Sex: F
Vaccine: TYP
Symptoms: Flushing
Clinical narrative: Steroid flush on the face; Spontaneous report received on 17DEC2019.  A female consumer reported that she experienced "steroid flush on the face" (PT: Flushing) while being on oral Vivotif for typhoid fever prophylaxis and cortisone injection for an unknown indication. She had taken two doses of Vivotif whereas the third dose was due on 17DEC2019. On 16DEC2019, she received a cortisone injection on her shoulder. On 17DEC2019, she experienced a steroid flush from the injection on her face. Action taken with Vivotif and cortisone injection with respect to the reported event was unknown. At the time of report, the outcome of the reported event was unknown.  Medical history included high blood pressure and breast cancer which was cured with double mastectomy.  Concomitant medications included triamterene/hydrochlorothiazide (37.5/25mg), losartan (100 mg) and carvedilol (3.125 mg; one tablet in the morning and half tablet at night). All concomitant medications had been taken for high blood pressure on 16DEC2019.  Company Comment: A consumer took first two doses of Vivotif and then had a cortisone injection on her shoulder and the next day, she developed steroid flush on her face (Flushing of face). Further details of the event is limited. Considering the case information where she developed steroid flush after cortisone injection, the causality of the event is assessed as not related to Vivotif.  Follow up information was received on 26DEC2019 from a consumer.  Follow up information included age of consumer, indication of co-suspect, outcome of the event, therapy dates of Vivotif, action taken with Vivotif.  The age of the consumer was updated as 66 years.  The indication of cortisone injection was updated as rotator cuff injury, which was also a medical history that happened prior to Vivotif.  It was reported that the consumer took first and second dose of Vivotif on 13DEC2019 and 15DEC2019, respectively and after experiencing the reported event, the consumer continued further and took the remaining two doses on 17DEC2019 and 19DEC2019. Thus, action taken with Vivotif was updated as dose not changed.  The outcome of the event was updated as resolved on 18DEC2019 and no treatment was taken for the event.  Company Comment: A consumer took first two doses of Vivotif and then had a cortisone injection on her shoulder and the next day, she developed steroid flush on her face (Flushing of face). The event resolved after two days without any treatment while the consumer continued to take the remaining two doses of Vivotif. Considering the case information where the consumer developed steroid flush after cortisone injection which was resolved without any treatment while she continued to take the remaining two doses of Vivotif, the causality of the event is assessed as not related to Vivotif.  ; Sender's Comments: A consumer took first two doses of Vivotif and then had a cortisone injection on her shoulder and the next day, she developed steroid flush on her face (Flushing of face). The event resolved after two days without any treatment while the consumer continued to take the remaining two doses of Vivotif. Considering the case information where the consumer developed steroid flush after cortisone injection which was resolved without any treatment while she continued to take the remaining two doses of Vivotif, the causality of the event is assessed as not related to Vivotif.