COVID-19 mRNA Pfizer- BioNTech vaccine analysis print

Report Run Date: 04-Mar-2021

Data Lock Date: 03-Mar-2021 19:00:03

All UK spontaneous reports received between 9/12/20 and 21/02/21 for

mRNA Pfizer/BioNTech vaccine analysis print

Report Run Date: 04-Mar-2021, Page 1

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Blood disorders
Anaemias NEC
Anaemia 4 0
Anaemias haemolytic immune
Autoimmune haemolytic anaemia 1 0
Bleeding tendencies
Increased tendency to bruise 7 0
Coagulopathies
Coagulopathy 1 0
Lymphatic system disorders NEC
Granulomatous lymphadenitis 1 0
Lymph node pain 242 0
Lymphadenitis 37 0
Lymphadenopathy 1706 0
Lymphatic disorder 1 0
Pseudolymphoma 2 0
Marrow depression and hypoplastic anaemias
Myelosuppression 1 0
Pancytopenia 1 0
Neutropenias
Neutropenia 8 0
Platelet disorders NEC
Platelet anisocytosis 1 0
Spleen disorders
Splenomegaly 1 0
Thrombocytopenias
Immune thrombocytopenia 5 0
Thrombocytopenia 12 1
Thrombocytoses
Thrombocytosis 2 0
Blood disorders SOC TOTAL 2033 1

Report Run Date: 04-Mar-2021, Page 2

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Cardiac disorders
Cardiac conduction disorders
Bundle branch block right 1 0
Cardiac disorders NEC
Cardiac disorder 3 0
Cardiovascular disorder 1 0
Cardiac signs and symptoms NEC
Palpitations 471 0
Coronary artery disorders NEC
Coronary artery disease 1 1
Heart failures NEC
Cardiac failure 3 1
Cardiac failure congestive 1 0
Cardiopulmonary failure 1 1
Ischaemic coronary artery disorders
Acute myocardial infarction 7 0
Angina pectoris 11 0
Myocardial infarction 21 6
Left ventricular failures
Left ventricular failure 1 0
Myocardial disorders NEC
Left ventricular dysfunction 1 0
Myocardial fibrosis 1 0
Myocardial oedema 2 0
Right ventricular enlargement 1 0
Noninfectious myocarditis
Myocarditis 5 0
Noninfectious pericarditis
Pericarditis 6 0
Rate and rhythm disorders NEC
Arrhythmia 17 0
Bradycardia 14 0
Cardiac flutter 21 0
Extrasystoles 12 0
Postural orthostatic tachycardia syndrome 2 0
Tachycardia 293 0
Supraventricular arrhythmias
Arrhythmia supraventricular 5 0
Atrial fibrillation 44 1
Atrial flutter 1 0
Atrial tachycardia 2 0
Sinus bradycardia 1 0
Sinus tachycardia 24 0
Supraventricular tachycardia 11 0
Ventricular arrhythmias and cardiac arrest
Cardiac arrest 35 14
Cardio-respiratory arrest 1 1
Pulseless electrical activity 2 0
Ventricular arrhythmia 1 0
Ventricular extrasystoles 3 0
Ventricular fibrillation 4 0
Ventricular tachycardia 1 0
Cardiac disorders SOC TOTAL 1032 25

Report Run Date: 04-Mar-2021, Page 3

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Congenital disorders
Cardiac septal defects congenital
Hypertrophic cardiomyopathy 1 0
Neurological disorders congenital NEC
Familial hemiplegic migraine 1 0
Retinal disorders congenital
Retinitis pigmentosa 1 0
Congenital disorders SOC TOTAL 3 0

Report Run Date: 04-Mar-2021, Page 4

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Ear disorders
Ear disorders NEC
Ear canal erythema 1 0
Ear congestion 3 0
Ear discomfort 15 0
Ear disorder 2 0
Ear pain 186 0
Ear pruritus 1 0
Ear swelling 6 0
Otorrhoea 1 0
Eustachian tube disorders
Eustachian tube disorder 1 0
Eustachian tube dysfunction 2 0
External ear disorders NEC
Red ear syndrome 1 0
Hearing disorders NEC
Auditory disorder 1 0
Hearing losses
Deafness 19 0
Deafness neurosensory 2 0
Deafness unilateral 2 0
Hypoacusis 25 0
Sudden hearing loss 6 0
Hyperacusia
Hyperacusis 8 0
Inner ear disorders NEC
Acute vestibular syndrome 1 0
Inner ear disorder 2 0
Meniere's disease 2 0
Inner ear signs and symptoms
Motion sickness 13 0
Tinnitus 169 0
Vertigo 223 0
Vertigo labyrinthine 4 0
Vertigo positional 16 0
Middle ear infections and inflammations
Middle ear inflammation 1 0
Ear disorders SOC TOTAL 713 0

Report Run Date: 04-Mar-2021, Page 5

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Endocrine disorders
Acute and chronic thyroiditis
Thyroiditis subacute 1 0
Adrenal cortical hypofunctions
Adrenocortical insufficiency acute 3 0
Endocrine abnormalities of puberty
Premature menarche 1 0
Female gonadal function disorders
Anovulatory cycle 1 0
Thyroid disorders NEC
Goitre 2 0
Thyroid pain 1 0
Thyroid hypofunction disorders
Hypothyroidism 1 0
Endocrine disorders SOC TOTAL 10 0

Report Run Date: 04-Mar-2021, Page 6

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Eye disorders
Amblyopic vision impairment
Amblyopia 2 0
Choroid and vitreous haemorrhages and vascular disorders
Choroidal haemorrhage 1 0
Choroid and vitreous structural change, deposit and degeneration
Vitreous detachment 1 0
Vitreous floaters 10 0
Conjunctival and corneal bleeding and vascular disorders
Conjunctival haemorrhage 10 0
Corneal infections, oedemas and inflammations
Keratitis 2 0
Ulcerative keratitis 3 0
Eyelid movement disorders
Blepharospasm 18 0
Excessive eye blinking 1 0
Eyelid ptosis 5 0
Iris and uveal tract infections, irritations and inflammations
Autoimmune uveitis 1 0
Iridocyclitis 5 0
Iritis 1 0
Uveitis 7 0
Lacrimation disorders
Dry eye 26 0
Lacrimation increased 36 0
Lid, lash and lacrimal infections, irritations and inflammations
Blepharitis 2 0
Chalazion 1 0
Eczema eyelids 1 0
Erythema of eyelid 1 0
Eyelid irritation 1 0
Eyelid margin crusting 1 0
Eyelid oedema 1 0
Eyelid rash 4 0
Swelling of eyelid 26 0
Lid, lash and lacrimal structural disorders
Eyelid exfoliation 1 0
Lagophthalmos 1 0
Ocular bleeding and vascular disorders NEC
Eye haematoma 1 0
Eye haemorrhage 3 0
Ocular disorders NEC
Eye disorder 10 0
Eye oedema 3 0
Eye pain 219 0
Eye swelling 117 0
Eye ulcer 1 0
Eyelid disorder 2 0
Eyelid pain 3 0
Eyelids pruritus 1 0
Ocular discomfort 6 0
Periorbital oedema 9 0
Periorbital pain 1 0
Periorbital swelling 25 0

Report Run Date: 04-Mar-2021, Page 7

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Eye disorders Eye disorders cont'd
Ocular infections, inflammations and associated manifestations
Eye allergy 1 0
Eye discharge 6 0
Eye inflammation 4 0
Eye irritation 23 0
Eye pruritus 71 0
Limbal swelling 1 0
Ocular hyperaemia 50 0
Ocular nerve and muscle disorders
Binocular eye movement disorder 1 0
Extraocular muscle paresis 1 0
Eye movement disorder 5 0
Ophthalmoplegia 2 0
Strabismus 1 0
Ocular sensation disorders
Abnormal sensation in eye 5 0
Asthenopia 41 0
Eye paraesthesia 1 0
Foreign body sensation in eyes 8 0
Hypoaesthesia eye 2 0
Photophobia 91 0
Optic disc abnormalities NEC
Papilloedema 1 0
Pupil disorders
Miosis 1 0
Mydriasis 4 0
Pupillary disorder 1 0
Pupils unequal 2 0
Retinal bleeding and vascular disorders (excl retinopathy)
Retinal haemorrhage 1 0
Retinal vein occlusion 2 0
Retinal structural change, deposit and degeneration
Maculopathy 1 0
Retinal toxicity 1 0
Scleral infections, irritations and inflammations
Episcleritis 3 0
Visual colour distortions
Cyanopsia 1 0
Erythropsia 2 0
Visual disorders NEC
Diplopia 26 0
Halo vision 4 0
Metamorphopsia 2 0
Oscillopsia 1 0
Photopsia 25 0
Vision blurred 200 0
Visual brightness 1 0
Visual impairment and blindness (excl colour blindness)
Blindness 12 0
Blindness transient 2 0
Blindness unilateral 1 0
Central vision loss 1 0
Sudden visual loss 1 0

Report Run Date: 04-Mar-2021, Page 8

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Eye disorders Eye disorders cont'd
Visual acuity reduced 1 0
Visual impairment 61 0
Eye disorders SOC TOTAL 1242 0

Report Run Date: 04-Mar-2021, Page 9

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Gastrointestinal disorders
Abdominal findings abnormal
Gastrointestinal sounds abnormal 2 0
Acute and chronic pancreatitis
Pancreatitis 1 0
Pancreatitis necrotising 1 0
Anal and rectal disorders NEC
Anal sphincter atony 1 0
Anal and rectal pains
Proctalgia 3 0
Anal and rectal signs and symptoms
Anal spasm 1 0
Anorectal discomfort 3 0
Benign oral cavity neoplasms
Mouth cyst 2 0
Colitis (excl infective)
Colitis 4 0
Colitis ulcerative 2 0
Crohn's disease 6 0
Dental disorders NEC
Teething 1 0
Dental pain and sensation disorders
Dental discomfort 1 0
Dental paraesthesia 1 0
Hyperaesthesia teeth 7 0
Toothache 17 0
Diaphragmatic hernias
Hiatus hernia 1 0
Diarrhoea (excl infective)
Diarrhoea 1342 3
Diarrhoea haemorrhagic 3 0
Duodenal and small intestinal stenosis and obstruction
Small intestinal obstruction 1 0
Dyspeptic signs and symptoms
Dyspepsia 68 0
Epigastric discomfort 3 0
Eructation 13 0
Faecal abnormalities NEC
Abnormal faeces 3 0
Faeces discoloured 8 0
Faeces pale 2 0
Faeces soft 2 0
Flatulence, bloating and distension
Abdominal distension 42 0
Aerophagia 2 0
Flatulence 42 0
Gastric and oesophageal haemorrhages
Gastric haemorrhage 2 1
Gastritis (excl infective)
Gastritis 9 0
Reflux gastritis 3 0
Gastrointestinal and abdominal pains (excl oral and throat)
Abdominal pain 275 0
Abdominal pain lower 15 0

Report Run Date: 04-Mar-2021, Page 10

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Gastrointestinal disorders cont'd
Gastrointestinal disorders
Abdominal pain upper 426 0
Abdominal rigidity 2 0
Abdominal tenderness 3 0
Gastrointestinal pain 27 0
Gastrointestinal atonic and hypomotility disorders NEC
Constipation 34 0
Duodenogastric reflux 2 0
Gastric dilatation 1 0
Gastrooesophageal reflux disease 21 0
Intestinal pseudo-obstruction 1 0
Gastrointestinal disorders NEC
Functional gastrointestinal disorder 2 0
Gastric disorder 3 0
Gastrointestinal disorder 2 0
Gastrointestinal dyskinetic disorders
Dyschezia 1 0
Gastrointestinal motility disorder 1 0
Gastrointestinal inflammatory disorders NEC
Enteritis 1 0
Gastrointestinal mucosal dystrophies and secretion disorders
Hyperchlorhydria 1 0
Gastrointestinal signs and symptoms NEC
Abdominal discomfort 145 0
Anal incontinence 6 0
Breath odour 5 0
Dysphagia 43 0
Gastrointestinal spastic and hypermotility disorders
Defaecation urgency 2 0
Frequent bowel movements 9 0
Irritable bowel syndrome 13 0
Oesophageal spasm 2 0
Pylorospasm 1 0
Gastrointestinal stenosis and obstruction NEC
Intestinal obstruction 1 0
Gastrointestinal vascular malformations
Gastric antral vascular ectasia 1 0
Gastrointestinal vascular occlusion and infarction
Intestinal ischaemia 1 0
Gingival disorders, signs and symptoms NEC
Gingival blister 5 0
Gingival discomfort 2 0
Gingival pain 21 0
Gingival swelling 6 0
Gingivitis ulcerative 1 0
Noninfective gingivitis 1 0
Gingival haemorrhages
Gingival bleeding 5 0
Haemorrhoids and gastrointestinal varices (excl oesophageal)
Gastric varices 1 0
Haemorrhoids 4 0
Intestinal haemorrhages
Anal haemorrhage 4 0
Rectal haemorrhage 14 0

Report Run Date: 04-Mar-2021, Page 11

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Gastrointestinal disorders cont'd
Gastrointestinal disorders
Small intestinal haemorrhage 1 0
Intestinal ulcers and perforation NEC
Intestinal perforation 2 2
Malabsorption syndromes
Coeliac disease 1 0
Steatorrhoea 1 0
Nausea and vomiting symptoms
Discoloured vomit 3 0
Nausea 3975 1
Regurgitation 1 0
Retching 33 0
Vomiting 1075 2
Vomiting projectile 18 0
Non-site specific gastrointestinal haemorrhages
Gastrointestinal haemorrhage 3 0
Haematemesis 15 2
Haematochezia 6 0
Melaena 5 0
Upper gastrointestinal haemorrhage 2 0
Oesophageal stenosis and obstruction
Oesophageal stenosis 1 0
Oesophagitis (excl infective)
Oesophagitis 1 0
Oral dryness and saliva altered
Aptyalism 1 0
Dry mouth 155 0
Lip dry 12 0
Salivary hypersecretion 11 0
Oral soft tissue disorders NEC
Chapped lips 5 0
Cheilitis 9 0
Enlarged uvula 4 0
Lip blister 7 0
Lip disorder 2 0
Oral disorder 3 0
Oral lichen planus 1 0
Oral papule 1 0
Uvulitis 1 0
Oral soft tissue haemorrhages
Mouth haemorrhage 1 0
Oral blood blister 4 0
Oral soft tissue signs and symptoms
Anaesthesia oral 1 0
Hypoaesthesia oral 135 0
Lip discolouration 1 0
Lip erythema 1 0
Lip exfoliation 3 0
Lip pain 16 0
Lip pruritus 5 0
Lip scab 1 0
Odynophagia 2 0
Oral discomfort 19 0
Oral mucosal blistering 6 0

Report Run Date: 04-Mar-2021, Page 12

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Gastrointestinal disorders cont'd
Gastrointestinal disorders
Oral mucosal eruption 7 0
Oral mucosal erythema 1 0
Oral mucosal exfoliation 2 0
Oral pain 45 0
Oral pruritus 5 0
Paraesthesia oral 378 0
Oral soft tissue swelling and oedema
Lip oedema 3 0
Lip swelling 206 0
Mouth swelling 22 0
Oedema mouth 1 0
Palatal oedema 1 0
Palatal swelling 1 0
Peritoneal and retroperitoneal disorders
Ascites 1 0
Peritoneal and retroperitoneal fibrosis and adhesions
Abdominal adhesions 1 0
Rectal inflammations NEC
Proctitis 1 0
Proctitis ulcerative 1 0
Salivary gland disorders NEC
Salivary gland pain 2 0
Salivary gland enlargements
Parotid gland enlargement 2 0
Submaxillary gland enlargement 4 0
Stomatitis and ulceration
Aphthous ulcer 10 0
Lip ulceration 2 0
Mouth ulceration 91 0
Oral mucosa erosion 1 0
Palatal ulcer 1 0
Stomatitis 12 0
Tongue disorders
Glossitis 3 0
Plicated tongue 2 0
Tongue disorder 12 0
Tongue haemorrhage 1 0
Tongue ulceration 7 0
Tongue signs and symptoms
Glossodynia 60 0
Stiff tongue 1 0
Swollen tongue 162 0
Tongue blistering 3 0
Tongue coated 3 0
Tongue discolouration 5 0
Tongue discomfort 12 0
Tongue dry 5 0
Tongue eruption 4 0
Tongue erythema 1 0
Tongue movement disturbance 2 0
Tongue oedema 11 0
Tongue rough 2 0
Tongue spasm 3 0

Report Run Date: 04-Mar-2021, Page 13

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Gastrointestinal disorders cont'd
Gastrointestinal disorders
Gastrointestinal disorders SOC TOTAL 9360 11

Report Run Date: 04-Mar-2021, Page 14

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
General disorders
Administration site reactions NEC
Administration site bruise 2 0
Administration site erythema 1 0
Administration site extravasation 1 0
Administration site haematoma 1 0
Administration site inflammation 1 0
Administration site pain 4 0
Administration site warmth 1 0
Puncture site bruise 7 0
Puncture site pain 3 0
Puncture site swelling 1 0
Vessel puncture site bruise 1 0
Vessel puncture site erythema 1 0
Vessel puncture site pain 1 0
Adverse effect absent
No adverse event 3 0
Application and instillation site reactions
Application site bruise 1 0
Application site erythema 1 0
Application site haemorrhage 1 0
Application site joint pain 1 0
Application site pain 2 0
Application site pruritus 1 0
Application site reaction 1 0
Application site vesicles 1 0
Instillation site warmth 1 0
Asthenic conditions
Asthenia 384 1
Chronic fatigue syndrome 3 0
Fatigue 5761 1
Malaise 1356 0
Sluggishness 3 0
Body temperature altered
Hypothermia 12 0
Temperature regulation disorder 4 0
Breast complications associated with device
Capsular contracture associated with breast implant 1 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 93 93
Sudden death 14 14
Febrile disorders
Hyperpyrexia 3 0
Pyrexia 4786 0
Feelings and sensations NEC
Chills 3107 0
Feeling abnormal 273 0
Feeling cold 335 0
Feeling drunk 14 0
Feeling hot 332 0

Report Run Date: 04-Mar-2021, Page 15

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
General disorders General disorders cont'd
Feeling jittery 7 0
Feeling of body temperature change 92 0
Hangover 13 0
Hunger 5 0
Sensation of foreign body 17 0
Temperature intolerance 4 0
Thirst 72 0
Gait disturbances
Gait disturbance 30 0
Gait inability 19 0
Loss of control of legs 2 0
General signs and symptoms NEC
Condition aggravated 27 0
Crepitations 1 0
Crying 17 0
Disease recurrence 1 0
Energy increased 2 0
Exercise tolerance decreased 2 0
General physical health deterioration 2 0
Glassy eyes 2 0
Illness 389 0
Induration 2 0
Influenza like illness 710 0
Irritability postvaccinal 1 0
Local reaction 39 0
Multiple organ dysfunction syndrome 1 1
Peripheral swelling 718 0
Pre-existing condition improved 3 0
Screaming 2 0
Secretion discharge 4 0
Swelling 540 0
Swelling face 205 0
Inflammations
Inflammation 67 0
Papillitis 1 0
Systemic inflammatory response syndrome 1 0
Infusion site reactions
Infusion site coldness 1 0
Infusion site joint pain 2 0
Infusion site pain 1 0
Infusion site swelling 1 0
Infusion site urticaria 1 0
Injection site reactions
Injected limb mobility decreased 10 0
Injection site bruising 15 0
Injection site discolouration 2 0
Injection site discomfort 4 0
Injection site erythema 137 0
Injection site haemorrhage 2 0
Injection site hypoaesthesia 6 0
Injection site indentation 1 0
Injection site induration 1 0
Injection site inflammation 10 0

Report Run Date: 04-Mar-2021, Page 16

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
General disorders General disorders cont'd
Injection site joint pain 8 0
Injection site mass 120 0
Injection site necrosis 2 0
Injection site oedema 7 0
Injection site pain 1031 0
Injection site paraesthesia 4 0
Injection site pruritus 63 0
Injection site rash 33 0
Injection site reaction 11 0
Injection site scab 2 0
Injection site scar 2 0
Injection site swelling 128 0
Injection site urticaria 7 0
Injection site vesicles 3 0
Injection site warmth 42 0
Interactions
Alcohol interaction 2 0
Drug interaction 2 0
Mass conditions NEC
Cyst 2 0
Mass 4 0
Nodule 4 0
Necrosis NEC
Fat necrosis 1 0
Oedema NEC
Face oedema 10 0
Localised oedema 9 0
Oedema 6 0
Oedema peripheral 14 0
Pain and discomfort NEC
Axillary pain 268 0
Chest discomfort 346 0
Chest pain 453 0
Discomfort 34 0
Facial discomfort 6 0
Facial pain 52 0
Inflammatory pain 1 0
Non-cardiac chest pain 7 0
Pain 1860 0
Suprapubic pain 1 0
Tenderness 172 0
Therapeutic and nontherapeutic responses
Adverse drug reaction 3 0
Drug ineffective 80 0
Immediate post-injection reaction 2 0
No reaction on previous exposure to drug 9 0
Therapeutic product effect delayed 1 0
Therapeutic product effect increased 1 0
Therapeutic response unexpected 10 0
Treatment failure 3 0
Ulcers NEC
Ulcer 3 0
Vaccination site reactions

Report Run Date: 04-Mar-2021, Page 17

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
General disorders General disorders cont'd
Extensive swelling of vaccinated limb 2 0
Shoulder injury related to vaccine administration 1 0
Vaccination site bruising 34 0
Vaccination site cyst 1 0
Vaccination site dermatitis 1 0
Vaccination site discolouration 5 0
Vaccination site discomfort 19 0
Vaccination site eczema 1 0
Vaccination site erythema 235 0
Vaccination site haemorrhage 5 0
Vaccination site hypoaesthesia 1 0
Vaccination site induration 32 0
Vaccination site inflammation 27 0
Vaccination site irritation 4 0
Vaccination site joint discomfort 2 0
Vaccination site joint erythema 4 0
Vaccination site joint movement impairment 12 0
Vaccination site joint pain 20 0
Vaccination site joint swelling 2 0
Vaccination site joint warmth 1 0
Vaccination site lymphadenopathy 1 0
Vaccination site mass 62 0
Vaccination site movement impairment 22 0
Vaccination site oedema 3 0
Vaccination site pain 852 0
Vaccination site paraesthesia 4 0
Vaccination site pruritus 53 0
Vaccination site rash 36 0
Vaccination site reaction 12 0
Vaccination site swelling 253 0
Vaccination site ulcer 1 0
Vaccination site urticaria 5 0
Vaccination site vesicles 2 0
Vaccination site warmth 133 0
Withdrawal and rebound effects
Drug withdrawal syndrome 2 0
Withdrawal syndrome 1 0
General disorders SOC TOTAL 2639 111

Report Run Date: 04-Mar-2021, Page 18

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Hepatic disorders
Cholestasis and jaundice
Jaundice 3 0
Hepatic and hepatobiliary disorders NEC
Liver disorder 1 0
Hepatic failure and associated disorders
Hepatic failure 1 0
Hepatic vascular disorders
Hepatic artery embolism 1 0
Hepatobiliary signs and symptoms
Hepatic pain 6 0
Liver tenderness 1 0
Hepatocellular damage and hepatitis NEC
Hepatitis 2 0
Liver injury 2 0
Hepatic disorders SOC TOTAL 17 0

Report Run Date: 04-Mar-2021, Page 19

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Immune system disorders
Acute and chronic sarcoidosis
Sarcoidosis 5 0
Allergic conditions NEC
Allergic oedema 4 0
Allergy to arthropod bite 1 0
Hypersensitivity 216 0
Multiple allergies 1 0
Serum sickness 2 0
Serum sickness-like reaction 2 0
Type I hypersensitivity 1 0
Type IV hypersensitivity reaction 3 0
Allergies to foods, food additives, drugs and other chemicals
Allergic reaction to excipient 2 0
Allergy to chemicals 1 0
Allergy to vaccine 15 0
Contrast media reaction 1 0
Drug hypersensitivity 5 0
Food allergy 2 0
Reaction to preservatives 3 0
Anaphylactic and anaphylactoid responses
Anaphylactic reaction 173 0
Anaphylactic shock 7 0
Anaphylactoid reaction 8 0
Anaphylactoid shock 2 0
Atopic disorders
Seasonal allergy 1 0
Autoimmune disorders NEC
Autoimmune disorder 4 0
Immune and associated conditions NEC
Bacille Calmette-Guerin scar reactivation 4 0
Immune system disorder 2 0
Immune-mediated adverse reaction 1 0
Immune system disorders SOC TOTAL 466 0

Report Run Date: 04-Mar-2021, Page 20

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Infections
Abdominal and gastrointestinal infections
Appendicitis 3 0
Diverticulitis 1 0
Dysentery 1 0
Gastroenteritis 7 0
Aspergillus infections
Bronchopulmonary aspergillosis 1 0
Bacterial infections NEC
Arthritis bacterial 1 0
Bacterial diarrhoea 1 0
Cellulitis 52 0
Conjunctivitis bacterial 1 0
Ear infection bacterial 1 0
Injection site cellulitis 1 0
Tonsillitis bacterial 1 0
Urinary tract infection bacterial 1 0
Vaccination site cellulitis 11 0
Breast infections
Breast abscess 1 0
Mastitis 6 0
Candida infections
Anal candidiasis 1 0
Candida infection 5 0
Oral candidiasis 10 0
Vulvovaginal candidiasis 8 0
Central nervous system and spinal infections
Encephalitis 3 0
Meningitis 2 0
Meningitis aseptic 1 0
Myelitis 1 0
Clostridia infections
Clostridium difficile infection 1 0
Coronavirus infections
Asymptomatic COVID-19 6 0
COVID-19 402 19
COVID-19 pneumonia 10 3
Coronavirus infection 4 0
Suspected COVID-19 27 0
Coxiella infections
Q fever 6 0
Dental and oral soft tissue infections
Abscess oral 3 0
Gingivitis 2 0
Parotitis 5 0
Pulpitis dental 1 0
Sialoadenitis 1 0
Tooth abscess 1 0
Ear infections
Ear infection 11 0
Labyrinthitis 18 0
Epstein-Barr viral infections
Infectious mononucleosis 1 0
Eye and eyelid infections

Report Run Date: 04-Mar-2021, Page 21

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Infections Infections cont'd
Conjunctivitis 21 0
Eye abscess 1 0
Eye infection 3 0
Hordeolum 4 0
Periorbital infection 1 0
Female reproductive tract infections
Vulval abscess 1 0
Hepatobiliary and spleen infections
Biliary sepsis 1 0
Herpes viral infections
Disseminated varicella zoster virus infection 1 0
Eczema herpeticum 1 0
Genital herpes 5 0
Herpes ophthalmic 1 0
Herpes simplex 3 0
Herpes simplex reactivation 1 0
Herpes virus infection 3 0
Herpes zoster 200 0
Herpes zoster oticus 2 0
Ophthalmic herpes zoster 1 0
Oral herpes 74 0
Infections NEC
Abscess 3 0
Abscess limb 1 0
Abscess soft tissue 1 0
Infection 62 0
Injection site abscess 1 0
Injection site infection 3 0
Localised infection 5 0
Lymph gland infection 2 0
Respiratory tract infection 1 0
Vaccination site abscess 2 0
Vaccination site infection 7 0
Vestibulitis 1 0
Influenza viral infections
Influenza 375 0
Lower respiratory tract and lung infections
Bronchitis 4 0
Lower respiratory tract infection 35 5
Pneumonia 17 5
Sputum purulent 1 0
Male reproductive tract infections
Epididymitis 1 0
Orchitis 2 0
Mumps viral infections
Mumps 1 0
Muscle and soft tissue infections
Soft tissue infection 1 0
Neisseria infections
Gonorrhoea 1 0
Sepsis, bacteraemia, viraemia and fungaemia NEC
Sepsis 11 0
Urosepsis 2 0

Report Run Date: 04-Mar-2021, Page 22

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Infections Infections cont'd
Skin structures and soft tissue infections
Acne pustular 1 0
Folliculitis 3 0
Pustule 4 0
Rash pustular 2 0
Skin infection 5 0
Subcutaneous abscess 1 0
Vaccination site pustule 1 0
Staphylococcal infections
Furuncle 5 0
Pneumonia staphylococcal 1 0
Staphylococcal abscess 1 0
Streptococcal infections
Pharyngitis streptococcal 2 0
Trypanosomal infections
African trypanosomiasis 1 0
Upper respiratory tract infections
Laryngitis 1 0
Nasopharyngitis 175 0
Pharyngitis 5 0
Rhinitis 14 0
Sinusitis 18 0
Tonsillitis 20 0
Tracheitis 1 0
Urinary tract infections
Cystitis 11 0
Kidney infection 4 0
Pyelonephritis 1 0
Urinary tract infection 30 0
Vascular infections
Haematoma infection 1 0
Lymphangitis 1 0
Viral infections NEC
Conjunctivitis viral 1 0
Eye infection viral 1 0
Gastroenteritis viral 5 0
Pneumonia viral 1 1
Post viral fatigue syndrome 5 0
Sweating fever 32 0
Vestibular neuronitis 4 0
Viral infection 1 0
Viral labyrinthitis 2 0
Viral pharyngitis 4 0
Viral rash 13 0
Viral tonsillitis 1 0
Infections SOC TOTAL 1863 33

Report Run Date: 04-Mar-2021, Page 23

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Injuries
Abdominal and gastrointestinal injuries NEC
Oral contusion 1 0
Tongue injury 1 0
Accidental exposures to product
Accidental exposure to product 2 0
Anaesthetic and allied procedural complications
Delayed recovery from anaesthesia 1 0
Bone and joint injuries NEC
Joint injury 1 0
Chest and respiratory tract injuries NEC
Chest crushing 1 0
Conditions caused by cold
Chillblains 14 0
Exposures associated with pregnancy, delivery and lactation
Exposure during pregnancy 4 0
Exposure via breast milk 1 0
Foetal exposure during pregnancy 2 0
Maternal exposure before pregnancy 1 0
Maternal exposure during breast feeding 9 0
Maternal exposure during pregnancy 37 0
Eye injuries NEC
Eye contusion 5 0
Eye injury 2 0
Injury corneal 1 0
Periorbital haematoma 1 0
Gastrointestinal and hepatobiliary procedural complications
Post procedural constipation 1 0
Postoperative ileus 1 0
Procedural nausea 3 0
Heat injuries (excl thermal burns)
Heat illness 1 0
Heat oedema 3 0
Heat stroke 1 0
Limb fractures and dislocations
Atypical femur fracture 1 0
Clavicle fracture 1 0
Medication errors, product use errors and issues NEC
Medication error 3 0
Product use issue 5 0
Vaccination error 1 0
Wrong drug 1 0
Wrong technique in product usage process 1 0
Muscle, tendon and ligament injuries
Epicondylitis 2 0
Ligament sprain 1 0
Muscle injury 1 0
Muscle rupture 1 0
Muscle strain 3 0
Tendon injury 1 0
Musculoskeletal procedural complications
Post laminectomy syndrome 1 0
Nerve injuries NEC
Nerve injury 4 0

Report Run Date: 04-Mar-2021, Page 24

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Injuries Injuries cont'd
Neurological and psychiatric procedural complications
Procedural dizziness 4 0
Non-site specific injuries NEC
Bite 1 0
Electric shock 3 0
Fall 36 1
Wound 1 0
Wound complication 3 0
Wound secretion 1 0
Non-site specific procedural complications
Incision site pain 2 0
Infusion related reaction 3 0
Injection related reaction 18 0
Post procedural complication 2 0
Off label uses
Off label use 6 0
Overdoses NEC
Overdose 7 0
Peripheral nerve injuries
Ulnar nerve injury 2 0
Poisoning and toxicity
Poisoning 1 0
Product administration errors and issues
Accidental overdose 1 0
Contraindicated product administered 1 0
Inappropriate schedule of product administration 9 0
Incomplete course of vaccination 1 0
Product administered at inappropriate site 3 0
Product administered to patient of inappropriate age 1 0
Product administration error 1 0
Product dose omission issue 3 0
Product preparation errors and issues
Product preparation issue 3 0
Radiation injuries
Sunburn 3 0
Site specific injuries NEC
Face crushing 1 0
Head injury 1 0
Limb injury 5 0
Skin injuries NEC
Contusion 114 0
Nail avulsion 1 0
Scar 2 0
Scratch 1 0
Skin abrasion 3 0
Stoma complications
Gastrointestinal stoma complication 1 0
Stoma site discharge 1 0
Stoma site extravasation 1 0
Stoma site haemorrhage 1 0
Thermal burns
Airway burns 1 0
Burn oesophageal 1 0

Report Run Date: 04-Mar-2021, Page 25

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Injuries Injuries cont'd
Burn of internal organs 1 0
Burns second degree 2 0
Thermal burn 3 0
Thermal burns of eye 1 0
Underdoses NEC
Underdose 1 0
Vaccination related complications
Vaccination complication 13 0
Vaccination failure 1 0
Injuries SOC TOTAL 393 1

Report Run Date: 04-Mar-2021, Page 26

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Investigations
Adrenal cortex tests
Cortisol decreased 1 0
Autoimmunity analyses
Rheumatoid factor 1 0
Blood gas and acid base analyses
Blood lactic acid 1 0
Blood lactic acid increased 2 0
Blood pH 1 0
Blood pH increased 3 0
Oxygen consumption decreased 1 0
Oxygen saturation 4 0
Oxygen saturation decreased 22 0
Carbohydrate tolerance analyses (incl diabetes)
Blood glucose 2 0
Blood glucose abnormal 2 0
Blood glucose decreased 5 0
Blood glucose fluctuation 2 0
Blood glucose increased 32 0
Glycosylated haemoglobin increased 1 0
Cardiac auscultatory investigations
Cardiac murmur 1 0
Heart sounds abnormal 1 0
Cardiac function diagnostic procedures
Central venous pressure 1 0
Central nervous system imaging procedures
Magnetic resonance imaging brain 4 0
Chemistry analyses NEC
Inflammatory marker increased 2 0
Coagulation and bleeding analyses
Bleeding time abnormal 1 0
Coagulation time prolonged 1 0
Fibrin D dimer increased 2 0
International normalised ratio abnormal 1 0
International normalised ratio decreased 6 0
International normalised ratio increased 21 0
ECG investigations
Electrocardiogram ST segment elevation 2 0
Electrocardiogram abnormal 1 0
Endocrine analyses and imaging NEC
Hormone level abnormal 1 0
Haematological analyses NEC
Red blood cell sedimentation rate increased 2 0
Heart rate and pulse investigations
Heart rate 48 0
Heart rate abnormal 4 0
Heart rate decreased 9 0
Heart rate increased 152 0
Heart rate irregular 19 0
Pulse abnormal 6 0
Radial pulse abnormal 1 0
Immunology analyses NEC
Antibody test 1 0
Antibody test abnormal 1 0

Report Run Date: 04-Mar-2021, Page 27

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Investigations Investigations cont'd
Immunology test 3 0
Immunology skin tests NEC
Skin test positive 1 0
Investigations NEC
Blood test abnormal 2 0
Polymerase chain reaction positive 14 0
Systemic lupus erythematosus disease activity index increased 1 0
Liver function analyses
Alanine aminotransferase increased 3 0
Gamma-glutamyltransferase increased 1 0
Hepatic enzyme increased 1 0
Liver function test abnormal 2 0
Liver function test increased 5 0
Transaminases increased 1 0
Metabolism tests NEC
Blood ketone body 1 0
Blood ketone body increased 1 0
Microbiology and serology tests NEC
Culture negative 1 0
Mineral and electrolyte analyses
Blood copper increased 1 0
Blood magnesium decreased 1 0
Blood potassium abnormal 1 0
Blood potassium decreased 1 0
Serum ferritin increased 1 0
Musculoskeletal and soft tissue tests NEC
Swollen joint count increased 1 0
Neurologic diagnostic procedures
Coma scale abnormal 2 0
Ophthalmic function diagnostic procedures
Intraocular pressure increased 1 0
Physical examination procedures and organ system status
Body temperature 83 0
Body temperature abnormal 19 0
Body temperature decreased 11 0
Body temperature fluctuation 8 0
Body temperature increased 160 0
Body temperature normal 1 0
Breath sounds abnormal 1 0
Grip strength 2 0
Grip strength decreased 2 0
Lymph node palpable 8 0
Product residue present 1 0
Respiratory rate 2 0
Respiratory rate decreased 2 0
Respiratory rate increased 14 0
Skin temperature 12 0
Temperature difference of extremities 1 0
Weight 1 0
Weight decreased 8 0
Weight increased 1 0
Pituitary analyses anterior
Blood growth hormone 2 0

Report Run Date: 04-Mar-2021, Page 28

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Investigations Investigations cont'd
Blood thyroid stimulating hormone increased 1 0
Platelet analyses
Platelet count decreased 3 0
Protein analyses NEC
C-reactive protein increased 4 0
Red blood cell analyses
Haematocrit 1 0
Haemoglobin decreased 4 0
Respiratory and pulmonary function diagnostic procedures
Forced expiratory volume increased 1 0
Peak expiratory flow rate decreased 1 0
Vital capacity 1 0
Respiratory tract and thoracic histopathology procedures
Sputum abnormal 2 0
Skeletal and cardiac muscle analyses
Blood creatine phosphokinase increased 1 0
Troponin increased 3 0
Therapeutic drug monitoring analyses
Analgesic drug level 1 0
Anticoagulation drug level below therapeutic 4 0
Anticoagulation drug level increased 1 0
Drug level decreased 1 0
Thyroid analyses
Thyroid function test abnormal 1 0
Tri-iodothyronine 1 0
Tri-iodothyronine decreased 1 0
Tissue enzyme analyses NEC
Blood alkaline phosphatase increased 1 0
Urinalysis NEC
Blood urine present 5 0
Glucose urine present 1 0
pH urine 2 0
pH urine increased 1 0
Urinary tract function analyses NEC
Urine output 4 0
Urine output decreased 3 0
Urine output increased 1 0
Vascular tests NEC (incl blood pressure)
Blood pressure abnormal 3 0
Blood pressure decreased 10 0
Blood pressure increased 70 0
Blood pressure measurement 7 0
Blood pressure systolic decreased 1 0
Blood pressure systolic increased 1 0
Virus identification and serology
Coronavirus test positive 2 0
SARS-CoV-1 test positive 1 0
SARS-CoV-2 antibody test 2 0
SARS-CoV-2 antibody test negative 12 0
SARS-CoV-2 antibody test positive 1 0
SARS-CoV-2 test 11 0
SARS-CoV-2 test false positive 1 0
SARS-CoV-2 test negative 2 0

Report Run Date: 04-Mar-2021, Page 29

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Investigations Investigations cont'd
SARS-CoV-2 test positive 35 0
Viral test 1 0
White blood cell analyses
White blood cell count decreased 1 0
White blood cell count increased 1 0
Investigations SOC TOTAL 965 0

Report Run Date: 04-Mar-2021, Page 30

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Metabolic disorders
Appetite disorders
Appetite disorder 1 0
Decreased appetite 354 0
Eating disorder symptom 1 0
Food craving 2 0
Food refusal 4 0
Hypophagia 4 0
Increased appetite 3 0
Salt craving 1 0
Diabetes mellitus (incl subtypes)
Diabetes mellitus 1 0
Diabetes mellitus inadequate control 3 1
Type 1 diabetes mellitus 3 0
Diabetic complications NEC
Diabetic complication 1 0
Diabetic ketoacidosis 3 0
Disorders of purine metabolism
Gout 17 0
Electrolyte imbalance NEC
Fluid imbalance 1 0
Fluid intake increased
Polydipsia 2 0
Food malabsorption and intolerance syndromes (excl sugar intolerance)
Gluten sensitivity 1 0
Histamine intolerance 1 0
General nutritional disorders NEC
Abnormal weight gain 4 0
Feeding disorder 10 0
Food aversion 2 0
Overweight 1 0
Poor feeding infant 1 0
Hyperglycaemic conditions NEC
Hyperglycaemia 18 0
Insulin resistance 1 0
Hypoglycaemic conditions NEC
Hypoglycaemia 27 0
Postprandial hypoglycaemia 1 0
Lipid metabolism and deposit disorders NEC
Body fat disorder 1 0
Metabolic acidoses (excl diabetic acidoses)
Ketoacidosis 3 0
Metabolic acidosis 2 0
Mixed acid-base disorders
Acidosis 2 0
Potassium imbalance
Hyperkalaemia 1 0
Hypokalaemic syndrome 1 0
Sodium imbalance
Hyponatraemia 3 0
Total fluid volume decreased
Dehydration 41 0
Total fluid volume increased
Fluid retention 3 0

Report Run Date: 04-Mar-2021, Page 31

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Metabolic disorders Metabolic disorders cont'd
Metabolic disorders SOC TOTAL 525 1

Report Run Date: 04-Mar-2021, Page 32

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Muscle & tissue disorders
Arthropathies NEC
Arthritis 46 0
Arthropathy 4 0
Polyarthritis 1 0
Sacroiliitis 1 0
Bone disorders NEC
Medial tibial stress syndrome 2 0
Spinal disorder 1 0
Bone related signs and symptoms
Bone pain 78 0
Bone swelling 1 0
Coccydynia 1 0
Pain in jaw 76 0
Spinal pain 9 0
Bursal disorders
Bursitis 7 0
Cartilage disorders
Costochondritis 9 0
Connective tissue disorders NEC
Polymyalgia rheumatica 4 0
Sjogren's syndrome 1 0
Crystal arthropathic disorders
Crystal arthropathy 1 0
Epiphyseal disorders
Epiphyses premature fusion 1 0
Extremity deformities
Foot deformity 1 0
Musculoskeletal deformity 1 0
Joint related disorders NEC
Joint destruction 1 0
Joint lock 1 0
Periarthritis 9 0
Temporomandibular joint syndrome 1 0
Joint related signs and symptoms
Arthralgia 2412 0
Jaw clicking 2 0
Joint effusion 4 0
Joint noise 4 0
Joint range of motion decreased 2 0
Joint stiffness 51 0
Joint swelling 70 0
Joint vibration 1 0
Joint warmth 3 0
Lupus erythematosus (incl subtypes)
Systemic lupus erythematosus 2 0
Muscle infections and inflammations
Antisynthetase syndrome 1 0
Myositis 3 0
Polymyositis 1 0
Muscle pains
Fibromyalgia 14 0
Myalgia 3549 0
Myofascial pain syndrome 5 0

Report Run Date: 04-Mar-2021, Page 33

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Muscle & tissue disorders cont'd
Muscle & tissue disorders
Muscle related signs and symptoms NEC
Muscle atrophy 1 0
Muscle discomfort 1 0
Muscle disorder 2 0
Muscle fatigue 95 0
Muscle spasms 166 0
Muscle swelling 8 0
Muscle tightness 19 0
Muscle twitching 65 0
Muscle tone abnormalities
Muscle rigidity 7 0
Nuchal rigidity 4 0
Torticollis 2 0
Trismus 8 0
Muscle weakness conditions
Muscular weakness 181 0
Musculoskeletal and connective tissue conditions NEC
Limb mass 2 0
Mandibular mass 1 0
Mastication disorder 1 0
Mobility decreased 17 0
Musculoskeletal disorder 3 0
Musculoskeletal stiffness 273 0
Posture abnormal 1 0
Musculoskeletal and connective tissue infections and inflammations NEC
Fasciitis 1 0
Plantar fasciitis 1 0
Musculoskeletal and connective tissue pain and discomfort
Back pain 516 0
Flank pain 7 0
Limb discomfort 373 0
Musculoskeletal chest pain 33 0
Musculoskeletal discomfort 20 0
Musculoskeletal pain 16 0
Neck pain 427 0
Pain in extremity 2819 0
Rheumatic disorder 1 0
Myopathies
Rhabdomyolysis 3 0
Osteoarthropathies
Osteoarthritis 6 0
Psoriatic arthropathies
Psoriatic arthropathy 2 0
Rheumatoid arthropathies
Rheumatoid arthritis 14 0
Soft tissue disorders NEC
Axillary mass 36 0
Groin pain 23 0
Neck mass 7 0
Spondyloarthropathies
Ankylosing spondylitis 2 0
Arthritis reactive 6 0
Synovial disorders

Report Run Date: 04-Mar-2021, Page 34

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Muscle & tissue disorders cont'd
Muscle & tissue disorders
Synovial cyst 3 0
Synovitis 3 0
Tendon disorders
Tendon pain 2 0
Tendonitis 3 0
Tenosynovitis 1 0
Tenosynovitis stenosans 1 0
Trunk deformities
Drooping shoulder syndrome 1 0
Muscle & tissue disorders SOC TOTAL 11565 0

Report Run Date: 04-Mar-2021, Page 35

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Neoplasms
Breast and nipple neoplasms malignant
Breast cancer 1 0
Lymphomas unspecified NEC
Lymphoma 4 0
Metastases to specified sites
Metastases to lymph nodes 2 0
Myeloproliferative disorders (excl leukaemias)
Essential thrombocythaemia 1 0
Neoplasms malignant site unspecified NEC
Neoplasm malignant 1 0
Second primary malignancy 1 0
Oropharyngeal, nasopharyngeal and tonsillar neoplasms malignant and
unspecified
Tonsil cancer 1 0
Pancreatic neoplasms malignant (excl islet cell and carcinoid)
Pancreatic carcinoma 1 0
Plasma cell myelomas
Plasma cell myeloma 1 0
Skin neoplasms benign
Acrochordon 1 0
Anogenital warts 1 0
Melanocytic naevus 2 0
Skin papilloma 1 0
Soft tissue neoplasms benign NEC
Lipoma 1 0
Soft tissue sarcomas histology unspecified
Sarcoma 1 0
Neoplasms SOC TOTAL 20 0

Report Run Date: 04-Mar-2021, Page 36

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Nervous system disorders
Abnormal reflexes
Extensor plantar response 1 0
Hyperreflexia 1 0
Hyporeflexia 4 0
Abnormal sleep-related events
Sleep paralysis 2 0
Absence seizures
Petit mal epilepsy 5 0
Acute polyneuropathies
Guillain-Barre syndrome 3 0
Autonomic nervous system disorders
Anticholinergic syndrome 1 0
Autonomic nervous system imbalance 1 0
Central nervous system aneurysms and dissections
Vertebral artery dissection 1 0
Central nervous system haemorrhages and cerebrovascular accidents
Brain stem infarction 1 1
Cerebellar infarction 2 0
Cerebellar stroke 2 0
Cerebral artery occlusion 1 0
Cerebral haemorrhage 10 3
Cerebral infarction 7 0
Cerebrovascular accident 48 3
Embolic stroke 1 0
Haemorrhage intracranial 2 0
Haemorrhagic stroke 1 1
Ischaemic cerebral infarction 1 0
Ischaemic stroke 10 1
Lacunar infarction 2 0
Lacunar stroke 1 0
Subarachnoid haemorrhage 2 1
Central nervous system inflammatory disorders NEC
Gliosis 1 0
Cerebrovascular venous and sinus thrombosis
Cerebral venous sinus thrombosis 1 0
Cervical spinal cord and nerve root disorders
Cervicobrachial syndrome 1 0
Choreiform movements
Chorea 1 0
Coordination and balance disturbances
Ataxia 1 0
Balance disorder 77 0
Coordination abnormal 10 0
Dysstasia 13 0
Cortical dysfunction NEC
Aphasia 13 0
Neurologic neglect syndrome 1 0
Cranial nerve disorders NEC
Cranial nerve disorder 2 0
Dementia (excl Alzheimer's type)
Dementia 3 0
Dementia with Lewy bodies 1 0
Demyelinating disorders NEC

Report Run Date: 04-Mar-2021, Page 37

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Nervous system disorders cont'd
Nervous system disorders
Demyelination 1 0
Disturbances in consciousness NEC
Altered state of consciousness 4 0
Consciousness fluctuating 2 0
Depressed level of consciousness 6 0
Lethargy 676 0
Loss of consciousness 78 0
Sedation 3 0
Somnolence 210 0
Stupor 1 0
Syncope 278 0
Dyskinesias and movement disorders NEC
Akathisia 1 0
Bradykinesia 3 0
Dyskinesia 5 0
Extrapyramidal disorder 1 0
Fine motor skill dysfunction 2 0
Hypokinesia 4 0
Motor dysfunction 1 0
Movement disorder 8 0
Psychomotor hyperactivity 4 0
Dystonias
Dystonia 5 0
Writer's cramp 1 0
Encephalopathies NEC
Encephalopathy 1 0
Posterior reversible encephalopathy syndrome 1 0
Eye movement disorders
IIIrd nerve paralysis 2 0
VIth nerve paralysis 3 0
Facial cranial nerve disorders
Facial nerve disorder 1 0
Facial paralysis 135 0
Facial paresis 24 0
Facial spasm 10 0
Generalised tonic-clonic seizures
Generalised tonic-clonic seizure 5 0
Headaches NEC
Cervicogenic headache 1 0
Cluster headache 48 0
Cold-stimulus headache 2 0
Exertional headache 3 0
Headache 7776 0
Medication overuse headache 2 0
New daily persistent headache 2 0
Occipital neuralgia 2 0
Ophthalmoplegic migraine 1 0
Primary cough headache 2 0
Primary headache associated with sexual activity 1 0
Sinus headache 101 0
Tension headache 126 0
Thunderclap headache 1 0
Vascular headache 3 0

Report Run Date: 04-Mar-2021, Page 38

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Nervous system disorders cont'd
Nervous system disorders
Lumbar spinal cord and nerve root disorders
Sciatica 8 0
Memory loss (excl dementia)
Amnesia 11 0
Memory impairment 27 0
Transient global amnesia 1 0
Mental impairment (excl dementia and memory loss)
Cognitive disorder 9 0
Disturbance in attention 57 0
Mental impairment 7 0
Migraine headaches
Hemiplegic migraine 3 0
Migraine 529 0
Migraine with aura 30 0
Retinal migraine 8 0
Typical aura without headache 1 0
Vestibular migraine 1 0
Mononeuropathies
Carpal tunnel syndrome 2 0
Mononeuropathy 1 0
Nerve compression 3 0
Peroneal nerve palsy 2 0
Multiple sclerosis acute and progressive
Multiple sclerosis 5 0
Multiple sclerosis relapse 6 0
Muscle tone abnormal
Hypotonia 4 0
Muscle tone disorder 1 0
Serotonin syndrome 1 0
Stiff leg syndrome 1 0
Myelitis (incl infective)
Myelitis transverse 7 0
Narcolepsy and hypersomnia
Hypersomnia 21 0
Narcolepsy 1 0
Nervous system disorders NEC
Nervous system disorder 1 0
Neurologic visual problems NEC
Tunnel vision 4 0
Visual field defect 3 0
Neurological signs and symptoms NEC
Dizziness 2240 0
Dizziness exertional 11 0
Dizziness postural 192 0
Drooling 2 0
Head discomfort 53 0
Hyporesponsive to stimuli 1 0
Inability to crawl 1 0
Myoclonus 4 0
Neurological symptom 4 0
Persistent postural-perceptual dizziness 3 0
Presyncope 141 0
Slow response to stimuli 2 0

Report Run Date: 04-Mar-2021, Page 39

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Nervous system disorders cont'd
Nervous system disorders
Unresponsive to stimuli 15 0
Neuromuscular disorders NEC
Muscle contractions involuntary 5 0
Muscle spasticity 2 0
Neuromuscular pain 1 0
Neuromuscular junction dysfunction
Myasthenia gravis 2 0
Olfactory nerve disorders
Anosmia 61 0
Hyposmia 5 0
Parosmia 48 0
Optic nerve disorders NEC
Optic neuritis 4 0
Paraesthesias and dysaesthesias
Burning sensation 89 0
Dysaesthesia 3 0
Formication 8 0
Hemiparaesthesia 1 0
Hyperaesthesia 21 0
Hypoaesthesia 499 0
Paraesthesia 739 0
Synaesthesia 1 0
Paralysis and paresis (excl cranial nerve)
Diplegia 1 1
Hemiparesis 12 0
Hemiplegia 3 0
Locked-in syndrome 1 0
Monoparesis 16 0
Monoplegia 11 0
Paralysis 17 0
Paraparesis 1 0
Paresis 1 0
Parkinson's disease and parkinsonism
Freezing phenomenon 3 0
Parkinsonian gait 1 0
Parkinsonism 3 0
Partial complex seizures
Dreamy state 1 0
Temporal lobe epilepsy 1 0
Peripheral neuropathies NEC
Neuritis 2 0
Neuropathy peripheral 15 0
Peripheral sensory neuropathy 3 0
Seizures and seizure disorders NEC
Clonic convulsion 1 0
Epilepsy 21 0
Febrile convulsion 1 0
Partial seizures 2 0
Psychogenic seizure 3 0
Seizure 85 1
Seizure cluster 1 0
Status epilepticus 2 0
Tonic convulsion 5 0

Report Run Date: 04-Mar-2021, Page 40

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Nervous system disorders cont'd
Nervous system disorders
Sensory abnormalities NEC
Ageusia 127 0
Allodynia 3 0
Aura 7 0
Dysgeusia 334 0
Hypergeusia 1 0
Neuralgia 76 0
Phantom limb syndrome 1 0
Post herpetic neuralgia 2 0
Restless legs syndrome 22 0
Sensory disturbance 11 0
Sensory loss 10 0
Taste disorder 66 0
Sleep disturbances NEC
Poor quality sleep 45 0
Sleep deficit 2 0
Speech and language abnormalities
Dysarthria 28 0
Incoherent 1 0
Repetitive speech 1 0
Speech disorder 6 0
Spinal cord and nerve root disorders NEC
Radiculitis brachial 1 0
Radiculopathy 1 0
Structural brain disorders NEC
Brain injury 2 2
Transient cerebrovascular events
Transient ischaemic attack 18 0
Tremor (excl congenital)
Essential tremor 1 0
Resting tremor 1 0
Tremor 412 0
Trigeminal disorders
Facial neuralgia 9 0
Numb chin syndrome 1 0
Trigeminal nerve disorder 1 0
Trigeminal neuralgia 9 0
Nervous system disorders SOC TOTAL 16107 14

Report Run Date: 04-Mar-2021, Page 41

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Pregnancy conditions
Abortions spontaneous
Abortion spontaneous 16 0
Gestational age and weight conditions
Premature baby 1 1
Labour onset and length abnormalities
Premature delivery 1 0
Premature labour 1 0
Maternal complications of pregnancy NEC
Morning sickness 4 0
Preterm premature rupture of membranes 1 0
Normal pregnancy, labour and delivery
Pregnancy 5 0
Pregnancy conditions SOC TOTAL 29 1

Report Run Date: 04-Mar-2021, Page 42

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Device issues NEC
Device issue 1 0
Device malfunction events NEC
Device infusion issue 1 0
Device stimulation issue 1 0
Oversensing 5 0
Product physical issues
Product odour abnormal 1 0
Product taste abnormal 2 0
Product quality issues NEC
Product origin unknown 1 0
null SOC TOTAL 12 0

Report Run Date: 04-Mar-2021, Page 43

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Psychiatric disorders
Affect alterations NEC
Flat affect 1 0
Anxiety symptoms
Agitation 24 0
Anxiety 107 0
Nervousness 51 0
Stress 1 0
Tension 11 0
Behaviour and socialisation disturbances
Indifference 2 0
Paranoia 6 0
Social avoidant behaviour 2 0
Soliloquy 1 0
Bipolar disorders
Bipolar disorder 1 0
Cognitive and attention disorders and disturbances NEC
Daydreaming 1 0
Mental fatigue 36 0
Communications disorders
Communication disorder 2 0
Confusion and disorientation
Confusional state 171 0
Disorientation 57 0
Decreased physical activity levels
Catatonia 1 0
Deliria
Delirium 34 0
Delusional symptoms
Delusion 1 0
Depressive disorders
Depression 28 0
Dissociative states
Depersonalisation/derealisation disorder 2 0
Dissociation 4 0
Dissociative amnesia 1 0
Dissociative disorder 1 0
Disturbances in initiating and maintaining sleep
Initial insomnia 3 0
Insomnia 231 0
Middle insomnia 6 0
Terminal insomnia 1 0
Dyssomnias
Dyssomnia 1 0
Eating disorders NEC
Eating disorder 1 0
Emotional and mood disturbances NEC
Anger 3 0
Dysphoria 1 0
Emotional disorder 6 0
Emotional distress 6 0
Euphoric mood 5 0
Irritability 42 0
Mood altered 7 0

Report Run Date: 04-Mar-2021, Page 44

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Psychiatric disordersPsychiatric disorders cont'd
Fear symptoms and phobic disorders (incl social phobia)
Fear of falling 1 0
Phonophobia 1 0
Social fear 1 0
Fluctuating mood symptoms
Mood swings 5 0
Hallucinations (excl sleep-related)
Hallucination 50 0
Hallucination, auditory 3 0
Hallucination, olfactory 1 0
Hallucination, tactile 1 0
Hallucination, visual 5 0
Hallucinations, mixed 1 0
Increased physical activity levels
Restlessness 25 0
Mental disorders NEC
Mental disorder 2 0
Mental disorders due to a general medical condition NEC
Neuropsychiatric symptoms 1 0
Mood alterations with depressive symptoms
Decreased interest 3 0
Depressed mood 49 0
Feeling of despair 1 0
Feelings of worthlessness 1 0
Negative thoughts 1 0
Sense of a foreshortened future 2 0
Tearfulness 4 0
Mood alterations with manic symptoms
Hypomania 1 0
Mood disorders NEC
Apathy 4 0
Laziness 1 0
Listless 4 0
Narcolepsy and associated conditions
Sleep attacks 2 0
Obsessive-compulsive disorders and symptoms
Obsessive-compulsive symptom 1 0
Orgasmic disorders and disturbances
Anorgasmia 1 0
Panic attacks and disorders
Panic attack 24 0
Panic disorder 2 0
Panic reaction 5 0
Parasomnias
Abnormal dreams 43 0
Confusional arousal 1 0
Nightmare 35 0
Sleep terror 2 0
Perception disturbances NEC
Autoscopy 2 0
Derealisation 3 0
Flashback 1 0
Illusion 1 0

Report Run Date: 04-Mar-2021, Page 45

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Psychiatric disordersPsychiatric disorders cont'd
Psychiatric elimination disorders
Enuresis 4 0
Psychiatric symptoms NEC
Hypervigilance 1 0
Trance 1 0
Psychotic disorder NEC
Psychotic behaviour 1 0
Psychotic disorder 4 0
Sexual desire disorders
Loss of libido 1 0
Sleep disorders NEC
Sleep disorder 38 0
Somatic symptom disorders
Habit cough 5 0
Vomiting psychogenic 1 0
Speech and language usage disturbances
Disorganised speech 2 0
Logorrhoea 1 0
Speech articulation and rhythm disturbances
Dysphemia 1 0
Pressure of speech 1 0
Stereotypies and automatisms
Bruxism 3 0
Head banging 2 0
Stereotypy 1 0
Suicidal and self-injurious behaviour
Intentional self-injury 2 0
Suicidal ideation 1 0
Suicide attempt 1 0
Thinking disturbances
Bradyphrenia 10 0
Tachyphrenia 1 0
Thinking abnormal 3 0
Psychiatric disorders SOC TOTAL 1235 0

Report Run Date: 04-Mar-2021, Page 46

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Renal & urinary disorders
Bladder and urethral symptoms
Bladder discomfort 1 0
Dysuria 9 0
Incontinence 8 0
Micturition disorder 1 0
Micturition urgency 6 0
Pollakiuria 15 0
Urethral pain 1 0
Urinary incontinence 15 0
Urinary retention 14 0
Urine flow decreased 1 0
Bladder disorders NEC
Bladder disorder 3 0
Genital and urinary tract disorders NEC
Urinary tract disorder 2 0
Glomerulonephritis and nephrotic syndrome
Glomerulonephritis minimal lesion 1 0
Nephrotic syndrome 2 0
Myoneurogenic bladder disorders
Bladder dysfunction 1 0
Hypertonic bladder 1 0
Loss of bladder sensation 1 0
Neurogenic bladder 1 0
Nephritis NEC
Nephritis 1 0
Tubulointerstitial nephritis 1 0
Renal failure and impairment
Acute kidney injury 10 0
Anuria 1 0
Chronic kidney disease 1 0
Renal failure 3 0
Urinary abnormalities
Chromaturia 12 0
Haematuria 6 0
Proteinuria 2 0
Urine abnormality 4 0
Urine odour abnormal 2 0
Urinary tract signs and symptoms NEC
Costovertebral angle tenderness 1 0
Haemorrhage urinary tract 4 0
Nocturia 1 0
Polyuria 1 0
Renal pain 53 0
Urinary tract pain 1 0
Renal & urinary disorders SOC TOTAL 187 0

Report Run Date: 04-Mar-2021, Page 47

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Reproductive & breast disorders
Benign and malignant breast neoplasms
Breast cyst 2 0
Breast disorders NEC
Breast mass 7 0
Gynaecomastia 1 0
Breast signs and symptoms
Breast discomfort 2 0
Breast oedema 1 0
Breast pain 46 0
Breast swelling 10 0
Breast tenderness 6 0
Nipple pain 5 0
Nipple swelling 2 0
Erection and ejaculation conditions and disorders
Erectile dysfunction 7 0
Menopausal effects NEC
Menopausal symptoms 2 0
Menopausal effects on the genitourinary tract
Postmenopausal haemorrhage 1 0
Menstruation and uterine bleeding NEC
Dysmenorrhoea 18 0
Menstrual disorder 19 0
Menstruation irregular 17 0
Metrorrhagia 8 0
Premenstrual pain 2 0
Menstruation with decreased bleeding
Amenorrhoea 7 0
Hypomenorrhoea 11 0
Menstruation delayed 32 0
Oligomenorrhoea 1 0
Menstruation with increased bleeding
Menorrhagia 38 0
Polymenorrhoea 5 0
Ovarian and fallopian tube disorders NEC
Ovulation pain 3 0
Pelvis and broad ligament disorders NEC
Adnexa uteri pain 3 0
Pelvic haemorrhage 1 0
Penile disorders NEC (excl erection and ejaculation)
Penile swelling 3 0
Prostatic signs, symptoms and disorders NEC
Prostatomegaly 1 0
Reproductive tract disorders NEC (excl neoplasms)
Genital haemorrhage 1 0
Genital ulceration 2 0
Reproductive tract infections and inflammations NEC
Genital tract inflammation 1 0
Reproductive tract signs and symptoms NEC
Genital pain 2 0
Pelvic discomfort 2 0
Pelvic pain 7 0
Perineal pain 1 0
Scrotal disorders NEC

Report Run Date: 04-Mar-2021, Page 48

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Reproductive & breastReproductive
disorders & breast disorders cont'd
Scrotal erythema 1 0
Scrotal exfoliation 1 0
Scrotal pain 3 0
Scrotal swelling 3 0
Sexual function and fertility disorders NEC
Infertility 1 0
Spermatogenesis and semen disorders
Haematospermia 1 0
Testicular and epididymal disorders NEC
Testicular pain 5 0
Testicular swelling 3 0
Uterine disorders NEC
Endometriosis 2 0
Uterine pain 1 0
Uterine tone disorders
Uterine spasm 1 0
Vulvovaginal disorders NEC
Vaginal haemorrhage 34 0
Vulval ulceration 2 0
Vulvovaginal signs and symptoms
Vaginal discharge 1 0
Vulval oedema 1 0
Vulvovaginal pruritus 1 0
Reproductive & breast disorders SOC TOTAL 338 0

Report Run Date: 04-Mar-2021, Page 49

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Respiratory disorders
Breathing abnormalities
Apnoea 1 0
Dyspnoea 816 2
Dyspnoea at rest 1 0
Dyspnoea exertional 7 1
Hyperventilation 9 0
Hypopnoea 14 0
Irregular breathing 6 0
Mouth breathing 2 0
Orthopnoea 2 0
Respiration abnormal 16 0
Respiratory arrest 5 0
Respiratory distress 4 0
Sleep apnoea syndrome 1 0
Tachypnoea 14 0
Bronchial conditions NEC
Bronchial secretion retention 1 0
Bronchiectasis 3 0
Bronchospasm and obstruction
Asthma 76 0
Asthma late onset 1 0
Bronchospasm 6 0
Chronic obstructive pulmonary disease 5 0
Obstructive airways disorder 1 0
Reversible airways obstruction 1 0
Wheezing 101 0
Conditions associated with abnormal gas exchange
Hypoxia 9 1
Coughing and associated symptoms
Allergic cough 1 0
Cough 594 0
Haemoptysis 7 0
Productive cough 36 0
Sputum discoloured 1 0
Laryngeal and adjacent sites disorders NEC (excl infections and
neoplasms)
Laryngeal disorder 1 0
Laryngeal spasm, oedema and obstruction
Epiglottic oedema 1 0
Laryngeal obstruction 1 0
Laryngospasm 1 0
Stridor 8 0
Lower respiratory tract inflammatory and immunologic conditions
Hypersensitivity pneumonitis 1 0
Pneumonia aspiration 3 2
Pneumonitis 8 3
Lower respiratory tract signs and symptoms
Hiccups 3 0
Increased bronchial secretion 1 0
Pleuritic pain 4 0
Pulmonary pain 25 0
Rales 2 0
Nasal congestion and inflammations

Report Run Date: 04-Mar-2021, Page 50

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Respiratory disordersRespiratory disorders cont'd
Nasal congestion 52 0
Nasal inflammation 1 0
Rhinitis allergic 3 0
Nasal disorders NEC
Epistaxis 147 0
Intranasal hypoaesthesia 1 0
Intranasal paraesthesia 1 0
Nasal disorder 1 0
Nasal dryness 5 0
Nasal odour 4 0
Nasal oedema 1 0
Nasal pruritus 3 0
Paranasal sinus disorders (excl infections and neoplasms)
Allergic sinusitis 1 0
Paranasal sinus inflammation 1 0
Sinonasal obstruction 3 0
Sinus congestion 13 0
Sinus disorder 2 0
Parenchymal lung disorders NEC
Atelectasis 1 0
Emphysema 1 0
Pharyngeal disorders (excl infections and neoplasms)
Pharyngeal erythema 3 0
Pharyngeal haemorrhage 1 0
Pharyngeal hypoaesthesia 10 0
Pharyngeal inflammation 3 0
Pharyngeal oedema 4 0
Pharyngeal paraesthesia 25 0
Pharyngeal swelling 70 0
Pharyngeal ulceration 5 0
Tonsillar erythema 1 0
Tonsillar hypertrophy 21 0
Tonsillar inflammation 3 0
Pleural infections and inflammations
Pleurisy 4 0
Pneumothorax and pleural effusions NEC
Pleural effusion 1 0
Pneumothorax 1 0
Pulmonary oedemas
Pulmonary congestion 3 0
Pulmonary oedema 2 0
Pulmonary thrombotic and embolic conditions
Pulmonary embolism 13 1
Pulmonary infarction 1 0
Pulmonary thrombosis 1 0
Respiratory failures (excl neonatal)
Acute respiratory failure 2 1
Respiratory signs and symptoms NEC
Painful respiration 3 0
Respiratory symptom 3 0
Respiratory tract disorders NEC
Aspiration 2 1
Respiratory disorder 2 0

Report Run Date: 04-Mar-2021, Page 51

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Respiratory disordersRespiratory disorders cont'd
Respiratory tract irritation 1 0
Respiratory tract oedema 1 0
Thoracic musculoskeletal disorders
Respiratory muscle weakness 1 0
Tracheal disorders (excl infections and neoplasms)
Tracheal pain 1 0
Upper respiratory tract neoplasms
Tonsillar cyst 1 0
Upper respiratory tract signs and symptoms
Aphonia 16 0
Catarrh 7 0
Choking 3 0
Dry throat 47 0
Dysphonia 36 0
Increased upper airway secretion 3 0
Increased viscosity of upper respiratory secretion 3 0
Nasal discharge discolouration 1 0
Nasal discomfort 11 0
Nasal obstruction 2 0
Oropharyngeal blistering 6 0
Oropharyngeal discomfort 20 0
Oropharyngeal pain 698 0
Paranasal sinus discomfort 10 0
Rhinalgia 6 0
Rhinorrhoea 182 0
Sinus pain 49 0
Sneezing 90 0
Snoring 2 0
Throat clearing 3 0
Throat irritation 63 0
Throat tightness 81 0
Upper airway obstruction 2 0
Upper-airway cough syndrome 2 0
Yawning 2 0
Respiratory disorders SOC TOTAL 3575 12

Report Run Date: 04-Mar-2021, Page 52

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Skin disorders
Acnes
Acne 8 0
Alopecias
Alopecia 13 0
Angioedemas
Angioedema 54 0
Circumoral swelling 1 0
Apocrine and eccrine gland disorders
Cold sweat 173 0
Hyperhidrosis 464 0
Miliaria 18 0
Night sweats 172 0
Bullous conditions
Blister 63 0
Blood blister 2 0
Dermatitis bullous 4 0
Erythema multiforme 8 0
Fracture blisters 1 0
Pemphigoid 4 0
Pemphigus 2 0
Stevens-Johnson syndrome 2 0
Toxic epidermal necrolysis 2 1
Connective tissue disorders
Dermatomyositis 1 0
Dermal and epidermal conditions NEC
Acute febrile neutrophilic dermatosis 1 0
Dermatosis 1 0
Dry skin 38 0
Macule 2 0
Pain of skin 79 0
Papule 16 0
Pathergy reaction 1 0
Peau d'orange 2 0
Scar pain 4 0
Sensitive skin 45 0
Skin burning sensation 50 0
Skin discolouration 25 0
Skin discomfort 1 0
Skin disorder 1 0
Skin indentation 1 0
Skin induration 2 0
Skin lesion 8 0
Skin necrosis 1 0
Skin odour abnormal 2 0
Skin reaction 31 0
Skin sensitisation 5 0
Skin swelling 18 0
Skin tightness 12 0
Skin warm 85 0
Skin weeping 1 0
Sticky skin 1 0
Yellow skin 5 0
Dermatitis and eczema

Report Run Date: 04-Mar-2021, Page 53

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Skin disorders Skin disorders cont'd
Dermatitis 27 0
Dermatitis allergic 54 0
Dermatitis atopic 3 0
Dyshidrotic eczema 2 0
Eczema 31 0
Eczema asteatotic 1 0
Eczema nummular 2 0
Eczema weeping 1 0
Perioral dermatitis 1 0
Skin irritation 28 0
Dermatitis ascribed to specific agent
Drug eruption 11 0
Fixed eruption 1 0
Toxic skin eruption 1 0
Erythemas
Erythema 654 0
Red man syndrome 1 0
Exfoliative conditions
Dermatitis exfoliative 1 0
Exfoliative rash 2 0
Skin exfoliation 20 0
Hyperpigmentation disorders
Ephelides 1 0
Skin hyperpigmentation 1 0
Hypopigmentation disorders
Skin hypopigmentation 1 0
Lipodystrophies
Lipoatrophy 1 0
Nail and nail bed conditions (excl infections and infestations)
Nail discolouration 4 0
Nail disorder 1 0
Onychalgia 3 0
Panniculitides
Erythema nodosum 5 0
Papulosquamous conditions
Erythema annulare 1 0
Lichen planus 1 0
Pityriasis rosea 18 0
Photosensitivity and photodermatosis conditions
Photosensitivity reaction 9 0
Pigmentation changes NEC
Haemosiderin stain 1 0
Pigmentation disorder 2 0
Pilar disorders NEC
Piloerection 3 0
Pruritus NEC
Itching scar 4 0
Pruritus 1202 0
Psoriatic conditions
Psoriasis 15 0
Pustular psoriasis 1 0
Purpura and related conditions
Petechiae 23 0

Report Run Date: 04-Mar-2021, Page 54

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Skin disorders Skin disorders cont'd
Purpura 7 0
Rashes, eruptions and exanthems NEC
Rash 1224 0
Rash erythematous 276 0
Rash macular 125 0
Rash maculo-papular 19 0
Rash morbilliform 7 0
Rash papular 68 0
Rash pruritic 255 0
Rash vesicular 9 0
Systemic lupus erythematosus rash 1 0
Rosaceas
Rosacea 3 0
Scaly conditions
Pityriasis 5 0
Skin and subcutaneous conditions NEC
Cutaneous symptom 1 0
Skin mass 3 0
Skin and subcutaneous tissue ulcerations
Scleroderma associated digital ulcer 1 0
Skin erosion 9 0
Skin ulcer 1 0
Skin cysts and polyps
Dermal cyst 1 0
Skin haemorrhages
Haemorrhage subcutaneous 2 0
Skin haemorrhage 2 0
Skin hyperplasias and hypertrophies
Skin hypertrophy 1 0
Skin vasculitides
Cutaneous vasculitis 1 0
Vasculitic rash 2 0
Skin vasomotor conditions
Livedo reticularis 12 0
Urticarias
Chronic spontaneous urticaria 1 0
Cold urticaria 1 0
Idiopathic urticaria 1 0
Mechanical urticaria 1 0
Urticaria 430 0
Urticaria chronic 1 0
Urticaria papular 2 0
Urticaria thermal 2 0
Skin disorders SOC TOTAL 6042 1

Report Run Date: 04-Mar-2021, Page 55

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Social circumstances
Criminal activity
Verbal abuse 1 0
Disability issues
Bedridden 8 0
Breast prosthesis user 1 0
Immobile 2 0
Sight disability 1 0
Educational issues
Illiteracy 1 0
Pregnancy related circumstances
Breast feeding 1 0
Tobacco use
Non-tobacco user 1 0
Social circumstances SOC TOTAL 16 0

Report Run Date: 04-Mar-2021, Page 56

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Surgical & medical procedures
Bronchial and pulmonary therapeutic procedures
Airway secretion clearance therapy 1 0
Contraceptive methods male
Condom 1 0
Dietary and nutritional therapies
Diabetic diet 1 0
Medical diet 1 0
Gastrointestinal therapeutic procedures NEC
Prophylaxis of nausea and vomiting 5 0
Immunisations
COVID-19 immunisation 13 0
Immunisation 4 0
Joint therapeutic procedures
Joint surgery 1 0
Limb therapeutic procedures
Limb immobilisation 2 0
Limb operation 1 0
Mastectomies
Breast conserving surgery 1 0
Psychiatric therapies
Electroconvulsive therapy 1 0
Renal therapeutic procedures
Dialysis 1 0
Respiratory tract therapeutic procedures NEC
Asthma prophylaxis 2 0
Therapeutic procedures NEC
Abscess drainage 1 0
Anaphylaxis treatment 1 0
Bed rest 2 0
Fatigue management 1 0
Hospitalisation 1 0
Injection 2 0
Product used for unknown indication 1 0
Therapy change 1 0
Surgical & medical procedures SOC TOTAL 45 0

Report Run Date: 04-Mar-2021, Page 57

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
Report Run Date: 04-Mar-2021 Data Lock Date: 03-Mar-2021 19:00:03
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Vascular disorders
Accelerated and malignant hypertension
Hypertensive crisis 1 0
Aortic necrosis and vascular insufficiency
Aortic stenosis 1 0
Arterial infections and inflammations
Arteritis 1 0
Giant cell arteritis 2 0
Blood pressure disorders NEC
Blood pressure fluctuation 2 0
Labile blood pressure 2 0
Circulatory collapse and shock
CT hypotension complex 2 0
Circulatory collapse 27 0
Neurogenic shock 12 0
Peripheral circulatory failure 2 0
Shock 2 0
Haemorrhages NEC
Haematoma 10 0
Haemorrhage 18 1
Venous haemorrhage 1 0
Lymphangiopathies
Lymphocele 1 0
Lymphoedemas
Lymphoedema 32 0
Non-site specific embolism and thrombosis
Thrombosis 9 0
Non-site specific necrosis and vascular insufficiency NEC
Haemorrhagic infarction 1 0
Vasospasm 1 0
Non-site specific vascular disorders NEC
Superficial vein prominence 1 0
Vascular pain 2 0
Vasodilatation 5 0
Vein discolouration 1 0
Vein disorder 2 0
Vein rupture 2 0
Peripheral embolism and thrombosis
Blue toe syndrome 3 0
Deep vein thrombosis 7 0
Thrombophlebitis 2 0
Peripheral vascular disorders NEC
Cyanosis 13 0
Flushing 170 0
Hot flush 267 0
Peripheral vasoconstriction, necrosis and vascular insufficiency
Peripheral coldness 70 0
Peripheral ischaemia 1 0
Poor peripheral circulation 1 0
Raynaud's phenomenon 9 0
Vasoconstriction 1 0
Phlebitis NEC
Phlebitis 2 0
Site specific vascular disorders NEC

Report Run Date: 04-Mar-2021, Page 58

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