Table 7.
Vaccine group | Subject code | Country | Age at onset, years | Gender | MedDRA Preferred term | Day of onset post-vaccination |
---|---|---|---|---|---|---|
QIV N = 3036 |
461 |
Taiwan |
85 |
M |
Sudden death |
86 |
|
2140 |
Republic of Korea |
85 |
F |
Cardiac failure congestive Myocardial infarction |
131 |
|
3023 |
Germany |
84 |
F |
Death |
62 |
|
4373 |
Romania |
81 |
F |
Cardiopulmonary failure |
87 |
Intestinal infarction |
86 |
|||||
|
6609 |
US |
71 |
M |
Pulmonary hypertension |
162 |
|
7347 |
US |
72 |
F |
Myocardial infarction |
35 |
|
987 |
Republic of Korea |
68 |
F |
Coma hepatic |
95 |
|
5468 |
Spain |
73 |
M |
Cerebrovascular accident |
191 |
|
6594 |
US |
71 |
F |
Small cell lung cancer stage unspecified |
51 |
TIV-Vic N = 1010 |
3735 |
Romania |
86 |
M |
Cardiac arrest |
75 |
Myocardial infarction |
|
|||||
|
4362 |
Romania |
69 |
M |
Cardio-respiratory arrest |
97 |
5518 | Spain | 69 | M | Cardiac disorder | 15 |
SAE serious adverse event, QIV inactivated quadrivalent influenza vaccine, TIV-Vic inactivated trivalent influenza vaccine Victoria lineage B strain, MedDRA Medical Dictionary for Regulatory Activities, F female, M male.