Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site pain, Musculoskeletal discomfort, Ocular hyperaemia, Paraesthesia
Clinical narrative: Information has been received from 2 nurses concerning an approximately 60 year old female who "about a month ago" in June 2007, was vaccinated subcutaneously with Zostavax (Oka/Merck). Subsequently, the patient developed "numbness in her arm and itching." Unspecified medical attention was sought. The patient was told to take BENADRYL for itching, but the patient reported "it is not helping". The patient was scheduled to be seen in the office on 26-JUL-2007. At the time of this report the patient had not recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Initial and follow up information has been received from 2 nurses and a physician concerning a 78 year old female who on 30-MAY-2007 at 11:45 was vaccinated subcutaneously in the left deltoid with a single first dose of ZOSTAVAX (Oka/Merck) (Lot#657676/0619U). On 14-JUN-2007 at 9:45 am the patient was vaccinated IM in the left deltoid with a single first dose of PNEUMOVAX (MSD) (Lot#655152/0869F). There was no illness at the time of vaccination. Subsequently, the patient developed "numbness in her arm and itching". Unspecified medical attention was sought. The patient was told to take BENADRYL for itching, but the patient reported "it is not helping". The patient was scheduled to be seen in the office on 26-JUL-2007. At the time of this report the patient had not recovered. No further information was provided. There was no product quality complaint involved. Follow up information from the physician indicated that the patient has allergies to sulfa and aspirin, has a history of peripheral neuropathy of the left foot, radiculopathy and sciatica and degenerative joint disease of the cervical spine. Concomitant medications include ZOLOFT 100 mg, AMBIEN 5 mg at bedtime as needed, and unspecified vitamins daily. On 26-JUL-2007 a lab study was performed with results of a sed rate of 10mm/hr. Her blood pressure was 128/62 with an irregular pulse of 68 beats per minute. She's been having pain at her left deltoid at the site where she had ZOSTAVAX (Oka/Merck) and PNEUMOVAX (MSD). According to the physician this "most likely this represents a small hematoma in the deltoid muscle". The physician recommended rubbing it. There was no abnormality palpated other than a slight density. The patient had been having some numbness and tingling in the glove and stocking distribution of the left leg that went up to the mid-calf. She still had sensation there, but it was diminished or altered. She had good range of motion. She was able to walk on her heels and toes. Strength was 5/5 in all of her muscle groups. She has had LESI injections in the left L4 and L5 nerve sheaths in the past for sciatica and the physician thought this was possibly a continuation of this. Labs were to be checked. The patient had some left ulnar neuropathy. She was having left D4 and D5 numbness, tingling and radiation of pain. She does have DJD of her spine, has noted some more popping and clicking in her neck most recently and is concerned about this. The patient's skin had itching everywhere. She had a rash and dyshidrosis around her left eye. She had an itchy nose, ear canals, and a sense of itchiness around her rectum and gluteal fold. Her ear canals were clear, nasal passages patent and dry without abnormalities. She had a red raised patchy irritation around the left eye. In the gluteal fold she had a rash consistent with an intertriginous yeast infection. She was to use hydrocortisone cream 1% to the left eye dyshidrosis along with a good topical face cream. For the gluteal fold yeast she was to use MONISTAT twice daily to the affected area. No further information was provided. Additional information has been requested.