Sex: M
Vaccine: HEP, TYP
Symptoms: Abdominal pain, Diarrhoea haemorrhagic, Hyperhidrosis, Mucous stools
Clinical narrative: Sweating through the entire t-shirt; Severe abdominal cramping; Diarrhea with bloody mucus; Bloody mucus alone; A spontaneous report was received from a 54-year-old male patient on 12JAN2023. On 10JAN2023 at 8:00 PM, the patient took the first dose of Vivotif capsule (Typhoid vaccine live oral Ty21A) (lot number: unknown) followed by a hepatitis B vaccine at 1:30 PM for immunisation. The patient subsequently had "diarrhea with bloody mucus" (PT: Diarrhoea haemorrhagic), "bloody mucus alone" (PT: Mucous stools), "severe abdominal cramping" (PT: Abdominal pain) and was "sweating through the entire t-shirt" (PT: Hyperhidrosis).  The patient's medical history included high blood pressure, high cholesterol and had seasonal allergies.  Concomitant medications included verapamil (verapamil hydrochloride; 240 mg once a day), Lisinopril-HCTZ (hydrochlorothiazide, lisinopril; 10 or 20 mg once a day), pravastatin (once a day), omeprazole (10 mg once a day), Mens multivitamin (ascorbic acid, calcium pantothenate, cyanocobalamin, ergocalciferol, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin sodium phosphate, thiamine mononitrate, tocopheryl acetate; once a day), Coq10 (ubidecarenone; once a day) and Vitamin D (ergocalciferol; once a day).  On 11JAN2023 at 3:15 AM (in the middle of the night), the patient woke up with severe abdominal cramping and was sweating through his entire t-shirt. Reportedly after that, the patient spent the next 10 hours in and out of the bathroom due to diarrhea with bloody mucus and bloody mucus alone. The patient did not do any lab work or specific tests for the reported events and did not take any medications specifically to address the symptoms other than his standard medications. Furthermore, the patient reached out to his doctor who advised him to stop taking the medication, therefore no further doses of Vivotif were administered by the patient. The patient stated that he got considerably better but had still been experiencing some cramping and the bloody mucus was not resolved. Additionally, it was reported that the patient did not make any changes before, during or after stopping the Vivotif, to his medication list.  The patient was recovering from the event of "severe abdominal cramping" but had not recovered from the event "bloody mucus alone". The outcome of the reported events "diarrhea with bloody mucus" and "sweating through the entire t-shirt" were unknown. Action taken with Vivotif with respect to the reported events was drug withdrawn while action taken with hepatitis B vaccine was not applicable.  No additional information was reported.  Company comment: A consumer took the first dose of Vivotif for immunisation and had diarrhea with bloody mucus (Diarrhoea haemorrhagic), bloody mucus alone (mucous stools), severe abdominal cramping (abdominal pain) and was sweating through the entire t-shirt (hyperhidrosis). He also received the hepatitis B vaccine along with Vivotif. Considering the case information, the role of Vivotif cannot be ruled out, and the causality of diarrhoea haemorrhagic, mucous stools, abdominal pain and hyperhidrosis is assessed as possible (confounded by hepatitis B vaccine. The case is considered serious due to the medical significance of  diarrhoea haemorrhagic. Diarrhoea haemorrhagic, mucous stools and hyperhidrosis are unlisted as per package insert. Abdominal pain is considered listed as per package insert.  Company Comment:; Sender's Comments: A spontaneous report case regarding a 54-year-old male with medical history of hypertension, hypercholesterolemia, and seasonal allergies who experienced abdominal pain and hemorrhagic and mucoid diarrhea the following day after the administration of Vivotif and Hepatitis B vaccine (preceded Vivotif administration) for immunization. Concomitant medications included verapamil, lisinopril-hydrochlorothiazide, pravastatin, omeprazole, multivitamin, Coq10 and vitamin D. No treatment of event or hospitalization was reported. Patient reported an improvement in his symptoms and the recommendation to discontinue the Vivotif treatment after a single dose. The outcome of the event is reported as not resolved as the time of reporting by the consumer. No details regarding the treatment of event. Diarrhea is a known effect from both vaccines and bloody diarrhea has been reported with Hepatitis B vaccine with unknown specific incidence. The causality of the hemorrhagic diarrhea is assessed as related to Vivotif with the confounding by the Hepatitis B vaccine administration.