Age: 27.0
Sex: F
Vaccine: RAB
Symptoms: Myalgia, Nausea, Oropharyngeal pain, Pyelonephritis, Pyrexia
Clinical narrative: Initial report (SAE report) received on 20 March 2013 and follow up information received on 21 March 2013 from an investigator participating in a study. A 27-year-old female subject was diagnosed with urinary tract infection on 19 March 2013 i.e. 20 days after receiving second dose of Purified Vero Rabies Vaccine - Serum Free on 27 February 2013 (Batch number, route and site of administration not reported). The subject received first dose of the study vaccine on 19 February 2013. The subject had no reported medical history. The subject had no reported concomitant therapies. On an unspecified date, the subject was hospitalized due to urinary tract infection. The lab investigations were not reported. The corrective treatment details were not reported. The outcome of the event of urinary tract infection was not reported. The event of urinary tract infection was not related to the study vaccine or to the trial procedure. The serious adverse event did not lead to the termination of the subject from the study. List of documents held by sender: None. Follow up information received on 26 March 2013 and 02 April 2013: The event term was updated to pyelonephritis with urosepsis from urinary tract infection. The subject was diagnosed with pyelonephritis with urosepsis on 17 March 2013 i.e. 18 days after second intramuscular dose of Purified Vero Rabies Vaccine - Serum Free in the left deltoid on 27 February 2013. The subject had no medical history. The subject was concomitantly on DEPO-PROVERA 1 ml intramuscular indicated as contraception from an unspecified date in 2005, Sertraline 50 mg per os indicated for anxiety from an unspecified date in November 2010 to 19 March 2013, ALLEGRA D 24 1 tab per os indicated in allergies from an unspecified date in 1998, Ibuprofen 500 mg per os indicated for headaches from an unspecified date in 2003, BACTRIM 500 mg per os indicated for urinary tract infection from 17 March 2013 to 18 March 2013 and ZOFRAN 4 mg per os indicated for nausea and vomiting from 17 March 2013 to 19 March 2013. The subject had nausea, fever 101.4, myalgia, abdominal pain, dry mouth, constipation, sore throat and headache on 17 March 2013. The subject was admitted to the hospital on 19 March 2013 due to symptoms that were consistent with pyelonephritis. The subject had no corrective treatment and lab investigations. The associated symptoms of nausea, fever 101.4, myalgia, abdominal pain, dry mouth, constipation, sore throat and headache were resolved on 21 March 2013. The event of pyelonephritis with urosepsis was ongoing at the time of report. However the subject was discharged from the hospital on 21 March 2013. Follow up information received on 07 May 2013: The event was updated to pyelonephritis from pyelonephritis with urosepsis. The subject was diagnosed with pyelonephritis on 14 March 2013 and not on 17 March 2013 as reported earlier i.e. 15 days after receiving second intramuscular dose of Purified Vero Rabies Vaccine - Serum Free in the left deltoid on 27 February 2013. The subject has a past medical history of recurrent urinary tract infections over the last 3 years and anxiety. BACTRIM and ZOFRAN were no longer reported as concomitant medications. The subject also had symptom of urinary tract infection from 14 March 2013 which resolved on 17 March 2013. The subject went to E.R. and was hypotensive after being treated for urinary tract infection 3 days ago. The subject began having bilateral flank pain, nausea and vomiting and complained of fevers as high as 101.8, sweats and chills. The subject received corrective treatment with BACTRIM, ZOFRAN, Ciprofloxacin, Lorazepam, Phenazopyridine, IV URASYN, Morphine and REGLAN. The subject recovered from the event of pyelonephritis on 04 April 2013. Unblinding information received on 03 October 2013: The subject received IMOVAX rabies TM as 2nd dose of study vaccine. Code broken date was 26 September 2013. Follow up information received on 19 October 2013 and 22 October 2013: The subject received third dose of the study vaccine IMOVAX rabies TM on 25 March 2013. The investigator has results for the urine culture but it appeared that the hospital did not include the blood culture results with the medical records. The investigator will call and see if they could send them to them and then update the EDC. Follow up information received on 16 January 2013 and 17 January 2013: Urine culture showed >100,000 cfus/ml E.coli. Medical records show that a Bcb was ordered but results were never received site had requested them. According to the investigator, the date of onset was 14 March 2013. Treatments were provided in the section and there were no previous episodes of urinary tract infection.