Table 4.
Correlation between adverse reactions and anti-spike IgG titers.
|
Primary series |
p-value |
Monovalent booster |
p-value | Fold change, mean (95 % CI) | p-value |
Bivalent booster |
p-value | Fold change, mean (95 % CI) | p-value | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No. (%) | GMT (95 % CI), AU/mL | No. (%) | GMT (95 % CI), AU/mL | No. (%) | GMT (95 % CI), AU/mL | |||||||||||||
| Local reactions | ||||||||||||||||||
| Pain at injection site | No | 18 (6.1) | 8,502 (5,281–13,687) | 0.759 | 3 (1.0) | 14,818 (4,032–54,450) | 0.738 | 23.89 (10.88–52.44) | 0.658 | 2 (2.3) | 18,690 (416–839,267) | 0.660 | 3.08 (0.48–19.68) | 0.630 | ||||
| Yes | 278 (93.9) | 9,131 (8,426–9,895) | 314 (99.1) | 16,990 (15,711–18,378) | 28.84 (26.58–31.30) | 84 (97.7) | 24,033 (20,202–28,596) | 4.38 (3.51–5.46) | ||||||||||
| Redness | No | 124 (79.4) | 8,892 (8,106–9,757) | 0.285 | 208 (65.6) | 16,893 (15,353–18,587) | 0.873 | 28.0 (25.30–31.0) | 0.353 | 66 (76.7) | 23,302 (19,489–27,868) | 0.599 | 4.35 (3.40–5.58) | 0.961 | ||||
| Yes | 61 (20.6) | 9,901 (8,486–11,553) | 109 (34.4) | 17,120 (14,949–19,602) | 30.35 (26.52–34.75) | 20 (23.3) | 25,948 (16,259–41,400) | 4.30 (2.67–6.93) | ||||||||||
| Swelling | No | 174 (58.8) | 8,925 (8,000–9,954) | 0.585 | 166 (52.4) | 17,045 (15,262–19,041) | 0.905 | 30.0 (26.95–33.38) | 0.296 | 50 (58.1) | 27,002 (22,009–33,128) | 0.092 | 4.21 (3.15–5.62) | 0.736 | ||||
| Yes | 122 (41.2) | 9,337 (8,304–10,498) | 151 (47.6) | 16,885 (15,125–18,854) | 27.52 (24.32–31.14) | 36 (41.9) | 20,160 (15,031–27,046) | 4.53 (3.23–6.35) | ||||||||||
| Systemic reactions | ||||||||||||||||||
| Fever | < 38.0°C | 231 (78.0) | 8,222 (7,528–8,983) | < 0.001 | 234 (73.8) | 15,318 (14,022–16,738) | < 0.001 | 27.61 (25.20–30.26) | 0.088 | 77 (89.5) | 22,423 (18,797–26,749) | 0.029 | 4.36 (3.44–5.53) | 0.890 | ||||
| ≥ 38.0°C | 65 (22.0) | 12,993 (11,069–15,248) | 83 (26.2) | 22,646 (19,561–26,218) | 32.39 (27.29–38.43) | 9 (10.5) | 41,115 (22,830–74,063) | 4.15 (2.64–6.52) | ||||||||||
| Duration | r = 0.288a | < 0.001 | r = 0.237a | < 0.001 | r = 0.103a | 0.067 | r = 0.244a | 0.009 | r = -0.010a | 0.928 | ||||||||
| Fatigue | No | 49 (16.6) | 6,433 (5,092–8,125) | 0.001 | 48 (15.1) | 13,571 (11,089–16,607) | 0.017 | 24.47 (19.20–31.19) | 0.095 | 17 (19.8) | 25,722 (17,993–36,771) | 0.671 | 5.71 (3.20–10.20) | 0.211 | ||||
| Yes | 247 (83.5) | 9,739 (8,972–10,571) | 269 (84.9) | 17,660 (16,241–19,204) | 29.63 (27.21–32.28) | 69 (80.2) | 23,464 (19,271–28,569) | 4.06 (3.21–5.12) | ||||||||||
| Headache | No | 107 (36.2) | 8,024 (6,953–9,260) | 0.020 | 102 (32.2) | 14,883 (13,152–16,842) | 0.022 | 28.35 (24.58–32.70) | 0.797 | 35 (40.7) | 20,716 (15,004–28,602) | 0.197 | 4.75 (3.37–6.69) | 0.496 | ||||
| Yes | 189 (63.9) | 9,759 (8,876–10,730) | 215 (67.8) | 18,059 (16,372–19,920) | 29.0 (26.27–32.02) | 51 (59.3) | 26,351 (21,837–31,798) | 4.08 (3.06–5.43) | ||||||||||
| Chills | No | 150 (50.7) | 7,588 (6,778–8,494) | < 0.001 | 150 (47.3) | 14,911 (13,421–16,562) | 0.002 | 26.72 (23.67–30.18) | 0.086 | 51 (59.3) | 24,121 (19,884–29,255) | 0.901 | 4.53 (3.35–6.13) | 0.639 | ||||
| Yes | 146 (49.3) | 10,947 (9,845–12,176) | 167 (52.7) | 19,063 (17,049–21,311) | 30.78 (27.62–34.30) | 35 (40.7) | 23,567 (17,073–32,531) | 4.08 (2.99–5.57) | ||||||||||
| Muscle pain | No | 121 (40.9) | 7,997 (7,032–9,095) | 0.008 | 46 (14.5) | 17,167 (14,151–20,831) | 0.904 | 29.25 (23.21–36.89) | 0.872 | 24 (27.9) | 20,946 (13,140–33,389) | 0.452 | 4.91 (2.93–8.22) | 0.486 | ||||
| Yes | 175 (59.1) | 9,936 (8,983–10,990) | 271 (85.5) | 16,936 (15,552–18,446) | 28.71 (26.33–31.31) | 62 (72.1) | 25,142 (21,375–29,573) | 4.14 (3.28–5.23) | ||||||||||
| Joint pain | No | 154 (52.0) | 8,422 (7,487–9,473) | 0.049 | 145 (45.7) | 16,413 (14,682–18,353) | 0.441 | 27.52 (24.20–31.28) | 0.313 | 55 (64.0) | 22,361 (17,832–28,041) | 0.305 | 4.45 (3.37–5.87) | 0.763 | ||||
| Yes | 142 (48.0) | 9,879 (8,878–10,993) | 172 (54.3) | 17,454 (15,649–19,463) | 29.91 (26.96–33.18) | 31 (36.1) | 26,872 (20,735–34,826) | 4.15 (2.90–5.96) | ||||||||||
| Antipyretic use | ||||||||||||||||||
| Before vaccination | No | 295 (99.7) | 9,097 (8,397–9,858) | N/A | 297 (93.7) | 17,065 (15,743–18,501) | 0.581 | 26.55 (22.91–30.78) | 0.700 | 80 (93.0) | 23,233 (19,404–27,816) | 0.234 | 4.46 (3.57–5.58) | 0.355 | ||||
| Yes | 1 (0.3) | N/A | 20 (6.3) | 15,599 (11,474–21,203) | 36.93 (3.06–445.96) | 6 (7.0) | 34,706 (22,151–54,375) | 3.00 (0.96–9.43) | ||||||||||
| After vaccination | No | 144 (48.7) | 8,549 (7,577–9,645) | 0.141 | 171 (53.9) | 16,669 (15,087–18,420) | 0.627 | 28.48 (25.40–31.93) | 0.777 | 41 (47.7) | 22,116 (16,757–29,188) | 0.391 | 4.56 (3.39–6.12) | 0.672 | ||||
| Yes | 152 (51.4) | 9,638 (8,668–10,715) | 146 (46.1) | 17,326 (15,321–19,593) | 29.15 (25.98–32.72) | 45 (52.3) | 25,639 (20,716–31,725) | 4.15 (3.0–5.74) | ||||||||||
GMT, geometric mean titer; CI, confidence interval; N/A, not available.
a
r values refer to the Spearman’s correlation coefficient.