Age: 29.0
Sex: F
Vaccine: CHOL
Symptoms: Abnormal faeces, Cholera, Diarrhoea, Vaccination failure, Vomiting
Clinical narrative: This spontaneous case report was received from a physician (PVX2018-2732) on 10-Sep-2018 and an additional information was received on 11-Sep-2018 and 18-Sep-2018 respectively. The report describes a 29-year-old female consumer who had suspected cholera and suspected vaccination failure following the intake of VAXCHORA as cholera vaccine. The consumer was a part of emergency response to a cholera outbreak. The consumer was a high-risk traveler, doing high-risk activities, in high-risk destinations and was very well vaccinated traveler from prior travels. The consumer's medical history included malaria (which was diagnosed on 05-Jun-2018) and migraines. The consumer took atovaquone-proguanil for malaria (took last dose on 07-Jun-2018) and after that switched to artemether-lumefantrine (took last dose on 09-Jun-2018) which led to rapid improvement. The consumer was exposed while taking Atovaquone-proguanil chemoprophylaxis. It was reported that on 28-Jun-18, she was vaccinated with IPV (Inactivated polio vaccine), Tdap (Tetanus, diphtheria, and pertussis), TYPHIM. The consumer took VAXCHORA dose on 29-Jun-2018, on an empty stomach. She was also vaccinated with yellow fever vaccine on 08-Jul-2018 and hepatitis A, hepatitis B, Human papillomavirus (HPV) vaccine, MMR (measles, mumps and rubella) vaccine, MCV4 (Meningococcal conjugate vaccines) vaccine. She had rice water stool with smell and vomiting. Her colleague recognized that these were signs of cholera and kept her hydrated and got ORS (Oral Rehydration Solutions). The patient experienced suspected cholera on 22-Jul-2018. She also took a dose of doxycycline. The consumer works with Vibrio cholerae in laboratory but she believed that she picked it up from food at the hotel (though coworkers were asymptomatic) or maybe in a field setting. The consumer's concomitant medication included IMITREX and REGLAN for migraine when necessary. The action taken with VAXCHORA with respect to the event suspected cholera and suspected vaccination failure was not applicable. The clinical outcome of the event suspected cholera was resolved while that of the event suspected vaccination failure was unknown. Sender's Comments: Company's Comment: In this case, a 29-year-old female consumer had suspected cholera and suspected vaccination failure following the intake of VAXCHORA. The consumer took VAXCHORA dose on 29-Jun-2018, on an empty stomach and developed clinical symptoms of cholera on 22-Jul-2018. In view of suspected vaccination failure this event has been upgraded as serious. The consumer was working in a high-risk area and her work was dealing with high risk field setting for cholera which increases the probability of acquiring the illness. Further, there is high chance that the patient might had a high-CFU exposure, or even ingestion of pre-formed toxin. In view of these facts, suspected cholera is considered as not related to VAXCHORA vaccine. Although cholera was confirmed clinically, however no laboratory parameters were available which could have confirmed the vaccination failure. Considering, the limited information, a definitive diagnosis for vaccination failure could not be made and the causality for suspected vaccination failure is considered as unassessable with VAXCHORA. Further, this is the first case of suspected vaccination failure with VAXCHORA and do not change the benefit risk profile of the vaccine.