National Vaccine Adverse Event Reporting Survey and Etiology

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

Interventions

BIOLOGICAL

vaccinated

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)

Sponsors & Collaborators

• Ramos Injury Law Firm

  collaborator UNKNOWN

• Neuroganics LLC

  lead INDUSTRY

Principal Investigators

• Donald C Cooper, Ph.D. · Chief Science Officer/ Principal Investigator

Eligibility

Min Age

5 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-15

Primary Completion

2024-04-01

Completion

2024-04-01

FDA Drug

Yes

Countries

• United States

Study Locations