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NINE PAGES REFERENCE
There is much talk about 9 pages of side effects. This comes from Pfizer/FDA document titled ‘BNT 162b2 – 5.3.6 – Cumulative Analysis of Adverse Events Reports. The 9-pages are Appendi1. LIST OF ADVERSE EVENTS OF SPECIAL INTEREST. It is a lot of medical terminology which is not relevant for non-medical people. You may follow the link to see these adverse events.
In all, it is a 38-page document (including 9 pages). I shall give some of these here as extracted from Table 7 of this document. This portion is titled ‘3.1.3. Review of Adverse Events of Special Interest (AESIs). Table 7 provides a summary review of cumulative cases within AESI categories from the Pfizer database.
Cardiovascular AESIs – Number of cases 1403 (3.3% of Total Post-marketing Database) – 241 medically confirmed and 1162 non-medically confirmed – Fatal 136 – Serious 946
Tachycardia 1,098; Arrhythmias 102; Myocardial Infarction 89; Cardiac failure 80; Acute myocardial infarction 41; Cardiac failure acute 11; Cardiogenic shock and Postural orthostatic tachycardia syndrome 7; Coronary artery disease 7
Hematological AESIs – Total cases 932 – 524 medically confirmed – 408 non-medically confirmed – Fatal 34 – Serious 681
Epistaxis (nosebleed) 127; Contusion (bruising) 112; Vaccination site bruising 96; Vaccination site hemorrhage 51; Petechiae (minute round patches) 50; Hemorrhage 42; Hematochezia (bloody stools) 34; Thrombocytopenia (reduced platelets) 33; Vaccination site hematoma 32; Conjunctival hemorrhage 29; Vaginal hemorrhage 29; Hematoma (blood accumulation under the skin 27; Hemoptysis (bloody coughing) 27; Menorrhagia (excessive menstruation) 27; Hematemesis (bloody vomiting) 25; Eye hemorrhage 23; Rectal hemorrhage 22; Immune thrombocytopenia 20; Blood urine present 19; Hematuria (bloody urination) 16; Neutropenia (reduced white cells) 16; Purpura (bleeding) 16; Diarrhea hemorrhage 15
Immune-mediated / Autoimmune AESIs – Total cases 1050 – 760 medically confirmed – 290 non-medically confirmed – Fatal 12 – Serious 780
Hypersensitivity 596; Neuropathy peripheral 49; Pericarditis (heart membrane inflammation 32; Myocarditis (hear muscle inflammation) 25; Dermatitis 24; Diabetes mellitus 16; Encephalitis (brain inflammation) 16; Psoriasis 14; Others 11 each
Musculoskeletal AESIs – Total cases 3600 – Medically confirmed 2045 – non-medically confirmed 1555 – Serious 1600
Arthralgia (joint pains) 3525; Arthritis (joints inflammation) 70
Others – less frequent
Neurological AESIs – Total cases 501 – Medically confirmed 365 – non-medically confirmed 136 – Fatal 16 – Serious 515
Seizure 204; Epilepsy 83; General tonic-clonic seizure 33; Guillain-Barre syndrome 24; Fibromyalgia 17; Trigeminal Neuralgia 17; Febrile convulsions 15; Status epilepticus 12; Myelitis transverse & Aura 11 each; Multiple sclerosis relapse & Optic neuritis 10 each; Petit mal epilepsy & Tonic convulsions 9 each; Ataxia 8; Encephalopathy & Tonic clonic movement 7 each; Foaming at mouth 5; Multiple sclerosis, Narcolepsy & Partial seizures 4 each; Bad sensation, Demyelination, Meningitis 3 each.
Other AESIs – Total cases 8152 – Medically confirmed 4977 – non-medically confirmed 3175 – Serious 3674
Fever 7666; Herpes zoster 259; Inflammation 132; Oral herpes 80; Multiple organ dysfunction syndrome 18; Herpes virus infection 17; Herpes simplex 13; Ophthalmic herpes zoster 10; Herpes ophthalmic and Herpes zoster reactivation 6 each.
Renal (kidney related) AESIs – Total cases 69 – medically confirmed 57 – non-medically confirmed – Fatal 23 – All Serious
Hepatic (liver related) AESIs – Total cases 70 – Fatal 5 – Serious 53
Respiratory AESIs – Total cases 130 – medically confirmed 107 – Fatal 41 – Serious 126
Includes: Respiratory failure 44 – Hypoxia 42 – Respiratory disorder 36 – Acute respiratory distress syndrome 10 – Chronic respiratory syndrome 3 – Severe acute respiratory syndrome 2
Thromboembolic Events – Total cases 151 – Medically confirmed 111 – Fatal 18 – Serious 148
Include: Pulmonary embolism 60 – Thrombosis 39 – Deep vein thrombosis 35 – Thrombophlebitis superficial 6 – Venous thrombosis limb 4 – Embolism, Micro-embolism, Thrombophlebitis, Venous thrombosis 3 each.
Stroke – Total cases 275 – Medically confirmed 180 – Fatal 61 – All Serious
Facial Paralysis – Total cases 449 – Medically confirmed 314 – Serious 399
This is not the complete list, but these are the major reported ones. In the next part, which will be last of this series, we shall discuss the significance and implications of Adverse Events of Special Interest.
To be Concluded……
Disclaimer: Most pictures in these blogs are taken from Google Images and Pexels. Credit is given where known; some do not show copyright ownership. However, if a claim is lodged at any stage, we shall either mention the ownership clearly, or remove the picture with suitable regrets.
https://phmpt.org/wp-content/uploads/2021/11/5.3.6-postmarketing-experience.pdf https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccines
