Age: 68.0
Sex: F
Vaccine: TYP
Symptoms: Appendicitis, Incomplete course of vaccination, Labelled drug-drug interaction medication error, Vomiting
Clinical narrative: This spontaneous case report was received from a pharmacist on 12-Sep-2016. The report describes an elderly female patient who "took antibiotics after third dose of VIVOTIF". The patient experienced the event appendicitis and she "could not take the fourth dose". The patient was taking oral VIVOTIF (one capsule every other day) for typhoid fever. It was reported that the patient started taking VIVPTIF on 04-Sep-2016 and took three doses as schedule. On 09-Sep-2016, due to appendix crisis, the patient was given a bunch of antibiotics and could not take the fourth dose. The patient experienced vomiting and then went to the Emergency Room where the patient was diagnosed with appendicitis. The patient was then hospitalized. The reporter further stated that they do not have any further information regarding the hospitalization and the lab tests were performed but they do not have access to the records. The patient did not have any 'remarkable history of appendicitis or GI disorders. The action taken with VIVOTIF with respect to the events "took antibiotics after third dose of VIVOTIF" and "could not take the fourth dose" was not applicable and with respect to the event appendicitis was drug discontinued. The clinical outcome of the events "took antibiotics after third dose of VIVOTIF", "could not take the fourth dose", and appendicitis (hospitalization) was unknown. Company comment: In this case, the patient experienced  appendicitis for which she took antibiotics after the third VIVOTIF dose. Also, the details regarding the laboratory tests, or the progression and outcome of event are not available in the case. Although the event occurred after the administration of vaccine, the event was presumed to have a coincidental infectious etiology and was treated and resolved with antibiotics. Moreover, Out of more than 150 million doses administered over the last 35 years, only four cases of appendicitis were previously reported with VIVOTIF, as available in the safety database. In all  these cases, the causal association between the vaccine and the event was considered as unlikely/doubtful. In view of the available facts, the causal association between the vaccine and the event is considered as unrelated.; Reporter's Comments: In this case, the patient experienced appendicitis for which she took antibiotics after the third VIVOTIF dose. Also, the details regarding the laboratory tests, or the progression and outcome of event are not available in the case. Although the event occurred after the administration of vaccine, the event was presumed to have a coincidental infectious etiology and was treated and resolved with antibiotics. Moreover, Out of more than 150 million doses administered over the last 35 years, only four cases of appendicitis were previously reported with VIVOTIF, as available in the safety database. In all  these cases, the causal association between the vaccine and the event was considered as unlikely/doubtful. In view of the available facts, the causal association between the vaccine and the event is considered as unrelated. Sender's Comments: In this case, the patient experienced appendicitis for which she took antibiotics after the third VIVOTIF dose. Also, the details regarding the laboratory tests, or the progression and outcome of event are not available in the case. Although the event occurred after the administration of vaccine, the event was presumed to have a coincidental infectious etiology and was treated and resolved with antibiotics. Moreover, Out of more than 150 million doses administered over the last 35 years, only four cases of appendicitis were previously reported with VIVOTIF, as available in the safety database. In all  these cases, the causal association between the vaccine and the event was considered as unlikely/doubtful. In view of the available facts, the causal association between the vaccine and the event is considered as unrelated.