Clinical and Translational Research Section (Volume 2)

Volume 2

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ARTICLE

 

Significant Under-Reporting of Quadrivalent Human Papillomavirus Vaccine-Associated Adverse Events in the United States: Time for Change?

Lucija Tomljenovic, Emily Tarsell, James Garrett, Christopher A. Shaw, & Mary S. Holland

Correspondence:  chris.shaw [at] ubc.ca

Peer-Reviewed; Published 5/17/2021

Abstract

The Vaccine Adverse Event Reporting System (VAERS) was created in 1990 by the Center for Disease Control and Prevention (CDC) to track adverse events following inoculations (AEFIs). Less than 1% of AEFIs are reported and accurate recording of AEFIs is compromised on many levels. One contributing error to the accurate monitoring of
vaccine safety may be the CDC’s apparent use of a truncated definition of what constitutes a serious adverse event (SAE) to rate cases rather than the statutory Code of Federal
Regulation (CFR) definition. The authors set out to test if this criteria error affected rates of reported SAEs for the quadrivalent human papillomavirus (qHPV) vaccine, Gardasil, in the FDA/CDC’s 2009 VAERS-based safety study, which concluded that 6.2% of AEFI reports were “serious” but did not signal a safety concern. A panel of volunteer, licensed
physicians were asked to independently rate VAERS reports from the same data pool by applying both the 2009 study definition and the more inclusive CFR definition, respectively.
The independent physicians rated 12% of the AEFIs as “serious” using the 2009 study definition and 24.2% of the AEFIs as “serious” using the CFR one, supporting the
conclusion that errant interpretation of Federal Code applied to VAERS data reduced the ability of the 2009 study authors to detect significant SAEs, thereby compromising safety
surveillance. Other serious problems with VAERS are also discussed herein.
Keywords: adverse events following inoculations, AEFI , Gardasil, quadrivalent human papillomavirus
vaccine, qHPV, SAE, serious adverse event, Vaccine Adverse Event Reporting System, VAERS

Cite As:  Tomljenovic, L., E Tarsell, J Garrett, C Shaw and MS Holland 2021 Significant under-reporting of quadrivalent human papillomavirus vaccine- associated serious adverse events in the United States: Time for Change? Sci Publ Health Pol & Law 2:37-58.

Reviewing Editor: James Lyons-Weiler, PhD

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ARTICLE

NOTICE 5/21/2021. THIS PAPER HAS BEEN EDITED TO CORRECT FIGURE REFERENCE AND PLACEMENT.  CHECK BACK SOON FOR THE CORRECTED VERSION. -ED

A Report on the US Vaccine Adverse Events Reporting System (VAERS) of the COVID-19 Messenger Ribonucleic Acid (mRNA) Biologicals

Jessica Rose

Correspondence: jrose [at] ipaknowledge.org

Peer-Reviewed; Published 5/17/2021

Abstract

Following the global roll-out and administration of the Pfizer/BioNTech (BNT1 62b2) and Moderna (mRNA-1 273) COVID-1 9 vaccines on December 1 7, 2020 in the United States, and of the Janssen COVID-1 9 Vaccine PF (produced by Johnson & Johnson) on April 1st, 2021, tens of thousands of individuals have reported adverse events (AEs) using the Vaccine Adverse Events Reports System (VAERS). This work summarizes this data to date and serves as information for the public and a reminder of the relevance of any
adverse events, including deaths, that occur as a direct result of biologicals as prophylactic treatments. This is especially relevant in the context of technologically novel treatments in the experimental phase of development. Analysis suggests that the vaccines are likely the cause of reported deaths, spontaneous abortions, anaphylactic reactions and cardiovascular, neurological and immunological AEs. The precautionary principle promotes transparency and the adoption of preventative measures to address potential risks to the public in the arena of vaccination programs, and it is vital that individuals are informed of these potential risks before agreeing to participate in any medically involved treatment program. VAERS reporting and recording is essential to the proper functioning of this system. It cannot be over-emphasized that the public should know how to use this system such that they actually do use it, and that once reports are made, responsible individuals enter each report into the database accordingly.

Cite As: Rose, J. 2021. A report on the US Vaccine Adverse Events Reporting System (VAERS) of the COVID-19 messenger ribonucleic acid (mRNA) biologicals. Sci Publ Health Pol & Law 2:59-80.

Reviewing Editor: James Lyons-Weiler, PhD

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ARTICLE

A Novel Approach to Treating COVID-19 Using
Nutritional and Oxidative Therapies

David Brownstein, M.D., Richard Ng, M.D., Robert Rowen, M.D., Jennie-Dare Drummond, PA, Taylor Eason, NP, Hailey Brownstein, D.O., and Jessica Brownstein

Peer Reviewed; Published 7/20/2020

Correspondence: info@drbrownstein.com

Abstract

Objective: This report is a case series of consecutive patients diagnosed with COVID-19 treated with a nutritional and oxidative medical approach. We describe the treatment program and report the response of the 107 COVID-19 patients.

Study Design: Observational case series consecutive.
Setting: A family practice office in a suburb of Detroit, Michigan.
Patients: All patients seen in the office from February through May 2020 diagnosed with COVID-19 were included in the study. COVID-19 was either diagnosed via PCR or antibody testing as well as those not tested diagnosed via symptomology.
Interventions: Oral Vitamins A, C, D, and iodine were given to 107 subjects (99%). Intravenous solutions of hydrogen peroxide and Vitamin C were given to 32 (30%) and 37 (35%) subjects. Thirty-seven (35%) of the cohort was treated with intramuscular ozone. A dilute, nebulized hydrogen peroxide/ saline mixture, with Lugol’s iodine, was used by 91 (85%).
Main Outcome Measures: History and physical exam were reviewed for COVID-19 symptoms including cough, fever, shortness of breath, and gastrointestinal complaints. Laboratory reports were examined for SARS-CoV-2 results. Symptomatic improvement after treatment was reported for each patient consisting of first improvement, mostly better, and completely better. 

Results: There were a total of 107 patients diagnosed with COVID-19. Thirty-four were tested for SARS-CoV-2(32%) and twenty-seven (25%) tested positive. Three were hospitalized (3%) with two of the three hospitalized before instituting treatment and only one requiring hospitalization after beginning treatment. There were no deaths. The most common symptoms in the cohort were fever (81%), shortness of breath (68%), URI which included cough (69%), and gastrointestinal distress symptoms (27%). For the entire cohort, first improvement was noted in 2.4 days. The cohort reported symptoms mostly better after 4.4 days and completely better 6.9 days after starting the program. For the SARS-CoV-2 test positive patients, fever was present in 25 (93%), shortness of breath in 20 (74%) and upper respiratory symptoms including cough in 21 (78%) while gastrointestinal symptoms were present in 9 (33%). The time to improvement in the SARS-CoV-2 test positive group was slightly longer than the entire cohort.
Conclusion: At present, there is no published cure, treatment, or preventive for COVID-19 except for a recent report on dexamethasone for seriously ill patients. A novel treatment program combining nutritional and oxidative therapies was shown to successfully treat the signs and symptoms of 100% of 107 patients diagnosed with COVID-19.
Each patient was treated with an individualized plan consisting of a combination of oral, IV, IM, and nebulized nutritional and oxidative therapies which resulted in zero deaths and recovery from COVID-19.

Keywords: SARS-CoV-2, COVID-19, ozone therapy, hydrogen peroxide therapy, Vitamin A, iodine, Vitamin C, Vitamin D, immune system, antiviral.

Cite As: Brownstein, D, R Ng, R Rowen, J-D Drummond, T Eason, H Brownstein and J Brownstein. 2020. A Novel Approach to Treating COVID-19 Using Nutritional and Oxidative Therapies. Science, Public Health Policy & the Law 2:4-22.
 

Reviewing Editor: James Lyons-Weiler, PhD

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