Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print

Report Run Date: 31-Jan-2021

Data Lock Date: 28-Jan-2021 19:00:04

ALL UK spontaneous reports received between 9/12/20 and 24/01/21 for mRNA
Pfizer- BioNTech vaccine analysis print

Report Run Date: 31-Jan-2021, Page 1

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Blood disorders
Anaemias NEC
Anaemia 2 0
Bleeding tendencies
Increased tendency to bruise 1 0
Lymphatic system disorders NEC
Lymph node pain 151 0
Lymphadenitis 18 0
Lymphadenopathy 969 0
Lymphatic disorder 1 0
Pseudolymphoma 1 0
Marrow depression and hypoplastic anaemias
Pancytopenia 1 0
Neutropenias
Neutropenia 2 0
Thrombocytopenias
Immune thrombocytopenia 1 0
Thrombocytopenia 4 0
Thrombocytoses
Thrombocytosis 1 0
Blood disorders SOC TOTAL 1152 0

Report Run Date: 31-Jan-2021, Page 2

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Cardiac disorders
Cardiac conduction disorders
Bundle branch block right 2 0
Cardiac disorders NEC
Cardiac disorder 1 0
Cardiac signs and symptoms NEC
Palpitations 254 0
Heart failures NEC
Cardiopulmonary failure 1 1
Ischaemic coronary artery disorders
Acute myocardial infarction 4 0
Angina pectoris 4 0
Myocardial infarction 13 3
Left ventricular failures
Left ventricular failure 1 0
Myocardial disorders NEC
Right ventricular enlargement 1 0
Noninfectious myocarditis
Myocarditis 5 0
Noninfectious pericarditis
Pericarditis 2 0
Rate and rhythm disorders NEC
Arrhythmia 7 0
Bradycardia 11 0
Cardiac flutter 8 0
Extrasystoles 7 0
Postural orthostatic tachycardia syndrome 1 0
Tachycardia 193 0
Supraventricular arrhythmias
Arrhythmia supraventricular 2 0
Atrial fibrillation 24 1
Atrial tachycardia 1 0
Sinus bradycardia 1 0
Sinus tachycardia 18 0
Supraventricular tachycardia 7 0
Ventricular arrhythmias and cardiac arrest
Cardiac arrest 16 7
Pulseless electrical activity 1 0
Ventricular extrasystoles 2 0
Ventricular fibrillation 2 0
Ventricular tachycardia 1 0
Cardiac disorders SOC TOTAL 590 12

Report Run Date: 31-Jan-2021, Page 3

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Congenital disorders
Neurological disorders congenital NEC
Familial hemiplegic migraine 1 0
Congenital disorders SOC TOTAL 1 0

Report Run Date: 31-Jan-2021, Page 4

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Ear disorders
Ear disorders NEC
Ear canal erythema 1 0
Ear congestion 2 0
Ear discomfort 9 0
Ear disorder 1 0
Ear pain 98 0
Ear pruritus 1 0
Ear swelling 1 0
Hearing losses
Deafness 5 0
Hypoacusis 13 0
Sudden hearing loss 1 0
Hyperacusia
Hyperacusis 5 0
Inner ear disorders NEC
Acute vestibular syndrome 1 0
Inner ear disorder 1 0
Inner ear signs and symptoms
Motion sickness 9 0
Tinnitus 72 0
Vertigo 105 0
Vertigo labyrinthine 2 0
Vertigo positional 6 0
Middle ear infections and inflammations
Middle ear inflammation 1 0
Ear disorders SOC TOTAL 334 0

Report Run Date: 31-Jan-2021, Page 5

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Endocrine disorders
Endocrine abnormalities of puberty
Premature menarche 1 0
Thyroid disorders NEC
Goitre 1 0
Endocrine disorders SOC TOTAL 2 0

Report Run Date: 31-Jan-2021, Page 6

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Eye disorders
Amblyopic vision impairment
Amblyopia 1 0
Choroid and vitreous structural change, deposit and degeneration
Vitreous floaters 4 0
Conjunctival and corneal bleeding and vascular disorders
Conjunctival haemorrhage 6 0
Corneal infections, oedemas and inflammations
Ulcerative keratitis 1 0
Eyelid movement disorders
Blepharospasm 8 0
Eyelid ptosis 1 0
Iris and uveal tract infections, irritations and inflammations
Iridocyclitis 3 0
Uveitis 1 0
Lacrimation disorders
Dry eye 10 0
Lacrimation increased 17 0
Lid, lash and lacrimal infections, irritations and inflammations
Blepharitis 1 0
Erythema of eyelid 1 0
Eyelid irritation 1 0
Eyelid margin crusting 1 0
Eyelid rash 2 0
Swelling of eyelid 15 0
Lid, lash and lacrimal structural disorders
Eyelid exfoliation 1 0
Ocular disorders NEC
Eye disorder 9 0
Eye oedema 2 0
Eye pain 122 0
Eye swelling 56 0
Eye ulcer 1 0
Eyelid pain 1 0
Eyelids pruritus 1 0
Ocular discomfort 4 0
Periorbital oedema 3 0
Periorbital pain 1 0
Periorbital swelling 13 0
Ocular infections, inflammations and associated manifestations
Eye allergy 1 0
Eye discharge 3 0
Eye inflammation 2 0
Eye irritation 13 0
Eye pruritus 32 0
Ocular hyperaemia 25 0
Ocular nerve and muscle disorders
Binocular eye movement disorder 1 0
Eye movement disorder 4 0
Ophthalmoplegia 1 0
Ocular sensation disorders
Abnormal sensation in eye 4 0
Asthenopia 22 0

Report Run Date: 31-Jan-2021, Page 7

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Eye disorders Eye disorders cont'd
Eye paraesthesia 1 0
Foreign body sensation in eyes 5 0
Hypoaesthesia eye 1 0
Photophobia 50 0
Optic disc abnormalities NEC
Papilloedema 1 0
Pupil disorders
Miosis 1 0
Mydriasis 2 0
Pupils unequal 2 0
Retinal structural change, deposit and degeneration
Maculopathy 1 0
Scleral infections, irritations and inflammations
Episcleritis 1 0
Visual disorders NEC
Diplopia 12 0
Halo vision 2 0
Metamorphopsia 2 0
Oscillopsia 1 0
Photopsia 10 0
Vision blurred 106 0
Visual brightness 1 0
Visual impairment and blindness (excl colour blindness)
Blindness 5 0
Blindness transient 2 0
Central vision loss 1 0
Visual acuity reduced 1 0
Visual impairment 31 0
Eye disorders SOC TOTAL 634 0

Report Run Date: 31-Jan-2021, Page 8

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Gastrointestinal disorders
Abdominal findings abnormal
Gastrointestinal sounds abnormal 1 0
Anal and rectal disorders NEC
Anal sphincter atony 1 0
Anal and rectal pains
Proctalgia 2 0
Anal and rectal signs and symptoms
Anorectal discomfort 1 0
Benign oral cavity neoplasms
Mouth cyst 1 0
Colitis (excl infective)
Colitis 1 0
Crohn's disease 1 0
Dental disorders NEC
Teething 1 0
Dental pain and sensation disorders
Hyperaesthesia teeth 3 0
Toothache 8 0
Diarrhoea (excl infective)
Diarrhoea 732 1
Diarrhoea haemorrhagic 2 0
Duodenal and small intestinal stenosis and obstruction
Small intestinal obstruction 1 0
Dyspeptic signs and symptoms
Dyspepsia 34 0
Epigastric discomfort 1 0
Eructation 7 0
Faecal abnormalities NEC
Abnormal faeces 3 0
Faeces discoloured 6 0
Faeces pale 2 0
Flatulence, bloating and distension
Abdominal distension 21 0
Aerophagia 2 0
Flatulence 20 0
Gastritis (excl infective)
Gastritis 4 0
Reflux gastritis 2 0
Gastrointestinal and abdominal pains (excl oral and throat)
Abdominal pain 156 0
Abdominal pain lower 8 0
Abdominal pain upper 214 0
Abdominal tenderness 2 0
Gastrointestinal pain 10 0
Gastrointestinal atonic and hypomotility disorders NEC
Constipation 12 0
Duodenogastric reflux 1 0
Gastrooesophageal reflux disease 13 0
Gastrointestinal disorders NEC
Functional gastrointestinal disorder 2 0
Gastric disorder 2 0
Gastrointestinal disorder 1 0

Report Run Date: 31-Jan-2021, Page 9

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Gastrointestinal disorders cont'd
Gastrointestinal disorders
Gastrointestinal dyskinetic disorders
Dyschezia 1 0
Gastrointestinal motility disorder 1 0
Gastrointestinal inflammatory disorders NEC
Enteritis 1 0
Gastrointestinal mucosal dystrophies and secretion disorders
Hyperchlorhydria 1 0
Gastrointestinal signs and symptoms NEC
Abdominal discomfort 66 0
Anal incontinence 2 0
Breath odour 5 0
Dysphagia 27 0
Gastrointestinal spastic and hypermotility disorders
Defaecation urgency 2 0
Frequent bowel movements 8 0
Irritable bowel syndrome 6 0
Oesophageal spasm 1 0
Gingival disorders, signs and symptoms NEC
Gingival blister 2 0
Gingival discomfort 1 0
Gingival pain 9 0
Gingival swelling 2 0
Gingivitis ulcerative 1 0
Noninfective gingivitis 1 0
Gingival haemorrhages
Gingival bleeding 4 0
Haemorrhoids and gastrointestinal varices (excl oesophageal)
Haemorrhoids 2 0
Intestinal haemorrhages
Anal haemorrhage 1 0
Rectal haemorrhage 7 0
Malabsorption syndromes
Steatorrhoea 1 0
Nausea and vomiting symptoms
Discoloured vomit 2 0
Nausea 2365 0
Regurgitation 1 0
Retching 14 0
Vomiting 616 2
Vomiting projectile 10 0
Non-site specific gastrointestinal haemorrhages
Gastrointestinal haemorrhage 2 0
Haematemesis 9 2
Haematochezia 2 0
Melaena 2 0
Upper gastrointestinal haemorrhage 2 0
Oesophagitis (excl infective)
Oesophagitis 1 0
Oral dryness and saliva altered
Aptyalism 1 0
Dry mouth 76 0
Lip dry 5 0

Report Run Date: 31-Jan-2021, Page 10

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Gastrointestinal disorders cont'd
Gastrointestinal disorders
Salivary hypersecretion 6 0
Oral soft tissue disorders NEC
Chapped lips 3 0
Cheilitis 5 0
Enlarged uvula 2 0
Lip blister 5 0
Lip disorder 2 0
Oral disorder 3 0
Oral papule 1 0
Uvulitis 1 0
Oral soft tissue haemorrhages
Mouth haemorrhage 1 0
Oral blood blister 3 0
Oral soft tissue signs and symptoms
Hypoaesthesia oral 81 0
Lip discolouration 1 0
Lip erythema 1 0
Lip pain 8 0
Lip pruritus 2 0
Lip scab 1 0
Odynophagia 2 0
Oral discomfort 6 0
Oral mucosal blistering 6 0
Oral mucosal eruption 3 0
Oral mucosal exfoliation 2 0
Oral pain 18 0
Oral pruritus 4 0
Paraesthesia oral 255 0
Oral soft tissue swelling and oedema
Lip oedema 1 0
Lip swelling 113 0
Mouth swelling 9 0
Oedema mouth 1 0
Peritoneal and retroperitoneal fibrosis and adhesions
Abdominal adhesions 1 0
Rectal inflammations NEC
Proctitis 1 0
Proctitis ulcerative 1 0
Salivary gland disorders NEC
Salivary gland pain 2 0
Salivary gland enlargements
Parotid gland enlargement 1 0
Submaxillary gland enlargement 3 0
Stomatitis and ulceration
Aphthous ulcer 7 0
Lip ulceration 2 0
Mouth ulceration 46 0
Oral mucosa erosion 1 0
Stomatitis 6 0
Tongue disorders
Glossitis 2 0
Plicated tongue 2 0

Report Run Date: 31-Jan-2021, Page 11

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Gastrointestinal disorders cont'd
Gastrointestinal disorders
Tongue disorder 4 0
Tongue haemorrhage 1 0
Tongue ulceration 7 0
Tongue signs and symptoms
Glossodynia 31 0
Stiff tongue 1 0
Swollen tongue 88 0
Tongue blistering 2 0
Tongue coated 1 0
Tongue discolouration 1 0
Tongue discomfort 6 0
Tongue dry 4 0
Tongue eruption 3 0
Tongue erythema 1 0
Tongue movement disturbance 1 0
Tongue oedema 2 0
Tongue spasm 2 0
Gastrointestinal disorders SOC TOTAL 5314 5

Report Run Date: 31-Jan-2021, Page 12

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
General disorders
Administration site reactions NEC
Administration site bruise 1 0
Administration site erythema 1 0
Administration site pain 3 0
Administration site warmth 1 0
Puncture site bruise 3 0
Puncture site pain 3 0
Puncture site swelling 1 0
Vessel puncture site bruise 1 0
Adverse effect absent
No adverse event 1 0
Application and instillation site reactions
Application site bruise 1 0
Application site erythema 1 0
Application site pain 1 0
Instillation site warmth 1 0
Asthenic conditions
Asthenia 223 0
Chronic fatigue syndrome 1 0
Fatigue 3230 0
Malaise 779 0
Sluggishness 2 0
Body temperature altered
Hypothermia 8 0
Temperature regulation disorder 3 0
Complications associated with device NEC
Medical device pain 1 0
Medical device site swelling 1 0
Death and sudden death
Clinical death 1 1
Death 59 53
Sudden death 7 7
Febrile disorders
Hyperpyrexia 2 0
Pyrexia 3173 0
Feelings and sensations NEC
Chills 1994 0
Feeling abnormal 144 0
Feeling cold 191 0
Feeling drunk 10 0
Feeling hot 233 0
Feeling jittery 5 0
Feeling of body temperature change 66 0
Hangover 5 0
Hunger 3 0
Sensation of foreign body 10 0
Temperature intolerance 1 0
Thirst 37 0
Gait disturbances
Gait disturbance 15 0
Gait inability 10 0
Loss of control of legs 1 0

Report Run Date: 31-Jan-2021, Page 13

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
General disorders General disorders cont'd
General signs and symptoms NEC
Condition aggravated 14 0
Crying 4 0
Disease recurrence 1 0
Exercise tolerance decreased 2 0
General physical health deterioration 1 0
Glassy eyes 2 0
Illness 203 0
Induration 2 0
Influenza like illness 412 0
Local reaction 25 0
Peripheral swelling 380 0
Pre-existing condition improved 1 0
Screaming 1 0
Secretion discharge 2 0
Swelling 328 0
Swelling face 102 0
Inflammations
Inflammation 35 0
Systemic inflammatory response syndrome 1 0
Infusion site reactions
Infusion site erythema 1 0
Infusion site joint pain 2 0
Infusion site pain 1 0
Injection site reactions
Injected limb mobility decreased 7 0
Injection site bruising 10 0
Injection site discolouration 1 0
Injection site discomfort 2 0
Injection site erythema 96 0
Injection site haemorrhage 2 0
Injection site hypoaesthesia 4 0
Injection site induration 1 0
Injection site inflammation 6 0
Injection site joint pain 3 0
Injection site mass 63 0
Injection site oedema 4 0
Injection site pain 699 0
Injection site paraesthesia 2 0
Injection site pruritus 39 0
Injection site rash 13 0
Injection site reaction 5 0
Injection site scab 1 0
Injection site scar 2 0
Injection site swelling 85 0
Injection site urticaria 4 0
Injection site vesicles 2 0
Injection site warmth 29 0
Interactions
Alcohol interaction 2 0
Drug interaction 2 0
Mass conditions NEC

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

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
General disorders General disorders cont'd
Cyst 1 0
Mass 3 0
Nodule 3 0
Oedema NEC
Face oedema 4 0
Localised oedema 6 0
Oedema 5 0
Oedema peripheral 9 0
Pain and discomfort NEC
Axillary pain 145 0
Chest discomfort 190 0
Chest pain 242 0
Discomfort 20 0
Facial discomfort 3 0
Facial pain 28 0
Non-cardiac chest pain 2 0
Pain 1176 0
Tenderness 93 0
Therapeutic and nontherapeutic responses
Adverse drug reaction 599 0
Adverse event 5 0
Adverse reaction 4 0
Drug ineffective 58 0
Immediate post-injection reaction 1 0
No reaction on previous exposure to drug 4 0
Therapeutic product effect delayed 1 0
Therapeutic response unexpected 4 0
Treatment failure 1 0
Vaccination site reactions
Extensive swelling of vaccinated limb 1 0
Shoulder injury related to vaccine administration 1 0
Vaccination site bruising 26 0
Vaccination site discolouration 4 0
Vaccination site discomfort 11 0
Vaccination site eczema 1 0
Vaccination site erythema 151 0
Vaccination site haemorrhage 4 0
Vaccination site hypoaesthesia 1 0
Vaccination site induration 23 0
Vaccination site inflammation 24 0
Vaccination site irritation 3 0
Vaccination site joint discomfort 2 0
Vaccination site joint erythema 3 0
Vaccination site joint movement impairment 8 0
Vaccination site joint pain 18 0
Vaccination site joint swelling 2 0
Vaccination site joint warmth 1 0
Vaccination site lymphadenopathy 1 0
Vaccination site mass 37 0
Vaccination site movement impairment 10 0
Vaccination site oedema 3 0
Vaccination site pain 624 0

Report Run Date: 31-Jan-2021, Page 15

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
General disorders General disorders cont'd
Vaccination site paraesthesia 4 0
Vaccination site pruritus 43 0
Vaccination site rash 21 0
Vaccination site reaction 9 0
Vaccination site swelling 171 0
Vaccination site ulcer 1 0
Vaccination site urticaria 4 0
Vaccination site vesicles 1 0
Vaccination site warmth 91 0
General disorders SOC TOTAL 16749 61

Report Run Date: 31-Jan-2021, Page 16

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Hepatic disorders
Cholestasis and jaundice
Jaundice 1 0
Hepatic vascular disorders
Hepatic artery embolism 1 0
Hepatobiliary signs and symptoms
Hepatic pain 4 0
Hepatocellular damage and hepatitis NEC
Hepatitis 1 0
Liver injury 1 0
Hepatic disorders SOC TOTAL 8 0

Report Run Date: 31-Jan-2021, Page 17

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Immune system disorders
Allergic conditions NEC
Allergic oedema 2 0
Hypersensitivity 121 0
Type IV hypersensitivity reaction 1 0
Allergies to foods, food additives, drugs and other chemicals
Allergy to vaccine 12 0
Drug hypersensitivity 2 0
Reaction to preservatives 3 0
Anaphylactic and anaphylactoid responses
Anaphylactic reaction 91 0
Anaphylactic shock 2 0
Anaphylactoid reaction 6 0
Anaphylactoid shock 2 0
Atopic disorders
Seasonal allergy 1 0
Autoimmune disorders NEC
Autoimmune disorder 1 0
Immune and associated conditions NEC
Bacille Calmette-Guerin scar reactivation 2 0
Immune system disorder 1 0
Immune-mediated adverse reaction 1 0
Immune system disorders SOC TOTAL 248 0

Report Run Date: 31-Jan-2021, Page 18

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Infections
Abdominal and gastrointestinal infections
Appendicitis 2 0
Gastroenteritis 3 0
Bacterial infections NEC
Bacterial diarrhoea 1 0
Cellulitis 35 0
Injection site cellulitis 1 0
Tonsillitis bacterial 1 0
Vaccination site cellulitis 6 0
Breast infections
Breast abscess 1 0
Mastitis 3 0
Candida infections
Candida infection 2 0
Oral candidiasis 5 0
Vulvovaginal candidiasis 4 0
Central nervous system and spinal infections
Myelitis 1 0
Clostridia infections
Clostridium difficile infection 1 0
Coronavirus infections
Asymptomatic COVID-19 4 0
COVID-19 217 10
COVID-19 pneumonia 2 1
Coronavirus infection 5 0
Severe acute respiratory syndrome 1 0
Suspected COVID-19 15 0
Coxiella infections
Q fever 4 0
Dental and oral soft tissue infections
Abscess oral 1 0
Gingivitis 1 0
Parotitis 4 0
Ear infections
Ear infection 5 0
Labyrinthitis 9 0
Eye and eyelid infections
Conjunctivitis 10 0
Eye abscess 1 0
Eye infection 1 0
Hordeolum 2 0
Female reproductive tract infections
Vulval abscess 1 0
Hepatobiliary and spleen infections
Biliary sepsis 1 0
Herpes viral infections
Genital herpes 1 0
Herpes simplex 1 0
Herpes simplex reactivation 1 0
Herpes virus infection 3 0
Herpes zoster 70 0
Herpes zoster oticus 1 0

Report Run Date: 31-Jan-2021, Page 19

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Infections Infections cont'd
Oral herpes 30 0
Infections NEC
Abscess 3 0
Infection 56 0
Injection site infection 1 0
Localised infection 2 0
Lymph gland infection 2 0
Vaccination site abscess 1 0
Vaccination site infection 6 0
Influenza viral infections
Influenza 192 0
Lower respiratory tract and lung infections
Bronchitis 1 0
Lower respiratory tract infection 14 4
Pneumonia 8 2
Sputum purulent 1 0
Male reproductive tract infections
Orchitis 1 0
Muscle and soft tissue infections
Soft tissue infection 1 0
Sepsis, bacteraemia, viraemia and fungaemia NEC
Sepsis 3 0
Urosepsis 1 0
Skin structures and soft tissue infections
Acne pustular 1 0
Folliculitis 2 0
Pustule 2 0
Rash pustular 1 0
Skin infection 1 0
Staphylococcal infections
Furuncle 2 0
Staphylococcal abscess 1 0
Streptococcal infections
Pharyngitis streptococcal 2 0
Trypanosomal infections
African trypanosomiasis 1 0
Upper respiratory tract infections
Nasopharyngitis 90 0
Pharyngitis 4 0
Rhinitis 10 0
Sinusitis 4 0
Tonsillitis 11 0
Tracheitis 1 0
Urinary tract infections
Cystitis 4 0
Kidney infection 2 0
Pyelonephritis 1 0
Urinary tract infection 11 0
Vascular infections
Haematoma infection 1 0
Viral infections NEC
Conjunctivitis viral 1 0

Report Run Date: 31-Jan-2021, Page 20

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Infections Infections cont'd
Eye infection viral 1 0
Gastroenteritis viral 3 0
Post viral fatigue syndrome 4 0
Sweating fever 21 0
Vestibular neuronitis 3 0
Viral infection 1 0
Viral labyrinthitis 2 0
Viral pharyngitis 3 0
Viral rash 6 0
Viral tonsillitis 1 0
Infections SOC TOTAL 948 17

Report Run Date: 31-Jan-2021, Page 21

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Injuries
Abdominal and gastrointestinal injuries NEC
Oral contusion 1 0
Anaesthetic and allied procedural complications
Delayed recovery from anaesthesia 1 0
Conditions caused by cold
Chillblains 4 0
Exposures associated with pregnancy, delivery and lactation
Exposure during pregnancy 5 0
Maternal exposure during breast feeding 8 0
Maternal exposure during pregnancy 10 0
Eye injuries NEC
Eye contusion 2 0
Eye injury 2 0
Injury corneal 1 0
Gastrointestinal and hepatobiliary procedural complications
Post procedural constipation 1 0
Postoperative ileus 1 0
Procedural nausea 1 0
Heat injuries (excl thermal burns)
Heat illness 1 0
Heat oedema 1 0
Heat stroke 1 0
Medication errors, product use errors and issues NEC
Medication error 1 0
Muscle, tendon and ligament injuries
Muscle strain 2 0
Nerve injuries NEC
Nerve injury 2 0
Neurological and psychiatric procedural complications
Procedural dizziness 2 0
Non-site specific injuries NEC
Bite 1 0
Electric shock 2 0
Fall 18 0
Wound complication 1 0
Non-site specific procedural complications
Incision site pain 1 0
Infusion related reaction 2 0
Injection related reaction 7 0
Off label uses
Off label use 1 0
Overdoses NEC
Overdose 6 0
Poisoning and toxicity
Poisoning 1 0
Product administration errors and issues
Accidental overdose 1 0
Contraindicated product administered 1 0
Inappropriate schedule of product administration 4 0
Product administered at inappropriate site 3 0
Product administered to patient of inappropriate age 1 0
Product administration error 1 0

Report Run Date: 31-Jan-2021, Page 22

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Injuries Injuries cont'd
Product dose omission issue 1 0
Product preparation errors and issues
Product preparation issue 3 0
Radiation injuries
Sunburn 1 0
Site specific injuries NEC
Face crushing 1 0
Head injury 1 0
Limb injury 1 0
Skin injuries NEC
Contusion 47 0
Scar 1 0
Skin abrasion 2 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
Burns second degree 1 0
Thermal burn 2 0
Vaccination related complications
Vaccination complication 9 0
Injuries SOC TOTAL 172 0

Report Run Date: 31-Jan-2021, Page 23

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Investigations
Adrenal cortex tests
Cortisol decreased 1 0
Blood gas and acid base analyses
Blood lactic acid increased 2 0
Blood pH increased 1 0
Oxygen consumption decreased 1 0
Oxygen saturation decreased 16 0
Carbohydrate tolerance analyses (incl diabetes)
Blood glucose decreased 4 0
Blood glucose increased 13 0
Glycosylated haemoglobin increased 1 0
Cardiac function diagnostic procedures
Central venous pressure 1 0
Chemistry analyses NEC
Inflammatory marker increased 1 0
Coagulation and bleeding analyses
Fibrin D dimer increased 1 0
International normalised ratio decreased 1 0
International normalised ratio increased 8 0
ECG investigations
Electrocardiogram ST segment elevation 1 0
Haematological analyses NEC
Red blood cell sedimentation rate increased 1 0
Heart rate and pulse investigations
Heart rate 16 0
Heart rate abnormal 2 0
Heart rate decreased 5 0
Heart rate increased 98 0
Heart rate irregular 8 0
Pulse abnormal 5 0
Immunology analyses NEC
Immunology test 1 0
Investigations NEC
Blood test abnormal 2 0
Polymerase chain reaction positive 3 0
Liver function analyses
Alanine aminotransferase increased 1 0
Gamma-glutamyltransferase increased 1 0
Hepatic enzyme increased 1 0
Liver function test increased 1 0
Transaminases increased 1 0
Metabolism tests NEC
Blood ketone body increased 1 0
Microbiology and serology tests NEC
Culture negative 1 0
Mineral and electrolyte analyses
Blood potassium abnormal 1 0
Neurologic diagnostic procedures
Coma scale abnormal 1 0
Ophthalmic function diagnostic procedures
Intraocular pressure increased 1 0
Physical examination procedures and organ system status

Report Run Date: 31-Jan-2021, Page 24

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Investigations Investigations cont'd
Body temperature 59 0
Body temperature abnormal 17 0
Body temperature decreased 6 0
Body temperature fluctuation 4 0
Body temperature increased 120 0
Body temperature normal 1 0
Breath sounds abnormal 1 0
Grip strength 1 0
Grip strength decreased 2 0
Lymph node palpable 3 0
Respiratory rate decreased 1 0
Respiratory rate increased 11 0
Skin temperature 4 0
Weight decreased 3 0
Pituitary analyses anterior
Blood growth hormone 1 0
Protein analyses NEC
C-reactive protein increased 2 0
Red blood cell analyses
Haemoglobin decreased 3 0
Respiratory and pulmonary function diagnostic procedures
Forced expiratory volume increased 1 0
Skeletal and cardiac muscle analyses
Blood creatine phosphokinase increased 1 0
Troponin increased 2 0
Therapeutic drug monitoring analyses
Anticoagulation drug level increased 1 0
Thyroid analyses
Tri-iodothyronine 1 0
Tri-iodothyronine decreased 1 0
Urinalysis NEC
Blood urine present 4 0
pH urine 1 0
Urinary tract function analyses NEC
Urine output 2 0
Urine output decreased 3 0
Urine output increased 1 0
Vascular tests NEC (incl blood pressure)
Blood pressure abnormal 2 0
Blood pressure decreased 9 0
Blood pressure increased 37 0
Blood pressure measurement 5 0
Blood pressure systolic decreased 1 0
Blood pressure systolic increased 1 0
Virus identification and serology
SARS-CoV-2 test 1 0
SARS-CoV-2 test false positive 1 0
SARS-CoV-2 test positive 20 0
White blood cell analyses
White blood cell count decreased 1 0
Investigations SOC TOTAL 538 0

Report Run Date: 31-Jan-2021, Page 25

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Metabolic disorders
Appetite disorders
Appetite disorder 1 0
Decreased appetite 210 0
Eating disorder symptom 1 0
Food craving 1 0
Food refusal 1 0
Hypophagia 2 0
Increased appetite 1 0
Diabetes mellitus (incl subtypes)
Diabetes mellitus inadequate control 2 1
Type 1 diabetes mellitus 1 0
Diabetic complications NEC
Diabetic complication 1 0
Diabetic ketoacidosis 3 0
Disorders of purine metabolism
Gout 4 0
Electrolyte imbalance NEC
Fluid imbalance 1 0
Fluid intake decreased
Fluid intake reduced 1 0
Fluid intake increased
Polydipsia 1 0
General nutritional disorders NEC
Abnormal weight gain 1 0
Feeding disorder 5 0
Hyperglycaemic conditions NEC
Hyperglycaemia 11 0
Hypoglycaemic conditions NEC
Hypoglycaemia 14 0
Lipid metabolism and deposit disorders NEC
Body fat disorder 1 0
Metabolic acidoses (excl diabetic acidoses)
Ketoacidosis 1 0
Mixed acid-base disorders
Acidosis 2 0
Sodium imbalance
Hyponatraemia 2 0
Total fluid volume decreased
Dehydration 20 0
Total fluid volume increased
Fluid retention 2 0
Metabolic disorders SOC TOTAL 290 1

Report Run Date: 31-Jan-2021, Page 26

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Muscle & tissue disorders
Arthropathies NEC
Arthritis 18 0
Arthropathy 2 0
Sacroiliitis 1 0
Bone disorders NEC
Medial tibial stress syndrome 1 0
Spinal disorder 1 0
Bone related signs and symptoms
Bone pain 44 0
Bone swelling 2 0
Coccydynia 1 0
Pain in jaw 42 0
Spinal pain 6 0
Bursal disorders
Bursitis 2 0
Cartilage disorders
Costochondritis 2 0
Connective tissue disorders NEC
Polymyalgia rheumatica 2 0
Extremity deformities
Foot deformity 1 0
Joint related disorders NEC
Joint lock 1 0
Periarthritis 4 0
Temporomandibular joint syndrome 1 0
Joint related signs and symptoms
Arthralgia 1414 0
Jaw clicking 2 0
Joint effusion 3 0
Joint noise 2 0
Joint range of motion decreased 1 0
Joint stiffness 25 0
Joint swelling 31 0
Joint warmth 1 0
Lupus erythematosus (incl subtypes)
Systemic lupus erythematosus 1 0
Muscle infections and inflammations
Myositis 2 0
Muscle pains
Fibromyalgia 6 0
Myalgia 2280 0
Myofascial pain syndrome 2 0
Muscle related signs and symptoms NEC
Muscle discomfort 1 0
Muscle disorder 2 0
Muscle fatigue 47 0
Muscle spasms 87 0
Muscle swelling 5 0
Muscle tightness 6 0
Muscle twitching 28 0
Muscle tone abnormalities
Muscle rigidity 5 0

Report Run Date: 31-Jan-2021, Page 27

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Muscle & tissue disorders cont'd
Muscle & tissue disorders
Nuchal rigidity 2 0
Torticollis 1 0
Trismus 2 0
Muscle weakness conditions
Muscular weakness 101 0
Musculoskeletal and connective tissue conditions NEC
Limb mass 2 0
Mastication disorder 1 0
Mobility decreased 11 0
Musculoskeletal disorder 3 0
Musculoskeletal stiffness 149 0
Musculoskeletal and connective tissue infections and inflammations NEC
Fasciitis 1 0
Plantar fasciitis 1 0
Musculoskeletal and connective tissue pain and discomfort
Back pain 304 0
Flank pain 6 0
Limb discomfort 193 0
Musculoskeletal chest pain 16 0
Musculoskeletal discomfort 12 0
Musculoskeletal pain 10 0
Neck pain 260 0
Pain in extremity 1530 0
Myopathies
Rhabdomyolysis 3 0
Osteoarthropathies
Osteoarthritis 1 0
Psoriatic arthropathies
Psoriatic arthropathy 1 0
Rheumatoid arthropathies
Rheumatoid arthritis 5 0
Soft tissue disorders NEC
Axillary mass 22 0
Groin pain 13 0
Neck mass 5 0
Spondyloarthropathies
Ankylosing spondylitis 1 0
Arthritis reactive 3 0
Synovial disorders
Synovial cyst 1 0
Synovitis 2 0
Tendon disorders
Tendon pain 1 0
Tendonitis 1 0
Muscle & tissue disorders SOC TOTAL 6746 0

Report Run Date: 31-Jan-2021, Page 28

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Neoplasms
Lymphomas unspecified NEC
Lymphoma 1 0
Metastases to specified sites
Metastases to lymph nodes 1 0
Neoplasms SOC TOTAL 2 0

Report Run Date: 31-Jan-2021, Page 29

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Nervous system disorders
Abnormal reflexes
Extensor plantar response 1 0
Hyperreflexia 1 0
Hyporeflexia 3 0
Absence seizures
Petit mal epilepsy 3 0
Acute polyneuropathies
Guillain-Barre syndrome 1 0
Autonomic nervous system disorders
Anticholinergic syndrome 1 0
Central nervous system aneurysms and dissections
Vertebral artery dissection 1 0
Central nervous system haemorrhages and cerebrovascular accidents
Brain stem infarction 1 1
Cerebellar infarction 2 0
Cerebellar stroke 1 0
Cerebral artery occlusion 1 0
Cerebral haemorrhage 4 1
Cerebral infarction 4 0
Cerebrovascular accident 21 1
Haemorrhage intracranial 2 0
Ischaemic cerebral infarction 1 0
Ischaemic stroke 6 1
Lacunar infarction 2 0
Lacunar stroke 1 0
Subarachnoid haemorrhage 2 1
Central nervous system inflammatory disorders NEC
Gliosis 1 0
Cerebrovascular venous and sinus thrombosis
Cerebral venous sinus thrombosis 1 0
Coordination and balance disturbances
Balance disorder 38 0
Coordination abnormal 7 0
Dysstasia 9 0
Cortical dysfunction NEC
Aphasia 7 0
Cranial nerve disorders NEC
Cranial nerve disorder 1 0
Dementia (excl Alzheimer's type)
Dementia 1 0
Disturbances in consciousness NEC
Altered state of consciousness 3 0
Consciousness fluctuating 1 0
Depressed level of consciousness 4 0
Lethargy 390 0
Loss of consciousness 42 0
Sedation 2 0
Somnolence 105 0
Stupor 1 0
Syncope 151 0
Dyskinesias and movement disorders NEC
Bradykinesia 2 0

Report Run Date: 31-Jan-2021, Page 30

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Nervous system disorders cont'd
Nervous system disorders
Dyskinesia 1 0
Fine motor skill dysfunction 1 0
Hypokinesia 2 0
Motor dysfunction 1 0
Movement disorder 5 0
Psychomotor hyperactivity 3 0
Dystonias
Dystonia 5 0
Writer's cramp 1 0
Encephalopathies NEC
Posterior reversible encephalopathy syndrome 1 0
Eye movement disorders
VIth nerve paralysis 1 0
Facial cranial nerve disorders
Facial nerve disorder 1 0
Facial paralysis 58 0
Facial paresis 11 0
Facial spasm 6 0
Generalised tonic-clonic seizures
Generalised tonic-clonic seizure 4 0
Headaches NEC
Cervicogenic headache 1 0
Cluster headache 29 0
Cold-stimulus headache 1 0
Exertional headache 3 0
Headache 4570 0
Medication overuse headache 2 0
New daily persistent headache 1 0
Ophthalmoplegic migraine 1 0
Primary cough headache 1 0
Primary headache associated with sexual activity 1 0
Sinus headache 55 0
Tension headache 79 0
Thunderclap headache 1 0
Lumbar spinal cord and nerve root disorders
Sciatica 7 0
Memory loss (excl dementia)
Amnesia 7 0
Memory impairment 14 0
Mental impairment (excl dementia and memory loss)
Cognitive disorder 6 0
Disturbance in attention 37 0
Mental impairment 5 0
Migraine headaches
Migraine 308 0
Migraine with aura 21 0
Retinal migraine 2 0
Typical aura without headache 1 0
Vestibular migraine 1 0
Mononeuropathies
Carpal tunnel syndrome 1 0
Mononeuropathy 1 0

Report Run Date: 31-Jan-2021, Page 31

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Nervous system disorders cont'd
Nervous system disorders
Nerve compression 2 0
Multiple sclerosis acute and progressive
Multiple sclerosis 1 0
Multiple sclerosis relapse 2 0
Muscle tone abnormal
Muscle tone disorder 1 0
Serotonin syndrome 1 0
Stiff leg syndrome 1 0
Myelitis (incl infective)
Myelitis transverse 1 0
Narcolepsy and hypersomnia
Hypersomnia 14 0
Narcolepsy 1 0
Nervous system disorders NEC
Nervous system disorder 2 0
Neurologic visual problems NEC
Tunnel vision 3 0
Visual field defect 1 0
Neurological signs and symptoms NEC
Dizziness 1278 0
Dizziness exertional 3 0
Dizziness postural 117 0
Head discomfort 29 0
Hyporesponsive to stimuli 1 0
Myoclonus 1 0
Neurological symptom 2 0
Persistent postural-perceptual dizziness 1 0
Presyncope 95 0
Slow response to stimuli 1 0
Unresponsive to stimuli 12 0
Neuromuscular disorders NEC
Muscle contractions involuntary 4 0
Neuromuscular junction dysfunction
Myasthenia gravis 1 0
Olfactory nerve disorders
Anosmia 38 0
Hyposmia 4 0
Parosmia 20 0
Optic nerve disorders NEC
Optic neuritis 1 0
Paraesthesias and dysaesthesias
Burning sensation 51 0
Dysaesthesia 1 0
Formication 3 0
Hemiparaesthesia 1 0
Hyperaesthesia 13 0
Hypoaesthesia 259 0
Paraesthesia 394 0
Paralysis and paresis (excl cranial nerve)
Hemiparesis 10 0
Hemiplegia 1 0
Locked-in syndrome 1 0

Report Run Date: 31-Jan-2021, Page 32

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Nervous system disorders cont'd
Nervous system disorders
Monoparesis 4 0
Monoplegia 4 0
Paralysis 14 0
Parkinson's disease and parkinsonism
Freezing phenomenon 1 0
Parkinsonian gait 1 0
Parkinsonism 1 0
Partial complex seizures
Dreamy state 1 0
Peripheral neuropathies NEC
Neuropathy peripheral 8 0
Peripheral sensory neuropathy 2 0
Seizures and seizure disorders NEC
Epilepsy 4 0
Febrile convulsion 1 0
Partial seizures 1 0
Seizure 34 0
Tonic convulsion 2 0
Sensory abnormalities NEC
Ageusia 82 0
Allodynia 3 0
Aura 6 0
Dysgeusia 205 0
Neuralgia 31 0
Restless legs syndrome 13 0
Sensory disturbance 10 0
Sensory loss 3 0
Taste disorder 38 0
Sleep disturbances NEC
Poor quality sleep 20 0
Speech and language abnormalities
Dysarthria 14 0
Repetitive speech 1 0
Speech disorder 5 0
Spinal cord and nerve root disorders NEC
Radiculopathy 1 0
Transient cerebrovascular events
Transient ischaemic attack 11 0
Tremor (excl congenital)
Essential tremor 1 0
Resting tremor 1 0
Tremor 221 0
Trigeminal disorders
Facial neuralgia 2 0
Trigeminal nerve disorder 1 0
Trigeminal neuralgia 3 0
Nervous system disorders SOC TOTAL 9204 5

Report Run Date: 31-Jan-2021, Page 33

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Pregnancy conditions
Abortions spontaneous
Abortion spontaneous 4 0
Maternal complications of pregnancy NEC
Morning sickness 1 0
Normal pregnancy, labour and delivery
Pregnancy 3 0
Pregnancy conditions SOC TOTAL 8 0

Report Run Date: 31-Jan-2021, Page 34

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Device malfunction events NEC
Device stimulation issue 1 0
Oversensing 4 0
Product contamination and sterility issues
Product contamination physical 1 0
null SOC TOTAL 6 0

Report Run Date: 31-Jan-2021, Page 35

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Psychiatric disorders
Anxiety symptoms
Agitation 18 0
Anxiety 55 0
Nervousness 30 0
Tension 12 0
Behaviour and socialisation disturbances
Indifference 2 0
Paranoia 2 0
Social avoidant behaviour 2 0
Cognitive and attention disorders and disturbances NEC
Mental fatigue 18 0
Communications disorders
Communication disorder 1 0
Confusion and disorientation
Confusional state 86 0
Disorientation 26 0
Deliria
Delirium 21 0
Depressive disorders
Depression 9 0
Dissociative states
Depersonalisation/derealisation disorder 2 0
Dissociation 3 0
Dissociative amnesia 1 0
Disturbances in initiating and maintaining sleep
Initial insomnia 3 0
Insomnia 129 0
Middle insomnia 3 0
Dyssomnias
Dyssomnia 1 0
Eating disorders NEC
Eating disorder 1 0
Emotional and mood disturbances NEC
Anger 2 0
Emotional disorder 5 0
Emotional distress 2 0
Euphoric mood 3 0
Irritability 15 0
Mood altered 3 0
Fear symptoms and phobic disorders (incl social phobia)
Phonophobia 1 0
Social fear 1 0
Fluctuating mood symptoms
Mood swings 1 0
Hallucinations (excl sleep-related)
Hallucination 31 0
Hallucination, auditory 2 0
Hallucination, olfactory 1 0
Hallucination, tactile 1 0
Hallucination, visual 4 0
Increased physical activity levels
Restlessness 18 0

Report Run Date: 31-Jan-2021, Page 36

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Psychiatric disordersPsychiatric disorders cont'd
Mental disorders NEC
Mental disorder 1 0
Mood alterations with depressive symptoms
Decreased interest 2 0
Depressed mood 21 0
Negative thoughts 1 0
Tearfulness 2 0
Mood disorders NEC
Apathy 1 0
Laziness 1 0
Listless 1 0
Narcolepsy and associated conditions
Sleep attacks 2 0
Obsessive-compulsive disorders and symptoms
Obsessive-compulsive symptom 1 0
Panic attacks and disorders
Panic attack 11 0
Panic disorder 1 0
Panic reaction 3 0
Parasomnias
Abnormal dreams 25 0
Nightmare 23 0
Sleep terror 1 0
Perception disturbances NEC
Autoscopy 1 0
Derealisation 2 0
Illusion 1 0
Psychiatric elimination disorders
Enuresis 4 0
Psychiatric symptoms NEC
Trance 1 0
Psychotic disorder NEC
Psychotic behaviour 1 0
Sleep disorders NEC
Sleep disorder 23 0
Somatic symptom disorders
Habit cough 2 0
Vomiting psychogenic 1 0
Speech and language usage disturbances
Disorganised speech 2 0
Logorrhoea 1 0
Stereotypies and automatisms
Head banging 2 0
Stereotypy 1 0
Suicidal and self-injurious behaviour
Intentional self-injury 1 0
Thinking disturbances
Bradyphrenia 7 0
Thinking abnormal 3 0
Psychiatric disorders SOC TOTAL 665 0

Report Run Date: 31-Jan-2021, Page 37

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Renal & urinary disorders
Bladder and urethral symptoms
Bladder discomfort 1 0
Dysuria 6 0
Incontinence 4 0
Micturition disorder 1 0
Micturition urgency 1 0
Pollakiuria 6 0
Urinary incontinence 8 0
Urinary retention 8 0
Bladder disorders NEC
Bladder disorder 3 0
Genital and urinary tract disorders NEC
Urinary tract disorder 1 0
Myoneurogenic bladder disorders
Hypertonic bladder 1 0
Loss of bladder sensation 1 0
Renal failure and impairment
Acute kidney injury 3 0
Renal failure 2 0
Urinary abnormalities
Chromaturia 11 0
Haematuria 3 0
Proteinuria 1 0
Urine abnormality 2 0
Urine odour abnormal 2 0
Urinary tract signs and symptoms NEC
Costovertebral angle tenderness 1 0
Haemorrhage urinary tract 1 0
Nocturia 1 0
Polyuria 1 0
Renal pain 29 0
Renal & urinary disorders SOC TOTAL 98 0

Report Run Date: 31-Jan-2021, Page 38

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Reproductive & breast disorders
Benign and malignant breast neoplasms
Breast cyst 1 0
Breast disorders NEC
Breast mass 3 0
Breast signs and symptoms
Breast discomfort 1 0
Breast pain 22 0
Breast swelling 8 0
Breast tenderness 2 0
Nipple pain 3 0
Nipple swelling 2 0
Erection and ejaculation conditions and disorders
Erectile dysfunction 3 0
Menopausal effects NEC
Menopausal symptoms 2 0
Menstruation and uterine bleeding NEC
Dysmenorrhoea 9 0
Menstrual disorder 5 0
Menstruation irregular 7 0
Metrorrhagia 2 0
Menstruation with decreased bleeding
Amenorrhoea 1 0
Hypomenorrhoea 2 0
Menstruation delayed 7 0
Menstruation with increased bleeding
Menorrhagia 15 0
Polymenorrhoea 3 0
Ovarian and fallopian tube disorders NEC
Ovulation pain 2 0
Pelvis and broad ligament disorders NEC
Adnexa uteri pain 1 0
Penile disorders NEC (excl erection and ejaculation)
Penile swelling 1 0
Prostatic signs, symptoms and disorders NEC
Prostatomegaly 1 0
Reproductive tract signs and symptoms NEC
Pelvic discomfort 1 0
Pelvic pain 2 0
Perineal pain 1 0
Scrotal disorders NEC
Scrotal erythema 1 0
Scrotal exfoliation 1 0
Scrotal pain 2 0
Scrotal swelling 1 0
Testicular and epididymal disorders NEC
Testicular pain 2 0
Testicular swelling 1 0
Uterine tone disorders
Uterine spasm 1 0
Vulvovaginal disorders NEC
Vaginal haemorrhage 16 0
Vulval ulceration 2 0

Report Run Date: 31-Jan-2021, Page 39

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Reproductive
Reproductive & breast disorders & breast disorders cont'd
Vulvovaginal signs and symptoms
Vulvovaginal pruritus 1 0
Reproductive & breast disorders SOC TOTAL 135 0

Report Run Date: 31-Jan-2021, Page 40

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Respiratory disorders
Breathing abnormalities
Dyspnoea 415 0
Dyspnoea exertional 6 1
Hyperventilation 5 0
Hypopnoea 6 0
Irregular breathing 1 0
Mouth breathing 1 0
Orthopnoea 2 0
Respiration abnormal 7 0
Respiratory arrest 2 0
Respiratory distress 1 0
Tachypnoea 11 0
Bronchial conditions NEC
Bronchial secretion retention 1 0
Bronchospasm and obstruction
Asthma 37 0
Bronchospasm 3 0
Obstructive airways disorder 1 0
Wheezing 55 0
Conditions associated with abnormal gas exchange
Hypoxia 4 1
Coughing and associated symptoms
Cough 325 0
Haemoptysis 5 0
Productive cough 18 0
Sputum discoloured 1 0
Laryngeal spasm, oedema and obstruction
Epiglottic oedema 1 0
Stridor 1 0
Lower respiratory tract inflammatory and immunologic conditions
Hypersensitivity pneumonitis 1 0
Pneumonia aspiration 2 2
Pneumonitis 3 0
Lower respiratory tract signs and symptoms
Hiccups 2 0
Pleuritic pain 4 0
Pulmonary pain 9 0
Rales 1 0
Nasal congestion and inflammations
Nasal congestion 27 0
Rhinitis allergic 2 0
Nasal disorders NEC
Epistaxis 80 0
Intranasal hypoaesthesia 1 0
Intranasal paraesthesia 1 0
Nasal disorder 1 0
Nasal dryness 3 0
Nasal odour 1 0
Nasal oedema 1 0
Nasal pruritus 1 0
Paranasal sinus disorders (excl infections and neoplasms)
Sinonasal obstruction 2 0

Report Run Date: 31-Jan-2021, Page 41

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Respiratory disordersRespiratory disorders cont'd
Sinus congestion 6 0
Sinus disorder 1 0
Sinusitis noninfective 1 0
Parenchymal lung disorders NEC
Atelectasis 1 0
Pharyngeal disorders (excl infections and neoplasms)
Pharyngeal erythema 3 0
Pharyngeal haemorrhage 1 0
Pharyngeal hypoaesthesia 7 0
Pharyngeal inflammation 1 0
Pharyngeal oedema 3 0
Pharyngeal paraesthesia 16 0
Pharyngeal swelling 37 0
Pharyngeal ulceration 2 0
Tonsillar hypertrophy 9 0
Tonsillar inflammation 1 0
Pleural infections and inflammations
Pleurisy 1 0
Pneumothorax and pleural effusions NEC
Pleural effusion 1 0
Pulmonary oedemas
Pulmonary congestion 1 0
Pulmonary oedema 2 0
Pulmonary thrombotic and embolic conditions
Pulmonary embolism 2 0
Pulmonary infarction 1 0
Respiratory failures (excl neonatal)
Acute respiratory failure 1 1
Respiratory signs and symptoms NEC
Painful respiration 2 0
Respiratory symptom 1 0
Respiratory tract disorders NEC
Aspiration 1 0
Respiratory disorder 1 0
Respiratory tract irritation 1 0
Respiratory tract oedema 1 0
Upper respiratory tract neoplasms
Tonsillar cyst 1 0
Upper respiratory tract signs and symptoms
Aphonia 10 0
Catarrh 3 0
Choking 2 0
Dry throat 26 0
Dysphonia 21 0
Increased upper airway secretion 3 0
Increased viscosity of upper respiratory secretion 2 0
Nasal discharge discolouration 1 0
Nasal discomfort 5 0
Nasal obstruction 2 0
Oropharyngeal blistering 5 0
Oropharyngeal discomfort 10 0
Oropharyngeal pain 386 0

Report Run Date: 31-Jan-2021, Page 42

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Respiratory disordersRespiratory disorders cont'd
Paranasal sinus discomfort 4 0
Rhinalgia 4 0
Rhinorrhoea 77 0
Sinus pain 25 0
Sneezing 45 0
Snoring 2 0
Throat clearing 2 0
Throat irritation 37 0
Throat tightness 51 0
Respiratory disorders SOC TOTAL 1880 5

Report Run Date: 31-Jan-2021, Page 43

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Skin disorders
Acnes
Acne 4 0
Alopecias
Alopecia 4 0
Angioedemas
Angioedema 27 0
Circumoral swelling 1 0
Apocrine and eccrine gland disorders
Cold sweat 102 0
Hyperhidrosis 251 0
Miliaria 8 0
Night sweats 104 0
Bullous conditions
Blister 26 0
Blood blister 1 0
Dermatitis bullous 3 0
Erythema multiforme 3 0
Stevens-Johnson syndrome 1 0
Toxic epidermal necrolysis 1 1
Dermal and epidermal conditions NEC
Dermatosis 1 0
Dry skin 20 0
Macule 1 0
Pain of skin 45 0
Papule 11 0
Peau d'orange 2 0
Scar pain 3 0
Sensitive skin 27 0
Skin burning sensation 24 0
Skin discolouration 17 0
Skin disorder 1 0
Skin induration 1 0
Skin lesion 3 0
Skin odour abnormal 2 0
Skin reaction 17 0
Skin sensitisation 4 0
Skin swelling 10 0
Skin tightness 11 0
Skin warm 45 0
Sticky skin 1 0
Yellow skin 3 0
Dermatitis and eczema
Dermatitis 15 0
Dermatitis allergic 29 0
Dyshidrotic eczema 1 0
Eczema 7 0
Skin irritation 11 0
Dermatitis ascribed to specific agent
Drug eruption 2 0
Fixed eruption 1 0
Toxic skin eruption 1 0
Erythemas

Report Run Date: 31-Jan-2021, Page 44

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Skin disorders Skin disorders cont'd
Erythema 371 0
Exfoliative conditions
Skin exfoliation 9 0
Hyperpigmentation disorders
Ephelides 1 0
Nail and nail bed conditions (excl infections and infestations)
Nail discolouration 2 0
Nail disorder 1 0
Onychalgia 1 0
Panniculitides
Erythema nodosum 1 0
Papulosquamous conditions
Lichen planus 1 0
Pityriasis rosea 7 0
Photosensitivity and photodermatosis conditions
Photosensitivity reaction 6 0
Pigmentation changes NEC
Pigmentation disorder 1 0
Pilar disorders NEC
Piloerection 3 0
Pruritus NEC
Itching scar 3 0
Pruritus 612 0
Psoriatic conditions
Psoriasis 4 0
Purpura and related conditions
Petechiae 15 0
Purpura 6 0
Rashes, eruptions and exanthems NEC
Rash 648 0
Rash erythematous 132 0
Rash macular 69 0
Rash maculo-papular 12 0
Rash morbilliform 4 0
Rash papular 42 0
Rash pruritic 102 0
Rash vesicular 4 0
Rosaceas
Rosacea 1 0
Scaly conditions
Pityriasis 3 0
Skin and subcutaneous conditions NEC
Skin mass 3 0
Skin and subcutaneous tissue ulcerations
Skin erosion 3 0
Skin ulcer 1 0
Skin cysts and polyps
Dermal cyst 1 0
Skin haemorrhages
Haemorrhage subcutaneous 1 0
Skin haemorrhage 1 0
Skin hyperplasias and hypertrophies

Report Run Date: 31-Jan-2021, Page 45

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Skin disorders Skin disorders cont'd
Skin hypertrophy 1 0
Skin vasculitides
Vasculitic rash 1 0
Skin vasomotor conditions
Livedo reticularis 8 0
Urticarias
Cold urticaria 1 0
Mechanical urticaria 1 0
Urticaria 217 0
Urticaria papular 1 0
Urticaria thermal 1 0
Skin disorders SOC TOTAL 3154 1

Report Run Date: 31-Jan-2021, Page 46

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Social circumstances
Disability issues
Bedridden 5 0
Breast prosthesis user 1 0
Immobile 2 0
Impaired work ability 1 0
Social circumstances SOC TOTAL 9 0

Report Run Date: 31-Jan-2021, Page 47

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Surgical & medical procedures
Gastrointestinal therapeutic procedures NEC
Prophylaxis of nausea and vomiting 4 0
Immunisations
COVID-19 immunisation 3 0
Immunisation 1 0
Limb therapeutic procedures
Limb immobilisation 1 0
Respiratory tract therapeutic procedures NEC
Asthma prophylaxis 1 0
Skin and subcutaneous tissue therapeutic procedures NEC
Dermal filler injection 1 0
Therapeutic procedures NEC
Bed rest 1 0
Fatigue management 1 0
Hospitalisation 1 0
Injection 1 0
Surgical & medical procedures SOC TOTAL 15 0

Report Run Date: 31-Jan-2021, Page 48

 Case Series Drug Analysis Print
Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print
analysis print
Report Run Date: 31-Jan-2021 Data Lock Date: 28-Jan-2021 19:00:04
Earliest Reaction Date: 19-Jan-2001 MedDRA Version: MedDRA 23.1
Reaction Name Total Fatal
Vascular disorders
Blood pressure disorders NEC
Blood pressure fluctuation 2 0
Circulatory collapse and shock
Circulatory collapse 21 0
Neurogenic shock 6 0
Peripheral circulatory failure 2 0
Haemorrhages NEC
Haematoma 3 0
Haemorrhage 5 0
Lymphoedemas
Lymphoedema 17 0
Non-site specific embolism and thrombosis
Thrombosis 6 0
Non-site specific vascular disorders NEC
Superficial vein prominence 1 0
Vasodilatation 1 0
Vein discolouration 1 0
Vein disorder 2 0
Vein rupture 1 0
Peripheral embolism and thrombosis
Blue toe syndrome 1 0
Deep vein thrombosis 5 0
Peripheral vascular disorders NEC
Cyanosis 8 0
Flushing 106 0
Hot flush 152 0
Peripheral vasoconstriction, necrosis and vascular insufficiency
Peripheral coldness 43 0
Peripheral ischaemia 1 0
Poor peripheral circulation 1 0
Raynaud's phenomenon 3 0
Vasoconstriction 1 0
Site specific vascular disorders NEC
Pallor 32 0
Vascular hypertensive disorders NEC
Hypertension 78 0
Vascular hypotensive disorders
Hypotension 62 0
Orthostatic hypotension 3 0
Vasculitides NEC
Vasculitis 4 0
Vena caval embolism and thrombosis
Vena cava embolism 1 0
Vena cava thrombosis 1 0
Vascular disorders SOC TOTAL 570 0
TOTAL REACTIONS FOR DRUG 49472 107

TOTAL REPORTS 16756

TOTAL FATAL OUTCOME REPORTS 107

Report Run Date: 31-Jan-2021, Page 49