How to report COVID-19 vaccines side effects on Health Canada portal as consumer
You don't need a doctor to report vaccine side-effects, you need the exact URL link and your Patient ID, which is your initials...
Background:
I did not have side-effects from COVID vaccine. However, I met several people who had. And, I found that most of them could not report them as a vaccine side-effect, because they were not able to prove to their doctor that these were from the vaccine. This included kidney problems, menstrual problems, arthritis, shingles, heart discomfort, to name a few.
Yes, it happened after the vaccine. Yes, these people did not have those problems before the vaccine. But still, they were not able to prove that these new problems were related to vaccine. These new problems were “not serious” (meaning, “not life-threatening”), and because of that Doctors do not need to report them. According to their code, it’s only “serious” adverse events that they must - by their regulations - report. As for “non-serious”, most of them just don’t have time to do it - you know how swamped they are already with their work…
That’s why back in December 2021, we (myself with several colleagues from other government departments) built a step-by-step guide which tells you how you can report a vaccine side-effort yourself. Yes - you can do it yourself, and you don’t need a doctor to do it for you! In fact, Health Canada website encourages you to do that. But you probably just don’t know about it, do you? Noone told you about that, right?
How did we find out about that? Not from the doctor - as you could guess, and not from “Google” - good luck trying to find it this way!
We were able to find out all the details of the adverse reaction reporting process because the wife of one of my colleagues who attended the data science Lunch-n-Learn seminars that I led every Friday during the pandemic, happened to work in Health Canada exactly in the directorate that processed these reports. What a coincidence! Lucky coincidence.
She told us all detailed step-by-step instructions on how we can do it, which were then posted on our GitHub portal: https://open-canada.github.io/vitals/report-side-effect.
The direct link to the Health Canada online form:
Please note that there are also several other portals that allow you to report COVID-19 vaccine side-effects, and which allow you include more details (CAERS in Canada, VAERS in US). However please always start from reporting to Health Canada, and only then - if you wish so - report elsewhere.
Below - as a reference - is also the official statistics on Serious Adverse Reactions (SAR) as published the Public Health Agency of Canada at the time of writing this article. The data is taken directly from the source and visualized in this Googlesheet.
How to report COVID-19 vaccine side-effect on Health Canada portal
Original source: https://open-canada.github.io/vitals/report-side-effect
Background
Reporting of serious (or life threatening) side effects of vaccines is mandatory in Canada. However, reporting of non-serious (or not life threatening) side effects in Canada is voluntary. Many doctors may not have time to do it, nor they provide guidance to their patients on how they can do it.
For this reason many non-serious side effects remain unreported. Many doctors will not do it, and consumers do not know how to do it. In fact, many Canadians may not even know that they can do report vaccine side-effect themselves, i.e. without a medical doctor. There are no instructions on the Health Canada portal on how to do it. The link to the Health Canada Voluntary Side Effect Reporting portal may also be rather difficult to find.
This page is created to address this gap and to help Canadians to report any vaccine (or any drug) side-effect, as a consumer. Health Canada encourages everyone to do so. – It is thanks to such efforts that vaccines (and drugs) can be improved for the benefits of all.
Once you know how to do it, it should not take more than fifteen minutes to do it. This is how you do it. An Example is provided here.
Submitting Voluntary Side Effect Report via Health Canada portal
Step 1: Go to the Health Canada Voluntary Side Effect Reporting portal : https://hpr-rps.hres.ca/side-effects-reporting-form.php?form=voluntary
Step 2: Submit electronic form there as shown in this Example.
There are three places there that you need to know how to fill out:
- in Section B: Patient ID write your initials;
- in Section D: Product DIN and Product Name - paste the vaccine names (and batch/lot number, if available), as printed on your receipt.Make sure you provide a valid email address, which will be used to send you to further instructions on how ontinue side-effect report process.
If you still have problems submitting the form (i.e., clicking on button “SUBMIT” does not lead you anywhere),
call Heath Canada Voluntary Reporting support line: Tel. 866-234-2345, if you leave a message. They should respond within 24 hours. If they did not, please call again.
Step 3: A few (2-5) days later you should receive email from Canada Vigilance (HC/SC) canadavigilance@hc-sc.gc.ca (with Subject: “Correspondence from the Marketed Health Products Directorate - Adverse Reaction Number 0009xxxxx), which will provide you with the
Adverse Reaction Report (AER) number and which will ask you to submit additional details though their portal.
If you don’t receive email from them within 5 business days, please check you Spam folder and, if it is not there, please call them at Tel. 866-234-2345 and leave a message.
As they note in their email: “Posting of reports in the online database remains 3 months behind the date of reporting. This delay accounts for the necessary activities involved in report processing”
Additional resources:
The following additional resources are provided to help you prepare your side-effect report. There you can check if your symptoms are already reported in national adverse event reporting systems, and if so, how common they are, for which type of vaccine, and which vaccine batch (a.k.a. lot, which is the number printed on your vaccination receipt)
Recalls and safety alerts, Government of Canada: https://recalls-rappels.canada.ca/ (for [Moderna], for [Pfizer], for [Astrazeneca] )
‘Reported side effects following COVID-19 vaccination in Canada’, Canadian COVID-19 vaccination safety report, Public Health Agency of Canada, https://health-infobase.canada.ca/covid-19/vaccine-safety/
US Government Vaccine Adverse Event Reports (VAERS): https://vaers.hhs.gov.
(You can also check if your vaccine batch (lot) is among the “bad ones”, according to VAERS data, here)
Comprehensive world-wide COVID-19 vaccine reports repository
CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021. Prepared by Pfizer, Released under the court order on 17 November 2021 https://phmpt.org/wp-content/uploads/2021/11/5.3.6-postmarketing-experience.pdf