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. 2013 Jul 24;13:343. doi: 10.1186/1471-2334-13-343

Table 6.

Overview of unsolicited AEs and MAEs in the total vaccinated cohort

 
QIV
TIV-Vic
TIV-Yam
  N = 3036 N = 1010 N = 610
Adverse events Day 0–20, n (%)
 
 
 
  Subjects with ≥ 1 event
379 (12.5)
138 (13.7)
92 (15.1)
  Subjects with ≥ 1 Grade 3 event
39 (1.3)
7 (0.7)
2 (0.3)
  Subjects with ≥ 1 event related to vaccination
64 (2.1)
26 (2.6)
14 (2.3)
  No. of events by MedDRA preferred term
558
195
125
  No. of Grade 3 events by MedDRA preferred term
52
8
2
  No. of events by MedDRA preferred term related to vaccination
89
38
16
Medically-attended adverse events Day 0–20, n (%)
 
 
 
  Subjects with ≥ 1 event
193 (6.4)
60 (5.9)
47 (7.7)
  No. of events by MedDRA preferred term
250
75
63
Medically-attended adverse events Day 0–180, n (%)
 
 
 
  Subjects with ≥ 1 event
688 (22.7)
216 (21.4)
NA*
  No. of events by MedDRA preferred term 1151 379 NA*

AE adverse event, MAE medically-attended adverse event, QIV inactivated quadrivalent influenza vaccine, TIV-Vic inactivated trivalent influenza vaccine Victoria lineage B strain, TIV-Yam inactivated trivalent influenza vaccine Yamagata lineage B strain, MedDRA Medical Dictionary for Regulatory Activities, NA not applicable, Based on investigator’s assessment of causality; *TIV-YAM group was followed up until Day 21.