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 (11 ページ)
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Most frequent MedDRA Preferred Terms* in reports to VAERS following primary series
Pfizer-BioNTech vaccination in children ages 6 months–4 years† (as of August 21, 2022)
N=496, clinical outcomes only shown‡
N=496, all reports
Rank
MedDRA PT (not mutually exclusive)
n (%)
Rank
MedDRA PT (not mutually exclusive)
n (%)
1
Incorrect Dose Administered
87 (18)
1
Pyrexia/fever
84 (17)
2
Pyrexia/fever
84 (17)
2
Rash
52 (11)
3
Product Administered to Patient of
Inappropriate Age
55 (11)
3
Vomiting
39 (8)
4
No Adverse Event
54 (11)
4
Fatigue
30 (6)
5
Rash
52 (11)
5
Urticaria
23 (5)
6
Product Preparation Issue
50 (10)
6
COVID-19
19 (4)
7
Vomiting
39 (8)
7
Diarrhoea
19 (4)
8
Wrong Product Administered
34 (7)
8
SARS-CoV-2 Test Positive
18 (4)
9
Fatigue
30 (6)
9
Cough
17 (3)
10
SARS-CoV-2 Test Negative
24 (5)
10
Decreased Appetite
17 (3)
* Medical Dictionary for Regulatory Activities Preferred Terms (https://www.meddra.org/how-to-use/basics/hierarchy)
† Among children ages 6 months–4 years vaccinated during June 18–August 21, 2022; reports received and processed as of August 23, 2022
‡ Determined by subject matter expert review
11
Pfizer-BioNTech vaccination in children ages 6 months–4 years† (as of August 21, 2022)
N=496, clinical outcomes only shown‡
N=496, all reports
Rank
MedDRA PT (not mutually exclusive)
n (%)
Rank
MedDRA PT (not mutually exclusive)
n (%)
1
Incorrect Dose Administered
87 (18)
1
Pyrexia/fever
84 (17)
2
Pyrexia/fever
84 (17)
2
Rash
52 (11)
3
Product Administered to Patient of
Inappropriate Age
55 (11)
3
Vomiting
39 (8)
4
No Adverse Event
54 (11)
4
Fatigue
30 (6)
5
Rash
52 (11)
5
Urticaria
23 (5)
6
Product Preparation Issue
50 (10)
6
COVID-19
19 (4)
7
Vomiting
39 (8)
7
Diarrhoea
19 (4)
8
Wrong Product Administered
34 (7)
8
SARS-CoV-2 Test Positive
18 (4)
9
Fatigue
30 (6)
9
Cough
17 (3)
10
SARS-CoV-2 Test Negative
24 (5)
10
Decreased Appetite
17 (3)
* Medical Dictionary for Regulatory Activities Preferred Terms (https://www.meddra.org/how-to-use/basics/hierarchy)
† Among children ages 6 months–4 years vaccinated during June 18–August 21, 2022; reports received and processed as of August 23, 2022
‡ Determined by subject matter expert review
11