Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Emotional distress, Herpes zoster, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Shingles/ a bad case of shingles; Injection site reaction described as a red, swollen, itchy rash; Injection site reaction described as red; Injection site reaction described as swollen; Information has been received from a pharmacist concerning a 61 year old female patient with drug reaction to betadyne, amitryptiline, hydrocodone, lorazepam (ATIVAN), clonazepam (KLONOPIN), mirtazapine (MSD), tetracycline and blue dye allergy who on 11-MAR-2011 was vaccinated with a single dose of zoster vaccine live (Oka/Merck), 0.65ml, subcutaneous. (Lot number not reported).  The pharmacist reported that on 11-MAR-2011 the patient developed an injection site reaction described as a red, swollen, itchy rash in the evening following administration of the vaccine. The rash spread down the rest of the arm, down the hand and into the fingers during the next day, and it continued unabated to the present day. The pharmacist reported that the patient had a pre-planned hospital admission to an unspecified facility, for an unspecified surgical procedure, at an unspecified time during the week following the vaccination; she also reported that the hospital admission was not related to the vaccination. The patient sought medical attention by visiting unspecified physician. The pharmacist reported that patient's physician had sent off samples for unspecified lab work to determine if the patient had developed a case of shingles. Diphenhydramine hydrochloride (BENADRYL) and diphenhydramine hydrochloride (BENADRYL) cream were given as a treatment for the experience.   At the time of the report, the patient had not recovered.   Follow up information has been received from the pharmacist reporting that the 61 year old female patient was still having active break outs with swelling and itching. Her physician (name unspecified) confirmed that she had shingles by doing an unspecified test (previously reported).   At the time of the report, the patient had not recovered.   Follow up information has been received from the doctor of pharmacy reporting that the white 61 year old female patient with drug allergy to acetaminophen (+) propoxyphene napsylate (DARVOCET), amitriptyline, clonazepam (KLONOPIN), hydrocodone, blue dye, lorazepam (ATIVAN), mirtazapine (REMERON), povidone-iodine (BETADINE) and tetracycline, who on 11-MAR-2011 was vaccinated in her right arm, with the first dose of zoster vaccine live (Oka/Merck) (Lot number 669533/1383Z) at 18:30 p.m in a pharmacy with private funds. On 11-MAR-2011 at 19:00 the patient experienced swelling/redness at injection site. It was reported that later, the patient experienced swelling, redness and itching on entire arm lasted over a month with continued side effects-confirmed active shingles. At the time of the report, the patient had not recovered from active shingles.   Follow-up information has been received on 15-JAN-2021 from a lawyer, regarding a case in litigation and refers to a 61-year-old female patient. On or around 11-MAR-2011, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving the vaccine, she suffered a bad case of the shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to using the product. She also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was considered to be not recovered.  The event was considered to be disabling.