Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Impaired work ability, Injection site erythema, Injection site pain, Tinnitus
Clinical narrative: This spontaneous report as received from a 63 year old female patient who is a cancer survivor of ten years (no chemotherapy needed). The patient's concurrent conditions were not reported. On 30-DEC-2014, the patient was vaccinated with a dose of ZOSTAVAX 19400 (Plaque forming units) injection in her right arm, (Lot#, expiration date, dose, route of administration were not provided). Unspecified thyroid medication was taken as concomitant therapy since the "late seventies". On an unknown date, "shortly" after vaccination with ZOSTAVAX, the patient experienced erythema reported as "monstrous" redness from her right shoulder where it met the torso to her elbow, the patient had the redness for a long, long time, it never blistered and she felt like "a burn on the back of her arm", she needed to wear satiny or silky clothes over the redness on her right arm. Additionally, the injection site was also "very painful". In approximately January 2015 reported as "within two weeks", the patient experienced a "hearing disorder" described as "bilateral hearing loss" and also "tinnitus, in the same arm where the injection was received" she said it felt like "a ceiling fan gone amok", it got louder when she talked, the patient stated that the tinnitus was "so loud that she could not hear or concentrate". She also had "blurred vision" at unspecified time. Moreover, she experienced "heavy fatigue" she had to force herself to shower and cook, it was "insane", she did not even want to get together with her family. The patient explained that the fatigue was not nearly as debilitating as the other symptoms she experienced. She also reported that using the right arm "made the symptoms worse". Additionally, she "weighed down", on an unspecified date. The patient went back to her physician at an unknown date after experiencing the listed adverse reactions. Therefore, she was referred to numerous specialists by her physician including three different ear, nose and throat specialists, an ophthalmologist and a neurologist. None of the physicians could determine why she had these symptoms. The various unspecified physicians recommended a series of tests including Computed Tomography (CT) scan of the neck, wearing a heart monitor, Magnetic Resonance imaging (MRI) of the brain, Magnetic resonance angiogram (MRA) of the carotid artery, unspecified allergy tests, a thyroid biopsy and unspecified hearing tests reported as "every hearing test known to man". She explained that there was no difference in her regimen when these symptoms began, except the ZOSTAVAX  vaccine. The redness of the patient's arm did not go away "for a long time, months and months", it got smaller over time, but took months to completely go away. The patient stated that she could not work after she was vaccinated with ZOSTAVAX. In March 2016, the patient "began to come out of whatever was affecting her". By May 2016, she "was a lot improved". She explained that "she was getting   [Due to memory limitations, the remainder of this text could not be compared.]  better as suddenly as she got ill", but it took "one and one half years". Again, she stated that nothing had changed in her regimen. The patient reported that she was still not 100%, but was a lot better. At the reporting time, she still experienced "buzzing and hissing in her ears 24 hours a day". She still had fatigue, but it was "not as debilitating as it was". She stated that her "cancer treatment did not stop her like this". She also still has "blurred vision and tinnitus". Additionally, the patient reported that she had "thousand of dollars in medical costs". No product quality issue was involved. The outcome of deafness bilateral, injection site pain, disturbance in attention, weight decreased, burning sensation, erythema and fatigue was recovering. The outcome of vision blurred and tinnitus was not recovered. The relationship between ZOSTAVAX and the events was unknown. Upon internal review bilateral hearing loss was considered as medically significant. Additional information has been requested.