Sex: M
Vaccine: TYP, UNK
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination, Sinusitis
Clinical narrative: Sinus infection; Took first dose of Vivotif on 11DEC2019 and third dose on 14DEC2019; Started taking Zithromax concomitantly with Vivotif on 15DEC2019; Spontaneous report received on 20DEC2019. Additional information was received on 23DEC2019 and 27DEC2019.  A nurse reported that a male consumer developed "sinus infection" (PT: Sinusitis) and he "took the first dose of Vivotif on 11DEC2019 and third dose of Vivotif on 14DEC2019" (PT: Inappropriate schedule of product administration). He was receiving Vivotif for immunisation and "started taking Zithromax concomitantly with Vivotif on 15DEC2019" (PT: Labelled drug-drug interaction medication error).  The consumer started Vivotif on 11DEC2019 and took his third dose on 14DEC2019. On an unknown date, he developed sinus infection and did not take the fourth dose of Vivotif. Action taken with Vivotif with respect to the event sinus infection was drug withdrawn while with respect to the event "took the first dose of Vivotif on 11DEC2019 and second dose of Vivotif on 14DEC2019" and "started taking Zithromax concomitantly with Vivotif on 15DEC2019" was not applicable. At the time of report, the event "sinus infection" was resolved and the clinical outcome of all of other events was unknown.  He took 4 doses of Zithromax (azithromycin) in three days as a treatment for sinus infection (from 15DEC2019 to 17DEC2019).   Consumer's medical history included benign prostate hyperplasia and had two artificial knees, which he had for about 4 years.   On 19DEC2019, he took amoxicillin for his dentist appointment as pre-medication due to his knees. Other concomitant medications included alfuzosin (5 mg daily), lisinopril (5 mg daily), amlodipine (5 mg daily) and finasteride (5 mg daily). The consumer did not know the indications of his medications. He stated that two were used for blood pressure; one was used to keep the elasticity of his bladder; one was used for his prostrate.  Company Comment: A consumer took the first dose of Vivotif on 11DEC2019 and third dose of Vivotif on 14DEC2019 (Inappropriate schedule of Vaccine administered) and also developed sinus infection for which he started taking Zithromax on 15DEC2019 (Labelled drug-drug interaction medication error). The consumer did not take the fourth dose and sinus infection was resolved with antibiotic course. Antibiotics should be taken at least three days after completing the vivotif course, and the causality of the events Inappropriate schedule of Vaccine administered, and Labelled drug-drug interaction medication error is assessed as not related to Vivotif due to the nature of the events. The causality of sinus infection is assessed as not related to Vivotif due to the infectious nature of the event.; Sender's Comments: A consumer took the first dose of Vivotif on 11DEC2019 and third dose of Vivotif on 14DEC2019 (Inappropriate schedule of Vaccine administered) and also developed sinus infection for which he started taking Zithromax on 15DEC2019 (Labelled drug-drug interaction medication error). The consumer did not take the fourth dose and sinus infection was resolved with antibiotic course. Antibiotics should be taken at least three days after completing the vivotif course, and the causality of the events Inappropriate schedule of Vaccine administered, and Labelled drug-drug interaction medication error is assessed as not related to Vivotif due to the nature of the events. The causality of sinus infection is assessed as not related to Vivotif due to the infectious nature of the event.