Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | PO / MO |
Patient received one dose of Vivotif and felt very nauseated; Patient received first dose of Vivotif which was left out of the fridge for about a week; Patient received first dose of Vivotif which was left out of the fridge for about a week; Case reference number US-BN-2024-002109 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-1448) on 24-Jun-2024 and concerns an 18-year-old male patient. The patient's medical history and concomitant medication were not provided. On 23-Jun-2024, the patient took the first dose of Vivotif (batch number: unknown) at an unknown dose, orally for typhoid immunization. As reported, patient received first dose of Vivotif which was left out of the fridge for about a week (explicitly coded as 'product storage error' and 'product administration error'). On an unspecified date, the patient felt very nauseated. At the time of the initial report, it was unknown if the patient recovered from nauseated. The reporter assessed the event nauseated as non-serious and causality as possible for the event nauseated. No further information was provided.; Reporter's Comments: An 18-year-old male patient felt nauseated within one day after he took the first dose of Vivotif, at an unknown dose, orally for typhoid immunization. Reportedly, the patient received first dose of Vivotif which was left out of the fridge for about a week, and that is considered as product storage error and product administration error. Nausea is listed and expected according to CCDS v8 and USPI while product storage error and product administration error are both considered listed per company conventions. The outcome of event nausea was unknown. The patient's medical history and concomitant medication were not provided. Nausea is assessed as related due to plausible temporal relationship, known product safety profile and since contributory role of suspect product cannot be excluded. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: An 18-year-old male patient felt nauseated within one day after he took the first dose of Vivotif, at an unknown dose, orally for typhoid immunization. Reportedly, the patient received first dose of Vivotif which was left out of the fridge for about a week, and that is considered as product storage error and product administration error. Nausea is listed and expected according to CCDS v8 and USPI while product storage error and product administration error are both considered listed per company conventions. The outcome of event nausea was unknown. The patient's medical history and concomitant medication were not provided. Nausea is assessed as related due to plausible temporal relationship, known product safety profile and since contributory role of suspect product cannot be excluded. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None.