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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.

Health ministry releases list of blood clot symptoms after taking Covishield

According to the AEFI Committee, it has completed an in-depth case review of 498 serious and severe events, of which 26 cases have been reported to be potential thromboembolic (formation of a clot in a blood vessel that might also break loose and carried by the bloodstream to plug another vessel) events - following the administration of Covishield vaccine - with a reporting rate of 0.61 cases per million doses. The Union health ministry said on Monday that the number of blood clot cases in people who received AstraZeneca s Covid-19 vaccine (called Covishield) in India was minuscule . Covishield - one of three shots granted emergency approval in India - is the most widely used in the country and is manufactured by Pune-based Serum Institute (SII).

Coronavirus | Few clotting events post-Covishield jab: AEFI panel

Health Ministry issues advisory of potential thromboembolic incidents Adverse Event Following Immunisation (AEFI) data in India showed that there is a minuscule but definitive risk of thromboembolic events after the AstraZeneca-Oxford vaccine (Covishield in India). A statement issued by the Health Ministry on Monday noted that the reporting rate of these events in India is around 0.61/million doses, which is much lower than the four cases/million reported by UK’s regulator Medical and Health Regulatory Authority (MHRA). Germany has reported 10 events per million doses. There were no potential thromboembolic events reported following administration of Covaxin vaccine. Bleeding and clotting cases following COVID vaccination in India are minuscule and in line with the expected number of diagnoses of these conditions in the country, a report submitted by the National AEFI to the Health Ministry noted.

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