Age: 12.0
Sex: U
Vaccine: HEPA, MNQ, TDAP
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy
Clinical narrative: This case was reported in a literature article and described the occurrence of chronic inflammatory demyelinating polyradiculoneuropathy in a 12-year-old subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, less than a month after receiving Meningococcal ACWY-CRM vaccine, dTpa vaccine and Hepatitis A vaccine and less than a month after receiving Meningococcal ACWY-CRM vaccine, dTpa vaccine, and Hepatitis A vaccine, the subject developed chronic inflammatory demyelinating polyradiculoneuropathy. Serious criteria included GSK medically significant and other: Serious per reporter. The outcome of chronic inflammatory demyelinating polyradiculoneuropathy was unknown. The investigator considered the chronic inflammatory demyelinating polyradiculoneuropathy to be possibly related to Meningococcal ACWY-CRM vaccine, dTpa vaccine, and Hepatitis A vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) in 12-year-old of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline), unspecified DTaP and HAV vaccines (manufacturer unknown for both). The patient's VAERS ID was 443662. 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 was a healthy person. 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, unspecified DTaP and HAV vaccines (administration route and site unspecified; dosages unknown; batch number not provided for all). On an unspecified date, less than 21 days after vaccination, the patient developed CDIP. 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 CDIP and MENVEO, unspecified DTaP and HAV vaccines. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). As per reported in the VAERS, the event was possibly related to vaccines. 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.