Incidence and Characteristics of Adverse Events after COVID-19 Vaccination in a Population-Based Programme
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Triage and Risk Stratification
2.3. Triage for the Second Dose
2.4. Reporting of AEs
2.5. Data Sources
2.6. Definition of Adverse Events
2.7. Statistical Analysis
3. Results
3.1. First Dose
3.2. Second Dose
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
- Palamenghi, L.; Barello, S.; Boccia, S.; Graffigna, G. Mistrust in biomedical research and vaccine hesitancy: The forefront challenge in the battle against COVID-19 in Italy. Eur. J. Epidemiol. 2020, 35, 785–788. [Google Scholar] [CrossRef] [PubMed]
- OurWorldInData. Coronavirus (COVID-19) Vaccinations. Available online: https://ourworldindata.org/covid-vaccinations (accessed on 28 December 2021).
- Ministry of Health of Italy. COVID-19 Vaccines Report. Available online: https://www.governo.it/it/cscovid19/report-vaccini/ (accessed on 22 December 2021).
- Polack, F.P.; Thomas, S.J.; Kitchin, N.; Absalon, J.; Gurtman, A.; Lockhart, S. Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine. N. Engl. J. Med. 2020, 383, 2603–2615. [Google Scholar] [CrossRef] [PubMed]
- Baden, L.R.; El Sahly, H.M.; Essink, B.; Kotloff, K.; Frey, S.; Novak, R.; Diemert, D.; Spector, S.A.; Rouphael, N.; Creech, B.; et al. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N. Engl. J. Med. 2021, 384, 403–416. [Google Scholar] [CrossRef] [PubMed]
- Voysey, M.; Clemens, S.A.C.; Madhi, S.A.; Weckx, L.Y.; Folegatti, P.M.; Aley, P.K.; Angus, B.; Baillie, V.L.; Barnabas, S.L.; Bhorat, Q.E.; et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: An interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet 2021, 397, 99–111. [Google Scholar] [CrossRef]
- Sadoff, J.; Gray, G.; Vandebosch, A.; Cárdenas, V.; Shukarev, G.; Grinsztejn, B.; Goepfert, P.A.; Truyers, C.; Fennema, H.; Spiessens, B.; et al. Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against COVID-19. N. Engl. J. Med. 2021, 384, 2187–2201. [Google Scholar] [CrossRef] [PubMed]
- Beatty, A.L.; Peyser, N.D.; Butcher, X.E.; Cocohoba, J.M.; Lin, F.; Olgin, J.E.; Pletcher, M.J.; Marcus, G.M. Analysis of COVID-19 Vaccine Type and Adverse Effects Following Vaccination. JAMA Netw. Open 2021, 4, e2140364. [Google Scholar] [CrossRef] [PubMed]
- Almohaya, A.M.; Qari, F.; Zubaidi, G.A.; Alnajim, N.; Moustafa, K.; Alshabi, M.M.; Alsubaie, F.M.; Almutairi, I.; Alwazna, Q.; Al-Tawfiq, J.A.; et al. Early solicited adverse events following the BNT162b2 mRNA vaccination, a population survey from Saudi Arabia. Prev. Med. Rep. 2021, 24, 101595. [Google Scholar] [CrossRef] [PubMed]
- Hwang, I.; Park, K.; Kim, T.E.; Kwon, Y.; Lee, Y.K. COVID-19 vaccine safety monitoring in Republic of Korea from February 26, 2021 to October 31, 2021. Osong Public Health Res. Perspect. 2021, 12, 396–402. [Google Scholar] [CrossRef] [PubMed]
- Klein, N.P.; Lewis, N.; Goddard, K.; Fireman, B.; Zerbo, O.; Hanson, K.E.; Donahue, J.G.; Kharbanda, E.O.; Naleway, A.; Nelson, J.C.; et al. Surveillance for Adverse Events After COVID-19 mRNA Vaccination. JAMA 2021, 326, 1390–1399. [Google Scholar] [CrossRef] [PubMed]
- European Medicines Agency. Meeting Highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7–10 February 2022. Available online: https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-7-10-february-2022 (accessed on 1 March 2022).
- García-Grimshaw, M.; Ceballos-Liceaga, S.E.; Hernández-Vanegas, L.E.; Núñez, I.; Hernández-Valdivia, N.; Carrillo-García, D.A.; Michel-Chávez, A.; Galnares-Olalde, J.A.; Carbajal-Sandoval, G.; Del Mar Saniger-Alba, M.; et al. Neurologic adverse events among 704,003 first-dose recipients of the BNT162b2 mRNA COVID-19 vaccine in Mexico: A nationwide descriptive study. Clin. Immunol. 2021, 229, 108786. [Google Scholar] [CrossRef] [PubMed]
- Kewan, T.; Flores, M.; Mushtaq, K.; Alwakeel, M.; Burton, R.; Campbell, J.; Perry, H.; Al-Jaghbeer, M.; Abi Fadel, F. Characteristics and outcomes of adverse events after COVID-19 vaccination. J. Am. Coll. Emerg. Physicians Open 2021, 2, e12565. [Google Scholar] [CrossRef] [PubMed]
- Ughi, N.; Del Gaudio, F.; Dicuonzo, A.; Orso, M.; Micheloni, G.; Puoti, M.; Pani, A.; Scaglione, F.; Zoppini, L.; Rossetti, C.; et al. Host factors and history of SARS-CoV-2 infection impact the reactogenicity of BNT162b2 mRNA vaccine: Results from a cross-sectional survey on 7,014 workers in healthcare. Eur. Rev. Med. Pharmacol. Sci. 2021, 25, 7985–7996. [Google Scholar] [PubMed]
- Valera-Rubio, M.M.; Sierra-Torres, M.I.M.; Castillejo García, R.R.; Cordero-Ramos, J.J.; López-Márquez, M.R.M.; Cruz-Salgado, Ó.O.; Calleja-Hernández, M.Á.M. Adverse events reported after administration of BNT162b2 and mRNA-1273 COVID-19 vaccines among hospital workers: A cross-sectional survey-based study in a Spanish hospital. Expert Rev. Vaccines 2022, 21, 533–540. [Google Scholar] [CrossRef] [PubMed]
- Lim, S.H.; Choi, S.H.; Kim, B.; Kim, J.Y.; Ji, Y.S.; Kim, S.H.; Kim, C.K.; Kim, T.; Choo, E.J.; Moon, J.E.; et al. Serum Antibody Response Comparison and Adverse Reaction Analysis in Healthcare Workers Vaccinated with the BNT162b2 or ChAdOx1 COVID-19 Vaccine. Vaccines 2021, 9, 1379. [Google Scholar] [CrossRef] [PubMed]
- CDC. Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States—Appendix B. Available online: https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html?CDC (accessed on 28 December 2021).
- The Italian Society of Allergy, Asthma and Clinical Immunology (SIAAIC). COVID-19 Vaccines: Guidelines for the Management of Patients at Risk of Allergic Reactions. Available online: https://www.siaaic.org/?p=5949 (accessed on 1 March 2022).
- Italian Medicines Agency. Procedura Operativa AIFA per I Responsabili Locali di Farmacovigilanza: Gestione Delle Segnalazioni Nella Rete Nazionale di Farmacovigilanza. (AIFA Operative Procedure for the Local Persons Responsible for Pharmacovigilance: Management of the Reporting in the National Network of Pharmacovigilance). Available online: https://www.aifa.gov.it/documents/20142/0/Procedura_Operativa_RLFV_ottobre-2018.pdf (accessed on 14 March 2022).
- Shavit, R.; Maoz-Segal, R.; Iancovici-Kidon, M.; Offengenden, I.; Haj Yahia, S.; Machnes Maayan, D.; Lifshitz-Tunitsky, Y.; Niznik, S.; Frizinsky, S.; Deutch, M.; et al. Prevalence of Allergic Reactions After Pfizer-BioNTech COVID-19 Vaccination Among Adults with High Allergy Risk. JAMA Netw. Open 2021, 4, e2122255. [Google Scholar] [CrossRef] [PubMed]
- Italian Agency for Drugs Authorization. COVID-19 Vaccine Safety Annual Report. Available online: https://www.aifa.gov.it/documents/20142/1315190/Rapporto_annuale_su_sicurezza_vaccini%20anti-COVID-19.pdf (accessed on 14 March 2022). (In Italian)
- Gee, J.; Marquez, P.; Su, J.; Calvert, G.M.; Liu, R.; Myers, T.; Nair, N.; Martin, S.; Clark, T.; Markowitz, L.; et al. First Month of COVID-19 Vaccine Safety Monitoring—United States, 14 December 2020–13 January 2021. MMWR Morb. Mortal. Wkly. Rep. 2021, 70, 283–288. [Google Scholar] [CrossRef] [PubMed]
- Chapin-Bardales, J.; Gee, J.; Myers, T. Reactogenicity Following Receipt of mRNA-Based COVID-19 Vaccines. JAMA 2021, 325, 2201–2202. [Google Scholar] [CrossRef] [PubMed]
- Shimabukuro, T.; Nair, N. Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine. JAMA 2021, 325, 780–781. [Google Scholar] [CrossRef] [PubMed]
- Potluri, T.; Fink, A.L.; Sylvia, K.E.; Dhakal, S.; Vermillion, M.S.; Vom Steeg, L.; Deshpande, S.; Narasimhan, H.; Klein, S.L. Age-associated changes in the impact of sex steroids on influenza vaccine responses in males and females. NPJ Vaccines 2019, 4, 29. [Google Scholar] [CrossRef] [PubMed]
- Furman, D.; Hejblum, B.P.; Simon, N.; Jojic, V.; Dekker, C.L.; Thiébaut, R.; Tibshirani, R.J.; Davis, M.M. Systems analysis of sex differences reveals an immunosuppressive role for testosterone in the response to influenza vaccination. Proc. Natl. Acad. Sci. USA 2014, 111, 869–874. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Kovats, S.; Carreras, E.; Agrawal, H. Sex Steroid Receptors in Immune Cells. In Sex Hormones and Immunity to Infection; Klein, S., Roberts, C., Eds.; Springer: Berlin/Heidelberg, Germany, 2010; pp. 53–91. [Google Scholar]
Dose I | Dose II | |||||
---|---|---|---|---|---|---|
N of AEs | N of Vaccinated | Incidence (95% CI) | N of AEs | N of Vaccinated | Incidence (95% CI) | |
Overall | 521 | 182,056 | 286.2 (262.2–311.8) | 322 | 169,191 | 190.3 (170.1–212.3) |
Severity | ||||||
Severe | 45 | 182,056 | 24.7 (18.0–33.1) | 27 | 169,191 | 16.0 (10.5–23.2) |
Other clinically relevant condition | 20 | 11 | ||||
Death | 3 | 4 | ||||
Severe or permanent disability | 0 | 1 | ||||
(Prolonged) hospitalisation | 20 | 5 | ||||
Life-threatening condition | 2 | 6 | ||||
Not severe | 476 | 182,056 | 261.5 (238.5–286.0) | 295 | 169,191 | 174.4 (155.0–195.4) |
Onset time | ||||||
Immediate (≤24 h) | 409 | 182,056 | 224.7 (203.4–247.5) | 273 | 169,191 | 161.4 (142.8–181.7) |
Non-immediate (>24 h) | 112 | 182,056 | 61.5 (50.7–74.0) | 49 | 169,191 | 29.0 (21.4–38.3) |
Local vs. systemic AE | ||||||
Local | 36 | 182,056 | 19.8 (13.9–27.4) | 14 | 169,191 | 8.3 (4.5–13.9) |
Systemic | 445 | 182,056 | 244.4 (222.3–268.2) | 284 | 169,191 | 167.9 (148.9–188.5) |
Insufficient information | 40 | 182,056 | 22.0 (15.7–29.9) | 24 | 169,191 | 14.2 (9.1–21.1) |
Allergic vs. not allergic AE | ||||||
Allergic | 2 | 182,056 | 1.1 (0.1–4.0) | 4 | 169,191 | 2.4 (0.6–6.1) |
Not allergic | 483 | 182,056 | 265.3 (242.2–290.0) | 302 | 169,191 | 178.5 (159.0–199.8) |
Doubtful | 33 | 182,056 | 18.1 (12.5–25.5) | 12 | 169,191 | 7.1 (3.7–12.4) |
Insufficient information | 3 | 182,056 | 1.7 (0.3–4.8) | 4 | 169,191 | 2.4 (0.6–6.1) |
Type of reporter | ||||||
Self-reported | 281 | 182,056 | 154.4 (136.8–173.5) | 133 | 169,191 | 78.6 (65.8–93.2) |
Health worker | 240 | 182,056 | 131.8 (115.7–149.6) | 189 | 169,191 | 111.7 (96.4–128.8) |
Sex | ||||||
Male | 140 | 78,883 | 177.5 (149.3–209.4) | 82 | 73,230 | 112.0 (89.1–139.0) |
Female | 381 | 103,176 | 369.3 (333.2–408.2) | 240 | 95,961 | 250.1 (219.5–283.8) |
Age | ||||||
<50 | 219 | 37,849 | 578.6 (504.7–660.3) | 162 | 35,144 | 461.0 (392.8–537.5) |
50–59 | 104 | 24,844 | 418.6 (342.2–507.0) | 73 | 23,094 | 316.1 (247.9–397.3) |
60–69 | 84 | 41,101 | 204.4 (163.1–253.0) | 39 | 36,375 | 107.2 (76.3–146.5) |
70–79 | 85 | 43,174 | 196.9 (157.3–243.4) | 22 | 40,843 | 53.9 (33.8–81.5) |
80+ | 29 | 35,088 | 82.6 (55.4–118.7) | 26 | 33,735 | 77.1 (50.4–112.9) |
Vaccine type | ||||||
Pfizer/Moderna | 212 | 124,852 | 169.8 (147.7–194.2) | 294 | 116,738 | 251.8 (223.9–828.3) |
AZ/JJ | 309 | 57,204 | 540.2 (481.8–603.7) | 28 | 52,453 | 53.4 (35.5–77.1) |
Vaccination motive | ||||||
Population | 184 | 97,711 | 188.3 (162.1–217.5) | 63 | 91,652 | 68.7 (52.8–87.9) |
Comorbidity | 58 | 45,349 | 127.9 (97.1–165.3) | 71 | 41,032 | 173.0 (135.2–218.2) |
Long-term care facility (LTCF) | 4 | 3148 | 127.1 (34.6–325.0) | 2 | 2669 | 74.9 (9.1–270.4) |
Work | 275 | 35,848 | 767.1 (679.4–863.0) | 186 | 33,838 | 549.7 (473.7–634.3) |
Previous SARS-CoV-2 infection | ||||||
No | 485 | 173,444 | 279.6 (255.3–305.6) | 312 | 165,468 | 188.6 (168.2–210.7) |
Yes | 36 | 8612 | 418.0 (292.9–578.3) | 10 | 3723 | 268.6 (128.9–493.4) |
Dose I | |||||||||
---|---|---|---|---|---|---|---|---|---|
Green Pathway | Yellow Pathway without Allergology Visit | Yellow Pathway with Allergology Visit | |||||||
N of AEs | N of Vaccinated | Incidence (95% CI) | N of AEs | N of Vaccinated | Incidence (95% CI) | N of AEs | N of Vaccinated | Incidence (95% CI) | |
Overall | 518 | 180,305 | 287.3 (263.1–313.1) | 2 | 1601 | 124.9 (15.1–450.5) | 1 | 150 | 666.7 (16.9–3658.3) |
Severity | |||||||||
Severe | 45 | 180,305 | 25.0 (18.2–33.4) | 0 | 1601 | 0 | 0 | 150 | 0 |
Other clinically relevant condition | 20 | 0 | 0 | ||||||
Death | 3 | 0 | 0 | ||||||
Severe or permanent disability | 0 | 0 | 0 | ||||||
(Prolonged) hospitalisation | 20 | 0 | 0 | ||||||
Life threatening condition | 2 | 0 | 0 | ||||||
Not severe | 473 | 180,305 | 262.3 (239.3–287.0) | 2 | 1601 | 124.9 (15.1–450.5) | 1 | 150 | 666.7 (16.9–3658.3) |
Onset time | |||||||||
Immediate (≤24 h) | 407 | 180,305 | 225.7 (204.4–248.7) | 1 | 1601 | 62.5 (1.6–347.5) | 1 | 150 | 666.7 (16.9–3658.3) |
Non-immediate (>24 h) | 111 | 180,305 | 61.6 (50.7–74.1) | 1 | 1601 | 62.5 (1.6–347.5) | 0 | 150 | 0 |
Local vs. systemic AE | |||||||||
Local | 36 | 180,305 | 20.0 (14.0–27.6) | 0 | 1601 | 0 | 0 | 150 | 0 |
Systemic | 442 | 180,305 | 245.1 (222.8–269.1) | 2 | 1601 | 124.9 (15.1–450.5) | 1 | 150 | 666.7 (16.9–3658.3) |
Insufficient information | 40 | 180,305 | 22.2 (15.9–30.2) | 0 | 1601 | 0 | 0 | 150 | 0 |
Allergic vs. not allergic AE | |||||||||
Allergic | 2 | 180,305 | 1.1 (0.1–4.0) | 0 | 1601 | 0 | 0 | 150 | 0 |
Not allergic | 481 | 180,305 | 266.8 (243.5–291.7) | 1 | 1601 | 62.5 (1.6–347.5) | 1 | 150 | 666.7 (16.9–3658.3) |
Doubtful | 32 | 180,305 | 17.8 (12.1–25.1) | 1 | 1601 | 62.5 (1.6–347.5) | 0 | 150 | 0 |
Insufficient information | 3 | 180,305 | 1.7 (0.3–4.9) | 0 | 1601 | 0 | 0 | 150 | 0 |
Type of reporter | |||||||||
Self-reported | 279 | 180,305 | 154.7 (137.1–174.0) | 1 | 1601 | 62.5 (1.6–347.5) | 1 | 150 | 666.7 (16.9–3658.3) |
Health worker | 239 | 180,305 | 132.6 (116.3–150.5) | 1 | 1601 | 62.5 (1.6–347.5) | 0 | 150 | 0 |
Sex | |||||||||
Male | 139 | 78,299 | 177.5 (149.3–209.5) | 1 | 565 | 177.0 (4.5–982.2) | 0 | 19 | 0 |
Female | 379 | 102,006 | 371.5 (335.1–410.8) | 1 | 1039 | 96.2 (2.4–535.1) | 1 | 131 | 763.4 (19.3–4179.7) |
Age | |||||||||
<50 | 219 | 37,690 | 581.1 (506.8–663.1) | 0 | 127 | 0 | 0 | 32 | 0 |
50–59 | 103 | 24,671 | 417.5 (340.9–506.1) | 0 | 141 | 0 | 1 | 32 | 3125.0 (79.1–16,217.1) |
60–69 | 83 | 40,837 | 203.2 (161.9–251.9) | 1 | 240 | 416.7 (10.6–2299.5) | 0 | 24 | 0 |
70–79 | 84 | 42,130 | 199.4 (159.1–246.8) | 1 | 1012 | 98.8 (2.5–549.3) | 0 | 32 | 0 |
80+ | 29 | 34,977 | 82.9 (55.5–119.1) | 0 | 81 | 0 | 0 | 30 | 0 |
Vaccine type | |||||||||
Pfizer/Moderna | 209 | 123,101 | 169.8 (147.6–194.4) | 2 | 1601 | 124.9 (15.1–450.5) | 1 | 150 | 666.7 (16.9–3658.3) |
AZ/JJ | 309 | 57,204 | 540.2 (481.8–603.7) | 0 | 0 | - | 0 | 0 | - |
Vaccination motive | |||||||||
Population | 183 | 97,168 | 188.3 (162.1–217.7) | 1 | 475 | 210.5 (5.3–1167.4) | 0 | 68 | 0 |
Comorbidity | 57 | 44,273 | 128.7 (97.5–166.8) | 1 | 1027 | 97.4 (2.5–541.3) | 0 | 49 | 0 |
Long-term care facility (LTCF) | 4 | 3147 | 127.1 (34.6–325.1) | 0 | 1 | 0 | 0 | 0 | - |
Work | 274 | 35,717 | 767.1 (679.3–863.2) | 0 | 98 | 0 | 1 | 33 | 3030.3 (76.7–15,759.4) |
Dose II | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Green Pathway | Yellow Pathway | |||||||||||
Reaction to Dose I | No Reaction to Dose I | Reaction to Dose I | No Reaction to Dose I | |||||||||
N of AEs | N of Vaccinated | Incidence (95% CI) | N of AEs | N of Vaccinated | Incidence (95% CI) | N of AEs | N of Vaccinated | Incidence (95% CI) | N of AEs | N of Vaccinated | Incidence (95% CI) | |
Overall | 3 | 39 | 7692.3 (1615.3–20,870.2) | 315 | 167,468 | 188.1 (167.9–210.0) | 0 | 1 | 0 | 4 | 1683 | 237.7 (64.8–607.4) |
Severity | ||||||||||||
Severe | 0 | 26 | 167,468 | 15.5 (10.1–22.8) | 0 | 1 | 1683 | 59.4 (1.5–330.6) | ||||
Other clinically relevant condition | 0 | 11 | 0 | 0 | ||||||||
Death | 0 | 4 | 0 | 0 | ||||||||
Severe or permanent disability | 0 | 1 | 0 | 0 | ||||||||
(Prolonged) hospitalisation | 0 | 5 | 0 | 0 | ||||||||
Life threatening condition | 0 | 5 | 0 | 1 | ||||||||
Not severe | 3 | 39 | 7692.3 (1615.3–20,870.2) | 289 | 167,468 | 172.6 (153.3–193.6) | 0 | 1 | 0 | 3 | 1683 | 178.3 (36.8–520.0) |
Onset time | ||||||||||||
Immediate (≤24 h) | 2 | 39 | 5128.2 (672.2–17,324.5) | 267 | 167,468 | 159.4 (140.9–179.7) | 0 | 1 | 0 | 4 | 1683 | 237.7 (64.8–607.4) |
Non-immediate (>24 h) | 1 | 39 | 2564.1 (64.9–13,476.4) | 48 | 167,468 | 28.7 (21.1–38.0) | 0 | 1 | 0 | 0 | 1683 | 0 |
Local vs. systemic AE | ||||||||||||
Local | 0 | 39 | 0 | 14 | 167,468 | 8.4 (4.6–14.0) | 0 | 1 | 0 | 0 | 1683 | 0 |
Systemic | 3 | 39 | 7692.3 (1615.3–20,870.2 | 277 | 167,468 | 165.4 (146.5–186.1) | 0 | 1 | 0 | 4 | 1683 | 237.7 (64.8–607.4) |
Insufficient information | 0 | 39 | 0 | 24 | 167,468 | 14.3 (9.2–21.3) | 0 | 1 | 0 | 0 | 1683 | 0 |
Allergic vs. not allergic reactions | ||||||||||||
Allergic | 0 | 39 | 0 | 4 | 167,468 | 2.4 (0.7–6.1) | 0 | 1 | 0 | 0 | 1683 | 0 |
Not allergic | 3 | 39 | 7692.3 (1615.3–20,870.2 | 296 | 167,468 | 176.8 (157.2–198.1) | 0 | 1 | 0 | 3 | 1683 | 178.3 (36.8–520.0) |
Doubtful | 0 | 39 | 0 | 11 | 167,468 | 6.6 (3.3–11.8) | 0 | 1 | 0 | 1 | 1683 | 59.4 (1.5–330.6) |
Insufficient information | 0 | 39 | 0 | 4 | 167,468 | 2.4 (0.7–6.1) | 0 | 1 | 0 | 0 | 1683 | 0 |
Type of reporter | ||||||||||||
Self-reported | 0 | 39 | 0 | 132 | 167,468 | 78.8 (66.0–93.5) | 0 | 1 | 0 | 1 | 1683 | 59.4 (1.5–330.6) |
Healthcare worker | 3 | 39 | 7692.3 (1615.3–20,870.2 | 183 | 167,468 | 109.3 (94.0–126.3) | 0 | 1 | 0 | 3 | 1683 | 178.3 (36.8–520.0) |
Sex | ||||||||||||
Male | 0 | 3 | 0 | 80 | 72,664 | 110.1 (87.3–137.0) | 0 | 0 | - | 2 | 563 | 355.2 (43.1–1277.3) |
Female | 3 | 36 | 8333.3 (1752.7–22,469.0) | 235 | 94,804 | 247.9 (217.2–281.6) | 0 | 1 | 0 | 2 | 1120 | 178.6 (21.6–643.6) |
Age | ||||||||||||
<50 | 1 | 15 | 6666.7 (168.6–31,948.5) | 160 | 34,982 | 457.4 (389.4–533.8) | 0 | 0 | - | 1 | 147 | 680.3 (17.2–3731.8) |
50–59 | 2 | 13 | 15,384.6 (1920.7–45,447.1) | 69 | 22,920 | 301.1 (234.3–380.8) | 0 | 1 | 0 | 2 | 160 | 1250.0 (151.7–4442.3) |
60–69 | 0 | 2 | 0 | 39 | 36,123 | 108.0 (76.8–147.6) | 0 | 0 | - | 0 | 250 | 0 |
70–79 | 0 | 6 | 0 | 21 | 39,813 | 52.7 (32.7–80.6) | 0 | 0 | - | 1 | 1024 | 97.7 (2.5–542.9) |
80+ | 0 | 3 | 0 | 26 | 33,630 | 77.3 (50.5–113.3) | 0 | 0 | - | 0 | 102 | 0 |
Vaccine type | ||||||||||||
Pfizer/Moderna | 3 | 34 | 8823.5 (1858.0–23,677.5) | 287 | 115,020 | 249.5 (221.5–280.1) | 0 | 1 | 0 | 4 | 1683 | 237.7 (64.8–607.4) |
AZ/JJ | 0 | 5 | 0 | 28 | 52,448 | 53.4 (35.5–77.2) | 0 | 0 | - | 0 | 0 | - |
Vaccination motive | ||||||||||||
Population | 0 | 9 | 0 | 62 | 91,127 | 68.0 (52.2–87.2) | 0 | 0 | - | 1 | 516 | 193.8 (4.9–1075.0) |
Comorbidity | 0 | 4 | 0 | 70 | 39,981 | 175.1 (136.5–221.2) | 0 | 0 | - | 1 | 1047 | 95.5 (2.4–531.0) |
Long-term care facility (LTCF) | 0 | 0 | - | 2 | 2668 | 75.0 (9.1–270.5) | 0 | 0 | - | 0 | 1 | 0 |
Work | 3 | 26 | 11,538.5 (2445.8–30,154.0) | 181 | 33692 | 537.2 (462.0–621.2) | 0 | 1 | 0 | 2 | 119 | 1680.7 (204.2–5939.3) |
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Bonzano, L.; Djuric, O.; Mancuso, P.; Fares, L.; Brancaccio, R.; Ottone, M.; Bisaccia, E.; Vicentini, M.; Cocconcelli, A.; Motolese, A.; et al. Incidence and Characteristics of Adverse Events after COVID-19 Vaccination in a Population-Based Programme. Vaccines 2022, 10, 1111. https://doi.org/10.3390/vaccines10071111
Bonzano L, Djuric O, Mancuso P, Fares L, Brancaccio R, Ottone M, Bisaccia E, Vicentini M, Cocconcelli A, Motolese A, et al. Incidence and Characteristics of Adverse Events after COVID-19 Vaccination in a Population-Based Programme. Vaccines. 2022; 10(7):1111. https://doi.org/10.3390/vaccines10071111
Chicago/Turabian StyleBonzano, Laura, Olivera Djuric, Pamela Mancuso, Lidia Fares, Raffaele Brancaccio, Marta Ottone, Eufemia Bisaccia, Massimo Vicentini, Alessia Cocconcelli, Alfonso Motolese, and et al. 2022. "Incidence and Characteristics of Adverse Events after COVID-19 Vaccination in a Population-Based Programme" Vaccines 10, no. 7: 1111. https://doi.org/10.3390/vaccines10071111
APA StyleBonzano, L., Djuric, O., Mancuso, P., Fares, L., Brancaccio, R., Ottone, M., Bisaccia, E., Vicentini, M., Cocconcelli, A., Motolese, A., Boyko, R., Giorgi Rossi, P., & Motolese, A. (2022). Incidence and Characteristics of Adverse Events after COVID-19 Vaccination in a Population-Based Programme. Vaccines, 10(7), 1111. https://doi.org/10.3390/vaccines10071111