Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Blood pressure, Ear, nose and throat examination normal, Erythema multiforme, Gait disturbance, Head circumference normal
Clinical narrative: This case was reported by a consumer and described the occurrence of erythema multiforme in a female subject of unspecified age who was vaccinated with hepatitis A vaccine inactivated (Havrix, GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report. The reporter is the mother of the subject. On an unspecified date the subject received unspecified dose of Havrix (unknown). At an unspecified time after vaccination with Havrix, the subject experienced erythema multiforme. It was described as a "severe reaction" by the subject's mother. She was treated with several unspecified medications (prescription and over the counter). The subject had numerous appointments with her pediatrician and specialist. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. Allergy and Immunology evaluation received on 25 February 2008 via the mother. The 6 year old female subject was seen on 05 February 2008 by a pediatric allergist. Family history was negative for atopic disease, drug allergy, food allergy, immunodeficiency, or cystic fibrosis in first degree relatives. It was reported that the subject received her first dose of Havrix manufactured by GlaxoSmithKline on 17 January 2008. Approximately three to four hours after she received the Havrix injection, she developed hives over her trunk that resolved with Benadryl. The next morning she again developed hives on her trunk that responded to Benadryl. The following day she developed a hive-like rash over her whole body with the exception of her face and head. The rash was extremely itchy as were the earlier lesions. She was treated with Benadryl which led to a partial response. The following day she continued to develop lesions over her whole body including her neck, face and ears and continued to take Benadryl on a scheduled basis. The next day, the subject complained that she could not walk because her feet were "lumpy". She was seen by her pediatrician where a diagnosis of erythema multiforme was made. Prednisone was prescribed and was effective in helping the joint swelling and significantly helping the rash. The next morning her rash reappeared. Atarax was prescribed in place of Benadryl. The Atarax seemed more helpful with the itching. On 25 January 2008, the subject had no erythema when she awoke. On 27 January 2008, she had erythema on her buttocks and backs of her thighs. No additional symptoms after 27 January 2008. The subject had no fever, upper respiratory infection symptoms, gastrointestinal symptoms or other signs of infection. She was not on any new medications at the time. The subject had received all of her childhood vaccinations on schedule and never had any other adverse reactions. No prior history of chronic nasal or ocular symptoms suggestive of allergies. No history of eczema, urticaria, wheezing or diagnosis of asthma. Subject described as healthy. History of constipation reported. No known drug allergies. The impression of the physician was reported as likely adverse reaction to hepatitis a vaccine. He noted that this type of reaction is very rare, but the timing is very suspicious. The physician reviewed  pictures provided by the mother and noted that the urticarial lesions could be consistent with urticaria or erythema multiforme throughout her entire body. It was recommended that the subject not have future doses of Havrix.