Table 6

Adverse events of the BNT162b2 vaccine in patients with AIIRD and controls

Adverse event	After the first vaccine dose				After the second vaccine dose
Adverse event	Controls n=121		AIIRD n=673		Controls n=121		AIIRD n=670
Local reactions, n (%)
Pain	69 (57.02)		377 (56.02)		51 (42.5)		314 (46.87)
Erythema	4 (3.31)		12 (1.78)		6 (5)		10 (1.49)*
Swelling	6 (4.69)		18 (2.68)		6 (5)		15 (2.24)
Pruritus	3 (2.48)		8 (1.19)		2 (1.67)		4 (0.6)
Tingling	7 (5.79)		3 (0.45)**		1 (0.83)		0
Systemic reactions, n (%)
Fever ≥38.0°C	1 (0.83)		8 (1.19)		6 (4.96)		35 (5.24)
Nausea	0		7 (1.04)		2 (1.67)		14 (2.09)
Vomiting	1 (0.83)		3 (0.45)		0		1 (0.15)
Rhinorrhea	3 (2.48)		0 *		0		1 (0.15)
Cough	1 (0.83)		2 (0.3)		0		1 (0.15)
Myalgia	5 (4.13)		25 (3.71)		21 (17.36)		63 (9.4)*
Arthralgia	1 (0.83)		23 (3.42)		6 (4.96)		49 (7.32)
Chills	2 (1.65)		13 (1.93)		21 (17.36)		60 (8.96)*
Malaise	1 (0.83)		13 (1.93)		21 (17.36)		53 (7.91)*
Headache	7 (5.97)		47 (6.98)		18 (14.88)		85 (12.69)
Allergic reaction	0		0		0		1 (0.15)
Lethargy	6 (4.96)		36 (5.35)		10 (8.26)		90 (13.49)
Worsening of rheumatological symptoms	NA		17 (2.53)		NA		12 (1.79)
Other symptoms, n	Dizziness	2	Throat pain	5	Weakness	3	Weakness	28
	Numbness	1	Arm numbness	5	Dizziness	1	Dizziness	11
	Throat pain	1	Dizziness	4	Numbness	3	Throat pain	6
	Chest pain	1	Weakness	4	Facial pain	1	Excessive sweating	3
			Rash	2	Chest pain	2	Pericarditis	1
			Flu-like	2			Chest pain	1
			Diarrhoea	2			Local lymphadenopathy	2
			Pruritus	2			Vaginal bleeding	2
			Palpitations	2			Lack of appetite	2
			Uveitis	1			Diarrhoea	2
			Herpes Labialis	1			High blood pressure	2
			Other	3			Herpes zoster	6
							Uveitis	2
							Other	7
Death	0		0		0		2 (0.3)