Appendix 1
Listing of AEFI reports received through CIR up to 11/9/2021
Essential information about this data:
An assessment of the safety of Comirnaty vaccine cannot be made using only the information contained in this spreadsheet. Patients
are advised NOT to make any decisions about vaccination based on information contained here.
What to remember when viewing this information:
The likelihood of experiencing an adverse reaction to Comirnaty cannot be estimated from this database as the extent of under-
reporting is not known.
For these reasons, it is also not possible to directly compare the risks of Comiranty with other vaccines.
Reports (including CIR reports) are sent to the Centre for Adverse Reactions Monitoring (CARM) if the reporter suspects that
Comirnaty caused an event. This does not necessarily mean that Comirnaty caused the reaction. CARM and Medsafe staff consider
many factors when assessing whether a medicine has caused an adverse reaction.
The number of reports for a medicine can be influenced by how many patients are taking the medicine, media attention, the nature
of the reactions, and other factors which vary over time.
The quality of the information here is limited by the quality of the original report.
The information shown here will change over time due to quality control procedures and/or receipt of further information. Reactions
may also be caused by other ingredients in the medicine (excipients). The information here does not represent all the available
information on the benefits and risks of Comirnaty. This information should not be used in isolation when making treatment
decisions.
Any vaccinaton concerns should be discussed with a healthcare professional. Patients are advised not to make any vaccination
decision based on the information contained here.
The reporting channel can not be used to identify how soon after the vaccine, or where the event took place.
Preferred term
# reported cases
Dizziness (10013573)
3125
Nausea (10028813)
1122
Headache (10019211)
748
Syncope (10042772)
691
Hypoaesthesia (10020937)
449
Injection site pain (10022086)
404
Hypertension (10020772)
347
under the Official Information Act 1982
Chest discomfort (10008469)
315
Tachycardia (10043071)
312
Lethargy (10024264)
300
Rash (10037844)
231
Paraesthesia (10033775)
219
Anxiety (10002855)
213
Released
Vomiting (10047700)
189
Dyspnoea (10013968)
185
Throat tightness (10043528)
184
Presyncope (10036653)
178
Pallor (10033546)
176
Depressed level of consciousness (10012373)
170
Urticaria (10046735)
164
Pruritus (10037087)
163
Feeling hot (10016334)
156
Appendix 1
Flushing (10016825)
151
Pyrexia (10037660)
144
Hyperhidrosis (10020642)
137
Paraesthesia oral (10057372)
137
Swelling (10042674)
129
Vision blurred (10047513)
91
Palpitations (10033557)
90
Anaphylactic reaction (10002198)
88
Dysgeusia (10013911)
82
Abdominal pain (10000081)
79
Injection site swelling (10053425)
75
Hypotension (10021097)
70
Pain in extremity (10033425)
64
Injection site urticaria (10022107)
61
1982
Tremor (10044565)
61
Seizure (10039906)
56
Act
Malaise (10025482)
55
Wheezing (10047924)
50
Throat irritation (10043521)
48
Arthralgia (10003239)
46
Feeling of body temperature change (10061458)
46
Cough (10011224)
45
Cold sweat (10009866)
44
Bradycardia (10006093)
36
Information
Injection site erythema (10022061)
35
Musculoskeletal pain (10028391)
32
Visual impairment (10047571)
26
Injection site pruritus (10022093)
25
Fatigue (10016256)
24
Official
Muscle twitching (10028347)
24
Rash pruritic (10037884)
22
the
Lip swelling (10024570)
21
Myalgia (10028411)
21
Tinnitus (10043882)
20
Oedema peripheral (10030124)
19
under
Angioedema (10002424)
18
Hot flush (10060800)
18
Injection site paraesthesia (10022088)
18
Chills (10008531)
17
Face oedema (10016029)
17
Feeling cold (10016326)
17
Released
Injection site rash (10022094)
17
Swollen tongue (10042727)
17
Rash erythematous (10037855)
16
Chest pain (10008479)
14
Injection site haemorrhage (10022067)
14
Somnolence (10041349)
14
Pain (10033371)
13
Agitation (10001497)
12
Back pain (10003988)
12
Appendix 1
Depersonalisation/derealisation disorder (10077805)
12
Diarrhoea (10012735)
12
Dry mouth (10013781)
12
Hyperventilation (10020910)
12
Influenza like illness (10022004)
11
Injection site warmth (10022112)
11
Musculoskeletal stiffness (10052904)
11
Dysphagia (10013950)
10
Oropharyngeal pain (10068319)
10
Oxygen saturation decreased (10033318)
10
Asthma (10003553)
9
Feeling abnormal (10016322)
9
Abdominal discomfort (10000059)
8
Asthenia (10003549)
8
1982
Bronchospasm (10006482)
8
Dysphonia (10013952)
8
Act
Eructation (10015137)
8
Hypoacusis (10048865)
8
Lymphadenopathy (10025197)
8
Periorbital oedema (10034545)
8
Pharyngeal swelling (10082270)
8
Tongue disorder (10043951)
8
Vertigo (10047340)
8
Burning sensation (10006784)
7
Information
Injection site inflammation (10022078)
7
Muscular weakness (10028372)
7
Neuralgia (10029223)
7
Tachypnoea (10043089)
7
Blood pressure fluctuation (10005746)
6
Official
Disorientation (10013395)
6
Dysarthria (10013887)
6
the
Erythema (10015150)
6
Hypoaesthesia oral (10057371)
6
Limb discomfort (10061224)
6
Muscle tightness (10049816)
6
under
Rhinitis (10039083)
6
Thirst (10043458)
6
Anaphylactoid reaction (10002216)
5
Dry throat (10013789)
5
Epistaxis (10015090)
5
Eye pain (10015958)
5
Released
Facial paralysis (10016062)
5
Gait disturbance (10017577)
5
Head injury (10019196)
5
Ocular hyperaemia (10030041)
5
Panic reaction (10033670)
5
Angina pectoris (10002383)
4
Confusional state (10010305)
4
Cyanosis (10011703)
4
Decreased appetite (10061428)
4
Appendix 1
Dehydration (10012174)
4
Eye pruritus (10052140)
4
Hypoglycaemia (10020993)
4
Hypokinesia (10021021)
4
Injection site bruising (10022052)
4
Migraine (10027599)
4
Muscle spasms (10028334)
4
Nasal congestion (10028735)
4
Rash maculo‐papular (10037868)
4
Rhinorrhoea (10039101)
4
Aphasia (10002948)
3
Arrhythmia (10003119)
3
Arthropod sting (10003402)
3
Atrial fibrillation (10003658)
3
1982
Generalised tonic‐clonic seizure (10018100)
3
Herpes zoster (10019974)
3
Act
Hypoxia (10021143)
3
Injection site hypoaesthesia (10074586)
3
Lip disorder (10048470)
3
Loss of consciousness (10024855)
3
Nervousness (10029216)
3
Pain in jaw (10033433)
3
Product administration error (10081576)
3
Respiratory disorder (10038683)
3
Information
Retching (10038776)
3
Salivary hypersecretion (10039424)
3
Speech disorder (10041466)
3
Stridor (10042241)
3
Tearfulness (10043169)
3
Official
Ataxia (10003591)
2
Bronchitis (10006451)
2
the
Diplopia (10013036)
2
Eye discharge (10015915)
2
Eye irritation (10015946)
2
Facial pain (10016059)
2
under
Fall (10016173)
2
Feeling drunk (10016330)
2
Feeling jittery (10016338)
2
Hemiplegia (10019468)
2
Hypersensitivity (10020751)
2
Injection site haematoma (10022066)
2
Released
Injection site mass (10022081)
2
Injury associated with device (10069803)
2
Localised oedema (10048961)
2
Lymphadenitis (10025188)
2
Mouth ulceration (10028034)
2
Nasal discomfort (10052437)
2
Oedema mouth (10030110)
2
Pericarditis (10034484)
2
Photophobia (10034960)
2
Appendix 1
Pulse abnormal (10037466)
2
Urinary incontinence (10046543)
2
Alopecia (10001760)
1
Amnesia (10001949)
1
Apnoea (10002974)
1
Arrhythmia supraventricular (10003130)
1
Arterial thrombosis (10003178)
1
Breath holding (10006322)
1
Deep vein thrombosis (10051055)
1
Defaecation urgency (10012110)
1
Depression (10012378)
1
Dyspepsia (10013946)
1
Ear disorder (10014004)
1
Ear pain (10014020)
1
1982
Ecchymosis (10014080)
1
Electric shock sensation (10014358)
1
Act
Electrocardiogram abnormal (10014363)
1
Eyelid oedema (10015993)
1
Fibromyalgia (10048439)
1
Frequent bowel movements (10017367)
1
Gastritis (10017853)
1
Gastrooesophageal reflux disease (10017885)
1
Guillain‐Barre syndrome (10018767)
1
Haematuria (10018867)
1
Information
Hallucination, visual (10019075)
1
Hepatic enzyme increased (10060795)
1
Hyperaesthesia (10020568)
1
Hypopnoea (10021079)
1
Hypotonic‐hyporesponsive episode (10021121)
1
Official
Injection site cellulitis (10050057)
1
Injection site coldness (10050082)
1
the
Injection site discomfort (10054266)
1
Injection site hyperaesthesia (10073418)
1
Injection site irritation (10022079)
1
Injection site reaction (10022095)
1
under
Insomnia (10022437)
1
Intermenstrual bleeding (10022559)
1
Lip dry (10024552)
1
Lip ulceration (10024572)
1
Meningitis (10027199)
1
Menstrual disorder (10027327)
1
Released
Miliaria (10027627)
1
Muscle contractions involuntary (10028293)
1
Mydriasis (10028521)
1
Myocardial infarction (10028596)
1
Myoclonus (10028622)
1
Orthostatic hypotension (10031127)
1
Paraesthesia mucosal (10033780)
1
Peripheral coldness (10034568)
1
Petechiae (10034754)
1
Appendix 1
Photopsia (10034962)
1
Photosensitivity reaction (10034972)
1
Pulmonary embolism (10037377)
1
Rash macular (10037867)
1
Rosacea (10039218)
1
Scleritis (10039705)
1
Sinusitis (10040753)
1
Skin irritation (10040880)
1
Sleep disorder (10040984)
1
Synovitis (10042868)
1
Thrombosis (10043607)
1
Transient ischaemic attack (10044390)
1
Vasculitis (10047115)
1
1982
Act
Information
Official
the
under
Released
