“There is no need to prove that the medicine caused the adverse reaction, just the suspicion is good enough.”
Dr. June Raine, Chief Executive Officer of the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), quoted in The Guardian
What is an adverse reaction or event, and why should I report it?
An adverse reaction or event is any negative change in your health or new illness that happens during or after treatment with a medicine.
Adverse reactions include physical events such as headache or an allergic reaction, a psychological symptom such as brain fog, a change in clinical measurements, such as reduced blood platelet levels, or a worsening of a pre-existing medical condition, such as diabetes. These reactions can happen at any time – shortly after using a medicine or even many years later.
Individuals and their health care provider must report adverse events so that regulatory authorities can monitor a medicine’s safety and identify any problems that have not been discovered yet. It also helps the authorities to change advice for healthcare workers and the public.
How do I report a Covid-19 vaccine adverse event or side effect?
Covid-19 vaccines are a new type of therapy and their safety is unknown; therefore it is especially important to report serious side effects. Depending on where you are in the world, there are various databases set up to record adverse drug reactions:
|UK||Medicines and Healthcare products Regulatory Advisory (MHRA)||In the UK, the Medicines and Healthcare products Regulatory Advisory (MHRA) uses the Yellow Card System to monitor reports, and any individual who suspects an adverse reaction can report it directly onto their website: https://coronavirus-yellowcard.mhra.gov.uk|
|USA||Vaccine Adverse Event Reporting System (VAERS)||In the USA, the Centres for Disease Control (CDC) and the Food and Drug Administration (FDA) manage the Vaccine Adverse Event Reporting System (VAERS) database, which allows individuals to send in reports through the website: https://vaers.hhs.gov/reportevent.html|
|Canada||Government of Canada||In Canada, you can report an adverse event at the Government of Canada website: https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html. There is also the Canada Vigilance Adverse Reaction Online Database: https://cvp-pcv.hc-sc.gc.ca/arq-rei/index-eng.jsp|
|Australia||Therapeutic Goods Administration||In Australia, the Therapeutic Goods Administration (TGA) monitors adverse events and a report can be filed here: https://aems.tga.gov.au|
|France||Signalement-sante.gouv.fr||In France, https://solidarites-sante.gouv.fr/soins-et-maladies/signalement-sante-gouv-fr/|
|South Africa||South African VAERS||In South Africa, https://thj-africa.org.za/ has a link to the South African VAERS.|
|New Zealand||Government of New Zealand official reporting system||In New Zealand Health Professionals, public and 'others' can report adverse reactions here - https://report.vaccine.covid19.govt.nz/s/|
|Central America||Noti-FACEDRA reporting system||http://www.notificacentroamerica.net/n/Pages/mapa.aspx#no-back-button|
Are there support groups for people injured by the Covid-19 vaccines?
The World Council for Health suggests that you visit the following websites if you experience a health condition as a result of a Covid-19 vaccination: