Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Bursitis, Herpes zoster, Incorrect route of drug administration, Pelvic pain
Clinical narrative: Information has been received from a consumer concerning his wife, a 66 year old female with no pertinent medical history, drug reactions or allergies who on 16-APR-2008 was vaccinated with "a single dose" of zoster vaccine live (Oka/Merck). Concomitant therapy included Fosamax and Xalatan, also reported as "not under any medication on a continuous basis." On 20-APR-2008, the patient developed shingles, with progressively severe pain. The patient was prescribed antiretroviral therapy with famciclovir to be taken over one week. There were no lab diagnostic studies performed. There was no product quality complaint. At the time of reporting the patient had not yet recovered. Follow-up information received 12-MAY-2008 via medical records: On 16-APR-2008, the patient was vaccinated intramuscular with a dose of zoster vaccine (Oka/Merck). The patient's medical history consisted of osteopenia (12-MAR-2007), eczema (12-MAR-2007), internal haemorrhoids (12-MAR-2007), borderline glaucoma (12-MAR-2004) irritable colon (12-MAR-2007), flat feet (12-MAR-2004), derangement meniscus NEC(12-MAR-2004), malignant neoplasm uterus NOS (12-MAR-2004), symptomatic female climacteric (24-FEB-2004), and a history of vaginitis atrophic (24-Feb-2004) and a hysterectomy. The patient's concomitant medications were updated to include the following: alendronate sodium (MSD), Xalatan, timolol maleate (MSD), Anusol HC and Citracal +D. On 16-APR-2008, the patient contacted her physician with complaints of "pain in the side" and a "rash under breast." On 21-APR-2008, the patient was seen by her physician and assessed for diabetes, hypertension, cardiovascular disease, unintentional weight loss/gain, difficulty chewing and/or swallowing (no findings). The patient described the rash as itching and burning on her right side (thoracic at bra line). The physical examination revealed classic lesions of vesicle in linear pattern (general impression herpes zoster post vaccination). The patient identified an increase in pain located in the nerves. On a pain scale her pain was characterized as a 4 out of 10 that occurred constantly. The patient was treated with Famvir 500 mg table three times a day for one week, Darvocet 100/650 mg tablet one-two every 6 hours as needed for pain at night and Tylenol during the day. On 01-MAY-2008 the patient was seen by her physician for follow-up medical problems related to the "dermatomal rash" she developed post vaccination. It was noted the rash has nearly healed (few erythematous papules under left breast). The patient was discontinued from Famvir 500 mg table three times a day for one week and Darvocet 100/650 mg table one-two every 6 hours as needed for pain. The physician also reported it was difficult to determine if the vaccine was associated or coincidental to shingles. Information received on 12-MAY-2008 contained the following adverse experiences: trochanteric bursitis (12-MAY-2008), joint pain pelvis - primary encounter diagnosis (12-MAY-2008) and sleep apnea (NOS) (12-MAY-2008). Additional information is expected. All available medical records will be provided upon request.