Report can be returned by fax to 2319 6319
For Follow-up report (see Guidance),
Please provide previous case Ref. No.:____________
Department of Health
Adverse Drug Reactions (ADR) Report Form
Please read the following instructions:
1. Please read the Guidance for Healthcare Professionals ([Link] and Guidance for Pharmaceutical
Industry ([Link] before completing the ADR report form.
2. ADR can be briefly described as a noxious and unintended response to a pharmaceutical product (i.e. drug or vaccine).
3. If the ADR of a newborn/child may be related to the mother, please submit a separate report for the mother.
4. Please provide information to every section.
5. Full name and any kind of personal identifier of the patient, such as identity card number and hospital admission number,
should not be provided on the report form.
6. Information of individual reporter will be treated in strict confidence. Please read the Statement of Purposes overleaf in respect
of the collection of your personal data.
7. As limited space is provided, please use another page for additional information if necessary.
8. For further enquiries, please contact the Adverse Drug Reaction and Adverse Event Following Immunization Unit of Drug Office
of the DH at 2319 2920.
Section (A): Patient Information
Patient initials or ref. no.: _____________________________________________ (Please read instruction 5 above)
Sex: M F Unknown For woman, is she pregnant? No Yes Unknown
Weight (if known): ________ kg Date of birth: (dd/mm/yyyy) / / or age (at last birthday):___________
Ethnic group: Chinese Asian (Not Chinese) African Caucasian Eurasian Unknown Others___________
Section (B): About the Adverse Drug Reaction
Date of onset of ADR: (dd/mm/yyyy) / /
Description of event: ________________________________________________________________________________________
__________________________________________________________________________________________________________
ADR category (for vaccine related ADR only):
Allergic reaction Local reaction Systemic reaction Neurological disorders
Severity (can tick more than 1 box if appropriate):
Life threatening Prolonged Hospitalization Hospitalized on: (dd/mm/yyyy) / /
Hospitalization NOT required
Laboratory result (if applicable):______________________________________________________________
All Drug Therapies/Vaccines Prior
Daily Dosage
to ADR
(dose number Date Date
(Please use trade names and, for Route Reason for Use
for vaccines Begun Stopped
vaccine, indicate batch number.
e.g. 1st DTP)
Please circle the suspected drug.)
Section (C): Treatment & Outcome
Treatment for ADR: No Yes. Details (including dosage, frequency, route, duration) __________________________________
Laboratory result (if applicable): _______________________________________________________________________________
Outcome: Recovered on: (dd/mm/yyyy) / / Not yet recovered Unknown Died on: (dd/mm/yyyy) / /
Sequelae: No Yes: Persistent disability Birth defect Medically significant events Details:______________________
Allergies or other relevant history (including medical history, liver/kidney problems, smoking, alcohol use etc)
__________________________________________________________________________________________________________
Section (D): Reporter Details (Please read instruction 6 above)
Name of Reporter and Organization:______________________________ Sector of service: Private Public
Occupation: Doctor Chinese medicine practitioner Dentist Pharmacist Nurse Others_____________
Correspondence Address:_________________________________________________________________________________
Tel. no.: __________________________Fax. no.: ________________________ Email: _______________________________
Also report to: Manufacturer Distributor/Importer Others_____________ Date of this report:_______________________
DH 2580 (06/2021)
Please fold inside along the dotted line and seal the edge
Please
To: Adverse Drug Reaction and Adverse Event Following Immunization Unit Affix
Drug Office Stamp
Department of Health
Room 1856, 18/F, Wu Chung House
213 Queen’s Road East, Wan Chai, Hong Kong
Statement of Purposes
Purpose of Collection
Please seal the edge
Please seal the edge
This personal data are provided by reporter for the purposes of reporting adverse drug reaction of the patient to the
Department of Health (DH). The personal data provided will be used by DH for the following purposes:
(a) follow-up of the case report; and
(b) surveillance of drug-related events.
2. The provision of personal data is voluntary. If you do not provide sufficient information, we may not be able to assess
the report properly.
Classes of Transferees
3. The personal data you provide are mainly for use within DH. Apart from this, the data may only be disclosed to
parties where you have given consent to such disclosure or where such disclosure is allowed under the Personal Data
(Privacy) Ordinance.
Access to Personal Data
4. You have a right of access and correction with respect to personal data as provided for in sections 18 and 22 and
Principle 6 of Schedule 1 of the Personal Data (Privacy) Ordinance. Your right of access includes the right to obtain a
copy of your personal data. A fee may be imposed for complying with a data access request.
Enquiries
5. Enquiries concerning the personal data provided, including the making access and corrections, should be addressed to:
Senior Pharmacist
Adverse Drug Reaction and Adverse Event Following Immunization Unit
Drug Office
Department of Health
Room 1856, 18/F, Wu Chung House
213 Queen’s Road East, Wan Chai, Hong Kong
Tel: 2319 2920
