Sex: F
Vaccine: VARZOS
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Asthenia, Blood albumin decreased, Blood bilirubin decreased
Clinical narrative: acute viral syndrome; This subject was enrolled in a blinded study. The subject received daprodustat (gsk1278863) vs rhepo from 27th July 2018, for chronic renal failure anemia.   On 12th June 2019, 320 days after the first dose of daprodustat (gsk1278863) vs rhepo, the subject developed mild - grade 1 weakness generalized. Serious criteria included clinically significant/intervention required. Daprodustat (gsk1278863) vs rhepo was continued with no change. The outcome of weakness generalized was recovered/resolved on 16th June 2019.   The investigator considered that there was no reasonable possibility that the weakness generalized may have been caused by daprodustat (gsk1278863) vs rhepo.  Follow up information received on 03 Jul 2019: The subject's demographics age sex (Female) and weight (88.1 kg) were included. This 71 year old female subject was enrolled in a blinded study. Concurrent medical conditions End stage renal disease and Diabetic peripheral neuropathy were included. The Seriousness Criteria of the event Generalized weakness is updated to requires or prolongs hospitalization (Previously it was clinically significant) Other possible cause of the event Generalized weakness included medical condition (End stage renal disease and Diabetic peripheral neuropathy). Concomitant medications sevelamer carbonate, pantoprazole dr, gabapentin, docusate, diltiazem and apixaban were included. Treatment medications 0.9 percent sodium chloride, acetaminophen, albumin, ceftriaxone, hydrocodone-acetaminophen 5-325, insulin glargine, lidocaine 5% patch, senna, simethicone and vancomycin were included. Other Relevant Risk Factors were none.  Relevant lab: On 14 Jun 2019: labs baseline for patient glucose 175, 307. On 16 Jun 2019: labs baseline for patient except glucose 169. On 15 Jun 2019: normal x ray for pelvis, left. Elbow, right. Elbow, lumbar x ray no evidence of acute trauma. Right and left knee no evidence of fracture were included.  Narrative remark: 14 jun2019 subject went to  emergency room and complained of generalized weakness and myalgia's x2 days since receiving shingles vaccine. Upon admission, patient started vancomycin or ceftriaxone, discharged on 14 Jun 2019 low suspicion for bacterial process. Patient missed dialysis of 11 Jun2019, 13 Jun2019 and 15 Jun2019. patient reported fall at home, patient monitored closely at hospital due to high fall risk. Patient denied head strike. Knee, elbows, pelvis and lumber spine x ray completed. Patient discharged with pain controlled, per oral tolerated, worked with physical therapy or occupational therapy.  Query responses: The site confirmed that the primary discharged diagnosis was generalized weakness. Thought to be a result of Acute Viral Syndrome indicated as separate AE(Adverse event).  Follow up information received on 05 Jul 2019: Verbatim was updated to acute viral syndrome (previously reported generalized weakness). Relevant assessment: On 15 Jun 2019 total bilirubin was 0.1, Alanine aminotransferase was 13, Aspartate aminotransferase was 17. On an unknown date albumin was 3.1. Query response: Site confirmed that albumin for subject was baseline 3.1, but low comparatively to reference ranges. No loss of consciousness, arrhythmias or seizures noted by subject or discharge summary. Glucose reference range was 70-100 mg/dL.  Follow up information received on 22 Jul 2019 : Shingrix was updated as concomitant medication. Narrative remark: 14 Jun2019 subject went to emergency room and complained of generalized weakness and myalgia's x2 days since receiving shingles vaccine (Shingrix).  Follow up information received on 24 Jul 2019 and 26 Jul 2019 : The adverse event (Acute viral syndrome) form includes following information : Narrative remarks : Weakness and myalgias were deemed likely due to recent shingles vaccine (Shingrex), Per discharge summary. Patient presented with general weakness & myalgias x 2days, post-shingrix dose. Patient was admitted and monitored. Influenza panel was negative and workout unremarkable. Symptoms improved with care and deemed likely due to shingrix. Query response from site : The site confirmed that shingles vaccine (SHINGRIX) was likely the cause of the weakness and myalgias patient discharge summary shows that.  Follow up information received on 14 Aug 2019 : The intensity of the event (Acute viral infection) was updated to Moderate-Grade 2 (Previously reported as Mild Grade-1). Query response from site : The event term was verified and updated.  Follow up information received on 20 Aug 2019 : Shingrex updated as co suspect medication. The subject was vaccinated with shingrex on 12 Jun 2019 the dose was 50 ug single. The other possible cause for the event was updated as concomitant medication and medical condition. (Previously reported only medical condition). Narrative remarks : 14 Jun2019 subject went to  emergency room and complained of generalized weakness and myalgia's x2 days since receiving shingles vaccine (Shingrex). Query response from site : The site confirmed that fall was caused by generalized weakness -fall was reported as AE and generalized weakness reported as AE .; Reporter's Comments: The company considers that there was no reasonable possibility that the event viral infection may have been caused by the study drug. The patient's medical history/risk factors could be considered as confounding factors. The co-medication (shingrix) could be considered as alternative cause.