Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Alanine aminotransferase increased, Ankle fracture, Antibody test normal, Antinuclear antibody negative
Clinical narrative: Report received regarding a case in litigation, as reported by a psychiatric registered nurse concerning herself on 26-Apr-2010. The 65 year-old female reported receiving AFLURIA (lot # 03149111A) at a hospital on 24-OCT-2008. She has a medical history of TYLENOL allergy. The patient reported that she has had itching for past "2 years" post-AFLURIA immunization and was taking prednisone 10-20 mg daily since Oct-2008 for ongoing pruritus and urticaria discomfort. She reported that every effort was attempted by numerous physicians, including herself, to find another solution to "address this uncomfortable sensation which centers mainly between the two shoulder blades, but can occur frequently on the right foot and left extremity". The patient is aware of the side effects of long term steroid use. In Sep-2009, during the first week of graduate school, the patient suffered a fractured ankle from a fall "while standing perfectly still". Before this fracture, a bone scan indicated decreasing bone mineral density and an increase on the probability for fracture. The patient reports tremendous pain while ambulating. She was also working at that time with limited ambulation and consistent swelling. Post-leg injury, her left hand, "without explanation", became sore and "practically immobile". Her hand was not fractured, but she had to wear a hand brace "constantly" the following weeks. This injury also impaired her ability to work. She was uncomfortable wearing both an ankle brace and hand brace while working. At the end of the year (2009), she suffered an eye hemorrhage, "so severe" that she lost vision in her right eye for one week due to the accumulation of blood. She was treated at urgent care. She stated her eye was so badly bruised, it appeared like she had been "assaulted". She now has a cataract on her right eye "addressing the loss of vision in the right eye with new corrective lenses". During the latter part of 2009 and into Feb-2010, she struggles with increases in blood pressure and blood sugar. She now has Type II diabetes. During the first week of Feb-2010, "without warning", two boils (the size of two golf balls) appeared on the left side of her labia. She was unable to seek medical attention until 08-Feb-2010. Treatment included unspecified antibiotic therapy while culture was pending. The prescribed antibiotic did not address the full blown MRSA (methicillin-resistant staphylococcus aureus) that was not only painful but actively spreading to "every available pocket in her left buttock cheek". Walking was difficult and sitting was very painful. The blood loss from the wound was significant with blood leaking from a "now open" and very painful wound. MRSA was identified on 13-Feb-2010. She was treated on the 13-Feb-2010 and 14-Feb-2010. She had to return to urgent care every twelve hours as late as 2300 hours for the fourth infusion of VANCOMYCIN (1 gram per infusion). On the 14-Feb-2010, she was started on BACTRIM 800mg/160 two tablets for fourteen days. She was so nauseated during that time. She was able to take very few solids but was able to manage liquids. She returned to work on 15-Feb-2010, still suffering the pain and discomfort associated with the experienced and treatment of MRSA. On 03-Mar-2010, she was restarted on BACTRIM because the MRSA wound was not completely healed. Weakened by MRSA, she had to request a medical withdrawal from graduate school. On 05-Apr-2010, the nurse had a nail removed "nail was full of fungus" from the great toe of her right foot due to being full of fungus. Her toe remains "significant" and red despite continuation of the BACTRIM. This created issues related to pain and discomfort while working. The reporter was alleging itching/pruritus for the past 2 years post-AFLURIA immunization. Additional information has been requested. The case was reported as serious due to significant disability. The company considers events possible to suspect drug, FLUVAX. Information derived from the AE report does not change the current safety profile of the product. Follow up information received from the reporter on 12-May-2010. Follow up information was received from the reporter (patient) on 16-May-2010. On 24-Oct-2010 at 9:00 am, the 65 year-old female patient received a single dose (pre-filled syringe) of AFLURIA. On 26-Oct-2008 at 8:00 am, the patient developed severe and ongoing itching. She went to the emergency room on 27-Oct-2008 for treatment; she was given prednisone for 5 days and hydroxyzine for 7 days. The following medications were given after 27-Oct-2008: Prednisone: 11-Nov-2008 for 5 days, 21-Nov-2008 for 12 days, 23-Dec-2008 for 21 days, 03-Jan-2009 for 12 days, 25-Feb-2009 for 25 days, 02-Apr-2009 for 30 days, 05-May-2009 for 20 days, 20-Jun-2009 for 20 days, 28-Jul-2009 for 20 days, 27-Aug-2009 for 30 days, 19-Oct-2009 for 30 days, 30-Nov-2009 for 30 days, 06-Jan-2010 for 22 days, 08-Feb-2010 for 7 days, 03-Mar-2010 for 10 days, 05-Apr-2010 for 30 days; Triamcinolone: 23-Dec-2008 for 30 days; Chlorhexadine: 12-Sep-2009 for 30 days, 25-Oct-2009 for 30 days; Alendronate: 24-Nov-2009 for 30 days; Ergocalciferol: 24-Nov-2009 for 28 days, 29-Dec-2009 for 28 days, 15-Mar-2010 for 28 days; Ciprofloxacin: 01-Dec-2009 for 7 days, 08-Feb-2010 for 10 days; Metformin: 29-Dec-2009 for 30 days, 08-Feb-2010 for 30 days; One Touch Ultra Glucose Control: 29-Dec-2009 for 30 days; Sulfamethoxazole-Trimethoprim: 13-Feb-2010 for 14 days, 03-Mar-2010 for 10 days, 05-Apr-2010 for 20 days; Ketoconazole: 25-Feb-2009 for 30 days; Cephalixin: 12-Nov-2009 for 10 days, 29-Dec-2009 for 10 days; Fluocinonide: 29-Dec-2009 for 30 days; Fexofenadine: 06-Jan-2010 for 30 days; Mupirocin 2%: 14-Feb-2010 for 7 days, 05-Apr-2010 for 30 days; Nystatin/Triamcinolone: 01-Apr-2010 for 14 days. There were no other vaccinations within 4 weeks prior to her AFLURIA vaccination. At the time of her AFLURIA vaccination patient had no illness and on no other medications. The patient has an allergy to TYLENOL. She had to take sick leave from Oct-2009 to Dec-2009 (60 hrs) and from Jan-2010 to May-2010 (60 hrs). Per the "Influenza Screening and Administration Record of Visit" dated 24-Oct-2008: Patient has no allergy to eggs or Thimerosal. She has never required medical care because of a reaction to a previous immunization. Patient was not pregnant at time of AFLURIA vaccination. She had never been diagnosed with Guillain-Barre syndrome. She was not ill with anything more than a cold at the time of vaccination. Patient does not have asthma, heart disease, lung disease, kidney disease, diabetes, a blood disorder nor is she immune compromised. She had not had any live viral vaccines (MMR, varicella) within 30 days of 24-Oct-2008. She was not receiving aspirin therapy. Patient provided an eye/vision examination records dated 28-Dec-2009 which diagnosed her with hypermetropia, regular astigmatism, presbyopia, nuclear sclerosis and dry eye syndrome. The patient considered her event (ongoing itching) as serious due to 'required emergency room/doctor visit'. Additional information is expected. Medical records were received regarding the curse on 08-JUL-2010: On 27-Oct-2008, a probable allergic reaction to the flu vaccine was noted by the physician. At the time, the patient had generalized itching, no true rash, few excoriations, no fever or body aches. The patient had continued generalized pruritus. A probable allergic reaction to the flu vaccine was suspected. The patient was prescribed ATARAX 25 mg tablet, 1 -2 tablets PRN 4-6 hours PRN for itching and prednisone 20 tablet, 3 tablets daily for 5 days. Her vital signs were: oral temperature of 97.8 degrees Fahrenheit (36.6 degrees Centigrade). pulse of 103, respirations 20, and blood pressure of 132/87 mmHg. Her pain level was 0 (scale 0-10). ALT (alanine aminotransferase) was 65U/L, AST (aspartate aminotransferase)67U/L and haemoglobin was 15.4g/dl. No further flu vaccines were noted by the physician. The patient was to call the physician if her itching continued after 5 days. On 21-Nov-2008, the patient was seen for unresolved itching. The patient did not take prednisone as directed and had left over. Her current medications were noted to be hydroxyzine. Her itching improved, but had not cleared. Vital signs revealed an oral temperature of 97.7 F (36.5 degrees Centigrade), pulse 107, respirations 22, and blood pressure 128/74. A few tiny papules were noted on her breasts and scratch marks on her lower back. Possible allergic reaction and rash were noted. Prednisone 10 mg tablets, decreasing daily doses every 3 days (40-30-20-10 mg) and CLARITIN or ZYRTEC were prescribed. The patient was noted to be menopausal/ On 23-Dec-2008, the patient was seen (rash in inner thigh, back, chest area and itch) and stated prednisone was the only treatment medication that helped. She denied blood or chemical exposure at work. There was no similar problem in the past. Her current medication was hydroxyzine 25 mg tablet. She was prescribed dose tapering prednisone 10 mg tablet, 60-50-40-30-20-10 mg every 2 days. She was schedule to see a dermatologist. On 07-Jan-2009, the patient was noted to have continued itching, especially in the mid-lower back and breast region. She has been prescribed TMC 0.1% cream. The patient had discontinued vitamins since 25-Oct-2008 and noted some improvement with decreased coffee consumption. She received TMC 80mg intra muscular injection and was prescribed ZYRTEC and CLARITIN. On a 25-Feb-2009 office visit, the patient requested prednisone 20-30 mg daily PRN for flares of itching/rash. The main itching was on her back and arms. There was no visible rash at that time. The best relief was with KENALOG shot 5 weeks previously. The patient had monilial dermatitis under the left breast and seborrheic keratosis which "frozen off". Medication therapy included ketoconazole 2% cream to be applied twice daily to the left breast rash and prednisone two 10 mg tablets taken daily with food. On a 23-Sep-2009 visit, the patient was seen for complaints in her right ankle. The patient reported inversion injury to her ankle after falling one week prior. On examination there was swelling of the ankle and complaints of pain. She was diagnosed with a closed lateral malleolus (new) fracture. The patient has a history of a previous ankle injury. The radiograph indicates a possible old avulsion fracture. There was no evidence of osteoporosis on x-ray. A 9 month history of prednisone use was noted. No significant history for diabetes. The physician felt that prednisone may be the cause of the fracture. She was fitted with a AFO brace and worn for 8 weeks. On 07-OCT-2009, the results of the bone mass density (BMD) results were as follows. The total lumbar spine )L1-L4) BMD was 1.027 g/cm2 (T-score: -1.6, z-score: 1.7). The left femoral neck BMD was 0.677 g/cm2 (T-score: -0.2, Z-score: 0.0) and the total hip BMD was 1.011 g/cm2 (T-score 0.6, Z-score: 1.9). The patient has low bone mass and is at higher risk for fractures. On 24-Oct-2009, DXA scanning revealed low bone mass and high risk fractures. Recommendations included weight bearing exercise 3 times per week, calcium intake of 1500 mg and vitamin D supplementation. On 04-Nov-2009, patient complaining of pain in ankle. There is mild swelling and she is tender at the tip of the right malleolus. Radiology x-ray indicates that the fracture is healing though not healed. A rash has developed on her foot. On 12-Nov-2009, results indicated that the patient had hypokalemia-serum potassium of 3.4 (3.5-5.5 MEQ/L). Her blood pressure was 160/98. Itching is ongoing and usually aggravated by diet. Findings of mammogram indicate that the stromal pattern is predominantly fatty, with scattered strands of fibroglandular tissue bilaterally. There was no dominant masses, clustered microcalcifications, skin changes or nipple retractions. On 24-Nov-2009, the patient was seen for left hand pain and slight edema of the third MCP joint from typing. In November 2009, the patient used the hot tub at an exercise facility. On 24-NOV-2010, the body mass index was noted to be 29.43kg/m2, body surface area 2.19m2. Visit diagnoses: Hand pain, osteopenia, chronic urticaria. Current medications include carbonate-Vit D2 600-400mg twice daily and prednisone 10 mg, 2 tablets daily. Slight oedema of left hand with ecchymotic change about 1.5cm in dorsum of left 3rd MCP. No evidence of fracture or any other gross bone or joint abnormality. Alendronate 70mg weekly was added to chronic prednisone therapy. On 30-NOV-2009, the patient was diagnosed with lower urinary tract infection. She was prescribed ciprofloxacin 500 mg tablet every 12 hours for seven days. Her current medication therapy included: alendronate 70 mg, Vitamin D2 50, 000 unit capsule, calcium, vitamin D3 600-400 mg, prednisone 10 mg tablet, triamcinolone acetonide 0.1% topical cream. In December 2009, the patient was diagnosed with type II diabetes mellitus as a result of prednisone use. On 13-Dec-2009, the patient was diagnosed with right eye conjunctival hemorrhage. ADVIL 1000 mg was taken as treatment. Pain score was 10. On 29-Dec-2009, the patient was diagnosed with bilateral hallux and ingrown nails. The patient states that she gets occasional severe rash on right foot. She notes increased erythema, dry and scaly skin. Treatment included KEFLEX and topical LIDEX 0.05% topical cream for itching. On 30-Dec-2010, random glucose reading was 145. On 06-Jan-2010, the patient was seen for eczema dermatitis. Current active conditions: chronic urticaria, osteopenia, long term steroid use, hypokalemia, hyperglycaemia and controlled diabetes mellitus. On 08-Feb-2010, the patient was seen for a painful lump on the left labia major (bartholin gland abscess) since 04-Feb-2010. On 12-Feb-2010, the left labia abscess and right mons boil were draining. The patient was on Cipro 500mg 1 twice daily. Culture and sensitivity showed MRSA of the bartholin cyst specimen resistant to ciprofloxacin. The patient had a left peritoneal abscess/cellulitis with 10 day spontaneous drainage. On 13-FEB-2010, the patient was scheduled for vancomycin 1 gm IV infusion every 12 hours and BACTRIM DS, two tablets BID for 2 weeks. The patient accepts an intra-muscular dose of tetanus booster. Vancomycin was discontinued after the fourth dose on 14-Feb-2010. On 17-Feb-2010, vulvitis is improving. Prednisone dose continued at 20mg daily. Patient currently prescribed mupirocin 2%, sulfamethoxazole-trimethoprim 800/160mg, vancomycin 1000mg IV solution, ciprofloxacin 500mg, fexofenadine 180mg, fluocinonide cream 0.05%, metformin 500mg, blood glucose test strips, alendronate 70mg, ergocalciferol 50,000 units, calcium carbonate-Vitamin D3 600/400mg and triamcinolone acetonide 0.1% cream. On 23-Feb-2010, the patient was seen for MRSA vulvitis and was better. Complained of nausea. The patient continued prednisone 20 mg daily for body pruritus (possibly tapering dose). BACTRIM therapy was completed 28-Feb-2010. On 01-Apr-2010, the patient was diagnosed with onychomycosis of the right great toenail and irritated rash (erythematous, papular rash consistent of tinea) of the left groin. She was placed on BACTRIM 800/160mg, 1 tablet 12 hourly and nystatin-triamincinolone (100,00-0.1 unit/g % topically) for groin rash twice daily. Her diabetes was controlled with GLUCOPHAGE. She is taking prednisolone 15mg daily. Recent vulval boils (x2) had resolved. On 04-Apr-2010, she underwent removal of the right 1st toe hallux nail plate. On 15-Apr-2010, a physician's office record noted her itching and redness reaction 48 hours after influenza vaccine. Described as 'beet red' Prednisone was prescribed. The rash resolved and the itching continued. The patient occasionally experiences a rash on her face and foot. Attempts were made to taper off prednisone and use antihistamines. The patient reported wanting and needing (prednisone). The patient was taking "10-20" mg of prednisone daily. The itching was located mainly between her shoulder blades. Her foot can also itch where she "literally can tear skin of foot". She tried creams and food elimination. An allergist had suspected bed mite or eczema. The dermatologist rules out eczema. The patient refused testing for bed mites. In Sep or Oct 2009, patient fell and damaged right ankle and developed problems with right hand. In late 2009, the patient had a bad headache around right eye-had eye haemorrhage, healed and now has cataract. The patient's labial boil had resolved. It was noted the patient was "recently" found to be hypertensive and diabetic (blood sugar 153 fasting). Her medications were listed as sulfamethoxazole-trimethoprim 400-80mg tablet BID, mupirocin 2% topical ointment to affected area, prednisone 10 mg tablet, two tablets orally daily, metformin 500 mg tablet daily, vitamin E, fish oil, calcium and CENTRUM multivitamins. The patient's medical history included being menopausal and a non-smoker. Other medical history included blurred vision from TYLENOL allergy, laparoscopic cholecystectomy, occasional seasonal rhinitis and no alcohol use. The patient had not returned to the gym since November 2009. The patient's mother had been diagnosed with breast cancer at 43 years of age. Additional information is expected. On 27-OCT-2008 the reporter (doctor) considered the events probably an allergic reaction to the suspect flu vaccine. The company considers events possible to the suspect drug, AFLURIA. Information derived from this AE report does not change the current safety profile of the product.