Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
General disorders
Administration site reactions NEC
Administration site bruise 1 0
Administration site erythema 1 0
Administration site pain 3 0
Administration site warmth 1 0
Puncture site bruise 3 0
Puncture site pain 3 0
Puncture site swelling 1 0
Vessel puncture site bruise 1 0
Adverse effect absent
No adverse event 1 0
Application and instillation site reactions
Application site bruise 1 0
Application site erythema 1 0
Application site pain 1 0
Instillation site warmth 1 0
Asthenic conditions
Asthenia 223 0
Chronic fatigue syndrome 1 0
Fatigue 3230 0
Malaise 779 0
Sluggishness 2 0
Body temperature altered
Hypothermia 8 0
Temperature regulation disorder 3 0
Complications associated with device NEC
Medical device pain 1 0
Medical device site swelling 1 0
Death and sudden death
Clinical death 1 1
Death 59 53
Sudden death 7 7
Febrile disorders
Hyperpyrexia 2 0
Pyrexia 3173 0
Feelings and sensations NEC
Chills 1994 0
Feeling abnormal 144 0
Feeling cold 191 0
Feeling drunk 10 0
Feeling hot 233 0
Feeling jittery 5 0
Feeling of body temperature change 66 0
Hangover 5 0
Hunger 3 0
Sensation of foreign body 10 0
Temperature intolerance 1 0
Thirst 37 0
Gait disturbances
Gait disturbance 15 0
Gait inability 10 0
Loss of control of legs 1 0
Report Run Date: 31-Jan-2021, Page 13
Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
General disorders General disorders cont'd
General signs and symptoms NEC
Condition aggravated 14 0
Crying 4 0
Disease recurrence 1 0
Exercise tolerance decreased 2 0
General physical health deterioration 1 0
Glassy eyes 2 0
Illness 203 0
Induration 2 0
Influenza like illness 412 0
Local reaction 25 0
Peripheral swelling 380 0
Pre-existing condition improved 1 0
Screaming 1 0
Secretion discharge 2 0
Swelling 328 0
Swelling face 102 0
Inflammations
Inflammation 35 0
Systemic inflammatory response syndrome 1 0
Infusion site reactions
Infusion site erythema 1 0
Infusion site joint pain 2 0
Infusion site pain 1 0
Injection site reactions
Injected limb mobility decreased 7 0
Injection site bruising 10 0
Injection site discolouration 1 0
Injection site discomfort 2 0
Injection site erythema 96 0
Injection site haemorrhage 2 0
Injection site hypoaesthesia 4 0
Injection site induration 1 0
Injection site inflammation 6 0
Injection site joint pain 3 0
Injection site mass 63 0
Injection site oedema 4 0
Injection site pain 699 0
Injection site paraesthesia 2 0
Injection site pruritus 39 0
Injection site rash 13 0
Injection site reaction 5 0
Injection site scab 1 0
Injection site scar 2 0
Injection site swelling 85 0
Injection site urticaria 4 0
Injection site vesicles 2 0
Injection site warmth 29 0
Interactions
Alcohol interaction 2 0
Drug interaction 2 0
Mass conditions NEC
Report Run Date: 31-Jan-2021, Page 14
Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
General disorders General disorders cont'd
Cyst 1 0
Mass 3 0
Nodule 3 0
Oedema NEC
Face oedema 4 0
Localised oedema 6 0
Oedema 5 0
Oedema peripheral 9 0
Pain and discomfort NEC
Axillary pain 145 0
Chest discomfort 190 0
Chest pain 242 0
Discomfort 20 0
Facial discomfort 3 0
Facial pain 28 0
Non-cardiac chest pain 2 0
Pain 1176 0
Tenderness 93 0
Therapeutic and nontherapeutic responses
Adverse drug reaction 599 0
Adverse event 5 0
Adverse reaction 4 0
Drug ineffective 58 0
Immediate post-injection reaction 1 0
No reaction on previous exposure to drug 4 0
Therapeutic product effect delayed 1 0
Therapeutic response unexpected 4 0
Treatment failure 1 0
Vaccination site reactions
Extensive swelling of vaccinated limb 1 0
Shoulder injury related to vaccine administration 1 0
Vaccination site bruising 26 0
Vaccination site discolouration 4 0
Vaccination site discomfort 11 0
Vaccination site eczema 1 0
Vaccination site erythema 151 0
Vaccination site haemorrhage 4 0
Vaccination site hypoaesthesia 1 0
Vaccination site induration 23 0
Vaccination site inflammation 24 0
Vaccination site irritation 3 0
Vaccination site joint discomfort 2 0
Vaccination site joint erythema 3 0
Vaccination site joint movement impairment 8 0
Vaccination site joint pain 18 0
Vaccination site joint swelling 2 0
Vaccination site joint warmth 1 0
Vaccination site lymphadenopathy 1 0
Vaccination site mass 37 0
Vaccination site movement impairment 10 0
Vaccination site oedema 3 0
Vaccination site pain 624 0
Report Run Date: 31-Jan-2021, Page 15
Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
General disorders General disorders cont'd
Vaccination site paraesthesia 4 0
Vaccination site pruritus 43 0
Vaccination site rash 21 0
Vaccination site reaction 9 0
Vaccination site swelling 171 0
Vaccination site ulcer 1 0
Vaccination site urticaria 4 0
Vaccination site vesicles 1 0
Vaccination site warmth 91 0
General disorders SOC TOTAL 16749 61
Report Run Date: 31-Jan-2021, Page 16
Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Hepatic disorders
Cholestasis and jaundice
Jaundice 1 0
Hepatic vascular disorders
Hepatic artery embolism 1 0
Hepatobiliary signs and symptoms
Hepatic pain 4 0
Hepatocellular damage and hepatitis NEC
Hepatitis 1 0
Liver injury 1 0
Hepatic disorders SOC TOTAL 8 0
Report Run Date: 31-Jan-2021, Page 17
Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Immune system disorders
Allergic conditions NEC
Allergic oedema 2 0
Hypersensitivity 121 0
Type IV hypersensitivity reaction 1 0
Allergies to foods, food additives, drugs and other chemicals
Allergy to vaccine 12 0
Drug hypersensitivity 2 0
Reaction to preservatives 3 0
Anaphylactic and anaphylactoid responses
Anaphylactic reaction 91 0
Anaphylactic shock 2 0
Anaphylactoid reaction 6 0
Anaphylactoid shock 2 0
Atopic disorders
Seasonal allergy 1 0
Autoimmune disorders NEC
Autoimmune disorder 1 0
Immune and associated conditions NEC
Bacille Calmette-Guerin scar reactivation 2 0
Immune system disorder 1 0
Immune-mediated adverse reaction 1 0
Immune system disorders SOC TOTAL 248 0
Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Social circumstances
Disability issues
Bedridden 5 0
Breast prosthesis user 1 0
Immobile 2 0
Impaired work ability 1 0
Social circumstances SOC TOTAL 9 0
Report Run Date: 31-Jan-2021, Page 47
Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Surgical & medical procedures
Gastrointestinal therapeutic procedures NEC
Prophylaxis of nausea and vomiting 4 0
Immunisations
COVID-19 immunisation 3 0
Immunisation 1 0
Limb therapeutic procedures
Limb immobilisation 1 0
Respiratory tract therapeutic procedures NEC
Asthma prophylaxis 1 0
Skin and subcutaneous tissue therapeutic procedures NEC
Dermal filler injection 1 0
Therapeutic procedures NEC
Bed rest 1 0
Fatigue management 1 0
Hospitalisation 1 0
Injection 1 0
Surgical & medical procedures SOC TOTAL 15 0
Report Run Date: 31-Jan-2021, Page 48
Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Vascular disorders
Blood pressure disorders NEC
Blood pressure fluctuation 2 0
Circulatory collapse and shock
Circulatory collapse 21 0
Neurogenic shock 6 0
Peripheral circulatory failure 2 0
Haemorrhages NEC
Haematoma 3 0
Haemorrhage 5 0
Lymphoedemas
Lymphoedema 17 0
Non-site specific embolism and thrombosis
Thrombosis 6 0
Non-site specific vascular disorders NEC
Superficial vein prominence 1 0
Vasodilatation 1 0
Vein discolouration 1 0
Vein disorder 2 0
Vein rupture 1 0
Peripheral embolism and thrombosis
Blue toe syndrome 1 0
Deep vein thrombosis 5 0
Peripheral vascular disorders NEC
Cyanosis 8 0
Flushing 106 0
Hot flush 152 0
Peripheral vasoconstriction, necrosis and vascular insufficiency
Peripheral coldness 43 0
Peripheral ischaemia 1 0
Poor peripheral circulation 1 0
Raynaud's phenomenon 3 0
Vasoconstriction 1 0
Site specific vascular disorders NEC
Pallor 32 0
Vascular hypertensive disorders NEC
Hypertension 78 0
Vascular hypotensive disorders
Hypotension 62 0
Orthostatic hypotension 3 0
Vasculitides NEC
Vasculitis 4 0
Vena caval embolism and thrombosis
Vena cava embolism 1 0
Vena cava thrombosis 1 0
Vascular disorders SOC TOTAL 570 0
TOTAL REACTIONS FOR DRUG 49472 107