Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Dysstasia, Gastroenteritis viral, Inappropriate schedule of product administration, Vomiting projectile
Clinical narrative: Patient waited 2 days to restart dose 3 and took dose 3 and 4, 3 days apart; Stomach flu; Projectile vomiting; Could not stand up; Stomach pain; A spontaneous report was received from a 64-year-old female patient on 01MAR2023 who had "projectile vomiting" (PT: Vomiting projectile), "stomach pain" (PT: Abdominal pain upper) and "could not stand up" (Dysstasia) following the administration of Vivotif capsule (Typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history included hypothyroidism, swelling, arthritis and heartburn. Surgical history included removal of right adrenal gland due to benign tumours, double knee replacement, and had a club foot surgery when she was a child.  The patient was allergic to narcotic medications and would start vomiting if she took them.  Concomitant medications included Armour thyroid (one tablet of 20 mg; by mouth once a day) for hypothyroidism, hydrochlorothiazide (one tablet of 25 mg; by mouth once a day) for swelling, Aleve (naproxen sodium; one tablet of 220 mg; by mouth once a day in morning) and Tylenol (paracetamol; one tablet of 500 mg; by mouth once a day at bedtime) for arthritis, magnesium, (one tablet of 500 mg; by mouth once a day) as a supplement, and Pepcid (famotidine; one tablet of 10 mg by mouth once a day at bedtime) for heartburn.  On 26FEB2023 (Sunday), the patient received the first dose of Vivotif, followed by the second dose on 28FEB2023 (Tuesday morning). Reportedly, the patient was doing fine after taking the first dose of Vivotif; however, 18 hours after taking the second dose, the patient woke up with stomach pain. It was reported that the patient had projectile vomiting for four hours and she could not stand up. Furthermore, it was reported that the patient felt much better since the vomiting stopped six hours ago. The patient only drank cola and water and took no treatment for her condition. Moreover, the patient did not get any tests done, and neither she saw a healthcare provider.  Additionally, the patient stated that she did not make any changes to her medications before starting the Vivotif and was not sure whether she would take further doses of Vivotif.  The patient had recovered from the event of "projectile vomiting" on 01MAR2023 while the outcome for the events "stomach pain" and "could not stand up" was unknown at the time of the report.  The action taken with Vivotif with respect to the reported events was unknown.  No additional information was reported.  Company comment: It was reported that a patient took Vivotif for immunisation and had projectile vomiting, stomach pain (abdominal pain upper) and could not stand up (dysstasia). She had recovered from the event of projectile vomiting. Considering the case information, the role of Vivotif cannot be ruled out, and the causality of vomiting projectile, abdominal pain upper and dysstasia is assessed as possible (confounded by underlying condition of heartburn). The case is considered non-serious as per medical assessment.  Significant follow-up information was received from the patient on 10MAR2023.  The follow-up information included additional events of "stomach flu" (PT: Gastroenteritis viral) and "patient waited 2 days to restart dose 3 and took dose 3 and 4, 3 days apart" (PT: Inappropriate schedule of product administration).  It was reported that the patient had no history of reported events. The patient was confident that it was some kind of stomach flu which she thought was unrelated to Vivotif, as the other people in their family also became sick.  Reportedly, the patient took the third dose of Vivotif two days after the second dose and the fourth dose three days after the third dose.  The patient recovered from the events of "stomach flu", "stomach pain" and "could not stand up" approximately on 07MAR2023 or 08MAR2023 (6 to 7 days after initial reporting) while the outcome for the event "patient waited 2 days to restart dose 3 and took dose 3 and 4, 3 days apart" was not applicable.  No action was taken with Vivotif with respect to the events "stomach flu", "stomach pain", "projectile vomiting" and "could not stand up" while the action taken was not applicable with respect to the event "patient waited 2 days to restart dose 3 and took dose 3 and 4, 3 days apart".  Company comment: It was reported that a patient took Vivotif for immunisation and had projectile vomiting, stomach pain (abdominal pain upper), stomach flu (gastroenteritis viral), could not stand up (dysstasia) and patient waited 2 days to restart dose 3 and took dose 3 and 4, 3 days apart (inappropriate schedule of product administration). Considering the case information, the causality of vomiting projectile, abdominal pain upper, dysstasia and gastroenteritis viral is assessed as not related. Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a patient took Vivotif for immunisation and had projectile vomiting, stomach pain (abdominal pain upper), stomach flu (gastroenteritis viral), could not stand up (dysstasia) and patient waited 2 days to restart dose 3 and took dose 3 and 4, 3 days apart (inappropriate schedule of product administration). Considering the case information, the causality of vomiting projectile, abdominal pain upper, dysstasia and gastroenteritis viral is assessed as not related. Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non-serious as per medical assessment.