Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, MNQ
Symptoms: Malaise, Nausea
Clinical narrative: This case was reported in a literature article and described the occurrence of unknown cause of death in a 16-year-old female subject who received Meningococcal ACWY-CRM. Co-suspect products included GARDASIL. Previously administered products included MENACTRA. Concurrent medical conditions included asthma. Concomitant products included FLUZONE. In October 2013, 61 days after receiving Meningococcal ACWY-CRM vaccine and Hepatitis A vaccine, the subject developed feeling unwell. Serious criteria included death. Additional event(s) included brain neoplasm on 25th November 2013 with serious criteria of death, disability and GSK medically significant, brain stem glioma on 25th November 2013 with serious criteria of death and GSK medically significant, nausea on 25th November 2013 with serious criteria of death, dizziness on 25th November 2013 with serious criteria of death and unknown cause of death on 18th June 2014 with serious criteria death and GSK medically significant. The outcome of feeing unwell was fatal. The outcome(s) of the additional event(s) included unknown cause of death (fatal), brain neoplasm (fatal), brain stem glioma (fatal), nausea (fatal) and dizziness (fatal). The subject died on 18th June 2014. The reported cause of death was unknown cause of death, dizziness, brain tumor, brain stem glioma, feeling unwell and nausea. It was unknown if the investigator considered the feeling unwell, brain neoplasm, brain stem glioma, nausea, dizziness and unknown cause of death to be related to Meningococcal ACWY-CRM vaccine and Hepatitis A vaccine. Diagnostic results (unless otherwise stated, normal values were not provided): In October 2013, Computerised tomogram result was unknown. On 25th November 2013, Computerised tomogram result was unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of death NOS in 16-year-old female patient who was vaccinated with MENVEO, HAVRIX (GlaxoSmithKline for both) and GARDASIL (Merck and Co). The patient's VAERS ID was 612719. The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)-to summarize reports following immunization with MENVEO. The patient had pre-existing asthma. On 25 February 2009, the patient had received MENACTRA. The patient's concomitant medication include FLUZONE received on 3 October 2013. No information on family history was provided. On 19 August 2013, the patient received MENVEO (lot no. M12092) and HAVRIX (lot no. 5J5HT) (dosages unknown) at unknown site intramuscularly. The patient also received 2nd dose of GARDASIL (lot no. J006236) at unknown site intramuscularly. On an unspecified date in October 2013, 2 months after vaccination, the patient reported that she was not feeling well and had a feeling of something in her head. The patient had computed tomography (CT). On 25 November 2013, 98 days after vaccination, the patient awake with nausea, dizziness and got another CT scan. Approximately after 5 months of vaccination, on 13 January 2014, the patient was brought to emergency room and diagnosed with Pontine Glioma Tumor Brain. On 18 June 2014, the patient died. The cause of death was unknown. It was reported that unable to review medical records, autopsy reported or a death certificate for this patient. Treatment was unknown. The authors did not comment on the relationship between the event of Pontine Glioma Tumor Brain and MENVEO and HAVRIX (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporarily-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 valid cases in the same literature article.