Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Electroencephalogram normal, Fatigue, Gait disturbance, Generalised tonic-clonic seizure, Hypothyroidism
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of grand mal seizure in a 59-year-old female patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis. Co-suspect products included fampridine (Ampyra) tablet for multiple sclerosis and alemtuzumab (Lemtrada) for drug use for unknown indication. Concurrent medical conditions included multiple sclerosis and gait disturbance. Concomitant products included fish oil, fluoxetine hydrochloride (Prozac) and mirabegron (Myrbetriq). On 30th April 2018, the patient received the 1st dose of Hz/su + AS01B. On 8th January 2016, the patient started Ampyra (oral) 10 mg at an unknown frequency. In February 2017, the patient started Lemtrada at an unknown dose and frequency. On 7th May 2018, 7 days after receiving Hz/su + AS01B, the patient experienced grand mal seizure (serious criteria hospitalization, GSK medically significant and other: As per reporter), incontinence (serious criteria hospitalization), postictal state (serious criteria hospitalization and other: As per reporter) and unresponsive to stimuli (serious criteria GSK medically significant). On an unknown date, the patient experienced hypothyroidism (serious criteria other: As per reporter), tiredness, sleepiness and walking difficulty. The action taken with Ampyra was unknown (Dechallenge was unknown). Rechallenge with Ampyra was unknown. The action taken with Lemtrada was unknown (Dechallenge was unknown). Rechallenge with Lemtrada was unknown. On an unknown date, the outcome of the grand mal seizure, incontinence, tiredness and sleepiness were recovered/resolved and the outcome of the postictal state, unresponsive to stimuli, hypothyroidism and walking difficulty were unknown. It was unknown if the reporter considered the grand mal seizure, incontinence, postictal state, unresponsive to stimuli, hypothyroidism, tiredness, sleepiness and walking difficulty to be related to Hz/su + AS01B. Additional details were provided as follows: The information was received from the patient's spouse (who was also a physician). From 8th January 2016 to 7th May 2018, Ampyra was started at 10 mg, orally every 12 hours for multiple Sclerosis. The patient received dose of SHINGRIX in the afternoon. The patient had a witnessed generalized grand mal seizure in the evening. The seizure involved all upper extremities and some lower extremities. During the seizure, the patient was incontinent. After the seizure, the patient was unresponsive for approximately 30 minutes and then postical. The patient's spouse took her to the emergency room where the patient was admitted overnight for observation. No abnormal findings on Electroencephalogram (EEG) or magnetic resonance imaging (MRl). MRI had not changed from MRI taken a couple of years before the present one (exact date unknown). The patient's spouse reported that it took about 36 hours for the patient to return to her baseline state. The patient took her last dose of Ampyra on 7th May 2018. Since stopping the Ampyra, the patient's walking had deteriorated. The patient's spouse also reported that the patient participated in the Lemtrada post-approval follow up studies in February 2017. The Lemtrada obliterated her thyroid and that was only discovered when the patient started complaining of tiredness and being sleepy all the time. The patient was started on Synthroid 0.1 mcg in the morning and the tiredness and sleepiness resolved. The patient's spouse also reported a years ago (date unknown), the patient took one dose of Celebrex and it caused her kidney function to get worse. The patient's kidney function returned to normal after a few days and had been normal since. At the time of this report, the patient was not taking Ampyra. The patient's spouse was not able to provide the lot number and expiration date for their Ampyra bottle.  No other information was currently available regarding this event. The patient's spouse declined to provide any contact information for himself and preferred that the patient's neurologists be contacted for follow up on the reported events. This case has been linked with the case US2018GSK192128, reported by the same reporter for same patient. Lab Comments: No abnormal findings on Electroencephalogram (EEG) or magnetic resonance imaging (MRl). MRI had not changed from MRI taken a couple of years ago (exact date unknown).