Sex: M
Vaccine: PNC13
Symptoms: Ileus, Mechanical ventilation, Muscle spasms, Nausea, Pain
Clinical narrative: This is a report from a Pfizer-Sponsored Interventional Study. A 77-years-old male subject received blinded therapy (PF-06290510; PLACEBO), intramuscular at single dose on 17May2017 for the prevention of postoperative invasive disease cause and PREVNAR 13, intramuscular at 0.5 ml, single on 31May2017 for pneumonia. Study drug most recent dose before the event was 320 mcg/vial. Medical history included hypertension (diet controlled, no antihypertensive), hyperlipidaemia from Nov2004 and ongoing (CRESTOR), hypothyroidism from Nov2004 and ongoing (SYNTHROID), acquired flat back syndrome from Apr2017 (reason for index surgery), benign prostatic hypertrophy in Sep2014, melanoma from 1996 to 1996 (s/p resection right flank), lumbar stenosis from Apr2001 and ongoing (s/p laminectomy 2001, 2013, reason for index surgery), glaucoma from 11Oct2016 and ongoing (uses Timolol Ophthalmic drops). Concomitant medication included paracetamol from 30May2017 and ongoing, albumin human from 30May2017 to 30May2017 for volume expander during surgery, bisacodyl from 01Jun2017 to 01Jun2017 for treat constipation, calcium gluconate from 30May2017 to 30May2017 for treat low ionized calcium level, cefazolin from 30May2017 to 31May2017 for surgical antibiotic prophylaxis, cyclobenzaprine from 30May2017 to 04Jun2017 for treat post-op muscle spasm, dexmedetomidine from 30May2017 to 30May2017 for surgical anesthesia/sedative, sodium amidotrizoate 05Jun2017 to 05Jun2017 for contrast for CT scan, diphenhydramine from 30May2017 to 31May2017 for prevention of blood transfusion reaction, ephedrine from 30May2017 to 30May2017 for prevent hypotension during surgery/Anesthesia, epinephrine from 30May2017 to 30May2017 for prevent hypotension during surgery/Anesthesia, fentanyl from 30May2017 to 30May2017 for Anesthesia for surgery, glycopyrronium from 30May2017 to 30May2017 for anesthesia reversal, heparin from 31May2017 and ongoing for deep venous thrombosis prevention, hydromorphone from 31May2017 to 31May2017 for post op pain control, ketamine from 30May2017 to 30May2017 for analgesia during surgery, ketorolac from 05Jun2017 and ongoing for treat post op pain, levothyroxine on ongoing for treat Hypothyroidism, lidocaine from 30May2017 to 30May2017 for perioperative anesthesia, magnesium hydroxide from 01Jun2017 to 01Jun2017 for supplement magnesium levels, midazolam from 30May2017 to 30May2017 for Anesthesia/sedation for surgery, morphine from 30May2017 to 30May2017 for Anesthesia for surgery, neostigmine from 30May2017 to 30May2017 for anesthesia reversal, norepinephrine from 30May2017 to 30May2017 for blood pressure support/ prevent hypotension during surgery/anesthesia, ondansetron from 30May2017 to 30May2017 for treat post op nausea, oxycodone from 31May2017 to 04Jun2017 for treat post op pain, pantoprazole from 31May2017 and ongoing for prophylaxis for gastric ulcer, phenylephrine from 30May2017 to 30May2017 for prevent hypotension during surgery/anesthesia, macrogol from 01Jun2017 to 04Jun2017 for treat constipation, potassium chloride from 05Jun2017 to 05Jun2017 for supplement to treat hypokalemia, propofol from 30May2017 to 30May2017 for sedation during surgery, rocuronium bromide from 30May2017 to 30May2017 for neuromuscular blockade for intubation/ventilation, rosuvastatin on ongoing treat hyperlipidemia, senna alexandrina from 30May2017 to 04Jun2017 for treat constipation, simethicone from 04Jun2017 to 05Jun2017 for treat excessive abdominal bloating/gas, sodium bicarbonate, sodium phosphate dibasic from 02Jun2017 to 02Jun2017 for treat constipation, suxamethonium chloride from 30May2017 to 30May2017 for muscle relaxant for intubation/ventilation, tamsulosin on ongoing for treat benign prostatic hypertrophy, timolol on ongoing for treat glaucoma, tranexamic acid from 30May2017 to 30May2017 for treat blood loss from surgery. The subject experienced ileus (hospitalization) on 06Jun2017 with outcome of recovering. The patient underwent lab tests and procedures which included abdominal X-ray: colonic distention on 02Jun2017, abdominal X-ray: ileus on 04Jun2017, abdominal X-ray: stable ileus on 05Jun2017, computerised tomogram abdomen: mild ileus; no bowel obstruction on 05Jun2017. Therapeutic measures were taken for the event included milk and molasses enema from 02Jun2017 to 02Jun2017 and Smog (saline, mineral oil, glycerin) enema from 04Jun2017 to 04Jun2017.  The clinical course was as follows: the subject with acquired flat back syndrome and lumbar stenosis, who underwent a T11-pelvis posterior instrumented fusion with an L3-4 and L6-S1 transforaminal lumbar interbody fusion on 30May2017. Post op course was initially unremarkable with the exception of abdominal distention that began on 02Jun2017, and constipation. Abdominal x-ray done on 04Jun2017 confirmed post-op ileus. Acute care surgery was consulted. Subject was made NPO and received 2 enemas. A nasogastric tube was placed on 05Jun2017. On 06Jun2017, subject reported improving symptoms, including having a bowel movement and reduced abdominal discomfort, and the nasogastric tube was removed. The diagnosis of ileus was determined to be progression from an adverse event to a serious adverse event due to prolongation of the subject's expected length of stay (7 days) post-op. The subject remains hospitalization as of 06Jun2017. The investigator considered there was not a reasonable possibility that the event was related to the study drug SA4Ag vaccine or placebo, concomitant drugs and clinical trial procedure. The reporter's assessment of the causal relationship of the event with the suspect product PREVNAR 13 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Sender's Comments: The company agrees with the assessment of the investigator and does not attribute the case to study therapy based on the information currently available, the known adverse event profile of the suspect product and the pathophysiology of the event.