Sex: F
Vaccine: HPVX
Symptoms: Fall, Head injury, Hormone level abnormal, Loss of consciousness, Malaise
Clinical narrative: This spontaneous report was received from an office manager via company representative regarding a post written by a mother referring to her daughter of 13 year old. The patient's concurrent condition, medical history and concomitant medication was not provided. On 10-MAR-2018 (reported as 59 days before), the patient was vaccinated with GARDASIL 9 or GARDASIL for prophylaxis (strength, dose, frequency, indication, lot number, expiry date unspecified). On 08-MAY-2018, when the patient was at the track practice, she was not feeling well and she went into the locker room and got dizzy. She remembers nothing but waking up on the floor (passed out). She went to emergency room (ER) and was told she was dehydrated but fine. The next day she went to her family doctor just to get checked out. On 10-MAY-2018, at school she passed out, but it was noticed she had some movement in her hand. On the same day, she went to her doctor and they did blood work with results normal. On 11-MAY-2018, on the way home she passed out in the back seat and her right hand was shaking. It was reported there was no response from her. An ambulance was called and took her to hospital. At the hospital, it was informed that, the patient needed to see a cardiologist to rule out a heart problem. On 12-MAY-2018 and 13-MAY-2018 (reported as Saturday, Sunday), the patient had same things, "passing out" with shaking in her right hand but now her right leg was shaking too. We took her back to the doctors and we were told they sounded more like seizures than just "passing out". On 14-MAY-2018 and 15-MAY-2018 (reported as Monday and Tuesday) she had more at school. On 16-MAY-2018 (Wednesday), the patient was having a seizure in the chair, she was on the floor and was shaking. The ambulance came and took her to children's hospital. The patient was hooked to electroencephalography (EEG), had computed tomography (CT) scan and a lot of blood work. She had a seizure when the EEG was on. The results showed non epileptic seizures. At the hospital, it was informed that more likely it was stress and she need to see a physiologist. Mother's co-worker told to look up the HPV vaccination. The mother called the physician who administered the vaccine, the doctor reassured that the vaccination was probably not the problem and after few days the mother received call back saying that, it could be the vaccination that caused the events to the patient. The patient had an appointment set up already with a psychologist and he confirmed that, the patient most likely had a side effect from the unidentified hpv vaccine. He reassured that he could help the patient. The patient was started doing Neuro-feedback and Bio-Feedback training. On an unknown date in 2018, the unidentified hpv vaccine altered her hormone (hormone level abnormal) and they were making her brainwaves not connect and causing the seizures. During this time, the patient was up to two seizures a day, that last on average 8-10 minutes long. She had had the seizures in many places including stores, in softball games, with friends and at the campground and all times of the day. On 06-JUL-2018, the patient was taken to the ER after falling (fall) when having a seizure and hitting her head on concrete floor. ER doctor confirmed that, the symptoms were side effects from the vaccination and that was what causing patient's seizures. The physician stated that the condition was not reversible, it altered her hormones for good. However, the patient can learn to control them with the feedback training. The patient was going to weekly doctor appointments and doctors set her up with home feedback training. That way she could do the exercises at home too. The patient continued to have seizures but had them controlled to about once a week (recovering). Outcome of loss of consciousness, fall, hormone level abnormal, dizziness and malaise was unknown. The reporter considered loss of consciousness, seizure and hormone level abnormal to be related to GARDASIL 9 or GARDASIL. Causality of the events dizziness, malaise and fall was not provided. No product quality complaint was involved. Upon internal review, the events loss of consciousness and seizure were determined to be medically significant.