Trial Outcomes & Findings for Study to Evaluate the Safety and Effectiveness of Zostavax™ in Subjects 50 - 59 Years of Age (V211-022) (NCT NCT00534248)

NCT ID: NCT00534248

Last Updated: 2017-04-12

Results Overview

Incidence rate of HZ cases was defined as the number of confirmed HZ cases per 1000 person-years of follow-up following vaccination. Vaccine efficacy for HZ was defined as the relative reduction in incidence rate of HZ in the group that received Zostavax™ compared with the group that received placebo based on the intent-to-treat population.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 22439 participants
• Primary outcome timeframe: 2 Years
• Results posted on: 2017-04-12

Participant Flow

Participant milestones

Measure	Zostavax™ Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).	Placebo Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
Overall Study STARTED	11211	11228
Overall Study VACCINATED	11186	11210
Overall Study COMPLETED	10550	10555
Overall Study NOT COMPLETED	661	673

Reasons for withdrawal

Measure	Zostavax™ Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).	Placebo Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
Overall Study Adverse Event	19	29
Overall Study Lost to Follow-up	353	375
Overall Study Other protocol specified criteria	13	3
Overall Study Physician Decision	10	7
Overall Study Protocol Violation	3	4
Overall Study Withdrawal by Subject	263	255

Baseline Characteristics

Study to Evaluate the Safety and Effectiveness of Zostavax™ in Subjects 50 - 59 Years of Age (V211-022)

Baseline characteristics by cohort

Measure	Zostavax™ n=11211 Participants Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).	Placebo n=11228 Participants Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.	Total n=22439 Participants Total of all reporting groups
Age, Continuous	54.9 years STANDARD_DEVIATION 2.8 • n=5 Participants	54.8 years STANDARD_DEVIATION 2.8 • n=7 Participants	54.8 years STANDARD_DEVIATION 2.8 • n=5 Participants
Sex: Female, Male Female	6913 Participants n=5 Participants	6972 Participants n=7 Participants	13885 Participants n=5 Participants
Sex: Female, Male Male	4298 Participants n=5 Participants	4256 Participants n=7 Participants	8554 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 Years

Population: Intent-to-treat population defined as all participants randomized in the study according to the planned treatment, Zostavax or placebo, they were assigned.

Incidence rate of HZ cases was defined as the number of confirmed HZ cases per 1000 person-years of follow-up following vaccination. Vaccine efficacy for HZ was defined as the relative reduction in incidence rate of HZ in the group that received Zostavax™ compared with the group that received placebo based on the intent-to-treat population.

Outcome measures

Measure	Zostavax™ n=11211 Participants Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).	Placebo n=11228 Participants Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
Incidence of Confirmed Herpes Zoster (HZ) Cases by Vaccination Group	1.994 number of HZ cases/1000 person-years Interval 1.346 to 2.847	6.596 number of HZ cases/1000 person-years Interval 5.361 to 8.03

SECONDARY outcome

Timeframe: 6 Weeks

Population: Random subcohort population included 10% of all randomized participants randomly selected for immunogenicity assay, were vaccinated (according to actual treatment received), had results at prevaccination and at 6 weeks postvaccination. Results from participants with protocol violations that may impact the immunogenicity analysis were excluded.

VZV antibody response as measured by Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) in the group that received Zostavax™ compared with the group that received placebo, based on the random subcohort population.

Outcome measures

Measure	Zostavax™ n=1088 Participants Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).	Placebo n=1087 Participants Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
Varicella-zoster Virus (VZV) Antibody Response at 6 Weeks Post Vaccination by Vaccination Group	660.0 gpELISA units/mL Interval 624.7 to 697.2	293.1 gpELISA units/mL Interval 274.7 to 312.6

SECONDARY outcome

Timeframe: Through 42 days post-vaccination

Population: All participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.

A serious adverse event is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing

hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement.

Outcome measures

Measure	Zostavax™ n=11094 Participants Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).	Placebo n=11116 Participants Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
Number of Participants Reporting One or More Serious Adverse Experiences by Vaccination Group During the 42-day Postvaccination Follow-up Period	69 participants Interval 0.48 to 0.79	61 participants Interval 0.42 to 0.7

Adverse Events

Zostavax™

Serious events: 243 serious events

Other events: 7228 other events

Deaths: 0 deaths

Placebo

Serious events: 233 serious events

Other events: 2183 other events

Deaths: 0 deaths

Serious adverse events

Measure	Zostavax™ n=11094 participants at risk Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).	Placebo n=11116 participants at risk Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neurilemmoma benign	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian epithelial cancer	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.02% 2/11116 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.03% 3/11094 • Number of events 3 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.04% 4/11116 • Number of events 4 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Throat cancer	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.02% 2/11094 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Waldenstrom's macroglobulinaemia	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Nervous system disorders Brain stem infarction	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Nervous system disorders Cerebellar infarction	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Nervous system disorders Cerebral infarction	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Nervous system disorders Cerebrovascular accident	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.03% 3/11116 • Number of events 3 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Nervous system disorders Cervical root pain	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Nervous system disorders Cervicobrachial syndrome	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Nervous system disorders Convulsion	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Nervous system disorders Cubital tunnel syndrome	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Nervous system disorders Encephalopathy	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Nervous system disorders Epilepsy	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Nervous system disorders Facial palsy	0.02% 2/11094 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Nervous system disorders Headache	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.02% 2/11116 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Nervous system disorders Hypoaesthesia	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Nervous system disorders Intracranial aneurysm	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Nervous system disorders Migraine	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Nervous system disorders Migraine with aura	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Nervous system disorders Myasthenia gravis	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Nervous system disorders Nerve compression	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Nervous system disorders Neuropathy peripheral	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Nervous system disorders Paraesthesia	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Nervous system disorders Parkinson's disease	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Nervous system disorders Transient ischaemic attack	0.02% 2/11094 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.02% 2/11116 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Psychiatric disorders Acute psychosis	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Psychiatric disorders Affective disorder	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Psychiatric disorders Alcohol abuse	0.02% 2/11094 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Psychiatric disorders Alcohol withdrawal syndrome	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.03% 3/11116 • Number of events 6 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Psychiatric disorders Completed suicide	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.03% 3/11116 • Number of events 3 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Psychiatric disorders Confusional state	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Psychiatric disorders Depression	0.04% 4/11094 • Number of events 4 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Psychiatric disorders Depression suicidal	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Psychiatric disorders Drug dependence	0.01% 1/11094 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Psychiatric disorders Major depression	0.02% 2/11094 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.02% 2/11116 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Psychiatric disorders Post-traumatic stress disorder	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Psychiatric disorders Suicidal behaviour	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Psychiatric disorders Suicidal ideation	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Psychiatric disorders Suicide attempt	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Renal and urinary disorders Calculus urinary	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Renal and urinary disorders Nephrolithiasis	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.02% 2/11116 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Renal and urinary disorders Renal colic	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Renal and urinary disorders Renal failure acute	0.02% 2/11094 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Renal and urinary disorders Renal failure chronic	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Renal and urinary disorders Renal infarct	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Reproductive system and breast disorders Endometrial hyperplasia	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Reproductive system and breast disorders Uterine prolapse	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Respiratory, thoracic and mediastinal disorders Asthma	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.03% 3/11094 • Number of events 3 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.02% 2/11116 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Respiratory, thoracic and mediastinal disorders Laryngeal cyst	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.03% 3/11094 • Number of events 3 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.03% 3/11116 • Number of events 3 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Skin and subcutaneous tissue disorders Angioedema	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Skin and subcutaneous tissue disorders Psoriasis	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Vascular disorders Aortic stenosis	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Vascular disorders Arterial occlusive disease	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Vascular disorders Deep vein thrombosis	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Vascular disorders Haemorrhage	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Vascular disorders Hypertension	0.02% 2/11094 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Vascular disorders Hypertensive crisis	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Vascular disorders Orthostatic hypotension	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Blood and lymphatic system disorders Anaemia	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Blood and lymphatic system disorders Nephrogenic anaemia	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Blood and lymphatic system disorders Splenic infarction	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Cardiac disorders Acute myocardial infarction	0.03% 3/11094 • Number of events 3 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.02% 2/11116 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Cardiac disorders Angina pectoris	0.02% 2/11094 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Cardiac disorders Angina unstable	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Cardiac disorders Arteriosclerosis coronary artery	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.03% 3/11116 • Number of events 3 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Cardiac disorders Atrial fibrillation	0.02% 2/11094 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.05% 6/11116 • Number of events 6 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Cardiac disorders Bradycardia	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Abdominal abscess	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Cardiac disorders Cardiac arrest	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Cardiac disorders Cardiac failure congestive	0.05% 5/11094 • Number of events 5 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Cardiac disorders Cardiomegaly	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Cardiac disorders Cardiomyopathy	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Cardiac disorders Coronary artery disease	0.02% 2/11094 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.02% 2/11116 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Cardiac disorders Coronary artery occlusion	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Cardiac disorders Coronary artery stenosis	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Cardiac disorders Coronary artery thrombosis	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.02% 2/11116 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Cardiac disorders Hypertensive heart disease	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Cardiac disorders Hypertrophic cardiomyopathy	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Cardiac disorders Mitral valve prolapse	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Cardiac disorders Myocardial infarction	0.04% 4/11094 • Number of events 4 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.04% 5/11116 • Number of events 5 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Cardiac disorders Stress cardiomyopathy	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Cardiac disorders Supraventricular tachycardia	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Cardiac disorders Tachycardia	0.03% 3/11094 • Number of events 3 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Cardiac disorders Ventricular tachycardia	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Congenital, familial and genetic disorders Congenital diaphragmatic hernia	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Congenital, familial and genetic disorders Porphyria acute	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Ear and labyrinth disorders Deafness neurosensory	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Ear and labyrinth disorders Vertigo	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Ear and labyrinth disorders Vertigo positional	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Endocrine disorders Goitre	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Endocrine disorders Hyperparathyroidism	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Appendicitis	0.05% 6/11094 • Number of events 6 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.06% 7/11116 • Number of events 7 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Endocrine disorders Thyroiditis	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Eye disorders Diplopia	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Eye disorders Retinal vein occlusion	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Gastrointestinal disorders Abdominal hernia	0.02% 2/11094 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Gastrointestinal disorders Abdominal pain upper	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Gastrointestinal disorders Anal fistula	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Gastrointestinal disorders Ascites	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Arthritis bacterial	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Gastrointestinal disorders Colitis	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Gastrointestinal disorders Colitis ulcerative	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Gastrointestinal disorders Colonic polyp	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Gastrointestinal disorders Constipation	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Bursitis infective staphylococcal	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Gastrointestinal disorders Diverticulum	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Cellulitis	0.02% 2/11094 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.04% 5/11116 • Number of events 5 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Gastrointestinal disorders Haematemesis	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Gastrointestinal disorders Inguinal hernia	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Gastrointestinal disorders Intestinal obstruction	0.02% 2/11094 • Number of events 3 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Gastrointestinal disorders Large intestine perforation	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Gastrointestinal disorders Mechanical ileus	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Gastrointestinal disorders Oesophageal achalasia	0.01% 1/11094 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Gastrointestinal disorders Oesophageal ulcer	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Gastrointestinal disorders Pancreatic disorder	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Gastrointestinal disorders Pancreatitis	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.04% 4/11116 • Number of events 4 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Gastrointestinal disorders Pancreatitis acute	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Gastrointestinal disorders Peritonitis	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Gastrointestinal disorders Rectal prolapse	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Gastrointestinal disorders Small intestinal obstruction	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.02% 2/11116 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
General disorders Chest discomfort	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
General disorders Chest pain	0.06% 7/11094 • Number of events 7 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.06% 7/11116 • Number of events 7 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
General disorders Death	0.03% 3/11094 • Number of events 3 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.02% 2/11116 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
General disorders Hernia obstructive	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
General disorders Impaired healing	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
General disorders Inflammation	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
General disorders Non-cardiac chest pain	0.05% 5/11094 • Number of events 5 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.06% 7/11116 • Number of events 7 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
General disorders Pyrexia	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Hepatobiliary disorders Alcoholic liver disease	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Hepatobiliary disorders Cholangitis	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Hepatobiliary disorders Cholecystitis	0.03% 3/11094 • Number of events 3 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.03% 3/11116 • Number of events 3 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Hepatobiliary disorders Cholecystitis acute	0.02% 2/11094 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Hepatobiliary disorders Cholelithiasis	0.02% 2/11094 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.03% 3/11116 • Number of events 3 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.02% 2/11116 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Hepatobiliary disorders Hepatic failure	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Hepatobiliary disorders Perforation bile duct	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Immune system disorders Allergic oedema	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Immune system disorders Anaphylactic reaction	0.02% 2/11094 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Immune system disorders Anaphylactic shock	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Device related infection	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Diabetic gangrene	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Diverticulitis	0.03% 3/11094 • Number of events 3 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.02% 2/11116 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Endocarditis bacterial	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Epidemic nephropathy	0.02% 2/11094 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Erysipelas	0.04% 4/11094 • Number of events 4 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.02% 2/11116 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Furuncle	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Gastroenteritis	0.03% 3/11094 • Number of events 3 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.03% 3/11116 • Number of events 3 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Gastroenteritis viral	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Infection	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Lobar pneumonia	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Localised infection	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Meningitis aseptic	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Osteomyelitis	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Peritonitis bacterial	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Pharyngeal abscess	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Pneumonia	0.04% 4/11094 • Number of events 4 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.07% 8/11116 • Number of events 8 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Pneumonia bacterial	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Post procedural infection	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Pyelonephritis	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Pyelonephritis acute	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.02% 2/11116 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Respiratory tract infection	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Sepsis	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Sinusitis	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Superinfection	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Upper respiratory tract infection	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Urosepsis	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Infections and infestations Vestibular neuronitis	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.02% 2/11116 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Alcohol poisoning	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Ankle fracture	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.04% 4/11116 • Number of events 4 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Bladder injury	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Brain contusion	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Concussion	0.02% 2/11094 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Contusion	0.02% 2/11094 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Device failure	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Drug toxicity	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.02% 2/11116 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Facial bones fracture	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Foot fracture	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Hand fracture	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Head injury	0.02% 2/11094 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Hip fracture	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Humerus fracture	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Incisional hernia	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Joint dislocation	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Limb traumatic amputation	0.01% 1/11094 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Meniscus lesion	0.02% 2/11094 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Overdose	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Postoperative ileus	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Skull fracture	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Soft tissue injury	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Spinal compression fracture	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Splenic rupture	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Stent occlusion	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Subdural haemorrhage	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Synovial rupture	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Tibia fracture	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Traumatic brain injury	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Ureteric injury	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Urinary retention postoperative	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Wound	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Wound complication	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.02% 2/11116 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Metabolism and nutrition disorders Dehydration	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Metabolism and nutrition disorders Diabetes mellitus	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Metabolism and nutrition disorders Hyperglycaemia	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.02% 2/11116 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.02% 2/11116 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Metabolism and nutrition disorders Hypokalaemia	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.02% 2/11116 • Number of events 3 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Metabolism and nutrition disorders Obesity	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Musculoskeletal and connective tissue disorders Arthralgia	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Musculoskeletal and connective tissue disorders Back pain	0.03% 3/11094 • Number of events 3 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.02% 2/11094 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.04% 4/11094 • Number of events 4 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.02% 2/11116 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.02% 2/11094 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.02% 2/11116 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Musculoskeletal and connective tissue disorders Patellofemoral pain syndrome	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.13% 14/11094 • Number of events 14 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.09% 10/11116 • Number of events 10 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign lung neoplasm	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of cervix uteri	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Borderline ovarian tumour	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.09% 10/11094 • Number of events 10 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.06% 7/11116 • Number of events 7 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer in situ	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage II	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.02% 2/11094 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer metastatic	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer stage III	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fallopian tube cancer	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroadenoma of breast	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.02% 2/11094 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.02% 2/11116 • Number of events 2 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple myeloma	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.00% 0/11116 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasal cavity cancer	0.00% 0/11094 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.01% 1/11094 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.01% 1/11116 • Number of events 1 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.

Other adverse events

Measure	Zostavax™ n=11094 participants at risk Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).	Placebo n=11116 participants at risk Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
General disorders Injection site erythema	48.2% 5351/11094 • Number of events 5409 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	4.3% 483/11116 • Number of events 484 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
General disorders Injection site pain	54.1% 6005/11094 • Number of events 6276 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	9.2% 1025/11116 • Number of events 1052 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
General disorders Injection site pruritus	11.6% 1287/11094 • Number of events 1307 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	0.70% 78/11116 • Number of events 84 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
General disorders Injection site swelling	40.6% 4500/11094 • Number of events 4549 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	2.8% 309/11116 • Number of events 311 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.
Nervous system disorders Headache	9.4% 1041/11094 • Number of events 1509 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.	8.2% 917/11116 • Number of events 1357 • Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. AEs and SAEs were reported in participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.

Additional Information

Vice President of Late Stage Development

Merck Sharp & Dohme Corp

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60