National Vaccine Adverse Event Reporting Survey and Etiology

NCT05095844 | Unknown FDA Drug

• 1 other identifier: NVAERS_1121
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 1

Brief Summary

If your serious vaccine-induced adverse event has been entered in the CDC Vaccine Adverse Event Reporting System (VAERS) we are interested in enrolling you for this study in order to log your symptoms. The primary goal of this study is to create a national database and gather vaccine-associated serious adverse events/injury data from newly vaccinated individuals in the US in order to identify the possible underlying causal relationships and plausible underlying biological mechanisms. The project aims to identify the genetic determinants of vaccine-induced adverse response by studying host genetics. We plan to use whole genome sequencing to identify single nucleotide polymorphisms associated with cardiovascular, neurological, gastrointestinal, musculoskeletal and immunological symptoms induced by vaccine administration. The secondary goal is to establish criteria that enable classification of vaccine-induced adverse events/injuries compare data from our database with the official Vaccine Injury Table National Vaccine Injury Compensation Program on or after March 21, 2017. The tertiary goal is to establish a database to gather detailed long-term adverse reaction data from subjects enrolled in FDA Emergency Use Authorized vaccine clinical trials.

Conditions

COVID-19; Vaccine Adverse Reaction; Vaccine Reaction; Vaccine or Biological Substance, Unspecified Causing Adverse Effects in Therapeutic Use; Corona Virus Infection; Blood Clot; Thrombocytopenia; Neuritis; Vasculitis; Influenza; Guillain-Barré; GWAS; Genetic Sequencing

Keywords

COVID-19; coronavirus; vaccine; influenza; injury; compensation; Pfizer; Moderna; BioNTech; Johnson and Johnson; Comirnaty; Flu Vaccination; Quadrivalent; Flucelvax; Flu Shots; Afluria Quadrivalent (Seqirus); Fluarix; FluLaval; Fluzone; Walgreens; CVS; Pharmacy

Outcome Measures

Primary Outcomes (1)

• Adverse Event

  Reported adverse event occurring less than 60 days after administration of vaccine.

  2 years

Secondary Outcomes (1)

• Vaccine manufacturer efficacy

  2 years

Study Arms (1)

Vaccinated

All individuals who have received a vaccine dose.

Biological: vaccinated

Interventions

vaccinated BIOLOGICAL

Pfizer-BioNTech COVID-19 Vaccine, Moderna or J\&J/Janssen COVID-19 Vaccine, Diphtheria (e.g., DTP, DTaP, Tdap, DT, Td, TT) Haemophilus influenza type b polysaccharide conjugate vaccines (e.g., Hib) Hepatitis A (e.g., HAV) Hepatitis B (e.g., HBV) Human papillomavirus (e.g., HPV) Seasonal influenza (e.g., Flu) Measles (e.g., MMR) Mumps (e.g., MMR, MR, M) Meningococcal (e.g., MCV4, MPSV4, MenB-FHbp, MenB-4C) Pertussis (e.g., DTP, DTaP, Tdap) Pneumococcal conjugate (e.g., PCV) Polio (e.g., OPV or IPV) Rotavirus (e.g., RV) Rubella (e.g., MMR, MR, R) Tetanus (e.g., Td) Varicella (e.g., VAR)

Vaccinated

Eligibility Criteria

• Age: 5 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

US citizens or permanent residents and their dependents who have been vaccinated in the past 3 years and experienced a documented adverse event within 60 days of vaccination

You may qualify if:

• Individuals who have received at least one vaccine dose of ANY of the following vaccines (below) and experienced adverse reaction within 60 days of vaccine administration:
• Pfizer-BioNTech COVID-19 Vaccine
• Moderna COVID-19 Vaccine
• J\&J/Janssen COVID-19 Vaccine
• Diphtheria (e.g., DTP, DTaP, Tdap, DT, Td, TT)
• Haemophilus influenza type b polysaccharide conjugate vaccines (e.g., Hib)
• Hepatitis A (e.g., HAV)
• Hepatitis B (e.g., HBV)
• Human papillomavirus (e.g., HPV)
• Seasonal influenza (e.g., Flu)
• Measles (e.g., MMR)
• Mumps (e.g., MMR, MR, M)
• Meningococcal (e.g., MCV4, MPSV4, MenB-FHbp, MenB-4C)
• Pertussis (e.g., DTP, DTaP, Tdap)
• Pneumococcal conjugate (e.g., PCV)

You may not qualify if:

• Non citizens or permanent residents of the US
• Individuals who have not received at least one vaccine dose in the past 3 years.
• Individuals whose vaccine was administered more than 60 days before symptoms of the serious adverse event.

Sponsors & Collaborators

• Neuroganics LLC: lead
• Ramos Injury Law Firm: collaborator

Study Sites (1)

Neuroganics LLC

Northglenn, Colorado, 80265, United States

RECRUITING

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Thrombosis; Thrombocytopenia; Neuritis; Vasculitis; Influenza, Human; Guillain-Barre Syndrome; Wounds and Injuries

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Orthomyxoviridae Infections; Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Polyneuropathies; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Donald C Cooper, Ph.D.

  Chief Science Officer/ Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donald C Cooper, Ph.D.

CONTACT

303.733.6353; vaccinestudy@protonmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: October 27, 2021
• Study Start: March 15, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: March 18, 2022

Record last verified: 2022-03

Locations

US (1)