Vacuna contra la COVID-19 y menstruación, desde el desconocimiento a la información: revisión sistemática / Vaccine against COVID-19 and menstruation, from ignorance to information: a systematic review

La creación de una vacuna para enfrentar la pandemia de COVID-19 conllevó un vacío de información sobre las posibles alteraciones del ciclo menstrual. El objetivo fue verificar las posibles alteraciones que se pudiesen haber generado en el ciclo menstrual de las mujeres posterior a la inoculación de la vacuna contra la COVID-19. Se realizó una revisión sistemática en las bases bibliografías Medline, Medline Complete, LILACS, CINAHL y ScIELO, utilizando los descriptores “Women”, “Woman”, “Fertile period”, “Vaccination”, “Mass vaccination”, “Immunization”, “COVID-19 vaccines”, “SARS-CoV-2 infection”, “COVID-19”, “Menstrual cycle”, “Menstruation”, “Endometrial cycle”, “Dysmenorrhea” y “Menstruation disturbances”. Mediante la utilización del protocolo PRISMA, de los 319 artículos localizados, 17 fueron incluidos en el análisis. La mayoría de los estudios incluyeron, principalmente, las vacunas Pfizer, Moderna, AstraZeneca y Johnson&Johnson/Janssen con una a tres dosis administradas. El porcentaje de ciclos menstruales alterados fue del 8,0% al 77,8%, y la alteración con mayor frecuencia referida fue la duración del ciclo menstrual, que fue desde 0,3 hasta 12 días de retraso de la menstruación. Todos los estudios refieren cambios en el ciclo menstrual con diversas prevalencias, con y sin significación estadística; sin embargo, también concluyen que estas alteraciones son reversibles y en un corto periodo de tiempo.

The creation of a vaccine to face the COVID-19 pandemic, led to an information gap on possible alterations of the menstrual cycle. The objective was to verify the possible alterations that could have been generated in the menstrual cycle of women, after the inoculation of the vaccine against COVID-19. A systematic review was carried out in the Medline, Medline Complete, LILACS, CINAHL and ScIELO bibliographic databases, using the descriptors “Women”, “Woman”, “Fertile period”, “Vaccination”, “Mass vaccination”, “Immunization”, “COVID-19 vaccines”, “SARS-CoV-2 infection”, “COVID-19”, “Menstrual cycle”, “Menstruation”, “Endometrial cycle”, “Dysmenorrhea” and “Menstruation disturbances”. Using the PRISMA protocol, of the 319 articles located, 17 were included in the analysis. Most of the studies mainly included the Pfizer, Moderna, AstraZeneca and Johnson&Johnson/Janssen vaccines with one to three doses administered. The percentage of altered menstrual cycles ranged from 8.0% to 77.8%, and the most frequently reported alteration was the length of the menstrual cycle, which occurred from 0.3 to 12 days late in menstruation. All the studies refer to changes in the menstrual cycle with different prevalences, with and without statistical significance; however, the same studies also conclude that these alterations are reversible and in a short period of time.

Immunogenicity and reactogenicity of heterologous immunization schedules with COVID-19 vaccines: a systematic review and network meta-analysis / 中华医学杂志(英文版)

BACKGROUND@#Data on the immunogenicity and safety of heterologous immunization schedules are inconsistent. This study aimed to evaluate the immunogenicity and safety of homologous and heterologous immunization schedules.@*METHODS@#Multiple databases with relevant studies were searched with an end date of October 31, 2021, and a website including a series of Coronavirus disease 2019 studies was examined for studies before March 31, 2022. Randomized controlled trials (RCTs) that compared different heterologous and homologous regimens among adults that reported immunogenicity and safety outcomes were reviewed. Primary outcomes included neutralizing antibodies against the original strain and serious adverse events (SAEs). A network meta-analysis (NMA) was conducted using a random-effects model.@*RESULTS@#In all, 11 RCTs were included in the systematic review, and nine were ultimately included in the NMA. Among participants who received two doses of CoronaVac, another dose of mRNA or a non-replicating viral vector vaccine resulted in a significantly higher level of neutralizing antibody than a third CoronaVac 600 sino unit (SU); a dose of BNT162b2 induced the highest geometric mean ratio (GMR) of 15.24, 95% confidence interval [CI]: 9.53-24.39. Following one dose of BNT162b2 vaccination, a dose of mRNA-1273 generated a significantly higher level of neutralizing antibody than BNT162b2 alone (GMR = 1.32; 95% CI: 1.06-1.64), NVX-CoV2373 (GMR = 1.60; 95% CI: 1.16-2.21), or ChAdOx1 (GMR = 1.80; 95% CI: 1.25-2.59). Following one dose of ChAdOx1, a dose of mRNA-1273 was also more effective for improving antibody levels than ChAdOx1 (GMR = 11.09; 95% CI: 8.36-14.71) or NVX-CoV2373 (GMR = 2.87; 95% CI: 1.08-3.91). No significant difference in the risk for SAEs was found in any comparisons.@*CONCLUSIONS@#Relative to vaccination with two doses of CoronaVac, a dose of BNT162b2 as a booster substantially enhances immunogenicity reactions and has a relatively acceptable risk for SAEs relative to other vaccines. For primary vaccination, schedules including mRNA vaccines induce a greater immune response. However, the comparatively higher risk for local and systemic adverse events introduced by mRNA vaccines should be noted.@*REGISTRATION@#PROSPERO; https://www.crd.york.ac.uk/PROSPERO/ ; No. CRD42021278149.

Tiroiditis subaguda posterior a la administración de la vacuna COVID-19. Presentación de tres casos clínicos / Subacute thyroiditis following COVID-19 vaccine administration. Presentation of three clinical cases

La tiroiditis subaguda (TSA) es un trastorno inflamatorio autolimitado de la glándula tiroides. Es más común en mujeres y se caracteriza por dolor cervical, síntomas inflamatorios sistémicos y disfunción tiroidea. La TSA se ha asociado a una infección viral previa, generalmente respiratoria o enteral. Múltiples virus se han relacionado con TSA. Desde mayo de 2020 se reportaron casos de TSA relacionados con la infección por SARS-CoV-2. Describimos 3 casos de SAT después de la vacuna COVID-19. Dos casos fueron inoculados con vacuna SARS-CoV-2 inactivada (CoronaVac) y uno con vacuna de ARNm Pfizer-BioNTech. Los síntomas clínicos comenzaron pocas semanas después de la inoculación. Presentaron dolor cervical anterior, fiebre, astenia y tirotoxicosis transitoria. En todos los casos la evolución fue favorable. Hasta donde sabemos, estos son los primeros casos de SAT posteriores a la vacuna COVID-19 descritos en Chile.

Subacute thyroiditis (SAT) is a self-limited inflammatory disorder of the thyroid gland. The disease is more common in women and is characterized by neck pain, systemic symptoms, and thyroid dysfunction. SAT It has been associated with viral, respiratory or enteral infection. Multiple viruses had been related to SAT. Since May 2020, cases of SAT related to SARS-CoV-2 infection were reported. We describe 3 cases of SAT following COVID-19 vaccine. Two cases were inoculated with inactivated SARS-CoV-2 vaccine (CoronaVac) and one with mRNA vaccine Pfizer­BioNTech. The clinical symptoms began few weeks after inoculation. They presented with neck pain, fever, general malaise and transient thyrotoxicosis. All cases revered spontaneously. To our knowledge, these are the first cases of SAT following COVID-19 vaccine described in Chile.

Cetoacidosis diabética posterior a vacuna contra SARS-CoV-2: reporte de un caso / Diabetic ketoacidosis following SRS-CoV-2 vaccination: a one case report

Las emergencias hiperglicémicas como la cetoacidosis diabética (CAD) y el síndrome hiperglicémico hiperosmolar (SHH) se han descrito en el contexto de infección por SARS-CoV-2, como también secundarias a las múltiples vacunas desarrolladas contra el virus. La fisiopatología que explicaría esta asociación aún no está clara, pero existen diversas teorías que incluyen la destrucción directa de los islotes pancreáticos por el virus o secundario a mecanismos inmuno-inflamatorios. Presentamos el caso de un paciente que debutó con CAD al tercer día de la primera dosis de CoronaVac, y que posteriormente presentó hiperglicemia sin cumplir criterios de CAD luego de la segunda y tercera dosis de CoronaVac y Pfizer respectivamente. La temporalidad, como la falta de gatillante y la evolución del cuadro, apuntan a la vacuna como el principal precipitante. Por lo anterior, es importante mantener una vigilancia estricta de los efectos adversos de las vacunas y educar sobre los síntomas sugerentes de una crisis hiperglicémica para pesquisarla a tiempo y actuar oportunamente.

Hyperglycemic emergencies such as diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic syndrome (HHS) have been reported in SARS-CoV-2 infections and after vaccination. The pathophysiology behind this association is still unclear, several theories have been described that include the direct destruction of the pancreatic islets by the virus, and some immuno-inflammatory mechanisms. We present the case of a patient who develope DKA the third day after the first dose of CoronaVac vaccine, and then hypergycemia after the second and third dose of CoronaVac and Pfizer repectively. The temporal relation, lack of a trigger and evolution of the disease, point the vaccine as the main precipitant. The strict surveillance of vaccines adverse effects and education of symptoms suggestive of hyperglicemic emergency are critical to prevent and treat promptly this kind of situations.

Fatores associados a eventos supostamente atribuíveis à vacinação para SARS-CoV-2 entre idosos: estudo retrospectivo em Teresina-PI, Brasil / Factores asociados a eventos presuntamente atribuibles a la vacunación contra el SARS-CoV-2en ancianos: estudio retrospectivo en Teresina-PI, Brasil / Factors associated with events allegedly attributable to SARS-CoV-2 vaccination among older adults: retrospective study in Teresina-PI, Brazil

Resumo Objetivo Analisar os fatores associados aos Eventos Supostamente Atribuíveis à Vacinação ou Imunização para SARS-CoV-2 entre idosos. Método Estudo censitário, descritivo e retrospectivo, realizado em Teresina, Piauí e aprovado pelo Comitê de Ética em Pesquisa. Participaram 51 idosos que receberam, pelo menos, uma dose de vacina contra COVID-19 e que apresentaram ou não evento notificado entre fevereiro a setembro de 2021. Resultados 76,5% dos idosos receberam a vacina AstraZeneca na 1a dose. A média de ocorrência dos eventos foi de 3,45. Quanto à gravidade, 82,4% foram classificados como não graves; 17,6% graves, dos quais 66,7% resultaram em hospitalização, 22,2% em óbito e 11,1% em incapacidade permanente. Eventos mais frequentes estiveram relacionados ao sistema musculoesquelético, seguidos de cefaleia, relacionados ao sistema neurológico e digestivo. Observou-se associação estatisticamente significativa do evento relacionado ao sistema respiratório com faixa etária e do erro de imunização com o gênero. Conclusão e implicações para a prática Apesar de ser observado eventos supostamente atribuíveis à vacinação/imunização em idosos, nota-se que estão dentro do esperado, sendo seu comportamento com tipologia não grave e de baixo risco para este grupo, além de assegurados os benefícios frente aos riscos.

Resumen Objetivo Analizar factores asociados a los Eventos Supuestamente Atribuibles a la Vacunación o Inmunización para el SARS-CoV-2 en adultos mayores. Método Estudio censal, descriptivo y retrospectivo, realizado en Teresina, Piauí, y aprobado por el Comité de Ética en Investigación. Participaron 51 personas mayores, que recibieron al menos una dosis de vacuna contra la COVID-19 y que presentaron o no evento informado entre febrero y septiembre de 2021. Resultados El 76,5% del grupo recibió la vacuna AstraZeneca, en la 1ª dosis. La media de ocurrencia de eventos fue de 3,45. En cuanto a la gravedad, el 82,4% se clasificó como no grave; el 17,6% fueron graves, de los cuales el 66,7% resultaron en hospitalización, 22,2% en muerte y 11,1% en invalidez permanente. Los eventos más frecuentes estuvieron relacionados con el sistema musculoesquelético, seguido de cefalea, relacionada con el sistema neurológico y digestivo. Hubo asociación estadísticamente significativa, relacionando el sistema respiratorio con el grupo etario y el error de inmunización al género. Conclusión e implicaciones para la práctica Se observaron eventos supuestamente atribuibles a la vacunación/inmunización en mayores, que está dentro de lo esperado, con un comportamiento no grave y de bajo riesgo, además que los beneficios se superponen a los riesgos.

Abstract Objective To analyze the factors associated with Events Supposedly Attributable to Vaccination or Immunization for SARS-CoV-2 among older adults. Method Census, descriptive and retrospective study, carried out in Teresina, Piauí and approved by the Research Ethics Committee. A total of 51 elderly participated, who received at least one dose of the vaccine against COVID-19 and who presented or not a reported event between February and September 2021. Results 76.5% of the older adults received the AstraZeneca vaccine in the 1st dose. The mean occurrence of events was 3.45. As for severity, 82.4% were classified as not severe; 17.6% were severe, of which 66.7% resulted in hospitalization, 22.2% in death and 11.1% in permanent disability. The most frequent events were related to the musculoskeletal system, followed by headache, related to the neurological and digestive system. There was a statistically significant association of the event related to the respiratory system with age group and of the immunization error with gender. Conclusion and implications for practice Although events supposedly attributable to vaccination/immunization in older adults have been observed, it is noted that they are within the expected range, with their behavior being of a not severe, low-risk type for this group, in addition to being ensured the benefits when compared to the risks.

Hipertiroidismo por enfermedad de Graves posterior a vacuna contra SARS-CoV-2: reporte de 2 casos / Graves' disease hyperthyroidism following SARS-CoV-2 vaccination: a two cases report

Luego del inicio de las campañas de vacunación masiva contra la infección por COVID-19, se han publicado una serie de reportes que muestran la posible asociación entre la vacuna y alteraciones de la función tiroidea. Desde entonces, múltiples teorías han intentado explicar este hallazgo, en su mayoría de índole autoinmune. Dentro de estas destaca el síndrome autoinmune-autoinflamatorio secundario a adyuvantes (ASIA), que podría generar desórdenes tiroideos de novo o exacerbar los ya existentes. Presentamos dos casos de enfermedad de Graves Basedow posterior al uso de Coronavac. Ambas pacientes presentaron características similares a las descritas en la literatura y cumplen con los criterios de ASIA. No obstante, los beneficios de las vacunas superan los posibles riesgos asociados.

After the beginning of COVID-19 vaccination campaigns, a number of reports have shown the potential association between vaccines and thyroid disfunction. Since then several theories have tried to explain this finding, mostly autoinmmune. One of them is the autoimmune/inflammatory syndrome induced by adjuvants, that could trigger or exacerbate thyroid disease. We present two cases of Graves' disease post Coronavac vaccination. Both pacients share similar features than cases published previously and meet criteria for ASIA syndrome. Nevertheless, the benefts of vaccination largely outweigh any adverse events associated.

Adverse Events Related to COVID-19 Vaccines Reported in Pregnant Women in Brazil / Eventos adversos pós-vacina contra COVID-19 em gestantes no Brasil

Abstract Regulations for the vaccination of pregnant women in Brazil occurred in March 2021. Despite the absence of robust data in the literature on the coronavirus disease 2019 (COVID-19) vaccinations in pregnant women, it is understood that the benefit-risk ratio tends to be favorable when considering the pandemic and the high burden of the disease. However, it is still important to monitor for Events Supposedly Attributable to Vaccination or Immunization (ESAVI) and to draw safety profiles of the different platforms used in pregnant and postpartum women. The present study aims to describe the main characteristics of ESAVIs related to COVID-19 vaccines occurring in pregnant women in the first months of the vaccination campaign in Brazil. During the evaluation period, 1,674 notifications of ESAVIs in pregnant women were recorded, and 582 notifications were included for the analysis. Of the 582 ESAVIs identified, 481 (82%) were classified as non-serious adverse events and 101 (17%) as serious adverse events. Ten deaths were identified, including one death which was considered to be causally related to the vaccine. The other nine maternal deaths had causality C, that is, without causal relationship with the vaccine, and most were due to complications inherent to pregnancy, such as pregnancy-specific hypertensive disorder (PSHD) in 4 cases and 3 due to COVID-19. Despite some limitations in our study, we believe it brings new insights into COVID-19 vaccines in this group and will add to the available evidence.

Resumo As determinações vacinação nas gestantes foram estabelecidas em março de 2021, no Brasil. Apesar da ausência de dados robustos na literatura da vacinação contra coronavirus disease 2019 (COVID-19) nesse grupo, entende-se que a relação de benefício versus risco tende a ser favorável considerando a situação pandêmica e a elevada carga de doença, tendo justificado o uso dessas vacinas em ampla escala nas gestantes de todo o mundo. Entretanto, o monitoramento dos eventos adversos pós vacinação (EAPVs) torna-se ainda mais importante para traçar um perfil de segurança das diferentes plataformas nas gestantes e puérperas. O presente estudo tem como objetivo descrever as principais características dos EAPVs contra COVID-19 ocorridos nas gestantes nos primeiros meses de campanha da vacinação no Brasil. Foram identificadas 1.674 notificações em gestantes, com a inclusão de 582 EAPVs analisados. Dos 582 EAPVs identificados, 481 (82%) foram classificados como eventos adversos não-graves e 101 (17%) como eventos adversos graves, sendo 10 (9,9%) destes referentes aos óbitos. Apenas um caso de óbito materno teve relação causal com a vacinação comprovada (causalidade A1), e foi secundário à síndrome trombocitopênica trombótica (TTS) após a vacina AstraZeneca/Fiocruz. Os outros nove óbitos maternos tiveram causalidade C, ou seja, sem relação causal com a vacina, e a maioria por complicações inerentes à gravidez, como a doença hipertensiva específica da gestação (DHEG) e COVID-19. Apesar de algumas limitações em nosso estudo, acreditamos que ele traz dados importantes sobre as vacinas COVID-19 neste grupo aumentando as evidências disponíveis.

Efectos secundarios posteriores a inmunización Sinovac® contra SARS-CoV-2, en estudiantes de Odontología de 20-30 años / Side effects after SARS-CoV-2 Sinovac® immunization, applied to dental students aged 20-30 years

El Sistema de Notificación de Eventos Adversos de la FDA (FAERS por sus siglas en inglés), ha informado sobre ciertas reacciones ad- versas a las vacunas que de forma poco común se presentan, siendo los síntomas neurológicos los más frecuentes, como mareos, dolor de cabeza, neuralgias, espasmos musculares, mialgias y parestesias. CoronaVac-Sinovac® es una vacuna de virus completo químicamente inactivo para COVID-19, creada a partir de células renales de mono verde africano que han sido inoculadas con la cepa SARS-CoV-2 CZ02. Noventa jóvenes estudiantes voluntarios entre 20 y 30 años recibieron el esquema de inmunización en dos dosis con 50 días de diferencia. En el presente estudio se observaron síntomas secundarios a la primera y segunda dosis, empleando un instrumento de recolección de informa- ción referente al estado de salud previo y posterior a la administración de la primera y segunda dosis, enfocado a los efectos secundarios. Los resultados manifestaron como las sintomatologías más frecuentes: insomnio, cansancio, dolor en articulaciones, somnolencia y dolor localizado en zona de punción, siendo esta última la más frecuente, también se observó una asociación estrecha con el sexo, la edad y el índice de masa corporal. Son necesarios estudios con mayor número de población observada para establecer resultados concluyentes (AU)

The FAERS, FDA Adverse Event Reporting System, has reported certain adverse reactions to vaccines that may occur uncommonly, with neurological symptoms being the most frequent of this group, manifesting as dizziness, pain headache, neuralgia, muscle spasms, myalgia, and paraesthesia. CoronaVac-Sinovac® is a chemically inactive whole virus vaccine for COVID-19, created from African green monkey kidney cells that have been inoculated with the SARS-CoV-2 CZ02 strain. 90 young volunteer students between 20 and 30 years old received the immunization schedule in two doses 50 days apart, in the present study the symptoms secondary to the first and second dose were observed, using an instrument for collecting information regarding the health status before and after the administration of the first and second dose of vaccination, focused on side effects. The results showed as the most frequent symptoms: Insomnia, tiredness, joint pain, drowsiness and localized pain in the puncture area, the latter being the most frequent, a close association was also observed with sex, age, and body mass index. Studies with a larger number of observed populations are necessary to establish conclusive results (AU)

Two cases of subacute thyroiditis after different types of SARS-CoV-2 vaccination

SUMMARY Although the development of subacute thyroiditis (SAT) following viral infections is well-documented, the actual mechanism has not been clearly elucidated. The occurrence of SAT after vaccination has been reported in several case series and possible mechanisms such as molecular mimicry due to the exposure to viral proteins and/or abnormal reactogenicity by adjuvants have been implicated. We describe two cases who developed SAT three days after the messenger RNA vaccine against COVID-19 (Pfizer-BioNTech®) and six days after the inactivated COVID-19 vaccine (CoronaVac®). SAT diagnosis of these patients was delayed for more than two weeks. When the current cases were evaluated together with 1 Pfizer-BioNTech® and 3 CoronaVac® related cases reported previously, the patients were female aged between 30-42, except for the male patient we presented, and the complaints of the patients initiated within the first 2-7 days. While two Pfizer-BioNTech® vaccine-related cases were severely symptomatic and thyrotoxic at presentation, there were cases with mild to moderate clinical manifestations in CoronaVac® vaccine-related group. Physicians should be aware of SAT that may occur within a few days following the COVID-19 vaccination.

Reporte de un caso de Síndrome de Guillain Barré post vacuna Coronavac: ¿rol causal o asociación temporal? / Guillain Barre syndrome associated with Coronavac vaccine: report of one case

We report a 50-year-old woman with a history of celiac disease, who presented with lumbar pain and progressive flaccid tetraparesis 48 hours after the inoculation of the first dose of CoronaVac inactivated SARS-CoV-2 vaccine. CSF was normal and electrodiagnostic studies showed an axonal motor polyneuropathy. No other triggers were identified, and other etiologies were ruled out. The presentation was compatible with the AMAN (Acute Motor Axonal Neuropathy) subtype of GBS, and intravenous immunoglobulin halted the progression of symptoms. Intensive neurorehabilitation was performed. The patient was discharged five weeks after admission, walking with poles and climbing stairs with minimal assistance. To date no cases of inactivated SARSCoV-2 vaccine related GBS have been reported. Thus, description of its clinical presentation is relevant. We discuss the current evidence relating GBS with vaccines, highlighting that vaccine associated GBS is a controversial entity and causality must be interpreted cautiously given the actual COVID-19 pandemic context.

Early assessment of the safety and immunogenicity of a third dose (booster) of COVID-19 immunization in Chinese adults / 医学前沿

Inducing durable and effective immunity against severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) via vaccination is essential to combat the current pandemic of coronavirus disease 2019 (COVID-19). It has been noticed that the strength of anti-COVID-19 vaccination-induced immunity fades over time, which calls for an additional vaccination regime, as known as booster immunization, to restore immunity among previously vaccinated populations. Here we report a pilot open-label trial of a third dose of BBIBP-CorV, an inactivated SARS-CoV-2 vaccine (Vero cell), on 136 participants aged between 18 to 63 years. Safety and immunogenicity in terms of neutralizing antibody titers and cytokine/chemokine responses were analyzed as the main endpoint until day 28. While systemic reactogenicity was either absent or mild, SARS-CoV-2-specific neutralizing antibody titers rapidly arose in all participants within 4 weeks, surpassing the peak antibody titers elicited by the initial two-dose immunization regime. Broad increases of cellular immunity-associated cytokines and chemokines were also detected in the majority of participants after the third vaccination. Furthermore, in an exploratory study, a newly developed recombinant protein vaccine, NVSI-06-08 (CHO Cells), was found to be safe and even more effective than BBIBP-CorV in eliciting humoral immune responses in BBIBP-CorV-primed individuals. Together, these results indicate that a third immunization schedule with either homologous or heterologous vaccine showed favorable safety profiles and restored potent SARS-CoV-2-specific immunity, providing support for further trials of booster vaccination in larger populations.

A review of the safety and efficacy of current COVID-19 vaccines / 医学前沿

Vaccination is the most effective and feasible way to contain the Coronavirus disease 2019 (COVID-19) pandemic. The rapid development of effective COVID-19 vaccines is an extraordinary achievement. This study reviewed the efficacy/effectiveness, immunogenicity, and safety profile of the 12 most progressed COVID-19 vaccines and discussed the challenges and prospects of the vaccine-based approaches in a global crisis. Overall, most of the current vaccines have shown safety and efficacy/effectiveness during actual clinical trials or in the real-world studies, indicating a development of pandemic control. However, many challenges are faced by pandemic control in terms of maximizing the effect of vaccines, such as rapid vaccine coverage, strategies to address variants with immune escape capability, and surveillance of vaccine safety in the medium- and long-terms.

Pericarditis and myocarditis after COVID-19 mRNA vaccination in a nationwide setting

INTRODUCTION@#Despite reports suggesting an association between COVID-19 mRNA vaccination and pericarditis and myocarditis, detailed nationwide population-based data are sparsely available. We describe the incidence of pericarditis and myocarditis by age categories and sex after COVID-19 mRNA vaccination from a nationwide mass vaccination programme in Singapore.@*METHODS@#The incidence of adjudicated cases of pericarditis and myocarditis following COVID-19 mRNA vaccination that were reported to the vaccine safety committee between January to July 2021 was compared with the background incidence of myocarditis in Singapore.@*RESULTS@#As of end July 2021, a total of 34 cases were reported (9 pericarditis only, 14 myocarditis only, and 11 concomitant pericarditis and myocarditis) with 7,183,889 doses of COVID-19 mRNA vaccine administered. Of the 9 cases of pericarditis only, all were male except one. The highest incidence of pericarditis was in males aged 12-19 years with an incidence of 1.11 cases per 100,000 doses. Of the 25 cases of myocarditis, 80% (20 cases) were male and the median age was 23 years (range 12-55 years) with 16 cases after the second dose. A higher-than-expected number of cases were seen in males aged 12-19 and 20-29 years, with incidence rates of 3.72 and 0.98 case per 100,000 doses, respectively.@*CONCLUSION@#Data from the national registry in Singapore indicate an increased incidence of pericarditis and myocarditis in younger men after COVID-19 mRNA vaccination.

Relatório de recomendação para adoção de um protocolo estadual para atendimento de casos suspeitos ou confirmados de síndrome de trombose com trombocitopenia (STT) associada à vacinação com as vacinas de vetor de adenovírus não replicante contra a covid-19 em Santa Catarina / Recommendation report for the adoption of a state protocol for the care of suspected or confirmed cases of thrombosis syndrome with thrombocytopenia (STT) associated with vaccination with non-replicating adenovirus vector vaccines against covid-19 in Santa Catarina

Este relatório refere-se à análise crítica dos documentos apresentados pelo CRIE/DIVE/SES/SC para a elaboração de um Protocolo Estadual de atendimento para casos de Síndrome de Trombose com Trombocitopenia (STT) associada à vacinação com vacinas de vetor de adenovírus não replicante contra a COVID-19, baseados na Nota Técnica CGPNI/DEIDT/SVS/MS nº 933/2021. Na Nota Técnica emitida pelo Ministério da Saúde consta uma breve contextualização, a investigação da STT, protocolo de investigação laboratorial, manejo clínico de casos e definição de casos para investigação de STT. O documento enviado pelo CRIE/DIVE/SES/SC intitulado "Fluxograma de Atendimento TTS" apresentou os dados da nota supracitada resumidos com a adição de um fluxograma de atendimento hospitalar. Este relatório visa avaliar e emitir um parecer técnico embasado em evidências científicas sobre a disponibilização dos medicamentos Imunoglobulina Humana intravenosa (IGHIV) e Rivaroxabana para o tratamento de STT, fluxo de aces o aos medicamentos e avaliação do impacto orçamentário, para posterior elaboração de um Protocolo Estadual para esta síndrome, destinado aos profissionais da saúde, pacientes e gestores do estado de Santa Catarina.

Immune thrombocytopenic purpura following CoronaVac vaccination: a case report

Immune thrombocytopenic purpura (ITP), an autoimmune disorder, has been documented as a result of SARS-CoV-2 infection and a vaccination side effect. The COVID-19 pandemic has led to the creation of CoronaVac vaccine and has been widely administered in Brazil.Patient, in the case, is an 82-years-old female who received the vaccine two days before an acute episode of gingivorrhagia and diffuse cutaneous petechiae. Other exams were made to look for other causes of secondary thrombocytopenia and all the results were normal. The patient showed improvement on the platelet levels three day after the beginning of the treatment with high dosage methylprednisolone.Knowing that other kinds of vaccine can generate ITP, the SARS-CoV-2 vaccine could be related to the symptoms.

Pityriasis rosea-like rash after COVID-19 vaccination with Oxford-AstraZeneca: a possible trigger?

Scholars around the world have dedicated themselves to developing an effective vaccine against SARS-CoV-2. However, vaccines have produced adverse effects in some patients. We report the case of a 44-year-old man who developed a pruritic papulosquamous rash on the trunk with a characteristic pattern known as Christmas tree after receiving the first dose of the Oxford-AstraZeneca COVID-19 vaccine, similar to pityriasis rosea (PR). He had no previous symptoms of viral infection and tested negative for neutralizing antibodies (enzyme immunoassay) against COVID-19. There are few reports in the literature about the relationship between the onset of cutaneous adverse reactions and the Oxford-AstraZeneca vaccine, therefore, the dissemination of this case is of paramount importance.

Primeiros casos de rejeição em transplante penetrante após vacina contra COVID-19 / First cases of penetrating corneal transplant rejection after COVID-19 vaccines

RESUMO Este artigo descreve dois casos de reação imunológica de rejeição de transplante penetrante após a aplicação de dois tipos de vacina contra a COVID-19 - CoronaVac (Sinopharm/Butantan) e MRNA BNT162&2 (Pfizer-BioNTech) - com intervalo de 1 e 10 dias, respectivamente. A rejeição se manifestou com hiperemia, edema corneano e embaçamento da visão, que responderam rapidamente ao uso de corticoide tópico e subconjuntival. Até onde sabemos, este é o primeiro relato de rejeição de transplante penetrante de córnea pós-vacina anti-COVID-19. Recomendamos, presentemente, como prevenção, colírio de prednisolona a 1% 4 dias antes e durante 2 semanas após receber qualquer tipo de vacina para a COVID-19.

ABSTRACT This paper describes two cases of allograft corneal transplant rejection after the application of two types of COVID-19 vaccines - Coronavac (Sinopharm/Butantan) and MRNA BNT162&2 (Pfizer-BioNTech) vaccines - with an interval of 1 to 10 days, respectively. The rejection manifested in the form of corneal edema, hyperemia and blurred vision, which responded rapidly to the use of topical and subconjunctival corticosteroid. As far as we know, this is the first published report of immunological rejection of penetrating corneal transplant after COVID-19 vaccination. As a preventative measure, we now recommend the use of 1% prednisolone eye drop 4 days before and during 2 weeks after having received any type of COVID-19 vaccine.