Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Culture stool positive, Culture urine, Death, EGFR status assay, Eosinophil count increased
Clinical narrative: This is a spontaneous report from a contactable nurse. A 73-year-old female patient received PREVNAR 13, (Lot unknown) 0.5 ml single, intramuscular in the left deltoid on 23May2016 for immunisation. Medical history included hypertension, type 2 diabetes mellitus, renal failure, depression, renal transplant, lipidosis, vitamin d deficiency, heart palpitation and pain. Concomitant medication included TYLENOL for pain from 29May2013, NORVASC from 04Jan2016, CELEXA for depression from 23May2016, VITAMIN D3 for Vitamin D deficiency from 03Aug2011, LASIX from 25Jan2016, GLUCOTROL for Diabetes type 2 from 29May2016, LOPRESSOR from 22Jan2014, CELLCEPT from 02Jul2013, DELTASONE from 03Mar2016, ZANTAC from 18Sep2013, PROGRAF from 02Jul2013, and LEVEMIR. The patient experienced bronchopneumonia on an unspecified date and died on 17Jun2016. The autopsy was done. The cause of death was Bronchopneumonia. The nurse mentioned that the day of vaccination it was reported that the patient was clear with her lungs. The patient underwent lab tests and procedures which included: On 26May2016, blood culture no growth detected, Influenza virus test not detected. On 27May2016, clostridium difficile colitis not detected, Culture stool: Mixed flora, probable contamination; Leukocytes were positive for wbc and urine culture; Negative for shigella and campylobacter Yersinia; Negative for salmonella. On 28May2016, blood thyroid stimulating hormone 1.09, Sputum culture: polymorphonuclear leukocytes; Respiratory flora, light gram positive cocci. SP4 was 1.45. On 02Jun2016, Alanine aminotransferase 19, anaplastic lymphoma kinase gene mutation 81, anion gap 10, aspartate aminotransferase 20, atrioventricular block , base excess -7, basophil count 0.2 , blood albumin 2.1, blood calcium 1.04 and 7.8, blood bilirubin 1, blood bicarbonate 18.9, blood chloride 103, blood creatinine 3.2, blood glucose 161 and 196, blood lactic acid 0.93, blood magnesium 2, blood phosphorus 4.7, blood potassium 3.8, blood sodium 134, blood triglycerides 163, blood urea 44, blood urea/creatinine ratio 14, brain natriuretic peptide 454, carbon dioxide 21, EGFR status assay 17, eosinophil count 4.5, fraction of inspired oxygen 90, haematocrit 30.9, haemoglobin 10.2, International normalised ratio 1.1, lymphocyte count 13.7 and 1.2, monocyte count 9.8 and 0.9, neutrophil count 70.2, oxygen saturation 90, PCO2 39.9 and 20, protein total 5.7, prothrombin time 12.4, red blood cell count 3.59, white blood cell count 20 and 8.8, pH body fluid 7.284, pH urine 5.0, Rate hz arterial 7, Prest/tinsp arterial 26, Peak arterial 10. Sender's Comments: Based on the information provided in the case, a lack of efficacy with PREVENAR 13 in this patient cannot be excluded. Further information like causative agent and serotyping results is needed for a full medical assessment. 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. Reported Cause(s) of Death: Bronchopneumonia.