Adverse events reports

The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS collects and analyzes information from reports of adverse reactions after immunization. Anyone can report to VAERS, and reports are sent in by vaccine manufacturers, health care providers, and vaccine recipients and their parents or guardians. An example of the VAERS and instructions for completing the form are found in Appendix F. Any clinically significant adverse event that occurs after the administration of any vaccine should be reported. Individuals are encouraged to provide the information on the form even if the individual is uncertain if the event was related to the... 

The FDA Safety Information and Adverse Event Reporting Program... 

The FDA Safety Information and Adverse Event Reporting Program Food and Drug Administrstion 5600 Fishers Lene Rockville, MD 20852-9787... 

Appendix F is a Vaccine Adverse Event Reporting Form. 

GL24 Pharmacovigilance Pharmacovigilance of veterinary medicinal products management of Adverse Event Reports (AERs)... 

GL42 Pharmacovigilance Data elements Pharmacovigilance Data Elements for Submission of Adverse Events Reports... 

Investigation should be performed in circumstances similar to the intended use conditions. Adverse Event Reporting... 

Corrections or removals of devices from the market may be necessitated either as a consequence of adverse event reports or the discovery of manufacturing or other defects that pose a risk to public health. The manufacturer must submit a report to the FDA within 10 days of initiating such corrections or removals. This should provide information on the identity and number of devices concerned, the reasons for doing so, and the communication of the action. The manufacturer must also maintain records of other corrections or removals that need not be reported. 

Swanson K, Abdellatif M, Fye C, Reda D, Williams D, Harris C, Clegg D. Adverse event reporting and monitoring system for the Glucosamine/Chondroi-tin Arthritis Intervention Trial (GAIT). Clin Trials 2005 2 S49. 

Continuous infusions of nitroglycerin should be initiated at a dose of 5 to 10 mcg/minute and increased every 5 to 10 minutes until symptomatic or hemodynamic improvement. Effective doses range from 35 to 200 mcg/minute. The most common adverse events reported are headache, dose-related hypotension, and tachycardia. A limitation to nitroglycerin s use is the development of tachyphylaxis, or tolerance to its effects,... 

Ezetimibe 1 0 mg tablet 10 mg once daily The overall incidence of adverse events reported with ezetimibe alone was similar to that reported with placebo and generally similar between ezetimibe with a statin and statin alone. The frequency of increased transaminases was slightly higher in patients receiving ezetimibe plus a statin compared with those receiving statin monotherapy (1.3% versus 0.4%). 

Gastrointestinal adverse events reported with lubiprostone include nausea, diarrhea, abdominal distention, abdominal pain, flatulence, vomiting, loose stools, and dyspepsia. Nausea is a prominent adverse effect and may be minimized when lubiprostone is taken with food. 

The most common adverse events reported with sirolimus are leukopenia (20%), thrombocytopenia (13% to 30%), and hyperlipidemia (38% to 57%).11,31 Other adverse effects include delayed wound healing, anemia, diarrhea, arthralgias, rash, and mouth ulcers. Sirolimus has an FDA black-box warning in newly transplanted liver and lung recipients.11 In liver transplant recipients, use of sirolimus immediately after transplant is associated with an increased risk of hepatic artery thrombosis, graft loss, and death. In lung transplant... 

Vaccine safety is monitored by the FDA and CDC through a passive reporting system that allows anyone, health professionals or lay public, to report any event. Health care professionals are bound by federal regulation to report certain adverse events (Table 83-2). Additionally, any serious, life-threatening or unusual reactions should also be reported. The Vaccine Adverse Event Reporting System (VAERS) can be found at http //vaers.hhs.gov. 

VAERS Vaccine Adverse Event Reporting System... 

Davies GC, Huster WJ, Lu Y, Plouffe L, Lakshmanan M (1999) Adverse events reported by postmenopausal women in controlled trials withs raloxifene. Obstet Gynecol 93 558-565... 

In any case, injection site responses (erythemia, edema, pain, and tenderness) and systemic responses are both evaluated in subjects (Mathieu, 1997). USFDA also has specific guidance on the tracking and reporting of adverse clinical responses to vaccines. Any adverse events or product problems with vaccines should not be sent to MedWatch but to the Vaccine Adverse Event Reporting System (VAERA), operated jointly by FDA and the national Centers for Disease Control and Prevention. For a copy of the VAERS form, call 1-800-822-7967, or download the form (in PDF format) from www.fda.gov/cber/vaers/vaersl.pdf on FDA s Website. 

Vaccine Adverse Event Reporting System (VAERS) form. For drugs and therapeutic biologies, the MedWatch (3500A) form replaces the 1639 reporting form. 

FDA does not want reports on every adverse event observed that would not be practical for reporters or FDA because of the sheer volume of adverse-event reports already being sent to the agency each year (about 130,000 in 1994). While 80-85% of these reports are submitted by the manufacturer, 10-15% are received by MedWatch directly from physicians, pharmacists, other health care professionals, and consumers. MedWatch encourages reporters to be selective by limiting their reports to events for which the outcome was serious (Table 20.2). This enables FDA to focus on those events with potentially the largest public health impact. Reporters are encouraged to fill out the reporting form as completely and accurately as possible. 

In response to the National Childhood Vaccine Injury Act of 1988, which required health workers to report vaccine adverse events, the CDC and the FDA collaborated in 1990 to implement the Vaccine Adverse Event Reporting System (VAERS) to monitor the safety of vaccines in both sectors. Health care professionals and parent or other caretakers are encouraged to report all clinically significant vaccine adverse events. Narrative diagnostic reports are reviewed and assigned standard codes using Coding Symbols for a Thesaurus of Adverse Reaction Terms. The source of the vaccines (public versus private provider) is recorded on the form. 

Niu, M.T., Saline, M.E. and Ellenberg, S.S. (1999). Neonatal deaths after hepatitis B vaccine The vaccine adverse event reporting system, 1991-1998. Arch. Pediatr. Adolesc. Med. 153 1279-1282. 

Varrincchio, F. (1998). The vaccine adverse event reporting system. Clin. Toxicology 36 765-768. 

United States Adopted Name Council United States Department of Agriculture United States Environmental Protection Agency United States Pharmacopoeia Vaccine Adverse Event Reporting System Vaccine Safety Data Link World Health Organization... 

USFDA drug adverse event reporting system... 

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