RESUMO
OBJECTIVES: Allergic patients may be concerned about more frequent and/or more severe adverse events following vaccination, which may lead to the refusal of vaccines among these patients. The aim of this study is to assess whether allergic patients have more frequent adverse events (AEs) after vaccination than healthy individuals. METHODS: Study participants (N = 591) underwent vaccination of their choice at a selected Vaccination and Travel Medicine Centre. At a 10 to 14-day interval, they were contacted for a telephone questionnaire survey on the occurrence of AEs after vaccination. A group of allergic patients (n = 188) and healthy controls (n = 403) were followed in the study. RESULTS: No significant difference was found in the occurrence of AEs between study and control group. Only in redness and swelling, which was more common in allergic patients, but only in a few individuals. All side effects were minor, such as pain at the injection site or fatigue. No participant experienced a serious or life-threatening adverse event. In the studied group, no statistically significant differences were found even in the occurrence of AEs after singular vs. simultaneous administration of vaccines (p = 0.094), nor after vaccination with inactivated vs. attenuated vaccines (p = 0.655), or after vaccination against bacterial vs. viral infections (p = 0.140). CONCLUSIONS: Vaccination of allergic patients did not cause more frequent and/or more serious adverse events in our study compared to healthy people. If general contraindications are observed, then vaccination of allergic patients is considered safe.
Assuntos
Hipersensibilidade , Vacinação , Humanos , Masculino , Feminino , Estudos Prospectivos , Hipersensibilidade/epidemiologia , Adulto , Vacinação/efeitos adversos , Pessoa de Meia-Idade , Inquéritos e Questionários , Adolescente , IdosoRESUMO
BACKGROUND: Several cases of renal complications, including acute kidney injury (AKI), after influenza vaccination have been reported, but the association remains unproven. We evaluated the association between influenza vaccination and AKI occurrence among the Korean elderly in the 2018-2019 and 2019-2020 seasons. METHODS: We used a large database combining vaccination registration data from the Korea Disease Control and Prevention Agency and claims data from the National Health Insurance Service. The study subjects were patients hospitalized with AKI for the first-time following vaccination among those who received one influenza vaccine in the 2018-2019 or 2019-2020 season. Only those aged 65 or older at the date of vaccination were included. We performed a self-controlled case series study, designating the risk period as 1 to 28 days post-vaccination and the observation period as each influenza season. The adjusted incidence rate ratio (aIRR) was calculated by adjusting for nephrotoxic drug use and influenza infection that may influence AKI occurrence using a conditional Poisson regression model. RESULTS: A total of 16 713 and 16 272 AKI events were identified during the 2018-2019 and 2019-2020 seasons, respectively. The aIRR for AKI was 0.83 (95% confidence interval [CI] = 0.79-0.87) in the 2018-2019 season. The aIRR for the 2019-2020 influenza season was similar to the 2018-2019 season (aIRR = 0.86; 95% CI = 0.82-0.90). CONCLUSIONS: Influenza vaccination is associated with a lower risk of AKI in the elderly over 65. This evidence supports the recommendation of annual influenza vaccination for the elderly. Further studies are needed to determine the biological mechanisms linking the influenza vaccine and AKI.
Assuntos
Injúria Renal Aguda , Vacinas contra Influenza , Influenza Humana , Humanos , Vacinas contra Influenza/efeitos adversos , Vacinas contra Influenza/administração & dosagem , Injúria Renal Aguda/epidemiologia , Injúria Renal Aguda/induzido quimicamente , Injúria Renal Aguda/etiologia , Idoso , Masculino , Feminino , Influenza Humana/prevenção & controle , Influenza Humana/epidemiologia , República da Coreia/epidemiologia , Idoso de 80 Anos ou mais , Incidência , Vacinação/efeitos adversos , Vacinação/estatística & dados numéricos , Bases de Dados Factuais , Hospitalização/estatística & dados numéricos , Estações do Ano , Fatores de RiscoRESUMO
OBJECTIVE: To analyze the effect of breastfeeding on reducing Pentavalent vaccination pain in infants and to identify the necessary breastfeeding interval for antinociceptive action. METHOD: Open parallel randomized clinical trial. Ninety mother-infant dyads participated, distributed into intervention group 1 (n = 30), which breastfed five minutes before vaccination; intervention group 2 (n = 30), which breastfed five minutes before and during vaccination; and control group (n = 30), which did not breastfeed. The outcome variable was the pain level measured by the FLACC Scale. Data analysis was conducted using descriptive and inferential statistics, applying Fisher's Exact, Kolmogorov-Smirnov, Kruskal-Wallis and Dunn's multiple comparison tests, with 0.05 significance level. RESULTS: Pain induced by the Pentavalent vaccine was reduced in intervention groups 1 and 2 (mean pain of 6.06 versus 3.83, respectively) compared to the control group (mean of pain of 7.43), which was significant for intervention group 2 (p < 0.001), indicating that, to achieve lower levels of pain, breastfeeding should be carried out before and during vaccination. CONCLUSION: Longer breastfeeding, conducted five minutes before and during vaccination, reduces the pain induced by the Pentavalent vaccine. No vaccination risks were identified to outweigh the benefits. These results endorse that health professionals should encourage breastfeeding at least five minutes before and during vaccine injection for an antinociception effect. Brazilian Clinical Trials Registry: RBR-9vh37wr.
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Aleitamento Materno , Dor , Humanos , Lactente , Feminino , Masculino , Dor/etiologia , Dor/prevenção & controle , Vacinação/efeitos adversos , Adulto , Vacinas Combinadas/efeitos adversos , Vacinas Combinadas/administração & dosagem , Vacinas contra Hepatite B/administração & dosagem , Vacinas contra Hepatite B/efeitos adversos , Vacinas Anti-Haemophilus/administração & dosagem , Vacinas Anti-Haemophilus/efeitos adversos , Fatores de Tempo , Medição da Dor , Vacina Antipólio de Vírus Inativado/efeitos adversos , Vacina Antipólio de Vírus Inativado/administração & dosagemAssuntos
Vacinas contra COVID-19 , COVID-19 , Células Th1 , Células Th2 , Síndrome Uveomeningoencefálica , Humanos , Vacina BNT162/efeitos adversos , COVID-19/prevenção & controle , COVID-19/imunologia , Vacinas contra COVID-19/efeitos adversos , Vacinas contra COVID-19/imunologia , Células Th1/imunologia , Células Th2/imunologia , Síndrome Uveomeningoencefálica/imunologia , Síndrome Uveomeningoencefálica/induzido quimicamente , Síndrome Uveomeningoencefálica/diagnóstico , Vacinação/efeitos adversosRESUMO
Importance: Although influenza vaccination has been found to be safe in pregnancy, few studies have assessed repeated influenza vaccination over successive pregnancies, including 2 vaccinations in a year, in terms of adverse perinatal outcomes. Objective: To examine the association of seasonal influenza vaccination across successive pregnancies with adverse perinatal outcomes and whether the association varies by interpregnancy interval (IPI) and vaccine type (quadrivalent or trivalent). Design, Setting, and Participants: This retrospective cohort study included individuals with at least 2 successive singleton live-birth pregnancies between January 1, 2004, and December 31, 2018. Data were collected from the Vaccine Safety Datalink, a collaboration between the Centers for Disease Control and Prevention and integrated health care organizations. Data analysis was performed between January 8, 2021, and July 17, 2024. Exposures: Influenza vaccination was identified using vaccine administration codes. The vaccinated cohort consisted of people who received influenza vaccines during the influenza season (August 1 through April 30) in 2 successive pregnancies. The comparator cohort consisted of people identified as unvaccinated during both pregnancies. Main Outcomes and Measures: Main outcomes were risk of preeclampsia or eclampsia, placental abruption, fever, preterm birth, preterm premature rupture of membranes, chorioamnionitis, and small for gestational age among individuals with and without vaccination in both pregnancies. Adjusted relative risks (RRs) from Poisson regression were used to assess the magnitude of associations. The associations with adverse outcomes by IPI and vaccine type were evaluated. Results: Of 82â¯055 people with 2 singleton pregnancies between 2004 and 2018, 44â¯879 (54.7%) had influenza vaccination in successive pregnancies. Mean (SD) age at the start of the second pregnancy was 32.2 (4.6) years for vaccinated individuals and 31.2 (5.0) years for unvaccinated individuals. Compared with individuals not vaccinated in both pregnancies, vaccination in successive pregnancies was not associated with increased risk of preeclampsia or eclampsia (adjusted RR, 1.10; 95% CI, 0.99-1.21), placental abruption (adjusted RR, 1.01; 95% CI, 0.84-1.21), fever (adjusted RR, 0.87; 95% CI, 0.47-1.59), preterm birth (adjusted RR, 0.83; 95% CI, 0.78-0.89), preterm premature rupture of membranes (RR, 1.00; 95% CI, 0.94-1.06), chorioamnionitis (adjusted RR, 1.03; 95% CI, 0.90-1.18), or small for gestational age birth (adjusted RR, 0.99; 95% CI, 0.93-1.05). IPI and vaccine type did not modify the observed associations. Conclusions and Relevance: In this large cohort study of successive pregnancies, influenza vaccination was not associated with increased risk of adverse perinatal outcomes, irrespective of IPI and vaccine type. Findings support recommendations to vaccinate pregnant people or those who might be pregnant during the influenza season.
Assuntos
Vacinas contra Influenza , Influenza Humana , Humanos , Feminino , Gravidez , Vacinas contra Influenza/efeitos adversos , Vacinas contra Influenza/administração & dosagem , Estudos Retrospectivos , Adulto , Influenza Humana/prevenção & controle , Influenza Humana/epidemiologia , Complicações Infecciosas na Gravidez/prevenção & controle , Complicações Infecciosas na Gravidez/epidemiologia , Estações do Ano , Resultado da Gravidez/epidemiologia , Nascimento Prematuro/epidemiologia , Vacinação/efeitos adversos , Vacinação/estatística & dados numéricos , Adulto Jovem , Recém-NascidoRESUMO
BACKGROUND: COVID-19 vaccines can lead to diverse local and systemic side effects, but there is limited evidence concerning their association with menstrual cycle changes. This study aimed to assess the prevalence of menstrual cycle alterations after COVID-19 vaccination among adult women. METHODS: We systematically searched the PubMed, Web of Science and Science Direct databases for observational studies that included adult women and investigated the range of menstrual alterations. The quality of the studies was evaluated via the Newcastle-Ottawa scale. All the data were analyzed via Comprehensive Meta-Analysis Software Version 4.0. Forest plots were created to calculate the individual and pooled prevalence rates of different types of menstrual changes and 95% confidence intervals (CI) via fixed-effects and random-effects models, as appropriate. Heterogeneity was assessed with Q statistics and the I2 test. RESULTS: Eleven studies, encompassing 26,283 adult women, met our eligibility criteria. Among the selected studies, five were cohort studies, five were cross-sectional studies, and one employed a caseâcontrol design. The menstrual changes included abnormal cycle duration, dysmenorrhea, irregular cycles, and abnormal cycle flow (heavy and light flow), with pooled percentages of 27.3% (CI: 7.2-64.6%), 22% (CI: 5.2-59.4%), 16% (CI: 5.8-37.2%), 11.7% (CI: 5.8-22%), and 5.5% (CI: 2.3-12.5%), respectively. CONCLUSIONS: This review highlights the prevalence of menstrual changes after COVID-19 vaccination and emphasizes the importance of considering menstrual health as an integral part of postvaccination monitoring and health care interventions. However, longitudinal studies are essential for establishing a definitive causal relationship between COVID-19 vaccination and menstrual alterations.
Assuntos
Vacinas contra COVID-19 , COVID-19 , Humanos , Feminino , Vacinas contra COVID-19/efeitos adversos , Prevalência , COVID-19/prevenção & controle , COVID-19/epidemiologia , Distúrbios Menstruais/epidemiologia , Adulto , Vacinação/estatística & dados numéricos , Vacinação/efeitos adversos , SARS-CoV-2RESUMO
With the global introduction and widespread administration of COVID-19 vaccines, there have been emerging reports of associated vasculitis, including leukocytoclastic cutaneous vasculitis (LCV). In this paper, we present a case of a 68-year-old female patient who developed painful purpuric skin lesions on her feet 12 days after administration of the inactivated COVID-19 vaccine BBIBP Cor-V with histopathological confirmation of LCV and no signs of systemic involvement. The case is followed by a comprehensive literature review of documented LCV cases associated with COVID-19 vaccination with overall 39 articles and 48 cases of LCV found in total. In the majority of cases (56.3%) the first symptom occurred after the first dose of the COVID-19 vaccine, with symptoms manifesting within an average of seven days (6.8 ± 4.8) post-vaccination. The adenoviral vaccine Oxford-AstraZeneca (41.7%) and the mRNA vaccine Pfizer-BioNTech (27.1%) were most frequently associated with LCV occurrences. On average, LCV resolved within 2.5 (± 1.5) weeks. The preferred treatment modality were glucocorticoids, used in 70.8% of cases, resulting in a positive outcome in most cases, including our patient. While the safety of a subsequent dose appears favorable based on our review, individual risk-benefit assessment is crucial. This review emphasis the importance of considering COVID-19 vaccination as a potential trigger for the development of cutaneous vasculitis. Despite rare adverse events, the benefits of the COVID-19 vaccination outweigh the risks, highlighting the importance of immunization programs.
Assuntos
Vacinas contra COVID-19 , COVID-19 , Vasculite Leucocitoclástica Cutânea , Humanos , Vasculite Leucocitoclástica Cutânea/etiologia , Vasculite Leucocitoclástica Cutânea/induzido quimicamente , Feminino , Idoso , Vacinas contra COVID-19/efeitos adversos , COVID-19/prevenção & controle , COVID-19/complicações , SARS-CoV-2 , Vacinação/efeitos adversos , Vacina BNT162/efeitos adversosRESUMO
To assess the safety of varicella vaccine (VarV) by conducting post-marketing surveillance on adverse events following immunization (AEFI) in Jiangsu Province, China. METHODS: We utilized the AEFI Information System of mainland China to monitor and categorize adverse reactions associated with VarV. RESULTS: The incidence rate of AEFI was significantly higher after the first dose (48.79/100,000 doses) compared to the second dose (45.18/100,000 doses) (χ2 = 4.63, P = 0.031). Regional variations in AEFI incidence were observed within Jiangsu Province. Common reactions comprised 90.96% of AEFIs, while rare reactions and coincidental events accounted for 6.59% and 0.51%, respectively. Notably, there were no adverse events linked to vaccine quality, program errors, psychogenic reactions, or fatalities. Over 96% of AEFIs occurred within three days of VarV administration, with redness at the injection site (2.6 cm to 5 cm in diameter) being the most frequently observed symptom. CONCLUSION: VarV demonstrates a commendable safety profile. Although there was a slight increase in AEFI incidence between 2022 and 2023, common vaccine reactions were predominantly observed, and the rates of rare reactions remained very low.
Assuntos
Vacina contra Varicela , Varicela , Humanos , Vacina contra Varicela/efeitos adversos , Vacina contra Varicela/administração & dosagem , China/epidemiologia , Masculino , Feminino , Lactente , Criança , Pré-Escolar , Incidência , Varicela/prevenção & controle , Varicela/epidemiologia , Vigilância de Produtos Comercializados , Adolescente , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Vacinação/efeitos adversos , Adulto Jovem , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Pessoa de Meia-IdadeRESUMO
BACKGROUND: COVID-19 vaccination has been inconsistently associated with an increased risk of heavy menstrual bleeding in previous studies. This study aimed to assess the risk of heavy menstrual bleeding requiring hospital care following COVID-19 vaccination according to the number of doses received and the time elapsed since vaccination. METHODS: Using comprehensive data of the French National Health Data System, we carried out a case-control study. Non-pregnant 15-50 years old women who had a hospital discharge diagnosis of heavy menstrual bleeding between May 12, 2021, and August 31, 2022 (cases) were randomly matched to up to 30 controls of same age, place of residence, social deprivation index, and contraceptive use profile at the date of case hospital admission (index date). Conditional logistic regression models were used to estimate the risk of hospital care for heavy menstrual bleeding associated with primary or booster doses and delay since last COVID-19 vaccination at index date, adjusting for socio-demographic characteristics, comorbidities, healthcare use indicators, and recent SARS-CoV-2 infection. RESULTS: A total of 4610 cases and 89,375 matched controls were included (median age, 42 years). Compared to unvaccinated women, the risk of hospital care for heavy menstrual bleeding was increased in those having received a last dose of primary vaccination in the preceding 1-3 months (Odds Ratio, 1.20 [95% confidence interval, 1.07-1.35]). This association was marked among women residing in the most deprived municipalities (1.28 [1.07-1.52]) and those who were not using hormonal contraception (1.28 [1.11-1.48]). Assuming a causal relationship, a total of 103 cases [54-196] were estimated to be attributable to primary vaccination in France. CONCLUSION: These findings provide evidence of an increased risk of heavy menstrual bleeding during the three-month period following primary COVID-19 mRNA vaccination. No increased risk was found beyond 3 months after primary vaccination nor following booster doses.
Assuntos
Vacinas contra COVID-19 , COVID-19 , Menorragia , SARS-CoV-2 , Humanos , Feminino , Estudos de Casos e Controles , Adulto , Pessoa de Meia-Idade , COVID-19/prevenção & controle , COVID-19/epidemiologia , COVID-19/complicações , Vacinas contra COVID-19/efeitos adversos , Vacinas contra COVID-19/administração & dosagem , França/epidemiologia , Adolescente , Adulto Jovem , Menorragia/epidemiologia , Menorragia/etiologia , Vacinação/efeitos adversos , Vacinação/estatística & dados numéricos , Fatores de RiscoRESUMO
Vasovagal syncope, or fainting, can be triggered by various stimuli, including medical procedures. Syncope after vaccination has been reported, most commonly among adolescents, and can result in injuries. Using the Vaccine Adverse Event Reporting System (VAERS), we reviewed and summarized reports of syncope after live attenuated influenza vaccine, intranasal (LAIV) administered as the sole vaccine (i.e., no concomitant injections). From June 17, 2003 (date of LAIV licensure in the US) through May 31, 2024, VAERS received 50 reports of syncope after LAIV. Nearly half (23; 46 %) pertained to individuals 10-19 years of age. While the vast majority of reports (35; 70 %) did not describe any injuries, 15 people (30 %) were injured, most commonly by falling and hitting their head or face. Twenty-two people (44 %) required evaluation in the emergency department or doctor's office, including an individual who lost consciousness while he was driving home from the vaccination appointment. He did not report any injuries, but the car was severely damaged. Nearly three-quarters of people (37; 74 %) developed syncope within 15 min after vaccination, but fewer than half of reports (24; 48 %) stated that the patient had waited in the observation area for at 15 min. Based on approximately 111.9 million doses of LAIV distributed in the US during the same time period, the reporting rate is approximately 0.4 per million doses, suggesting that syncope following LAIV is rare. The information summarized here may enable clinicians, patients, and caregivers to make a more informed decision regarding preventing injuries that may occur following LAIV-related syncope.
Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Vacinas contra Influenza , Síncope , Vacinas Atenuadas , Humanos , Vacinas contra Influenza/efeitos adversos , Vacinas contra Influenza/administração & dosagem , Adolescente , Vacinas Atenuadas/efeitos adversos , Vacinas Atenuadas/administração & dosagem , Adulto Jovem , Adulto , Masculino , Feminino , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Criança , Síncope/etiologia , Síncope/epidemiologia , Pessoa de Meia-Idade , Influenza Humana/prevenção & controle , Influenza Humana/complicações , Estados Unidos/epidemiologia , Idoso , Vacinação/efeitos adversos , Administração IntranasalRESUMO
The BCG vaccine is considered a safe and efficacious vaccine in the prevention of severe forms of tuberculosis. BCG osteomyelitis is a rare complication of the BCG vaccine that occurs in vaccinated young children. We report a case of BCG osteomyelitis in a male toddler, presenting with painful left wrist swelling without preceding fever or systemic symptoms. Radiographic evidence of osteomyelitis in the left wrist was observed. Initial treatment with conventional antibiotics for acute haematogenous osteomyelitis showed no improvement. The diagnosis of Mycobacterium bovis BCG osteomyelitis was confirmed via tissue samples for histopathological examination and mycobacterial cultures. The patient responded well to treatment with oral antituberculous therapy. This case highlights the importance of considering BCG osteomyelitis in the differential diagnosis of unexplained joint swelling in BCG-vaccinated young children.
Assuntos
Vacina BCG , Mycobacterium bovis , Osteomielite , Humanos , Osteomielite/etiologia , Osteomielite/tratamento farmacológico , Osteomielite/diagnóstico , Osteomielite/microbiologia , Vacina BCG/efeitos adversos , Masculino , Mycobacterium bovis/isolamento & purificação , Antituberculosos/uso terapêutico , Lactente , Diagnóstico Diferencial , Vacinação/efeitos adversosRESUMO
Sudden sensorineural hearing loss (SSNHL) has emerged as a potential complication of COVID-19 infection and vaccination. Various mechanisms by which the SARS-CoV-2 virus can cause hearing loss have been reported, including direct viral invasion, neuroinflammation, blood flow disturbances, and immune-mediated response. However, the temporal relationship between COVID-19 infection and SSNHL remains unclear, with mixed findings and conflicting results reported in different studies. Similarly, while anecdotal reports have linked COVID-19 vaccination to SSNHL, evidence remains scarce. Establishing a correlation between COVID-19 vaccines and SSNHL implies a complex and multifactorial pathogenesis involving interactions between the immune system and the body's stress response. Nevertheless, it is important to consider the overwhelming evidence of the vaccines' safety and efficacy in limiting the spread of the disease and remains the primordial tool in reducing death.
Assuntos
Vacinas contra COVID-19 , COVID-19 , Perda Auditiva Súbita , SARS-CoV-2 , Humanos , COVID-19/imunologia , COVID-19/prevenção & controle , COVID-19/complicações , Perda Auditiva Súbita/etiologia , Perda Auditiva Súbita/imunologia , Perda Auditiva Súbita/virologia , Vacinas contra COVID-19/efeitos adversos , Vacinas contra COVID-19/imunologia , SARS-CoV-2/imunologia , Vacinação/efeitos adversos , Orelha Interna/imunologia , Perda Auditiva Neurossensorial/virologia , Perda Auditiva Neurossensorial/imunologia , Perda Auditiva Neurossensorial/etiologiaRESUMO
Hypersensitivity reactions represent one of the most common causes of hesitancy for adherence to national vaccination programs. The majority of hypersensitivity reactions after vaccination are mild, and anaphylaxis is reported to be rare, although it remains challenging to estimate the frequency attributed to each single vaccine, either because of the lower number of administered doses of less common vaccines, or the administration of simultaneous vaccine in most of the vaccination programs. Although literature remains scattered, international consensus guides clinicians in identifying patients who might need the administration of vaccines in protected environments due to demonstrated hypersensitivity to vaccine components or adjuvants. Here we provide the current guidance on hypersensitivity reactions to vaccines and on vaccination of children with allergy disorders.
Assuntos
Hipersensibilidade , Vacinação , Vacinas , Humanos , Vacinas/efeitos adversos , Vacinas/administração & dosagem , Vacinação/efeitos adversos , Criança , Anafilaxia/prevenção & controle , Guias de Prática Clínica como AssuntoRESUMO
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Assuntos
Vacinas contra COVID-19 , COVID-19 , Complicações Infecciosas na Gravidez , SARS-CoV-2 , Vacinação , Humanos , Gravidez , Feminino , Vacinas contra COVID-19/efeitos adversos , Vacinas contra COVID-19/administração & dosagem , COVID-19/prevenção & controle , Complicações Infecciosas na Gravidez/prevenção & controle , Vacinação/efeitos adversos , GestantesRESUMO
HepB-CpG is a licensed adjuvanted two-dose hepatitis B vaccine for adults, with limited data on exposure during pregnancy. We assessed the risk of pregnancy outcomes among individuals who received HepB-CpG or the 3-dose HepB-alum vaccine ≤28 d prior to conception or during pregnancy at Kaiser Permanente Southern California (KPSC). The pregnancy cohort included KPSC members aged ≥18 y who received ≥1 dose of hepatitis B vaccine (HepB-CpG or HepB-alum) at KPSC outpatient family or internal medicine departments from August 2018 to November 2020. We followed these individuals through electronic health records from the vaccination date until the end of pregnancy, KPSC health plan disenrollment, or death, whichever came first. Among 81 and 125 eligible individuals who received HepB-CpG and HepB-alum, respectively, live births occurred in 84% and 74%, spontaneous abortion occurred in 7% and 17% (adjusted relative risk [aRR] 0.40, 95% CI: 0.16-1.00), and preterm birth occurred in 15% and 14% of liveborn infants (aRR 0.97, 95% CI 0.47-1.99). No major birth defects were identified through 6 months of age. The study found no evidence of adverse pregnancy outcomes for recipients of HepB-CpG in comparison to HepB-alum.
Assuntos
Vacinas contra Hepatite B , Hepatite B , Resultado da Gravidez , Vigilância de Produtos Comercializados , Humanos , Gravidez , Feminino , Adulto , Vacinas contra Hepatite B/administração & dosagem , Vacinas contra Hepatite B/efeitos adversos , Vigilância de Produtos Comercializados/estatística & dados numéricos , Adulto Jovem , Hepatite B/prevenção & controle , Adolescente , California/epidemiologia , Recém-Nascido , Vacinação/efeitos adversos , Vacinação/estatística & dados numéricos , Nascimento Prematuro/epidemiologia , Aborto Espontâneo/epidemiologia , Adjuvantes Imunológicos/efeitos adversos , Adjuvantes Imunológicos/administração & dosagem , Nascido Vivo/epidemiologiaRESUMO
OBJECTIVE: The study aims to show the efficacy/effectiveness and safety of vaccinations in patients with multiple sclerosis. MATERIALS AND METHODS: This systematic review was conducted following the guidelines of the Cochrane Collaboration and the meta-analysis of observational studies in epidemiology (MOOSE). RESULTS: At the end of the review process, 133 studies were included; the bibliographic search was conducted on PubMed/Medline and Scopus, combining free text and words. CONCLUSIONS: In general, vaccinations do not seem to aggravate multiple sclerosis (MS) or increase the probability of relapse, particularly for inactivated vaccines and, in general, for the rest of the vaccines. However, it is advisable, especially for vaccines with a live attenuated virus, to carefully evaluate the risks and benefits of these vaccinations; as regards the effectiveness in relation to the drug taken, there is great variability in response. In particular, vaccinations are less effective in patients undergoing therapy with anti-CD20 and S1P modulators. At the same time, a small response is likely to be better than none. Whenever possible, vaccinations should be offered and recommended to patients with multiple sclerosis.
Assuntos
Esclerose Múltipla , Vacinação , Humanos , Esclerose Múltipla/tratamento farmacológico , Vacinação/efeitos adversos , Vacinas/efeitos adversosRESUMO
Objective: To evaluate the safety of COVID-19 vaccines in patients with multiple sclerosis (MS) by assessing their impact on serum neurofilament light chain (sNfL) levels as a marker of neuroaxonal damage. Methods: Single-center observational longitudinal study including patients with MS who consecutively received their initial vaccination against SARS-CoV-2 at Hospital Universitario Ramón y Cajal, following the first national immunization program in Spain. Serum samples were collected at baseline and after receiving the second dose of the vaccine. sNfL levels were quantified using the single molecule array (SIMOA) technique. Adverse events, including clinical or radiological reactivation of the disease, were recorded. Results: Fifty-two patients were included (median age, 39.7 years [range, 22.5-63.3]; 71.2% female). After SARS-CoV-2 vaccination, no increased inflammatory activity, either determined by the presence of relapses and/or new MRI lesions and/or high sNfL levels, was detected. Accordingly, there was no difference between median sNfL levels before and after vaccination (5.39 vs. 5.76 pg/ml, p=0.6). Despite this, when looking at baseline patient characteristics before vaccination, younger age associated with disease activity after vaccination (OR 0.87, 95% CI: 0.77-0.98, p=0.022). Larger studies are needed to validate these results. Conclusion: COVID-19 vaccines did not cause reactivation of disease at a clinical, radiological or molecular level, thus suggesting that they are safe in MS patients.
Assuntos
Vacinas contra COVID-19 , COVID-19 , Esclerose Múltipla , Proteínas de Neurofilamentos , SARS-CoV-2 , Humanos , Feminino , Masculino , Adulto , Pessoa de Meia-Idade , Esclerose Múltipla/imunologia , Esclerose Múltipla/sangue , COVID-19/imunologia , COVID-19/prevenção & controle , COVID-19/sangue , Vacinas contra COVID-19/efeitos adversos , Vacinas contra COVID-19/imunologia , Proteínas de Neurofilamentos/sangue , SARS-CoV-2/imunologia , Adulto Jovem , Estudos Longitudinais , Biomarcadores/sangue , Axônios/patologia , Espanha/epidemiologia , Vacinação/efeitos adversosRESUMO
Myocarditis is the most salient serious adverse event following messenger RNA-based Covid-19 vaccines. The highest risk is observed after the second dose compared to the first, whereas the level of risk associated with more distant booster doses seems to lie in between. We aimed to assess the relation between dosing interval and the risk of myocarditis, for both the two-dose primary series and the third dose (first booster). This matched case-control study included 7911 cases of myocarditis aged 12 or more in a period where approximately 130 million vaccine doses were administered. Here we show that longer intervals between each consecutive dose, including booster, may decrease the occurrence of vaccine-associated myocarditis by up to a factor of 4, especially under age 50. These results suggest that a minimum 6-month interval might be required when scheduling additional booster vaccination.