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Trial Outcomes & Findings for Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects (NCT NCT00500357)

NCT ID: NCT00500357

Last Updated: 2011-04-19

Results Overview

Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

105 participants

Primary outcome timeframe

Month 1 / Year 0 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)

Results posted on

2011-04-19

Participant Flow

915 participants were enrolled in core study NCT00269672 (6115A1-500); 914 participants received 13-valent pneumococcal conjugate vaccine plus or minus aluminum phosphate (13vPnC+AlPO4 or 13vPnC-AlPO4) or 23-valent pneumococcal polysaccharide vaccine (23vPS) in Year 0 (Vaccination 1 \[Vax 1\]) followed by 13vPnC+AlPO4 or 23vPS in Year 1 (Vax 2).

105 participants from the core study NCT00269672 (6115A1-500) who had received 13vPnC+AlPO4 (13vPnC) followed by 23vPS enrolled in the follow-up study NCT00500357 (6115A1-3009) 1 year after completion of the core study and received a subsequent 13vPnC dose at Year 2 (Vax 3).

Participant milestones

Participant milestones
Measure
13vPnC (Vax 3 Follow-up / NCT00500357)
Administered 13vPnC 0.5 milliliters (mL) intramuscularly (IM) at Year 0 (Vaccination 1 \[Vax 1\]) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
Overall Study
STARTED
105
Overall Study
Received 13vPnC (Vax 3)
105
Overall Study
Evaluable Immunogenicity Population
98
Overall Study
COMPLETED
104
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Reasons for withdrawal
Measure
13vPnC (Vax 3 Follow-up / NCT00500357)
Administered 13vPnC 0.5 milliliters (mL) intramuscularly (IM) at Year 0 (Vaccination 1 \[Vax 1\]) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
Overall Study
Death
1

Baseline Characteristics

Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
13vPnC (Vax 3 Follow-up / NCT00500357)
n=105 Participants
Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
Age Continuous
72.8 years
STANDARD_DEVIATION 4.9 • n=5 Participants
Sex: Female, Male
Female
56 Participants
n=5 Participants
Sex: Female, Male
Male
49 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Month 1 / Year 0 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)

Population: Evaluable Immunogenicity population includes participants from the evaluable immunogenicity population for Vax 1 and Vax 2 in the core study/NCT00269672, received 13vPnC in follow-up study/NCT00500357, and had at least 1 assay result in the follow-up study. N=number of participants with a determinate antibody titer for the specified serotype.

Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.

Outcome measures

Outcome measures
Measure
13vPnC (Vax 1 Core Study/NCT00269672)
n=96 Participants
13vPnC 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500).
13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
n=96 Participants
13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Serotype 4
2210 geometric mean titer
Interval 1603.5 to 3045.2
1254 geometric mean titer
Interval 926.6 to 1695.7
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Serotype 1
198 geometric mean titer
Interval 133.7 to 293.0
78 geometric mean titer
Interval 55.4 to 108.8
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Serotype 3
126 geometric mean titer
Interval 94.2 to 167.8
104 geometric mean titer
Interval 81.5 to 132.5
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Serotype 5
413 geometric mean titer
Interval 278.0 to 614.9
170 geometric mean titer
Interval 119.7 to 241.3
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Serotype 6A
4931 geometric mean titer
Interval 3391.0 to 7170.8
3158 geometric mean titer
Interval 2369.3 to 4209.7
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Serotype 6B
3251 geometric mean titer
Interval 2105.0 to 5019.6
2440 geometric mean titer
Interval 1753.2 to 3395.1
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Serotype 7F
869 geometric mean titer
Interval 540.3 to 1398.0
353 geometric mean titer
Interval 221.7 to 561.0
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Serotype 9V
977 geometric mean titer
Interval 588.6 to 1620.4
247 geometric mean titer
Interval 142.9 to 426.8
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Serotype 14
982 geometric mean titer
Interval 676.0 to 1425.8
550 geometric mean titer
Interval 392.5 to 769.8
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Serotype 18C
2860 geometric mean titer
Interval 1899.9 to 4304.6
1457 geometric mean titer
Interval 1057.8 to 2008.1
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Serotype 19A
1141 geometric mean titer
Interval 832.4 to 1564.3
431 geometric mean titer
Interval 340.3 to 546.1
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Serotype 19F
1014 geometric mean titer
Interval 654.4 to 1572.6
494 geometric mean titer
Interval 341.4 to 715.5
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Serotype 23F
523 geometric mean titer
Interval 315.4 to 867.7
661 geometric mean titer
Interval 443.6 to 985.8

SECONDARY outcome

Timeframe: Month 1 / Year 1 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)

Population: Evaluable Immunogenicity population; N=number of participants with a determinate antibody titer for the specified serotype.

Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.

Outcome measures

Outcome measures
Measure
13vPnC (Vax 1 Core Study/NCT00269672)
n=97 Participants
13vPnC 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500).
13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
n=97 Participants
13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Serotype 1
184 geometric mean titer
Interval 136.2 to 249.2
81 geometric mean titer
Interval 58.3 to 112.5
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Serotype 3
131 geometric mean titer
Interval 102.2 to 168.9
104 geometric mean titer
Interval 81.5 to 132.5
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Serotype 4
1457 geometric mean titer
Interval 1092.8 to 1942.2
1406 geometric mean titer
Interval 1098.1 to 1799.8
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Serotype 5
326 geometric mean titer
Interval 228.4 to 464.0
219 geometric mean titer
Interval 153.6 to 312.8
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Serotype 6A
1732 geometric mean titer
Interval 1163.1 to 2580.0
3443 geometric mean titer
Interval 2678.7 to 4425.1
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Serotype 6B
1862 geometric mean titer
Interval 1333.5 to 2600.7
2505 geometric mean titer
Interval 1798.8 to 3488.1
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Serotype 7F
1292 geometric mean titer
Interval 925.2 to 1803.5
351 geometric mean titer
Interval 224.5 to 550.1
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Serotype 9V
624 geometric mean titer
Interval 371.0 to 1051.1
267 geometric mean titer
Interval 153.9 to 463.0
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Serotype 14
808 geometric mean titer
Interval 599.4 to 1089.7
557 geometric mean titer
Interval 399.0 to 778.9
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Serotype 18C
1753 geometric mean titer
Interval 1214.9 to 2528.5
1452 geometric mean titer
Interval 1049.6 to 2009.0
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Serotype 19A
756 geometric mean titer
Interval 581.2 to 983.9
511 geometric mean titer
Interval 408.5 to 639.1
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Serotype 19F
901 geometric mean titer
Interval 689.1 to 1177.3
527 geometric mean titer
Interval 369.1 to 752.7
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Serotype 23F
484 geometric mean titer
Interval 323.7 to 723.6
731 geometric mean titer
Interval 499.0 to 1071.9

SECONDARY outcome

Timeframe: Month 1 / Year 0 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)

Population: Evaluable Immunogenicity population; N=number of participants with a determinate antibody concentration for the specified serotype.

Pneumococcal IgG GMCs measured as micrograms per milliliter (mcg/mL) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMCs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Outcome measures

Outcome measures
Measure
13vPnC (Vax 1 Core Study/NCT00269672)
n=98 Participants
13vPnC 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500).
13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
n=98 Participants
13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Serotype 5
19.51 geometric mean concentration (mcg/mL)
Interval 13.92 to 27.36
6.33 geometric mean concentration (mcg/mL)
Interval 5.08 to 7.9
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Serotype 6A
9.12 geometric mean concentration (mcg/mL)
Interval 6.7 to 12.42
8.22 geometric mean concentration (mcg/mL)
Interval 6.3 to 10.72
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Serotype 1
7.67 geometric mean concentration (mcg/mL)
Interval 5.48 to 10.72
4.99 geometric mean concentration (mcg/mL)
Interval 4.06 to 6.14
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Serotype 3
2.60 geometric mean concentration (mcg/mL)
Interval 2.04 to 3.33
1.35 geometric mean concentration (mcg/mL)
Interval 1.12 to 1.62
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Serotype 4
4.68 geometric mean concentration (mcg/mL)
Interval 3.4 to 6.43
2.96 geometric mean concentration (mcg/mL)
Interval 2.3 to 3.81
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Serotype 6B
13.03 geometric mean concentration (mcg/mL)
Interval 9.11 to 18.62
10.32 geometric mean concentration (mcg/mL)
Interval 8.1 to 13.14
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Serotype 7F
6.93 geometric mean concentration (mcg/mL)
Interval 5.45 to 8.81
5.02 geometric mean concentration (mcg/mL)
Interval 4.23 to 5.95
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Serotype 9V
11.56 geometric mean concentration (mcg/mL)
Interval 8.68 to 15.4
5.77 geometric mean concentration (mcg/mL)
Interval 4.7 to 7.09
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Serotype 14
17.51 geometric mean concentration (mcg/mL)
Interval 12.7 to 24.13
13.34 geometric mean concentration (mcg/mL)
Interval 10.67 to 16.69
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Serotype 18C
20.59 geometric mean concentration (mcg/mL)
Interval 15.35 to 27.62
7.82 geometric mean concentration (mcg/mL)
Interval 6.39 to 9.56
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Serotype 19A
29.52 geometric mean concentration (mcg/mL)
Interval 22.14 to 39.36
17.80 geometric mean concentration (mcg/mL)
Interval 14.67 to 21.6
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Serotype 19F
13.39 geometric mean concentration (mcg/mL)
Interval 9.47 to 18.92
8.55 geometric mean concentration (mcg/mL)
Interval 6.6 to 11.07
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Serotype 23F
10.16 geometric mean concentration (mcg/mL)
Interval 7.06 to 14.64
7.73 geometric mean concentration (mcg/mL)
Interval 5.77 to 10.36

SECONDARY outcome

Timeframe: Month 1 / Year 1 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)

Population: Evaluable Immunogenicity population; N=number of participants with a determinate antibody concentration for the specified serotype.

Pneumococcal IgG GMCs measured as micrograms per milliliter (mcg/mL) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMCs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Outcome measures

Outcome measures
Measure
13vPnC (Vax 1 Core Study/NCT00269672)
n=98 Participants
13vPnC 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500).
13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
n=98 Participants
13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Serotype 7F
7.41 geometric mean concentration (mcg/mL)
Interval 6.07 to 9.04
5.02 geometric mean concentration (mcg/mL)
Interval 4.23 to 5.95
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Serotype 23F
7.27 geometric mean concentration (mcg/mL)
Interval 5.52 to 9.57
7.73 geometric mean concentration (mcg/mL)
Interval 5.77 to 10.36
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Serotype 1
7.29 geometric mean concentration (mcg/mL)
Interval 5.96 to 8.93
4.99 geometric mean concentration (mcg/mL)
Interval 4.06 to 6.14
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Serotype 3
2.46 geometric mean concentration (mcg/mL)
Interval 2.01 to 3.01
1.36 geometric mean concentration (mcg/mL)
Interval 1.13 to 1.64
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Serotype 4
3.93 geometric mean concentration (mcg/mL)
Interval 3.03 to 5.11
2.96 geometric mean concentration (mcg/mL)
Interval 2.3 to 3.81
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Serotype 5
9.29 geometric mean concentration (mcg/mL)
Interval 7.37 to 11.71
6.33 geometric mean concentration (mcg/mL)
Interval 5.08 to 7.9
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Serotype 6A
5.51 geometric mean concentration (mcg/mL)
Interval 4.25 to 7.15
8.22 geometric mean concentration (mcg/mL)
Interval 6.3 to 10.72
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Serotype 6B
9.67 geometric mean concentration (mcg/mL)
Interval 7.47 to 12.53
10.32 geometric mean concentration (mcg/mL)
Interval 8.1 to 13.14
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Serotype 9V
9.60 geometric mean concentration (mcg/mL)
Interval 7.68 to 12.0
5.77 geometric mean concentration (mcg/mL)
Interval 4.7 to 7.09
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Serotype 14
22.67 geometric mean concentration (mcg/mL)
Interval 17.89 to 28.72
13.34 geometric mean concentration (mcg/mL)
Interval 10.67 to 16.69
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Serotype 18C
11.66 geometric mean concentration (mcg/mL)
Interval 9.66 to 14.07
7.82 geometric mean concentration (mcg/mL)
Interval 6.39 to 9.56
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Serotype 19A
22.78 geometric mean concentration (mcg/mL)
Interval 18.47 to 28.11
17.80 geometric mean concentration (mcg/mL)
Interval 14.67 to 21.6
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Serotype 19F
15.82 geometric mean concentration (mcg/mL)
Interval 11.97 to 20.91
8.55 geometric mean concentration (mcg/mL)
Interval 6.6 to 11.07

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 1 through 14 / Year 2 (Follow-up study/NCT00500357)

Population: Safety population included all participants who received the vaccine sequence 13vPnC / 23vPS / 13vPnC. N=number of participants with reactogenicity events (reported Yes for at least 1 day or No for all days); (n)=number of participants with known values for 13vPnC / 23vPS / 13vPnC (Vax 3). Participants may be represented in more than 1 category.

Local reactions reported using electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters \[cm\] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (\> 10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move shoulder).

Outcome measures

Outcome measures
Measure
13vPnC (Vax 1 Core Study/NCT00269672)
n=91 Participants
13vPnC 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500).
13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Redness: Any (n=79)
7.6 percentage of participants
—
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Redness: Mild (n=79)
6.3 percentage of participants
—
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Redness: Moderate (n=78)
3.8 percentage of participants
—
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Redness: Severe (n=78)
0.0 percentage of participants
—
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Swelling: Any (n=83)
16.9 percentage of participants
—
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Swelling: Mild (n=81)
12.3 percentage of participants
—
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Swelling: Moderate (n=81)
8.6 percentage of participants
—
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Swelling: Severe (n=78)
0.0 percentage of participants
—
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Pain: Any (n=89)
40.4 percentage of participants
—
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Pain: Mild (n=88)
34.1 percentage of participants
—
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Pain: Moderate (n=83)
15.7 percentage of participants
—
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Pain: Severe (n=78)
0.0 percentage of participants
—
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Limitation of arm movement: Any (n=80)
11.3 percentage of participants
—
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Limitation of arm movement: Mild (n=80)
8.8 percentage of participants
—
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Limitation of arm movement: Moderate (n=78)
2.6 percentage of participants
—
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Limitation of arm movement: Severe (n=79)
1.3 percentage of participants
—

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 1 through 14 / Year 2 (Follow-up study/NCT00500357)

Population: Safety population; N=number of participants with reactogenicity events (reported Yes for at least 1 day or No for all days); (n)=number of participants with known values for 13vPnC / 23vPS / 13vPnC (Vax 3). Participants may be represented in more than 1 category.

Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius \[C\]); Mild (≥38 but \<38.5 degrees C); Moderate (≥38.5 but \<39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (\>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Aggravated muscle pain, New joint pain, and Aggravated joint pain.

Outcome measures

Outcome measures
Measure
13vPnC (Vax 1 Core Study/NCT00269672)
n=91 Participants
13vPnC 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500).
13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Potentially life-threatening >40 degrees C (n=79)
1.3 percentage of participants
—
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Decreased appetite (n=82)
18.3 percentage of participants
—
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Fever: Any ≥38 degrees C (n=81)
7.4 percentage of participants
—
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Fever: Mild ≥38 but <38.5 degrees C (n=80)
3.8 percentage of participants
—
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Fever: Moderate ≥38.5 but <39 degrees C (n=78)
2.6 percentage of participants
—
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Fever: Severe ≥39 but ≤40 degrees C (n=80)
2.5 percentage of participants
—
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Fatigue (n=83)
27.7 percentage of participants
—
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Headache (n=81)
19.8 percentage of participants
—
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Chills (n=79)
8.9 percentage of participants
—
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Rash (n=78)
2.6 percentage of participants
—
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Vomiting (n=79)
1.3 percentage of participants
—
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
New muscle pain (n=84)
21.4 percentage of participants
—
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Aggravated muscle pain (n=80)
12.5 percentage of participants
—
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
New joint pain (n=78)
7.7 percentage of participants
—
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Aggravated joint pain (n=79)
6.3 percentage of participants
—

Adverse Events

13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study)

Serious events: 2 serious events
Other events: 46 other events
Deaths: 0 deaths

13vPnC+AlPO4 (After Vax 1 Core Study)

Serious events: 2 serious events
Other events: 70 other events
Deaths: 0 deaths

13vPnC-AlPO4 (After Vax 1 Core Study)

Serious events: 4 serious events
Other events: 58 other events
Deaths: 0 deaths

23vPS (After Vax 1 Core Study)

Serious events: 1 serious events
Other events: 80 other events
Deaths: 0 deaths

13vPnC+AlPO4/13vPnC+AlPO4 (After Vax 2 Core Study)

Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths

13vPnC+AlPO4/23vPS (After Vax 2 Core Study)

Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths

13vPnC-AlPO4/23vPS (After Vax 2 Core Study)

Serious events: 1 serious events
Other events: 76 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study)
n=105 participants at risk
Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009). For 13vPnC / 23vPS / 13vPnC (Vax 3 follow-up study) Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=7; systematic (solicited) Any Local Reactions N=41; systematic (solicited) Any Systemic Events N=46.
13vPnC+AlPO4 (After Vax 1 Core Study)
n=308 participants at risk
Administered 13vPnC+AlPO4 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
13vPnC-AlPO4 (After Vax 1 Core Study)
n=304 participants at risk
Administered 13vPnC-AlPO4 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
23vPS (After Vax 1 Core Study)
n=302 participants at risk
Administered 23vPS 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
13vPnC+AlPO4/13vPnC+AlPO4 (After Vax 2 Core Study)
n=139 participants at risk
Administered 13vPnC + AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 13vPnC+AlPO4 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
13vPnC+AlPO4/23vPS (After Vax 2 Core Study)
n=128 participants at risk
Administered 13vPnC+AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
13vPnC-AlPO4/23vPS (After Vax 2 Core Study)
n=273 participants at risk
Administered 13vPnC-AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
Cardiac disorders
Bradycardia
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Injury, poisoning and procedural complications
Hip fracture
0.95%
1/105 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Cardiac disorders
Cardio-respiratory arrest
0.95%
1/105 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Cardiac disorders
Myocardial ischaemia
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Cardiac disorders
Angina unstable
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Cardiac disorders
Myocardial infarction
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.37%
1/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Congenital, familial and genetic disorders
Phimosis
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.72%
1/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Hepatobiliary disorders
Cholelithiasis
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Musculoskeletal and connective tissue disorders
Exostosis
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Musculoskeletal and connective tissue disorders
Arthralgia
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.78%
1/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.72%
1/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.72%
1/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Nervous system disorders
Hydrocephalus
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.72%
1/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Vascular disorders
Hypertension
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.

Other adverse events

Other adverse events
Measure
13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study)
n=105 participants at risk
Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009). For 13vPnC / 23vPS / 13vPnC (Vax 3 follow-up study) Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=7; systematic (solicited) Any Local Reactions N=41; systematic (solicited) Any Systemic Events N=46.
13vPnC+AlPO4 (After Vax 1 Core Study)
n=308 participants at risk
Administered 13vPnC+AlPO4 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
13vPnC-AlPO4 (After Vax 1 Core Study)
n=304 participants at risk
Administered 13vPnC-AlPO4 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
23vPS (After Vax 1 Core Study)
n=302 participants at risk
Administered 23vPS 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
13vPnC+AlPO4/13vPnC+AlPO4 (After Vax 2 Core Study)
n=139 participants at risk
Administered 13vPnC + AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 13vPnC+AlPO4 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
13vPnC+AlPO4/23vPS (After Vax 2 Core Study)
n=128 participants at risk
Administered 13vPnC+AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
13vPnC-AlPO4/23vPS (After Vax 2 Core Study)
n=273 participants at risk
Administered 13vPnC-AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
Skin and subcutaneous tissue disorders
Pain (severe)
0.00%
0/78 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
General disorders
Fatigue
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
2.9%
9/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
5.6%
17/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
7.3%
22/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
3.6%
5/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
6.2%
8/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
6.2%
17/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Immune system disorders
Drug hypersensitivity
0.95%
1/105 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Infections and infestations
Gastroenteritis
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.97%
3/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.66%
2/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.72%
1/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.78%
1/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
1.5%
4/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Infections and infestations
Cystitis
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.65%
2/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.72%
1/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Infections and infestations
Viral rhinitis
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.78%
1/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Musculoskeletal and connective tissue disorders
Myalgia
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
1.9%
6/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
2.3%
7/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
3.3%
10/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
2.9%
4/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
5.5%
7/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
3.3%
9/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Nervous system disorders
Headache
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
3.6%
11/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
5.6%
17/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
5.3%
16/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
4.3%
6/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
7.0%
9/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
4.4%
12/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Skin and subcutaneous tissue disorders
Redness (any)
7.6%
6/79 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Skin and subcutaneous tissue disorders
Redness (mild)
6.3%
5/79 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Skin and subcutaneous tissue disorders
Redness (moderate)
3.8%
3/78 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Skin and subcutaneous tissue disorders
Redness (severe)
0.00%
0/78 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Skin and subcutaneous tissue disorders
Swelling (any)
16.9%
14/83 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Skin and subcutaneous tissue disorders
Swelling (mild)
12.3%
10/81 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Skin and subcutaneous tissue disorders
Swelling (moderate)
8.6%
7/81 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Skin and subcutaneous tissue disorders
Swelling (severe)
0.00%
0/78 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Skin and subcutaneous tissue disorders
Pain (any)
40.4%
36/89 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Skin and subcutaneous tissue disorders
Pain (mild)
34.1%
30/88 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Skin and subcutaneous tissue disorders
Pain (moderate)
15.7%
13/83 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Skin and subcutaneous tissue disorders
Limitation of arm movement (any)
11.2%
9/80 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Skin and subcutaneous tissue disorders
Limitation of arm movement (mild)
8.8%
7/80 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Skin and subcutaneous tissue disorders
Limitation of arm movement (moderate)
2.6%
2/78 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Skin and subcutaneous tissue disorders
Limitation of arm movement (severe)
1.3%
1/79 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
General disorders
Fever (any) ≥ 38 degrees Celsius (C)
7.4%
6/81 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
General disorders
Fever (mild) ≥ 38 but <38.5 degrees C
3.8%
3/80 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
General disorders
Fever (moderate) ≥ 38.5 but <39 degrees C
2.6%
2/78 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
General disorders
Fever (severe) ≥ 39 but ≤40 degrees C
2.5%
2/80 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
General disorders
Fever (potentially life-threatening) >40 degrees C
1.3%
1/79 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
General disorders
Headache
19.8%
16/81 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
General disorders
Chills
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.72%
1/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.37%
1/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
General disorders
Rash
2.6%
2/78 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
General disorders
Vomiting
1.3%
1/79 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
General disorders
Decreased appetitie
18.3%
15/82 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
General disorders
New muscle pain
21.4%
18/84 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
General disorders
Aggravated muscle pain
12.5%
10/80 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
General disorders
New joint pain
7.7%
6/78 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
General disorders
Aggravated joint pain
6.3%
5/79 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Blood and lymphatic system disorders
Lymphadenitis
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Cardiac disorders
Cardiac failure congestive
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Cardiac disorders
Angina pectoris
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Cardiac disorders
Palpitations
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Ear and labyrinth disorders
Vertigo
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.78%
1/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Endocrine disorders
Hypothyroidism
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Eye disorders
Conjunctivitis
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.37%
1/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Eye disorders
Dacryoadenitis acquired
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.72%
1/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Eye disorders
Eye pain
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.37%
1/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Gastrointestinal disorders
Vomiting
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.99%
3/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.72%
1/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Gastrointestinal disorders
Abdominal pain upper
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.37%
1/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Gastrointestinal disorders
Diarrhoea
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.72%
1/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.78%
1/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.73%
2/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Gastrointestinal disorders
Toothache
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Gastrointestinal disorders
Hiatus hernia
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Gastrointestinal disorders
Anal haemorrhage
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Gastrointestinal disorders
Anal polyp
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Gastrointestinal disorders
Enterocolitis
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Gastrointestinal disorders
Erosive oesophagitis
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Gastrointestinal disorders
Melaena
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Gastrointestinal disorders
Abdominal discomfort
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.78%
1/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Gastrointestinal disorders
Abdominal pain
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.37%
1/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Gastrointestinal disorders
Dyspepsia
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.37%
1/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
General disorders
Injection site pain
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
1.9%
6/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
3.0%
9/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
3.0%
9/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
4.3%
6/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
6.2%
8/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
6.6%
18/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
General disorders
Injection site movement impairment
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
1.9%
6/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
2.0%
6/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
2.0%
6/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.72%
1/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
3.1%
4/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
4.4%
12/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
General disorders
Injection site erythema
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
2.9%
9/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.99%
3/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
2.0%
6/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
1.4%
2/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
5.5%
7/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
7.3%
20/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
General disorders
Injection site swelling
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
1.9%
6/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
1.3%
4/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.99%
3/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.72%
1/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
7.0%
9/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
7.0%
19/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
General disorders
Pyrexia
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.66%
2/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.66%
2/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.37%
1/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
General disorders
Injection site inflammation
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
General disorders
Injection site joint movement impairment
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
General disorders
Malaise
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
General disorders
Asthenia
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
General disorders
Chest pain
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
General disorders
Injection site induration
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
General disorders
Injection site pruritus
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.72%
1/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
General disorders
Injection site rash
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.37%
1/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Hepatobiliary disorders
Cholecystitis
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Hepatobiliary disorders
Cholelithiasis
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Immune system disorders
Hypersensitivity
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Infections and infestations
Pharyngitis
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.65%
2/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.99%
3/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Infections and infestations
Influenza
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.99%
3/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.78%
1/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Infections and infestations
Nasopharyngitis
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.66%
2/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.66%
2/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.72%
1/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.37%
1/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Infections and infestations
Bronchitis
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
1.3%
4/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.72%
1/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.73%
2/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Infections and infestations
Sinusitis
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.72%
1/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.78%
1/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.37%
1/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Infections and infestations
Rhinitis
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.66%
2/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Infections and infestations
Upper respiratory tract infection
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.99%
3/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.78%
1/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
1.1%
3/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Infections and infestations
Cellulitis
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Infections and infestations
Urinary tract infection
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
1.6%
2/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.37%
1/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Infections and infestations
Herpes simplex
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Infections and infestations
Tinea infection
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Infections and infestations
Tooth abscess
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.37%
1/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Infections and infestations
Herpes zoster
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Infections and infestations
Respiratory tract infection
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Infections and infestations
Parotitis
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Infections and infestations
Viral pharyngitis
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Infections and infestations
Lower respiratory tract infection
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.37%
1/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Infections and infestations
Viral upper respiratory tract infection
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.37%
1/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Injury, poisoning and procedural complications
Arthropod bite
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Injury, poisoning and procedural complications
Injury
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Injury, poisoning and procedural complications
Joint injury
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Injury, poisoning and procedural complications
Joint sprain
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Injury, poisoning and procedural complications
Meniscus lesion
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Injury, poisoning and procedural complications
Muscle strain
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Injury, poisoning and procedural complications
Road traffic accident
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Injury, poisoning and procedural complications
Animal bite
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.37%
1/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Injury, poisoning and procedural complications
Limb injury
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Injury, poisoning and procedural complications
Muscle injury
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Injury, poisoning and procedural complications
Pelvic fracture
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.72%
1/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Injury, poisoning and procedural complications
Skeletal injury
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.72%
1/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Injury, poisoning and procedural complications
Skin laceration
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.78%
1/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Injury, poisoning and procedural complications
Stress fracture
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.72%
1/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Investigations
Body temperature increased
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Metabolism and nutrition disorders
Decreased appetite
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
1.9%
6/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
1.6%
5/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.99%
3/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
1.4%
2/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
1.6%
2/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
1.1%
3/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Metabolism and nutrition disorders
Gout
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Metabolism and nutrition disorders
Hypercholesterolaemia
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.78%
1/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Metabolism and nutrition disorders
Hypokalaemia
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Musculoskeletal and connective tissue disorders
Arthralgia
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
2.6%
8/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
2.3%
7/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
3.0%
9/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
2.2%
3/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.78%
1/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
1.1%
3/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Musculoskeletal and connective tissue disorders
Muscle spasms
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.65%
2/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Musculoskeletal and connective tissue disorders
Osteoarthritis
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.78%
1/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.37%
1/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Musculoskeletal and connective tissue disorders
Joint swelling
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.66%
2/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Musculoskeletal and connective tissue disorders
Arthritis
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.78%
1/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.37%
1/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Musculoskeletal and connective tissue disorders
Back pain
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Musculoskeletal and connective tissue disorders
Monarthritis
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.72%
1/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Musculoskeletal and connective tissue disorders
Tendonitis
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.37%
1/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.37%
1/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Nervous system disorders
Dizziness
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.78%
1/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Nervous system disorders
Migraine
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.78%
1/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Nervous system disorders
Neuralgia
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.37%
1/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Psychiatric disorders
Anxiety
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.72%
1/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Psychiatric disorders
Insomnia
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Renal and urinary disorders
Urinary retention
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Reproductive system and breast disorders
Vaginal haemorrhage
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Respiratory, thoracic and mediastinal disorders
Epistaxis
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Respiratory, thoracic and mediastinal disorders
Cough
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.72%
1/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.78%
1/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.37%
1/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.37%
1/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.37%
1/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Respiratory, thoracic and mediastinal disorders
Dry throat
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.37%
1/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Respiratory, thoracic and mediastinal disorders
Pleurisy
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.78%
1/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Respiratory, thoracic and mediastinal disorders
Sneezing
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.78%
1/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Skin and subcutaneous tissue disorders
Rash
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.66%
2/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.99%
3/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.37%
1/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Skin and subcutaneous tissue disorders
Hyperkeratosis
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Skin and subcutaneous tissue disorders
Lentigo
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Skin and subcutaneous tissue disorders
Rash macular
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Skin and subcutaneous tissue disorders
Erythema
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Skin and subcutaneous tissue disorders
Dermatitis contact
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.73%
2/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Skin and subcutaneous tissue disorders
Rash maculo-papular
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.37%
1/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Skin and subcutaneous tissue disorders
Rash vesicular
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.37%
1/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Vascular disorders
Thrombophlebitis
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.32%
1/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.72%
1/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Vascular disorders
Hypertension
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.33%
1/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
—
0/0 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/308 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/304 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/302 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/139 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.00%
0/128 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
0.37%
1/273 • Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Results disclosure agreements

  • Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
  • Publication restrictions are in place

Restriction type: OTHER