Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic, Skin burning sensation, Sleep apnoea syndrome
Clinical narrative: Patient developed typical zoster rash on 4/21 (4 days after receiving Zostavax). This is in follow-up to report(s) previously submitted on 6/24/2008. 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 ZOSTAVAD (Merck). Concomitant therapy included FOSAMAX and XALATAN, also reported as "not under any medicatin on a continuous basis". On 20-Apr-2008 the patient developed shingles, with progessively severe pain. The patient was prescribed anti retroviral therapy with famcicivoir 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 2009 via medical records: On 16-Apr-2008 the patient was vaccinated intramuscular with a dose of roster vaccine live (Merck). The patient's medical history consisted of oteropenia (12-Mar-2004), eczema (12-Mar-2004) internal haemorrhoids (12-Mar-2004), borderline glaucoma (12-Mar-2004), irritable colon (12-Mar-2004), flat feet (12-Mar-2004), derangement minscus NEC (12-Mar-2004), malignant neoplasm uterus NOS (12-Mar-2004), symtosatic female cilmacteric (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: MSD, XALATAN, 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 paitent was seen by her physician and assessed for diabetes, hypertension, cadiovasular disease, unintentional weight loss/gain, difficulty chewing and/or swollowing (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 on 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 tablet 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 erythamatous papules under left breast). The patient was discontinued from FAMVIR 500 mg tablet three times a day for one week and DARVOCET 100/650 mg tablet one - two every 6 hours as need for pain. The physician also reported it was difficult to determine if the vaccine was associated or concidental shingles. Information received on 12-May-2008 contained the following adverse experiences: trochanteric buruitis (12-May-2008), joint pain pelvis - primary encounter diagnosis (12-May-2008) and sleep apnea (12-May-2008). Additional information is expected.