Age: 18.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Autopsy, Congestive cardiomyopathy, Death, Myocarditis, Pulmonary oedema
Clinical narrative: This unsolicited case was received from a literature via search on the VAERS database on 09-Sep-2015. This case is linked to cases: 2015SA141673 and U2003-00017 (same literature). The following is verbatim from the article: Background: Vaccines are among the safest medical products in use today. Hundreds of millions of vaccinations are administered each year. Serious adverse reactions are uncommon. However, temporally associated deaths can occur following vaccination. Our aim was to characterize main causes of death among reports submitted to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous vaccine safety surveillance system. Methods. We searched VAERS for reports of death after any vaccination from 1 July 1997 through 31 December 2013. Available medical records, autopsy reports, and death certificates were reviewed to identify cause of death. VAERS is a national vaccine safety surveillance system, coadministered by the Centers of Disease Control and Prevention (CDC) and the Food and Drug Administration, that receives spontaneous reports of adverse events follow vaccination. VAERS accepts reports from vaccine manufacturers, healthcare providers, vaccine recipients, and others. The VAERS report form collects information on age, sex, vaccines administered, the AE experienced, and health history. Signs and symptoms of adverse events are coded by trained personnel using the Medical Dictionary for Regulatory Activities (MedDRA), a clinically validated, internationally standardized terminology. Each VAERS report may be assigned 1 or more MedDRA preferred terms. A report is considered serious based on the Code of Federal Regulations definition in 1 or more of the following is reported: death, life-threatening illness, hospitalization or prolongation of existing hospitalization, or permanent disability. For non-manufacturer serious reports, medical records are routinely requested and made available to VAERS personnel. For death reports, efforts are made to obtain autopsy reports and death certificates that contain information on the cause of death. We analyzed VAERS death reports received by 1 June 2014 for individuals vaccinated with any vaccine from 1 July 1997 through 31 December 2013. International and duplicate death reports were excluded. Hearsay reports (secondhand reports) with no vaccination date recorded were also excluded. Conclusions: No concerning pattern was noted among death reports submitted to VAERS during 1997-2013. The main causes of death were consistent with the most common causes of death in the population. This case involves an 18 year old male patient who was vaccinated with a dose of Smallpox vaccine, (manufacturer: unknown, dose details, batch number, route and site of administration were not reported), a dose of Typhoid Fever Vaccine (manufacturer: unknown, dose details, batch number, route and site of administration were not reported), a dose of Anthrax vaccine (manufacturer: other, dose details, batch number, route and site of administration were not reported), all on an unspecified date. The medical history and concomitant medications were not provided. On an unspecified date post-vaccination, the patient died after 2 weeks. The cause of death was complications from smallpox vaccination. Autopsy findings included myocarditis with dilated cardiopathy and pulmonary edema. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome was reported as fatal. Documents held by sender: none.