{"schema":"https://ver.cy/schemas/card/1.0.0","id":"vr.tr.side-effect","code":"thing-q3269441","url":"https://ver.cy/models/thing/q3269441/","name":"side effect","alternateNames":[],"kind":"thing","status":"research-draft","version":"0.2.0-wave.4","language":"en","classifiers":{"family":"Thing Registry","category":"","entryKind":"","plane":"","domain":["XCT.STA"],"industry":[],"navPath":"","tags":[],"facets":{}},"whatItIs":"An effect of a drug, treatment, medical device or intervention other than the one intended, which may be harmful, called an adverse effect or adverse reaction, or occasionally beneficial, monitored through clinical trials and pharmacovigilance systems such as the UK Yellow Card scheme and the US FDA s MedWatch; the registry aliases name specific device and treatment complications, intrauterine device migration, where an IUD moves out of place, artificial lens implant migration after cataract surgery, and tube dependency in children fed by feeding tubes, which are instances of adverse outcomes. People should not stop prescribed medicines without advice, and severe reactions such as breathing difficulty or swelling need emergency services.","purpose":"Let an agent explain side effects in general terms, relay classification, frequency terms, monitoring and reporting from pharmacology and regulatory sources, route severe reactions to emergency services and routine concerns to clinicians or pharmacists, describe the named complications, and distinguish side effects from allergies, overdoses, drug interactions, nocebo effects and the intended therapeutic effect.","scope":{"in":[],"out":[],"boundaries":[]},"distinguishingFeatures":["Unintended","Harmful or beneficial","Monitored after approval","Reportable"],"structure":{"bundles":[{"id":"understand","name":"Understand","description":"What a side effect is.","layers":[{"id":"definition","name":"Definition","description":"Definition.","findings":[{"id":"definition-finding","name":"Definition","description":"Definition.","questions":[{"text":"Is someone having breathing difficulty, facial swelling, a severe rash or collapse after a medicine, in which case call emergency services now?","kind":"boundary"},{"text":"What is a side effect, and how does it differ from allergies, overdoses, interactions, nocebo effects and intended effects?","kind":"definition"}]}]},{"id":"complications","name":"Complications","description":"Named complications.","findings":[{"id":"complications-finding","name":"Complications","description":"Complications.","questions":[{"text":"What are IUD migration, lens implant migration and tube dependency?","kind":"definition"},{"text":"Which entry fits the specific complication?","kind":"action"}]}]}]},{"id":"pharmacology","name":"Pharmacology","description":"Classification.","layers":[{"id":"types","name":"Types","description":"Types of reactions.","findings":[{"id":"types-finding","name":"Types","description":"Types.","questions":[{"text":"How are adverse reactions classified, such as Type A and Type B?","kind":"provenance"},{"text":"Which references are standard?","kind":"provenance"}]}]},{"id":"frequency","name":"Frequency","description":"Frequency terms.","findings":[{"id":"frequency-finding","name":"Frequency","description":"Frequency.","questions":[{"text":"What do very common, common and rare mean on medicine leaflets?","kind":"measurement"},{"text":"Which sources are cited?","kind":"provenance"}]}]}]},{"id":"reporting","name":"Reporting","description":"Reporting.","layers":[{"id":"systems","name":"Systems","description":"Reporting systems.","findings":[{"id":"systems-finding","name":"Systems","description":"Systems.","questions":[{"text":"How can patients report side effects through Yellow Card, MedWatch or national systems?","kind":"provenance"},{"text":"Which entry fits pharmacovigilance?","kind":"action"}]}]},{"id":"advice","name":"Advice","description":"Talking to clinicians.","findings":[{"id":"advice-finding","name":"Advice","description":"Advice.","questions":[{"text":"Why should people speak to a pharmacist or doctor before stopping a medicine?","kind":"provenance"},{"text":"Which entry fits pharmacist?","kind":"action"}]}]}]},{"id":"context","name":"Context","description":"Perception.","layers":[{"id":"nocebo","name":"Nocebo","description":"Nocebo effects.","findings":[{"id":"nocebo-finding","name":"Nocebo","description":"Nocebo.","questions":[{"text":"What does research say about nocebo effects in reported side effects, with findings attributed?","kind":"provenance"},{"text":"Is the presentation neutral and attributed?","kind":"boundary"}]}]},{"id":"devices","name":"Devices","description":"Device complications.","findings":[{"id":"devices-finding","name":"Devices","description":"Devices.","questions":[{"text":"How are complications of implants and devices monitored?","kind":"provenance"},{"text":"Which entry fits medical device?","kind":"action"}]}]}]}]},"agentConduct":{"may":["explain classification and frequency terms","relay reporting systems","describe named complications","route severe reactions"],"mustNot":[],"requiresHuman":["People should not stop prescribed medicines without advice, and severe reactions such as breathing difficulty or swelling need emergency services."]},"ethics":{"considerations":["An effect of a drug, treatment, medical device or intervention other than the one intended, which may be harmful, called an adverse effect or adverse reaction, or occasionally beneficial, monitored through clinical trials and pharmacovigilance systems such as the UK Yellow Card scheme and the US FDA s MedWatch; the registry aliases name specific device and treatment complications, intrauterine device migration, where an IUD moves out of place, artificial lens implant migration after cataract surgery, and tube dependency in children fed by feeding tubes, which are instances of adverse outcomes.","Harmful or beneficial"],"affectedParties":[]},"owners":{"steward":"","roles":[],"masterSystems":[]},"relations":[{"target":"health risk","type":"related","note":"in registry terms"},{"target":"pharmacovigilance","type":"related"},{"target":"drug allergy","type":"related"},{"target":"nocebo","type":"related"}],"interaction":{"identity":{"applicability":"required","items":[]},"properties":{"applicability":"not-applicable","items":["frequency terms: very common over 1 in 10 to very rare under 1 in 10,000 note - EU convention","UK Yellow Card scheme: 1964 year","US MedWatch: 1993 year"]},"recognition":{"applicability":"optional","items":["Unintended effect of a treatment","Intrauterine device migration, artificial lens implant migration, tube dependency, adverse effect, adverse drug reaction","Allergies are immune reactions; overdoses exceed doses; interactions involve combinations; nocebo effects arise from expectations; therapeutic effects are intended","Not a single appearance; symptoms or findings after treatment."]},"capabilities":{"applicability":"required","items":["explain classification and frequency terms","relay reporting systems","describe named complications","route severe reactions"]},"hazards":{"applicability":"required","items":["Encouraging stopping medicines without advice","Missing anaphylaxis","Overstating rare risks"]},"interfaces":{"applicability":"required","items":["ICH E2 pharmacovigilance guidelines","EU and FDA adverse event reporting rules","Medical device vigilance regulations"]},"context":{"applicability":"required","items":["Understanding unintended effects of treatments.","adverse drug reactions","device complications","procedure complications","beneficial side effects","long-term treatment effects"]}},"sources":[],"openQuestions":["The registry aliases for IUD migration, lens implant migration and tube dependency should be moved to specific complication entries","How should reporting systems be linked by country?","Should beneficial side effects be a separate entry?","Which entry fits the specific complication?","Which entry fits pharmacovigilance?","Which entry fits pharmacist?"],"resources":{"spec":"/models/things/publications/thing-q3269441/spec.json"},"provenance":{"origin":"thing registry research (pass 2)","builtFrom":["models/things/publications/thing-q3269441/spec.json"],"providers":["Claude"],"researchStatus":"unreviewed","generatedAt":"2026-09-13T22:45:28Z","builder":"tools/build_cards.py@1.0.0"},"completeness":{"sections":{"classifiers":"filled","whatItIs":"filled","purpose":"filled","distinguishingFeatures":"filled","structure":"filled","agentConduct":"derived","ethics":"derived","owners":"missing","relations":"filled","interaction.identity":"missing","interaction.properties":"not-applicable","interaction.recognition":"filled","interaction.capabilities":"filled","interaction.hazards":"filled","interaction.interfaces":"filled","interaction.context":"filled","sources":"missing"},"notes":{"agentConduct":"Affordances listed as what may be done; prohibitions collected from the text.","interaction.properties":"Plane XCT: no invented physical properties.","sources":"Written from model knowledge without web access; claims are unverified."},"score":0.75}}