Adverse Events of Special Interest
Cross-source consensus on Adverse Events of Special Interest from 1 sources and 5 claims.
1 sources · 5 claims
Risks & contraindications
Other
Other
Other
Highlighted claims
- Potential cases are considered new onset only if the diagnosis in the observation window is the first such diagnosis within 365 days. — Postmarketing safety surveillance for GSK’s AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study
- GBS and ADEM are identified using ICD-10-CM diagnosis codes. — Postmarketing safety surveillance for GSK’s AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study
- The primary 42-day risk window for GBS is based on literature precedent, and ADEM uses the same window because it is also an inflammatory neurological disease. — Postmarketing safety surveillance for GSK’s AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study
- Trial data showed an imbalance in atrial fibrillation events within 30 days after vaccination, with 10 vaccinated cases and 4 placebo cases. — Postmarketing safety surveillance for GSK’s AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study
- The primary 8-day risk window for atrial fibrillation was selected based on postmarketing safety reports indicating onset 3-8 days after vaccination. — Postmarketing safety surveillance for GSK’s AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study