Table 2.

Short-term AEFI reported by AusVaxSafety participants following live attenuated herpes zoster vaccine live (ZVL) by sex and concomitant vaccination

	Males n (%)	Females n (%)	RR (95% CI) (female vs male)	ZVL alone n (%)	ZVL+concomitant vaccine/s n (%)	RR (95% CI) (concomitant vs ZVL alone)
Any AEFI *	426 (5.2)	993 (10.7)	2.07 (1.86 to 2.31)	1082 (8.0%)	337 (8.4%)	1.05 (0.93 to 1.18)
Injection site reaction †	86 (1.1)	291 (3.4)	3.12 (2.45 to 3.96)	304 (2.4%)	73 (1.9%)	0.81 (0.63 to 1.05)
Fever †	23 (0.3)	60 (0.7)	2.40 (1.49 to 3.88)	56 (0.4%)	27 (0.7%)	1.63 (1.03 to 2.58)
Rash †	12 (0.2)	54 (0.6)	4.14 (2.22 to 7.74)	59 (0.5%)	7 (0.2%)	0.40 (0.18 to 0.88)
Medical attendance ‡	16 (0.2)	33 (0.4)	1.85 (1.02 to 3.35)	38 (0.3%)	11 (0.3%)	0.98 (0.50 to 1.91)

*Denominator includes SmartVax participants responding to an opt-out SMS within 7 days of vaccination (M=8214, F=9241, total: 17 458, sex missing in 3). ZVL alone was received by 13 465 participants and concomitant vaccine/s by 3993 participants.

†Denominator includes SmartVax participants who reported any AEFI within 7 days of vaccination and then also responded to a survey within 7 days of vaccination, and SmartVax participants who reported no AEFI within 7 days of vaccination (M: 7932, F: 8614, total: 16 549, sex missing in n=3). In this subset, ZVL alone was received by 12 778 participants and concomitant vaccines were received by 3771 participants.

‡Denominator includes SmartVax participants who reported any AEFI within 7 days of vaccination and then also provided medical attendance information within 7 days via SMS and/or the online survey, and SmartVax participants who or reported no AEFI within 7 days of vaccination (M=8107, F=9055, Total: 17 165, sex missing in 3). In this subset, ZVL alone was received by 13 246 participants and concomitant vaccines were received by 3919 participants.

AEFI, adverse events following immunisation; SMS, short message service.