Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | Unknown | — |
The patient received three doses of Vivotif vaccine instead of four; The patient vomited the full capsule three hours after the ingestion of the first dose; Case reference number US-BN-2024-000566 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number: USBAV24-0415) on 29-Feb-2024 and concerns a 17-year-old male patient. The patient's medical history and concomitant medication details were not provided. On 28-Feb-2024, the patient took the first dose of Vivotif (batch number: not provided), at an unknown dose, orally, for unknown indication. On the same day, *three* hours after taking the first dose, the patient vomited the full capsule. As reported, patient most likely adsorbed the first dose of Vivotif vaccine even though vomited capsule three hours later. On unspecified date, unknown amount of time after the first dose, the patient took the second dose of Vivotif (batch number: not provided), at an unknown dose and route, for unknown indication. On unspecified date, unknown amount of time after the second dose, the patient took the third dose of Vivotif (batch number: not provided), at an unknown dose, and route, for unknown indication. As reported, the patient received three doses of Vivotif instead of four doses and *no issues were reported* (explicitly coded as 'incomplete course of vaccination'). At the time of the follow up, the outcome for the event of vomiting of medication was unknown. The reporter did not provide seriousness or causality assessment for the event of vomiting of medication. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow-up information received from the pharmacist on 10-Mar-2024: New information included confirmation that the patient took three doses of Vivotif vaccine instead of four, and time interval between vaccination and event of vomiting. Follow-up information received from the pharmacist on 22-Mar-2024: New information included confirmation that the patient used three caps of the four dose pack of Vivotif, no issues were reported.; Reporter's Comments: A 17-year-old male patient took the first dose of Vivotif for unknown indication and on the same day (four hours after taking the dose) vomited the full capsule. Reportedly, patient most likely adsorbed the first dose of Vivotif vaccine due to the time lapse of vomiting. As reported, the patient received three doses of Vivotif instead of four doses, which is considered as incomplete course of vaccination. Vomiting is listed and expected for Viviotif according to CCDS version 8.0 and USPI. Incomplete course of vaccination is considered s listed per company convention. The outcome of vomiting was unknown. The patient's medical history and concomitant medication details were not provided. Due to plausible temporal relationship and product known safety profile, the causality is assessed as related to Vivotif for the event of vomiting. Incomplete course of vaccination is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 17-year-old male patient took the first dose of Vivotif for unknown indication and on the same day (four hours after taking the dose) vomited the full capsule. Reportedly, patient most likely adsorbed the first dose of Vivotif vaccine due to the time lapse of vomiting. As reported, the patient received three doses of Vivotif instead of four doses, which is considered as incomplete course of vaccination. Vomiting is listed and expected for Viviotif according to CCDS version 8.0 and USPI. Incomplete course of vaccination is considered s listed per company convention. The outcome of vomiting was unknown. The patient's medical history and concomitant medication details were not provided. Due to plausible temporal relationship and product known safety profile, the causality is assessed as related to Vivotif for the event of vomiting. Incomplete course of vaccination is assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None.