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Covid-19 Vaccine Injuries

Ensuring Injuries are reported

The Complete Picture

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When our Health Minister, Greg Hunt, was hospitalised after receiving his AstraZeneca vaccine, with cellulitis announced as the cause, in spite of cellulitis being named as a known and fatal reaction, officials claim there is no causal link.

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Due to this dismissive defiance, it is of grave concern that side-effects of these vaccines may not be getting reported, for in order to determine the general rule-of-thumb, we must look at the exceptions.

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In light of this attitude, we cannot rely on healthcare professionals to report post vaccine reactions, so the onus is on the person injured, or their family to report it. And to get a more complete picture of vaccine safety, all adverse events should be reported no matter what the severity is.

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We wanted to provide the links and some tips on how to ensure your post vaccine reactions are reported through the proper channels.

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The Therapeutic Goods Administration (TGA) have a weekly wrap-up on the reported covid-19 vaccine adverse events, and this report is being used to imply transparency and encourage Australians to take these vaccines, but if all events aren't being reported, the results may be misleading us.

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Below is a step by step guide on how to officially report any vaccine reactions to the TGA. 

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In the event you have been seriously injured and you are not satisfied with the TGA's response, please click here to complete a contact form and we will be in touch to assist you in any way we can.

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Step 1

Access Online Reporting Form

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Go to the TGA link for consumer reporting - https://aems.tga.gov.au/privacy/

 

Read their privacy statement and click "I agree" to proceed.

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An online form is created with a six step wizard for you to complete.

Step 2

Reporter Details​

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Step one of the form wizard is where you must record the details of the person who is reporting the event. The minimum contact details required is an email address, telephone or postal address.

 

After entering your contact details, click "Next step" to continue.

Step 3

Patient Details​

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Step two of the form wizard is where you must record the details of the patient who experienced the event. Not all fields a mandatory, but for quality of data for assessment purposes, it is recommended that you fill out as much detail as possible. 

 

After entering your contact details, click "Next step" to continue.

Step 4

Medicine Details​

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Step three of the form wizard is where you must record the details of the vaccine administered to the patient who experienced the event.

 

Click the button labelled "+ Add a medicine"

 

A window will open where you can enter the details of the vaccine administered. If you have the AUST L or AUST R number located on the packaging, enter it where indicated. Otherwise record into the trade/brand name, one of the following:-

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  • COVID-19 Vaccine AstraZeneca (ChAdOx1-S)

  • COMIRNATY (BNT162b2 [mRNA]) Pfizer COVID-19 VACCINE

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Under "Action taken with medicine" and "Product's role in adverse event?" you must tick an option.

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Click "Add medicine". This will take you back to the form wizard.

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Click "Next step" to continue.

Step 5

Reaction Details​

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Step four of the form wizard is where you must record the details of the reaction to the vaccine. Multiple reactions can be added here.

 

Click the button labelled "+ Add a reaction"

 

A window will open where you can enter the details of the vaccine reaction. Not all fields a mandatory, but for quality of data for assessment purposes, it is recommended that you fill out as much detail as possible. 

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Click "Add reaction". This will take you back to the form wizard.

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To add another reaction, repeat the above steps.

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Click "Next step" to continue.

Step 6

Further Information​

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Step five of the form wizard is where you can include information on the sequence of events, any treatment provided, or any other relevant information such as medical history, test results, known allergies, or rechallenge if performed.

 

If you have supporting documentation, click the button labelled "+ Add a supporting document

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A window will open where you can click "Choose file" to browse your local directory to add the supporting document. 

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Click "Add supporting document". This will take you back to the form wizard.

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To add another supporting document, repeat the above steps.

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Click "Next step" to continue.

Step 7

Summary Report​

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Step six of the form wizard is the final step where you can view, save or print a summary of your submission and ultimately submit it to the TGA.

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Click the button labelled "View summary report (.PDF)

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A window will open asking where you wish to save your report. Make a note of the directory on your device that you have saved the report to.

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Click "Submit report". This will submit the report to the TGA.

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