Age: 15.0
Sex: F
Vaccine: DTP, HIBV, MMR
Symptoms: Death, Dyspnoea, Electroencephalogram normal, Enterobacter infection, Face oedema
Clinical narrative: This case was reported in a literature article and described the occurrence of varicella in a 15-year-old female subject who received DTP (A or W not known) vaccine. Previously administered products included DTP (A or W unknown) vaccine with an associated reaction of no adverse event (1st dose), DTP (A or W not known) vaccine with an associated reaction of no adverse event (2nd dose), DTP (A or W not known) vaccine with an associated reaction of no adverse event (3rd dose) and MMR vaccine with an associated reaction of no adverse event (2nd dose). Concomitant products included MMR vaccine. On an unknown date, an unknown time after receiving DTP (A or W not known) vaccine and Hib vaccine, the subject developed severe - grade 3 varicella. Serious criteria included death and hospitalization. Additional event(s) included fever, shortness of breath, face edema, petechial rash, hypotension, pneumonia with serious criteria of GSK medically significant, acute respiratory distress syndrome with serious criteria of GSK medically significant, pancytopenia with serious criteria of GSK medically significant, multi-organ failure with serious criteria of GSK medically significant, iatrogenic infection, enterobacter cloacae infection with serious criteria of GSK medically significant, respiratory tract infection with serious criteria of GSK medically significant, urinary tract infection pseudomonal with serious criteria of GSK medically significant, Stenotrophomonas sepsis with serious criteria of GSK medically significant, thrombocytopenia, leukopenia with serious criteria of GSK medically significant and lung consolidation. The subject was treated with acyclovir, antibiotics unknown, antifungals for systemic use, ciprofloxacin, meropenem, Sulfamethoxazole + Trimethoprim, Ticarcillin + Clavulanate and tigecycline. The outcome of varicella was fatal. The outcome(s) of the additional event(s) included fever (unknown), shortness of breath (unknown), face edema (unknown), petechial rash (unknown), hypotension (unknown), pneumonia (unknown), acute respiratory distress syndrome (unknown), pancytopenia (unknown), multi-organ failure (unknown), iatrogenic infection (unknown), enterobacter cloacae infection (unknown), respiratory tract infection (unknown), urinary tract infection pseudomonal (unknown), Stenotrophomonas sepsis (unknown), thrombocytopenia (unknown), leukopenia (unknown) and lung consolidation (unknown). The reported cause of death was varicella. It was unknown if the investigator considered the varicella, fever, shortness of breath, face edema, petechial rash, hypotension, pneumonia, acute respiratory distress syndrome, pancytopenia, multi-organ failure, iatrogenic infection, enterobacter cloacae infection, respiratory tract infection, urinary tract infection pseudomonal, Stenotrophomonas sepsis, thrombocytopenia, leukopenia and lung consolidation to be related to DTP (A or W not known) vaccine and Hib vaccine. Diagnostic results (unless otherwise stated, normal values were not provided): On 14th March 2009, Varicella virus test result was Positive absent. On an unknown date, Aspiration bone marrow result was no evidence of leukaemia absent. On an unknown date, Blood culture result was Negative absent. On an unknown date, Blood culture result was Positive for Stenotrophomonas maltophilia absent. On an unknown date, Body temperature result was 101.1 degree F. On an unknown date, Chest X-ray result was Alveolar consolidation absent. On an unknown date, Computerised tomogram result was no intracranial lesions absent. On an unknown date, Electroencephalogram result was excluded subclinical seizures absent. On an unknown date, Platelet count result was 30,000 /mcL. On an unknown date, White blood cell count result was 1,400 /mcL. Additional information received: This case was reported in a literature article and it described the occurrence of a varicella infection in a 15-year-old female patient who had been vaccinated with unspecified DTP vaccines, unspecified Hib vaccine and unspecified MMR vaccines (manufacturers unknown). The patient had been healthy prior to the event and had no known underlying medical conditions according to the authors. She lived in a community with low rates of varicella vaccination and the source individual was never identified. No further information on the patient's medical or family history, concurrent medical conditions or concomitant medication was provided. On an unspecified dates, the patient received 4 doses of an unspecified DTP vaccine, 1 dose of an unspecified Hib vaccine and 2 doses of an unspecified MMR (administration routes and sites unspecified; dosages unknown, batch numbers not provided). Please note that the authors commented that she had not been vaccinated against varicella. On 12 March 2009, an unknown period after the vaccinations she was admitted to hospital with a 3-day history of a rash consistent with varicella and a 1-day history of fever and shortness of breath. Upon examination on admission, she was noted to be awake and alert, febrile (101.1 deg. F) dyspnoeic, had facial oedema, generalized petechial rash and hypotension; so she was diagnosed with septic shock. She was initially placed on non-invasive mechanical ventilation, but her respiratory function continued to deteriorate and she required invasive mechanical ventilation after 6 hours. In addition to this, she later developed pneumonia complicated by acute respiratory distress syndrome, pancytopenia, multi-organ dysfunction, iatrogenic colonization and infection (respiratory tract colonization with Enterobacter cloacae and urinary tract infection with Pseudomonas aeruginosa) and sepsis. Further deterioration of her respiratory function require progressively higher levels of oxygen and pressure during her last week in hospital. She died on day 21 of admission. Varicella was recorded as the underlying cause of death, and this was validated by an investigation performed by the state Department of Health. The authors did not mention if a post-mortem had been performed. Laboratory tests performed on admission revealed thrombocytopenia (platelet count: 30,000/mcL) and leucopoenia (white blood cell count: 1,400/mcL). Blood cultures taken on admission were negative, but direct fluorescent antibody test performed on a sample of vesicular fluid collected on 14 March 2009 was positive for varicella-zoster virus. Blood cultures taken on hospital days 19 and 20 were positive for Stenotrophomonas maltophilia. Further blood cultures collected while she was on antibiotics were negative. In addition to this the authors commented that she had been diagnosed with Enterobacter cloacae respiratory tract colonization and Pseudomonas aeruginosa urinary tract infection, but the details of those tests were not provided. She underwent multiple chest X-Rays that showed diffuse, tiny nodules in the lung parenchyma consistent with alveolar consolidation. Computed tomography scan did not identify any intracranial lesions and electroencephalography excluded any subclinical seizures. Bone marrow aspirate obtained during her hospitalisation showed no evidence of leukaemia according to the authors. Initial treatment consisted of intravenous acyclovir (started on day 4 of illness) and broad-spectrum antibiotics and antifungals, in addition to respiratory support. She was later commenced on ciprofloxacin, meropenem, trimethoprim-sulfamethoxazole, ticarcillin-clavulanate and tigecycline. The outcome of the event was death. The authors did not comment on any causal relationship between the vaccines the patient received and this event. The authors concluded that "Severe varicella can develop among unvaccinated healthy persons, and which patients might develop an especially severe course often is unpredictable. Persons without evidence of immunity to varicella should received 2 doses of varicella vaccine or a second dose if they have received only 1 dose, to prevent varicella and its severe complications."