Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Appendicectomy, Appendicitis, Diarrhoea, Laparoscopic surgery
Clinical narrative: Acute appendicitis; Worsening stomach pains; Vomiting; Watery diarrhea; Mild nausea; A spontaneous report was received from a nurse on 16DEC2022. It described a 13-year-old female patient who developed "watery diarrhea" (PT: Diarrhoea), "mild nausea" (PT: Nausea), "vomiting" (PT: Vomiting), and "worsening stomach pains" (PT: Abdominal pain upper). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunization. It was reported that the patient was administered the first dose of Vivotif on 09DEC2022 followed by the second dose and third dose on 11DEC2022 and 13DEC2022 respectively. Following the administration of Vivotif, the patient had about 4-5 episodes of watery diarrhea, mild nausea, and vomiting. Reportedly, the symptoms were severe on the days that Vivotif was administered and mild in between the doses. Additionally, it was reported that the patient had no fever and started experiencing worsening stomach pains on 16DEC2022. The patient did not receive any treatment for the reported events. Furthermore, the patient was advised to discontinue Vivotif and reach out to the treating physician for further medical evaluation and treatment.   The patient had not recovered from the event of "worsening stomach pains" while the outcome for the events "watery diarrhea", "mild nausea", and "vomiting" was unknown, at the time of this report.  No action was taken with Vivotif, with respect to the events "watery diarrhea", "mild nausea", and "vomiting". However, post the event "worsening stomach pains" Vivotif was discontinued.  It was reported that the patient did not have any history or other medical conditions and no known drug allergies. The patient did not take any other medications during the time of vaccination.   No additional information was reported.  Company comment: It was reported that a consumer had watery diarrhea (diarrhoea), mild nausea (nausea), vomiting, and worsening stomach pains (abdominal pain upper) following the administration of Vivotif for immunization. Further information regarding the events was limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of diarrhoea, nausea, vomiting, and abdominal pain upper is assessed as possible. The case is considered non-serious as per medical assessment.  Significant follow-up information was received from a nurse on 23DEC2022.  It was reported that the patient had "acute appendicitis" (PT: Appendicitis) and had to undergo appendectomy on 16DEC2022.  On 09DEC2022 or 10DEC2022 (as per the reporter), the patient experienced symptoms of watery diarrhea, mild nausea and vomiting. The patient had of watery diarrhea with 4-5 bowel movements a day and was taking fluids and food. On 14DEC2022, the nurse advised the patient's mother not to take anymore capsules of Vivotif. On 16DEC2022, the patient had abdominal pain, nausea, vomiting and had normal temperature even though she did not take Vivotif for 3 days starting from 14DEC2022 to 16DEC2022. On 16DEC2022, as recommended by the nurse, the patient saw the pediatrician and was sent to the emergency room (ER). On the same day, the patient was diagnosed with acute appendicitis which was possibly from the gastroenteritis exposure from her brother who contracted it from school on 08DEC2022. On 16DEC2022, stomach pain became severe, and the patient underwent laparoscopic appendectomy because of acute appendicitis. Reportedly, the patient was home schooled and did not go to same school as brother. On an unknown date in DEC2022, the patient developed infection related to appendectomy and the patient was started on antibiotics (unspecified) for infection due to surgery. The pediatrician did not believe that appendicitis was due to Vivotif. Fourth dose of Vivotif vaccination was not completed.  On an unknown date in DEC2022, the patient had recovered from the events of "watery diarrhea", "mild nausea" and "vomiting", had not recovered from the events of "worsening stomach pains" and "acute appendicitis".  Action taken with Vivotif with respect to the events "acute appendicitis" was not applicable.  Company comment: It was reported that a consumer had watery diarrhea (diarrhoea), mild nausea (nausea), vomiting, worsening stomach pains (abdominal pain upper), and acute appendicitis (appendicitis) following the administration of Vivotif for immunization. In response to appendicitis, the patient underwent laparoscopic appendectomy which developed an infection, and antibiotics were started. Considering the case information, the role of Vivotif cannot be ruled out and the causality of diarrhoea, nausea, vomiting, and abdominal pain upper is assessed as possible. The causality of appendicitis is assessed as not related to Vivotif. The case is considered serious due to the medical significance of the event appendicitis which required intervention. Appendicitis is unlisted whereas are diarrhoea, nausea, vomiting and abdominal pain upper are considered listed as per the PI of Vivotif.  Medical Review Company Comment: A spontaneous report case regarding a 13-year-old female with no reported medical history and concomitant medications who experienced watery diarrhea, mild nausea, vomiting, and worsening abdominal pain following the administration of Vivotif for immunization and after the 3rd dose of Vivotif. The consumer was subsequently diagnosed with acute appendicitis for which a laparoscopic appendectomy was performed. The possibility of cross infection with gastroenteritis from the consumer's brother was considered by her pediatrician. She was treated with antibiotics for post-operative infection. Further information regarding the events is limited including detailed medical history and concomitant medications. The causality of the serious event of appendicitis (unlisted per the PI for Vivotif) is assessed as unlikely related to Vivotif due to lack of a plausible mechanism. The case is upgraded to serious due to medical significance of the event appendicitis. The benefit-risk profile of Vivotif remains unchanged.; Sender's Comments: A spontaneous report case regarding a 13-year-old female with no reported medical history and concomitant medications who experienced watery diarrhea, mild nausea, vomiting, and worsening abdominal pain following the administration of Vivotif for immunization and after the 3rd dose of Vivotif. The consumer was subsequently diagnosed with acute appendicitis for which a laparoscopic appendectomy was performed. The possibility of cross infection with gastroenteritis from the consumer's brother was considered by her pediatrician. She was treated with antibiotics for post-operative infection. Further information regarding the events is limited including detailed medical history and concomitant medications. The causality of the serious event of appendicitis (unlisted per the PI for Vivotif) is assessed as unlikely related to Vivotif due to lack of a plausible mechanism. The case is upgraded to serious due to medical significance of the event appendicitis. The benefit-risk profile of Vivotif remains unchanged.