Reactogenicity of COVID-19 vaccine in hemodialysis patients: a single-center retrospective study

Introduction Some hemodialysis patients are reluctant to COVID-19 for the development of adverse events (AEs). The aim of this study was to verify the safety of mRNA-1273 vaccine in hemodialysis patients. Methods We conducted a retrospective analysis of in-center hemodialysis patients who underwent mRNA-1273 vaccine from March 1st to April 30th, 2021. All AEs occurring after the first and the second doses were collected and classified as local or systemic. Results Overall, 126 patients on chronic maintenance dialysis were vaccinated with two doses of mRNA-1273 vaccine. Mean age was 68 (IQR, 54,7-76) years and 53.6% of patients were aged ≥ 65 years. During the observational period of 68 (IQR, 66-70) days, AEs occurred in 57.9% and 61.9% of patients after the first dose and second dose, respectively. The most common AEs were: injection-site pain (61.9%), erythema (4.8%), itching (4.8%), swelling (16.7%), axillary swelling/tenderness (2.4%), fever (17.5%) headache (7.9%), fatigue (23.8%), myalgia (17.5%), arthralgia (12.7%), dyspnoea (2.4%); nausea/ vomiting (7.1%), diarrhoea (5.6%), shivers (4%) and vertigo (1.6%). The rates of local AEs were similar after the first and second doses (P=0.8), whereas systemic AEs occurred more frequently after the second dose (P=0.001). Fever (P=0.03), fatigue (P=0.02) and nausea/vomiting (P=0.03) were significantly more frequent after the second dose of vaccine. There were no age-related differences in the rate of AEs. Overall, vaccine-related AEs in hemodialysis patients seem lower than in the general population. Conclusion RNA-1273 vaccine is associated with the development of transient AEs after the first (57.9%) and second dose (61.9%) in patients on chronic maintenance dialysis. Systemic AEs were more common after the second dose. Overall, all AEs lasted for a few days, without any apparent sequelae.

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A Retrospective Study of Injection Site Pain from Azithromycin Injection in Japanese Patient

The Showa University Journal of Medical Sciences ◽

10.15369/sujms.32.207 ◽

2020 ◽

Vol 32 (3) ◽

pp. 207-213

Author(s):

Hironori TANAKA ◽

Makoto HAYASHI ◽

Mariko AWAYA ◽

Yumiko KUSUNOKI ◽

Nao TANAKA ◽

...

Keyword(s):

Retrospective Study ◽

Injection Site ◽

Japanese Patient ◽

Injection Site Pain ◽

Site Pain

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Combination therapy with beraprost sodium and aspirin for acute ischemic stroke: a single-center retrospective study

Journal of International Medical Research ◽

10.1177/0300060519850401 ◽

2019 ◽

Vol 47 (7) ◽

pp. 3014-3024 ◽

Cited By ~ 1

Author(s):

De Cai ◽

Xiao-Pu Chen ◽

Dun-Can Wei ◽

Qian Zhang ◽

Si-Qia Chen ◽

...

Keyword(s):

Ischemic Stroke ◽

Retrospective Study ◽

Combination Therapy ◽

Adverse Events ◽

Acute Ischemic Stroke ◽

Blood Coagulation ◽

Control Group ◽

Single Center ◽

Beraprost Sodium ◽

Significant Difference

Objectives To evaluate the effectiveness and safety of the combination of beraprost sodium (BPS) and aspirin in patients with acute ischemic stroke (AIS). Methods There were 384 patients with AIS enrolled in this single-center, retrospective study. The BPS group comprised patients who received combination therapy with BPS and aspirin, and the control group comprised those who received only aspirin. Primary measurements were glomerular filtration rate (GFR), cystatin-c (Cys-C), National Institute of Health Stroke Scale (NIHSS) score, modified activities of daily living index (MBI), modified Rankin scale (mRS), and blood coagulation indexes. Recurrence and adverse events were recorded. Results There were no significant differences in patient characteristics at baseline between the two groups. GFR and Cys-C levels increased in the BPS group compared with the control group. After treatment, the NIHSS and mRS score were significantly lower in the BPS group compared with the control group, whereas the MBI scores were significantly higher in the BPS group compared with the control group. There was no significant difference in blood coagulation between the two groups. There were no serious adverse events in either group. Conclusions Combination therapy with BPS and aspirin may be a safe and effective treatment for AIS.

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167 Randomized, Double-Blind, Active-Controlled Study of Starting Aripiprazole Lauroxil with 1-Day Initiation in Acutely Ill Patients with Schizophrenia

CNS Spectrums ◽

10.1017/s1092852920000838 ◽

2020 ◽

Vol 25 (2) ◽

pp. 306-307

Author(s):

Peter J. Weiden ◽

Amy Claxton ◽

Yangchun Du ◽

Sergey Yagoda ◽

David Walling ◽

...

Keyword(s):

Adverse Events ◽

Outpatient Setting ◽

Controlled Study ◽

Injection Site Pain ◽

Efficacy And Safety ◽

Double Blind ◽

Secondary Analyses ◽

Site Pain ◽

Over Time ◽

Funding Acknowledgements

Abstract:Objective:Evaluate efficacy and safety of a 2-month dose of aripiprazole lauroxil (AL) with a 1-day initiation regimen during hospitalization for an acute exacerbation of schizophrenia.Methods:In the phase 3b double-blind ALPINE study, adults with schizophrenia were randomized to AL (AL NanoCrystal® Dispersion + oral aripiprazole 30 mg day 1; AL 1064 mg day 8 and every 8 weeks) or paliperidone palmitate (PP 234 mg day 1; PP 156 mg day 8 and every 4 weeks). Patients were discharged after 2 weeks of hospitalization and followed through week 25. Primary endpoint was within-group changes in PANSS total score from baseline to week 4 (observed cases). Secondary analyses included within-group changes at weeks 9 and 25 (observed) and between-group comparisons at weeks 4, 9, and 25 (MMRM). Adverse events (AEs) were monitored throughout the study.Results:200 patients were randomized (AL, n=99; PP, n=101); 56.6% and 42.6%, respectively, completed the study. Within-group changes from baseline in PANSS were −17.4 for AL and −20.1 for PP at week 4 (both groups, P<0.001) and continued to decline at weeks 9 (AL, −19.8; PP, −22.5) and 25 (AL, −23.3; PP, −21.7). The change in PANSS over time was similar between groups. AEs occurring in ≥10% of patients in either group were injection site pain (AL, 17.2%; PP, 24.8%), akathisia (AL, 9.1%; PP, 10.9%), and weight increased (AL, 9.1%; PP, 16.8%).Conclusions:AL and PP were effective and well-tolerated for initiating treatment of schizophrenia in the hospital and continuing in the outpatient setting.Funding Acknowledgements:This study was funded by Alkermes, Inc.

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1045. Safety of the Synthetic Saponin Adjuvant TQL1055: Preliminary Results from a First-in-humans Trial

Open Forum Infectious Diseases ◽

10.1093/ofid/ofab466.1239 ◽

2021 ◽

Vol 8 (Supplement_1) ◽

pp. S614-S614

Author(s):

Sean R Bennett ◽

Tyler Martin

Keyword(s):

Adverse Events ◽

Injection Site ◽

Dose Escalation ◽

Large Scale ◽

Phase 1 ◽

Safety Data ◽

Synthetic Analog ◽

Injection Site Pain ◽

The Mean ◽

Site Pain

Abstract Background Saponin adjuvants reliably enhance immune response to a variety of antigens, but their use is hindered by dose-limiting toxicities and supply constraints. TQL1055 is a semi-synthetic analog of the natural saponin adjuvant QS-21, rationally modified to improve tolerability and enable large-scale manufacturing. We previously showed that the combination of acellular pertussis vaccine (aP) and TQL1055 was well-tolerated and increased anti-pertussis toxin (PT) antibody responses in mice and rabbits, with a no observed adverse effect level (NOAEL) > 2000 mcg/dose. Methods Here we report interim results from a Phase 1 first-in-humans dose-escalation study of TQL1055. Healthy adults 18 to 50 years of age were sequentially enrolled into 6 groups (n=12/group) and randomized 10:2 to receive one intramuscular dose of aP + TQL1055 or aP alone on Day 1. TQL1055 dose increased by group from 25 to 800 mcg (Figure 1). Local adverse events (AEs) (injection site pain, redness, swelling) and systemic AEs (fever, chills, headache, fatigue, myalgia, arthralgia, nausea, vomiting, diarrhea) were solicited through Day 8. Clinical laboratory panels (chemistry, hematology, coagulation) were performed on Days 1 (pre-dose), 8, and 29. Serious AEs were collected through Day 365. Antibodies to PT were assessed at all visits. Figure 1. Study Design Results Blinded safety data from the first four groups (n=48) through Day 8 were analyzed, including 2 subjects/group receiving aP alone. All solicited AEs were mild or moderate (Figure 2). Local AEs, mainly injection site pain, occurred in 75% of subjects (mild 65%, moderate 10%). The incidence of total local AEs increased with TQL1055 dose, from 50% at 25 mcg to 92% at 200 mcg. The mean duration of local AEs was 1.8 days and also increased with TQL1055 dose, from 1.3 days at 25 mcg to 2.1 days at 200 mcg. Systemic AEs, mostly fatigue, headache, and nausea, occurred in 63% of subjects (mild 40%, moderate 23%), with no fevers. The mean duration of systemic AEs was 1.4 days, with no association with TQL1055 dose. No severe or serious adverse events were reported. Figure 2. Solicited Adverse Events by Severity and TQL1055 Dose Conclusion In this early analysis, the safety profile of aP + TQL1055 appears similar to that of licensed aP vaccines, without severe or prolonged injection site pain. These data support further dose escalation and assessment of immunogenicity. Disclosures Sean R. Bennett, MD PhD, Adjuvance Technologies (Employee) Tyler Martin, MD, Adjuvance Technologies (Employee, Shareholder)

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Adverse events following immunization with Covi-shield tm vaccine: a descriptive cross-sectional study at a tertiary center, Nepal

International Journal of Multidisciplinary Research and Growth Evaluation ◽

10.54660/anfo.2021.2.6.10 ◽

2021 ◽

pp. 163-163

Author(s):

Gopal Lama ◽

Runa Jha ◽

Sagar K Rajbhandari ◽

Jenish Neupane ◽

Anup Bastola

Keyword(s):

Adverse Events ◽

Injection Site ◽

Cross Sectional Study ◽

Injection Site Pain ◽

Sectional Study ◽

Serious Adverse Events ◽

Cross Sectional ◽

Tertiary Center ◽

National Public Health ◽

Site Pain

Introduction: As the COVID-19 pandemic continues to unfold, rapid global efforts to develop and test vaccines against SARS-CoV-2 have started. Adverse events after immunization are a common issue seen in many vaccines. This study aims at finding the adverse events following the first dose of CovishieldTM vaccine administered to the staffs at two health institutions in Kathmandu. Methods: This was a descriptive cross sectional study conducted among the staffs at National Public Health Laboratory and Sukraraj Tropical and Infectious Disease Hospital, Kathmandu between February to April, 2021. It included 162 participants who had taken the first dose of CovishieldTM vaccine. Ethical approval was taken from Nepal Health Research Council. Statistical Package for the Social Sciences were used for analysis. Results: Various adverse events were seen in 139 (85.8%) participants which were all minor events. None of the participants developed serious adverse events. Very common adverse events experienced were Injection site pain 116 (71.6%), myalgia 76 (46.9%), chills 68 (42%), headache 65 (40.1%), fever 54 (33.3%), dizziness 43 (26.5%) and nausea 20 (12.4%). Similarly, the range of time period from onset to recovery of adverse event was different for different adverse reactions. Conclusions: The adverse events following first dose of CovishieldTM vaccine were all minor reactions with commonest being injection site pain followed by myalgia, chills, headache and fever.

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Use of iliac vein tunneled cuffed catheters in elderly hemodialysis patients: a single-center retrospective study

Journal of Nephrology ◽

10.1007/s40620-015-0198-9 ◽

2015 ◽

Vol 29 (1) ◽

pp. 105-110 ◽

Cited By ~ 3

Author(s):

Lihua Wang ◽

Fang Wei ◽

Guijiang Sun ◽

Haiyan Chen ◽

Haibo Yu ◽

...

Keyword(s):

Retrospective Study ◽

Iliac Vein ◽

Hemodialysis Patients ◽

Single Center ◽

Elderly Hemodialysis Patients

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POS1248 SAFETY PROFILE OF PFIZER-BIONTECH COVID-19 VACCINE IN PATIENTS WITH RHEUMATIC DISEASES: PRELIMINARY ASSESSMENT

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.3529 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 907.2-908

Author(s):

G. Cuomo ◽

M. Atteno ◽

C. Naclerio ◽

L. E. Adinolfi ◽

C. Romano

Keyword(s):

Adverse Events ◽

Injection Site ◽

Rheumatic Diseases ◽

Healthy Subjects ◽

Vaccine Dose ◽

Injection Site Pain ◽

Multicenter Observational Study ◽

Lymph Node Enlargement ◽

Preliminary Study ◽

Site Pain

Background:Efficacious vaccines are urgently needed to contain the ongoing coronavirus disease 2019 (Covid-19) pandemic of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Pfizer-BioNTech COVID-19 vaccine to prevent COVID-19, administered as 2 doses separated by 21 days (1)On December 27, 2020, Italy started use of Pfizer-BioNTech COVID-19 vaccine and initial doses were reserved for health care personnelObjectives:The primary end points were the safety of each administered dose in patients with Rheumatic diseases (RD’s)Methods:In this multicenter, observational study, we interviewed by phone 27 patients with rheumatic diseases (RDs) and 30 healthy subjects receiving the Pfizer-BioNTech vaccine (0.3 ml i.m. in two doses 21 days apart, time 0 and 3 weeks).Results:As of 30 January 2021, 57 subjects (27 patients and 30 healthy subjects) were interviewed. The epidemiological and clinical features of the 27 patients are reported in Table 1. Among the whole population, 35 subjects (16 patients and 19 healthy subjects) complained of an adverse event after the first vaccine dose, with symptom onset occurring within 1 day of vaccination. All adverse events (100%) were classified as nonserious and included: injection site pain (17), fatigue (5), headache (16), fever (3), tachycardia (2), and paresthesia (2).After 21 days, 6 patients and 11 healthy subjects received the second vaccine dose. Fifteen (5 patients and 10 healthy subjects) of them (88%) reported adverse events, again categorized as nonserious. Specifically, injection site pain (7), fatigue (10), headache (10), fever (10), paresthesia (1), cutaneous vasculitis (1), itchy and scratchy throat (1), diarrhea (4), lymph node enlargement (1) were recorded. No differences were noted between patients with RDs and healthy subjects in terms of adverse events.Conclusion:This preliminary study shows that the Pfizer-BioNTech COVID-19 vaccine is as safe in patients with RDs as in healthy subjects. Whether patients with RDs will develop protective titers of anti-SARS-CoV-2 antibodies as compared to healthy subjects will be evaluated in further, ongoing studies.References:[1]Dooling K et al. MMWR Morb Mortal Wkly Rep 2020; 69:1857Table 1.Acknowledgements:I thank the Italian League of Systemic Sclerosis for launching a survey for ssc patients.Disclosure of Interests:None declared

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