COVID-19: Reporting vaccine adverse reactions is a must

THE National Institute for Communicable Diseases (NICD) is urging people to report adverse events, as the country’s mass Covid-19 vaccination programme is under way.

According to the NICD, an adverse event following immunisation (AEFI) is any ‘untoward’ health event that occurs 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 raised blood pressure.

However, the health event may or may not be caused by the vaccine, the NICD said.

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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 after vaccination, even though there is no time limit to reporting an event. ‘All health events after vaccination are important to investigate as vaccines are given to healthy people.

‘Therefore, while 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.’

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 or without a 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 are extremely rare.

These include 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, depending on which blood vessels and organs are affected.

Whether adverse events after vaccination have improved clinically or resolve spontaneously, all should be reported.

If an adverse effect occurs after a Covid-19 vaccine, it can be reported to:

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.

Health practitioners and members of the public may report the adverse event using the Med Safety App, which is available on Google Play or other app stores.

The app will ask for details of the person reporting the event so 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

For assistance with the Med Safety App, contact the helpline 012 5010311 on weekdays during office hours or send an email to adr@sahpra.org.za

Source: SAnews.gov.za

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