Serious adverse events following Immunisation (AEFIs)

  • • Serious AEFIs, including AESIs are extremely rare for COVID-19 vaccines.

  • • Serious AEFIs and AESIs are investigated by the NISEC Committee, (who are a group of experts appointed by the Minister of Health), provided complete information is available as explained under Causality assessment.

  • • Non-serious AEFIs, usually resolve within a few days with minimal medical intervention, and without any prolonged or persistent negative outcomes.

  • • SAHPRA also monitors non-serious AEFIs to ensure that the rates are low and acceptable.

  • • Currently, the rates for both serious and non-serious AEFIs are very low.

An AEFI is considered to be serious if:

  • • it is a medically important event
  • • it requires hospitalisation or prolongs an existing hospitalisation
  • • it is life threatening
  • • it causes a congenital anomaly/birth defect
  • • it results in death.

Adverse events of special interest (AESIs)

AESI is an AEFI of significant scientific, medical and public interest. AESIs need to be carefully monitored, and any potential association to vaccination confirmed by further investigation.

Serious AEFIs statistics

  • • As of 17 May 2021 to 31 March 2023 38 021 051 doses of COVID-19 vaccines have been administered in South Africa.
  • • For this period, SAHPRA and NISEC received 242 reports of death (0.00064%) among people who received COVID-19 vaccines.
  • • 10 cases are under investigation and
  • • 232 have been investigated and causality assessed.

  • Outcome of Causality assessment

  • • 192 cases were found to be coincidental, 96 of which had COVID-19 disease and 4 cases were breakthrough infections.
  • • 3 cases of death were investigated and causality linked to the use of the vaccine.
  • • 37 cases were unclassifiable due to inadequate information.