Table 5.
Rates of Emergent Outpatient, Emergency Room Visit, and Hospitalization Day 0 Outcomes among 4vhpv vaccine recipients and Concurrent Controls with Td/Tdap, Meningococcal, or Influenza Vaccine.
| Dose sub-group (N doses) |
Acute Event | Gardasil |
Concurrent controls |
||
|---|---|---|---|---|---|
| N Event | Ratea(95%CI) | N Event | Ratea(95%CI) | ||
| All doses (N = 160,867)b |
Syncope | 88 | 5.47(4.39–6.74) | 87 | 5.41(4.33–6.67) |
| Epilepsy, Convulsions | 91 | 5.66(4.55–6.95) | 122 | 7.58(6.30–9.06) | |
| Head Trauma | 126 | 7.83(6.52–9.33) | 124 | 7.71(6.41–9.19) | |
| Allergic Reactions | 339 | 21.07(18.89–23.44) | 184 | 11.44(9.84–13.22) | |
| Total | 644 | 40.03(37.00–43.25) | 517 | 32.14(29.43–35.03) | |
| Dose 1 (N = 109,864b) |
Syncope | 85 | 7.74(6.18–9.57) | 61 | 5.55(4.25–7.13) |
| Epilepsy, Convulsions | 68 | 6.19(4.81–7.85) | 75 | 6.83(5.37–8.56) | |
| Head Trauma | 104 | 9.47(7.73–11.47) | 87 | 7.92(6.34–9.77) | |
| Allergic Reactions | 242 | 22.03(19.34–24.98) | 116 | 10.56(8.72–12.66) | |
| Total | 499 | 45.42(41.52–49.59) | 339 | 30.86(27.66–34.32) | |
a.Rate = Number of events per 10,000 doses.
b.Number of doses matched per comparison group.