In total, 1294 participant responses were collected. Data of 167 responses were excluded due to invalid study identification numbers, 141 responses were excluded due to incomplete questionnaire data, 170 responses were excluded due to data duplets and data of 23 participants were excluded because their age did not match the inclusion criterion of 5–11 years at the time of the first BNT162b2 vaccine dose. This resulted in 793 data sets which were included in the study analysis comprising 179 responses concerning children with comorbidities and 614 concerning children without comorbidities. The group with comorbidities included 41 vaccinations in children with pulmonary comorbidities, 22 with rheumatologic comorbidities, 21 with cardiological comorbidities, 9 with malignant comorbidities, 4 with primary immunodeficiency, 10 with genetic, 9 with gastrointestinal diseases as well as 20 with type 1 diabetes and 43 with other diseases (Fig. 1 and Table S2, supplement). 506 data sets contained information on the first BNT162b2 vaccine dose, 21.74% of these data sets were from participants with comorbidities. 287 data sets entailed information regarding the second dose of which 24.04% participants had comorbidities. Caregivers of healthy participants completed the online survey at a median of 17 days after the administration of the respective dose, caregivers of children with comorbidities did so after a median of 18 days. The median age in healthy children was 8 years, median height was 135 cm and median weight was 30 kg. The median age in children with comorbidities was 9 years, median height was 132 cm and the median weight was 29 kg (Table S1, supplement). There was no significant difference concerning the age of the two cohort, however children with comorbidities were smaller and lighter.
Frequency of post-vaccination symptomsIn total, children with comorbidities and their legal guardians reported certain systemic events and local reactions after vaccination with BNT162b2 more frequently than children who were healthy (Fig. 2). 76.54% of children with comorbidities reported any symptoms at all, whereas for 72.31% of the healthy children any symptoms after vaccination were described. Local reactions were most reported side effects occurring in both cohorts, thereof in 63.36% (389/614) of healthy children and in 67.60% (121/179) of children with comorbidities (OR: 1.21 [95% CI: 0.8534 to 1.724], Table 1). Children with comorbidities reported more swelling on injection site than healthy children (12.85% (23/179) vs. 6.84% (42/614); OR: 2.01 [95% CI: 1.178 to 3.442], Table 2). Pain at the injection site was reported in 61.07% (375/614) of healthy children and 60.89% (109/179) in children with comorbidities and was treated with pain medication in 12 children overall. The local reactions reported lasted on average one to two days. More detailed information is shown in Tables S11 and S21, supplement.
Fig. 2Summarized local and systemic reactions after BNT162b2 vaccination in healthy children and children with comorbidities. (A) are the most frequently reported local and systemic post-vaccination symptoms (absolute numbers (relative frequencies in %)) in healthy children (light grey) and children with comorbidities (dark grey with cross) after the first and second dose of BNT162b2 added together. Comorbidities included pulmonary, malignant, rheumatologic, cardiological, genetic and gastrointestinal diseases, as well as primary immunodeficiencies and other diseases. Other reactions included musculoskeletal, gastrointestinal, otolaryngologic, neurologic and dermatologic symptoms. (B) depicts the most reported symptoms. (C) shows the differences in symptoms by organ category. The Figure was partly generated using Servier Medical Art, provided by Servier, licensed under a Creative Commons Attribution 3.0 unproved license
Table 1 Post-vaccination symptoms in healthy children and children with comorbiditiesTable 2 Most frequent local and systemic post-vaccination symptoms in healthy children and children with comorbiditiesSystemic symptoms were reported in both children with and without comorbidities. Fatigue was the most frequently reported systemic reaction with 12.87% (79/614) in healthy children and 20.11% (36/179) in children with comorbidities (OR: 1.71, [95% CI: 1.088 to 2.605]). Fever above 38.5 °C was reported in 0.81% (5/614) of healthy children and 4.47% (8/179) in children with comorbidities (OR: 5.70, [95% CI: 1.796 to 15.60], Table 2). The average duration of fever was 1.8 days and was treated with antipyretics in 9 of 13 cases. Another leading systemic symptom was generalized weakness in both healthy children and children with comorbidities. This symptom was reported in 4.4% (27/614) of healthy children and 7.26% (13/179) of children with comorbidities. The most common musculoskeletal symptom was pain in the arms, reported in 7.27% (8/110) after the first BNT162b2 dose and 4.35% (3/69) after the second BNT162b2 dose in children with comorbidities and in 6.82% (27/396) of healthy children after first BNT162b2 dose, and in 5.5% (12/218) of healthy children after the second BNT162b2 dose, respectively. Children with comorbidities reported more frequently joint pain (0.33% (2/614) in healthy vs. 2.23% (4/179) in children with comorbidities, OR: 6.99, [95% CI: 1.614 to 36.91], Table 2). In general, musculoskeletal symptoms resolved within 1 to 8 days. Pain medications were used due to pain in the arms and legs, joint pain and swelling and neck and back pain (Tables S13 and S23, supplement).
Children with comorbidities reported more gastrointestinal post-vaccination symptoms (OR: 2.35, [95% CI: 1.231 to 4.665], see Table 1). The leading gastrointestinal symptoms were pain in the upper and lower abdomen, nausea/vomiting and diarrhoea in children with and without comorbidities. Children with comorbidities were 4.4 times more likely to experience nausea and vomiting after receiving a BNT162b2 vaccination than healthy children (OR: 4.40, [95% CI: 1.868 to 10.71]). It was reported in 1.47% of healthy children and 6.15% of children with comorbidities. Pain in the lower abdomen presented in 1.52% (6/396) of healthy children and 2.73% (3/110) of children with comorbidities after the first BNT162b2 dose and 0.92% (2/218), 4.35% (3/69) respectively after second BNT162b2 dose. One healthy child required ambulatory treatment due to pain in the lower abdomen, nausea and vomiting after vaccination. One child with pulmonary comorbidity required ambulatory treatment due to pain in the upper and lower abdomen (Tables S14 and S24, supplement).
The most common otolaryngologic symptom was a sore throat in healthy children as well as in children with comorbidities. The sore throat resolved after an average of 6 days; two healthy children received analgesics as treatment.
Pulmonary symptoms were more frequent after BNT162b2 vaccination in children with comorbidities than in healthy children (OR: 7.14, [95% CI: 2.039 to 21.48]). One healthy child (0.25%) and three children with comorbidities (2.73%) presented with cough after receiving the first BNT162b2 vaccine dose of which one child with comorbidities was treated with both oral medication cough syrup and ß2-mimetic inhalation medication. After the second BNT162b2 vaccine dose 0.92% (2/218) of healthy children and 1.45% (1/69) of children with comorbidities reported cough.
Cardiovascular post-vaccination symptoms were very rarely reported after BNT162b2 vaccinations in both cohorts (0.49% (3/614) in healthy children, 1.12% (2/179) in children with comorbidity). Symptoms reported included chest pain, tachycardia and other non-specified discomforts. Notably, no cases of myocarditis or pericarditis as well as no anaphylaxis were reported.
Headache was the leading neurological symptom and was reported after the first BNT162b2 dose in 8.33% (33/396) of healthy children and in 14.55% (16/110) of children with comorbidities, as well as in 8.72% (19/218) of healthy children and 11.43% (8/69) of children with comorbidities after receiving the second BNT162b2 dose. 2.93% (18/614) of healthy children and 4.47% (8/179) of children with comorbidity received pain medication for headache after BNT162b2 vaccination.
Psychological symptoms after BNT162b2 vaccination were reported more often in children with comorbidities than in healthy children (OR: 3.56, [95% CI: 1.461 to 8.62]). The most frequently reported symptom was sleeping disorder. Parents of children with comorbidities observed sleeping disorders in 2.73% (3/110) of children after the first BNT162b2 dose and in 5.8% (4/69) after the second BNT162b2 dose, whereas only one healthy child was affected after the first BNT162b2 dose (0.25%). Other reported psychological symptoms included concentration problems, hyperactivity and mood swings. One patient reported ongoing sleeping disorders, all other psychological symptoms resolved after a maximum of 17 days. More detailed information is shown in Tables S19 and S29, supplement.
Dermatological symptoms after BNT162b2 vaccination were more frequent in children with comorbidities than in healthy children (OR: 2.28, [95%CI: 1.220 to 4.172]). Lymphadenopathy was reported after the first BNT162b2 dose (1.77%, 7/396) and after the second vaccination (2.29%, 5/218) in healthy children, in no child with comorbidities after the first BNT162b2 dose and in four children (5.8%) after the second BNT162b2 dose. Dermatological symptoms persisted for four days on average, requiring the use of pain medication in two children. Local rashes were seen in no healthy child after the first BNT162b2 vaccine dose and in four healthy children after the second BNT162b2 vaccine dose. Two children with comorbidities showed a local rash after their first dose, whereas three reported on a local rash after dose two of BNT162b2, one required topical dermatological treatment against the local rash, three children with comorbidities required topical treatment against pruritus, dry skin and/or eczema.
No child needed to be hospitalized after BNT162b2 vaccination, no fatalities were reported.
Frequency of post-vaccination symptoms in children with and without comorbidities after first and second doseA more detailed analysis regarding post-vaccination symptoms after first and second BNT162b2 doses was performed as displayed in Tables S7 and S8, supplement. Overall, children with comorbidities showed more dermatological symptoms (OR: 4.42, [95% CI: 1.465 to 11.70], p 0.0073) after the second BNT162b2 dose than after the first BNT162b2 dose. Similar results could be seen in healthy children. 2.78% (11/396) reported on dermatological symptoms after the first dose, 7.34% (16/218) after the second dose of BNT162b2. A trend in reported symptoms was also visible for general symptoms (affecting 22 of 110 children with comorbidities after the first BNT162b2 dose and 20 of 69 after the second BNT162b2 dose). Especially, lymphadenopathy was reported in 4 children with comorbidity after the second BNT162b2 dose and in 0 children after the first BNT162b2 dose).
Differences between immunocompromising and non-immunocompromising comorbiditiesWhen comparing children with comorbidities that compromise the immune system such as rheumatological diseases, malignant diseases and primary immunodeficiencies with children affected by underlying comorbidities that don’t affect the immune system, no significant differences in reported symptoms were seen (table S31). However, a trend was detected towards more dermatological symptoms in the immunocompromised group (14.29%, 5/35) than in the group of children with non-immunocompromising comorbidities (8.33%, 12/144).
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