The official European Union database of suspected drug reaction website is now reporting 30,551 fatalities and 1,163,356 adverse drug reac...
The official European Union database of suspected drug reaction website is now reporting 30,551 fatalities and 1,163,356 adverse drug reactions from COVID vaccines Pfizer, Moderna, Johnson & Johnson, and AztraZeneca through November 13, 2021 based on the data submitted to its system.
According to European Medicines Agency, an official website of the European Union, the data of adverse reaction from COVID-19 vaccines were posted in ADRreports.eu portal that “allows users to view the total number of individual suspected side effect reports (also known as Individual Case Safety Reports, or ICSRs).”
All the data shown in the website and individual case report forms were taken from EudraVigilance, “a system designed for collecting reports of suspected side effects, used for evaluating the benefits and risks of medicines during their development and monitoring their safety following their authorization in the European Economic Area (EEA).”
The information were submitted electronically to EudraVigilance by “national medicines regulatory authorities and by pharmaceutical companies that hold marketing authorisations (licences) for the medicines.”
From ADRreports website:
- Pharmaceutical companies that hold the marketing authorisation of a medicine, as well as medicines regulatory authorities in the EEA, are legally required to submit reports of suspected side effects to EudraVigilance. This includes reports received from healthcare professionals and patients. This excludes non-serious side effects occurring outside the EEA.
- The web report does not include reports from studies (e.g. clinical trial, non-interventional study) or other types of reports (i.e. only spontaneous reports).
- A side effect is classified as ‘serious’ if it (i) results in death, (ii) is life-threatening, (iii) requires hospitalisation or prolongation of existing hospitalisation, (iv) results in persistent or significant disability/incapacity (as per reporter’s opinion), (v) is a congenital anomaly/birth defect, or (vi) results in some other medically important conditions.
A report from Health Impact News mentioned that the database maintained at EudraVigilance is only for countries in Europe who are part of the European Union (EU), which comprises 27 countries. That means, adverse reaction from the COVID vaccines would be much higher if we include all countries in Europe.
Here is the summary of data through November 13, 2021.
Total reactions for the mRNA vaccine Tozinameran (code BNT162b2, Comirnaty) from BioNTech/ Pfizer: 14,303 fatalities and 562,213 cases of adverse reaction to 11/13/2021 as identified in EudraVigilance:
No comments