Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Abdominal discomfort, Alanine aminotransferase increased, Analgesic drug level decreased, Analgesic drug level therapeutic, Antinuclear antibody negative
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer colleague, who reported the same event for 4 patients. This is the second of 4 reports. A 77-years-old female patient of an unspecified ethnicity received PREVNAR 13, intramuscular on 05Mar2015 at 0.5 ml, single. Medical history included ongoing rheumatic heart disease, thyroid cancer, ongoing hypertension, atrial fibrillation from 08Mar2012 and ongoing Stabilized on Amiodarone and Warfarin, mitral valve incompetence, migraine, thyroid neoplasm, hypothyroidism, varicose vein, neoplasm malignant. Concomitant medication included Valsartan + Hydrochlorothiazide, amiodarone, atenolol, warfarin, PACERONE, CORDARONE, Vitamin C, TENORMIN, Calcium 500+D, ZYRTEC, LEVOTHROID, LEVOXYL, SYNTHROID, ESTRACE, VISINE, JANTOVEN, COUMADIN. The patient previously took TIKOSYN and experienced drug hypersensitivity and palpitations. The patient experienced hepatitis/acute hepatitis on 10Mar2015 was hospitalized from 10Mar2015 to 13Mar2015, with outcome of recovered. Clinical course was as follow: the patient received PREVNAR 13 on 05Mar2015. On 07Mar2015, patient started experiencing increased cough with vomiting, on 10Mar2015 was admitted to the hospital. Physical Examination revealed: oriented to person, place, and time. She appears well-developed and well nourished. No distress. Normocephalic and atraumatic. External ears normal. Nose normal. Oropharynx is clear and moist. Conjunctivae and EOM are normal. Pupils are equal, round, and reactive to light. No scleral icterus. No thyromegaly present. Normal heart rate, regular rhythm, normal heart sounds and intact distal pulses. Exam reveals no gallop and no friction rub. No murmur heard. Effort normal and breath sounds normal. Abdomen soft. Bowel sounds are normal. She exhibits no mass. There is no splenomegaly or hepatomegaly. There is no tenderness. She exhibits no musculoskeletal edema. She has no cervical adenopathy. She is alert and oriented to person, place, and time. She has normal strength and normal reflexes. No cranial nerve deficit. Skin is warm and dry. She is not diaphoretic. She has a normal mood and affect. Her behaviour is normal. X ray Chest 2 Views 10Mar2015 no radiographic features of pneumonia. Ultrasound Abdomen Limited 10Mar2015 normal right upper quadrant ultrasound. The patient underwent lab tests and procedures which showed the following out of range results: activated partial thromboplastin time: 35.1 seconds on 10Mar2015; alanine aminotransferase IU/l: 38 on 09Feb2015, 890 on 10Mar2015, 757 on 11Mar2015, 560 on 12Mar2015, 453 on 13Mar2015; aspartate aminotransferase IU/l: 755 on 10Mar2015, 462 on 11Mar2015, 242 on 12Mar2015, 157 on 13Mar2015; Blood albumin g/dl: 30 on 11Mar2015, 3.0 on 12Mar2015, 3.3 on 13Mar2015; Blood calcium mg/dl: 7.5 on 11Mar2015, 7.5 on 12Mar2015, 8 on 13Mar2015; Blood chloride mmol: 95 on 11Mar2015, 96 on 12Mar2015, 94 on 13Mar2015; Blood glucose mg/dl: 121 on 11Mar2015, 106 on 12Mar2015; Blood potassium mmol/l: 302 on 11Mar2015; Blood sodium mmol/l: 133 on 11Mar2015, 132 on 12Mar2015, 134 on 13Mar2015; INR 2.4 on 10Mar2015, 3.5 on 11Mar2015, 4.3 on 12Mar2015, 4.7 on 13Mar2015; Lymphocyte count Thou/ul: 0.6 on 12Mar2015; Lymphocyte percentage %: 10.3 on 12Mar2015; Mean cell haemoglobin pg: 33.8 on 11Mar2015; Mean cell volume fl: 99 on 11Mar2015, 99.5 on 12Mar2015; Monocyte percentage % 14.0 on 12Mar2015; platelet count Thou/ul: 142 on 11Mar2015, 130 on 12Mar2015; Protein total g/dl: 5.4 on 11Mar2015, 5.2 on 12Mar2015, 5.4 on 13Mar2015. Diagnosis was Acute hepatitis, nausea and vomiting. The cause of the current hepatitis is not known. It was not alcohol. Her Hep C and HBSAG is negative. Other Hep B and her hepatitis A are pending. The only thing new for her was the PREVNAR 13 vaccine she received 2 days before she became ill. Will give IV fluid and antiemetics. She had mild hyponatremia which she has had before. She does appear to have asymptomatic UTI. Doubt that plays a role. Not started on antibiotics at that time. Discharge summary: Acute hepatitis of unclear etiology, possible medication effect, reaction to immunization, viral. Patient was admitted for further work-up and underwent ultrasound which was negative. Hepatitis labs negative. Further rheumatologic work-up was obtained during admission without obvious etiology. GI consult was obtained for further evaluation and discussion. Patient's hydrochlorothiazide was held during admission. Labs improved and plan to recheck as outpatient the following week. Acute diarrhea: patient was placed in soap and water precautions, C diff obtained and negative. IV hydration was used and symptoms improved prior to discharge. Paroxysmal atrial fibrillation-on chronic anticoagulation. Medications were continued, no concerns during admission. Supratherapeutic INR-last COUMADIN dose was Mar2010. Has been trending up since that time.