SUSPECTED VACCINE ADVERSE EVENT (VAE) ONLINE REPORTING FORM
Fields marked * are mandatory.
Please fill in as much information as you can. Do not delay reporting if some details are not known. Further relevant information can be provided at a later date when it is available.
CONFIDENTIAL
1. PARTICULARS OF PATIENT
Name:
Date of birth (dd/mm/yyyy): Click Here to Pick up the date NRIC/Identification no:
Age:
Please enter age or approximate age. If age is unknown, type UNK in the field.
Weight: kg
Sex: Ethnic group:

2. DETAILS OF ADVERSE EVENT(S)
Date of onset (dd/mm/yyyy): Click Here to Pick up the date Tick if the date is an estimate
Outcome:
If Fatal, indicate the Date of Death: Click Here to Pick up the date
If Recovered, indicate the Date of Recovery: Click Here to Pick up the date
Type of Event :            
Description of adverse event (Please enclose relevant lab results)(max 2500 characters ):


3. VACCINE ADMINISTERED
Suspected Vaccine (Brand Name) :
Dose
Amount: Unit:
Date given (dd/mm/yyyy): Click Here to Pick up the date Route:
Indication:
Batch number:
Place of vaccination:

4. DETAILS OF CONCOMITANT VACCINES/DRUGS (including complementary medicines/vaccines given or consumed at the same time and/or 3 months before)
Concomitant vaccines/drugs:
Dose
Amount: Unit:
Frequency: Route:
Date started (dd/mm/yyyy): Click Here to Pick up the date Date stopped (dd/mm/yyyy): Click Here to Pick up the date
Indication:
Batch Number: Duration of therapy:

5. OTHER RELEVANT INFORMATION
Supporting Attachments

6. MANAGEMENT OF ADVERSE EVENT
Hospitalisation? Yes No Already hospitalised
Causality? Certain Probable Possible Unlikely Unconfirmed Not known
Do you consider the adverse event to be serious? Yes No Not known
If yes, please indicate why the adverse event is considered to be serious (Please tick all that apply):







Yes No
Yes No
If yes, indicate the type(s) of treatment given (max 255 characters):

7. REPORTERS PARTICULARS
Name:
Profession / Type: Report Reference No. (if any):
Tel No: Fax No.:
Email:
Place of Practice
Name:
Address:
(max 255 characters)

8. EXPLANATORY NOTE
An adverse event (AE) is defined as an event which is harmful (noxious) and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or treatment of a disease, or for the modification of a physiological function.
Please report adverse event(s) which:
1. a. Are life threatening or fatal.
b. Require in-patient hospitalisation or prolong existing hospitalisation.
c. Cause persistent incapacity or disability.
d. Cause birth defect.
e. Are medically significant.
2. All adverse event to recently marketed health products that have been introduced into Singapore in the recent few years, regardless of their nature and severity.
Please do not be deterred from reporting because some details are not known.
Submission of follow-up reports
Any follow-up information (e.g. lab results) for an AE that has already been reported can be sent to us via Internet or other available modes of reporting e.g. fax, email or post. Please indicate that it is a follow-up report as it is important that reports are identified and linked to the original report.
    

Contact the Vigilance Branch,
Vigilance, Compliance & Enforcement Division
Health Products Regulation Group, HEALTH SCIENCES AUTHORITY
if you have any problems or queries on AE reporting.