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. 2023 Apr 19;19(1):2190690. doi: 10.1080/21645515.2023.2190690

Table 2.

Summary of unsolicited TEAEs through 28 days following any vaccination (safety population).

  mRNA-1283
mRNA-1273
n (%) 10 µg
(n = 21)
30 µg
(n = 22)
100 µg
(n = 21)
Placebo +
100 µg (n = 18)
100 µg
(n = 22)
All unsolicited TEAEs          
 All AEs 8 (38.1) 9 (40.9) 9 (42.9) 4 (22.2) 7 (31.8)
 SAEs 0 0 0 0 0
 Fatal AEs 0 0 0 0 0
 MAAEs 3 (14.3) 2 (9.1) 2 (9.5) 2 (11.1) 3 (13.6)
 AEs leading to vaccination discontinuation 0 0 0 0 1 (4.5)
 AEs leading to study discontinuation 0 0 0 0 0
 Severe 0 0 0 0 0
 AESIs 0 0 0 0 0
Related unsolicited TEAEs          
 All AEs 2 (9.5) 4 (18.2) 4 (19.0) 2 (11.1) 4 (18.2)
 SAEs 0 0 0 0 0
 Fatal AEs 0 0 0 0 0
 MAAEs 0 1 (4.5) 1 (4.8) 0 1 (4.5)
 AEs leading to vaccination discontinuation 0 0 0 0 1 (4.5)
 AEs leading to study discontinuation 0 0 0 0 0
 Severe 0 0 0 0 0
 AESIs 0 0 0 0 0

A TEAE is any event not present before exposure to study vaccination or any event already present that worsened in intensity or frequency after exposure.

Abbreviations: AE, adverse event; AESI, adverse event of special interest; MAAE, medically attended adverse event; mRNA, messenger RNA; SAE, serious adverse event; TEAE, treatment-emergent adverse event.