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What is not Suspected Cannot be Reported, Monitored, or Acted Upon!
Defining possible Adverse Events following Covid-19 Vaccination is essential for reporting, monitoring, and ultimately for determining the population health outcomes of the ongoing mass intervention.
Under court order, Pfizer released its first set of C-19 Vaccine documents in early March of 2022. This document included 9 pages of possible adverse reactions that should be looked out for by medical professionals administering these vaccines and monitoring recipients post receipt.
We should probably question why Pfizer has been singled out and why AstraZeneca, Moderna, Sinovac and all the other manufacturers haven’t likewise been required to release their research and application for approval documents.
Regardless, clearly the manufacturers KNOW that adverse reactions can and do result from their products.
THE PHILIPPINES GOVERNMENT ALSO KNOWS THAT ADVERSE REACTIONS ARE POSSIBLE
In their Press Release on 14th January 2021, announcing EUA authorization for Pfizer the Philippines FDA stated “Adverse events following immunization shall be closely monitored….. the vaccinations must be done by health professionals trained to recognize and manage adverse reactions…” “Reporting of the patient’s response to the vaccine shall be through the pharmacovigilance system that will be activated once the vaccination program is implemented.” “The FDA commits to its job to ensure that Filipinos can have access to vaccines that hold greater benefits and outweigh the risks and possible adverse effects during this time of pandemic.”
Effected on February 26 2021 RA11525, Sec. 10. sets up a National Vaccine Indemnity Fund of PHP500 Million “to compensate any person inoculated through the COVID-19 Vaccine Program, in the case of death, permanent disability or hospital confinement for any SAEs: Provided, That in case of death and permanent disability, PhilHealth is hereby authorized to pay compensation from the indemnity fund.”
The Covid-19 Vaccine rollout then officially started on 1st of March 2021.
The importance of identifying, reporting, and compensating AEs is therefore acknowledged by the Philippines Government, and as discussed in my post yesterday there is indeed weekly reporting by the Philippines FDA of suspected adverse reactions and deaths. Despite these reports now reaching nearly 100,000 cases, to date this has not apparently raised any alarms nor triggered any questions about the rationality of the continuing mass population vaccination and now vaccine boosting program [DOH has just applied to FDA for delivery of 2nd Boosters / 4th Doses to vulnerable populations].
WHAT IS NOT RECOGNIZED CANNOT BE REPORTED
It is critically important that health outcomes following vaccination be reported, documented, and acted upon not just for the sake of the individuals involved, but also for the sake and future of the health of the nation.
An adverse event may be either an entirely new medical condition or it may be a sudden and unexplained worsening of an existing condition. The development of an adverse reactions may be immediate (minutes to hours), short-term (days), medium-term (weeks to months), or long-term (years). Epigenetic changes may even affect offspring of recipients; taking generations to become apparent.
I am providing here an initial list, in no particular order of priority, of the broad types of adverse health outcomes that have been recognized by local and international AE reporting systems. Similar outcomes in recipients should be reported, regardless of severity levels, pre-existing comorbidities, or presumed cause.
Any death within 2 months of vaccine receipt. Ideally a full autopsy is performed! Unexpected and sudden death of any person, regardless of time since vaccine receipt must also be investigated and reported.
Acute reactions including injection site pain and swelling, fevers, headaches, muscle and joint pains, fatigue, diarrhea and vomiting, etc; even if these resolve within a short time.
Anaphylaxis, allergic, and hypersensitivity reactions. These are not just to the vaccines, but can also include development of new food or environmental allergies.
Neurological conditions including dizziness, confusion, loss of consciousness, seizures, stroke, paralysis including Gillian-Barre Syndrome, Bells Palsy (drooping on half of the face), transverse myelitis, movement disorders, nerve pains, dementias, new psychiatric conditions, loss and/or changes in vision and hearing, etc.
Cardiovascular reactions; changes in blood pressure, heart attack, myocarditis, pericarditis, chest pain, breathing difficulties / shortness of breath, fatigue, heart beat irregularities, etc.
Blood and lymphatic disorders, including abnormal bleeding, abnormal blood clotting, bruising, aneurism, Capillary Leak Syndrome, Thrombosis-thrombocytopenia Syndrome.
Skin conditions, rashes, new allergies.
Respiratory conditions, breathing difficulties, cough, congestion, shortness of breath.
Worsening of any pre-existing medical condition; there are reports of previously well-managed medical conditions suddenly becoming very difficult to manage and rapidly progressing, some with fatal outcome.
Cancers; new or recurrence of previously treated cancer; an increase in new, aggressive, and rare cancers in young people are being increasingly reported.
Infections of all types, including reactivation of previous infections including shingles (chickenpox virus reactivation), herpes (cold sores), tuberculosis, Epstein Barr (mononucleosis), hepatitis, etc.
New autoimmune diseases including Immune Thrombocytopenia, Arthritis, Type 1 Diabetes, Thyroid disorders, Psoriasis, Multiple Sclerosis, etc.
Menstrual disorders and infertility; changes in menstrual cycle, vaginal bleeding in pre-adolescent girls or post-menopausal women, new menstrual pain, premature menopause. Infertility and miscarriage.
Pregnancy related AEs including pregnancy losses must be reported, regardless of the trimester or suspected causes. Other adverse outcomes to be reported include premature delivery, placenta issues, birth defects, genetic abnormalities, still birth.
Adverse outcomes in breast fed babies of vaccinated women; rashes, infant bleeding disorders, failure to thrive, infant death.
Male infertility, erectile dysfunction, pain.
Gastrointestinal problems including pain, vomiting, diarrhea, changes in appetite.
Systemic reactions including such as joint and muscle pain, fatigue, exercise and/or work intolerance, feeling unwell.
Liver and kidney / renal issues, jaundice, kidney or liver failure, Type 2 diabetes.
These are only a partial list of the types of reactions that have been reported to date but should give a good guideline of things to look out for.
The bottom line is that any new or sudden change in health status following vaccine receipt should be reported. Given the safety implications of these EUA products, and their still experimental nature, there needs to be a very high degree of suspicion; GUILTY UNTIL AND UNLESS PROVEN INNOCENT!
Reports may be made by individuals, their friends / relatives, or their doctors. Typically reports will require brief personal details, vaccine details, description of the event, medical transcripts, and death certificates, as appropriate.
In addition to making report to the Philippines FDA [https://www.fda.gov.ph/covid-19-vaccine-report-a-side-effect/], I would also urge reporting to the CDCpH independent reporting system which has a link to the reporting form halfway down their page [https://cdcph.org/].
Government Publication References:
Republic Act No. 11525, February 26, 2021: https://elibrary.judiciary.gov.ph/thebookshelf/showdocs/2/92964
FDA Press Statement January 14 2021: https://www.fda.gov.ph/wp-content/uploads/2021/01/FDA-Press-Statement-EUA-Pfizer-January-14-2021.pdf
I accessed the Pfizer documents at https://www.icandecide.org/pfizer-documents, though there are also many other sites they can be accessed at.