Adverse Reactions to Anti-SARS-CoV-2 Vaccine: A Prospective Cohort Study Based on an Active Surveillance System
To date, Coronavirus disease (COVID-19) has caused high morbidity and mortality worldwide. To counteract the pandemic scenario, several vaccines against the etiological factor of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were developed and tested. At the end of December 2020, BNT1...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-02-01
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| Series: | Vaccines |
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| Online Access: | https://www.mdpi.com/2076-393X/10/3/345 |
| _version_ | 1797441203738771456 |
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| author | Emanuele Amodio Giuseppa Minutolo Alessandra Casuccio Claudio Costantino Giorgio Graziano Walter Mazzucco Alessia Pieri Francesco Vitale Maurizio Zarcone Vincenzo Restivo |
| author_facet | Emanuele Amodio Giuseppa Minutolo Alessandra Casuccio Claudio Costantino Giorgio Graziano Walter Mazzucco Alessia Pieri Francesco Vitale Maurizio Zarcone Vincenzo Restivo |
| author_sort | Emanuele Amodio |
| collection | DOAJ |
| description | To date, Coronavirus disease (COVID-19) has caused high morbidity and mortality worldwide. To counteract the pandemic scenario, several vaccines against the etiological factor of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were developed and tested. At the end of December 2020, BNT162b2 (Comirnaty, Pfizer-BioNTech) was the first and only authorized vaccine in Italy for selected categories, such as healthcare workers, fragile patients and people aged over 80 years old. To master our knowledge about BNT162b2 adverse reactions (ARs), an active surveillance system based on instant messaging was realized for voluntary participants who had been vaccinated at COVID-19 Vaccination Center of the Palermo University Hospital. Overall, 293 vaccinated persons were included in this study, which were more frequently healthcare workers (<i>n</i> = 207, 70.6% with a median age of 36 years, IQR = 29–55) followed by health professional students (<i>n</i> = 31, 10.6% with a median age of 27 years, IQR = 25–29), reporting 82.6% of at least one local or systemic AR. In details, the frequency of at least one local or systemic AR after the second dose of Comirnaty (<i>n</i> = 235, 80.2%) was statistically significant with higher value in comparison to the first one (<i>n</i> = 149, 50.9%; <i>p</i> < 0.001). However, local pain, swelling, joint pain and muscular pain after the second dose were the symptom causing a statistically significant working limitation. The youngest persons showed a higher risk to have either local or systemic ARs (aOR = 7.5, CI 95% = 2.9–18.9), while females had a higher risk of having systemic ARs (aOR = 1.8, CI 95% = 1.1–3.0). Despite the small sample examined, this active surveillance system by instant messaging seems to detect a higher ARs prevalence with respect to data obtained by the passive surveillance. Further studies could be required in order to optimize this clinical monitoring that could be considered an efficient and timely active surveillance. |
| first_indexed | 2024-03-09T12:19:38Z |
| format | Article |
| id | doaj.art-2e1128ed637345b7afd43a7cc6c8ed32 |
| institution | Directory Open Access Journal |
| issn | 2076-393X |
| language | English |
| last_indexed | 2024-03-09T12:19:38Z |
| publishDate | 2022-02-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj.art-2e1128ed637345b7afd43a7cc6c8ed322023-11-30T22:41:39ZengMDPI AGVaccines2076-393X2022-02-0110334510.3390/vaccines10030345Adverse Reactions to Anti-SARS-CoV-2 Vaccine: A Prospective Cohort Study Based on an Active Surveillance SystemEmanuele Amodio0Giuseppa Minutolo1Alessandra Casuccio2Claudio Costantino3Giorgio Graziano4Walter Mazzucco5Alessia Pieri6Francesco Vitale7Maurizio Zarcone8Vincenzo Restivo9Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, 90127 Palermo, ItalyDepartment of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, 90127 Palermo, ItalyDepartment of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, 90127 Palermo, ItalyDepartment of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, 90127 Palermo, ItalyUnità Operativa Complessa di Epidemiologia Clinica con Registro Tumori, Azienda Ospedaliera Universitaria Policlinico “Paolo Giaccone”, 90127 Palermo, ItalyDepartment of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, 90127 Palermo, ItalyUnità Operativa Complessa di Epidemiologia Clinica con Registro Tumori, Azienda Ospedaliera Universitaria Policlinico “Paolo Giaccone”, 90127 Palermo, ItalyDepartment of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, 90127 Palermo, ItalyUnità Operativa Complessa di Epidemiologia Clinica con Registro Tumori, Azienda Ospedaliera Universitaria Policlinico “Paolo Giaccone”, 90127 Palermo, ItalyDepartment of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, 90127 Palermo, ItalyTo date, Coronavirus disease (COVID-19) has caused high morbidity and mortality worldwide. To counteract the pandemic scenario, several vaccines against the etiological factor of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were developed and tested. At the end of December 2020, BNT162b2 (Comirnaty, Pfizer-BioNTech) was the first and only authorized vaccine in Italy for selected categories, such as healthcare workers, fragile patients and people aged over 80 years old. To master our knowledge about BNT162b2 adverse reactions (ARs), an active surveillance system based on instant messaging was realized for voluntary participants who had been vaccinated at COVID-19 Vaccination Center of the Palermo University Hospital. Overall, 293 vaccinated persons were included in this study, which were more frequently healthcare workers (<i>n</i> = 207, 70.6% with a median age of 36 years, IQR = 29–55) followed by health professional students (<i>n</i> = 31, 10.6% with a median age of 27 years, IQR = 25–29), reporting 82.6% of at least one local or systemic AR. In details, the frequency of at least one local or systemic AR after the second dose of Comirnaty (<i>n</i> = 235, 80.2%) was statistically significant with higher value in comparison to the first one (<i>n</i> = 149, 50.9%; <i>p</i> < 0.001). However, local pain, swelling, joint pain and muscular pain after the second dose were the symptom causing a statistically significant working limitation. The youngest persons showed a higher risk to have either local or systemic ARs (aOR = 7.5, CI 95% = 2.9–18.9), while females had a higher risk of having systemic ARs (aOR = 1.8, CI 95% = 1.1–3.0). Despite the small sample examined, this active surveillance system by instant messaging seems to detect a higher ARs prevalence with respect to data obtained by the passive surveillance. Further studies could be required in order to optimize this clinical monitoring that could be considered an efficient and timely active surveillance.https://www.mdpi.com/2076-393X/10/3/345adverse reactionvaccinecoronavirusSARS-CoV-2m-RNAfemale |
| spellingShingle | Emanuele Amodio Giuseppa Minutolo Alessandra Casuccio Claudio Costantino Giorgio Graziano Walter Mazzucco Alessia Pieri Francesco Vitale Maurizio Zarcone Vincenzo Restivo Adverse Reactions to Anti-SARS-CoV-2 Vaccine: A Prospective Cohort Study Based on an Active Surveillance System Vaccines adverse reaction vaccine coronavirus SARS-CoV-2 m-RNA female |
| title | Adverse Reactions to Anti-SARS-CoV-2 Vaccine: A Prospective Cohort Study Based on an Active Surveillance System |
| title_full | Adverse Reactions to Anti-SARS-CoV-2 Vaccine: A Prospective Cohort Study Based on an Active Surveillance System |
| title_fullStr | Adverse Reactions to Anti-SARS-CoV-2 Vaccine: A Prospective Cohort Study Based on an Active Surveillance System |
| title_full_unstemmed | Adverse Reactions to Anti-SARS-CoV-2 Vaccine: A Prospective Cohort Study Based on an Active Surveillance System |
| title_short | Adverse Reactions to Anti-SARS-CoV-2 Vaccine: A Prospective Cohort Study Based on an Active Surveillance System |
| title_sort | adverse reactions to anti sars cov 2 vaccine a prospective cohort study based on an active surveillance system |
| topic | adverse reaction vaccine coronavirus SARS-CoV-2 m-RNA female |
| url | https://www.mdpi.com/2076-393X/10/3/345 |
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