Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Headache, Insomnia
Clinical narrative: DIARRHEA; STOMACH PAIN; HEADACHE; VOMITING; TIREDNESS; This spontaneous case report was received from a consumer on 15-Jan-2019 and a follow-up was received on 16-Jan-2019. The report describes a male consumer who experienced diarrhea, stomach pain, headache, and vomiting following the intake of Vivotif for typhoid prophylaxis. The consumer also experienced tiredness from not sleeping last night.  The consumer's concomitant medication included simvastatin (40 mg daily) for cholesterol, citalopram (10 mg daily as happy pill, and multivitamin. The consumer's past medication included peg-intron for cancer treatment.  It was reported that the consumer took the fourth dose of Vivotif on 14-Jan-2019 and he woke up with diarrhea, stomach pain, a bad headache, and vomiting. At the time of the call, he had light stomach pain, a light headache, and a little bit of fatigue, but he stated that the fatigue was from not getting much sleep last night. He was getting much better as the day went on. He stated that he was able to eat everything now. He had not taken any treatment for his adverse events.   He stated that he had no medical history of headaches, although he had finished treatment about a year ago for cancer (melanoma), and the cancer treatment (peg-intron) had given him headaches. He had stopped taking the treatment in Mar 2018. The consumer had been taking citalopram for about a year and seven months, and simvastatin for fifteen years or so.   The action taken with Vivotif with respect to the events diarrhea, stomach pain, headache, vomiting, and tiredness was not applicable.  The clinical outcome of the events diarrhea, stomach pain, headache, vomiting, and tiredness was resolved.  The reporter's causality with respect to the events diarrhea, stomach pain, headache, and vomiting was not provided while with respect to the event tiredness was not related.  Company Comment: In this case a male consumer experienced diarrhea, stomach pain, headache, vomiting following the intake of Vivotif. The consumer also experienced tiredness from not sleeping the last night. There seems to be a temporal association between the intake of the vaccine and the events diarrhea, stomach pain, headache and vomiting. Also, diarrhea, stomach pain, headache and vomiting are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. The causality of the event tiredness was assessed as not related with Vivotif as it was associated with the reported events.; Sender's Comments: Company Comment : In this case a male consumer  experienced diarrhea, stomach pain, headache, vomiting following the intake of Vivotif. The consumer also experienced tiredness from not sleeping last night.There seems to be a temporal association between the intake of the vaccine and the events diarrhea, stomach pain, headache and vomiting. Also, diarrhea, stomach pain, headache and vomiting are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. The causality of the event tiredness was assessed as not related with vivotif as it was associated with the reported events.