Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chest X-ray normal, Computerised tomogram, Electrocardiogram normal, Eye pain, Headache
Clinical narrative: This spontaneous report was received from a 63 year old female patient concerning herself. Allergy to penicillin (details unspecified). Pertinent medical history was none. On 01-NOV-2013, the patient was vaccinated with ZOSTAVAX (reported as directed dosage) (lot# and strength unknown) subcutaneous prevention of shingles. Concomitant therapies included cetirizine hydrochloride (ZYRTEC) and AFLURIA (also reported as unspecified flu vaccine) received on 15-OCT-2013. On 14-NOV-2013, about 2 weeks after having the vaccine, the patient developed a lot of floaters in her eyes (hospitalization).  Approximately on an unknown date in November 2013, within less than 1 month the patient developed papilledema with inflammation (hospitalization). She was then tested for tumors and last week on approximately 05-FEB-2014, star showed "exidant" was present on her retina (hospitalization).  These reactions have caused vision problems in both of her eyes (hospitalization). She had been treated with Prednisone and Acyclovir (details unspecified), and in hospital for these conditions and has been hospitalized from 20-DEC-2013 to 21-DEC-2013. On an unknown date, patient had MRI (Nuclear magnetic resonance imaging), CAT (Computerized tomogram) scan and other unspecified tests and results unspecified. She sought medical attention and visited physicians office. Product quality complaint was not reported. The patient had not recovered from the all the events. The causality of the events with suspect product was unknown. Information has been received from medical records concerning 63 year old female non smoker and social alcohol drinker with seasonal allergies and allergies to penicillin and meperidine. Concomitant medications included cetirizine hydrocloride (ZYRTEC), aspirin 81 mg, multivitamins and a fish oil suppliment. On 01-NOV-2013, the patient received a dose of ZOSTAVAX in her left arm (lot # J007208). On 15-NOV-2013 the patient experienced bilateral papillary edema. On 19-DEC-2013 the patient was sent by her physician's office to the emergency room to be evaluated. The patient was complaining of vision problems. She had optic nerve inflammation that started two days prior. The patient had awakened with increased eye and head pain. She was diagnosed with bilateral papillary edema with blurred vision. Vital signs showed that the patient was hypertensive. Tests performed included a chest x-ray with normal results, a normal EKG and and MRI which was a normal study. Laboratory studies were performed. Abnormal values were: mean corpuscular hemoglobin: 35.4%, neutrophils: 87.7%, lymphcytes: 8.30%, monocytes: 2.30%, neutrophil count: 7.8 k/cm, Lymphocyte count: 0.74 k/cm, total albumin: 1.4 mg/dl, alanine aminotransferase: 45 IU/L, rapid creatinine kinase MB: <1.0 ng/ml, Total protein: 8.3 g/dl, albumin 5.0 g/dl, prothrombin time international: 1.0.  The patient was started on prednisone. Her headache had improved. A lumbar puncture was not performed at that time as there were no symptoms of SAH or meningitis. The patient was discharged to home. Diagnoses included, iritis, optic neuritis and visual disturbance on the right. On 20-DEC-2013 pt was admitted to the hospital after being seen in the neurology clinic for papilledema and vision loss. She was admitted for treatment with IV steroids. She received a total of 1500 mg of methylprednisolone sodium succinate (SOLUMEDROL) without improvement of her vision. An MRI was performed with and without contrast which showed no abnormalities in the orbits or optic nerve. A lumbar puncture was performed and the result were a normal glucose, protein and cell count. The spinal fluid was also sent for neuromyelitis optical antibody and oligoclonal banding (no results reported). On 21-DEC-2013 the patient was discharged to home. She was to resume a tapering dose of prednisone. She was to return to clinic in two weeks. On 05-FEB-2014 ophthalmology visit to follow-up on papilledema in both eyes, pterygium left eye, family history of glaucoma and posterior vitreous detachment right eye. The patient was reported to be light sensitive in both eyes with blurred vision. The patient reported no changes since her last visit. She was continuing on her prednisone 20 mg tablets twice per day. A dilation of the eye to visualize the macula showed a star shaped pattern of exudates in the right eye. The plan included a CT of the brain ASAP and to rule out giant cell. The patient needed an neurological evaluation, a MRI and and a trial of steroids. There was no cause identified for the papilledema/ iritis. She was to see neurologist in two days. There was a question of viral neuroretinitis and acyclovir 800 mg was prescribed. 10-MAR-2014 pt follow-up with ophthalmologist. The patient reported "maybe a little bit" improved since her last visit. The patient needed a brain CT, MRI and to rule out giant cell and a neurological evaluation. The cause for papilledema or iritis has not been identified. Pt to see neurologist in two days. There was still a question of neuroretinitis and acyclovir was prescribed. It was reported that the patient has not recovered and the event of bilateral papilledema has resulted in persistent or significant disability/incapacity. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 03-DEC-2019 froma lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-NOV-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles or zoster related injuries as intended, and the patient subsequently developed zoster related vision loss and other complications. On or about 17-DEC-2013, the patient was treated for vision loss. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown and causality Bilateral papilledema was considered disabing by the physician. Upon internal review, it was determined that vision loss was considered medically significant. Additional information has been requested. All available medical records will be provided upon request.