Table 2.

Multivariable logistic regression analysis investigating the risk factors associated with increased likelihood of Grade 3 (severe) or Grade 4 (medically urgent) adverse reactions after immunisation with the first and second dose of Sputnik V (n = 6190) - Republic of San Marino (2021).

Baseline characteristic	Dose 1			Dose 2
	OR	P-value	95% CI	OR	P-value	95% CI
Grade 3–4 reactions
Female sex (ref.: male)	6·14	<0·001	3·38–11·14	1·68	<0·001	1·49–1·89
Age, y	0·98	0·001	0·97–0·99	0·95	<0·001	0·95–0·96
Food allergy (ref.: no)	3·87	<0·001	1·99–7·52	1·61	0·05	1·01–2·59
Grade 3–4 systemic reactions
Female sex (ref.: male)	7·47	<0·001	3·38–16·50	1·55	<0·001	1·37–1·75
Age, y	0·98	0·01	0·97–1·00	0·96	<0·001	0·96–0·96
Food allergy (ref.: no)	2·75	0·03	1·10–6·88	1·87	0·01	1·19–2·94
Grade 3–4 local reactions
Female sex (ref.: male)	5·92	0·04	1·06–33·05	1·70	<0·001	1·51–1·91
Age, y	0·99	0·18	0·97–1·01	0·97	<0·001	0·96–0·97
Food allergy (ref.: no)	9·18	0·001	2·40–35·08	0·78	0·17	0·55–1·11

Notes: Covariates to include in the model were chosen using an iterative procedure described in the Methods section.

OR, odds ratio; CI, confidence interval.