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Table 3 Vaccinee reporting rate by PRAC adverse drug reactions occurring within 7 days after vaccination

From: Enhanced passive safety surveillance of a quadrivalent inactivated split virion influenza vaccine in Finland during the influenza season 2020/21

 

Total number of VCs distributed N = 1008

n

(%) (95% CI)

PRAC ADRs of interest

72

7.14 (5.63, 8.91)

Injection site reactions

45

2.18 (1.37, 3.29)

 Vaccination site pain

19

1.88 (1.14, 2.93)

 Vaccination site erythema

15

1.49 (0.84, 2.44)

 Vaccination site swelling

11

1.09 (0.55, 1.94)

Myalgia

9

0.89 (0.41, 1.69

Headache

7

0.69 (0.28, 1.43)

Fever

3

0.30 (0.06, 0.87)

Nausea

3

0.30 (0.06, 0.87)

Arthralgia

2

0.20 (0.02, 0.71)

Malaise

2

0.20 (0.02, 0.71)

Allergic and hypersensitivity reactions

1

0.10 (0.00, 0.55)

  1. ADR, adverse drug reaction; CI, confidence interval; PRAC, Pharmacovigilance Risk Assessment Committee (PRAC ADRs of interest were ADRs recognized as being of particular interest by the Pharmacovigilance Risk Assessment Committee); VC, vaccination card