Sex: F
Vaccine: TYP, UNK
Symptoms: Blood urine present, Contraindication to vaccination, Pain, Pollakiuria
Clinical narrative: WILL NOT BE CONTINUING VIVOTIF; BAD STINGING/ PAIN; BLOOD IN URINE; FREQUENT URINATION; ACHY BODY; TOOK PENICILLIN AND VIVOTIF ON THE SAME DAY; This spontaneous case report was received from a caregiver (PVX2019-368) on 11-Feb-2019. The report describes a 66-year-old female consumer who had bad stinging, blood in urine, frequent urination, and achy body following the intake of oral Vivotif (one dose on every other day) for typhoid fever prophylaxis. The consumer also "took penicillin and Vivotif on the same day" and "will not be continuing the Vivotif". The consumer was receiving penicillin tablet (500 mg; 4 times a day in every 6 hour) (non-company suspect) for treatment of the mentioned adverse events.  The consumer had a history of 7 cervical spine fusion including laminectomies/ disc replacement fusions, severe scoliosis, degenerative disc disease, arthritis, GI eosinophilic esophagitis (irritation of esophagus), Hiatal hernia, mild cognitive impairment, borderline cholesterol and also had UTI (urinary tract infection) about 20-30 year ago.  The consumer's medication included omeprazole (20 mg; once a day) for GI hiatal hernia, pravastatin tablet (20 mg; once a day) for lowering cholesterol, Vitamin D3 (cholecalciferol; 1.25 mg; once a week) for increasing her Vitamin D, magnesium tablet (70 mg; once a day), Vitamin C (L-ascorbic acid; 120 mg) and AZO cranberry urinary tract pill (500 mg cranberry with 120 mg vitamin C; took 2 soft gels a day for the last 3 days).  It was reported that the consumer took the first dose of Vivotif on 09-Feb-2019. Less then 1 hour after taking Vivotif, she experienced symptoms similar to an UTI infection such as bad stinging/ pain and blood in her urine. She was urinating every 15-30 minutes which became much more frequently by the day went. Her body was also achy which started on the same day.   As a result, for treatment she started antibiotic penicillin on 09-Feb-2019. She took a total of 4 doses. The caregiver further reported that the consumer will not be continuing the Vivotif.  The action taken with Vivotif with respect to the events bad stinging, blood in urine, frequent urination, and achy body was drug discontinued, while with respect to the event "took penicillin and Vivotif on the same day" and "will not be continuing the Vivotif" was not applicable.  The action taken with penicillin with respect to the events bad stinging, blood in urine, frequent urination, achy body and "took penicillin and Vivotif on the same day" and "will not be continuing the Vivotif" was not applicable.  The clinical outcome of the events bad stinging, blood in urine, frequent urination, and achy body was resolved, while with respect to the events "took penicillin and Vivotif on the same day" and "will not be continuing the Vivotif" was unknown.  Company's comment: In this case, a 66-year-old female consumer developed bad stinging, blood in urine, frequent urination, and achy body following the intake of oral Vivotif.  The consumer also "took penicillin and Vivotif on the same day" and "will not be continuing the Vivotif". Although the events are reported with reasonable time relationship with intake of vivotif, the events are suggestive of UTI and resolved on starting penicillin. Due to the fact that UTI is an infectious condition the causality of the events "bad stinging, blood in urine, frequent urination" was assessed as unlikely with Vivotif. The consumer stated that her body responds to weather so it is not unusual to get an achy feeling hence the causality of the event achy body is assessed as not related to vivotif. The causality of the events "took penicillin and Vivotif on the same day" and "will not be continuing the Vivotif" was considered as not applicable.; Sender's Comments: Company's comment: In this case, a 66-year-old female consumer developed bad stinging, blood in urine, frequent urination, and achy body following the intake of oral Vivotif .  The consumer also "took penicillin and Vivotif on the same day" and "will not be continuing the Vivotif". Although the events are reported with reasonable time relationship with intake of vivotif, the events are suggestive of UTI and resolved on starting penicillin. Due to the fact that UTI is an infectious condition the causality of the events "bad stinging, blood in urine, frequent urination" was assessed as unlikely with Vivotif. The consumer stated that her body responds to weather so it is not unusual to get an achy feeling hence the causality of the event achy body is assessed as not related to vivotif. The causality of the events "took penicillin and Vivotif on the same day" and "will not be continuing the Vivotif" was considered as not applicable.