Sex: M
Vaccine: TYP
Symptoms: Bacterial infection, Fatigue, Genital rash, Headache, Hyperhidrosis
Clinical narrative: Lymph nodes were swollen; Throat was very sore; Rash and hives mostly concentrated in the genital area; Rash and hives mostly concentrated in the genital area; Extreme fatigue; Sweating; High fever; Headache; Bacterial infection; Itching; A spontaneous report was received from a patient on 27APR2023 regarding a patient of unknown age and gender who had "bacterial infection" (PT: Bacterial infection), "high fever" (PT: Pyrexia), "sweating" (PT: Hyperhidrosis), "headache" (PT: Headache), "extreme fatigue" (PT: Fatigue), "rash and hives mostly concentrated in the genital area" (PT: Genital rash and PT: Urticaria), "itching" (PT: Pruritus), "throat was very sore" (PT: Oropharyngeal pain) and "lymph nodes were swollen" (PT: Lymphadenopathy) following the administration of oral Vivotif capsule (typhoid vaccine live oral Ty21A) (lot number: unknown) for typhoid fever immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.   On 21APR2023, Friday afternoon, the patient took the first dose of Vivotif and had high fever, sweating, and headache later that evening. Reportedly, the patient had fever with headache and extreme fatigue most of the day on Saturday. On 23APR2023, Sunday, the patient took the second dose and quickly developed a rash and hives which were mostly concentrated in the genital area. By Monday (24APR2023), the patient had a very sore throat and lymph nodes were swollen. Furthermore, the patient also developed bacterial infection and had itching. The patient was advised to stop taking Vivotif on Monday and was prescribed antibiotics (unspecified) for a bacterial infection and antihistamines (unspecified) for hives and itching. It was reported that severe fatigue and headache were the worst.  The outcome of reported events was unknown at the time of this report.  No action was taken with Vivotif with respect to the events "high fever", "sweating", "headache" and "extreme fatigue", while it was withdrawn with respect to the events "bacterial infection", "rash and hives mostly concentrated in the genital area", "itching", "throat was very sore" and "lymph nodes were swollen".  No additional information was reported.  Company comment: A consumer had bacterial infection, high fever (pyrexia), sweating (hyperhidrosis), headache, extreme fatigue, rash and hives mostly concentrated in the genital area (genital rash and urticaria), itching (pruritus), throat was very sore (oropharyngeal pain), and lymph nodes were swollen (lymphadenopathy). Considering the case information, the role of Vivotif cannot be ruled out, and the causality of bacterial infection, pyrexia, hyperhidrosis, headache, fatigue, genital rash and urticaria, pruritus, oropharyngeal pain and lymphadenopathy is assessed as possible. The case is considered non serious as per medical assessment.  Significant follow-up information was received from the patient on 17MAY2023. Patient demographics (gender, date of birth) were added. Additionally, the time (07:00 pm) of the earliest symptom was added to the case.  It described a 58-year-old male patient who had no prior history or allergies of similar reactions. Reportedly, the patient received antibiotics (unspecified) for the events "throat was very sore" and "lymph nodes were swollen" following a virtual doctor visit on 25APR2023.  It was updated that the patient had no medical history or any illness at the time of vaccination.  Reportedly, on 07MAY2023 at 8:00 am, the patient recovered from all the reported events.  Company comment: A consumer had bacterial infection, high fever (pyrexia), sweating (hyperhidrosis), headache, extreme fatigue, rash and hives mostly concentrated in the genital area (genital rash and urticaria), itching (pruritus), throat was very sore (oropharyngeal pain) and lymph nodes were swollen (lymphadenopathy). Considering the case information, the role of Vivotif cannot be ruled out, and the causality of bacterial infection, pyrexia, hyperhidrosis, headache, fatigue, genital rash and urticaria, pruritus, oropharyngeal pain and lymphadenopathy is assessed as possible. The case is considered non serious as per medical assessment.; Sender's Comments: A consumer had bacterial infection, high fever (pyrexia), sweating (hyperhidrosis), headache, extreme fatigue, rash and hives mostly concentrated in the genital area (genital rash and urticaria), itching (pruritus), throat was very sore (oropharyngeal pain) and lymph nodes were swollen (lymphadenopathy). Considering the case information, the role of Vivotif cannot be ruled out, and the causality of bacterial infection, pyrexia, hyperhidrosis, headache, fatigue, genital rash and urticaria, pruritus, oropharyngeal pain and lymphadenopathy is assessed as possible. The case is considered non serious as per medical assessment.