Age: 63.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain, Abnormal faeces, Computerised tomogram, Constipation, Decreased immune responsiveness
Clinical narrative: These case reports were previously actioned by Crucell (CRX-2013-001047). The data was taken directly from the company database repository and entered verbatim (including labeling and causality assessments) on to the company safety database. Where labeling and causality assessments were absent, company 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 was received from a 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). The patient's medical history was reported as insulin-dependent diabetes and post-colorectal cancer. It was noted that on 31.Jul.2013 the patient received ZOSTAVAX. No other concomitant medications were reported. On 19.Aug.2013, following the second oral VIVOTIF administration, the patient developed a very dry mouth and slight constipation. It was noted that the patient continued with the VIVOTIF and completed the course of 4 pills. On 26.Aug.2013 the patient was admitted to hospital because he continued to have 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 initially reported the event was also contacted but had no update on the 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 had received a hepatitis vaccination (manufacturer unknown). On 17.Aug.2013, 19.Aug.2013, 21.Aug.2013 and 23.Aug.2013 the patient had taken his VIVOTIF capsules correctly (batch no: 3000425, expiry date Feb. 2014). They had been taken 1 hour before a meal. He had been diagnosed with stage 1 colorectal cancer in Apr. 2009 which had been treated with surgery and has a fragile intestinal system. The VIVOTIF had an immediate effect on his bowel movements in that he had a thin slimy stool following the first dose and then constipation. The patient has had constipation before the VIVOTIF administration, but mild and took only mild laxatives. He also reported that he had become dehydrated and tired. He also had a fever but only in the beginning. It was reported that 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. It was suggested by the doctor that the patient continued with the lactulose for a few more days but again there was no effect. On 26.Aug.2013 the patient visited his oncologist who admitted him to hospital. A CT scan and x-rays were undertaken (no results reported). The patient was given two colonoscopy preps to clear his system with no result. No stools. The patient spent one day in hospital and he spent the following two weeks visiting various specialists. The patient reported that he had been taking a daily regimen of strong laxatives, such as castor oil, magnesium citrate, AMITIZA and now had watery bowel movements. At night he had about 8 watery bowel movements. The patient also reported that up to the present time he had been extremely dehydrated. In addition, he reported a raging thirst, drinking high quantities of water to satisfy his thirst. The patient also felt his quality of life had deteriorated although he was back at work. In the Hospital, both were excluded: Reoccurrence of rectal cancer and bowel obstruction. No further information was available. Follow-up information received from the patient on 27-Sep-2013. He still experienced the reported events, however as per the patient "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/resolving. Follow-up information received from the patient via GlaxoSmithKline (GSK ref number A1042488A) on 14-Oct-2013. Additional current medical condition included high blood pressure. Concomitant medication included insulin injections for diabetes, hydrochlorothiazide for unknown indication and unknown blood pressure medication. On 16-Aug-2013 at 06:15 pm, the patient received the first dose of injectable hepatitis A vaccine inactivated (manufacturer and batch number unknown). On 17-Aug-2013 at 3:00, 9 hours after vaccination with hepatitis A vaccine and the same day as the first VIVOTIF administration, the patient experienced injection site soreness. The pain subsided on an unknown date. In Aug.2013, less than a month after the hepatitis A vaccination, the patient experienced bruise and his arm swelled at injection site. At the time of this report, over a month after vaccination with hepatitis A vaccine and less than a month after completion of the VIVOTIF doses, the patient experienced also quality of life decreased. The outcome of injection site soreness, injection site bruising and injection site swelling was reported as resolved at the time of this report. No additional information was reported. Follow-up was received from the patient on 11.Nov.2013. The patient reported that he had further reduced his laxatives and, since 10.Oct.2013, has had normal bowel movements. The patient also reported that he had had two upper respiratory tract infections in a row, the first starting on an unspecified date at the end of Oct.2013 and the second on 05.Nov.2013. He was treated with antibiotics and at the time of reporting was recovering from the second episode. The patient expressed concern that the VIVOTIF had "weakened his autoimmune system". No further information was reported. Case updated on 11.Mar.2014 following "Data Quality Checking": Insulin was added as a concomitant medication and the pharmaceutical form was added for hydrochlorothiazide and VIVOTIF. Surgery was added in the patient's medical history, and the continuing field was amended to "yes" for the patient's current medical condition of hypertension NOS. The additional reactions of injection site pain, injection site bruising and quality of life decreased were added. Details of the CT scan and x-ray were appended. This case version was created on 30-OCT-2014 for the purposes of quality improvement. Upon review the following corrections were made: The batch number was confirmed as 300425 (previously reported as 3000425). Revision to the information received on 30-OCT-2014.