Table 1.

Vaccine-related risk estimates (R) of serious outcomes per 100,000 exposed individuals, relative risk estimates (RR) and 99% confidence intervals (CI) in EudraVigilance and VAERS databases.

		EudraVigilance				VAERS
		Exposed	Cases	R	RR 99% CI	Exposed	Cases	R	RR 99% CI
Death cases
Agea, b	18–64 Years	183,061,142	3,759	2.053	Ref.	15,2704,862	1,781	1.166	Ref.
	More than 65 Years	63,473,405	11,209	17.659	8.60 [8.19–9.03]	52,777,199	5,297	10.037	8.61 [8.02–9.23]
Sex	Female	123267273.5	7,202	5.843	Ref.	102,741,030	3,029	2.948	Ref.
	Male	123267273.5	8,330	6.758	1.16 [1.11–1.21]	10,2741,030	3,970	3.864	1.31 [1.23–1.39]
COVID vaccine	Astra	34,643,783	3,574	10.316	2.09 [1.88–2.32]
	Janssen	14,723,578	727	4.938	Ref.	17,509,539	636	3.632	Ref.
	Moderna	24957523	3680	14.745	2.99 [2.69–3.32]	80561024	3238	4.019	1.11 [0.99–1.24]
	Pfizer	172,209,328	7,929	4.604	0.93 [0.84–1.03]	107,411,499	3204	2.983	0.82 [0.73–0.92]
All COVID vaccines		246,534,547	15,910	6.453	42.53 [33.49–54.01]	205,482,061	7,078	3.445	345.42 [224.61–531.20]
Influenza vaccines		7.71e+07	117	0.152	Ref.	3.61e+08	36	0.01	Ref.
Hospitalisations
Age	18–64 Years	183,061,142	54,786	29.928	Ref.	15,2704,862	16,990	11.126	Ref.
	More than 65 Years	63,473,405	33,872	53.364	1.78 [1.75–1.82]	52,777,199	16,799	31.83	2.86 [2.78–2.94]
Sex	Female	123267273.5	51,885	42.091	Ref.	102,741,030	17,862	17.385	Ref.
	Male	123267273.5	39,879	32.352	0.77 [0.76–0.78]	10,2741,030	15,812	15.39	0.89 [0.86–0.91]
COVID vaccine	Astra	34,643,783	25,453	73.471	2.56 [2.45–2.67]
	Janssen	14,723,578	4,231	28.736	Ref.	17,509,539	3,670	20.96	Ref.
	Moderna	24,957,523	19,864	79.591	2.77 [2.65–2.89]	80561024	13628	16.916	0.81 [0.77–0.85]
	Pfizer	172209328	43420	25.214	0.88 [0.84–0.91]	107,411,499	16,491	15.353	0.73 [0.70–0.77]
All COVID vaccines		246534547	92968	37.71	45.71 [41.26–50.65]	205,482,061	33,789	16.444	189.65 [163.85–219.53]
Influenza vaccines		7.71e+07	636	0.825	Ref.	3.61e+08	313	0.087	Ref.
Life-threatening reactions
Age	18–64 Years	18,3061,142	13,997	7.646	Ref.	152,704,862	57,07	3.737	Ref.
	More than 65 Years	63,473,405	7,248	11.419	1.49 [1.44–1.55]	52,777,199	3,139	5.948	1.59 [1.50–1.69]
Sex	Female	123267273.5	12,122	9.834	Ref.	102741030	4858	4.728	Ref.
	Male	123267273.5	9785	7.938	0.81 [0.78–0.84]	102,741,030	3,958	3.852	0.81 [0.77–0.86]
COVID vaccine	Astra	34,643,783	7,534	21.747	2.75 [2.54–2.99]
	Janssen	14723578	1163	7.899	Ref.	17509539	1108	6.328	Ref.
	Moderna	249,57,523	4,336	17.374	2.20 [2.02–2.39]	80,561,024	3535	4.388	0.69 [0.63–0.76]
	Pfizer	172,209,328	9,221	5.355	0.68 [0.63–0.73]	107,411,499	4,203	3.913	0.62 [0.57–0.67]
All COVID vaccines		246,534,547	22,254	9.027	56.13 [44.51–70.78]	205,482,061	8,846	4.305	196.72 [147.04–263.19]
Influenza vaccines		7.71e+07	124	0.161	Ref.	3.61e+08	79	0.022	Ref.

Ref: Reference category for the estimation of the relative risks.

^aThe number of exposed individuals aged 18 to 64 years in the European Union corresponds to the interval 18–69 years since the official EU statistics on vaccination coverage contains only 10-year age intervals.

^bGermany, Liechtenstein and Netherlands supply total numbers only. Based on national health authorities estimates, the number of exposed individuals in the 18–69 age interval is about 60%.