GOT UP EVERY TWO HOURS TO GET WATER; REALLY AWFUL/ REALLY SICK; FLU-LIKE SYMPTOMS; POUNDING HEADACHE; FELT LIKE SHE WAS GOING TO THROW UP; TOOK AN UNREFRIGERATED DOSE OF VIVOTIF; A spontaneous case report was received from a physician on 04-Jun-2019 for two consumers.  Based on the information obtained from the physician, two individual case safety reports PVX201906-000454 (PVX2019-1437; son) and PVX201906-000455 (PVX2019-1438, daughter) were created and cross-linked in the database.  This case describes a female consumer who experienced "pounding headache, she also got up every two hours to get water, felt really sick, flu-like symptoms and, nausea" after the administration of Vivotif for an unknown indication. She also "took an unrefrigerated dose of Vivotif".  Case report: The consumer took an unrefrigerated dose of Vivotif on 02-Jun-2019 at night. Approximately after half an hour, she experienced pounding headache and that night she also got up every two hours for water. Subsequently, after 12 hours she felt "really awful" or "really sick" and almost flu-like symptoms; she had a sore throat. The sore throat was currently ongoing.  Additionally, she experienced nausea and felt like she was going to throw up. The physician reported that the events may be due to the streptococcal infection as she was susceptible to streptococcal and usually gets it once a year with yellow spots on the back of her throat. However, the consumer was tested negative for streptococcal test. Thus, the treating physician was not sure if the sickness was viral or related to Vivotif.  The treating physician stated that her throat was red however, the physician did not mention anything about yellow spots on her throat.  The consumer's medical history included heart murmur (since birth) and strep throat infection (twice in the past year).  The consumer did not take any concomitant and treatment medications.  Action taken with Vivotif with respect to the events "pounding headache, she also got up every two hours to get water, really sick, flu-like symptoms, and nausea" was unknown, while with respect to the event "took an unrefrigerated dose of Vivotif" was not applicable.  The consumer did not recover from the reported events of pounding headache, she also got up every two hours to get water, really sick, flu-like symptoms, and nausea while the clinical outcome of the event "took an unrefrigerated dose of Vivotif" was unknown.  Company's Comment: In this case, a female consumer experienced "pounding headache, she also got up every two hours to get water, felt really sick, flu-like symptoms, and nausea" after the administration of Vivotif. She also "took an unrefrigerated dose of Vivotif". There seems to be temporal association between the intake of vaccine and the events. Hence, the causality of the events is assessed possible with Vivotif vaccine. The causality of the event "took unrefrigerated doses" was considered as not applicable. ; Sender's Comments: Company's Comment: In this case, a female consumer experienced "pounding headache, she also got up every two hours to get water, felt really sick, flu-like symptoms, and nausea" after the administration of Vivotif. She also "took an unrefrigerated dose of Vivotif". There seems to be temporal association between the intake of vaccine and the events. Hence, the causality of the events is assessed possible with Vivotif vaccine. The causality of the event "took unrefrigerated doses" was considered as not applicable. US-PaxVax Berna GmbH-PVX201906-000454: