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EXCLUSIVE: European Medicines Agency Data Shows 1,163,356 Adverse Drug Reactions and 30,551 Fataliti




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).”

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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.”


  • 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:


Fatalities:

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  • Blood and lymphatic system disorders include 200 fatalities and 12,412 not recovered

  • Cardiac disorders include 2,095 fatalities and 10,336 not recovered

  • Congenital, familial and genetic disorders include 32 fatalities and 125 not recovered

  • Ear and labyrinth disorders include 10 fatalities and 7,561 not recovered

  • Endocrine disorders include 5 fatalities and 512 not recovered

  • Eye disorders include 31 fatalities and 6,636 not recovered

  • Gastrointestinal disorders include 573 fatalities and 25,520 not recovered

  • General disorders and administration site conditions include 4,057 fatalities and 82,029 not recovered

  • Hepatobiliary disorders include 73 fatalities and 334 not recovered

  • Immune system disorders include 74 fatalities and 1,911 not recovered

  • Infections and infestations include 1,545 fatalities and 11,502 not recovered

  • Injury, poisoning and procedural complications include 235 fatalities and 1,915 not recovered

  • Investigations include 440 fatalities and 7,080 not recovered

  • Metabolism and nutrition disorders include 247 fatalities and 2,249 not recovered

  • Musculoskeletal and connective tissue disorders include 177 fatalities and 45,626 not recovered

  • Neoplasms benign, malignant and unspecified (incl cysts and polyps) include 111 fatalities and 369 not recovered

  • Nervous system disorders include 1,532 fatalities and 60,907 not recovered

  • Pregnancy, puerperium and perinatal conditions include 55 fatalities and 253 not recovered

  • Product issues include 2 fatalities and 26 not recovered

  • Psychiatric disorders include 172 fatalities and 6,633 not recovered

  • Renal and urinary disorders include 223 fatalities and 1,213 not recovered

  • Reproductive system and breast disorders include 5 fatalities and 19,918 not recovered

  • Respiratory, thoracic and mediastinal disorders include 1,599 fatalities and 15,449 not recovered

  • Skin and subcutaneous tissue disorders include 123 fatalities and 17,883 not recovered

  • Social circumstances include 19 fatalities and 888 not recovered

  • Surgical and medical procedures include 55 fatalities and 237 not recovered

  • Vascular disorders include 613 fatalities and 8,618 not recovered

Total reactions for the mRNA vaccine mRNA-1273(CX-024414) from Moderna: 8,385 fatalities and 155,793 adverse reaction to 11/13/2021:

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