Notes

šŸ”„FDA: VACCINE PACKAGE INSERTS & PRODUCT APPROVALS + ACAM2000 Mpox/Monkeypox/Smallpox (posted 09/18/24)

immunize.org/official-guidance/fda/pkg-ā€¦

The FDA vaccine package inserts and product approvals are frightening and revelatory!

  1. Go to the link above.

  2. Search in the Vaccine or Disease Name dropdown for the ā€œdiseaseā€ youā€™re interested in such as COVID-19 or Mpox or Monkeypox.

    1. Youā€™ll see the package insert and product approval link(s) for the selected items.

  3. Click the View PDF and/or the Product Approval link.

WARNING: The information provided by the FDA may not be accurate and may downplay side effects, so beware of conclusions such as ā€œno vaccine-related adverse effects onā€¦ā€

Example: ACAM2000 Mpox/Monkeypox/Smallpox

Just one example that should shake you to the core: ACAM2000 Mpox/Monkeypox/Smallpox shot, approved 08/28/24. It is a LIVE smallpox injection that can be deadly to those who are vaccinated as well as those who are not vaccinated but come in contact with the vaccinated.

Mpox (Monkeypox): Excerpt from section 5.1 of package insert:

5.1 Serious Complications

Serious complications that may follow either primary or revaccination with ACAM2000 include: myocarditis and/or pericarditis, encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia (vaccinia necrosum), generalized vaccinia, severe vaccinial skin infections, erythema multiforme major (including Stevens-Johnson syndrome), eczema vaccinatum, accidental eye infection (ocular vaccinia) which can cause ocular complications including keratitis and corneal scarring that may lead to blindness, and fetal death in pregnant women. These complications may rarely lead to severe disability, permanent neurological sequalae and death.

Based on ACAM2000 clinical trials, symptoms of suspected myocarditis or pericarditis (such as chest pain, raised troponin/cardiac enzymes, or ECG abnormalities) occurred in 5.7 per 1000 primary vaccinations. This finding includes cases of acute symptomatic or asymptomatic myocarditis or pericarditis or both. Historically, death following vaccination with live vaccinia virus is a rare event; approximately 1 death per million primary vaccinations and 1 death per 4 million revaccinations have occurred after vaccination with live vaccinia virus.

Death is most often the result of sudden cardiac death, post-vaccinial encephalitis, progressive vaccinia, or eczema vaccinatum. Death has also been reported in unvaccinated contacts accidentally infected by individuals who have been vaccinated.

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Sep 18, 2024