This blog covers:
- Signs and symptoms in case processing
- How to handle reports containing signs and symptoms
- MedDRA coding conventions and best practices
Table of Contents
Introduction
Pharmacovigilance coding involves several complex and often confusing areas, including indications, adverse events, and current conditions.
In this article, we will explore how signs, symptoms, and adverse events are identified, evaluated, and coded into a safety database, along with best practices for accurate and consistent reporting.
Signs and symptoms: An overview by reports
Signs and symptoms” are two related but distinct medical terms:
- Signs → Objective evidence of disease that can be observed or measured by a doctor, nurse, or other examiner (e.g., fever, rash, high blood pressure, swelling).
- Symptoms → Subjective experiences reported by the patient, which cannot be directly observed by others (e.g., headache, fatigue, dizziness, pain).
In short:
- Signs = what the doctor sees.
- Symptoms = what the patient feels.
When adverse event report is made it has more than just AE, most of time the report consist of Signs and symptoms.
Adverse Events vs Signs and Symptoms
Not every report is required to include signs and symptoms, but in many cases, they are present. The complexity arises when trying to classify the information between adverse events (AEs) and signs or symptoms.
Adverse events are not always explicitly provided as separate or classified terms in reports. This is where the knowledge and expertise of the reviewer come into play — by analyzing the information and differentiating between the two. Often, the information needed to understand an event fully may be a diagnosis, especially when only signs and symptoms are reported.
“Accurate coding of adverse events begins with a clear understanding of the signs and symptoms—what is reported matters as much as how it’s interpreted.”
Description of reported signs and symptoms:
A reported sign or symptom is often the term used to describe an adverse event.
Signs and symptoms are closely associated and interrelated with adverse events but are not the same. They support the understanding of an AE but do not independently define it.
In cases where the reporting healthcare professional has not provided a formal diagnosis, the Marketing Authorization Holder (MAH) may suggest a diagnosis based on the symptom complex.
This suggested diagnosis, along with the individual signs, symptoms, and laboratory data, can be used to describe and assess the case.
Handling Reports: Adverse Events, Signs, and Symptoms
In pharmacovigilance case processing, reports often contain adverse events (AEs) along with associated signs and symptoms. A critical part of handling such reports is assessing and differentiating which terms represent the AE and which represent related signs and symptoms.
When other events are reported in the narrative that are not typically part of the primary diagnosis or provisional diagnosis but are suspected to be adverse reactions, they should also be listed and MedDRA-coded.
Whenever possible, an attempt should be made to establish a specific diagnosis in addition to describing the reported signs and symptoms. If multiple signs and symptoms can be grouped under a single diagnosis, the diagnosis should be prioritized and reported, while the signs and symptoms can be included in the free-text description for clarity.
Onset and End Dates
- Start date: When multiple terms (e.g. diagnosis with signs and symptoms) are reported but the reporter does not provide specific onset dates for each, the start date should reflect the date of the first symptom.
- End date: Similarly, if specific stop dates are not provided, the end date should correspond to the last reported symptom.
Data Elements
- ICH-E2B(R2): Use “Sender’s diagnosis/syndrome and/or reclassification of reaction/event” when combining reported signs and symptoms into a single diagnosis. The rationale should be included in data element “Sender’s comments.”
- ICH-E2B(R3): Use “Sender’s Diagnosis” when combining signs and symptoms into a diagnosis. The reasoning should be noted in data element “Sender’s Comments.”
Coding into the Database: Key Scenarios
Scenario 1 – Initial Report with Only Signs and Symptoms
When a report includes only signs and symptoms with no confirmed associated AE, the signs and symptoms should be coded individually since there is no diagnosis to associate them with.
Scenario 2 – Follow-up Report with Diagnosis
If a follow-up report confirms a diagnosis based on previously reported signs and symptoms, the diagnosed condition should be coded as the primary AE. The earlier coded signs and symptoms can be removed or de-prioritized. The diagnosis provides clearer context, and regulations require reporting the confirmed AE rather than the associated symptoms.
Example:
A 45-year-old female developed an allergic reaction to amoxicillin, presenting with rash, facial swelling, tachycardia, hypotension, and patient-reported symptoms of itching, shortness of breath, chest tightness, and dizziness.
- Diagnosis (AE):
→ Allergic reaction to amoxicillin - Signs (clinician-observed):
→ Rash, facial swelling, tachycardia, hypotension - Symptoms (patient-reported):
→ Itching, shortness of breath, chest tightness, dizziness
Note: Some organizations choose to retain both the coded AE and associated signs and symptoms in the database, while providing clarifications in the narrative and sender’s comments.
Additional Notes
- Signs and symptoms such as pain or discomfort are generally excluded when they do not fulfill the definition of an important medical event (IME).
- Accurate classification and coding ensure consistent reporting and proper assessment of drug safety.
Key Takeaways
When a report includes both an adverse event (AE) and associated signs or symptoms, prioritize coding the primary diagnosis of the AE and exclude the individual signs or symptoms where appropriate.
Signs and symptoms are closely related to the main diagnosis but are not the same and should be interpreted in that context.
Relevant signs and symptoms may contribute to assessing the seriousness of the AE and should be considered when evaluating the case.
Is the safety of a drug keeping you up at night?
“Take the next step toward improving patient safety—ensure every reported sign and symptom is accurately coded. Stay informed, stay thorough, and help transform data into meaningful insights for better healthcare outcomes.”
Conclusion
The article above has provided clarity on handling reports, particularly in assessing adverse events associated with signs and symptoms.
This structured approach ensures that case reports are coded accurately while capturing both clinical observations and patient-reported information. By prioritizing diagnoses when available and clearly describing associated signs and symptoms, pharmacovigilance teams can maintain data integrity and regulatory compliance.
We hope this article helps you better understand how to handle such reports effectively.
Let me know if you want sample templates, coding workflows, or further explanations on applying these conventions in real case processing.
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