ADR Reporting > Adverse Drug Reactions (ADR) Report Form > Adverse Drug Reactions (ADR) Online Reporting

Adverse Drug Reactions (ADR) Online Reporting

** Please DO NOT use this report form for reporting COVID-19 Vaccine adverse event.

Section (A): Patient Information

Patient initials or ref. no. (Please read instruction 5 below):

Sex:

M F: Pregnant? No Yes Unknown

Weight (if known):

Weightkg

Date of birth:

Date of birth / Date of birth Date of birth / (dd/mm/yyyy) or age (at last birthday): age

Ethnic group:

Chinese Asian African Caucasian Eurasian Unknown
Others Ethnic group

Section (B): About the Adverse Drug Reaction

Date of onset of ADR:

Date of onset of ADR / Date of onset of ADR / Date of onset of ADR (dd/mm/yyyy)

Description:

Description

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
Hospitalised on: Hospitalised on / Hospitalised on / Hospitalised on (dd/mm/yyyy) Hospitalisation NOT required
Laboratory result (if applicable): Laboratory result

All Drug Therapies/Vaccines Prior to ADR (Please use trade names and, for vaccine, indicate batch number. Please mark the suspected drug with asterisk*.)	Daily Dosage (dose number for vaccines e.g. 1st DTP)	Route	Date Begun	Date Stopped	Reason for Use
All Drug Therapies/Vaccines Prior to ADR	Daily Dosage	Route	Date Begun	Date Stopped	Reason for Use
All Drug Therapies/Vaccines Prior to ADR	Daily Dosage	Route	Date Begun	Date Stopped	Reason for Use
All Drug Therapies/Vaccines Prior to ADR	Daily Dosage	Route	Date Begun	Date Stopped	Reason for Use
All Drug Therapies/Vaccines Prior to ADR	Daily Dosage	Route	Date Begun	Date Stopped	Reason for Use
All Drug Therapies/Vaccines Prior to ADR	Daily Dosage	Route	Date Begun	Date Stopped	Reason for Use
All Drug Therapies/Vaccines Prior to ADR	Daily Dosage	Route	Date Begun	Date Stopped	Reason for Use

Section (C): Treatment & Outcome

Treatment of ADR:

No
Yes. Details (including dosage, frequency, route, duration): Yes. Details (including dosage, frequency, route, duration)

Laboratory result (if applicable):

Laboratory result (if applicable)

Outcome:

Recovered on: Recovered on / Recovered on / Recovered on (dd/mm/yyyy)
Not yet recovered Unknown
Died on: Died on / Died on / Died on (dd/mm/yyyy)

Sequelae:

Yes: Persistent disability Birth defect Medically significant events
Details: Details

Allergies or other relevant history (including medical history, liver / kidney problems, smoking, alcohol use etc):

Allergies or other relevant history (including medical history, liver / kidney problems, smoking, alcohol use etc)

Other Information:

Other Information

Section (D): Reporter Details (Please read instruction 6 below)

Name:

Name

Sector of service:

Private Public

Occupation:

Doctor Chinese medicine practitioner Dentist Pharmacist Nurse
Others Others

Correspondence Address:

Correspondence Address

Tel. no.:

Tel. no.

Fax. no.:

Fax. no.

Email:

Also report to:

Manufacturer Distributor / Importer Others Others
Date of this report: Date of this report

Please read the following instructions:

Please read the Guidance for Healthcare Professionals (http://www.drugoffice.gov.hk/adr.html); and Guidance for Pharmaceutical Industry (http://www.drugoffice.gov.hk/adr_industry.html) before completing the ADR report form.
ADR can be briefly described as a noxious and unintended response to a pharmaceutical product (i.e. drug or vaccine).
If the ADR of a newborn/child may be related to the mother, please submit a separate report for the mother.
Please provide information to every section.
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.
Information of individual reporter will be treated in strict confidence. Please read the Statement of Purposes in respect of the collection of your personal data.
As limited space is provided, please use another page for additional information if necessary.
For further enquires, please contact the Adverse Drug Reaction and Adverse Event Following Immunization Unit of Drug Office of the DH at 2319 2920.

(Revised in 06/2021)

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