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Life Threatening? No
Write-up: Initial Follow-up information has been received from a physician concerning a 14 year old girl patient with pollinosis, fruit allergy (itching in the mouth when eating peach, apple and kiwi) and with no medical history who on an unknown dates was placed on therapy with the first and second dose of GARDASIL intramuscular injection (dose and lot number were not reported). In around January to February 2013, the patient received the third vaccination of GARDASIL (dose and lot number were not reported) (as the vaccination was performed at another hospital, Lot No. and vaccination status were unknown). Other concomitant medications were not reported. In around June 2013, suspected linear scleroderma developed. On 27-SEP-2013, the patient made the first visit to the hospital for symptoms of localized scleroderma (in the right thigh with itching). Light brown plaque with mild infiltration (25 x 7 mm in size) was observed on the extensor side of the right thigh. External use of METHADERM cream was started. Antinuclear antibody was detected (1:40), anti-topoisomerase (anti-SCL-70) (units not provided) antibody was negative and rheumatoid factor (RF) was 0. On 31-OCT-2013, slight improvement was observed. Therapy with METHADERM cream was continued. On 07-DEC-2013, slight improvement was observed. Therapy with METHADERM was continued. On 08-MAR-2014, slight improvement was observed. Therapy with METHADERM was continued. Antinuclear antibody was detected (1:40), anti-SCL-70 antibody was negative and RF was 0 (units not provided). On 28-MAR-2014, slight improvement was observed. Therapy with METHADERM was continued. On 30-JUL-2014, there was a question about the causal relationship between the event and GARDASIL. Suspected linear scleroderma (localized scleroderma) was not resolved. At the time of report on 27-AUG-2014, suspected linear scleroderma (localized scleroderma) had not yet improved and the patient was making visits to the reporting hospital. At the time of report on 26-SEP-2014, suspected linear scleroderma (localized scleroderma) was not resolved. Reporter''s comment (at the time of report on 27-AUG-2014): The causal relationship was unknown. Although the event was not considered to be serious, the seriousness could not be determined conclusively given that the event had not yet improved. Reporter''s comment (at the time of report on 26-SEP-2014): The event was not serious but it seemed that the symptoms would persist for a long time. The causal relationship was unknown. The reporting physician considered suspected linear scleroderma as serious due to disability. The reporting physician felt that the causal relationship of suspected linear scleroderma to GARDASIL was unknown, and considered that other causative factor was also unknown. Additional information has been requested.
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