Sex: F
Vaccine: FLUX, HEPA, HPVX
Symptoms: Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: Initial unsolicited report received from literature on 02-Aug-2018. The following is verbatim from the article: RATIONALE: Human papillomavirus (HPV) vaccination prevents infections with HPV strains that cause certain cancers. Reports of postural orthostatic tachycardia syndrome (POTS) following HPV vaccination have raised safety concerns. We reviewed POTS reports submitted to the Vaccine Adverse Event Reporting System (VAERS). Methods: We searched the VAERS database for reports of POTS following any type of HPV vaccination (bivalent, quadrivalent, or nonavalent) from June 2006 to August 2015.We reviewed reports and applied established POTS diagnostic criteria. We calculated unadjusted POTS case reporting rates based on HPV vaccine doses distributed and conducted empirical Bayesian data mining to screen for disproportional reporting of POTS following HPV vaccination. Results: Among 40,735 VAERS reports following HPV vaccination, we identified 29 POTS reports that fully met diagnostic criteria. Of these, 27 (93.1%) were in females and mean age was 14 years (range 12-32). Median time from vaccination to start of symptoms was 43 days (range 0-407); most (18, 75.0%) had onset between 0 and 90 days. Symptoms frequently reported concomitantly included headache (22, 75.9%) and dizziness (21, 72.4%). Twenty (68.9%) reports documented a history of pre-existing medical conditions, of which chronic fatigue (5, 17.2%), asthma (4, 13.8%), and chronic headache (3, 10.3%) were most common. Approximately one POTS case is reported for every 6.5 million HPV vaccine doses distributed. No empirical Bayesian data mining safety signals for POTS and HPV vaccination were detected. Conclusion: POTS is rarely reported following HPV vaccination. Our review did not detect any unusual or unexpected reporting patterns that would suggest a safety problem. This case involves a female patient (mean age was 14 years from range 12-32) who was vaccinated with a dose of INFLUENZA VACCINE, hepatitis A vaccine and HP vaccine (human papillomavirus) (batch number, expiry date, dose, route and site of administration were not reported) on an unknown date. The patient's concomitant medication and previous medications were not reported. The patient's past medical history included fatigue, asthma and headache as pre-existing medical condition. On an unspecified date (reported as median time from vaccination to start of symptoms was 43 days (range 0-407), following the vaccination, the patient developed postural orthostatic tachycardia syndrome, fainting, headache, dizziness, fatigue, nausea and weakness. The patient's laboratory investigations were not reported. The patient's a corrective treatment was not reported. The event outcome was reported as unknown for all the events. Final diagnosis was reported as postural orthostatic tachycardia. This case was assessed as serious due to medically significant event: postural orthostatic tachycardia. List of documents held by sender: none. Sender's Comments: This case involves an adult female patient who experienced postural orthostatic tachycardia syndrome, syncope, headache, dizziness, fatigue, nausea and asthenia after vaccination. Time to onset is not known. More details regarding patient's medical history, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Some Based on the available information the role of vaccine cannot be assessed.