Sex: U
Vaccine: MNQ
Symptoms: Febrile convulsion
Clinical narrative: This case was reported in a literature article and described the occurrence of febrile convulsion in a child subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, less than a month after receiving Meningococcal ACWY-CRM vaccine, the subject developed febrile convulsion. Serious criteria included GSK medically significant and other: serious per author. The outcome of febrile convulsion was unknown. It was unknown if the investigator considered the febrile convulsion 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 febrile convulsion in a child aged between 2 and 10 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the retrospective observational cohort study that summarized the occurrence of 26 pre-specified events of interest (EOI)  and serious medically attended events (SMAEs) occurring up to 1 year after vaccination with MenACWY-CRM in children aged 2 through 10 years (inclusive-i.e., did not reach their 11th birthday) in routine clinical care. The study was conducted as part of a postmarketing commitment required by the regulatory authority at three medical centers within a particular healthcare system. In this study, most of the children had not received any prior MCV4 vaccinations. The patient was enrolled at healthcare  system  for 6 or more months prior to the first dose of MenACWY-CRM in order to have 6 or more months of observation time to identify pre-existing diagnoses. No information on patient's medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date between 30 September 2011 and 30 September 2014, the patient received MENVEO (administration site and route unspecified; dosages unknown; batch number not provided). (It was reported, in January 2011, MENVEO, (GSK) was approved by the Food and Drug Administration for children aged 2-10 years in this  country). [In this study, most children had not received another dose of MCV4 during their observation period (out of 327, 318 received 1 dose and 9 received 2 doses). The majority of children (n=236) received their index vaccination between 7 and 10 years of age]. The age of vaccination was not provided. On an unspecified date, within 30 days of vaccination, the patient was diagnosed with febrile convulsion. (In this study, febrile convulsion was considered as an SMAE). This case has been considered serious per author "SMAE". Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of febrile convulsion and MENVEO. The authors concluded, "Data from this descriptive study do not suggest safety concerns associated with MenACWY-CRM vaccination when used as part of routine clinical care of children aged 2 through 10. However, the generalizability of the study results to the high risk child population with complement component deficiencies or functional or anatomic asplenia is more limited due to the small sample size of children with these medical conditions in our population". This is 1 of the 5 valid cases reported in the same literature article. Comment: suspected reasonable causal relationship based on febrile convulsion was upgraded as those events are listed for Meningococcal ACWY-CRM vaccine.