よむ、つかう、まなぶ。
資料１－３ ワクチンの安全性に関する評価について (15 ページ)
出典
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| 出典情報 | 薬事・食品衛生審議会 薬事分科会医薬品等安全対策部会（令和3年度 第3回 3／11）《厚生労働省》 |
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(https://www.cdc.gov/vaccines/covid-
pericarditis such as (acute and persisting) chest pericarditis such as (acute and persisting) chest
19/clinical-considerations/myocarditis.html).
pain, shortness of breath, or palpitations
pain, shortness of breath, or palpitations
following vaccination.
following vaccination.
Healthcare professionals should consult
Healthcare professionals should consult
guidance and/or specialists to diagnose and
guidance and/or specialists to diagnose and
treat this condition.
treat this condition.
The risk of myocarditis after a third dose of
The risk of myocarditis after a third dose of
Comirnaty has not yet been characterised.
Comirnaty has not yet been characterised.
6 OVERALL SAFETY SUMMARY
4.8 Undesirable effects
4.8 Undesirable effects
Myocarditis and pericarditis have been
Table 1
Tabulated list of adverse reactions from
reported following administration of the
Comirnaty clinical trials and post-
clinical studies and post-authorisation
Pfizer-BioNTech COVID-19 Vaccine.
authorisation
experience in individuals 12 years of age and
experience in individuals 12 years of age
older
6.2 Post Authorization Experience
and older
Cardiac disorders
The following adverse reactions have been
Cardiac disorders
Not known (cannot be estimated from the
identified during post authorization use of
Not known (cannot be estimated from the
available data): Myocarditisd; Pericarditisd
Pfizer-BioNTech COVID-19 Vaccine.
available data): Myocarditisd, Pericarditisd
d. Adverse reaction determined post-authorisation.
Because these reactions are reported
d. Adverse reaction determined post-authorisation.
Adverse reactions from
voluntarily, it is not always possible to reliably
estimate their frequency or establish a causal
relationship to vaccine exposure.
15
pericarditis such as (acute and persisting) chest pericarditis such as (acute and persisting) chest
19/clinical-considerations/myocarditis.html).
pain, shortness of breath, or palpitations
pain, shortness of breath, or palpitations
following vaccination.
following vaccination.
Healthcare professionals should consult
Healthcare professionals should consult
guidance and/or specialists to diagnose and
guidance and/or specialists to diagnose and
treat this condition.
treat this condition.
The risk of myocarditis after a third dose of
The risk of myocarditis after a third dose of
Comirnaty has not yet been characterised.
Comirnaty has not yet been characterised.
6 OVERALL SAFETY SUMMARY
4.8 Undesirable effects
4.8 Undesirable effects
Myocarditis and pericarditis have been
Table 1
Tabulated list of adverse reactions from
reported following administration of the
Comirnaty clinical trials and post-
clinical studies and post-authorisation
Pfizer-BioNTech COVID-19 Vaccine.
authorisation
experience in individuals 12 years of age and
experience in individuals 12 years of age
older
6.2 Post Authorization Experience
and older
Cardiac disorders
The following adverse reactions have been
Cardiac disorders
Not known (cannot be estimated from the
identified during post authorization use of
Not known (cannot be estimated from the
available data): Myocarditisd; Pericarditisd
Pfizer-BioNTech COVID-19 Vaccine.
available data): Myocarditisd, Pericarditisd
d. Adverse reaction determined post-authorisation.
Because these reactions are reported
d. Adverse reaction determined post-authorisation.
Adverse reactions from
voluntarily, it is not always possible to reliably
estimate their frequency or establish a causal
relationship to vaccine exposure.
15