Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Local reaction, Malaise, Mobility decreased
Clinical narrative: Information has been received from a registered nurse concerning an 83 year old female with lactose intolerance and allergic to penicillin (unspecified) and sulfa who on 24-APR-2012 was vaccinated on her left arm with ZOSTAVAX (Merck). Concomitant therapy included PLAQUENIL. The nurse reported that the patient called the office and presented to the office today with injection site pain, swelling, joint & muscle pain, fever unspecified temperature, hives, and a rash on her left leg. AE onset date was unspecified. No treatment was given for AE. At the time of reporting, the patient was not recovered. The patient sought medical attention by visiting the office. Follow-up information has been received from medical records concerning an 83 year old female ex-smoker (ceased more than 10 years ago), alcohol use (1 drink per day), lactose intolerant (digestive aids), allergic to latex (eye swelling), gluten, local anesthetics with preservative (Ester - Lidocaine), (Amide - Procaine) (cardiac arrest), penicillins (rash), and sulfa drugs (rash), with stomach ulcers, gastroesophageal reflux disease, thyroid disease, asthma, osteoporosis, anemia, mixed hyperlipidemia, essential hypertension, colitis, arthritis, chronic back problems, and a history of heart attack. Surgical history includes hemorrhoidectomy (1972), D&C (1987), bunionectomy (1991), gallbladder resection (1997), colonoscopy (2004), cataract removal (2007), arthroscopic knee surgery (2008), cardiac catheterization (2009), pacemaker placement (2009), and knee surgery (2009). On 24-APR-2012, the patient was vaccinated with a first dose of ZOSTAVAX (Merck) (Lot #672557/1601AA) subcutaneously. Secondary suspect therapy included PLAQUENIL. Concomitant medications included EPIPEN, NITROLINGUAL, potassium chloride, CRESTOR, NEURONTIN, SYNTHROID, vitamins (unspecified), ascorbic acid, FLOVENT, ALLEGRA, ESTRACE, DIOVAN HCT, PROAIR HFA, pantoprazole sodium, nitroglycerin, COQ10, metoprolol succinate, METAMUCIL, aspirin, OPTIVAR OPHTHALMIC SOLUTION, ASTELIN, and omega-3. On 30-APR-2012, the patient called a nurse to discuss a reaction she was having to the shingles shot. She described local site reaction with redness, warmth, and swelling to her left upper outer arm. That evening, the patient developed a fever of 103. Subsequently, on 01-MAY-2012, the patient reported she was doing great until the middle of the night when she experienced aching in her legs, arms, and every joint in her body. She had pain in her left foot that started at the hip area and radiated downward. Her feet were numb and she couldn't lift her arms. The patient said she needed something and  was scheduled for a nurse visit. On 02-MAY-2012, the patient presented to the office after she awoke with red blotches to her face, neck, left chest over her pacemaker site, and a light rash to her left lower leg. At this point, the physician came in to observe the patient and noted that she had symptoms suspicious for a reaction to the shingles vaccine with malaise, fatigue, and somnolence that began on 29-APR-2012. Shortly thereafter, the patient noticed a local reaction consisting of a lemon-sized patch of skin on the left arm that was erythematous and tender. Over the next few days, she experienced myalgias, arthralgias, and pain in the left sciatic distribution. She also noticed hives and a more diffuse erythematous rash on the lateral aspect of her left leg. The physician noted that the patient's only recent medication change had been PLAQUENIL that was added approximately 3 weeks previously to treat a mixed connective tissue disorder. Assessment included local and systemic reaction to ZOSTAVAX (Merck). The physician thought the patient should be treated symptomatically and observed. He treated her significant left leg pain with hydrocodone + ibuprofen and recommended rest, plenty of fluids, and an antipyretic as needed. Consideration was given to an antiviral such as ZOVIRAX and also a corticosteroid, however the physician was not sure of their value in this setting and was awaiting further information. On 03-MAY-2012, the patient reported that she had slept very well the previous night due to the pain medications, that her rash and shooting pains had subsided, but that her knee, shoulder, and hand pains remained. The patient had stopped her hydroxychloroquineSO4 the previous night. She did not take her gabapentin because she was unsure about taking it concomitantly with her pain medication. Later in the morning on 03-MAY-2012, the physician contacted the patient and informed her that she may take gabapentin concomitantly with her pain medication. Although the physician felt more than likely the patient's symptoms were from a reaction to the shingles vaccine, he agreed with holding her hydroxychloroquineSO4 for the time being to eliminate it as a variable. On 03-MAY-2012 in the evening, the nurse contacted the patient and learned that she was doing better overall, that her pain was starting to ease and she was sleeping a lot due to the pain medication. On 21-MAY-2012, the patient stated she had started back on hydroxychloroquineSO4 after being examined by her physician. Assessment included contact dermatitis and other eczema and enthesopathy of hip region. The physician reported that the patient's experience required an emergency room/doctor visit and medical/surgical intervention to prevent a serious outcome. Additional information has been requested.