Serious Safety Signals and Prediction Features Following COVID-19 mRNA Vaccines Using the Vaccine Adverse Event Reporting System
Abstract
:1. Introduction
2. Results
2.1. ICSRs by Demographic Characteristics
2.2. Serious AEFIs
2.3. Disproportionality Analysis for Signal Detection of Serious AEFIs
2.4. Predicting the Incidence of the Serious AEFIs and the Associated Features
3. Discussion
4. Materials and Methods
4.1. Data Source
4.2. Patient Medical History Coding
4.3. Study Design
4.3.1. Incidences of ICSR and Serious AEFI
4.3.2. Signal Detection for Serious AEFI
4.3.3. Prediction for Serious AEFIs
4.4. Statistical Analysis
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Characteristics | Pfizer–BioNTech Vaccine (BNT162b2) (n = 266,369) | Moderna Vaccine (mRNA-1273) (n = 288,664) | |||
---|---|---|---|---|---|
Serious ICSR (n = 28,267) | Non-Serious ICSR (n = 238,102) | Serious ICSR (n = 23,231) | Non-Serious ICSR (n = 265,433) | ||
n (%) | n (%) | n (%) | n (%) | ||
Sex | Female | 15,368 (54.4) | 172,592 (72.5) | 12,132 (52.2) | 196,952 (74.2) |
Male | 12,899 (45.6) | 65,510 (27.5) | 11,099 (47.8) | 68,481 (25.8) | |
Age (years) | Average ± SD | 60.9 ± 19.0 | 48.4 ± 16.7 | 63.0 ± 18.5 | 52.5 ± 17.5 |
18–64 | 14,784 (52.3) | 192,886 (81.0) | 10,907 (47.0) | 187,333 (70.6) | |
over 65 | 13,483 (47.7) | 45,216 (19.0) | 12,324 (53.1) | 78,100 (29.4) | |
Time to onset of AEFIs (days) | 0–7 | 12,004 (42.5) | 194,233 (81.6) | 10,612 (45.7) | 199,417 (75.1) |
>7 | 15,398 (54.5) | 32,432 (13.6) | 11,934 (51.4) | 51,702 (19.5) | |
Unknown | 865 (3.1) | 11,437 (4.8) | 685 (3.0) | 14,314 (5.4) | |
Emergency room or urgent care visit | Visit | 12,024 (42.5) | 29,810 (12.5) | 9041 (38.9) | 22,932 (8.6) |
No visit | 16,243 (57.5) | 208,292 (87.5) | 14,190 (61.1) | 242,501 (91.4) | |
Doctor or other healthcare provider office/clinic visit | Visit | 8005 (28.3) | 55,531 (23.3) | 5915 (25.5) | 50,206 (18.9) |
No visit | 20,262 (71.7) | 182,571 (76.7) | 17,316 (74.5) | 215,227 (81.1) | |
Prognosis after the AEFIs | Recovered | 4734 (16.8) | 79,115 (33.2) | 4639 (20.0) | 97,522 (36.7) |
Not recovered | 14,290 (50.6) | 94,345 (39.6) | 11,226 (48.3) | 90,091 (33.9) | |
Unknown | 9243 (32.7) | 64,642 (27.2) | 7366 (31.7) | 77,820 (29.3) | |
Top 5 comorbidity * | Hypertension | 6247 (22.1) | 23,523 (9.9) | 5215 (22.5) | 24,228 (9.1) |
Type 2 diabetes mellitus | 3470 (12.3) | 10,763 (4.5) | 2992 (12.9) | 11,357 (4.3) | |
Hyperlipidemia | 3028 (10.7) | 8912 (3.7) | 2543 (11.0) | 9485 (3.6) | |
Asthma | 1428 (5.1) | 14,640 (6.2) | 1068 (4.6) | 13,541 (5.1) | |
Hypothyroid disease | 1339 (4.7) | 8756 (3.7) | 1206 (5.2) | 8682 (3.3) | |
Unknown or vague description | 12,751 (45.1) | 130,241 (54.7) | 10,907 (47.0) | 168,965 (63.7) |
SOC | PT | Serious AEFI (Total n = 271,444) | Pfizer–BioNTech Vaccine (BNT162b2) (n = 150,575) | Moderna Vaccine (mRNA-1273) (n = 120,869) | |||
---|---|---|---|---|---|---|---|
n | % | n | % | n | % | ||
General disorders and administration site conditions | Death | 7694 | 2.8 | 4021 | 2.7 | 3673 | 3.0 |
Pyrexia | 6536 | 2.4 | 3455 | 2.3 | 3081 | 2.6 | |
Fatigue | 5668 | 2.1 | 3160 | 2.1 | 2508 | 2.1 | |
Asthenia | 5183 | 1.9 | 2765 | 1.8 | 2418 | 2.0 | |
Pain | 4336 | 1.6 | 2420 | 1.6 | 1916 | 1.6 | |
Chest pain | 4333 | 1.6 | 2439 | 1.6 | 1894 | 1.6 | |
Condition aggravated | 3927 | 1.5 | 2200 | 1.5 | 1727 | 1.4 | |
Chills | 3168 | 1.2 | 1659 | 1.1 | 1509 | 1.3 | |
Malaise | 2648 | 1.0 | 1375 | 0.9 | 1273 | 1.1 | |
Others | 17,656 | 6.5 | 9205 | 6.1 | 8451 | 7.0 | |
Total | 61,149 | 22.5 | 32,699 | 21.7 | 28,450 | 23.5 | |
Nervous system disorders | Headache | 4517 | 1.7 | 2463 | 1.6 | 2054 | 1.7 |
Dizziness | 3503 | 1.3 | 1943 | 1.3 | 1560 | 1.3 | |
Cerebrovascular accident | 2230 | 0.8 | 1139 | 0.8 | 1091 | 0.9 | |
Hypoaesthesia | 2156 | 0.8 | 1264 | 0.8 | 892 | 0.7 | |
Others | 27,345 | 10.1 | 14,981 | 10.0 | 12,364 | 10.2 | |
Total | 39,751 | 14.6 | 21,790 | 14.5 | 17,961 | 14.9 | |
Respiratory, thoracic, and mediastinal disorders | Dyspnoea | 10,752 | 4.0 | 6042 | 4.0 | 4710 | 3.9 |
Cough | 5039 | 1.9 | 3093 | 2.1 | 1946 | 1.6 | |
Pulmonary embolism | 2396 | 0.9 | 1237 | 0.8 | 1159 | 1.0 | |
Hypoxia | 2259 | 0.8 | 1280 | 0.9 | 979 | 0.8 | |
Others | 18,195 | 6.7 | 10,457 | 6.9 | 7738 | 6.4 | |
Total | 38,641 | 14.2 | 22,109 | 14.7 | 16,532 | 13.7 | |
Infections and infestations | COVID-19 | 14,143 | 5.2 | 8628 | 5.7 | 5515 | 4.6 |
COVID-19 pneumonia | 2907 | 1.1 | 1831 | 1.2 | 1076 | 0.9 | |
Pneumonia | 2065 | 0.8 | 1115 | 0.7 | 950 | 0.8 | |
Others | 9189 | 3.4 | 5324 | 3.5 | 3865 | 3.2 | |
Total | 28,304 | 10.4 | 16,898 | 11.2 | 11,406 | 9.4 | |
Gastrointestinal disorders | Nausea | 3960 | 1.5 | 2155 | 1.4 | 1805 | 1.5 |
Vomiting | 3096 | 1.1 | 1652 | 1.1 | 1444 | 1.2 | |
Diarrhea | 2567 | 1.0 | 1493 | 1.0 | 1074 | 0.9 | |
Others | 9278 | 3.4 | 5155 | 3.4 | 4123 | 3.4 | |
Total | 18,901 | 7.0 | 10,455 | 6.9 | 8446 | 7.0 | |
Musculoskeletal and connective tissue disorders | Pain in extremity | 3047 | 1.1 | 1668 | 1.1 | 1379 | 1.1 |
Arthralgia | 2209 | 0.8 | 1239 | 0.8 | 970 | 0.8 | |
Others | 11,886 | 4.4 | 6556 | 4.4 | 5330 | 4.4 | |
Total | 17,142 | 6.3 | 9463 | 6.3 | 7679 | 6.4 |
SOC | Pfizer–BioNTech Vaccine (BNT162b2) ROR [95% CI] | Moderna Vaccine (mRNA-1273) ROR [95% CI] |
---|---|---|
Cardiac disorders | 3.12 [2.91–3.34] | 3.24 [3.02–3.48] |
Infections and infestations | 2.62 [2.50–2.75] | 2.16 [2.06–2.27] |
Renal and urinary disorders | 2.18 [1.95–2.44] | 2.04 [1.82–2.28] |
PT | Pfizer–BioNTech Vaccine (BNT162b2) | Moderna Vaccine (mRNA-1273) | ||
---|---|---|---|---|
n | ROR [95% CI] | n | ROR [95% CI] | |
Acute myocardial infarction | 467 | 10.75 [6.20–18.66] | 358 | 10.27 [5.90–17.86] |
Pulmonary embolism | 1237 | 8.27 [6.14–11.13] | 1159 | 9.66 [7.17–13.02] |
Acute kidney injury | 1001 | 7.51 [5.48–10.31] | 620 | 5.79 [4.20–7.97] |
Myocardial infarction | 526 | 3.84 [2.79–5.28] | 500 | 4.55 [3.31–6.26] |
Atrial fibrillation | 814 | 3.54 [2.76–4.52] | 703 | 3.81 [2.97–4.87] |
Cerebrovascular accident | 1139 | 3.49 [2.84–4.29] | 1091 | 4.17 [3.39–5.13] |
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Choi, J.Y.; Lee, Y.; Park, N.G.; Kim, M.S.; Rhie, S.J. Serious Safety Signals and Prediction Features Following COVID-19 mRNA Vaccines Using the Vaccine Adverse Event Reporting System. Pharmaceuticals 2024, 17, 356. https://doi.org/10.3390/ph17030356
Choi JY, Lee Y, Park NG, Kim MS, Rhie SJ. Serious Safety Signals and Prediction Features Following COVID-19 mRNA Vaccines Using the Vaccine Adverse Event Reporting System. Pharmaceuticals. 2024; 17(3):356. https://doi.org/10.3390/ph17030356
Chicago/Turabian StyleChoi, Jung Yoon, Yongjoon Lee, Nam Gi Park, Mi Sung Kim, and Sandy Jeong Rhie. 2024. "Serious Safety Signals and Prediction Features Following COVID-19 mRNA Vaccines Using the Vaccine Adverse Event Reporting System" Pharmaceuticals 17, no. 3: 356. https://doi.org/10.3390/ph17030356