2nd November 2022 This week CMN Analysts have focused on Adverse Events (AE) reported via the DAEN (Database of Adverse Events Notification) compared to AusVaxSafety Surveys done for kids aged 5 to 11 from 10/1/22 to 17/10/22.
The purpose of this comparison is to establish if there is an under-Reporting factor associated with the reports received via the DAEN, and if so, estimate the likely numbers of Adverse Events being experienced for children aged 5 to 17 in Australia.
Please review slide 6 of the report (accessed here or attached). Slide No 6 shows that there have been 1,501 cases of Adverse Events reported to the TGA via the DAEN for kids aged 5 to 11 between 10/01/2022 to 17/10/2022.
Let’s compare this data to the completed surveys received via AusVaxSafety for kids aged 5 to 11 over the same period (please review slide No 5), where 56,545 AEs were reported experiencing 1 or more Adverse Events (25% of 133,717 surveys after dose 1 and 28% of 82,555 surveys after dose 2).
This is 38 TIMES HIGHER than the number of Adverse Events being reported via the DAEN (56,545 versus 1,501).
In this report, the under-reporting factor (x38) is being used to estimate the number of Adverse Events occurring for kids aged 5 to 11 and 12 to 17. By using this under-reporting factor, it is possible to arrive at the number of Adverse Events and other outcomes that were reported for kids aged 5 to 11 (slide No 8). Plus, the under-reporting factor can be used to estimate the number of Adverse Events and other outcomes that may have been experienced by kids aged 12 to 17 (slide No 9) by utilising the data from the Survey for kids aged 5 to 11 as a guide (no current survey is available for kids aged 12 to 17). There are a number of factors that need to be considered in this analysis:
- The numbers reported in slide 9 (for kids aged 12 to 17) are estimates only, however consider them to be lower than the actual numbers (discussed further below).
- The AusVaxSafety Survey only reported data from day 3 after vaccination. Data on day 8 and day 42 is also captured in Surveys but NOT REPORTED. See image below
- It is noted and yet difficult to quantify that certain Adverse Events will be reported more frequently via the AusVaxSafety Survey compared to the DAEN. i.e., a person is more likely to report a sore arm (or other minor Adverse Events) after vaccination via an ‘active’ text survey (out of convenience) compared to a ‘passive’ system such as the DAEN and the need to report this Adverse Event via a complicated online process. However, this must be weighed against the number of Adverse Events that were reported (minor and serious) AFTER day 3 of vaccination that have not been included in the day 3 survey data.
Why do Adverse Events numbers such as those found in slide 9 appear under-estimated?
One explanation is many of the Serious Adverse Events are being missed on the day 3 follow up survey for several reasons. E.G. Cardiac Disorders such as Chest Pain, Increased Troponin levels, and Heart Inflammation (Myocarditis and Pericarditis). The TGA state in its Safety Report that most Heart Inflammation cases (such as Myocarditis) occur within the first 3 days of vaccination.
It does concede that some of these events occur after 3 days, but these are in the minority. This does not appear in the data. The TGA cites a Study from May 2021 to back this claim up.
Closer examination of the above quote from the study that the TGA cites, Myocarditis occurs as a median of 3.5 days after vaccination. The minimum number of days to onset was 3 and maximum was 10.8 days. This means that none of these cases happened within 3 days. Therefore, the majority of these Cases would NOT have been reported in the day 3 follow up survey by AusVaxSafety.
The second quote relates to Pericarditis, where the median number of days to onset was 20. The minimum number of days to onset was 6 and the maximum was 41. This means that 100% of cases happened after 3 days. None of these cases would have been included in the 3-day follow-up report. This also supports why the number of visits to the GP / Hospital Emergency Department were estimated at only 677 for kids aged 12 to 17 (see slide No 9), as very few of these events would have been reported in the day 3 follow up survey as they would NOT have occurred yet!
For those appointed to oversee pharmacovigilance, why is the NCIRS (National Centre for Immunisation Research and Surveillance) NOT releasing reports on day 8 and day 42 of the surveys? Full transparency is required and until this is done, it appears there is something to hide.
The TGA has also observed that those at highest risk of suffering Myocarditis after vaccination are males aged 12 to 17 (13 cases per 100,000 after second dose). Rates are also high in males aged 18 to 29 (9.2 cases per 100,000 after second dose).
The report it cites is not up to date given it was from May 2021 and did not include those aged 12 to 17 (the rollout for this cohort had not commenced yet). Therefore, a review of more up to date studies was undertaken to see what the latest data was indicating for kids of this age. The CMN analysts found a Systematic review from April 2022:
‘COVID-19 Vaccine-Induced Myocarditis: A Systemic Review and Literature Search.’ This was a Review of 19,742 papers that eventually was reduced to 29 papers and 276 patients – after strict criteria conditions were used.
The findings from these studies are concerning and revealed the following:
- Number of Patients N=276
- Number of Males = N=262 (94%)
- Number positive for Myocarditis N=260 (89%)
- Number positive for Pericardial Effusion N=27 (7.2%)
- Number of occurrences after dose 2 N=262 (94%)
- Symptom onset after 2 dose vaccination – Median = 3 days (range 0 to 4 days)
- Days to hospitalisation after vaccination – Median 3 days (range 1 to 25 days)
- Number of patients presenting with chest pain/discomfort N=276 (100%)
Considering the findings of these studies and then applying them to the Australian reporting systems, the following has been identified.
- 50% of these patients were aged 17 to 22.
- 50% of the patients who showed symptoms after the second dose (262) did not show symptoms
- Within the first 3 days and would have been excluded in the AusVaxSafety reports.
- 50% of the hospitalisations did NOT seek medical treatment within the first 3 days and would have been excluded in the AusVaxSafety reports.
- 100% of these patients experienced chest pain/discomfort and many of them did not report this within the first 3 days of vaccination, therefore they too would have been excluded in the AusVaxSafety reports.
Final Summary / Conclusions:
It is reasonable to conclude that many Adverse Events are NOT being captured within the DAEN. CMN Analysts have pinpointed that this could represent at the very least a 38 times under-reporting rate. This claim can be supported by the large disparity between Adverse Events being reported on day 3 of the AusVaxSafety Surveys compared to the DAEN reports. However, the under-reporting may be much higher than this for several other reasons:
- Adverse Events via the AusVaxSafety Survey are only shown for events on or before day 3 after vaccination. Day 8 and Day 42 are also surveyed but the data is NOT released to the general public.
- Only 10.42% of kids aged 5 to 11 had a completed survey done and used in the AusVaxSafety Survey report. It is not clear why the other 89.58% have not been surveyed. This is also similar to surveys done across all ages.
- Multiple studies have shown that many serious Cardiac Events such as Chest Pain, Myocarditis, Pericarditis and Elevated Troponin levels are showing up later than 3 days after vaccination. In the study cited in this report, as many as 50% of these cases would not be reported via the AusVaxSafety system had these events occurred in Australia.
- There is anecdotal evidence that much of the strain on GPs and the hospital system is as a result of increased presentation of many people after COVID-19 vaccination due to a number of medical conditions. Many of these are not being reported via DAEN or AusVaxSafety.
- The Government, TGA and ATAGI, MUST halt the rollout of all COVID-19 vaccines until a full and independent investigation has been completed on the safety of these vaccines.