Age: 1.25
Sex: F
Vaccine: DTAP, FLUX, HIBV
Symptoms: Cafe au lait spots, Haematoma, Idiopathic urticaria, Injection site mass, Injection site nodule
Clinical narrative: This serious initial spontaneous case, was received from other health professional via health authority (VAERS ID: 698534) on 10-Dec-2017, concerning a 1.25-year-old infant female patient. The patient had no medical history. The subject did not receive any concomitant medications. On 06-Mar-2014, the patient was administered with Influenza vaccine (dose, batch number, expiry date, manufacturer, trade name, route of administration, anatomical location: not reported), INFANRIX (batch number: AC14B182BA, anatomical location: left thigh, dose, route of administration, expiry date: not reported) and PEDVAXHIB (batch number: J009714, anatomical location: left thigh, dose, route of administration, expiry date: not reported). On 01-Jul-2014, the patient was also administered with HAV (hepatitis A vaccine) (dose, batch number, expiry date, manufacturer, trade name, route of administration, anatomical location: not reported) for an unknown indication. On 02-Feb-2015, after 10 months 28 days of vaccination, the patient's mother noticed lump on left thigh (which was for 1 month) and site was itchy while applying lotion to the skin and lotion helped. The patient had dimple to right chest "small less than pea size" nodule on left anterior thigh, no erythema or tenderness were observed on examination. On 10-Feb-2015, Doppler color ultrasound was performed, which showed hypoechoic area measuring 5 mm x 3 mm x 5 mm, with some areas of increased echogenicity and component with some increase in flow mixed echogenicity lesion and small amount of fluid or small hematoma. The vascular area could be related to post-surgical scar tissue/granuloma. 08-May-2015, nodule waxes and wanes were frequently painful and pruritic and hypoechoic area in the subcutaneous tissues of left thigh did not demonstrate increased vascularity or aggressive features. No discrete palpable mass was identified. On 01-Aug-2015, after 1 year 5 months of vaccination, the patient experienced sore and itchy thigh (reported as last night). On 01-Se0-2015, on pediatric surgeons followed up, it was reported that, the patient had history of intermittent swelling and itching over left anterior thigh and no palpable mass was observed and patient was referred to the pediatric allergy department, as symptoms were chronic fluctuating response from a prior vaccination. On 05-Oct-2015, it was reported the itchy bump to left thigh for 2 months after 18 months of shots HAV (hepatitis A virus) and PCV13 (pneumococcal conjugate vaccine) for 3 months and lasted in 1-2 days. On the same day, skin exam was performed, and skin complexion was fair, nodular lesions of approximately 5 mm showed in the proximal anterior left thigh, which was non-tender, non-fluctuant, scattered brown macular lesions x 1 on the right thigh and right abdomen and negative. Larger faint brown patch of 1-2 cm on the upper, lateral right thigh. Darier's signs were found to be negative. General appearance, texture, color, pigmentation, moisture, and temperature were normal. The patient was suggested to have biopsy (unspecified). The patient diagnosed with urticaria idiopathic. On 16-Dec-2016, the patient diagnosed with café au lait spots x 2 on left thigh and buttocks. On 06-Apr-2017, the patient diagnosed with dermatographic urticaria by dermatologist in which one flat uniform hyperpigmented café au lait oblong spot on left thigh (lateral aspect) of 2.3 cm x 0.8 cm was noted, which was very light in color. On an unspecified date in 2017, the patient recovered from all the events and was monitored.