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Table 7 Description of fatal SAEs in the total vaccinated cohort

From: Immunogenicity, reactogenicity and safety of an inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine: a phase III, randomized trial in adults aged ≥18 years

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
  1. 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.
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