Reporting Adverse Drug Reactions and Adverse Events Following Immunisation
- Please report ALL suspected Adverse Drug Reactions (ADRs) (including those for traditional products) and Adverse Events Following Immunisation (AEFIs) to the National Centre for Adverse Drug Reactions Monitoring.
- Do not hesitate to report if some details are not known.
- The identities of Reporter, Patient and Institution will remain confidential.
- Kindly report ADR/AEFI through only ONE channel:
- PhIS version 1.7 & above*, OR
- online web form, OR
- manual submission by mail/fax/email.
Repeated submission using multiple channels is NOT necessary.
*Note: If your facility is equipped with PhIS version 1.7 & above, your PhIS ADR report will be automatically pushed to NPRA. For any enquiries related to PhIS reporting, please contact PhIS Helpdesk.
IMPORTANT NOTES FOR ONLINE REPORTING:
- Please use 'Google Chrome' as your web browser.
- Mandatory fields (marked with *): Please fill in all mandatory fields in order to successfully submit the form.
- Non-mandatory fields: Please give as much information as you can. If the relevant information is not known, kindly leave the field(s) blank.
- Numeric fields: Please fill in whole numbers only (no decimal points) [Refer user guide for details]
- Please read this user guide BEFORE proceeding to complete the online reporting form.
ADR/AEFI Web Form
To report an adverse event online, click Online Reporting as below.
Manual ADR/AEFI Reporting Form
To report an adverse event via ADR/AEFI Reporting form, click Download ADR/AEFI Reporting Form as below. You may:
a) Print the form and fill in manually, or
b) Fill in the form via Adobe Acrobat (recommended) and click "Save As" to save your completed form.
Please email your completed form to fv@npra.gov.my
Guide for ADR Reporters
- Definitions
- Checklist for ADR Reporters
- Submitting Samples for Laboratory Testing of Suspected Adulterated Products
- VigiAccess: A Public Gateway to the WHO ADR Database
- ADR Reports on AntiTB drugs
Adverse Drug Reaction (ADR) / Adverse Event Following Immunisation (AEFI) Reporting Manual for Healthcare Professionals
- ADR / AEFI Reporting Guideline for Healthcare Professionals
Malaysian Guidelines on Good Pharmacovigilance Pratices (GVP) for Product Registration Holders (1st Edition, August 2021)
- Introduction to Pharmacovigilance
Cutaneous Adverse Drug Reaction (ADR) Classification
