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AUSTRALIA TGA WEEKLY SAFETY SURVEILLANCE - 26.08.2021

Updated: Aug 28, 2021

AUSTRALIAN THERAPEUTIC GOODS ADMINISTRATION

WEEKLY SURVEILLANCE

26.08.2021

 

Adverse event reports: 52,849 Doses administered: 17,150,654

 
 
 

SAFETY SURVEILLANCE DETAILS

TTS (Clots with low platelets)

118 cases (1 / 50,000 initial doses)

6 fatalities (6% case fatal)

 

Status of TTS

 

Myocarditis / Pericarditis

DAEN Total: 251 Cases (up to 12 Aug)

TGA Total: 235 Cases (up to 22 Aug)*

PERICARDITIS: 180 Cases

MYOCARDITIS: 71 Cases - 1 death

1 in 33,067 doses

*Variance in case numbers is likely due to the fact that people may be diagnosed witg both myocarditis and pericardities

 

Facial swelling in people who have had dermal filler injections

 

Thrombosis

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

 

Guillain-Barre Syndrome

89 cases (1 in 99,000 doses)

 

Immune Thrombocytopenia (ITP)

56 cases (1 in 157,142 doses)

 

AUSTRALIA COVID-19 VACCINE ROLLOUT DATA

VIEW LATEST ROLLOUT REPORTS

 

AGED CARE COVID-19 VACCINATION RATES MAP

Updated 5pm daily

 

VACCINE HESITANCY MONITORING

Operation COVID Shield COVID-19 Vaccine Sentiment Summary

 

AusVax Safety Surveillance

PFIZER

DOSE 1:

  • 1,007,479 people responded to an SMS/email about their health in the three days after their COVID-19 vaccinations.

  • 62.8% reported no adverse event

  • 37.2% (374,832 people) reported any adverse event

  • 6.7% reported missing work, study or routine duties for a short period (<1 day missed by the majority).

  • 0.5% reported seeing a doctor or going to emergency department in the days after vaccination.

DOSE 2:

  • 770,864 people responded to an SMS/email about their health in the three days after their COVID-19 vaccinations.

  • 43.6% reported no adverse event

  • 56.4% (434,988 people) reported any adverse event

  • 21.2% reported missing work, study or routine duties for a short period (<1 day missed by the majority)

  • 1.3% reported seeing a doctor or going to emergency department in the days after vaccination.


ASTRAZENECA

DOSE 1:

  • 429,723 people responded to an SMS/email about their health in the three days after their COVID-19 vaccinations.

  • 44.4% reported no adverse event

  • 55.6% (238,715 people) reported any adverse event

  • 17.6% reported missing work, study or routine duties for a short period (<1 day missed by the majority).

  • 1.0% reported seeing a doctor or going to emergency department in the days after vaccination.

DOSE 2:

  • 199,174 people responded to an SMS/email about their health in the three days after their COVID-19 vaccinations.

  • 73.6% reported no adverse event

  • 26.4% (52,489 people) reported any adverse event

  • 5.3% reported missing work, study or routine duties for a short period (<1 day missed by the majority).

  • 0.5% reported seeing a doctor or going to emergency department in the days after vaccination.

 

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?

 
 

THE CHOICE IS YOURS


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