Sex: U
Vaccine: FLU3, MNQ
Symptoms: Guillain-Barre syndrome
Clinical narrative: This case was reported in a literature article and described the occurrence of Guillain Barre syndrome in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, 1 day after receiving Meningococcal ACWY-CRM vaccine and Flu seasonal TIV Dresden, the subject developed Guillain Barre syndrome. Serious criteria included GSK medically significant and other: Serious per reporter. The outcome of Guillain Barre syndrome was unknown. It was unknown if the investigator considered the Guillain Barre syndrome to be related to Meningococcal ACWY-CRM vaccine and Flu seasonal TIV Dresden. Additional information was provided. This case was reported in a literature article and described the occurrence of Guillain Barre Syndrome (GBS) in a patient aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline) and unspecified trivalent influenza vaccine (manufacturer unknown). 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. (In this study, viral illness prior to onset of symptoms was noted for two of the reports. In one case, records indicated that the patient experienced severe gastroenteritis followed by lower extremity weakness in the weeks immediately before vaccination, although symptoms had improved before receiving 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 and unspecified trivalent influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided for both). [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 (32), Tdap (776) and HPV (608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (43)]. On an unspecified date, between 1-55 days after vaccination, the patient developed Guillain Barre Syndrome (GBS). In this study, 1 report met the definition for Brighton level 1, and 3 reports met the definition for Brighton level 2). 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. (In this study, 3 of the 4 classified reports were documented as fully recovered at 1 year, while the fourth reported unresolved symptoms of neuropathy in both feet). The authors did not comment on the relationship between the event GBS 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.