Covid-19 Vaccine Adverse Event Reporting in The Philippines

We need comprehensive population health data to study the impacts of the vaccine intervention. Please report all health outcomes to FDA at www.fda.gov.ph/covid-19-vaccine-report-a-side-effect/

While the Philippines Department of Health continues to preach that covid-19 vaccines are safe and effective, suitable and recommended for everyone in multiple doses, and have only minor side effects at worst, the Philippines FDA releases a weekly summary on suspected adverse reactions.

While the report clearly states that deaths and adverse events (AEs) are not necessarily related to the vaccines; the fact remains that someone thought there was enough of a relationship to make a report. Below is the cover page for the latest report from 13th March 2022; the weekly reports are publicly available on-line.

Very high incidence of underreporting is expected in all such reporting systems and this has been documented in international research to be in the range of 40 to >100x.

In the Philippines the availability of an adverse reaction reporting system is not well publicized. Access also requires computer literacy, time, and knowledge. First issue is that many people are not aware of what health issues may result post-vaccination, and thus, they may not link their new health conditions or worsened health with the C-19 vaccines. Further, from personal on the ground local reports I have heard that it is common for people’s post vaccination experiences to be downplayed and disregarded, and for the reporting of AEs to be actively discouraged. Which official or health / medical personnel would want to acknowledge that their action had resulted in a poor outcome? Thus, surely the locally reported AEs and deaths likely represent only a very small portion of the actual outcomes.

The Philippines has 9 covid-19 vaccines currently under EUA approval, with 8 currently under distribution. As of 13 March 2022, 138 million doses of vaccines have been given. The table below, from this FDA report sets out numbers of vaccines given and the numbers of severe and mild AEs. There are 91,485 suspected AE reports. If this is under reported it could represent anywhere between say 3.6 million and well over 9.1 million actual AEs.

As of March 13, 2022 there are also reports of 1988 deaths, including 2 from children aged 7 to 11, and 21 for children aged 12 to 17. While all deaths should be carefully evaluated (are autopsies being conducted?), these pediatric deaths should require even closer scrutiny because children do not typically die from covid-19, nor do they have serious sequalae after recovery from infection.

Interesting that the “preexisting comorbidities” being blamed for the deaths are also the same conditions that are being attributed as AEs to the vaccines, and that fatal C-19 infections were seen following vaccination.

The vaccines were all approved under Emergency Use Authorisation (EUA), and rolled out to the entire population after mere months of research! None have yet completed licensing studies. Long-term consequences are unknown. As all recipients are part of the experiment they need to be encouraged to contribute to the data collection.

Any vaccine recipients should report health outcomes; minor or major; without their personal judgement on cause. On a population basis, whether or not particular outcomes are vaccine related will only become apparent if we can collect sufficient population data to compare population health and historical incidence of various conditions before and after vaccines. The temporal relationship may be immediate, it may be days, months, or even years.

All new conditions and deaths in persons who have received the vaccines must be reported. I would ask my readers to report their experiences, and to please encourage and even help others to make such reports.

The reporting procedure is fairly straightforward. You make an initial report filling in a questionnaire and basic details. You can expect to receive a follow-up email from the Pharmacovigilance Team who will reassure you of confidentiality of the information you send them, and they will ask for vaccine card, medical / hospital transcripts, and death certificate, as relevant. I made such a report for the death of a previously healthy man in his 40s, who died in late December 2021 within 48 hrs of a “cardioembolic stroke” following a second dose of vaccine a month ago, but not have not heard back after submitting the requested information. I can only presume that my case report was included in the data.

Reports of AEs can be made at www.fda.gov.ph/covid-19-vaccine-report-a-side-effect/.

I will address some of the more typical types of reactions seen and suspected in a separate post.