Sex: F
Vaccine: HEP, HEPA, TYP, UNK, UNK, YF
Symptoms: Erythema, Hot flush, Inappropriate schedule of product administration
Clinical narrative: FLUSHED RED AND HOT FACE ON AND OFF; DID NOT SKIP A DAY BETWEEN FIRST AND SECOND DOSE; This spontaneous case report (PVX2019-2813) was received from a consumer on 14-Nov-2019. It described a female patient who "did not skip a day between first and second dose" (PT: Inappropriate schedule of product administration) and reported "flushed red and hot face on and off" (PT: Hot flush), following administration of oral Vivotif for typhoid fever prophylaxis, yellow fever vaccine, polio vaccine, Hepatitis A vaccine, Hepatitis B vaccine, and Meningitis vaccines for an unknown indication.  Case report:  It was reported that the consumer received yellow fever vaccine, polio vaccine, Hepatitis A vaccine, Hepatitis B vaccine, and Meningitis vaccines on 11-Nov-2019. Then, she took first two doses of Vivotif in a row. The doses were taken on 12-Nov-2019 and 13-Nov-2019, respectively. Later, on 13-Nov-2019, she reported flushed red and hot face on and off. It was reported that she was not sure if the events were related to Vivotif and other vaccines she received.  The consumer's current condition included hypothyroidism and chronic pain.  The consumer's concomitant medications included oral levothyroxine oral (137 mcg once daily) for hypothyroidism and oral Celebrex (celecoxib; 200 mg once daily) for chronic pain.  Action taken with Vivotif, yellow fever vaccine, polio vaccine, Hepatitis A vaccine, Hepatitis B vaccine, and Meningitis vaccines with respect to the reported event "flushed red and hot face on and off" was unknown, while with respect to the "did not skip a day between first and second dose" was not applicable.  The consumer had not recovered from the event "flushed red and hot face on and off" and the clinical outcome of the event "did not skip a day between first and second dose" was unknown.  Company Comment: It was reported that a patient did not skip a day between first and second dose of Vivotif (Inappropriate schedule of product administration), and was having a flushed red and hot face on and off (Hot flush) which started a couple of hours after second Vivotif dose. The patient had multiple vaccinations (yellow fever vaccine, polio vaccine, Hepatitis A vaccine, Hepatitis B vaccine, and Meningitis vaccines) a day before Vivotif was started. Considering the case information, the role of Vivotif cannot be ruled out and the causality of the event hot flush is assessed as possible (Confounded with multiple vaccines). The causality for the event, Inappropriate schedule of product administration is assessed as not related to Vivotif.; Sender's Comments: It was reported that a patient did not skip a day between first and second dose of Vivotif (Inappropriate schedule of product administration), and was having a flushed red and hot face on and off (Hot flush) which started a couple of hours after second Vivotif dose. The patient had multiple vaccinations (yellow fever vaccine, polio vaccine, Hepatitis A vaccine, Hepatitis B vaccine, and Meningitis vaccines) a day before Vivotif was started. Considering the case information, the role of Vivotif cannot be ruled out and the causality of the event hot flush is assessed as possible (Confounded with multiple vaccines). The causality for the event, Inappropriate schedule of product administration is assessed as not related to Vivotif.