Age: 66.0
Sex: F
Vaccine: FLUX, PNC13, FLU3, PNC13
Symptoms: Injection site warmth, Lymphocyte count normal, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal
Clinical narrative: This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. A 66-year-old female patient of unspecified ethnicity received PREVNAR 13 on right arm single dose and flu shot on left arm, both via an unspecified route of administration on 13Sep2015. Medical history included erythromycin base allergy, allergy, 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 respiratory infection, chronic pancreatitis, pain in joint, ankle, and foot, thoracic radiculitis, osteoporosis, abdominal pain, abnormal glucose tolerance test. Surgical history included hysterectomy-Fibroid/Ovaries still present in 1986, tonsillectomy in 1968. Family history included father: heart disease-CABG, obesity, diagnosed with unspecified heart disease; mother, congestive heart failure, hypertensive disorder, diagnosed with hypertension, unspecified heart disease. The patient's concomitant medications included ALIGN (capsule), AMPYRA (10 mg tablet extended release) 1 tablet twice a day, Aspirin low dose 81mg tablet once a day, AVONEX Pen (30 mcg/0.5mL kit 0.5) once per week, calcium 600+D3 600-400 mg-Unit 1 tablet with food BID, magnesium oxide 400 mg tablet once a day, multivitamins capsule, Niacin (250mg tablet) 1 tablet once a day, Vitamin C 250 mg 1 tablet once a day, Vitamin D 5000 1 tablet daily except Monday and Friday take 2 tablets, ZYRTEC 10 mg once a day, Cyanocobalamin 100 mcg 1 tablet once a day, PROLIA (60 mg/ml solution) next injection on 24Oct2015, simvastatin 20mg one tablet by mouth once daily, XANAX (0.25 mg tablet) 1 tablet once a day, ARMOUR THYROID 60 mg 1 tablet once a day, lisinopril 10 mg 1 tablet BID and duloxetine HCl 60mg capsule delayed release one by mouth once daily. The patient had three siblings one brother, diagnosed with obesity and two daughters healthy. The patient experienced cellulitis, vaccination site rash, essential hypertension, the area of injection was red, over area warmth to touch, injection site became infected and inflamed on an unspecified date with outcome of unknown. The patient was treated for the cellulitis with KEFLEX capsule, 500 mg, 1 capsule, orally, TID. The outcome of the events was unknown. The lab data was the following, basophil count 0.04 k/ul, basophil percentage 0.5%, blood pressure 133/79mmHg, body mass index 25.60, body temperature 98.2 Fahrenheit, eosinophil count 0.32 k/ul, eosinophil percentage 4.7%, haematocrit 39.1%, haemoglobin 12.9g/dl, heart rate 89/min, lymphocyte count 2.39 k/ul, lymphocyte percentage 35.3%, mean cell haemoglobin 30.9pg, mean cell haemoglobin concentration 32.9g/dl, mean cell volume 94.0 fl, mean platelet volume 7.6%, monocyte count 0.35 k/ul, monocyte percentage 5.2, neutrophil count 3.68 k/ul, neutrophil percentage 54.3, platelet count 255 k/ul, red blood cell count 4.2 M/ul, red cell distribution width 12.6%, respiratory rate 18/min, white blood cell count 6.8 k/ul. The physician stated that it was his hypothesis that the injection shot site, was not properly cleaned prior to vaccine administration, causing it to become infected and inflamed. Follow-up (20NOV2015): Follow-up attempts are completed. No further information is expected. Follow-up (28Dec2015): Additional information from a contactable physician includes age and gender, information on concomitant medications and medical history, date of vaccination. Cellulitis, vaccination site rash, essential hypertension, the area of injection was redness, over area warmth to touch added as adverse events. Case upgraded to serious.