Sex: U
Vaccine: MNQ
Symptoms: Abdominal discomfort, Diarrhoea, Epistaxis, Injection site pruritus, Somnolence
Clinical narrative: This case was reported in a literature article and described the occurrence of diarrhea in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, an unknown time after receiving Meningococcal ACWY-CRM vaccine, the subject developed diarrhea. Serious criteria included other: serious per author. Additional event(s) included injection site itching with serious criteria of other: serious per author, epistaxis with serious criteria of other: serious per reporter, somnolence with serious criteria of other: serious per reporter and upset stomach with serious criteria of other: serious per reporter. The outcome of diarrhea was unknown. The outcome(s) of the additional event(s) included injection site itching (unknown), epistaxis (unknown), somnolence (unknown) and upset stomach (unknown). It was unknown if the investigator considered the diarrhea, injection site itching, epistaxis, somnolence and upset stomach to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of diarrhoea, itching at injection site, nosebleed, somnolence and upset stomach in a patient aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). 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. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (n=32), Tdap (n=776) and HPV (n=608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (n=43)]. On an unspecified date, between 0-734 days after vaccination, the patient had diarrhoea, itching at injection site, nosebleed, somnolence and upset stomach. (In this study, day 0 set as the day of vaccination). This case has been considered serious per reporter (In this study, reports are classified as serious or non-serious, using the definition for serious based on the Code of Regulations). Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of diarrhoea, itching at injection site, nosebleed, somnolence and upset stomach and MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-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 reported cases in the same literature article.