Age: 68.0
Sex: F
Vaccine: TYP
Symptoms: Condition aggravated, Diarrhoea, Underdose
Clinical narrative: Fully intact Vivotif capsule was visible in the toilet; Fully intact Vivotif capsule was visible in the toilet; Diarrhea; Spontaneous report received on 13FEB2020.  A healthcare professional reported that a female consumer had diarrhoea (PT: Diarrhoea) while being on Vivotif capsule for immunisation. It was noticed by her that the fully intact capsule was visible in the toilet (PT: Product residue present and Product complaint). It was reported that she took the first dose of Vivotif and less than an hour after taking the pill she experienced diarrhea and noticed that the intact Vivotif capsule was visible in the toilet. Action taken with Vivotif with respect to event diarrhoea was unknown while that with fully intact capsule was visible in the toilet was not applicable. The outcome of the reported events was unknown.  Company Comment: A consumer had diarrhea and noticed fully intact vivotif capsule in stool in less than an hour after taking first dose of Vivotif. Information on medial history, concomitant medication and further details of the event is limited. This consumer had diarrhea within an hour of taking vivotif dose which could have led to the passage of intact vivotif capsule in the stool. Considering the potential of vivotif to cause diarrhea, the causality of the event is assessed as possible. The causality of capsule in stool and product complaint is assessed as unlikely. Product complaint would be further investigated.  Follow up information received on 20FEB2020.  A healthcare professional reported that the consumer took one dose of Vivotif on 12FEB2020 in the morning. She had colitis and due to that, diarrhea and stomach upset were common for her. She had discontinued the Vivotif after one dose and the injectable version of the typhoid vaccine was administered. The consumer had not seen any other medication in stool in the past before starting Vivotif.  Concurrent condition included microscopic colitis, Type 2 diabetes mellitus, arthritis, bladder cancer in remission for 1 year, hypertension and stomach upset.  Concomitant medication included losartan (25 mg; once daily), metformin (1000 mg; twice daily), meloxicam (15 mg; once daily), tramadol (100 mg; three times a day), amlodipine (5 mg; once daily) and Lexapro (escitalopram; 20 mg once daily).  The consumer mentioned that the event diarrhea was not related to Vivotif.  Company Comment: A consumer had diarrhea and noticed fully intact Vivotif capsule in stool in less than an hour after taking first dose of Vivotif. This patient has a history of colitis and frequent diarrhea and stomach upset are common for her. In response to the events, Vivotif was discontinued and she was give injectable typhoid vaccine. This consumer had diarrhea within an hour of taking Vivotif dose which could have led to the passage of intact Vivotif capsule in the stool. Considering her history of colitis with frequent diarrhea, the causality of diarrhea is assessed as unlikely with Vivotif. The causality of capsule in stool and product complaint is assessed as unlikely. Product complaint would be further investigated.; Sender's Comments: A consumer had diarrhea and noticed fully intact Vivotif capsule in stool in less than an hour after taking first dose of Vivotif. This patient has a history of colitis and frequent diarrhea and stomach upset are common for her. In response to the events, Vivotif was discontinued and she was give injectable typhoid vaccine. This consumer had diarrhea within an hour of taking Vivotif dose which could have led to the passage of intact Vivotif capsule in the stool. Considering her history of colitis with frequent diarrhea, the causality of diarrhea is assessed as unlikely with Vivotif. The causality of capsule in stool and product complaint is assessed as unlikely. Product complaint would be further investigated.