Table 3.
Hazard ratios (HR) with 95% confidence interval (CI) for menstrual disturbance and bleeding after each dose in one to seven days and 8-90 days risk windows in the subpopulation with primary care data (Stockholm region and Västra Götaland region, approximately 40% of total population), among women in a Swedish population cohort
| Risk windows | Person-years | Cases | Incidence rate (per 100 000 person-years) |
Crude model,* HR (95% CI) | Full model,† HR (95% CI) |
|---|---|---|---|---|---|
| Postmenopausal bleeding (45-74 years, n=590 271) | |||||
| Unvaccinated | 252 977 | 1345 | 531.7 | ref | ref |
| Any dose: | |||||
| 1-7 days | 28 623 | 175 | 611.4 | 1.26 (1.06 to 1.49) | 1.16 (0.97 to 1.37) |
| 8-90 days | 243 943 | 1287 | 527.6 | 1.15 (1.03 to 1.28) | 1.05 (0.94 to 1.17) |
| Dose 1: | |||||
| 1-7 days | 10 281 | 75 | 729.5 | 1.30 (1.02 to 1.66) | 1.23 (0.96 to 1.57) |
| 8-90 days | 60 233 | 311 | 516.3 | 1.04 (0.89 to 1.21) | 0.95 (0.81 to 1.11) |
| Dose 2: | |||||
| 1-7 days | 10 134 | 50 | 493.4 | 1.15 (0.85 to 1.56) | 1.02 (0.75 to 1.39) |
| 8-90 days | 119 097 | 597 | 501.3 | 1.21 (1.04 to 1.40) | 1.08 (0.93 to 1.25) |
| Dose 3: | |||||
| 1-7 days | 8209 | 50 | 609.1 | 1.41 (0.98 to 2.02) | 1.18 (0.82 to 1.69) |
| 8-90 days | 64 613 | 379 | 586.6 | 1.34 (1.03 to 1.74) | 1.13 (0.86 to 1.49) |
| Menstrual disturbance (12-49 years, n=664 201) | |||||
| Unvaccinated | 446 270 | 6092 | 1365.1 | ref | ref |
| Any dose: | |||||
| 1-7 days | 24 260 | 374 | 1 541.6 | 1.28 (1.15 to 1.43) | 1.11 (0.99 to 1.23) |
| 8-90 days | 188 275 | 2802 | 1 488.2 | 1.27 (1.20 to 1.34) | 1.06 (1.00 to 1.12) |
| Dose 1: | |||||
| 1-7 days | 10 331 | 169 | 1635.9 | 1.41 (1.21 to 1.65) | 1.25 (1.07 to 1.46) |
| 8-90 days | 61 602 | 813 | 1319.8 | 1.16 (1.07 to 1.26) | 1.03 (0.95 to 1.12) |
| Dose 2: | |||||
| 1-7 days | 9776 | 144 | 1473.0 | 1.15 (0.97 to 1.37) | 1.05 (0.88 to 1.24) |
| 8-90 days | 109 514 | 1701 | 1553.2 | 1.26 (1.18 to 1.35) | 1.07 (0.99 to 1.14) |
| Dose 3: | |||||
| 1-7 days | 4153 | 61 | 1468.7 | 1.03 (0.78 to 1.35) | 0.87 (0.66 to 1.15) |
| 8-90 days | 17 159 | 288 | 1678.4 | 1.28 (1.08 to 1.51) | 1.00 (0.85 to 1.19) |
| Premenopausal bleeding (12-49 years, n=664 201) | |||||
| Unvaccinated | 449 008 | 1210 | 269.5 | ref | ref |
| Any dose: | |||||
| 1-7 days | 24 459 | 75 | 306.6 | 1.33 (1.04 to 1.69) | 1.00 (0.78 to 1.28) |
| 8-90 days | 190 173 | 603 | 317.1 | 1.39 (1.23 to 1.57) | 0.99 (0.87 to 1.13) |
| Dose 1: | |||||
| 1-7 days | 10 398 | 32 | 307.8 | 1.37 (0.96 to 1.96) | 1.13 (0.79 to 1.61) |
| 8-90 days | 62 149 | 162 | 260.7 | 1.21 (1.01 to 1.45) | 0.95 (0.79 to 1.14) |
| Dose 2: | |||||
| 1-7 days | 9852 | 22 | 223.3 | 0.92 (0.60 to 1.42) | 0.73 (0.47 to 1.13) |
| 8-90 days | 110 609 | 371 | 335.4 | 1.44 (1.24 to 1.67) | 1.04 (0.89 to 1.22) |
| Dose 3: | |||||
| 1-7 days | 4209 | 21 | 498.9 | 1.62 (0.99 to 2.66) | 1.15 (0.70 to 1.88) |
| 8-90 days | 17 414 | 70 | 402.0 | 1.27 (0.90 to 1.80) | 0.83 (0.59 to 1.17) |
*
Crude model included no covariates.
†
Full model included age, country of birth, employed as a healthcare worker, marital status, education, and health seeking behaviours during 2018-19 (ie, no. of primary care visits, no. of specialist outpatient visits, and days of inpatient stay), and prior comorbidities and treatments listed in supplement table S1.