Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Gamma-glutamyltransferase increased, Hepatitis acute, Immunology test normal, International normalised ratio increased, Liver function test abnormal
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer colleague and via a Pfizer sales representative and report from a contactable physician. This pharmacist reported similar event for 4 patients. This is the third of 4 reports. A 86-years-old female patient of an unspecified ethnicity received PREVNAR 13, intramuscular on 27Oct2015 at 0.5 ml, single. Medical history included ongoing atrial fibrillation controlled with diltiazem and warfarin, ongoing type 2 diabetes mellitus managed with insulin therapy, ongoing cardiac failure, drug-induced liver injury from 2012 to an unknown date possible medication induced hepatitis/drug induced transaminitis in 2012 (now resolved), bile duct stone from 2013 which was treated with ERCP/Stone removal and oral antibiotics. Concomitant medication included FLUZONE, insulin, diltiazem XR, insulin glargine, warfarin, pravastatin, insulin regular, calcium plus vitamin D, CENTRUM SILVER, cholecalciferol, diltiazem, docusate sodium, fluticasone, lactobacillus, loperamide, omeprazole, oxymetazoline, polyethylene glycol, tramadol, TUMS E-X, vitamin E + magnesium. The patient previously took nitrofurantoin and experienced drug hypersensitivity and anaphylactic reaction, ibuprofen and experienced drug hypersensitivity, contrast media and experienced drug hypersensitivity. The patient experienced hepatitis/acute hepatitis on 29Oct2015 with outcome of recovering, shoulder and upper arm pain bilateral on Oct2015 with outcome of recovered, and thrombocytopenia on 30Oct2015 with outcome of recovered. The patient was hospitalized for hepatitis/acute hepatitis from 29Oct2015 to 03Nov2015. Clinical course was as follow: presented to the emergency department on 29Oct2015 with nausea and vomiting, yellowing of skin, and very dark urine. Onset of these symptoms took place about 2 days after receiving PREVNAR 13 from her primary care doctor on 27Oct2015. She was otherwise in normal state of health prior to that. AST/ALT/Alk Phos/D.Bili/GGT/INR all elevated on admission. On the night of the vaccination, the patient reported shoulder and upper arm pain bilaterally, which resolved prior to hospital admission. Nausea/vomiting/decrease appetite followed the shoulder/arm pain. Hepatic function, full blood count and INR and labs were monitored. Due to elevated INR her warfarin was held. Her bilirubin on 4.9 did improve down to 1.3, and then to 1.6. ALT and AST improved. Alkaline phosphate improved but then rose. GGT elevated. Ultrasound showed no obstruction. Labs show no viral or autoimmune or other cause of this hepatitis obstructive process. GI consulted, magnetic resonance cholangiopancreatography shows no stone or obstruction. She did have elevated LFT's on unknown cause years ago. Did have obstructing biliary duct stone in 2013 requiring MRCP and then ERCP and sphincterotomy. However no significant bile duct dilatation this time. Had cholecystectomy years ago. She does take some TYLENOL for pain and pravastatin. Was weak but improving. Thrombocytopenia resolved. CPK normal at admit. Other lab tests and procedures included aminotransferase: 19 on Sep2014, aspartate aminotransferase: 23 on Sep2014, bilirubin conjugated: <0.1 on Sep2014, blood alkaline phosphatase: 63 on Sep2014, chest x-ray: 2 views PA and lat on an unknown date, full blood count on an unknown date, international normalised ratio on an unknown date, liver function test on an unknown date, liver function test abnormal: 300 on 27Jul2012, magnetic resonance cholangiopancreatography on an unknown date: no stone or obstruction, ultrasound scan on an unknown date: showed no obstruction, ultrasound scan: distal common bile duct obstructing stone in 2013.