Side Effects (SE) and Adverse Events (AE): Basics and new developments for health care providers

Introduction When it comes to vaccines and vaccination, nothing worries patients more than potential side effects. The fear that vaccination could lead to death or disability dates back to the time of Jenner and has persisted ever since. This review aims to provide practitioners and other health‑care professionals with a clear, up‑to‑date framework to understand adverse events (AEs) and side effects (SEs), to communicate benefit–risk appropriately, and to respond to questions from patients, families, and colleagues. We begin with three short questions to stimulate thinking about causality, coincidence, and reporting. Question 1 A 75‑year‑old man receives his annual influenza vaccine, waits the usual 15–30 minutes for any immediate reaction, leaves the practice, is hit by a car, and dies. Did influenza vaccination cause the death? Must this be reported as an AE? Question 2 In a primary school pertussis outbreak, 11 children contracted the disease. Of these, 7 of the 11 sick children were DTP‑vaccinated, and...