Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | Unknown | — |
| TYP | TYPHOID VI POLYSACCHARIDE (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | Unknown | IM |
Patient had nausea after receiving fist dose of Vivotif; The patient had one or two bouts of diarrhea after second dose of Vivotif; Patient experienced diarrhea after third dose of Vivotif; Patient had never taken the fourth dose of Vivotif; The patient took three doses of Vivotif and dose of Typhoid IM; Case reference number US-BN-2024-002677 is a spontaneous case initially received from a nurse via Med Communication (reference number: USBAV24-2771) on 21-Oct-2024 and concerns a patient of unknown age and gender. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient took the first dose of Vivotif (batch number: unknown) at an unknown dose (pill), and route of administration, for unknown indication. On an unspecified date, reported as after receiving the first dose of Vivotif patient experienced *a bit of* nausea. On unspecified date, unknown amount of time after administration of first dose of Vivotif, the patient took the second dose of Vivotif (batch number: unknown) at an unknown dose (pill) and route of administration. On an unspecified date, reported as after receiving the second dose of Vivotif patient experienced *one or two bouts* of diarrhea. On unspecified date, unknown amount of time after administration of first dose of Vivotif, the patient took the third dose of Vivotif (batch number: unknown) at an unknown dose (pill) and route of administration. On an unspecified date, reported as after receiving the third dose of Vivotif patient experienced severe diarrhea. As reported patient had never taken the fourth dose of Vivotif, since side effects were too severe (explicitly coded as 'incomplete course of vaccination'). *On an unspecified date, the patient a dose received Typhoid (batch number: unknown), at unknown dose or site of administration, intramuscularly for unknown indication (explicitly coded as 'interchange of vaccine products'). * *At the time of the follow up report, it was unknown if the patient recovered from the events of 'diarrhea' after second and third dose of Vivotif and nausea. * The reporter did not provide seriousness and causality assessment for the events of nausea and *'diarrhea' after second and third dose of Vivotif. * Additional information received from a nurse on 23-Oct-2024: Information included Vivotif dosage information, events (nausea and diarrhea). All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up information received from a nurse on 05-Nov-2024: New information included added reporter details, confirmation for adverse events and that the patient did not take the last dose of Vivotif, and that the patient received Typhoid IM instead.; Reporter's Comments: A patient of unknown age and gender experienced nausea after taking the first dose of Vivotif for unknown indication. Also, on an unspecified date, reported as after receiving the second dose of Vivotif the patient experienced diarrhea. Following the third dose of Vivotif, the patient experienced diarrhea again. Since side effects were severe, the patient did not receive the fourth dose of Vivotif, and was administered intramuscular Typhoid instead (which is considered incomplete course of vaccination and interchange of vaccine products). Diarrhoea and nausea are listed and expected for Vivotif per CCDS v8 and USPI, whilst incomplete course of vaccination and interchange of vaccine products are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and known vaccine safety profile, as well as the two-time occurrence of diarrhea, the reported events are considered related to Vivotif. Incomplete course of vaccination and interchange of vaccine products are not related to the suspect vaccine, but to a human factor. The case is non-serious.; Sender's Comments: A patient of unknown age and gender experienced nausea after taking the first dose of Vivotif for unknown indication. Also, on an unspecified date, reported as after receiving the second dose of Vivotif the patient experienced diarrhea. Following the third dose of Vivotif, the patient experienced diarrhea again. Since side effects were severe, the patient did not receive the fourth dose of Vivotif, and was administered intramuscular Typhoid instead (which is considered incomplete course of vaccination and interchange of vaccine products). Diarrhoea and nausea are listed and expected for Vivotif per CCDS v8 and USPI, whilst incomplete course of vaccination and interchange of vaccine products are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and known vaccine safety profile, as well as the two-time occurrence of diarrhea, the reported events are considered related to Vivotif. Incomplete course of vaccination and interchange of vaccine products are not related to the suspect vaccine, but to a human factor. The case is non-serious.
Comments: None.