Age: 61.0
Sex: F
Vaccine: HEP
Symptoms: Fungal skin infection, Pain, Pyrexia, Rash, Rash pruritic
Clinical narrative: Information has been received from a RN concerning a 60 year old white female with a history of hypertension, angina pectoris, and a cardiac murmur and no known allergies who on 01/03/03 at 14:00 was vaccinated IM in the left deltoid with a third dose of hepatitis B vaccine recombinant (yeast)(Lot # 64204/1570L).  There was no illness at the time of vaccination.  There were no adverse symptoms with previous injections of hepatitis B vaccine recombinant (yeast).  Concomitnat medications included amlodipine besylate (+( benazepril hydrochloride for hypertension and echinacea.  On 01/04/03, the pt developed itchiness and a rash on her shoulders and the back of her calves.  On 01/27/03, she developed facial swelling and "whelps" on her back, chest, stomach, legs, face and under her arms.  She was given diphenhydramine hydrochloride and desloratadine (also reported as clarinex) for histamine reaction. The "whelps" resolved in 24 hours but a red rash continued with the itching.  The itching resolved temporarily with topical OTC ointments.  Follow-up information indicated that on 01/28/03, the pt went to see a physician and the welts had completely resolved. She was then diagnosed with a histamine reaction and ring worm on her calves.  She was treated with terbinafine for the ring worm and desloratadine for the rash.  The pt was still experiencing intermittent itching and a rash on her calves which was reported as almost resolved.  It was also reported that the pt experienced injection site soreness/achiness upon movement or palpation. The soreness/achiness was described as a deep pain not on the surface.  The reporter indicated that it bothered her when she raised her arm or moved her arm back when it was at shoulder height.  It did not bother her when she moved it forward, just backwards.  It was noted that the pt had not missed any work due to her events. Follow-up information received from a RN indicated that on 01/04/03, the pt awoke at 5am which itching of her left shoulder above the injection site.  No rash was noted.  Later that AM, she noted a petechiae-like rash on her left shoulder and both leg calves with increased itching.  She also noted a "ring-worm looking", nickel-sized spot on her right calf.  Between 01/04/03 and 01/26/03, the itching and the rash continued in those areas.  The pt applied vitamin/body lotions, oils, OTC cortisone cream and took diphenhydramine hydrochloride.  She had short-term, temporary relief with these treatments.  It was also indicated that she had occasional chills and ran a low grade fever over the entire three weeks.  On 01/27/03, the pt awoke to the lower half of her face swelling that resolved by the afternoon.  Large, thick, pink whelps appeared on her calves, stomach, chest, on her back, under both arms.  The intense itching, chills and low-grade fever persisted.  The reporter indicated that the pt took Benadryl that night, and the whelps, chills and fever resolved  On 01/28/03, she went to a free-standing clinic. A microscopic slide was diagnostic of a fungal spot on the right leg's calf.  She saw the physician and was diagnosed with ringworm on the right calf and a histamine reaction to the third hepatitis B vaccine recombinant (yeast) vaccination.  The pt was treated with Lamisil AT for 3-4 weeks on the fungal lesion and Clarinex 5mg daily for 20 days for the rash.  On 01/31/03, the rash was almost all gone, few petechiae remained on her calves, some occasional itching of her legs remained, and fungal lesion was resolving.  No fever or chills were noted.  Additional follow up information indicated that "all adverse reactions have resolved (rash, ringworm, petechiae, itching) except employee still notes occasional muscle soreness above injection site."  The reporter indicated that one other pt had similar injection site soreness/ achiness after vaccination with hepatitis B vaccine recombinant (yeast)(Lot # 642004/1570L) (WAES#0302USA00412).  Upon internal review, the histamine reaction was considered an other important medical event (OMIC).  Additional information has been requested.