Cumulative incidence of adverse events following immunisation (AEFI) in days 1 and 2 in children who did or did not previously have the same AEFI at prior doses
| Doses 1–3 | Dose 1* | Dose 2* | Dose 2* | Dose 3 | Dose 3 | Dose 3 | Dose 4 | Dose 4 | Dose 4 | Dose 4 | |
| Overall n (%) | n (%) | No prior AEFI n (%) | Prior AEFI at dose 1 n (%) | No prior AEFI n (%) | One prior AEFI at dose 1 or 2 n (%) | Two prior AEFIs at dose 1 and 2 n (%) | No prior AEFI n (%) | One prior AEFI† n (%) | Two prior AEFIs‡ n (%) | Three prior AEFIs§ n (%) | |
| Fever≥38°C | |||||||||||
| Overall | 10 366 (62) | 3576 (63) | 975 (48) | 2790 (79) | 238 (23) | 740 (44) | 2047 (74) | 17 (25) | 55 (29) | 202 (45) | 511 (60) |
| 4CMenB | 794 (43) | 312 (49) | 111 (36) | 174 (58) | 38 (19) | 63 (27) | 96 (56) | 10 (29) | 20 (24) | 101 (46) | 267 (59) |
| Routine¶ | 2004 (43) | 657 (41) | 359 (39) | 434 (67) | 108 (20) | 201 (35) | 245 (57) | NA | NA | NA | NA |
| Co-administration | 7568 (75) | 2607 (76) | 505 (64) | 2182 (85) | 92 (33) | 476 (54) | 1706 (79) | 7 (22) | 35 (32) | 101 (44) | 244 (62) |
| Crying | |||||||||||
| Overall | 8679 (52) | 3201 (57) | 797 (33) | 2238 (71) | 248 (16) | 672 (40) | 1523 (69) | 31 (11) | 83 (25) | 154 (37) | 290 (56) |
| 4CMenB | 848 (46) | 313 (50) | 101 (33) | 205 (68) | 38 (19) | 75(38) | 116 (58) | 13 (9) | 40 (23) | 75 (35) | 145 (56) |
| Routine¶ | 1598 (34) | 595 (37) | 256 (26) | 330 (57) | 88 (12) | 150 (30) | 179 (55) | NA | NA | NA | NA |
| Co-administration | 6233 (62) | 2293 (67) | 440 (40) | 1703 (75) | 122 (19) | 447 (45) | 1228 (72) | 18 (13) | 43 (26) | 79 (39) | 145 (56) |
| Diarrhoea | |||||||||||
| Overall | 2460 (15) | 910 (16) | 578 (12) | 313 (35) | 337 (8) | 203 (17) | 119 (39) | 98 (10) | 73 (19) | 38 (28) | 14 (45) |
| 4CMenB | 220 (12) | 82 (13) | 55 (10) | 26 (33) | 34 (7) | 12 (11) | 11 (42) | 44 (9) | 37 (18) | 18 (29) | 4 (29) |
| Routine¶ | 569 (12) | 196 (12) | 143 (10) | 69 (35) | 88 (7) | 46 (17) | 27 (40) | NA | NA | NA | NA |
| Co-administration | 1671 (16) | 632 (18) | 380 (14) | 218 (35) | 215 (9) | 145 (19) | 81 (38) | 54 (11) | 36 (20) | 20 (28) | 10 (59) |
| Change in eating habits | |||||||||||
| Overall | 6188 (37) | 2375 (42) | 742 (23) | 1241 (53) | 451 (19) | 663 (37) | 717 (58) | 116 (22) | 155 (34) | 170 (48) | 120 (56) |
| 4CMenB | 625 (34) | 269 (43) | 66 (19) | 126 (48) | 43 (15) | 57 (29) | 64 (52) | 62 (23) | 73 (32) | 97 (52) | 56 (53) |
| Routine¶ | 1217 (26) | 458 (29) | 192 (17) | 215 (47) | 132 (14) | 121 (28) | 100 (47) | NA | NA | NA | NA |
| Co-administration | 4346 (43) | 1648 (48) | 484 (28) | 900 (55) | 276 (22) | 485 (41) | 553 (62) | 54 (21) | 82 (36) | 73 (44) | 64 (59) |
| Tenderness (at 4CMenB injection site) | |||||||||||
| Overall | 7620 (64) | 2641 (65) | 572 (42) | 1963 (76) | 215 (27) | 648 (54) | 1581 (81) | 94 (39) | 153 (57) | 294 (74) | 567 (88) |
| 4CMenB | 1013 (55) | 376 (59) | 85 (35) | 244 (66) | 34 (22) | 94 (46) | 180 (75) | 46 (37) | 82 (59) | 152 (78) | 284 (86) |
| Co-administration | 6607 (66) | 2265 (66) | 487 (43) | 1719 (77) | 181 (29) | 554 (56) | 1401 (82) | 48 (42) | 71 (55) | 142 (70) | 283 (89) |
*Excludes children who have received their first two doses of 4CMenB at ≥12 months of age.
†One prior AEFI at dose 1, 2 or 3.
‡Two prior AEFIs at doses 1 and 2, 1 and 3 or 2 and 3.
§Three prior AEFIs at doses 1, 2 and 3.
¶At dose 1, 2 and 3, the routine vaccines are DTaP-IPV-Hib-HepB and PCV7, and at dose 4, the routine vaccine is MMRV.
4CMenB, four-component meningococcal serogroup B vaccine; DTaP-IPV-Hib-HepB, hexavalent combined diphtheria-tetanus-acellular pertussis-inactivated polio-Haemophilus influenzae type b-hepatitis B vaccine; MMRV, measles-mumps-rubella-varicella vaccine; NA, not applicable (at dose 4, the routine vaccine was MMRV, which was administered once); PCV7, seven-valent pneumococcal conjugate vaccine.