Weird how that image was cropped.... wonder what was cropped out (and why)? OH! The details show how rare these events are and that nothing currently indicates VAED/VAERD is anything but a theoretical risk.
Quote:
No post-authorized AE reports have been identified as cases of VAED/VAERD, therefore, there is no
observed data at this time. An expected rate of VAED is difficult to establish so a meaningful
observed/expected analysis cannot be conducted at this point based on available data. The feasibility of
conducting such an analysis will be re-evaluated on an ongoing basis as data on the virus grows and the
vaccine safety data continues to accrue.
The search criteria utilised to identify potential cases of VAED for this report includes PTs indicating a
lack of effect of the vaccine and PTs potentially indicative of severe or atypical COVID-19a
.
Since the first temporary authorization for emergency supply under Regulation 174 in the UK (01
December 2020) and through 28 February 2021, 138 cases [0.33% of the total PM dataset], reporting 317
potentially relevant events were retrieved:
Country of incidence: UK (71), US (25), Germany (14), France, Italy, Mexico, Spain, (4 each), Denmark
(3); the remaining 9 cases originated from 9 different countries;
Cases Seriousness: 138;
Seriousness criteria for the total 138 cases: Medically significant (71, of which 8 also serious for
disability), Hospitalization required (non-fatal/non-life threatening) (16, of which 1 also serious for
disability), Life threatening (13, of which 7 were also serious for hospitalization), Death (38).
Gender: Females (73), Males (57), Unknown (8);
Age (n=132) ranged from 21 to 100 years (mean = 57.2 years, median = 59.5);
Case outcome: fatal (38), resolved/resolving (26), not resolved (65), resolved with sequelae (1), unknown
(8);
Of the 317 relevant events, the most frequently reported PTs (≥2%) were: Drug ineffective (135),
Dyspnoea (53), Diarrhoea (30), COVID-19 pneumonia (23), Vomiting (20), Respiratory failure (8), and
Seizure (7).
Conclusion: VAED may present as severe or unusual clinical manifestations of COVID-19. Overall, there
were 37 subjects with suspected COVID-19 and 101 subjects with confirmed COVID-19 following one
or both doses of the vaccine; 75 of the 101 cases were severe, resulting in hospitalisation, disability,
life-threatening consequences or death. None of the 75 cases could be definitively considered as
VAED/VAERD.
In this review of subjects with COVID-19 following vaccination, based on the current evidence,
VAED/VAERD remains a theoretical risk for the vaccine. Surveillance will continue.
The highest death-rate in the past month among the fully vaccinated was recorded as 14.05 per 100,000 individuals in the week beginning 8th Jan 22.
But at the same time the rate per 100,000 unvaccinated individuals was recorded as being 10.4. Meaning during this week the fully vaccinated were statistically 1.4 times more likely to die of Covid-19 than the unvaccinated.
Lie? Or just an inconvenient truth?