National Adverse Events Following Immunisation Aefi Reporting Form Feb 2021

TGA use only
Date report received:

Notification ID:
This form, when completed, will be classified as 'For official use only'.
For guidance on how your information will be treated by the TGA see: Treatment of information provided to the TGA at
<https://www.tga.gov.au/treatment-information-provided-tga>.
National Adverse Events Following Immunisation (AEFI) reporting form

Vaccinated person’s details
Personal Details
Surname First Name
Sex Female Male Other/unknown Age/DOB
Street Address
Suburb Postcode State
Phone: Email:
Name of Parent/Guardian (if relevant)
Indigenous Status: is the person of Aboriginal Aboriginal Torres Strait Island Both
or Torres Strait Islander origin? No Prefer not to say
What is the ethnicity of the person?
Personal Details
Was the vaccinated person pregnant at the time of vaccination? Yes No
Unknown
Has the vaccinated person ever been diagnosed with COVID-19? Yes No
Unknown
Does the vaccinated person have any allergies (please provide details)
Has the vaccinated person had previous reactions to vaccinations? Yes No

Unknown
Past medical history: (please provide
details of any medical history including
details of previous vaccination reactions)
PO Box 100 Woden ACT 2606 ABN 40 939 406 804

Phone: 1800 020 653 Fax: 02 6203 1605 Email: info@tga.gov.au https://www.tga.gov.au
Vaccination provider details
Surname First Name
Street Address
Phone: Email:
Profession Medical practitioner Registered Nurse
Other: please specify
Clinical Setting GP Practice Hospital School Aged Care Facility Council Clinic
Disability Care Facility Other: Please Specify
Adverse event details

Onset of event Date: Time:
Please describe the events,
including timeline of occurrences:
(additional information can be
added to page 4).
Who treated the reaction?

Please tell us the treatment/care
provided (eg antibiotics, adrenaline,
advice, counselling etc)
Please tell us about the medications

and/or vaccines the person has had
in the last 4 weeks
Was the person sick when they had
the vaccination?
Has this report been sent to others?
How many vaccines did the person 1
have together?
Adverse event Outcome

Have the symptoms resolved? Yes Date: Time:
No Symptoms ongoing as at Date:
Please describe ongoing symptoms
Unknown
National Adverse Events Following Immunisation (AEFI) reporting form (February 2021) Page 2 of 5
For official use only
Vaccine details
Vaccine 1 Brand Name Date Given
Dose No. Batch No. Time Given
Route of Oral Intramuscular Intranasal Intradermal Subcutaneous Unknown
administration
Injection Site Leg Right Leg Left Arm Right Arm Left Buttocks Unknown/N/A
administration
administration
administration
administration
administration
administration
Reporter details
As per vaccinated person As per vaccination provider or below
Surname First Name Practice name
Street Address
Phone: Email:
Reporter Consent
I, the reporter, agree to be contacted for further follow up regarding the adverse event if
necessary. Yes No (Please also advise patient)
Signature:
Once completed send to the TGA

 By mail to: Pharmacovigilance and Special Access Branch’Branch,
Reply Paid 100, Woden ACT 2606
 By fax to: 02 6232 8392
 By email to: adr.reports@tga.gov.au
Privacy statement
Health Professionals reporting on behalf of a patient should provide the patient with a copy
of this privacy statement.
For general privacy information, go to <https://www.tga.gov.au/privacy>.

The Therapeutic Goods Administration (the TGA) is part of the Department of Health. The TGA
can be contacted by phone on 1800 020 653, by email at info@tga.gov.au, or by post at PO Box
100, Woden ACT 2606, Australia.
Information in this report is collected to assist in the post market monitoring of the safety of
therapeutic goods under the Therapeutic Goods Act 1989 (the Act). All reports of AEFIs are
assessed and entered into the TGA's Australian Adverse Drugs Reactions System (the ADRS).
The TGA collects personal information relating to adverse events following immunisation (AEFIs).
At times, this information is collected from someone other than the individual to whom the personal
information relates. This can occur when AEFIs are reported to a person or an entity other than the
TGA (such as a health professional), and that person or entity passes the information on to the
TGA (either directly or through a State or Territory health agency).
Collection of personal information from sponsors of therapeutic goods is required or authorised
under Chapter 3 of the Act.
Personal information about patients is collected and used to:
Assess the safety of vaccines under the Act.

Contact the reporter (if additional information is needed to evaluate the reported adverse
events).
Check that the same information has not been received multiple times for the same adverse
event.
Contact representatives of entities that supply therapeutic goods, to discuss reported adverse
events.
Personal information collected in this report may be disclosed by consent or where the disclosure
is required by, or authorised under, a law (for example, under section 61 of the Act). For reports
related to vaccine events, personal information about the reporter or the patient may be disclosed
to State and Territory health agencies under subsection 61(3) of the Act.

National Adverse Events Following Immunisation Aefi Reporting Form Feb 2021

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National Adverse Events Following Immunisation Aefi Reporting Form Feb 2021

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TGA use only

Date report received:

National Adverse Events Following Immunisation (AEFI) reporting form

Has the vaccinated person had previous reactions to vaccinations? Yes No

PO Box 100 Woden ACT 2606 ABN 40 939 406 804

Adverse event details

Who treated the reaction?

Please tell us about the medications

Adverse event Outcome

Once completed send to the TGA

For general privacy information, go to <https://www.tga.gov.au/privacy>.

Assess the safety of vaccines under the Act.

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