Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haemorrhage, Injection site inflammation, Injection site mass, Injection site rash, Injection site vesicles
Clinical narrative: Information has been received from a 62 year old female consumer reporting on herself with no drug reaction or allergies and no pertinent medical history, who on 31-MAY-2012, was vaccinated with a dose of ZOSTAVAX (Merck) 0.65ml, SC (lot number not provided). Concomitant therapy included mometasone furoate and beclomethasone dipropionate. It was reported that by the next morning, 01-JUN-2012, the patient had a rash at the injection site that was the size of a dime. By 02-JUN-2012, her upper left arm (site of injection) was "inflamed and oozing". The patient went to a clinic in her area and was told to go to the ER. The patient went to the ER and was told she had cellulitis. She was put on antibiotics and released. The consumer stated that on 03-JUN-2012, the rash had spread down to her elbow and she went to the ER again. She was put on another antibiotic and told to stay home for 2 weeks and avoid contact with pregnant women, newborns and immunocompromised people. She saw her own physician this morning, 04-JUN-2012 and again was told to go "nowhere for 2 weeks". Treatment given for the adverse event was cephalexin, sulfamethoxazole/trimethoprim and BENADRYL. There was "blood work" performed (results not provided). At the time of the report, the patient's outcome was not recovered. Additional information was received from the patient in the form of a letter and medical records. The 62 year old postmenopausal female, never smoked, with chronic allergic rhinitis and asthma, was inoculated by a pharmacist with ZOSTAVAX (Merck) at approximately noon on 31-MAY-2012. Concurrent medications included mometasone furoate nasal spray and beclomethasone dipropionate inhalation aerosol. The patient reported a large rash, swollen arm, and pustules (considered symptoms of cellulitis) had developed on 01-JUN-2012. On 01-JUN-2012 at approximately 9:00 AM, she removed the band-aid to find a rash the size of a dime. That evening at 6:00 PM, the rash was the size of a silver dollar. By the morning of 02-JUN-2012, at approximately 8:00 AM, the rash was a 4 inch arm band on her upper left arm at the site of the vaccination. She went to a clinic with symptoms of itching, pain/tenderness, redness, swelling and warmth with onset reported as 2 days prior. she had used over-the-counter ADVIL with no effect. Diagnosis: Open wound upper arm with infection, possible cellulitis to left upper arm and spreading. She was referred to urgent care. The patient reported that she went to the hospital and was treated with BENADRYL and KEFLEX. She was told to put ice on it and keep arm stationary. She followed the physician's orders and took the medicine as prescribed. On 03-JUN-2012, she awoke to find the rash had spread to her elbow and the site of the injection was a blistery mass. She went to another hospital emergency room to get a second opinion. Per the patient, at the hospital, a regime of sulphamethoxazole-TMP was added. The patient was told it was as serious reaction to the vaccination and she had developed cellulitis. Hospital discharge instructions noted the patient should continue KEFLEX as directed, take BACTRIM DS for 5 days, and BENADRYL as needed for itching. She was to return to the emergency room with any increase in discomfort and was to follow-up with her primary physician on 04-JUN-2012. On 04-JUN-2012, the patient reported she was to have blood tests to check her kidneys due to the extreme doses of antibiotics (results not provided). As of 04-JUN-2012, the patient had not recovered. Information has been received from a third party claims administrator regarding a female. On 31-MAY-2012, the female was vaccinated with a dose of ZOSTAVAX (Merck) (1715AA, expiration 02-FEB-2013) and sustained what appeared to be an allergic reaction after receiving the vaccine. All available medical records will be provided upon request. Additional information has been requested.