Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome, Residual symptom, Rheumatoid factor, Somnolence, Tilt table test positive
Clinical narrative: postural tachycardia syndrome (POTS); Information has been received from the authors in a published literature article title as stated below, concerning a 20 year old female who was unremarkable for pre-existing orthostatic symptoms or exercise intolerance. Concurrent conditions, medical history, or concomitant therapies were not reported. On an unspecified date, the patient was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL) (dose, route, lot#, and expiration date not reported).   Two weeks prior to symptom onset, there were no other factors or events preceding the illness. Two weeks after receiving Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL), the patient developed dizziness, exercise intolerance, fatigue, nausea and a loss of appetite. Initially, a viral illness was suspected, but after months of persistent and debilitating symptoms, accompanied by a weight loss of 20 pounds in 3 months and no serologic evidence of an infectious disease, this diagnosis was refuted. Subsequently, an eating disorder was considered, but after a thorough medical evaluation and a consultation with psychiatrist, this diagnosis was also excluded.   Eventually, after  numerous unrevealing cardiac, endocrine and rheumatologic tests, a tilt table test confirmed the diagnosis of postural tachycardia syndrome (POTS) by demonstrating an increase in heart rate from 72 bpm supine to 140 bpm within 10 minutes of tilt without orthostatic hypotension and accompanied by symptoms of orthostatic intolerance. The patient tested negative for ganglionic acetylcholine receptor antibody.  The patient had no family history of cardiac, autoimmune or autonomic disorders. Other than vaccination with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL) 2 weeks prior to symptoms onset, there were no other factors or events preceding the illness.  The reporting physician/author considered that the temporal relationship between vaccination and illness onset suggested a possible association between POTS and Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL)  To date, this was the first case report describing POTS after vaccination with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL). Given an increased prevalence of POTS in young women and an indication for vaccination with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL) in the same patient population, physicians should be aware of a possible association between vaccination with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL) and de novo POTS.   Follow up was received from the author of the article reporting that with the use of pharmacotherapy consisting of pyridostigmine for postural tachycardia and orthostatic intolerance and bupropion and modafinil for fatigue and daytime somnolence, as well as non-pharmacological management with increased salt and fluid consumption, the patient's symptoms of orthostatic intolerance and gastrointestinal disturbance had gradually improved over the course of 15 months. The patient was able to return to school full-time but continued to experience some functional limitations and was unable to resume her previous athletic activities.  The reporter stated that nevertheless, none of the patients experienced complete resolution of symptoms, and all patients continued to experience some residual symptoms.   Possible pathogenesis of the new onset POTS after vaccination may include the mechanism of molecular mimicry, whereas Human papillomavirus( HPV) vaccine epitopes may induce formation of cross-reacting antibodies against potential targets of the autonomic ganglia, neurons, cardiac proteins or 31 /2-adrenergic and M2/3 muscarinic receptors. Additionally, induction of bystander lymphocyte lymphocyte activation and a broad spectrum of cytokine responses elicited by the HPV vaccine may also be involved. The reporter stated that The temporal association between vaccination with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL)  and the onset of symptoms of POTS in healthy young women was significant and deserved further investigation for assessment of a possible causal relationship.  Upon internal review, postural orthostatic tachycardia syndrome was considered disabling since it was reported that  the patient was able to return to school full-time but continued to experience some functional limitations and was unable to resume her previous activities.  Follow-up information was received from the physician. It was reported that the physician was unable to share any patient identifiers as for a majority of the patients, the physician would need parental consent. The physician had no other information to share at this moment.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports from the same literature article.  Lot # is being requested and will be submitted if received.  Follow-up information has been received from the neurologist via a company representative on 10-JUN-2024. It was reported that the patient was an athlete.  It was reported that there were multiple reports from numerous countries. One country had actually suspended their mass human papilloma virus (HPV) vaccination program.   Sender's Comments: , MERCK1007USA02012:Mfr number