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AUSTRALIA TGA SAFETY SURVEILLANCE - 19.08.2021

  • Writer: MyBody MyRisk
    MyBody MyRisk
  • Aug 21, 2021
  • 1 min read

AUSTRALIAN THERAPEUTIC GOODS ADMINISTRATION

WEEKLY SURVEILLANCE REPORT

19.08.2021

Adverse event reports: 50,597 Doses administered: 15,341,039

1 adverse event report submitted for every 303 doses administered

TTS (Clots with low platelets)

112 cases (1 / 50,000 initial doses)

6 fatalities (6% case fatal)

Current Status of TTS cases

Myocarditis / Pericarditis

DAEN: 208 cases (1 / 37,583 doses)

TGA: 188 cases

Facial swelling in people who have had dermal filler injections

THROMBOSIS CASES

As reported in the Database of Adverse Event Notifications (DAEN)


Guillain-Barre Syndrome

82 cases (1 / 86,000 doses)

Immune Thrombocytopenia Purpura (ITP)

47 cases (1 / 150,000 doses)

DATABASE OF ADVERSE EVENT NOTIFICATIONS MOVED TO 14 DAYS

MODERNA 'SPIKEVAX' APPROVED BY THE TGA

CLICK HERE to access the Australian Public Assessment Report

WANT MORE INFORMATION ON THE PFIZER COVID-19 VACCINES APPROVALS IN AUSTRALIA?


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