Adherence to and early adverse events of COVID-19 vaccine in a cohort of 600 Italian breastfeeding and pregnant physicians

Figures & data

Table 1. The main epidemiological and clinical sample features.

Feature (n, %)	Breastfeeding N = 469	Pregnancy N = 131
Age 24–30 years 31–40 years 41–50 years 51–60 years	20 (4.3) 367 (78.3) 81 (17.3) 1 (0.2)	9 (6.9) 114 (87.0) 8 (6.1) 0 (0.0)
Italian region Northern Central Southern	206 (42.9) 150 (32.0) 113 (24.1)	73 (53.4) 38 (29.0) 20 (15.3)
Cohabitation with subject/s aged ≥65 years Yes No	42 (9.0) 427 (91.0)	18 (13.7) 113 (86.3)
Diabetes mellitus Yes No	26 (5.5) 443 (94.5)	11 (8.4) 120 (91.6)
Previous confirmed COVID-19 infection Yes No	29 (6.2) 440 (93.8)	9 (6.9) 122 (93.1)
Vaccination for influenza (2020/21) Yes No	340 (72.5) 129 (27.5)	99 (72.8) 35 (26.7)
COVID vaccination intentions Vaccinated during breastfeeding/pregnancy Extremely/somewhat likely to get vaccinated but it was not permitted by the authorities Unsure or unlikely Unsure The vaccine might have dangerous side effects Past SARS-CoV-2 infection I have certified contraindications No answer	382 (81.4) 61 (13.0) 13 (2.8) 1 (0.2) 8 (1.7) 2 (0.4) 11 (2.3) 2 (0.4)	35 (26.7) 27 (20.6) 38 (29.0) 8(6.1) 26 (19.8) 2 (1.5) 31 (23.7) 0 (0.0)

Table 2. Variables associated with vaccine hesitancy in pregnant physicians (n = 100) in multiple logistic regression analysis.

	Multivariable model
	OR	95% C.I.	p-value
Age 24-30 31-40 41-50	5.03 1.00 0.69	0.47–53.6 0.07–6.82	.180 .750
Italian Region Northern Central Southern	1.00 0.96 0.57	0.34–2.67 0.16–1.99	.938 .382
Cohabitation with subject/s aged ≥65 years Diabetes mellitus Previous confirmed COVID-19 infection Vaccination for influenza (2020/21)	0.31 3.20 1.89 0.35	0.58–1.62 0.66–15.47 0.27–13.08 0.13–0.97	.164 .148 .520 .044

Table 3. Variables associated with vaccine hesitancy among breastfeeding physicians (n = 453) in multiple logistic regression analysis.

	Multivariable model
	OR	95% C.I.	p-value
Age 24-30 31-40 41-50	1.46 1.00 0.51	0.17–12.5 0.63–4.08	.728 .525
Italian Region Northern Central Southern	1.00 2.01 1.43	0.54–7.44 0.31–6.69	.295 .647
Cohabitation with subject/s aged ≥65 years* Diabetes mellitus Previous confirmed COVID-19 infection* Vaccination for influenza (2020/21)	1.00 4.25 1.00 0.27	0.81–22.30 0.09–0.86	.087 .026

*Variable predicts failure perfectly.

Table 4. Adverse Events Following Immunization (AEFI) reported by vaccinated pregnant (a) and breastfeeding (b) women.

a)	Pregnancy
	First dose	Second dose	p
	(n = 31)	(n = 17)
b)	Breastfeeding
	First dose	Second dose	p
	(n = 315)	(n = 174)
Symptoms (n, median)	1 [0;1]	2 [1;4]
Patients with at least one symptom (n, %)	16 (51.6)	14 (82.4)	.043
Local reactions (i.e. pain, itching or paresthesia) in the vaccination site	2 (6.5)	1 (5.9)	.900
Fever	2 (6.5)	2 (11.8)	.530
<38°C	2 (6.5)	2 (11.8)	.530
>38°C	0	0	0
Fatigue	8 (25.8)	12 (70.6)	.004
Myalgia/arthralgia	4 (12.9)	7 (41.2)	.033
Headache	4 (12.9)	4 (23.5)	.351
Tachycardia/tachyarrhythmia	3 (9.7)	1 (5.9)	.650
Diarrhea	1 (3.2)	0 (0.0)	.744
Nausea/vomiting	20 (64.5)	13 (76.5)	.396
Other	1* (3.2)	1** (5.9)	.664
Symptoms (n, median)	1 [0;2]	2 [1;4]
Patients with at least one symptom (n, %)	237 (75.2)	142 (81.6)	.107
Local reactions (i.e. pain, itching or paresthesia) in the vaccination site	13 (4.1)	6 (3.4)	.710
Fever	12 (3.8)	58 (33.3)	<.001
<38°C	7 (2.2)	38 (21.8)	<.001
>38°C	5 (1.6)	17 (9.8)	<.001
Fatigue	89 (28.3)	85 (48.9)	<.001
Myalgia/Arthralgia	54 (17.1)	86 (49.4)	<.001
Headache	83 (26.3)	68 (39.1)	<.001
Urticaria	5 (1.6)	2 (1.1)	.698
Tachycardia/Tachyarrhythmia	15 (4.8)	6 (3.4)	.495
Lymphadenopathy	11 (3.5)	12 (6.9)	.095
Diarrhoea	7 (2.2)	6 (3.4)	.423
Nausea/Vomiting	189 (60.0)	89 (51.1)	.059
Flushing	15 (4.8)	14 (8.0)	.145
Syncope	2 (0.6)	2 (1.1)	.551
Other	10* (3.5)	11** (6.3)	.107

*See Supplementary Material, Table S3; **Flushing; ***Low back pain.