Reporting Adverse Effects

Reporting Adverse Effects

What is an ‘adverse event’ following immunisation/vaccination?
An ‘adverse event following immunisation’ (AEFI) is any untoward health event which happens after a person receives a vaccine. A ‘health event’ is a symptom...
What adverse effects can be expected after COVID-19 vaccines?
All vaccines (and medicines) have side effects. COVID-19 vaccines have mild side effects, which differ slightly among the vaccines that are available. Most ...
Which adverse effects that happen after a COVID-19 vaccine should be reported?
Theoretically, all adverse events after vaccination should be reported, even those that have improved clinically or resolved spontaneously. However, adverse...
If an adverse effect happens after a COVID-19 vaccine, who should report it?
Any health practitioner or member of the public may report that an adverse event following immunisation has occurred. When the vaccine is given at a vaccina...
How should an adverse event after immunisation be reported?
The adverse event may be reported using the MedSafety App (see below) or by completing a paper ‘case report form’ which may be found at https://www.nicd.ac....
How can a member of the public report an adverse event after a COVID-19 vaccine?
The best way for a member of the public to report an adverse effect is by using the ‘MedSafety App’ . The ‘Med Safety App’ may be found on Google Play S...
Who is responsible for investigating the adverse events that are reported?
Each province and district has allocated persons who are responsible for investigating adverse events following vaccination. Usually these persons will belo...
What investigations are done after an adverse event following COVID-19 vaccination is reported?
The person responsible for investigating the event will complete a ‘case investigation form’. This form asks a set of comprehensive questions that will prov...
How are adverse effects following COVID-19 vaccination investigated?
The provincial committee responsible for reviewing the adverse event or NISEC uses the World Health Organization (WHO) algorithm to examine what is reported...
What is the National Immunisation Safety Expert Committee (NISEC)?
This committee is appointed by the Minister of Health. It includes experts from all clinical disciplines whose expertise may contribute to determining the r...