Sex: F
Vaccine: TYP
Symptoms: Sensation of foreign body
Clinical narrative: LUMP IN THROAT; This spontaneous case report was received from a consumer (PVX2019-079) on 08-Jan-2019. The report describes a 39-year-old adult female consumer who had a "lump in throat" following the intake of oral Vivotif (one capsule every other day) for typhoid vaccine.  The consumer had a history of sulfites allergy.  The consumer's concomitant medication included birth control pills (once daily). The consumer's past medication included Influenza vaccine (injected into left upper arm) as flu shot and Hepatitis B vaccine (injected into right upper arm) for Hepatitis B prevention on 07-Jan-2019.  It was reported that the consumer took the first dose of Vivotif on 08-Jan-2019 and on the same day, she felt a lump in her throat, which was similar to the reaction from sulfites in the past. She was unsure if the lump was due to sulfites or if she was getting sick. She confirmed that she did not have any other symptoms for feeling sick. She confirmed that she still has the lump in her throat and did not take any medication for it. She did not consume any foods containing sulfites the day she felt the lump in her throat.   She elaborated that when she consumes dehydrated fruits or frozen potatoes, which contain sulfites, then she develops a lump in her throat that lasts for less than one day to a couple of days. She stated the last time she had this type of reaction was about 1-2 years ago due to dehydrated coconut. She does not recall how long it usually takes for the lump to form after consumption of sulfites.   On 09-Jan-2019, an additional information was received in which the consumer confirmed that the lump went away.  The action taken with Vivotif with respect to the event "lump in throat" was unknown.  The clinical outcome of the event "lump in throat" was resolved.  The reporter's causality with respect to the event "lump in throat" was not related.  Company's Comment: In this case, a 39-year-old adult female consumer had a "lump in throat" following the intake of oral Vivotif on 08-Jan-2019. She also received Influenza vaccine (injected into left upper arm) as flu shot and Hepatitis B vaccine (injected into right upper arm) for Hepatitis B prevention on 07-Jan-2019. Although, the events were reported with reasonable time relationship to intake of the Vivotif vaccine, however there is intake multiple concomitant vaccines, which could have contributed to these events. Lump in throat is unlabeled as per CCDS. Hence, the causality of the event "lump in throat" with Vivotif is considered as not related.; Sender's Comments: Company's Comment: In this case, a 39-year-old adult female consumer had a "lump in throat" following the intake of oral Vivotif on 08-Jan-2019. She also received Influenza vaccine (injected into left upper arm) as flu shot and Hepatitis B vaccine (injected into right upper arm) for Hepatitis B prevention on 07-Jan-2019. Although, the events were reported with reasonable time relationship to intake of the Vivotif vaccine, however there is intake multiple concomitant vaccines, which could have contributed to these events. Lump in throat is unlabeled as per CCDS. Hence, the causality of the event "lump in throat" with Vivotif is considered as not related.