Age: 64.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Myalgia, Neuralgia, Neurological examination normal, Pain
Clinical narrative: Information has been received from a 64 year old female with asthma and a drug reaction/allergy to morphine who in November 2007, was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included influenza virus vaccine (unspecified), fluticesone propionate (+) salmeterol xinafoate (ADVAIR), albuterol sulfate (+) ipratropium bromide (DUONEB) and prednisone. In November 2007, at the same visit, the patient was vaccinated with zoster vaccine live (Oka/Merck) and influenza virus vaccine (unspecified). Ten days after the vaccinations, she had horrific rolling cramps all over her body (particularly in the legs, arm, back and ripples near the rib cage) for at least six weeks. Subsequently she consumed large amounts of water and Gatorade in hopes of having these help the cramps and pain. The patient indicated the patient was sharp, deep in the muscles or of or near the bones, random in area and time, short in duration (like 3 minutes), and very painful. She also had pain the eye. She was seen by an orthopedic who said the pain was related to the nerves and muscles. Subsequently the patient saw a neurologist who put her on gabapentin (NEURONTIN) (dose and duration not reported). The gabapentin (NEURONTIN) relieved the pain and cramps. However, she experienced delusions of stationary objects moving or swaying. The patient went off gabapentin (NEURONTIN) for five days and the delusions went away. The pain came back. It was reported a CAT scan was performed (results not provided). At the time of the report, the patient was reported as not recovered, but indicated the pain was less severe. Additional information has been requested.  09/24/2008 This is in follow-up to report(s) previously submitted on 6/24/2008. Information has been received from a 64 year old female with asthma, drug reaction/allergy to morphine and irritable bowel colitis type loose stools who on 26-OCT-2007 (previously reported as in November 2007), was vaccinated with ZOSTAVAX (Oka/Merck) (lot number 658209/1085U). Concomitant therapy included influenza virus vaccine (unspecified), ADVAIR, DUONEB, prednisone and ipratropium bromide. On 26-OCT-2007 (previously reported as in November 2007), at the same visit, the patient was vaccinated with ZOSTAVAX (Oka/Merck) and influenza virus vaccine (unspecified). Ten days after the vaccinations, she had horrific rolling cramps all over her body (particularly in the legs, arm, back and ripples near the rib cage) for at least six weeks. Subsequently she consumed large amounts of water and Gatorade in hopes of having these help the cramps and pain. The patient indicated the pain was sharp, deep in the muscles or near the bones, random in area and time, short in duration (like 3 minutes), and very painful. She also had pain in her eye. She was seen by an orthopedic who said the pain was related to the nerves and muscles. Subsequently the patient saw a neurologist who put her on NEURONTIN (dose and duration not reported). The NEURONTIN relieved the pain and cramps. However, she experienced delusions of stationary objects moving or swaying. The patient went off the NEURONTIN for five days and the delusions went away. The pain came back. It was reported a CAT scan was performed (results not provided). At the time of the report, the patient was reported as not recovered, but indicated the pain was less severe. Follow-up information was received on 21-JUL-2008 in the form of medical records from the responsible physician. It was reported that on 26-OCT-2007 the patient had an office visit with her primary physician to follow-up on her asthma. It was noted that her chemistries "were satisfactory and her lipids were to goal". She was reassured about her asthma and was given a prescription for ipratropium via a nebulizer and was also given a vaccination of ZOSTAVAX (Oka/Merck) 0.65 ml, SC, right arm (lot # 658209/1085U) and flu shot. On 16-NOV-2007 the patient had an office visit for the complaints of shooting pains not in her joints, but seemingly in her bones. She in fact saw another physician the week before, who felt this was not an orthopedic issue, but possibly some sort of the neuropathy. The patient started with this on approximately 12-OCT-2007 "about five weeks ago" and it was in her right shin initially. But as of 16-NOV-2007 she was having in the number of different locations in her arm and legs and a couple of shooting pains in her head happening as often as four times a day then. Unfortunately, the pain only lasted 30 to 60 seconds, but was very intense. The patient had never had this before. She had had no medication change and was otherwise well. She apparently had done a little reading on this and was wondering about the possibility of multiple myeloma. The neurologic exam was grossly intact and there was no evidence of any synovitis or skin changes. Assessment indicated a very atypical presentation of multiple myeloma with her previously normal protein and calcium. The physician stated that it seemed unlikely but was reasonable to check an immunoprotein electrophoresis and a complete blood count and sedimentation rate (results not provided). In addition the patient was to see the neurologists. On 11-JAN-2008 the patient had an office visit with her primary physician due to "a pretty severe lancinating pain in the patient's "long bones" which persisted and was limiting in her work. She also got some muscle cramps. She had apparently felt very dissatisifed with her neurologic consultation that was given. She had been going to a chiropractor who was equally frustrated, feeling that there had to be some metabolic issue. The patient had tried the ULTRAM and TYLENOL without much relief. She sometimes woke up in the night with the pain. She did have a long history of irritable bowel colitis type loose stools and wondered about electrolyte imbalance. The physician noted that some labs had been done previously and there was really no change in the exam, but clearly the patient was in a lot of discomfort with this and looked pretty frazzled. The workup thus far unfortunately did not give the physician any clue, possibility of electrolyte disturbances certainly wanted to consider, but the physician do not think likely. The patient did have a family history of rheumatoid arthritis. This was certainly again not the clinical picture of that either, but the physician was really not certain on what to pin this, and would like to get yet another opinion especially given the limited information gleaned from neurology. The patient was to see a rheumatologist and the patient's electrolytes would be checked (no results provided). On 28-JAN-2008 the patient had another follow-up visit with her primary physician who noted that the symptoms had not gone. "All those seemed to be bothersome. The patient now felt more hypersensitive to touch in the number of places and continued to have generalized pain as well as dull headache. The physician again reviewed her history with the onset initially of the shooting bone pain and a dull headache. At that time, that became generalized. All over her pain that was quite severe associated with a muscular spasm in her face and at the time of follow-up some subsiding to the more rolling muscle spasms and hyperesthesia" that she described that day. The physician explained again that the whole picture had been atypical. The neurologist did not feel there was any apparent neurologic disease and ruled out Lyme disease and her labs had been unrevealing. "She did however due to the history that recognized on October 26. She received her ZOSTAVAX (Oka/Merck) and her symptoms started about 11:10." Her neuro exam remained intact. The physician's assessment was as follows: He was "still have lost account for this and unfortunately have not heard back from the rheumatologists consultation point may not, but it does seem not inconceivable, but this could be an unusual adverse effect from the ZOSTAVAX (Oka/Merck)". She was to be tried on NEURONTIN to see if it would afford her some type of relief. She was started on 100 mg a day for three days, 300 mg twice a day and then work up to 300 mg three times a day. She was to also proceed with a rheumatology appointment as soon as possible. On 03-MAR-2008, the patient had a follow-up visit with her primary physician and reported feeling 100% better 3 days after starting gabapentin. There were no side effects after first few days. BP 136/74, Pulse 64, Temp 97.2 degrees F, Wt 158 lbs. No results in previous 1 Week(s) from current visit. Latest known result is: Lyme Disease Antibody Screen (INDEX) 21-JAN-2008 Value <0.91 Status: Final. The rest of the physician exam was without any abnormalities. The plan was to discontinue gabapentin over the next three weeks. At the time of the report, the patient was not recovered from the reported adverse events. Additional information is not expected.