よむ、つかう、まなぶ。
参考資料15 COVID-19 vaccine safety update; Primary series in young children and booster doses in older children and adults, ACIP September 1, 2022 (21 ページ)
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| 出典情報 | 第85回厚生科学審議会予防接種・ワクチン分科会副反応検討部会、令和４年度第14回薬事・食品衛生審議会薬事分科会医薬品等安全対策部会安全対策調査会（合同開催）（10／7）《厚生労働省》 |
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Most frequent MedDRA Preferred Terms* in reports to VAERS following 1st booster dose
mRNA COVID-19 vaccinations, ages 5–11 years† (as of August 21, 2022)
N=727, all reports
N=727, clinical outcomes only shown‡
Rank
MedDRA PT (not mutually exclusive)
n (%)
Rank
MedDRA PT (not mutually exclusive)
n (%)
1
Product Preparation Issue
197 (27)
1
Pyrexia/Fever
51 (7)
2
Incorrect Dose Administered
164 (23)
2
Pain In Extremity
40 (6)
3
No Adverse Event
139 (19)
3
Fatigue
37 (5)
4
Product Preparation Error
69 (9)
4
Vomiting
27 (4)
5
Product Administered To Patient Of
Inappropriate Age
67 (9)
5
Dizziness
24 (3)
6
Expired Product Administered
53 (7)
6
Headache
23 (3)
7
Pyrexia/Fever
51 (7)
7
Injection Site Pain
23 (3)
8
Pain In Extremity
40 (6)
8
Pain
21 (3)
9
Fatigue
37 (5)
9
Chills
18 (2)
10
Vomiting
27 (4)
10
Lymphadenopathy
18 (2)
* Medical Dictionary for Regulatory Activities Preferred Terms (https://www.meddra.org/how-to-use/basics/hierarchy)
† Among children ages 5–11 years receiving Pfizer-BioNTech dose 3 during May 17–August 21, 2022; reports received and processed as of August 23, 2022
‡ Determined by subject matter expert review
21
mRNA COVID-19 vaccinations, ages 5–11 years† (as of August 21, 2022)
N=727, all reports
N=727, clinical outcomes only shown‡
Rank
MedDRA PT (not mutually exclusive)
n (%)
Rank
MedDRA PT (not mutually exclusive)
n (%)
1
Product Preparation Issue
197 (27)
1
Pyrexia/Fever
51 (7)
2
Incorrect Dose Administered
164 (23)
2
Pain In Extremity
40 (6)
3
No Adverse Event
139 (19)
3
Fatigue
37 (5)
4
Product Preparation Error
69 (9)
4
Vomiting
27 (4)
5
Product Administered To Patient Of
Inappropriate Age
67 (9)
5
Dizziness
24 (3)
6
Expired Product Administered
53 (7)
6
Headache
23 (3)
7
Pyrexia/Fever
51 (7)
7
Injection Site Pain
23 (3)
8
Pain In Extremity
40 (6)
8
Pain
21 (3)
9
Fatigue
37 (5)
9
Chills
18 (2)
10
Vomiting
27 (4)
10
Lymphadenopathy
18 (2)
* Medical Dictionary for Regulatory Activities Preferred Terms (https://www.meddra.org/how-to-use/basics/hierarchy)
† Among children ages 5–11 years receiving Pfizer-BioNTech dose 3 during May 17–August 21, 2022; reports received and processed as of August 23, 2022
‡ Determined by subject matter expert review
21