Association between COVID-19 Vaccines and Menstrual Disorders: Retrospective Cohort Study of Women Aged 12–55 Years Old in Catalonia, Spain
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design, Setting, and Data Sources
2.2. Population
2.3. Variables
2.3.1. Exposure
2.3.2. Outcome
2.3.3. Covariates
2.4. Statistical Analysis
3. Results
3.1. Heavy Menstrual Bleeding
3.1.1. Socio-Demographic Characteristics
3.1.2. Chronic Degenerative Diseases
3.1.3. Hormonal Medication Use
3.1.4. Lifestyle
3.1.5. History of COVID-19
3.1.6. Vaccination Status and Incidence Rate of Heavy Menstrual Bleeding
3.1.7. Association between COVID-19 Vaccination and Heavy Menstrual Bleeding by Types and Doses
3.2. Amenorrhea
3.2.1. Socio-Demographic Characteristics
3.2.2. Chronic Degenerative Diseases
3.2.3. Hormonal Medication Use
3.2.4. Lifestyle
3.2.5. History of COVID-19
3.2.6. Vaccination Status and Incidence Rate of Amenorrhea
3.2.7. Association between COVID-19 Vaccination and Amenorrhea by Types and Doses
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Heavy Menstrual Bleeding | Amenorrhea | |||||
---|---|---|---|---|---|---|
yes | no | yes | no | |||
(n = 25,014) | (n = 1,147,607) | (n = 37,923) | (n = 1,134,698) | |||
Socio-demographic and socioeconomic characteristics | ||||||
Country of Birth | *** | *** | ||||
Out of Spain | 5266 (26.5) | 182,041 (20.8) | 7574 (25.1) | 179,733 (20.8) | ||
Spain | 14,597 (73.5) | 691,697 (79.2) | 22,654 (74.9) | 683,640 (79.2) | ||
Missing | 5151 | 273,869 | 7695 | 271,325 | ||
Age (in years) | *** | *** | ||||
Mean (SD) | 36.50 (11.25) | 35.61 (12.50) | 28.38 (11.28) | 35.87 (12.44) | ||
Median | 39.60 | 37.40 | 26.70 | 37.80 | ||
Q1–Q3 | 28.70–45.30 | 25.30–46.30 | 18.00–38.50 | 25.80–46.40 | ||
Min–Max | 12.00–55.00 | 12.00–55.00 | 12.00–55.00 | 12.00–55.00 | ||
Age (by groups) | *** | *** | ||||
12–18 | 2562 (10.2) | 143,783 (12.5) | 9289 (24.5) | 137,056 (12.1) | ||
19–25 | 2254 (9.0) | 134,618 (11.7) | 7975 (21.0) | 128,897 (11.4) | ||
26–35 | 4416 (17.7) | 231,483 (20.2) | 8464 (22.3) | 227,435 (20.0) | ||
36–45 | 9069 (36.3) | 307,643 (26.8) | 8801 (23.2) | 307,911 (27.1) | ||
46–55 | 6713 (26.8) | 330,080 (28.8) | 3394 (8.9) | 333,399 (29.4) | ||
Socioeconomic index MEDEA | *** | *** | ||||
Q1 | 627 (14.4) | 40,723 (21.0) | 982 (15.3) | 40,368 (21.0) | ||
Q2 | 857 (19.7) | 39,770 (20.5) | 1188 (18.5) | 39,439 (20.5) | ||
Q3 | 956 (22.0) | 39,335 (20.3) | 1287 (20.1) | 39,004 (20.3) | ||
Q4 | 967 (22.2) | 38,183 (19.7) | 1430 (22.3) | 37,720 (19.6) | ||
Q5 | 941 (21.6) | 36,064 (18.6) | 1529 (23.8) | 35,476 (18.5) | ||
Missing | 20,666 | 953,532 | 31,507 | 942,691 | ||
Concomitant chronic-degenerative diseases | ||||||
Type 1 and 2 Diabetes Mellitus | *** | *** | ||||
Yes | 445 (1.8) | 13,659 (1.2) | 389 (1.0) | 13,715 (1.2) | ||
No | 24,569 (98.2) | 1,133,948 (98.8) | 37,534 (99.0) | 1,120,983 (98.8) | ||
HIV | * | * | ||||
Yes | 4 (0.0) | 255 (0.0) | 4 (0.0) | 255 (0.0) | ||
No | 25,010 (100.0) | 1,147,352 (100.0) | 37,919 (100.0) | 1,134,443 (100.0) | ||
Hypertension | *** | *** | ||||
Yes | 1418 (5.7) | 42,634 (3.7) | 858 (2.3) | 43,194 (3.8) | ||
No | 23,596 (94.3) | 1,104,973 (96.3) | 37,065 (97.7) | 1,091,504 (96.2) | ||
Auto-immune chronic diseases | *** | *** | ||||
Yes | 279 (1.1) | 8948 (0.8) | 404 (1.1) | 8823 (0.8) | ||
No | 24,735 (98.9) | 1,138,659 (99.2) | 37,519 (98.9) | 1,125,875 (99.2) | ||
Chronic kidney disease | *** | ** | ||||
Yes | 110 (0.4) | 3518 (0.3) | 94 (0.2) | 3534 (0.3) | ||
No | 24,904 (99.6) | 1,144,089 (99.7) | 37,829 (99.8) | 1,131,164 (99.7) | ||
Dyslipidemia | *** | *** | ||||
Yes | 844 (3.4) | 31,765 (2.8) | 789 (2.1) | 31,820 (2.8) | ||
No | 24,170 (96.6) | 1,115,842 (97.2) | 37,134 (97.9) | 1,102,878 (97.2) | ||
Obesity | *** | *** | ||||
Yes | 1225 (4.9) | 41,146 (3.6) | 1792 (4.7) | 40,579 (3.6) | ||
No | 23,789 (95.1) | 1,106,461 (96.4) | 36,131 (95.3) | 1,094,119 (96.4) | ||
Polycystic ovary syndrome | *** | *** | ||||
Yes | 339 (1.4) | 10,290 (0.9) | 925 (2.4) | 9704 (0.9) | ||
No | 24,675 (98.6) | 1,137,317 (99.1) | 36,998 (97.6) | 1,124,994 (99.1) | ||
Chronic respiratory diseases | *** | *** | ||||
Yes | 2302 (9.2) | 74,492 (6.5) | 3021 (8.0) | 73,773 (6.5) | ||
No | 22,712 (90.8) | 1,073,115 (93.5) | 34,902 (92.0) | 1,060,925 (93.5) | ||
Serious heart conditions | *** | * | ||||
Yes | 89 (0.4) | 2327 (0.2) | 69 (0.2) | 2347 (0.2) | ||
No | 24,925 (99.6) | 1,145,280 (99.8) | 37,854 (99.8) | 1,132,351 (99.8) | ||
Hormonal medication | ||||||
Sex hormones and modulators | *** | *** | ||||
Yes | 7038 (28.1) | 128,314 (11.2) | 10,753 (28.4) | 124,599 (11.0) | ||
No | 17,976 (71.9) | 1,019,293 (88.8) | 27,170 (71.6) | 1,010,099 (89.0) | ||
Lifestyle | ||||||
Alcohol consumption | * | * | ||||
Nonalcoholic | 3385 (56.8) | 157,030 (57.9) | 5136 (58.2) | 155,279 (57.9) | ||
Low Risk | 2478 (41.6) | 109,386 (40.4) | 3547 (40.2) | 108,317 (40.4) | ||
High Risk | 100 (1.7) | 4582 (1.7) | 138 (1.6) | 4544 (1.7) | ||
Missing | 19,051 | 876,609 | 29,102 | 866,558 | ||
IMC | * | * | ||||
Mean (SD) | 27.49 (5.47) | 27.48 (5.61) | 27.46 (5.54) | 27.48 (5.61) | ||
Median | 27.07 | 26.96 | 26.98 | 26.96 | ||
Q1–Q3 | 23.81–30.59 | 23.68, 30.66 | 23.76, 30.47 | 23.68, 30.67 | ||
Min–Max | 14.22–54.80 | 6.3859.82 | 11.6058.48 | 6.3859.82 | ||
Missing | 20,842 | 959,013 | 31,854 | 948,001 | ||
Smoking status | * | * | ||||
Non-smoker | 3901 (72.0) | 178,055 (72.4) | 5822 (72.6) | 176,134 (72.4) | ||
Smoker | 1011 (18.7) | 46,436 (18.9) | 1494 (18.6) | 45,953 (18.9) | ||
Former smoker | 503 (9.3) | 21,388 (8.7) | 708 (8.8) | 21,183 (8.7) | ||
Missing | 19,599 | 901,728 | 29,899 | 891,428 | ||
Sleeping duration (daily) | * | * | ||||
Mean (SD) | 7.50 (2.12) | 7.19 (1.58) | 6.83 (1.40) | 7.21 (1.59) | ||
Median | 7.50 | 7.00 | 6.50 | 7.00 | ||
Q1–Q3 | 6.75–8.25 | 6.00–8.00 | 6.00–8.00 | 6.00, 8.00 | ||
Min–Max | 6.00–9.00 | 3.00–18.00 | 5.00–9.00 | 3.0018.00 | ||
Missing | 25,012 | 1,147,355 | 37,911 | 1,134,456 | ||
COVID-19 history | ||||||
COVID-19 vaccination (dose) | ** | * | ||||
Mean (SD) | 2.40 (0.73) | 2.41 (0.72) | 2.26 (0.69) | 2.42 (0.72) | ||
Median | 2.00 | 2.00 | 2.00 | 2.00 | ||
Q1–Q3 | 2.00–3.00 | 2.00–3.00 | 2.00–3.00 | 2.00–3.00 | ||
Min–Max | 1.00–5.00 | 1.00–5.00 | 1.00–5.00 | 1.00–5.00 | ||
COVID-19 infection | *** | *** | ||||
Yes | 13,520 (54.0) | 569,949 (49.7) | 20,009 (52.8) | 563,460 (49.7) | ||
No | 11,494 (46.0) | 577,658 (50.3) | 17,914 (47.2) | 571,238 (50.3) |
Heavy Menstrual Bleeding | Amenorrhea | |||||||
---|---|---|---|---|---|---|---|---|
N (%) | p-Value | IR * | N (%) | p-Value | IR * | |||
Dose 1 by manufacturer (n = 1,172,621) | ||||||||
AstraZeneca® | 272 | (6.6) | <0.001 | 330.0 | 302 | (4.6) | <0.001 | 366.4 |
Janssen® | 914 | (22.0) | 1428.0 | 1039 | (15.9) | 1623.3 | ||
Moderna® | 883 | (21.3) | 426.5 | 1540 | (23.5) | 743.8 | ||
Pfizer/BioNTech® | 2083 | (50.2) | 254.3 | 3661 | (56.0) | 446.9 | ||
Total | 4152 | 354.1 | 6542 | 557.9 | ||||
Dose 2 by manufacturer (n = 1,063,341) | ||||||||
AstraZeneca® | 625 | (4.5) | <0.001 | 885.5 | 773 | (3.3) | <0.001 | 1095.2 |
Janssen® | <5 | (0.0) | 1851.8 | 5 | (0.0) | 4629.6 | ||
Moderna® | 3261 | (23.5) | 1351.6 | 5235 | (22.5) | 2169.7 | ||
Pfizer/BioNTech® | 9987 | (72.0) | 1329.1 | 17,298 | (74.2) | 2302.2 | ||
Total | 13,875 | 1304.8 | 23,311 | 2192.2 | ||||
Dose 3 by manufacturer (n = 534,621) | ||||||||
AstraZeneca® | <5 | (0.0) | <0.001 | 1515.1 | <5 | (0.0) | <0.001 | 4545.5 |
Janssen® | 0 | (0.0) | 0 | 0 | (0.0) | 0.0 | ||
Moderna® | 5828 | (83.8) | 1371.24 | 6200 | (76.5) | 1458.8 | ||
Pfizer/BioNTech® | 1125 | (16.2) | 1027.15 | 1902 | (23.5) | 1736.6 | ||
Total | 6954 | 1300.73 | 8105 | 1516.0 | ||||
Dose 4 by manufacturer (n = 55,610) | ||||||||
AstraZeneca® | 0 | (0.0) | 0.003 | 0.0 | 0 | (0) | <0.001 | 0.0 |
Janssen® | 0 | (0.0) | 0.9 | 0 | (0) | 0.0 | ||
Moderna® | 21 | (5.) | 1500.0 | 20 | (6.0) | 1428.6 | ||
Pfizer/BioNTech® | 361 | (94.5) | 666.0 | 313 | (94.0) | 577.4 | ||
Total | 382 | 686.93 | 333 | 598.8 | ||||
Dose 5 by manufacturer (n = 199) | ||||||||
AstraZeneca® | 0 | (0.0) | 0.803 | 0.0 | 0 | (0.0) | 0.0 | |
Janssen® | 0 | (0.0) | 0.0 | 0 | (0.0) | 0.0 | ||
Moderna® | 0 | (0.0) | 0.0 | 0 | (0.0) | 0.0 | ||
Pfizer/BioNTech® | <5 | (100.0) | 1538.5 | 0 | (0.0) | 0.0 | ||
Total | <5 | 1505.5 | 0 | 0.0 |
Heavy Menstrual Bleeding | Amenorrhea | |||
---|---|---|---|---|
OR | 95% CI | OR | 95% CI | |
Pfizer/BioNTech® (Ref.) | ||||
AstraZeneca® | 1.765 | (1.527–2.033) | 1.623 | (1.416–1.854) |
Janssen® | 2.155 | (1.873–2.476) | 1.989 | (1.740–2.269) |
Moderna® | 1.153 | (0.997–1.329) | 0.992 | (0.878–1.119) |
Time between first and second dose | 1.007 | (1.007–1.007) | 1.007 | (1.007–1.008) |
Age 12–18 (Ref.) | ||||
Age 19–25 | 0.979 | (0.755–1.274) | 1.011 | (0.873–1.173) |
Age 26–35 | 1.105 | (0.875–1.408) | 0.718 | (0.622–0.829) |
Age 36–45 | 1.863 | (1.500–2.340) | 0.498 | (0.431–0.577) |
Age 46–55 | 1.752 | (1.406–2.206) | 0.241 | (0.202–0.287) |
COVID-19 infection | 1.222 | (1.106–1.351) | 1.132 | (1.035–1.238) |
Type 1 and 2 Diabetes Mellitus | 1.027 | (0.712–1.430) | 1.616 | (1.135–2.228) |
Hypertension | 1.699 | (1.413–2.028) | 0.831 | (0.617–1.095) |
Auto-immune chronic diseases | 1.476 | (0.946–2.181) | 1.634 | (1.101–2.324) |
Chronic kidney disease | 0.694 | (0.273–1.430) | 1.281 | (0.542–2.532) |
Dyslipidemia | 1.156 | (0.906–1.452) | 1.409 | (1.077–1.811) |
Obesity | 1.376 | (1.115–1.679) | 1.512 | (1.249–1.813) |
Polycystic ovary syndrome | 1.456 | (0.973–2.086) | 1.962 | (1.525–2.482) |
Chronic respiratory diseases | 1.396 | (1.190–1.629) | 1.247 | (1.068–1.447) |
Serious heart conditions | 1.403 | (0.598–2.750) | 1.056 | (0.326–2.479) |
Sex hormones and modulators | 3.214 | (2.879–3.583) | 2.908 | (2.649–3.189) |
Heavy Menstrual Bleeding | Amenorrhea | |||
---|---|---|---|---|
OR | 95% CI | OR | 95% CI | |
Pfizer/BioNTech® (Ref.) | ||||
AstraZeneca® | 1.050 | (0.935–1.175) | 0.950 | (0.852–1.057) |
Moderna® | 0.852 | (0.771–0.939) | 0.862 | (0.791–0.938) |
Time between second and third dose | 1.004 | (1.004–1.004) | 1.004 | (1.004–1.004) |
Age 12–18 (Ref.) | ||||
Age 19–25 | 0.745 | (0.580–0.968) | 0.719 | (0.631–0.821) |
Age 26–35 | 0.967 | (0.768–1.233) | 0.454 | (0.400–0.516) |
Age 36–45 | 1.605 | (1.287–2.031) | 0.380 | (0.336–0.432) |
Age 46–55 | 1.316 | (1.054–1.667) | 0.160 | (0.139–0.183) |
COVID-19 infection | 1.088 | (1.016–1.166) | 1.023 | (0.961–1.089) |
Type 1 and 2 Diabetes Mellitus | 1.327 | (1.052–1.648) | 1.276 | (0.973–1.639) |
Hypertension | 1.420 | (1.244–1.614) | 1.122 | (0.943–1.325) |
Auto-immune chronic diseases | 1.272 | (0.914–1.717) | 1.524 | (1.140–1.988) |
Chronic kidney disease | 1.363 | (0.887–1.994) | 0.814 | (0.420–1.408) |
Dyslipidemia | 1.108 | (0.938–1.300) | 1.180 | (0.976–1.414) |
Obesity | 1.240 | (1.061–1.439) | 1.320 | (1.138–1.522) |
Polycystic ovary syndrome | 0.973 | (0.703–1.308) | 1.752 | (1.457–2.088) |
Chronic respiratory diseases | 1.180 | (1.049–1.323) | 1.098 | (0.980–1.226) |
Serious heart conditions | 1.740 | (1.074–2.652) | 0.649 | (0.256–1.326) |
Sex hormones and modulators | 3.898 | (3.611–4.205) | 2.896 | (2.704–3.101) |
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Esteban-Cledera, L.; Bissacco, C.A.; Pallejá-Millán, M.; Villalobos, M.; Villalobos, F. Association between COVID-19 Vaccines and Menstrual Disorders: Retrospective Cohort Study of Women Aged 12–55 Years Old in Catalonia, Spain. Int. J. Environ. Res. Public Health 2024, 21, 1090. https://doi.org/10.3390/ijerph21081090
Esteban-Cledera L, Bissacco CA, Pallejá-Millán M, Villalobos M, Villalobos F. Association between COVID-19 Vaccines and Menstrual Disorders: Retrospective Cohort Study of Women Aged 12–55 Years Old in Catalonia, Spain. International Journal of Environmental Research and Public Health. 2024; 21(8):1090. https://doi.org/10.3390/ijerph21081090
Chicago/Turabian StyleEsteban-Cledera, Laura, Carlo Alberto Bissacco, Meritxell Pallejá-Millán, Marcela Villalobos, and Felipe Villalobos. 2024. "Association between COVID-19 Vaccines and Menstrual Disorders: Retrospective Cohort Study of Women Aged 12–55 Years Old in Catalonia, Spain" International Journal of Environmental Research and Public Health 21, no. 8: 1090. https://doi.org/10.3390/ijerph21081090