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 (12 ページ)
出典
| 公開元URL | https://www.mhlw.go.jp/stf/shingi2/0000208910_00052.html |
| 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 primary
series Moderna vaccination in children ages 6 months–5 years† (as of August 21, 2022)
N=521, clinical outcomes only shown‡
N=521, all reports
Rank
MedDRA PT (not mutually exclusive)
n (%)
Rank
MedDRA PT (not mutually exclusive)
n (%)
1
Pyrexia/Fever
115 (22)
1
Pyrexia/Fever
115 (22)
2
Rash
45 (9)
2
Rash
45 (9)
3
Vomiting
45 (9)
3
Vomiting
45 (9)
4
Urticaria
43 (8)
4
Urticaria
43 (8)
5
No Adverse Event
42 (8)
5
Cough
35 (7)
6
Expired Product Administered
36 (7)
6
Irritability
33 (6)
7
Cough
35 (7)
7
Fatigue
31 (6)
8
Incorrect Dose Administered
35 (7)
8
Decreased Appetite
30 (6)
9
SARS-CoV-2 Test Negative
35 (7)
9
Rash Erythematous
28 (5)
10
Irritability
33 (6)
10
Diarrhoea
27 (5)
* Medical Dictionary for Regulatory Activities Preferred Terms (https://www.meddra.org/how-to-use/basics/hierarchy)
† Among children ages 6 months–5 years vaccinated during June 18–August 21, 2022; reports received and processed as of August 23, 2022
‡ Determined by subject matter expert review
12
series Moderna vaccination in children ages 6 months–5 years† (as of August 21, 2022)
N=521, clinical outcomes only shown‡
N=521, all reports
Rank
MedDRA PT (not mutually exclusive)
n (%)
Rank
MedDRA PT (not mutually exclusive)
n (%)
1
Pyrexia/Fever
115 (22)
1
Pyrexia/Fever
115 (22)
2
Rash
45 (9)
2
Rash
45 (9)
3
Vomiting
45 (9)
3
Vomiting
45 (9)
4
Urticaria
43 (8)
4
Urticaria
43 (8)
5
No Adverse Event
42 (8)
5
Cough
35 (7)
6
Expired Product Administered
36 (7)
6
Irritability
33 (6)
7
Cough
35 (7)
7
Fatigue
31 (6)
8
Incorrect Dose Administered
35 (7)
8
Decreased Appetite
30 (6)
9
SARS-CoV-2 Test Negative
35 (7)
9
Rash Erythematous
28 (5)
10
Irritability
33 (6)
10
Diarrhoea
27 (5)
* Medical Dictionary for Regulatory Activities Preferred Terms (https://www.meddra.org/how-to-use/basics/hierarchy)
† Among children ages 6 months–5 years vaccinated during June 18–August 21, 2022; reports received and processed as of August 23, 2022
‡ Determined by subject matter expert review
12