EUDRA Adverse Reaction Stats Through November 13th, 2021

European Medicines Agency Data Shows 1,163,356 Adverse Drug Reactions and 30,551 Fatalities by COVID-19 Vaccinations



HAF
November 20, 2021





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:



Fatalities:

• 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:



Fatalities:

• Blood and lymphatic system disorders incl. 94 fatalities and 2,977 not recovered
  
• Cardiac disorders incl. 895 fatalities and 3,504 not recovered
  
• Congenital, familial and genetic disorders incl. 6 fatalities  and 52 not recovered
  
• Ear and labyrinth disorders incl. 2 fatalities and 2,401 not recovered
  
• Endocrine disorders incl. 3 fatalities and 160 not recovered
  
• Eye disorders incl. 29 fatalities and 2,197 not recovered
  
• Gastrointestinal disorders incl. 324 fatalities and 7,467 not recovered
  
• General disorders and administration site conditions incl. 2,944 fatalities and 31,159 not recovered
  
• Hepatobiliary disorders incl. 40 fatalities and 192 not recovered
  
• Immune system disorders incl. 15 fatalities and 650 not recovered
  
• Infections and infestations incl. 769 fatalities and 3,864 not recovered
  
• Injury, poisoning and procedural complications incl. 156 fatalities and 1,201 not recovered
  
• Investigations incl. 136 fatalities and 1,883 not recovered
  
• Metabolism and nutrition disorders incl. 204 fatalities and 1,048 not recovered
  
• Musculoskeletal and connective tissue disorders incl. 170 fatalities and 14,145 not recovered
  
• Neoplasms benign, malignant and unspecified (incl cysts and polyps) incl. 65 fatalities and 193 not recovered
  
• Nervous system disorders incl. 810 fatalities and 18,937 not recovered
  
• Pregnancy, puerperium and perinatal conditions incl. 7 fatalities and 121 not recovered
  
• Product issues incl. 2 fatalities and 5 not recovered
  
• Psychiatric disorders incl. 140 fatalities and 2,118 not recovered
  
• Renal and urinary disorders incl. 164 fatalities and 587 not recovered
  
• Reproductive system and breast disorders incl. 7 fatalities and 3,554 not recovered
  
• Respiratory, thoracic and mediastinal disorders incl. 900 fatalities and 5,291 not recovered
  
• Skin and subcutaneous tissue disorders incl. 76 fatalities and 6,658 not recovered
  
• Social circumstances incl. 35 fatalities and 802 not recovered
  
• Surgical and medical procedures incl. 77 fatalities and 268 not recovered
  
• Vascular disorders incl. 315 fatalities and 2,788 not recovered
  

Total reactions for the COVID-19 vaccine JANSSEN (AD26.COV2.S) from Johnson & Johnson: 1,793 fatalities and 37,038 adverse reaction to 11/13/2021:



Fatalities:

• Blood and lymphatic system disorders incl. 39 fatalities and 388 not recovered
  
• Cardiac disorders incl. 154 fatalities and 517 not recovered
  
• Congenital, familial and genetic disorders incl. 0 fatalities  and 18 not recovered
  
• Ear and labyrinth disorders incl. 2 fatalities and 528 not recovered
  
• Endocrine disorders incl. 1 fatalities and 36 not recovered
  
• Eye disorders incl. 7 fatalities and 598 not recovered
  
• Gastrointestinal disorders incl. 74 fatalities and 2,100 not recovered
  
• General disorders and administration site conditions incl. 479 fatalities and 8,852 not recovered
  
• Hepatobiliary disorders incl. 11 fatalities and 39 not recovered
  
• Immune system disorders incl. 9 fatalities and 106 not recovered
  
• Infections and infestations incl. 140 fatalities and 669 not recovered
  
• Injury, poisoning and procedural complications incl. 18 fatalities and 262 not recovered
  
• Investigations incl. 101 fatalities and 1,778 not recovered
  
• Metabolism and nutrition disorders incl. 45 fatalities and 192 not recovered
  
• Musculoskeletal and connective tissue disorders incl. 42 fatalities and 5,125 not recovered
  
• Neoplasms benign, malignant and unspecified (incl cysts and polyps) incl. 3 fatalities and 25 not recovered
  
• Nervous system disorders incl. 195 fatalities and 6,390 not recovered
  
• Pregnancy, puerperium and perinatal conditions incl. 1 fatalities and 8 not recovered
  
• Product issues incl. 0 fatalities and 1 not recovered
  
• Psychiatric disorders incl. 16 fatalities and 445 not recovered
  
• Renal and urinary disorders incl. 21 fatalities and 140 not recovered
  
• Reproductive system and breast disorders incl. 6 fatalities and 1,059 not recovered
  
• Respiratory, thoracic and mediastinal disorders incl. 227 fatalities and 1,385 not recovered
  
• Skin and subcutaneous tissue disorders incl. 7 fatalities and 1,131 not recovered
  
• Social circumstances incl. 4 fatalities and 157 not recovered
  
• Surgical and medical procedures incl. 53 fatalities and 328 not recovered
  
• Vascular disorders incl. 138 fatalities and 1,222 not recovered
  

Total reactions for the vaccine AZD1222/VAXZEVRIA (CHADOX1 NCOV-19) from Oxford/ AstraZeneca: 6,070 fatalities and 408,312 cases to 11/13/2021:



Fatalities:

• Blood and lymphatic system disorders incl. 246 fatalities and 4,787 not recovered
  
• Cardiac disorders incl. 685 fatalities and 4,253 not recovered
  
• Congenital, familial and genetic disorders incl. 7 fatalities  and 67 not recovered
  
• Ear and labyrinth disorders incl. 3 fatalities and 5,412 not recovered
  
• Endocrine disorders incl. 4 fatalities and 250 not recovered
  
• Eye disorders incl. 29 fatalities and 6,475 not recovered
  
• Gastrointestinal disorders incl. 312 fatalities and 21,929 not recovered
  
• General disorders and administration site conditions incl. 1,450 fatalities and 70,400 not recovered
  
• Hepatobiliary disorders incl. 59 fatalities and 276 not recovered
  
• Immune system disorders incl. 28 fatalities and 863 not recovered
  
• Infections and infestations incl. 407 fatalities and 7,177 not recovered
  
• Injury, poisoning and procedural complications incl. 175 fatalities and 2,665 not recovered
  
• Investigations incl. 147 fatalities and 4,983 not recovered
  
• Metabolism and nutrition disorders incl. 89 fatalities and 3,365 not recovered
  
• Musculoskeletal and connective tissue disorders incl. 92 fatalities and 46,384 not recovered
  
• Neoplasms benign, malignant and unspecified (incl cysts and polyps) incl. 22 fatalities and 184 not recovered
  
• Nervous system disorders incl. 948 fatalities and 58,962 not recovered
  
• Pregnancy, puerperium and perinatal conditions incl. 12 fatalities and 71 not recovered
  
• Product issues incl. 1 fatalities and 68 not recovered
  
• Psychiatric disorders incl. 58 fatalities and 5,353 not recovered
  
• Renal and urinary disorders incl. 58 fatalities and 1,109 not recovered
  
• Reproductive system and breast disorders incl. 2 fatalities and 7,424 not recovered
  
• Respiratory, thoracic and mediastinal disorders incl. 722 fatalities and 11,185 not recovered
  
• Skin and subcutaneous tissue disorders incl. 48 fatalities and 14,633 not recovered
  
• Social circumstances incl. 6 fatalities and 470 not recovered
  
• Surgical and medical procedures incl. 25 fatalities and 300 not recovered
  
• Vascular disorders incl. 435 fatalities and 7,180 not recovered
  

Summary of cases and fatalities of each vaccines:




As reported from Health Impact News, “the fatalities are grouped by symptoms, and some fatalities may have resulted from multiple symptoms.”
Source: TheGatewayPundit.com / References: EMA.Europa.eu [pdf]; ADRreports.eu


https://humansarefree.com/2021/11/european-medicines-agency-data-fatalities-by-covid-19-vaccinations.html
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