ACID REFLUX; REGURGITATED DOSE; BIT INTO THE REGURGITATED DOSE; FEVER; This spontaneous case report was received from consumer (PVX2019-161) on 17-Jan-2019 and a follow-up was received on 18-Jan-2019. The report describes a 54-year-old adult male consumer who experienced acid reflux, regurgitated dose, and fever following the intake of oral Vivotif capsule (one dose every other day; lot no: 3003239 and expiry date: Nov 2019) for typhoid prevention. The consumer also "bit into the regurgitated dose".  The consumer did not take any other medications or have any pre-existing health conditions.  It was reported that the consumer took his first dose of Vivotif on 16-Jan-2019 on an empty stomach with 15 to 20 oz. of cold tap water. He had his breakfast about 2.5 hours. Later, he had spaghetti for lunch. He went for a walk and then had dinner and a snack. He stated he had soybeans in the evening. Later that night around midnight, about 13 hours to 14 hours after taking the Vivotif dose, he regurgitated it and accidentally bit into it. He stated he did not vomit but had acid reflux and regurgitated the dose. The capsule was intact and the lettering on the capsule was still there. It did not dissolve at all. When he bit into the capsule inadvertently, there was some juice that came out of it that he believed was the vaccine serum. He stated he had acid reflux at night about 2 to 3 times a month, not frequently enough to receive treatment for it.   He also reported that he had a mild fever after taking the first dose. He said this lasted for a few hours in the afternoon on 16-Jan-2019. He said he broke his fever because he had a little bit of a sweat around 06:00 PM that day. He did not take anything to treat the fever.   The consumer stated that his physician advised him to take Pepcid (famotidine) 20 mg at 7:30 AM, then eat breakfast at 8:00 AM, take Vivotif at 11:30 AM, and eat lunch around 1:00 PM. His physician advised him to drink 8 to 10 glasses of water throughout the day because he thinks there was not enough fluid in his body to get Vivotif to the "gut" or intestines.  He took his second dose on 18-Jan-2019 around 11:30 AM. This was after taking Pepcid at 07:30 AM. The consumer stated he had not been diagnosed with acid reflux and had not received treatment for it. He had at most 2-3 acid related incidents per month. Sometimes, he goes several months without any incidents. He is unsure exactly how long this had been happening for, but stated it was for years. He stated he usually does not get upset stomach or belching but this acid incident happens very occasionally. He repeated he did not have acid reflux. He was aware that certain foods trigger this. He stated his trigger was spicy Italian food, and he agreed that the spaghetti he consumed for lunch on 16-Jan-2019 was spicy Italian food. He stated he had never regurgitated a capsule before. He confirmed he had never smoked or consumed alcohol.   The laboratory test included body temperature that was found to be 100-degree Fahrenheit.  The action taken with Vivotif with respect to the events acid reflux, regurgitated dose, fever, and "bit into the regurgitated dose" was dosage maintained.  The clinical outcome of the events acid reflux, regurgitated dose, and "bit into the regurgitated dose" was unknown and with respect to the event fever was resolved.  Company's Comment: In this case, a 54-year-old adult male consumer experienced acid reflux, fever and regurgitated the dose following the intake of oral Vivotif capsule. The consumer also "bit into the regurgitated dose". Although, the events were reported with reasonable time relationship to intake of the Vivotif vaccine, the patient had similar episodes of acid reflux in the past. He also consumed spicy Italian food earlier that day which could have triggered acid reflux and regurgitation of dose. Hence the causality of the events acid reflux, regurgitated dose was assessed as unlikely. The event fever was reported with reasonable time relationship to intake of the vaccine. Also, fever is labeled as per CCDS. Hence, the causality of the event fever with Vivotif is assessed as possible. The causality of the event "bit into the regurgitated dose" was considered as not applicable. ; Sender's Comments: Company's Comment: In this case, a 54-year-old adult male consumer experienced acid reflux, fever and regurgitated the dose following the intake of oral Vivotif capsule.The consumer also "bit into the regurgitated dose". Although, the events were reported with reasonable time relationship to intake of the Vivotif vaccine, the patient had similar episodes of acid reflux in the past. He also consumed spicy italian food earlier that day which could have triggered acid reflux and regurgitation of dose. Hence the causality of the events  acid reflux, regurgitated dose was assessed as unlikely. The event fever was reported with reasonable time relationship to intake of the vaccine. Also fever is labeled as per CCDS . Hence, the causality of the event fever with Vivotif is assessed as possible.The causality of the event "bit into the regurgitated dose"" was considered as not applicable.