Sex: M
Vaccine: HEP, IPV, PPV, UNK
Symptoms: Injection site granuloma, Microscopy, Skin lesion, Staphylococcus test positive, Vaccination site erythema
Clinical narrative: consistent with autosomal dominant hyper-IgE syndrome (HIES); Consistent with botryomycosis; Annular plaques and nodules at vaccination sites; Annular plaques and nodules at vaccination sites; This is a literature report.  A 5-month-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), as dose number unknown, single (Batch/Lot number: unknown) for pneumococcal immunisation; hepatitis B vaccine (HEPATITIS B VACCINE), as dose number unknown, single) for hepatitis b immunisation; diphtheria vaccine toxoid, pertussis vaccine, tetanus vaccine toxoid (DIPHTHERIA AND TETANUS TOXOIDS AND PERTUSSIS), as dose number unknown, single) for diphtheria immunisation, tetanus immunisation, pertussis immunisation; polio vaccine (POLIO VACCINE), as dose number unknown, single) for polio immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: HYPER IGE SYNDROME (medically significant), 1 week after the suspect product(s) administration, outcome "recovering", described as "consistent with autosomal dominant hyper-IgE syndrome (HIES)"; BOTRYOMYCOSIS (medically significant), 1 week after the suspect product(s) administration, outcome "recovering", described as "Consistent with botryomycosis"; VACCINATION SITE NODULE (non-serious), VACCINATION SITE PLAQUE (non-serious), all with latency 1 week after the suspect product(s) administration, outcome "recovering" and all described as "Annular plaques and nodules at vaccination sites". The patient underwent the following laboratory tests and procedures: Bacterial test: grew methicillin-sensitive Staphylococcus aureus; Biopsy skin: grew methicillin-sensitive Staphylococcus aureus; Gene mutation identification test: revealed an inactivating mutation, notes: in the signal transducer and activator of transcription 3 gene. consistent with autosomal dominant hyper-IgE syndrome (HIES); Gram stain: Present with a surrounding eosinophilic zone, notes: (Splendore-Hoeppli phenomenon) consistent with botryomycosis; Histology: showed suppurative neutrophilic dermal, notes: with connection to the overlying epidermal surface; Microscopy: without evidence of hyphae or fungal forms; Physical examination: annular red-purple plaques, notes: with peripheral scale and overlying indurated papulo pustules on both thighs. Focal excoriation and yellow debris were noted within many of the papules; Staphylococcus test: grew methicillin-sensitive Staphylococcus aureus. Therapeutic measures were taken as a result of hyper ige syndrome, botryomycosis, vaccination site nodule, vaccination site plaque. Case report: A 5-month-old boy with no significant past medical history, including no atopic dermatitis, presented with a 3-month history of a pruritic,  progressively enlarging rash on the bilateral thighs at the sites of his 2-month routine vaccinations. The eruption began 1 week after receiving the following vaccinations: subunit hepatitis B, inactivated diphtheria, tetanus and pertussis (DTaP), inactivated polio, and pneumococcal conjugate. The patient had been treated with triamcinolone 0.1% cream without improvement in symptoms and with ongoing expansion of his rash. On physical examination, there were annular red-purple plaques with peripheral scale and overlying indurated papulopustules on both thighs. Focal excoriation and yellow debris were noted within many of the papules. A 4-mm punch biopsy from the right lateral thigh was taken. Diagnosis: Botryomycosis. Histopathology showed suppurative neutrophilic dermal inflammation with surrounding granulomatous inflammation with connection to the overlying epidermal surface. Within the inflammatory focus, basophilic grains and clumps of Gram-positive bacteria were present with a surrounding eosinophilic zone (Splendore-Hoeppli phenomenon) consistent with botryomycosis. Bacterial culture from the punch biopsy grew methicillin-sensitive Staphylococcus aureus. Scales obtained from the plaques were examined with a potassium hydroxide preparation, without evidence of hyphae or fungal forms on microscopic examination. The significant infection in an otherwise healthy child led to a work-up for underlying immunodeficiency which revealed an inactivating mutation in the signal transducer and activator of transcription 3 gene (STAT3), consistent with autosomal dominant hyper-IgE syndrome (HIES). The patient was treated with oral trimethoprim-sulfamethoxazole (TMP-SMX) 10 mg/kg/day divided twice daily with significant clinical improvement in the thickness and size of the existing lesions over the course of 3 months. He was subsequently switched to daily chronic prophylactic oral TMP-SMX 5 mg/kg/day divided twice daily and oral fluconazole 40 mg daily for coccidioidomycosis meningitis prophylaxis.  No follow-up attempts are possible.; Sender's Comments: The events hyper IgE syndrome, and botryomycosis are conservatively assessed as related to the suspect drug PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN) based on close temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.