Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rheumatoid arthritis, Sacroiliac joint dysfunction, Sciatica, Sinus pain
Clinical narrative: Rheumatoid arthritis involving both wrists; type 2 diabetes mellitus without complication; lower back pain/L4, L5 and left L5 lower back tenderness, some left sacroiliac joint involvement; fell sideways, left lateral mostly hitting her arm and shoulder; fell sideways, left lateral mostly hitting her arm and shoulder; nasal congestion; Osteoarthritis of both knees; shingles (herpes zoster) polyneuropathy/classic post vaccination rash, cutaneous symptoms; sinus pain; pure hypercholesterolemia; postnasal drip; vitamin b12 deficiency; vitamin D deficiency; shingles/shingles on right side involving T4, active red vesicular lesions right on the bra line/fatigue; left hip and leg pain related to a lumbar radicular process/hip pain/left lateral hip tenderness/pain in lateral thigh and lateral calf/lateral thigh tenderness, intermittent aching at lateral calf; THR- total hip replacement; Information has been received from a lawyer regarding a case in litigation which referred to a patient (pt) of unknown gender and age. Information regarding concomitant medications, concurrent conditions or medical history was not provided. On or about 04-APR-2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (exact dose, dose number, route of administration, anatomical site of vaccination, were not provided; lot number and expiration date were not provided). Subsequently, on an unknown date, the pt was treated by a physician due to shingles (herpes zoster), and other zoster related conditions (ill-defined disorder). The outcome of the events was unknown. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.  Follow-up (FU) information was received on 25-FEB-2022 via Medical records, regarding a case in litigation, concerning a nonsmoker 71-year-old female pt. She drank alcohol every day. Current conditions included squamous cell carcinoma skin and restless leg syndrome (conditions reported as part of an unspecified list, no dates provided or additional details). Her past surgical history included appendectomy, arthroscopic knee surgery, breast augmentation surgery, diverticulitis, endometrial ablation, knee replacement bilateral, and tonsillectomy. Historical conditions: trigger finger (acquired). Family history included diverticulitis of colon, heart disease, lung neoplasm malignant, and prostate neoplasm malignant. On an unknown date, pt had an office visit (OV). Her listed conditions included shingles (herpes zoster) polyneuropathy (post herpetic neuralgia (PHN)). Additional notes included: "21-JUL-2017: classic post vaccination rash cutaneous symptoms". Medication list on that visit: "ACCU-CHEK AVIVA PLUS", aspirin, carvedilol, citalopram, clindamycin, folic acid, lorazepam, losartan, methotrexate sodium, amlodipine besilate (NORVASC), pravastatin, sulfasalazine, levothyroxine sodium (SYNTHROID), vitamin B12, vitamin D3. On 27-JUL-2017, the pt had an OV. The reason for visit included recent diagnosis of a right suspect T4 shingles; history of shingles vaccination, just started valacyclovir course yesterday. Approximately one week before the visit, she developed shingles. Physical examination noted: shingles on the right side involving what appears to be fourth thoracic vertebra (T4), there were active red vesicular lesions right on the bra line. Pt had started valacyclovir course the day before the OV (reported as "yesterday"). On an unknown date, the pt had an OV. It was confirmed that she was vaccinated with with zoster vaccine live (ZOSTAVAX) on 04-APR-2014 (lot number J008436, expiration date was not reported but upon internal validation was established as 11-OCT-2014). Other vaccines administered to her included: an unspecified influenza vaccine (30-SEP-2011, 27-OCT-2016), influenza vaccine inact split 3v (FLULAVAL) (06-NOV-2013), influenza vaccine (FLUZONE) (09-OCT-2014), and influenza vaccine inact split 3v (FLUARIX) (08-OCT-2015). The outcome of the events herpes zoster and PHN was unknown. The relationship to the vaccine was not provided. The claimed event ill-defined disorder was deleted, since more specific related events were reported in medical record.  Information received on 25-FEB-2022 contained the following events: rheumatoid arthritis (onset and outcome were unknown, treatment: methotrexate and folate), hip arthroplasty (onset 12-SEP-2016, outcome was unknown); type 2 diabetes mellitus, type IIa hyperlipidemia, fall, limb injury, back pain, sinus pain, nasal congestion, upper-airway cough syndrome (onset, treatment and outcome were unknown); sciatica (onset July 2017, treatment and outcome were unknown); vitamin B12 deficiency, vitamin D deficiency (onset and outcome were unknown, treatment: vitamin B12 and vitamin D3, respectively); and osteoarthritis (onset and outcome were unknown, treatment: status post (s/p) bilateral total knee replacement (TKR) (inconsistent information, historical conditions included bilateral knee replacement)).  Upon internal review, the events rheumatoid arthritis, hip arthroplasty, and type 2 diabetes mellitus were determined to be medically significant.  All available medical records will be provided upon request.