Age: 46.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain, Computerised tomogram abdomen normal, Diarrhoea, Enema administration, Flatulence
Clinical narrative: These case reports were previously actioned by Crucell (CRX-2013-001116). 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 forwarded by Crucell with the reference number CVAE-056-2013. Initial spontaneous case received on 11-Sep-2013 from a physician and from the patient and processed together with follow-up information received on 13-Sep2013 from the physician, which concerns a 46-year old male patient who received 3 oral doses of Vivotif (batch 3000421, expiry date not reported), as a prophylactic vaccination. First dose of Vivotif taken on unspecified date in Aug-2013 (24.Aug.2013 and 25.Aug.2013 were reported), second capsule on 27-Aug-2013 and third capsule on 29-Aug-2013 respectively. The patient did not take the fourth capsule. The patient had no medical pre-existent condition. The physician reported the patient had normal physical examination with normal routine chemistries and complete blood count (CBC) before vaccination. Concomitant medication not provided. On 26-Aug-2013, the patient experienced diarrhea. On 27-Aug-2013, he took second dose and experienced intense abdominal pain. On 28.Aug.2013, the pain subsided, but not completely. After intake of the third capsule of Vivotif, on 29-Aug-2013, the patient reported recurrence of intense abdominal pain and diarrhea. Tests showed negative / normal abdominal CT and MRI, normal blood tests after the patient stopped the vaccine course two weeks before the date of this report. No treatment taken for the reported events. The reporting physician was considering antibiotic therapy with azithromycin or ciprofloxacin to treat the patient. As per the physician, at the time of report, the patient still having persistent burning abdominal pain and diarrhea several weeks after vaccine administration. The events were assessed as serious, medically important by the reporter physician. No further details were provided. Follow-up information received from the patient on 04.Oct.2013: The expiry date of the Vivotif capsules used was 31.Jan.2014. The patient had no concomitant medications. The patient reported he was 90% recovered. No medication was prescribed to treat symptoms. After several unspecified tests, which all came out normal, it was determined that the patient was producing excessive gas. Treatment included enema, which helped. Case updated on 11.Mar.2014: Test previously coded as 'CT scan' was recoded to 'computerized tomogram abdomen'. Pharmaceutical form of Vivotif was updated as 'capsule'. Initial receipt date previously reported as 12.Sep.2013 in the narrative was corrected to 11.Sep.2013. Case version [4] was created using [11-MAR-2014] as the date to action case quality corrections to legacy data. The following fields were updated [Country Where Drug Obtained] no other changes were made to the case.