Nodule at injection site as an adverse event following immunization: case definition and guidelines for data collection, analysis, and presentation

Rothstein, Edward; Kohl, Katrin; Ball, L.; Halperin, Scott A.; Halsey, Neal A.; Hammer, Sandra Jo; Heath, Paul T; Hennig, Renald; Kleppinger, Cynthia; Labadie, Jerry; Varricchio, Frederick; Vermeer, Patricia; Walop, Wikke

doi:10.1016/j.vaccine.2003.09.005

Cited by 47 publications

(20 citation statements)

References 35 publications

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“…{ Nodules were not considered adverse events (AEs) unless accompanied by prolonged pain, induration, redness, bleeding, or inflammation. 37 EQW, exenatide once weekly.…”

mentioning

confidence: 99%

Encapsulation of Exenatide in Poly-(d,l-Lactide-Co-Glycolide) Microspheres Produced an Investigational Long-Acting Once-Weekly Formulation for Type 2 Diabetes

DeYoung¹,

MacConell²,

Sarin

et al. 2011

Diabetes Technology & Therapeutics

220

199

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Exenatide once-weekly (EQW [2 mg s.c.]) is under development as monotherapy as an adjunct to diet and exercise or as a combination therapy with an oral antidiabetes drug(s) in adults with type 2 diabetes. This longacting formulation contains the active ingredient of the original exenatide twice-daily (EBID) formulation encapsulated in 0.06-mm-diameter microspheres of medical-grade poly-(d,l-lactide-co-glycolide) (PLG). After mechanical suspension and subcutaneous injection by the patient, EQW microspheres hydrate in situ and adhere to one another to form an amalgam. A small amount of loosely bound surface exenatide, typically less than 1%, releases in the first few hours, whereas drug located in deeper interstices diffuses out more slowly (time to maximum, *2 weeks). Fully encapsulated exenatide (i.e., drug initially inaccessible to diffusion) releases over a still longer period (time to maximum, *7 weeks) as the PLG matrix hydrolyzes into lactic acid and glycolic acid, which are subsequently eliminated as carbon dioxide and water. For EQW, plasma exenatide concentrations reach the therapeutic range by 2 weeks and steady state by 6-7 weeks. This gradual approach to steady state seems to improve tolerability, as nausea is less frequent with EQW than EBID. EQW administrations may be associated with palpable skin nodules that generally resolve without further medical intervention. In comparative trials, EQW improved hemoglobin A1c more than EBID, sitagliptin, pioglitazone, or insulin glargine and reduced fasting plasma glucose more than EBID. Weight loss due to EQW or EBID was similar. EQW is the first glucose-lowering agent that is administered once weekly.

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“…{ Nodules were not considered adverse events (AEs) unless accompanied by prolonged pain, induration, redness, bleeding, or inflammation. 37 EQW, exenatide once weekly.…”

mentioning

confidence: 99%

Encapsulation of Exenatide in Poly-(d,l-Lactide-Co-Glycolide) Microspheres Produced an Investigational Long-Acting Once-Weekly Formulation for Type 2 Diabetes

DeYoung¹,

MacConell²,

Sarin

et al. 2011

Diabetes Technology & Therapeutics

220

199

View full text Add to dashboard Cite

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“…Case definition and time limit for onset of each AEFIc were determined. Brighton collaboration case definitions, WHO documents on vaccine pharmacovigilance, and published articles were perused in this process (Table 1) [38][39][40][41][42][43][44][45][46][47][48][49][50]. Using the case definition and onset time limit criteria, two investigators independently went through the data and identified the cases which were within the selected six AEFIc under review.…”

Section: Methodsmentioning

confidence: 99%

Active safety monitoring of measles-mumps-rubella vaccine in the National Immunisation Programme of Sri Lanka

et al. 2017

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Objectives This study was designed to report incidence and characteristics of selected adverse events following immunisation which have consistent causal association (AEFIc) with Measles-Mumps-Rubella (MMR) vaccination given at the age of one year in the National Immunisation Programme of Sri Lanka.Methods The data presented here were obtained from a cohort event monitoring study. It was carried out in the Jaffna Regional Directorate of Health Services area from November 2012 to December 2014. A representative sample of 3002 infants who received MMR immunisation were actively followed up for adverse events (AE) using over the phone interviews, self-reporting, and home or hospital visits up to 45 days. All AEs were reviewed by two investigators independently in two step-wise processes to detect the AEFIc. Seven AEFIc were detected using standard case definitions and onset time limit criteria. They were subjected to further analysis to describe the incidence rates and characteristics.Results Of the 2398 (80%) infants who completed follow up of 45 days, 1321 infants experienced 2621 AEFI. Of them 209 were classified as AEFIc. Incidence of AEFIc was 87/ 1000 immunisation. They were mainly nonserious and resolved completely. There were no fatal or life threatening AEFIs. Incidence per 1000 immunisations; allergic reactions 0.83, injection site reactions 4.58, fever100.4° F or lasting more than  3 days 9.59, macular papular rash 2.92, parotitis 2.92 and generalised convulsions 1.25. ConclusionThe MMR vaccine used in NIP of Sri Lanka had low incidence of AEFIc and were mainly non-serious in nature.

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“…• Brighton has developed six case definitions for local reactions (a local reaction, cellulitis, abscess, swelling, induration, and nodule) (Gidudu J et al, 2008;Halperin S et al, 2007;Kohl K S et al, 2007;Rothstein E et al, 2004) for use in identification of various local reactions following administration of vaccines including non-antigen components. Injection site pain had been associated with some adjuvanted vaccines and a definition for injection site is being developed.…”

Section: Thematic Area Backgroundmentioning

confidence: 99%

Preterm birth, vaccination and neurodevelopmental disorders: a cross-sectional study of 6- to 12-year-old vaccinated and unvaccinated children

Mawson¹,

Bhuiyan²,

Jacob³

et al. 2017

J Transl Sci

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Ongoing Development of the ISO Scientific AgendaISO acknowledges that the need to formulate specific vaccine safety questions is an ongoing process. Selected studies may be required to answer complex research questions. With this in mind, ISO will generate a list of testable hypotheses to be prioritized according to the considerations outlined in the emerging issues and core activities in Section 1 of Box 1. This process may also be informed by conclusions from the Health Services and Resources Administration-sponsored IOM review currently underway of vaccine adverse events for several vaccines (http://www.hrsa.gov/vaccinecompensation/adverseeffects.htm).ISO plans to present progress on the Agenda to NVAC periodically. Priority studies and other research activities will also be regularly updated on the CDC Web site (http://www.cdc.gov/vaccinesafety/index.html) to inform stakeholders and the public of ongoing and planned research activities. ISO will review its Scientific Agenda periodically to identify new gaps and communicate research priorities.The Agenda makes recommendations for a 5-year period in three main scientific areas: vaccine safety research, selected surveillance, and selected clinical guidance activities.

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Nodule at injection site as an adverse event following immunization: case definition and guidelines for data collection, analysis, and presentation

Cited by 47 publications

References 35 publications

Encapsulation of Exenatide in Poly-(d,l-Lactide-Co-Glycolide) Microspheres Produced an Investigational Long-Acting Once-Weekly Formulation for Type 2 Diabetes

Encapsulation of Exenatide in Poly-(d,l-Lactide-Co-Glycolide) Microspheres Produced an Investigational Long-Acting Once-Weekly Formulation for Type 2 Diabetes

Active safety monitoring of measles-mumps-rubella vaccine in the National Immunisation Programme of Sri Lanka

Preterm birth, vaccination and neurodevelopmental disorders: a cross-sectional study of 6- to 12-year-old vaccinated and unvaccinated children

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