Trial Outcomes & Findings for Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older (NCT NCT00976027)

NCT ID: NCT00976027

Last Updated: 2012-08-01

Results Overview

The presence (and specific identification) of influenza virus in the respiratory tract of vaccinated individuals with influenza like illness (ILI) was confirmed by tissue culture (for infectious virus) and molecular techniques (polymerase chain reaction based assays), with results reported for cases cause by any viral type or subtype.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 9172 participants
• Primary outcome timeframe: Day 0 (pre-vaccination) up to Year 1 post-vaccination
• Results posted on: 2012-08-01

Participant Flow

Participants were enrolled in the study from 22 September 2009 to 07 November 2009 at 99 clinical centers in the US.

A total of 9158 of the 9172 participants that were randomized were vaccinated, evaluated, and reported in this report.

Participant milestones

Measure	Fluzone® High Dose All participants received a single dose of Fluzone High Dose vaccine on Day 0.	Fluzone® All subjects received a single dose of Fluzone vaccine on Day 0.
Overall Study STARTED	6108	3050
Overall Study COMPLETED	5697	2835
Overall Study NOT COMPLETED	411	215

Reasons for withdrawal

Measure	Fluzone® High Dose All participants received a single dose of Fluzone High Dose vaccine on Day 0.	Fluzone® All subjects received a single dose of Fluzone vaccine on Day 0.
Overall Study Serious Adverse Event	36	17
Overall Study Adverse Event	0	2
Overall Study Protocol Violation	60	27
Overall Study Lost to Follow-up	208	103
Overall Study Withdrawal by Subject	107	66

Baseline Characteristics

Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older

Baseline characteristics by cohort

Measure	Fluzone® High Dose n=6108 Participants All participants received a single dose of Fluzone High Dose vaccine on Day 0.	Fluzone® n=3050 Participants All subjects received a single dose of Fluzone vaccine on Day 0.	Total n=9158 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	6108 Participants n=5 Participants	3050 Participants n=7 Participants	9158 Participants n=5 Participants
Age Continuous	72.8 Years STANDARD_DEVIATION 6.0 • n=5 Participants	72.8 Years STANDARD_DEVIATION 5.9 • n=7 Participants	72.8 Years STANDARD_DEVIATION 6.0 • n=5 Participants
Sex: Female, Male Female	3268 Participants n=5 Participants	1647 Participants n=7 Participants	4915 Participants n=5 Participants
Sex: Female, Male Male	2840 Participants n=5 Participants	1403 Participants n=7 Participants	4243 Participants n=5 Participants
Region of Enrollment United States	6108 Participants n=5 Participants	3050 Participants n=7 Participants	9158 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0 (pre-vaccination) up to Year 1 post-vaccination

Population: Efficacy was assessed in all participants who met all study inclusion criteria and none of the exclusion criteria, received the vaccine to which they were randomized, and had no protocol violations that might have interfered with evaluation of primary endpoints (Per Protocol Analysis Set).

The presence (and specific identification) of influenza virus in the respiratory tract of vaccinated individuals with influenza like illness (ILI) was confirmed by tissue culture (for infectious virus) and molecular techniques (polymerase chain reaction based assays), with results reported for cases cause by any viral type or subtype.

Outcome measures

Measure	Fluzone® High Dose n=6013 Participants All participants received a single dose of Fluzone High Dose vaccine on Day 0.	Fluzone® n=3008 Participants All subjects received a single dose of Fluzone vaccine on Day 0.
Efficacy of Fluzone High Dose Relative to Fluzone in the Prevention of Laboratory Confirmed Influenza Caused by Viral Types and Subtypes That Are Antigenically Similar to Those Contained in the Respective Annual Vaccine Formulations. Laboratory Confirmed Cases of ILI	14 Participants	8 Participants
Efficacy of Fluzone High Dose Relative to Fluzone in the Prevention of Laboratory Confirmed Influenza Caused by Viral Types and Subtypes That Are Antigenically Similar to Those Contained in the Respective Annual Vaccine Formulations. Culture Confirmed Cases of ILI	13 Participants	7 Participants
Efficacy of Fluzone High Dose Relative to Fluzone in the Prevention of Laboratory Confirmed Influenza Caused by Viral Types and Subtypes That Are Antigenically Similar to Those Contained in the Respective Annual Vaccine Formulations. PCR Confirmed Cases of ILI	14 Participants	8 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 (pre-vaccination) up to the end of the influenza season

Population: The occurrence of events associated with ILI was assessed in all participants who met all study inclusion and exclusion criteria, received the vaccine to which they were randomized, and had no protocol violations that might have interfered with evaluation of primary endpoints (Per-Protocol Analysis Set).

Events associated with Protocol defined influenza-like Illnesses (ILI) were defined as pneumonia, new onset or exacerbation of pre-existing cardio respiratory conditions, health care visits, and medication use (including nonsteroidal anti-inflammatory drugs, NSAIDs).

Outcome measures

Measure	Fluzone® High Dose n=6013 Participants All participants received a single dose of Fluzone High Dose vaccine on Day 0.	Fluzone® n=3008 Participants All subjects received a single dose of Fluzone vaccine on Day 0.
Number of Participants Reporting Events Associated With All Cases of Protocol Defined Influenza-Like Illness (ILI) Pneumonia	28 Participants	14 Participants
Number of Participants Reporting Events Associated With All Cases of Protocol Defined Influenza-Like Illness (ILI) Cardio Respiratory Conditions	10 Participants	6 Participants
Number of Participants Reporting Events Associated With All Cases of Protocol Defined Influenza-Like Illness (ILI) Any Health Care Visit	478 Participants	245 Participants
Number of Participants Reporting Events Associated With All Cases of Protocol Defined Influenza-Like Illness (ILI) Hospitalization	31 Participants	18 Participants
Number of Participants Reporting Events Associated With All Cases of Protocol Defined Influenza-Like Illness (ILI) Emergency Room Visit	40 Participants	19 Participants
Number of Participants Reporting Events Associated With All Cases of Protocol Defined Influenza-Like Illness (ILI) Non Routine Medical Office Visits	439 Participants	226 Participants
Number of Participants Reporting Events Associated With All Cases of Protocol Defined Influenza-Like Illness (ILI) Any Medication Use (Taken or Prescribed)	781 Participants	402 Participants
Number of Participants Reporting Events Associated With All Cases of Protocol Defined Influenza-Like Illness (ILI) Antipyretics, NSAIDs, Analgesics Use	552 Participants	289 Participants
Number of Participants Reporting Events Associated With All Cases of Protocol Defined Influenza-Like Illness (ILI) Antiviral Use	37 Participants	12 Participants
Number of Participants Reporting Events Associated With All Cases of Protocol Defined Influenza-Like Illness (ILI) Antibiotic Use	374 Participants	194 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 14 (post-vaccination) up to 12 Months post-vaccination

Population: The occurrence of events associated with CDC defined ILI was assessed in all participants who met all study inclusion and exclusion criteria, received the vaccine to which they were randomized, and had no protocol violations that might have interfered with evaluation of primary endpoints (Per-Protocol Analysis Set).

Events associated with CDC defined influenza-like Illnesses (ILI) were defined as pneumonia, new onset or exacerbation of pre existing cardio respiratory conditions, health care visits, and medication use (including nonsteroidal anti-inflammatory drugs, NSAIDs).

Outcome measures

Measure	Fluzone® High Dose n=6013 Participants All participants received a single dose of Fluzone High Dose vaccine on Day 0.	Fluzone® n=3008 Participants All subjects received a single dose of Fluzone vaccine on Day 0.
Number of Participants Reporting Events Associated With All Cases of CDC Defined Influenza-Like Illness (ILI) Pneumonia	13 Participants	7 Participants
Number of Participants Reporting Events Associated With All Cases of CDC Defined Influenza-Like Illness (ILI) New Onset or Exacerbation of Cardio Respiratory	3 Participants	1 Participants
Number of Participants Reporting Events Associated With All Cases of CDC Defined Influenza-Like Illness (ILI) Any Health Care Visit	145 Participants	82 Participants
Number of Participants Reporting Events Associated With All Cases of CDC Defined Influenza-Like Illness (ILI) Hospitalization	12 Participants	6 Participants
Number of Participants Reporting Events Associated With All Cases of CDC Defined Influenza-Like Illness (ILI) Emergency Room Visit	14 Participants	9 Participants
Number of Participants Reporting Events Associated With All Cases of CDC Defined Influenza-Like Illness (ILI) Non Routine Medical Office Visits	129 Participants	76 Participants
Number of Participants Reporting Events Associated With All Cases of CDC Defined Influenza-Like Illness (ILI) Any Medication Use (Taken or Prescribed)	220 Participants	132 Participants
Number of Participants Reporting Events Associated With All Cases of CDC Defined Influenza-Like Illness (ILI) Antipyretics, NSAIDs, Analgesics Use	153 Participants	94 Participants
Number of Participants Reporting Events Associated With All Cases of CDC Defined Influenza-Like Illness (ILI) Antiviral Use	17 Participants	6 Participants
Number of Participants Reporting Events Associated With All Cases of CDC Defined Influenza-Like Illness (ILI) Antibiotic Use	123 Participants	67 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 before vaccination to Day 180 after vaccination

Population: Adverse events of special interest were assessed in all participants who received study vaccine (Full Analysis Set).

Adverse events of special interest: new onset of Guillain Barre Syndrome (GBS), Bell's Palsy, encephalitis or myelitis, optic neuritis, Stevens Johnson Syndrome, and toxic epidermal necrolysis

Outcome measures

Measure	Fluzone® High Dose n=6108 Participants All participants received a single dose of Fluzone High Dose vaccine on Day 0.	Fluzone® n=3008 Participants All subjects received a single dose of Fluzone vaccine on Day 0.
Number of Participants Reporting Adverse Events of Special Interest (AESIs) and Serious Adverse Events Post-vaccination With Either Fluzone High-Dose and Fluzone Serious Adverse Events (SAE)	493 Participants	236 Participants
Number of Participants Reporting Adverse Events of Special Interest (AESIs) and Serious Adverse Events Post-vaccination With Either Fluzone High-Dose and Fluzone Death	31 Participants	12 Participants
Number of Participants Reporting Adverse Events of Special Interest (AESIs) and Serious Adverse Events Post-vaccination With Either Fluzone High-Dose and Fluzone Guillain Barre Syndrome	0 Participants	0 Participants
Number of Participants Reporting Adverse Events of Special Interest (AESIs) and Serious Adverse Events Post-vaccination With Either Fluzone High-Dose and Fluzone Bell's Palsy	3 Participants	2 Participants
Number of Participants Reporting Adverse Events of Special Interest (AESIs) and Serious Adverse Events Post-vaccination With Either Fluzone High-Dose and Fluzone Encephalitis or Myelitis	1 Participants	0 Participants
Number of Participants Reporting Adverse Events of Special Interest (AESIs) and Serious Adverse Events Post-vaccination With Either Fluzone High-Dose and Fluzone Optic Neuritis	0 Participants	0 Participants
Number of Participants Reporting Adverse Events of Special Interest (AESIs) and Serious Adverse Events Post-vaccination With Either Fluzone High-Dose and Fluzone Stevens Johnson Syndrome	0 Participants	0 Participants
Number of Participants Reporting Adverse Events of Special Interest (AESIs) and Serious Adverse Events Post-vaccination With Either Fluzone High-Dose and Fluzone Toxic Epidermal Necrolysis	0 Participants	0 Participants
Number of Participants Reporting Adverse Events of Special Interest (AESIs) and Serious Adverse Events Post-vaccination With Either Fluzone High-Dose and Fluzone SAE Leading to Study Discontinuation	36 Participants	17 Participants
Number of Participants Reporting Adverse Events of Special Interest (AESIs) and Serious Adverse Events Post-vaccination With Either Fluzone High-Dose and Fluzone Related SAE	2 Participants	2 Participants
Number of Participants Reporting Adverse Events of Special Interest (AESIs) and Serious Adverse Events Post-vaccination With Either Fluzone High-Dose and Fluzone Related SAE Leading to Study Discontinuation	0 Participants	0 Participants

Adverse Events

Fluzone® High Dose

Serious events: 493 serious events

Other events: 0 other events

Deaths: 0 deaths

Fluzone®

Serious events: 236 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fluzone® High Dose n=6108 participants at risk All participants received a single dose of Fluzone High Dose vaccine on Day 0.	Fluzone® n=3050 participants at risk All subjects received a single dose of Fluzone vaccine on Day 0.
Nervous system disorders Subarachnoid haemorrhage	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Blood and lymphatic system disorders Anaemia	0.08% 5/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Blood and lymphatic system disorders Coagulopathy	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Blood and lymphatic system disorders Splenomegaly	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Acute Coronary Syndrome	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.07% 2/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Acute Myocardial Infarction	0.05% 3/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.13% 4/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Angina Pectoris	0.05% 3/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.16% 5/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Angina Unstable	0.11% 7/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.10% 3/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Aortic Valve Incompetence	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Arrhythmia	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Atrial Fibrillation	0.26% 16/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.23% 7/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Atrioventricular Block Complete	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Atrioventricular Block First Degree	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Atrioventricular Block Second Degree	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Bradyarrhythmia	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Bradycardia	0.08% 5/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Cardiac Arrest	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.10% 3/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Cardiac Failure	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.07% 2/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Cardiac Failure Acute	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Cardiac Failure Chronic	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.07% 2/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Cardiac Failure Congestive	0.33% 20/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.36% 11/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Cardiac Valve Disease	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Cardiomegaly	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Cardiomyopathy	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Coronary Artery Disease	0.18% 11/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.13% 4/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Coronary Artery Occlusion	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Coronary Artery Stenosis	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Ischaemic Cardiomyopathy	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Mitral Valve Incompetence	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Myocardial Infarction	0.10% 6/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.26% 8/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Myocardial Ischaemia	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Pericardial Effusion	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Pericarditis	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Sick Sinus Syndrome	0.07% 4/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Cardiac disorders Sinus Bradycardia	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Congenital, familial and genetic disorders Arteriovenous Malformation	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Congenital, familial and genetic disorders Atrial Septal Defect	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Ear and labyrinth disorders Vertigo	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.10% 3/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Eye disorders Retinal Artery Occlusion	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Abdominal Hernia	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Abdominal Pain	0.05% 3/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Abdominal Pain Upper	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Colitis	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Colitis Ischaemic	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Colitis Ulcerative	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Constipation	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Diarrhoea	0.10% 6/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Diverticular Perforation	0.05% 3/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Diverticulitis Intestinal Haemorrhagic	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Diverticulum Intestinal Haemorrhagic	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Duodenal Ulcer Haemorrhagic	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Duodenal Ulcer Perforation	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Dyspepsia	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Faecaloma	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Faeces Discolored	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Food Poisoning	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Gastric Ulcer	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Gastric Ulcer Haemorrhage	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Gastritis	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.08% 5/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.10% 3/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.07% 2/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Haemorrhoids	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Hiatus Hernia	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Ileus Paralytic	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Inguinal Hernia	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Intestinal Ischaemia	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Intestinal Obstruction	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.07% 2/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Intestinal Ulcer	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Intra Abdominal Haematoma	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Large Intestine Perforation	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Melaena	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Obstruction Gastric	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Oesophageal Ulcer	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Oesophageal Ulcer Hemorrhage	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Pancreatitis	0.11% 7/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Pancreatitis Acute	0.07% 4/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Pancreatitis Relapsing	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Peptic Ulcer	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Rectal Haemorrhage	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Reflux Oesophagitis	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Small Intestinal Obstruction	0.08% 5/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.16% 5/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Spigelian Hernia	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Swollen Tongue	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Umbilical Hernia Obstructive	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Gastrointestinal disorders Upper Gastrointestinal Haemorrhage	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
General disorders Adverse Drug Reaction	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
General disorders Asthenia	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
General disorders Catheter Site Haematoma	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
General disorders Chest Pain	0.16% 10/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.30% 9/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
General disorders Chills	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
General disorders Death	0.07% 4/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
General disorders Fatigue	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
General disorders Hernia	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
General disorders Hernia Obstructive	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
General disorders Influenza Like Illness	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
General disorders Non Cardiac Chest Pain	0.05% 3/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.07% 2/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
General disorders Oedema Peripheral	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
General disorders Pyrexia	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Hepatobiliary disorders Cholangitis	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Hepatobiliary disorders Cholecystitis	0.07% 4/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.13% 4/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.07% 2/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Hepatobiliary disorders Cholelithiasis	0.07% 4/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Immune system disorders Drug hypersensitivity	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Immune system disorders Hypersensitivity	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Abdominal abscess	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Abscess limb	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Actinomycotic pulmonary infection	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Appendicitis	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Application site cellulitis	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Arthritis bacterial	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Bacterial infection	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Biliary sepsis	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Bronchitis	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Bronchitis viral	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Cellulitis	0.15% 9/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Cellulitis staphylococcal	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Clostridial infection	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Clostridium difficile colitis	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Diverticulitis	0.13% 8/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Endocarditis bacterial	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Escherichia urinary tract infection	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Gangrene	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Sepsis syndrome	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Septic arthritis staphylococcal	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Septic shock	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Sialoadenitis	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Staphylococcal bacteraemia	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Staphylococcal infection	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Staphylococcal sepsis	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Subcutaneous abscess	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Tracheobronchitis	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Upper respiratory tract infection	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Urinary tract infection	0.13% 8/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Urinary tract infection enterococcal	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Urinary tract infection staphylococcal	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Urosepsis	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Viral infection	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Wound infection	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Accidental overdose	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Anaemia postoperative	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Ankle fracture	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Back injury	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Brain contusion	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Burns second degree	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Compression fracture	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Concussion	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Drug toxicity	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Femoral neck fracture	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Fractured sacrum	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Hand fracture	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Head injury	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Hip fracture	0.07% 4/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.10% 3/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Humerus fracture	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Ilium fracture	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Incisional hernia	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Joint dislocation	0.05% 3/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Lower limb fracture	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Medical device complication	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Multiple fractures	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Muscle injury	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Muscle strain	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Pelvic fracture	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.10% 3/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Post procedural complication	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Rib fracture	0.05% 3/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Road traffic accident	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Spinal compression fracture	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Splenic rupture	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Sternal fracture	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Subdural haematoma	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.07% 2/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Subdural haemorrhage	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Tendon injury	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Tendon rupture	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Upper limb fracture	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Injury, poisoning and procedural complications Wrist fracture	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Investigations Heart rate irregular	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Investigations International normalised ratio increased	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Metabolism and nutrition disorders Dehydration	0.08% 5/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.07% 2/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Metabolism and nutrition disorders Diabetic foot	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Metabolism and nutrition disorders Failure to thrive	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Metabolism and nutrition disorders Fluid retention	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Metabolism and nutrition disorders Hyperglycaemia	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Metabolism and nutrition disorders Hyperkalaemia	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.10% 3/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Metabolism and nutrition disorders Hypokalaemia	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Metabolism and nutrition disorders Hyponatraemia	0.05% 3/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.07% 2/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Musculoskeletal and connective tissue disorders Arthralgia	0.07% 4/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.07% 2/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Musculoskeletal and connective tissue disorders Arthritis	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Musculoskeletal and connective tissue disorders Back disorder	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Musculoskeletal and connective tissue disorders Back pain	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Musculoskeletal and connective tissue disorders Costochondritis	0.05% 3/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.08% 5/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.33% 20/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.30% 9/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Musculoskeletal and connective tissue disorders Spinal disorder	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Musculoskeletal and connective tissue disorders Synovial cyst	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoid cystic carcinoma	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.08% 5/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer recurrent	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.10% 6/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.07% 2/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast neoplasm	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.08% 5/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.07% 2/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer metastatic	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease stage IV	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraocular melanoma	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large cell lung cancer stage II	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer stage III	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyosarcoma	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.07% 4/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage unspecified	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal squamous cell carcinoma	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.07% 2/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paget's disease of the breast	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.05% 3/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer recurrent	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Splenic marginal zone lymphoma	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Splenic neoplasm malignancy unspecified	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testis cancer	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thymoma	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Nervous system disorders Balance disorder	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Nervous system disorders Carotid artery occlusion	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Nervous system disorders Carotid artery stenosis	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Nervous system disorders Cerebral haemorrhage	0.07% 4/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Nervous system disorders Cerebral ischaemia	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Nervous system disorders Cerebrovascular accident	0.18% 11/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.20% 6/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Nervous system disorders Cervicobrachial syndrome	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Nervous system disorders Drug withdrawal convulsions	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Nervous system disorders Epilepsy	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Nervous system disorders Facial palsy	0.05% 3/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.07% 2/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Nervous system disorders Global amnesia	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Nervous system disorders Haemorrhage intracranial	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Nervous system disorders Haemorrhagic stroke	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Nervous system disorders Hypertensive encephalopathy	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Nervous system disorders Intracranial aneurysm	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Nervous system disorders Ischaemic stroke	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Nervous system disorders Lumbar radiculopathy	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Nervous system disorders Myelitis transverse	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Nervous system disorders Nerve compression	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Nervous system disorders Normal pressure hydrocephalus	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Nervous system disorders Paraesthesia	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Nervous system disorders Presyncope	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Nervous system disorders Syncope	0.25% 15/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.13% 4/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Nervous system disorders Transient ischaemic attack	0.08% 5/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.16% 5/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Psychiatric disorders Alcohol abuse	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Psychiatric disorders Alcoholism	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Psychiatric disorders Anxiety disorder	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Psychiatric disorders Bipolar disorder	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Psychiatric disorders Completed suicide	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Psychiatric disorders Delusion	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Psychiatric disorders Depressed mood	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Psychiatric disorders Depression	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Psychiatric disorders Disorientation	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Psychiatric disorders Major depression	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Psychiatric disorders Mental disorder	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Psychiatric disorders Mental status changes	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Renal and urinary disorders Anuria	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Renal and urinary disorders Bladder obstruction	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Renal and urinary disorders Calculus bladder	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Renal and urinary disorders Calculus ureteric	0.05% 3/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Renal and urinary disorders Haematuria	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Renal and urinary disorders Incontinence	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Renal and urinary disorders Nephrolithiasis	0.07% 4/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Renal and urinary disorders Renal artery stenosis	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Renal and urinary disorders Renal failure	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Renal and urinary disorders Renal failure acute	0.11% 7/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.10% 3/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Renal and urinary disorders Renal failure chronic	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.07% 2/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Renal and urinary disorders Renal mass	0.05% 3/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Renal and urinary disorders Urinary incontinence	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Renal and urinary disorders Urinary retention	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Reproductive system and breast disorders Cystocele	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.07% 2/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Reproductive system and breast disorders Uterine prolapse	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Respiratory, thoracic and mediastinal disorders Asthma	0.10% 6/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.10% 3/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.34% 21/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.43% 13/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Respiratory, thoracic and mediastinal disorders Cough	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.05% 3/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.07% 2/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.07% 4/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.07% 4/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Skin and subcutaneous tissue disorders Angioedema	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Skin and subcutaneous tissue disorders Diabetic ulcer	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Surgical and medical procedures Colectomy	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Surgical and medical procedures Hospitalisation	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Surgical and medical procedures Knee arthroplasty	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Surgical and medical procedures Shoulder arthroplasty	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Vascular disorders Aneurysm	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Vascular disorders Aortic aneurysm	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Vascular disorders Arterial occlusive disease	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Vascular disorders Arterial thrombosis limb	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Vascular disorders Arteriosclerosis	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Vascular disorders Deep vein thrombosis	0.07% 4/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Vascular disorders Embolism	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Vascular disorders Femoral artery embolism	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Vascular disorders Femoral artery occlusion	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Vascular disorders Haematoma	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Vascular disorders Hypertension	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Vascular disorders Hypertensive crisis	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Vascular disorders Hypotension	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Vascular disorders Ischaemia	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Vascular disorders Ischaemic limb pain	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Vascular disorders Orthostatic hypotension	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Vascular disorders Peripheral artery aneurysm	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Vascular disorders Thrombosis	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Vascular disorders Vascular rupture	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Gastroenteritis	0.07% 4/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Infection	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Influenza	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Kidney infection	0.03% 2/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Klebsiella infection	0.00% 0/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Lobar pneumonia	0.05% 3/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Orchitis	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Osteomyelitis	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Otitis media	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Perineal abscess	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Pneumonia	0.26% 16/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.43% 13/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Pneumonia staphylococcal	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Post procedural infection	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Respiratory tract infection	0.02% 1/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.00% 0/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Infections and infestations Sepsis	0.05% 3/6108 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.	0.03% 1/3050 • Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.

Other adverse events

Adverse event data not reported

Additional Information

Medical Director

Sanofi Pasteur Inc.

Email: RegistryContactUs@sanofipasteur.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
• Publication restrictions are in place

Restriction type: OTHER