Table 2.

Top 50 prevalent adverse events screened from the US data, and comparisons between the US and European data.

Adverse events	US FLU3a reports, 1990-2017					European flu vaccine reports, 2003-2016					US vs Europe, P value, total
	Total (‰)	GBSb (‰)	Non-GBS (‰)	P value	Total (‰)		GBS (‰)	Non-GBS (‰)	P value
Pyrexia	138.85	58.23	139.88	<.001	140.86		79.44	141.93	.01	.55
Injection-site erythema	126.36	2.01	127.94	<.001	15.53		0	15.80	.06	<.001
Pain	125.40	113.45	125.55	.25	29.77		112.15	28.34	<.001	<.001
Injection-site pain	119.16	7.03	120.58	<.001	30.97		4.67	31.43	.03	<.001
Erythema	89.69	3.01	90.79	<.001	23.37		4.67	23.70	.07	<.001
Pain in extremity	86.79	73.29	86.97	.13	46.74		177.57	44.46	<.001	<.001
Injection-site swelling	86.07	3.01	87.13	<.001	12.48		0	12.70	.10	<.001
Headache	77.52	61.24	77.73	.05	103.16		88.79	103.41	.49	<.001
Pruritus	71.33	2.01	72.22	<.001	23.53		18.69	23.61	.64	<.001
Chills	68.46	22.09	69.06	<.001	37.21		32.71	37.29	.73	<.001
Dizziness	63.45	32.13	63.85	<.001	60.02		65.42	59.93	.74	.14
Nausea	62.70	25.10	63.18	<.001	55.14		23.36	55.70	.04	.001
Urticaria	60.75	2.01	61.49	<.001	27.85		0	28.34	.01	<.001
Rash	59.50	10.04	60.13	<.001	26.57		9.35	26.87	.11	<.001
Injection-site warmth	55.91	< 0.01	56.62	<.001	4.08		0	4.15	.34	<.001
Dyspnea	50.67	57.23	50.58	.34	47.94		70.09	47.55	.13	.19
Myalgia	49.52	49.20	49.52	.96	66.43		56.07	66.61	.54	<.001
Vomiting	45.60	26.10	45.85	.003	42.26		37.38	42.34	.72	.09
Asthenia	44.78	296.18	41.58	<.001	39.62		121.50	38.19	<.001	.01
Fatigue	37.96	59.24	37.69	<.001	72.91		135.51	71.82	<.001	<.001
Paresthesia	37.57	332.33	33.81	<.001	43.06		345.79	37.78	<.001	.003
Cough	37.16	32.13	37.23	.40	38.02		23.36	38.27	.26	.64
Edema, peripheral	35.20	9.04	35.54	<.001	5.52		4.67	5.54	.87	<.001
Malaise	32.22	27.11	32.29	.36	55.62		56.07	55.61	.98	<.001
Skin, warm	31.34	1.00	31.73	<.001	1.92		0	1.95	.52	<.001
Hypesthesia	31.31	289.16	28.03	<.001	26.65		285.05	22.15	<.001	.005
Swelling	30.76	3.01	31.11	<.001	5.28		0	5.37	.28	<.001
Arthralgia	28.59	19.08	28.71	.07	39.06		37.38	39.08	.90	<.001
Injection-site edema	28.09	1.00	28.44	<.001	2.40		0	2.44	.47	<.001
Injection-site hypersensitivity	26.38	2.01	26.69	<.001	0.24		0	0.24	.82	<.001
Diarrhea	24.30	24.10	24.31	.97	27.29		42.06	27.03	.18	.05
Hyperhidrosis	23.08	7.03	23.28	<.001	18.65		9.35	18.81	.31	.002
Tremor	21.82	14.06	21.91	.09	9.68		32.71	9.28	<.001	<.001
Injection-site pruritus	21.26	< 0.01	21.53	<.001	3.60		0	3.66	.38	<.001
Injected-limb mobility decreased	20.78	2.01	21.02	<.001	2.96		0	3.01	.42	<.001
Feeling hot	19.88	< 0.01	20.14	<.001	10.40		9.35	10.42	.88	<.001
Injection-site reaction	19.39	1.00	19.62	<.001	8.48		0	8.63	.17	<.001
Musculoskeletal pain	18.91	12.05	19.00	.11	11.20		46.73	10.59	<.001	<.001
Injection-site induration	18.86	< 0.01	19.10	<.001	4.16		0	4.23	.34	<.001
Cellulitis	18.63	1.00	18.86	<.001	2.16		0	2.20	.49	<.001
Muscular weakness	17.75	230.92	15.03	<.001	25.13		266.36	20.93	<.001	<.001
Vasodilatation	17.61	2.01	17.81	<.001	0.32		0	0.33	.79	<.001
Neck pain	17.51	16.06	17.53	.73	7.20		4.67	7.25	.66	<.001
Mobility decreased	16.32	24.10	16.22	.05	3.92		14.02	3.75	.02	<.001
Immediate postinjection reaction	16.28	3.01	16.45	<.001	0		0	0	—c	—
Chest pain	16.21	18.07	16.18	.64	13.93		14.02	13.92	.99	.06
Rash, erythematous	15.61	2.01	15.79	<.001	4.88		0	4.97	.30	<.001
Injection-site rash	15.45	1.00	15.63	<.001	1.36		0	1.38	.59	<.001
Syncope	15.42	8.03	15.52	.06	29.21		4.67	29.64	.03	<.001
Tenderness	15.40	3.01	15.56	.001	1.20		4.67	1.14	.14	<.001

^aFLU3: trivalent influenza vaccine.

^bGBS: Guillain-Barré syndrome.

^cNot available.