Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Swelling face, Vomiting
Clinical narrative: Information has been received from a consumer's mother concerning a 15 year old female with penicillin allergy who on 14-OCT-2008 was vaccinated with the first dose of GARDASIL (lot # 659964/1978U) on her right arm, on 29-DEC-2008 with the second dose (lot # 659964/1978U) on the left arm, and on 14-JUL-2009 with the third dose (lot # 659964/1978U) on her right arm. Concomitant therapy included gabapentin, nortriptyline and omeprazole. On 14-OCT-2008 the patient experienced weakness, tiredness, chest pain, swelling on face and hands, hair loss, leg pain, menstrual cycle lasting a month, and could not keep food down. The reporter stated she had taken her daughter to see a specialist. It was reported that her "daughter still could not hold any food down and her stomach still hurts". CT Scan, Blood work, MRI, Nerve Conductions Test, PMG and Spinal Tap was performed and "all her tests (unspecified) came out negative". The patient's physician stated that patient was still experiencing feelings of nausea and her stomach still hurt, he ruled out a problem with her gallbladder. He was referring her to a Gastrointestinal Specialist for an endoscopy. The physician also reported that patient was diagnosed with Amplified Pain Syndrome. The patient required hospitalization or prolonged. The patient had not recovered at the time of report. The events of "weakness, tiredness, chest pain, swelling on face and hands, hair loss, leg pain, menstrual cycle lasting a month, could not keep food down, her stomach still hurts, amplified pain syndrome and nausea were considered to be disabling by the patient's mother. Follow up information received a medical assistant who took this call but asked the questions of the physician who was in the background. According to the medical assistant, the GARDASIL vaccinations were given elsewhere (no details in the chart). Regarding the concomitant medications (gabapentin 600mg TID, nortriptyline 10mg taken at night, and omeprazole 40mg once a day) listed by the consumer, the medical assistant said these were treatment medications, not concomitant ones at the time of the event. The patient was first seen in their office in September 2009. Regarding the hospitalization, the physician admitted the patient to hospital on 18-JUN-2010. Follow up information also received from a physician in a clinic reported that the patient was seen as an outpatient at their Clinic from 30-NOV-2009 through 08-DEC-2009. The diagnosis of Amplified Pain Syndrome (made in September 2009 at an unknown facility) was confirmed by the physician. His records showed the onset of pain as January 2009. An EMG and an autonomic reflex study done were negative. Only the exercise physiology study was abnormal (during this test, the patient was only able to reach 69%, where above 85% is normal). The reporter had nothing in his records as to where the GARDASIL vaccinations were given. His records showed no pertinent medical history prior to the first vaccine on 14-OCT-2008. He has not seen the patient since 08-DEC-2009, and no return visits were scheduled. The physician reported that it was "hard to say" and "impossible to prove" the causality of the events. Additional information has been requested.