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1.
Int J Immunopathol Pharmacol ; 36: 3946320221128534, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36123789

RESUMO

In the current international scientific panorama, rare cases of venous thrombotic complications following mRNA vaccine administration have been reported, consisting mainly of cerebral sinus thromboses and acute venous thromboembolism. The present paper describes the case of a 75-year-old woman in good health who developed cerebral venous thrombosis, deep venous thrombosis, and bilateral pulmonary emboli after receiving a second dose of Pfizer-BioNTech COVID-19 vaccine. A series of laboratory tests performed during hospitalization yielded interesting results, allowing us to exclude thrombophilic risk factors and to certify the absence of thrombocytopenia in the patient. Although COVID-19 vaccination is the most important tool in stopping the pandemic, pharmacovigilance is crucial for detecting potential multisystem thrombotic events, even for mRNA vaccines.


Assuntos
COVID-19 , Trombocitopenia , Trombose , Idoso , Vacina BNT162 , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Feminino , Humanos , Trombocitopenia/induzido quimicamente , Vacinas Sintéticas , Vacinas de mRNA
2.
Vaccine ; 40(41): 5959-5964, 2022 Sep 29.
Artigo em Inglês | MEDLINE | ID: mdl-36085256

RESUMO

OBJECTIVES: To study the rate of SARS-CoV-2 vaccination and post-vaccination disease flares in patients with systemic lupus erythematosus (SLE). METHODS: Patients who fulfilled ≥ 4 of the ACR criteria for SLE were identified and their SARS-CoV-2 vaccination status was traced. Flares of SLE at 6-week post-vaccination were reviewed retrospectively. Clinical characteristics of patients with and without vaccination, and those who did or did not experience post-vaccination flares were compared by statistical analyses. RESULTS: 914 adult patients with SLE were studied (92.5 % women, age 48.6 ± 14.0 years; SLE duration 14.5 ± 8.6 years). Two doses of the SARS-Cov-2 vaccines (61.5 % BioNTech; 38.5 % CoronaVac) were received by 449 (49.1 %) patients. The vaccination rate in SLE was significantly lower than that of the adult general population (77.8 %; p < 0.001) at the time of data analysis. Patients who were hesitant for vaccination were more likely to be hypertensive, have a history of neuromuscular manifestations, and a significantly higher organ damage score (1.10 ± 1.45 vs 0.74 ± 1.15; p < 0.001). However, none of these factors were significantly associated with vaccine hesitancy on multivariate analysis. Among 449 vaccinated patients, 37(8.2 %) experienced SLE flares: mild/moderate in 34; severe in 3. In an equal number of unvaccinated SLE controls randomly matched for the post-vaccination observation period, 28(6.2 %) had SLE flares: mild/moderate in 17; severe in 11 (odds ratio [OR] for flare in vaccinated patients 1.40[0.81-2.43]; p = 0.23, adjusted for age, sex, active serology, SLE duration and prednisolone use). In vaccinated patients, logistic regression revealed that active lupus serology before vaccination (OR 2.63[1.05-6.62]; p = 0.04) and a history of arthritis (OR 2.71[1.05-7.00]; p = 0.04) or discoid skin lesion (OR 4.73[1.90-11.8]; p = 0.001) were associated with SLE flares following vaccination, adjusted for confounders. CONCLUSION: Hesitancy for COVID-19 vaccination is common in SLE patients. Vaccination against SARS-CoV-2 is not significantly associated with increased SLE flares. Patients with active SLE serology or a history of arthritis/discoid lesion are more likely to flare after vaccination.


Assuntos
Artrite , COVID-19 , Lúpus Eritematoso Sistêmico , Adulto , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Feminino , Humanos , Lúpus Eritematoso Sistêmico/complicações , Masculino , Pessoa de Meia-Idade , Prednisolona , Estudos Retrospectivos , SARS-CoV-2 , Vacinação
3.
Cancer Invest ; 40(9): 760-766, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-36062881

RESUMO

Little data are available regarding the effects of COVID-19 vaccine in cancer patients undergoing immunotherapy. Thereby, COVID-19 vaccine-related adverse events were monitored through a short questionnaire in solid cancer patients receiving immunotherapy. A total of 95 patients were included in this study. Two doses of vaccines were administered to cancer patients which mainly received Pembrolizumab (51.1%). Respectively 78.2% and 62.2% of patients reported no adverse events after the first and the second dose regardless of the type of vaccine used. Considering the high mortality rate due to COVID-19 among cancer patients, this study demonstrated the good tolerance of COVID-19 vaccine.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Neoplasias , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Humanos , Imunoterapia , Neoplasias/tratamento farmacológico
4.
Vaccine ; 40(41): 5942-5949, 2022 Sep 29.
Artigo em Inglês | MEDLINE | ID: mdl-36068110

RESUMO

BACKGROUND: In 2021, four vaccines against Covid-19 (BNT162b2, mRNA-1273, ChAdOx1nCoV-19, and JNJ-78436735) were employed in the region of Valencia, Spain. We conducted a survey to identify real-world, self-reported frequency and severity of side effects during the week after vaccination. METHODS: Survey data was obtained from April 19, 2021, to October 6, 2021, at three different moments in time: day one, day three and day seven after vaccination. Answers were linked to individual-level, personal and clinical information. Respondents were stratified by the vaccine they received and reported effects were presented over time and stratified by severity. We compared our results per vaccine with the frequencies stated in each Summary of Product Characteristics (SmPC). We used binomial logistic models to identify associations between respondent characteristics and side effects. RESULTS: No symptoms were reported by 1,986 respondents (14.35 %), 6,254 informed exclusively mild symptoms (45.20 %), 3,444 up to moderate symptoms (24.89 %), and 2,153 people (15.56 %) notified also severe symptoms. Among the latter, the more frequent were extreme tiredness (7.0 %), and nausea or vomiting (7.1 %). The reported frequency of facial paralysis (0.4 %) was much higher than reflected in SmPCs. Female sex, younger age, previous positive Active Infection Diagnostic Test, chronicity, and vaccination with other than the BNT162b2 vaccine were associated to an increased risk of side effects (p < 0.001). CONCLUSIONS: Side effects after vaccination are common in the real-world. However, they are principally mild, and their frequency declines after a few days. Providing patients with dependable, beforehand information about side effects may improve outcomes and reinforce vaccination programs.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Vacina de mRNA-1273 contra 2019-nCoV , Ad26COVS1 , Vacina BNT162 , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , ChAdOx1 nCoV-19 , Feminino , Humanos , Espanha/epidemiologia , Inquéritos e Questionários , Vacinação/efeitos adversos
5.
Vaccine ; 40(41): 5997-6000, 2022 Sep 29.
Artigo em Inglês | MEDLINE | ID: mdl-36068111

RESUMO

Coronavirus disease 2019 (COVID-19) vaccine administration started in February 2021 in Japan. As of December 2021, approximately 75% of the population aged ≥12 years had received two doses of vaccine. We conducted a study to investigate vasovagal reactions (VVR) after COVID-19 vaccination using data on adverse events following immunization. The crude reporting rate of VVR (cases/1,000,000 doses) after vaccination was 9.6 in all age groups combined, and was more frequent in the younger age groups: 28.6 and 37.2 in individuals aged 10-19 years and 20-29 years, respectively. In individuals aged 10-29 years, the rate was similar in males and females (33.0 and 34.2, respectively, p = 0.53); but was higher after dose 1 than after dose 2 (57.4 and 8.8, respectively, p < 0.001). Based on these results, caution needs to be exercised when vaccinating adolescents and young adults, especially with dose 1 of COVID-19 vaccines.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Síncope Vasovagal , Adolescente , Adulto , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Criança , Feminino , Humanos , Japão/epidemiologia , Masculino , Síncope Vasovagal/induzido quimicamente , Vacinação/efeitos adversos , Adulto Jovem
6.
Front Immunol ; 13: 919958, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36119091

RESUMO

Background: Androgen sensitivity, which was established as the leading etiology of androgenetic alopecia (AGA) and benign prostatic hyperplasia (BPH), plays an important role in SARS-CoV-2 infection. Vaccination is essential for AGA and BPH patients in view of the high risk from SARS-CoV-2 infection. Purpose: We aimed to investigate the associated factors for SARS-CoV-2 vaccination and its side effects in populations with AGA and BPH. Method: We collected the data on SARS-CoV-2 vaccination and adverse reactions of male AGA and BPH patients visited the outpatient of Xiangya hospital by telephone and web-based questionnaires. Vaccination rate and adverse reactions were compared by different vaccine types and use of anti-androgen therapy. Result: A total of 457 AGA patients and 397 BPH patients were recruited in this study. Among which, 92.8% AGA patients and 61.0% BPH patients had at least the first dose of SARS-CoV-2 vaccination (p < 0.001). Having comorbidities and use of anti-androgen therapy increased the risk of un-vaccination among AGA by 2.875 and 3.729 times, respectively (p < 0.001). Around 31.1% AGA patients and 9.5% BPH patients presented adverse reactions, which were mostly mild. Anti-androgen therapy increased the inclination of injection site pain after vaccination (18.7% vs 11.9%; OR: 1.708, 95% CI: 1.088-2.683, p = 0.019). Conclusion: Co-existence of other systemic diseases and anti-androgen therapy were the limiting factors for SARS-CoV-2 unvaccination, especially in AGA patients. The importance of SARS-CoV-2 vaccines should be strengthened and popularized in androgen sensitive phenotypes.


Assuntos
COVID-19 , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Hiperplasia Prostática , Vacinas , Alopecia/complicações , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/complicações , Humanos , Hiperplasia , Masculino , Fenótipo , Próstata , Hiperplasia Prostática/tratamento farmacológico , SARS-CoV-2 , Vacinação/efeitos adversos
7.
Front Immunol ; 13: 975363, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36119092

RESUMO

Evaluation of the safety and immunogenicity of new vaccine platforms is needed to increase public acceptance of coronavirus disease 2019 (COVID-19) vaccines. Here, we evaluated the association between reactogenicity and immunogenicity in healthy adults following vaccination by analyzing blood samples before and after sequential two-dose vaccinations of BNT162b2 and ChAdOx1 nCoV-19. Outcomes included anti-S IgG antibody and neutralizing antibody responses, adverse events, and proinflammatory cytokine responses. A total of 59 and 57 participants vaccinated with BNT162b2 and ChAdOx1 nCoV-19, respectively, were enrolled. Systemic adverse events were more common after the first ChAdOx1 nCoV-19 dose than after the second. An opposite trend was observed in BNT162b2 recipients. Although the first ChAdOx1 nCoV-19 dose significantly elevated the median proinflammatory cytokine levels, the second dose did not, and neither did either dose of BNT162b2. Grades of systemic adverse events in ChAdOx1 nCoV-19 recipients were significantly associated with IL-6 and IL-1ß levels. Anti-S IgG and neutralizing antibody titers resulting from the second BNT162b2 dose were significantly associated with fever. In conclusion, systemic adverse events resulting from the first ChAdOx1 nCoV-19 dose may be associated with proinflammatory cytokine responses rather than humoral immune responses. Febrile reactions after second BNT162b2 dose were positively correlated with vaccine-induced immune responses rather than with inflammatory responses.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Adulto , Anticorpos Neutralizantes , Vacina BNT162 , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , ChAdOx1 nCoV-19 , Humanos , Imunoglobulina G , Interleucina-6
8.
Clin Adv Hematol Oncol ; 20(9): 572-578, 2022 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-36125949

RESUMO

BACKGROUND: The COVID-19 pandemic gave rise to rapid development of anti-SARS-CoV-2 vaccines using established and new technologies. Immune thrombocytopenia (ITP) is a bleeding disorder that has been associated with COVID-19 vaccine products that are currently in use. We reviewed the available evidence regarding the most commonly used vaccines against SARS-CoV-2 in North America and Europe and their association with ITP. We found that population-based studies suggested a small increase in the incidence of ITP in persons receiving the ChAdOx1 nCoV-19 vaccine from Oxford-AstraZeneca, on the order of 6 cases per million doses administered. Severe bleeding was an even rarer event. Both messenger RNA-based and adenovirus-based vaccines have been associated with exacerbation of preexisting ITP in 6% to 20% of patients. ITP exacerbation is readily treatable with standard approaches when needed. Severe bleeding events are rare both in the general population and in persons with preexisting ITP, and overall, the benefits of vaccination outweigh the risks. Further identification of persons at the highest risk for complications (including those with ITP, vaccine-induced immune thrombotic thrombocytopenia, and myocarditis) and clear communication of both risks and benefits of immunization will continue to be paramount in the global campaign against COVID-19.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Trombocitopenia , COVID-19/epidemiologia , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , ChAdOx1 nCoV-19 , Humanos , Pandemias , SARS-CoV-2 , Trombocitopenia/induzido quimicamente
9.
Front Immunol ; 13: 882919, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36131922

RESUMO

Given that vaccine-induced adverse effects were mostly based on previous laboratory research and clinical trials, real-world data on the safety of coronavirus disease 2019 (COVID-19) vaccination were lacking. This study reported the adverse events (AEs) among inactivated COVID-19 vaccine recipients. Data were collected from a total of 2,808 hospital employees and their family members in Wuhan, China, with all of them receiving the first dose of inactivated COVID-19 vaccines from two pharmaceutical companies. The first dose was given between 29th April and 13th May 2021. A total of 2,732 vaccinees received the second dose between 27th May and 8th July 2021. The whole process of receiving the vaccine was monitored by clinical pharmacists, and the information on AEs including demographics, occurrence, types, and severity was recorded through an online questionnaire and telephone follow-up. Most of the common AEs were mild and tolerable, and the overall incidence of AEs was lower than the data from the safety profile in clinical trials. Moreover, the incidence of AEs in the first dose (21.30%, 598) was higher than that in the second dose (16.07%, 439). Furthermore, the first injection had more severe AEs (4, 0.14%) than the second injection (2, 0.07%). The AEs involved the skin, muscle, respiratory tract, gastrointestinal tract, cardiovascular system, and other tissues and systems. The most common AE was pain at the injection site (first dose: 10.19%, second dose: 12.55%). All the vaccinees with AEs for both doses recovered fully in the end. It was noted that some AEs might cause blood coagulation disorder and bleeding risk. Therefore, ongoing monitoring of AEs after COVID-19 vaccination is essential in evaluating the benefits and risks of each vaccine.


Assuntos
COVID-19 , Vacinas , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Humanos , Preparações Farmacêuticas , Farmacêuticos
10.
JAMA Netw Open ; 5(9): e2230495, 2022 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-36074467

RESUMO

Importance: COVID-19 vaccine boosters or third doses are recommended for adolescents and adults who completed their initial COVID-19 vaccine course more than 5 months prior. Minimal data are available on COVID-19 vaccine booster or third dose reactogenicity among pregnant and lactating individuals. Objective: To describe the reactions to the booster or third dose of the COVID-19 vaccine and vaccine experiences among pregnant and lactating individuals. Design, Setting, and Participants: Beginning in October 2021, a follow-up Research Electronic Data Capture (REDCap) survey regarding a COVID-19 vaccine booster or third dose was sent to 17 504 participants in an ongoing online prospective cohort study on COVID-19 vaccines among pregnant and lactating individuals. A convenience sample of adults enrolled in the online prospective study who were pregnant, lactating, or neither pregnant nor lactating at the time of their booster or third dose was eligible for this follow-up survey; 17 014 (97.2%) completed the follow-up survey. Exposure: Receipt of a booster or third dose of the COVID-19 vaccine. Main Outcomes and Measures: Self-reported vaccine reactions less than 24 hours after the dose. Results: As of April 4, 2022, 17 014 eligible participants (mean [SD] age, 33.3 [3.5] years) responded to the booster or third dose survey; of these, 2009 (11.8%) were pregnant at the time of their booster or third dose, 10 279 (60.4%) were lactating, and 4726 (27.8%) were neither pregnant nor lactating. After a COVID-19 booster or third dose, most individuals (14 074 of 17 005 [82.8%]) reported a local reaction, and 11 542 of 17 005 (67.9%) reported at least 1 systemic symptom. Compared with individuals who were neither pregnant nor lactating, pregnant participants were more likely to report any local reaction to a COVID-19 booster or third dose (adjusted odds ratio [aOR], 1.2; 95% CI, 1.0-1.4; P = .01) but less likely to report any systemic reaction (aOR, 0.7; 95% CI, 0.6-0.8; P < .001). Most pregnant (1961 of 2009 [97.6%]) and lactating (9866 of 10 277 [96.0%]) individuals reported no obstetric or lactation concerns after vaccination. Conclusions and Relevance: This study suggests that COVID-19 vaccine boosters or third doses were well tolerated among pregnant and lactating individuals. Data to evaluate tolerability of boosters or additional doses among pregnant and lactating individuals will be important as they are considered for these populations.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Complicações Infecciosas na Gravidez , Vacinas , Adolescente , Adulto , COVID-19/epidemiologia , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Feminino , Humanos , Imunização Secundária/efeitos adversos , Lactação , Gravidez , Complicações Infecciosas na Gravidez/prevenção & controle , Estudos Prospectivos
11.
Croat Med J ; 63(4): 389-393, 2022 Aug 31.
Artigo em Inglês | MEDLINE | ID: mdl-36046936

RESUMO

Since the beginning of mass vaccination against coronavirus disease 2019 (COVID-19), vaccine-linked immune-mediated diseases have been increasingly reported. The development of these diseases after COVID-19 vaccination may be attributed to the mechanisms of molecular mimicry and cross-reactivity between the viral spike protein and self-antigens. The most frequent vaccine-linked glomerular disease is immunoglobulin A nephropathy (IgAN). Cutaneous vasculitis has also been reported after COVID-19 vaccination. In both diseases, deposition of immune complexes activates the inflammatory response with end-organ damage. We report on a case of de novo IgAN in a young man and a case of severe cutaneous vasculitis in a 68-year-old woman, both after the second dose of Pfizer-BioNTech COVID-19 vaccine. Neither of the patients had a history of autoimmunity or adverse reactions to vaccines. The temporal association between vaccination and disease development in the absence of other possible intercurrent inciting events suggests a causal mechanism, although coincidental co-occurrence cannot be excluded. In both cases, immunosuppressive treatment was warranted to stop disease progression and to partially or completely resolve the disease. A timely reaction is needed if new-onset signs of an immune-mediated disease appear after vaccination.


Assuntos
COVID-19 , Vacinas , Vasculite , Idoso , Vacina BNT162 , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Feminino , Humanos , Masculino , Vacinação/efeitos adversos , Vacinas/efeitos adversos , Vasculite/induzido quimicamente
12.
Clin Lymphoma Myeloma Leuk ; 22 Suppl 2: S287-S288, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-36163909

RESUMO

INTRODUCTION: Effectiveness and safety of new vaccines against new COVID-19 infection in patients with chronic myeloid leukemia (CML) need evaluation. AIM: To evaluate prospectively adverse events (AEs) and antibody formation after vaccination against SARS-CoV-2 in CML patients in a single center. CML patients applied for outpatient/remote consultations were suggested to report the post-vaccination AEs after the vector-based vaccine GamCovidVac (Sputnik V). At least 3 weeks after the 2nd injection patients were administered a blood test for SARS-CoV-2 spike(S) protein-specific antibodies by a semi-quantitative immunoassay (ELISA) which was considered positive at cut-off index (CI)>1. Other available tests for antibody detection were allowed as well. RESULTS: Nighty-five chronic phase CML patients with a median (Me) age 54 years (range 29-89), received Sputnik V (DEC.2020-JUL.2021), 40(42%) were males. Me CML duration was 8 years (range 0-20), 75(79%) patients received TKIs at vaccination, 20(21%) were off-therapy: 17(18%) in treatment-free remission, 3(3%) with CML onset. Seventeen (18%) patients had a prior history of COVID-19. AEs were reported in 53(56%) patients: local pain/discomfort -30(31.5%), weakness/drowsiness -29 (30.5%), fever and/or chills -28(29%), other AEs -10(12%): headache, heartbeat, limbs/back pain, herpes reactivation. General reactions stopped in 1-2 days. No severe or life-threatening AEs were observed. Antibodies were detected in 66(93%) of 71 patients by any method, Me time after 2nd injection was 31 days (range 5-179). ELISA test was positive in 48(94%) of 55 tested patients with Me CI 7.7 (range 1.1-12), consistent with values of healthy people. Three of 7 negative by ELISA patients (Me age 58 years (range 40-70)) revealed antibodies by other tests with levels slightly above threshold. A very weak reverse correlation of the antibody levels with post-vaccination time (r =- 0.32) and with age (r =- 0.28) was observed. CONCLUSIONS: Sputnik V vaccine showed no unexpected or severe AEs in CML patients. Seroconversion rate of about 93-94% was close to the 3-phase trial data (94-97%). No strong age-dependent/time-dependent correlation of antibody levels was found in the tested time period. Sputnik V vaccination is safe and acceptable in CML patients.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Leucemia Mielogênica Crônica BCR-ABL Positiva , Adulto , Idoso , Idoso de 80 Anos ou mais , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Feminino , Humanos , Leucemia Mielogênica Crônica BCR-ABL Positiva/terapia , Masculino , Pessoa de Meia-Idade
13.
Clin Lymphoma Myeloma Leuk ; 22 Suppl 2: S435, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-36164200

RESUMO

CONTEXT: Acquired hemophilia A is an autoimmune bleeding disorder that results from autoantibodies against coagulation factor VIII. Failure to recognize AHA as a cause of bleeding results in delayed management. OBJECTIVE: Case report of acquired hemophilia after receiving COVID-19 vaccines (Pfizer-BioNTech SARS-CoV-2 mRNA vaccine). Design and Patient Criteria: A case report of a lady who attended the haematology clinic at the University College London hospital. This included history taking, physical examination, full blood count, coagulation screen and factor assay, factor VIII inhibitor assay, immune workup, and CT scan. MAIN OUTCOME: We reported this 40-year-old lady with no previous medical history. She presented with massive vaginal bleeding and anemia which needed a blood transfusion. This coincided with her first dose of the Pfizer vaccine. Investigations showed high APTT at 45 sec, Factor VIII level at 0.3 IU/ml, Factor VIII Bethesda antibodies assay at 0.8 with normal other coagulation work up. Immune profile (ANA, Anti-dsDNA, C3, C4, and lupus workup) was negative and CT whole body showed no abnormalities. She was started on prednisolone 60 mg after which her bleeding improved and factor VIII level increased to 0.5 IU/ml. Once she started steroid withdrawal bleeding re-occurred and factor VIII level dropped to 0.21 IU/mL with APTT prolongation to 45 sec. Subsequently, she received 4 weeks of rituximab resulting in Factor VIII level normalization at 1.51 IU/ml, normal clotting screen and resolution of bleeding which has been sustained since November 2021. CONCLUSIONS: While thrombosis is a side effect of COVID-19 infection, bleeding can still happen in the setting of COVID-19 infection/vaccination. Till recently, only a few cases of acquired hemophilia have been reported after receiving mRNA-derived COVID-19 vaccines. Related Haematologic autoimmune disease may involve stimulation of auto-antibody production from preexisting B cells by triggering autoimmunity. It is crucial to raise awareness about this side effect that may be directly induced by the mRNA COVID-19 vaccine. We highly recommend screening for an antibody inhibitor with unexplained bleeding and/or isolated activated partial thromboplastin time prolongation following the COVID vaccine.


Assuntos
COVID-19 , Hemofilia A , Adulto , Autoanticorpos , Vacinas contra COVID-19/efeitos adversos , Fator VIII/uso terapêutico , Feminino , Hemofilia A/diagnóstico , Hemofilia A/etiologia , Humanos , Prednisolona/uso terapêutico , RNA Mensageiro , Rituximab/uso terapêutico , SARS-CoV-2 , Tomografia Computadorizada por Raios X , Vacinas Sintéticas , Vacinas de mRNA
14.
Psychiatr Danub ; 34(Suppl 8): 56-59, 2022 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-36170703

RESUMO

Vaccines are crucial to ending the COVID-19 pandemic. An mRNA-based COVID-19 vaccine can cause mild to moderate side effects. A number of cases of cardiac, gastrointestinal, and psychiatric side effects have been reported as rare side effects associated with the COVID-19 vaccine. This article presents a patient, who after the second injection of the mRNA-based COVID-19 vaccine, immediately developed anxiety, nonspecific fear, and insomnia as the prodromal phase of psychosis. Starting from the second week, the patient manifested delusions of persecution, delusions of influence, thoughts insertion, and delusional behaviour, culminating in the suicide attempt. The duration of psychosis was eight weeks, and symptom reduction was observed only after the gradual administration of antipsychotics over four weeks. The investigations of the patient did not support any structural changes of the brain, any severe medical conditions, a neurological abnormality, a confusion or a state of unconsciousness or alterations in laboratory tests. Psychosis due to the use of alcohol or psychoactive substances was excluded. The psychological assessment of the patient demonstrated the endogenous type of thinking, and the patient had schizoid and paranoid personality traits strongly associated with schizophrenia. This case indicates a strong causal relationship between the mRNA-based COVID-19 vaccine injection and the onset of psychosis. We intend to follow up this case for possible development of schizophrenia and understand that the COVID-19 vaccine could possible play a trigger role in the development of primary psychosis. Longer-term supporting evidence is needed to estimate the prevalence of psychosis following vaccination with the mRNA-based COVID-19 vaccine.


Assuntos
COVID-19 , Transtornos Psicóticos , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Humanos , Pandemias , Transtornos Psicóticos/psicologia , RNA Mensageiro , Vacinação
15.
Eur J Endocrinol ; 187(1): K7-K11, 2022 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-36073554

RESUMO

Objective: Coronavirus disease-2019 (COVID-19) causes acute respiratory distress syndrome. Patients with adrenal insufficiency (AI) may develop severe complications due to this infection and should undergo COVID-19 vaccination; however, there is no consensus about the management of their replacement therapy. The aim of our study was to evaluate the tolerability and need for glucocorticoid dose adjustment related to COVID-19 mRNA vaccines in a cohort of patients with AI. Design and methods: We prospectively administered to 88 patients (51 M/37 F; mean age: 62.3 ± 16 years), with AI (28 primary and 60 secondary AI), a questionnaire about the occurrence, severity and duration of the side effects and the need for glucocorticoid dose adjustment within 1 week after the first and the second dose of COVID-19 mRNA vaccines (Pfizer-BioNTech and Moderna). Results: Side effects of mild to moderate severity occurred in about 70% of patients after both vaccine doses. The most common adverse events were pain at the injection site, fatigue, fever and flu-like symptoms. The occurrence and severity of the side effects were not correlated to gender, type of AI and mRNA vaccine, but their total number was higher after the second vaccine dose. Doubling the oral glucocorticoid dose was needed in up to 8% of patients, especially after the second vaccine dose, but no parenteral administration was required. Conclusions: COVID-19 mRNA vaccines were well tolerated in patients with AI. Side effects were similar to those observed in the general population, and increasing glucocorticoid replacement therapy before vaccine administration was not needed.


Assuntos
Insuficiência Adrenal , COVID-19 , Vacinas , Insuficiência Adrenal/tratamento farmacológico , Idoso , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Glucocorticoides/efeitos adversos , Humanos , Pessoa de Meia-Idade , Vacinas/uso terapêutico , Vacinas Sintéticas , Vacinas de mRNA
16.
Cancer Control ; 29: 10732748221106266, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36066031

RESUMO

Coronavirus disease 2019 (COVID-19) infection is caused by severe acute respiratory syndrome coronavirus 2. Adults with cancer are immunocompromised due to several causes including cancer itself and immunosuppressive therapy. Thus, cancer patients are more susceptible to develop COVID-19 infection. As COVID-19 vaccines became available, patients with cancer would benefit from receiving the vaccine. This article aims to review the recent evidences and recommendations about COVID-19 vaccination in cancer patients.Current guidelines recommend that patients with cancer should have the priority to receive the vaccine given their immunocompromised state. The timing of administration varies depending on cancer type and treatment. Generally, the vaccine should be given before starting the chemotherapy if possible or in between chemotherapy cycles and away from nadir phase. For other cancer treatments, it is recommended to give the vaccine when there is evidence of blood count recovery. In general, induction therapy and treatment for newly diagnosed patients should not be delayed for the vaccination purpose. It is noteworthy to mention that cancer patients especially those with hematologic malignancies might have absented or attenuated response to the vaccine due to their pathophysiological status.On the other hand, the current vaccine guidelines have been criticized for lacking evidence on some important topics that need to be addressed. Firstly, some vaccines have been granted an emergency use authorization, prior to the usual comprehensive safety and efficacy evaluation process. Secondly, specific populations including cancer patients were excluded from the approval trials for safety reasons. Finally, some recommendations regarding the COVID-19 vaccines are extrapolated from other vaccines studies. Further studies are required to fill these gaps and observational studies that include cancer patients are warranted to have a better understanding of the safety and efficacy of the vaccines in cancer patients.


Assuntos
COVID-19 , Neoplasias , Vacinas , Adulto , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Humanos , Hospedeiro Imunocomprometido , Neoplasias/complicações , Neoplasias/tratamento farmacológico , Vacinação , Vacinas/uso terapêutico
17.
West Afr J Med ; 39(9): 889-895, 2022 Sep 16.
Artigo em Inglês | MEDLINE | ID: mdl-36116070

RESUMO

BACKGROUND: COVID-19 vaccine hesitancy is a global public health problem. It is a complex and context-specific phenomenon that varies within and across nations. Despite COVID-19 vaccine programmes in Nigeria, there are possibilities that vaccine uptake and coverage among adult citizens will suffer setbacks amidst various interventions by the Federal Government of Nigeria. AIM: The study aimed to determine the drivers, dangers, and corrective measures for COVID-19 vaccine hesitancy and potential penalties for declining vaccination among adults in South-eastern Nigeria. METHODS: A descriptive study was carried out from March to April, 2021 on a cross section of 400 adults in South-eastern Nigeria. Data collection was done using a structured, pretested, and interviewer administered questionnaire. The questionnaire elicited information on drivers, dangers and corrective measures for COVID-19 vaccine hesitancy and potential penalties for declining vaccination. RESULTS: The study participants were aged 18-86 (51±14.2) years. There were 227(56.8%) females. The most common driver of refusal of COVID-19 vaccination was the safety of COVID-19 vaccines(100.0%). The most perceived dangers of refusing the COVID-19 vaccine were the risks of contracting COVID-19 infection(100.0%) and dying from its complications(100.0%). The most common corrective measure for refusal of the COVID-19 vaccine was public health information and education on vaccine safety(100.0%). The predominant potential penalty for declining the COVID-19 vaccine was restricting access to air travel (100.0%). CONCLUSION: This study has shown that the most common driver of vaccine hesitancy was vaccine safety while the most commonly perceived dangers were risks of contracting COVID-19 infection and dying from its complications. The most common corrective measure for refusal of the COVID-19 vaccine was public health information and education on vaccine safety. The most preeminent penalty for declining the COVID-19 vaccine was restricting access to air travel. There is a need to address these context-specific drivers and dangers that promote vaccine hesitancy. Public health information and education strategies to reduce vaccine hesitancy should be the focus of intervention to improve uptake of COVID-19 vaccination and safeguard the health of Nigerians.


CONTEXTE: L'hésitation à se faire vacciner contre le COVID-19 est un problème de santé publique mondial. Il s'agit d'un phénomène complexe et spécifique au contexte qui varie au sein d'une même nation et d'une nation à l'autre. Malgré les programmes de vaccination contre le COVID-19 au Nigeria, il est possible que l'adoption et la couverture vaccinale chez les adultes subissent des revers malgré les diverses interventions du gouvernement fédéral du Nigeria. OBJECTIF: L'étude visait à déterminer les moteurs, les dangers et les mesures correctives de l'hésitation à se faire vacciner contre le COVID- 19 et les sanctions potentielles en cas de refus de vaccination chez les adultes du sud-est du Nigeria. MÉTHODES: Une étude descriptive a été menée de mars à avril 2021 sur un échantillon de 400 adultes du sud-est du Nigeria. La collecte des données a été effectuée à l'aide d'un questionnaire structuré, testé au préalable et administré par un enquêteur. Le questionnaire a permis d'obtenir des informations sur les facteurs, les dangers et les mesures correctives de l'hésitation à se faire vacciner par le COVID-19 et les sanctions potentielles en cas de refus de la vaccination. RÉSULTATS: Les participants à l'étude étaient âgés de 18 à 86 ans (51±14,2). Il y avait 227 (56,8 %) femmes. Le motif le plus courant de refus de la vaccination par le COVID-19 était l'innocuité des vaccins COVID-19 (100,0 %). Les dangers les plus perçus du refus du vaccin COVID-19 étaient les risques de contracter une infection au COVID-19 (100,0%) et de mourir de ses complications (100,0%). La mesure corrective la plus courante pour le refus du vaccin COVID-19 était l'information et l'éducation en matière de santé publique sur la sécurité du vaccin (100,0%). La pénalité potentielle prédominante pour le refus du vaccin COVID-19 était la restriction de l'accès aux voyages aériens (100,0 %). CONCLUSION: Cette étude a montré que le facteur le plus courant de l'hésitation à se faire vacciner était la sécurité du vaccin, tandis que les dangers les plus couramment perçus étaient les risques de contracter l'infection au COVID-19 et de mourir de ses complications. La mesure corrective la plus courante pour le refus du vaccin COVID-19 était l'information et l'éducation de la santé publique sur la sécurité du vaccin. La sanction la plus prééminente pour le refus du vaccin COVID-19 était la restriction de l'accès aux voyages aériens. Il est nécessaire de s'attaquer à ces facteurs et dangers spécifiques au contexte qui favorisent l'hésitation à se faire vacciner. Les stratégies d'information et d'éducation en matière de santé publique visant à réduire l'hésitation à se faire vacciner devraient être au centre de l'intervention afin d'améliorer l'adoption de la vaccination par le COVID-19 et de préserver la santé des Nigérians. Mots clés: Vaccin COVID-19, Dangers, Facteurs d'incitation, Hésitation, Nigeria, Pénalités.


Assuntos
COVID-19 , Vacinas , Adulto , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Estudos Transversais , Feminino , Humanos , Masculino , Nigéria , Aceitação pelo Paciente de Cuidados de Saúde , Vacinação/efeitos adversos , Hesitação Vacinal
19.
Vaccine ; 40(40): 5798-5805, 2022 Sep 22.
Artigo em Inglês | MEDLINE | ID: mdl-36055877

RESUMO

INTRODUCTION: In 2020, prior to COVID-19 vaccine rollout, the Brighton Collaboration created a priority list, endorsed by the World Health Organization, of potential adverse events relevant to COVID-19 vaccines. We adapted the Brighton Collaboration list to evaluate serious adverse events of special interest observed in mRNA COVID-19 vaccine trials. METHODS: Secondary analysis of serious adverse events reported in the placebo-controlled, phase III randomized clinical trials of Pfizer and Moderna mRNA COVID-19 vaccines in adults (NCT04368728 and NCT04470427), focusing analysis on Brighton Collaboration adverse events of special interest. RESULTS: Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI -0.4 to 20.6 and -3.6 to 33.8), respectively. Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95 % CI 2.1 to 22.9); risk ratio 1.43 (95 % CI 1.07 to 1.92). The Pfizer trial exhibited a 36 % higher risk of serious adverse events in the vaccine group; risk difference 18.0 per 10,000 vaccinated (95 % CI 1.2 to 34.9); risk ratio 1.36 (95 % CI 1.02 to 1.83). The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000 (95 % CI -23.2 to 37.4); risk ratio 1.06 (95 % CI 0.84 to 1.33). Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients: risk difference 13.2 (95 % CI -3.2 to 29.6); risk ratio 1.16 (95 % CI 0.97 to 1.39). DISCUSSION: The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes. These analyses will require public release of participant level datasets.


Assuntos
COVID-19 , Vacinas , Adulto , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Humanos , RNA Mensageiro , Ensaios Clínicos Controlados Aleatórios como Assunto , Vacinação/efeitos adversos , Vacinas Sintéticas , Vacinas de mRNA
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