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2022 ◽  
Vol 12 (1) ◽  
Author(s):  
Jeong Woo Yoo ◽  
Kyo Chul Koo ◽  
Byung Ha Chung ◽  
Kwang Suk Lee

AbstractWe analyzed the intensity of pain at each site of systemic prostate biopsy (SBx) and compared the intensity of pain among magnetic resonance (MRI)-targeted transrectal biopsies according to the periprostatic nerve block (PNB) site. We collected data from 229 consecutive patients who had undergone MRI-targeted biopsy. Patients were stratified into two groups according to the site of PNB (base versus base and apex PNB). Pain was quantified at the following time points: probe insertion, injection at the prostate base, injection at the prostate apex, MRI cognitive biopsy (CBx), MRI/transrectal ultrasound fusion biopsy (FBx), SBx, and 15 min after biopsy. For all biopsy methods, the average pain were significantly higher in the base PNB group than in the base and apex PNB group (CBx, p < 0.001; FBx, p = 0.015; SBx, p < 0.001). In the base and apex PNB group, FBx was significantly more painful than SBx (p = 0.024). Overall, regardless of the PNB site, pain at the anterior sites was more than that at the posterior sites in FBx (p = 0.039). Base and apex PNB provided better overall pain control than base-only PNB in all biopsy methods. In the base and apex PNB group, FBx was more painful than CBx and SBx.


2022 ◽  
Vol 0 (0) ◽  
Author(s):  
Sylvia Marshall ◽  
Sara Winter ◽  
John D. Capobianco

Abstract Pfizer-BioNTech BNT162b2 is one of the three U.S. Food and Drug Administration (FDA)-approved vaccines for the prevention of COVID-19. Its most common side effect, injection site pain, occurs because of locally recruited inflammatory mediators and is mitigated by the lymphatic system. Side effects may discourage individuals from receiving vaccines; therefore, reducing the duration of injection site pain can promote vaccination compliance. Osteopathic manipulative treatments (OMT) can directly affect the physiology underlying muscle soreness; however, there is currently no literature that supports the use of OMT in this scenario. In this case report, an otherwise healthy male presented with acute left deltoid soreness after receiving the Pfizer COVID-19 vaccine. The pain began 5 h prior to the visit. Three hours after being treated with lymphatic OMT, the severity of the pain was significantly reduced and was alleviated 8h after onset in comparison to the median duration of 24–48 h. He received his second dose 3 weeks later. This case report can provide future studies with the groundwork for further investigating the role of OMT in treating postvaccination muscle soreness, which can improve patient satisfaction and potentially promote vaccination compliance.


2021 ◽  
Author(s):  
Simbarashe Takuva ◽  
Azwidhwi Takalani ◽  
Ishen Seocharan ◽  
Nonhlanhla Yende-Zuma ◽  
Tarylee Reddy ◽  
...  

Background: The Sisonke openlabel phase 3b implementation study aimed to assess the safety and effectiveness of the Janssen Ad26.CoV2.S vaccine among health care workers (HCWs) in South Africa. Here, we present the safety data. Methods: We monitored adverse events (AEs) at vaccination sites, through self reporting triggered by text messages after vaccination, health care provider reports and by active case finding. The frequency and incidence rate of non serious and serious AEs were evaluated from day of first vaccination (17 February 2021) until 28 days after the final vaccination (15 June 2021). COVID 19 breakthrough infections, hospitalisations and deaths were ascertained via linkage of the electronic vaccination register with existing national databases. Findings: Of 477,234 participants, 10,279 (2.2%) reported AEs, of which 139 (1.4%) were serious. Women reported more AEs than men (2.3% vs. 1.6%). AE reports decreased with increasing age (3.2% for 18 to 30, 2.1% for 31 to 45, 1.8% for 46 to 55 and 1.5% in >55 year olds). Participants with previous COVID 19 infection reported slightly more AEs (2.6% vs. 2.1%). The commonest reactogenicity events were headache and body aches, followed by injection site pain and fever, and most occurred within 48 hours of vaccination. Two cases of Thrombosis with Thrombocytopenia Syndrome and four cases of Guillain Barre Syndrome were reported post-vaccination. Serious AEs and AEs of special interest including vascular and nervous system events, immune system disorders and deaths occurred at lower than the expected population rates. Interpretation: The single-dose Ad26.CoV2.S vaccine had an acceptable safety profile supporting the continued use of this vaccine in our setting.


Author(s):  
Gopal Lama ◽  
Runa Jha ◽  
Sagar K Rajbhandari ◽  
Jenish Neupane ◽  
Anup Bastola

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.


2021 ◽  
Vol 9 (4) ◽  
pp. 16-24
Author(s):  
Ana Cecilia Amado Xavier de Oliveira ◽  
◽  
Isabella Fernandes Delgado ◽  
Francisco José Roma Paumgartten ◽  
◽  
...  

Introduction: The COVID-19 vaccines in use (inactivaded virus, encapsulated m-RNA, non-replicating adenovirus-vectored DNA) were clinically tested in randomized placebocontrolled phase-3 studies. Objective: To address certainties and uncertainties about safety and effectiveness of COVID-19 vaccines that were approved for use in various countries. Method: The evidence provided by clinical studies on the efficacy and safety of COVID-19 vaccines was critically appraised. Results: COVID-19 vaccines proved to be efficacious and safe in clinical trials. Adverse events were mostly those of minor severity commonly noted with other vaccines such as injection site pain, mild flu-like symptoms, headache and asthenia. Although being very rare, anaphylaxis-like reactions were noted with mRNA vaccines. Uncertainties regarding vaccine effectiveness refer mainly to the (long-term) duration of immunity provided by vaccination, the degree of protection conferred to elderly people, and how effective vaccines are against emerging SARS-CoV-2 variants. There are few uncertainties about vaccine safety including the absence of clinical trial data in pregnant women (and the impact on the unborn child), children and adolescents. Conclusions: Notwithstanding the knowledge gaps about effectiveness and safety of COVID-19 vaccines (to be further addressed by observational studies), there is overwhelming evidence that public health benefits of vaccination by far outweigh any foreseeable risk.


2021 ◽  
Author(s):  
Gaetano Alfano ◽  
Niccol&oacute Morisi ◽  
Fontana Francesco ◽  
Roberta Scarmignan ◽  
Laura Tonelli ◽  
...  

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.


2021 ◽  
Author(s):  
Shira Landau ◽  
Ariel A. Szklanny ◽  
Majd Machour ◽  
Ben Kaplan ◽  
Yulia Shandalov ◽  
...  

Abstract Microtia is a small, malformed external ear, which occurs at an incidence of 1-10 per 10,000 births. Autologous reconstruction using costal cartilage is the most widely accepted surgical microtia repair technique. Yet, the method involves donor-site pain and discomfort and relies on the artistic skill of the surgeon to create an aesthetic ear. This study employed novel tissue engineering techniques to overcome these limitations, by developing a clinical-grade, 3D-printed biodegradable auricle scaffold that formed stable, custom-made, neocartilage implants. The unique scaffold design combined strategically reinforced areas to maintain the complex topography of the outer ear and micropores to allow cell adhesion for the effective production of stable cartilage. The auricle construct was CT scan-based composed of a 3D-printed clinical-grade polycaprolactone (PCL) scaffold loaded with patient‐derived chondrocytes produced from either auricular cartilage or costal cartilage biopsies combined with adipose-derived MSCs. Cartilage formation was measured within the construct in vitro, and cartilage maturation and stabilization were observed 12 weeks after its subcutaneous implantation into a murine model. The proposed technology is simple and effective and is


2021 ◽  
Author(s):  
Chris Ka Pun Mok ◽  
Samuel M.S. Cheng ◽  
Chunke Chen ◽  
Karen Yiu ◽  
Tat-On Chan ◽  
...  

Background. Poor immunogenicity and antibody waning were found in vaccinees of CoronaVac. There is lack of randomized controlled trial (RCT) data to compare the immunogenicity and safety of schedules using homologous and heterologous vaccine as a booster dose. Methods. We randomly assigned adults who had received 2 doses of CoronaVac with low antibody response to receive an additional booster dose of either BNT162b2 or CoronaVac. The local and systemic adverse reactions were recorded. Levels of SARS-CoV-2 neutralizing and spike binding antibody in plasma were measured. Findings. At one month after the third dose of vaccine, BNT162b2 vaccines elicited significantly higher surrogate virus neutralizing test (sVNT), spike receptor binding, spike N terminal domain binding, spike S2 domain binding levels than CoronaVac. More participants from the BNT162b2 group reported injection site pain and swelling as well as fatigue and muscle pain than those who received CoronaVac as the third dose. The mean results of the sVNT against the wild type, beta, gamma and delta variants in the BNT162b2 boosted group was 96.83%, 92.29%, 92.51% and 95.33% respectively which were significantly higher than the CoronaVac boosted group (Wild type: 57.75%; Beta: 38.79 %; Gamma: 32.22%; Delta: 48.87%) Conclusion. Our RCT study shows that BNT162b2 booster dose for those people who poorly responded to the previous vaccination of CoronaVac is significantly more immunogenic than a CoronaVac booster. BNT162b2 also elicits higher levels of SARS-CoV-2 specific neutralizing antibodies to different variants of concern. The adverse reactions were only mild and short-lived.


2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S614-S614
Author(s):  
Sean R Bennett ◽  
Tyler Martin

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) &gt; 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)


2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S131-S131
Author(s):  
Lidia Serra ◽  
Susan Mather ◽  
Cindy Burman ◽  
Chris Webber

Abstract Background MenACWY-TT (Nimenrix®), a quadrivalent meningococcal tetanus toxoid conjugate vaccine, was first licensed in 2012 and is available in 82 countries but not in the United States. MenACWY-TT is administered in infants as a 2 + 1 (6 weeks to &lt; 6 months of age) or 1 + 1 (6 to &lt; 12 months of age) schedule with the booster dose at 12 months of age, and from 12 months of age as a single dose. In addition to its widespread use to protect against meningococcal serogroups A, C, W, and Y, MenACWY-TT is a constituent of an investigational pentavalent meningococcal (MenABCWY) vaccine currently undergoing clinical development. Methods Using the MenACWY-TT Periodic Safety Update Report (PSUR) with format and content in accordance with Good Pharmacovigilance Practice Module VII and International Council for Harmonisation Guideline E2C, for data up to April 19, 2020, postmarketing safety experience with MenACWY-TT is considered. The PSUR data included herein are spontaneous adverse events (AEs) from the Pfizer safety database. AEs were coded by system organ class (SOC) and preferred term (PT) using MedDRA v.22.1J. Results The cumulative estimated exposure of MenACWY-TT was nearly 26 million doses, with the majority administered in 0- to 16-year-olds and in the Western European Union (Figure 1). Over the reporting period, 13,301 cumulative AEs occurred. The most common SOCs in the reporting period were general disorders and administration site conditions (n=5169; 39%); nervous system disorders (n=1986; 15%); injury, poisoning and procedural complications (n=1266; 10%); and gastrointestinal disorders (n=1031; 8%) (Figure 2). By PT, the most common AEs were pyrexia (n=1613; 12%), headache (n=738; 6%), and vaccination site pain (n=394; 3%) (Figure 3). Of the 3299 serious AEs reported, the most common were pyrexia (n=317; 10%) and headache (n=209; 6%). Conclusion Based on cumulative safety data in conjunction with existing efficacy and effectiveness data, the benefit-risk profile of MenACWY-TT remains favorable and is consistent with the safety profile of MenACWY-TT established in clinical studies. Disclosures Lidia Serra, MS, Pfizer Inc (Employee, Shareholder) Susan Mather, MD, Pfizer Inc (Employee, Shareholder) Cindy Burman, PharmD, Pfizer Inc (Employee, Shareholder) Chris Webber, MD, Pfizer (Employee, Shareholder)


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