Table 2.
Events of interest among the other (non-herpes zoster) vesicular and bullous cutaneous eruptions identified with the search using the MedDRA® preferred terms indicative of other vesicular and bullous cutaneous eruptions,a that contained sufficient information for assessment and were classified as non-injection site eruptions based on medical review of the case narrative
| Event typeb | Number of reportsc (N = 557) | Reporting rate per 100,000 doses distributed | Number of serious reportsc | TTOd (post-vaccination) |
|---|---|---|---|---|
| pIMDs | 19 | 0.06 | 17 | 3 h–< 9 months |
| Autoimmune bullous skin disease (pemphigus, pemphigoid) | 11 | 0.03 | 11 | 1 day–< 2 years |
| Stevens–Johnson syndrome | 3 | 0.01 | 3 | 3 h–7 days |
| Erythema multiforme | 2 | 0.01 | 2 | 21 days |
| Psoriasis (rash vesicular) | 2 | 0.01 | 0 | 2 days; < 9 months |
| Systemic lupus erythematosus (blister) | 1 | 0.00 | 1 | 2 days |
| Non-injection site hypersensitivity rashese | 102 | 0.31 | 12 | Immediately–160 days |
| Rash vesicular | 51 | 0.16 | 5 | Immediately–2 months |
| Blister | 38 | 0.12 | 2 | Immediately–160 days |
| Pustule | 9 | 0.03 | 2 | < 1 day–18 days |
| Rash pustular | 5 | 0.02 | 0 | 4 h–8 days |
| Anaphylactic reaction (rash vesicular) | 1 | 0.00 | 1 | 2 h |
| Other aetiologies | 436 | 1.34 | 39 | Immediately–< 2 years |
| Oral herpes | 149 | 0.46 | 8 | 1 day–< 1 year |
| Blister | 120 | 0.37 | 7 | Immediately–< 2 years |
| Rash vesicular | 80 | 0.25 | 5 | Immediately–< 2 years |
| Herpes simplex | 45 | 0.14 | 11 | 1 day–< 1 year |
| Varicella | 39 | 0.12 | 3 | 1 day–45 days |
| Herpes virus infection | 13 | 0.04 | 1 | Immediately–< 4 months |
| Genital herpes | 13 | 0.04 | 0 | Immediately–< 2 years |
| Rash pustular | 10 | 0.03 | 0 | 2 days–4 months |
| Ophthalmic herpes simplex | 9 | 0.03 | 9 | 4 days–< 2 months |
| Herpes ophthalmic | 8 | 0.02 | 8 | 2 days–< 1 year |
| Acne (acne pustular, rash vesicular) | 3 | 0.01 | 0 | 1 day–14 days |
| Injection site vesicles | 1 | 0.00 | 0 | 24 days |
ESM electronic supplementary material, MedDRA® Medical Dictionary for Regulatory Activities, N total number of reports classified as non-injection site eruptions, pIMD potential immune-mediated disease, PT preferred term, TTO time to onset
aSee ESM 3
bEvents of interest were reviewed and classified manually based on the diagnosis or possible aetiology. Consequently, the reported event type may not be a MedDRA® PT. In such cases, the corresponding MedDRA® PT (ESM 3) is reported between brackets
cOne report could contain more than one adverse event reported by the same individual
dTime to onset was not available for all reports
eAssessed as immediate- or delayed-type hypersensitivity reaction based on the event description and considering the time to onset