Table 10.6-2. Adverse events with administration of elasomeran, stratified by age of clinical trial participants

Adverse events within 7 days of administration; study participants aged 18-64 years

Adverse event reported

Dose 1 (%)

Dose 2 (%)

Local erythema

3.0

8.9

Local swelling

6.7

12.6

Pain at injection site

86.9

89.9

Axillary tenderness/swelling

11.6

16.2

Fatigue

38.4

67.6

Headache

35.3

62.8

Chills

9.2

48.6

Nausea/vomiting

9.4

21.4

Fever

0.9

17.4

Myalgia

23.7

61.6

Arthralgia

16.6

45.5

Adverse events within 7 days of administration; study participants aged ≥65 years

Adverse event reported

Dose 1 (%)

Dose 2 (%)

Local erythema

2.3

7.5

Local swelling

4.4

10.8

Pain at injection site

74.0

83.2

Axillary tenderness/swelling

6.1

8.5

Fatigue

33.3

58.3

Headache

24.5

46.2

Chills

5.4

30.9

Nausea/vomiting

5.2

11.8

Fever

0.3

10.0

Myalgia

19.7

47.1

Arthralgia

16.4

35.0

Adapted from N Engl J Med. 2020 Dec 30. doi: 10.1056/NEJMoa2035389 and Product Monograph: Moderna COVID-19 Vaccine, mRNA-1273 SARS-CoV-2 vaccine.