Greece’s National Organization for Medicines EOF released its report on side effects and deaths caused by vaccines against COvid-19.
63 deaths and 1,633 side effects have been officially recorded by EOF in the two years of vaccinations.
Among a total of 22,120,416 doses of vaccines for the coronavirus that have been administered to date in Greece, EOF recorded and made public for the first time on Monday afternoon the following data regarding deaths and adverse reactions.
Note: a publicized information about reports of suspected (alleged)
adverse effects constitute medical events that are reported spontaneously either
by a citizen or a health professional after the vaccine has been administered and
not necessarily related to or caused by the vaccine.
o The medical events reported may have been caused by another disease
or be associated with co-administration of other drugs at the time
vaccination.
During the evaluation by the competent scientific bodies of the mentioned
of suspected adverse effects are taken into account and many are taken into account
factors, such as the medical history of the vaccinee, the frequency of the presumed
adverse event in the vaccinated population as a function of/compared to
incidence of the same medical events in the general population.
Each report of a suspected adverse event concerns each vaccinee
Separately. However, each reference can include more than one
suspected side effects. Therefore, the number of recorded
of suspected side effects does not equate to the number of reports.
The assessment of the association of reported suspected adverse ene
Side effects
The reports of possible adverse reactions (side-effects) submitted to the EOF in 2022 via a Yellow Card, (2021-2022) either directly by vaccinated patients or by health professionals, are:
1,344 serious side effects after vaccination against Covid-19
289 of which were related to simple incidents.
60.2% of the reports were made by women and 37.48% by men, while the ages that showed the highest percentage of side effects are between 30 and 49 years old, who declared at a rate of 39.93% that they had adverse effects from the vaccine.
Side-effects by Pfizer Vaccine
The publicized information about reports of suspected (alleged)
adverse effects constitute medical events that are reported spontaneously either
by a citizen or a health professional after the vaccine has been administered and
not necessarily related to or caused by the vaccine.
o The medical events reported may have been caused by another disease
or be associated with co-administration of other drugs at the time vaccination.
During the evaluation by the competent scientific bodies of the mentioned
of suspected adverse effects are taken into account and many are taken into account factors, such as the medical history of the vaccinated person the frequency of the presumed adverse event in the vaccinated population as a function of/compared to incidence of the same medical events in the general population.
Each report of a suspected adverse event concerns each vaccinee separately. However, each reference can include more than one suspected side effects. Therefore, the number of recorded of suspected side effects does not equate to the number of reports.
The assessment of the association of reported suspected adverse effects are done according to international standards.
Deaths
A total of 63 deaths
Of them:
49 related to Pfizer vaccine ( with which the vast majority of Greeks were vaccinated)
6 related Moderna’s vaccine,
3 related to AstraZeneca vaccine (given only in 2021)
5 related to Johnson & Johnson vaccine
According to the EOF, these incidents were either initially reported as deaths, or the outcome information was received by the EOF as part of a search for additional data (follow-up) for the evaluation of the report.
Of these incidents, 38 took place in 2021, 21 took place in 2022 and for 4 the relevant information is not available.
Time interval between vaccination and reported fatal event
Time period Number Percentage
0 to 7 days 16 25.4%
8 to 14 days 3 4.76%
15 to 30 days 4 6.35%
Beyond 30 days 32 50.79%
Unknown 8 12.7%
Total 63 100%
2 of these reports were evaluated as having a possibility of association with
vaccination (possible), 1 with Comirnaty and 1 with Vaxzevria
12 of these reports were evaluated as not likely to be related to
vaccination (unlikely)
14 of these reports could not be evaluated from the available data
unassailable
35 reports have not been evaluated, because they are expected additionally
data requested (e.g. autopsy results and other information)
Vaccine doses
Doses of vaccines against Covid-19 that have been administered in 2022 in Greece:
COMIRNATY (Pfizer) : 4,050,772
SPIKEVAX (Moderna): 278,123
VAXZEVRIA (Astra Zeneca): 0
JCOVDEN (Johnson & Johnson): 118,128
NUVAXOVID (Novavax): 9,094
All of the above vaccines, which were administered or are still administered in Greece, have received a regular marketing authorization from the European Medicines Agency (EMA), except for Nuvaxovid, which has received a conditional marketing authorization, in accordance with the provisions of the EU Regulations. 726/2004 and 507/2006.
In addition, all the above vaccines are subject to additional monitoring, as is the case with all medicines.
Classification of adverse reactions
An adverse reaction is a response to a drug administered according to its marketing authorization that is harmful and unintended.
A serious (in the judgment of the petitioner) adverse event is one that results in death, is immediately life-threatening, requires hospitalization or prolonged hospitalization, results in permanent or significant disability or incapacity, or causes a congenital abnormality or birth defect, or is major medical event.
Unexpected side effect is the side effect whose nature, severity or effect is not according to the Summary of Product Characteristics.
Full report of EOF here in Greek