Age: 16.0
Sex: F
Vaccine: MENB, MENB, MENB, MENB
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Injection site swelling, Metabolic function test, Mononucleosis heterophile test negative
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 16-year-old female patient who received BEXSERO. Previously administered products included measles vaccine with an associated reaction of rash. On 9th August 2016, the patient received the 1st dose of BEXSERO (intramuscular). On 9th August 2016, 7 hrs after receiving BEXSERO, the patient experienced headache (serious criteria hospitalization), numbness of lower extremities (serious criteria hospitalization), tingling of extremity (serious criteria hospitalization), fever, nausea, appetite absent, weakness, sore back, neck pain, visual disturbance, injection site pain and viral infection. On 14th August 2016, the patient experienced unable to walk (serious criteria hospitalizations and GSK medically significant). The patient was treated with doxycycline. BEXSERO was discontinued (Dechallenge was unknown). On 10th August 2016, the outcome of the fever was recovered/resolved. On 18th August 2016, the outcome of the nausea was recovered/resolved. On an unknown date, the outcome of the headache, numbness of lower extremities and tingling of extremity were not recovered/not resolved and the outcome of the unable to walk and appetite absent were recovering/resolving and the outcome of the weakness, visual disturbance and viral infection were unknown and the outcome of the sore back, neck pain and injection site pain were recovered/resolved. The reporter considered the headache, numbness of lover extremities, tingling of extremity, unable to walk, fever, nausea, appetite absent, weakness, sore back, neck pain, visual disturbance, injection site pain and viral infection to be related to BEXSERO. Additional details were provided as follows: The case was reported by the patient's mother. The patient received BEXSERO on the left arm. On 9th August 2016, at 9:00 hours, the patient received BEXSERO. On the same day by 4:00pm, the patient developed headache, fever, nausea, vision changes and numbness or tingling in her legs and feet. Less than a day after receiving BEXSERO, the patient experienced no appetite, weakness, injection site pain, back pain and neck pain. The patient went to soccer practice that evening, but was too weak to kick the ball and went home early. In the evening they called the emergency number for the pediatrician's office. It was thought, the patient coincidentally caught a virus and were told the symptoms would subside. The fever was resolved in the afternoon of 10th August 2016. The pain at the injection site resolved about 4 days after the injection. The other symptoms persisted and on 11th August 2016, the patient went to the emergency room because of a severe headache and numbness in her legs. The worse the headache, the worse the numbness and tingling in her legs. They performed a spinal tap and put her on doxycycline just in case it was tick borne. No ticks was found and she had no response to doxycycline. On 14th August 2016, the patient went to the emergency room again because of a severe headache and related numbness or tingling. By the time the patient got to the emergency room, she could not walk, her legs were so numb. The patient stayed 12 to 24 hours and was put in critical care. The headache was gotten under control and a magnetic resonance imaging (MRI) and computerized tomogram (CT scan) performed. The scans did not determine a cause of the symptoms. It was thought the headache was exacerbated by the spinal tap, which in turn exacerbated the numbness or tingling. The patient could tell the difference between the spinal tap headache and the reaction headache, and the spinal tap headache seemed to have resolved. On 19th August 2016, the patient has some appetite for the first time since the vaccination. On 20th August 2016, the patient was able to go out and about for about an hour and take a walk to their barn. Previously car rides had exacerbated her headache. On 21st August 2016, the patient woke up and the headache and tingling or numbness had returned. The patient's mother stated that the doctor called in the reaction on 12th August 2016, however, no duplicate case found.