Table 2.
Severity of side-effects after bivalent booster vaccination
| Ad/P group (n=42) | mRNA/P group (n=44) | Ad/M group (n=45) | mRNA/M group (n=56) | |
|---|---|---|---|---|
| Fatigue | ||||
| Not at all | 19 (45%) | 21 (48%) | 21 (47%) | 24 (43%) |
| A little, but it did not hinder my daily activity | 16 (38%) | 14 (32%) | 17 (38%) | 20 (36%) |
| Quite, it hindered my daily activity | 6 (14%) | 7 (16%) | 7 (16%) | 10 (18%) |
| Significantly, I could not perform my daily activity | 1 (2%) | 2 (5%) | 0 | 2 (4%) |
| Shiver | ||||
| Not at all | 35 (83%) | 33 (75%) | 35 (78%) | 42 (75%) |
| A little, but it did not hinder my daily activity | 7 (17%) | 10 (23%) | 6 (13%) | 6 (11%) |
| Quite, it hindered my daily activity | 0 | 1 (2%) | 4 (9%) | 4 (7%) |
| Significantly, I could not perform my daily activity | 0 | 0 | 0 | 4 (7%) |
| Fever | ||||
| Not at all | 35 (83%) | 38 (86%) | 35 (78%) | 45 (80%) |
| A little, but it did not hinder my daily activity | 5 (12%) | 5 (11%) | 7 (16%) | 7 (13%) |
| Quite, it hindered my daily activity | 2 (5%) | 1 (2%) | 2 (4%) | 2 (4%) |
| Significantly, I could not perform my daily activity | 0 | 0 | 1 (2%) | 2 (4%) |
| Nausea | ||||
| Not at all | 39 (93%) | 42 (95%) | 39 (87%) | 51 (91%) |
| A little, but it did not hinder my daily activity | 3 (7%) | 2 (5%) | 4 (9%) | 3 (5%) |
| Quite, it hindered my daily activity | 0 | 0 | 2 (4%) | 0 |
| Significantly, I could not perform my daily activity | 0 | 0 | 0 | 2 (4%) |
| Headache | ||||
| Not at all | 28 (67%) | 20 (45%) | 25 (56%) | 27 (48%) |
| A little, but it did not hinder my daily activity | 10 (24%) | 22 (50%) | 17 (38%) | 17 (30%) |
| Quite, it hindered my daily activity | 4 (10%) | 2 (4%) | 2 (4%) | 9 (16%) |
| Significantly, I could not perform my daily activity | 0 | 2 (5%) | 1 (2%) | 3 (5%) |
| Muscle ache | ||||
| Not at all | 26 (62%) | 20 (45%) | 25 (56%) | 30 (54%) |
| A little, but it did not hinder my daily activity | 14 (33%) | 16 (36%) | 17 (38%) | 16 (29%) |
| Quite, it hindered my daily activity | 1 (2%) | 7 (16%) | 3 (7%) | 7 (13%) |
| Significantly, I could not perform my daily activity | 1 (2%) | 1 (2%) | 0 | 3 (5%) |
| Joint pain | ||||
| Not at all | 36 (86%) | 39 (89%) | 30 (67%) | 37 (66%) |
| A little, but it did not hinder my daily activity | 6 (14%) | 2 (5%) | 13 (29%) | 15 (27%) |
| Quite, it hindered my daily activity | 0 (0%) | 3 (7%) | 2 (4%) | 3 (5%) |
| Significantly, I could not perform my daily activity | 0 | 0 | 0 | 1 (2%) |
| Red spot at vaccination site, cm | ||||
| 0 | 40 (95%) | 40 (91%) | 39 (87%) | 50 (89%) |
| 2·5–5·0 | 2 | 4 (9%) | 5 (11%) | 5 (9%) |
| 5·1–10·0 | 0 | 0 | 1 (2%) | 0 |
| >10·0 | 0 | 0 | 0 | 1 (2%) |
| Swelling at vaccination site, cm | ||||
| 0 | 39 (93%) | 38 (86%) | 40 (89%) | 46 (82%) |
| 2·5–5·0 | 3 (7%) | 5 (11%) | 4 (9%) | 8 (14%) |
| 5·1–10·0 | 0 | 1 (2%) | 1 (2%) | 1 (2%) |
| >10·0 cm | 0 | 0 | 0 | 1 (2%) |
| Pain at vaccination site | ||||
| Not at all | 10 (24%) | 9 (20%) | 10 (22%) | 13 (23%) |
| A little, but it did not hinder my daily activity | 31 (74%) | 33 (75%) | 33 (73%) | 35 (63%) |
| Quite, it hindered my daily activity and I took mild painkillers (eg, paracetamol) but not strong painkillers (eg, morphine or oxycodone) | 1 (2%) | 2 (5%) | 2 (4%) | 8 (14%) |
Data are n (%). Percentages might not sum to 100 because of rounding. Participants in the direct boost group were divided into four groups: (1) Ad26.COV2.S prime and BNT162b2 OMI BA.1 boost (Ad/P), (2) mRNA-based prime and BNT162b2 OMI BA.1 boost (mRNA/P), (3) Ad26.COV2.S prime and mRNA-1273·214 boost (Ad/M), and (4) mRNA-based prime and mRNA-1273·214 boost (mRNA/M). The BNT162b2 BA.1 boost was given to participants younger than 45 years, and the mRNA-1273·214 boost was given to participants 45 years or older, as per Dutch guidelines. Participants were asked in an electronic questionnaire how severely they were affected by these side-effects in the 7 days after booster vaccination.