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Write-up: Initial unsolicited report received from the literature on 16-Aug-2017. This case was linked with 2017SA151529, 2017SA151538, 2017SA151548. (Same article). The following is the verbatim from the article: Immunization plays an important role in the prevention of infectious diseases and it is currently one of the best measures to prevent diseases. With the implementation of the Expanded Program on Immunization, the types of vaccines have increased and the immunization rate of type 2 vaccines has also increased. The constant public attention paid to suspected abnormal reactions to immunization and the increasing number of negative reports related to vaccines, caused people to be more worried about the safety of vaccines. The improper handling of this matter can easily lead to medical disputes. Past literatures reported that most cases of deaths reported following vaccination are pure coincidences, while there were also some reports that believed vaccines can induce or aggravate potential diseases. This paper determined the cause of death of four infants who died following vaccination through an autopsy of their bodies, determining the relation between the vaccines and cause of death, and providing a reference for reducing the occurrence of coincidental events and the promotion of safe vaccination services. At the same time, it can help to reduce the negative impact of vaccine events and reduce public concerns about vaccination. Materials and Methods: Data Source: The diagnostic data of four cases of deaths following vaccination between January-2010 to December-2016 from an expert group on abnormal reactions to vaccination were collected. The data were taken from the AEFI Surveillance System. Each case has complete birth information, vaccination information, death information, laboratory test results, as well as the autopsy reports. They were all cases of death following vaccination, and the possibility of death by violence and exogenous intoxication was ruled out. Analysis Method: The vaccination units reported the deaths due to suspected abnormal reactions to vaccination to the county-level disease control and prevention institution where the vaccine recipients were located. Either by the fastest methods, such as phone call, within two hours in accordance with the requirements of the "National Suspected Abnormal Reactions to Vaccination Surveillance Program". The county-level disease control and prevention institution immediately submit direct online reports of the cases through the National Immunization Information Management System after verification. Investigation of deaths due to suspected abnormal reactions to vaccination after receiving the report, the municipal center for disease control and prevention immediately organized experts on the diagnosis and investigation of abnormal reactions to vaccination to conduct an investigation and collect vaccination, clinical treatment, death and other related data. The preliminary results of the investigation were reported within seven days. The parents were persuaded to carry out an autopsy during the investigation and the results of the autopsies were recorded. Diagnosis of deaths due to suspected abnormal reactions to vaccination the investigation was carried out by the municipal or provincial expert group on the investigation and diagnosis of abnormal reactions to vaccination. Clinical manifestations, autopsy results and the results of vaccine quality test were combined for a comprehensive analysis and a conclusion was made on the investigation and diagnosis based on the laws, administrative regulations, departmental regulations and technical specifications. Epidemiological analysis a descriptive approach was used to analyze the autopsy results and the investigation and diagnostic data of the death cases. This case involves 12-months-old female patient who was vaccinated with first dose of INFLUENZA VACCINE on the deltoid region of her left upper arm, and second dose of MENINGOCOCCAL POLYSACCHARIDE on the deltoid region of her right upper arm (Batch number, expiry date, dose, and route of administration were not reported for both the vaccines) on 25 Oct 2010 at 11:20:00 A.M. The patient medical history and concomitant medications were not reported. On 25 Oct 2010, 50 minutes after the vaccinations, the patient died due to anaphylactic shock, and the patient also had a cyanosis of the lips and fingernail beds (as per autopsy report). The patient relevant lab tests and corrective treatment were not reported. The patient autopsy revealed that the patient had normal development. A microscopic examination of the laryngeal mucosa revealed vasodilation, congestion, localized tissue edema, inflammatory cell infiltration and the presence of eosinophils. There was diffuse alveolar septal widening, inflammatory cell infiltration and eosinophils in the lungs. Toluidine blue staining indicated an increase in mast cells in the submucosal layer of multiple sites and degranulation of mast cells. Identification of the cause of death: Death caused by anaphylactic shock. The diagnostic conclusion of the municipal expert group on the diagnosis of abnormal reactions was an abnormal reaction to vaccination. Upon internal review the company decided to consider the event as serious due to important medical event cyanosis of the lips and fingernail beds. List of documents held by sender: none. Sender''s Comments: Patient died due to anaphylactic shock 50 minutes after receiving a group A meningococcal polysaccharide and split-virus influenza vaccines. Time to onset is compatible with the role of vaccines. The autopsy revealed that the child had normal development and that here was cyanosis of the lips and fingernail beds. A microscopic examination of the laryngeal mucosa revealed vasodilation, congestion, localized tissue edema, inflammatory cell infiltration and the presence of eosinophils. There was diffuse alveolar septal widening, inflammatory cell infiltration and eosinophils in the lungs. Toluidine blue staining indicated an increase in mast cells in the submucosal layer of multiple sites and degranulation of mast cells. As a result the cause of death was identified as anaphylactic shock however autopsy report was not provided. Additional information including but not limited to the patient anamnesis including allergic history (food allergy and patient''s immunization history are needed to further assess this case. Moreover, as two vaccines were administered concomitantly, the role of each component cannot be assessed separately. Reported Cause(s) of Death: Anaphylactic shock; Autopsy-determined Cause(s) of Death: Anaphylactic shock.
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