Table 10.6-1. Adverse events with administration of tozinameran, stratified by age of clinical trial participants

Adverse events within 7 days of administration; study participants aged 18-55 years

Adverse event reported

Dose 1 (%)

Dose 2 (%)

Local erythema

4.5

5.9

Local swelling

5.8

6.3

Pain at injection site

83.1

77.8

Temperature ≥38°C

3.7

15.8

Fatigue

47.4

59.4

Headache

41.9

51.7

Chills

14.0

35.1

Vomiting

1.2

1.9

Diarrhea

11.1

10.4

New or worsened myalgia

21.3

37.3

New or worsened arthralgia

11.0

21.9

Adverse events within 7 days of administration; study participants aged ≥56 years

Adverse event reported

Dose 1 (%)

Dose 2 (%)

Local erythema

4.7

7.2

Local swelling

6.5

7.5

Pain at injection site

71.1

66.1

Temperature ≥38°C

1.4

10.9

Fatigue

34.1

50.5

Headache

25.2

39.0

Chills

6.3

22.7

Vomiting

0.5

0.7

Diarrhea

8.2

8.3

New or worsened myalgia

13.9

28.7

New or worsened arthralgia

8.6

18.9

Adapted from N Engl J Med. 2020 Dec 10. doi: 10.1056/NEJMoa2034577 and the Pfizer-BioNTech COVID-19 Vaccine [COVID-19 mRNA Vaccine] Product Monograph.