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1.
Medicine (Baltimore) ; 103(31): e39166, 2024 Aug 02.
Artículo en Inglés | MEDLINE | ID: mdl-39093750

RESUMEN

RATIONALE: Acquired hemophilia A (AHA) is a rare autoimmune disease caused by an antibody that inhibits coagulation factor VIII activity. More than half of patients with AHA cannot identify underlying disorders. The remaining patients are associated with malignancies, autoimmune diseases, skin diseases, infections, and medications. Here, we present a case of 56-year-old Korean man with underlying hypertension, dyslipidemia, and diabetes mellitus who developed AHA following the second dose of BNT162b2 COVID-19 vaccination. PATIENT CONCERNS: He presented with a large 20 × 30 cm-sized hematoma along the psoas muscle and intracranial hemorrhage, necessitating intensive care with mechanical ventilation and continuous renal replacement therapy. Laboratory testing demonstrated that activated partial thromboplastin time and prothrombin times were 74.7 seconds (normal range 29-43 seconds) and 17.2 seconds (normal range 12.5-14.7 seconds), respectively. DIAGNOSES: Laboratory tests confirmed AHA with undetectable factor VIII activity (<1.5%) and a positive factor VIII antibody with a titer of 8.49 Bethesda units/mL. INTERVENTIONS: Recombinant factor VIIa (NovoSeven®) was administered every 2 hours to control the bleeding, alongside immunosuppression with methylprednisolone 1 mg/kg daily and cyclophosphamide 2 mg/kg daily to eliminate the autoantibody. OUTCOMES: Despite the treatments, the patient developed sepsis and succumbed 14 weeks after admission. LESSONS: This rare case underscores the importance of monitoring for AHA following COVID-19 vaccination. Although the benefits outweigh the risks of vaccination, AHA should be considered in the differential diagnosis of unusual bleeding following the vaccinations. Early diagnosis and management before severe bleeding are critical for successfully controlling life-threatening bleeding.


Asunto(s)
Vacuna BNT162 , Vacunas contra la COVID-19 , COVID-19 , Hemofilia A , Humanos , Masculino , Persona de Mediana Edad , Hemofilia A/tratamiento farmacológico , Hemofilia A/complicaciones , Vacunas contra la COVID-19/efectos adversos , COVID-19/prevención & control , COVID-19/complicaciones , Vacuna BNT162/efectos adversos , SARS-CoV-2 , Factor VIIa/uso terapéutico , Proteínas Recombinantes/uso terapéutico , Proteínas Recombinantes/efectos adversos
2.
Sci Rep ; 14(1): 18767, 2024 08 13.
Artículo en Inglés | MEDLINE | ID: mdl-39138276

RESUMEN

The vaccination against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is an important public health strategy to prevent people from the pandemic. Vaccines are a game-changing tool, it is essential to understand the adverse events after COVID-19 vaccination. This study explored the adverse events of COVID-19 Vaccination Oxford-AstraZeneca, Pfizer-BioNTech, Moderna, Johnson and Johnson on Guillain-Barré Syndrome (GBS). In this study, initially 128 documents were identified from the databases, including Pub-Med, Web of Science-Clarivate Analytics, Scopus, and Google Scholar. The articles on COVID-19 vaccination and GBs were searched using the keywords "SARS-CoV-2, COVID-19, Vaccination, and Guillain Barré Syndrome, GBS", finally, 16 documents were included in the analysis and synthesis. After administering 1,680,042,214 doses of COVID-19 vaccines, 6177 cases were identified with 10.5 cases per million vaccine doses. A significant positive risk was found between COVID-19 vaccine administration and GBS with a risk rate of RR 1.97 (95% CI 1.26-3.08, p = 0.01). The mRNA vaccines were associated with 2076 cases, and 1,237,638,401 vaccine doses were linked with 4.47 GBS events per million vaccine doses. The first dose of the m-RNA vaccine was associated with 8.83 events per million doses compared to the second dose with 02 events per million doses. The viral-vector vaccine doses 193,535,249 were linked to 1630 GBS cases with 11.01 cases per million doses. The incidence of GBS after the first dose was 17.43 compared to 1.47 cases per million in the second dose of the viral-vector vaccine. The adverse events of the Oxford-AstraZeneca vaccine were linked to 1339 cases of GBS following 167,786,902 vaccine doses, with 14.2 cases per million doses. The Oxford-AstraZeneca vaccine significantly increased the risk of GBS RR: 2.96 (95% CI 2.51-3.48, p = 0.01). For the Pfizer-BioNTech vaccine, there were 7.20 cases per million doses of the vaccine, and no significant association was identified between the Pfizer-BioNTech vaccine and GBS incidence RR: 0.99 (95% CI 0.75-1.32, p = 0.96). Moderna vaccine was related with 419 cases of GBS after administering 420,420,909 doses, with 2.26 cases per million doses. However, Johnson and Johnson's vaccination was linked to 235 GBS after 60,256,913 doses of the vaccine with 8.80 cases per million doses. A significant association was seen between the risk of GBS and Ad.26.COV2. S vaccine, RR: 2.47 (95% CI 1.30-4.69, p < 0.01). Overall, a significant association was seen between the COVID-19 vaccines and the risk of GBS. The incidence of GBS was higher after the first dose compared to GBS cases per million in the second dose.


Asunto(s)
Vacunas contra la COVID-19 , COVID-19 , Síndrome de Guillain-Barré , Humanos , Vacuna BNT162/efectos adversos , ChAdOx1 nCoV-19/efectos adversos , COVID-19/prevención & control , COVID-19/epidemiología , Vacunas contra la COVID-19/efectos adversos , Síndrome de Guillain-Barré/inducido químicamente , Síndrome de Guillain-Barré/epidemiología , Vacunación/efectos adversos
3.
Hum Vaccin Immunother ; 20(1): 2368681, 2024 Dec 31.
Artículo en Inglés | MEDLINE | ID: mdl-38953297

RESUMEN

Despite a lack of clinical data demonstrating the effectiveness of alcohol swab cleansing prior to vaccinations as a prophylactic measure to prevent skin infections, it is recommended for vaccine administration by the Canadian Immunization Guide. The objective of this study was to evaluate the risk of adverse events after omitting alcohol skin cleansing in long-term care (LTC) residents receiving vaccinations during the COVID-19 pandemic. Two medium-sized LTC homes participated in a cohort study, whereby one LTC used alcohol swab cleansing prior to resident vaccinations and the other did not. All residents received two doses of the BNT162b2 COVID-19 vaccine separated by an average (SD) 29.3 (8.5) days. The electronic chart records of participants were reviewed by researchers blinded to group allocation to assess for the presence of adverse events following immunization (AEFI), including reactogenicity, cellulitis, abscess, or systemic reactions. Log-binomial regression was used to compute risk ratios (with 95% confidence intervals) of an AEFI according to alcohol swab status. 189 residents were included, with a total of 56 AEFI between the two doses. The risk of reactogenicity (adjusted RR 0.54, 95% CI 0.17-1.73) or systemic reactions (adjusted RR 0.75, 95% CI 0.26-2.13) did not differ for the residents that received alcohol skin antisepsis compared to those that did not. There were no cases of cellulitis or abscess. This study did not demonstrate an elevated risk of AEFI in LTC residents receiving two doses of the BNT162b2 mRNA COVID vaccine without alcohol skin antisepsis.


Asunto(s)
Vacuna BNT162 , Vacunas contra la COVID-19 , COVID-19 , Cuidados a Largo Plazo , Vacunación , Humanos , Masculino , Femenino , COVID-19/prevención & control , Anciano , Estudios de Cohortes , Vacuna BNT162/administración & dosificación , Vacuna BNT162/efectos adversos , Vacunación/efectos adversos , Vacunas contra la COVID-19/efectos adversos , Vacunas contra la COVID-19/administración & dosificación , Anciano de 80 o más Años , SARS-CoV-2/inmunología , Canadá , Etanol/efectos adversos , Etanol/administración & dosificación
4.
BMJ Case Rep ; 17(7)2024 Jul 11.
Artículo en Inglés | MEDLINE | ID: mdl-38991576

RESUMEN

Systemic capillary leak syndrome (SCLS) is a rare and life-threatening disorder characterised by leaking of intravascular fluid to extravascular tissues. An association with immunotherapy and COVID-19 vaccination has been reported as potential triggers. A case of a patient in her 70s developing SCLS after the BNT162b2 (Pfizer-BioNTech) COVID-19 vaccination with a history of metastatic melanoma treated with nivolumab (PD-1 monoclonal antibody) and ipilimumab (anti-CTLA4 monoclonal antibody) is reported. The aetiology and management of SCLS are also reviewed in this case context.


Asunto(s)
COVID-19 , Síndrome de Fuga Capilar , Ipilimumab , Melanoma , Nivolumab , Humanos , Melanoma/tratamiento farmacológico , Síndrome de Fuga Capilar/inducido químicamente , Nivolumab/efectos adversos , Femenino , Ipilimumab/efectos adversos , Anciano , COVID-19/complicaciones , Vacunas contra la COVID-19/efectos adversos , Vacuna BNT162/efectos adversos , SARS-CoV-2 , Inmunoterapia/efectos adversos , Inmunoterapia/métodos , Neoplasias Cutáneas/tratamiento farmacológico , Antineoplásicos Inmunológicos/efectos adversos , Antineoplásicos Inmunológicos/uso terapéutico
5.
J Oral Sci ; 66(3): 193-197, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39010168

RESUMEN

PURPOSE: Nausea and vomiting during pregnancy (NVP) are common among pregnant women and can be severe enough to require hospitalization. However, the mechanism underlying NVP pathogenesis remains unclear. This study examined factors associated with adverse events after vaccination, including a past history of NVP. METHODS: A questionnaire-based survey was completed by non-pregnant women working at Nagasaki University Hospital who received two doses of the BNT162b2 coronavirus disease 2019 (COVID-19) vaccine. This study primarily examined the association between a past history of NVP and post-vaccination fever, as fever was determined to be the most objective and reliable indicator of the surveyed adverse events. RESULTS: Multivariate logistic regression analysis showed that post-vaccination fever was more strongly associated with a past history of NVP (odds ratio, 1.88; 95% confidence interval, 1.16-3.07) than either age (0.73; 0.56-0.96) or weight (0.85; 0.70-1.15), which were previously considered to be highly associated with the incidence of adverse events following COVID-19 vaccination. CONCLUSION: These results suggest an involvement of a similar pathological condition in developing NVP and post-vaccination fever.


Asunto(s)
Vacuna BNT162 , Fiebre , Náusea , Vómitos , Humanos , Femenino , Embarazo , Adulto , Vacuna BNT162/efectos adversos , Náusea/etiología , Fiebre/etiología , COVID-19/prevención & control , Encuestas y Cuestionarios , Vacunas contra la COVID-19/efectos adversos , Vacunación/efectos adversos , Adulto Joven , SARS-CoV-2
6.
Nat Commun ; 15(1): 6085, 2024 Jul 31.
Artículo en Inglés | MEDLINE | ID: mdl-39085208

RESUMEN

The first dose of COVID-19 vaccines led to an overall reduction in cardiovascular events, and in rare cases, cardiovascular complications. There is less information about the effect of second and booster doses on cardiovascular diseases. Using longitudinal health records from 45.7 million adults in England between December 2020 and January 2022, our study compared the incidence of thrombotic and cardiovascular complications up to 26 weeks after first, second and booster doses of brands and combinations of COVID-19 vaccines used during the UK vaccination program with the incidence before or without the corresponding vaccination. The incidence of common arterial thrombotic events (mainly acute myocardial infarction and ischaemic stroke) was generally lower after each vaccine dose, brand and combination. Similarly, the incidence of common venous thrombotic events, (mainly pulmonary embolism and lower limb deep venous thrombosis) was lower after vaccination. There was a higher incidence of previously reported rare harms after vaccination: vaccine-induced thrombotic thrombocytopenia after first ChAdOx1 vaccination, and myocarditis and pericarditis after first, second and transiently after booster mRNA vaccination (BNT-162b2 and mRNA-1273). These findings support the wide uptake of future COVID-19 vaccination programs.


Asunto(s)
Vacunas contra la COVID-19 , COVID-19 , Enfermedades Cardiovasculares , Vacunación , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Vacuna nCoV-2019 mRNA-1273/administración & dosificación , Vacuna nCoV-2019 mRNA-1273/efectos adversos , Vacuna BNT162/efectos adversos , Vacuna BNT162/administración & dosificación , Enfermedades Cardiovasculares/epidemiología , ChAdOx1 nCoV-19/administración & dosificación , ChAdOx1 nCoV-19/efectos adversos , Estudios de Cohortes , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , Vacunas contra la COVID-19/administración & dosificación , Inglaterra/epidemiología , Inmunización Secundaria/efectos adversos , Incidencia , Infarto del Miocardio/epidemiología , Infarto del Miocardio/etiología , Miocarditis/epidemiología , Miocarditis/etiología , Embolia Pulmonar/epidemiología , Embolia Pulmonar/etiología , Trombosis/epidemiología , Trombosis/etiología , Vacunación/efectos adversos , Adolescente , Adulto Joven , Anciano de 80 o más Años
7.
Dermatol Online J ; 30(2)2024 Apr 15.
Artículo en Inglés | MEDLINE | ID: mdl-38959927

RESUMEN

Dermatomyositis (DM) is a multi-organ idiopathic inflammatory myopathy that presents with proximal symmetric muscle weakness accompanied by characteristic cutaneous findings. Most individuals present with skin manifestations prior to muscle involvement and its course can involve the blood vessels, joints, esophagus, and lungs and can be paraneoplastic, making a malignancy assessment imperative. Although its etiology is unknown, type I interferon appears to be a component in evoking the characteristic inflammatory response and patients with DM often have an increase in type I inducible genes. Suspected triggers for DM are environmental factors, drugs, viral infections, and vaccines. The association of DM with vaccination poses a new conundrum within the medical community as people continue to get vaccinated and boosted with SARS-CoV2 vaccines, though it is worth noting that the most common challenges arose as type I hypersensitivity reactions and new onset autoimmune disorders are rare. Presented here is a 53-year-old man who was diagnosed with DM after receiving the second dose of the Pfizer vaccine. His case highlights the importance of the potential onset of autoimmune diseases following the COVID-19 vaccine, a phenomenon that clinicians should be aware of as the discourse concerning the pandemic continues.


Asunto(s)
Dermatomiositis , Humanos , Dermatomiositis/inducido químicamente , Masculino , Persona de Mediana Edad , Vacunas contra la COVID-19/efectos adversos , Vacuna BNT162/efectos adversos , COVID-19/prevención & control
8.
Dermatol Online J ; 30(2)2024 Apr 15.
Artículo en Inglés | MEDLINE | ID: mdl-38959931

RESUMEN

Chronic spontaneous urticaria (CSU) involves recurrent, pruritic wheals lasting more than 6 weeks in response to various etiologies, including unknown causality. Though most cutaneous reactions to the COVID-19 vaccine series are self-limited and of short duration, more complex presentations including chronic spontaneous urticaria have been described. To the best of our knowledge, this is the first report of chronic spontaneous urticaria following heterologous mRNA COVID-19 booster vaccination that includes vaccination with both forms of the mRNA vaccine. Our patient received Pfizer-BioNTech for the primary series and Moderna for the booster. After failing several therapies, our patient's urticaria was refractory even to omalizumab. The source for chronic spontaneous urticaria development in our patient may be related to the unique humoral response elicited by receipt of a different mRNA vaccine manufacturer.


Asunto(s)
Vacunas contra la COVID-19 , Urticaria Crónica , Inmunización Secundaria , Humanos , Vacunas contra la COVID-19/efectos adversos , Inmunización Secundaria/efectos adversos , Vacuna BNT162/efectos adversos , Femenino , Omalizumab/uso terapéutico , COVID-19/prevención & control , COVID-19/complicaciones , Persona de Mediana Edad , Masculino , Adulto
9.
Rheumatol Int ; 44(9): 1725-1731, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-39003346

RESUMEN

Notwithstanding the wealth of literature on COVID-19, studies focusing on young adults with autoimmune diseases (AD) are lacking. To determine early (within 7 days) and late (after 7 days) anti-SARS-CoV-2 vaccine-related adverse events (AEs), post-vaccine disease flares, COVID-19 severity and breakthrough infections (B-INFs) in young people with rheumatic diseases (RMDs) and non-rheumatic autoimmune diseases (nr-ADs) compared to healthy controls (HC). Data were captured through the international COVID-19 vaccination in autoimmune diseases (COVAD) 1 and 2 questionnaires. Of 20,685 complete responses, we identified 6010 from patients aged 18-35 years (1692 RMD, 400 nrADs, 3918 HC) who received up to 4 vaccine doses. BNT162b2 was the most frequently administered vaccine and prior to vaccination, 7% of people with nrAD were taking immunosuppressants (IS) versus 80% in RMDs. Early mild AEs were more frequent in RMDs (93%) and nr-ADs (92%) compared to HC (85%). The frequency of late mild AEs was < 20% in all groups. Severe AEs were rare. SARS-CoV-2 infection rates were similar across all groups, however, RMD patients reported a single episode of infection more frequently than nrADs and HC, while nrADs reported multiple infections more frequently than RMD. Self-reported disease flares were reported by 10% or RMD and 7% of nrAD patients. Our study reinforces the safety of anti-SARS-CoV-2 vaccine also in young people with ADs, but it also highlights that among young individuals the number and clinical picture of SARS-CoV-2 infections is affected more by the type of AD rather than by coexisting IS therapy.


Asunto(s)
Enfermedades Autoinmunes , Vacunas contra la COVID-19 , COVID-19 , SARS-CoV-2 , Índice de Severidad de la Enfermedad , Humanos , COVID-19/prevención & control , Adulto Joven , Femenino , Adulto , Masculino , Vacunas contra la COVID-19/efectos adversos , Vacunas contra la COVID-19/administración & dosificación , Adolescente , SARS-CoV-2/inmunología , Enfermedades Reumáticas/tratamiento farmacológico , Vacuna BNT162/efectos adversos , Vacunación/efectos adversos , Infección Irruptiva
11.
BMC Nephrol ; 25(1): 196, 2024 Jun 13.
Artículo en Inglés | MEDLINE | ID: mdl-38872134

RESUMEN

BACKGROUND: TAFRO syndrome is a rare disorder that causes thrombocytopenia, generalized oedema, fever, organ enlargement, and renal impairment. Few reports have suggested an association with vaccines, and few cases have undergone renal biopsy. TAFRO syndrome is often severe and fatal, and its cause is unknown. We report a case of TAFRO syndrome that occurred after vaccination with the coronavirus disease 2019 (COVID-19) vaccine. CASE PRESENTATION: An 82-year-old woman received two doses of the BNT162b2 mRNA vaccine 3 weeks apart. Two weeks later, she was admitted to the hospital with oedema, accompanied with renal failure and thrombocytopenia. After close examination, she was diagnosed with TAFRO syndrome. She was treated with steroids, cyclosporine, and thrombopoietin receptor agonists. The patient was discharged after several months in remission. CONCLUSIONS: Although an incident of TAFRO syndrome after COVID-19 vaccination has been previously reported, this is a rare case in which the patient went into remission and was discharged. A renal biopsy was also performed in this case, which was consistent with previous reports. The favorable treatment course for TAFRO syndrome provides valuable insights.


Asunto(s)
Ciclosporina , Humanos , Femenino , Ciclosporina/uso terapéutico , Ciclosporina/efectos adversos , Anciano de 80 o más Años , Trombocitopenia/inducido químicamente , Vacuna BNT162/efectos adversos , Inmunosupresores/uso terapéutico , Inmunosupresores/efectos adversos , Vacunas contra la COVID-19/efectos adversos , Edema/etiología , Edema/inducido químicamente , COVID-19/complicaciones , COVID-19/prevención & control
13.
Nat Commun ; 15(1): 5490, 2024 Jun 28.
Artículo en Inglés | MEDLINE | ID: mdl-38944652

RESUMEN

The widespread administration of COVID-19 vaccines has prompted a need to understand their safety profile. This investigation focuses on the safety of inactivated and mRNA-based COVID-19 vaccines, particularly concerning potential cardiovascular and haematological adverse events. A retrospective cohort study was conducted for 1.3 million individuals residing in Abu Dhabi, United Arab Emirates, who received 1.8 million doses of the inactivated BBIBP CorV (by SinoPharm) and mRNA-based BNT162b2 (Pfizer-BioNTech) vaccines between June 1, 2021, and June 30, 2022. The study's primary outcome was to assess the occurrence of selected cardiovascular and haematological events leading to hospitalization or emergency room visits within 21 days post-vaccination. Results showed no significant increase in the incidence rates of these events compared to the subsequent 22 to 42 days following vaccination. Analysis revealed no elevated risk for adverse outcomes following first (IRR 1·03; 95% CI 0·82-1·31), second (IRR 0·92; 95% CI 0·72-1·16) and third (IRR 0·82; 95% CI 0·66-1·00) doses of either vaccine. This study found no substantial link between receiving either mRNA and inactivated COVID-19 vaccines and a higher likelihood of cardiovascular or haematological events within 21 days after vaccination.


Asunto(s)
Vacuna BNT162 , Vacunas contra la COVID-19 , COVID-19 , Enfermedades Cardiovasculares , SARS-CoV-2 , Vacunación , Vacunas de Productos Inactivados , Humanos , Estudios Retrospectivos , Emiratos Árabes Unidos/epidemiología , Masculino , Femenino , Vacunas contra la COVID-19/efectos adversos , Vacunas contra la COVID-19/inmunología , Vacunas contra la COVID-19/administración & dosificación , Persona de Mediana Edad , Adulto , COVID-19/prevención & control , COVID-19/epidemiología , COVID-19/inmunología , Enfermedades Cardiovasculares/epidemiología , Vacuna BNT162/efectos adversos , Vacuna BNT162/inmunología , Vacunas de Productos Inactivados/efectos adversos , Vacunas de Productos Inactivados/inmunología , Vacunas de Productos Inactivados/administración & dosificación , SARS-CoV-2/inmunología , Vacunación/efectos adversos , Anciano , Adulto Joven , Enfermedades Hematológicas/epidemiología , Adolescente
14.
BMC Genom Data ; 25(1): 51, 2024 Jun 06.
Artículo en Inglés | MEDLINE | ID: mdl-38844841

RESUMEN

Vaccine-related myocarditis associated with the BNT162b2 vaccine is a rare complication, with a higher risk observed in male adolescents. However, the contribution of genetic factors to this condition remains uncertain. In this study, we conducted a comprehensive genetic association analysis in a cohort of 43 Hong Kong Chinese adolescents who were diagnosed with myocarditis shortly after receiving the BNT162b2 mRNA COVID-19 vaccine. A comparison of whole-genome sequencing data was performed between the confirmed myocarditis cases and a control group of 481 healthy individuals. To narrow down potential genomic regions of interest, we employed a novel clustering approach called ClusterAnalyzer, which prioritised 2,182 genomic regions overlapping with 1,499 genes for further investigation. Our pathway analysis revealed significant enrichment of these genes in functions related to cardiac conduction, ion channel activity, plasma membrane adhesion, and axonogenesis. These findings suggest a potential genetic predisposition in these specific functional areas that may contribute to the observed side effect of the vaccine. Nevertheless, further validation through larger-scale studies is imperative to confirm these findings. Given the increasing prominence of mRNA vaccines as a promising strategy for disease prevention and treatment, understanding the genetic factors associated with vaccine-related myocarditis assumes paramount importance. Our study provides valuable insights that significantly advance our understanding in this regard and serve as a valuable foundation for future research endeavours in this field.


Asunto(s)
Vacuna BNT162 , Predisposición Genética a la Enfermedad , Estudio de Asociación del Genoma Completo , Miocarditis , Humanos , Vacuna BNT162/efectos adversos , Miocarditis/genética , Miocarditis/epidemiología , Miocarditis/etiología , Miocarditis/inducido químicamente , Masculino , Adolescente , Hong Kong/epidemiología , Femenino , Vacunas contra la COVID-19/efectos adversos , COVID-19/prevención & control , COVID-19/genética , COVID-19/epidemiología , Secuenciación Completa del Genoma , SARS-CoV-2/genética , SARS-CoV-2/inmunología
15.
Ann Intern Med ; 177(7): 892-900, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38857503

RESUMEN

BACKGROUND: Concern about side effects is a common reason for SARS-CoV-2 vaccine hesitancy. OBJECTIVE: To determine whether short-term side effects of SARS-CoV-2 messenger RNA (mRNA) vaccination are associated with subsequent neutralizing antibody (nAB) response. DESIGN: Prospective cohort study. SETTING: San Francisco Bay Area. PARTICIPANTS: Adults who had not been vaccinated against or exposed to SARS-CoV-2, who then received 2 doses of either BNT162b2 or mRNA-1273. MEASUREMENTS: Serum nAB titer at 1 month and 6 months after the second vaccine dose. Daily symptom surveys and objective biometric measurements at each dose. RESULTS: 363 participants were included in symptom-related analyses (65.6% female; mean age, 52.4 years [SD, 11.9]), and 147 were included in biometric-related analyses (66.0% female; mean age, 58.8 years [SD, 5.3]). Chills, tiredness, feeling unwell, and headache after the second dose were each associated with 1.4 to 1.6 fold higher nAB at 1 and 6 months after vaccination. Symptom count and vaccination-induced change in skin temperature and heart rate were all positively associated with nAB across both follow-up time points. Each 1 °C increase in skin temperature after dose 2 was associated with 1.8 fold higher nAB 1 month later and 3.1 fold higher nAB 6 months later. LIMITATIONS: The study was conducted in 2021 in people receiving the primary vaccine series, making generalizability to people with prior SARS-CoV-2 vaccination or exposure unclear. Whether the observed associations would also apply for neutralizing activity against non-ancestral SARS-CoV-2 strains is also unknown. CONCLUSION: Convergent self-report and objective biometric findings indicate that short-term systemic side effects of SARS-CoV-2 mRNA vaccination are associated with greater long-lasting nAB responses. This may be relevant in addressing negative attitudes toward vaccine side effects, which are a barrier to vaccine uptake. PRIMARY FUNDING SOURCE: National Institute on Aging.


Asunto(s)
Vacuna nCoV-2019 mRNA-1273 , Anticuerpos Neutralizantes , Vacuna BNT162 , Vacunas contra la COVID-19 , COVID-19 , SARS-CoV-2 , Humanos , Femenino , Persona de Mediana Edad , Masculino , Estudios Prospectivos , Anticuerpos Neutralizantes/sangre , COVID-19/prevención & control , COVID-19/inmunología , Vacuna BNT162/efectos adversos , SARS-CoV-2/inmunología , Vacunas contra la COVID-19/efectos adversos , Vacunas contra la COVID-19/inmunología , Vacuna nCoV-2019 mRNA-1273/efectos adversos , Adulto , Anticuerpos Antivirales/sangre , Escalofríos/inducido químicamente , Cefalea/inducido químicamente , Fatiga/inducido químicamente , Anciano
16.
Int J Infect Dis ; 146: 107149, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-38909928

RESUMEN

OBJECTIVES: To evaluate the difference between BNT162b2 and CoronaVac in vaccine effectiveness and safety. METHODS: This target trial emulation study included individuals aged ≥12 during 2022. Propensity score matching was applied to ensure group balance. The Cox proportional hazard model was used to compare the effectiveness outcomes including COVID-19 infection, severity, 28-day hospitalization, and 28-day mortality after infection. Poisson regression was used for safety outcomes including 32 adverse events of special interests between groups. RESULTS: A total of 639,818 and 1804,388 individuals were identified for the 2-dose and 3-dose comparison, respectively. In 2-dose and 3-dose comparison, the hazard ratios (95% confidence intervals [CI]) were 0.844 [0.833-0.856] and 0.749 [0.743-0.755] for COVID-19 infection, 0.692 [0.656-0.731] and 0.582 [0.559-0.605] for hospitalization, 0.566 [0.417-0.769] and 0.590 [0.458-0.76] for severe COVID-19, and 0.563 [0.456-0.697] and 0.457 [0.372-0.561] for mortality for BNT162b2 recipients versus CoronaVac recipients, respectively. Regarding safety, 2-dose BNT162b2 recipients had a significantly higher incidence of myocarditis (incidence rate ratio [IRR] [95% CI]: 8.999 [1.14-71.017]) versus CoronaVac recipients, but the difference was insignificant in 3-dose comparison (IRR [95% CI]: 2.000 [0.500-7.996]). CONCLUSION: BNT162b2 has higher effectiveness among individuals aged ≥12 against COVID-19-related outcomes for SARS-CoV-2 omicron compared to CoronaVac, with almost 50% lower mortality risk.


Asunto(s)
Vacuna BNT162 , Vacunas contra la COVID-19 , COVID-19 , Hospitalización , Vacunas de Productos Inactivados , Adolescente , Adulto , Anciano , Niño , Femenino , Humanos , Masculino , Persona de Mediana Edad , Adulto Joven , Vacuna BNT162/administración & dosificación , Vacuna BNT162/efectos adversos , COVID-19/mortalidad , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , Vacunas contra la COVID-19/administración & dosificación , Hong Kong/epidemiología , Hospitalización/estadística & datos numéricos , SARS-CoV-2 , Eficacia de las Vacunas , Vacunas de Productos Inactivados/administración & dosificación , Vacunas de Productos Inactivados/efectos adversos
17.
Vaccine ; 42(18): 3830-3837, 2024 Jul 11.
Artículo en Inglés | MEDLINE | ID: mdl-38729910

RESUMEN

BACKGROUND: A large vaccination campaign was initiated worldwide in December 2020 in order to prevent infection with SARS-CoV-2 and severe Covid-19 disease. However, long-term adverse effects of vaccination remain unclear. Therefore, our objective was to examine the association between vaccination and the incidence of autoimmune diagnoses in the first year after vaccine uptake. METHODS: This retrospective cohort study based on Clalit Health Services (CHS) comprehensive database compared the rates of immune-mediated diagnoses among BNT162b2 vaccinated versus unvaccinated individuals. As a reference, a secondary cohort compared individuals infected with Sars-CoV-2 versus uninfected individuals. The minimum follow-up period was 4 months. The cohorts were divided into 4 age groups (12-17, 18-44, 45-64, 65 years or older). Multivariate Cox proportional hazard regression models were applied, followed by a correction for multiple comparisons using the False Discovery Rate (FDR) method, hence accounting for the investigation of multiple clinical outcomes. RESULTS: Increased risk for immune-mediated diagnoses following vaccination with BNT162b2 was observed for psoriasis in all age groups (HR 1.41-1.69), colitis among patients younger than 65 years (HR 1.38-1.93), vitiligo in patients aged 45-64 (HR 2.82, 95 %CI: 1.57-5.08) and for polymyalgia-rheumatica in patients aged 65 years or older (HR 2.12, 95 % CI: 1.3-3.47). In the reference cohort, patients who were infected by Covid-19 were at increased risk for fibromyalgia (HR 1.72, 95 % CI: 1.36-2.19 in individuals aged 18-44; HR 1.71, 95 % CI: 1.31-2.22 in individuals aged 45-64), and hypothyroidism (HR 1.54, 95 % CI: 1.15-2.07 in individuals aged 65 years or older). CONCLUSIONS: The BNT162b2 vaccine was associated with increased risk (though rare) for psoriasis, colitis and polymyalgia rheumatica. These findings should be considered as a part of the risk-benefit assessment when planning future vaccination programs for various population groups.


Asunto(s)
Vacuna BNT162 , COVID-19 , Humanos , Vacuna BNT162/inmunología , Vacuna BNT162/efectos adversos , Persona de Mediana Edad , Estudios Retrospectivos , Masculino , Adulto , Femenino , COVID-19/prevención & control , COVID-19/epidemiología , COVID-19/inmunología , Anciano , Adolescente , Adulto Joven , Incidencia , Niño , Vacunación/efectos adversos , Vacunación/estadística & datos numéricos , SARS-CoV-2/inmunología , Comorbilidad , Enfermedades Autoinmunes/epidemiología , Enfermedades Autoinmunes/etiología , Vacunas contra la COVID-19/efectos adversos , Vacunas contra la COVID-19/inmunología , Vacunas contra la COVID-19/administración & dosificación , Psoriasis/epidemiología , Psoriasis/inmunología
18.
Vaccine ; 42(18): 3819-3829, 2024 Jul 11.
Artículo en Inglés | MEDLINE | ID: mdl-38714447

RESUMEN

This study examined short-to-medium term safety of COVID-19 vaccines among adults aged ≥65 years using the Canadian National Vaccine Safety Network active safety surveillance data. Both vaccinated and unvaccinated older adult participants recruited from seven provinces and territories were included in the analysis. Safety was assessed at 7 days after COVID-19 vaccination (dose 1, 2 and 3), and 7 months after dose 1. Multivariable logistic regression was used to examine the association between BNT162b2/mRNA-1273 COVID-19 vaccines and two short-term health events: 1) health event preventing daily activities and/or required medical consultation, 2) serious health events resulting in an emergency department visit and/or hospitalization within 7 days following each dose. We also assessed the rates of serious health events for the period between dose 1 and 2, and 7-months following dose 1. Between December 2020 and February 2022, a total of 173,038, 104,452, and 13,970 older adults completed dose 1, dose 2, and dose 3 surveys, respectively. The control survey was completed by 2,955 unvaccinated older adults. Health events occurred more frequently among recipients after dose 2 homologous mRNA-1273 (adjusted odds ratio [95 % confidence interval]: 2.91 [2.24-3.79]) and dose two heterologous (BNT162b2 followed by mRNA-1273): 1.50 [1.12-2.02] compared to unvaccinated counterparts. There was no difference in event rates after any dose of BNT162b2 and unvaccinated participants. The rates of serious health events following COVID-19 vaccination were very low (≤0.3 %) across all vaccine products and doses, and were not higher compared to unvaccinated controls, and were not associated with an emergency department visit or hospitalization within 7 days following vaccination. Reported symptoms were self-limited and rarely required medical assessment. Our findings further strengthen the current evidence that mRNA COVID-19 vaccines are safe and can be used to inform older adults about expected adverse events following COVID-19 vaccination.


Asunto(s)
Vacuna nCoV-2019 mRNA-1273 , Vacuna BNT162 , Vacunas contra la COVID-19 , COVID-19 , SARS-CoV-2 , Humanos , Anciano , Masculino , Femenino , Canadá , COVID-19/prevención & control , COVID-19/epidemiología , Vacuna BNT162/administración & dosificación , Vacuna BNT162/efectos adversos , Vacunas contra la COVID-19/efectos adversos , Vacunas contra la COVID-19/administración & dosificación , Anciano de 80 o más Años , SARS-CoV-2/inmunología , Vacunación/efectos adversos , Hospitalización/estadística & datos numéricos
19.
J Investig Med High Impact Case Rep ; 12: 23247096241231645, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38761096

RESUMEN

Pfizer/BioNTech (BNT162b2) is a messenger RNA (mRNA) vaccine that is highly effective in preventing the most severe outcomes of COVID-19 infection. Nucleoside-modified severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA vaccines induce effective stimulation of T follicular helper (TFH) cells, leading to a robust germinal center B cell response. Side effects from the BNT162b2 vaccination, including significant lymphadenopathy, have been reported previously. Here, we present a case of angioimmunoblastic lymphoma (AITL), a rare, peripheral T-cell lymphoma with RHOA-G17v-mutated gene developing in a patient following BNT162B2 vaccine with a plausible explanation. A 60-year-old Asian female received her first dose of Pfizer BNT162B2 mRNA vaccine in August 2021. Right after her vaccination, she developed right axillary lymphadenopathy. She received her second vaccine dose in September 2021. Thereafter, she developed lymph node (LN) enlargement in her neck and groin. She underwent left posterior cervical and left groin LN excisional biopsy in April 2022 due to persistent palpable lymphadenopathy. Biopsy results then demonstrated benign follicular hyperplasia. For progressive B symptoms, a right axillary LN biopsy was done, which demonstrated AITL, with molecular studies revealing mutation in TET-2, IDH-2, and RHOA-G17v genes. Progression of AITL following BNT162B2 mRNA vaccine is limited in literature. Our case demonstrates a plausible correlation between the diagnosis of AITL following mRNA vaccination due to the malignant transformation of the TFH cells in patients who have a predisposing mutation of RHOA-17v. Given the rarity of AITL and the heterogeneity of molecular findings, more studies are needed to establish such an association.


Asunto(s)
Vacuna BNT162 , Humanos , Femenino , Vacuna BNT162/efectos adversos , Persona de Mediana Edad , Proteína de Unión al GTP rhoA/genética , Linfadenopatía Inmunoblástica , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , Linfoma de Células T Periférico , SARS-CoV-2
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