Report Your Reaction

The Therapeutic Goods Administration (TGA) is Australia’s drug regulator responsible for ensuring that vaccines are safe for the Australian marketplace. As part of its responsibilities, it collects reports (from doctors and patients) on adverse events following immunisation (AEFI) in order to monitor the safety of vaccines.

This role is particularly important for the COVID-19 vaccines, which have not undergone long-term safety monitoring prior to being rolled out into the community.

For this reason, it is extremely important that every adverse reaction to a COVID-19 vaccine is reported, no matter the severity, longevity or whether you or your doctors think it’s related to the vaccine or not.

Lots of data is key to understanding vaccine adverse reactions.

If your doctors have not submitted an adverse event report, or if you are unsure whether this has been done, you are able to submit a report yourself. It’s quite simple.

Have these pieces of information ready before you begin:

• Brand of vaccine and date of administration
• Medicare number
• Details of any other medications you are taking
• Details of any pre-existing medical conditions
• Hospital and specialist reports related to your adverse reaction
• List of all symptoms you have experienced since your vaccination

Once your report is verified by the TGA (you may receive a phone call from an official or nurse from your state’s public health department), it will be uploaded to DAEN (Database of Adverse Event Notifications), with basic aspects of your report made public (date of report, your age, your sex, and the symptoms you are reporting).

How to submit your report

There are several ways to send details of your adverse reaction to the TGA.

Contact the NPS Medicinewise Adverse Medicine Events line on 1300 134 237

adr.reports@tga.gov.au
Be sure to include the above information, including scans of any reports.

aems.tga.gov.au
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Remember

While TGA will not assist with your recovery, trends in adverse events are key to keeping the wider community safe.

Records

You should be given a reference number for your submission. If recording online you also have the ability to print what you have lodged. Keep all of this information.

Submit follow-up reports

One of the major failings of the TGA’s adverse event reporting system is that they rarely follow up on any of the reports submitted. So it is up to you to let the TGA know about your ongoing vaccine-related issues.

After submitting your initial report, we suggest setting reminders on your phone at 3 or 6-month intervals to make follow-up reports to the TGA. Using the original reference number the TGA gave you (or even by replying to the confirmation email they sent you) simply update the TGA of your ongoing symptoms and severity, details of any new symptoms, and include scans of any relevant medical tests, doctor reports or diagnoses.

This is an important activity for us all, as it provides the TGA with long-term safety data. Without it, they have no way to know that these vaccines are causing these types of harm.

Other places to log a report

The TGA is the official Australian agency for monitoring adverse events and accepting reports.

However, there are other places where you can also submit a report. Whilst this is not necessary (your reports to the TGA will suffice), you may feel compelled to make additional reports.

VAERS (Vaccine Adverse Event Reporting System)

The US system of adverse event reporting is called VAERS. This system can accept reports from people all over the world, and is perhaps the most utilised reporting system for independent researchers seeking to gain insight into drug adverse reactions.

Bear in mind that if you submit a report to VAERS that you are sending your medical data to an entity of a foreign government, and are unlikely to be protected by Australian privacy or security laws.

Submit a report online: vaers.hhs.gov

Vaccine manufacturers

Vaccine manufacturers have their own reporting procedures for patients who experience an adverse reaction to their product.

Below are some of the manufacturer’s own adverse event reporting websites that you may also consider submitting a report to:

AstraZeneca

aereporting.astrazeneca.com

Janssen

www.janssen.com/patient-safety

Novavax

au.novavaxmedinfo.com/report-adverse-event

Moderna

report.moderna.convergehealthsafety.com

Pfizer

www.pfizersafetyreporting.com