Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Haemorrhoids, Hyperlipidaemia, Loss of consciousness, Melanocytic naevus, Memory impairment
Clinical narrative: This case was reported by a pharmacist via other manufacturer and described the occurrence of complex partial seizures in a 53-year-old female patient who received ENGERIX B adult. The patient's past medical history included hysterectomy and hip arthroplasty. Concurrent medical conditions included hypertension, osteoarthritis, fibromyalgia, hyperlipidemia, hypoglycemia, otitis externa, myositis, obesity, alcohol use (3 to 5 times per week), glucose tolerance impaired, myalgia, pain, fatigue, nausea, arthralgia, muscle weakness, depression, melanocytic nevus, hemorrhoids, rash, memory impairment, insomnia, amnesia, feeling abnormal and drug hypersensitivity (rash/hives). Concomitant products included ENGERIX B adult, gabapentin, pravastatin, fluticasone, salsalate, Amoxicillin-Clavulanate, hydrochlorothiazide + losartan, nortriptyline and CIPRODEX. On 15th September 2014, the patient received ENGERIX B adult. In September 2014, less than a month after receiving ENGERIX B adult, the patient experienced complex partial seizures (serious criteria hospitalization, GSK medically significant and other: As per reporter), consciousness disturbed (serious criteria GSK medically significant) and confusion. On 14th November 2014, the patient experienced blackout spell (serious criteria GSK medically significant). The patient was treated with KEPPRA, ferrous sulfate and TYLENOL. On an unknown date, the outcome of the complex partial seizures and blackout spell were unknown and the outcome of the consciousness disturbed and confusion were recovered/resolved. The reporter considered the complex partial seizures to be possibly related to ENGERIX B adult. It was unknown if the reporter considered the consciousness disturbed, blackout spell and confusion to be related to ENGERIX B adult. Additional details were received as follows: The blinded study vaccine was confirmed to be ENGERIX B adult. Patient was 53 years old woman, who was enrolled in the other manufacturer's sponsored study. The patient experienced an important medical event of complex partial seizures and was hospitalized. Relevant medical history included hypertension (1999), total hysterectomy (2001), osteoarthritis bilateral hands (2003), fibromyalgia (2008), left hip replacement (2008), hyperlipidaemia (2011), reactive hypoglycaemia (2013), swimmer's ear (2014), alcohol use (3-5 times/week), prediabetes, allergy to topical povidone iodine, myalgia, myositis, and obesity. Relevant concomitant medications included gabapentin, salsalate, amoxicillin-clavulanate, losartan/hydrochlorothiazide, nortriptyline, pravastatin, fluticasone and CIPRODEX. On 18th August 2014, the patient received the first dose of blinded study vaccine (ENGERIX B adult). On 15th September 2014, the patient received the second dose of blinded study vaccine (ENGERIX B adult). The study site reported that on an unspecified date in September 2014, the patient experienced episodes of loss of awareness associated with some confusional behavior which last around a minute or so and then completely resolved. On 16th September 2014, the patient went to her PCP for her annual exam and for the management of her fibromyalgia and hypertension. During the evaluation the patient complained of widespread pain present for more than 3 months, chronic fatigue, change in her activities including household functions, social interaction, and in work/school activities. The patient also complained of compliance problems with diet and exercise, nausea, joint pain, muscle weakness and depression. She was concerned about a mole on her left arm, hemorrhoids, and a rash underneath her breasts. She also had concerns about her memory. She stated that people would tell her things that she would forget half an hour later. She also stated that she would forget where she put things such as her glasses, and car keys. She stated that she could not sleep, as her mind was racing. Vital signs on presentation were as follows: pulse rate 78 beats per minute, and blood pressure 124/70 mmHg. Physical examination was unremarkable except for a small nevus on the left arm measuring less than 0.5 cm. Laboratory test results were as follows: sodium 142 mmol/L, potassium 4.3 mmol/L, glucose 97 mg/dL, blood urea nitrogen (BUN) 13 mg/dL, creatinine 0.64 mg/dL and vitamin D3 20 ng/mL (low). The patient was primarily diagnosed with myalgia and myositis, obesity, unspecified, other and unspecified hyperlipidemia, unspecified essential hypertension, and vitamin D deficiency. The patient was referred to dermatology only for lesion removal. On 14th November 2014, 61 days after the second dose of study vaccine, the patient presented to the emergency room (ER) with complaints of blackout spells, associated with amnesia but without syncopal episodes, she also complained of intermittent chest pain. She had some reproducible chest pain which she related to her fibromyalgia and osteoarthritis of her spine. Her constellation of symptoms was deemed not consistent with acute coronary syndrome. An electrocardiogram revealed sinus rhythm with moderate ST depression. A chest x-ray showed no acute cardiopulmonary abnormality. The admitting physician was concerned that the patient could be experiencing subclinical seizures and neurology was consulted. On 5th November 2014, the patient was evaluated by a neurologist. During the evaluation, the patient complained of several episodes of loss of awareness associated with some confusional behavior which lasted around a minute or so and before resolving completely. The patient was amnestic for these events except for the end when she had a weird feeling. Nuclear magnetic resonance imaging (MRI) of the brain without contrast showed no intracranial abnormality and minimal non-specific white matter change, MRI with contrast was reported to show no significant changes and no abnormal contrast enhancement. Carotid ultrasound showed normal right and left internal carotid arteries. Neurology concurred with the concern for a complex partial seizure and KEPPRA 500 mg bid was initiated. The patient was discharged home and the event was considered recovered/resolved. The patient was afebrile, clinically and hemodynamically stable. No acute cardiac events were seen on telemetry. Her blood pressure at the time of discharge was 144/91 mmHg. Discharge diagnoses were suspect complex partial seizures, chronic intermittent chest pains, hypertension, and fibromyalgia. The patient was discharged on the following medications: KEPPRA, TYLENOL, ferrous sulfate, gabapentin, losartan hydrochlorothiazide, nortriptyline, pravastatin, and salsalate. She was scheduled to follow-up with her PCP in 2 weeks. On 19th November 2014, an electroencephalogram (EEG), performed while the patient was awake and at sleep, and was reported to be normal.