Case Series Drug Analysis Print

Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print

Report Run Date: 14-Jun-2021
Data Lock Date: 09-Jun-2021 19:00:03

All UK spontaneous reports received up to and including 09/06/2021 for

COVID-19 vaccine mRNA Pfizer BioNTech.

A report of a suspected ADR to the Yellow Card scheme does not necessarily
mean that it was caused by the vaccine, only that the reporter has a suspicion
it may have. Underlying or previously undiagnosed illness unrelated to vaccination
can also be factors in such reports. The relative number and nature of reports
should therefore not be used to compare the safety of the different vaccines.
All reports are kept under continual review in order to identify possible new risks.

Report Run Date: 14-Jun-2021, Page 1

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Blood disorders
Anaemia deficiencies
Anaemia vitamin B12 deficiency 2 0
Deficiency anaemia 1 0
Iron deficiency anaemia 3 0
Anaemias NEC
Anaemia 44 0
Anaemia megaloblastic 1 0
Autoimmune anaemia 2 0
Anaemias haemolytic NEC
Haemolytic anaemia 5 0
Anaemias haemolytic immune
Autoimmune haemolytic anaemia 8 1
Anaemias haemolytic mechanical factor
Microangiopathic haemolytic anaemia 1 0
Bleeding tendencies
Haemorrhagic diathesis 1 0
Increased tendency to bruise 19 0
Spontaneous haematoma 1 0
Coagulation factor deficiencies
Acquired haemophilia 2 0
Coagulopathies
Abnormal clotting factor 3 0
Antiphospholipid syndrome 4 0
Coagulopathy 5 0
Disseminated intravascular coagulation 1 0
Hypercoagulation 3 0
Thrombotic microangiopathy 2 0
Eosinophilic disorders
Eosinophilia 10 0
Haematological disorders
Mast cell activation syndrome 3 0
Methaemoglobinaemia 1 0
Haemolyses NEC
Haemolysis 7 0
Intravascular haemolysis 1 0
Leukocytoses NEC
Leukocytosis 1 0
Lymphocytosis 4 0
Neutrophilia 2 0
Leukopenias NEC
Leukopenia 3 0
Lymphopenia 2 0
Lymphatic system disorders NEC
Abdominal lymphadenopathy 2 0
Hilar lymphadenopathy 1 0
Lymph node pain 820 0
Lymphadenitis 96 0
Lymphadenopathy 5611 0
Lymphatic disorder 1 0
Necrotic lymphadenopathy 1 0
Pseudolymphoma 5 0
Retroperitoneal lymphadenopathy 1 0
Marrow depression and hypoplastic anaemias

Report Run Date: 14-Jun-2021, Page 2

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Blood disorders Blood disorders cont'd
Aplasia pure red cell 2 0
Myelosuppression 1 0
Pancytopenia 3 0
Neutropenias
Autoimmune neutropenia 2 0
Neutropenia 29 0
Platelet disorders NEC
Platelet anisocytosis 1 0
Purpuras (excl thrombocytopenic)
Purpura non-thrombocytopenic 1 0
Red blood cell abnormal findings NEC
Polychromasia 1 0
Red blood cell abnormality 2 0
Spleen disorders
Spleen atrophy 1 0
Splenic infarction 1 0
Splenic vein thrombosis 1 0
Splenomegaly 7 0
Thrombocytopenias
Immune thrombocytopenia 55 0
Thrombocytopenia 124 1
Thrombocytopenic purpura 2 0
Thrombotic thrombocytopenic purpura 6 0
Thrombocytoses
Thrombocytosis 4 0
Blood disorders SOC TOTAL 6923 2

Report Run Date: 14-Jun-2021, Page 3

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Cardiac disorders
Cardiac conduction disorders
Atrioventricular block 4 0
Atrioventricular block complete 1 0
Atrioventricular block second degree 1 0
Bundle branch block 2 0
Bundle branch block right 1 0
Cardiac disorders NEC
Acute cardiac event 3 0
Cardiac disorder 21 0
Cardiac dysfunction 1 0
Cardiovascular disorder 1 0
Intracardiac thrombus 2 0
Cardiac hypertensive complications
Hypertensive heart disease 1 0
Cardiac signs and symptoms NEC
Cardiac discomfort 3 0
Palpitations 1228 0
Cardiac valve disorders NEC
Cardiac valve disease 1 0
Cardiomyopathies
Cardiomyopathy 2 0
Congestive cardiomyopathy 2 0
Stress cardiomyopathy 2 0
Coronary artery disorders NEC
Coronary artery disease 4 2
Coronary artery occlusion 1 0
Coronary artery thrombosis 1 0
Heart failures NEC
Cardiac failure 28 4
Cardiac failure acute 2 0
Cardiac failure chronic 1 0
Cardiac failure congestive 3 1
Cardiogenic shock 4 0
Cardiopulmonary failure 1 1
Ischaemic coronary artery disorders
Acute coronary syndrome 3 0
Acute myocardial infarction 16 1
Angina pectoris 52 0
Angina unstable 1 0
Arteriospasm coronary 1 0
Microvascular coronary artery disease 2 0
Myocardial infarction 119 24
Myocardial ischaemia 6 2
Left ventricular failures
Acute left ventricular failure 1 1
Left ventricular failure 4 2
Mitral valvular disorders
Mitral valve incompetence 1 0
Mitral valve prolapse 1 0
Myocardial disorders NEC
Cardiac amyloidosis 1 0
Cardiomegaly 3 0
Left ventricular dysfunction 3 0

Report Run Date: 14-Jun-2021, Page 4

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Cardiac disorders Cardiac disorders cont'd
Myocardial fibrosis 1 0
Myocardial haemorrhage 1 0
Myocardial oedema 2 0
Myocardial rupture 1 0
Right ventricular enlargement 1 0
Ventricular hypertrophy 2 0
Noninfectious myocarditis
Myocarditis 39 0
Noninfectious pericarditis
Pericarditis 27 1
Pericardial disorders NEC
Pericardial effusion 7 0
Pericardial haemorrhage 2 2
Rate and rhythm disorders NEC
Arrhythmia 43 0
Bradycardia 36 0
Cardiac flutter 76 0
Extrasystoles 48 0
Paroxysmal arrhythmia 1 0
Postural orthostatic tachycardia syndrome 7 0
Tachyarrhythmia 1 0
Tachycardia 493 0
Right ventricular failures
Cor pulmonale 1 0
Supraventricular arrhythmias
Arrhythmia supraventricular 8 0
Atrial fibrillation 113 0
Atrial flutter 9 0
Atrial tachycardia 3 0
Nodal arrhythmia 1 0
Sinus arrest 1 0
Sinus bradycardia 3 0
Sinus tachycardia 33 0
Supraventricular tachycardia 21 0
Tricuspid valvular disorders
Tricuspid valve incompetence 1 0
Ventricular arrhythmias and cardiac arrest
Cardiac arrest 68 26
Cardio-respiratory arrest 1 1
Pulseless electrical activity 3 0
Ventricular arrhythmia 4 0
Ventricular extrasystoles 11 0
Ventricular fibrillation 5 1
Ventricular tachycardia 6 0
Cardiac disorders SOC TOTAL 2615 69

Report Run Date: 14-Jun-2021, Page 5

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Congenital disorders
Cardiac disorders congenital NEC
Heart disease congenital 5 0
Cardiac septal defects congenital
Hypertrophic cardiomyopathy 1 0
Central nervous system disorders congenital NEC
Spina bifida 1 0
Cerebellar disorders congenital
Hereditary ataxia 1 0
Cerebral disorders congenital
Cerebral palsy 1 0
Coagulation disorders congenital
Haemophilia 1 0
Connective tissue disorders congenital
Ehlers-Danlos syndrome 1 0
Gastrointestinal tract disorders congenital NEC
Gastroschisis 1 0
Great vessel disorders congenital
Transposition of the great vessels 1 0
Haematological disorders congenital NEC
Amegakaryocytic thrombocytopenia 1 0
Haemoglobinopathies congenital
Congenital methaemoglobinaemia 1 0
Thalassaemia minor 1 0
Lymphatic system disorders congenital
Cystic lymphangioma 1 0
Musculoskeletal and connective tissue disorders of skull congenital
Craniosynostosis 1 0
Musculoskeletal disorders congenital NEC
Congenital multiplex arthrogryposis 1 0
Neurological disorders congenital NEC
Familial hemiplegic migraine 2 0
Familial periodic paralysis 1 0
Moebius II syndrome 1 0
Peripheral nervous system disorders congenital NEC
Hereditary neuropathy with liability to pressure palsies 1 0
Pulmonary and bronchial disorders congenital
Congenital cystic lung 1 0
Retinal disorders congenital
Retinitis pigmentosa 1 0
Tongue disorders congenital
Ankyloglossia congenital 1 0
Congenital disorders SOC TOTAL 27 0

Report Run Date: 14-Jun-2021, Page 6

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Ear disorders
Ear disorders NEC
Ear canal erythema 1 0
Ear congestion 13 0
Ear discomfort 45 0
Ear disorder 11 0
Ear haemorrhage 6 0
Ear pain 510 0
Ear pruritus 6 0
Ear swelling 18 0
Otorrhoea 2 0
Eustachian tube disorders
Eustachian tube disorder 1 0
Eustachian tube dysfunction 6 0
Eustachian tube obstruction 1 0
External ear disorders NEC
Excessive cerumen production 1 0
External ear pain 2 0
Red ear syndrome 2 0
External ear infections and inflammations
External ear inflammation 2 0
Hearing disorders NEC
Auditory disorder 4 0
Hearing losses
Conductive deafness 1 0
Deafness 115 0
Deafness bilateral 5 0
Deafness neurosensory 11 0
Deafness transitory 3 0
Deafness unilateral 22 0
Hypoacusis 88 0
Sudden hearing loss 21 0
Hyperacusia
Hyperacusis 23 0
Misophonia 3 0
Inner ear disorders NEC
Acute vestibular syndrome 1 0
Inner ear disorder 7 0
Meniere's disease 7 0
Vestibular disorder 3 0
Inner ear infections and inflammations
Inner ear inflammation 3 0
Inner ear signs and symptoms
Motion sickness 30 0
Tinnitus 981 0
Vertigo 728 0
Vertigo labyrinthine 8 0
Vertigo positional 49 0
Mastoid disorders
Mastoid effusion 1 0
Middle ear disorders NEC
Middle ear disorder 3 0
Middle ear infections and inflammations
Middle ear inflammation 1 0

Report Run Date: 14-Jun-2021, Page 7

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Ear disorders Ear disorders cont'd
Ear disorders SOC TOTAL 2745 0

Report Run Date: 14-Jun-2021, Page 8

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Endocrine disorders
Acute and chronic thyroiditis
Thyroiditis 6 0
Thyroiditis subacute 2 0
Adrenal cortical hypofunctions
Addison's disease 1 0
Adrenocortical insufficiency acute 8 0
Adrenal gland disorders NEC
Adrenal haemorrhage 1 0
Endocrine abnormalities of puberty
Delayed menarche 1 0
Premature menarche 8 0
Female gonadal function disorders
Anovulatory cycle 7 0
Ovulation delayed 3 0
Thyroid disorders NEC
Autoimmune thyroid disorder 1 0
Goitre 7 0
Thyroid disorder 2 0
Thyroid pain 2 0
Thyroid hyperfunction disorders
Basedow's disease 1 0
Hyperthyroidism 15 0
Thyroid hypofunction disorders
Autoimmune hypothyroidism 1 0
Hypothyroidism 14 0
Endocrine disorders SOC TOTAL 80 0

Report Run Date: 14-Jun-2021, Page 9

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Eye disorders
Amblyopic vision impairment
Amblyopia 5 0
Cataract conditions
Cataract 5 0
Choroid and vitreous haemorrhages and vascular disorders
Choroidal haemorrhage 1 0
Choroidal neovascularisation 1 0
Vitreous haemorrhage 3 0
Choroid and vitreous structural change, deposit and degeneration
Chorioretinopathy 2 0
Vitreous detachment 15 0
Vitreous floaters 42 0
Colour blindness (incl acquired)
Dyschromatopsia 1 0
Conjunctival and corneal bleeding and vascular disorders
Conjunctival haemorrhage 25 0
Conjunctival infections, irritations and inflammations
Conjunctival hyperaemia 2 0
Conjunctival irritation 1 0
Conjunctival oedema 2 0
Corneal infections, oedemas and inflammations
Keratitis 4 0
Ulcerative keratitis 4 0
Eyelid movement disorders
Blepharospasm 62 0
Excessive eye blinking 1 0
Eyelid function disorder 2 0
Eyelid myokymia 2 0
Eyelid ptosis 26 0
Glaucomas (excl congenital)
Angle closure glaucoma 2 0
Glaucoma 5 0
Iris and ciliary body structural change, deposit and degeneration
Eye colour change 1 0
Iris and uveal tract infections, irritations and inflammations
Autoimmune uveitis 1 0
Iridocyclitis 7 0
Iritis 3 0
Uveitis 19 0
Lacrimation disorders
Dry eye 84 0
Lacrimation increased 81 0
Lid bleeding and vascular disorders
Eyelid bleeding 1 0
Lid, lash and lacrimal infections, irritations and inflammations
Blepharitis 7 0
Chalazion 3 0
Eczema eyelids 2 0
Erythema of eyelid 4 0
Eyelid cyst 3 0
Eyelid irritation 2 0
Eyelid margin crusting 3 0
Eyelid oedema 3 0

Report Run Date: 14-Jun-2021, Page 10

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Eye disorders Eye disorders cont'd
Eyelid rash 10 0
Swelling of eyelid 70 0
Lid, lash and lacrimal structural disorders
Dermatochalasis 1 0
Eyelash changes 1 0
Eyelid exfoliation 2 0
Eyelid skin dryness 1 0
Growth of eyelashes 2 0
Lagophthalmos 2 0
Ocular bleeding and vascular disorders NEC
Eye haematoma 3 0
Eye haemorrhage 13 0
Ocular vascular disorder 1 0
Ophthalmic vein thrombosis 1 0
Ocular disorders NEC
Dark circles under eyes 4 0
Eye disorder 15 0
Eye oedema 8 0
Eye pain 567 0
Eye swelling 280 0
Eye symptom 5 0
Eye ulcer 2 0
Eyelid disorder 5 0
Eyelid pain 8 0
Eyelids pruritus 3 0
Ocular discomfort 18 0
Periorbital oedema 14 0
Periorbital pain 1 0
Periorbital swelling 71 0
Retinal disorder 1 0
Vitreous disorder 1 0
Ocular infections, inflammations and associated manifestations
Eye allergy 4 0
Eye discharge 14 0
Eye inflammation 15 0
Eye irritation 60 0
Eye pruritus 147 0
Limbal swelling 2 0
Ocular hyperaemia 128 0
Ocular nerve and muscle disorders
Binocular eye movement disorder 1 0
Extraocular muscle disorder 1 0
Extraocular muscle paresis 1 0
Eye movement disorder 16 0
Ocular myasthenia 1 0
Ophthalmoplegia 2 0
Strabismus 2 0
Ocular sensation disorders
Abnormal sensation in eye 9 0
Asthenopia 87 0
Eye paraesthesia 1 0
Foreign body sensation in eyes 14 0
Hypoaesthesia eye 8 0

Report Run Date: 14-Jun-2021, Page 11

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Eye disorders Eye disorders cont'd
Photophobia 215 0
Optic disc abnormalities NEC
Papilloedema 3 0
Optic nerve bleeding and vascular disorders
Optic disc haemorrhage 1 0
Optic ischaemic neuropathy 2 0
Orbital infections, inflammations and irritations
Parophthalmia 1 0
Orbital structural change, deposit and degeneration
Orbital oedema 2 0
Pupil disorders
Miosis 2 0
Mydriasis 11 0
Pupil fixed 1 0
Pupils unequal 5 0
Retinal bleeding and vascular disorders (excl retinopathy)
Retinal artery occlusion 4 0
Retinal artery thrombosis 1 0
Retinal haemorrhage 2 0
Retinal vein occlusion 16 0
Retinal vein thrombosis 2 0
Retinal structural change, deposit and degeneration
Macular degeneration 1 0
Macular hole 1 0
Macular rupture 1 0
Maculopathy 1 0
Neovascular age-related macular degeneration 1 0
Retinal detachment 3 0
Retinal tear 1 0
Retinal toxicity 2 0
Retinal, choroid and vitreous infections and inflammations
Macular oedema 2 0
Retinal vasculitis 2 0
Retinopathies NEC
Retinal exudates 2 0
Retinopathy 1 0
Scleral infections, irritations and inflammations
Episcleritis 6 0
Scleritis 2 0
Scleral structural change, deposit and degeneration
Scleral discolouration 2 0
Visual colour distortions
Chloropsia 2 0
Cyanopsia 1 0
Erythropsia 2 0
Xanthopsia 1 0
Visual disorders NEC
Diplopia 90 0
Glare 1 0
Halo vision 6 0
Metamorphopsia 9 0
Oscillopsia 2 0
Photopsia 70 0

Report Run Date: 14-Jun-2021, Page 12

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Eye disorders Eye disorders cont'd
Scintillating scotoma 3 0
Vision blurred 593 0
Visual brightness 2 0
Visual snow syndrome 2 0
Visual field disorders
Visual field defect 10 0
Visual impairment and blindness (excl colour blindness)
Amaurosis fugax 1 0
Blindness 46 0
Blindness transient 6 0
Blindness unilateral 8 0
Central vision loss 2 0
Sudden visual loss 2 0
Visual acuity reduced 12 0
Visual impairment 170 0
Visual pathway disorders
Optic nerve disorder 1 0
Eye disorders SOC TOTAL 3398 0

Report Run Date: 14-Jun-2021, Page 13

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Gastrointestinal disorders
Abdominal findings abnormal
Abdominal mass 1 0
Gastrointestinal sounds abnormal 10 0
Abdominal hernias NEC
Abdominal hernia 1 0
Acute and chronic pancreatitis
Obstructive pancreatitis 1 0
Pancreatitis 4 0
Pancreatitis acute 6 0
Pancreatitis necrotising 1 0
Anal and rectal disorders NEC
Anal fissure 1 0
Anal sphincter atony 1 0
Anal and rectal pains
Proctalgia 7 0
Anal and rectal signs and symptoms
Anal hypoaesthesia 1 0
Anal spasm 1 0
Anorectal discomfort 3 0
Anorectal swelling 1 0
Rectal discharge 1 0
Benign oral cavity neoplasms
Mouth cyst 3 0
Tongue cyst 2 0
Colitis (excl infective)
Colitis 23 1
Colitis ischaemic 1 0
Colitis microscopic 1 0
Colitis ulcerative 40 0
Crohn's disease 21 0
Eosinophilic colitis 1 0
Dental and periodontal infections and inflammations
Dental caries 1 0
Dental disorders NEC
Teething 3 0
Tooth disorder 1 0
Dental pain and sensation disorders
Dental discomfort 3 0
Dental paraesthesia 7 0
Hyperaesthesia teeth 20 0
Toothache 74 0
Dental surface disorders
Tooth discolouration 1 0
Diaphragmatic hernias
Hiatus hernia 3 0
Diarrhoea (excl infective)
Diarrhoea 2933 2
Diarrhoea haemorrhagic 14 0
Diverticula
Diverticulum 2 0
Diverticulum intestinal 1 0
Duodenal and small intestinal stenosis and obstruction
Small intestinal obstruction 1 0

Report Run Date: 14-Jun-2021, Page 14

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Gastrointestinal disorders cont'd
Gastrointestinal disorders
Duodenal ulcers and perforation
Duodenal ulcer haemorrhage 1 0
Duodenal ulcer perforation 2 0
Dyspeptic signs and symptoms
Dyspepsia 188 0
Epigastric discomfort 10 0
Eructation 29 0
Faecal abnormalities NEC
Abnormal faeces 9 0
Faecaloma 1 0
Faeces discoloured 25 0
Faeces hard 1 0
Faeces pale 3 0
Faeces soft 9 0
Mucous stools 3 0
Flatulence, bloating and distension
Abdominal distension 163 0
Aerophagia 3 0
Flatulence 96 0
Gastric and oesophageal haemorrhages
Gastric haemorrhage 4 1
Mallory-Weiss syndrome 1 0
Oesophageal varices haemorrhage 1 0
Gastric ulcers and perforation
Gastric ulcer 3 0
Gastritis (excl infective)
Chronic gastritis 2 0
Gastritis 26 0
Reflux gastritis 4 0
Gastrointestinal and abdominal pains (excl oral and throat)
Abdominal migraine 2 0
Abdominal pain 671 0
Abdominal pain lower 45 0
Abdominal pain upper 1109 0
Abdominal rigidity 7 0
Abdominal tenderness 5 0
Gastrointestinal pain 72 0
Oesophageal pain 2 0
Gastrointestinal atonic and hypomotility disorders NEC
Constipation 128 0
Duodenogastric reflux 2 0
Gastric dilatation 3 0
Gastrooesophageal reflux disease 61 0
Impaired gastric emptying 5 0
Infrequent bowel movements 2 0
Intestinal pseudo-obstruction 2 0
Gastrointestinal disorders NEC
Food poisoning 1 0
Functional gastrointestinal disorder 5 0
Gastric disorder 4 0
Gastrointestinal disorder 8 0
Stomach mass 1 0
Gastrointestinal dyskinetic disorders

Report Run Date: 14-Jun-2021, Page 15

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Gastrointestinal disorders cont'd
Gastrointestinal disorders
Change of bowel habit 3 0
Dyschezia 1 0
Gastrointestinal motility disorder 1 0
Gastrointestinal fistulae
Diverticular fistula 1 0
Gastrointestinal inflammatory disorders NEC
Duodenitis 1 0
Enteritis 3 0
Epiploic appendagitis 1 0
Gastrointestinal inflammation 1 0
Intestinal angioedema 1 0
Gastrointestinal mucosal dystrophies and secretion disorders
Hyperchlorhydria 3 0
Gastrointestinal signs and symptoms NEC
Abdominal discomfort 346 0
Abdominal symptom 1 0
Acute abdomen 3 0
Anal incontinence 10 0
Breath odour 9 0
Dysphagia 109 1
Odynophagia 11 0
Gastrointestinal spastic and hypermotility disorders
Defaecation urgency 6 0
Frequent bowel movements 15 0
Irritable bowel syndrome 40 0
Oesophageal spasm 3 0
Pylorospasm 1 0
Gastrointestinal stenosis and obstruction NEC
Intestinal obstruction 2 0
Gastrointestinal vascular malformations
Gastric antral vascular ectasia 6 0
Gastrointestinal vascular occlusion and infarction
Intestinal ischaemia 3 2
Mesenteric vein thrombosis 4 0
Visceral venous thrombosis 1 0
Gingival disorders, signs and symptoms NEC
Gingival blister 8 0
Gingival discomfort 2 0
Gingival disorder 3 0
Gingival erythema 1 0
Gingival pain 57 0
Gingival pruritus 1 0
Gingival swelling 17 0
Gingivitis ulcerative 1 0
Noninfective gingivitis 4 0
Gingival haemorrhages
Gingival bleeding 28 0
Haemorrhoids and gastrointestinal varices (excl oesophageal)
Gastric varices 1 0
Haemorrhoids 17 0
Haemorrhoids thrombosed 1 0
Intestinal haemorrhages
Anal haemorrhage 10 0

Report Run Date: 14-Jun-2021, Page 16

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Gastrointestinal disorders cont'd
Gastrointestinal disorders
Rectal haemorrhage 38 0
Small intestinal haemorrhage 5 0
Intestinal ulcers and perforation NEC
Intestinal perforation 4 2
Large intestine perforation 1 0
Malabsorption syndromes
Bile acid malabsorption 1 0
Coeliac disease 7 0
Steatorrhoea 3 0
Nausea and vomiting symptoms
Discoloured vomit 8 0
Nausea 8065 1
Regurgitation 1 0
Retching 51 0
Vomiting 2284 2
Vomiting projectile 36 0
Non-mechanical ileus
Ileus paralytic 1 0
Non-site specific gastrointestinal haemorrhages
Gastrointestinal haemorrhage 11 0
Haematemesis 22 2
Haematochezia 24 0
Melaena 7 0
Upper gastrointestinal haemorrhage 2 0
Oesophageal stenosis and obstruction
Oesophageal stenosis 2 0
Oesophagitis (excl infective)
Eosinophilic oesophagitis 1 0
Oesophagitis 1 0
Oral dryness and saliva altered
Aptyalism 2 0
Dry mouth 326 0
Lip dry 27 0
Saliva altered 2 0
Salivary hypersecretion 26 0
Oral soft tissue disorders NEC
Angina bullosa haemorrhagica 1 0
Chapped lips 13 0
Cheilitis 19 0
Enlarged uvula 9 0
Lip blister 15 0
Lip disorder 4 0
Oral disorder 7 0
Oral lichen planus 3 0
Oral mucosal hypertrophy 1 0
Oral papule 1 0
Uvulitis 2 0
Oral soft tissue haemorrhages
Mouth haemorrhage 6 0
Oral blood blister 8 0
Oral purpura 1 0
Oral soft tissue infections
Angular cheilitis 1 0

Report Run Date: 14-Jun-2021, Page 17

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Gastrointestinal disorders cont'd
Gastrointestinal disorders
Oral soft tissue signs and symptoms
Anaesthesia oral 1 0
Burning mouth syndrome 4 0
Coating in mouth 1 0
Hypoaesthesia oral 287 0
Lip discolouration 2 0
Lip erythema 1 0
Lip exfoliation 5 0
Lip pain 36 0
Lip pruritus 7 0
Lip scab 1 0
Oral discomfort 50 0
Oral dysaesthesia 1 0
Oral mucosal blistering 10 0
Oral mucosal discolouration 1 0
Oral mucosal eruption 10 0
Oral mucosal erythema 3 0
Oral mucosal exfoliation 6 0
Oral mucosal roughening 3 0
Oral pain 109 0
Oral pruritus 15 0
Paraesthesia oral 658 0
Pigmentation lip 1 0
Oral soft tissue swelling and oedema
Lip oedema 3 0
Lip swelling 429 0
Mouth swelling 55 0
Oedema mouth 4 0
Palatal oedema 2 0
Palatal swelling 1 0
Peptic ulcers and perforation
Peptic ulcer haemorrhage 6 0
Peritoneal and retroperitoneal disorders
Ascites 1 0
Peritoneal and retroperitoneal fibrosis and adhesions
Abdominal adhesions 1 0
Peritoneal and retroperitoneal haemorrhages
Haemoperitoneum 1 0
Retroperitoneal haemorrhage 1 1
Rectal inflammations NEC
Proctitis 1 0
Proctitis ulcerative 1 0
Salivary gland disorders NEC
Salivary gland pain 8 0
Salivary gland enlargements
Parotid gland enlargement 6 0
Salivary gland enlargement 3 0
Submaxillary gland enlargement 6 0
Salivary gland infections and inflammations
Noninfective sialoadenitis 1 0
Stomatitis and ulceration
Aphthous ulcer 27 0
Lip ulceration 10 0

Report Run Date: 14-Jun-2021, Page 18

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Gastrointestinal disorders cont'd
Gastrointestinal disorders
Mouth ulceration 249 0
Oral mucosa erosion 1 0
Palatal ulcer 1 0
Stomatitis 39 0
Tongue disorders
Glossitis 10 0
Plicated tongue 2 0
Tongue disorder 22 0
Tongue haemorrhage 1 0
Tongue ulceration 18 0
Trichoglossia 2 0
Tongue signs and symptoms
Glossodynia 129 0
Scalloped tongue 4 0
Stiff tongue 2 0
Swollen tongue 314 0
Tongue blistering 10 0
Tongue coated 11 0
Tongue discolouration 18 0
Tongue discomfort 28 0
Tongue dry 11 0
Tongue eruption 8 0
Tongue erythema 4 0
Tongue exfoliation 1 0
Tongue movement disturbance 3 0
Tongue oedema 18 0
Tongue pruritus 1 0
Tongue rough 2 0
Tongue spasm 6 0
Gastrointestinal disorders SOC TOTAL 20395 15

Report Run Date: 14-Jun-2021, Page 19

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
General disorders
Administration site reactions NEC
Administration site bruise 4 0
Administration site erythema 2 0
Administration site extravasation 2 0
Administration site haematoma 3 0
Administration site inflammation 1 0
Administration site irritation 1 0
Administration site joint discomfort 1 0
Administration site joint movement impairment 1 0
Administration site pain 12 0
Administration site rash 1 0
Administration site swelling 2 0
Administration site warmth 2 0
Puncture site bruise 16 0
Puncture site pain 5 0
Puncture site reaction 1 0
Puncture site swelling 2 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 16 0
Application and instillation site reactions
Application site acne 2 0
Application site bruise 4 0
Application site burn 1 0
Application site erythema 8 0
Application site haemorrhage 1 0
Application site hypoaesthesia 1 0
Application site irritation 1 0
Application site joint erythema 1 0
Application site joint pain 1 0
Application site mass 1 0
Application site odour 1 0
Application site pain 7 0
Application site pruritus 4 0
Application site rash 2 0
Application site reaction 1 0
Application site swelling 2 0
Application site vesicles 3 0
Instillation site warmth 2 0
Asthenic conditions
Asthenia 901 1
Chronic fatigue syndrome 36 0
Decreased activity 2 0
Fatigue 12612 0
Malaise 2915 0
Sluggishness 7 0
Body temperature altered
Hyperthermia 5 0
Hypothermia 18 0
Temperature regulation disorder 6 0
Breast complications associated with device

Report Run Date: 14-Jun-2021, Page 20

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
General disorders General disorders cont'd
Capsular contracture associated with breast implant 1 0
Complications associated with device NEC
Capsular contracture associated with implant 1 0
Injury associated with device 2 0
Medical device pain 1 0
Medical device site swelling 1 0
Death and sudden death
Clinical death 1 1
Death 126 126
Sudden death 23 23
Febrile disorders
Hyperpyrexia 6 0
Pyrexia 8572 0
Feelings and sensations NEC
Chills 5805 0
Feeling abnormal 722 0
Feeling cold 718 0
Feeling drunk 44 0
Feeling hot 653 0
Feeling jittery 12 0
Feeling of body temperature change 182 0
Hangover 37 0
Hunger 14 0
Sensation of foreign body 31 0
Temperature intolerance 19 0
Thirst 186 0
Gait disturbances
Gait disturbance 87 0
Gait inability 36 0
Loss of control of legs 9 0
General signs and symptoms NEC
Adhesion 1 0
Condition aggravated 85 0
Crepitations 1 0
Crying 57 0
Deformity 2 0
Developmental delay 1 0
Discharge 2 0
Disease progression 2 0
Disease recurrence 15 0
Effusion 2 0
Energy increased 9 0
Exercise tolerance decreased 4 0
Foaming at mouth 1 0
General physical health deterioration 11 1
General symptom 1 0
Glassy eyes 2 0
High-pitched crying 2 0
Illness 912 0
Induration 3 0
Influenza like illness 1429 0
Irritability postvaccinal 2 0
Local reaction 65 0

Report Run Date: 14-Jun-2021, Page 21

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
General disorders General disorders cont'd
Moaning 1 0
Multiple organ dysfunction syndrome 3 1
Nonspecific reaction 1 0
Peripheral swelling 1887 0
Pre-existing condition improved 8 0
Prolapse 1 0
Screaming 8 0
Secretion discharge 6 0
Swelling 1423 0
Swelling face 488 0
Symptom recurrence 1 0
Implant and catheter site reactions
Implant site discolouration 2 0
Implant site pain 1 0
Implant site rash 1 0
Implant site swelling 1 0
Implant site warmth 1 0
Inflammations
Granuloma 1 0
Inflammation 174 0
Papillitis 1 0
Serositis 1 0
Systemic inflammatory response syndrome 1 0
Infusion site reactions
Infusion site coldness 1 0
Infusion site joint pain 2 0
Infusion site mass 1 0
Infusion site pain 1 0
Infusion site swelling 1 0
Infusion site urticaria 1 0
Infusion site warmth 1 0
Injection site reactions
Injected limb mobility decreased 20 0
Injection site bruising 37 0
Injection site coldness 1 0
Injection site cyst 2 0
Injection site discolouration 4 0
Injection site discomfort 9 0
Injection site erythema 225 0
Injection site haemorrhage 4 0
Injection site hypoaesthesia 8 0
Injection site indentation 2 0
Injection site induration 2 0
Injection site inflammation 23 0
Injection site joint discomfort 1 0
Injection site joint movement impairment 1 0
Injection site joint pain 11 0
Injection site lymphadenopathy 1 0
Injection site macule 1 0
Injection site mass 282 0
Injection site necrosis 3 0
Injection site oedema 11 0
Injection site pain 1864 0

Report Run Date: 14-Jun-2021, Page 22

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
General disorders General disorders cont'd
Injection site paraesthesia 9 0
Injection site pruritus 107 0
Injection site rash 84 0
Injection site reaction 20 0
Injection site scab 2 0
Injection site scar 3 0
Injection site swelling 198 0
Injection site urticaria 16 0
Injection site vesicles 7 0
Injection site warmth 102 0
Interactions
Alcohol interaction 2 0
Drug interaction 16 0
Mass conditions NEC
Cyst 12 0
Mass 24 0
Nodule 17 0
Mucosal findings abnormal
Mucosa vesicle 1 0
Mucosal dryness 1 0
Mucosal haemorrhage 5 0
Mucosal inflammation 1 0
Oedema mucosal 1 0
Polyp 1 0
Necrosis NEC
Fat necrosis 1 0
Necrosis 1 0
Oedema NEC
Face oedema 21 0
Generalised oedema 1 0
Localised oedema 14 0
Oedema 33 0
Oedema peripheral 49 0
Pain and discomfort NEC
Axillary pain 1291 0
Chest discomfort 722 0
Chest pain 1255 0
Discomfort 163 0
Facial discomfort 11 0
Facial pain 118 0
Inflammatory pain 3 0
Non-cardiac chest pain 16 0
Pain 4184 0
Suprapubic pain 1 0
Tenderness 397 0
Visceral pain 1 0
Therapeutic and nontherapeutic responses
Adverse drug reaction 15 0
Adverse event 3 0
Adverse reaction 8 0
Drug ineffective 139 1
Immediate post-injection reaction 2 0
Inadequate analgesia 4 0

Report Run Date: 14-Jun-2021, Page 23

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
General disorders General disorders cont'd
No reaction on previous exposure to drug 33 0
Product intolerance 1 0
Therapeutic product effect delayed 2 0
Therapeutic product effect increased 1 0
Therapeutic product ineffective 2 0
Therapeutic response decreased 2 0
Therapeutic response unexpected 37 0
Treatment failure 5 0
Vaccination failure 6 0
Trophic disorders
Calcinosis 1 0
Ulcers NEC
Ulcer 10 0
Vaccination site reactions
Extensive swelling of vaccinated limb 9 0
Shoulder injury related to vaccine administration 10 0
Vaccination site bruising 72 0
Vaccination site coldness 1 0
Vaccination site cyst 2 0
Vaccination site dermatitis 1 0
Vaccination site discolouration 9 0
Vaccination site discomfort 35 0
Vaccination site dryness 1 0
Vaccination site eczema 1 0
Vaccination site erythema 385 0
Vaccination site granuloma 1 0
Vaccination site haematoma 1 0
Vaccination site haemorrhage 9 0
Vaccination site hypersensitivity 2 0
Vaccination site hypoaesthesia 10 0
Vaccination site induration 58 0
Vaccination site inflammation 40 0
Vaccination site irritation 7 0
Vaccination site joint discomfort 2 0
Vaccination site joint erythema 6 0
Vaccination site joint movement impairment 12 0
Vaccination site joint pain 23 0
Vaccination site joint swelling 2 0
Vaccination site joint warmth 1 0
Vaccination site lymphadenopathy 3 0
Vaccination site macule 1 0
Vaccination site mass 144 0
Vaccination site movement impairment 49 0
Vaccination site nerve damage 1 0
Vaccination site nodule 1 0
Vaccination site oedema 3 0
Vaccination site pain 1374 0
Vaccination site paraesthesia 4 0
Vaccination site pruritus 94 0
Vaccination site rash 70 0
Vaccination site reaction 22 0
Vaccination site scab 1 0
Vaccination site swelling 377 0

Report Run Date: 14-Jun-2021, Page 24

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
General disorders General disorders cont'd
Vaccination site ulcer 1 0
Vaccination site urticaria 8 0
Vaccination site vesicles 2 0
Vaccination site warmth 189 0
Withdrawal and rebound effects
Drug withdrawal syndrome 4 0
Withdrawal syndrome 13 0
General disorders SOC TOTAL 55292 154

Report Run Date: 14-Jun-2021, Page 25

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Hepatic disorders
Bile duct infections and inflammations
Biliary colic 3 0
Cholangitis 1 0
Cholecystitis and cholelithiasis
Cholelithiasis 5 0
Cholestasis and jaundice
Cholestasis 2 0
Cholestasis of pregnancy 1 0
Jaundice 13 0
Jaundice cholestatic 2 0
Gallbladder disorders NEC
Gallbladder disorder 1 0
Hepatic and hepatobiliary disorders NEC
Liver disorder 5 0
Hepatic enzymes and function abnormalities
Hepatic function abnormal 1 0
Hepatic failure and associated disorders
Acute hepatic failure 1 0
Hepatic failure 1 0
Hepatic fibrosis and cirrhosis
Hepatic cirrhosis 1 0
Hepatic vascular disorders
Congestive hepatopathy 1 0
Hepatic artery embolism 1 0
Hepatic haemorrhage 1 0
Hepatic vein thrombosis 5 0
Portal vein thrombosis 2 0
Hepatobiliary signs and symptoms
Hepatic pain 11 0
Liver tenderness 3 0
Hepatocellular damage and hepatitis NEC
Autoimmune hepatitis 3 0
Drug-induced liver injury 3 0
Hepatitis 7 0
Immune-mediated hepatic disorder 1 0
Liver injury 8 0
Hepatic disorders SOC TOTAL 83 0

Report Run Date: 14-Jun-2021, Page 26

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Immune system disorders
Acute and chronic sarcoidosis
Sarcoidosis 10 0
Allergic conditions NEC
Allergic oedema 10 0
Allergy to arthropod bite 2 0
Allergy to arthropod sting 1 0
Allergy to metals 1 0
Hypersensitivity 536 0
Mite allergy 1 0
Multiple allergies 5 0
Serum sickness 2 0
Serum sickness-like reaction 3 0
Type I hypersensitivity 1 0
Type III immune complex mediated reaction 1 0
Type IV hypersensitivity reaction 6 0
Allergies to foods, food additives, drugs and other chemicals
Allergic reaction to excipient 4 0
Allergy to chemicals 2 0
Allergy to vaccine 27 0
Contrast media allergy 1 0
Contrast media reaction 1 0
Drug hypersensitivity 16 0
Food allergy 11 0
Oral allergy syndrome 2 0
Reaction to colouring 1 0
Reaction to excipient 5 0
Reaction to preservatives 3 0
Rubber sensitivity 1 0
Anaphylactic and anaphylactoid responses
Anaphylactic reaction 328 2
Anaphylactic shock 26 0
Anaphylactoid reaction 18 0
Anaphylactoid shock 4 0
Atopic disorders
Atopy 1 0
Seasonal allergy 25 0
Autoimmune disorders NEC
Autoimmune disorder 20 0
Immune and associated conditions NEC
Bacille Calmette-Guerin scar reactivation 19 0
Graft versus host disease 1 0
Immune system disorder 13 0
Immune-mediated adverse reaction 4 0
Immunisation reaction 1 0
Sensitisation 2 0
Systemic immune activation 2 0
Immunodeficiency disorders NEC
Hypogammaglobulinaemia 1 0
Immunodeficiency 1 0
Transplant rejections
Corneal graft rejection 4 0
Kidney transplant rejection 1 0
Solid organ transplant rejection 1 0

Report Run Date: 14-Jun-2021, Page 27

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Immune system disorders cont'd
Immune system disorders
Immune system disorders SOC TOTAL 1125 2

Report Run Date: 14-Jun-2021, Page 28

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Infections
Abdominal and gastrointestinal infections
Abdominal abscess 1 0
Abdominal infection 1 0
Anal abscess 1 0
Appendicitis 15 0
Appendicitis perforated 1 0
Diverticulitis 4 0
Dysentery 1 0
Gastric infection 2 0
Gastroenteritis 21 0
Mesenteric abscess 1 0
Peritonitis 1 1
Rectal abscess 1 0
Aspergillus infections
Bronchopulmonary aspergillosis 1 0
Bacterial infections NEC
Arthritis bacterial 2 0
Bacterial diarrhoea 1 0
Bacterial infection 3 0
Cellulitis 117 0
Conjunctivitis bacterial 1 0
Ear infection bacterial 1 0
Folliculitis 8 0
Injection site cellulitis 2 0
Meningitis bacterial 2 0
Paronychia 1 0
Perichondritis 1 0
Periorbital cellulitis 1 0
Tonsillitis bacterial 2 0
Urinary tract infection bacterial 1 0
Vaccination site cellulitis 14 0
Bartonella infections
Cat scratch disease 1 0
Bone and joint infections
Abscess jaw 1 0
Osteomyelitis 1 0
Borrelial infections
Lyme disease 1 0
Relapsing fever 1 0
Breast infections
Breast abscess 2 0
Mastitis 28 0
Caliciviral infections
Gastroenteritis norovirus 1 0
Campylobacter infections
Campylobacter gastroenteritis 1 0
Candida infections
Anal candidiasis 2 0
Candida infection 19 0
Oral candidiasis 28 0
Systemic candida 1 0
Vulvovaginal candidiasis 17 0
Central nervous system and spinal infections

Report Run Date: 14-Jun-2021, Page 29

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Infections Infections cont'd
Cavernous sinus thrombosis 1 0
Encephalitis 12 0
Meningitis 4 0
Meningitis aseptic 1 0
Myelitis 4 0
Clostridia infections
Clostridium difficile infection 2 0
Coronavirus infections
Asymptomatic COVID-19 10 0
COVID-19 670 32
COVID-19 pneumonia 26 12
Coronavirus infection 6 0
Severe acute respiratory syndrome 1 0
Suspected COVID-19 38 1
Coxiella infections
Q fever 9 0
Dental and oral soft tissue infections
Abscess oral 3 0
Gingivitis 7 0
Parotitis 7 0
Pulpitis dental 1 0
Sialoadenitis 3 0
Tooth abscess 6 0
Tooth infection 4 0
Ear infections
Ear infection 46 0
Labyrinthitis 58 0
Mastoiditis 1 0
Otitis media 2 0
Otitis media acute 1 0
Ectoparasitic infestations
Acarodermatitis 3 0
Bed bug infestation 1 0
Epstein-Barr viral infections
Epstein-Barr virus infection 1 0
Infectious mononucleosis 15 0
Eye and eyelid infections
Conjunctivitis 41 0
Eye abscess 1 0
Eye infection 12 0
Eyelid infection 2 0
Hordeolum 14 0
Periorbital infection 2 0
Female reproductive tract infections
Bartholinitis 1 0
Endometritis 1 0
Vulval abscess 1 0
Fungal infections NEC
Fungal infection 5 0
Fungal skin infection 1 0
Onychomycosis 1 0
Pneumonia fungal 1 0
Vulvovaginal mycotic infection 2 0

Report Run Date: 14-Jun-2021, Page 30

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Infections Infections cont'd
Hepatitis virus infections
Hepatitis A 1 0
Hepatitis E 1 0
Hepatobiliary and spleen infections
Biliary sepsis 1 0
Herpes viral infections
Disseminated varicella zoster virus infection 1 0
Eczema herpeticum 2 0
Genital herpes 39 0
Genital herpes simplex 4 0
Herpes ophthalmic 3 0
Herpes simplex 14 0
Herpes simplex encephalitis 1 1
Herpes simplex reactivation 2 0
Herpes virus infection 5 0
Herpes zoster 903 0
Herpes zoster meningoencephalitis 1 0
Herpes zoster oticus 7 0
Herpes zoster reactivation 1 0
Nasal herpes 3 0
Ophthalmic herpes zoster 2 0
Oral herpes 193 0
Varicella 17 0
Varicella zoster virus infection 1 0
Infections NEC
Abscess 24 0
Abscess limb 3 0
Abscess soft tissue 1 0
Genital abscess 1 0
Infected bite 1 0
Infected cyst 1 0
Infection 128 0
Injection site abscess 1 0
Injection site infection 4 0
Localised infection 17 0
Lymph gland infection 5 0
Lymph node abscess 2 0
Respiratory tract infection 4 0
Vaccination site abscess 3 0
Vaccination site infection 11 0
Vaccine breakthrough infection 23 0
Vestibulitis 2 0
Infectious transmissions
Secondary transmission 2 0
Influenza viral infections
Influenza 884 0
Klebsiella infections
Klebsiella infection 1 0
Lower respiratory tract and lung infections
Bronchitis 9 0
Infectious pleural effusion 1 0
Lower respiratory tract infection 111 7
Pneumonia 65 9

Report Run Date: 14-Jun-2021, Page 31

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Infections Infections cont'd
Sputum purulent 1 0
Male reproductive tract infections
Epididymitis 2 0
Orchitis 3 0
Prostate infection 1 0
Mumps viral infections
Mumps 5 0
Muscle and soft tissue infections
Infective tenosynovitis 1 0
Necrotising fasciitis 1 0
Soft tissue infection 1 0
Neisseria infections
Gonorrhoea 1 0
Pneumocystis infections
Pneumocystis jirovecii pneumonia 1 0
Polyomavirus infections
Progressive multifocal leukoencephalopathy 1 0
Prion-associated disorders
Creutzfeldt-Jakob disease 1 0
Retroviral infections
HIV infection 1 0
Rotaviral infections
Gastroenteritis rotavirus 1 0
Rubeola viral infections
Measles 2 0
Sepsis, bacteraemia, viraemia and fungaemia NEC
Bacteraemia 1 0
Neutropenic sepsis 2 0
Sepsis 28 3
Sepsis syndrome 1 0
Septic shock 4 1
Urosepsis 3 0
Skin structures and soft tissue infections
Abscess sweat gland 1 0
Acne pustular 1 0
Dermatitis infected 1 0
Impetigo 3 0
Infected skin ulcer 1 0
Injection site pustule 1 0
Pustule 8 0
Rash pustular 9 0
Skin infection 21 0
Subcutaneous abscess 6 0
Vaccination site pustule 2 0
Staphylococcal infections
Furuncle 27 0
Pneumonia staphylococcal 1 0
Staphylococcal abscess 1 0
Staphylococcal infection 2 0
Staphylococcal sepsis 1 0
Streptococcal infections
Meningitis pneumococcal 1 0
Pharyngitis streptococcal 5 0

Report Run Date: 14-Jun-2021, Page 32

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Infections Infections cont'd
Streptococcal abscess 1 0
Streptococcal endocarditis 1 0
Streptococcal sepsis 1 0
Tinea infections
Body tinea 1 0
Tinea infection 1 0
Tinea versicolour 1 0
Treponema infections
Syphilis 1 0
Trypanosomal infections
African trypanosomiasis 1 0
Tuberculous infections
Lymph node tuberculosis 1 0
Pulmonary tuberculosis 1 0
Upper respiratory tract infections
Acute sinusitis 2 0
Croup infectious 1 0
Epiglottitis 1 0
Laryngitis 16 0
Nasopharyngitis 486 0
Pharyngitis 13 0
Rhinitis 32 0
Sinusitis 74 0
Tonsillitis 50 0
Tracheitis 4 0
Upper respiratory tract infection 3 0
Urinary tract infections
Cystitis 38 0
Kidney infection 12 0
Pyelonephritis 1 0
Urinary tract infection 76 0
Vascular infections
Haematoma infection 1 0
Infusion site infection 1 0
Lymphangitis 5 0
Viral infections NEC
Arthritis viral 1 0
Conjunctivitis viral 2 0
Encephalitis viral 3 0
Eye infection viral 2 0
Gastroenteritis viral 12 0
Hepatitis viral 2 0
Meningitis viral 7 0
Oral viral infection 1 0
Pneumonia viral 1 1
Post viral fatigue syndrome 25 0
Sweating fever 59 0
Vestibular neuronitis 14 0
Viral diarrhoea 1 0
Viral infection 28 0
Viral labyrinthitis 3 0
Viral pericarditis 1 0
Viral pharyngitis 8 0

Report Run Date: 14-Jun-2021, Page 33

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Infections Infections cont'd
Viral rash 32 0
Viral sinusitis 1 0
Viral tonsillitis 1 0
Infections SOC TOTAL 5030 68

Report Run Date: 14-Jun-2021, Page 34

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Injuries
Abdominal and gastrointestinal injuries NEC
Mouth injury 3 0
Oral contusion 1 0
Palate injury 1 0
Rectal injury 1 0
Splenic rupture 3 0
Tongue injury 1 0
Tooth fracture 1 0
Accidental exposures to product
Accidental exposure to product 14 0
Anaesthetic and allied procedural complications
Delayed recovery from anaesthesia 3 0
Sedation complication 1 0
Atmospheric pressure injuries
Barotitis media 1 0
Hypobarism 1 0
Bone and joint injuries NEC
Joint injury 3 0
Cardiovascular injuries
Heart injury 2 0
Vascular injury 3 0
Cerebral injuries NEC
Brain contusion 1 0
Concussion 1 0
Craniocerebral injury 1 0
Subdural haematoma 4 0
Subdural haemorrhage 4 0
Traumatic intracranial haemorrhage 1 1
Chemical injuries
Chemical cystitis 1 0
Chest and respiratory tract injuries NEC
Chest crushing 7 0
Foreign body in throat 1 0
Conditions caused by cold
Chillblains 39 0
Cranial nerve injuries
Vth nerve injury 1 0
Ear injuries NEC
Ear injury 1 0
Exposures associated with pregnancy, delivery and lactation
Exposure during pregnancy 8 0
Exposure via breast milk 20 0
Foetal exposure during pregnancy 13 0
Maternal exposure before pregnancy 1 0
Maternal exposure during breast feeding 462 0
Maternal exposure during pregnancy 243 0
Paternal exposure before pregnancy 1 0
Paternal exposure during pregnancy 3 0
Exposures to agents or circumstances NEC
Exposure to SARS-CoV-2 1 0
Exposure to vaccinated person 1 0
Eye and ear procedural complications
Toxic anterior segment syndrome 1 0

Report Run Date: 14-Jun-2021, Page 35

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Injuries Injuries cont'd
Eye injuries NEC
Eye contusion 12 0
Eye injury 8 0
Foreign body in eye 1 0
Injury corneal 1 0
Periorbital haematoma 1 0
Retinal injury 2 0
Superficial injury of eye 1 0
Fractures and dislocations NEC
Bone fragmentation 1 0
Fracture 1 0
Joint dislocation 2 0
Gastrointestinal and hepatobiliary procedural complications
Post procedural constipation 1 0
Postoperative ileus 1 0
Procedural nausea 5 0
Procedural vomiting 1 0
Heat injuries (excl thermal burns)
Heat cramps 1 0
Heat exhaustion 1 0
Heat illness 1 0
Heat oedema 7 0
Heat stroke 3 0
Intentional product use issues
Intentional product use issue 1 0
Limb fractures and dislocations
Atypical femur fracture 1 0
Clavicle fracture 16 0
Wrist fracture 1 0
Medication errors, product use errors and issues NEC
Circumstance or information capable of leading to medication error 2 0
Dose calculation error 1 0
Medication error 11 0
Prescription drug used without a prescription 2 0
Product use complaint 1 0
Product use issue 8 0
Vaccination error 5 0
Wrong dose 2 0
Wrong drug 9 0
Wrong technique in product usage process 3 0
Muscle, tendon and ligament injuries
Epicondylitis 7 0
Ligament sprain 4 0
Mallet finger 1 0
Muscle injury 10 0
Muscle rupture 2 0
Muscle strain 17 0
Tendon injury 5 0
Tendon rupture 2 0
Musculoskeletal procedural complications
Periprosthetic osteolysis 1 0
Post laminectomy syndrome 1 0
Nerve injuries NEC

Report Run Date: 14-Jun-2021, Page 36

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Injuries Injuries cont'd
Nerve injury 26 0
Neurological and psychiatric procedural complications
Post procedural stroke 1 0
Procedural dizziness 10 0
Non-occupational environmental exposures
Exposure to extreme temperature 1 0
Non-site specific injuries NEC
Arthropod sting 1 0
Bite 1 0
Electric shock 8 0
Fall 86 1
Foreign body 2 0
Injury 5 0
Traumatic haematoma 1 0
Wound 4 0
Wound complication 7 0
Wound haematoma 1 0
Wound haemorrhage 1 0
Wound secretion 2 0
Non-site specific procedural complications
Incision site pain 2 0
Infusion related reaction 6 0
Injection related reaction 33 0
Post procedural complication 3 0
Procedural pain 1 0
Occupational exposures
Occupational exposure to SARS-CoV-2 1 0
Occupational exposure to product 1 0
Off label uses
Off label use 42 0
Overdoses NEC
Overdose 18 0
Pathways and sources of exposure
Exposure via unknown route 1 0
Peripheral nerve injuries
Brachial plexus injury 1 0
Ulnar nerve injury 4 0
Poisoning and toxicity
Alcohol poisoning 1 0
Poisoning 7 0
Toxicity to various agents 2 0
Product administration errors and issues
Accidental overdose 3 0
Contraindicated product administered 1 0
Expired product administered 9 0
Inappropriate schedule of product administration 60 0
Incomplete course of vaccination 1 0
Incorrect dose administered 49 0
Incorrect drug administration rate 1 0
Incorrect product formulation administered 2 0
Incorrect route of product administration 2 0
Poor quality product administered 2 0
Product administered at inappropriate site 8 0

Report Run Date: 14-Jun-2021, Page 37

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Injuries Injuries cont'd
Product administered to patient of inappropriate age 1 0
Product administration error 4 0
Product dose omission issue 3 0
Wrong product administered 12 0
Product confusion errors and issues
Product label confusion 1 0
Product dispensing errors and issues
Product dispensing error 3 0
Product monitoring errors and issues
Drug monitoring procedure incorrectly performed 1 0
Product preparation errors and issues
Product preparation error 1 0
Product preparation issue 5 0
Product prescribing errors and issues
Contraindicated product prescribed 2 0
Product selection errors and issues
Product selection error 2 0
Radiation injuries
Sunburn 13 0
Renal and urinary tract injuries NEC
Foreign body in urogenital tract 1 0
Site specific injuries NEC
Face crushing 1 0
Head injury 20 0
Limb crushing injury 2 0
Limb injury 40 0
Nasal injury 1 0
Neck injury 1 0
Skin injuries NEC
Contusion 534 0
Nail avulsion 1 0
Scar 4 0
Scratch 3 0
Skin abrasion 5 0
Skin injury 1 0
Skin wound 1 0
Subcutaneous haematoma 1 0
Skull fractures, facial bone fractures and dislocations
Fractured skull depressed 1 0
Spinal fractures and dislocations
Spinal fracture 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
Burn of internal organs 1 0
Burn oral cavity 1 0
Burns second degree 4 0
Thermal burn 12 0

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 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Injuries Injuries cont'd
Thermal burns of eye 8 0
Underdoses NEC
Underdose 5 0
Vaccination related complications
Adverse event following immunisation 1 0
Vaccination complication 39 0
Injuries SOC TOTAL 2182 2

Report Run Date: 14-Jun-2021, Page 39

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Investigations
Adrenal cortex tests
Cortisol decreased 2 0
Adrenal medulla tests
Epinephrine increased 1 0
Auditory and vestibular diagnostic procedures
Acoustic stimulation tests 5 0
Autoimmunity analyses
Antinuclear antibody 1 0
Antinuclear antibody increased 1 0
Antiphospholipid antibodies 1 0
Rheumatoid factor 3 0
Rheumatoid factor increased 1 0
Blood counts NEC
Blood count 3 0
Blood count abnormal 2 0
Blood gas and acid base analyses
Blood lactic acid 3 0
Blood lactic acid decreased 1 0
Blood lactic acid increased 2 0
Blood pH 4 0
Blood pH increased 5 0
Oxygen consumption decreased 1 0
Oxygen saturation 5 0
Oxygen saturation decreased 42 0
Bone marrow and immune tissue histopathology procedures
Aspiration bone marrow 1 0
Biopsy lymph gland 1 0
Bone marrow and immune tissue imaging procedures
Lymph nodes scan abnormal 1 0
Scan lymph nodes 1 0
Carbohydrate tolerance analyses (incl diabetes)
Blood glucose 6 0
Blood glucose abnormal 8 0
Blood glucose decreased 20 0
Blood glucose fluctuation 13 0
Blood glucose increased 73 0
Glycosylated haemoglobin increased 1 0
Cardiac auscultatory investigations
Cardiac murmur 9 0
Heart sounds 1 0
Heart sounds abnormal 2 0
Cardiac function diagnostic procedures
Cardiac output 1 0
Central venous pressure 1 0
Stroke volume decreased 1 0
Cell marker analyses
Prostatic specific antigen increased 1 0
Central nervous system imaging procedures
Computerised tomogram head 2 0
Magnetic resonance imaging head 10 0
Magnetic resonance imaging head abnormal 1 0
Chemistry analyses NEC
Inflammatory marker increased 3 0

Report Run Date: 14-Jun-2021, Page 40

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Investigations Investigations cont'd
Cholesterol analyses
Blood cholesterol increased 2 0
Remnant-like lipoprotein particles 3 0
Coagulation and bleeding analyses
Activated partial thromboplastin time prolonged 15 0
Bleeding time 1 0
Bleeding time abnormal 1 0
Bleeding time prolonged 1 0
Blood thromboplastin 1 0
Clot retraction 1 1
Coagulation factor VIII level decreased 1 0
Coagulation time prolonged 4 0
Coagulation time shortened 1 0
Fibrin D dimer increased 4 0
International normalised ratio abnormal 4 0
International normalised ratio decreased 18 0
International normalised ratio fluctuation 1 0
International normalised ratio increased 42 0
ECG investigations
Electrocardiogram 1 0
Electrocardiogram ST segment elevation 3 0
Electrocardiogram T wave inversion 2 0
Electrocardiogram abnormal 7 0
Endocrine analyses and imaging NEC
Hormone level abnormal 8 0
Faecal analyses NEC
Faecal calprotectin 2 0
Faecal calprotectin increased 3 0
Fertility analyses
Semen volume decreased 2 0
Foetal and neonatal diagnostic procedures
Foetal heart rate abnormal 1 1
Foetal non-stress test 1 0
Gastrointestinal and abdominal imaging procedures
Computerised tomogram abdomen 1 0
Sigmoidoscopy abnormal 1 0
Gastrointestinal, pancreatic and APUD hormone analyses
Blood insulin 1 0
Blood insulin decreased 1 0
Haematological analyses NEC
Plasma viscosity 1 0
Red blood cell sedimentation rate increased 5 0
Heart rate and pulse investigations
Carotid pulse 1 0
Heart rate 168 0
Heart rate abnormal 18 0
Heart rate decreased 24 0
Heart rate increased 381 0
Heart rate irregular 60 0
Pulse abnormal 9 0
Pulse pressure increased 1 0
Radial pulse abnormal 1 0
Sinus rhythm 1 0

Report Run Date: 14-Jun-2021, Page 41

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Investigations Investigations cont'd
Imaging procedures NEC
Computerised tomogram 1 0
Magnetic resonance imaging 1 0
Magnetic resonance imaging abnormal 1 0
Immunoglobulin analyses
Blood immunoglobulin G increased 1 0
Blood immunoglobulin M 1 0
Blood immunoglobulin M increased 1 0
Immunology analyses NEC
Antibody test 1 0
Immunology test 6 0
Immunology skin tests NEC
Skin test positive 1 0
Investigations NEC
Blood test 8 0
Blood test abnormal 15 0
False positive investigation result 1 0
Laboratory test 1 0
Polymerase chain reaction positive 33 0
Systemic lupus erythematosus disease activity index increased 1 0
Liver function analyses
Alanine aminotransferase increased 11 0
Aspartate aminotransferase increased 1 0
Blood bilirubin increased 2 0
Gamma-glutamyltransferase increased 3 0
Hepatic enzyme increased 4 0
Liver function test 1 0
Liver function test abnormal 17 0
Liver function test increased 10 0
Transaminases increased 2 0
Metabolism tests NEC
Blood ketone body 3 0
Blood ketone body increased 1 0
Blood uric acid increased 1 0
Brain natriuretic peptide increased 1 0
Ubiquinone 1 0
Microbiology and serology tests NEC
Culture negative 1 0
Mineral and electrolyte analyses
Blood copper increased 1 0
Blood iron 1 0
Blood iron decreased 2 0
Blood magnesium decreased 1 0
Blood phosphorus decreased 1 0
Blood potassium abnormal 1 0
Blood potassium decreased 4 0
Blood potassium increased 1 0
Blood sodium decreased 5 0
Serum ferritin decreased 1 0
Serum ferritin increased 1 0
Musculoskeletal and soft tissue imaging procedures
Skull X-ray 5 0
Musculoskeletal and soft tissue tests NEC

Report Run Date: 14-Jun-2021, Page 42

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Investigations Investigations cont'd
Swollen joint count increased 1 0
Mycobacteria identification and serology
Tuberculin test positive 1 0
Neurologic diagnostic procedures
Coma scale abnormal 2 0
Hoover's sign of leg paresis 1 0
Lumbar puncture 1 0
Temperature perception test abnormal 1 0
Temperature perception test increased 1 0
Ophthalmic function diagnostic procedures
Corneal reflex decreased 1 0
Intraocular pressure increased 5 0
Physical examination procedures and organ system status
Body temperature 165 0
Body temperature abnormal 25 0
Body temperature decreased 25 0
Body temperature fluctuation 18 0
Body temperature increased 261 0
Body temperature normal 1 0
Breath sounds abnormal 1 0
General physical condition abnormal 1 0
Grip strength 2 0
Grip strength decreased 10 0
Head lag 1 0
Lymph node palpable 24 0
Muscle strength abnormal 1 0
Ophthalmological examination 1 0
Orthopaedic examination abnormal 1 0
Palpatory finding abnormal 1 0
Product residue present 2 0
Psoriasis area severity index decreased 1 0
Respiratory rate 3 0
Respiratory rate decreased 4 0
Respiratory rate increased 25 0
Skin temperature 24 0
Temperature difference of extremities 6 0
Weight 1 0
Weight decreased 35 0
Weight increased 7 0
Pituitary analyses anterior
Blood growth hormone 2 0
Blood prolactin increased 1 0
Blood thyroid stimulating hormone decreased 1 0
Blood thyroid stimulating hormone increased 2 0
Platelet analyses
Mean platelet volume decreased 1 0
Platelet count decreased 43 0
Platelet count increased 1 0
Protein analyses NEC
Alpha 1 globulin decreased 1 0
Alpha 2 globulin decreased 1 0
C-reactive protein increased 11 0
Red blood cell analyses

Report Run Date: 14-Jun-2021, Page 43

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Investigations Investigations cont'd
Haematocrit 1 0
Haemoglobin decreased 8 0
Red blood cell count decreased 1 0
Renal function analyses
Glomerular filtration rate decreased 1 0
Reproductive hormone analyses
False negative pregnancy test 1 0
Pregnancy test 2 0
Pregnancy test false positive 1 0
Pregnancy test positive 1 0
Reproductive organ and breast histopathology procedures
Smear cervix 1 0
Reproductive organ and breast imaging procedures
Hysteroscopy 1 0
Respiratory and pulmonary function diagnostic procedures
Forced expiratory volume increased 2 0
Maximal voluntary ventilation 1 0
Peak expiratory flow rate 1 0
Peak expiratory flow rate decreased 4 0
Pulmonary function test 2 0
Vital capacity 1 0
Respiratory tract and thoracic histopathology procedures
Sputum abnormal 3 0
Respiratory tract and thoracic imaging procedures
Chest X-ray 11 0
Chest X-ray normal 1 0
Chest scan 1 0
Computerised tomogram thorax 1 0
Skeletal and cardiac muscle analyses
Blood creatine phosphokinase increased 3 0
Troponin 1 0
Troponin increased 4 0
Therapeutic drug monitoring analyses
Analgesic drug level 2 0
Anticoagulation drug level above therapeutic 1 0
Anticoagulation drug level below therapeutic 5 0
Anticoagulation drug level increased 1 0
Drug level decreased 1 0
Thyroid analyses
Anti-thyroid antibody 1 0
Thyroid function test abnormal 2 0
Thyroxine free increased 2 0
Tri-iodothyronine 1 0
Tri-iodothyronine decreased 3 0
Tissue enzyme analyses NEC
Blood alkaline phosphatase increased 2 0
Toxicology laboratory analyses
Drug screen positive 1 0
Opiates 1 0
Urinalysis NEC
Blood urine 7 0
Blood urine present 20 0
Cells in urine 1 0

Report Run Date: 14-Jun-2021, Page 44

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Investigations Investigations cont'd
Glucose urine present 1 0
Urine analysis abnormal 4 0
pH urine 5 0
pH urine increased 1 0
Urinary tract function analyses NEC
Urine output 8 0
Urine output decreased 5 0
Urine output increased 4 0
Urinary tract imaging procedures
Cystoscopy 2 0
Vascular imaging procedures NEC
Venogram 1 0
Vascular tests NEC (incl blood pressure)
Blood pressure abnormal 4 0
Blood pressure decreased 37 0
Blood pressure diastolic 1 0
Blood pressure diastolic decreased 1 0
Blood pressure diastolic increased 2 0
Blood pressure increased 137 0
Blood pressure measurement 24 0
Blood pressure systolic 1 0
Blood pressure systolic decreased 3 0
Blood pressure systolic increased 1 0
Virus identification and serology
Coronavirus test 8 0
Coronavirus test positive 3 0
SARS-CoV-1 test positive 1 0
SARS-CoV-2 antibody test 5 0
SARS-CoV-2 antibody test negative 10 0
SARS-CoV-2 antibody test positive 2 0
SARS-CoV-2 test 20 0
SARS-CoV-2 test false negative 1 0
SARS-CoV-2 test false positive 2 0
SARS-CoV-2 test negative 4 0
SARS-CoV-2 test positive 80 0
Viral test 4 0
Vitamin analyses
Blood folate decreased 3 0
Vitamin B12 decreased 1 0
Vitamin D 2 0
Vitamin D decreased 1 0
Water and electrolyte analyses NEC
Volume blood 1 0
White blood cell analyses
Lymphocyte count 1 0
Lymphocyte count decreased 1 0
Neutrophil count 1 0
Neutrophil count decreased 2 0
White blood cell count 1 0
White blood cell count decreased 8 0
White blood cell count increased 3 0
Investigations SOC TOTAL 2436 2

Report Run Date: 14-Jun-2021, Page 45

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Metabolic disorders
Appetite disorders
Appetite disorder 7 0
Decreased appetite 697 0
Eating disorder symptom 1 0
Food craving 7 0
Food refusal 6 0
Hyperphagia 2 0
Hypophagia 10 0
Increased appetite 11 0
Salt craving 2 0
Calcium metabolism disorders
Hypocalcaemia 3 0
Tetany 2 0
Diabetes mellitus (incl subtypes)
Diabetes mellitus 29 0
Diabetes mellitus inadequate control 6 1
Increased insulin requirement 1 0
Insulin resistant diabetes 1 0
Latent autoimmune diabetes in adults 1 0
Type 1 diabetes mellitus 11 0
Type 2 diabetes mellitus 2 0
Diabetic complications NEC
Diabetic complication 2 0
Diabetic ketoacidosis 9 0
Diabetic ketosis 1 0
Disorders of purine metabolism
Gout 56 0
Electrolyte imbalance NEC
Fluid imbalance 1 0
Fluid intake increased
Polydipsia 5 0
Food malabsorption and intolerance syndromes (excl sugar intolerance)
Alcohol intolerance 2 0
Dairy intolerance 1 0
Food intolerance 4 0
Gluten sensitivity 2 0
Histamine intolerance 3 0
General nutritional disorders NEC
Abnormal loss of weight 6 0
Abnormal weight gain 6 0
Cachexia 1 0
Feeding disorder 33 0
Food aversion 6 0
Neonatal insufficient breast milk syndrome 1 0
Overweight 1 0
Poor feeding infant 5 0
Weight loss poor 1 0
Hyperglycaemic conditions NEC
Hyperglycaemia 57 0
Insulin resistance 4 0
Hypoglycaemic conditions NEC
Glycopenia 1 0
Hypoglycaemia 62 0

Report Run Date: 14-Jun-2021, Page 46

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Metabolic disorders Metabolic disorders cont'd
Postprandial hypoglycaemia 1 0
Iron deficiencies
Iron deficiency 3 0
Lipid metabolism and deposit disorders NEC
Body fat disorder 1 0
Metabolic acidoses (excl diabetic acidoses)
Ketoacidosis 4 0
Metabolic acidosis 2 0
Mixed acid-base disorders
Acidosis 3 0
Potassium imbalance
Hyperkalaemia 2 0
Hypokalaemia 2 0
Hypokalaemic syndrome 1 0
Sodium imbalance
Hyponatraemia 6 0
Hyponatraemic syndrome 2 0
Sugar intolerance (excl glucose intolerance)
Lactose intolerance 1 0
Total fluid volume decreased
Dehydration 97 0
Total fluid volume increased
Fluid retention 25 0
Hypervolaemia 1 0
Vitamin deficiencies NEC
Hypovitaminosis 2 0
Metabolic disorders SOC TOTAL 1222 1

Report Run Date: 14-Jun-2021, Page 47

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Muscle & tissue disorders
Arthropathies NEC
Arthritis 142 0
Arthropathy 17 0
Autoimmune arthritis 2 0
Haemarthrosis 5 0
Joint microhaemorrhage 1 0
Palindromic rheumatism 1 0
Polyarthritis 11 0
Rheumatic fever 1 0
Sacroiliitis 3 0
Seronegative arthritis 1 0
Bone disorders NEC
Jaw disorder 3 0
Medial tibial stress syndrome 3 0
Osteitis 2 0
Osteonecrosis of jaw 2 0
Spinal disorder 1 0
Bone related signs and symptoms
Bone pain 213 0
Bone swelling 4 0
Coccydynia 2 0
Pain in jaw 185 0
Pubic pain 1 0
Spinal pain 32 0
Bursal disorders
Bursitis 34 0
Cartilage disorders
Chondritis 1 0
Costochondritis 29 0
Osteochondritis 1 0
Polychondritis 2 0
Connective tissue disorders NEC
Connective tissue disorder 1 0
Polymyalgia rheumatica 31 0
Sjogren's syndrome 4 0
Crystal arthropathic disorders
Crystal arthropathy 1 0
Epiphyseal disorders
Epiphyses premature fusion 1 0
Extremity deformities
Bone deformity 1 0
Foot deformity 1 0
Hand deformity 2 0
Knee deformity 1 0
Limb deformity 3 0
Musculoskeletal deformity 1 0
Joint related disorders NEC
Chondromalacia 1 0
Joint destruction 1 0
Joint laxity 3 0
Joint lock 12 0
Patellofemoral pain syndrome 1 0
Periarthritis 70 0

Report Run Date: 14-Jun-2021, Page 48

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Muscle & tissue disorders cont'd
Muscle & tissue disorders
Rotator cuff syndrome 6 0
Temporomandibular joint syndrome 4 0
Joint related signs and symptoms
Arthralgia 5249 0
Jaw clicking 4 0
Joint effusion 12 0
Joint noise 16 0
Joint range of motion decreased 8 0
Joint stiffness 127 0
Joint swelling 257 0
Joint vibration 1 0
Joint warmth 10 0
Loose body in joint 1 0
Ligament disorders
Symphysiolysis 1 0
Lupus erythematosus (incl subtypes)
Lupus-like syndrome 1 0
Systemic lupus erythematosus 13 0
Metabolic bone disorders
Osteopenia 1 0
Osteoporosis 1 0
Muscle infections and inflammations
Antisynthetase syndrome 1 0
Myositis 14 0
Polymyositis 3 0
Muscle pains
Fibromyalgia 53 0
Myalgia 6720 0
Myalgia intercostal 1 0
Myofascial pain syndrome 6 0
Muscle related signs and symptoms NEC
Haematoma muscle 1 0
Muscle atrophy 8 0
Muscle discomfort 2 0
Muscle disorder 3 0
Muscle fatigue 206 0
Muscle mass 2 0
Muscle spasms 539 0
Muscle swelling 13 0
Muscle tightness 41 0
Muscle twitching 177 0
Muscle tone abnormalities
Muscle rigidity 7 0
Nuchal rigidity 8 0
Torticollis 3 0
Trismus 17 0
Muscle weakness conditions
Muscular weakness 464 0
Musculoskeletal and connective tissue conditions NEC
Back disorder 1 0
Limb mass 8 0
Mandibular mass 2 0
Mastication disorder 1 0

Report Run Date: 14-Jun-2021, Page 49

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Muscle & tissue disorders cont'd
Muscle & tissue disorders
Mobility decreased 41 0
Musculoskeletal disorder 7 0
Musculoskeletal stiffness 699 0
Posture abnormal 1 0
Musculoskeletal and connective tissue deformities of skull, face and
buccal cavity
Head deformity 1 0
Musculoskeletal and connective tissue infections and inflammations NEC
Dactylitis 1 0
Dupuytren's contracture 1 0
Fasciitis 1 0
Plantar fasciitis 5 0
Musculoskeletal and connective tissue pain and discomfort
Back pain 1198 0
Flank pain 22 0
Limb discomfort 818 0
Musculoskeletal chest pain 93 0
Musculoskeletal discomfort 51 0
Musculoskeletal pain 32 0
Neck pain 1018 0
Pain in extremity 6832 0
Rheumatic disorder 5 0
Myopathies
Myopathy 4 0
Rhabdomyolysis 4 0
Osteoarthropathies
Nodal osteoarthritis 1 0
Osteoarthritis 26 0
Psoriatic arthropathies
Psoriatic arthropathy 11 0
Rheumatoid arthropathies
Rheumatoid arthritis 71 0
Soft tissue disorders NEC
Axillary mass 144 0
Fluctuance 1 0
Groin pain 61 0
Neck mass 16 0
Purple glove syndrome 1 0
Soft tissue disorder 1 0
Soft tissue swelling 3 0
Spine and neck deformities
Kyphosis 1 0
Lordosis 1 0
Neck deformity 1 0
Scoliosis 1 0
Spondyloarthropathies
Ankylosing spondylitis 6 0
Arthritis reactive 22 0
Spondylitis 1 0
Synovial disorders
Synovial cyst 11 0
Synovitis 4 0
Tendon disorders

Report Run Date: 14-Jun-2021, Page 50

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Muscle & tissue disorders cont'd
Muscle & tissue disorders
Enthesopathy 1 0
Tendon pain 8 0
Tendonitis 16 0
Tenosynovitis 2 0
Tenosynovitis stenosans 1 0
Trigger finger 12 0
Trunk deformities
Drooping shoulder syndrome 1 0
Muscle & tissue disorders SOC TOTAL 26106 0

Report Run Date: 14-Jun-2021, Page 51

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Neoplasms
B-cell lymphomas NEC
Follicular lymphoma 3 0
Bone neoplasms unspecified malignancy
Bone neoplasm 1 0
Breast and nipple neoplasms malignant
Breast cancer 25 0
Breast cancer female 1 0
Breast cancer stage I 1 0
Breast cancer stage III 1 0
Invasive ductal breast carcinoma 1 0
Triple negative breast cancer 2 0
Colorectal neoplasms malignant
Colon cancer 1 0
Colorectal cancer 1 0
Rectal cancer 1 0
Endocrine neoplasms malignant and unspecified NEC
Thyroid neoplasm 1 0
Follicular lymphomas
Primary gastrointestinal follicular lymphoma 1 0
Gastric neoplasms malignant
Gastric cancer 1 1
Gastrointestinal neoplasms malignant NEC
Gastrointestinal carcinoma 2 0
Hodgkin's disease NEC
Hodgkin's disease 2 0
Islet cell neoplasms and APUDoma NEC
Pancreatic neuroendocrine tumour 1 0
Leukaemias acute NEC
Acute leukaemia 1 0
Leukaemias chronic lymphocytic
Chronic lymphocytic leukaemia 2 0
Lip and oral cavity neoplasms malignant
Lip and/or oral cavity cancer recurrent 1 0
Lymphomas unspecified NEC
Lymphoma 13 1
Lymphoproliferative disorders NEC (excl leukaemias and lymphomas)
Lymphoproliferative disorder 1 0
Metastases to specified sites
Metastases to liver 1 0
Metastases to lymph nodes 5 0
Metastases to unknown and unspecified sites
Metastasis 1 0
Myelodysplastic syndromes
Myelodysplastic syndrome 1 0
Myeloproliferative disorders (excl leukaemias)
Essential thrombocythaemia 1 0
Neoplasms malignant site unspecified NEC
Neoplasm malignant 2 0
Second primary malignancy 1 0
Squamous cell carcinoma 3 0
Neoplasms unspecified malignancy and site unspecified NEC
Neoplasm 1 0
Neoplasm recurrence 1 0

Report Run Date: 14-Jun-2021, Page 52

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Neoplasms Neoplasms cont'd
Nervous system neoplasms benign NEC
Cranial nerve neoplasm benign 1 0
Nervous system neoplasms unspecified malignancy NEC
Brain neoplasm 1 0
Neuromas
Acoustic neuroma 1 0
Non-Hodgkin's lymphomas NEC
Non-Hodgkin's lymphoma 1 0
Oesophageal neoplasms malignant
Oesophageal cancer metastatic 1 0
Oropharyngeal, nasopharyngeal and tonsillar neoplasms malignant and
unspecified
Tonsil cancer 2 0
Pancreatic neoplasms malignant (excl islet cell and carcinoid)
Pancreatic carcinoma 4 0
Plasma cell myelomas
POEMS syndrome 1 0
Plasma cell myeloma 1 0
Plasma cell neoplasms NEC
TEMPI syndrome 1 0
Prostatic neoplasms malignant
Prostate cancer 2 0
Renal neoplasms malignant
Renal cancer 2 0
Respiratory tract and pleural neoplasms malignant cell type unspecified
NEC
Lung neoplasm malignant 4 0
Skin melanomas (excl ocular)
Malignant melanoma 1 0
Skin neoplasms benign
Acrochordon 2 0
Anogenital warts 2 0
Haemangioma of skin 1 0
Melanocytic naevus 4 0
Skin papilloma 4 0
Skin neoplasms malignant and unspecified (excl melanoma)
Basal cell carcinoma 2 0
Neoplasm skin 1 0
Squamous cell carcinoma of skin 1 0
Soft tissue neoplasms benign NEC
Lipoma 2 0
Lymphangioma 1 0
Soft tissue sarcomas histology unspecified
Sarcoma 1 0
Thyroid neoplasms malignant
Papillary thyroid cancer 2 0
Thyroid cancer 1 0
Uterine neoplasms benign
Uterine leiomyoma 5 0
Neoplasms SOC TOTAL 133 2

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 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Nervous system disorders
Abnormal reflexes
Areflexia 4 0
Extensor plantar response 1 0
Hyperreflexia 1 0
Hyporeflexia 5 0
Abnormal sleep-related events
Sleep paralysis 11 0
Absence seizures
Petit mal epilepsy 16 0
Acute polyneuropathies
Guillain-Barre syndrome 38 2
Subacute inflammatory demyelinating polyneuropathy 1 0
Autonomic nervous system disorders
Anticholinergic syndrome 1 0
Autonomic nervous system imbalance 5 0
Horner's syndrome 1 0
Central nervous system aneurysms and dissections
Intracranial aneurysm 1 0
Vertebral artery dissection 1 0
Central nervous system haemorrhages and cerebrovascular accidents
Brain stem infarction 1 1
Brain stem stroke 1 0
Carotid artery thrombosis 2 0
Cerebellar haemorrhage 1 0
Cerebellar infarction 2 0
Cerebellar ischaemia 1 0
Cerebellar stroke 3 0
Cerebral artery embolism 3 1
Cerebral artery occlusion 1 0
Cerebral artery thrombosis 3 0
Cerebral haemorrhage 28 6
Cerebral infarction 22 1
Cerebral thrombosis 5 0
Cerebrovascular accident 245 12
Embolic stroke 5 0
Haemorrhage intracranial 6 1
Haemorrhagic cerebral infarction 1 0
Haemorrhagic stroke 8 3
Internal capsule infarction 1 0
Intracranial haematoma 1 0
Ischaemic cerebral infarction 1 0
Ischaemic stroke 30 1
Lacunar infarction 2 0
Lacunar stroke 2 0
Lateral medullary syndrome 1 0
Subarachnoid haemorrhage 8 3
Thalamic infarction 1 0
Thrombotic stroke 2 0
Central nervous system inflammatory disorders NEC
Gliosis 1 0
Central nervous system vascular disorders NEC
Brain hypoxia 1 1
Central nervous system vasculitis 1 0

Report Run Date: 14-Jun-2021, Page 54

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Nervous system disorders cont'd
Nervous system disorders
Cerebral small vessel ischaemic disease 1 0
Cerebrovascular disorder 1 0
Reversible cerebral vasoconstriction syndrome 1 0
Cerebrovascular venous and sinus thrombosis
Cerebral venous sinus thrombosis 26 1
Cerebral venous thrombosis 4 0
Superior sagittal sinus thrombosis 3 0
Transverse sinus thrombosis 1 0
Cervical spinal cord and nerve root disorders
Cervicobrachial syndrome 3 0
Choreiform movements
Chorea 2 0
Chronic polyneuropathies
Demyelinating polyneuropathy 1 0
Coma states
Coma 4 0
Diabetic coma 1 0
Hypoglycaemic coma 1 0
Coordination and balance disturbances
Ataxia 6 0
Balance disorder 204 0
Coordination abnormal 26 0
Dysdiadochokinesis 1 0
Dysstasia 27 0
Nystagmus 8 0
Cortical dysfunction NEC
Aphasia 38 0
Apraxia 1 0
Neurologic neglect syndrome 1 0
Sensory processing disorder 1 0
Visuospatial deficit 1 0
Cranial nerve disorders NEC
Cranial nerve disorder 2 0
Dementia (excl Alzheimer's type)
Dementia 9 0
Dementia with Lewy bodies 1 0
Senile dementia 1 0
Demyelinating disorders NEC
Acute disseminated encephalomyelitis 3 0
Clinically isolated syndrome 1 0
Demyelination 7 0
Neuromyelitis optica spectrum disorder 1 0
Disturbances in consciousness NEC
Altered state of consciousness 9 0
Consciousness fluctuating 2 0
Depressed level of consciousness 23 1
Lethargy 1396 0
Loss of consciousness 258 0
Sedation 5 0
Somnolence 545 0
Stupor 3 0
Syncope 808 0
Disturbances in sleep phase rhythm

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 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Nervous system disorders cont'd
Nervous system disorders
Irregular sleep wake rhythm disorder 1 0
Dyskinesias and movement disorders NEC
Akathisia 2 0
Bradykinesia 7 0
Clumsiness 9 0
Dyskinesia 31 0
Extrapyramidal disorder 1 0
Fine motor skill dysfunction 7 0
Hyperkinesia 3 0
Hypokinesia 30 1
Motor dysfunction 2 0
Movement disorder 28 0
Psychomotor hyperactivity 13 0
Synkinesis 1 0
Tardive dyskinesia 2 0
Dystonias
Dystonia 12 0
Writer's cramp 1 0
Encephalitis NEC
Encephalitis autoimmune 1 0
Limbic encephalitis 1 0
Noninfective encephalitis 1 0
Encephalopathies NEC
Encephalopathy 2 0
Posterior reversible encephalopathy syndrome 1 0
Eye movement disorders
IIIrd nerve disorder 1 0
IIIrd nerve paralysis 5 0
IVth nerve paralysis 1 0
VIth nerve paralysis 6 0
Facial cranial nerve disorders
Bell's palsy 269 0
Facial nerve disorder 3 0
Facial paralysis 216 0
Facial paresis 57 0
Facial spasm 25 0
Generalised tonic-clonic seizures
Generalised tonic-clonic seizure 21 0
Headaches NEC
Cervicogenic headache 3 0
Cluster headache 125 0
Cold-stimulus headache 10 0
Drug withdrawal headache 2 0
Exertional headache 5 0
External compression headache 1 0
Headache 15739 0
Medication overuse headache 2 0
New daily persistent headache 4 0
Occipital neuralgia 6 0
Ophthalmoplegic migraine 1 0
Primary cough headache 3 0
Primary headache associated with sexual activity 1 0
Sinus headache 214 0

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 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Nervous system disorders cont'd
Nervous system disorders
Tension headache 303 0
Thunderclap headache 3 0
Vascular headache 11 0
Hydrocephalic conditions
Hydrocephalus 1 0
Hypoglossal nerve disorders
Tongue paralysis 1 0
Increased intracranial pressure disorders
Brain oedema 1 0
Idiopathic intracranial hypertension 3 0
Intracranial pressure increased 1 0
Intellectual disabilities
Intellectual disability 1 0
Lumbar spinal cord and nerve root disorders
Sciatica 41 0
Memory loss (excl dementia)
Amnesia 77 0
Memory impairment 70 0
Transient global amnesia 6 0
Mental impairment (excl dementia and memory loss)
Cognitive disorder 45 0
Cognitive linguistic deficit 1 0
Disturbance in attention 155 0
Mental impairment 26 0
Migraine headaches
Hemiplegic migraine 11 0
Migraine 1456 0
Migraine with aura 102 0
Migraine without aura 11 0
Ophthalmic migraine 4 0
Retinal migraine 19 0
Typical aura without headache 4 0
Vestibular migraine 11 0
Mixed cranial nerve disorders
Bulbar palsy 1 0
Mononeuropathies
Carpal tunnel syndrome 10 0
Cubital tunnel syndrome 1 0
Mononeuropathy 1 0
Nerve compression 9 0
Peripheral nerve lesion 1 0
Peroneal nerve palsy 6 0
Sciatic nerve neuropathy 2 0
Ulnar neuritis 1 0
Multiple sclerosis acute and progressive
Band sensation 1 0
Multiple sclerosis 21 0
Multiple sclerosis relapse 16 0
Tumefactive multiple sclerosis 1 1
Muscle tone abnormal
Hypotonia 11 0
Muscle tone disorder 1 0
Serotonin syndrome 1 0

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 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Nervous system disorders cont'd
Nervous system disorders
Stiff leg syndrome 1 0
Myelitis (incl infective)
Myelitis transverse 19 0
Narcolepsy and hypersomnia
Cataplexy 1 0
Hypersomnia 52 0
Narcolepsy 3 0
Nervous system disorders NEC
Central nervous system lesion 2 0
Nervous system disorder 6 0
Neurologic visual problems NEC
Hemianopia 1 0
Hemianopia homonymous 1 0
Quadrantanopia 1 0
Tunnel vision 8 0
Neurological signs and symptoms NEC
Clonus 1 0
Dizziness 5285 0
Dizziness exertional 28 0
Dizziness postural 453 0
Drooling 13 0
Fontanelle bulging 1 0
Head discomfort 157 0
Hyporesponsive to stimuli 2 0
Inability to crawl 2 0
Infant irritability 2 0
Myoclonus 12 0
Neurological symptom 25 0
Patient elopement 1 0
Persistent postural-perceptual dizziness 9 0
Presyncope 302 0
Sensory overload 2 0
Slow response to stimuli 2 0
Tongue biting 2 0
Unresponsive to stimuli 27 1
Neuromuscular disorders NEC
Muscle contractions involuntary 12 0
Muscle spasticity 8 0
Neuromuscular pain 2 0
Neuromuscular junction dysfunction
Myasthenia gravis 6 0
Myasthenia gravis crisis 2 0
Olfactory nerve disorders
Anosmia 126 0
Hyposmia 9 0
Parosmia 130 0
Optic nerve disorders NEC
Optic neuritis 18 0
Paraesthesias and dysaesthesias
Burning feet syndrome 5 0
Burning sensation 263 0
Dysaesthesia 5 0
Formication 28 0

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 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Nervous system disorders cont'd
Nervous system disorders
Hand-arm vibration syndrome 2 0
Hemiparaesthesia 1 0
Hyperaesthesia 48 0
Hypoaesthesia 1414 0
Paraesthesia 1997 0
Reversed hot-cold sensation 2 0
Synaesthesia 1 0
Paralysis and paresis (excl cranial nerve)
Diplegia 6 1
Hemiparesis 23 0
Hemiplegia 19 0
Locked-in syndrome 1 0
Monoparesis 36 0
Monoplegia 31 0
Paralysis 68 0
Paraparesis 3 0
Paresis 4 0
Parkinson's disease and parkinsonism
Freezing phenomenon 7 0
Parkinson's disease 3 0
Parkinsonian gait 1 0
Parkinsonism 4 0
Reduced facial expression 3 0
Partial complex seizures
Dreamy state 6 0
Focal dyscognitive seizures 1 0
Temporal lobe epilepsy 1 0
Peripheral neuropathies NEC
Neuralgic amyotrophy 1 0
Neuritis 5 0
Neuropathy peripheral 55 0
Peripheral sensory neuropathy 6 0
Thoracic outlet syndrome 1 0
Seizures and seizure disorders NEC
Atonic seizures 4 0
Clonic convulsion 1 0
Epilepsy 105 0
Epileptic aura 2 0
Epileptic encephalopathy 1 0
Febrile convulsion 14 0
Partial seizures 12 0
Post stroke seizure 1 0
Psychogenic seizure 6 0
Seizure 289 0
Seizure anoxic 1 0
Seizure cluster 4 0
Seizure like phenomena 1 0
Status epilepticus 37 0
Tonic clonic movements 2 0
Tonic convulsion 12 0
Tonic posturing 1 0
Sensory abnormalities NEC
Ageusia 285 0

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 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Nervous system disorders cont'd
Nervous system disorders
Allodynia 11 0
Aura 10 0
Complex regional pain syndrome 1 0
Dysgeusia 780 0
Electric shock sensation 15 0
Hypergeusia 1 0
Hypogeusia 1 0
Loss of proprioception 3 0
Neuralgia 274 0
Persistent genital arousal disorder 1 0
Phantom limb syndrome 3 0
Post herpetic neuralgia 12 0
Restless legs syndrome 58 0
Sensory disturbance 41 0
Sensory loss 39 0
Taste disorder 161 0
Visual perseveration 1 0
Sleep disturbances NEC
Sleep deficit 2 0
Sudden onset of sleep 1 0
Speech and language abnormalities
Dysarthria 94 0
Incoherent 5 0
Language disorder 1 0
Repetitive speech 1 0
Slow speech 6 0
Speech disorder 27 0
Spinal cord and nerve root disorders NEC
Radiculitis brachial 7 0
Radiculopathy 4 0
Structural brain disorders NEC
Brain injury 3 2
Hyperintensity in brain deep nuclei 1 0
Transient cerebrovascular events
Transient ischaemic attack 95 1
Tremor (excl congenital)
Action tremor 1 0
Essential tremor 2 0
Head titubation 5 0
Resting tremor 1 0
Tremor 893 0
Trigeminal disorders
Facial neuralgia 12 0
Numb chin syndrome 1 0
Trigeminal nerve disorder 1 0
Trigeminal neuralgia 28 0
Vertigos NEC
Vertigo CNS origin 1 0
Nervous system disorders SOC TOTAL 37404 41

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 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Pregnancy conditions
Abortions not specified as induced or spontaneous
Abortion missed 2 0
Abortions spontaneous
Abortion spontaneous 110 2
Foetal complications NEC
Foetal hypokinesia 2 0
Hydrops foetalis 1 0
Foetal growth complications
Foetal growth restriction 1 1
Gestational age and weight conditions
Premature baby 1 1
Labour onset and length abnormalities
Premature delivery 1 0
Premature labour 1 0
Premature rupture of membranes 1 0
Maternal complications of pregnancy NEC
Ectopic pregnancy 1 0
Morning sickness 9 0
Preterm premature rupture of membranes 2 0
Newborn complications NEC
Neonatal disorder 1 0
Normal newborn status
Normal newborn 1 0
Normal pregnancy, labour and delivery
Pregnancy 14 0
Pregnancy complicated by maternal disorders
Gestational diabetes 5 0
Stillbirth and foetal death
Foetal death 4 0
Stillbirth 3 1
Umbilical cord complications
Umbilical cord abnormality 1 0
Unintended pregnancies
Pregnancy after post coital contraception 2 0
Pregnancy on contraceptive 1 0
Pregnancy on oral contraceptive 1 0
Pregnancy with contraceptive device 2 0
Pregnancy with implant contraceptive 2 0
Unintended pregnancy 1 0
Pregnancy conditions SOC TOTAL 170 5

Report Run Date: 14-Jun-2021, Page 61

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Device issues NEC
Device connection issue 1 0
Device issue 2 0
Device malfunction events NEC
Device infusion issue 1 0
Device pacing issue 1 0
Device stimulation issue 1 0
Oversensing 13 0
Thrombosis in device 3 0
Device physical property and chemical issues
Device defective 6 0
Device kink 1 0
Needle issue 2 0
Product contamination and sterility issues
Product contamination 5 0
Product contamination physical 1 0
Product physical issues
Liquid product physical issue 7 0
Product odour abnormal 1 0
Product physical issue 2 0
Product taste abnormal 5 0
Product quality issues NEC
Product origin unknown 5 0
Product supply and availability issues
Product availability issue 1 0
null SOC TOTAL 58 0

Report Run Date: 14-Jun-2021, Page 62

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Psychiatric disorders
Abnormal behaviour NEC
Abnormal behaviour 8 0
Behaviour disorder 1 0
Breath holding 1 0
Staring 3 0
Adjustment disorders
Adjustment disorder with depressed mood 2 0
Affect alterations NEC
Affect lability 5 0
Constricted affect 1 0
Flat affect 4 0
Inappropriate affect 7 0
Amnestic symptoms
Paramnesia 3 0
Anxiety symptoms
Agitation 51 0
Anxiety 320 0
Immunisation anxiety related reaction 1 0
Nervousness 104 0
Stress 20 0
Tension 17 0
Attention deficit and disruptive behaviour disorders
Attention deficit hyperactivity disorder 2 0
Behaviour and socialisation disturbances
Aggression 5 0
Aversion 1 0
Homicidal ideation 1 0
Indifference 5 0
Paranoia 12 0
Personality change 3 0
Social avoidant behaviour 4 0
Soliloquy 1 0
Suspiciousness 1 0
Bipolar disorders
Bipolar I disorder 1 0
Bipolar disorder 4 0
Cognitive and attention disorders and disturbances NEC
Daydreaming 3 0
Distractibility 1 0
Mental fatigue 116 0
Communications disorders
Communication disorder 4 0
Mutism 2 0
Confusion and disorientation
Confusional state 484 0
Disorientation 153 0
Decreased physical activity levels
Catatonia 1 0
Deliria
Delirium 68 0
Delusional symptoms
Delusion 6 0
Depressive disorders

Report Run Date: 14-Jun-2021, Page 63

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Psychiatric disordersPsychiatric disorders cont'd
Agitated depression 1 0
Depression 133 0
Depression suicidal 4 0
Major depression 3 0
Mixed anxiety and depressive disorder 1 0
Dissociative states
Depersonalisation/derealisation disorder 5 0
Dissociation 18 0
Dissociative amnesia 2 0
Dissociative disorder 1 0
Disturbances in initiating and maintaining sleep
Initial insomnia 10 0
Insomnia 622 0
Middle insomnia 14 0
Terminal insomnia 8 0
Dyssomnias
Dyssomnia 1 0
Poor quality sleep 109 0
Eating disorders NEC
Bulimia nervosa 1 0
Eating disorder 6 0
Selective eating disorder 1 0
Emotional and mood disturbances NEC
Anger 12 0
Dysphoria 2 0
Emotional disorder 22 0
Emotional distress 14 0
Emotional poverty 1 0
Euphoric mood 26 0
Frustration tolerance decreased 1 0
Irritability 95 0
Mood altered 24 0
Factitious disorders
Factitious disorder 2 0
Fear symptoms and phobic disorders (incl social phobia)
Agoraphobia 1 0
Fear 7 0
Fear of falling 3 0
Fear of injection 2 0
Osmophobia 1 0
Phobia 1 0
Phonophobia 1 0
Social fear 1 0
Fluctuating mood symptoms
Mood swings 31 0
Hallucinations (excl sleep-related)
Hallucination 111 0
Hallucination, auditory 8 0
Hallucination, olfactory 4 0
Hallucination, tactile 1 0
Hallucination, visual 17 0
Hallucinations, mixed 1 0
Increased physical activity levels

Report Run Date: 14-Jun-2021, Page 64

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Psychiatric disordersPsychiatric disorders cont'd
Restlessness 75 0
Infancy, childhood and adolescence psychiatric disorders NEC
Social (pragmatic) communication disorder 1 0
Learning disorders
Learning disorder 1 0
Mental disorders NEC
Mental disorder 7 0
Mental status changes 1 0
Mental disorders due to a general medical condition NEC
Neuropsychiatric symptoms 1 0
Mood alterations with depressive symptoms
Decreased interest 7 0
Depressed mood 159 0
Feeling of despair 1 0
Feelings of worthlessness 1 0
Negative thoughts 1 0
Sense of a foreshortened future 2 0
Tearfulness 23 0
Mood alterations with manic symptoms
Hypomania 1 0
Mania 7 0
Mood disorders NEC
Apathy 15 0
Laziness 1 0
Listless 13 0
Narcolepsy and associated conditions
Hypnagogic hallucination 3 0
Hypnopompic hallucination 2 0
Sleep attacks 3 0
Obsessive-compulsive disorders and symptoms
Obsessive-compulsive symptom 1 0
Orgasmic disorders and disturbances
Anorgasmia 2 0
Female orgasmic disorder 1 0
Panic attacks and disorders
Panic attack 67 0
Panic disorder 3 0
Panic reaction 14 0
Parasomnias
Abnormal dreams 105 0
Abnormal sleep-related event 1 0
Confusional arousal 1 0
Nightmare 113 0
Parasomnia 1 0
Sleep talking 2 0
Sleep terror 11 0
Somnambulism 2 0
Perception disturbances NEC
Autoscopy 9 0
Deja vu 2 0
Derealisation 6 0
Flashback 2 0
Illusion 1 0

Report Run Date: 14-Jun-2021, Page 65

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Psychiatric disordersPsychiatric disorders cont'd
Near death experience 1 0
Personality disorders NEC
Personality disorder 1 0
Pervasive developmental disorders NEC
Autism spectrum disorder 2 1
Psychiatric elimination disorders
Enuresis 13 0
Psychiatric symptoms NEC
Hypervigilance 3 0
Psychiatric symptom 2 0
Psychological trauma 1 0
Trance 1 0
Psychotic disorder NEC
Psychotic behaviour 1 0
Psychotic disorder 11 0
Schizophrenia NEC
Schizophrenia 1 0
Sexual arousal disorders
Disturbance in sexual arousal 1 0
Sexual desire disorders
Libido decreased 4 0
Libido increased 2 0
Loss of libido 8 0
Sleep disorders NEC
Sleep disorder 103 0
Sleep disorder due to general medical condition, insomnia type 1 0
Somatic symptom disorders
Conversion disorder 4 0
Habit cough 11 0
Somatic symptom disorder 1 0
Vomiting psychogenic 1 0
Speech and language usage disturbances
Disorganised speech 3 0
Logorrhoea 2 0
Speech articulation and rhythm disturbances
Dysphemia 8 0
Lack of spontaneous speech 1 0
Pressure of speech 1 0
Stereotypies and automatisms
Bruxism 7 0
Head banging 4 0
Stereotypy 1 0
Stress disorders
Burnout syndrome 1 0
Post-traumatic stress disorder 2 0
Substance related and addictive disorders
Alcohol problem 1 0
Alcoholic hangover 1 0
Suicidal and self-injurious behaviour
Intentional self-injury 4 0
Self-injurious ideation 2 0
Suicidal ideation 14 0
Suicide attempt 8 0

Report Run Date: 14-Jun-2021, Page 66

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Psychiatric disordersPsychiatric disorders cont'd
Thinking disturbances
Bradyphrenia 25 0
Intrusive thoughts 3 0
Morbid thoughts 1 0
Tachyphrenia 2 0
Thinking abnormal 10 0
Tic disorders
Tic 4 0
Psychiatric disorders SOC TOTAL 3702 1

Report Run Date: 14-Jun-2021, Page 67

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Renal & urinary disorders
Bladder and urethral symptoms
Bladder discomfort 2 0
Bladder irritation 1 0
Bladder pain 14 0
Dysuria 31 0
Incontinence 17 0
Lower urinary tract symptoms 2 0
Micturition disorder 1 0
Micturition urgency 20 0
Pollakiuria 55 0
Urethral pain 1 0
Urge incontinence 1 0
Urinary hesitation 1 0
Urinary incontinence 36 0
Urinary retention 28 0
Urine flow decreased 5 0
Bladder disorders NEC
Bladder disorder 4 0
Bladder fibrosis 1 0
Urinary bladder haemorrhage 1 0
Bladder infections and inflammations
Cystitis interstitial 2 0
Genital and urinary tract disorders NEC
Genitourinary symptom 1 0
Urinary tract disorder 3 0
Glomerulonephritis and nephrotic syndrome
Glomerulonephritis 1 0
Glomerulonephritis minimal lesion 4 0
Glomerulonephritis rapidly progressive 1 0
IgA nephropathy 1 0
Nephrotic syndrome 13 0
Myoneurogenic bladder disorders
Bladder dysfunction 3 0
Hypertonic bladder 1 0
Hypotonic urinary bladder 1 0
Loss of bladder sensation 1 0
Neurogenic bladder 1 0
Nephritis NEC
Lupus nephritis 1 0
Nephritis 2 0
Tubulointerstitial nephritis 1 0
Renal disorders NEC
Renal disorder 2 0
Renal haemorrhage 1 0
Renal mass 1 0
Renal failure and impairment
Acute kidney injury 31 1
Anuria 3 0
Chronic kidney disease 1 0
Oliguria 1 0
Renal failure 11 1
Renal impairment 13 0
Renal injury 1 0

Report Run Date: 14-Jun-2021, Page 68

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Renal & urinary disorders cont'd
Renal & urinary disorders
Renal lithiasis
Nephrolithiasis 3 0
Renal neoplasms
Renal cyst 1 0
Renal structural abnormalities and trauma
Kidney small 1 0
Renal vascular and ischaemic conditions
Renal infarct 1 0
Renal vasculitis 1 1
Structural and obstructive urethral disorders (excl congenital)
Urethral stenosis 1 0
Ureteric disorders NEC
Ureteric stenosis 1 0
Urinary abnormalities
Albuminuria 1 0
Chromaturia 27 0
Haematuria 23 0
Proteinuria 4 0
Urine abnormality 8 0
Urine odour abnormal 4 0
Urinary tract signs and symptoms NEC
Costovertebral angle tenderness 1 0
Cystitis-like symptom 1 0
Haemorrhage urinary tract 9 0
Nocturia 2 0
Polyuria 3 0
Renal colic 1 0
Renal pain 145 0
Urinary tract pain 2 0
Renal & urinary disorders SOC TOTAL 563 3

Report Run Date: 14-Jun-2021, Page 69

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Reproductive & breast disorders
Benign and malignant breast neoplasms
Breast cyst 5 0
Breast disorders NEC
Breast enlargement 1 0
Breast mass 44 0
Gynaecomastia 2 0
Breast signs and symptoms
Breast discharge 2 0
Breast discomfort 5 0
Breast engorgement 1 0
Breast haematoma 1 0
Breast oedema 4 0
Breast pain 240 0
Breast swelling 50 0
Breast tenderness 23 0
Nipple pain 12 0
Nipple swelling 3 0
Cervix disorders NEC
Cervical dysplasia 2 0
Cervix disorder 1 0
Cervix haemorrhage uterine 1 0
Ectropion of cervix 1 0
Cervix neoplasms
Cervical polyp 1 0
Erection and ejaculation conditions and disorders
Ejaculation disorder 1 0
Ejaculation failure 1 0
Erectile dysfunction 26 0
Erection increased 2 0
Organic erectile dysfunction 2 0
Painful ejaculation 1 0
Lactation disorders
Galactorrhoea 2 0
Lactation puerperal increased 1 0
Suppressed lactation 7 0
Menopausal effects NEC
Artificial menopause 1 0
Menopausal symptoms 7 0
Premature menopause 7 0
Menopausal effects on the genitourinary tract
Atrophic vulvovaginitis 1 0
Postmenopausal haemorrhage 58 0
Menstruation and uterine bleeding NEC
Abnormal uterine bleeding 4 0
Dysmenorrhoea 254 0
Intermenstrual bleeding 149 0
Menstrual discomfort 1 0
Menstrual disorder 241 0
Menstruation irregular 341 0
Premenstrual dysphoric disorder 2 0
Premenstrual headache 1 0
Premenstrual pain 11 0
Premenstrual syndrome 6 0

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 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Reproductive & breast Reproductive
disorders & breast disorders cont'd
Withdrawal bleed 3 0
Menstruation with decreased bleeding
Amenorrhoea 90 0
Hypomenorrhoea 71 0
Menstruation delayed 367 0
Oligomenorrhoea 12 0
Menstruation with increased bleeding
Heavy menstrual bleeding 640 0
Menometrorrhagia 3 0
Polymenorrhoea 95 0
Ovarian and fallopian tube cysts and neoplasms
Ovarian cyst 2 0
Polycystic ovaries 8 0
Ovarian and fallopian tube disorders NEC
Adnexal torsion 1 0
Ovarian haemorrhage 1 0
Ovulation pain 7 0
Premature ovulation 2 0
Pelvis and broad ligament disorders NEC
Adnexa uteri pain 10 0
Pelvic haemorrhage 6 0
Penile disorders NEC (excl erection and ejaculation)
Penile discomfort 1 0
Penile erythema 1 0
Penile swelling 4 0
Penis disorder 3 0
Prostate and seminal vesicles infections and inflammations
Prostatitis 2 0
Prostatic signs, symptoms and disorders NEC
Prostatomegaly 3 0
Reproductive tract disorders NEC (excl neoplasms)
Genital haemorrhage 6 0
Genital lesion 1 0
Genital ulceration 3 0
Reproductive tract infections and inflammations NEC
Genital tract inflammation 1 0
Reproductive tract signs and symptoms NEC
Genital pain 2 0
Genital rash 1 1
Genital swelling 1 0
Pelvic discomfort 3 0
Pelvic pain 36 0
Perineal pain 1 0
Pruritus genital 1 0
Scrotal disorders NEC
Scrotal discomfort 1 0
Scrotal erythema 1 0
Scrotal exfoliation 1 0
Scrotal pain 4 0
Scrotal swelling 4 0
Sexual function and fertility disorders NEC
Dyspareunia 2 0
Infertility 1 0

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 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Reproductive & breastReproductive
disorders & breast disorders cont'd
Spermatogenesis and semen disorders
Aspermia 2 0
Haematospermia 4 0
Semen discolouration 1 0
Testicular and epididymal disorders NEC
Testicular disorder 1 0
Testicular pain 17 0
Testicular swelling 5 0
Uterine disorders NEC
Adenomyosis 1 0
Endometrial thickening 1 0
Endometriosis 19 0
Uterine haemorrhage 5 0
Uterine pain 5 0
Uterine tone disorders
Uterine spasm 6 0
Vulvovaginal cysts and neoplasms
Vaginal cyst 2 0
Vulvovaginal disorders NEC
Vaginal haemorrhage 293 0
Vulval haemorrhage 9 0
Vulval ulceration 3 0
Vulvovaginal ulceration 3 0
Vulvovaginal signs and symptoms
Coital bleeding 1 0
Vaginal discharge 12 0
Vaginal odour 1 0
Vulval oedema 1 0
Vulvovaginal burning sensation 2 0
Vulvovaginal dryness 2 0
Vulvovaginal pain 8 0
Vulvovaginal pruritus 2 0
Vulvovaginal swelling 1 0
Reproductive & breast disorders SOC TOTAL 3335 1

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 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Respiratory disorders
Breathing abnormalities
Apnoea 3 0
Apnoeic attack 1 0
Dyspnoea 1956 6
Dyspnoea at rest 6 0
Dyspnoea exertional 18 1
Hyperventilation 24 0
Hypopnoea 51 0
Irregular breathing 9 0
Mouth breathing 3 0
Nocturnal dyspnoea 1 0
Orthopnoea 3 0
Respiration abnormal 28 0
Respiratory arrest 8 0
Respiratory depression 1 0
Respiratory distress 11 0
Sleep apnoea syndrome 6 0
Tachypnoea 21 0
Bronchial conditions NEC
Bronchial secretion retention 1 0
Bronchiectasis 10 0
Bronchospasm and obstruction
Asthma 175 0
Asthma late onset 2 0
Bronchospasm 12 0
Chronic obstructive pulmonary disease 13 0
Cough variant asthma 3 0
Obstructive airways disorder 4 0
Reversible airways obstruction 1 0
Wheezing 245 0
Conditions associated with abnormal gas exchange
Asphyxia 1 0
Cyanosis central 1 0
Hyperoxia 1 0
Hypoxia 20 1
Respiratory acidosis 2 0
Coughing and associated symptoms
Allergic cough 4 0
Cough 1297 2
Cough decreased 2 0
Haemoptysis 22 0
Productive cough 83 0
Sputum discoloured 4 0
Sputum increased 1 0
Laryngeal and adjacent sites disorders NEC (excl infections and
neoplasms)
Laryngeal disorder 1 0
Vocal cord disorder 1 0
Laryngeal spasm, oedema and obstruction
Epiglottic oedema 1 0
Laryngeal obstruction 1 0
Laryngeal oedema 1 0
Laryngospasm 1 0

Report Run Date: 14-Jun-2021, Page 73

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Respiratory disordersRespiratory disorders cont'd
Stridor 15 0
Lower respiratory tract inflammatory and immunologic conditions
Alveolitis 1 0
Hypersensitivity pneumonitis 1 0
Pneumonia aspiration 7 5
Pneumonitis 18 1
Pulmonary sarcoidosis 1 0
Lower respiratory tract signs and symptoms
Hiccups 14 0
Increased bronchial secretion 1 0
Lung opacity 2 0
Pleuritic pain 9 0
Pulmonary pain 50 0
Rales 4 0
Nasal congestion and inflammations
Nasal congestion 131 0
Nasal inflammation 1 0
Rhinitis allergic 7 0
Nasal disorders NEC
Epistaxis 514 0
Intranasal hypoaesthesia 1 0
Intranasal paraesthesia 1 0
Nasal crusting 1 0
Nasal disorder 1 0
Nasal dryness 18 0
Nasal odour 6 0
Nasal oedema 4 0
Nasal pruritus 8 0
Neonatal hypoxic conditions
Dry lung syndrome 1 0
Infantile apnoea 1 0
Paranasal sinus disorders (excl infections and neoplasms)
Allergic sinusitis 1 0
Paranasal sinus inflammation 1 0
Sinonasal obstruction 7 0
Sinus congestion 33 0
Sinus disorder 4 0
Parenchymal lung disorders NEC
Atelectasis 1 0
Emphysema 2 0
Interstitial lung disease 4 0
Lung infiltration 1 0
Pulmonary alveolar haemorrhage 1 0
Pulmonary cavitation 1 0
Pulmonary fibrosis 3 0
Pharyngeal disorders (excl infections and neoplasms)
Pharyngeal erythema 5 0
Pharyngeal haemorrhage 2 0
Pharyngeal hypoaesthesia 21 0
Pharyngeal inflammation 4 0
Pharyngeal oedema 8 0
Pharyngeal paraesthesia 40 0
Pharyngeal swelling 137 0

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 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Respiratory disordersRespiratory disorders cont'd
Pharyngeal ulceration 10 0
Tonsillar erythema 3 0
Tonsillar haemorrhage 1 0
Tonsillar hypertrophy 40 0
Tonsillar inflammation 3 0
Tonsillar ulcer 1 0
Pleural infections and inflammations
Pleurisy 16 0
Pneumothorax and pleural effusions NEC
Pleural effusion 11 0
Pneumothorax 3 0
Pneumothorax spontaneous 1 0
Pulmonary hypertensions
Pulmonary hypertension 2 0
Pulmonary oedemas
Acute respiratory distress syndrome 1 0
Pulmonary congestion 5 0
Pulmonary oedema 14 1
Pulmonary thrombotic and embolic conditions
Pulmonary embolism 246 18
Pulmonary infarction 3 0
Pulmonary thrombosis 2 0
Respiratory failures (excl neonatal)
Acute respiratory failure 2 1
Respiratory failure 8 1
Respiratory signs and symptoms NEC
Allergic respiratory symptom 5 0
Diaphragmalgia 4 0
Nasal flaring 1 0
Painful respiration 5 0
Respiratory symptom 7 0
Suffocation feeling 1 0
Respiratory tract disorders NEC
Aspiration 3 2
Lung disorder 2 0
Pulmonary mass 2 0
Respiratory disorder 6 0
Respiratory tract congestion 2 0
Respiratory tract inflammation 1 0
Respiratory tract irritation 5 0
Respiratory tract oedema 2 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 60 0
Catarrh 12 0
Choking 10 1
Choking sensation 2 0
Dry throat 109 0

Report Run Date: 14-Jun-2021, Page 75

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Respiratory disordersRespiratory disorders cont'd
Dysphonia 97 0
Increased upper airway secretion 4 0
Increased viscosity of upper respiratory secretion 15 0
Nasal discharge discolouration 2 0
Nasal discomfort 32 0
Nasal obstruction 2 0
Oropharyngeal blistering 9 0
Oropharyngeal discomfort 37 0
Oropharyngeal pain 1592 0
Oropharyngeal plaque 1 0
Paranasal sinus discomfort 23 0
Rhinalgia 6 0
Rhinorrhoea 475 0
Sinus pain 119 0
Sneezing 199 0
Snoring 4 0
Throat clearing 5 0
Throat irritation 143 0
Throat tightness 158 0
Upper airway obstruction 2 0
Upper-airway cough syndrome 4 0
Yawning 11 0
Vascular pulmonary disorders NEC
Acute chest syndrome 1 0
Respiratory disorders SOC TOTAL 8709 40

Report Run Date: 14-Jun-2021, Page 76

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Skin disorders
Acnes
Acne 43 0
Acne cystic 3 0
Dermatitis acneiform 3 0
Alopecias
Alopecia 91 0
Alopecia areata 7 0
Alopecia totalis 1 0
Androgenetic alopecia 1 0
Madarosis 1 0
Angioedemas
Angioedema 124 0
Circumoral swelling 1 0
Apocrine and eccrine gland disorders
Anhidrosis 1 0
Cold sweat 386 0
Hidradenitis 1 0
Hyperhidrosis 1093 0
Miliaria 49 0
Night sweats 355 0
Bullous conditions
Blister 260 0
Blister rupture 1 0
Blood blister 19 0
Dermatitis bullous 9 0
Erythema multiforme 21 0
Fracture blisters 1 0
Pemphigoid 13 0
Pemphigus 5 0
Stevens-Johnson syndrome 4 0
Toxic epidermal necrolysis 2 1
Connective tissue disorders
Dermatomyositis 4 0
Dermal and epidermal conditions NEC
Acute febrile neutrophilic dermatosis 1 0
Dermatosis 1 0
Dry skin 130 0
Macule 2 0
Pain of skin 163 0
Papule 42 0
Pathergy reaction 1 0
Peau d'orange 2 0
Scab 11 0
Scar pain 10 0
Sensitive skin 88 0
Skin burning sensation 130 0
Skin degenerative disorder 1 0
Skin discolouration 63 0
Skin discomfort 2 0
Skin disorder 6 0
Skin fissures 3 0
Skin indentation 2 0
Skin induration 3 0

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 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Skin disorders Skin disorders cont'd
Skin lesion 28 0
Skin lesion inflammation 1 0
Skin necrosis 1 0
Skin odour abnormal 10 0
Skin plaque 1 0
Skin reaction 81 0
Skin sensitisation 16 0
Skin swelling 46 0
Skin tightness 21 0
Skin warm 172 0
Skin weeping 5 0
Sticky skin 1 0
Transient acantholytic dermatosis 1 0
Yellow skin 8 0
Dermatitis and eczema
Dermatitis 65 0
Dermatitis allergic 141 0
Dermatitis atopic 14 0
Dermatitis contact 6 0
Dermatitis diaper 1 0
Dyshidrotic eczema 10 0
Eczema 115 0
Eczema asteatotic 6 0
Eczema nummular 4 0
Eczema weeping 1 0
Perioral dermatitis 1 0
Seborrhoeic dermatitis 2 0
Skin irritation 59 0
Dermatitis ascribed to specific agent
Drug eruption 22 0
Drug reaction with eosinophilia and systemic symptoms 1 0
Fixed eruption 1 0
Toxic skin eruption 1 0
Erythemas
Erythema 1344 0
Palmar erythema 4 0
Red man syndrome 1 0
Exfoliative conditions
Dermatitis exfoliative 1 0
Dermatitis exfoliative generalised 2 0
Exfoliative rash 12 0
Keratolysis exfoliativa acquired 2 0
Skin exfoliation 52 0
Granulomatous and deep cutaneous inflammatory conditions
Cutaneous sarcoidosis 1 0
Granuloma annulare 1 0
Hyperkeratoses
Hyperkeratosis 1 0
Keratosis pilaris 3 0
Lichenoid keratosis 2 0
Hyperpigmentation disorders
Argyria 1 0
Chloasma 1 0

Report Run Date: 14-Jun-2021, Page 78

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Skin disorders Skin disorders cont'd
Ephelides 1 0
Skin hyperpigmentation 2 0
Solar lentigo 2 0
Hypertrichoses
Hirsutism 1 0
Hypopigmentation disorders
Skin depigmentation 3 0
Skin hypopigmentation 1 0
Vitiligo 3 0
Lipodystrophies
Lipoatrophy 2 0
Lipodystrophy acquired 1 0
Nail and nail bed conditions (excl infections and infestations)
Nail discolouration 5 0
Nail disorder 2 0
Nail pigmentation 2 0
Onychalgia 6 0
Onychoclasis 3 0
Onychomadesis 2 0
Splinter haemorrhages 1 0
Panniculitides
Erythema nodosum 14 0
Papulosquamous conditions
Erythema annulare 2 0
Lichen planus 6 0
Lichen sclerosus 2 0
Parapsoriasis 2 0
Pityriasis rosea 53 0
Photosensitivity and photodermatosis conditions
Photosensitivity reaction 29 0
Polymorphic light eruption 1 0
Pigmentation changes NEC
Haemosiderin stain 1 0
Pigmentation disorder 4 0
Pilar disorders NEC
Hair colour changes 7 0
Hair disorder 1 0
Hair growth abnormal 1 0
Hair texture abnormal 4 0
Piloerection 11 0
Pseudofolliculitis 1 0
Pruritus NEC
Itching scar 5 0
Pruritus 2964 0
Psoriatic conditions
Dermatitis psoriasiform 2 0
Guttate psoriasis 10 0
Nail psoriasis 1 0
Palmoplantar pustulosis 1 0
Psoriasis 86 0
Pustular psoriasis 1 0
Purpura and related conditions
Henoch-Schonlein purpura 2 0

Report Run Date: 14-Jun-2021, Page 79

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Skin disorders Skin disorders cont'd
Petechiae 76 0
Purpura 29 0
Pustular conditions
Acute generalised exanthematous pustulosis 1 0
Rashes, eruptions and exanthems NEC
Butterfly rash 3 0
Rash 3130 1
Rash erythematous 676 0
Rash macular 293 0
Rash maculo-papular 38 0
Rash morbilliform 24 0
Rash papular 196 0
Rash pruritic 685 0
Rash vesicular 37 0
Systemic lupus erythematosus rash 5 0
Rosaceas
Rosacea 16 0
Scaly conditions
Dandruff 3 0
Pityriasis 11 0
Sebaceous gland disorders
Seborrhoea 3 0
Skin and subcutaneous conditions NEC
Cutaneous symptom 3 0
Reactive perforating collagenosis 1 0
Skin mass 9 0
Skin and subcutaneous tissue ulcerations
Mucocutaneous ulceration 1 0
Scleroderma associated digital ulcer 1 0
Skin erosion 17 0
Skin ulcer 7 0
Skin cysts and polyps
Dermal cyst 4 0
Skin dystrophies
Skin wrinkling 2 0
Skin haemorrhages
Haemorrhage subcutaneous 4 0
Skin haemorrhage 7 0
Skin hyperplasias and hypertrophies
Skin hypertrophy 1 0
Skin hypoplasias and atrophies
Skin striae 4 0
Skin injuries and mechanical dermatoses
Decubitus ulcer 2 0
Skin preneoplastic conditions NEC
Actinic keratosis 1 0
Skin vasculitides
Cutaneous vasculitis 7 0
Vasculitic rash 12 0
Skin vasomotor conditions
Livedo reticularis 17 0
Urticarias
Chronic spontaneous urticaria 3 0

Report Run Date: 14-Jun-2021, Page 80

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Skin disorders Skin disorders cont'd
Cold urticaria 2 0
Idiopathic urticaria 1 0
Mechanical urticaria 3 0
Solar urticaria 2 0
Urticaria 976 0
Urticaria chronic 6 0
Urticaria contact 1 0
Urticaria papular 2 0
Urticaria thermal 3 0
Urticarial vasculitis 2 0
Skin disorders SOC TOTAL 15005 2

Report Run Date: 14-Jun-2021, Page 81

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Social circumstances
Age related issues
Infant 1 0
Menopause 9 0
Postmenopause 2 0
Criminal activity
Verbal abuse 1 0
Dependents
Sick relative 1 0
Disability issues
Bedridden 18 0
Breast prosthesis user 1 0
Hearing disability 1 0
Housebound 1 0
Immobile 8 0
Impaired driving ability 1 0
Impaired work ability 5 0
Loss of personal independence in daily activities 6 0
Physical disability 2 0
Sight disability 4 0
Sitting disability 1 0
Walking disability 1 0
Economic circumstances
High income 1 0
Low income 1 0
Employment issues
Retirement 2 0
Non-occupational and unspecified environmental problems
Water pollution 2 0
Pregnancy related circumstances
Breast feeding 5 0
Multigravida 1 0
Social issues NEC
Hair dye user 2 0
Tobacco use
Ex-tobacco user 1 0
Non-tobacco user 4 0
Social circumstances SOC TOTAL 82 0

Report Run Date: 14-Jun-2021, Page 82

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Surgical & medical procedures
Anaesthesia and allied procedures
Nerve block 1 0
Antiinfective therapies
COVID-19 treatment 2 0
Arterial therapeutic procedures (excl aortic)
Splenic artery embolisation 1 0
Blood and blood product treatment
Transfusion 1 0
Breast therapeutic procedures NEC
Axillary lymphadenectomy 1 0
Bronchial and pulmonary therapeutic procedures
Airway secretion clearance therapy 1 0
Cardiac therapeutic procedures NEC
Cardiac operation 1 0
Contraceptive methods female
Contraceptive implant 1 0
Contraceptive methods male
Condom 1 0
Dietary and nutritional therapies
Medical diet 3 0
Nothing by mouth order 5 0
Wheat-free diet 1 0
Fertility and fertilisation interventions female
Endometrial scratching 1 0
Gastrointestinal therapeutic procedures NEC
Intestinal anastomosis 1 0
Prophylaxis of nausea and vomiting 11 0
Gynaecological therapeutic procedures NEC
Menstrual cycle management 1 0
Haematological therapeutic procedures NEC
Anticoagulant therapy 1 0
Hormonal therapeutic procedures NEC
Hormone replacement therapy 1 0
Immunisations
COVID-19 immunisation 61 1
Immunisation 16 0
Joint therapeutic procedures
Joint surgery 1 0
Knee arthroplasty 1 0
Large intestine therapeutic procedures
Appendicectomy 1 0
Limb therapeutic procedures
Limb immobilisation 7 0
Limb operation 5 0
Lymphoid tissue therapeutic procedures
Lymphadenectomy 1 0
Mastectomies
Breast conserving surgery 2 0
Nail therapeutic procedures
Nail operation 1 0
Nervous system therapeutic procedures NEC
Multiple sclerosis relapse prophylaxis 2 0
Phototherapies

Report Run Date: 14-Jun-2021, Page 83

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Surgical & medical procedures cont'd
Surgical & medical procedures
UV light therapy 1 0
Prophylactic procedures NEC
Anaphylaxis prophylaxis 2 0
Immune tolerance induction 1 0
Reproductive system disorder prophylaxis 1 0
Psychiatric therapies
Electroconvulsive therapy 1 0
Renal therapeutic procedures
Dialysis 1 0
Respiratory tract therapeutic procedures NEC
Asthma prophylaxis 2 0
Skin and subcutaneous tissue therapeutic procedures NEC
Dermal filler injection 3 0
Therapeutic procedures NEC
Abscess drainage 1 0
Anaphylaxis treatment 3 0
Bed rest 2 0
Fatigue management 1 0
Hospitalisation 6 0
Injection 12 0
Interchange of vaccine products 2 0
Mass excision 1 0
Medication dilution 1 0
Product used for unknown indication 2 0
Therapeutic procedure 1 0
Therapy change 1 0
Surgical & medical procedures SOC TOTAL 178 1

Report Run Date: 14-Jun-2021, Page 84

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Vascular disorders
Accelerated and malignant hypertension
Hypertensive crisis 8 0
Hypertensive urgency 1 0
Malignant hypertension 3 0
Aneurysms and dissections non-site specific
Artery dissection 1 0
Aortic aneurysms and dissections
Acute aortic syndrome 1 0
Aortic aneurysm rupture 1 0
Aortic dissection 1 0
Aortic embolism and thrombosis
Aortic embolus 3 0
Aortic thrombosis 1 0
Arterial infections and inflammations
Arteritis 1 0
Giant cell arteritis 8 0
Blood pressure disorders NEC
Blood pressure fluctuation 8 0
Labile blood pressure 2 0
Bruising, ecchymosis and purpura
Achenbach syndrome 2 0
Circulatory collapse and shock
CT hypotension complex 2 0
Circulatory collapse 42 0
Hypoperfusion 1 0
Neurogenic shock 19 0
Peripheral circulatory failure 3 0
Shock 9 0
Shock symptom 1 0
Haemorrhages NEC
Bloody discharge 3 0
Haematoma 22 0
Haemorrhage 227 2
Internal haemorrhage 5 0
Venous haemorrhage 1 0
Lymphangiopathies
Lymphangiopathy 1 0
Lymphocele 3 0
Lymphoedemas
Lymphoedema 131 0
Non-site specific embolism and thrombosis
Arterial thrombosis 2 0
Embolism 60 0
Embolism venous 3 0
Microembolism 1 0
Thrombosis 173 7
Venous thrombosis 4 0
Non-site specific necrosis and vascular insufficiency NEC
Arterial occlusive disease 2 0
Haemorrhagic infarction 1 0
Infarction 2 0
Ischaemia 3 0
Vasospasm 1 0

Report Run Date: 14-Jun-2021, Page 85

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Vascular disorders Vascular disorders cont'd
Non-site specific vascular disorders NEC
Superficial vein prominence 1 0
Vascular pain 10 0
Vasodilatation 16 0
Vein discolouration 4 0
Vein disorder 5 0
Vein rupture 3 0
Peripheral embolism and thrombosis
Blue toe syndrome 18 0
Deep vein thrombosis 156 0
Femoral artery embolism 1 0
Jugular vein thrombosis 2 0
Pelvic venous thrombosis 4 0
Peripheral embolism 1 0
Subclavian vein thrombosis 1 0
Thrombophlebitis 14 0
Thrombophlebitis superficial 7 0
Peripheral vascular disorders NEC
Cyanosis 27 0
Erythromelalgia 1 0
Flushing 316 0
Hot flush 616 0
Peripheral vasoconstriction, necrosis and vascular insufficiency
Extremity necrosis 1 0
Intermittent claudication 1 0
Ischaemic limb pain 1 0
Peripheral arterial occlusive disease 1 0
Peripheral artery occlusion 1 0
Peripheral coldness 191 0
Peripheral ischaemia 9 0
Poor peripheral circulation 7 0
Raynaud's phenomenon 42 0
Vasoconstriction 2 0
Phlebitis NEC
Phlebitis 18 0
Phlebitis superficial 3 0
Site specific vascular disorders NEC
Pallor 159 0
Varicose veins NEC
Spider vein 2 0
Varicophlebitis 1 0
Varicose vein 8 0
Vascular hypertensive disorders NEC
Diastolic hypertension 1 0
Essential hypertension 3 0
Hypertension 328 1
Labile hypertension 1 0
Orthostatic hypertension 1 0
Secondary hypertension 1 0
Systolic hypertension 2 0
Vascular hypotensive disorders
Capillary leak syndrome 1 0
Hypotension 231 0

Report Run Date: 14-Jun-2021, Page 86

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print
Report Run Date: 14-Jun-2021 Data Lock Date: 09-Jun-2021 19:00:03
Earliest Reaction Date: 13-Apr-1968 MedDRA Version: MedDRA 24.0
Reaction Name Total Fatal
Vascular disorders Vascular disorders cont'd
Orthostatic hypotension 16 0
Vasculitides NEC
Behcet's syndrome 4 0
Granulomatosis with polyangiitis 1 0
MAGIC syndrome 1 0
Vasculitis 32 0
Vena caval embolism and thrombosis
Vena cava embolism 1 0
Vena cava thrombosis 1 0
Vascular disorders SOC TOTAL 3038 10
TOTAL REACTIONS FOR DRUG 202036 421

TOTAL REPORTS 70950

TOTAL FATAL OUTCOME REPORTS 421

Report Run Date: 14-Jun-2021, Page 87