Vaccine Online Report

SUSPECTED VACCINE ADVERSE EVENT ONLINE REPORTING FORM FOR HEALTHCARE PROFESSIONALS & COMPANIES
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
Initials: *		Name:
Date of birth (dd/mm/yyyy):		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): *	Tick if the date is an estimate
Outcome: *
If Fatal, indicate the Date of Death:
If Recovered, indicate the Date of Recovery:
Description of adverse event (Please enclose relevant lab results)(max 2500 characters ): *
Non-serious reactions need not be reported e.g. fever <39 °C, myalgia, local induration and pain

3. VACCINE ADMINISTERED
Suspected Vaccine (Brand Name) : *
Dose
Amount:		Unit:
Date given (dd/mm/yyyy):		Route:
Indication:
Batch number:
Place of vaccination:	(max 1200 characters)
Click Save to enter another suspected vaccine

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):		Date stopped (dd/mm/yyyy):
Indication:
Batch Number:		Duration of therapy:
Click Save to enter another concomitant vaccine/drug

5. OTHER RELEVANT INFORMATION

E.g. medical history, allergies, pregnancy, smoking, alcohol use, rechallenge (if performed) (max 2500 characters).

Supporting Attachments

Please attach relevant supporting documents if any (e.g. laboratory results)

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):
Patient died due to reaction Life threatening Congenital anomaly Involved or prolonged in-patient hospitalisation Involved persistent or significant disability or incapacity Medically significant
Please state why it was considered medically significant (max 255 characters)
Sequelae (any permanent complications or injuries as a result of the AE)?	Yes	No
Was treatment given?	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:

Email:

Place of Practice

Name: *

Address:
(max 255 characters)

I wish to receive information about other local reports associated with this suspected vaccine

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