Sex: M
Vaccine: TYP
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Anaphylactic reaction/ allergic reaction to tree nuts; A spontaneous report was received from a physician and a pharmacist on 20FEB2023 with additional information received from a physician on 22FEB2023 regarding an 18-year-old male patient who experienced "anaphylactic reaction/ allergic reaction to tree nuts" (PT: Anaphylactic reaction) following the administration of Vivotif capsule (Typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.   On 16FEB2023, the patient took the first dose of Vivotif. It was reported that the patient had an allergic reaction after drinking a protein shake with nuts in it. Reportedly, the allergic reaction to tree nuts presented as hives and swelling of lips and tongue. On 18FEB2023, the patient was rushed to the emergency room (ER), where he was given a short course of oral steroids (unspecified) and missed the second dose of Vivotif, due on the same date. Furthermore, the patient had an overnight stay in the ER and was discharged in the early morning of 19FEB2023.  Additionally, it was reported that the physician did not believe that the allergic reaction was associated with Vivotif.  The patient was recovering from the reported event, at the time of this report. The action taken with Vivotif was drug withdrawn with respect to the reported event.  No additional information was reported.  Company comment: It was reported that a patient took Vivotif for immunisation and experienced an anaphylactic reaction/ allergic reaction to tree nuts (anaphylactic reaction). In response to anaphylactic reaction, he was treated with steroids and discharged. Considering the case information, the causality of anaphylactic reaction is assessed as not related to Vivotif. The case is considered serious due to medical significance of anaphylactic reaction which is listed as per PI of Vivotif.  Updated Company Comment: A spontaneous case report regarding an 18-year-old male consumer, with no reported medical history and concomitant medications, who experienced hives with lips and tongue swellings after drinking a protein shake that contained nuts two days following the first dose of Vivotif. He was treated with a short course of an unspecified steroid at the ER where he had an overnight stay and was discharged the following day. The second dose of Vivotif was held. No further information regarding the details of treatment of event was provided. The outcomes of the events were not reported. Based on the possibility of allergic reaction to tree nuts, the causality of the allergic reaction is assessed as not related to Vivotif given the confounding by the tree nuts allergy.; Sender's Comments: A spontaneous case report regarding an 18-year-old male consumer, with no reported medical history and concomitant medications, who experienced hives with lips and tongue swellings after drinking a protein shake that contained nuts two days following the first dose of Vivotif. He was treated with a short course of an unspecified steroid at the ER where he had an overnight stay and was discharged the following day. The second dose of Vivotif was held. No further information regarding the details of treatment of event was provided. The outcomes of the events were not reported. Based on the possibility of allergic reaction to tree nuts, the causality of the allergic reaction is assessed as not related to Vivotif given the confounding by the tree nuts allergy.