Risk of Adverse Events of Live-Attenuated COVID-19 Vaccination Among Atopic Patients

Figures & data

Table 1 Baseline Characteristics (n=3016)

Baseline Characteristics	Category	n (%)
Gender	Male	1086(36)
	Female	1930(64)
Age group (n=2998)	<40 yr.	885(29.5)
	40–44 yr.	193(6.4)
	45–49 yr.	201(6.7)
	50–54 yr.	247(8.2)
	55–60 yr.	313(10.4)
	>60 yr.	1159(38.4)
Atopic disease	Asthma	83(2.8)
	Allergic rhinitis	556(18.4)
	Atopic conjunctivitis	5(0.2)
	Atopic dermatitis	12(0.4)
	Urticaria	23(0.8)
	Contact dermatitis	37(1.2)
	Angioedema	1(0.03)
	Oral allergy	1(0.03)
	Drug allergy	86(2.9)
	Food allergy	73(2.4)
	Vaccine allergy	1(0.03)
Type of vaccine	AstraZeneca	3016(100)
Underlying	Diabetes mellitus (yes)	299(9.9)
	Hypertension (yes)	616(20.4)
	Cancer (yes)	40(1.3)
	Obesity (yes)	23(0.8)
	COPD (yes)	9(0.3)
	Old CVA (yes)	7(0.2)
	Hyperlipidemia (yes)	359(11.9)
	Hyperthyroidism (yes)	31(1)
	Migraine (yes)	14(0.5)
	Heart disease (yes)	43(1.4)
	Anemia (yes)	9(0.3)
	Other disease (yes)	98(3.2)

Table 2 Characteristic Data (n=3016)

Characteristic Data	Category	Atopic (n=732)	None Atopic (n=2284)	p-value
		n(%)	n(%)
Gender	Male	244(33.3)	842(36.8)	0.047^a,*
	Female	488(66.7)	1442(63.2)
Age group	<40 yr.	250(34.3)	635(27.9)	0.001^a,*	0.038*
	40–44 yr.	46(6.3)	147(6.5)	0.884^a
	45–49 yr.	42(5.8)	159(7)	0.248^a
	50–54 yr.	60(8.2)	187(8.2)	0.994^a
	55–60 yr.	71(9.8)	242(10.7)	0.489^a
	>60 yr.	259(35.9)	900(10.7)	0.052^a
Type of vaccine	AstraZeneca	732(100.0)	2283(100.0)	-
Underlying	Diabetes mellitus (yes)	91(12.4)	208(9.1)	0.009^a,*
	Hypertension (yes)	188(25.7)	428(18.7)	<0.001^a,*
	Cancer (yes)	12(1.6)	28(1.2)	0.395^a
	Obesity (yes)	8(1.1)	15(0.7)	0.238^b
	COPD (yes)	4(0.5)	5(0.2)	0.157^b
	Old CVA (yes)	3(0.4)	4(0.2)	0.251^b
	Hyperlipidemia (yes)	127(17.3)	201(8.8)	<0.001^a,*
	Hyperthyroidism (yes)	2(0.3)	24(1.2)	0.042^a,*
	Migraine (yes)	6(0.9)	7(0.4)	0.102^b
	Heart disease (yes)	12(1.8)	30(1.5)	0.577^a
	Anemia (yes)	1(0.2)	8(0.4)	0.466^b
	Other disease (yes)	185(25.3)	367(16.1)	<0.001^a,*

Note: n is frequency, % is percentage, ^ais Pearson’s chi-square test was used, ^bis Fisher’s exact test was used, and *is significance with alpha=0.05.

Figure 1 Percentages of fever adverse effect in atopic and non-atopic patients and their atopic subgroups.

Figure 2 Percentages of skin rash (urticaria) adverse effect in atopic and non-atopic patients and their atopic subgroups.

Figure 3 Percentages of local reactions adverse effect in atopic and non-atopic patients and their atopic subgroups.

Figure 4 Percentages of nausea and vomiting adverse effect in atopic and non-atopic patients and their atopic subgroups.

Table 3 Differences in Adverse Reactions of Live-Attenuated Oxford/AstraZeneca COVID-19 Vaccination Between Hypertension (n=616) and Non-Hypertension (n=2400) Groups

Sign effect	Category	1st Dose				2nd Dose
		Hypertension (n=616)	Non-Hypertension (n=2400)	RR (95% CI)	p-value	Hypertension (n=616)	None Hypertension (n=2400)	RR (95% CI)	p-value
		n(%)	n(%)			n(%)	n(%)
Within 30 minutes	Fever, mild headache or high grade fever, severe headache	9(1.5)	29(1.2)	1.2 (0.575to2.514)	0.616	1(0.2)	1(0.01)	3.9 (0.244to62.20)	0.336
	Chest discomfort or breathing difficulties	-	-	-	-	-	-	-	-
	Nausea or vomiting (no more than 5 times)	0(0)	5(0.2)	--	-	-	-	-	-
	Skin rash /urticaria	1(0.2)	6(0.2)	0.8 (0.091 to 6.658)	0.82	1(0.2)	0(0)	-	-
	Pain, swelling, redness and warmth at the injection site	4(0.6)	14(0.6)	1.1 (0.368to3.37)	0.85	-	-	-	-
Within 6 hours	Fever, mild headache or high grade fever, severe headache	51(8.3)	210(8.8)	1 (0.706 to 1.268)	0.711	7(1.1)	43(1.8)	0.6 (0.287to1.4)	0.26
	Chest discomfort or breathing difficulties	-	-	-	-	-	-	-	-
	Nausea or vomiting (no more than 5 times)	4(0.6)	17(0.7)	0.9 (0.31 to 2.715)	0.875	0(0)	3(0.1)	-	-
	Skin rash /urticaria	3(0.5)	22(0.9)	0.5 (0.16 to 1.769)	0.302	1(0.2)	3(0.1)	1.3 (0.135to12.46)	0.821
	Pain, swelling, redness and warmth at the injection site	15(2.4)	58(2.4)	1 (0.575 to 1.765)	0.979	4(0.6)	14(0.6)	1.1 (0.368to3.37)	0.85
Within 24 hours	Fever, mild headache or high grade fever, severe headache	198(32.1)	740(30.8)	1.1 (0.916 to 1.187)	0.531	109(17.7)	436(18.2)	0.98 (0.805to1.178)	0.786
	Chest discomfort or breathing difficulties	2(0.3)	1(0.001)	7.8 (0.708 to 85.79)	0.093	-	-	-	-
	Nausea or vomiting (no more than 5 times)	7(1.1)	58(2.4)	0.5 (0.216 to 1.025)	0.057	3(0.5)	10(0.4)	1.2 (0.323to4.234)	0.812
	Skin rash /urticaria	14(2.3)	71(3)	0.8 (0.436 to 1.353)	0.36	3(0.5)	15(0.6)	0.8 (0.226to2.683)	0.692
	Pain, swelling, redness and warmth at the injection site	91(14.8)	314(13.1)	1.1 (0.91 to 1.401)	0.273	31(5)	150(6)	0.8 (0.553to1.173)	0.257
After 24 hours	Fever, mild headache or high grade fever, severe headache	68(11)	365(15.2)	0.7 (0.569 to 0.926)	0.009*	49(8)	251(10.5)	0.8 (0.567to1.02)	0.065
	Chest discomfort or breathing difficulties	2(0.3)	2(0.1)	3.9 (0.55 to 27.603)	0.174	-	-	-	-
	Nausea or vomiting (no more than 5 times)	5(0.8)	29(1.2)	0.7 (0.261 to 1.728)	0.409	3(0.5)	7(0.3)	1.7 (0.433to6.438)	0.457
	Skin rash /urticaria	13(2.1)	43(1.8)	1.2 (0.637 to 2.177)	0.602	3(0.5)	15(0.6)	0.8 (0.226to2.683)	0.692
	Pain, swelling, redness and warmth at the injection site	32(5.2)	183(7.6)	0.7 (0.473 to 0.981)	0.038*	18(2.9)	125(5.2)	0.6 (0.345to0.912)	0.019*
Within 3 days	Fever, mild headache or high grade fever, severe headache	63(10.2)	357(14.9)	0.7 (0.534 to 0.885)	0.003*	49(8)	249(10.4)	0.8 (0.572to1.03)	0.073
	Chest discomfort or breathing difficulties	2(0.3)	1(0.01)	7.8 (0.708 to 85.79)	0.093	-	-	-	-
	Nausea or vomiting (no more than 5 times)	5(0.8)	25(1)	0.8 (0.3 to 2.027)	0.609	3(0.5)	7(0.3)	1.7 (0.433to6.438)	0.457
	Skin rash /urticaria	11(1.8)	38(1.6)	1.1 (0.58 to 2.193)	0.723	2(0.3)	12(0.5)	0.6 (0.146to2.894)	0.571
	Pain, swelling, redness and warmth at the injection site	32(5.2)	180(7.5)	0.7 (0.481 to 0.998)	0.047*	18(2.9)	123(5.1)	0.6 (0.35to0.928)	0.023*
Within 7 days	Fever, mild headache or high grade fever, severe headache	67(10.9)	365(15.2)	0.7 (0.56 to 0.914)	0.006*	49(8)	251(10.5)	0.8 (0.567to1.02)	0.065
	Chest discomfort or breathing difficulties	2(0.3)	2(0.1)	3.9 (0.55 to 27.603)	0.174	-	-	-	-
	Nausea or vomiting (no more than 5 times)	5(0.8)	27(1.1)	0.7 (0.279 to 1.866)	0.5	3(0.5)	7(0.3)	1.7 (0.433to6.438)	0.457
	Skin rash /urticaria	13(2.1)	41(1.7)	1.2 (0.666 to 2.291)	0.503	3(0.5)	15(0.6)	0.8 (0.226to2.683)	0.692
	Pain, swelling, redness and warmth at the injection site	32(5.2)	183(7.6)	0.7 (0.473 to 0.981)	0.038*	18(2.9)	125(5.2)	0.6 (0.345to0.912)	0.019*

Note: *is significance with alpha=0.05.

Table 4 Differences in Adverse Reactions of Live-Attenuated Oxford/AstraZeneca COVID-19 Vaccination Between Hyperthyroid (n=31) and Non-Hyperthyroid (n=2985) Groups

Sign Effect	Category	1st Dose				2nd Dose
		Hyperthyroid (n=31)	Non-Hyperthyroid (n=2985)	RR (95% CI)	p-value	Hyperthyroid (n=31)	None Hyperthyroid (n=2985)	RR (95% CI)	p-value
		n(%)	n(%)			n(%)	n(%)
Within 30 minutes	Fever, mild headache or high grade fever, severe headache	2(6.5)	36(1.2)	1.1 (0.963 to 1.158)	0.051	0(0)	2(0.1)	-	-
	Chest discomfort or breathing difficulties	-	-	-	-	-	-	-	-
	Nausea or vomiting (no more than 5 times)	0(0)	5(0.2)	-	-	-	-	-	-
	Skin rash /urticaria	0(0)	6(0.2)	-	-	0(0)	2(0.1)	-	-
	Pain, swelling, redness and warmth at the injection site	2(6.5)	16(0.5)	12.8 (2.814 to 58.21)	0.001*	-	-	-	-
Within 6 hours	Fever, mild headache or high grade fever, severe headache	6(19.4)	255(8.5)	2.6 (1.04 to 6.321)	0.04*	0(0)	50(1.7)	-	-
	Chest discomfort or breathing difficulties	-	-	-	-	-	-	-	-
	Nausea or vomiting (no more than 5 times)	0(0)	21(0.7)	-	-	0(0)	3(0.1)	-	-
	Skin rash /urticaria	0(0)	25(0.8)	-	-	0(0)	4(0.2)	-	-
	Pain, swelling, redness and warmth at the injection site	2(6.5)	71(2.4)	2.8 (0.663 to 12.09)	0.16	0(0)	18(0.6)	-	-
Within 24 hours	Fever, mild headache or high grade fever, severe headache	13(41.9)	925(31)	0.7 (0.487 to 1.22)	0.194	5(16.6)	540(18.1)	0.97 (0.836to1.141)	0.778
	Chest discomfort or breathing difficulties	0(0)	3(0.1)	-	-	-	-	-	-
	Nausea or vomiting (no more than 5 times)	0(0)	65(2.2)	-	-	0(0)	13(0.4)	-	-
	Skin rash /urticaria	2(6.5)	83(2.8)	1 (0.947 to 1.140)	0.234	0(0)	18(0.6)	-	-
	Pain, swelling, redness and warmth at the injection site	7(22.6)	398(13.3)	1.1 (0.925 to1.355)	0.14	3(9.7)	178(6)	1.1 (0.927to1.169)	0.392
After 24 hours	Fever, mild headache or high grade fever, severe headache	4(12.9)	429(14.4)	0.9 (0.858 to 1.27)	0.817	4(12.9)	296(9.9)	1 (0.903to1.185)	0.582
	Chest discomfort or breathing difficulties	0(0)	4(0.1)	-	-	-	-	-	-
	Nausea or vomiting (no more than 5 times)	0(0)	34(1.1)	-	-	0(0)	10(0.3)	-	-
	Skin rash /urticaria	0(0)	56(1.9)	-	-	0(0)	18(0.6)	-	-
	Pain, swelling, redness and warmth at the injection site	4(12.9)	211(7.1)	1.1 (0.931 to 1.222)	0.217	3(9.7)	140(4.7)	1.1 (0.94to1.438)	0.205
Within 3 days	Fever, mild headache or high grade fever, severe headache	4(12.9)	416(13.9)	0.9 (0.319 to 2.628)	0.869	4(12.9)	294(9.8)	1.4 (0.471to3.902)	0.572
	Chest discomfort or breathing difficulties	0(0)	3(0.1)	-	-	-	-	-	-
	Nausea or vomiting (no more than 5 times)	0(0)	30(1)	-	-	0(0)	10(0.3)	-	-
	Skin rash /urticaria	0(0)	49(1.6)	-	-	0(0)	14(0.5)	-	-
	Pain, swelling, redness and warmth at the injection site	4(12.8)	208(7)	2 (0.686 to 5.706)	0.207	3(9.7)	138(4.6)	2.2 (0.664to7.36)	0.196
Within 7 days	Fever, mild headache or high grade fever, severe headache	4(12.9)	428(14.3)	0.9 (0.308 to 2.542)	0.821	4(12.9)	296(9.9)	1 (0.903to1.185)	0.582
	Chest discomfort or breathing difficulties	0(0)	4(0.1)	-	-	-	-	-	-
	Nausea or vomiting (no more than 5 times)	0(0)	30(1)	-	-	0(0)	10(0.3)	-	-
	Skin rash /urticaria	0(0)	54(1.8)	-	-	0(0)	18(0.6)	-	-
	Pain, swelling, redness and warmth at the injection site	4(12.9)	211(7.1)	2 (0.675to5.618)	0.217	3(9.7)	140(4.7)	1.1 (0.94to1.438)	0.205

Table 5 Differences in Adverse Reactions of Live-Attenuated Oxford/AstraZeneca COVID-19 Vaccination Between Hyperlipidemia (n=359) and Non-Hyperlipidemia (n=2657) Groups

Sign Effect	Category	1st Dose				2nd Dose
		Hyperlipidemia (n=359)	Non-Hyperlipidemia (n=2657)	RR (95% CI)	p-value	Hyperlipidemia (n=359)	None Hyperlipidemia (n=2657)	RR (95% CI)	p-value
		N (%)	N (%)			n(%)	n(%)
Within 30 minutes	Fever, mild headache or high grade fever, severe headache	4(1.1)	34(1.3)	0.9 (0.307to2.46)	0.792	0(0)	2(0.1)	-	-
	Chest discomfort or breathing difficulties	-	-	-	-	-	-	-	-
	Nausea or vomiting (no more than 5 times)	0(0)	5(0.2)	-	-	-	-	-	-
	Skin rash /urticaria	1(0.3)	5(0.2)	1.5 (0.173 to 12.7)	0.72	1(0.3)	0(0)	-	-
	Pain, swelling, redness and warmth at the injection site	2(0.6)	16(0.6)	0.9 (0.21 to 4.04)	0.917	-	-	-	-
Within 6 hours	Fever, mild headache or high grade fever, severe headache	36(10)	225(8.5)	1.2 (0.83 to 1.75)	0.324	9(2.5)	41(1.5)	1.6 (0.79to3.41)	0.184
	Chest discomfort or breathing difficulties	-	-	-	-	-	-	-	-
	Nausea or vomiting (no more than 5 times)	1(0.3)	20(0.8)	0.4 (0.5 to 2.75)	0.33	1(0.3)	2(0.1)	3.7 (0.335to40.99)	0.285
	Skin rash /urticaria	2(0.6)	23(0.9)	0.6 (0.15 to 2.73)	0.548	1(0.3)	3(0.1)	2.5 (0.256to23.8)	0.434
	Pain, swelling, redness and warmth at the injection site	8(2.2)	65(2.4)	0.9 (0.43 to 1.91)	0.801	4(1.1)	14(0.5)	2.1 (0.69to6.5)	0.185
Within 24 hours	Fever, mild headache or high grade fever, severe headache	131(36.5)	807(30.4)	1.3 1.046 to 1.65)	0.019*	87(24.2)	458(17.2)	1.5 (1.18to1.99)	0.001*
	Chest discomfort or breathing difficulties	1(0.3)	2(0.1)	3.7 (0.335 to 40.9)	0.285	-	-	-	-
	Nausea or vomiting (no more than 5 times)	5(1.4)	60(2.3)	0.6 (0.244 to 1.53)	0.294	3(0.8)	10(0.4)	2.2 (0.611to8.14)	0.255
	Skin rash /urticaria	7(1.9)	78(2.9)	0.7 (0.301 to 1.43)	0.301	3(0.8)	15(0.6)	1.5 (0.428to5.15)	0.534
	Pain, swelling, redness and warmth at the injection site	54(15)	351(13.2)	1.2 (0.853 to 1.59)	0.34	27(7.5)	154(5.8)	1.3 (0.86to2.02)	0.198
After 24 hours	Fever, mild headache or high grade fever, severe headache	49(13.6)	384(14.5)	0.9 (0.679 to 1.29)	0.684	46(12.8)	254(9.6)	1.4 (0.994to1.94)	0.054
	Chest discomfort or breathing difficulties	1(0.3)	3(0.1)	2.5 (0.256 to 23.8)	0.434	-	-	-	-
	Nausea or vomiting (no more than 5 times)	4(1.1)	30(1.1)	1 (0.346 to 2.82)	0.98	4(1.1)	6(0.2)	5 (1.39to17.73)	0.013*
	Skin rash /urticaria	12(3.3)	44(1.7)	2.1 (1.074 to 3.93)	0.03*	3(0.8)	15(0.6)	1.5 (0.428to5.152)	0.534
	Pain, swelling, redness and warmth at the injection site	24(6.7)	191(7.2)	0.9 (0.6 to 1.44)	0.728	20(5.6)	123(4.6)	1.2 (0.78to1.98)	0.431
Within 3 days	Fever, mild headache or high grade fever, severe headache	47(13.1)	373(14)	0.9 (0.67 to 1.27)	0.627	45(12.5)	253(9.5)	1.4 (0.97to1.91)	0.074
	Chest discomfort or breathing difficulties	1(0.3)	2(0.1)	3.7 (0.34 to 40.99)	0.285	-	-	-	-
	Nausea or vomiting (no more than 5 times)	4(1.1)	26(1)	1.1 (0.39 to 3.29)	0.808	4(1.1)	6(0.2)	5 (1.39to17.73)	0.013*
	Skin rash /urticaria	11(3.1)	38(1.4)	2.2 (1.103to4.3)	0.025*	2(0.6)	12(0.5)	1.2 (0.28to5.54)	0.783
	Pain, swelling, redness and warmth at the injection site	24(6.7)	188(7.1)	0.9 (0.61 to 1.46)	0.786	19(5.3)	122(4.6)	1.1 (0.71to1.91)	0.555
Within 7 days	Fever, mild headache or high grade fever, severe headache	49(13.6)	383(14.4)	0.9 (0.68 to 1.29)	0.698	46(12.8)	254(9.6)	1.4 (0.99to1.94)	0.054
	Chest discomfort or breathing difficulties	1(0.3)	3(0.1)	2.5 (0.26 to 23.8)	0.434	-	-	-	-
	Nausea or vomiting (no more than 5 times)	4(1.1)	28(1.1)	1.1 (0.37 to 3.03)	0.917	4(1.1)	6(0.2)	5 (1.39to17.73)	0.013*
	Skin rash /urticaria	12(3.3)	42(1.6)	2.2 (1.12 to 4.13)	0.021*	3(0.8)	15(0.6)	1.5 (0.428to5.15)	0.534
	Pain, swelling, redness and warmth at the injection site	24(6.7)	191(7.2)	0.9 (0.6 to 1.44)	0.728	20(5.6)	123(4.6)	1.2 (0.78to1.98)	0.431

Note: *is significance with alpha=0.05.