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Table 2 Comparison of reporting rates of suspected ADRs between NH influenza Season 2019/20 and NH influenza Season 2020/21

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

 

NH Influenza Season 2019/2020a

NH Influenza Season 2020/2021

 

 ≤ 7 days

Total

 ≤ 7 days

Totalb

Total number of VCs distributed

 

939

 

1008

Overall ADRs

 Total number of vaccinees who reported at least one suspected ADR

38

56

28

29

 Vaccinees reporting rate, % (95% CI)

4.05 (2.79, 5.31)

5.96 (4.45, 7.48)

2.78 (1.85, 3.99)

2.88 (1.94, 4.11)

 Total number of suspected ADRs

117

163

79

82

 ADR reporting rate,% (95% CI)

12.46 (10.41, 14.74)

17.36 (14.99, 19.94)

7.84 (6.25, 9.67)

8.13 (6.52, 10.00)

PRAC ADRs of interest

 Total number of vaccinees who reported at least one PRAC ADRs of interest

36

56

27

28

 Vaccinees reporting rate, % (95% CI)

3.83 (2.61, 5.06)

5.96 (4.45, 7.48)

2.68 (1.77, 3.87)

2.78 (1.85, 3.99)

 Total number of PRAC ADRs of interest

77

112

72

74

 PRAC ADRs of interest reporting rate,% (95% CI)

8.20 (6.53, 10.14)

11.93 (9.92, 14.17)

7.14 (5.63, 8.91)

7.34 (5.81, 9.13)

  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)
  2. aData obtained from EPSS conducted during the NH 2019/20 flu season [12]
  3. bIncludes unknown time to onset