The National Institute for Communicable Diseases (NICD) is urging people to report adverse events, as the country’s mass COVID-19 vaccination programme is underway.
According to the NICD, an adverse event following immunisation (AEFI) is any “untoward” health event that happens after a person receives a vaccine.
The NICD defined a health event as a symptom – something a person complains of, for example, a headache or a sign that a health practitioner notices, such as a raised blood pressure.
However, the health event may or may not be caused by the vaccine, the NICD said.
According to the institute, adverse events might include a person having a stroke or heart attack after receiving a COVID-19 jab.
“Any of these events may or may not be associated with vaccination, but all of these events are AEFI.”
The NICD said an AEFI usually occurs within 28 days following vaccination, even though there is no time limit to reporting an event.
“All health events after vaccination are important to investigate because vaccines are given to healthy people. Therefore, whilst some mild and short-lasting symptoms are acceptable, moderately severe and severe side effects are not acceptable, and should be fully investigated to understand if the vaccination was responsible.”
What adverse effects can be expected after COVID-19 vaccines?
All vaccines and medicines have side effects, the NICD said.
Most COVID-19 vaccines cause mild fever, pain or redness at the injection site.
Some people may complain about high fever, fatigue, headache, muscle pain, rash at the injection site, chills, and mild diarrhoea.
“Most reactions to vaccines are mild and go away within a few days on their own,” the NICD said.
Allergic reactions are also common after any kind of shot and can be mild such as a rash or itchiness around the injection site or very uncommonly, severe.
Meanwhile, a severe allergic reaction, known as anaphylaxis, leads to low blood pressure, collapse, difficulty breathing with/without skin rash, the NICD said.
“This reaction needs emergency treatment including fluid, oxygen and adrenaline,” said the NICD.
More serious or long-lasting side effects to vaccines have been reported but extremely rare, which includes a condition known as vaccine-induced thrombosis and thrombocytopenia (VITT).
Symptoms appear between 10 and 14 days after vaccination and may include symptoms of a stroke, or bleeding, and depend on which blood vessels and organs are affected.
“The exact mechanism of this is not clearly understood, but is likely to occur because of antibody responses to parts of the vaccine,” the NICD explained.
Which adverse effects that happen after a COVID-19 vaccine should be reported?
All adverse events after vaccination should be reported, said the NICD, including those that have improved clinically or resolved spontaneously.
However, the NICD said adverse events that occur commonly, such as mild fever, tiredness or headache are often not reported.
“Uncommon and serious side effects should always be reported. Serious adverse effects are those that need medical attention or admission to hospitalisation.”
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 has occurred following immunisation.
When the jab was given at a vaccination site, the vaccinator or person responsible for the centre or the facility manager should report the adverse event.
How should an adverse event after immunisation be reported?
Health practitioners and members of the public may report the adverse event using the Med Safety App, which is available on Google Play or the App stores.
The app will ask for details of the person reporting the event so that the public health authorities can investigate the event. However, the patient details are not mandatory fields on the app.
People have an option of completing a paper case report form, which may be found on https://www.nicd.ac.za/diseases-a-z-index/adverse-event-following-immunization-aefi/.
The form should then be emailed to AEFI@health.gov.za.
Who is responsible for investigating the adverse events that are reported?
Each province and district has people responsible for investigating adverse events following vaccination.
The person responsible for investigating the event will ask a set of comprehensive questions and obtain medical records before making a judgement.
The investigator will then submit data to the provincial or the National Immunisation Safety Expert Committee (NISEC), appointed by the Minister of Health.
The committee includes experts from all clinical disciplines, whose expertise may contribute to determining the role of vaccines causing adverse events.
The NISEC will then report findings to the Minister of Health, the National Department of Health and the Provincial Departments of Health, the South African Health Products Regulatory Authority (SAHPRA) and the World Health Organisation.
For assistance with the Med Safety App, contact the helpline 012 501 0311 on weekdays during office hours or send an email to firstname.lastname@example.org.