Injection Site Soreness Research Articles

"I Feel Like I Don't Even Have HIV Anymore"-Facilitators, Barriers, and Experience regarding Use of Long-Acting Injectable Antiretroviral Therapy Among Persons with HIV in North Carolina.

As access to long-acting injectable antiretroviral therapy (LAI ART) expands, understanding patient perceptions and experiences around LAI should inform equitable scale-up and effective implementation strategies. This study used qualitative research design relying on semi-structured interviews conducted among persons with HIV (PWH) who were either virally suppressed on oral treatment (n = 11) or had received at least one dose of injectables (n = 7). Approximately half of participants identified as male (10/18) and most identified as African American (17/18). Among participants on oral ART, many described the prospect of injectable treatment as likely convenient and discreet, relieving the stress of remembering to take daily pill. Nearly all had heard of LAI ART prior to the interview, often from television or internet commercials. Most were excited about less frequent dosing, though expressed concern about the logistics involved in coming to clinic every two months. Many expressed uncertainties regarding the relative effectiveness of LAI ART compared with oral therapy and were wary of potential pain related to injections. In contrast, all persons on LAI ART described injection-site soreness as manageable. In addition to acknowledging the convenience of every-two-month injections, some persons receiving LAI ART expressed relief by lifting the emotional stress of taking a daily-pill that reminded them of their HIV positive status. Emerging clinical trial data supports the individual and public health benefits of LAI ART, regardless of prior viral-suppression; our work adds to a growing body of literature demonstrating the potential psychological benefits associated with this novel treatment modality for PWH regardless of recent viral-suppression.

Short-term COVID-19 vaccine adverse effects among adults in Ekiti State, Nigeria

Background The safety of the COVID-19 vaccines has been a topic of concern globally. This issue of safety is associated with vaccine hesitancy due to concerns about the adverse effects of the vaccines. Consequently, this study determined the short-term safety profile of the Oxford/AstraZeneca COVID-19 vaccine in Ekiti State, Nigeria. Methods Descriptive cross-sectional study conducted between May and July 2021 among individuals who had received the first dose of the first batch of the Oxford/AstraZeneca COVID-19 vaccine at Ekiti State University Teaching Hospital (EKSUTH), Ado-Ekiti, Nigeria. A Google form was used to collect data on the adverse effects of the vaccine. Results Out of over 1,000 individuals who were approached, 758 respondents completed the study. A large percentage (57.4%) of those who received the vaccines were healthcare workers. Adverse effects were reported in 70.8% of the participants with most manifesting on the first day of the vaccination. The predominant adverse effects were injection site soreness (28.5%), followed by fatigue (18.7%) and muscle pain (8.6%). There was no report of severe adverse effects such as anaphylactic reactions, thrombosis, myocarditis, transient myelitis, or Guillen-Barre syndrome. Conclusion This study found that self-reported adverse effects of the Oxford/AstraZeneca COVID-19 vaccine were mild and short in duration. This outcome has promising implications for improving COVID-19 vaccine uptake in the immediate environment and Nigeria.

Side effects of COVID-19 vaccinations in patients treated for breast cancer.

Lymph node swelling is a side effect of the mRNA COVID-19 vaccines, a distressing side effect for women treated for breast cancer. The purpose of this study is to present side effects reported by a cohort of patients treated for breast cancer. A survey link was sent to 4945 women who received breast cancer treatment and were prospectively screened for breast cancer-related lymphedema. In total, 621 patients who received an mRNA vaccine and responded to the survey were included in analysis. We assessed the frequency and predictors of side effects. The most frequent side effects reported were injection site soreness, fatigue, generalized muscle soreness, headache, and chills, with median duration ≤ 48h. Lymph node swelling occurred most often in the axilla ipsilateral to the vaccine. The median duration was 1 week or less after all doses. These data will inform patient education regarding future vaccine doses, including reassurances about which side effects to expect, particularly lymph node swelling which may impact mammograms after vaccination. Type and duration of side effects were similar to that reported by the general population in Phase 3 testing trials of the mRNA vaccines. Clinical Trial Registration NCT04872738 posted May 4, 2021.

Abstract P1-12-04: Side Effects of the mRNA COVID-19 Vaccines in Women Treated for Breast Cancer

Abstract Background: The introduction of the novel COVID-19 vaccination raised concerns regarding side effects from patients who had undergone breast cancer treatment. Lymph node swelling after the mRNA vaccines (Moderna, Pfizer) is a distressing side effect for women treated for breast cancer as it may indicate cancer progression or recurrence. Patients at risk of breast cancer-related lymphedema (BCRL) are fearful that lymph node swelling from the vaccine could incite or worsen BCRL. Data investigating associated side effects in this population is essential for patient education and future self-advocacy. Purpose: The purpose of this study was to elicit side effects associated with the COVID vaccine in women treated for breast cancer. Methods: 4,945 surveys were sent to women over the age of 18 who had received breast cancer treatment and had been prospectively screened for BCRL with perometry. 621 participants who received an mRNA vaccine and responded to the survey were included in analysis, 469 of whom completed booster dose surveys. Participants were asked about type and duration of side effects after each vaccine dose. Solicited side effects included injection site soreness, swelling, or redness; swelling, numbness, or heaviness of the arm; generalized muscle soreness (GMS); fatigue; headache; joint pain; chills; nausea; vomiting; fever; Bell’s palsy; axillary or supraclavicular lymph node swelling; other; or none of the above. We computed frequencies and the median duration of side effects for each dose. To investigate predictors of side effects, we fit multivariable logistic regression models separately for each side effect, with random effects for participants to account for clustered responses. We considered significant predictors those with p < 0.05. Results: Of the 621 participants, the median follow-up time between breast surgery and date of first vaccine dose was 69 months. The distribution of the top 5 side effects is presented in Table 1. Of note, the majority of participants who reported lymph node swelling (9.8% dose 1, 12.9% dose 2, 11.3% dose 3) reported it in the axilla ipsilateral to the vaccine (54.1% D1, 61.3% D2, 71.7% D3). Lymph node swelling was also reported in the axilla contralateral to the vaccine (45.9% D1, 45% D2, 24.5% D3), supraclavicular region ipsilateral (29.5% D1, 26.3% D2, 32.1% D3) and contralateral (18% D1, 18.8% D2, 9.4% D3) to the vaccine. Older patients reported each side effect significantly less frequently. Those who had received neoadjuvant chemotherapy reported significantly more GMS and headache than those who did not. Those who had received regional lymph node radiation were less likely to report GMS, as were patients who had sentinel lymph node biopsies (vs. no lymph node surgery). The median duration of side effects for all three doses was 48 hours or less, with the plurality (41.0% D1, 38.7% D2, 44.1% D3) of participants reporting side effects lasting 24 hours or less. While all side effects apart from injection site soreness were significantly more common in the second than the first doses, the duration of side effects only increased for 28.1% of participants. Conclusion: Over 86% of women treated for breast cancer may experience at least one side effect after any dose of the COVID-19 vaccine. This data, collected specifically for patients with breast cancer, will help enhance guidelines for structured and universal education regarding additional doses of the vaccine in the future. This will allow patients to better understand COVID vaccine side effect profiles after breast cancer treatment and self-advocate prior to future doses. Table 1. Top 5 Side Effects Reported Citation Format: Brooke Juhel, Cheryl L. Brunelle, Madison C. Bernstein, Louisa H. Smith, Amanda W. Jung, Elizabeth K. Hausman, Loryn K. Bucci, George E. Naoum, Alphonse G. Taghian. Side Effects of the mRNA COVID-19 Vaccines in Women Treated for Breast Cancer [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P1-12-04.

Evaluation Of Antibody Response To Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccination In Patients With Lymphoid And Solid Organ Malignancies

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is responsible for the current COVID-19 pandemic. There is emerging evidence regarding suboptimal response to vaccination against COVID-19 in patients with hematologic and solid organ malignancies. We conducted a single-center prospective study assessing seroconversion in response to vaccination against COVID-19 in 53 patients with chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), multiple myeloma (MM), and solid organ malignancies. A quantitative immunoassay of IgG antibodies to SARS-CoV-2 Spike (S) protein was measured prior to vaccination and at 2 weeks after completion of two-dose vaccination series. A fourfold increase in antibody titers was considered positive seroconversion. Through a predesigned survey, patients also self-reported side effects from each dose of vaccination. Seroconversion on vaccination was seen in 6/12 (50%) patients with CLL, 7/11 (63.6%) patients with NHL, 9/10 (90%) patients with MM, and 17/20 (85%) patients with solid organ malignancy. Only 6 of the 14 (42.8%) patients currently on or with previous history of rituximab use seroconverted. Injection site soreness was the most reported side effect. The only severe side effect occurred in a patient with solid organ malignancy who developed Parsonage-Turner syndrome. Patients with CLL and NHL appear less likely to respond to vaccination against COVID-19 in contrast to patients with MM or solid organ malignancies. Previous treatment with rituximab is a possible risk factor for suboptimal response to vaccination. These data highlight the importance of continuing risk mitigation strategies against COVID-19 in individuals with hematologic malignancy, particularly those with CLL or on treatment with rituximab.

COVID-19 Vaccine-Associated Lymphadenopathy in Breast Imaging Recipients: A Review of Literature.

The unpredictability of the coronavirus disease 2019 (COVID-19) pandemic has created an ongoing global healthcare crisis. Implementation of a mass vaccination program to accelerate disease control remains in progress. Although injection site soreness, fatigue, and fever are the most common adverse reactions reported after a COVID-19 vaccination, ipsilateral lymph node enlargement has increasingly been observed. In patients undergoing routine screening and surveillance for breast cancer, interpreting lymphadenopathy (LAP) is challenging in the setting of a recent COVID-19 vaccination. With a growing proportion of the population receiving the vaccine, a multifaceted approach is necessary to avoid unnecessary and costly workup. In this comprehensive review, we summarize the existing literature on COVID-19 vaccine-associated LAP in breast imaging patients.

Ultrasound-guided Cervical Retro-laminar Block for Cervical Radicular Pain: A Comparative Analysis.

Cervical radiculopathy is a common clinical condition, often treated with cervical epidural steroid injections (ESI). Retro-laminar cervical blocks (RLCB) may be considered safer than ESI as they do not require entering the neuroaxis.In this study, we evaluated the outcome of RLCB in patients with cervical radiculopathy who had failed conservative treatment and were candidates for cervical spine decompression surgery. Recently, we reported a clinical pilot study investigating the treatment of cervical radiculopathy with an ultrasound-guided RLCB. A retrospective, comparative analysis of prospectively collected data was carried out on the medical records of all patients who underwent RLCB for cervical radicular pain, between August 2019 and March 2021. Ninety-eight patients were included in the analysis, with a total of 139 procedures.A significant pain reduction was achieved for most patients immediately after the procedure and at the final follow up (16.9±13.4wk). The mean numerical rating scale for the whole cohort changed from 7.21±2.51 to 4.04±2.51 ( P -value <0.01) at the time of discharge, with similar patterns at the subgroup level. A functional evaluation was carried out by a questionnaire (Neck Disability Index-NDI). Overall, 83% of patients had a lower postprocedural NDI than preprocedural NDI. For 80% of patients, the improvement of NDI surpassed the minimal clinically important change at the final assessment. Most patients (61%) were discharged after just one RLCB. Eight patients (8%) eventually underwent surgery. The most frequent complaint was injection site soreness; however, there were no major adverse events reported. These findings suggest that RLCB can be performed as an alternative to cervical ESI and decompressive surgery in patients with cervical radicular pain that's refractory to noninvasive treatment. More comparative and prospective studies are needed to confirm our results.

0862 A unique case of severe sleep onset and maintenance insomnia following COVID-19 vaccination

IntroductionThe COVID-19 vaccines have documented transient side effects, including injection site soreness, redness, headache, fatigue, and fever. In addition, there have been few reported long-term side effects, including Guillain-Barre, pericarditis, and cerebral venous sinus thrombosis. We present a rare case of severe insomnia as a long-term side effect following COVID-19 vaccination. Report of Cases: A 59-year-old female with a past medical history of well-controlled hypothyroidism and migraine presented to the sleep center with four months of insomnia. She had a history of COVID infection in November 2020 with only mild symptoms of sore throat and fatigue. The patient finished her two-shot series of the Moderna COVID-19 vaccine in April 2021. Immediately following the vaccination, the patient had severe trouble falling and staying asleep. Her insomnia was resistant to multiple medications including zolpidem Immediate-release(IR), Controlled-release(CR) formulas, zaleplon, eszopiclone, trazodone, melatonin, clonazepam, suvorexant, and lemborexant. However, magnetic resonance imaging (MRI) brain imaging only showed nonspecific white matter disease. She had no mood disorders or psychosocial stressors, and the patient had excellent sleep hygiene measures. However, insomnia caused severe impairment of her daily life activities to a point where she was almost seeking inpatient admission for her insomnia. During the COVID-19 pandemic, the effects on sleep have been significant, particularly insomnia. Prescriptions for sleep medications have increased. Many have attributed the rise of insomnia to pandemic-related stress, disturbance of circadian rhythm from home confinement, and worsening mental health.ConclusionTo our knowledge, there have not been documented side effects of insomnia on the COVID-19 vaccines, with some studies suggesting sleep deprivation reducing their effectiveness. As vaccination efforts continue worldwide, awareness of side effects from vaccines is paramount for clinicians facing the challenges in patient care.This case demonstrates that chronic insomnia can be a side effect of the COVID-19 vaccines. Therefore, further surveillance of patients and side effects from COVID-19 vaccination is warranted as insomnia can have significant clinical and psychosocial consequences.Support (If Any)

Active surveillance of adverse events following ChAdOx1 nCoV-19 immunization in geriatric population: a prospective multi-centric study from Jaipur, Rajasthan, India

India launched its coronavirus disease 2019 (COVID-19) vaccination drive starting with healthcare workers. The aim of the study was to evaluate adverse events following immunization (AEFI) amongst the Geriatric population associated with two doses of ChAdOx1 nCoV-19 vaccine. We also evaluated association of AEFI according to gender and elderly age groups. An observational study, conducted among 437 individuals vaccinated at multiple community healthcare centers in Jaipur, of AEFIs associated with both doses of ChAdOx1 nCoV-19 vaccine, via telephonic interviews on the day of vaccination-Day 0, Day 7 and Day 15 from vaccination. 463 vaccinated individuals who responded for first dose AEFIs, and 437 (94.3% 437/463) responded to the telephone interview regarding the second dose. Of these, 5.5% (24/437) reported AEFIs for the second dose. Among 60 respondents who reported AEFI (both doses) fever (26) and fatigue (22) were the most reported systemic AEFI. Local AEFIs were injection site soreness (23). The AEFIs (both systemic and local) in respondents mostly lasted for 1-2 days. AEFI reported by respondents in the age group 60- 70 years was higher than those above 70 years. Female respondents were associated with higher AEFI than the males. The AEFIs of both the doses were observed in the first 2 days predominantly. Symptoms were minor, short lived and selflimiting. No serious adverse events attributable to vaccines were reported in our study. Adverse event following immunization is independent of gender and age distribution for both the doses.

Evaluation of Antibody Response to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Immunizations in Patients with B-Cell Malignancies

BackgroundMultiple vaccines have been granted emergency use authorization by the Food and Drug Administration against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Of the currently available vaccines, none have been systematically studied for efficacy or toxicity in patients with immunodeficiency or with immunosuppressed states, such as B cell malignancy. The purpose of the study was to evaluate the immune response to currently available vaccines against COVID-19 in patients with hematologic and solid organ malignancies.MethodsThis prospective study enrolled 53 patients; 12 with CLL, 10 with multiple myeloma (MM), 11 with non-Hodgkin's lymphoma (NHL) and 21 with a solid organ malignancy. Using a quantitative assay, IgG antibodies to SARS-CoV-2 Spike (S) protein, and nucleocapsid (N) protein by enzyme immunoassay were measured at baseline prior to vaccination and at 2 weeks after completion of vaccination. A fourfold increase in IgG was considered a positive response to vaccination. Through a predesigned survey, patients also self-reported side effects from each dose of vaccination.ResultsSeroconversion with vaccination was seen in 9/10 (90%) patients with MM, 5/12 (41.7%) patients with CLL, 6/11 (54.1%) patients with NHL, and 17/21 (80.9%) patients with solid organ malignancy.Per univariate analysis, CLL (OR 0.23, 95% CI 0.05-0.88; p= 0.033) was associated with lower odds of seroconversion while NHL (OR 0.48, 95% CI 0.12-1.8; p =0.291), MM (OR 5.33, 95% CI 0.61-46.08; p= 0.128) and solid organ malignancy (OR 2.90, 95% CI 0.79-10.64; p= 0.107) were not.Among patients with hematological malignancies, 5/13 (38.3%) patients treated with rituximab and 2/7 (28.5%) patients on immunoglobulin replacement (IgR) therapy responded to vaccination. This corresponded to reduced odds of seroconversion, 0.18 (95% CI 0.047-0.69; p = 0.013) in patients treated with rituximab and 0.14 (95% CI 0.024-0.826; p=0.030) in patients on IgR.Among patients with solid organ malignancies, treatment with chemotherapy (OR 2.05, 95% CI 0.48-8.61; p=0.320), immunotherapy (OR 4.57, 95% CI 0.52-39.9; p=0.169) or endocrine therapy (OR 1.0) did not lower odds of seroconversion with vaccination.Multivariate analysis revealed patients who received rituximab were less likely to respond to vaccination as compared to patients not previously treated with rituximab (OR 0.22, 95% CI 0.05-0.955; p=0.044).Injection site soreness was the most commonly reported side effect. The only severe side effect occurred in a patient with solid organ malignancy who developed Parsonage Turner syndrome.ConclusionOur study, to the best of our knowledge, is the first study comparing pre and post vaccination IgG titers against the SARS-CoV-2 S protein. Majority of patients with MM and solid organ malignancies, including those receiving active treatment, responded adequately to immunization. Patients with CLL appear less likely to respond to vaccination against COVID-19 as compared to patients with NHL, MM or solid organ malignancies. Previous treatment with rituximab was the most significant risk factor for suboptimal response to vaccination, regardless of underlying hematologic malignancy. These data highlight the importance of continuing risk mitigation strategies against COVID-19 in individuals with hematologic malignancy, particularly those with CLL or on treatment with rituximab. Future research is needed to investigate approaches to provide protective IgG against SARS-CoV-2 in this at-risk population. [Display omitted] DisclosuresMustafa: Genentech: Speakers Bureau; GalaxoSmithKline: Speakers Bureau; CSL Behring: Speakers Bureau; Regeneron: Speakers Bureau; AstraZeneca: Speakers Bureau. Walsh: Janssen: Research Funding; Merck: Research Funding; Pfizer: Research Funding. Jamshed: Takeda: Honoraria.

Discovery of GNE-502 as an orally bioavailable and potent degrader for estrogen receptor positive breast cancer

Fulvestrant is an FDA-approved drug with a dual mechanism of action (MOA), acting as a full antagonist and degrader of the estrogen receptor protein. A significant limitation of fulvestrant is the dosing regimen required for efficacy. Due to its high lipophilicity and poor pharmacokinetic profile, fulvestrant needs to be administered through intramuscular injections which leads to injection site soreness. This route of administration also limits the dose and target occupancy in patients. We envisioned a best-in-class molecule that would function with the same dual MOA as fulvestrant, but with improved physicochemical properties and would be orally bioavailable. Herein we report our progress toward that goal, resulting in a new lead GNE-502 which addressed some of the liabilities of our previously reported lead molecule GNE-149.

Recombinant Herpes Zoster Vaccine (RZV) after Heart Transplantation: A Single Center Experience

Herpes zoster (HZ) results from reactivation of latent varicella zoster virus (VZV) presenting as a dermatomal rash. Diminished cellular immunity to VZV increases HZ risk and incidence in solid organ transplant (SOT) is higher than the general population. Immunogenicity and safety of the inactivated varicella vaccine (RZV, Shingrix) has been demonstrated in renal transplant (KT) but data in heart transplant (HT) are lacking. Retrospective single center observational study of 65 HT patients vaccinated with RZV between Sept 2018 and Jul 2019. RZV 0.5 mL was administered IM in two doses 2 to 6 months apart. Descriptive statistics were used for data analysis. Mean age was 66 +/- 12.7 y, 65% (n=41) male, and 75% (n=49) Caucasian. Mean time from HT to RZV was 11.4 +/- 6.6 y. The majority were HT alone, 7.7% (n=5) heart-kidney, and 4.6% (n=3) heart retransplant. Most (95%, n=62) were on calcineurin inhibitors (CNI) for immunosuppression, 54% (n=35) on antiproliferatives (mycophenolate mofetil (MMF)), 46% (n=30) on steroids, and 20% (n=13) on mTOR inhibitors. At the time of RZV, mean tacrolimus trough (t): 6.8 +/- 2.3 ng/mL, everolimus t: 6.5 +/- 1 ng/mL, sirolimus t: 7.5 +/- 2.9 ng/mL, prednisone dose: 4.2 +/- 1.3 mg, and MMF dose: 977.9 +/- 462 mg. Vaccination was well tolerated in all patients. 36 patients (55%) received both doses of RZV 4 +/- 1.4 mo apart. Adverse events (AE) occurred in 34% (n=22) after the first dose. The majority (83%, n=19) were injection site reactions (arm soreness, swelling), 1 with vomiting, 1 with fever, 1 with headache, 2 with fatigue. One developed HZ 2 months after vaccination and was a 65 yo F with heart retransplant, KT, and stem-cell transplant, received the vaccine 3.3 y from the second HT, and on tacrolimus, MMF, and prednisone. There was no allograft rejection following immunization. 16 patients are awaiting the second dose. After the second dose, 36% (n=13), had AE due to 13 injection site reactions and 1 fever. 12 patients did not receive the second dose due to cost (n=1), unavailability of the vaccine (n=3), treatment for PTLD (n=1), viral syndrome (n=4), development of HZ (n=1), and patient refusal (n=2). HT patients who received RZV tolerated it well with the most common AE being injection site soreness. Only one patient (1.5%) developed HZ 2 months following the vaccination. There was no evidence of increased allograft rejection.

The Influence of Local Anesthesia Depth on Procedural Pain During Fluoroscopically Guided Lumbar Transforaminal Epidural Injections: A Randomized Clinical Trial.

The aim of the study was to evaluate the influence of the depth of local anesthesia application on procedural pain during lumbar transforaminal epidural steroid injection. Sixty-eight patients were enrolled who were scheduled for single-level, unilateral fluoroscopically guided lumbar transforaminal epidural steroid injection. Patients were randomly allocated to receive either subcutaneous local anesthesia (group S) or deep local anesthesia (group D) for transforaminal epidural steroid injection. The data related to pain and technical performance during the procedure was compared. In addition, the incidence of injection site soreness was assessed 2 wks after transforaminal epidural steroid injection. Sixty-seven patients completed all assessments (group S, n = 33; group D, n = 34). There was no significant difference in procedural pain and discomfort level between the groups (P = 0.151, P = 0.183, respectively). Patients in group D showed lower behavioral pain scores (P = 0.017). There was no significant difference in the numbers of needle manipulations, fluoroscopy time, and radiation dose during the procedure between the groups. Two patients in group S and three in group D complained of injection site soreness after transforaminal epidural steroid injection for a few days, but there was no significant difference in its incidence (P = 0.667). Deep local anesthesia to reduce procedural pain during transforaminal epidural steroid injection seems to have no significant clinical benefit compared with conventional subcutaneous local anesthesia. Complete the self-assessment activity and evaluation online at http://www.physiatry.org/JournalCME CME OBJECTIVES: Reduce procedural pain by considering clinical factors of the patient during fluoroscopically guided lumbar transforaminal epidural injections.Upon completion of this article, the reader should be able to: (1) Understand the potential impact of procedural pain on the performance of transforaminal epidural steroid injections; (2) Distinguish cutaneous nociceptive afferents from nociceptive afferents in muscle; and (3) Explain the factors to reduce procedural pain during fluoroscopically guided lumbar transforaminal epidural injections. Advanced ACCREDITATION: The Association of Academic Physiatrists is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.The Association of Academic Physiatrists designates this Journal-based CME activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Local thermal reaction after influenza vaccination: Quantification by infrared imaging and biometric considerations

BackgroundExtensive clinical investigations are mandatory to evaluate the safety and reactogenicity of vaccines. The recording of common adverse events like injection site soreness or general discomfort derives from individual subjective perceptions. Thermal imaging at the injection site possibly provides a non-subjective and a non-invasive approach to supplement this evaluation. ResultsA protocol for quantified injection-site infrared imaging included 86 participants during a flu vaccine campaign, 40% of whom had a thermal reaction of 1 °C; 25–30% had no thermal response. There was little subjective pain reporting and no clinical correlations were observed except with post-vaccination erythema.Higher responses were linked with advanced age and multiple previous vaccinations. ConclusionEvan if influenza vaccine was only moderately reactogenic, a thermal response was detectable in about 70% of vaccinees, though no relationship to reactogenicity was seen.Infrared imaging might however be a prospective tool for individual studies of vaccine-induced vascular responses.

Adverse events associated with fluoroscopically guided lumbosacral transforaminal epidural steroid injections

Background contextAlthough the types and incidence of adverse events (AEs) associated with transforaminal epidural steroid injection (TFESI) have been described, no study has used a systematic standardized questionnaire to solicit AEs from patients to capture an accurate range and incidence of complications. PurposeThe aim was to systematically identify the types and incidence of AEs associated with TFESI. Additionally, this study evaluated demographic and clinical factors that may predict a higher risk of an AE. Study design/SettingThis was a retrospective cohort study from a multiphysician academic PM&R clinic. Patient samplePatients, aged 19 to 89, who underwent a fluoroscopically guided TFESI for lumbosacral radicular pain between 2004 and 2007 were included. Outcome measuresThe relationship of AEs with gender, age, trainee presence, steroid type, preprocedure visual analog scale (VAS) pain score, systolic blood pressure, fluoroscopy time, and corticosteroid injectate volume was analyzed. MethodsAdverse event data were collected using a survey both immediately and at 24 to 72 hours after TFESI. Statistical analysis was performed using the chi-square, Fisher exact, or Wilcoxon rank sum two-sided tests. Logistic regression analysis was also performed. C.P. is the owner of Rehabilitation Institute of Chicago Physiatric Log & Analysis System computer software. ResultsIn 1,295 consecutive patients undergoing 2,025 TFESI procedures, immediate AEs and delayed AEs occurred after 182 (9.2%) and 305 (20.0%) injections, respectively. The most common immediate AEs were: vasovagal reaction (4.2%) and interrupted procedure from intravascular flow (1.7%). Common delayed AEs included: pain exacerbation (5.0%), injection site soreness (3.9%), headache (3.9%), facial flushing/sweating (1.8%), and insomnia (1.6%). Significant associations were identified between AEs and gender, age, preprocedure VAS, steroid type, and fluoroscopy time. Trainee involvement in the procedure did not impact the complication rate. ConclusionsFluoroscopically guided lumbosacral TFESI is associated with a similar rate of minor AEs both immediately and 24 to 72 hours after procedure that are typical of other axial corticosteroid injections. Permanent AEs were not found in this sample. The most common AEs associated with TFESI include vasovagal episodes, procedure interruption from intravascular flow, pain exacerbation, injection site soreness, headache, and insomnia.

A first-in-human phase 1 dose-escalating trial of G305 in patients with solid tumors expressing NY-ESO-1.

Human tumor cells express antigens that serve as targets for the host cellular immune system. This phase 1 dose-escalating study was conducted to assess safety and tolerability of G305, a recombinant NY-ESO-1 protein vaccine mixed with glucopyranosyl lipid A (GLA), a synthetic TLR4 agonist adjuvant, in a stable emulsion (SE). Twelve patients with solid tumors expressing NY-ESO-1 were treated using a 3 + 3 design. The NY-ESO-1 dose was fixed at 250 µg, while GLA-SE was increased from 2 to 10 µg. Safety, immunogenicity, and clinical responses were assessed prior to, during, and at the end of therapy. G305 was safe and immunogenic at all doses. All related AEs were Grade 1 or 2, with injection site soreness as the most commonly reported event (100%). Overall, 75% of patients developed antibody response to NY-ESO-1, including six patients with increased antibody titer ( ≥ 4-fold rise) and three patients with seroconversion from negative (titer < 100) to positive (titer ≥ 100). CD4 T-cell responses were observed in 44.4% of patients; 33.3% were new responses and 1 was boosted ( ≥ 2-fold rise). Following treatment, 8 of 12 patients had stable disease for 3 months or more; at the end of 1 year, three patients had stable disease and nine patients were alive. G305 is a potent immunotherapeutic agent that can stimulate NY-ESO-1-specific antibody and T-cell responses. The vaccine was safe at all doses of GLA-SE (2–10 µg) and showed potential clinical benefit in this population of patients.

Adverse Events Associated with Fluoroscopically Guided Zygapophyseal Joint Injections

Background: In spite of the widespread performance of intra-articular zygapophyseal joint (IAZJ) injections, we know of no systematic analysis to date that examines the risks and types of adverse events when IAZJ injections are performed. Objective: To describe the type, incidence, and factors contributing to adverse events associated with fluoroscopically guided IAZJ injections. Study Design: A retrospective, cohort study of English-speaking adults aged 18 – 90 years who underwent fluoroscopically guided IAZJ injections between March 8, 2004, and April 19, 2007. Following IAZJ injections, 3 senior researchers recorded the presence and type of adverse events. The relationship of adverse events with age, gender, fluoroscopy time, vital signs, and trainee presence was analyzed with Fisher’s exact or Wilcoxon rank sum 2-sided tests. Frequency of immediate (during or immediately after the procedure) or delayed (within 24 – 72 hours following the procedure) adverse events. Setting: Tertiary, academic, outpatient physical medicine and rehabilitation interventional spine clinic. Results: One hundred ninety-one patients (111 men) underwent 239 procedures. The mean and standard deviation (SD) of subject age was 56.4 (16.6) years ranging from 20 to 89. The mean and SD of pre-procedure 11-point Visual Analog Pain Scale was 5.5 (2.2) ranging from 0 to 10, and for post-procedure was 2.6 (2.6) ranging from 0 to 10. Trainees were involved in 52.3% of procedures. Reported immediate adverse events were vasovagal reaction (3.8%, n = 9) and steroid clogged needle (0.4%, n = 1). Follow-up data were available for 185/239 procedures (77.4%). There were 35 adverse events reported at mean follow-up interval of 1.8 days, of which the most frequent were injection site soreness (6.0%, n = 11), pain exacerbation (4.3%, n = 8), sleeplessness (2.2%, n = 4), and transient headache (1.6%, n = 3). Patient gender, age, trainee involvement, pre-procedural pain score, systolic or diastolic blood pressure, pulse, hemoglobin saturation as measured by pulse oximetry, volume of corticosteroid injected, and duration of fluoroscopy were not found to have a significant effect on immediate or delayed adverse events. Limitations: This study is limited by a 24- to 72-hour follow-up window, which may have also been too small to capture more delayed complications, and a sample size too small to accurately define the incidence of rare complications. Conclusion: Fluoroscopically guided IAZJ injections have minimal adverse effects. The most common immediate adverse event was vasovagal reaction and most common delayed adverse event was injection site soreness. Key words: Fluoroscopic injection, facet joint, zygapophyseal joint, complications, adverse effects, steroid injection

Diminazene Diaceturate for Treatment of ChronicCytauxzoon felisParasitemia in Naturally Infected Cats

Cytauxzoon felis is a hemoprotozoal parasite that causes substantial morbidity and mortality during the acute phase of infection in cats. However, cats that survive the acute illness remain persistently infected and may serve as a reservoir for the tick-transmitted pathogen. We investigated the ability of the antiprotozoal compound diminazene diaceturate to eliminate the pathogen from naturally infected C. felis carriers. Seven healthy, chronically infected domestic cats housed in a research setting. Prospective clinical trial. Cats were treated in a masked fashion with diminazene diaceturate (3 mg/kg) or placebo IM in a series of 2 injections 7 days apart. Clearance of the organism was assessed by light microscopy and real-time polymerase chain reaction (PCR) at 0, 3, 6, and 10 weeks. In addition, cats were monitored for behavioral changes or for changes on physical examination, CBC, plasma biochemical profile, and urinalysis periodically. Cats that remained parasitemic at the end of 10 weeks were switched to the alternative treatment and similarly monitored for an additional 10 weeks. Adverse events associated with treatment were limited to self-resolving hypersalivation and injection site soreness; the former was ameliorated by premedication with atropine. Parasite burden, as assayed by both light microscopy and real-time PCR, was similar between diminazene- and placebo-treated cats. Diminazene diaceturate was unable to eliminate the pathogen or decrease parasite burden in healthy, chronically infected cats.

Adverse Events Associated With Fluoroscopically Guided Sacroiliac Joint Injections

To describe the type, incidence, and factors that contribute to adverse events associated with fluoroscopically guided intra-articular sacroiliac joint injections (IASIJ). A retrospective cohort study. Tertiary, academic, outpatient physical medicine and rehabilitation interventional spine clinic. English-speaking adults aged 18-90 years who underwent fluoroscopically guided IASIJ injections between March 8, 2004, and April 19, 2007. After IASIJ injections, 3 senior researchers recorded the presence and types of adverse events. The relationship of adverse events with age, gender, fluoroscopy time, vital signs, and trainee presence was analyzed with the Fisher exact or the Wilcoxon rank sum 2-sided tests. The frequency of immediate (during or immediately after the procedure) or delayed (within 24-72 hours after the procedure) adverse events. A total of 162 patients (133 women) underwent 191 procedures. The range of subject age was from 20 to 90 years (15.8 years, standard deviation [SD]). The range (SD) of the preprocedure 11-point Likert Pain Scale was from 1.0 to 10.0 (2.0) and for the postprocedure 11-point Likert Pain Scale was from 0.0 to 9.0 (2.5). Trainees were involved in 57% of the procedures. Reported immediate adverse events were vasovagal reaction (2.1% [n = 4]) and steroid-clogged needle (0.5% [n = 1]). Follow-up data were available for 132 of 191 procedures (69%). There were 32 adverse events reported at a mean follow-up interval of 2 days, of which, the most frequent adverse events were injection-site soreness (12.9% [n = 17]), pain exacerbation (5.3% [n = 7]), and facial flushing and/or sweating (2.3% [n = 3]). Delayed adverse events decreased with older age (P = .0029). The patients who underwent bilateral procedures experienced more delayed adverse events than the patients who underwent unilateral procedures (P = .024). Fluoroscopically guided IASIJ injection is associated with minimal adverse effects. The most common immediate adverse event was vasovagal reaction, and the most common delayed adverse event was injection-site soreness. Younger age is significantly related to reported delayed adverse events.

Comparison of serologic responses to vaccination with one dose or two doses of 7-valent pneumococcal conjugate vaccine in HIV-infected adult patients

BackgroundVaccination with 7-valent pneumococcal conjugate vaccine (PCV) has been shown to decrease the incidence of recurrent invasive pneumococcal disease among HIV-infected adults in Africa. Longitudinal follow-up studies of serologic responses to different doses of 7-valent PCV are rarely performed in HIV-infected adult patients receiving combination antiretroviral therapy (cART). MethodsFrom October 2008 to June 2010, 115 CD4-matched pairs of HIV-infected patients aged ≥20years who had no prior pneumococcal vaccination received one or two doses of 7-valent PCV. Anticapsular antibodies against 4 serotypes (6B, 14, 19F, and 23F) were examined at the 12th, 24th, 36th, and 48th week following vaccination. Significant antibody responses were defined as ≥2-fold increase in the IgG level plus a post-vaccination antibody level ≥1000ng/ml. ResultsThe most common reported adverse effects were injection site soreness (19.3%) and pain (4.8%). Significant antibody response rate was highest for serotype 14, followed by 23F, 19F, and 6B in all of the four time points examined. At week 48, patients who received two doses of 7-valent PCV had a significantly higher response rate to serotype 6B (P=0.03) and 23F (P=0.01) than those who received one dose; moreover, the former group also had a higher response rate to at least one (P=0.03) and two serotypes (P=0.02) in intention-to-treat analysis than the latter group. ConclusionsHIV-infected adult patients on cART who received two doses of 7-valent PCV achieved better serological responses to at least one serotype than those who received one dose during the 48weeks of follow-up.