Age: 66.0
Sex: F
Vaccine: FLUX, PNC13, FLU3, PNC13
Symptoms: Haematocrit, Haemoglobin normal, Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: Initial unsolicited report received from a physician on 06 January 2016. This case involves a 66-year-old female patient who was vaccinated with an injection of Influenza vaccine (manufacturer: unknown) on left side and with an injection of PREVENAR 13 (manufacturer: other) on right side (batch number, dose, dose in series and route of administration were not reported) on 13 September 2015. The patient's medical history included allergies/sinus; stomach problems; diarrhea of presumed infectious origin; hypothyroidism; vitamin D deficiency; pure hypercholesterolemia; disorder of magnesium metabolism; dehydration; pernicious anemia; anxiety; depressive disorder; multiple sclerosis; migraine; essential hypertension; acute sinusitis; acute upper respiratory infection; chronic pancreatitis; pain in joint, ankle and foot; thoracic radiculitis, osteoporosis, abdominal pain, abnormal glucose tolerance test, allergic to erythromycin base. The patient was not a tobacco user. Surgical history included hysterectomy-fibroid/ovaries still present in 1986 and tonsillectomy in 1968 for which the patient was hospitalized. The patient's father had heart disease-CABG, obesity (diagnosed with unspecified heart disease); mother had congestive heart failure, hypertensive disorder, diagnosed with hypertension, unspecified heart disease; children were alive, siblings such as brother was diagnosed with obesity and two daughters were healthy. Concomitant medications included ALIGN capsule, AMPYRA 10 mg extended release tablet twice a day for neurology disorder; Aspirin low dose 81 mg tablet once a day; AVONEX pen 30 mcg/0.5 ml kit,  0.5 once per week for neurology disorder; Calcium 600/vitamin D3 600-400 mg tablet with food twice a day; Magnesium oxide 400 mg tablet once a day; Multivitamin capsule; Niacin 250 mg tablet once a day; Vitamin C 250 mg tablet once a day; Vitamin D tablet 1 tab daily except Monday and Friday take 2 tablets; ZYRTEC 10 mg once a day; Cyanocobalamin 100 mcg tablet once a day; PROLIA 60 mg/ml solution (next injection: 24 October 2015); XANAX 0.25 mg tablet once a day as needed; ARMOUR THYROID 60 mg tablet once a day; Lisinopril 10 mg tablet twice a day; Duloxetine 60 mg capsule delayed release particles take one capsule orally once daily. On an unknown date, following the vaccination, the patient had developed cellulitis; skin has area of redness which was warmth to touch, slightly firm not fluctuant and hot, rash on PREVENAR 13 injection site which was increasing. It was reported that the patient noticed that the rash was small on Friday but over the weekend it was increased in size. Laboratory data included white blood cell count (WBC): 6.8 k/ul, red blood cells (RBC): 4.2 m/ul, hemoglobin (HGB): 12.9 g/dl, hematocrit (HCT): percent, mean corpuscular volume (MCV): 94.0 fl, mean corpuscular hemoglobin (MCH): 30.9, mean corpuscular hemoglobin concentration (MCHC): 32.9 g/dl, Red cell distribution width (RDW): 12.6 percent, platelet count (PLT): 255 k/ul, Mean platelet volume (MPV): 7.6, neutrophils: 54.3 percent, lymphocytes: 35.3 percent, monocytes: 5.2 percent, eosinophils: 4.7 percent, basophils: 0.5 percent, neutrophil count: 3.68 k/ul, lymphocyte count: 2.39 k/ul, monocyte count: 0.35 k/ul, eosinophil count: 0.32 k/ul, basophil count: 0.04 k/ul. Physical examinations included blood pressure (BP): 133/79 mmHg, temperature: 98.2 Fahrenheit, respiratory rate (RR): 18 per minute, Heart rate (HR): 89 per min, BMI: 25.60 index. The patient was treated with KEFLEX capsule (500 mg) 1 capsule orally thrice a day for 7 days. The patient was asked to apply ice or heat, cream. The outcomes of the events were not reported. Upon medical review, the case was considered as serious due to important medical event: cellulitis. List of documents held by sender: none.