Sex: M
Vaccine: TYP
Symptoms: Nausea, Product administration error
Clinical narrative: Nausea; Took the first 2 doses of Vivotif on a full stomach; A spontaneous report was received from a male patient of unknown age on 02JUN2023 who "took the first 2 doses of Vivotif on a full stomach" (PT: Product administration error) and experienced "nausea" (PT: Nausea). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient took the first two doses of Vivotif on a full stomach after eating breakfast. Reportedly, after taking the first dose, the patient experienced nausea (later in the day before bedtime) when his stomach was empty. The patient ate something, and the nausea went away. The patient was unsure whether nausea was due to Vivotif or not. Furthermore, it was reported that the patient took the next two doses of Vivotif appropriately.  The patient had recovered from the event "nausea", at the time of this report. The outcome for the event "took the first 2 doses of Vivotif on a full stomach" was not applicable.  No action was taken with Vivotif with respect to "nausea" whereas the action taken with respect to "took the first 2 doses of Vivotif on a full stomach" was not applicable.  No additional information was reported.  Company comment: A patient took the first 2 doses of Vivotif on a full stomach (Product administration error) and, after taking the first dose, he experienced nausea (nausea) later in the day when his stomach was empty. He had recovered from nausea after eating something. Considering nausea is a known effect of Vivotif, its role cannot be ruled out, and the causality is assessed as possible (confounded by hunger induced nausea). Furthermore, the causality of product administration error is assessed as not applicable with Vivotif. The case is considered non serious as per medical assessment.  Significant follow-up information was received from the patient on 13JUN2023. Patient demographics (age, height, weight, ethnicity, and race) were added.  It described a 65-year-old patient (height: 176.7 cm/5'8", weight: 156 or 157 lbs) who took two doses of Vivotif with food and then took two doses correctly without food, a couple weeks ago (dates unspecified).  It was reported that the patient had allergy induced asthma, sleep apnea and esophagitis which were under control. Further the patient was allergic to dust mites, dander, hair and pollen.  The patient's concomitant medications included general vitamin (unspecified), Vitamin D (colecalciferol), fish oil, montelukast (montelukast sodium), finasteride, quercetin, and magnesium glycinate all of which he took all once a day, in morning after breakfast by mouth.  Company comment: A patient took the first 2 doses of Vivotif on a full stomach (product administration error) and, after taking the first dose, he experienced nausea (nausea) later in the day when his stomach was empty. He had recovered from nausea after eating something. Considering nausea is a known effect of Vivotif, its role cannot be ruled out, and the causality is assessed as possible (confounded by hunger induced nausea and history of esophagitis). Furthermore, the causality of product administration error is assessed as not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: A patient took the first 2 doses of Vivotif on a full stomach (product administration error) and, after taking the first dose, he experienced nausea (nausea) later in the day when his stomach was empty. He had recovered from nausea after eating something. Considering nausea is a known effect of Vivotif, its role cannot be ruled out, and the causality is assessed as possible (confounded by hunger induced nausea and history of esophagitis). Furthermore, the causality of product administration error is assessed as not applicable with Vivotif. The case is considered non serious as per medical assessment.