Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Auricular swelling, Body mass index increased, Dysphagia, Dyspnoea, Erythema
Clinical narrative: Whole body pruritic rash, swollen lips, mild shortness of breath and some difficulty swallowing. Follow-up received 10/08/2008 from a physician concerning a female who on 16-MAY-2008 was vaccinated subcutaneously with a first dose of zoster vaccine live (Oka/Merck). On 19-MAY-2008 the patient developed an urticaria/rash on their back and chest. The patient was treated with epinephrine and other medications (unspecified). At the time of the reporting the patient had not yet recovered, although it was noted that  "when treated the swelling went down a little". There was no product quality complaint.  Follow-up information was received from the office manager inquiring about the VZV1P packet that the office has received. The reporter noted that the patient had no vesicles or papules, just urticaria therefore a specimen would not be submitted. The reporter noted that the patient had been vaccinated with zoster vaccine live (Oka/Merck) on 16-MAY-2008. On 18-MAY-2008 the patient awoke at 6 am with widespread urticaria on her arms, back and chest, her ear was reddened, inflamed and swollen. It was also noted that the patient developed shortness of breath (SOB).  It was noted that the patient took diphenhydramine hydrochloride (BENADRYL) "all day". "On Monday" (approximately 19 MAY 2008) the patient was seen in the office and was given epinephrine, levocotirizine dihydrochloride (XYZAL) and treated with a medrol dose-pak. It was reported that the patient was doing "better", but still had the rash. The patient was instructed to call the office later in the week with her progress. Follow-up information has been received from the physician's medical records dated 19-MAY-2008 (1:10 pm) concerning this 62 year old female patient with an allergy to amoxicillin (+) clavulanate potassium (AUGMENTIN) (hives) who on 16-MAY-2008 around 3:10 pm was vaccinated in the left deltoid with 5ml of zoster vaccine Live (Oka/Merck) (lot # 659323/0164X). Concomitant therapy included loratadine, gabapentin, meclizine hydrochloride, clobetasol propionate (TEMOVATE) fluvastatin sodium (LESCOL XL) calcium citrate (+) cholecalciferol (CITRACAL + D), ezetimibe (MSD), phenidmetrazine tartrate (PLEGINE), aspirin, esomeprazole magnesium (NEXIUM), potassium (unspecified) and omega-3 marine triglycerides. Medical records indicated that when the patient sought medical attention she appeared acutely ill and in mild-moderate distress. The patient presented for possible allergic reaction to zoster vaccine live (Oka/Merck) starting early Sunday morning 18-MAY-2008 around 6 am. The patient was woken out of her sleep with left proximal palmar itching. She thought she might have somehow been bitten by an insect. However, the patient developed a whole body pruritic rash, swollen lips, mild shortness of breath and some difficulty swallowing. The patient used diphenhydramine hydrochloride (BENADRYL) and loratadine (CLARITIN) without much relief. Fluticasone propionate (+) salmeterol xinaforte (ADVAIR DISKUS) was used and seemed to help some of the mild shortness of breath that she had experienced. The patient did not know of any allergy to neomycin nor gelatin. The patient had not eaten anything unusual nor had she had any recent illness or any other recent vaccinations or did any unusual traveling. It was also noted that the patient was in a hot tub around 2 am Sunday morning. At the time of the report the patient's status was not reported, but it was noted that the patient was currently under treatment. Follow-up information has been received from the office manager who completed the VZV form. The patient was vaccinated subcutaneously in left deltoid with a first dose of zoster vaccine live (Oka-Merck) on 16-MAY-2008 at 3:24 PM. The patient had no illness at time of vaccination and recovered from the events. On 26-MAY-2008, the patient recovered from whole body pruritic rash, swollen lips, mild shortness of breath and some difficulty swallowing. The patient also recovered from ear red, inflamed and swollen on an unspecified date. Additional information is not expected.