Sex: M
Vaccine: TYP
Symptoms: Malaria antibody test negative, Polymerase chain reaction, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: Lethargy; Dry cough; Gassy stools; Diarrhea; Abdominal cramping; Spontaneous report received on 23MAR2020.  A male consumer reported that he had dry cough (PT: Cough), lethargy (PT: Lethargy), gassy stools (PT: Flatulence), abdominal cramping (PT: Abdominal pain) and diarrhea (PT: Diarrhoea) while being on Vivotif for immunisation. On 28FEB2020, he took the first dose of Vivotif. After his first dose, he experienced a little abdominal cramping and loose stool and then it stopped. He also experienced a little bit of abdominal cramping and loose stool with the next dose of Vivotif. He stated it never got that bad so he completed his course. He stated that the abdominal cramps occur at night. He also stated his stool in the mornings were "gassy, soft, odorous, and semi-formed". He had one episode of true liquid diarrhea. His symptoms worsened 3-4 days after initiating the vaccine. The symptoms were "waxing and waning" for 2 weeks from the date of report. He completed his course of Vivotif on 06MAR2020. Three to four days after the last dose, he got significant abdominal cramping, lethargy, aches and cough. He stated that he was lethargic for 12-16 hours per day. Action taken with Vivotif with respect to the events "dry cough" and "lethargy" was not applicable while with respect to the events "gassy stools", "abdominal cramping" and "diarrhea" was dose not changed. The "dry cough" improved after the lethargy began but, the events "lethargy", "abdominal cramping", and "diarrhea" did not improve. The outcome of the event "gassy stools" was unknown  He visited his PCP (primary care provider) twice since the events began. His diagnostic tests included CBC (complete blood count- normal), chem 7 (normal), electrolytes (normal), covid-19 (coronavirus disease) was negative, initial malaria test (negative), flu test (negative), strep test (negative), dengue fever (result awaited), malaria PCR (polymerase chain reaction- result awaited) , bartonella test (result awaited), blood cultures (result awaited) and fecal cultures (result awaited).   He was not taking any concomitant medications.   He did not receive any treatment medications for his events.  Company Comment: A consumer started taking Vivotif and had abdominal pain, flatulence and diarrhea. He continued taking Vivotif doses and also experienced cough and lethargy. In response to the events, he consulted his physician twice and routine blood tests including initial malaria test, flu test, strep test and covid-19 tests were negative. Blood and fecal culture results were awaited. Cough was improved and the remaining events were not resolved. Considering the potential of Vivotif to cause abdominal pain, flatulence and diarrhea, the causality of these events is assessed as possible. Considering the case information, the causality of lethargy and cough is assessed as possible (role of vivotif cannot be ruled out). The case is considered non-serious as per medical assessment and case information.; Sender's Comments: A consumer started taking Vivotif and had abdominal pain, flatulence and diarrhea. He continued taking Vivotif doses and also experienced cough and lethargy. In response to the events, he consulted his physician twice and routine blood tests including initial malaria test, flu test, strep test and covid-19 tests were negative. Blood and fecal culture results were awaited. Cough was improved and the remaining events were not resolved. Considering the potential of Vivotif to cause abdominal pain, flatulence and diarrhea, the causality of these events is assessed as possible. Considering the case information, the causality of lethargy and cough is assessed as possible (role of vivotif cannot be ruled out). The case is considered non-serious as per medical assessment and case information.