Children experiencing reactions in the 7 days after each dose of vaccine, among vaccine-naive participants receiving the first dose at 60 months of age (for dose 1, n = 50; for dose 2, n = 46)
| Reaction | Severity of reaction;* dose number; no. (%) of children) | |||||||
|---|---|---|---|---|---|---|---|---|
| Mild | Moderate | Severe | Overall† | |||||
| Dose 1 | Dose 2 | Dose 1 | Dose 2 | Dose 1 | Dose 2 | Dose 1 | Dose 2 | |
| Solicited local | 49 (98) | 45 (98) | ||||||
| Pain | 17 (34) | 10 (22) | 17 (34) | 27 (59) | 6 (12) | 2 (4) | ||
| Erythema | 37 (74) | 36 (78) | 6 (12) | 3 (7) | 4 (8) | 1 (2) | ||
| Swelling | 14 (28) | 18 (39) | 3 (6) | 1 (2) | 2 (4) | 0 (0) | ||
| Induration | 19 (38) | 19 (41) | 4 (8) | 0 (0) | 0 (0) | 0 (0) | ||
| Solicited systemic | 35 (70) | 35 (76) | ||||||
| Change in appetite | 14 (28) | 13 (28) | 3 (6) | 2 (4) | 0 (0) | 1 (2) | ||
| Sleepiness | 15 (30) | 9 (20) | 3 (6) | 5 (11) | 0 (0) | 1 (2) | ||
| Vomiting | 2 (4) | 1 (2) | 3 (6) | 2 (4) | 0 (0) | 1 (2) | ||
| Diarrhea | 4 (8) | 4 (9) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | ||
| Irritability | 15 (30) | 14 (30) | 9 (18) | 5 (11) | 0 (0) | 1 (2) | ||
| Headache | 3 (6) | 2 (4) | 2 (4) | 1 (2) | 0 (0) | 0 (0) | ||
| Arthralgia | 5 (10) | 5 (11) | 4 (8) | 7 (15) | 1 (2) | 0 (0) | ||
| Rash | 2 (4) | 3 (7) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | ||
| Fever (temperature > 38°C) | 2 (4) | 1 (2) | 3 (6) | 1 (2) | 0 (0) | 0 (0) | ||
| Other adverse events‡ | 4 (8) | 5 (11) | ||||||
| Pain > 7 d§ | 0 (0) | 1 (2) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | ||
| Erythema > 7 d§ | 1 (2) | 1 (2) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | ||
| Swelling > 7 d§ | 1 (2) | 2 (4) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | ||
| Induration > 7 d§ | 1 (2) | 2 (4) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | ||
| Abdominal pain | 1 (2) | 1 (2) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | ||
| Injection-site reaction | 1 (2) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | ||
| Tonsillitis | 1 (2) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | ||
| Nausea | 0 (0) | 1 (2) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | ||
| Cough | 0 (0) | 1 (2) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | ||
| Serious adverse event | ||||||||
| Admission to hospital, death, permanent disability | None judged to be related to vaccine (see text for details) | 2 (4)¶ | ||||||
↵* Mild = no limitation to normal activity (for pain, sleepiness, arthralgia, headache, irritability), 1–25 mm (for erythema, swelling, induration), complete meals twice a day (for change in appetite), 1 or 2 vomits/day (for vomiting), 2 or 3 loose stools/day (for diarrhea), temperature 38–38.9°C (for fever); moderate = some limitation to normal activity, 25–50 mm, missed 1 or 2 meals a day, more than 2 vomits/day, 4 or 5 loose stools/day, temperature 39–39.9°C; severe = unable to perform normal activity, > 50 mm, no meals, vomits requiring intravenous hydration, 6 or more loose stools or required intravenous hydration, temperature ≥ 40°C.
↵† Some participants had more than one reaction.
↵‡ At least possibly related to vaccination.
↵§ Pain, erythema, induration and swelling lasting more than 7 days were classified as separate adverse events.
↵¶ Both of these events occurred 2 months after the second dose and were judged to be unrelated to the vaccine.