Reports of Suspected Adverse Events Following Covid-19 Vaccination - PH Pharmacovigilance Report Effective as of 30 June 2024. AEFI Reports Risen to 113,218, SAE to 10,828, Deaths to 2,871.
What is not documented cannot be examined or acted upon! Responsible citizens should be speaking out and sharing C19 vax outcomes. FDA reporting form linked! Filipinos, PH residents please report!
FDA has issued a new Pharmacovigilance report on the AEFI reported following Covid-19 vaccination as of 30 June 2024. I don’t know when this was published, but I am late reporting it as I seldom visit the FDA site these days.
The prior report had been issued effective as of 31 December 2023.
In the 6 months since the last report, there has been no change in the number of Covid-19 vaccines listed, Covid-19 vaccination in the Philippines having stopped in 2023. This new report contains 52 new AEFI reports to bring the new total to 113,218; 23 new serious reactions to bring the SAE to 10,828, and 7 new reported deaths to bring the death total up to 2,871.
The report is nearly word for word the same as the prior report. It emphasizes that the benefits of the vaccines in preventing severe and critical disease cause by COVID-19 far outweigh any current known adverse reactions in most of the vaccinated individuals.
It does state as a new clause that all EUA on Covid-19 vaccines were only valid until 20 July 2024. Covid-19 vaccines are not currently commercially available in the Philippines.
A breakdown of adverse reactions by vaccine type, without breakdown of deaths is provided. There were 7 new reports (4 serious) for Coronavac, 13 new reports (3 serious) for AstraZeneca, 27 new reports (12 serious) for Comirnaty (Pfizer), 1 new serious report each for Moderna and Sinopharm, and 3 new reports (2 serious) for Janssen.
From the breakdown discussion section of the document:-
There was 1 new serious report from a lactating mother.
8 of the new reports were related to the first booster, some of the prior serious reports were reclassified as non-serious.
2 of the new reports were related to a second booster, some of the prior serious reports were reclassified as non-serious.
3 of the new reports (1 serious) were related to the bivalent booster.
There has been little movement on the assessment of any of the conditions of special concern
Still 13 reported cases of thrombosis-thrombocytopenia syndrome with 2 assessed as product-related and the rest under monitoring.
Still 31 reported cases of myocarditis and 4 of pericarditis, 14 and 1 respectively assessed as product related, and the rest under monitoring.
1 new case of GBS reported. But still 13 listed as product-related, 6 indeterminate, 2 as coincidental, and the rest under monitoring.
Still 12 reported cases of immune thrombocytopenia with 6 assessed as product related, 3 indeterminate, 1 coincidental and 1 under monitoring.
Still 7 reported cases of encephalitis, 1 assessed as product related, 3 as coincidental, and the rest under monitoring.
Still 28 cases of heavy menstrual bleeding, 9 serious; 2 assessed as coincidental and the rest under monitoring.
Still 2 cases of transverse myelitis; 1 assessed as product related and the other under monitoring.
What does under monitoring mean? It sure looks like shelved and hoped to be forgotten, considering that there has been no movement on any of the under monitoring for the 6-months between this and the prior report. How can 113,218 AEFI with 10,828 SAE reports hold so few adverse events of special concern?
7 new deaths are added to bring total deaths up to 2,871; +2 aged 60+, +7 aged 40-59; with the difference being 2 persons removed from the unknown age. The average age of fatal cases has dropped from 59.17 to 59.15 years. These vaccine SAE death reports are far lower than the average age of death of Filipinos, which is in the low 70s.
The FDA no longer provides a dedicated portal for reporting of Covid-19 vaccine adverse reactions. Reports now have to be made via the challenging to access regular reporting system. They should only be made by the patient or a relative, or a medical professional. The following fillable form can be used to make a report. Click on the form below to access it. Instruction on how to file your report by mail, email etc. are on the second page. I urge everyone who has had any adverse reaction to Covid-19 vaccines or any other medical product to report their adverse outcome.
Miscarriages, infertility, cancers, sudden deaths, unexplained new health concerns, everything needs to be reported! What is not documented cannot be examined or acted upon! Responsible citizens should be speaking out and sharing their health outcomes with the authorities.
Reporting is essential in order for Authorities to identify adverse outcomes!
Reporting is confidential!
Reporting Form! Please use it! Please fill it out as completely as you can and submit it. Please add vaccine details / batch numbers. Keep a copy of your completed form for reference.
If you feel willing to share your story or are willing to help me compile adverse reactions by Covid-19 vaccine type and batch numbers, I can be emailed at super_sally888@protonmail.com. I may possibly ask if I can use your story as a case study for a future article, of course with no personally identifying information ever to be revealed, and only ever with your consent!
Percentage should be calculated on the number 1ste booster as one was only fully vaccinated after the 3th jab.
This brings adverse reaction to 0.48%.