Age: 63.0
Sex: M
Vaccine: TYP
Symptoms: Dry mouth, Fatigue, Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: These case reports were previously actioned by Crucell (CRX-2013-001047). The data was taken directly from the database repository and entered verbatim (including labeling and causality assessments) on to the safety database. Where labeling and causality assessments were absent, facility took the decision to assign according to company guidelines. This case was received from a nurse and forwarded by Crucell, No: CVAE-049-2013. An initial report received from nurse on 26.Aug.2013 and concerns a 63-year-old male patient who, on 17.Aug.2013, received the first oral administration of Vivotif (batch no: not reported) as  prophylactic vaccination. The patient's medical history reported as insulin-dependent diabetes and post-colorectal cancer. It was noted that on 31.Jul.2013 the patient received Zostavax vaccine as prophylactic vaccination. No other concomitant medications were reported. On 19.Aug.2013, following the second oral Vivotif administration, the patient developed dry mouth and slight constipation. The patient continued with the Vivotif and completed the course of 4 pills. On 26.Aug.2013 the patient was admitted to hospital for bowel blockage. No further information was available. At the date of the report, the outcome of the events was unknown. The events were considered serious (hospitalisation). Follow-up information received on 16.Sep.2013 from the patient's wife and the nurse: The patient received treatment for the adverse events on 16.Sep.2013. The patient's wife reported that he was still going through tests in hospital. The nurse who reported the event was contacted but had no update on patient's condition. At the time of this report no hospital record was available. Follow-up information was received from the patient on 18.Sep.2013. It was reported that on 13.Aug.2013 the patient received a hepatitis vaccination (mfr unknown) as a prophylactic vaccination. On 17th, 19th, 21st and 23 of Aug2013, the patient had taken his Vivotif capsules correctly (batch no: 3000425, expiry date Feb.2014), 1 hour before a meal. He was diagnosed with stage 1 colorectal cancer in Apr.2009 which was treated with surgery and has a fragile intestinal system. The Vivotif had an immediate effect on his bowel movements with a thin slimy stool following the first dose and then constipation. The patient had had constipation before the Vivotif administration, but mild and took only mild laxatives. He also reported that he had become dehydrated and tired. He had a fever in the beginning. On 24.Aug.2013 the patient had gone 4 days without bowel movements. At his oncologists suggestion he went to the emergency room to check for a bowel obstruction. The patient was prescribed lactulose to no effect. The physician suggested the patient continued with the lactulose for a few more days but there was no effect. On 26.Aug.2013 the patient visited his oncologist who admitted him to hospital. CT scan / x-rays were undertaken (no results reported). Two colonoscopy preps to clear system with no results. The patient had been taking daily regimen of strong laxatives, such as castor oil, magnesium citrate, Amitiza (lubiprostone) and had watery bowel movements. At night he had about 8 watery bowel movements. The patient reported that he been extremely dehydrated and reported a raging thirst, drinking high quantities of water. The patient also felt his quality of life had deteriorated although he was back at work. In the Hospital, both were excluded: Reoccurence of rectal cancer and bowel obstruction. Follow-up information rcvd from patient on 27-Sep-2013: He still experienced the reported events, however ''it is slowly getting better''. The patient reported he reduced the extreme amount of laxative therapy since 23-Sep-2013. Ongoing laxatives are unspecified stool softener and magnesium. He reported to have bowel movements with low amounts of soft stool, he had no diarrhea during the night. Abdominal pain and cramping resolved on an unknown date. He still suffers from thirst, he is tired however this condition is improving. At the time of this follow-up, the outcome was resolving / recovering. Follow-up information received from the patient on 04.Oct.2013: The patient reported that he was feeling physically much better, had no fatigue anymore, but was still a bit thirsty. He further reduced the stool softener, he even had watery bowel movements. At the time of this report the outcome was still recovering. Follow-up from patient (pt) via GlaxoSmithKline (GSK A1042488A) 14-Oct-2013: On 16-Aug-2013, pt rcvd hepatitis A vaccine (mfr / batch unknown). On 17-Aug-2013, pt experienced injection site soreness. Pain subsided on unknown date. In Aug.2013, pt experienced bruise and arm swelled at injection site. Month after hepatitis A vaccine, less than month after Vivotif doses, pt experienced quality of life decreased. Outcome of injection site soreness, injection site bruising, injection site swelling reported resolved. Followup from pt on 11.Nov.2013: Pt reduced laxatives and since 10.Oct.2013 had normal bowel movements. Pt had 2 respiratory infections end Oct.2013 and 05.Nov.2013. Treated with antibiotics and recovering. Pt concerned Vivotif weakened autoimmune system. Post Data Quality Checking of ICSRs transmitted to EV: Insulin added as medication, Formulations added for hydrochlorothiazide, Vivotif. Surgery added in med hx, continuing field amended yes, for hypertension. Reactions of inject site pain, inject site bruising, quality of life decreased added.