Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling cold, Helicobacter infection, Hypoaesthesia, Influenza, Muscular weakness
Clinical narrative: Information has been received from a patient's mother regarding her 11 year old daughter. The patient had not pertinent medical history, concurrent conditions, previous drug reactions, allergies or concomitant medication. On 17-AUG-2015, the patient was vaccinated with the first dose of an unidentified Merck Human Papillomavirus (HPV) vaccine, lot number: K016966; the 0.5ml dose, administered via parenteral for prophylaxis (trade name, anatomical location and expiration date were not provided). Approximately on the same day (reported as: 12 hours later), the patient experienced fever and respiratory flu symptoms. Then, in approximately September 2015 (reported as: within about 3 weeks), the patient developed stomach pain and nausea. On 31-DEC-2015, the patient was vaccinated with the second dose of an unidentified Merck Human Papillomavirus (HPV) vaccine, lot number: L028083; the 0.5ml dose was administered via parenteral for prophylaxis (trade name, anatomical location and expiration date were not provided). Approximately on the same day (reported as: 12 hours later), the patient was vomiting and her foot began to tingle, within about 36 hours (on approximately 01-JAN-2016), the tingling was everywhere throughout her body and the patient could not walk (abasia). The patient was recovered from the abasia ("she could walk again") on the same day six hours later. It was reported that since that moment, the "patient's issues" had continued; it took 3 months for the tingling to go away but it would randomly came back starting in the summer of 2016. On 21-JAN-2016, the patient's mother sought medical attention and brought the patient to the emergency room; the patient was there for 6 hours but was not admitted in the hospital. In addition, approximately in February 2016 (reported as "starting last February or March"), the patient experienced a body temperature fluctuation (the patient sometimes had a body temperature of 96° and in July 2016, the patient felt cold a lot and would need to wear jeans and a sweatshirt because she was "freezing"). In July of 2016, she was diagnosed with an H pylori stomach infection (helicobacter infection). On an unknown date, the patient had developed muscle weakness, extreme fatigue, neuropathy and her legs have gone completely numb. It was reported that the patient also had nerve pain in her back and she generally felt bad all the time, moreover, she had leg pain that could barely got up to go to school every day. On an unspecified date, the patient had a magnetic resonance imaging (MRI) done and the results came back okay. It was reported that the patient had seen a neurologist on an unknown dates and she will be having a nerve conduction study done. At the time of the report, the patient had not received any treatment for the events and she was not recovered from the events reported (except from abasia). The relatedness between the events and the unidentified Merck Human Papillomavirus (HPV) vaccine was not reported. Upon internal review, the abasia and the helicobacter infection were considered as medically significant events. There was no product quality complaint involved. This is one of three reports received by the same reporter. The first dose of the unidentified Merck Human Papillomavirus (HPV) vaccine with Lot number K016966 which was not valid for the GARDASIL 9. However, lot number K016966 is valid for the GARDASIL. The second dose of the unidentified Merck Human Papillomavirus (HPV) vaccine with Lot number L028083 which was not valid for the GARDASIL. However, lot number L028083 is valid for the GARDASIL 9. Additional information has been requested. Sender's Comments: US-009507513-1703USA004620: US-009507513-1703USA004619.