Surveillance of Adverse Events Following Immunization (AEFI) after Third Dose Booster Vaccination with mRNA-Based Vaccine in Universitas Indonesia Hospital Health Personnel
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Population
2.2. Data Collection and Analysis
2.3. Ethical Clearance
3. Results
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
- Ophinni, Y.; Hasibuan, A.S.; Widhani, A.; Maria, S.; Koesnoe, S.; Yunihastuti, E.; Karjadi, T.H.; Rengganis, I.; Djauzi, S. COVID-19 Vaccines: Current Status and Implication for Use in Indonesia. Acta Med. Indones. 2020, 52, 388–412. [Google Scholar] [PubMed]
- Kementerian Kesehatan Republik Indonesia. Vaksinasi COVID-19 Nasional. 2021. Available online: https://vaksin.kemkes.go.id/#/vaccines/ (accessed on 13 January 2022).
- Perhimpunan Dokter Spesialis Penyakit Dalam Indonesia. Vaksinasi COVID-19. 2021. Available online: https://www.papdi.or.id/ (accessed on 29 August 2021).
- PB PAPDI. Teknis Pelaksanaan Vaksin Covid dan Antisipasi KIPI. Available online: https://www.papdi.or.id/pdfs/1001/Dr%20Sukamto%20-%20Ws%20Vaksin%20Covid%20KIPI.pdf (accessed on 28 January 2022).
- Kadali, R.A.K.; Janagama, R.; Peruru, S.; Gajula, V.; Madathala, R.R.; Chennaiahgari, N.; Malayala, S.V. Non-life-threatening adverse effects with COVID-19 mRNA-1273 vaccine: A ran-domized, cross-sectional study on healthcare workers with detailed self-reported symptom. J. Med. Virol. 2021, 93, 4420–4429. [Google Scholar] [CrossRef] [PubMed]
- Hause, A.M.; Baggs, J.; Gee, J.; Marquez, P.; Myers, T.R.; Shimabukuro, T.T.; Shay, D.K. Safety Monitoring of an Additional Dose of COVID-19 Vaccine—United States, August 12–September 19, 2021. Morb. Mortal. Wkly. Rep. 2021, 70, 1379–1384. [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]
- Jackson, L.A.; Anderson, E.J.; Rouphael, N.G.; Roberts, P.C.; Makhene, M.; Coler, R.N.; McCullough, M.P.; Chappell, J.D.; Denison, M.R.; Stevens, L.J.; et al. An mRNA Vaccine against SARS-CoV-2—Preliminary Report. N. Engl. J. Med. 2020, 383, 1920–1931. [Google Scholar] [CrossRef] [PubMed]
- Einstein, E.H.; Shahzadi, A.; Desir, L.; Katz, J.; Boockvar, J.; D’Amico, R. New-Onset Neurologic Symptoms and Related Neuro-Oncologic Lesions Discovered After COVID-19 Vaccination: Two Neurosurgical Cases and Review of Post-Vaccine Inflammatory Responses. Cureus 2021, 13, e15664. [Google Scholar] [CrossRef] [PubMed]
- Desai, P.A.; Desai, P.A.; Loomis, G.J. Relationship between pre-existing allergies and anaphylactic reactions post mRNA COVID-19 vaccine administration. Vaccine 2021, 39, 4407–4409. [Google Scholar] [CrossRef] [PubMed]
- Banerji, A.; Wickner, P.G.; Saff, R.; Stone, C.A., Jr.; Robinson, L.B.; Long, A.A.; Blumenthal, K.G. mRNA Vaccines to Prevent COVID-19 Disease and Reported Allergic Reactions: Current Evidence and Suggested Approach. J. Allergy Clin. Immunol. Pract. 2021, 9, 1423–1437. [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, C.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]
- Meo, S.A.; Bukhari, I.A.; Akram, J.; Meo, A.S.; Klonoff, D.C. COVID-19 vaccines: Comparison of biological, pharmacological characteristics and adverse effects of Pfizer/BioNTech and Moderna Vaccines. Eur. Rev. Med. Pharmacol. Sci. 2021, 25, 1663–1669. [Google Scholar] [CrossRef] [PubMed]
- Alhumaid, S.; Al Mutair, A.; Al Alawi, Z.; Rabaan, A.A.; Tirupathi, R.; Alomari, M.A.; Alshakhes, A.S.; Alshawi, A.M.; Ahmed, G.Y.; Almusabeh, H.M.; et al. Anaphylactic and nonanaphylactic reactions to SARS-CoV-2 vaccines: A systematic review and meta-analysis. Allergy Asthma Clin. Immunol. 2021, 17, 1–24. [Google Scholar] [CrossRef] [PubMed]
- Göbel, C.H.; Heinze, A.; Karstedt, S. Clinical characteristics of headache after vaccination against COVID-19 (coronavirus SARS-CoV-2) with the BNT162b2 mRNA vaccine: A multicentre observational cohort study. Brain Commun. 2021, 3, fcab169. [Google Scholar] [CrossRef] [PubMed]
- CDC: National Center for Immunization and Respiratory Diseases. The Moderna COVID-19 Vaccine’s Local Reactions, Sys-temic Reactions, Adverse Events, and Serious Adverse Events. Available online: https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/reactogenicity.html (accessed on 20 November 2021).
- Menni, C.; Klaser, K.; May, A.; Polidori, L.; Capdevila, J.; Louca, P.; Spector, T.D. Vaccine side-effects and SARS-CoV-2 infection after vaccination in users of the COVID Symptom Study app in the UK: A prospective observational study. Lancet Infect. Dis. 2021, 21, 939–949. [Google Scholar] [CrossRef]
- Iguacel, I.; Maldonado, A.L.; Ruiz-Cabello, A.L.; Casaus, M.; Moreno, L.A.; Martínez-Jarreta, B. Association between COVID-19 Vaccine Side Effects and Body Mass Index in Spain. Vaccines 2021, 9, 1321. [Google Scholar] [CrossRef] [PubMed]
- Kadali, K.A.; Janagama, R.; Yedlapati, H.S. Side effects of messenger RNA vaccines and prior history of COVID-19, a cross-sectional study. Am. J. Infect. Control 2022, 50, 8–14. [Google Scholar] [CrossRef] [PubMed]
- Johnston, M.S.; Galan, A.; Watsky, K.L.; Little, A.J. Delayed Localized Hypersensitivity Reactions to the Moderna COVID-19 Vaccine: A Case Series. JAMA Dermatol. 2021, 157, 716–720. [Google Scholar] [CrossRef] [PubMed]
Characteristic | N (%) | Median (Range) |
---|---|---|
Sex | ||
Male | 69 (22.2%) | |
Female | 242 (77.8%) | |
Age (years) | ||
<25 | 98 (31.5%) | 25 (19–48) |
25–39 | 202 (65%) | |
≥40 | 11 (3.5%) | |
BMI (kg/m2) | ||
Underweight (<18.5) | 40 (12.9%) | 22.86 (15.40–63.29) |
Normal weight (18.5–24.9) | 173 (55.6%) | |
Overweight (≥25) | 71 (22.8%) | |
Obese (≥30) | 27 (8.7%) | |
Comorbidity | 33 (10,6%) | |
History of drug allergy | 28 (9%) | |
History of food allergy | 59 (19%) | |
Other history of allergy | 60 (19.3%) | |
Complains after the 1st or 2nd vaccination | 56 (18%) | |
History of COVID-19 | 68 (21.9%) | |
Exercise after 3rd vaccination | 107 (34.4%) | |
AEFI onset < 24 h | ||
Normal | 109 (35%) | |
Grade I | 161 (51.8%) | |
Grade II | 41 (13.2%) | |
AEFI onset 24–48 h | ||
Normal | 89 (28.6%) | |
Grade I | 172 (55.3%) | |
Grade II | 50 (16.1%) | |
AEFI onset 48 h–7 days | ||
Normal | 253 (81.4%) | |
Grade I | 55 (17.7%) | |
Grade II | 3 (1%) | |
AEFI onset 7–28 days | ||
Normal | 301 (96.8%) | |
Grade I | 8 (2.6%) | |
Grade II | 2 (0.6%) |
Complaint | <24 h (%) | 24–48 h (%) | 48 h–7 Days (%) | 7–28 Days (%) |
---|---|---|---|---|
Pain at injection site | 265 (85.2%) | 240 (77.2%) | 96 (31%) | 14 (4.6%) |
Fever | 118 (38%) | 158 (50.8%) | 14 (4.5%) | 6 (1.9%) |
Shoulder pain | 112 (36.1%) | 160 (51.4%) | 32 (10.3%) | 9 (2.9%) |
Headache | 13 (4.2%) | 104 (33.3%) | 16 (5.1%) | - |
Sore throat | 12 (3.9%) | 8 (2.6%) | - | - |
Diarrhea | 8 (2.6%) | 7 (2.3%) | - | - |
Skin rash | 6 (1.9%) | 8 (2.5%) | 2 (0.6%) | 5 (1.6%) |
Feverish | 3 (0.9%) | 4 (1.3%) | 8 (2.6%) | - |
Malaise | 3 (0.9%) | - | - | - |
Shorter breath | 3 (0.9%) | 4 (1.3%) | - | 2 (0.6%) |
Sleepy | 2 (0.6%) | - | - | |
Nausea | 1 (0.3%) | 6 (1.9%) | - | |
Myalgia | 1 (0.3%) | - | 1 (0.3%) | 3 (1%) |
Tiredness | 1 (0.3%) | - | - | - |
Itch and bruise at injection site | - | 4 (1.3%) | - | - |
Cough | - | 3 (1%) | 5 (1.6%) | 5 (1.6%) |
Palpitation | - | 3 (1%) | - | - |
Weakness | - | 3 (1%) | - | - |
Shivering | - | 2 (0.6%) | - | - |
Leg pain | - | - | - | 2 (0.6%) |
Possible Risk Factors | Severity < 24 h | p-Value | RR (95%CI) | Severity 24–48 h | p-Value | RR (95%CI) | Severity 48 h–7 days | p-Value | RR (95%CI) | Severity 7–28 days | p-Value | RR (95%CI) |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Have AEFI/No AEFI n (%) | Have AEFI/No AEFI n (%) | Have AEFI/No AEFI n (%) | Have AEFI/No AEFI n (%) | |||||||||
Comorbidities | ||||||||||||
Present | 18 (8.9)/15 (13.8) | 0.246 | 0.648 (0.340–1.233) | 26 (11.7)/7 (7.9) | 0.416 | 1.498 (0.671–3.306) | 6 (10.3)/27 (10.7) | 0.980 | 0.969 (0.420–2.239) | 2 (20.0)/31 (10.3) | 0.287 | 1.942 (0.538–7.010) |
Not Present | 184 (91.1)/94 (86.2) | 1.056 (0.969–1.152) | 196 (88.3)/82 (92.1) | 0.958 (0.887–1.035) | 52 (89.7)/226 (89.3) | 1.004 (0.911–1.106) | 8 (80.0)/270 (89.7) | 0.892 (0.653–1.219) | ||||
Drug allergy | ||||||||||||
Present | 24 (11.9)/4 (3.7) | 0.021 * | 3.238 (1.153–9.092) | 20 (9.0)/8 (9.0) | 1.000 | 1.002 (0.458–2.191) | 7 (12.1)/21 (8.3) | 0.443 | 1.454 (0.649–3.257) | 1 (10.0)/27 (9.0) | 1.000 | 1.115 (0.168–7.408) |
Not Present | 178 (88.1)/105 (96.3) | 0.915 (0.859–0.974) | 202 (91.0)/81 (91.0) | 1.000 (0.925–1.080) | 51 (87.9)/232 (91.7) | 0.959 (0.866–1.062) | 9 (90.0)/274 (91.0) | 0.989 (0.802–1.219) | ||||
Food allergy | ||||||||||||
Present | 40 (19.8)/19 (17.4) | 0.652 | 1.136 (0.693–1.862) | 41 (18.5)/18 (20.2) | 0.750 | 0.913 (0.556–1.500) | 7 (12.1)/52 (20.6) | 0.192 | 0.587 (0.281–1.255) | 2(20.0)/57 (18.9) | 1.000 | 1.056 (0.299–3.729) |
Not Present | 162 (80.2)/90 (82.6) | 0.971 (0.870–1.084) | 181 (81.5)/71 (79.8) | 1.022 (0.905–1.155) | 51 (87.9)/201 (79.4) | 1.107 (0.987–1.241) | 8 (80.0)/244 (81.1) | 0.987 (0.720–1.352) | ||||
Other allergies | ||||||||||||
Present | 44 (21.8)/16 (14.7) | 0.136 | 1.484 (0.880–2.503) | 44 (19.8)/16 (18.0) | 0.753 | 1.102 (0.658–1.848) | 13 (22.4)/47 (18.6) | 0.580 | 1.207 (0.700–2.078) | 0 (0.0)/60 (19.9) | 0.218 | – |
Not Present | 158 (78.2)/93 (85.3) | 0.917 (0.824–1.020) | 178 (80.2)/73 (82.0) | 0.978 (0.869–1.099) | 45 (77.6)/206 (81.4) | 0.953 (0.820–1.107) | 10 (100.0)/241 (80.1) | 1.249 (1.181–1.321) | ||||
Complaint following previous COVID-19 vaccination | ||||||||||||
Present | 42 (20.8)/14 (12.8) | 0.054 | 1.619 (0.926–2.829) | 48 (21.6)/8 (9.0) | 0.009* | 2.405 (1.186–4.878) | 16 (27.6)/40 (15.8) | 0.031 * | 1.745 (1.053–2.890) | 6 (60.0)/50 (16.6) | 0.003 * | 3.612 (2.051–6.360) |
Not Present | 160 (79.2)/95 (87.2) | 0.909 (0.822–1.005 | 174 (78.4)/81 (91.0) | 0.861 (0.783–0.947) | 42 (72.4)/213 (84.2) | 0.860 (0.727–1.017) | 4 (40.0)/251 (83.4) | 0.480 (0.224–1.026) | ||||
History of COVID-19 | ||||||||||||
Present | 46 (22.8)/22 (20.2) | 0.667 | 1.128 (0.718–1.772) | 53 (23.9)/15 (16.9) | 0.224 | 1.417 (0.844–2.377) | 20 (34.5)/48 (19.0) | 0.014 * | 1.818 (1.174–2.813) | 3 (30.03)/65 (21.6) | 0.460 | 1.389 (0.526–3.668) |
Not Present | 156 (77.2)/87 (79.8) | 0.958 (0.858–1.091) | 169 (76.1)/74 (83.1) | 0.916 (0.813–1.031) | 38 (65.5)/205 (81.0) | 0.809 (0.665–0.984) | 7 (70.0)/236 (78.4) | 0.893 (0.592–1.345) | ||||
Exercise after 3rd dose vaccination | ||||||||||||
Present | 57 (28.2)/50 (45.9) | 0.003 * | 0.615 (0.456–8.30) | 158 (71.2)/46 (51.7) | 0.001 * | 0.597 (0.443–0.804) | 40 (69.0)/164 (64.8) | 0.646 | 0.882 (0.581–1.341) | 8 (80.0)/196 (65.1) | 0.503 | 0.573 (0.164–1.999) |
Not Present | 145 (71.8)/58 (54.1) | 1.326 (1.093–1.609) | 64 (28.8)/43 (48.3) | 1.377 (1.108–1.712) | 18 (31.0)/89 (32.5) | 1.064 (0.875–1.293) | 2 (20.0)/105 (34.9) | 1.229 (0.891–1.693) | ||||
Age | ||||||||||||
<25 years | 75 (37.1)/23 (21.1) | 0.005 * | 1.760 (1.174–2.638) | 75 (33.8)/23 (25.8) | 0.180 | 1.307 (0.879–1.945) | 17 (29.3)/81 (32.0) | 0.755 | 0.915 (0.591–1.419) | 5 (50.0)/93 (30.9) | 0.297 | 1.618 (0.851–3.076) |
>25 years | 127 (62.9)/86 (78.9) | 0.979 (0.690–0.920) | 147 (66.2)/66 (74.2) | 0.893 (0.765–1.042) | 41 (70.7)/172 (68.0) | 1.040 (0.863–1.252) | 5 (50.0)/208 (69.1) | 0.724 (0.388–1.351) | ||||
BMI | ||||||||||||
<25 | 147 (72.8)/66 (60.6) | 0.030 * | 1.202 (1.010–1.429) | 155 (69.8)/58 (65.2) | 0.422 | 1.071 (0.900–1.276) | 39 (67.1)/174 (68.8) | 0.876 | 0.978 (0.802–1.192) | 5 (50.0)/208 (69.1) | 0.297 | 0.724 (0.388–1.351) |
≥25 | 55 (27.2)/43 (39.4) | 0.690 (0.499–0.954) | 67 (30.2)/31 (34.8) | 0.866 (0.612–1.227) | 19 (32.8)/79 (31.2) | 1.049 (0.695–1.583) | 5 (50.0)/93 (30.9) | 1.618 (0.851–3.076) | ||||
Gender | ||||||||||||
Male | 45 (22.3)/24 (22.0) | 1.000 | 1.012 (0.653–1.567) | 49 (22.1)/20 (22.5) | 1.000 | 0.982 (0.621–1.553) | 12 (20.7)/57 (22.5) | 0.862 | 0.918 (0.528–1.597) | 3 (30.0)/66 (21.9) | 0.467 | 1.368 (0.518–3.611) |
Female | 157 (77.7)/85 (78.0) | 0.997 (0.880–1.128) | 173 (77.9)/69 (77.5) | 1.005 (0.881–1.147) | 46 (79.3)/196 (77.5) | 1.024 (0.884–1.186) | 7 (70.0)/235 (78.1) | 0.897 (0.595–1.351) |
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Hidayat, R.; Mustika, A.P.; Avisha, F.; Djuliannisaa, Z.; Winari, D.D.; Putri, R.A.; Lisman, H.M.; Davin, V.; Widhani, A.; Aini, M.H.; et al. Surveillance of Adverse Events Following Immunization (AEFI) after Third Dose Booster Vaccination with mRNA-Based Vaccine in Universitas Indonesia Hospital Health Personnel. Vaccines 2022, 10, 877. https://doi.org/10.3390/vaccines10060877
Hidayat R, Mustika AP, Avisha F, Djuliannisaa Z, Winari DD, Putri RA, Lisman HM, Davin V, Widhani A, Aini MH, et al. Surveillance of Adverse Events Following Immunization (AEFI) after Third Dose Booster Vaccination with mRNA-Based Vaccine in Universitas Indonesia Hospital Health Personnel. Vaccines. 2022; 10(6):877. https://doi.org/10.3390/vaccines10060877
Chicago/Turabian StyleHidayat, Rakhmad, Alyssa Putri Mustika, Fhathia Avisha, Zlatikha Djuliannisaa, Dinisa Diah Winari, Ria Amiliah Putri, Heydi Marizky Lisman, Vandra Davin, Alvina Widhani, Muhammad Hafiz Aini, and et al. 2022. "Surveillance of Adverse Events Following Immunization (AEFI) after Third Dose Booster Vaccination with mRNA-Based Vaccine in Universitas Indonesia Hospital Health Personnel" Vaccines 10, no. 6: 877. https://doi.org/10.3390/vaccines10060877