Sex: F
Vaccine: FLUX, HEPA, TDAP, UNK
Symptoms: Vomiting
Clinical narrative: Nausea; Vomiting; Abdominal pain; Abdominal distension; Lung infiltrate/Pulmonary infiltration; Fever; Dizziness; Shortness of breath; Cough; Septic shock; severe bilateral community acquired pneumonia; Multi-organ failure; Respiratory arrest; Mulptiple cardiac arrest; Condition rapidly deteriorated; This case was reported in a literature article and described the occurrence of septic shock in a 19-year-old female patient who received Hepatitis A vaccine for prophylaxis.  Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis, DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis and adenovirus vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis A vaccine at an unknown dose, Influenza vaccine at an unknown dose, Tdap Vaccine at an unknown dose and adenovirus vaccine at an unknown dose and frequency. On an unknown date, unknown after receiving Hepatitis A vaccine, Influenza vaccine and Tdap Vaccine, the patient experienced septic shock (serious criteria death and GSK medically significant), community acquired pneumonia (serious criteria death and GSK medically significant), multi-organ failure (serious criteria death and GSK medically significant), respiratory arrest (serious criteria death and GSK medically significant), cardiac arrest (serious criteria death and GSK medically significant), general physical health deterioration (serious criteria death), nausea (serious criteria hospitalization), vomiting (serious criteria hospitalization), abdominal pain (serious criteria hospitalization), abdominal distension (serious criteria hospitalization), lung infiltration (serious criteria hospitalization), fever, dizziness, shortness of breath and cough. The subject was treated with clarithromycin. On an unknown date, the outcome of the septic shock, community acquired pneumonia, multi-organ failure, respiratory arrest, cardiac arrest and general physical health deterioration were fatal and the outcome of the nausea, vomiting, abdominal pain, abdominal distension, lung infiltration, fever, dizziness, shortness of breath and cough were unknown. The reported cause of death was septic shock, community acquired pneumonia, multi-organ failure, respiratory arrest, cardiac arrest and general physical health deterioration.   The reporter considered the septic shock, community acquired pneumonia, multi-organ failure, respiratory arrest, cardiac arrest, general physical health deterioration, nausea, vomiting, abdominal pain, abdominal distension, lung infiltration, fever, dizziness, shortness of breath and cough to be related to Hepatitis A vaccine, Influenza vaccine and Tdap Vaccine.  Additional details were reported as follows: This case was reported in a literature article and described the occurrence of septic shock due to severe bilateral community acquired pneumonia in a 19-year-old female patient who was vaccinated with unspecified hepatitis A, unspecified seasonal influenza, unspecified meningococcal conjugate and unspecified tetanus, diphtheria & acellular pertussis vaccine (Tdap) vaccines and unspecified adenovirus (manufacturer unknown for all vaccines) for prophylaxis. This case corresponds to 3.2.1. (Death report) reported in this literature article. The patient was the part of the observational study that aimed to investigate adverse event (AE) reports following the adenovirus vaccine submitted to the Vaccine Adverse Event Reporting System (VAERS). They searched the VAERS database for reports among persons who received adenovirus vaccine during 1st October 2011 through 31st July 2018 including participants in a observational study. [In this study, they identified those reports filled from 24th October 2011 to 5th October 2012, an FDA-mandated, post marketing observational study was conducted using the Medical Surveillance System (MSS) database. This study compared 100,000 recruits exposed to the adenovirus vaccine with a historical unexposed cohort and identified statistical signals for psoriasis, anaphylaxis and other hypersensitivity reactions as emergent AEs possibly related to vaccination. During the study period, VAERS received a total of 100 reports following adenovirus vaccine; among all reports, the earliest vaccination date with the adenovirus vaccine identified was on November 9, 2011]. The patient was from the observational study. No information on patient's medical or family history or concurrent condition or concomitant condition was provided. On unspecified date, the patient had received unspecified hepatitis A, unspecified seasonal influenza, unspecified meningococcal conjugate and unspecified tetanus, diphtheria & acellular pertussis vaccine (Tdap) vaccines and unspecified adenovirus (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date between 1st October 2011 through 31st July 2018, 1 day later, the patient presented to the Emergency Department (ED) with complaints of nausea, vomiting, abdominal pain and distension; a chest radiograph revealed a left lung infiltrate and was discharged on clarithromycin therapy. The patient returned to the ED with fever, dizziness, shortness of breath, cough and repeat chest radiograph demonstrated bilateral pulmonary infiltrates. The patient suffered a respiratory arrest, was intubated and placed on mechanical ventilation in intensive care unit (ICU); however, her condition rapidly deteriorated with development of multi-organ failure and following multiple cardiac arrests, resuscitation attempts were unsuccessful. The patient died. It was unknown whether the autopsy was performed or not. However the cause of death was mentioned as septic shock due to severe bilateral community acquired pneumonia. [In this study, 2 physicians (MMM and IPS) independently reviewed each report and accompanying medical records when available to confirm adenovirus vaccination and to confirm the diagnosis when possible. The main diagnosis for each report was categorized into a System Organ Class (SOC) grouping. Reports suggestive of anaphylaxis or GBS were further classified using the Brighton Collaboration criteria or a physician's diagnosis].  This case has been considered as serious due to death and hospitalization. [In this study, Reports are classified as serious based on the Code of Federal Regulations if one of the following is reported: death, life-threatening illness, hospitalization or prolongation of hospitalization, permanent disability, or congenital anomaly]. The author commented, "In addition, 95 percent of the adenovirus vaccine reports documented co-administration of other vaccines and 50 percent reported co-administration of penicillin G (or other antibiotic if allergic to penicillin) according to standard protocol in this population. The investigators of the earlier observational study also commented that concurrent vaccine exposures in the recruit population was an important limiting factor for attributing the statistical signaling outcomes including psoriasis, anaphylaxis and other hypersensitivity reactions as possibly related to the vaccine". The author concluded "The reporting rate for serious AEs was higher than with other vaccines administered in the comparison recruit population (39 percent vs 18 percent however, we identified no unexpected or concerning pattern of adenovirus vaccine AEs. Co-administration of vaccines and IM Pen G was commonly reported in this population. These exposures may have contributed to the GBS and anaphylaxis outcomes observed with the adenovirus vaccine. Future adenovirus vaccine safety studies in a population without these co-administrations would be helpful in clarifying the vaccine's safety profile". This is 1 of the 19 valid cases reported in this literature article.      Lab Comments: Lab test done on an unknown date. A chest radiograph revealed a left lung infiltrate. A repeat chest radiograph demonstrated bilateral pulmonary infiltrates.; Reported Cause(s) of Death: Septic shock; Community acquired pneumonia; Multi-organ failure; Respiratory arrest; Cardiac arrest; General physical health deterioration