Age: 12.0
Sex: M
Vaccine: FLU3, HPVX, MNQ, TDAP
Symptoms: Cardiac stress test, Dizziness, Electrocardiogram, Full blood count, Headache
Clinical narrative: This case was reported in a literature article and described the occurrence of postural orthostatic tachycardia syndrome in a 12-year-old male subject who received Meningococcal ACWY-CRM vaccine. On 18th November 2011, 24 days after receiving Meningococcal ACWY-CRM vaccine, Flu seasonal TIV Dresden, dTpa vaccine, and Human papilloma type 16 + 18 vaccine + AS04D, the subject developed postural orthostatic tachycardia syndrome. Serious criteria included other: serious per reporter. Additional event(s) included dizziness on 18th November 2011 with serious criteria of other: serious per reporter, loss of vision with serious criteria of GSK medically significant and other: serious per reporter, convulsion with serious criteria of GSK medically significant and other: serious per reporter, blackout with serious criteria of GSK medically significant and other: serious per reporter, metal poisoning with serious criteria of GSK medically significant and other: serious per reporter, activities of daily living impaired with serious criteria of other: serious per reporter, blood pressure decreased with serious criteria of other: serious per reporter, panic attack with serious criteria of other: serious per reporter, tremor of hands with serious criteria of other: serious per reporter, upset stomach with serious criteria of other: serious per reporter and headache with serious criteria of other: serious per reporter. The outcome of postural orthostatic tachycardia syndrome was unknown. The outcome(s) of the additional event(s) included loss of vision (unknown), convulsion (unknown), blackout (unknown), metal poisoning (unknown), dizziness (unknown), activities of daily living impaired (unknown), blood pressure decreased (unknown), panic attack (unknown), tremor of hands (unknown), upset stomach (unknown) and headache (unknown). It was unknown if the investigator considered the postural orthostatic tachycardia syndrome, dizziness, loss of vision, convulsion, blackout, metal poisoning, activities of daily living impaired, blood pressure decreased, panic attack, tremor of hands, upset stomach and headache to be related to Meningococcal ACWY-CRM vaccine, Flu seasonal TIV Dresden, dTpa vaccine, and Human papilloma type 16 + 18 + AS04D. Relevant Tests: Lab tests performed on unspecified date: The patient underwent multiple tests and seemed to think that his heart was fine. Hormone testing and DNA testing were performed (results unknown). Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Allergy test result was unknown. On an unknown date, Blood heavy metal test result was metal poisoning unknown. On an unknown date, Cardiac stress test result as unknown. On an unknown date, Electrocardiogram result was unknown. On an unknown date, Full blood count result was unknown. On an unknown date, Tilt table test result was unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of postural orthostatic tachycardia syndrome (POTS) in 12-year-old male who was vaccinated with MENVEO (GlaxoSmithKline), unspecified seasonal influenza vaccine; unspecified HPV vaccine; unspecified TDaP vaccine (manufacturer unknown for all). The patient's VAERS ID was 612692. 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 25 October 2011, the patient received MENVEO, unspecified TDaP vaccine, unspecified HPV vaccine (administration route and site unspecified; dosages unknown; batch number not provided for all) and 1 dose of unspecified seasonal influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). On 18 November 2011, 24 days after vaccination, the patient symptoms began with dizziness about once a week. The spells seemed minor at the time and was very random, thought might be related to his growth spurts. This patient never complaint so, as the dizzy spells got worse; The patient dealt with them without letting know anybody how frequent they were. The patient got concerned and aggravated that the spells were daily and sometimes multiple times a day, the patient asked to call the doctor. The patient was referred to a cardiologist. Cardiologist mentioned that he has seen similar symptoms following vaccinations. The patient underwent multiple tests and seemed to think that his heart was fine. The patient was sent home. About this time, the patient's symptoms worsened again and starting affecting his martial arts training. The dizzy spells seemed to worsen with cardio and then he experienced a blood pressure drop that caused convulsions and blacking out. The patient was treated at the emergency room (ER) but all they would treat was a panic attack. The patient was consulted again and a stress test was performed. The patient was started on blood pressure medications. After trying different prescriptions and natural suggestion, the patient was given a diagnosis of POTS. The patient decided to reach out to a doctor who had worked with vaccine injuries. Many tests were ordered one of which included heavy metal testing. Now the patient had also a Heavy Metal Toxicity diagnosis. These symptoms despite treatment have not gotten better but have continued to progress. The patient's hands now tremor so badly that cannot perform certain tasks easily. Even something as simple as buttoning his shirts was frustrating. Doable but frustrating. The patient had to give up part of his martial arts and struggled with and continued to train for Dizzy spells, loss of vision, hand tremors, stomach upset, and headaches are all things that patient deals with on a weekly and daily basis. 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 POTS with MENVEO, unspecified TDaP, unspecified HPV and unspecified influenza vaccines. (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.