Adverse Event: An adverse event (AE) is any drug reaction picked up in post-marketing after the manufacture drug trial ends. The pro-vaccine extremists do not accept these AEs.
Distribution of adverse drug events (ADEs), by patient age, 2004. *Adverse effects = effects of drugs properly administered in therapeutic or prophylactic dosage. **Poisoning = accidental overdose, wrong drugs given or taken in error, drugs taken inadvertently (Elixhauser et al., 2007).
Clinical Trial Experience HepB Engerix-B
In 36 clinical studies, a total of 13,495 doses of ENGERIX-B were administered to 5,071 healthy adults and children who were initially seronegative for hepatitis B markers, and healthy neonates. All subjects were monitored for 4 days post-administration… using a symptom checklist… parent or guardian completed forms for children and neonates… checklist did not include headache, fatigue, or dizziness (GlaxoSmithKline, 1989).
Clinical Trial Experience DTaP Tripedia
Safety data are available for 672 infants, including 505 received Tripedia vaccine and 167 who received whole-cell pertussis DTP vaccine (3 day observation) were collected using patient diaries, phone call follow-up, and/or by questioning the parent(s) at clinic visits (Sanofi Pasteur, 1997)
GSK Document Autism As Outcome In Vaccine Clinical Trials
CDC. (2012). Chronic disease and health promotion. Centers for Disease Control and Prevention. Retrieved from http://www.cdc.gov/chronicdisease/overview/index.htm#ref2
Elixhauser et al. (2007). Adverse drug events in U.S. hospitals, 2004. Statistical Briefs. Retrieved from http://www.ncbi.nlm.nih.gov/books/NBK63500/
GSK. (2011). Biological clinical safety and pharmacovigilance GlaxoSmithKline research and development. Retrieved from https://autismoevaccini.files.wordpress.com/2012/12/vaccin-dc3a9cc3a8s.pdf
GlaxoSmithKline. (1989). Engerix-B. Highlights of Prescribing Information. Retrieved from http://us.gsk.com/products/assets/us_engerixb.pdf
ICH Harmonised Tripartite Guideline. (1996). Guideline for good clinical practice E6(R1). ICH Steering Committee. Retrieved from http://private.ich.org/LOB/media/MEDIA482.pdf
Sanofi Pasteur. (1997). Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Absorbed Tripedia. Retrieved from http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM101580.pdf