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

Table 7 Description of fatal SAEs in the total vaccinated cohort

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
	4373	Romania	81	F	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
TIV-Vic N = 1010	3735	Romania	86	M	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.

ISSN: 1471-2334