Why report an adverse effect of a vaccine?


The UK, US, and EU each have official schemes for reporting vaccine adverse effects.   Reports of adverse effect (or side effects) are admissible for fully approved vaccines and, also most importantly in the case of the Covid-19 vaccines (which remain in third-stage trails until 2023), for vaccines in clinical trials.

Why report adverse effects?  To help gather valuable evidence to inform decisions on the safe and effective use of vaccines.

What to report on?  Any adverse effect, including fatalities, as a resulting of receiving a vaccine.  For example, a high number of reports for the Covid-19 vaccines include issues with blood clots.

Who can submit a report?  Any member of the public or a healthcare professional.

Is reporting of adverse effects mandatory?  No, it is voluntary and many people are not aware of its existence.

How many adverse effects get reported?  There is an estimate of about only 1% of cases in the US and about 10% in the UK.  Also there is a reported lag of 4-6 weeks (and increasing) in the reporting.

Key Points & Evidence

1. In the UK, the Medicines and Healthcare Regulatory Agency (MHRA), has overall responsibility for logging vaccine adverse effects via its MHRA Yellow Card reporting system.

Read more...yellowcard.mhra.gov.uk

2. European adverse events are reported via the EU's EudraVigliance database of suspected drug reaction reports.

Read more...adrreports.eu

3. US adverse effects reporting is accessed via the CDC's Vaccine Adverse Event Reporting System, known as VAERS.

Read more...vaers.hhs.gov

4. Vaccine Impact news also provides a monthly round-up of the EU - EudraVigilance, and US - Centre for Diseases Control (CDC) adverse reaction reports.

Read more...vaccineimpact.com


In the UK, the MHRA is responsible for investigating whether an effect was created by a vaccine or not, and is responsible for taking action in the case of a high number of reported adverse effects.  So far, however, (as is the US where there are reports of VAERS data having been deleted), the process for recording adverse effects in the UK has not been meticulous. Indeed, despite the high number of registered adverse effects for Covid-19 vaccines, they are not being investigated.

Posted: 19th July 2021

Tagged: Vaccines

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