Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | 3004009 | PO / MO |
| TYP | TYPHOID LIVE ORAL TY21A (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | Unknown | — |
The patient was unable to take the scheduled fourth dose of Vivotif; The patient received Vivotif and killed Typhoid vaccine; The patient felt mildly unwell after first dose of Vivotif; The patient become extremely nauseous and vomited after second dose of Vivotif; The patient become extremely nauseous and vomited after second dose of Vivotif; The patient vomited after third dose of Vivotif; The patient had severe nausea after third dose of Vivotif; Case reference number US-BN-2024-001776 is a spontaneous case report initially received from a physician (self-report) via Emergent BioSolutions (reference number: EMG2024-430) on 04-Apr-2024 and concerns a male patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient took the first dose of Vivotif (batch number: 3004009; expiration date: Oct-2024), at an unknown dose, orally, for unknown indication. On an unspecified date, for unknown amount of time after the first dose of Vivotif the patient felt mildly unwell. On an unspecified date, for unknown amount of time after first dose of Vivotif, the patient took the second dose of Vivotif (batch number: 3004009; expiration date: Oct-2024), at an unknown dose, orally. On an unspecified date, as reported about 12 hours after the second dose of Vivotif, the patient become extremely nauseous and vomited. On an unspecified date, for unknown amount of time after second dose of Vivotif, the patient took the third dose of Vivotif (batch number: 3004009; expiration date: Oct-2024), at an unknown dose, orally. On an unspecified date, as reported within 20 minutes, the patient vomited and for the next total of five days had severe nausea. As reported, the patient was unable to take the scheduled fourth dose of Vivotif (explicitly coded as 'inappropriate schedule of vaccine administered'), however received as reported co-suspect killed typhoid vaccine (brand name unknown; batch number unknown), at an unknown dose, route or site of administration, for unknown indication (explicitly coded as 'interchange of vaccine products'). At the time of the initial report, the outcome for the events of mildly unwell, an both instances of vomiting and nausea was unknown. The reporter did not provide seriousness assessment for the events of mildly unwell and both instances of vomiting and nausea, while the causality was assessed as possibly related to Vivotif, reported as adverse reaction. Additional information received from Med Communications on 05-Apr-2024, included additional reference number (USBAV24-0673).; Reporter's Comments: A male patient of unspecified age felt mildly unwell unknown amount of time after the first dose of Vivotif was administered for an unknown indication. Reportedly, 12 hours after the second dose of Vivotif, the patient become extremely nauseous and vomited. Within 20 minutes of receiving the third dose, the patient vomited and for the next total of five days had severe nausea. Additionally, the patient was unable to take the scheduled fourth dose of Vivotif, however received as reported co-suspect killed typhoid vaccine, which is considered as inappropriate schedule of vaccine administered and interchange of vaccine products. Malaise, nausea and vomiting are listed/expected for Vivotif according to CCDS version 8.0 and USPI, whilst inappropriate schedule of vaccine administered and interchange of vaccine products are listed per company convention. The patient's medical history and concomitant medication details were not provided. At the time of the initial report, the outcome for the events of mildly unwell, an both instances of vomiting and nausea was unknown. Due to plausible temporal relationship and product known safety profile, the causality for reported malaise, nause and vomiting is assessed as related to Vivotif. Inappropriate schedule of vaccine administered and interchange of vaccine products are not related to Vivotif, but to a human factor. The case is non-serious.; Sender's Comments: A male patient of unspecified age felt mildly unwell unknown amount of time after the first dose of Vivotif was administered for an unknown indication. Reportedly, 12 hours after the second dose of Vivotif, the patient become extremely nauseous and vomited. Within 20 minutes of receiving the third dose, the patient vomited and for the next total of five days had severe nausea. Additionally, the patient was unable to take the scheduled fourth dose of Vivotif, however received as reported co-suspect killed typhoid vaccine, which is considered as inappropriate schedule of vaccine administered and interchange of vaccine products. Malaise, nausea and vomiting are listed/expected for Vivotif according to CCDS version 8.0 and USPI, whilst inappropriate schedule of vaccine administered and interchange of vaccine products are listed per company convention. The patient's medical history and concomitant medication details were not provided. At the time of the initial report, the outcome for the events of mildly unwell, an both instances of vomiting and nausea was unknown. Due to plausible temporal relationship and product known safety profile, the causality for reported malaise, nause and vomiting is assessed as related to Vivotif. Inappropriate schedule of vaccine administered and interchange of vaccine products are not related to Vivotif, but to a human factor. The case is non-serious.
Comments: None