Sex: U
Vaccine: DTAP, MNQ
Symptoms: Autonomic nervous system imbalance, Migraine without aura, Orthostatic hypotension
Clinical narrative: This case was reported in a literature article and described the occurrence of migraine without aura in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, an unknown time after receiving Meningococcal ACWY-CRM vaccine and dTpa vaccine, the subject developed migraine without aura. Serious criteria included other: Serious per reporter. Additional event(s) included orthostatic hypotension with serious criteria of other: Serious per reporter and dysautonomia with serious criteria of other: Serious per reporter. The outcome of migraine without aura was unknown. The outcome(s) of the additional event(s) included orthostatic hypotension (unknown) and dysautonomia (unknown). It was unknown if the investigator considered the migraine without aura, orthostatic hypotension and dysautonomia to be related to Meningococcal ACWY-CRM vaccine and dTpa vaccine. Additional information was reported. This case was reported in a literature article and described the occurrence of migraine without aura; orthostatic hypotension dysautonomic syndrome in a patient aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline) and unspecified TDaP 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. 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 TDaP (administration route and site unspecified; dosages unknown; batch number not provided). On an unspecified date, between 0-734 days after vaccination, the patient developed migraine without aura and orthostatic hypotension dysautonomic syndrome. (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 migraine without aura and orthostatic hypotension dysautonomic syndrome related to 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.