Table 3. Description of adverse events of cases with skin manifestations after immunisation with an adjuvanted recombinant zoster vaccine, Germany, 2020 (n = 72).
Characteristics of adverse events | VZV-positive casesa | VZV-negative casesc | Total | p value | |||
---|---|---|---|---|---|---|---|
n | n | n | % | ||||
Number of cases | 27 | 45 | 72 | NA | |||
Dermatome locationd | |||||||
Cervical | 5 | 22 | 27 | 37.5 | 0.010 | ||
Thoracic | 13 | 19 | 32 | 44.4 | 0.624 | ||
Lumbar | 7b | 5 | 12b | 16.7 | 0.117e | ||
Sacral | 4 | 6 | 10 | 13.9 | 1.000e | ||
Skin eruptiond | |||||||
Erythema | 17b | 25 | 42b | 58.3 | 0.537 | ||
Macules | 0 | 9 | 9 | 12.5 | 0.022 e | ||
Papules | 7 | 15 | 22 | 30.6 | 0.509 | ||
Vesicles | 21b | 23 | 44b | 61.1 | 0.025 | ||
Pustules | 10b | 13 | 23b | 31.9 | 0.473 | ||
Haemorrhagic blisters | 2 | 1 | 3 | 4.2 | 0.552e | ||
Crusts | 8 | 13 | 21 | 29.2 | 0.947 | ||
Other symptoms | |||||||
Number of responses | 26 | 44 | 70 | NA | |||
Severe pain with skin eruption | 20b | 19 | 39b | 55.7 | 0.006 | ||
Severe pain without skin eruption | 4 | 3 | 7 | 10.0 | 0.411e | ||
Neurological symptom | 3 | 3 | 6 | 8.6 | 0.664e | ||
Pruritus | 16 | 34 | 50 | 71.4 | 0.159 | ||
Paraesthesia | 17 | 17 | 34 | 48.6 | 0.031 | ||
Number of responses | 25 | 44 | 69 | NA | |||
Other | 8b | 12 | 20b | 29.0 | 0.677 | ||
Duration (days) | Median | IQR | Median | IQR | Median | IQR | p value |
Skin eruption | 19.0 | 15.0–31.0 | 11.0 | 8.0–15.0 | 13.0 | 9.0–20.0 | 0.002 |
Severe pain with skin eruption | 20.0 | 12.0–35.0 | 7.0 | 4.0–16.0 | 12.0 | 7.0–22.0 | 0.002 |
Severe pain without skin eruption | 37.0 | NA | 20.0 | 1.0–38.0 | 28.5 | 10.5–37.5 | 1.000 |
Neurological symptom | 36.0 | 35.0–37.0 | 20.0 | 11.0–38.0 | 35.0 | 20.0–37.0 | 0.773 |
Pruritus | 26.0 | 12.0–35.0 | 9.0 | 4.0–14.0 | 12.0 | 7.0–24.0 | 0.006 |
Paraesthesia | 35.0 | 15.0–47.0 | 8.0 | 5.0–13.0 | 12.5 | 7.0–36.0 | 0.001 |
Other | 19.0 | 9.0–37.0 | 3.5 | 1.5–9.5 | 9.0 | 2.0–17.0 | 0.012 |
HSV: herpes-simplex virus; IQR: interquartile range; VZV: varicella-zoster virus.
a All VZV-positive samples were genotyped to wild-type VZV strains.
b One patient sample was PCR positive for VZV and HSV-1.
c Two VZV-negative samples were PCR positive for HSV-1 and five for HSV-2.
d Multiple answers possible.
e Fisher’s exact test.
Entries in bold represent statistically significant findings.
Percentages not included where n < 50.