | ID: covidwho-20243562

RESUMO

A 64-year-old woman received a third dose of SARS-CoV-2 mRNA vaccine. On the next day, she developed fever, diarrhea, and abdominal pain and had bloody stools. Total colonoscopy revealed deep ulceration on the whole colon. She was treated with corticosteroid and infliximab and her symptoms improved. She was diagnosed with severe enteritis resembling ulcerative colitis triggered by SARS-CoV-2 mRNA vaccination.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Colite Ulcerativa , Feminino , Humanos , Pessoa de Meia-Idade , Colite Ulcerativa/diagnóstico , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , RNA Mensageiro/uso terapêutico , SARS-CoV-2 , Vacinação
15.
PLoS Med ; 20(6): e1004245, 2023 Jun.
Artigo em Inglês | MEDLINE | ID: covidwho-20243323

RESUMO

BACKGROUND: An increased risk of myocarditis or pericarditis after priming with mRNA Coronavirus Disease 2019 (COVID-19) vaccines has been shown but information on the risk post-booster is limited. With the now high prevalence of prior Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection, we assessed the effect of prior infection on the vaccine risk and the risk from COVID-19 reinfection. METHODS AND FINDINGS: We conducted a self-controlled case series analysis of hospital admissions for myocarditis or pericarditis in England between 22 February 2021 and 6 February 2022 in the 50 million individuals eligible to receive the adenovirus-vectored vaccine (ChAdOx1-S) for priming or an mRNA vaccine (BNT162b2 or mRNA-1273) for priming or boosting. Myocarditis and pericarditis admissions were extracted from the Secondary Uses Service (SUS) database in England and vaccination histories from the National Immunisation Management System (NIMS); prior infections were obtained from the UK Health Security Agency's Second-Generation Surveillance Systems. The relative incidence (RI) of admission within 0 to 6 and 7 to 14 days of vaccination compared with periods outside these risk windows stratified by age, dose, and prior SARS-CoV-2 infection for individuals aged 12 to 101 years was estimated. The RI within 27 days of an infection was assessed in the same model. There were 2,284 admissions for myocarditis and 1,651 for pericarditis in the study period. Elevated RIs were only observed in 16- to 39-year-olds 0 to 6 days postvaccination, mainly in males for myocarditis. Both mRNA vaccines showed elevated RIs after first, second, and third doses with the highest RIs after a second dose 5.34 (95% confidence interval (CI) [3.81, 7.48]; p < 0.001) for BNT162b2 and 56.48 (95% CI [33.95, 93.97]; p < 0.001) for mRNA-1273 compared with 4.38 (95% CI [2.59, 7.38]; p < 0.001) and 7.88 (95% CI [4.02, 15.44]; p < 0.001), respectively, after a third dose. For ChAdOx1-S, an elevated RI was only observed after a first dose, RI 5.23 (95% CI [2.48, 11.01]; p < 0.001). An elevated risk of admission for pericarditis was only observed 0 to 6 days after a second dose of mRNA-1273 vaccine in 16 to 39 year olds, RI 4.84 (95% CI [1.62, 14.01]; p = 0.004). RIs were lower in those with a prior SARS-CoV-2 infection than in those without, 2.47 (95% CI [1.32,4.63]; p = 0.005) versus 4.45 (95% [3.12, 6.34]; p = 0.001) after a second BNT162b2 dose, and 19.07 (95% CI [8.62, 42.19]; p < 0.001) versus 37.2 (95% CI [22.18, 62.38]; p < 0.001) for mRNA-1273 (myocarditis and pericarditis outcomes combined). RIs 1 to 27 days postinfection were elevated in all ages and were marginally lower for breakthrough infections, 2.33 (95% CI [1.96, 2.76]; p < 0.001) compared with 3.32 (95% CI [2.54, 4.33]; p < 0.001) in vaccine-naïve individuals respectively. CONCLUSIONS: We observed an increased risk of myocarditis within the first week after priming and booster doses of mRNA vaccines, predominantly in males under 40 years with the highest risks after a second dose. The risk difference between the second and the third doses was particularly marked for the mRNA-1273 vaccine that contains half the amount of mRNA when used for boosting than priming. The lower risk in those with prior SARS-CoV-2 infection, and lack of an enhanced effect post-booster, does not suggest a spike-directed immune mechanism. Research to understand the mechanism of vaccine-associated myocarditis and to document the risk with bivalent mRNA vaccines is warranted.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Miocardite , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem , Vacina de mRNA-1273 contra 2019-nCoV , Vacina BNT162 , ChAdOx1 nCoV-19 , COVID-19/epidemiologia , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Inglaterra/epidemiologia , Vacinas de mRNA , Miocardite/epidemiologia , Miocardite/etiologia , SARS-CoV-2 , Vacinação/efeitos adversos
16.
Hum Vaccin Immunother ; 19(1): 2209919, 2023 12 31.
Artigo em Inglês | MEDLINE | ID: covidwho-20235641

RESUMO

During COVID-19 vaccination campaign, possible ChAdOx1-S-associated risks of thrombosis with thrombocytopenia syndrome led to implement ChAdOx1-S/BNT162b2 heterologous vaccination, despite the limited information on its reactogenicity and safety. We conducted a prospective observational post-marketing surveillance study to assess the safety of this heterologous schedule. A casually selected sample of recipients (n: 85; age: 18-60 years) of ChAdOx1-S/BNT162b2 at the vaccination hub of the Foggia Hospital, Italy, was matched with an equal sample of recipients of homologous BNT162b2. Safety was evaluated 7 days, 1 month and 14 weeks after the primary vaccination series using an adapted version of the "V-safe active surveillance for COVID-19 vaccine safety" CDC standardized questionnaire. After 7 days, local reactions were highly frequent (>80%) in both groups, and systemic reactions were less common (<70%). Moderate or severe pain at the injection site (OR = 3.62; 95%CI, 1.45-9.33), moderate/severe fatigue (OR = 3.40; 95%CI, 1.22-9.49), moderate/severe headache (OR = 4.72; 95%CI, 1.37-16.23), intake of antipyretics (OR = 3.05; 95 CI%, 1.35-6.88), inability to perform daily activities and work (OR = 2.64; 95%CI, 1.24-5.62) were significantly more common with heterologous than homologous vaccination. No significant difference in self-reported health status was recorded 1 month or 14 weeks after the second dose with BNT162b2 or ChAdOx1-S/BNT162b2. Our study confirms the safety of both heterologous and homologous vaccination, with a slight increase in some short-term adverse events for the heterologous regimen. Therefore, administering a second dose of a mRNA vaccine to the recipients of a previous dose of viral vector vaccine may have represented an advantageous strategy to improve flexibility and to accelerate the vaccination campaign.


Assuntos
Vacina BNT162 , COVID-19 , Humanos , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Vacinas contra COVID-19/efeitos adversos , COVID-19/prevenção & controle , Vacinação/efeitos adversos , Itália , Marketing
17.
Sci Rep ; 13(1): 9171, 2023 06 06.
Artigo em Inglês | MEDLINE | ID: covidwho-20235416

RESUMO

Throughout the pandemic era, COVID-19 was one of the remarkable unexpected situations over the past few years, but with the decentralization and globalization of efforts and knowledge, a successful vaccine-based control strategy was efficiently designed and applied worldwide. On the other hand, excused confusion and hesitation have widely impacted public health. This paper aims to reduce COVID-19 vaccine hesitancy taking into consideration the patient's medical history. The dataset used in this study is the Vaccine Adverse Event Reporting System (VAERS) dataset which was created as a corporation between the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) to gather reported side effects that may be caused by PFIEZER, JANSSEN, and MODERNA vaccines. In this paper, a Deep Learning (DL) model has been developed to identify the relationship between a certain type of COVID-19 vaccine (i.e. PFIEZER, JANSSEN, and MODERNA) and the adverse reactions that may occur in vaccinated patients. The adverse reactions under study are the recovery condition, possibility to be hospitalized, and death status. In the first phase of the proposed model, the dataset has been pre-proceesed, while in the second phase, the Pigeon swarm optimization algorithm is used to optimally select the most promising features that affect the performance of the proposed model. The patient's status after vaccination dataset is grouped into three target classes (Death, Hospitalized, and Recovered). In the third phase, Recurrent Neural Network (RNN) is implemented for both each vaccine type and each target class. The results show that the proposed model gives the highest accuracy scores which are 96.031% for the Death target class in the case of PFIEZER vaccination. While in JANSSEN vaccination, the Hospitalized target class has shown the highest performance with an accuracy of 94.7%. Finally, the model has the best performance for the Recovered target class in MODERNA vaccination with an accuracy of 97.794%. Based on the accuracy and the Wilcoxon Signed Rank test, we can conclude that the proposed model is promising for identifying the relationship between the side effects of COVID-19 vaccines and the patient's status after vaccination. The study displayed that certain side effects were increased in patients according to the type of COVID-19 vaccines. Side effects related to CNS and hemopoietic systems demonstrated high values in all studied COVID-19 vaccines. In the frame of precision medicine, these findings can support the medical staff to select the best COVID-19 vaccine based on the medical history of the patient.


Assuntos
COVID-19 , Aprendizado Profundo , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Vacinas , Estados Unidos , Humanos , Vacinas contra COVID-19/efeitos adversos , COVID-19/prevenção & controle , Saúde Pública , Vacinação/efeitos adversos
18.
West J Emerg Med ; 23(4): 570-578, 2022 Jul 11.
Artigo em Inglês | MEDLINE | ID: covidwho-20237020

RESUMO

INTRODUCTION: Unvaccinated emergency medical services (EMS) personnel are at increased risk of contracting coronavirus disease 2019 (COVID-19) and potentially transmitting the virus to their families, coworkers, and patients. Effective vaccines for the severe acute respiratory syndrome coronavirus 2 virus exist; however, vaccination rates among EMS professionals remain largely unknown. Consequently, we sought to document vaccination rates of EMS professionals and identify predictors of vaccination uptake. METHODS: We conducted a cross-sectional survey of North Carolina EMS professionals after the COVID-19 vaccines were widely available. The survey assessed vaccination status as well as beliefs regarding COVID-19 illness and vaccine effectiveness. Prediction of vaccine uptake was modeled using logistic regression. RESULTS: A total of 860 EMS professionals completed the survey, of whom 74.7% reported receiving the COVID-19 vaccination. Most respondents believed that COVID-19 is a serious threat to the population, that they are personally at higher risk of infection, that vaccine side effects are outweighed by illness prevention, and the vaccine is safe and effective. Despite this, only 18.7% supported mandatory vaccination for EMS professionals. Statistically significant differences were observed between the vaccinated and unvaccinated groups regarding vaccine safety and effectiveness, recall of employer vaccine recommendation, perceived risk of infection, degree of threat to the population, and trust in government to take actions to limit the spread of disease. Unvaccinated respondents cited reasons such as belief in personal health and natural immunity as protectors against infection, concerns about vaccine safety and effectiveness, inadequate vaccine knowledge, and lack of an employer mandate for declining the vaccine. Predictors of vaccination included belief in vaccine safety (odds ratio [OR] 5.5, P=<0.001) and effectiveness (OR 4.6, P=<0.001); importance of vaccination to protect patients (OR 15.5, P=<0.001); perceived personal risk of infection (OR 1.8, P=0.04); previous receipt of influenza vaccine (OR 2.5, P=0.003); and sufficient knowledge to make an informed decision about vaccination (OR 2.4, P=0.024). CONCLUSION: In this survey of EMS professionals, over a quarter remained unvaccinated for COVID-19. Given the identified predictors of vaccine acceptance, EMS systems should focus on countering misinformation through employee educational campaigns as well as on developing policies regarding workforce immunization requirements.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Serviços Médicos de Emergência , Pessoal de Saúde , Vacinação , COVID-19/prevenção & controle , Vacinas contra COVID-19/administração & dosagem , Vacinas contra COVID-19/efeitos adversos , Vacinas contra COVID-19/provisão & distribuição , Estudos Transversais , Tomada de Decisões , Pessoal de Saúde/psicologia , Pessoal de Saúde/estatística & dados numéricos , Inquéritos Epidemiológicos , Humanos , Vacinas contra Influenza/administração & dosagem , North Carolina , Saúde Ocupacional , Segurança do Paciente , Vacinação/legislação & jurisprudência , Vacinação/psicologia , Vacinação/estatística & dados numéricos
20.
Infect Dis Now ; 52(8S): S7-S8, 2022 Nov.
Artigo em Inglês | MEDLINE | ID: covidwho-20238432

RESUMO

Heterologous prime boost vaccination is a primary vaccination with different vaccines, most often from different vaccine platforms. It combines the immunological properties of the different vaccines and thereby induces humoral, cellular and, in some cases, mucosal response. For Covid prevention, it has been used in primary vaccination, due to safety issues and in boosters. We have evaluated some articles reporting on the results of this type of vaccine, and demonstrating its usefulness.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Humanos , Vacinas contra COVID-19/efeitos adversos , COVID-19/prevenção & controle , Imunização Secundária/métodos , Vacinação/métodos
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