Table 3.
Most frequently reported (≥9 cases) medically attended adverse events (MAEs) within the 31-day postvaccination period
| MAEs* | ImmunoComp | At-risk | Healthy | Total† |
|---|---|---|---|---|
| N=579 | N=7392 | N=1170 | N=9143 | |
| n (%) | n (%) | n (%) | n (%) | |
| At least one MAE | 107 (18.5) | 958 (13.0) | 154 (13.2) | 1219 (13.3) |
| Lower respiratory tract infection | 12 (2.1) | 94 (1.3) | 4 (0.3) | 110 (1.2) |
| Upper respiratory tract infection | 5 (0.9) | 56 (0.8) | 14 (1.2) | 75 (0.8) |
| Cough | 5 (0.9) | 49 (0.7) | 6 (0.5) | 60 (0.7) |
| Urinary tract infection | 5 (0.9) | 36 (0.5) | 12 (1.0) | 53 (0.6) |
| Asthma | 1 (0.2) | 39 (0.5) | 1 (0.1) | 41 (0.5) |
| Back pain | 2 (0.4) | 25 (0.3) | 2 (0.2) | 29 (0.3) |
| Abdominal pain | 4 (0.7) | 20 (0.3) | 2 (0.2) | 26 (0.3) |
| Diarrhoea | 2 (0.4) | 17 (0.2) | 2 (0.2) | 21 (0.2) |
| Arthralgia | 0 | 16 (0.2) | 4 (0.3) | 20 (0.2) |
| Oropharyngeal pain | 2 (0.4) | 16 (0.2) | 2 (0.2) | 20 (0.2) |
| Chronic obstructive pulmonary disease | 0 | 18 (0.2) | 0 | 18 (0.2) |
| Conjunctivitis | 1 (0.2) | 13 (0.2) | 3 (0.3) | 17 (0.2) |
| Headache | 2 (0.4) | 10 (0.1) | 5 (0.4) | 17 (0.2) |
| Dyspnoea | 5 (0.9) | 9 (0.1) | 3 (0.3) | 17 (0.2) |
| Rash | 0 | 16 (0.2) | 1 (0.1) | 17 (0.2) |
| Herpes zoster | 1 (0.2) | 13 (0.2) | 2 (0.2) | 16 (0.2) |
| Chest pain | 1 (0.2) | 13 (0.2) | 1 (0.1) | 15 (0.2) |
| Sinusitis | 0 | 10 (0.1) | 5 (0.4) | 15 (0.2) |
| Pain in extremity | 3 (0.5) | 10 (0.1) | 2 (0.2) | 15 (0.2) |
| Otitis externa | 0 | 13 (0.2) | 1 (0.1) | 14 (0.2) |
| Dizziness | 0 | 11 (0.2) | 3 (0.3) | 14 (0.2) |
| Dyspepsia | 0 | 11 (0.2) | 2 (0.2) | 13 (0.1) |
| Vomiting | 2 (0.4) | 8 (0.1) | 2 (0.2) | 12 (0.1) |
| Pyrexia | 0 | 7 (0.1) | 4 (0.3) | 11 (0.1) |
| Bronchitis | 2 (0.4) | 6 (0.1) | 2 (0.2) | 10 (0.1) |
| Cellulitis | 2 (0.4) | 7 (0.1) | 1 (0.1) | 10 (0.1) |
| Pharyngitis | 3 (0.5) | 5 (0.1) | 2 (0.2) | 10 (0.1) |
| Musculoskeletal chest pain | 1 (0.2) | 9 (0.1) | 0 | 10 (0.1) |
| Influenza-like illness | 3 (0.5) | 6 (0.1) | 0 | 9 (0.1) |
| Fall | 1 (0.2) | 7 (0.1) | 1 (0.1) | 9 (0.1) |
| Wheezing | 1 (0.2) | 7 (0.1) | 1 (0.1) | 9 (0.1) |
*MAEs were defined as events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If an MAE led to hospitalisation (or met any other serious adverse event (SAE) criteria), it was to be reported as an SAE.
†Information regarding the risk group was missing for two participants. Immunocomp, participants identified as immunocompromised on study initiation; N, number of participants in the cohort; n (%), number of participants reporting the event (percentage).