Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood folate normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Body temperature increased, Borrelia test negative
Clinical narrative: Vertigo/ severe refractory vertigo; epidemic vertigo; Vomiting; Headache; nausea; Legs locked up and she was temporarly unable to walk; gait instability; Fatigue; paralysis; balance issues; serious neurological problems; post herpetic neuralgia; sores in mouth; rash; temperature of 103; This spontaneous report was received from a 62-year-old female, referring to herself. The patient's pertinent medical history was not reported. Her previous drug reactions or allergies included codeine. Concomitant therapy included atorvastatin calcium (LIPITOR) and candesartan cilexetil (ATACAND) and few other medications. On 20-AUG-2007, the patient was vaccinated with a single dose of zoster Vaccine Live (ZOSTAVAX) (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On 22-AUG-2007, the patient experienced headaches, vertigo, dizziness, nausea and vomiting. In addition her legs locked up on her and she was temporarily unable to walk. When this occurred she had to be hospitalized for one week. While in the hospital many tests were performed (results not reported). Her legs returned to normal but the other adverse symptoms lasted through December 2007, before going away. Subsequently, the patient recovered from headache, vertigo, dizziness, nausea and vomiting. The causality assessment between zoster Vaccine Live (ZOSTAVAX) and the aforementioned events were not reported.    Follow-up (F/U) information was received from the consumer on 05-SEP-2008. On 16-AUG-2007 (previous reported 20-AUG-2007), the patient was vaccinated with a single dose of zoster Vaccine Live (ZOSTAVAX). On 24-AUG-2007, the patient's husband called an ambulance to take her to the emergency room and the patient was admitted to the hospital. The patient told them, she was given the zoster vaccine live (Oka/Merck) vaccination and the patient thought that was what was wrong as that was the only thing different that the patient had experienced and that the patient had been ill since being given the vaccination. The physicians ruled out everything else that would cause her to have these same symptoms. Finally it was concluded that the vaccination was the cause of her symptoms as the patient had not had anything like this before and the patient had not had anything like this since. The patient had go for therapy to learn to walk again properly. The patient took zoster Vaccine Live (ZOSTAVAX) because a lady in her school class had shingles and the virus went to her brain and paralyzed her. The patient recovered.  This is one of two reports received from the same reporter.   F/U had been received on 24-OCT-2008. Concerning a 61-year-old retired female with anxiety disorder, asthma, depression, hyperlipidemia, hypertension, overweight, non-smoker, abstains from alcohol, statin intolerance, hypercholesterolemia and a history of vertigo and migraines in the distant past, abnormal hepatic function, and a family history of heart disease. Additional concomitant therapy included meclizine, montelukast sodium (SINGULAIR), lansoprazole (PREVACID), escitalopram oxalate (LEXAPRO), lorazepam, and albuterol (manufacturer unknown). It was reported that on 24-AUG-2007, the patient was admitted through the emergency room for a work-up and evaluation of severe, refractory vertigo. The patient had been having trouble for about two days prior to admission with lightheadedness, headache, room spinning, and progressive difficulty with ambulation. It was reported that the patient had several near falls. On admission, the patient was unable to walk without  lots of help from her family and she was complaining of severe room spinning and dizziness. She had a CT of the head in the emergency room, which showed no acute abnormalities; however, she was clearly struggling, and she was admitted for a further inpatient work-up and management of her problems. The patient was put on meclizine hydrochloride (ANTIVERT) and intravenous methylprednisolone sodium succinate (SOLU-MEDROL). The physician felt like she had peripheral vestibulopathy. On 26-AUG-2007, an MRI with MRA was performed and the results were normal except for hypoplastic vertebral arteries and proximal basilar artery, which were deemed unlikely to be clinically significant. It was reported that metabolic studies including thyroid studies, cortisol levels, B12, folage, ANA, Lyme titer, HIV, and perioneoplastic studies were performed, all of which were negative. The patient had a slow but favorable response to the events. She was able to walk with less help, and her dizziness was  improved overall. She still had some weakness, but felt better overall. The patient was discharged from the hospital on 28-AUG-2007 with follow-up to be scheduled on an outpatient basis. The physician reported that on 13-SEP-2007, the patient came to the office for a follow up visit. She had a sensation of movement, but otherwise felt diffusely weak since the day before coming to the emergency room and getting prednisone. She was reported to be gradually tapering off the prednisone and was continuing the meclizine hydrochloride (ANTIVERT). On 13-SEP-2007, Lyme titer and HSV titers were performed, the results were all negative. The patient was started on lamotrigine (LAMICTAL) for dizziness, and referred to a physical therapist for vestibular rehab. The physician reported that on 25-SEP-2007, the patient came to the office for a follow up visit. She continued to have difficulties with vertigo as well as associated headache and nausea. The physician referred her to the vestibular  clinic, but had not gone because she reported that "her equilibrium and depth perception were off." The physician recommended that she try the vestibular clinic and a transderm scopolamine patch. The patient reported that she had taken ibuprofen (MOTRIN) for her headache, but it had not helped much. On 25-SEP-20007, the patient called to reported that she had started lamotrigine (LAMICTAL), and was having vertigo, dizziness, sores in mouth and a temperature of 103. The physician recommended that she stop taking lamotrigine (LAMICTAL)and also see her primary care physician, but did not think that the temperature was related to the lamotrigine (LAMICTAL). On 26-SEP-2007, the patient left a message saying that she stopped the lamotrigine (LAMICTAL) but had developed a rash. The physician reported that on 04-OCT-2007, the patient came to the office again for a follow up visit and had dizziness that appeared to be peripheral vestibulopathy. Lab studies were all negative. The patient was  referred to an ENT. The physician reported that on 20-NOV-2007, the patient came to the office again for a follow up visit and reported that she been doing better since her vestibular therapy. She had an ENT consult and the physician did not feel that she had Meniere's disease. The physician reported that on 29-NOV-2007, the patient came to the office again for a follow up visit. Her dizziness had improved, and she had gone to the vestibular clinic, which had helped. She had been doing head positioning exercises at home which have helped. The physician reported that on 30-JUL-2008, the patient came to the office for a follow up visit and reported that her dizziness had gotten better and she had no further symptoms.  It was reported that the patient has a family history of heart attack, her sister died at a relatively young age.  F/U information was received from a lawyer regarding a case in litigation on 26-OCT-2020. On or about 2007, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as subsequent to the vaccination, the patient was treated for postherpetic neuralgia, serious neurological problems, balance issues, paralysis, severe refractory vertigo and headaches. The reporter considered postherpetic neuralgia, nervous system disorder, balance disorder, paralysis, vertigo and headache to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, diplegia and paralysis were determined to be medically significant events.  records will be provided upon request; Sender's Comments:  US-009507513-0809USA01819: