BACKGROUND The Adverse Event Reporting System (AERS) is an FDA database providing rich information on voluntary reports of adverse drug events (ADEs). Normalizing data in the AERS would improve the mining capacity of the AERS for drug safety signal detection and promote semantic interoperability between the AERS and other data sources. In this study, we normalize the AERS and build a publicly a...

Accurate recording of adverse events post hip fracture surgery is vital for planning and allocating resources. The purpose of this study was to compare adverse events recorded prospectively at point of care with adverse recorded by the Hospital In-Patient Enquiry (HIPE) System. The study examined a two month period from August to September 2011 at University Hospital Limerick. Out of a sample s...

At the heart of improvement and safety in healthcare is the now-familiar tenet that was espoused decades ago by Demming and paraphrased by Berwick. Need we repeat it again? Every defect should lead to improvement processes that make care safer. It is time to deliver on the promise of reporting systems in patient safety. While it is clear that event-reporting systems are now central elements in ...

A 37 year old white woman with a well-known history of migraine headaches presented to an urgent care center with a chief complaint of severe headache with associated nausea that was unrelieved by medication that she had at home. She had taken Axert® (almotriptan) at home and repeated it once, without any improvement in her symptoms; she typically had good results with this medication. Upon pre...

Electroacupuncture (EA) is becoming more common as a treatment for chronic musculoskeletal pain. It can be associated with adverse events related to the small electric currents used, in addition to the adverse events related to needle penetration of tissues. This paper reports a case of minor tissue damage following high intensity EA for 30 min with a device delivering a waveform that does not ...

The death of a control subject after an oral load of methionine for a study of the possible relationship between homocysteine and Alzheimer’s disease is reported. The subject developed postload plasma concentrations of methionine far beyond those reported previously in humans given the usual oral loading dose of methionine (100 mg/kg body wt). Her preload plasma metabolite values rule out known...

A 24-year-old previously healthy woman was involved in a bus accident in Nepal and sustained major blunt abdominal trauma with complete transection of the pancreatic neck. After 16 days of emergency stabilization in a local hospital, she was transferred to our center. Even though she appeared asymptomatic, abdominal imaging confirmed disconnected pancreatic duct syndrome with a 10-cm fluid coll...

Immunizations against most vaccine-preventable diseases will be needed indefinitely unless the disease is eradicated. Public acceptance of immunizations may be threatened as vaccine coverage increases and disease decreases, however, due to the increase in both causally and coincidentally related vaccine adverse events. The post-marketing surveillance for such events in the USA in response to th...