Changes in Local and Systemic Adverse Effects following Primary and Booster Immunisation against COVID-19 in an Observational Cohort of Dutch Healthcare Workers Vaccinated with BNT162b2 (Comirnaty®)
Abstract
:1. Introduction
2. Methods
Study Design and Population
3. Results
3.1. Baseline Characteristics
3.2. Adverse Effects after Round 1
3.3. Adverse Effects after Round 2
3.4. Comparison between Rounds 1 and 2
3.5. Predictors of Adverse Effects after Round 1
3.6. Predictors of AEFI after Round 2
4. Discussion
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Round 1 | Round 2 | |
---|---|---|
N vaccinated | 702 (80.4% of invited) | 2448 (80.1% of all employees) |
N of participants in the study | 470 (67.0%) | 990 (40.4%) |
Age | 18–65 * | 18–70 (median 46.5) |
Female sex | Unknown * | 804 (81.2%) |
Job description | Exclusively HCWs in acute and critical care | All HCWs |
Previous proven SARS-CoV-2 infection | 135 (28.8%) | 449 (45.4%) |
Previous vaccine type | ||
mRNA vaccination (BNT162b2/Comirnaty® or Spikevax-Moderna | None (primary immunisation) | 727 (73.4%) |
non-mRNA/unknown | 263 (26.6%) |
Round 1, First Dose | Round 1, Second Dose | Round 2 | p (Any) * | p (Severe) ** | |
---|---|---|---|---|---|
Local AEFI | |||||
Injection site pain | 0.526 | 0.999 | |||
None | 92 (19.6%) | 85 (18.1%) | 199 (20.1%) | ||
Mild | 165 (35.1%) | 208 (44.3%) | 465 (47.0%) | ||
Moderate | 194 (41.3%) | 152 (32.4%) | 276 (27.9%) | ||
Severe | 19 (4.0%) | 24 (5.1%) | 50 (5.1%) | ||
Local erythema or swelling | 0.416 | 0.120 | |||
None | 458 (97.4%) | 445 (94.9%) | 949 (95.9%) | ||
Mild | 6 (1.3%) | 15 (3.2%) | 27 (2.7%) | ||
Moderate | 6 (1.3%) | 4 (0.9%) | 11 (1.1%) | ||
Severe | 0 | 5 (1.1%) | 3 (0.3%) | ||
Systemic AEFI | |||||
Fever | 0.181 | <0.001 | |||
None | 446 (94.9%) | 408 (87.0%) | 834 (84.2%) | ||
Mild | 12 (2.6%) | 22 (4.7%) | 75 (7.6%) | ||
Moderate | 9 (1.9%) | 0 (0%) | 56 (5.7%) | ||
Severe | 3 (6.3%) | 39 (8.3%) | 25 (2.5%) | ||
Fatigue | 0.910 | 0.054 | |||
None | 365 (77.7%) | 266 (56.7%) | 557 (56.3%) | ||
Mild | 61 (13.0%) | 91 (19.4%) | 239 (24.1%) | ||
Moderate | 39 (8.3%) | 84 (17.9%) | 158 (16.0%) | ||
Severe | 5 (1.1%) | 28 (6.0%) | 36 (3.6%) | ||
Headache | 0.001 | 0.094 | |||
None | 348 (74.0%) | 260 (55.4%) | 640 (64.6%) | ||
Mild | 62 (13.2%) | 84 (17.9%) | 181 (18.3%) | ||
Moderate | 44 (9.4%) | 91 (19.4%) | 119 (12.0%) | ||
Severe | 16 (3.4%) | 34 (7.2%) | 50 (5.1%) | ||
Arthralgia | 0.119 | 0.038 | |||
None | 433 (92.1%) | 378 (80.6%) | 761 (76.9%) | ||
Mild | 22 (4.7%) | 27 (5.8%) | 103 (10.4) | ||
Moderate | 13 (2.8%) | 42 (9.0%) | 101 (10.2%) | ||
Severe | 2 (0.4%) | 22 (4.7%) | 25 (2.5%) | ||
Chills | 0.056 | 0.500 | |||
None | 433 (92.1%) | 383 (81.7%) | 764 (77.2%) | ||
Mild | 22 (4.7%) | 31 (6.6%) | 100 (10.1%) | ||
Moderate | 13 (2.8%) | 31 (6.6%) | 84 (8.5%) | ||
Severe | 2 (0.4%) | 24 (5.1%) | 42 (4.2%) | ||
Any local AEFI, highest score | 0.436 | 0.357 | |||
None | 92 (19.6%) | 85 (18.1%) | 197 (19.9%) | ||
Mild | 165 (35.1%) | 208 (44.3%) | 467 (47.2%) | ||
Moderate | 194 (41.3%) | 149 (31.8%) | 275 (27.8%) | ||
Severe | 19 (4.0%) | 27 (5.8%) | 51 (5.2%) | ||
Any systemic AEFI, highest score | 0.099 | 0.012 | |||
None | 286 (60.9%) | 179 (38.2%) | 424 (42.8%) | ||
Mild | 94 (20.0%) | 99 (21.1%) | 243 (24.5%) | ||
Moderate | 68 (14.5%) | 120 (25.6%) | 220 (22.2%) | ||
Severe | 22 (4.7%) | 71 (15.1%) | 103 (10.4%) | ||
Called in sick because of AEFI | 0.261 | ||||
Yes. | 10 (2.1%) | 20 (4.3%) | 57 (5.8%) |
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Serbanescu-Kele Apor de Zalán, C.; Bouwman, M.; van Osch, F.; Damoiseaux, J.; Funnekotter-van der Snoek, M.-A.; Verduyn Lunel, F.; Van Hunsel, F.; de Vries, J. Changes in Local and Systemic Adverse Effects following Primary and Booster Immunisation against COVID-19 in an Observational Cohort of Dutch Healthcare Workers Vaccinated with BNT162b2 (Comirnaty®). Vaccines 2024, 12, 39. https://doi.org/10.3390/vaccines12010039
Serbanescu-Kele Apor de Zalán C, Bouwman M, van Osch F, Damoiseaux J, Funnekotter-van der Snoek M-A, Verduyn Lunel F, Van Hunsel F, de Vries J. Changes in Local and Systemic Adverse Effects following Primary and Booster Immunisation against COVID-19 in an Observational Cohort of Dutch Healthcare Workers Vaccinated with BNT162b2 (Comirnaty®). Vaccines. 2024; 12(1):39. https://doi.org/10.3390/vaccines12010039
Chicago/Turabian StyleSerbanescu-Kele Apor de Zalán, Christiaan, Maud Bouwman, Frits van Osch, Jan Damoiseaux, Mary-Anne Funnekotter-van der Snoek, Frans Verduyn Lunel, Florence Van Hunsel, and Janneke de Vries. 2024. "Changes in Local and Systemic Adverse Effects following Primary and Booster Immunisation against COVID-19 in an Observational Cohort of Dutch Healthcare Workers Vaccinated with BNT162b2 (Comirnaty®)" Vaccines 12, no. 1: 39. https://doi.org/10.3390/vaccines12010039
APA StyleSerbanescu-Kele Apor de Zalán, C., Bouwman, M., van Osch, F., Damoiseaux, J., Funnekotter-van der Snoek, M.-A., Verduyn Lunel, F., Van Hunsel, F., & de Vries, J. (2024). Changes in Local and Systemic Adverse Effects following Primary and Booster Immunisation against COVID-19 in an Observational Cohort of Dutch Healthcare Workers Vaccinated with BNT162b2 (Comirnaty®). Vaccines, 12(1), 39. https://doi.org/10.3390/vaccines12010039