Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Incomplete course of vaccination, Oral administration complication, Vomiting
Clinical narrative: DID NOT TAKE THE REMAINING CAPSULES; VOMITING; DIARRHEA; This spontaneous case report was received from a nurse and caregiver (PVX2019-400 and PVX2019-370) on 12-Feb-2019. The report describes a 12-year-old male (104 pounds/ 47.17 kg) consumer who had vomiting and diarrhea following the intake of oral Vivotif (one dose every other day) for typhoid prophylaxis. The consumer "did not take the remaining capsules".  The consumer had stomachache before he took Vivotif.  The consumer's concomitant medication included oral Claritin (loratadine; 10 mg once a day) for seasonal allergies on 09-Feb-2019 and antacid (aluminum hydroxide equivalent of dry gel USP 400 mg, magnesium hydroxide 200 mg) and simethicone 40 mg for stomachache.  It was reported that the consumer took the first dose of Vivotif on 09-Feb-2019 and threw it up. The caregiver stated that his son had a stomachache for the previous two days (before taking Vivotif) for which he took an antacid on 09-Feb-2019. He stated that he was not there when his son vomited but his wife saw him vomit the capsule back up about 20 minutes after taking the antacid. The caregiver confirmed that his son only vomited once, and he did not take the other capsules.  He suspected that his son might have been constipated because after he took the antacid and Vivotif, he had diarrhea. He said he thought the medication he gave his son was anti-diarrhea, but it turned out to be a laxative. He had several bouts of diarrhea starting about an hour after he vomited, had 2 bouts that night (09-Feb-2019) and on Sunday he had 4 bouts of diarrhea. Since the afternoon of 10-Feb-2019, he did not have diarrhea. He was given Imodium (loperamide hydrochloride) 2 mg for the diarrhea. He had two doses of loperamide after the first bout of diarrhea on 10-Feb-2019, one dose after a while, and then another after a while. The loperamide doses were given to him on Sunday 10-Feb-2019.  The action taken with Vivotif with respect to the events vomiting and diarrhea was dosage discontinued while with respect to the event "did not take the remaining capsules" was not applicable.  The clinical outcome of the events vomiting, and diarrhea was resolved while with respect to the event "did not take the remaining capsules" was unknown.  Company's Comment: In this case, a 12-year-old male consumer had vomiting and diarrhea following the intake of oral Vivotif. The consumer had stomachache before he took Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, diarrhea and vomiting are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. The causality of the event "did not take the remaining capsules" was considered as not applicable.  An updated information was received on 24-May-2019 from VAERS database search.  Lot number of Vivotif was updated as 3003239.  Company's Comment: In this case, a 12-year-old male consumer had vomiting and diarrhea following the intake of oral Vivotif. The consumer had stomachache before he took Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, diarrhea and vomiting are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. The causality of the event "did not take the remaining capsules" was considered as not applicable.; Sender's Comments: Company's Comment : In this case, a 12-year-old male consumer  had vomiting and diarrhea following the intake of oral Vivotif. The consumer had stomach ache before he took Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, diarrhea and vomiting are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. The causality of the event "did not take the remaining capsules" was considered as not applicable.