- A seven-year-old experienced a stroke.
- One child and one infant suffered facial paralysis.
- One infant had a kidney adverse event, either kidney injury or failure.
- Of the 34 cases, 24 (71%) were classified as serious.
- Predominantly female patients were affected — at least 25 of 34 (73.5%) patients.
- Table 6 reports 34 cases of use in pediatric individuals. However, 28 additional cases were excluded because details such as height and weight were “not consistent with pediatric subjects.”
- Ages ranged from two months to nine years, with median 4.0 years, which means half the children were under four years of age.
- 132 adverse events were reported in the 34 children – i.e., an average of 3.88 AEs per child.