Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | 3003908 | PO / MO |
Patient took first dose of Vivotif this morning but says the package that was left in a hot car for ten minutes prior to bringing into house and leaving on the counter for another hour; Patient took first dose of Vivotif this morning but says the package that was left in a hot car for ten minutes prior to bringing into house and leaving on the counter for another hour; Case reference number US-BN-2024-001965 is a spontaneous case report initially received from a nurse via Med Communication (reference number: USBAV24-1173) on 29-May-2024 and concerns a 31-year-old male patient. The patient's medical history and concomitant medication details were not provided. On 29-May-2024, the patient took the first dose of Vivotif (batch number: 3003908, expiry date: Jun-2024) at an unknown dose, via oral use, for typhoid prophylaxis. As reported, patient took first dose of Vivotif this morning but says the package was left in a hot car for ten minutes prior to bringing into house and leaving on the counter for another hour (explicitly coded as 'product storage error' and 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A 31-year-old male patient took the first dose of Vivotif, after storing it in a hot car and then for an hour indoors (which is considered product storage error and product administration error). No associated adverse events were reported. Product storage error and administration error are listed as per company conventions. No medical information was available. The events are considered not related to Vivotif, but to human error. The case is non-serious.; Sender's Comments: A 31-year-old male patient took the first dose of Vivotif, after storing it in a hot car and then for an hour indoors (which is considered product storage error and product administration error). No associated adverse events were reported. Product storage error and administration error are listed as per company conventions. No medical information was available. The events are considered not related to Vivotif, but to human error. The case is non-serious.
Comments: None.