COVID-19: What is the correct way to report vaccine-related adverse events?
Phase two of South Africa’s COVID-19 vaccine rollout aiming to vaccinate citizens over the age of 60 years is underway and members of the public are being asked to report any mild, moderate or severe adverse events experienced after receiving their jabs.
Reporting adverse events is a critical part of monitoring vaccine safety once a vaccine has been rolled out to the broader population. The timeous reporting specifically of serious adverse events means a specialist review or causality committee can either rule out or confirm whether there is a link to the vaccine.
Spotlight has been alerted to calls by an “independent” online organisation for members of the public to report adverse events they may experience on the organisation’s site. To avoid confusion, we spoke to the South African Health Products Regulatory Authority (SAHPRA) and the National Department of Health to map out the official and credible channels for reporting and to explain how to report mild, moderate or severe adverse events following immunisation.
Florah Matlala of SAHPRA’s Pharmacovigilance Unit and Hannelie Meyer, Professor in the School of Pharmacy and Head of the South African Vaccination and Immunisation Centre at Sefako Makgatho University, say that all adverse events should be reported, whether mild, moderate or severe. This means anything of concern must be reported.
Why should the public report an Adverse Event Following Immunisation (AEFI)?
When a new vaccine or medicine is registered for use, such as the COVID-19 vaccines, data on safety is limited to what has been identified in clinical trials. The main benefit of reporting an AEFI, whether minor or severe, is that everyone contributes to the safety surveillance of the vaccines and not just those who participate in trials.
Data on rare adverse events, or adverse events with a slow onset, can only be detected when vaccines are used by a large number of people and when these events are actually being reported.
Reporting assists the Department of Health and SAHPRA with the collection of data, but more importantly, this data is necessary to ensure the safety of the public. When a previously unknown rare event is reported, action can be taken to prevent others from also experiencing this rare event in future. By reporting adverse events, you are making an important contribution to ensuring the safety of vaccines and can help prevent further harm to yourself, your family, and others who may experience similar reactions.
South Africa is one of four pilot countries (South Africa, Nigeria, Ghana, Ethiopia) of the African Union Smart Safety Solutions (AU-3S) Programme, which is a 10-year programme aimed at strengthening pharmacovigilance (strict monitoring) in Africa. All AEFI reports submitted electronically through SAHPRA’s Med Safety App by the four countries will be pooled for signal detection. A committee of experts from the four countries will review and discuss possible signals, followed by communication with the relevant countries as appropriate.
When should people report an AEFI?
Ideally, it should be reported immediately.
All severe and serious AEFIs are investigated. First, an investigation is done by a multi-disciplinary team at the district or provincial level, within 48 hours of the reporting. A causality assessment is then conducted by the National Immunisation Safety Expert Committee (NISEC) to determine whether the event may have been caused by the vaccine or whether it was a coincidental event. The NISEC also does causality assessments for clusters, rare events or any other events of concern.
Depending on the outcome of the causality assessment, feedback is given to the programme and other ministerial appointed advisory committees. The aim is to ensure vaccine safety, mitigate any possible risks and maintain the integrity of the vaccination programme.
How can the public report an AEFI?
The Med Safety App allows members of the public to report an AEFI from the comfort of their home, directly to SAHPRA and to the National Department of Health.
People who do not have access to smartphones and/or who might not be able to use the App can still report an AEFI directly to their healthcare professionals. In the case of connectivity challenges, the App can also be used offline. The report can be saved and then submitted when connectivity is available. A dedicated email address (firstname.lastname@example.org) and helpline at SAHPRA (012-501 0311 on weekdays during office hours) are available for anyone experiencing challenges using the App for reporting and AEFI.
The Med Safety App is available for use by both healthcare professionals and the public. It can be downloaded to a smartphone from the Google Play Store or Apple App Store. Using it is simple:
- First, you choose your region
- Then you acknowledge the Privacy Statement
- Then create a profile as a member of the public or a healthcare worker
- And you are ready to report AEFIs/Adverse Drug Reactions
- Make sure you choose the correct reporting form as there are two reporting forms, one for reporting AEFIs (vaccines) and the other for ADR (medicines)
How does the Department of Health call centre work?
The call centre can be reached free of charge on the COVID-19 Public Hotline 0800 029 999. Selecting option 3 will divert your call to the safety desk where call centre staff can assist healthcare professionals or the public with questions post-vaccination.
Call centre staff at the safety desk have also been trained on the use of the Med Safety App and can respond to questions about using the App, assist callers to submit a report while they are on the call, as well as submit a report using the Med Safety App on behalf of callers who cannot do so themselves.
Is the NICD case reporting form for public use?
All the paper-based forms are available on the National Institute of Communicable Disease (NICD) and SAHPRA websites. These are specifically for use by health care professionals.
Although electronic reporting through the Med Safety App is now the preferred method of reporting, should a HCP not have access to the App or experience any challenges using the App, the paper-based reporting system can still be used. All paper-based reports must be emailed to a central email address (email@example.com) to prevent any delays in communication. These reports will be entered manually into the system at the provincial level.
What happens if a person has anaphylaxis – a rare but serious allergic reaction?
If a person experiences a serious adverse event, such as anaphylaxis, they need to go to a health facility or their doctor immediately to get the healthcare they need.
Anaphylaxis, in the majority of cases, occurs in the first 15 minutes after vaccination. This is why everyone is required to remain at the vaccination site for a 15 minute observation period post-vaccination. People with a history of allergies are required to stay at the site for observation for 30 minutes, as a precautionary measure.
The healthcare professional will report the AEFI using the Med Safety App as the preferred method of reporting or they will use the paper-based form.
Anaphylaxis is however very rare.
The majority of adverse reactions are mild-to-moderate in severity and resolved within 1-2 days of vaccination.
When a vaccinee is experiencing a mild AEFI, for example, fever, headache, or muscle aches, it can be managed symptomatically if necessary to provide relief, for example taking an analgesic such as paracetamol.
*Adele Baleta is an independent science writer and a member of the Vaccine Hesitancy Working Group for the National Advisory Group on Immunisation.