Adverse events following immunisation (AEFI) for COVID-19 vaccines

Introduction

This page provides information on reports of adverse events following immunisation (AEFIs) associated with COVID-19 vaccine administration. All medicines, including vaccines, can cause side effects. In the case of vaccines, side effects or adverse events that occur after vaccine administration are known as AEFIs. However, the benefits of COVID-19 vaccination outweighs the risks. COVID-19 vaccines have proven to prevent severe form of disease, hospitalisation and death.


An AEFI is an untoward medical event which follows immunisation and does not necessarily have a causal relationship with the administration of the vaccine. The adverse event may be an unfavourable or unintended sign, abnormal laboratory finding, symptom or disease. Most adverse events for COVID-19 vaccines are non-serious and mild, and resolve within the first 2-3 days after vaccination. For example, mild headache, pain and redness at the injection site, slight fever, etc. Not all suspected adverse events, whether minor or serious, are caused by the vaccine. It is possible that the timing of the suspected adverse event may be coincidental to the vaccination.

AEFIs are grouped into five categories, which are:

• • Vaccine product-related reaction
An AEFI that is caused or precipitated by a vaccine due to one or more of the inherent properties of the vaccine product e.g. Extensive limb swelling following a vaccination.
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• • Vaccine quality defect-related reaction
An AEFI that is caused or precipitated by a vaccine that is due to one or more quality defects of the vaccines product including its administration device as provided by the manufacturer.
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• • Immunisation error-related reaction
An AEFI that is caused by inappropriate vaccine handling, prescribing or administration and thus by its nature is preventable.
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• • Immunisation anxiety-related reaction
An AEFI arising from anxiety about the immunisation e.g. hyperventilation.
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• • Coincidental event
An AEFI that is caused by something other than the vaccine product, immunisation error or immunisation anxiety. E.g. a fever occurs at the time of the vaccination (temporal association) but is in fact caused by something else. Coincidental events reflect the natural occurrence of health problems in the community with common problems being frequently reported.
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The Sisonke Phase 3b clinical trial was a real-world study to monitor the effectiveness and safety of the COVID-19 Vaccine Janssen amongst healthcare workers. The Sisonke study commenced on 17 February 2021 and was completed 17 May 2021, after vaccinating 495 829 vaccine recipients including, 479 768 healthcare workers. Most of the adverse events reported during the Sisonke study were reported on a different platform, and therefore not included in this data. The adverse events from the Sisonke study were reported to SAHPRA under the clinical trial framework as summary reports. Find out more.

A national vaccine roll-out commenced mid May 2021 with both the Comirnaty (Pfizer-BioNTech) vaccine and COVID-19 Vaccine Janssen. The known AEFIs for the Comirnaty and the COVID-19 Vaccine Janssen are listed in the product’s Professional Information or Patients Information Leaflet (Facts sheet).

Suspected AEFIs to COVID-19 vaccines are reported by healthcare workers and the public to the South African Health Products Regulatory Authority (SAHPRA) and the National Department of Health (NDoH). SAHPRA has a mandate to oversee the safety, efficacy and quality of all medicines registered in South Africa. The NDoH through its Expanded Programme on Immunisation (EPI) is responsible for the vaccination programme, and therefore collaborates with SAHPRA to oversee the vaccine safety monitoring and reporting of AEFIs throughout the country. The National Immunisation Safety Expert Committee (NISEC), an independent ministerial advisory committee, is responsible for Causality assessment of all serious and severe AEFIs to determine whether the event may have been caused by the vaccine or whether it was coincidental. Reporting of AEFIs is very important, as it helps to monitor the safety of vaccines for the benefit of everyone.

SAHPRA and NDoH closely monitor the AEFIs reported from the use of the COVID-19 vaccines.

AEFI reporting is done through the Med Safety App which can be downloaded on both Android and iOS smart phones.

SAHPRA would like to thank you for your contribution in the monitoring of COVID-19 vaccines safety.