Characteristics of interstitial lung disease (ILD) and non-ILD cases from VigiBase database: primary analysis (compared COVID-19 vaccines with all other vaccines)
| ILD cases (N=679) | Non-cases (N=6790) | P value | |
| N (%) | N (%) | ||
| Reported quarter (Q) | 0.036 | ||
| 2020.4Q (13 December 2020–31 December 2020) | 0 (0.0) | 19 (0.3) | |
| 2021.1Q (1 January 2021–31 March 2021) | 49 (7.2) | 703 (10.4) | |
| 2021.2Q (1 April 2021–30 June 2021) | 104 (15.3) | 1193 (17.6) | |
| 2021.3Q (1 July 2021–30 September 2021) | 116 (17.1) | 1066 (15.7) | |
| 2021.4Q (1 October 2021–31 December 2021) | 104 (15.3) | 1002 (14.8) | |
| 2022.1Q (1 January 2022–31 March 2022 | 102 (15.0) | 883 (13.0) | |
| 2022.2Q (1 April 2022–30 June 2022) | 80 (11.8) | 820 (12.1) | |
| 2022.3Q (1 July 2022–30 September 2022) | 44 (6.5) | 463 (6.8) | |
| 2022.4Q (1 October 2022–31 December 2022) | 66 (9.7) | 560 (8.3) | |
| 2023.1Q (1 January 2023–26 January 2023) | 14 (2.1) | 81 (1.2) | |
| Age groups | 1 | ||
| 0–27 days | 2 (0.3) | 20 (0.3) | |
| 28 days to 23 months | 26 (3.8) | 260 (3.8) | |
| 2–11 years | 4 (0.6) | 40 (0.6) | |
| 12–17 years | 4 (0.6) | 40 (0.6) | |
| 18–44 years | 92 (13.6) | 920 (13.6) | |
| 45–64 years | 187 (27.5) | 1870 (27.5) | |
| 65–74 years | 144 (21.2) | 1440 (21.2) | |
| ≥75 years | 220 (32.4) | 2200 (32.4) | |
| Sex | 1 | ||
| Male | 356 (52.4) | 3560 (52.4) | |
| Female | 323 (47.6) | 3230 (47.6) | |
| Report type | <0.0001 | ||
| Spontaneous | 618 (91.0) | 6205 (91.4) | |
| Report from study | 54 (8.0) | 317 (4.7) | |
| Other | 7 (1.0) | 267 (3.9) | |
| Not available to sender (unknown) | 0 (0.0) | 1 (0.0) | |
| Vaccines type | |||
| COVID-19 vaccines | 626 (92.2) | 6331 (93.2) | 0.3039 |
| Tozinameran | 376 (55.4) | 3324 (49.0) | 0.0014 |
| Elasomeran | 78 (11.5) | 642 (9.5) | 0.0871 |
| Vaxzevria | 129 (19.0) | 1492 (22.0) | 0.073 |
| Ad26.COV2.S | 8 (1.2) | 224 (3.3) | 0.0024 |
| Gam-COVID-Vac | 0 (0.0) | 2 (0.0) | 0.6547 |
| NVX-CoV2373 | 0 (0.0) | 3 (0.0) | 1.000 |
| Influenza vaccines | 34 (5.0) | 123 (1.8) | <0.0001 |
| Pneumococcal vaccines | 11 (1.6) | 105 (1.6) | 0.8824 |
| Drug known to cause ILD included in the ICSRs* | |||
| Cancer therapy | 17 (2.5) | 10 (0.2) | <0.0001 |
| Rheumatology therapy | 27 (4.0) | 25 (0.4) | <0.0001 |
| Anti-infection agent | 3 (0.4) | 3 (0.0) | 0.0121 |
| Cardiology drugs | 62 (9.1) | 241 (3.6) | <0.0001 |
| Serious | <0.0001 | ||
| Yes | 625 (92.1) | 2323 (34.5) | |
| Seriousness | <0.0001 | ||
| Death | 116 (17.1) | 287 (4.2) | |
| Life threatening | 97 (14.3) | 162 (2.4) | |
| Caused/Prolonged hospitalisation | 285 (42.0) | 582 (8.6) | |
| Disabling/incapacitating | 13 (1.9) | 91 (1.3) | |
| Congenital anomaly/birth defect | 0 (0.0) | 3 (0.0) | |
| Other | 114 (16.8) | 1218 (17.9) | |
| Region | <0.0001 | ||
| African | 4 (0.6) | 364 (5.4) | |
| Americas | 54 (8.0) | 632 (9.3) | |
| South-East Asia | 6 (0.9) | 121 (1.8) | |
| European | 577 (85.0) | 4398 (64.8) | |
| Eastern Mediterranean | 8 (1.2) | 342 (5.0) | |
| Western Pacific | 30 (4.4) | 933 (13.7) | |
| Notifier type | <0.0001 | ||
| Physician | 527 (77.6) | 3675 (54.1) | |
| Pharmacist | 50 (7.4) | 1055 (15.5) | |
| Other health professional | 102 (15.0) | 2060 (30.3) | |
| Time to onset (case=574, non-case=6064) | 0.0077 | ||
| Mean±SD | 32.7±64.7 | 26.6±57.3 | |
| Median (Q1–Q3) | 7 (1–35) | 1 (0–15) | |
*Cancer therapy: bleomycin; gemcitabine; epidermal growth factor receptor-targeted agent (erlotinib, gefitinib, panitumumab, cetuximab); mammalian target of rapamycin-inhibitor (everolimus, temsirolimus, sirolimus); immune checkpoint inhibitor (nivolumab, pembrolizumab, avelumab, durvalumab, ipilimumab), rheumatology drugs: methotrexate; leflunomide, biological disease-modifying anti-rheumatic drugs (tumour necrosis factor) agent (infliximab, etanercept, adalimumab), tocilizumab, rituximab), anti-infection agents (nitrofurantoin, daptomycin, interferon), cardiology drugs (amiodarone, bepridil, statin (lovastatin, simvastatin, pravastatin, atorvastatin, fluvastatin, rosuvastatin, cerivastatin)).
ICSRs, individual case safety reports.