vaccine-associated adverse event

Canadian Adverse Events Following Immunization Surveillance System [ CAEFISS | Vaccine Associated Adverse Events Surveillance System ]

Immunization Monitoring Program, ACTive

Definition: This block contains a wide variety of disorders that differ in severity and clinical form but that are all attributable to the use of one or more psychoactive substances, which may or may not have been medically prescribed. The third character of the code identifies the substance involved, and the fourth character specifies the clinical state. The codes should be used, as required, for each substance specified, but it should be noted that not all fourth character codes are applicable to all substances. Identification of the psychoactive substance should be based on as many sources of information as possible. These include self-report data, analysis of blood and other body fluids, characteristic physical and psychological symptom ...[+++]s, clinical signs and behaviour, and other evidence such as a drug being in the patient's possession or reports from informed third parties. Many drug users take more than one type of psychoactive substance. The main diagnosis should be classified, whenever possible, according to the substance or class of substances that has caused or contributed most to the presenting clinical syndrome. Other diagnoses should be coded when other psychoactive substances have been taken in intoxicating amounts (common fourth character .0) or to the extent of causing harm (common fourth character .1), dependence (common fourth character .2) or other disorders (common fourth character .3-.9). Only in cases in which patterns of psychoactive substance-taking are chaotic and indiscriminate, or in which the contributions of different psychoactive substances are inextricably mixed, should the diagnosis of disorders resulting from multiple drug use (F19.-) be used. | Modifiers The following fourth-character subdivisions are for use with categories F10-F19: Code Title .0 Acute intoxication A condition that follows the administration of a psychoactive substance resulting in disturbances in level of consciousness, cognition, perception, affect or behaviour, o ...

Definition: Arises as a delayed or protracted response to a stressful event or situation (of either brief or long duration) of an exceptionally threatening or catastrophic nature, which is likely to cause pervasive distress in almost anyone. Predisposing factors, such as personality traits (e.g. compulsive, asthenic) or previous history of neurotic illness, may lower the threshold for the development of the syndrome or aggravate its course, but they are neither necessary nor sufficient to explain its occurrence. Typical features include episodes of repeated reliving of the trauma in intrusive memories ( flashbacks ), dreams or nightmares, occurring against the persisting background of a sense of numbness and emotional blunting, detachment f ...[+++]rom other people, unresponsiveness to surroundings, anhedonia, and avoidance of activities and situations reminiscent of the trauma. There is usually a state of autonomic hyperarousal with hypervigilance, an enhanced startle reaction, and insomnia. Anxiety and depression are commonly associated with the above symptoms and signs, and suicidal ideation is not infrequent. The onset follows the trauma with a latency period that may range from a few weeks to months. The course is fluctuating but recovery can be expected in the majority of cases. In a small proportion of cases the condition may follow a chronic course over many years, with eventual transition to an enduring personality change (F62.0). | Traumatic neurosis

Definition: A heterogeneous group of disorders characterized by the acute onset of psychotic symptoms such as delusions, hallucinations, and perceptual disturbances, and by the severe disruption of ordinary behaviour. Acute onset is defined as a crescendo development of a clearly abnormal clinical picture in about two weeks or less. For these disorders there is no evidence of organic causation. Perplexity and puzzlement are often present but disorientation for time, place and person is not persistent or severe enough to justify a diagnosis of organically caused delirium (F05.-). Complete recovery usually occurs within a few months, often within a few weeks or even days. If the disorder persists, a change in classification will be necessary. ...[+++] The disorder may or may not be associated with acute stress, defined as usually stressful events preceding the onset by one to two weeks.

The most important disease incidents notified during 2007 by the EU’s Early Warning and Response System (EWRS), set up by Decision No 2119/98/EC[19], were related to: the Chikungunya fever outbreak in Italy, haemorrhagic fever caused by Ebola Virus in Uganda, an HBV vaccine adverse event in Vietnam, the multidrug resistant tuberculosis incident affecting a US citizen travelling from the US to the EU, a Salmonella Tennessee event, and a legionellosis event involving EU tourists in Thailand.

The goal of the post-marketing safety program is to identify adverse events that were not identified prior to approval and to understand better the spectrum of adverse events associated with the drug, including adverse events identified prior to approval.

45. Encourages the Member States to provide patients with information on risks, safety levels and the measures taken to prevent adverse events in healthcare, in order to ensure that patients can give informed consent to the treatment they are being offered and, more generally, to enable patients to learn more about the issue of patient safety; requests that the Member States inform patients, through the appropriate organisational structures, about complaints procedures and the legal options available to them should adverse events in healthcare occur (e.g. through a patients’ rights representative);

45. Encourages the Member States to provide patients with information on risks, safety levels and the measures taken to prevent adverse events in healthcare, in order to ensure that patients can give informed consent to the treatment they are being offered and, more generally, to enable patients to learn more about the issue of patient safety; requests that the Member States inform patients, through the appropriate organisational structures, about complaints procedures and the legal options available to them should adverse events in healthcare occur (e.g. through a patients’ rights representative);