AUSTRALIA TGA WEEKLY SAFETY SURVEILLANCE - 26.08.2021
- MyBody MyRisk
- Aug 27, 2021
- 2 min read
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?



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