Trial Outcomes & Findings for Cross-vaccination Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK 1437173A) in Subjects Who Previously Received Placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) Studies. (NCT NCT02690207)

Last Updated: 2021-03-04

Results Overview

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related=AE assessed by the investigator as related to the vaccination.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

8687 participants

Primary outcome timeframe

During 30 days (Days 0-29) after any vaccination (across doses)

Results posted on

2021-03-04

Participant Flow

Potentially eligible subjects who received placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) studies were enrolled in this study.

8687 subjects were enrolled in this study and received Herpes Zoster sub-unit vaccine. Of these, 8434 subjects completed the trial and 253 subjects withdrew.

Participant milestones

Participant milestones
Measure	HZ/su Group Subjects received Herpes Zoster subunit vaccine, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
Overall Study STARTED	8687
Overall Study COMPLETED	8434
Overall Study NOT COMPLETED	253

Reasons for withdrawal

Reasons for withdrawal
Measure	HZ/su Group Subjects received Herpes Zoster subunit vaccine, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
Overall Study Lost to Follow-up	48
Overall Study Withdrawal by Subject	46
Overall Study Protocol Violation	2
Overall Study Serious adverse event	110
Overall Study Non-serious Adverse Event	18
Overall Study Migrated/moved from study area	5
Overall Study Suspected HZ Episode	1
Overall Study Other reasons for withdrawal	23

Baseline Characteristics

Cross-vaccination Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK 1437173A) in Subjects Who Previously Received Placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) Studies.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HZ/su Group n=8687 Participants Subjects received Herpes Zoster subunit vaccine, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
Age, Continuous	72.6 Years STANDARD_DEVIATION 9.4 • n=5 Participants
Age, Customized Age 18-64 years	2326 Participants n=5 Participants
Age, Customized Age 65-84 years	5574 Participants n=5 Participants
Age, Customized Age 85 years and over	787 Participants n=5 Participants
Sex/Gender, Customized Female	5254 Participants n=5 Participants
Sex/Gender, Customized Male	3433 Participants n=5 Participants
Race/Ethnicity, Customized African Heritage/ African American	72 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	7 Participants n=5 Participants
Race/Ethnicity, Customized Asian-Central/South Asian Heritage	5 Participants n=5 Participants
Race/Ethnicity, Customized Asian-East Asian Heritage	1202 Participants n=5 Participants
Race/Ethnicity, Customized Asian-Japanese Heritage	254 Participants n=5 Participants
Race/Ethnicity, Customized Asian-South East Asian Heritage	12 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants
Race/Ethnicity, Customized White-Arabic/North African Heritage	47 Participants n=5 Participants
Race/Ethnicity, Customized White-Caucasian / European Heritage	6361 Participants n=5 Participants
Race/Ethnicity, Customized Other	724 Participants n=5 Participants

PRIMARY outcome

Timeframe: During 30 days (Days 0-29) after any vaccination (across doses)

Population: This analysis was performed on Total vaccinated cohort, which included all subjects with at least one HZ/su vaccine administration documented for whom data were available.

Outcome measures

Outcome measures
Measure	HZ/su Group n=8687 Participants Subjects received Herpes Zoster subunit vaccine, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any AE(s)	5175 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 AE(s)	963 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related AE(s)	4422 Participants

PRIMARY outcome

Timeframe: From Month 0 until study end (Month 14, i.e. 12 months post dose 2)

Population: This analysis was performed on Total vaccinated cohort, which included all subjects with at least one HZ/su vaccine administration documented for whom data were available.

Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related=SAE assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	HZ/su Group n=8687 Participants Subjects received Herpes Zoster subunit vaccine, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
Number of Subjects With Any and Related Serious Adverse Events (SAEs) Any SAE(s)	734 Participants
Number of Subjects With Any and Related Serious Adverse Events (SAEs) Related SAE(s)	2 Participants

PRIMARY outcome

Timeframe: From Month 0 until study end (Month 14, i.e. 12 months post dose 2)

Population: This analysis was performed on Total vaccinated cohort, which included all subjects with at least one HZ/su vaccine administration documented for whom data were available.

pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Related pIMDs=pIMDs assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	HZ/su Group n=8687 Participants Subjects received Herpes Zoster subunit vaccine, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) Any pIMD(s)	62 Participants
Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) Related pIMD(s)	1 Participants

SECONDARY outcome

Timeframe: From Month 0 until study end (Month 14, i.e. 12 months post dose 2)

Population: This analysis was performed on Total vaccinated cohort, which included all subjects with at least one HZ/su vaccine administration documented for whom data were available.

A suspected case of HZ was defined as a new rash characteristic of HZ (e.g., unilateral, dermatomal and accompanied by pain broadly defined to include allodynia, pruritus or other sensations). Clinically confirmed HZ episode is suspected HZ episode confirmed by the Investigator/Delegate.

Outcome measures

Outcome measures
Measure	HZ/su Group n=8687 Participants Subjects received Herpes Zoster subunit vaccine, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
Number of Subjects With at Least One Suspected Herpes Zoster (HZ) Case(s) HZ episode	30 Participants
Number of Subjects With at Least One Suspected Herpes Zoster (HZ) Case(s) Suspected HZ episode only	8 Participants
Number of Subjects With at Least One Suspected Herpes Zoster (HZ) Case(s) Clinically confirmed HZ episode	22 Participants

Adverse Events

HZ/su Group

Serious events: 734 serious events

Other events: 5101 other events

Deaths: 107 deaths

Serious adverse events

Serious adverse events
Measure	HZ/su Group n=8687 participants at risk Subjects received Herpes Zoster subunit vaccine, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
Vascular disorders Extremity necrosis	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Haematoma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Hypertension	0.12% 10/8687 • Number of events 10 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Blood and lymphatic system disorders Anaemia	0.06% 5/8687 • Number of events 6 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Blood and lymphatic system disorders Febrile neutropenia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Blood and lymphatic system disorders Immune thrombocytopenic purpura	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Blood and lymphatic system disorders Leukocytosis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Acute coronary syndrome	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Acute myocardial infarction	0.21% 18/8687 • Number of events 19 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Angina pectoris	0.14% 12/8687 • Number of events 12 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Aortic valve stenosis	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Arrhythmia	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Arteriosclerosis coronary artery	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Atrial fibrillation	0.29% 25/8687 • Number of events 27 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Atrial flutter	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Atrial tachycardia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Atrioventricular block	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Atrioventricular block complete	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Atrioventricular block second degree	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Bradyarrhythmia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Bradycardia	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Cardiac arrest	0.09% 8/8687 • Number of events 8 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Cardiac failure	0.32% 28/8687 • Number of events 32 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Cardiac failure acute	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Cardiac failure chronic	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Cardiac failure congestive	0.16% 14/8687 • Number of events 14 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Cardiac ventricular thrombosis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Cardio-respiratory arrest	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Cardiogenic shock	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Cardiomegaly	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Cor pulmonale	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Coronary artery disease	0.10% 9/8687 • Number of events 10 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Coronary artery stenosis	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Hypertensive heart disease	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Ischaemic cardiomyopathy	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Mitral valve incompetence	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Mitral valve stenosis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Myocardial infarction	0.21% 18/8687 • Number of events 18 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Myocardial ischaemia	0.09% 8/8687 • Number of events 8 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Myocarditis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Nodal rhythm	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Parasystole	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Pericardial effusion	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Pericarditis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Prinzmetal angina	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Sinus node dysfunction	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Supraventricular tachycardia	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Tachyarrhythmia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Tachycardia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Ventricular tachycardia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Congenital, familial and genetic disorders Left ventricle outflow tract obstruction	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Congenital, familial and genetic disorders Type v hyperlipidaemia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Ear and labyrinth disorders Acute vestibular syndrome	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Ear and labyrinth disorders Vertigo	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Ear and labyrinth disorders Vertigo positional	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Endocrine disorders Goitre	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Endocrine disorders Toxic goitre	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Cataract	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Cataract nuclear	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Diplopia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Macular hole	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Retinal artery occlusion	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Retinal detachment	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Abdominal distension	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Abdominal pain upper	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Ascites	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Chronic gastritis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Colitis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Colitis ischaemic	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Colitis ulcerative	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Constipation	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Diarrhoea	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Diverticular perforation	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Diverticulum	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Diverticulum intestinal	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Duodenal ulcer	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Gastric ulcer	0.08% 7/8687 • Number of events 7 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Gastritis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.09% 8/8687 • Number of events 8 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Gastrointestinal inflammation	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Haematochezia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Haemorrhoids	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Hiatus hernia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Ileus	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Incarcerated umbilical hernia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Inguinal hernia	0.09% 8/8687 • Number of events 8 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Intestinal obstruction	0.06% 5/8687 • Number of events 5 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Large intestinal obstruction	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Large intestine polyp	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Mallory-weiss syndrome	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Melaena	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Mouth haemorrhage	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Mouth ulceration	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Nausea	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Obstructive pancreatitis	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Oesophageal perforation	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Pancreatitis	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Pancreatitis acute	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Pancreatitis chronic	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Peritoneal haemorrhage	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Small intestinal obstruction	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Spigelian hernia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Tooth impacted	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Volvulus	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Vomiting	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Accidental death	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Adverse drug reaction	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Chest discomfort	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Chest pain	0.09% 8/8687 • Number of events 8 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Death	0.07% 6/8687 • Number of events 6 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders General physical health deterioration	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Multiple organ dysfunction syndrome	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Oedema	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Oedema peripheral	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Pyrexia	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Sudden death	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Vascular stent stenosis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Vascular stent thrombosis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Hepatobiliary disorders Bile duct stone	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Hepatobiliary disorders Cholangitis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Hepatobiliary disorders Cholecystitis	0.06% 5/8687 • Number of events 5 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Hepatobiliary disorders Cholecystitis acute	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Hepatobiliary disorders Cholelithiasis	0.06% 5/8687 • Number of events 5 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Hepatobiliary disorders Hepatic cirrhosis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Hepatobiliary disorders Hepatic haematoma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Hepatobiliary disorders Jaundice	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Immune system disorders Anaphylactic reaction	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Immune system disorders Drug hypersensitivity	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Immune system disorders Hypersensitivity	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Abdominal abscess	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Abscess	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Abscess limb	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Appendicitis	0.06% 5/8687 • Number of events 5 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Appendicitis perforated	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Arthritis bacterial	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Atypical pneumonia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Bacterial infection	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Bone tuberculosis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Bronchitis	0.07% 6/8687 • Number of events 6 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Cellulitis	0.09% 8/8687 • Number of events 9 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Clostridium difficile colitis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Cytomegalovirus colitis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Diabetic foot infection	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Diverticulitis	0.08% 7/8687 • Number of events 7 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Endophthalmitis	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Erysipelas	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Escherichia bacteraemia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Escherichia infection	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Escherichia pyelonephritis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Gastric ulcer helicobacter	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Gastroenteritis	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Herpes simplex	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Infection	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Infectious pleural effusion	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Influenza	0.10% 9/8687 • Number of events 9 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Joint abscess	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Liver abscess	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Localised infection	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Lower respiratory tract infection	0.03% 3/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Necrotising fasciitis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Osteomyelitis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Otitis externa	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Paraoesophageal abscess	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Pathogen resistance	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Peritonitis	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Peritonsillar abscess	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Pilonidal cyst	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Pneumonia	0.62% 54/8687 • Number of events 58 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Pneumonia haemophilus	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Pneumonia viral	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Postoperative wound infection	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Pyelonephritis	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Respiratory tract infection	0.05% 4/8687 • Number of events 6 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Respiratory tract infection bacterial	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Sepsis	0.12% 10/8687 • Number of events 10 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Septic shock	0.02% 2/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Systemic candida	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Tooth abscess	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Upper respiratory tract infection	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Urinary tract infection	0.20% 17/8687 • Number of events 17 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Urosepsis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Vulval abscess	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Acetabulum fracture	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Alcohol poisoning	0.02% 2/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Anaemia postoperative	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Ankle fracture	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Cardiac valve rupture	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Chest injury	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Concussion	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Contusion	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Craniocerebral injury	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Facial bones fracture	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Fall	0.06% 5/8687 • Number of events 5 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Femoral neck fracture	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Femur fracture	0.09% 8/8687 • Number of events 8 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Head injury	0.07% 6/8687 • Number of events 6 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Hip fracture	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Humerus fracture	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Jaw fracture	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Joint injury	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Kidney contusion	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Ligament rupture	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Limb injury	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Liver contusion	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Lower limb fracture	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Multiple fractures	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Multiple injuries	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Patella fracture	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Periprosthetic fracture	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Poisoning	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Post procedural complication	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Post procedural haematoma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Post procedural swelling	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Pulmonary contusion	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Radiation proctitis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Radius fracture	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Rib fracture	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Road traffic accident	0.06% 5/8687 • Number of events 5 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Seroma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Shunt occlusion	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Skin injury	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Skin laceration	0.06% 5/8687 • Number of events 5 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Spinal column injury	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Spinal compression fracture	0.06% 5/8687 • Number of events 5 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Subdural haematoma	0.08% 7/8687 • Number of events 7 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Tendon rupture	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Tibia fracture	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Transfusion-related acute lung injury	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Traumatic liver injury	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Ulnar nerve injury	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Upper limb fracture	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Viith nerve injury	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Wound dehiscence	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Wrist fracture	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Investigations Blood potassium decreased	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Investigations Blood pressure increased	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Metabolism and nutrition disorders Dehydration	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Metabolism and nutrition disorders Gout	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Metabolism and nutrition disorders Hyperglycaemia	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Metabolism and nutrition disorders Hypoglycaemia	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Metabolism and nutrition disorders Hypokalaemia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Metabolism and nutrition disorders Hyponatraemia	0.06% 5/8687 • Number of events 5 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Metabolism and nutrition disorders Latent autoimmune diabetes in adults	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Metabolism and nutrition disorders Metabolic acidosis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Metabolism and nutrition disorders Tumour lysis syndrome	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.02% 2/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Arthralgia	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Arthritis	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Back pain	0.07% 6/8687 • Number of events 6 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Gouty arthritis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Haemarthrosis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Intervertebral disc compression	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Joint effusion	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.17% 15/8687 • Number of events 16 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Osteolysis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Osteoporosis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Periarthritis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Spinal stenosis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Tendonitis	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Tenosynovitis stenosans	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acoustic neuroma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B precursor type acute leukaemia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.07% 6/8687 • Number of events 6 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign lung neoplasm	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.14% 12/8687 • Number of events 12 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cardiac myxoma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ganglioneuroma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric neoplasm	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal carcinoma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal neoplasm	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma multiforme	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypopharyngeal neoplasm	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Insulinoma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive breast carcinoma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large intestine benign neoplasm	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip neoplasm malignant stage unspecified	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.09% 8/8687 • Number of events 8 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Marginal zone lymphoma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer recurrent	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Penile cancer	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.10% 9/8687 • Number of events 9 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal neoplasm	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma recurrent	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland neoplasm	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Basal ganglia haemorrhage	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Carotid artery stenosis	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Carotid sinus syndrome	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Cerebellar ataxia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Cerebellar infarction	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Cerebral haemorrhage	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Cerebral infarction	0.09% 8/8687 • Number of events 9 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Cerebral ischaemia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Cerebrovascular accident	0.16% 14/8687 • Number of events 14 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Coma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Dizziness	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Embolic cerebral infarction	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Epilepsy	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Facial paralysis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Haemorrhage intracranial	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Haemorrhagic stroke	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Haemorrhagic transformation stroke	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Headache	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Hemiparesis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Ischaemic stroke	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Lacunar stroke	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Loss of consciousness	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Myoclonus	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Neuroglycopenia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Normal pressure hydrocephalus	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Petit mal epilepsy	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Presyncope	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Radicular pain	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Sciatica	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Seizure	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Subarachnoid haemorrhage	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Syncope	0.09% 8/8687 • Number of events 8 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Transient global amnesia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Transient ischaemic attack	0.13% 11/8687 • Number of events 11 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Vith nerve paralysis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Psychiatric disorders Confusional state	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Psychiatric disorders Depression	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Psychiatric disorders Psychotic disorder	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Acute kidney injury	0.07% 6/8687 • Number of events 6 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Bladder obstruction	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Chronic kidney disease	0.07% 6/8687 • Number of events 6 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders End stage renal disease	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Glomerulonephritis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Haematuria	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Hydronephrosis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Nephrolithiasis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Prerenal failure	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Renal failure	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Renal impairment	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Renal injury	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Tubulointerstitial nephritis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Urethral stenosis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Ureterolithiasis	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Reproductive system and breast disorders Benign prostatic hyperplasia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Reproductive system and breast disorders Breast pain	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Reproductive system and breast disorders Cystocele	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Reproductive system and breast disorders Erectile dysfunction	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Reproductive system and breast disorders Menorrhagia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Reproductive system and breast disorders Ovarian cyst	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Reproductive system and breast disorders Prostatitis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Reproductive system and breast disorders Rectocele	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Asthma	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Atelectasis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.09% 8/8687 • Number of events 8 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Haemothorax	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Lung disorder	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.07% 6/8687 • Number of events 6 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.06% 5/8687 • Number of events 5 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.09% 8/8687 • Number of events 8 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.06% 5/8687 • Number of events 5 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Sinus perforation	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Diabetic foot	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Eczema	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Psoriasis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Rash pruritic	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Skin ulcer	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Urticaria	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Aortic aneurysm	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Aortic dissection	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Aortic rupture	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Aortic stenosis	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Arterial rupture	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Arteriosclerosis	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Deep vein thrombosis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Embolism venous	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Hypertensive crisis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Hypovolaemic shock	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Intermittent claudication	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Peripheral arterial occlusive disease	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Peripheral venous disease	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Phlebitis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Poor peripheral circulation	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Shock haemorrhagic	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Subclavian steal syndrome	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Temporal arteritis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Thrombosis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Sinusitis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Senile dementia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).

Other adverse events

Other adverse events
Measure	HZ/su Group n=8687 participants at risk Subjects received Herpes Zoster subunit vaccine, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
General disorders Inflammation	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Influenza like illness	0.75% 65/8687 • Number of events 74 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site bruising	0.16% 14/8687 • Number of events 14 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site discomfort	0.15% 13/8687 • Number of events 14 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site eczema	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Blood and lymphatic system disorders Anaemia	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Blood and lymphatic system disorders Increased tendency to bruise	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Blood and lymphatic system disorders Lymph node pain	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Blood and lymphatic system disorders Lymphadenopathy	0.03% 3/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Blood and lymphatic system disorders Pseudolymphoma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Angina pectoris	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Arrhythmia	0.10% 9/8687 • Number of events 11 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Atrial fibrillation	0.13% 11/8687 • Number of events 11 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Atrioventricular block	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Cardiac failure chronic	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Cardiac failure congestive	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Cardiovascular disorder	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Chronic left ventricular failure	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Dilatation ventricular	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Extrasystoles	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Hypertensive heart disease	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Mitral valve incompetence	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Mitral valve prolapse	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Myocardial ischaemia	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Palpitations	0.12% 10/8687 • Number of events 11 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Pericardial effusion	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Supraventricular tachycardia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Tachyarrhythmia	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Cardiac disorders Tachycardia	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Ear and labyrinth disorders Cerumen impaction	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Ear and labyrinth disorders Deafness	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Ear and labyrinth disorders Ear pain	0.14% 12/8687 • Number of events 12 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Ear and labyrinth disorders Ear pruritus	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Ear and labyrinth disorders Excessive cerumen production	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Ear and labyrinth disorders Hypoacusis	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Ear and labyrinth disorders Meniere's disease	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Ear and labyrinth disorders Motion sickness	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Ear and labyrinth disorders Tinnitus	0.06% 5/8687 • Number of events 6 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Ear and labyrinth disorders Vertigo	0.21% 18/8687 • Number of events 20 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Ear and labyrinth disorders Vertigo positional	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Endocrine disorders Hyperparathyroidism secondary	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Endocrine disorders Hypothyroidism	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Accommodation disorder	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Age-related macular degeneration	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Angle closure glaucoma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Asthenopia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Blepharitis	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Blepharospasm	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Blindness transient	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Cataract	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Conjunctival haemorrhage	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Conjunctivitis allergic	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Dry eye	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Eye haematoma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Eye haemorrhage	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Eye inflammation	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Eye irritation	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Eye pain	0.09% 8/8687 • Number of events 9 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Eye swelling	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Glaucoma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Iridocyclitis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Lacrimation decreased	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Lacrimation increased	0.02% 2/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Ocular discomfort	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Ocular hyperaemia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Panophthalmitis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Photophobia	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Retinal disorder	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Retinal drusen	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Retinal haemorrhage	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Retinal vein occlusion	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Swelling of eyelid	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Ulcerative keratitis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Eye disorders Vision blurred	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Abdominal discomfort	0.12% 10/8687 • Number of events 11 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Abdominal distension	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Abdominal pain	0.16% 14/8687 • Number of events 15 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Abdominal pain lower	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Abdominal pain upper	0.45% 39/8687 • Number of events 45 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Anal inflammation	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Angular cheilitis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Anorectal discomfort	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Cheilitis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Colitis	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Constipation	0.30% 26/8687 • Number of events 26 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Crohn's disease	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Dental caries	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Diarrhoea	1.2% 107/8687 • Number of events 114 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Diverticulum	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Dry mouth	0.09% 8/8687 • Number of events 9 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Dyspepsia	0.22% 19/8687 • Number of events 20 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Dysphagia	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Enteritis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Epigastric discomfort	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Eructation	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Faeces soft	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Flatulence	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Food poisoning	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Gastric disorder	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Gastric ulcer	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Gastritis	0.09% 8/8687 • Number of events 9 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Gastritis erosive	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Gastrointestinal disorder	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Gastrointestinal motility disorder	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Gastrointestinal pain	0.03% 3/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.14% 12/8687 • Number of events 12 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Gingival bleeding	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Gingival ulceration	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Glossodynia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Haematochezia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Haemorrhoids	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Irritable bowel syndrome	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Large intestine polyp	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Lip pain	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Lip swelling	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Lip ulceration	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Mouth ulceration	0.07% 6/8687 • Number of events 6 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Nausea	1.9% 164/8687 • Number of events 184 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Odynophagia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Oesophagitis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Oral discomfort	0.01% 1/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Oral mucosal blistering	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Oral pain	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Pancreatitis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Paraesthesia oral	0.02% 2/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Peptic ulcer	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Periodontal disease	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Proctitis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Rectal haemorrhage	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Rectal tenesmus	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Reflux gastritis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Retching	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Salivary gland calculus	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Stomatitis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Tongue blistering	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Tongue dry	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Tongue ulceration	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Tooth disorder	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Toothache	0.16% 14/8687 • Number of events 14 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Vomiting	0.43% 37/8687 • Number of events 38 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Administration site discomfort	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Administration site erythema	0.23% 20/8687 • Number of events 21 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Administration site oedema	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Administration site pain	0.58% 50/8687 • Number of events 57 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Administration site pruritus	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Administration site swelling	0.15% 13/8687 • Number of events 13 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Administration site warmth	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Application site burn	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Asthenia	0.85% 74/8687 • Number of events 81 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Axillary pain	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Chest discomfort	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Chest pain	0.15% 13/8687 • Number of events 14 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Chills	3.7% 319/8687 • Number of events 366 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Cyst	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Discomfort	0.17% 15/8687 • Number of events 16 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Facial pain	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Fatigue	4.4% 384/8687 • Number of events 448 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Feeling abnormal	0.08% 7/8687 • Number of events 7 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Feeling cold	0.54% 47/8687 • Number of events 52 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Feeling hot	0.33% 29/8687 • Number of events 31 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders General physical health deterioration	0.08% 7/8687 • Number of events 7 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Hyperthermia	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site erythema	15.1% 1311/8687 • Number of events 1717 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site exfoliation	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site extravasation	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site haematoma	0.15% 13/8687 • Number of events 13 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site haemorrhage	0.06% 5/8687 • Number of events 5 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site hyperaesthesia	0.08% 7/8687 • Number of events 8 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site hypersensitivity	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site hypertrophy	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site hypoaesthesia	0.10% 9/8687 • Number of events 9 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site induration	0.74% 64/8687 • Number of events 73 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site inflammation	0.98% 85/8687 • Number of events 94 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site irritation	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site joint discomfort	0.01% 1/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site joint pain	0.28% 24/8687 • Number of events 25 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site mass	0.07% 6/8687 • Number of events 7 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site movement impairment	0.15% 13/8687 • Number of events 13 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site nodule	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site oedema	0.26% 23/8687 • Number of events 24 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site pain	36.5% 3173/8687 • Number of events 4579 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site paraesthesia	0.07% 6/8687 • Number of events 6 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site pruritus	2.9% 248/8687 • Number of events 299 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site rash	0.53% 46/8687 • Number of events 51 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site reaction	0.28% 24/8687 • Number of events 27 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site scab	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site swelling	10.7% 928/8687 • Number of events 1194 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site urticaria	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site vesicles	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site warmth	2.0% 177/8687 • Number of events 211 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Malaise	2.6% 226/8687 • Number of events 258 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Nodule	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Oedema peripheral	0.12% 10/8687 • Number of events 10 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Pain	2.1% 183/8687 • Number of events 213 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Peripheral swelling	0.17% 15/8687 • Number of events 16 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Polyp	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Pyrexia	11.9% 1038/8687 • Number of events 1261 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Sluggishness	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Swelling	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Temperature intolerance	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Temperature regulation disorder	0.08% 7/8687 • Number of events 8 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Tenderness	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Thirst	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Vaccination site erythema	0.59% 51/8687 • Number of events 58 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Vaccination site induration	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Vaccination site inflammation	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Vaccination site irritation	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Vaccination site mass	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Vaccination site oedema	0.09% 8/8687 • Number of events 8 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Vaccination site pain	1.6% 135/8687 • Number of events 156 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Vaccination site paraesthesia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Vaccination site pruritus	0.13% 11/8687 • Number of events 12 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Vaccination site rash	0.01% 1/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Vaccination site swelling	0.43% 37/8687 • Number of events 40 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Vaccination site warmth	0.08% 7/8687 • Number of events 7 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Vessel puncture site bruise	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Hepatobiliary disorders Biliary colic	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Hepatobiliary disorders Cholelithiasis	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Hepatobiliary disorders Hepatic function abnormal	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Hepatobiliary disorders Hepatic steatosis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Immune system disorders Allergy to animal	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Immune system disorders Allergy to arthropod bite	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Immune system disorders Food allergy	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Immune system disorders Hypersensitivity	0.07% 6/8687 • Number of events 6 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Immune system disorders Multiple allergies	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Immune system disorders Reaction to food additive	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Immune system disorders Seasonal allergy	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Abscess	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Acarodermatitis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Acute sinusitis	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Blastocystis infection	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Borrelia infection	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Bronchiolitis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Bronchitis	0.46% 40/8687 • Number of events 41 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Cellulitis	0.09% 8/8687 • Number of events 8 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Chronic sinusitis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Conjunctivitis	0.21% 18/8687 • Number of events 18 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Cystitis	0.20% 17/8687 • Number of events 17 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Dacryocystitis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Dengue fever	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Dermatophytosis of nail	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Diverticulitis	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Ear infection	0.07% 6/8687 • Number of events 6 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Erysipelas	0.06% 5/8687 • Number of events 5 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Eye infection	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Folliculitis	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Fungal infection	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Fungal skin infection	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Furuncle	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Gastric infection	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Gastroenteritis	0.20% 17/8687 • Number of events 17 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Gastroenteritis viral	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Gastrointestinal viral infection	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Genital herpes	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Gingivitis	0.07% 6/8687 • Number of events 6 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Helicobacter infection	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Herpes simplex	0.22% 19/8687 • Number of events 22 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Hordeolum	0.06% 5/8687 • Number of events 5 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Impetigo	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Influenza	0.60% 52/8687 • Number of events 54 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Injection site cellulitis	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Injection site infection	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Labyrinthitis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Localised infection	0.06% 5/8687 • Number of events 5 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Lower respiratory tract infection	0.24% 21/8687 • Number of events 21 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Lyme disease	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Nasopharyngitis	2.6% 228/8687 • Number of events 239 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Onychomycosis	0.06% 5/8687 • Number of events 5 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Oral candidiasis	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Oral fungal infection	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Oral herpes	0.36% 31/8687 • Number of events 34 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Oral infection	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Otitis externa	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Otitis media	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Pathogen resistance	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Periodontitis	0.06% 5/8687 • Number of events 5 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Pertussis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Pharyngitis	0.18% 16/8687 • Number of events 16 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Pharyngotonsillitis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Pneumonia	0.07% 6/8687 • Number of events 6 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Pulpitis dental	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Pyelonephritis	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Respiratory tract infection	0.15% 13/8687 • Number of events 13 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Respiratory tract infection viral	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Rhinitis	0.21% 18/8687 • Number of events 18 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Sinusitis	0.29% 25/8687 • Number of events 26 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Skin candida	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Skin infection	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Subcutaneous abscess	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Syphilis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Testicular abscess	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Tinea infection	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Tinea pedis	0.07% 6/8687 • Number of events 7 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Tongue fungal infection	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Tonsillitis	0.06% 5/8687 • Number of events 5 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Tooth abscess	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Tooth infection	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Tracheitis	0.03% 3/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Tracheobronchitis	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Upper respiratory tract infection	0.92% 80/8687 • Number of events 86 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Urinary tract infection	0.73% 63/8687 • Number of events 66 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Vaginal infection	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Vaginitis gardnerella	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Viral infection	0.07% 6/8687 • Number of events 6 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Viral upper respiratory tract infection	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Infections and infestations Zika virus infection	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Alcohol poisoning	0.01% 1/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Animal bite	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Arthropod bite	0.09% 8/8687 • Number of events 8 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Arthropod sting	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Bone contusion	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Cervical vertebral fracture	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Contusion	0.13% 11/8687 • Number of events 11 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Deafness traumatic	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Ear injury	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Epicondylitis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Face injury	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Facial bones fracture	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Fall	0.13% 11/8687 • Number of events 12 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Foot fracture	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Head injury	0.06% 5/8687 • Number of events 5 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Heat stroke	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Joint injury	0.06% 5/8687 • Number of events 5 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Ligament rupture	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Ligament sprain	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Limb injury	0.06% 5/8687 • Number of events 5 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Muscle rupture	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Muscle strain	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Post procedural complication	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Procedural pain	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Radius fracture	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Skin abrasion	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Skin injury	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Skin laceration	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Snake bite	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Soft tissue injury	0.01% 1/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Splinter	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Sternal fracture	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Subcutaneous haematoma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Subdural haematoma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Tendon injury	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Tendon rupture	0.01% 1/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Tooth fracture	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Tooth injury	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Traumatic arthritis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Traumatic haematoma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Wound	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Injury, poisoning and procedural complications Wrist fracture	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Investigations Blood cholesterol increased	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Investigations Blood creatine phosphokinase increased	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Investigations Blood iron decreased	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Investigations Blood pressure decreased	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Investigations Blood pressure diastolic increased	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Investigations Blood pressure increased	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Investigations Blood triglycerides increased	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Investigations Blood urea decreased	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Investigations Blood uric acid increased	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Investigations Body temperature increased	0.87% 76/8687 • Number of events 86 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Investigations Cardiac murmur	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Investigations Haemoglobin decreased	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Investigations Heart rate increased	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Metabolism and nutrition disorders Decreased appetite	0.17% 15/8687 • Number of events 15 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Metabolism and nutrition disorders Dehydration	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Metabolism and nutrition disorders Dyslipidaemia	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Metabolism and nutrition disorders Gout	0.14% 12/8687 • Number of events 12 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Metabolism and nutrition disorders Hypercholesterolaemia	0.09% 8/8687 • Number of events 8 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Metabolism and nutrition disorders Hyperglycaemia	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Metabolism and nutrition disorders Hyperlipidaemia	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Metabolism and nutrition disorders Hypertriglyceridaemia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Metabolism and nutrition disorders Hyperuricaemia	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Metabolism and nutrition disorders Hypoglycaemia	0.03% 3/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Metabolism and nutrition disorders Hypovitaminosis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.08% 7/8687 • Number of events 7 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Metabolism and nutrition disorders Vitamin b12 deficiency	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Metabolism and nutrition disorders Vitamin d deficiency	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Arthralgia	2.4% 212/8687 • Number of events 237 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Arthritis	0.06% 5/8687 • Number of events 5 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Arthritis reactive	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Arthropathy	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Back pain	1.2% 100/8687 • Number of events 106 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Bone decalcification	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Bone pain	0.15% 13/8687 • Number of events 14 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Bursitis	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Coccydynia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Costochondritis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Exostosis	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Fibromyalgia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Flank pain	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Foot deformity	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Gouty arthritis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Groin pain	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Growing pains	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Intervertebral disc space narrowing	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.02% 2/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Joint stiffness	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Joint swelling	0.09% 8/8687 • Number of events 8 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Limb discomfort	0.05% 4/8687 • Number of events 5 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Muscle contracture	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Muscle fatigue	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Muscle spasms	0.28% 24/8687 • Number of events 30 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Muscle tightness	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Muscle twitching	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Muscular weakness	0.13% 11/8687 • Number of events 12 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.61% 53/8687 • Number of events 55 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.20% 17/8687 • Number of events 18 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Myalgia	4.4% 386/8687 • Number of events 481 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Myalgia intercostal	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Myosclerosis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Myositis	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Neck pain	0.48% 42/8687 • Number of events 43 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Nuchal rigidity	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Osteitis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.31% 27/8687 • Number of events 30 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Osteopenia	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Osteoporosis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Pain in extremity	1.2% 103/8687 • Number of events 115 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Pain in jaw	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Patellofemoral pain syndrome	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Periarthritis	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Scoliosis	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Senile osteoporosis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Spinal pain	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Spondyloarthropathy	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Synovial cyst	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Tendon pain	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Tendonitis	0.07% 6/8687 • Number of events 6 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Tenosynovitis	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Musculoskeletal and connective tissue disorders Torticollis	0.02% 2/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.06% 5/8687 • Number of events 5 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypergammaglobulinaemia benign monoclonal	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Aphonia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Ataxia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Balance disorder	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Burning sensation	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Carpal tunnel syndrome	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Cerebral ischaemia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Cervical radiculopathy	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Cervicobrachial syndrome	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Cognitive disorder	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Dementia alzheimer's type	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Dizziness	1.3% 117/8687 • Number of events 126 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Dysgeusia	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Essential tremor	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Facial paralysis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Hand-arm vibration syndrome	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Head discomfort	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Headache	7.8% 678/8687 • Number of events 896 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Hyperaesthesia	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Hypersomnia	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Hypoaesthesia	0.07% 6/8687 • Number of events 6 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Intercostal neuralgia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Lethargy	0.31% 27/8687 • Number of events 31 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Loss of consciousness	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Memory impairment	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Mental impairment	0.02% 2/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Migraine	0.17% 15/8687 • Number of events 18 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Morton's neuralgia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Muscle contractions involuntary	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Myasthenia gravis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Neuralgia	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Paraesthesia	0.07% 6/8687 • Number of events 6 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Poor quality sleep	0.06% 5/8687 • Number of events 6 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Presyncope	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Radiculopathy	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Sciatica	0.17% 15/8687 • Number of events 15 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Sensory disturbance	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Sinus headache	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Somnolence	0.25% 22/8687 • Number of events 22 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Syncope	0.07% 6/8687 • Number of events 6 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Taste disorder	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Tension headache	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Transient ischaemic attack	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Tremor	0.15% 13/8687 • Number of events 13 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Trigeminal neuralgia	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Nervous system disorders Vertebral artery occlusion	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Psychiatric disorders Agitation	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Psychiatric disorders Anxiety	0.06% 5/8687 • Number of events 5 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Psychiatric disorders Depressed mood	0.07% 6/8687 • Number of events 6 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Psychiatric disorders Depression	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Psychiatric disorders Generalised anxiety disorder	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Psychiatric disorders Insomnia	0.37% 32/8687 • Number of events 34 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Psychiatric disorders Irritability	0.01% 1/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Psychiatric disorders Listless	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Psychiatric disorders Middle insomnia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Psychiatric disorders Restlessness	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Psychiatric disorders Sleep disorder	0.07% 6/8687 • Number of events 6 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Acute kidney injury	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Bladder prolapse	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Calculus urinary	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Chromaturia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Chronic kidney disease	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Dysuria	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Ketonuria	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Nephroangiosclerosis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Nephrolithiasis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Nocturia	0.07% 6/8687 • Number of events 6 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Pollakiuria	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Polyuria	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Renal failure	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Renal impairment	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Renal pain	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Urethral polyp	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Urethral stenosis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Renal and urinary disorders Urinary incontinence	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Reproductive system and breast disorders Benign prostatic hyperplasia	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Reproductive system and breast disorders Breast cyst	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Reproductive system and breast disorders Breast enlargement	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Reproductive system and breast disorders Breast pain	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Reproductive system and breast disorders Pelvic pain	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Reproductive system and breast disorders Postmenopausal haemorrhage	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Reproductive system and breast disorders Prostatitis	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Reproductive system and breast disorders Vulvar erosion	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Reproductive system and breast disorders Vulvovaginal pruritus	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Allergic bronchitis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Asthma	0.10% 9/8687 • Number of events 10 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Catarrh	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Cough	1.0% 91/8687 • Number of events 96 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Dysphonia	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.10% 9/8687 • Number of events 9 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.13% 11/8687 • Number of events 13 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Laryngeal pain	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Lower respiratory tract congestion	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.21% 18/8687 • Number of events 19 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Nasal disorder	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Nasal obstruction	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.60% 52/8687 • Number of events 57 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Pharyngeal swelling	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Productive cough	0.08% 7/8687 • Number of events 7 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.22% 19/8687 • Number of events 20 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Sinus pain	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Sneezing	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Sputum discoloured	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Acne	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Actinic keratosis	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Blister	0.09% 8/8687 • Number of events 8 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Cold sweat	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Decubitus ulcer	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Dermal cyst	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Dermatitis	0.18% 16/8687 • Number of events 16 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Dermatitis allergic	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Dermatitis atopic	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Dermatitis contact	0.06% 5/8687 • Number of events 5 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Dry skin	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Ecchymosis	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Eczema	0.30% 26/8687 • Number of events 27 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Eczema asteatotic	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Erythema	0.33% 29/8687 • Number of events 30 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Generalised erythema	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Haemorrhage subcutaneous	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Hyperhidrosis	0.25% 22/8687 • Number of events 23 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Hyperkeratosis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Intertrigo	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Macule	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Night sweats	0.06% 5/8687 • Number of events 5 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Papule	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Pruritus	0.66% 57/8687 • Number of events 62 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Pruritus generalised	0.13% 11/8687 • Number of events 11 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Psoriasis	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Purpura	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Rash	0.56% 49/8687 • Number of events 51 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Rash erythematous	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Rash generalised	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Rash macular	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Rash maculovesicular	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Rash papular	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Rash pruritic	0.06% 5/8687 • Number of events 5 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Rosacea	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Sensitive skin	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Skin fissures	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Skin lesion	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Skin odour abnormal	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Skin ulcer	0.02% 2/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Urticaria	0.10% 9/8687 • Number of events 11 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Urticaria contact	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Skin and subcutaneous tissue disorders Vasculitic ulcer	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Deep vein thrombosis	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Essential hypertension	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Flushing	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Haematoma	0.05% 4/8687 • Number of events 4 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Hot flush	0.07% 6/8687 • Number of events 6 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Hypertension	0.23% 20/8687 • Number of events 21 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Hypertensive crisis	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Hypotension	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Pallor	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Peripheral venous disease	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Thrombophlebitis	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Thrombophlebitis superficial	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Thrombosis	0.02% 2/8687 • Number of events 2 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Vascular disorders Varicose vein	0.03% 3/8687 • Number of events 3 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
Gastrointestinal disorders Mouth swelling	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).
General disorders Injection site joint swelling	0.01% 1/8687 • Number of events 1 • Unsolicited AEs were collected during the 30 days (Days 0-29) follow-up period after any vaccination (across doses). SAEs were collected from Month 0 until study end (Month 14, i.e. 12 months post dose 2).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER