Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Liver function test, Nausea, Neck pain, Ocular hyperaemia
Clinical narrative: Information has been received from a consumer concerning her 11 year old daughter with spondylopathy, bipolar disorder, arthritis and "occasional stomach problems" from the arthritis medication (ETODOLAC) and a history of a severe reaction with parotitis and was hospitalized for 2 weeks while on prior therapy with a dose of MMR II (WAES# 0908USA04048) as a young child who on 13-AUG-2009 was vaccinated with a dose of RECOMBIVAX HB (dose, route, and lot# not reported). Concomitant therapy included SEROQUEL (50mg), ETODOLAC and NEXIUM. The consumer reported that her daughter received a dose of RECOMBIVAX HB and was later taken to the hospital emergency room. It was unknown if she received other hepatitis B vaccines recently but she did receive it as a baby without adverse reaction. On 13-AUG-2009 at 1:30 she received the vaccination and at 4:30-5 PM she experienced throat closing, could not breathe and chest pain. The patient was taken to physician's office with chills, burning of throat and chest "like severe reflex", pain in left elbow joint and left side of neck, stabbing pains in legs, and visual issues "like letters moving around". She then had a panic attack because she could not breathe and "everything got small around her". The patient was seen by doctor for 1-1.5 hours and then was taken home. She later went to the emergency room. She was treated with MAALOX and "something for pain." Since 15-AUG-2009 she had had a stabbing knife pains in back, ribs and side and cramping of stomach. The patient was taken to the emergency room on 16-AUG-2009. The patient was treated with ETODOLAC and ice packs to back. At the night of 20-AUG-2009, the patient had severe back pain and was given TYLENOL 600 mg. She might need to be hospitalized to assist with the pain. The patient took NEXIUM for relief of the "occasional stomach problems" from the arthritis medication, ETODOLAC. A liver panel and pancreas blood tests were performed and the results were unknown. At the time of the report, the patient had not recovered. Follow up information from the patient's mother indicated that her daughter was still having symptoms from RECOMBIVAX HB. In addition to the symptoms she was having before, she was nauseous all the time and went blind in one eye for about 13 hours on 21-SEP-2009. Since then she regained vision in her eye, but she saw black spots and had blurred vision all the time. The consumer stated that starting after the vaccine the patient had stabbing burning back pain that lasted until 17-SEP-2009. On 17-SEP-2009 she developed blindness in the left eye for 1 second. On 21-SEP-2009 her left eye was red and burning. At 10 am on 21-SEP-2009 she lost her vision in the left eye complained of "spots in the eyes and then it went black with light coming in as red" that lasted from 10:00 am until 11:30 pm that same day. On 22-SEP-2009 both eyes with blurred vision that continued still. The patient had nausea and vomiting from 22-SEP-2009 until 23-OCT-2009. She had been falling down every day and had hurt her ankle and her spine in these falls. She had complained of dizziness and "feels like the floor is at a tilt." The patient had had short term memory issues and confusion. Starting on 04-OCT-2009 she developed a burning itch on her legs that continued still. She had had times where "her body feels hot to touch but her actual temperature is normal." She stated that since the episodes of blindness, when she focused tool long she got black spots in her eyes. Since the blindness episode she had had a burning sensation off and on for 1 week. 1 week after the blindness she developed a headache over her eyes that continued still. Upon internal review, blindness in the left eye was determined to be an other important medical event. Additional information has been requested.