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 (17 ページ)
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| 公開元URL | https://www.mhlw.go.jp/stf/newpage_24331.html |
| 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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（モデルナ筋注）
米国添付文書（2021 年 11 月）
英国添付文書（2021 年 8 月）
欧州添付文書（2021 年 11 月）
5 WARNINGS AND PRECAUTIONS
4.4 Special warnings and precautions for
4.4 Special warnings and precautions for
5.2 Myocarditis and Pericarditis
use
use
Postmarketing data demonstrate increased
Myocarditis and pericarditis
Myocarditis and pericarditis
risks of myocarditis and pericarditis,
There have been very rare reports of
Very rare cases of myocarditis and pericarditis
particularly within 7 days following the
myocarditis and pericarditis occurring after
have been observed following vaccination
second dose. The observed risk is higher
vaccination with Spikevax, often in younger
with Spikevax. These cases have primarily
among males under 40 years of age than
men and shortly after the second dose of the
occurred within 14 days following
among females and older males. The observed
vaccine. These are typically mild cases and
vaccination, more often after the second
risk is highest in males 18 through 24 years of
individuals tend to recover within a short time
vaccination, and more often in younger men.
age. Although some cases required intensive
following standard treatment and rest.
Available data suggest that the course of
care support, available data from short-term
Healthcare professionals should be alert to the
myocarditis and pericarditis following
follow-up suggest that most individuals have
signs and symptoms of myocarditis and
vaccination is not different from myocarditis
had resolution of symptoms with conservative
pericarditis. Vaccinated individuals should
or pericarditis in general.
management. Information is not yet available
also seek immediate medical attention should
Healthcare professionals should be alert to the
about potential long-term sequelae.
they experience new onset of chest pain,
signs and symptoms of myocarditis and
Some, but not all, observational analyses of
shortness of breath, palpitations or
pericarditis.
postmarketing data suggest that there may be
arrhythmias.
Vaccinees should be instructed to seek
an increased risk of myocarditis and
immediate medical attention if they develop
pericarditis in males under 40 years of age
symptoms indicative of myocarditis or
following the second dose of the Moderna
pericarditis such as (acute and persisting) chest
COVID-19 Vaccine relative to other
17
米国添付文書（2021 年 11 月）
英国添付文書（2021 年 8 月）
欧州添付文書（2021 年 11 月）
5 WARNINGS AND PRECAUTIONS
4.4 Special warnings and precautions for
4.4 Special warnings and precautions for
5.2 Myocarditis and Pericarditis
use
use
Postmarketing data demonstrate increased
Myocarditis and pericarditis
Myocarditis and pericarditis
risks of myocarditis and pericarditis,
There have been very rare reports of
Very rare cases of myocarditis and pericarditis
particularly within 7 days following the
myocarditis and pericarditis occurring after
have been observed following vaccination
second dose. The observed risk is higher
vaccination with Spikevax, often in younger
with Spikevax. These cases have primarily
among males under 40 years of age than
men and shortly after the second dose of the
occurred within 14 days following
among females and older males. The observed
vaccine. These are typically mild cases and
vaccination, more often after the second
risk is highest in males 18 through 24 years of
individuals tend to recover within a short time
vaccination, and more often in younger men.
age. Although some cases required intensive
following standard treatment and rest.
Available data suggest that the course of
care support, available data from short-term
Healthcare professionals should be alert to the
myocarditis and pericarditis following
follow-up suggest that most individuals have
signs and symptoms of myocarditis and
vaccination is not different from myocarditis
had resolution of symptoms with conservative
pericarditis. Vaccinated individuals should
or pericarditis in general.
management. Information is not yet available
also seek immediate medical attention should
Healthcare professionals should be alert to the
about potential long-term sequelae.
they experience new onset of chest pain,
signs and symptoms of myocarditis and
Some, but not all, observational analyses of
shortness of breath, palpitations or
pericarditis.
postmarketing data suggest that there may be
arrhythmias.
Vaccinees should be instructed to seek
an increased risk of myocarditis and
immediate medical attention if they develop
pericarditis in males under 40 years of age
symptoms indicative of myocarditis or
following the second dose of the Moderna
pericarditis such as (acute and persisting) chest
COVID-19 Vaccine relative to other
17