Vaccination: What are adverse events, and where can you report them?

Citizens have been urged to report any side-effects they might experience after taking the Covid-19 vaccines.

This comes as the South African Health Products Regulatory Authority (Sahpra) continues to investigate the cause of death of 28 vaccinated individuals.

Saphra has been looking into adverse events reported by those who were administered with the double-dose Pfizer-BioNTech vaccines and the single-dose Johnson & Johnson (J&J) shot across the country.

An adverse event following immunisation is any detrimental health event that happens after a person receives a vaccine according to National Institute for Communicable Diseases (NICD).

Adverse events

Speaking to Newzroom Afrika, Mafora Matlala, who is the manager of Pharmacovigilance at Sahpra, explained how the regulator categorised the “adverse events following immunisation”.

“With regards to the adverse events following immunisation that we see, we have got two different categories. We have the non-serious, which relates to those chills, fever[s], a bit of headache, nausea here and there, and then furthermore we have got the ones that are more serious and severe.

“So the serious and severe, like we indicated, there would be thrombosis. It can also be death [and] it can be also hospitalisation.

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“We do see serious adverse events following immunisation, but those are at a very low level, if I may say and those are the ones that we call causality assessments, where we determine the linkage between the adverse events and the vaccine itself, so those are the ones we do investigations on,” she said.

Matlala revealed that the Department of Health has appointed a team of investigators to probe the matter.

She indicated that there was no evidence which suggested that the 28 deaths were linked to the vaccine to date, further calling on the public to report any adverse events.

When do adverse events occur and where to report them?

According to NICD, adverse events usually occur within 28 days following vaccination, however, there is no time limit to reporting an event.

Sahpra’s guidelines on health products vigilance state that anyone can report an adverse event.

People who report adverse events will be asked to provide the following:

• Patient identifier (such as initials, date of birth or age, but not their full name)
• Details of the product involved (preferably a trade name of the product)
• Details of the suspected adverse event (give description of the event)
• Contact details for the reporter (name, address, phone number, qualification)

Members of the public can report an adverse effect after vaccination through the MedSafety App. The app was developed to engage both patients and healthcare providers on medicines safety issues.

Click here to find instructions on how to use the app.