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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 (22 ページ)

公開元URL https://www.mhlw.go.jp/stf/shingi2/0000208910_00052.html
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Most frequent MedDRA Preferred Terms* in reports to VAERS following 1st booster dose
mRNA COVID-19 vaccinations, ages ≥12 years† (as of August 21, 2022)
N=57,048, non-serious reports (clinical outcomes)

N=7,217, serious reports (clinical outcomes)

Rank

Adverse event (not mutually exclusive)

n (%)

Rank

Adverse event (not mutually exclusive)

n (%)

1

Headache

7,006 (12)

1

COVID-19

2,479 (34)

2

Pyrexia/Fever

6,804 (12)

2

SARS-CoV-2 Test Positive

2,017 (28)

3

Pain

6,702 (12)

3

Dyspnoea

1,223 (17)

4

Fatigue

6,542 (11)

4

Death

794 (11)

5

Chills

5,310 (9)

5

Asthenia

730 (10)

6

COVID-19

4,957 (9)

6

Pyrexia/Fever

651 (9)

7

Pain In Extremity

4,272 (7)

7

Fatigue

646 (9)

8

Nausea

3,548 (6)

8

Vaccine Breakthrough Infection

618 (9)

9

Dizziness

3,353 (6)

9

Condition Aggravated

615 (9)

10

Urticaria

3,240 (6)

10

Chest Pain

578 (8)

* Medical Dictionary for Regulatory Activities Preferred Terms (https://www.meddra.org/how-to-use/basics/hierarchy)


Among persons receiving Pfizer-BioNTech dose 3: children and adolescents ages 12–15 years vaccinated during January 3–August 21, 2022, and ages 16–17 years vaccinated during
December 9, 2021–August 21, 2022; adults ages ≥18 years vaccinated during September 22, 2021–August 21, 2022. Among persons receiving Moderna dose 3: adults ages ≥18 years
vaccinated during October 20, 2021–August 21, 2022.

22