Information flow by diversions
Our national “Ad hoc Expert Group” concluded in its report on the assessment of an introduction of compulsory vaccination[1] in the following way:
Redoubler les efforts de sensibilisation et d’information de la population en fournissant des nombres clairs, corrects et compréhensibles pour mieux mettre en évidence l´effectivité de la vaccination contre la COVID-19.
Who could disagree with that? Of course, it would be even better if the side effects of vaccination were also considered in this context.
Whereas it would be hard indeed to miss the daily updates on the number of positive PCR tests and people who have died “of or with COVID-19” churned out by the mainstream media since the beginning of the pandemic, information on vaccination side effects is much harder to come by. While detailed data and statistics presented graphically are readily available for the former, the latter is limited to occasional reports which, due to a rather scientific presentation, are clearly not intended for a wider audience and seem to go largely unnoticed[2].
The vaccination side effects reported so far in Luxembourg can be found in the latest Pharmacovigilance report of 24 January 2022[3].
The situation is no easier if one wants to obtain information on this topic internationally. As a rule, the organisations responsible for this do not publish clear analyses intended for the public, but sometimes huge databases in raw format, which cannot be evaluated without the necessary knowledge.
In the following, we present 2 of these public institutions that collect reports on vaccination side effects, and show those interested how they can analyse this data themselves. For those less familiar with information technology, we also provide sources where this analysis has already been carried out by third parties.
Vigiaccess
Since 2015, the World Health Organization has made its data on reported possible side effects of medical products collected in the Vigibase database available to the public on the Vigiaccess portal: http://www.vigiaccess.org.
After confirming that you have read and understood a number of statements, including the usual disclaimer for the accuracy of the data, you will be given access to the search form.
It is important to note that the search term must be entered exactly. For example, if you search for Covid-19 vaccines, only the text “COVID-19 vaccine” will lead to the desired result; if you omit even just the hyphen, the search will return no hits.
The total number of adverse drug reactions reported to date is shown in the light blue area. Further information can be found in the “accordion”: for example, if you open the tab “ADR reports per year”, you will get a table with the reported cases per year.
The following chart was created in the described manner on 14 February 2022. The search terms used correspond to the drug names in the chart, the years in brackets to the respective observation period.
An image was shared on social media showing a table with data obtained in an analogous way from the Vigiaccess database under the WHO logo.
Obviously, this is not an official WHO publication, but an evaluation by a third party. Even if the data is correct, the formal implementation is unfortunate in our estimation, as the certainly unauthorized use of a logo alone is problematic in this context.
As expected, the “fact-checkers” reacted swiftly, using more or less the same arguments in the two articles mentioned here.
AFP immediately referred to the picture shown[4] and quoted a WHO spokesperson:
[…] The information on this website, therefore, does not reflect any confirmed link between a medicinal product and a side effect.
Correctiv had previously commented on the Vigiaccess data[5], the verdict here was:
Missing context. The WHO database “Vigiaccess” lists suspected cases for which a connection to vaccination does not have to be proven.
Interestingly, one of the arguments is precisely the one that was not allowed to be used in the discussion on “died of or with Covid-19”:
[…] because a man could have been vaccinated, for example, and then be hit by a car and die. Or a woman could die giving birth to her child without her death having anything to do with the Corona vaccination.
Even if these are suspected cases, the disproportionately higher number of reports for COVID-19 vaccines compared to other vaccines is nevertheless alarming and cannot be explained by the number of vaccinations carried out alone[6]. For example, the polio vaccine has been administered about 3 billion times since 1968, but only about 123,000 adverse events have been reported.
EudraVigilance
EudraVigilance is the “European database of reported suspected adverse drug reactions”: https://www.adrreports.eu/
Using this database is much more difficult than using Vigiaccess. After selecting the language and the field of human or veterinary medicine, you will be taken to the page where you must first accept the disclaimer:https://www.adrreports.eu/de/disclaimer.html.
The Covid-19 vaccine can then be accessed by clicking on the letter “C”, and on the page that then appears, selecting one of the 4 current vaccines in the list:
- COVID-19 MRNA VACCINE MODERNA (CX-024414)
- COVID-19 MRNA VACCINE PFIZER-BIONTECH (TOZINAMERAN)
- COVID-19 VACCINE ASTRAZENECA (CHADOX1 NCOV-19)
- COVID-19 VACCINE JANSSEN (AD26.COV2.S)
For Pfizer’s vaccine (tozinameran), this is how you get these data/graphs, among others (retrieved 12.02.2022):
EudraVigilance is overall “economical” with the presentation of information. If one wants further details beyond this data, such as the total number of reported suspected cases with fatal outcomes, one has no choice but to export the raw data and evaluate it in a spreadsheet programme (MS Excel, LibreOffice Calc), for example.
To do this, one has to click on the tab “Line listing” and gets a form to filter the returned data sets. The screenshot shows the selection “Serious” for the field “Seriousness”, for “Age Group” all options were selected.
Clicking on the link “Run Line Listing Report” displays the table with the records that meet the criteria.
Below the table you will find the link “Export” with which the data can be exported. Several export formats are available, including PDF, Excel and CSV (comma separated values).
The export file is generated and is automatically downloaded by the browser. In our example, the file contains around 48,000 records.
After importing the file into a spreadsheet programme, one can find the fatal cases in the column “Reaction List PT (Duration—Outcome—Seriousness Criteria)” by filtering with the options starting with “Death”.
In this way, we have obtained the reported adverse events only for the Pfizer vaccine and only for the year 2022. If we would like to run this analysis at regular intervals for all COVID-19 vaccines and the entire period of the vaccination campaign, we would therefore have to evaluate 12 (= 4 vaccines times 3 years) CSV files each time. It seems clear that other solutions must be found for this effort: the process must then be automated, for example with the programming language R, for which there are corresponding packages[7].
Fortunately, there are initiatives that do this work and make the results available to the public. For EudraVigilance, for example, there is the website https://impfnebenwirkungen.net/.
The information is offered in 3 versions:
- as an overview page (“one pager”) under https://www.impfnebenwirkungen.net/onepager.pdf
- as a detailed report (approx. 180 pages) at https://www.impfnebenwirkungen.net/report.pdf
- as online tables: https://impfnebenwirkungen.net/ema/tabellen/
The so-called “one pager” already gives a good overview: interesting here is the comparison with the flu vaccination.
The website https://impfnebenwirkungen.net/vaers/tabellen/ also provides its evaluations of the American reporting authority VAERS[8]. However, it would go beyond the scope of this article to go into this database as well.
Luxembourg
At this point, we would like to ask all affected persons who have been harmed by a COVID-19 vaccination to report this to the Patiente Vertiedung Asbl[9]. A form is available online for this purpose:
This will help us to conduct the debate on the basis of transparent data. It has been brought to our attention that in some cases potentially vaccine-injured people have unfortunately been advised not to report because, for example, the side effect in question would already be known to the Ministry of Health.
Finally, it must be noted that the number of unreported cases of adverse drug reactions has always been very high in general. According to a meta-study[10], only 5% of all cases are usually recorded.
Sources
[1] Avis du Groupe Ad hoc d’experts sur l’instauration d’une obligation de vaccination contre la Covid-19
https://download.rtl.lu/2022/01/14/36b57e00ccdd0d18c21d9e3ad1a2d225.pdf
[2] infoVAXX – Publications – Pharmacovigilance
https://covid19.public.lu/fr/vaccination/infovaxx.html
[3] Rapport Pharmacovigilance: Suivi des effets indésirables des vaccins – Données au 24.01.2022
https://covid19.public.lu/dam-assets/covid-19/vaccinations/pharmacovigilance/Rapport-10-Suivi-des-effets-indesirables-des-vaccins-11022022-.pdf
[4] AFP (30.11.2021): Social media posts misrepresent WHO data on vaccine side effects
https://factcheck.afp.com/http%253A%252F%252Fdoc.afp.com%252F9TA2ET-1
[5] Correctiv (15.06.2021): Impfdatenbank „Vigiaccess“: Daten zeigen keine Nebenwirkungen, sondern gemeldete Verdachtsfälle
https://correctiv.org/faktencheck/2021/06/15/impfdatenbank-vigiaccess-daten-zeigen-keine-nebenwirkungen-sondern-gemeldete-verdachtsfaelle/
[6] Transparenztest: WHO VigiAccess Datenbank: 2.727.041 Reports mit 6.552.626 einzelnen Impf Nebenwirkungen gemeldet
https://www.transparenztest.de/post/who-vigiaccess-datenbank-2727041-reports-mit-6552626-einzelnen-impf-nebenwirkungen-gemeldet
[7] Rdocumentation: read.csv.sql: Read File Filtered by SQL
https://www.rdocumentation.org/packages/sqldf/versions/0.4-11/topics/read.csv.sql
[8] Vaccine Adverse Event Reporting System (VAERS)
https://vaers.hhs.gov/
[9] Patiente Vertiedung Asbl
https://www.patientevertriedung.lu
[10] Lorna Hazell, Saad A W Shakir: Under-reporting of adverse drug reactions : a systematic review
https://pubmed.ncbi.nlm.nih.gov/16689555/
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