Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope, Tremor, Urinary incontinence, Visual brightness, Vomiting
Clinical narrative: syncopal reaction; extremaly bloated; cold sweat; sever stomach aches; diarrhoea; throw up 2 times; nauseous; vision was becoming bright; lightheaded; felt like instanlty to a bunch of people saying my name; i could talk again; discharged home with diagnosis of vasovagal episode; passed out; mild seizure like activity; urinated on myslef/ was incontinent while sitting in the chair; soaked in sweat/diaphoretic; freezing cold; trembling; blood pressure dropped; could barely feel my legs; This report was obtained on request by the Company from the agency (Agency number: 827967).  This spontaneous report as received from a healthcare professional and the patient and refers to a 26-year-old female patient. Her prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination included: metronidazole benzoate (FLAGYL), acetaminophen (TYLENOL) and metronidazole. She was allergic to penicillin, ibuprofen and aspirin. Her other illnesses at the time of vaccination included bacterial vaginosis (BV) diagnosed on 05-AUG-2019. She had no chronic or long- standing health condition.  On 08-AUG-2019 at 12:30 (also reported as at 12:45), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscularly in the left arm (lot # R009614 verified to be valid, expiry date not reported, but upon internal validation established as 30-NOV-2020) for prophylaxis.  On the same day, less than 1 minute after receiving injection, the patient had syncopal reaction. The patient stated she was feeling lightheaded. She remembered her nurse putting a band aid on her arm and instantly her vision was becoming bright and she felt nauseous. The nurse told her to stay seated. She was offered to get on exam table, she appeared to lose consciousness. The patient was upright in chair, diaphoretic and started to show signs of mild seizure like activity (also reported that she was told she had a seizure and she had an oxygen mask on). At this point she passed out. She woke up what felt like instantly to a bunch of people saying her name. She was told she was unconscious for 7+ minutes. There were 5 or 6 nurses holding her up in the chair, 2 doctors, and emergency medical technician (EMT) in the room. The patient was incontinent (she urinated on herself) while sitting in the chair. It was unable to safely lower her to floor, so the patient remained sitting in chair as it was attempted to bring her around, using ammonia inhalants. She was soaked in sweat, freezing cold and trembling. Her blood pressure dropped significantly. 2 EMTs carried her to the stretcher because she could barely feel her legs. Blood pressure (BP) and pulse were monitored. Oxygen was applied. The patient was sent out to emergency room (ER) by ambulance, for evaluation. When she arrived to the ER she felt almost normal, she could talk again (speech disorder) and she had quit trembling. On 09-AUG-2019 (reported as on day two), her body was instantly rejecting any food she ate - she have thrown up 2 times the day of the occurrence and had diarrhea. She was extremely bloated and had severe stomach aches that gave her the cold sweats. She would have a follow up appointment with the primary doctor on approximately 12-AUG-2019 (reported as next Monday). The outcome of syncope, loss of consciousness, lightheadedness, blood pressure decreased, urinary incontinence, diaphoresis, trembling, speech disorder and seizure was reported as recovered/resolved. The outcome of the remaining events was reported as unknown.  The relatedness between the events and the suspect vaccine was not provided.  Follow up information has been received from a health care professional on 19-NOV-2020.  On 08-AUG-2019, within 21 minutes from administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient complaint of feeling light headed, as the patient was moving from the chair to the exam table, she appeared to lose consciousness while remaining upright in sitting position, then, she started to move limbs in a manner that appeared to be seizure-like and was incontinent of urine. She eventually regained consciousness after several minutes with the use of inhalants. Blood pressure (98/40 units were not provided) and pulse (83 units not provided) were monitored throughout the process and oxygen was administered via nasal cannula. The patient was moved to emergency department and was discharged on an unknown date with a diagnosis of vasovagal episode (presyncope). Seriousness criteria reported as hospitalization. At the reporting time, the outcome of presyncope was reported as resolved on the same date. The causality assessment was not provided.  Upon internal review, syncope, loss of consciousness and seizure were determined to be medically significant.