Age: 17.0
Sex: F
Vaccine: HPV9, MENB, HPV4, MENB
Symptoms: Malaise, Mobility decreased, Multiple sclerosis, Nuclear magnetic resonance imaging
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of acute disseminated encephalomyelitis in a 17-year-old female patient who received BEXSERO (batch number 166801, expiry date unknown) for prophylaxis. Co-suspect products included GARDASIL (batch number M035486, expiry date unknown) for prophylaxis. On 21st February 2018, the patient received BEXSERO and GARDASIL. On 26th February 2018, 5 days after receiving BEXSERO, the patient experienced acute disseminated encephalomyelitis (serious criteria hospitalization and GSK medically significant), multiple sclerosis (serious criteria hospitalization and GSK medically significant), feelings of weakness (serious criteria hospitalization), joint range of motion decreased (serious criteria hospitalization), balance difficulty (serious criteria hospitalization), discomfort (serious criteria hospitalization) and walking difficulty (serious criteria hospitalization). The patient was treated with prednisolone. On an unknown date, the outcome of the acute disseminated encephalomyelitis and multiple sclerosis were unknown and the outcome of the feelings of weakness, joint range of motion decreased, balance difficulty, discomfort and walking difficulty were recovering/resolving. It was unknown if the reporter considered the acute disseminated encephalomyelitis, multiple sclerosis, feelings of weakness, joint range of motion decreased, balance difficulty, discomfort and walking difficulty to be related to BEXSERO. Additional details were provided as follows: The case was reported by the patient's father. The patient's concomitant medications included vitamins and iron. After vaccination, the patient expressed feeling weak and off balance on the left side of her body, discomfort and difficulty to walk increased during her school day and was picked up from school early by her parent. The patient visited her family physician and following an examination, the patient was advised to increase vitamins and iron, possibly related to her recent menstrual. The patient had no improvement and the physician was closed. The doctor's office was contacted and arranged an appointment in the evening at 3 PM. The physician examined the patient and advised to go directly to the emergency room at a hospital. After blood work, spinal tap, computerised tomogram scan and magnetic resonance imaging, the patient was admitted to the hospital on 2nd March 2018, and placed on high doses of Prednisolone for six days. At this point the patient had lost 90 percent of her movement and strength at her left arm and leg. Following the patient's hospital stay she was weaned off the Methylprednisolone with low doses for a month. The patient was scheduled to take another magnetic resonance imaging in July 2018 to learn if the patient had any other signs on the scan. The patient kept saying during this ordeal was that she just wanted to feel normal again. The patient's father was faced with a debt that he and his wife were not able to pay and wanted GSK to pay that bill or assist them. The hospital charging was 2,142.00 dollars after insurance and neurologist was charging 766.00 dollars and they still had one additional magnetic resonance imaging to come. The patient returned to full strength and was not 100 percent normal. The patient played tennis this past season and was doing great in school. It was unknown if the reporter considered the acute disseminated encephalomyelitis, multiple sclerosis, feelings of weakness, joint range of motion decreased, balance difficulty, discomfort and walking difficulty to be related to as well. The patient's father would greatly appreciate help from GSK.